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Sample records for 500-mg combination tablet

  1. Bioequivalence Comparison of Two Formulations of Fixed-Dose Combination Glimepiride/Metformin (2/500 mg)Tablets in Healthy Volunteers.

    PubMed

    Jung, Sang-Hoon; Chae, Jung-Woo; Song, Byung-Jeong; Kwona, Kwang-Il

    2014-01-01

    Glimepiride/metformin (2/500 mg) is an oral antihyperglycemic agent for the treatment of type 2 diabetes. A generic glimepiride/metformin (2/500 mg) fixed-dose combination (FDC) tablet was developed recently. This study was designed to collect data for submission to Korean regulatory authorities to allow the marketing of the test formulation. We evaluated the comparative bioavailability and tolerability of the test and reference formulations in healthy male adult volunteers. This single-dose, randomized, double-blind, two-way crossover trial was conducted at Bestian Medical Center in Bucheon, Korea. In total, 40 male Korean volunteers were enrolled. The subjects were randomized to receive an FDC tablet containing the glimepiride/metformin (2/500 mg) test or reference formulation, and pharmacokinetic(PK) parameters were measured. After a 1-week washout period, the other formulation was administered and the PK parameters were measured again. The Cmax and AUCt were determined from blood samples obtained at 0, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, and 24 h after drug administration. Bioequivalence was considered established if the 90% CIs of the geometric mean ratios(GMRs) of the test-to-reference formulations for Cmax and AUCt were within the predetermined regulatory range of 80-125%. In total, 40 healthy male subjects were enrolled and completed the study (mean [SD] age, 23.2[2.26]years[range, 19-30years];weight, 68.95[8.30]Kg[range, 52.0-87.0 Kg]; and height, 175.4[5.34] cm[range, 164-189 cm]). The GMRs(90% CI) of the glimepiride Cmax and AUCt were 1.006(0.947-1.069) and 1.010(0.953-1.071), respectively. For metformin, the values were 1.019(0.959-1.083) and 1.035(0.989-1.084), respectively. The test and reference formulations had similar PK parameters. The test formulation of glimepiride/metformin (2/500 mg) FDC tablets met the Korean regulatory criteria for bioequivalence. PMID:25237332

  2. Bioequivalence study of 500 mg cefuroxime axetil film-coated tablets in healthy volunteers.

    PubMed

    Kaza, Michał; Leś, Andrzej; Serafin-Byczak, Krystyna; Ksycińska, Hanna; Rudzki, Piotr J; Gutkowskpi, Piotr; Drewniak, Tomasz; Gutkowska, Anna; Tarasiuk, Andrzej; Piatkowska-Chabuda, Ewa; Skowrońska-Smolak, Małgorzata; Wilkowska, Ewa

    2012-01-01

    The aim of the study was to investigate the bioavailability of a generic product of 500 mg cefuroxime axetil film-coated tablets (test) as compared to that of a branded product (reference) at the same strength to determine bioequivalence and to apply for regulatory approval. The secondary objective of the study was to evaluate tolerability of both products. A double blinded, randomized, crossover, two-period, single-dose, comparative study was conducted in Caucasian healthy volunteers in fasting conditions. A single oral dose administration of the test or reference product was followed by 7-day wash-out period. The cefuroxime concentration was determined using a validated HPLC-UV method. The results of the single-dose study in healthy volunteers indicated that the film-coated tablets of Tarsime 500 mg manufactured by Tarchomińskie Zakłady Farmaceutyczne Polfa S.A. (test product) are bioequivalent to those of Zinnat manufactured by GlaxoSmithKline Export Ltd. (reference product). Both products were well tolerated.

  3. Bioavailability and safety study of resveratrol 500 mg tablets in healthy male and female volunteers

    PubMed Central

    SERGIDES, CHRISTAKIS; CHIRILĂ, MARINELA; SILVESTRO, LUIGI; PITTA, DAPHNE; PITTAS, ANDREAS

    2016-01-01

    Over the past few decades, trans-resveratrol has received widespread attention as a preventive agent for numerous diseases. Several studies have demonstrated that it has significant biological and pharmacological properties. Trans-resveratrol has been reported to possess anti-oxidant, anti-inflammatory, anticarcinogenic, antidiabetic, anti-aging, cardioprotective and neuroprotective properties, which can be relevant in chronic diseases and longevity in humans. The aim of the present study was to investigate the rate and extend of absorption, and also the safety of resveratrol following a single 500 mg oral dose. This was an open label, single dose, one period, bioavailability study in 15 healthy volunteers under fasting conditions. Blood samples were collected at predefined time points up to 24 h after resveratrol administration, and plasma concentrations of resveratrol and its conjugated (glucuronated and sulphated) metabolites were determined using a validated high performance liquid chromatography/tandem mass spectrometry method. Pharmacokinetic parameters, including Cmax, AUC0-t, AUC0-inf, Tmax, T1/2 and MRT, were determined from plasma concentration-time profiles and found to be in good agreement with previously reported data. Cmax and AUC0-inf were lower for resveratrol when compared with the values for its glucuronated and sulphated metabolites. Cmax for resveratrol, glucuronated resveratrol and sulphated resveratrol were 71.2±42.4 ng/ml, 4,083.9±1,704.4 ng/ml and 1,516.0±639.0 ng/ml, respectively, while the AUC0-inf values were 179.1±79.1 ng/ml, 39,732.4±16,145.6 ng/ml and 14,441.7±7,593.2 ng/ml, respectively. No adverse reactions associated with resveratrol were reported during the study. The plasma concentrations of resveratrol (free and conjugated) were in agreement with those mentioned in the literature, and were adequate to promote the pharmacological activities of resveratrol. In conclusion, resveratrol 500 mg tablets were well-tolerated by all

  4. Bioequivalence evaluation of two brands of metformin 500 mg tablets (Dialon & Glucophage)--in healthy human volunteers.

    PubMed

    Najib, Naji; Idkaidek, Nasir; Beshtawi, M; Bader, Mohammed; Admour, Isra'; Alam, S Mahmood; Zaman, Q; Dham, Ruwayda

    2002-10-01

    A randomized, two-way, crossover study was conducted in 24 fasting, healthy, male volunteers to compare the bioavailability of two brands of metformin 500 mg tablets; Dialon (Julphar, UAE) as test and Glucophage (Lipha Pharmaceutical Industries, France) as reference product. The study was performed at the International Pharmaceutical Research Centre (IPRC), in joint venture with Al-Mowasah Hospital, Amman, Jordan. The drug was administered with 240 ml of water after a 10-h overnight fasting on two treatment days separated by 1-week washout period. After dosing, serial blood samples were collected for a period of 30 h. Plasma harvested from blood was analyzed for metformin by validated HPLC method with UV-visible detector capable to detect metformin in the range of 0.05-5.0 microg/ml with limit of quantitation of 0.05 microg/ml. Various pharmacokinetic parameters including AUC(0-t), AUC(0-proportional to), C(max), T(max), T(1/2), and lambda(Z) were determined from plasma concentrations of both formulations and found to be in good agreement with reported values. AUC(0-t), AUC(0-proportional to) and C(max) were tested for bioequivalence after log-transformation of data. No significant difference was found based on ANOVA; 90% confidence interval (97.9-110.8% for AUC(0-t), 97.4-110.7% for AUC(0-proportional to); 95.3-110.5% for C(max)) of test/reference ratio for these parameters were found within bioequivalence acceptance range of 80-125%. Based on these statistical inferences, it was concluded that Dialon is bioequivalent to Glucophage.

  5. A multicentric, open label, randomised, postmarketing efficacy study comparing multidose of lincomycin hydrochloride capsule 500 mg with multidose cefpodoxime proxetil tablet 200 mg in patients with tonsillitis, sinusitis.

    PubMed

    Kothadiya, Ajay

    2012-08-01

    Tonsillitis causes considerable short and medium term morbidity, and can be recurrent. Sinusitis can be acute (less than 4 weeks), subacute (4-8 weeks) or chronic (8 weeks or more). To study the comparative efficacy and safety of multidose treatments of lincomycin hydrochloride 500 mg capsules against cefpodoxime proxetil 200 mg tablets on its outcome in the Indian scenario are the aims and objective of the study. A total of 41 tonsillitis, sinusitis cases of either gender aged above 18 years were enrolled in the study. The diagnosis of sonsillitis, sinusitis was made based on examination of symptoms and throat swab. A randomised treatment of either lincomycin hydrochloride 500 mg capsules or cefpodoxime proxetil 200 mg tablets twice daily for five days alongwith other concomitant medications depending on related symptoms was given to 40 patients. At the end of study, all patients were re-evaluated and the response rate was assessed. The most common clinical symptoms were body temperature, headache, throat pain, postnasal discharge, mucopus, odynophagia, sinus tenderness, nasal congestion, pharyngeal congestion and tonsillar congestion. The overall response rate of lincomycin hydrochloride in all the symptoms except headache was more effective than cefpodoxime proxetil. Out of 100% (n = 20) patients in each group, 67.89% in lincomycin and 52.27% in cefpodoxime patients achieved complete relief, in all the clinical symptoms. The study suggests that lincomycin hydrochloride capsules, a conventional antibiotic indicates effective treatment for relief from tonsillitis and sinusitis, as compared to new third generation antibiotic.

  6. A Phase III Randomized, Double-blind, Parallel-group Study to Evaluate the Efficacy and Safety of Acarmet (Metformin HCl 500 mg Plus Acarbose 50 mg Tablets) Versus Acarbose Alone in Subjects With Type 2 Diabetes Mellitus

    ClinicalTrials.gov

    2010-11-19

    The Objectives of the Study is to Evaluate the Efficacy and Safety of Acarmet (Metformin HCl 500 mg; Plus Acarbose 50 mg Tablets) Thrice Daily Versus Acarbose 50 mg Thrice Daily Over 16 Weeks in; Subjects With Type 2 Diabetes Mellitus.

  7. [Tramadol/acetaminophen combination tablets].

    PubMed

    Yokotsuka, Shoko; Kato, Jitsu

    2013-07-01

    Tramadol/acetaminophen fixed-dose combination tablets (Tramse) combine tramadol, a centrally acting week opioid analgesic, with low-dose acetaminophen. The action of tramadol may be described as a weak agonist at the mu-opioid receptor, inhibition of serotonin reuptake, and inhibition of noradrenaline reuptake. The second component in these tablets, acetaminophen mainly appears to act through central mechanism. Chronic pain may be broadly classified into nociceptive, neuropathic and mixed. Tramset may exert additive or synergic benefits in treating the multiple mechanism of pain. Clinical studies have revealed its efficacy and safety for a variety of pain condition such as chronic low back pain, rheumatoid arthritis, fibromyalgia and painful diabetic peripheral neuropathy. It is expected that Tramset is going to induce pain relief and to improve disturbance of daily life in patients with intractable chronic pain. However overuse of Tramset may induce severe adverse effects such as addiction, abuse and hepatotoxicity. Therefore clinician should continuously assess pain intensity, activity of daily life, mode of its consumption, and adverse effects after prescription. PMID:23905401

  8. Evaluation of efficacy and safety of fixed dose combination of glimepiride 2 mg pluspioglitazone 15 mg plus metformin SR 500 mg in the management of patients with type-2 diabetes mellitus.

    PubMed

    Meshram, D M; Langade, D G; Kinagi, Satish B; Naikwadi, Akram A; Morye, Vinita; Chopra, Dimple

    2005-08-01

    An estimated 25 million Indians currently have diabetes and the projections indicate Indians would be the largest group by the year 2025 AD. An open, phase III, multicentric study was conducted to determine the efficacy and tolerability of the triple drug combination glimepiride 2 mg plus pioglitazone hydrochloride 15 mg plus metformin SR 500 mg for 8 weeks in 101 Indian patients with type 2 diabetes mellitus. The study revealed that the triple drug combination could achieve the recommended goals, recommended by American Diabetic Association, for fasting blood glucose < or = 140 mg/dl and glycosylated haemoglobin (HbA1c) of < or = 8%. After 8 weeks, the mean fasting blood glucose (baseline 189.61) was reduced to 111.68 (41% reduction); the mean glycosylated haemoglobin (baseline 10.32) was significantly reduced to 7.54 (26% reduction). The triple drug combination significantly reduced the levels of triglyceride, low density lipoproteins and total cholesterol. These significant levels were achieved within 8 weeks and all patients tolerated the drug well with no reported case of serious adverse events including hypoglycaemia. There were also no reported drug interactions in the study. Since the decrease in HbA1c was continuous and throughout the study, a further decrease in the HbA1c levels would have been noted since the present trial was designed for a period of 8 weeks. Thus, the present study confirms the efficacy and safety of FDC of the triple drug combination in patients with type 2 diabetes. PMID:16363204

  9. The pharmacokinetic profile of a novel fixed-dose combination tablet of ibuprofen and paracetamol

    PubMed Central

    2010-01-01

    Background Ibuprofen and paracetamol differ in their mode of action and related therapeutic effects, suggesting that combined administration may offer improved analgesia. Reported here are the results of two studies on the pharmacokinetic properties of a novel ibuprofen (200 mg) and paracetamol (500 mg) fixed-dose combination tablet. Methods Both studies were open-label, randomised studies in healthy volunteers: Study 1 was a four-way crossover, single-dose study; Study 2 was a two-way cross-over, repeat-dose study. Results Pharmacokinetic parameters for ibuprofen and paracetamol were similar for the combination and monotherapy tablets (values falling within the 80% to 125% acceptable bioequivalence range) except for the rate of absorption of paracetamol from the combination (tmax), which was significantly faster compared with monotherapy (median difference 10 minutes; p < 0.05). Mean plasma concentrations of both drugs were higher, earlier, following administration of the combination tablet compared with monotherapy. Mean plasma levels at 10 and 20 minutes were 6.64 μg.mL-1 and 16.81 μg.mL-1, respectively, for ibuprofen from the combination, compared with 0.58 μg.mL-1 and 9.00 μg.mL-1, respectively, for monotherapy. For paracetamol, mean plasma levels at 10 and 20 minutes were 5.43 μg.mL-1 and 14.54 μg.mL-1, respectively, for the combination compared with 0.33 μg.mL-1 and 9.19 μg.mL-1, respectively, for monotherapy. The rate of absorption of both ibuprofen and paracetamol was significantly delayed when the combination tablet was administered in the fed versus fasted state; median delay was 25 minutes for ibuprofen (p > 0.05) and 55 minutes for paracetamol (p < 0.001). The pharmacokinetic parameters were comparable irrespective of whether the combination tablet was given twice or three times daily; systemic exposure was, however, approximately 1.4 times greater for both drugs when given three times daily. Conclusions Administration of ibuprofen and

  10. Four treatment failures of pharyngeal gonorrhoea with ceftriaxone (500 mg) or cefotaxime (500 mg), Sweden, 2013 and 2014.

    PubMed

    Golparian, D; Ohlsson, Ak; Janson, H; Lidbrink, P; Richtner, T; Ekelund, O; Fredlund, H; Unemo, M

    2014-07-31

    We describe four cases in Sweden of verified treatment failures of pharyngeal gonorrhoea with ceftriaxone (500 mg; n=3) or cefotaxime (500 mg; n=1) monotherapy. All the ceftriaxone treatment failures were caused by the internationally spreading multidrug-resistant gonococcal NG-MAST genogroup 1407 clone. Increased awareness of treatment failures is crucial particularly when antimicrobial monotherapy is used. Frequent test of cure and appropriate verification/falsification of suspected treatment failures, as well as implementation of recommended dual antimicrobial therapy are imperative.

  11. Activity of Daflon 500 mg on the hemorheological disorders in diabetes.

    PubMed

    Lacombe, C; Lelievre, J C; Bucherer, C; Grimaldi, A

    1989-01-01

    A rheological study was performed on blood samples from 10 insulin-treated diabetics with retinopathy. As part of their treatment, they all received 4 tablets of Daflon 500 mg per day for 30 days. Three complementary rheological criteria were used to characterize blood samples: 1) viscometry, using a Couette viscometer, which produces data on viscosity, shear-thinning, viscoelasticity and tixotropy of blood, 2) aggregametry, using an apparatus based on light reflectometry, using a filtrometer based on the deformations red cells undergo as they pass through narrow pores which produces information on red cell deformability. The main results were: a better red blood cell disaggregability, a decrease in red blood cell aggregation and no change in red blood cell deformability.

  12. The comparative bioavailability of an extended-release niacin and lovastatin fixed dose combination tablet versus extended-release niacin tablet, lovastatin tablet and a combination of extended-release niacin tablet and lovastatin tablet.

    PubMed

    Menon, R; Tolbert, D; Cefali, E

    2007-09-01

    Lovastatin and extended-release (ER) niacin in a fixed dose combination (Advicor) is approved for the treatment of dyslipidemia. Since both drugs are extensively metabolized, this study investigated the bioavailability and pharmacokinetics of their co-administration following single-dose administration. In a 4-way crossover study 40 subjects received: two 1000/20 Advicor tablets (ADV), two 1000 mg niacin ER tablets (NSP), two 20mg lovastatin tablets (Mevacor; MEV), and two niacin ER 1000 mg tablets with two lovastatin 20mg tablets (NSP+MEV). Plasma was assayed for niacin, nicotinuric acid (NUA), lovastatin, lovastatin acid and HMGCoA reductase inhibition. Urine was assayed for niacin and its metabolites, NUA, N-methylnicotinamide and N-methyl-2pyridone-5-carboxamide. Least square mean ratios and 90% confidence intervals for C(max) and AUC((0-t)) were determined for NSP+MEV versus MEV or NSP, ADV versus MEV or NSP, and ADV versus NSP+MEV. Co-administration of niacin and lovastatin did not significantly influence C(max) and AUC((0-t)) of lovastatin, niacin, NUA and total urinary recovery of niacin and metabolites. A 22 to 25% decrease in lovastatin acid C(max) was observed while lovastatin acid AUC((0-t)) was not affected. The HMGCoA reductase inhibition C(max) and AUC((0-t)) were not affected indicating that the difference in lovastatin acid C(max) was not clinically relevant.

  13. Drug evaluation: vildagliptin-metformin single-tablet combination.

    PubMed

    Tahrani, Abd A; Piya, Milan K; Barnett, Anthony H

    2009-02-01

    The single-tablet combination of vildagliptin and metformin addresses key defects of type 2 diabetes for improved glycemic control. By inhibiting the dipeptidyl peptidase-4 (DPP-4) enzyme, vildagliptin raises the levels of the active incretin hormones, glucagon-like peptide 1 and glucose-dependent insulinotropic peptide. This leads to increased synthesis and release of insulin from the pancreatic beta cells and decreased release of glucagon from the pancreatic alpha cells. The combination tablet also contains metformin, which addresses insulin resistance. The complementary mechanisms of action of the two agents in combination have been shown to provide additive and sustained reductions in hemoglobin A(1c) compared with metformin monotherapy. In active-controlled trials, the vildagliptin-metformin combination has been shown to produce equivalent reductions in hemoglobin A(1c) to pioglitazone-metformin and glimepiride-metformin combinations, without significant risk of hypoglycemia and without causing weight gain. In clinical trials, the overall incidence of any adverse event was similar in patients randomized to vildagliptin plus metformin and placebo plus metformin. Available data support the use of vildagliptin in combination with metformin as a promising second-line treatment for the management of type 2 diabetes and this is reflected in the latest UK National Institute for Health and Clinical Excellence draft guideline for consultation on new agents for blood glucose control in type 2 diabetes. PMID:19288260

  14. 75 FR 39025 - Determination That ACTONEL (Risendronate Sodium) Tablets, 75 Milligrams, and ACTONEL WITH CALCIUM...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-07-07

    ...) Tablets, 75 mg, is indicated for the treatment of postmenopausal osteoporosis in men, and Paget's disease... carbonate (copackaged)) Tablets, 35/ 500 mg, is indicated for the treatment of postmenopausal...

  15. The profiling of MDMA tablets: a study of the combination of physical characteristics and organic impurities as sources of information.

    PubMed

    Milliet, Quentin; Weyermann, Céline; Esseiva, Pierre

    2009-05-30

    The profiling of MDMA tablets can be carried out using different sets of characteristics. The first type of measurements performed on MDMA tablets are physical characteristics (i.e. post-tabletting characteristics). They yield preliminary profiling data that may be valuable in a first stage for investigation purposes. However organic impurities (i.e. pre-tabletting characteristics) are generally considered to bring more reliable information, particularly for presentation of evidence in court. This work aimed therefore at evaluating the added value of combining pre-tabletting characteristics and post-tabletting characteristics of seized MDMA tablets. In approximately half of the investigated cases, the post-tabletting links were confirmed with organic impurities analyses. In the remaining cases, post-tabletting batches (post-TBs) were divided in several pre-tabletting batches (pre-TBs), thus supporting the hypothesis that several production batches of MDMA powder (pre-TBs) were used to produce one single post-TB (i.e. tablets having the same shape, diameter, thickness, weight and score; but different organic impurities composition). In view of the obtained results, the hypotheses were discussed through illustrating examples. In conclusion, both sets of characteristics were found relevant alone and combined together. They actually provide distinct information about MDMA illicit production and trafficking.

  16. Evaluation of Rapidly Disintegrating Vaginal Tablets of Tenofovir, Emtricitabine and Their Combination for HIV-1 Prevention

    PubMed Central

    Clark, Meredith R.; Peet, M. Melissa; Davis, Sarah; Doncel, Gustavo F.; Friend, David R.

    2014-01-01

    Vaginal tablets are being developed as an alternative to gels as an inexpensive, discreet dosage form for the administration of microbicides. This work describes the pharmacokinetic (PK) evaluation of rapidly disintegrating vaginal tablets containing tenofovir (TFV, 10 mg), emtricitabine (FTC, 10 mg), and the combination of TFV and FTC (10 mg each) under in vitro and in vivo conditions, and in direct comparison to the clinical TFV 1% gel, a microbicide product in Phase III clinical testing. The PK of TFV and FTC from tablets were also evaluated in female rabbits following intravaginal administration. Direct comparison of a single dose of TFV tablets (intact or predissolved at 10 mg/mL) and TFV 1% gel showed no differences in the vaginal PK of TFV between groups; however systemic bioavailability of TFV was significantly higher from the gel. When rabbits were dosed either once or daily for seven days with intact tablets of TFV, FTC, or the combination of TFV/FTC, vaginal and systemic concentrations of TFV and FTC were unaffected by co-formulation. Moreover, plasma PK parameters were similar following a single dose or seven once-daily doses. Tissue concentrations of TFV and FTC in the cranial vagina 4 h after administration ranged between 104 and 105 ng/g. Concentrations of TFV-diphospate (TFV-DP, the active metabolite) were also high (over 103 ng/g or about 3000 to 6000 fmol/mg) in the cranial vagina 4 h after administration and similar to those measured following administration of TFV 1% gel. These data demonstrate that rapidly disintegrating vaginal tablets may be a suitable topical microbicide dosage form providing similar vaginal TFV PK to that of TFV 1% gel. The data also support co-administration of FTC with TFV in a single vaginal tablet to create a combination microbicide in a simple and inexpensive dosage form. PMID:25494201

  17. Oral levofloxacin 500 mg once daily in the treatment of chronic bacterial prostatitis.

    PubMed

    Naber, K G; Roscher, K; Botto, H; Schaefer, V

    2008-08-01

    The aim of this study was to confirm further the efficacy and safety of levofloxacin in patients with chronic bacterial prostatitis (CBP) in Europe. Men with a history of CBP were enrolled in a prospective, multinational (eight countries), open-label study to receive levofloxacin 500 mg once daily per os (p.o.) for 28 days. Patients were followed for 6 months. A total of 117 patients were treated. Gram-negative bacteria were identified in 57/106 patients (mainly Escherichia coli (n=37)) and Gram-positive bacteria in 60/106 patients (mainly Enterococcus faecalis (n=18) and Staphylococcus epidermidis (n=14)). Among the intention-to-treat population (n=116), the clinical success rate (cured and improved patients) was 92% (95% confidence interval (CI) 84.8-96.5%), 77.4% (95% CI 68.2-84.9%), 66.0% (95% CI 56.2-75.0%) and 61.9% (95% CI 51.9-71.2%) at 5-12 days, 1 month, 3 months and 6 months post treatment. The microbiological eradication rate according to evaluation scheme II was 82/98 (83.7%, 95% CI 74.8-90.4%) at 1 month and the continued eradication rate was 52/57 (91.2%, 95% CI 80.7-97.1%) at 6 months post treatment. Comparison of four classification schemes showed similar results. Thus, the present investigation is suitably comparable in methods and results to previous studies. Levofloxacin was well tolerated. Four patients (3.4%) discontinued therapy due to adverse events and 15 patients (12.8%) experienced at least one adverse event. Levofloxacin 500 mg p.o. once daily for 28 days is clinically and microbiologically effective in the treatment of CBP caused by susceptible pathogens and is well tolerated. PMID:18571904

  18. The combined effect of wet granulation process parameters and dried granule moisture content on tablet quality attributes.

    PubMed

    Gabbott, Ian P; Al Husban, Farhan; Reynolds, Gavin K

    2016-09-01

    A pharmaceutical compound was used to study the effect of batch wet granulation process parameters in combination with the residual moisture content remaining after drying on granule and tablet quality attributes. The effect of three batch wet granulation process parameters was evaluated using a multivariate experimental design, with a novel constrained design space. Batches were characterised for moisture content, granule density, crushing strength, porosity, disintegration time and dissolution. Mechanisms of the effect of the process parameters on the granule and tablet quality attributes are proposed. Water quantity added during granulation showed a significant effect on granule density and tablet dissolution rate. Mixing time showed a significant effect on tablet crushing strength, and mixing speed showed a significant effect on the distribution of tablet crushing strengths obtained. The residual moisture content remaining after granule drying showed a significant effect on tablet crushing strength. The effect of moisture on tablet tensile strength has been reported before, but not in combination with granulation parameters and granule properties, and the impact on tablet dissolution was not assessed. Correlations between the energy input during granulation, the density of granules produced, and the quality attributes of the final tablets were also identified. Understanding the impact of the granulation and drying process parameters on granule and tablet properties provides a basis for process optimisation and scaling. PMID:27016211

  19. The combined effect of wet granulation process parameters and dried granule moisture content on tablet quality attributes.

    PubMed

    Gabbott, Ian P; Al Husban, Farhan; Reynolds, Gavin K

    2016-09-01

    A pharmaceutical compound was used to study the effect of batch wet granulation process parameters in combination with the residual moisture content remaining after drying on granule and tablet quality attributes. The effect of three batch wet granulation process parameters was evaluated using a multivariate experimental design, with a novel constrained design space. Batches were characterised for moisture content, granule density, crushing strength, porosity, disintegration time and dissolution. Mechanisms of the effect of the process parameters on the granule and tablet quality attributes are proposed. Water quantity added during granulation showed a significant effect on granule density and tablet dissolution rate. Mixing time showed a significant effect on tablet crushing strength, and mixing speed showed a significant effect on the distribution of tablet crushing strengths obtained. The residual moisture content remaining after granule drying showed a significant effect on tablet crushing strength. The effect of moisture on tablet tensile strength has been reported before, but not in combination with granulation parameters and granule properties, and the impact on tablet dissolution was not assessed. Correlations between the energy input during granulation, the density of granules produced, and the quality attributes of the final tablets were also identified. Understanding the impact of the granulation and drying process parameters on granule and tablet properties provides a basis for process optimisation and scaling.

  20. Safety and benefits of a tablet combining losartan and hydrochlorothiazide in Japanese diabetic patients with hypertension.

    PubMed

    Kinouchi, Kenichiro; Ichihara, Atsuhiro; Sakoda, Mariyo; Kurauchi-Mito, Asako; Itoh, Hiroshi

    2009-12-01

    This study was conducted to determine the effects of a tablet combining losartan/hydrochlorothiazide (L/HCTZ) in comparison with losartan alone in Japanese diabetic patients with hypertension. Thirty consecutive Japanese diabetic patients with hypertension were randomly assigned to group A, receiving losartan alone for the first 3 months, then L/HCTZ for the next 3 months, or group B, receiving L/HCTZ for the first 3 months, then losartan alone for the next 3 months. Clinical and biological parameters were obtained before, and 3 and 6 months after the start of this study. The decreases in systolic and diastolic blood pressure (BP) during treatment with L/HCTZ were significantly greater than in treatment with losartan alone. Both treatments significantly and similarly decreased urinary albumin excretion, the cardio-ankle vascular index (CAVI) and augmentation index (AI). There was no significant difference in metabolic change during both the mono- and combination pharmacotherapies. The tablet combining L/HCTZ significantly reduced systolic and diastolic BP compared with the losartan monotherapy, and offered benefits similar to losartan monotherapy for albuminuria, arterial stiffness assessed by the CAVI and AI, and metabolic effects. Thus, the L/HCTZ tablet could be a useful drug for Japanese diabetic patients with hypertension. PMID:19763132

  1. Development and Validation of a Dissolution Test for Meloxicam and Pridinol Mesylate from Combined Tablet Formulation

    PubMed Central

    Vignaduzzo, S. E.; Castellano, P. M.; Kaufman, T. S.

    2010-01-01

    The association of meloxicam and pridinol is indicated for treating muscular contractures and low back pain. A dissolution test for the meloxicam-pridinol combined tablet formulation was developed and validated, using a suitable HPLC method for simultaneously quantitating both dissolved drugs. The optimized conditions include the use of USP apparatus 2 at a paddle rotation rate of 75 rpm and 900 ml of 50 mM phosphate buffer (pH= 7.5) as dissolution medium, at 37.0±0.5°. The test, which demonstrated to be robust against small changes in bath temperature, paddle rotation speed and pH of the dissolution medium, was applied to two different brands of tablets; the corresponding dissolution profiles were constructed and both brands showed to dissolve at least 75% of the drugs at the 45 min time point. PMID:20838523

  2. [Antidiabetic fixed-dose combination tablet for the management of type 2 diabetes].

    PubMed

    Sakane, Naoki

    2012-01-01

    How to use oral antidiabetic fixed-dose combination tablet for the management of type 2 diabetes (T2DM)? In addition to diet and exercise, the majority of diabetic patients need drug therapy to achieve optimal glycemic control. Monotherapy with oral antidiabetic agent is the firstline pharmacologic treatment option. However, in order to maintain glycemic control, additional oral antidiabetic agents are often added to monotherapies resulting in dual therapy. Dual therapy can be prescribed as separate pills, or as a single pill containing two agents. Randomized controlled trials of patients requiring dual therapy, have shown fixed-dose combination therapies to have superior efficacy when compared to loose-pills combination therapies. T2DM patients treated with fixed-dose combination therapies may have better adherence, improved satisfaction, and lower direct costs, compared to those treated with loose-pill combination therapies. PMID:22413513

  3. Development of fixed dose combination tablets of aripiprazole plus divalproex sodium and their simultaneous determination using HPLC-UV.

    PubMed

    Ahmed, Zia; Subhan, Fazal; Ahmed, Saba; Abdur Rasheed, Qazi; Ahmed, Sagheer; Shahid, Muhammad; Farooq, Saeed

    2016-09-01

    A vast majority of psychiatric patients are effectively treated with combination of drugs to improve efficacy and adherence, but due to limited research and development in fixed dose combination (FDC) in psychiatry, these products are not commonly available. The aim of this study is to prepare cost effective FDC tablets containing aripiprazole and divalproex sodium. Two batches of fixed dose combination tablets, FDC1 and FDC2, were successfully prepared using wet granulation technique. Furthermore, aripiprazole tablets A1 and A2 and divalproex tablets D1 were also formulated as reference to compare the in vitro availability profile. An accurate and simple isocratic HPLC method was established and validated for the simultaneous quantification of aripiprazole and valproic acid in the FDC tablets. A reversed-phase C18 (250 × 4.6 mm) column in isocratic mode was used. The mobile phase consisted of acetonitrile and 0.32% KH2PO4 (60:40, v/v), flow rate was set at 1.0 mL/min and the detection was performed at 210 nm. Average percent recoveries of aripiprazole and valproic acid were 96.0 and 95.5%, respectively, meeting the official requirements. The newly developed FDC product may be used for the better therapeutic outcomes of combined use of aripiprazole and valproic acid, which may improve patient adherence. PMID:26727505

  4. In vitro Evaluation of the Effect of Combination of Hydrophilic and Hydrophobic Polymers on Controlled Release Zidovudine Matrix Tablets.

    PubMed

    Ganesh, S; Radhakrishnan, M; Ravi, M; Prasannakumar, B; Kalyani, J

    2008-01-01

    The aim of the present study was to prepare and characterize controlled-release matrix tablets of zidovudine using hydrophilic HPMC K4 M or Carbopol 934 alone or in combination with hydrophobic ethyl cellulose. Release kinetics was evaluated by using USP XXIV dissolution apparatus No.2 (paddle) type. Scanning electron microscopy was used to visualize the effect of dissolution medium on matrix tablet surface. The in vitro results of controlled - release zidovudine tablets were compared with conventional marketed tablet Zidovir. The in vitro drug release study revealed that HPMC K4 M or Carbopol 934 preparation was able to sustain the drug release near to 6 hours. Combining HPMC K4 M or Carbopol 934 with ethyl cellulose sustained the drug release for nearly 12 h. The in vitro evaluation showed that the drug release may be by diffusion along with erosion. Results suggest that the developed controlled-release tablets of zidovudine could perform therapeutically better than marketed dosage forms, leading to improve efficacy, controlling the release and better patient compliance. PMID:20046771

  5. A stable fixed-dose combination tablet of pseudoephedrine and KOB extracts for the extended release.

    PubMed

    Hwang, C-J; Park, M-H; Jung, H-W; Park, Y-K; Kim, Y-H; Kang, J-S; Cho, C-W

    2013-11-01

    Allergic rhinitis (AR) is characterized by inflammation of the nasal mucosa with hypersensitivity resulting from seasonal or perennial responses to specific environmental allergens and by symptoms like nasal rubbing, sneezing, rhinorrhea, lacrimation, nasal congestion and obstruction, and less frequently cough. KOB extracts, which is a polyherbal medicine consisting of 5 different herbs (Atractylodes macrocephala, Astragalus membranaceus, Saposhnikovia divaricata, Ostericum koreanum and Scutellaria baicalensis) had commonly been used for the treatment of various allergic diseases showed an anti-allergic effect by modulating mast cell-mediated allergic responses in allergic rhinitis, recently. On the other hand, pseudoephedrine is a sympathomimetic amine commonly used to relieve congestion in patients with allergic rhinitis and common colds. Considering the KOB's therapeutic mechanism, the combination with pseudoephedrine would be suitable for allergic rhinitis. This study is to obtain an effective extended release formulation using pseudoephedrine and KOB extracts to reduce side effects of drug due to repeated dosing and improve the compliance of patients for treatment of rhinitis and nasal decongestion. So, the fixed-dose combination tablet of pseudoephedrine and KOB extracts was prepared by direct compression and characterized by drug content, flowing characteristics and dissolution test. The drug content of baicalin of KOB extracts was within the range of 95-105% except for T1 formulation. The hardness and friability values of all formulations ranged from 9 to 13 kp and less than 1%, respectively. Taken together, T4 or T8 could be a stable fixed-dose combination tablet for extended release of pseudoephedrine and KOB extracts for nasal rhinitis.

  6. Novel levocetirizine HCl tablets with enhanced palatability: synergistic effect of combining taste modifiers and effervescence technique

    PubMed Central

    Labib, Gihan S

    2015-01-01

    Objectives Levocetirizine HCl, a second-generation piperazine derivative and H1-selective antihistaminic agent, possesses few side effects. The first objective of the study was to compare and evaluate the taste-masking effect of different ratios of 2-hydroxypropyl-β-cyclodextrin and mannitol on levocetirizine HCl using an inclusion complex and solid dispersion, respectively. The second objective was to study the possibility of preparing and evaluating effervescent tablets from the best-chosen taste-masked blends for the purpose of their use either as orodispersible tablets or as water-soluble effervescent tablets, according to patients’ will. Materials and methods Prepared taste-masked blends were prepared and subjected to palatability, Fourier-transform infrared spectroscopy, and differential scanning calorimetry studies. Tablets containing different percentages of effervescent mixtures were prepared by direct compression on the selected taste-modified blends. Evaluation tests were conducted, including flowability and compressibility on the precompressed blends and hardness, friability, wetting time, effervescent time, in vitro, in vivo disintegration time, and in vitro dissolution study on the compressed tablets. Formulated tablets were evaluated and compared to marketed orodispersible tablets for mouth feel and palatability. Results All prepared tablets showed convenient physical and palatability properties compared to the selected brand. The in vitro drug-release study revealed fast release of levocetirizine HCl within 5 minutes from all prepared tablets. Conclusion Levocetirizine HCl effervescent tablets are likely to increase patient compliance with drug administration. Moreover, the use of these effervescent tablets in an orodispersible dosage form can improve oral drug bioavailability and act as an attractive pediatric dosage form. PMID:26379426

  7. Development of a novel combination tablet containing trimebutine maleate and mosapride citrate for the treatment of functional dyspepsia.

    PubMed

    Cho, Kwan Hyung; Choi, Young Keun; Kang, Jun Heok; Choi, Han-Gon; Yong, Chul Soon; Park, Young-Joon

    2010-11-15

    To develop a novel combination tablet which contained 100 mg trimebutine maleate and 5 mg mosapride citrate (TMCT) for the treatment of functional dyspepsia, the wet granulation method was used to prepare TMCTs with various amounts of diluents and stabilizers. The levels of impurities, the stability and the dissolution of the TMCTs were investigated. The oral bioavailability of drugs in the TMCTs was then evaluated and compared to the simultaneous oral administration of trimebutine maleate-loaded and mosapride citrate-loaded commercial products in the beagle dog. Among the diluents tested, D-mannitol was selected, since the microcrystalline cellulose and lactose did not inhibit the production of drug impurities due to their hygroscopic properties and chemical interactions, respectively. Furthermore, succinic acid was selected as the stabilizer because it gave the lowest level of total drug impurities of the organic acids tested. The combination tablet of trimebutine maleate and mosapride citrate prepared with D-mannitol and succinic acid gave a total drug content higher than 95% and total impurities lower than 0.5% at 25°C/60% RH and 40°C/75% RH during a 6-month period, indicating that the tablets were stable for at least 6 months. Furthermore, this combination tablet showed a similar dissolution to the trimebutine maleate-loaded and mosapride citrate-loaded commercial products and gave insignificantly different absorption compared to these commercial products in beagle dogs. Thus, the combination tablet of trimebutine maleate and mosapride citrate prepared with D-mannitol and succinic acid would be a stable and effective oral pharmaceutical product for the treatment of functional dyspepsia. PMID:20826201

  8. Combination effect of physical and gustatory taste masking for propiverine hydrochloride orally disintegrating tablets on palatability.

    PubMed

    Matsui, Rakan; Uchida, Shinya; Namiki, Noriyuki

    2015-01-01

    Orally disintegrating tablets (ODTs) containing propiverine hydrochloride (which is extremely bitter and leaves a feeling of numbness in the mouth) were prepared with a combined use of physical and organoleptic taste masking. Propiverine-loaded masking particles (PLMPs) were prepared with different amounts of gastric-soluble coatings as physical masking. ODTs without organoleptic masking were prepared by mixing each group of PLMPs with Ludiflash®, crospovidone, and magnesium stearate. ODTs with organoleptic masking were also prepared by addition of L-menthol, aspartame, thaumatin, and cinnamon. Fifteen-minute dissolution of propiverine in solutions with pH 1.2 was ≥ 85% for all ODTs, whereas that in pH 6.8 solutions was ≤ 85% and increased with physical masking. A single blind randomized crossover trial was conducted. Ten healthy volunteers were asked to quantify the bitterness, numbness, and overall palatability using a 100-mm visual analog scale (VAS) at the period of disintegration as well as 1 and 5 min later. VAS scores of bitterness, numbness, and overall palatability improved along with increasing amounts of physical masking, and the effects persisted for 5 min. VAS scores for numbness increased over time regardless of the amount of physical masking. Bitterness, numbness, and overall palatability were significantly improved by organoleptic masking if the amount of physical masking was small. Combined use of physical and organoleptic masking is useful for improving palatability of ODTs containing propiverine. PMID:25744453

  9. Combination effect of physical and gustatory taste masking for propiverine hydrochloride orally disintegrating tablets on palatability.

    PubMed

    Matsui, Rakan; Uchida, Shinya; Namiki, Noriyuki

    2015-01-01

    Orally disintegrating tablets (ODTs) containing propiverine hydrochloride (which is extremely bitter and leaves a feeling of numbness in the mouth) were prepared with a combined use of physical and organoleptic taste masking. Propiverine-loaded masking particles (PLMPs) were prepared with different amounts of gastric-soluble coatings as physical masking. ODTs without organoleptic masking were prepared by mixing each group of PLMPs with Ludiflash®, crospovidone, and magnesium stearate. ODTs with organoleptic masking were also prepared by addition of L-menthol, aspartame, thaumatin, and cinnamon. Fifteen-minute dissolution of propiverine in solutions with pH 1.2 was ≥ 85% for all ODTs, whereas that in pH 6.8 solutions was ≤ 85% and increased with physical masking. A single blind randomized crossover trial was conducted. Ten healthy volunteers were asked to quantify the bitterness, numbness, and overall palatability using a 100-mm visual analog scale (VAS) at the period of disintegration as well as 1 and 5 min later. VAS scores of bitterness, numbness, and overall palatability improved along with increasing amounts of physical masking, and the effects persisted for 5 min. VAS scores for numbness increased over time regardless of the amount of physical masking. Bitterness, numbness, and overall palatability were significantly improved by organoleptic masking if the amount of physical masking was small. Combined use of physical and organoleptic masking is useful for improving palatability of ODTs containing propiverine.

  10. Combined Fourier-transform infrared imaging and desorption electrospray-ionization linear ion-trap mass spectrometry for analysis of counterfeit antimalarial tablets.

    PubMed

    Ricci, Camilla; Nyadong, Leonard; Fernandez, Facundo M; Newton, Paul N; Kazarian, Sergei G

    2007-01-01

    This paper reports use of a combination of Fourier-transform infrared (FTIR) spectroscopic imaging and desorption electrospray ionization linear ion-trap mass spectrometry (DESI MS) for characterization of counterfeit pharmaceutical tablets. The counterfeit artesunate antimalarial tablets were analyzed by both techniques. The results obtained revealed the ability of FTIR imaging in non-destructive micro-attenuated total reflection (ATR) mode to detect the distribution of all components in the tablet, the identities of which were confirmed by DESI MS. Chemical images of the tablets were obtained with high spatial resolution. The FTIR spectroscopic imaging method affords inherent chemical specificity with rapid acquisition of data. DESI MS enables high-sensitivity detection of trace organic compounds. Combination of these two orthogonal surface-characterization methods has great potential for detection and analysis of counterfeit tablets in the open air and without sample preparation.

  11. Fast Disintegrating Combination Tablet of Taste Masked Levocetrizine Dihydrochloride and Montelukast Sodium: Formulation Design, Development, and Characterization.

    PubMed

    Gupta, M M; Gupta, Niraj; Chauhan, Bhupendra S; Pandey, Shweta

    2014-01-01

    The aim of this study was to prepare fast disintegrating combination tablet of taste masked Levocetrizine dihydrochloride and Montelukast sodium by using direct compression method. To prevent bitter taste and unacceptable odour of the Levocetrizine dihydrochloride drug, the drug was taste masked with ion exchange resins like Kyron-T-104 and Tulsion-412. Among the two resins, Kyron-T-104 was selected for further studies because of high drug loading capacity, low cost, and better drug release profile. An ion exchange resin complex was prepared by the batch technique and various parameters; namely, resin activation, drug: resin ratio, pH, temperature, and stirring time, and swelling time were optimized to successfully formulate the tasteless drug resin complex (DRC). The tablets were prepared using microcrystalline cellulose (MCC) PH 102 as diluent along with crospovidone (CP), croscarmellose sodium (CCM), and sodium starch glycolate (SSG) as a superdisintegrants. The tablets were evaluated for weight variation, hardness, friability, wetting time, water absorption ratio, disintegration time (DT), and dissolution study and it was concluded that the tablet formulation prepared with 2% SSG + CCS showed better disintegration time in comparison with other formulation and good drug release. The stability studies were carried out for the optimized batch for three months and it showed acceptable results. PMID:26556198

  12. One confirmed and one suspected case of pharyngeal gonorrhoea treatment failure following 500mg ceftriaxone in Sydney, Australia.

    PubMed

    Read, Phillip J; Limnios, E Athena; McNulty, Anna; Whiley, David; Lahra, Monica M

    2013-11-01

    Emerging antimicrobial resistance within Neisseria gonorrhoeae (NG) is a significant global public health threat. Detection and investigation of treatment failures is a crucial component of the World Health Organisation's response to this challenge. We report the cases of two homosexual men, both treated for pharyngeal NG with 500mg intramuscular ceftriaxone, in whom a test of cure 1 week after treatment showed persisting infection. Both men denied further sexual activity. In the first case, treatment failure was confirmed, since the isolates before and after treatment were identical by auxotype, antibiogram, multilocus sequence type (MLST) and multi-antigen sequence type (NG-MAST). In the second case, the MLSTs before and after treatment were identical, but NG-MAST results were similar but not indistinguishable. These cases underline the importance of test-of-cure and molecular investigations in identifying treatment failure, but also highlight the complexity of distinguishing treatment failure from reinfection when relying on highly variable molecular targets that may be subject to drug pressure.

  13. The rationale for recommending fixed-dose combination tablets for treatment of tuberculosis.

    PubMed Central

    Blomberg, B.; Spinaci, S.; Fourie, B.; Laing, R.

    2001-01-01

    There is considerable exigency to take all necessary steps to cure tuberculosis cases and prevent further emergence of drug-resistant tuberculosis. The most important of these steps is to ensure that the treatment, particularly of sputum smear-positive cases, is adequate and that patients adhere to their treatment by supervised, direct observation of drug-taking according to the standardized regimens. Use of fixed-dose combinations (FDCs) of tablets against tuberculosis is now being recommended by WHO and the International Union Against Tuberculosis and Lung Disease (IUATLD) as an additional step to ensuring proper treatment. FDCs simplify the prescription of drugs and the management of drug supply, and may also limit the risk of drug-resistant tuberculosis arising as a result of inappropriate drug selection and monotherapy. Only FDCs of proven quality and proven rifampicin bioavailability should be purchased and used. In most situations, blood levels of the drugs are inadequate because of poor drug quality rather than poor absorption. This is true irrespective of the human immunodeficiency virus (HIV) infection status of the tuberculosis patients (other than those with overt acquired immunodeficiency syndrome, with CD4 counts < 200 cells/mm3). Currently, WHO, IUATLD and their partners are developing strategies for ensuring that only quality FDCs are used in tuberculosis programmes. A simplified and effective protocol for assessment of rifampicin bioavailability has been developed, and laboratories are being recruited to form a supranational network for quality assurance of FDCs. Standardization of FDC drug formulations has been proposed, which limits rifampicin-containing preparations to nine (including a four-drug FDC and three paediatric FDCs). PMID:11217670

  14. The advantages of combination therapy on hypertension: development of immediate release perindopril-indapamide tablet and assessment of bioequivalence studies.

    PubMed

    Ölçer, A; Ölçer, M; İnce, I; Karasulu, E

    2016-03-01

    Hypertension has a major associated risk for organ damage and mortality, which is further heightened in patients with prior cardiovascular events, comorbid diabetes mellitus, microalbuminuria and renal impairment. Convers Plus tablet including perindopril erbumine (PE), which is an angiotensin converting enzyme (ACE) inhibitor, and indapamide, which is diuretic, was designed as a combined tablet to succes in the treatment of hypertension. Physico-pharmaceutical properties and characterization studies were evaluated in vitro conditions. Later on in vivo study was planned as a cross-designed, randomized, open-labeled, single-dose, single-center study via peroral route in 24 healthy male subjects. In this study, bioequivalence with primary pharmacokinetical target parameters reference (Bipreterax 4/1.25 mg Tablet-S.A.Servier Benelux N.V.) and test (Convers Plus 4/1.25 mg Tablet-ARGESAN Pharmaceutical Company) tablets have been found bioequivalent. The results of pharmacokinetic parameters for perindopril, perindoprilat and indapamide were found as Cmax = 23.179 µg/mL, tmax = 0.729 h, t1/2 = 1.429 h; AUC0-t = 26.998 µgs/mL, AUC0-inf = 27.117 µgs/mL; Cmax = 1.834 µg/mL, tmax = 8.792 h, t1/2 = 40.699 h; AUC0-t = 54.828 µgs/mL, AUC0-inf = 77.113 µgs/mL; Cmax = 18.994 µg/mL, tmax = 3.417 h, t1/2 = 16.626 h and AUC0-t = 385.829 µgs/mL, AUC0-inf = 410.728 µgs/mL respectively. In conclusion, physico-pharmaceutical properties and results of clinical trials show that Convers Plus tablets have been found as bioequivalent for perindopril, perindoprilat and indapamide in terms of AUC and Cmax, in 90% confidence limits. PMID:26794937

  15. Roller compaction of hydrophilic extended release tablets-combined effects of processing variables and drug/matrix former particle size.

    PubMed

    Heiman, Johanna; Tajarobi, Farhad; Gururajan, Bindhumadhavan; Juppo, Anne; Abrahmsén-Alami, Susanna

    2015-04-01

    The present study shows that roller compaction (RC) can successfully be used as a granulation method to prepare hydroxypropyl methylcellulose (HPMC)-based extended release matrix tablets containing a high drug load, both for materials deforming mainly by fragmentation (paracetamol) as for those having mainly plastic deformation (ibuprofen). The combined effect of RC process variables and composition on the manufacturability of HPMC tablets was investigated. Standard wet granulation grade HPMC was compared with a larger particle size direct compressible HPMC grade. Higher roll pressure was found to result in larger paracetamol granules and narrower granule particle size distributions, especially for formulations containing smaller size HPMC. However, for ibuprofen, no clear effect of roll pressure was observed. High roll pressure also resulted in denser ribbon and less bypass fines during RC. Loss of compactibility was observed for granules compared to powder blends, which was found to be related to differences in granule porosity and morphology. Using the large-sized HPMC grade did in some cases result in lower tensile strength tablets but had the advantage to improve the powder flow into the roller compactor. This work also indicates that when the HPMC level lies near the percolation threshold, significant changes can occur in the drug release rate due to changes in other factors (raw material characteristics and processing). PMID:25273028

  16. Roller compaction of hydrophilic extended release tablets-combined effects of processing variables and drug/matrix former particle size.

    PubMed

    Heiman, Johanna; Tajarobi, Farhad; Gururajan, Bindhumadhavan; Juppo, Anne; Abrahmsén-Alami, Susanna

    2015-04-01

    The present study shows that roller compaction (RC) can successfully be used as a granulation method to prepare hydroxypropyl methylcellulose (HPMC)-based extended release matrix tablets containing a high drug load, both for materials deforming mainly by fragmentation (paracetamol) as for those having mainly plastic deformation (ibuprofen). The combined effect of RC process variables and composition on the manufacturability of HPMC tablets was investigated. Standard wet granulation grade HPMC was compared with a larger particle size direct compressible HPMC grade. Higher roll pressure was found to result in larger paracetamol granules and narrower granule particle size distributions, especially for formulations containing smaller size HPMC. However, for ibuprofen, no clear effect of roll pressure was observed. High roll pressure also resulted in denser ribbon and less bypass fines during RC. Loss of compactibility was observed for granules compared to powder blends, which was found to be related to differences in granule porosity and morphology. Using the large-sized HPMC grade did in some cases result in lower tensile strength tablets but had the advantage to improve the powder flow into the roller compactor. This work also indicates that when the HPMC level lies near the percolation threshold, significant changes can occur in the drug release rate due to changes in other factors (raw material characteristics and processing).

  17. Floating tablets for controlled release of ofloxacin via compression coating of hydroxypropyl cellulose combined with effervescent agent.

    PubMed

    Qi, Xiaole; Chen, Haiyan; Rui, Yao; Yang, Fengjiao; Ma, Ning; Wu, Zhenghong

    2015-07-15

    To prolong the residence time of dosage forms within gastrointestinal trace until all drug released at desired rate was one of the real challenges for oral controlled-release drug delivery system. Herein, we developed a fine floating tablet via compression coating of hydrophilic polymer (hydroxypropyl cellulose) combined with effervescent agent (sodium bicarbonate) to achieve simultaneous control of release rate and location of ofloxacin. Sodium alginate was also added in the coating layer to regulate the drug release rate. The effects of the weight ratio of drug and the viscosity of HPC on the release profile were investigated. The optimized formulations were found to immediately float within 30s and remain lastingly buoyant over a period of 12 h in simulated gastric fluid (SGF, pH 1.2) without pepsin, indicating a satisfactory floating and zero-order drug release profile. In addition, the oral bioavailability experiment in New Zealand rabbits showed that, the relative bioavailability of the ofloxacin after administrated of floating tablets was 172.19%, compared to marketed common release tablets TaiLiBiTuo(®). These results demonstrated that those controlled-released floating tables would be a promising gastro-retentive delivery system for drugs acting in stomach.

  18. COMPARATIVE BIOAVAILABILITY OF A FIXED-DOSE COMBINATION TABLET OF OLMESARTAN MEDOXOMIL/HYDROCHLOROTHIAZIDE IN HEALTHY KOREAN VOLUNTEERS.

    PubMed

    Zheng, Renhua; Hwang, Ho Min; Kim, Bo-Hyung

    2016-01-01

    Combination therapy with diuretics and angiotensin II type 1 (AT1) receptor antagonist is frequently recommended for the control of blood pressure in hypertensive patients. This study was targeted to compare pharmacokinetic profiles of a new generic fixed-dose combination (FDC) tablet of olmesartan medoxomil/hydrochlorothiazide 20/12.5 mg and a reference formulation of Olmetec Plus 20/12.5 mg tablets in healthy volunteers. The study design was a randomized sequence and two-way crossover study in healthy subjects. They were to be randomly assigned to either one of the two sequence groups; each subject sequentially received a single oral dose of reference and test tablet with 7-day washout period. Blood sample was collected at pre-dose and at 0.33, 0.67, 1, 1.33, 1.67, 2, 2.5, 3, 4, 6, 8, 12, 24, 36 and 48 h post-dose. The blood concentrations were analyzed by LC-MS/MS. Both of the 90% CI for the treatment ratios (test/reference) of C(max) and AUC(last) were to be in the range of 0.800-1.250 with regards to olmesartan medoxomil and hydrochlorothiazide; the geometric mean ratios (test/reference) for olmesartan C(max) and AUC(last) were 0.979 (90% CI, 0.934-1.027) and 0.992 (0.946-1.041), respectively, and those for hydrochlorothiazide C(max) and AUC(last) were 0.966 (0.975-1.110) and 0.999 (0.963-1.038), respectively. No serious adverse events were reported during the study. The generic formulation of olmesartan medoxomil/hydrochlorothiazide 20/12.5 mg tablet was bioequivalent with the reference formulation of Olmetec Plus 20/12.5 mg tablet in regards to the pharmacokinetic parameters of olmesartan medoxomil and hydrochlorothiazide. Clinical Research Information Service (CRIS) Registration Number: KCT0001025. (https://cris.nih.go.kr/ Mar 18, 2014)

  19. Formulation and in vitro, in vivo evaluation of extended- release matrix tablet of zidovudine: influence of combination of hydrophilic and hydrophobic matrix formers.

    PubMed

    Kuksal, Atul; Tiwary, Ashok K; Jain, Narendra K; Jain, Subheet

    2006-01-01

    The aim of the present study was to prepare and characterize extended-release matrix tablets of zidovudine using hydrophilic Eudragit RLPO and RSPO alone or their combination with hydrophobic ethyl cellulose. Release kinetics was evaluated by using United States Pharmacopeia (USP)-22 type I dissolution apparatus. Scanning electron microscopy was used to visualize the effect of dissolution medium on matrix tablet surface. Furthermore, the in vitro and in vivo newly formulated sustained-release zidovudine tablets were compared with conventional marketed tablet (Zidovir, Cipla Ltd, Mumbai, India). The in-vitro drug release study revealed that either Eudragit preparation was able to sustain the drug release only for 6 hours (94.3% +/- 4.5% release). Combining Eudragit with ethyl cellulose sustained the drug release for 12 hours (88.1% +/- 4.1% release). Fitting the in vitro drug release data to Korsmeyer equation indicated that diffusion along with erosion could be the mechanism of drug release. In vivo investigation in rabbits showed sustained-release pharmacokinetic profile of zidovudine from the matrix tablets formulated using combination of Eudragits and ethylcellulose. In conclusion, the results suggest that the developed sustained-release tablets of zidovudine could perform therapeutically better than conventional dosage forms, leading to improve efficacy and better patient compliance. PMID:16584139

  20. Fulvestrant 500 mg versus anastrozole 1 mg for the first-line treatment of advanced breast cancer: follow-up analysis from the randomized 'FIRST' study.

    PubMed

    Robertson, John F R; Lindemann, Justin P O; Llombart-Cussac, Antonio; Rolski, Janusz; Feltl, David; Dewar, John; Emerson, Laura; Dean, Andrew; Ellis, Matthew J

    2012-11-01

    Fulvestrant fIRst-line Study comparing endocrine Treatments is a phase II, randomized, open-label study comparing fulvestrant 500 mg with anastrozole 1 mg as first-line endocrine therapy for postmenopausal women with hormone receptor-positive (HR+) advanced breast cancer. At data cut-off, only 36 % of patients had progressed and the median time to progression (TTP) had not been reached for fulvestrant. Here, we report follow-up data for TTP for fulvestrant 500 mg versus anastrozole 1 mg. Key inclusion criteria were postmenopausal women with estrogen receptor-positive and/or progesterone receptor-positive locally advanced or metastatic breast cancer and no prior endocrine therapy. Key exclusion criteria were presence of life-threatening metastases and prior treatment with a non-approved drug. Fulvestrant was administered 500 mg/month plus 500 mg on day 14 of month 1; anastrozole was administered 1 mg/day. TTP was defined by modified Response Evaluation Criteria in Solid Tumors v1.0 before data cut-off for the primary analysis, and investigator opinion after data cut-off. Best overall response to subsequent therapy and serious adverse events are also reported. In total, 205 patients received fulvestrant 500 mg (n = 102) or anastrozole (n = 103). Follow-up analysis was performed when 79.5 % of patients had discontinued study treatment. Median TTP was 23.4 months for fulvestrant versus 13.1 months for anastrozole; a 34 % reduction in risk of progression (hazard ratio 0.66; 95 % confidence interval: 0.47, 0.92; P = 0.01). Best overall response to subsequent therapy and clinical benefit rate for subsequent endocrine therapy was similar between the treatment groups. No new safety concerns for fulvestrant 500 mg were documented. These longer-term, follow-up results confirm efficacy benefit for fulvestrant 500 mg versus anastrozole as first-line endocrine therapy for HR+ advanced breast cancer in terms of TTP, and, importantly, show similar best overall response rates to

  1. Fulvestrant 500 mg Versus Anastrozole 1 mg for the First-Line Treatment of Advanced Breast Cancer: Overall Survival Analysis From the Phase II FIRST Study

    PubMed Central

    Ellis, Matthew J.; Llombart-Cussac, Antonio; Feltl, David; Dewar, John A.; Jasiówka, Marek; Hewson, Nicola; Rukazenkov, Yuri; Robertson, John F.R.

    2015-01-01

    Purpose To compare overall survival (OS) for fulvestrant 500 mg versus anastrozole as first-line endocrine therapy for advanced breast cancer. Patients and Methods The Fulvestrant First-Line Study Comparing Endocrine Treatments (FIRST) was a phase II, randomized, open-label, multicenter trial. Postmenopausal women with estrogen receptor–positive, locally advanced/metastatic breast cancer who had no previous therapy for advanced disease received either fulvestrant 500 mg (days 0, 14, 28, and every 28 days thereafter) or anastrozole 1 mg (daily). The primary end point (clinical benefit rate [72.5% and 67.0%]) and a follow-up analysis (median time to progression [23.4 months and 13.1 months]) have been reported previously for fulvestrant 500 mg and anastrozole, respectively. Subsequently, the protocol was amended to assess OS by unadjusted log-rank test after approximately 65% of patients had died. Treatment effect on OS across several subgroups was examined. Tolerability was evaluated by adverse event monitoring. Results In total, 205 patients were randomly assigned (fulvestrant 500 mg, n = 102; anastrozole, n = 103). At data cutoff, 61.8% (fulvestrant 500 mg, n = 63) and 71.8% (anastrozole, n = 74) had died. The hazard ratio (95% CI) for OS with fulvestrant 500 mg versus anastrozole was 0.70 (0.50 to 0.98; P = .04; median OS, 54.1 months v 48.4 months). Treatment effects seemed generally consistent across the subgroups analyzed. No new safety issues were observed. Conclusion There are several limitations of this OS analysis, including that it was not planned in the original protocol but instead was added after time-to-progression results were analyzed, and that not all patients participated in additional OS follow-up. However, the present results suggest fulvestrant 500 mg extends OS versus anastrozole. This finding now awaits prospective confirmation in the larger phase III FALCON (Fulvestrant and Anastrozole Compared in Hormonal Therapy Naïve Advanced Breast

  2. Design and in vitro evaluation of novel sustained- release matrix tablets for lornoxicam based on the combination of hydrophilic matrix formers and basic pH-modifiers.

    PubMed

    Hamza, Yassin El-Said; Aburahma, Mona Hassan

    2010-01-01

    The short half-life of lornoxicam, a potent non-steroidal anti-inflammatory drug, makes the development of sustained-release (SR) forms extremely advantageous. However, due to its weak acidic nature, its release from SR delivery systems is limited to the lower gastrointestinal tract which consequently leads to a delayed onset of its analgesic action. Accordingly, the aim of this study was to develop lornoxicam SR matrix tablets that provide complete drug release that starts in the stomach to rapidly alleviate the painful symptoms and continues in the intestine to maintain protracted analgesic effect as well as meets the reported SR specifications. The proposed strategy was based on preparing directly compressed hydroxypropylmethylcellulose matrix tablets to sustain lornoxicam release. Basic pH-modifiers, either sodium bicarbonate or magnesium oxide, were incorporated into these matrix tablets to create basic micro-environmental pH inside the tablets favorable to drug release in acidic conditions. All the prepared matrix tablets containing basic pH-modifiers showed acceptable physical properties before and after storage. Release studies, performed in simulated gastric and intestinal fluids used in sequence to mimic the GI transit, demonstrate the possibility of sustaining lornoxicam release by combining hydrophilic matrix formers and basic pH-Modifiers to prepare tablets that meet the reported sustained-release specifications. PMID:19895367

  3. A new derivative detected in accelerated ageing of artesunate-amodiaquine fixed dose combination tablets.

    PubMed

    Charrier, Cedric; Bertho, Gildas; Petigny, Olivier; Moneton, Philippe; Azerad, Robert

    2013-01-01

    An unknown impurity detected in small amounts during the heat treatment of artesunate-amodiaquine bilayer tablets was purified by semipreparative HPLC and identified by MS and NMR as the tetrahydrofuranyl acetate-rearranged derivative of anhydrodihydroartemisinin. When anhydrodihydroartemisinin was treated with a Fe(II) salt in acetonitrile-water solution, the same product was generated, together with an isomeric 2-deoxy-4α-hydroxy-anhydrodihydroartemisinin derivative, as expected from the usual homolytic radical opening of the endoperoxide bond previously described for other artemisinin derivatives.

  4. Micellar liquid chromatographic method for the simultaneous determination of Levofloxacin and Ambroxol in combined tablets: Application to biological fluids

    PubMed Central

    2013-01-01

    Background Levofloxacin hemihydrate (LEV) and ambroxol HCl (AMB) are available for the treatment of upper and lower respiratory tract infections. A survey of the literature reveals that two reversed phase HPLC methods were e reported for the simultaneous determination of LEV and AMB in pharmaceutical preparations. However the reported methods suffers from the low sensitivity, no application of the method in the combined tablets and no application to biological fluids. Also the toxic effects of the used solvents which are harmful to human beings. For this reason, our target was to develop a simple sensitive, less hazardous micellar HPLC method for the simultaneous determination of LEV and AMB in their combined dosage forms and plasma. Results The method showed good linearity over the ranges of 1–44 μg/mL and 1–20 μg/mL with limits of detection 0.26 and 0.07 μg/mL and limits of quantification 0.80 and 0.20 μg/mL for LEV and AMB, respectively. The method was further extended to the determination of LEV in spiked human plasma with mean percentage recoveries of 100.10% ± 1.14 as well as determination of LEV in real human plasma without prior extraction. Statistical evaluation of the data was performed according to ICH Guidelines. Conclusion The suggested method was successfully applied for the simultaneous analysis of the studied drugs in their co-formulated tablets and human plasma. The mean percentage recoveries in combined tablets were 100.20 ± 1.64 and 100.72 ± 1.11 for LEV and AMB, respectively and 100.10 ± 1.14 for LEV in spiked human plasma. Statistical comparison of the results with those of the comparison method revealed good agreement and proved that there were no significant difference in the accuracy and precision between the two methods respectively. PMID:24079576

  5. Combination treatment in the management of type 2 diabetes: focus on vildagliptin and metformin as a single tablet

    PubMed Central

    Halimi, Serge; Schweizer, Anja; Minic, Biljana; Foley, James; Dejager, Sylvie

    2008-01-01

    Vildagliptin is a potent and selective inhibitor of dipeptidyl peptidase-IV (DPP-4), orally active, that improves glycemic control in patients with type 2 diabetes (T2DM) primarily by enhancing pancreatic (α and β) islet function. Thus vildagliptin has been shown both to improve insulin secretion and to suppress the inappropriate glucagon secretion seen in patients with T2DM. Vildagliptin reduces HbA1c when given as monotherapy, without weight gain and with minimal hypoglycemia, or in combination with the most commonly prescribed classes of oral hypoglycemic drugs: metformin, a sulfonylurea, a thiazolidinedione, or insulin. Metformin, with a different mode of action not addressing β-cell dysfunction, has been used for about 50 years and still represents the universal first line therapy of all guidelines. However, given the multiple pathophysiological abnormalities in T2DM and the progressive nature of the disease, intensification of therapy with combinations is typically required over time. Recent guidelines imply that patients will require pharmacologic combinations much earlier to attain and sustain the increasingly stringent glycemic targets, with careful drug selection to avoid unwanted adverse events, especially hypoglycemia. The combination of metformin and vildagliptin offers advantages when compared to currently used combinations with additive efficacy and complimentary mechanisms of action, since it does not increase the risk of hypoglycemia and does not promote weight gain. Therefore, by specifically combining these agents in a single tablet, there is considerable potential to achieve better blood glucose control and to improve compliance to therapy. PMID:18827867

  6. Gender differences in pharmacokinetics of a combination tablet of niacin extended-release/simvastatin in healthy Chinese volunteers.

    PubMed

    Wang, Xiao-lin; Liu, Man; Yang, Man; Zhang, Ya-nan; Zhang, Dan; Zhang, Li-na; Han, Jing; Liu, Hui-chen

    2014-12-01

    The gender differences in pharmacokinetics of a combination tablet of niacin extended-release/simvastatin were evaluated in healthy Chinese volunteers. Thirty-six healthy male and female volunteers were enrolled in the study receiving a single oral dose of niacin extended-release/simvastatin 1,000/20 mg. The results indicated that the systemic exposure of simvastatin hydroxy acid and the total urine excretion of niacin were significantly higher for females compared with those for males, and the T max of niacin in plasma was significantly shorter for males than that for females. There were no significant differences in the systemic exposure of simvastatin, niacin, and NUA in plasma between males and females.

  7. Comparison of vaginal flora after treatment with a clotrimazole 500 mg vaginal pessary or a fluconazole 150 mg capsule for vaginal candidosis.

    PubMed Central

    Boag, F C; Houang, E T; Westrom, R; McCormack, S M; Lawrence, A G

    1991-01-01

    The effect of antifungal therapy on the vaginal microbial flora was studied in 23 patients suffering from culture-positive, symptomatic vaginal candidosis. They were randomly allocated to receive either a 500 mg clotrimazole vaginal pessary or a 150 mg fluconazole capsule. Quantitative microbiological examination was carried out on samples of vaginal secretions obtained prior, and at intervals up to 10 days after, treatment. No significant difference was found in the vaginal flora before or after therapy in individual patients or between the treatment groups. In patients with C glabrata or C krusei, the yeasts persisted longer in the vagina with poorer response to either of the medications. PMID:2071126

  8. Gamma scintigraphic evaluation of floating gastroretentive tablets of metformin HCl using a combination of three natural polymers in rabbits

    PubMed Central

    Razavi, Mahboubeh; Karimian, Hamed; Yeong, Chai Hong; Chung, Lip Yong; Nyamathulla, Shaik; Noordin, Mohamed Ibrahim

    2015-01-01

    The present research was aimed at formulating a metformin HCl sustained-release formulation from a combination of polymers, using the wet granulation technique. A total of 16 formulations (F1–F16) were produced using different combinations of the gel-forming polymers: tamarind kernel powder, salep (palmate tubers of Orchis morio), and xanthan. Post-compression studies showed that there were no interactions between the active drug and the polymers. Results of in vitro drug-release studies indicated that the F10 formulation which contained 5 mg of tamarind kernel powder, 33.33 mg of xanthan, and 61.67 mg of salep could sustain a 95% release in 12 hours. The results also showed that F2 had a 55% similarity factor with the commercial formulation (C-ER), and the release kinetics were explained with zero order and Higuchi models. The in vivo study was performed in New Zealand White rabbits by gamma scintigraphy; the F10 formulation was radiolabeled using samarium (III) oxide (153Sm2O3) to trace transit of the tablets in the gastrointestinal tract. The in vivo data supported the retention of F10 formulation in the gastric region for 12 hours. In conclusion, the use of a combination of polymers in this study helped to develop an optimal gastroretentive drug-delivery system with improved bioavailability, swelling, and floating characteristics. PMID:26273196

  9. Tamsulosin/solifenacin fixed-dose combination tablet for the treatment of male lower urinary tract symptoms.

    PubMed

    Romancik, M; Pandian, S; Drake, M J

    2014-12-01

    Men reporting mixed storage and voiding lower urinary tract symptoms (LUTS) often experience persisting storage LUTS after initial treatment. Combination therapy of an alpha-adrenergic antagonist and an antimuscarinic is increasingly recognized as a therapy option. Clinical trials have combined tamsulosin (0.4 mg) with different doses of solifenacin. In the SATURN study, greater efficacy benefits were observed for moderate to severe storage symptoms. Single tablet administration may offer improved compliance. Accordingly, the NEPTUNE study researched fixed-dose combination (FDC) therapy for mixed LUTS, using tamsulosin (oral controlled administration system formulation), with solifenacin (6 or 9 mg). The FDC containing tamsulosin and solifenacin 6 mg improved storage and voiding LUTS, with no additional benefit from the higher solifenacin dose. During the open-label extension study, symptom improvement was maintained. Adverse events reflected the known effects of the component therapies. Acute urinary retention, an adverse event of special interest, was seen in only a small number of treated men. PMID:25588085

  10. Gamma scintigraphic evaluation of floating gastroretentive tablets of metformin HCl using a combination of three natural polymers in rabbits.

    PubMed

    Razavi, Mahboubeh; Karimian, Hamed; Yeong, Chai Hong; Chung, Lip Yong; Nyamathulla, Shaik; Noordin, Mohamed Ibrahim

    2015-01-01

    The present research was aimed at formulating a metformin HCl sustained-release formulation from a combination of polymers, using the wet granulation technique. A total of 16 formulations (F1-F16) were produced using different combinations of the gel-forming polymers: tamarind kernel powder, salep (palmate tubers of Orchis morio), and xanthan. Post-compression studies showed that there were no interactions between the active drug and the polymers. Results of in vitro drug-release studies indicated that the F10 formulation which contained 5 mg of tamarind kernel powder, 33.33 mg of xanthan, and 61.67 mg of salep could sustain a 95% release in 12 hours. The results also showed that F2 had a 55% similarity factor with the commercial formulation (C-ER), and the release kinetics were explained with zero order and Higuchi models. The in vivo study was performed in New Zealand White rabbits by gamma scintigraphy; the F10 formulation was radiolabeled using samarium (III) oxide ((153)Sm2O3) to trace transit of the tablets in the gastrointestinal tract. The in vivo data supported the retention of F10 formulation in the gastric region for 12 hours. In conclusion, the use of a combination of polymers in this study helped to develop an optimal gastroretentive drug-delivery system with improved bioavailability, swelling, and floating characteristics. PMID:26273196

  11. Evaluation by lymphoscintigraphy of the effect of a micronized flavonoid fraction (Daflon 500 mg) in the treatment of upper limb lymphedema.

    PubMed

    Pecking, A P

    1995-09-01

    Upper limb lymphedema after conventional treatment of breast cancer occurs in about 20% of all treated cases, even after conservative therapy. Women with mild to severe upper limb lymphedema expect a decongestive therapy, which usually associates physiotherapy and medical treatment. Upper limb lymphoscintigraphy using rhenium colloids labelled with technetium 99m can be used as a lymphatic functional test in order to evaluate the efficacy of a therapy. We report here the results of a pilot, open study carried out on 10 female patients, age ranging from 44 to 64 years, previously treated for a breast cancer. The average time delay for the occurrence [correction of occurence] of lymphedema was 17 +/- 7 months. All patients received 500 mg twice daily of a micronized flavonoid fraction (Daflon 500 mg) for 6 months. At the end of the study, all patients had a clinical improvement of symptoms and limb volume and the mean decrease in volume of the swollen limb reached 6.80%. Functional parameters (half-life, clearance and lymphatic speed of the colloid) assessed with scintigraphy were significantly improved. These preliminary results suggest that this therapy is effective for the treatment of lymphedemas.

  12. A rapid and comprehensive quality assessing method of Yin-Qiao-Jie-Du tablets using UHPLC-QTOF-MS in combination with multivariate statistical analysis.

    PubMed

    He, Liping; Chen, Yong; Liang, Ziqiao; Li, Youzhi; Zhou, Minglin; Yuan, Zhiquan; Luo, Ling; Jin, Zhen; Yang, Yunyun; Chen, Jianxin

    2016-05-30

    Yin-Qiao-Jie-Du (YQJD) tablet is a well-known non-prescription Chinese patent drug widely used for the prevention and treatment of diseases in China. However, documented studies for assessing and controlling the quality of YQJD tablet are limited. In this article, a rapid and comprehensive method for the quality assessment and control of YQJD tablets was developed, via qualitative and quantitative analysis of the major active ingredients of YQJD tablets by ultra-high performance liquid chromatography coupled with quadrupole time-of-flight mass spectrometry (UHPLC-QTOF-MS) in combination with multivariate statistical analysis. The samples of YQJD tablets were triturated and then extracted with methanol, and the extracts were analyzed by UHPLC-QTOF-MS. A good separation was achieved within 30 min by using an Agilent RRHD SB-C18 (150 mm × 2.1mm I.D., 1.8 μm) column with a gradient elution of water (0.5% formic acid) and acetonitrile. Forty-one major chromatographic peaks were obtained, and 31 of them were identified according to the obtained data from the measurements of accurate mass, isotopic composition, and collision-induced dissociation. Among them, 21 were confirmed by the comparison of retention times, MS, and MS/MS information with those of their references. Quantitative analysis was performed based on the peak areas of extracted ion chromatograms of the exact pseudo-molecular ions (with a 0.01 Da window), and the result of method validation demonstrated that the proposed method possessed desirable specificity, linearity, precision, and accuracy. Subsequently, the method was utilized to analyze the major constituents in YQJD tablets of 18 batches produced by different manufacturers. The obtained contents of the 21 confirmed ingredients were applied for orthogonal partial-least squares to latent structures discriminant analysis (OPLS-DA). An assessment of the quality consistency and stability as well as tracing the origins of the investigated YQJD tablets

  13. Development and validation of a dissolution test for a once-a-day combination tablet of immediate-release cetirizine dihydrochloride and extended-release pseudoephedrine hydrochloride.

    PubMed

    Likar, Michael D; Mansour, Hany L; Harwood, Jeffrey W

    2005-09-15

    A dissolution test for a once daily combination tablet containing 10 mg of cetirizine dihydrochloride (cetirizine HCl) for immediate release and 240 mg of pseudoephedrine hydrochloride (pseudoephedrine HCl) for extended release was developed and validated according to current ICH and FDA guidelines. The cetirizine HCl is contained within an outer layer of the tablet while a semipermeable membrane of cellulose acetate and polyethylene glycol controls the rate at which pseudoephedrine HCl is released from the tablet core. The dissolution method, which uses USP apparatus 2 with paddles rotating at 50 rpm, 1000 ml of deaerated water as the dissolution medium, and reversed-phased HPLC for quantitation, was demonstrated to be robust, discriminating, and transferable. These test conditions were selected after it was demonstrated that the cetirizine HCl portion of the tablet rapidly dissolved in aqueous media over the physiologically relevant pH range of 1.1-7.5, and that the extended-release profile of pseudoephedrine HCl was independent of dissolution conditions (i.e., apparatus, pH, and agitation).

  14. Clinical effects of perazine ferulate tablets combined with eucalyptol limonene pinene enteric soft capsules for treatment of children with IgA nephropathy

    PubMed Central

    LIU, ZHIZHEN; PAN, JINGMEI; SUN, CHUNLEI; ZHOU, JUAN; LI, NA

    2016-01-01

    The clinical effects of piperazine ferulate tablets combined with eucalyptol limonene pinene enteric soft capsules for treatment of children with IgA nephropathy were investigated. Sixty children with IgA nephropathy were included in the study and were randomly divided into the control (n=30) and observation (n=30) groups. The patients in the control group were treated with conservative or hormone therapy while patients in the observation group were treated with piperazine ferulate tablets combined with eucalyptol-limonene-pinene enteric soft capsules. Clinical effects were observed and compared. The total effective rate of the observation group was significantly higher than that of the control group, while the incidence of complications was significantly lower than that of the control group (p<0.05). Serum IgA and fibronectin levels of the observation group were significantly lower than those of the control group, while the level of C3 was significantly higher than that of the control group (p<0.05). In conclusion, piperazine ferulate tablets combined with eucalyptus enteric soft capsule constituted a safe and effective for the treatment of children with IgA nephropathy. The treatment was superior to conservative or hormone therapy, and thus worthy of clinical promotion. PMID:27347034

  15. Use of weight-for-age-data to optimize tablet strength and dosing regimens for a new fixed-dose artesunate-amodiaquine combination for treating falciparum malaria.

    PubMed Central

    Taylor, Walter R. J.; Terlouw, Dianne J.; Olliaro, Piero L.; White, Nicholas J.; Brasseur, Philippe; ter Kuile, Feiko O.

    2006-01-01

    OBJECTIVE: To test a novel methodology to define age-based dosing regimens for the treatment of malaria with a new, user-friendly, blister-packaged fixed-dose combination of artesunate and amodiaquine. METHODS: A weight-for-age reference database of 88 054 individuals from sub-Saharan Africa was compiled using data from Demographic Health Surveys, observational and intervention studies, and standardized for sex, age and malaria risk. We then determined the optimal tablet strength (milligram (mg) per tablet) and age-dose categories for the combination of artesunate and amodiaquine. The proportions of patients predicted to receive doses within newly defined therapeutic ranges for amodiaquine (7-15 mg/kg/day) and artesunate (2-10 mg/kg/day), were estimated for different age categories and mg tablet strengths using models based on the weight-for-age reference database. FINDINGS: The optimal paediatric (p) and adult (a) strength tablets contained 25/67.5 and 100/270 mg artesunate/amodiaquine, respectively. A regimen with five age categories: 0-1 months (1/2 p), 2-11 months (1 p), 1-5 years (2 p), 6-13 years (1 a), and > 14 years (2 a) had an overall dosing accuracy of 83.4% and 99.9% for amodiaquine and artesunate, respectively. CONCLUSION: The proposed method to use weight-for-age reference data from countries where malaria is endemic is a useful tool for designing age-based dosing regimens for antimalarial drugs for drug registration and field use. PMID:17242831

  16. Tablet Weaving

    ERIC Educational Resources Information Center

    Kren, Margo

    1976-01-01

    Article described a weaving technique called tablet weaving, an ancient textile process that provides opportunity for making a variety of items, such as guitar straps, belts, and decorative bands. (Author/RK)

  17. Naproxen 500 mg bid versus acetaminophen 1000 mg qid: effect on swelling and other acute postoperative events after bilateral third molar surgery.

    PubMed

    Bjørnsson, G A; Haanaes, H R; Skoglund, L A

    2003-08-01

    A controlled, randomized, double-blind crossover study, in which the patients acted as their own controls, was carried out to test the efficacy of naproxen 500 mg x 2 versus acetaminophen 1000 mg x 4 for 3 days on the postoperative course following third molar surgery. Acetaminophen reduced the mean swelling on the 3rd postoperative day by 22.4% (p = 0.023) compared to that after naproxen. On the 6th postoperative day, there was 20.9% less mean swelling with naproxen (p = 0.44), although the total swelling measurements were much less than those measured on the 3rd postoperative day. Summed pain intensity (SUMPI3.5-11) on the day of surgery revealed no statistically significant difference between the acetaminophen or naproxen regimen with the exception of 0.5 hours (p = 0.002) and 1 hour (p = 0.009) after first medication when acetaminophen gave less pain than naproxen. Since the drug regimens were different, summed PI for the first acetaminophen dose interval (SUMPI3.5-6) and the first naproxen dose interval (SUMPI3.5-9) was calculated. There was a tendency toward a statistically significant difference in favor of acetaminophen for SUMPI3.5-6 (p = 0.055) but no statistically significant difference (p = 0.41) between the treatments with respect to SUMPI3.5-9. Naproxen was statistically superior (p < or = 0.002) to acetaminophen at 08:00, 12:00, and 16:00 hours on the 1st postoperative day and at 08:00 hours on the 2nd postoperative day, when the pain intensity level was lower than that on the day of surgery. A 3-day acetaminophen regimen reduces acute postoperative swelling better than naproxen on the 3rd postoperative day after third molar surgery but not on the 6th postoperative day when the total swelling is less. PMID:12953342

  18. Formulation Development and Evaluation of Fast Disintegrating Tablets of Salbutamol Sulphate, Cetirizine Hydrochloride in Combined Pharmaceutical Dosage Form: A New Era in Novel Drug Delivery for Pediatrics and Geriatrics

    PubMed Central

    Sharma, Deepak; Singh, Gurmeet; Kumar, Dinesh; Singh, Mankaran

    2015-01-01

    The objective of the present study was to prepare the fast disintegrating tablet of Salbutamol Sulphate, Cetirizine Hydrochloride in combined tablet dosage form for respiratory disorders such as bronchitis, asthma, and coughing for pediatrics and geriatrics. The tablets were prepared by direct compression technique. Superdisintegrant such as Sodium Starch Glycolate was optimized as 4% on the basis of least disintegration time. Different binders such as MCC and PVP K-30 were optimized along with optimized superdisintegrant concentration. 1% MCC was selected as optimum binder concentration on the basis of least disintegration time. The tablets were evaluated for hardness, friability, weight variation, wetting time, disintegration time, and drug content uniformity. Optimized formulation was further evaluated by in vitro dissolution test, drug-excipient compatibility, and accelerated stability study. Percent weight variation and content uniformity were within the acceptable limit. The friability was less than 1%. The wetting time and disintegration time were practically good for all formulations. FTIR studies and accelerated stability study showed that there was no interaction between the drug and excipients. It was concluded that, by employing commonly available pharmaceutical excipients such as superdisintegrants, hydrophilic and swellable excipients and proper filler, a fast disintegrating tablet of Salbutamol Sulphate, Cetirizine Hydrochloride in combined tablet dosage form, were formulated successfully with desired characteristics. PMID:25810924

  19. Clinical study of Shengxuening tablet combined with rHuEPO for the treatment of renal anemia of maintenance hemodialysis patients

    PubMed Central

    CHENG, XIN; YU, GUOJUN; HU, JIANGPING; XU, XUEFENG; LUO, FANG; SHEN, PING; ZHANG, GUOSHENG; YANG, NING

    2016-01-01

    The aim of the present study was to investigate the clinical effects of Shengxuening tablet (silkworm excrement) combined with recombinant human erythropoietin (rHuEPO) for the treatment of renal anemia of maintenance hemodialysis (MHD) patients. Seventy-two MHD patients with renal anemia were included in the study and randomly divided into the control (n=34) and observation (n=38) groups. Patients in the control group were treated by hypodermic injection of 100–150 U/(kg·w) rHuEPO and patients in the observation group were treated by rHuEPO + 1.0 g t.i.d. p.o. Shengxuening tablet. The two groups were assisted by conventional treatments including iron, folic acid, vitamin B12 and L-carnitine. After 3 and 6 months, improvement of anemia was compared. After 3 months, the hemoglobin, hematocrit, serum ferritin and transferrin saturation levels of the observation group were significantly higher than those of the control group (p<0.05). In addition, C-reactive protein and superoxide dismutase levels of the observation group were significantly lower than those of the control group (p<0.05). After 6 months, indices of the observation group were ameliorated while the improvement of control group was not obvious, and indices of the observation group were significantly higher than those of the control group (p<0.05). Consumption of rHuEPO in the observation group was significantly less than that of the control group, and the total effective rate was significantly higher than that of the control group (p<0.05). In conclusion, Shengxuening tablet combined with rHuEPO was safe and effective for the treatment of renal anemia of MHD patients. PMID:27347032

  20. Effect of Danhong Injection Combined with Naoxintong Tablets on Prognosis and Inflammatory Factor Expression in Acute Coronary Syndrome Patients Undergoing Percutaneous Coronary Intervention

    PubMed Central

    Lv*, Yun; Pan, Yaping; Gao*, Yan; Lu, Jingqian; Li, Yi; Bai, Jie; Zhai, Jing

    2015-01-01

    Background Danhong is a Chinese medical component that has been broadly used to treat various cerebrovascular diseases. This work aimed to investigate the effect of Danhong injection combined with Naoxintong tablets on the short-term prognosis and expression of inflammatory factor-soluble CD40 ligand (sCD40L) in acute coronary syndrome (ACS) patients undergoing percutaneous coronary intervention (PCI). Methods A total of 100 ACS patients with PCI were randomly divided equally into treatment and control groups. The control group was treated with conventional secondary prevention of coronary heart disease. Based on secondary prevention, Danhong injection combined with Naoxintong tablets was administered in the treatment group. The incidences of major adverse cardiovascular events and cardiac functions, including ejection fraction (EF) and six-minute walk test distance, during hospital discharge and at the third postoperative month were observed. The serum sCD40 levels at different times were also noted. Results There were 2 patients in the treatment group and 7 in the control group that were lost during follow-up, so the collected data were from only 48 patients in the treatment and 43 in the control group. During hospital discharge and at the third postoperative month, no significant difference in death, myocardial infarction, stroke, angina pectoris and readmission were observed between the two groups (p > 0.05). Upon hospital discharge, EF, six-minute walk test distance and serum sCD40L level in the two groups were not significantly different (p > 0.05). At the third postoperative month, EF and six-minute walk test distance in treatment group were significantly higher than those in the control group (p < 0.05), and the serum sCD40L level in the treatment group was significantly lower than that in the control group (p < 0.01). In addition, serum sCD40L levels in the two groups at the third postoperative month were significantly lower than those during hospital

  1. Optimal Dose of Vitamin D3 400 I.U. for Average Adults has A Significant Anti-Cancer Effect, While Widely Used 2000 I.U. or Higher Promotes Cancer: Marked Reduction of Taurine & 1α, 25(OH)2D3 Was Found In Various Cancer Tissues and Oral Intake of Optimal Dose of Taurine 175mg for Average Adults, Rather Than 500mg, Was Found to Be A New Potentially Safe and More Effective Method of Cancer Treatment.

    PubMed

    Omura, Yoshiaki; Lu, Dominic; Jones, Marilyn K; Nihrane, Abdallah; Duvvi, Harsha; Yapor, Dario; Shimotsuura, Yasuhiro; Ohki, Motomu

    2016-01-01

    During the past 10 years, the author had found that the optimal dose of Vitamin D3 400 I.U. has safe & effective anticancer effects, while commonly used 2000-5000 I.U. of Vit. D3 often creates a 2-3 time increase in cancer markers. We examined the concentration of Taurine in normal internal organs and in cancer using Bi-Digital O-Ring Test. We found that Taurine levels in normal tissue are 4-6ng. But, the amount of Taurine of average normal value of 5.0-5.25ng was strikingly reduced to 0.0025-0.0028ng in this study of several examples in adenocarcinomas of the esophagus, stomach, pancreas, colon, prostate, and lung, as well as breast cancer. The lowest Taurine levels of 0.0002-0.0005ng were found in so called Zika virus infected babies from Brazil with microcephaly. While Vitamin D3 receptor stimulant 1α, 25 (OH)2D3 in normal tissues was 0.45-0.53ng, they were reduced to 0.025-0.006ng in cancers (1/100th-1/200th of normal value), particularly in various adenocarcinomas. All of these adenocarcinomas had about 1500ng HPV-16 viral infection. In 500 breast cancers, about 97% had HPV-16. The optimal dose of Taurine for average adult has been found to be about 175mg, rather than the widely used 500mg. In addition, since Taurine is markedly reduced to close to 1/1000th-1/2000th of its normal value in these cancer tissues, we examined the effect of the optimal dose of Taurine on cancer patients. Optimal dose of Taurine produced a very significant decrease in cancer-associated parameters, such as Oncogene C-fosAb2 & Integrin α5β1 being reduced to less than 1/1,000th, and 8-OH-dG (which increases in the presence of DNA mutation) reduced to less than 1/10th. The optimal dose of Taurine 175mg for average adult various cancer patient 3 times a day alone provide beneficial effects with very significant anti-cancer effects with strikingly increased urinary excretion of bacteria, viruses, & funguses, asbestos, toxic metals & other toxic substances. However, optimal doses of

  2. Optimal Dose of Vitamin D3 400 I.U. for Average Adults has A Significant Anti-Cancer Effect, While Widely Used 2000 I.U. or Higher Promotes Cancer: Marked Reduction of Taurine & 1α, 25(OH)2D3 Was Found In Various Cancer Tissues and Oral Intake of Optimal Dose of Taurine 175mg for Average Adults, Rather Than 500mg, Was Found to Be A New Potentially Safe and More Effective Method of Cancer Treatment.

    PubMed

    Omura, Yoshiaki; Lu, Dominic; Jones, Marilyn K; Nihrane, Abdallah; Duvvi, Harsha; Yapor, Dario; Shimotsuura, Yasuhiro; Ohki, Motomu

    2016-01-01

    During the past 10 years, the author had found that the optimal dose of Vitamin D3 400 I.U. has safe & effective anticancer effects, while commonly used 2000-5000 I.U. of Vit. D3 often creates a 2-3 time increase in cancer markers. We examined the concentration of Taurine in normal internal organs and in cancer using Bi-Digital O-Ring Test. We found that Taurine levels in normal tissue are 4-6ng. But, the amount of Taurine of average normal value of 5.0-5.25ng was strikingly reduced to 0.0025-0.0028ng in this study of several examples in adenocarcinomas of the esophagus, stomach, pancreas, colon, prostate, and lung, as well as breast cancer. The lowest Taurine levels of 0.0002-0.0005ng were found in so called Zika virus infected babies from Brazil with microcephaly. While Vitamin D3 receptor stimulant 1α, 25 (OH)2D3 in normal tissues was 0.45-0.53ng, they were reduced to 0.025-0.006ng in cancers (1/100th-1/200th of normal value), particularly in various adenocarcinomas. All of these adenocarcinomas had about 1500ng HPV-16 viral infection. In 500 breast cancers, about 97% had HPV-16. The optimal dose of Taurine for average adult has been found to be about 175mg, rather than the widely used 500mg. In addition, since Taurine is markedly reduced to close to 1/1000th-1/2000th of its normal value in these cancer tissues, we examined the effect of the optimal dose of Taurine on cancer patients. Optimal dose of Taurine produced a very significant decrease in cancer-associated parameters, such as Oncogene C-fosAb2 & Integrin α5β1 being reduced to less than 1/1,000th, and 8-OH-dG (which increases in the presence of DNA mutation) reduced to less than 1/10th. The optimal dose of Taurine 175mg for average adult various cancer patient 3 times a day alone provide beneficial effects with very significant anti-cancer effects with strikingly increased urinary excretion of bacteria, viruses, & funguses, asbestos, toxic metals & other toxic substances. However, optimal doses of

  3. Meta-Analysis of Studies Comparing Single and Multi-Tablet Fixed Dose Combination HIV Treatment Regimens

    PubMed Central

    Clay, P.G.; Nag, S.; Graham, C.M.; Narayanan, S.

    2015-01-01

    Abstract Availability of a single source review of once-daily fixed-dose single tablet regimen (STR) and multiple tablet fixed-dose regimen (MTR) would optimally inform healthcare providers and policy makers involved in the management of population with human immunodeficiency virus (HIV). We conducted a meta-analysis of published literature to compare patient adherence, clinical, and cost outcomes of STR to MTR. Published literature in English between 2005 and 2014 was searched using Embase, PubMed (Medline in-process), and ClinicalTrials.Gov databases. Two-level screening was undertaken by 2 independent researchers to finalize articles for evidence synthesis. Adherence, efficacy, safety, tolerability, healthcare resource use (HRU), and costs were assessed comparing STR to MTR. A random-effects meta-analysis was performed and heterogeneity examined using meta-regression. Thirty-five articles were identified for qualitative evidence synthesis, of which 9 had quantifiable data for meta-analysis (4 randomized controlled trials and 5 observational studies). Patients on STR were significantly more adherent when compared to patients on MTR of any frequency (odds ratio [OR]: 2.37 [95% CI: 1.68, 3.35], P < 0.001; 4 studies), twice-daily MTR (OR: 2.53 [95% CI: 1.13, 5.66], P = 0.02; 2 studies), and once-daily MTR (OR: 1.81 [95% CI: 1.15, 2.84], P = 0.01; 2 studies). The relative risk (RR) for viral load suppression at 48 weeks was higher (RR: 1.09 [95% CI: 1.04, 1.15], P = .0003; 3 studies) while RR of grade 3 to 4 laboratory abnormalities was lower among patients on STR (RR: 0.68 [95% CI: 0.49, 0.94], P = 0.02; 2 studies). Changes in CD4 count at 48 weeks, any severe adverse events (SAEs), grade 3 to 4 AEs, mortality, and tolerability were found comparable between STR and MTR. Several studies reported significant reduction in HRU and costs among STR group versus MTR. Study depicted comparable tolerability, safety (All-SAE and Grade 3–4 AE), and

  4. A double-blind comparative study of Chinese herbal medicine Jinlianqingre Effervescent Tablets in combination with conventional therapy for the treatment of uncomplicated hand, foot, and mouth disease.

    PubMed

    He, L-Y; Zhang, G-L; Yan, S-Y; Liu, Y; Zhao, C-S; Wang, X-L; Li, Y; Mi, Y-Q; Liu, Y-M; Li, C-P; Kou, Y-H; Li, Y; Chang, K; Meng, X-L; Sun, X-J; Zhao, T; Li, J; Wang, Y-Y; Liu, B-Y

    2014-08-01

    Chinese herbal medicine Jinlianqingre Effervescent Tablets (JET) are the recommended control measure for uncomplicated hand, foot, and mouth disease (HFMD) by the Ministry of Health of China. However, high-quality evidence to support this recommendation is limited. A total of 288 patients ranging in age from 1 to 13 years were randomly assigned to JET in combination with conventional therapy (mainly including the reduction of temperature by applying physical cooling paste or warm bathing), or conventional therapy with placebo group for 7 days. The objective was to test the hypothesis that JET combination therapy is more effective than conventional therapy for uncomplicated HFMD. A randomized, double-blind, placebo-controlled trial was designed. Our study showed that, compared with conventional therapy, the median time to fever resolution was significantly shorter in the JET combination therapy (8 vs. 80 h; p < 0.0001); the risk of fever resolution increased in the JET combination therapy [hazard ratio, 19.8; 95% confidence interval (CI), 12.8 to 30.7]; the median healing time of rash or oral ulcer was significantly shorter in the JET combination therapy (14 vs. 74 h; p < 0.0001); and the median symptom score for skin or oral mucosa lesions improved more rapidly in the JET combination therapy during the follow-up period. The median duration of hospital stay was 6 days in the JET combination therapy and 7 days in the conventional therapy (p < 0.0001). No significant adverse events and complications were found in both groups. The addition of JET to conventional therapy reduced fever clearance time, healing time of skin or oral mucosa lesions, and duration of hospital stay in children with uncomplicated HFMD. PMID:24643639

  5. Tablet Use within Medicine

    ERIC Educational Resources Information Center

    Hogue, Rebecca J.

    2013-01-01

    This paper discusses the scholarly literature related to tablet computer use in medicine. Forty-four research-based articles were examined for emerging categories and themes. The most studied uses for tablet computers include: patients using tablets to complete diagnostic survey instruments, medical professionals using tablet computers to view…

  6. Development of two step liquid-liquid extraction tandem UHPLC-MS/MS method for the simultaneous determination of Ginkgo flavonoids, terpene lactones and nimodipine in rat plasma: Application to the pharmacokinetic study of the combination of Ginkgo biloba dispersible tablets and Nimodipine tablets.

    PubMed

    Xiao, Jie; Wang, Tianyang; Li, Pei; Liu, Ran; Li, Qing; Bi, Kaishun

    2016-08-15

    A sensitive, reliable and accurate UHPLC-MS/MS method has been firstly established and validated for the simultaneous quantification of ginkgo flavonoids, terpene lactones and nimodipine in rat plasma after oral administration of Ginkgo biloba dispersible tablets, Nimodipine tablets and the combination of the both, respectively. The plasma samples were extracted by two step liquid-liquid extraction, nimodipine was extracted by hexane-ether (3:1, v/v) at the first step, after that ginkgo flavonoids and terpene lactones were extracted by ethyl acetate. Then the analytes were successfully separated by running gradient elution with the mobile phase consisting of 0.1% formic acid in water and methanol at a flow rate of 0.6mL/min. The detection of the analytes was performed on a UHPLC-MS/MS system with turbo ion spray source in the negative ion and multiple reaction monitoring (MRM) mode. The calibration curves for the determination of all the analytes showed good linearity (R(2)>0.99), and the lower limits of quantification were 0.50-4.00ng/mL. Intra-day and inter-day precisions were in the range of 3.6%-9.2% and 3.2%-13.1% for all the analytes. The mean extraction recoveries of the analytes were within 69.82%-103.5% and the matrix were within 82.8%-110.0%. The validated method had been successfully applied to compare the pharmacokinetic parameters of ginkgo flavonoids, terpene lactones and nimodipine in rat plasma after oral administration of Ginkgo biloba dispersible tablets, Nimodipine tablets with the combination of the both. There were no statistically significant differences on the pharmacokinetic behaviors of all the analytes between the combined and single administration groups. Results showed that the combination of the two agents may avoid dosage adjustments in clinic and the combination is more convenient as well as efficient on different pathogenesis of cerebral ischemia.

  7. Development of two step liquid-liquid extraction tandem UHPLC-MS/MS method for the simultaneous determination of Ginkgo flavonoids, terpene lactones and nimodipine in rat plasma: Application to the pharmacokinetic study of the combination of Ginkgo biloba dispersible tablets and Nimodipine tablets.

    PubMed

    Xiao, Jie; Wang, Tianyang; Li, Pei; Liu, Ran; Li, Qing; Bi, Kaishun

    2016-08-15

    A sensitive, reliable and accurate UHPLC-MS/MS method has been firstly established and validated for the simultaneous quantification of ginkgo flavonoids, terpene lactones and nimodipine in rat plasma after oral administration of Ginkgo biloba dispersible tablets, Nimodipine tablets and the combination of the both, respectively. The plasma samples were extracted by two step liquid-liquid extraction, nimodipine was extracted by hexane-ether (3:1, v/v) at the first step, after that ginkgo flavonoids and terpene lactones were extracted by ethyl acetate. Then the analytes were successfully separated by running gradient elution with the mobile phase consisting of 0.1% formic acid in water and methanol at a flow rate of 0.6mL/min. The detection of the analytes was performed on a UHPLC-MS/MS system with turbo ion spray source in the negative ion and multiple reaction monitoring (MRM) mode. The calibration curves for the determination of all the analytes showed good linearity (R(2)>0.99), and the lower limits of quantification were 0.50-4.00ng/mL. Intra-day and inter-day precisions were in the range of 3.6%-9.2% and 3.2%-13.1% for all the analytes. The mean extraction recoveries of the analytes were within 69.82%-103.5% and the matrix were within 82.8%-110.0%. The validated method had been successfully applied to compare the pharmacokinetic parameters of ginkgo flavonoids, terpene lactones and nimodipine in rat plasma after oral administration of Ginkgo biloba dispersible tablets, Nimodipine tablets with the combination of the both. There were no statistically significant differences on the pharmacokinetic behaviors of all the analytes between the combined and single administration groups. Results showed that the combination of the two agents may avoid dosage adjustments in clinic and the combination is more convenient as well as efficient on different pathogenesis of cerebral ischemia. PMID:27318642

  8. Spectrophotometric and reversed-phase high-performance liquid chromatographic methods for simultaneous determination of escitalopram oxalate and clonazepam in combined tablet dosage form.

    PubMed

    Gandhi, Santosh Vilashchand; Dhavale, Nilesh Dnyandev; Jadhav, Vijay Yeshawantrao; Sabnis, Shweta Sadanand

    2008-01-01

    Simple, accurate, precise, and sensitive ultraviolet spectrophotometric and reversed-phase high-performance liquid chromatographic (RP-HPLC) methods for simultaneous estimation of escitalopram oxalate (ESC) and clonazepam (CLO) in combined tablet dosage form have been developed and validated. The spectroscopic method employs an absorbance correction method using 238.6 and 308 nm as 2 wavelengths for estimation with methanol and water as solvents. Beer's law is obeyed in the concentration range of 10.0-50.0 and 0.5-3.0 micro/mL for ESC and CLO, respectively. The RP-HPLC method uses a Jasco HPLC system with HiQ SiL C18 column (250 x 4.6 mm id) acetonitrile-0.005 M tetrabutylammonium hydrogen sulfate (55 + 45, v/v) as the mobile phase, and satranidazole as an internal standard. The detection was carried out using an ultraviolet detector set at 287 nm. For the HPLC method, Beer's law is obeyed in the concentration range of 10.0-60.0 and 0.5-3.0 microg/mL for ESC and CLO, respectively. Both methods have been successfully applied for the analysis of the drugs in a pharmaceutical formulation. Results of analysis were validated statistically and by recovery studies. PMID:18376583

  9. Tablet Splitting: A Risky Practice

    MedlinePlus

    ... and splitting tablets in an effort to save money. Regarding the practice of splitting tablets, the Food ... tablet. So a patient may try to save money by buying the 30 mg tablets and splitting ...

  10. Development of a Suitable Dissolution Method for the Combined Tablet Formulation of Atorvastatin and Ezetimibe by RP-LC Method.

    PubMed

    Ozkan Cansel, Kose; Ozgur, Esim; Sevinc, Kurbanoglu; Ayhan, Savaser; Ozkan, Sibel A; Yalcin, Ozkan

    2016-01-01

    Pharmaceutical preparations of ezetimibe and atorvastatin are generally used to regulate the lipid level in blood. It decreases the secondary events for patients with high cholesterol and clinical cardiovascular disease such as non-fatal or fatal heart attack. There is no any pharmacopoeia method available for the dissolution testing recommended by the FDA. Development of dissolution tests method is very critical parameter especially for the pharmaceutical preparations that contain Class II drugs (slightly soluble, good permeable). In the proposed method, the effects of pH and surfactant on the dissolution of poorly water soluble combined drug therapy with a different pKa values in an in vitro environment is investigated. The content of our study was designed to answer these open-ended questions. The optimized test conditions achieved under sink conditions with USP apparatus 2 at a paddle rotation speed of 75 rpm and 900 ml in 0.01 M Acetate buffer (pH= 6.8) containing 0.45% SDS as a dissolution medium. Quantification of dissolution samples were analyzed with a new fully validated RP-LC method with UV detection at 242 nm. PMID:26638976

  11. Objective color classification of ecstasy tablets by hyperspectral imaging.

    PubMed

    Edelman, Gerda; Lopatka, Martin; Aalders, Maurice

    2013-07-01

    The general procedure followed in the examination of ecstasy tablets for profiling purposes includes a color description, which depends highly on the observers' perception. This study aims to provide objective quantitative color information using visible hyperspectral imaging. Both self-manufactured and illicit tablets, created with different amounts of known colorants were analyzed. We derived reflectance spectra from hyperspectral images of these tablets, and successfully determined the most likely colorant used in the production of all self-manufactured tablets and four of five illicit tablets studied. Upon classification, the concentration of the colorant was estimated using a photon propagation model and a single reference measurement of a tablet of known concentration. The estimated concentrations showed a high correlation with the actual values (R(2) = 0.9374). The achieved color information, combined with other physical and chemical characteristics, can provide a powerful tool for the comparison of tablet seizures, which may reveal their origin.

  12. The efficacy and safety of clotrimazole vaginal tablet vs. oral fluconazole in treating severe vulvovaginal candidiasis.

    PubMed

    Zhou, Xiaofang; Li, Ting; Fan, Shangrong; Zhu, Yuxia; Liu, Xiaoping; Guo, Xuedong; Liang, Yiheng

    2016-07-01

    To compare the efficacy and safety of two doses of clotrimazole vaginal tablet 500 mg with two doses of oral fluconazole 150 mg in treating severe vulvovaginal candidiasis (SVVC), 240 consecutive patients with SVVC were studied at the Department of Obstetrics and Gynaecology of Peking University Shenzhen Hospital between June 2014, and September 2015. Patients were randomly assigned in a 1 : 1 ratio to receive treatment with either two doses of clotrimazole vaginal tablet or two doses of oral fluconazole. The clinical cure rates in the clotrimazole group and the fluconazole group at days 7-14 follow-up were 88.7% (102/115) and 89.1% (98/110) respectively; the clinical cure rates at days 30-35 in the two groups were 71.9% (82/114) and 78.0% (85/109) respectively. The mycological cure rates at days 7-14 follow-up in the two groups were 78.3% (90/115) and 73.6% (81/110) respectively. The mycological cure rates of the patients at days 30-35 in the two groups were 54.4% (62/114) and 56.0% (61/109) respectively (P > 0.05). The adverse events of clotrimazole were mainly local. This study demonstrated that two doses of clotrimazole vaginal tablet 500 mg were as effective as two doses of oral fluconazole 150 mg in the treatment of patients with SVVC and could be an appropriate treatment for this disorder.

  13. Porous hydroxyapatite tablets as carriers for low-dosed drugs.

    PubMed

    Cosijns, A; Vervaet, C; Luyten, J; Mullens, S; Siepmann, F; Van Hoorebeke, L; Masschaele, B; Cnudde, V; Remon, J P

    2007-09-01

    The present study evaluated an innovative technique for the manufacturing of low-dosed tablets. Tablets containing hydroxyapatite and a pore forming agent (50% (w/w) Avicel PH 200/20, 37.5% and 50% corn starch/37.5% sorbitol) were manufactured by direct compression followed by sintering. The influence of pore forming agent (type and concentration), sinter temperature and sinter time on tablet properties was investigated. Sintering (1250 degrees C) revealed tablets with an acceptable friability (<1%). Using 50% (w/w) Avicel PH 200 as pore forming agent resulted in tablets combining the highest porosity (50%) and the highest median pore diameter (5 microm). Aqueous drug solutions (metoprolol tartrate, riboflavin sodium phosphate) were spiked on the tablet surface. The maximum volume of drug solution absorbed was limited (2x100 microl), revealing that these porous carriers were ideal for low dosed formulations. Drug release from the tablets was slow, independent of the drug. To accelerate drug release, tablets were manufactured using a modified gelcasting technique yielding tablets with a median pore size of 60 and 80 microm. Release from these tablets was drastically increased indicating that the permeability of the tablets was influenced by the pore size, shape and connectivity of the porous network. Changing and controlling these parameters made it possible to obtain drug delivery systems providing different drug delivery behaviour.

  14. Optimization of fast dissolving etoricoxib tablets prepared by sublimation technique.

    PubMed

    Patel, D M; Patel, M M

    2008-01-01

    The purpose of this investigation was to develop fast dissolving tablets of etoricoxib. Granules containing etoricoxib, menthol, crospovidone, aspartame and mannitol were prepared by wet granulation technique. Menthol was sublimed from the granules by exposing the granules to vacuum. The porous granules were then compressed in to tablets. Alternatively, tablets were first prepared and later exposed to vacuum. The tablets were evaluated for percentage friability and disintegration time. A 3(2) full factorial design was applied to investigate the combined effect of 2 formulation variables: amount of menthol and crospovidone. The results of multiple regression analysis indicated that for obtaining fast dissolving tablets; optimum amount of menthol and higher percentage of crospovidone should be used. A surface response plots are also presented to graphically represent the effect of the independent variables on the percentage friability and disintegration time. The validity of a generated mathematical model was tested by preparing a checkpoint batch. Sublimation of menthol from tablets resulted in rapid disintegration as compared with the tablets prepared from granules that were exposed to vacuum. The optimized tablet formulation was compared with conventional marketed tablets for percentage drug dissolved in 30 min (Q(30)) and dissolution efficiency after 30 min (DE(30)). From the results, it was concluded that fast dissolving tablets with improved etoricoxib dissolution could be prepared by sublimation of tablets containing suitable subliming agent.

  15. On-line identification of lysergic acid diethylamide (LSD) in tablets using a combination of a sweeping technique and micellar electrokinetic chromatography/77 K fluorescence spectroscopy.

    PubMed

    Fang, Ching; Liu, Ju-Tsung; Lin, Cheng-Huang

    2003-03-01

    This work describes a novel method for the accurate determination of lysergic acid diethylamide (LSD) in tablets. A technique involving sweeping-micellar electrokinetic chromatography (MEKC) was used for the initial on-line concentration and separation, after which a cryogenic molecular fluorescence experiment was performed at 77 K. Using this approach, not only the separation of LSD from the tablet extract was achieved, but on-line spectra were readily distinguishable and could be unambiguously assigned. The results are in agreement with analyses by gas chromatography-mass spectrometry (GC-MS). Thus, this method, which was found to be accurate, sensitive and rapid, has the potential for use as a reliable complementary method to GC-MS in such analyses.

  16. Instability of nitroglycerin tablets

    PubMed Central

    Mayer, G. A.

    1974-01-01

    Nitroglycerin is a volatile substance which evaporates from tablets if strict precautions are not taken. The tablets kept in small, amber, tightly capped glass bottles in a refrigerator maintain their potency for three to five months if bottles are opened once a week. After five months the unused tablets should be discarded. Tablets kept in a pill box and carried with the patient will deteriorate in a week and should be discarded thereafter. Cotton, plastic or paper stuffed in the bottle and frequent opening will reduce the potency of NG tablets considerably. Physicians, pharmacists and drug manufacturers should supply full instructions to patients on how to prevent rapid deterioration of their supply. PMID:4207612

  17. Abuse and diversion of buprenorphine sublingual tablets and film.

    PubMed

    Lavonas, Eric J; Severtson, S Geoffrey; Martinez, Erin M; Bucher-Bartelson, Becki; Le Lait, Marie-Claire; Green, Jody L; Murrelle, Lenn E; Cicero, Theodore J; Kurtz, Steven P; Rosenblum, Andrew; Surratt, Hilary L; Dart, Richard C

    2014-07-01

    Buprenorphine abuse is common worldwide. Rates of abuse and diversion of three sublingual buprenorphine formulations (single ingredient tablets; naloxone combination tablets and film) were compared. Data were obtained from the Researched Abuse, Diversion, and Addiction-Related Surveillance (RADARS) System Poison Center, Drug Diversion, Opioid Treatment (OTP), Survey of Key Informants' Patients (SKIP), and College Survey Programs through December 2012. To control for drug availability, event ratios (rates) were calculated quarterly, based on the number of patients filling prescriptions for each formulation ("unique recipients of a dispensed drug," URDD) and averaged and compared using negative binomial regression. Abuse rates in the OTP, SKIP, and College Survey Programs were greatest for single ingredient tablets, and abuse rates in the Poison Center Program and illicit diversion rates were greatest for the combination tablets. Combination film rates were significantly less than rates for either tablet formulation in all programs. No geographic pattern could be discerned.

  18. Abuse and diversion of buprenorphine sublingual tablets and film.

    PubMed

    Lavonas, Eric J; Severtson, S Geoffrey; Martinez, Erin M; Bucher-Bartelson, Becki; Le Lait, Marie-Claire; Green, Jody L; Murrelle, Lenn E; Cicero, Theodore J; Kurtz, Steven P; Rosenblum, Andrew; Surratt, Hilary L; Dart, Richard C

    2014-07-01

    Buprenorphine abuse is common worldwide. Rates of abuse and diversion of three sublingual buprenorphine formulations (single ingredient tablets; naloxone combination tablets and film) were compared. Data were obtained from the Researched Abuse, Diversion, and Addiction-Related Surveillance (RADARS) System Poison Center, Drug Diversion, Opioid Treatment (OTP), Survey of Key Informants' Patients (SKIP), and College Survey Programs through December 2012. To control for drug availability, event ratios (rates) were calculated quarterly, based on the number of patients filling prescriptions for each formulation ("unique recipients of a dispensed drug," URDD) and averaged and compared using negative binomial regression. Abuse rates in the OTP, SKIP, and College Survey Programs were greatest for single ingredient tablets, and abuse rates in the Poison Center Program and illicit diversion rates were greatest for the combination tablets. Combination film rates were significantly less than rates for either tablet formulation in all programs. No geographic pattern could be discerned. PMID:24680219

  19. 21 CFR 520.1199 - Ivermectin, pyrantel, and praziquantel tablets.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 6 2014-04-01 2014-04-01 false Ivermectin, pyrantel, and praziquantel tablets. 520.1199 Section 520.1199 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN... lb: use the appropriate combination of tablets. (2) Indications for use. Prevents canine...

  20. 21 CFR 520.1199 - Ivermectin, pyrantel, and praziquantel tablets.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 6 2013-04-01 2013-04-01 false Ivermectin, pyrantel, and praziquantel tablets. 520.1199 Section 520.1199 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN... lb: use the appropriate combination of tablets. (2) Indications for use. Prevents canine...

  1. Gravimetric Analysis of Bismuth in Bismuth Subsalicylate Tablets: A Versatile Quantitative Experiment for Undergraduate Laboratories

    ERIC Educational Resources Information Center

    Davis, Eric; Cheung, Ken; Pauls, Steve; Dick, Jonathan; Roth, Elijah; Zalewski, Nicole; Veldhuizen, Christopher; Coeler, Joel

    2015-01-01

    In this laboratory experiment, lower- and upper-division students dissolved bismuth subsalicylate tablets in acid and precipitated the resultant Bi[superscript 3+] in solution with sodium phosphate for a gravimetric determination of bismuth subsalicylate in the tablets. With a labeled concentration of 262 mg/tablet, the combined data from three…

  2. Integrating a Single Tablet PC in Chemistry, Engineering, and Physics Courses

    ERIC Educational Resources Information Center

    Rogers, James W.; Cox, James R.

    2008-01-01

    A tablet PC is a versatile computer that combines the computing power of a notebook with the pen functionality of a PDA (Cox and Rogers 2005b). The authors adopted tablet PC technology in order to improve the process and product of the lecture format in their chemistry, engineering, and physics courses. In this high-tech model, a single tablet PC…

  3. Monitoring the quality consistency of Weibizhi tablets by micellar electrokinetic chromatography fingerprints combined with multivariate statistical analyses, the simple quantified ratio fingerprint method, and the fingerprint-efficacy relationship.

    PubMed

    Liu, Yingchun; Sun, Guoxiang; Wang, Yan; Yang, Lanping; Yang, Fangliang

    2015-06-01

    Micellar electrokinetic chromatography fingerprinting combined with quantification was successfully developed and applied to monitor the quality consistency of Weibizhi tablets, which is a classical compound preparation used to treat gastric ulcers. A background electrolyte composed of 57 mmol/L sodium borate, 21 mmol/L sodium dodecylsulfate and 100 mmol/L sodium hydroxide was used to separate compounds. To optimize capillary electrophoresis conditions, multivariate statistical analyses were applied. First, the most important factors influencing sample electrophoretic behavior were identified as background electrolyte concentrations. Then, a Box-Benhnken design response surface strategy using resolution index RF as an integrated response was set up to correlate factors with response. RF reflects the effective signal amount, resolution, and signal homogenization in an electropherogram, thus, it was regarded as an excellent indicator. In fingerprint assessments, simple quantified ratio fingerprint method was established for comprehensive quality discrimination of traditional Chinese medicines/herbal medicines from qualitative and quantitative perspectives, by which the quality of 27 samples from the same manufacturer were well differentiated. In addition, the fingerprint-efficacy relationship between fingerprints and antioxidant activities was established using partial least squares regression, which provided important medicinal efficacy information for quality control. The present study offered an efficient means for monitoring Weibizhi tablet quality consistency.

  4. Calcification prevention tablets

    NASA Technical Reports Server (NTRS)

    Lindsay, Geoffrey A.; Hasting, Michael A.; Gustavson, Michael A.

    1991-01-01

    Citric acid tablets, which slowly release citric acid when flushed with water, are under development by the Navy for calcification prevention. The citric acid dissolves calcium carbonate deposits and chelates the calcium. For use in urinals, a dispenser is not required because the tablets are non-toxic and safe to handle. The tablets are placed in the bottom of the urinal, and are consumed in several hundred flushes (the release rate can be tailored by adjusting the formulation). All of the ingredients are environmentally biodegradable. Mass production of the tablets on commercial tableting machines was demonstrated. The tablets are inexpensive (about 75 cents apiece). Incidences of clogged pipes and urinals were greatly decreased in long term shipboard tests. The corrosion rate of sewage collection pipe (90/10 Cu/Ni) in citric acid solution in the laboratory is several mils per year at conditions typically found in traps under the urinals. The only shipboard corrosion seen to date is of the yellow brass urinal tail pieces. While this is acceptable, the search for a nontoxic corrosion inhibitor is underway. The shelf life of the tablets is at least one year if stored at 50 percent relative humidity, and longer if stored in sealed plastic buckets.

  5. Fast dispersible/slow releasing ibuprofen tablets.

    PubMed

    Fini, Adamo; Bergamante, Valentina; Ceschel, Gian Carlo; Ronchi, Celestino; de Moraes, Carlos Alberto Fonseca

    2008-05-01

    Eight formulations were developed containing ibuprofen in the form of orally disintegrating tablets. To prevent bitter taste and side effects of the drug, the drug was associated with Phospholipon 80H, a saturated lecithin, by wet granulation. The granules were then coated using different film forming agents (Kollicoat SR 30, Amprac 01, Kollidon 90F, Eudragit RD 100) obtaining four lots 1-4. Coated granules were then formulated with a sweetener (Aspartame), a mannitol-based diluent (Pearlitol SD 200) and Kollidon CL (1-4K) or Explotab (1-4E) were added as superdisintegrants and compacted under low compression force. The eight lots of tablets, 1-4K and 1-4E, were assessed if suitable as oral disintegrating tablets by determination of a range of technological parameters. Wetting and disintegregation time matched with the requirements of EP IV Ed., for almost all these formulations. Dissolution profiles suggested that the combined action of the hydrophobic lecithin and the coating delay the release of the drug from tablets with respect to when it is free or in the form of simple granules. By an appropriate combination of excipients it was thus possible to obtain orally disintegrating tablets and a delayed release of ibuprofen using simple and conventional techniques.

  6. Clinitest tablets poisoning

    MedlinePlus

    Urine sugar reagent poisoning; Anhydrous Benedict's reagent poisoning ... Symptoms of poisoning from Clinitest tablets are: Blood in urine Burns and burning pain in the mouth and throat Collapse Convulsions ...

  7. Axial strength test for round flat faced versus capsule shaped bilayer tablets.

    PubMed

    Franck, Jason; Abebe, Admassu; Keluskar, Rekha; Martin, Kyle; Majumdar, Antara; Kottala, Niranjan; Stamato, Howard

    2015-03-01

    There has been increasing interest in fixed dose combination (FDC) therapy. Multi-layer tablets are a popular choice among various technologies to deliver FDCs. In most cases, round flat faced tooling is used in testing tablets as they have the simplest geometry. However, shaped tooling is more common for commercial products and may have an effect on bilayer tablet strength. Capsule shaped bilayer tablets, similar to a commercial image, and holders conforming to the tablet topology, were compared with similar round flat faced bilayer tablets and their corresponding holders. Bilayer tablets were subjected to an axial test device, until fracture and the quantitative breaking force value was recorded. As the second layer compression force increases, regardless of holder design, an increase in breaking force occurs as expected. This consistent trend provides insight regarding the breaking force of capsule shaped bilayer tablets. The results of this study show that at lower second layer compression forces, tablet geometry does not significantly impact the results. However, at higher compression forces, a significant difference in breaking force between tablet geometries exists. Therefore, using a test geometry close to the final commercial tablet image is recommended to have the most accurate prediction for tablet breakage.

  8. A two-step strategy to design high bioavailable controlled-release nimodipine tablets: the push-pull osmotic pump in combination with the micronization/solid dispersion techniques.

    PubMed

    Liu, Xiaohong; Wang, Shang; Chai, Liqing; Zhang, Dong; Sun, Yinghua; Xu, Lu; Sun, Jin

    2014-01-30

    In order to decrease the fluctuation of blood concentration and to increase the oral bioavailability of nimodipine (NMD), a two-step strategy including the push-pull osmotic pump (PPOP) method in combination with micronization and solid dispersion techniques, was used to prepare the controlled-release high-bioavailability solid dosages. The optimization of formulation and process was conducted by comparing effects of different solubilization methods on release behavior of NMD. The in vitro dissolution studies indicated that both the two strategies were able to deliver NMD in the predetermined zero-order manner from 2 to 12h, regardless of effects of release media and agitation rates. Although the Cmax values of two PPOP tablets were lower than that of the reference formulation, both the Tmax values were prolonged, demonstrating the prominent controlled release performance. In comparison with the commercial reference tables, the relative bioavailability of the two formulations was 67.0% and 121.1%, respectively, indicating the solid dispersion technique was more efficient than the micronization technique in terms of solubilization capability and absorption enhancement. In summary, the two-step strategy, combining the push-pull osmotic pump method with the solid dispersion technique, is a very effective method to prepare high bioavailable controlled-release formulations of the poorly soluble drugs, i.e. NMD, taking into account the therapeutical efficiency and safety.

  9. CES 2011: Tablet Crazy

    ERIC Educational Resources Information Center

    Rapp, David

    2011-01-01

    Ereaders are so last year. Tablets were the watchword at this year's annual Consumer Electronics Show (CES) in Las Vegas, January 6-9. This year, the show set new records, with some 2700 companies from around the world exhibiting at the multiple exhibition halls and 30,000 attendees gawking at the products. What did they see? There were still some…

  10. A randomized, open, multicenter clinical study on the short course of intravenous infusion of 750 mg of levofloxacin and the sequential standard course of intravenous infusion/oral administration of 500 mg of levofloxacin for treatment of community-acquired pneumonia

    PubMed Central

    Zhao, Tiemei; Chen, Liang-An; Wang, Ping; Tian, Guizhen; Ye, Feng; Zhu, Huili; He, Bei; Zhang, Baiying; Shao, Changzhou; Jie, Zhijun; Gao, Xiwen; Wang, Dongxia; Song, Weidong; Pan, Zhijie; Chen, Jin; Zhang, Xingyi; Gao, Zhancheng; Chen, Ping

    2016-01-01

    Background To compare 5-day regimen of levofloxacin 750 mg IV daily with 7–14-day conventional regimen of levofloxacin 500 mg intravenous to oral (IV/PO) daily for treatment of community-acquired pneumonia (CAP) in Chinese population. Methods This was a non-inferiority study to assess the difference of clinical efficacy at the end of treatment (EOT) between two regimens. Adult CAP patients with CURB-65 score 0–2 were enrolled from 17 hospitals in China from November 2012 to July 2014. The subjects were randomized into levofloxacin 750 or 500 mg group and the clinical data were collected. Sputum and blood specimens were sent for bacterial culture. The urinary antigen of Streptococcus pneumoniae (S. pneumoniae) was detected as well. At EOT, the clinical efficacy (primary endpoint), microbiological efficacy and safety were evaluated. Results A total of 457 patients were enrolled. Intent-to-treat (ITT) for primary endpoint analysis and per-protocol set (PPS) populations were 448 and 427 patients respectively. The therapeutic durations were 4.86 and 10.35 days and the mean drug exposure was 3,641.4 and 5,169.6 mg in 750 and 500 mg groups respectively. The clinical efficacy rate was 91.40% (202/221) in 750 mg group and 94.27% (214/227) in 500 mg group (ITT, P=0.2449). The difference in clinical efficacy rate was −2.87 (95% CI: −7.64, 1.90) between the two groups. The non-inferiority hypothesis of two groups was tenable (Δ=10%). The bacterial eradication rate was 100.00% in both groups. The most common drug-related clinical adverse events were injection site and gastrointestinal reactions. The most common drug-related laboratory abnormalities were WBC decrease and ALT/AST elevation. No statistical difference was found between two groups (P>0.05). Conclusions The 5-day regimen of levofloxacin 750 mg daily is non-inferior to 7–14-day conventional regimen of 500 mg daily in clinical efficacy for treatment of mild to moderate Chinese CAP population. The short

  11. Monitoring and Evaluating the Quality Consistency of Compound Bismuth Aluminate Tablets by a Simple Quantified Ratio Fingerprint Method Combined with Simultaneous Determination of Five Compounds and Correlated with Antioxidant Activities

    PubMed Central

    Liu, Yingchun; Liu, Zhongbo; Sun, Guoxiang; Wang, Yan; Ling, Junhong; Gao, Jiayue; Huang, Jiahao

    2015-01-01

    A combination method of multi-wavelength fingerprinting and multi-component quantification by high performance liquid chromatography (HPLC) coupled with diode array detector (DAD) was developed and validated to monitor and evaluate the quality consistency of herbal medicines (HM) in the classical preparation Compound Bismuth Aluminate tablets (CBAT). The validation results demonstrated that our method met the requirements of fingerprint analysis and quantification analysis with suitable linearity, precision, accuracy, limits of detection (LOD) and limits of quantification (LOQ). In the fingerprint assessments, rather than using conventional qualitative “Similarity” as a criterion, the simple quantified ratio fingerprint method (SQRFM) was recommended, which has an important quantified fingerprint advantage over the “Similarity” approach. SQRFM qualitatively and quantitatively offers the scientific criteria for traditional Chinese medicines (TCM)/HM quality pyramid and warning gate in terms of three parameters. In order to combine the comprehensive characterization of multi-wavelength fingerprints, an integrated fingerprint assessment strategy based on information entropy was set up involving a super-information characteristic digitized parameter of fingerprints, which reveals the total entropy value and absolute information amount about the fingerprints and, thus, offers an excellent method for fingerprint integration. The correlation results between quantified fingerprints and quantitative determination of 5 marker compounds, including glycyrrhizic acid (GLY), liquiritin (LQ), isoliquiritigenin (ILG), isoliquiritin (ILQ) and isoliquiritin apioside (ILA), indicated that multi-component quantification could be replaced by quantified fingerprints. The Fenton reaction was employed to determine the antioxidant activities of CBAT samples in vitro, and they were correlated with HPLC fingerprint components using the partial least squares regression (PLSR) method

  12. Developing a mapping tool for tablets

    NASA Astrophysics Data System (ADS)

    Vaughan, Alan; Collins, Nathan; Krus, Mike

    2014-05-01

    Digital field mapping offers significant benefits when compared with traditional paper mapping techniques in that it provides closer integration with downstream geological modelling and analysis. It also provides the mapper with the ability to rapidly integrate new data with existing databases without the potential degradation caused by repeated manual transcription of numeric, graphical and meta-data. In order to achieve these benefits, a number of PC-based digital mapping tools are available which have been developed for specific communities, eg the BGS•SIGMA project, Midland Valley's FieldMove®, and a range of solutions based on ArcGIS® software, which can be combined with either traditional or digital orientation and data collection tools. However, with the now widespread availability of inexpensive tablets and smart phones, a user led demand for a fully integrated tablet mapping tool has arisen. This poster describes the development of a tablet-based mapping environment specifically designed for geologists. The challenge was to deliver a system that would feel sufficiently close to the flexibility of paper-based geological mapping while being implemented on a consumer communication and entertainment device. The first release of a tablet-based geological mapping system from this project is illustrated and will be shown as implemented on an iPad during the poster session. Midland Valley is pioneering tablet-based mapping and, along with its industrial and academic partners, will be using the application in field based projects throughout this year and will be integrating feedback in further developments of this technology.

  13. Development of Buccal Adhesive Tablet with Prolonged Antifungal activity: Optimization and ex vivo Deposition Studies.

    PubMed

    Madgulkar, A; Kadam, S; Pokharkar, V

    2009-05-01

    The purpose of the present work was to prepare buccal adhesive tablets of miconazole nitrate. The simplex centroid experimental design was used to arrive at optimum ratio of carbopol 934P, hydroxypropylmethylcellulose K4M and polyvinylpyrollidone, which will provide desired drug release and mucoadhesion. Swelling index, mucoadhesive strength and in vitro drug release of the prepared tablet was determined. The drug release and bioadhesion was dependent on type and relative amounts of the polymers. The optimized combination was subjected to in vitro antifungal activity, transmucosal permeation, drug deposition in mucosa, residence time and bioadhesion studies. IR spectroscopy was used to investigate any interaction between drug and excipients. Dissolution of miconazole from tablets was sustained for 6 h. based on the results obtained, it can be concluded that the prepared slow release buccoadhesive tablets of miconazole would markedly prolong the duration of antifungal activity. Comparison of in vitro antifungal activity of tablet with marketed gel showed that drug concentrations above the minimum inhibitory concentration were achieved immediately from both formulations but release from tablet was sustained up to 6 h, while the gel showed initially fast drug release, which did not sustain later. Drug permeation across buccal mucosa was minimum from the tablet as well as marketed gel; the deposition of drug in mucosa was higher in case of tablet. In vitro residence time and bioadhesive strength of tablet was higher than gel. Thus the buccoadhesive tablet of miconazole nitrate may offer better control of antifungal activity as compared to the gel formulation. PMID:20490296

  14. Assessing Student Writing on Tablets

    ERIC Educational Resources Information Center

    Davis, Laurie Laughlin; Orr, Aline; Kong, Xiaojing; Lin, Chow-Hong

    2015-01-01

    There is increasing expectation that schools should be able to use tablets for a range of instructional and assessment purposes. This article considers the comparability of student writing on tablets and laptops to ensure that writing assessment is conducted in a way that is fair to all students. Data were collected from a sample of 826 students…

  15. Tablet PCs: The Write Approach

    ERIC Educational Resources Information Center

    Milner, Jacob

    2006-01-01

    This article discusses the transforming effects of tablet PCs in the classroom. As 1-to-1 computing becomes the goal on K-12 campuses, school districts are turning to this newer, pen-based technology. Saint Mary's School's new Lenovo ThinkPad X41 tablet PCs had transformed the way Saint Mary's teachers did their jobs. Teachers created outlines for…

  16. Nanoscale toughening mechanism of nacre tablet.

    PubMed

    Zhang, Ning; Yang, Shengfeng; Xiong, Liming; Hong, Yu; Chen, Youping

    2016-01-01

    Nacre has attracted widespread interest because its unique hierarchical structure, which is assembled by 95 wt% brittle aragonite and 5 wt% soft organic materials, leads to several orders of improvement in fracture toughness. Apart from the well proposed toughening mechanisms such as mineral bridges and tablets interlocks, the organic materials including biopolymers between tablets and proteins exist within a tablet can also potentially improve the toughness. In this work, we employ a novel approach combining steered molecular dynamics (SMD) and classical molecular dynamics (MD) to build a model of mineral-protein composite to mimic nacre tablet. The critical role of protein in improving the fracture toughness of nacre is investigated for the first time. MD simulations of single crystalline aragonite, polycrystalline aragonite and mineral-protein composite under uniaxial tensile loading are performed, and the obtained constitutive responses are compared with experimental measurements of nacre under tension. It is shown that the fracture toughness of mineral-protein composite is significantly larger than that of single crystalline or polycrystalline aragonite. Detailed atomic configuration analyses reveal that the fracture of individual computer model is governed by its unique failure mechanisms. Dislocation motion and phase transformation are observed during the failure of single crystalline aragonite. Polycrystalline aragonite fails by the inter-granular cleavage, as well as phase transformation within grain. It is surprisingly noted that other than the stretching of protein chains on grain boundaries, intra-granular fracture is triggered in mineral-protein composites. Proteins serve as strong glue between the inorganic nanograins. It is believed that the strong electrostatic interaction between protein and aragonite nanograins, combined with the remarkable plastic ductility of protein lead to the intra-granular failure, which consequently enhance the fracture

  17. Formulation, Characterization and Physicochemical Evaluation of Potassium Citrate Effervescent Tablets

    PubMed Central

    Aslani, Abolfazl; Fattahi, Fatemeh

    2013-01-01

    Purpose: The aim of this study was to design and formulation of potassium citrate effervescent tablet for reduction of calcium oxalate and urate kidney stones in patients suffering from kidney stones. Methods: In this study, 13 formulations were prepared from potassium citrate and effervescent base in different concentration. The flowability of powders and granules was studied. Then effervescent tablets were prepared by direct compression, fusion and wet granulation methods. The prepared tablets were evaluated for hardness, friability, effervescent time, pH, content uniformity. To amend taste of formulations, different flavoring agents were used and then panel test was done by using Latin Square method by 30 volunteers. Results: Formulations obtained from direct compression and fusion methods had good flow but low hardness. Wet granulation improves flowability and other physicochemical properties such as acceptable hardness, effervescence time ≤3 minutes, pH<6, friability < 1%, water percentage < 0.5% and accurate content uniformity. In panel test, both of combination flavors; (orange - lemon) and (strawberry - raspberry) had good acceptability. Conclusion: The prepared tablets by wet granulation method using PVP solution had more tablet hardness. It is a reproducible process and suitable to produce granules that are compressed into effervescent tablets due to larger agglomerates. PMID:24312839

  18. Preparation and biological efficacy of haddock bone calcium tablets

    NASA Astrophysics Data System (ADS)

    Huo, Jiancong; Deng, Shanggui; Xie, Chao; Tong, Guozhong

    2010-03-01

    To investigate the possible use of waste products obtained after processing haddock, the present study prepared haddock bone calcium powder by NaOH and ethanol soaking (alkalinealcohol method) and prepared haddock bone calcium tablets using the powder in combination with appropriate excipients. The biological efficacy of the haddock bone calcium tablets was investigated using Wistar rats as an experiment model. Results show that the optimal parameters for the alkalinealcohol method are: NaOH concentration 1 mol/L, immersion time 30 h; ethanol concentration 60%, immersion time 15 h. A mixture of 2% polyvinylpyrrolidone in ethanol was used as an excipient at a ratio of 1:2 to full-cream milk powder, without the use of a disintegrating agent. This process provided satisfactory tablets in terms of rigidity and taste. Animal studies showed that the haddock bone calcium tablets at a dose of 2 g·kg-1·d-1 or 5g·kg-1·d-1 significantly increased blood calcium and phosphorus levels and bone calcium content in rats. Therefore, these tablets could be used for calcium supplementation and prevent osteoporosis. Although the reasons of high absorption in the rats fed with haddock bone calcium tablets are unclear, it is suggested that there are some factors, such as treatment with method of alkaline-alcohol or the added milk, may play positive roles in increasing absorption ratio.

  19. Recent development of single preparations and fixed-dose combination tablets for the treatment of non-insulin-dependent diabetes mellitus : A comprehensive summary for antidiabetic drugs.

    PubMed

    Li, Jianwen; Lian, He

    2016-06-01

    As a complex endocrine and metabolic disorder, type 2 diabetes mellitus (non-insulin-dependent diabetes mellitus, NIDDM) has become a major threat to human health. Because of the heterogeneous and progressive disorders induced by insulin resistance and pancreatic b-cell dysfunction, the treatment of NIDDM is still challenging. Although antidiabetic drugs with different pharmacological mechanisms of action have been used clinically, different degrees of undesirable glucose control and the incidences of a variety of side effects, including hypoglycemia, cardiovascular complications and weight gain require the better treatment options. This article has overviewed the current literature about commercially available antidiabetic drugs with different pharmacological mechanisms of action in the treatment of NIDDM, and summarized the published data regarding the efficacy, tolerability, and safety of currently available single preparations and fixed-dose combinations, aiming to provide important information for the development and application of antidiabetic drugs in the future. The literature search from 1989 to 2015 was conducted by PubMed, ScienceDirect, Springer, American Diabetes Association, and U.S. FDA Drugs databases. PMID:27230777

  20. Recent development of single preparations and fixed-dose combination tablets for the treatment of non-insulin-dependent diabetes mellitus : A comprehensive summary for antidiabetic drugs.

    PubMed

    Li, Jianwen; Lian, He

    2016-06-01

    As a complex endocrine and metabolic disorder, type 2 diabetes mellitus (non-insulin-dependent diabetes mellitus, NIDDM) has become a major threat to human health. Because of the heterogeneous and progressive disorders induced by insulin resistance and pancreatic b-cell dysfunction, the treatment of NIDDM is still challenging. Although antidiabetic drugs with different pharmacological mechanisms of action have been used clinically, different degrees of undesirable glucose control and the incidences of a variety of side effects, including hypoglycemia, cardiovascular complications and weight gain require the better treatment options. This article has overviewed the current literature about commercially available antidiabetic drugs with different pharmacological mechanisms of action in the treatment of NIDDM, and summarized the published data regarding the efficacy, tolerability, and safety of currently available single preparations and fixed-dose combinations, aiming to provide important information for the development and application of antidiabetic drugs in the future. The literature search from 1989 to 2015 was conducted by PubMed, ScienceDirect, Springer, American Diabetes Association, and U.S. FDA Drugs databases.

  1. Benefits of combined preventive therapy with co-trimoxazole and isoniazid in adults living with HIV: time to consider a fixed-dose, single tablet coformulation.

    PubMed

    Harries, Anthony D; Lawn, Stephen D; Suthar, Amitabh B; Granich, Reuben

    2015-12-01

    Antiretroviral therapy (ART) is the main intervention needed to reduce morbidity and mortality and to prevent tuberculosis in adults living with HIV. However, in most resource-limited countries, especially in sub-Saharan Africa, ART is started too late to have an effect with substantial early morbidity and mortality, and in high tuberculosis burden settings ART does not reduce the tuberculosis risk to that reported in individuals not infected with HIV. Co-trimoxazole preventive therapy started before or with ART, irrespective of CD4 cell count, reduces morbidity and mortality with benefits that continue indefinitely. Isoniazid preventive therapy as an adjunct to ART prevents tuberculosis in high-exposure settings, with long-term treatment likely to be needed to sustain this benefit. Unfortunately, both preventive therapies are underused in low-income and high-burden settings. ART development has benefited from patient-centred simplification with several effective regimens now available as a one per day pill. We argue that co-trimoxazole and isoniazid should also be combined into a single fixed-dose pill, along with pyridoxine (vitamin B6), that would be taken once per day to help with individual uptake and national scale-up of therapies. PMID:26515525

  2. Effect of Combined Use of Calcium and Vitamin B6 on Premenstrual Syndrome Symptoms: a Randomized Clinical Trial

    PubMed Central

    Masoumi, Seyedeh Zahra; Ataollahi, Maryam; Oshvandi, Khodayar

    2016-01-01

    Introduction: Premenstrual syndrome is one of the most common disorders in women, which includes a group of psychological and physical symptoms. The aim of this study was to examine the impact of combined use of calcium and vitamin B6 on premenstrual syndrome symptoms. Methods: This double blind randomized controlled was carried out on 76 students of Hamadan University of Medical Sciences. Students were randomly allocated to two groups. (38 people in each group). Student in intervention groups received calcium tablet (500mg) and vitamin B6 (40 mg) and student in intervention groups received only vitamin B6 twice a day for two consecutive months. The symptoms were assessed by Beck depression inventory (BDI) and daily symptom records (DSR) questionnaires. Analyses were carried out by test-retest method, Chi-square, Mann-Whitney, Independent t-test, and paired t-test using SPSS software ver.13. Results The result showed that although the severity of symptoms decreased in both groups, but this reduction was more significant in the combined calcium and vitamin B6 group. Conclusion: According to the result, using of combination of calcium and vitamin B6 leads to better controlling of the premenstrual syndrome symptoms. Therefore it is recommended for women who suffer from these syndromes. PMID:26989667

  3. 21 CFR 520.1510 - Nitenpyram tablets.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... flavored milbemycin/lufenuron tablets as in paragraph (d)(1)(ii)(B) of this section shall be by or on the... use of nitenpyram tablets as in paragraph (d)(1)(i)(B) of this section with either flavored lufenuron tablets as in § 520.1288(c)(1) of this chapter or flavored milbemycin and lufenuron tablets as in §...

  4. Formulation and optimization of orodispersible tablets of flutamide

    PubMed Central

    Elkhodairy, Kadria A.; Hassan, Maha A.; Afifi, Samar A.

    2013-01-01

    The present study aimed to formulate orodispersible tablets of flutamide (FTM) to increase its bioavailability. Orodispersible tablets were prepared by direct compression technique using three different approaches namely; super-disintegration, effervescence and sublimation. Different combined approaches were proposed and evaluated to optimize tablet characteristics. Sodium starch glycolate (SSG) was used as the superdisintegrant. The prepared powder mixtures were subjected to both pre and post compression evaluation parameters including; IR spectroscopy, micromeritics properties, tablet hardness, friability, wetting time, disintegration time and in-vitro drug release. IR studies indicated that there was no interaction between the drug and the excipients used except Ludipress. The results of micromeritics studies revealed that all formulations were of acceptable to good flowability. Tablet hardness and friability indicated good mechanical strength. Wetting and dispersion times decreased from 46 to 38 s by increasing the SSG concentration from 3.33 to 6.66% w/w in tablets prepared by superdisintegration method. The F8 formulation which was prepared by combined approaches of effervescence and superdisintegrant addition gave promising results for tablet disintegration and wetting times but failed to give faster dissolution rate. The incorporation of 1:5 solid dispersion of FTM: PEG 6000 instead of the pure drug in the same formulation increased the drug release rate from 73.12 to 96.99% after 15 min. This increase in the dissolution rate may be due to the amorphization of the drug during the solid dispersion preparation. The presence of the amorphous form of the drug was shown in the IR spectra. PMID:24493974

  5. Multispectral UV imaging for fast and non-destructive quality control of chemical and physical tablet attributes.

    PubMed

    Klukkert, Marten; Wu, Jian X; Rantanen, Jukka; Carstensen, Jens M; Rades, Thomas; Leopold, Claudia S

    2016-07-30

    Monitoring of tablet quality attributes in direct vicinity of the production process requires analytical techniques that allow fast, non-destructive, and accurate tablet characterization. The overall objective of this study was to investigate the applicability of multispectral UV imaging as a reliable, rapid technique for estimation of the tablet API content and tablet hardness, as well as determination of tablet intactness and the tablet surface density profile. One of the aims was to establish an image analysis approach based on multivariate image analysis and pattern recognition to evaluate the potential of UV imaging for automatized quality control of tablets with respect to their intactness and surface density profile. Various tablets of different composition and different quality regarding their API content, radial tensile strength, intactness, and surface density profile were prepared using an eccentric as well as a rotary tablet press at compression pressures from 20MPa up to 410MPa. It was found, that UV imaging can provide both, relevant information on chemical and physical tablet attributes. The tablet API content and radial tensile strength could be estimated by UV imaging combined with partial least squares analysis. Furthermore, an image analysis routine was developed and successfully applied to the UV images that provided qualitative information on physical tablet surface properties such as intactness and surface density profiles, as well as quantitative information on variations in the surface density. In conclusion, this study demonstrates that UV imaging combined with image analysis is an effective and non-destructive method to determine chemical and physical quality attributes of tablets and is a promising approach for (near) real-time monitoring of the tablet compaction process and formulation optimization purposes.

  6. Enhanced oral bioavailability of felodipine by novel solid self-microemulsifying tablets.

    PubMed

    Jing, Boyu; Wang, Zhiyuan; Yang, Rui; Zheng, Xia; Zhao, Jia; Tang, Si; He, Zhonggui

    2016-01-01

    The novel self-microemulsifying (SME) tablets were developed to enhance the oral bioavailability of a poor water-soluble drug felodipine (FDP). Firstly, FDP was dissolved in the optimized liquid self-microemusifying drug delivery systems (SMEDDS) containing Miglyol® 812, Cremophor® RH 40, Tween 80 and Transcutol® P, and the mixture was solidified with porous silicon dioxide and crospovidone as adsorbents. Then after combining the solidified powders with other excipients, the solid SME tablets were prepared by wet granulation-compression method. The prepared tablets possessed satisfactory characterization; the droplet size of the SME tablets following self-emulsification in water was nearly equivalent to the liquid SMEDDS (68.4 ± 14.0 and 64.4 ± 12.0 nm); differential scanning calorimetry (DSC) and powder X-ray diffractometry (PXRD) analysis demonstrated that FDP in SME tablets had undergone a polymorphism transition from a crystal form to an amorphous state, which was further confirmed by transmission electron microscopy (TEM). A similar dissolution performance of SME tablets and liquid SMEDDS was also obtained under the sink condition (85% within 10 min), both significantly higher than commercial tablets. The oral bioavailability was evaluated for the SME tablets, liquid SMEDDS and commercial conventional tablets in the fasted beagle dogs. The AUC of FDP from the SME tablets was about 2-fold greater than that of conventional tablets, but no significant difference was found when compared with the liquid SMEDDS. Accordingly, these preliminary results suggest that this formulation approach offers a useful large-scale producing method to prepare the solid SME tablets from the liquid SMEDDS for oral bioavailability equivalent enhancement of poorly soluble FDP. PMID:26177197

  7. Non-fatal overdose of duloxetine in combination with other antidepressants and benzodiazepines.

    PubMed

    Menchetti, Marco; Gozzi, Beatrice Ferrari; Saracino, Maria Addolorata; Mercolini, Laura; Petio, Carmine; Raggi, Maria Augusta

    2009-01-01

    The pharmaco-toxicological profile of duloxetine, a novel SNRI antidepressant, is still not completely known; in particular, intoxication cases have been scarcely studied. Here a duloxetine overdose case, in combination with other antidepressants and benzodiazepines, is reported and the chemical-clinical correlations discussed; this is probably the first detailed report of such a case. The patient referred to have ingested nine tablets of Cymbalta (more than 500 mg of duloxetine) and high amounts of four other drugs (venlafaxine, trazodone, sertraline and clonazepam). The patient was dozy and confused and some electrolyte imbalances were found. After gastrolavage, toxicological analyses revealed high plasma levels of duloxetine (384 ng/ml) and low levels of the other supposedly involved drugs. The overdose resulted to be not fatal and the outcome was relatively benign, also thanks to the fast emergency assistance. This case suggests that clinicians should be alerted to the possibility of toxic effects caused by simultaneous overdoses of duloxetine and other antidepressants and that caution should be used when prescribing more than one of these drugs to patients at risk of suicide.

  8. Astronomy Learning Activities for Tablets

    NASA Astrophysics Data System (ADS)

    Pilachowski, Catherine A.; Morris, Frank

    2015-08-01

    Four web-based tools allow students to manipulate astronomical data to learn concepts in astronomy. The tools are HTML5, CSS3, Javascript-based applications that provide access to the content on iPad and Android tablets. The first tool “Three Color” allows students to combine monochrome astronomical images taken through different color filters or in different wavelength regions into a single color image. The second tool “Star Clusters” allows students to compare images of stars in clusters with a pre-defined template of colors and sizes in order to produce color-magnitude diagrams to determine cluster ages. The third tool adapts Travis Rector’s “NovaSearch” to allow students to examine images of the central regions of the Andromeda Galaxy to find novae. After students find a nova, they are able to measure the time over which the nova fades away. A fourth tool, Proper Pair, allows students to interact with Hipparcos data to evaluate close double stars are physical binaries or chance superpositions. Further information and access to these web-based tools are available at www.astro.indiana.edu/ala/.

  9. Formulation and evaluation of fast dissolving tablets of cinnarizine using superdisintegrant blends and subliming material

    PubMed Central

    Basu, Biswajit; Bagadiya, Abhishek; Makwana, Sagar; Vipul, Vora; Batt, Devraj; Dharamsi, Abhay

    2011-01-01

    The aim of this investigation was to develop fast dissolving tablet of cinnarizine. A combination of super disintegrants, i.e., sodium starch glycolate (SSG) and crosscarmellose sodium (CCS) were used along with camphor as a subliming material. An optimized concentration of camphor was added to aid the porosity of the tablet. A 32 full factorial design was applied to investigate the combined effect of two formulation variables: Amount of SSG and CCS. Infrared (IR) spectroscopy was performed to identify the physicochemical interaction between drug and polymer. IR spectroscopy showed that there is no interaction of drug with polymer. In the present study, direct compression was used to prepare the tablets. The powder mixtures were compressed into tablet using flat face multi punch tablet machine. Camphor was sublimed from the tablet by exposing the tablet to vacuum drier at 60°C for 12 hours. All the formulations were evaluated for their characteristics such as average weight, hardness, wetting time, friability, content uniformity, dispersion time (DT), and dissolution rate. An optimized tablet formulation (F 9) was found to have good hardness of 3.30 ± 0.10 kg/cm2, wetting time of 42.33 ± 4.04 seconds, DT of 34.67 ± 1.53 seconds, and cumulative drug release of not less than 99% in 16 minutes. PMID:22247895

  10. Formulation and evaluation of fast dissolving tablets of cinnarizine using superdisintegrant blends and subliming material.

    PubMed

    Basu, Biswajit; Bagadiya, Abhishek; Makwana, Sagar; Vipul, Vora; Batt, Devraj; Dharamsi, Abhay

    2011-10-01

    The aim of this investigation was to develop fast dissolving tablet of cinnarizine. A combination of super disintegrants, i.e., sodium starch glycolate (SSG) and crosscarmellose sodium (CCS) were used along with camphor as a subliming material. An optimized concentration of camphor was added to aid the porosity of the tablet. A 3(2) full factorial design was applied to investigate the combined effect of two formulation variables: Amount of SSG and CCS. Infrared (IR) spectroscopy was performed to identify the physicochemical interaction between drug and polymer. IR spectroscopy showed that there is no interaction of drug with polymer. In the present study, direct compression was used to prepare the tablets. The powder mixtures were compressed into tablet using flat face multi punch tablet machine. Camphor was sublimed from the tablet by exposing the tablet to vacuum drier at 60°C for 12 hours. All the formulations were evaluated for their characteristics such as average weight, hardness, wetting time, friability, content uniformity, dispersion time (DT), and dissolution rate. An optimized tablet formulation (F 9) was found to have good hardness of 3.30 ± 0.10 kg/cm(2), wetting time of 42.33 ± 4.04 seconds, DT of 34.67 ± 1.53 seconds, and cumulative drug release of not less than 99% in 16 minutes. PMID:22247895

  11. Engaging or Distracting: Children's Tablet Computer Use in Education

    ERIC Educational Resources Information Center

    McEwen, Rhonda N.; Dubé, Adam K.

    2015-01-01

    Communications studies and psychology offer analytical and methodological tools that when combined have the potential to bring novel perspectives on human interaction with technologies. In this study of children using simple and complex mathematics applications on tablet computers, cognitive load theory is used to answer the question: how…

  12. Effect of the surface free energy of materials on the lamination tendency of bilayer tablets.

    PubMed

    Papós, Kitti; Kása, Péter; Ilič, Ilija; Blatnik-Urek, Sandra; Regdon, Géza; Srčič, Stane; Pintye-Hódi, Klára; Sovány, Tamás

    2015-12-30

    Dosage forms with fixed dose combinations of drugs is a frequent and advantageous mode of administration, but their production involves a number of technological problems. Numerous interactions in a homogeneous vehicle may be avoided through the use of layered tablets. The mechanical properties of these dosage forms depend on numerous process parameters and material characteristics. The aim of the present study was a detailed investigation of the relationships between the surface characteristics and deformation properties of tableting materials and the tendency of bilayer tablets to undergo lamination. Bilayer tablets were compressed from unlubricated materials with different plastic-elastic properties and surface free energies according to a mixed 2 and 3-level half-replicated factorial design. The results revealed that the surface characteristics play the main role in the lamination of layered tablets and the effect of the plastic-elastic behavior cannot be interpreted without a knowledge of these properties. PMID:26546910

  13. Quality by design, part I: application of NIR spectroscopy to monitor tablet manufacturing process.

    PubMed

    Tabasi, Simin Hassannejad; Fahmy, Raafat; Bensley, Dennis; O'Brien, Charles; Hoag, Stephen W

    2008-09-01

    To monitor tableting production using near infrared (NIR) spectroscopy, chemometric models were developed to analyze peak compression force, crushing strength and content uniformity. To measure tablet content uniformity, orbifloxacin tablets with drug content ranging from 60 to 90 mg were made and analyzed using ultraviolet (UV) and NIR spectroscopy. To assess the compression force and crushing strength, several batches of tablets were made on a Stokes B2 rotary tablet press and compression force was varied from 360 to 3500 lb. Principal component analysis (PCA) was used to identify tablets with regular and capped tablets breakage patterns. Comparison of statistical parameters showed that partial least squares (PLS) models gave better fit than the multiple linear regression (MLR) models. The best fit PLS models had a standard error of calibration (SEC) and a standard error of prediction (SEP) for content uniformity of 1.13 and 1.36 mg; for compression force of 69.86 and 59.48 lb and for crushing strength 0.55 kP and 0.57 kP, respectively. NIR spectroscopy in combination with multivariate modeling is a rapid and nondestructive technique that could reliably predict content uniformity, compression force and crushing strength for orbifloxacin tablets.

  14. Smartphones, Tablets Keep Kids Buzzing At Bedtime

    MedlinePlus

    ... page: https://medlineplus.gov/news/fullstory_161773.html Smartphones, Tablets Keep Kids Buzzing at Bedtime Children with ... 31, 2016 MONDAY, Oct. 31, 2016 (HealthDay News) -- Smartphones, tablets and other portable media devices can harm ...

  15. 21 CFR 520.581 - Dichlorophene tablets.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ...) Specifications. Each tablet contains 1 gram of dichlorophene. (b) Sponsor. See 023851 in § 510.600(c) of this.... Dogs(1) Amount. Single dose of 1 tablet (1 gram of dichlorophene) for each 10 pounds of body weight....

  16. Characterization of omega-3 tablets.

    PubMed

    Vestland, Tina Lien; Jacobsen, Øyvind; Sande, Sverre Arne; Myrset, Astrid Hilde; Klaveness, Jo

    2016-04-15

    Omega-3 nutraceuticals are extensively used as health supplements worldwide. Various administration forms for delivery of omega-3 are available. However, the niche omega-3 tablets have so far remained unexplored. In this work tablets containing 25-40% (w/w) omega-3 oil as triglycerides or ethyl esters were prepared utilizing a direct compaction grade powder with β-cyclodextrin as encapsulating agent. It was found that powders with up to 35% (w/w) triglyceride oil and 30% (w/w) ethyl ester oil, respectively, can be directly compressed into tablets of excellent quality. Physical properties of omega-3 containing powders and tablets are described. The powder X-ray diffractograms of the powders and crushed tablets show evidence of the formation of new crystalline phases not present in β-cyclodextrin. In addition, (1)H NMR data suggest that the ethyl esters form inclusion complexes with β-cyclodextrin. Compaction of other, commercially available, omega-3 powders was performed as a comparison and deemed unsuccessful. PMID:26616980

  17. Characterization of omega-3 tablets.

    PubMed

    Vestland, Tina Lien; Jacobsen, Øyvind; Sande, Sverre Arne; Myrset, Astrid Hilde; Klaveness, Jo

    2016-04-15

    Omega-3 nutraceuticals are extensively used as health supplements worldwide. Various administration forms for delivery of omega-3 are available. However, the niche omega-3 tablets have so far remained unexplored. In this work tablets containing 25-40% (w/w) omega-3 oil as triglycerides or ethyl esters were prepared utilizing a direct compaction grade powder with β-cyclodextrin as encapsulating agent. It was found that powders with up to 35% (w/w) triglyceride oil and 30% (w/w) ethyl ester oil, respectively, can be directly compressed into tablets of excellent quality. Physical properties of omega-3 containing powders and tablets are described. The powder X-ray diffractograms of the powders and crushed tablets show evidence of the formation of new crystalline phases not present in β-cyclodextrin. In addition, (1)H NMR data suggest that the ethyl esters form inclusion complexes with β-cyclodextrin. Compaction of other, commercially available, omega-3 powders was performed as a comparison and deemed unsuccessful.

  18. Galileo's Telescopy and Jupiter's Tablet

    NASA Astrophysics Data System (ADS)

    Usher, P. D.

    2003-12-01

    A previous paper (BAAS 33:4, 1363, 2001) reported on the dramatic scene in Shakespeare's Cymbeline that features the descent of the deity Jupiter. The paper suggested that the four ghosts circling the sleeping Posthumus denote the four Galilean moons of Jupiter. The god Jupiter commands the ghosts to lay a tablet upon the prone Posthumus, but says that its value should not be overestimated. When Posthumus wakens he notices the tablet, which he calls a "book." Not only has the deity's "tablet" become the earthling's "book," but it appears that the book has covers which Posthumus evidently recognizes because without even opening the book he ascribes two further properties to it: rarity, and the very property that Jupiter had earlier attributed, viz. that one must not read too much into it. The mystery deepens when the Jovian gift undergoes a second metamorphosis, to "label." With the help of the OED, the potentially disparate terms "tablet," "book," and "label," may be explained by terms appropriate either to supernatural or worldly beings. "Tablet" may recognize the Mosaic artifact, whereas "book" and "label" are probably mundane references to Galileo's Sidereus Nuncius which appeared shortly before Cymbeline. The message of the Olympian god indicates therefore that the book is unique even as its contents have limited value. The first property celebrates the fact that Galileo's book is the first of its kind, and the second advises that all results except the discovery of Jupiter's moons have been reported earlier, in Hamlet.

  19. 21 CFR 520.1451 - Moxidectin tablets.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 6 2012-04-01 2012-04-01 false Moxidectin tablets. 520.1451 Section 520.1451 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS ORAL DOSAGE FORM NEW ANIMAL DRUGS § 520.1451 Moxidectin tablets. (a) Specifications. Each tablet contains 30,...

  20. Mathematics Instruction and the Tablet PC

    ERIC Educational Resources Information Center

    Fister, K. Renee; McCarthy, Maeve L.

    2008-01-01

    The use of tablet PCs in teaching is a relatively new phenomenon. A cross between a notebook computer and a personal digital assistant (PDA), the tablet PC has all of the features of a notebook with the additional capability that the screen can also be used for input. Tablet PCs are usually equipped with a stylus that allows the user to write on…

  1. 21 CFR 520.1288 - Lufenuron tablets.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 6 2013-04-01 2013-04-01 false Lufenuron tablets. 520.1288 Section 520.1288 Food... DRUGS, FEEDS, AND RELATED PRODUCTS ORAL DOSAGE FORM NEW ANIMAL DRUGS § 520.1288 Lufenuron tablets. (a) Specifications—(1) Tablets containing 45, 90, 204.9, or 409.8 milligrams (mg) lufenuron for use as in...

  2. Scaffolding Equals Success in Teaching Tablet PCs

    ERIC Educational Resources Information Center

    Dickerson, Jeremy; Williams, Scott; Browning, J. B.

    2009-01-01

    After many years of using the mouse and keyboard as the primary means of computer input, people are seeing a strong surge into a new generation of input technologies such as tablet PCs. As more professionals adopt tablet PCs for use in the workplace, there is a subsequent increased demand for tablet PC instruction in the classroom. Examples of…

  3. Touch Screen Tablets and Emergent Literacy

    ERIC Educational Resources Information Center

    Neumann, Michelle M.; Neumann, David L.

    2014-01-01

    The use of touch screen tablets by young children is increasing in the home and in early childhood settings. The simple tactile interface and finger-based operating features of tablets may facilitate preschoolers' use of tablet application software and support their educational development in domains such as literacy. This article reviews…

  4. Principles of Tablet Computing for Educators

    ERIC Educational Resources Information Center

    Katzan, Harry, Jr.

    2015-01-01

    In the study of modern technology for the 21st century, one of the most popular subjects is tablet computing. Tablet computers are now used in business, government, education, and the personal lives of practically everyone--at least, it seems that way. As of October 2013, Apple has sold 170 million iPads. The success of tablets is enormous and has…

  5. Automated visual inspection of imprinted pharmaceutical tablets

    NASA Astrophysics Data System (ADS)

    Bukovec, Marko; Špiclin, Žiga; Pernuš, Franjo; Likar, Boštjan

    2007-09-01

    This paper is on automated visual inspection of tablets that may, in contrast to manual tablet sorting, provide objective and reproducible tablet quality assurance. Visual inspection of the ever-increasing numbers of produced imprinted tablets, regulatory enforced for unambiguous identification of active ingredients and dosage strength of each tablet, is especially demanding. The problem becomes more tractable by incorporating some a priori knowledge of the imprint shape and/or appearance. For this purpose, we consider two alternative automated tablet defect detection methods. The geometrical method, incorporating geometrical a priori knowledge of the imprint shape, enables specific inspection of the imprinted and non-imprinted tablet surface, while the statistical method exploits statistical a priori knowledge of tablet surface appearance, derived from a training image database. The two methods were evaluated on a large tablet image database, consisting of 3445 images of four types of imprinted tablets, with and without typical production defects. A 'gold standard' for testing the performances of the two inspection methods was established by manually classifying the tablets into good and five defective classes. The results, obtained by ROC (receiver operating characteristics) analysis, indicate that the statistical method yields better defect detection sensitivity and specificity than the geometrical method. Both presented image analysis methods are quite general and promising tools for automated visual inspection of imprinted pharmaceutical tablets.

  6. Formulation and evaluation of floating tablets of liquorice extract

    PubMed Central

    Ram, H. N. Aswatha; Lachake, Prachiti; Kaushik, Ujjwal; Shreedhara, C. S.

    2010-01-01

    Background: Floating tablets prolong the gastric residence time of drugs, improve bioavailability, and facilitate local drug delivery to the stomach. With this objective, floating tablets containing aqueous extract of liquorice as drug was prepared for the treatment of Helicobacter pylori and gastric ulcers. Methods: The aqueous extract of liquorice was standardized by HPTLC. Tablets containing HPMC K100M (hydrophilic polymer), liquorice extract, sodium bicarbonate (gas generating agent), talc, and magnesium stearate were prepared using direct compression method. The formulations were evaluated for physical parameters like diameter, thickness, hardness, friability, uniformity of weight, drug content, buoyancy time, dissolution, and drug release mechanism. The formulations were optimized on the basis of buoyancy time and in vitro drug release. Results: The diameter of all formulations was in the range 11.166–11.933 mm; thickness was in the range 4.02–4.086 mm. The hardness ranged from 3.1 to 3.5 kg/cm2. All formulations passed the USP requirements for friability and uniformity of weight. The buoyancy time of all tablet formulations was less than 5 min and tablet remained in floating condition throughout the study. All the tablet formulations followed zero-order kinetics and Korsemeyer-Peppas model in drug release. Conclusion: The optimized formulation was found to be F6 which released 98.3% of drug in 8 h in vitro, while the buoyancy time was 3.5 min. Formulations containing psyllium husk, sodium bicarbonate and HPMC K100M in combination can be a promising for gastroretentive drug delivery systems. PMID:21589757

  7. Water-sorption properties of tablet disintegrants.

    PubMed

    Khan, K A; Rhodes, C T

    1975-03-01

    The water-sorption properties of four tablet disintegrants, starch, sodium carboxymethylcellulose, sodium starch glycolate, and a cation-exchange resin, were examined in the form of powders and in compressed tablets prepared from calcium phosphate dibasic dihydrate. Dissolution properties of the tablets compare well to the water-sorption properties. The effect of storage in the presence of water vapor upon tablets containing the various disintegrants was evaluated in terms of tablet hardness and disintegration time. Differences in the effects produced in the various tablet formulations can be related to the differing mechanisms whereby the disintegrants effect tablet rupture. Photomicrographic data support the conclusions drawn from the water-sorption, disintegration, and dissolution studies. Sodium starch glycolate and the cation-exchange resin merit careful consideration by formulators using calcium phosphate dibasic dihydrate or similar direct compression matrixes. PMID:1151632

  8. Learning, Tablet, Culture-Coherence?

    ERIC Educational Resources Information Center

    Norqvist, Lars

    2016-01-01

    This paper presents understandings of learning in schools where Internet-enabled Information and Communication Technologies (ICTs) are taken for granted. The context is a full-scale 1:1 tablet project in Danish municipality schools where this study bring forward expressions of learning from one class (12-13 year old children) in order to offer…

  9. Bilayer matrix tablets for prolonged actions of metformin hydrochloride and repaglinide.

    PubMed

    He, Wei; Huang, Shijing; Zhou, Chunyan; Cao, Lin; Yao, Jing; Zhou, Jianping; Wang, Guangji; Yin, Lifang

    2015-04-01

    A combination therapy of metformin hydrochloride (MH) and repaglinide (RG) achieves a perfect glycemic control; however, the combination formulation of immediate release must be taken several times a day, compromising the therapeutic benefits and causing inconveniences to the patients. Herein, a bilayer matrix tablet that aimed at continuously releasing both MH and RG over time was developed, in which the two drugs were formulated into two separated layers. The tablets were prepared by wet granulation method, and the optimized formulation was obtained by evaluating the factors that affected the drug release. The bilayer tablets simultaneously released the two drugs over 12 h; and a better in vivo performance with a steady plasma concentration, markedly lower Cmax, prolonged Tmax, and perfect absorption was obtained. Summarily, the bilayer matrix tablets sustained both MH and RG release over time, thereby prolonging the actions for diabetic therapy and producing better health outcomes. PMID:25319054

  10. Pharmacokinetics of colon-specific pH and time-dependent flurbiprofen tablets.

    PubMed

    Vemula, Sateesh Kumar; Veerareddy, Prabhakar Reddy; Devadasu, Venkat Ratnam

    2015-09-01

    Present research deals with the development of compression-coated flurbiprofen colon-targeted tablets to retard the drug release in the upper gastro intestinal system, but progressively release the drug in the colon. Flurbiprofen core tablets were prepared by direct compression method and were compression coated using sodium alginate and Eudragit S100. The formulation is optimized based on the in vitro drug release study and further evaluated by X-ray imaging and pharmacokinetic studies in healthy humans for colonic delivery. The optimized formulation showed negligible drug release (4.33 ± 0.06 %) in the initial lag period followed by progressive release (100.78 ± 0.64 %) for 24 h. The X-ray imaging in human volunteers showed that the tablets reached the colon without disintegrating in the upper gastrointestinal tract. The C max of colon-targeted tablets was 12,374.67 ng/ml at T max 10 h, where as in case of immediate release tablets the C max was 15,677.52 ng/ml at T max 3 h, that signifies the ability of compression-coated tablets to target the colon. Development of compression-coated tablets using combination of time-dependent and pH-sensitive approaches was suitable to target the flurbiprofen to colon.

  11. THE INFLUENCE OF EXCIPIENTS ON PHYSICAL PROPERTIES OF TABLETS AND DISSOLUTION OF CAFFEINE.

    PubMed

    Szumiło, Michał; Świader, Katarzyna; Belniak, Piotr; Wojciechowska, Jessica; Poleszak, Ewa

    2015-01-01

    Caffeine is a common component of everyday diet but also a popular ingredient of some analgesics. Before it is administered to a patient, it has to be properly prepared using appropriate procedures to get the suitable drug form with various excipients. The tablets with caffeine were obtained using a wet granulation method. Three groups with four series of tablets were obtained with the constant concentration of caffeine but with different combinations of excipients, including potato starch and lactose, microcrystalline cellulose and lactose and D-mannitol alone. The binder solution of polyvinylpyrrolidone was added in all series of granules used in tabletting but in different quantities. A number of pharmacopoeial tests were conducted to determine the properties of the obtained tablets. All series of tablets positively passed physical tests. More than 80% of caffeine dissolved after 45 min from most series. Only two of 12 series of tablets did not meet pharmacopoeial requirements in a dissolution test. The results of the study indicated that proposed compositions of the tablets are suitable for administration of caffeine in that drug form. PMID:26647637

  12. 21 CFR 520.1284 - Sodium liothyronine tablets.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 6 2013-04-01 2013-04-01 false Sodium liothyronine tablets. 520.1284 Section 520... liothyronine tablets. (a) Specifications. Sodium liothyronine tablets consist of tablets intended for oral administration which contain liothyronine at 60 or 120 micrograms per tablet, as the sodium salt. (b)...

  13. 21 CFR 520.1284 - Sodium liothyronine tablets.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 6 2014-04-01 2014-04-01 false Sodium liothyronine tablets. 520.1284 Section 520... liothyronine tablets. (a) Specifications. Sodium liothyronine tablets consist of tablets intended for oral administration which contain liothyronine at 60 or 120 micrograms per tablet, as the sodium salt. (b)...

  14. Efficacy of a single dose of milbemycin oxime/praziquantel combination tablets, Milpro(®), against adult Echinococcus multilocularis in dogs and both adult and immature E. multilocularis in young cats.

    PubMed

    Cvejic, Dejan; Schneider, Claudia; Fourie, Josephus; de Vos, Christa; Bonneau, Stephane; Bernachon, Natalia; Hellmann, Klaus

    2016-03-01

    Two single-site, laboratory, negatively controlled, masked, randomised dose confirmation studies were performed: one in dogs, the other in cats. After a period of acclimatisation, both the dogs and cats were orally infected with Echinococcus multilocularis protoscoleces. In the dog study, 10 dogs received a single dose of Milpro® tablets at a minimum dose of 0.5 mg/kg milbemycin oxime and 5 mg/kg praziquantel 18 days post-infection and 10 dogs received no treatment. In the cat study, 10 cats received a single dose of Milpro® tablets at a minimum dose of 2 mg/kg milbemycin oxime and 5 mg/kg praziquantel 7 days post-infection, 10 cats received a single dose of the treatment 18 days post-infection and 10 cats remained untreated. In both studies, intestinal worm counts were performed 23 days post-infection at necropsy. No worms were retrieved from any of the 30 treated animals. Nine of 10 control dogs had multiple worms (geometric mean 91, arithmetic mean 304) and all 10 control cats had multiple worms (geometric mean 216, arithmetic mean 481). The difference in worm counts between all three treated groups and their controls was highly significant (ANOVA p values of log transformed data <0.0001). Efficacy of 100 % was demonstrated for the elimination of adult E. multilocularis in dogs and cats as well as for elimination of immature E. multilocularis in cats as evidenced by the effectiveness of treatment 7 days post-infection. The treatments were well accepted and tolerated, and there were no adverse drug reactions observed.

  15. Efficacy of a single dose of milbemycin oxime/praziquantel combination tablets, Milpro(®), against adult Echinococcus multilocularis in dogs and both adult and immature E. multilocularis in young cats.

    PubMed

    Cvejic, Dejan; Schneider, Claudia; Fourie, Josephus; de Vos, Christa; Bonneau, Stephane; Bernachon, Natalia; Hellmann, Klaus

    2016-03-01

    Two single-site, laboratory, negatively controlled, masked, randomised dose confirmation studies were performed: one in dogs, the other in cats. After a period of acclimatisation, both the dogs and cats were orally infected with Echinococcus multilocularis protoscoleces. In the dog study, 10 dogs received a single dose of Milpro® tablets at a minimum dose of 0.5 mg/kg milbemycin oxime and 5 mg/kg praziquantel 18 days post-infection and 10 dogs received no treatment. In the cat study, 10 cats received a single dose of Milpro® tablets at a minimum dose of 2 mg/kg milbemycin oxime and 5 mg/kg praziquantel 7 days post-infection, 10 cats received a single dose of the treatment 18 days post-infection and 10 cats remained untreated. In both studies, intestinal worm counts were performed 23 days post-infection at necropsy. No worms were retrieved from any of the 30 treated animals. Nine of 10 control dogs had multiple worms (geometric mean 91, arithmetic mean 304) and all 10 control cats had multiple worms (geometric mean 216, arithmetic mean 481). The difference in worm counts between all three treated groups and their controls was highly significant (ANOVA p values of log transformed data <0.0001). Efficacy of 100 % was demonstrated for the elimination of adult E. multilocularis in dogs and cats as well as for elimination of immature E. multilocularis in cats as evidenced by the effectiveness of treatment 7 days post-infection. The treatments were well accepted and tolerated, and there were no adverse drug reactions observed. PMID:26660919

  16. Erosive potential of vitamin and vitamin+mineral effervescent tablets.

    PubMed

    Wegehaupt, Florian J; Lunghi, Nancy; Hogger, Vanessa M G; Attin, Thomas

    2016-01-01

    The extrinsic sources for erosion-causing acids are primarily acidic beverages and foodstuffs. Effervescent tablets also contain organic acids (e.g. citric, tartaric, malic) in order to form carbon dioxide by contact with water – with the help of the carbonate salts of the tablets. To adequately inform patients about the possible erosive potential of effervescent tablets, this study was undertaken in order to investigate the erosive potential of effervescent tablets (ET), containing either a combination of vitamins and minerals or vitamins only, commercially available in Switzerland. One hundred and ninety-two bovine enamel samples were prepared and allocated to 16 groups (A–H and 1–8; n = 12/group). Samples were eroded (120 s/erosive cycle) in freshly prepared solutions (200 ml/12 samples) comprised of tap water and a supplement as follows: none (control groups, A and 1); vitamin+mineral ET: Qualite and Prix (B), Optisana (C), Well and Active (D), Actilife All in One (E), Berocca (F), Isostar (G) and Qualite and Prix Mg + Vit C (H); vitamin ET: Actilife-Multivitamin (2), Sunlife Vitamin C (3), Optisana Vitamin C (4), Optisana Multivitamin (5), Well and Active Multivitamin (6), Kneipp Vitamin C+Zink (7) and Sunlife Multivitamin (8). Enamel loss was measured using profilometry after 10 and 20 erosive cycles. For the vitamin+mineral ET, no loss was observed in groups B–E. Significantly highest enamel loss (mean ± SD) after 20 cycles was observed for Isostar (5.26 ± 0.76 µm) and Qualite and Prix Mg + Vit C (5.12 ± 0.67 µm). All vitamine ET showed erosive enamel loss. Significantly highest loss was observed for Sunlife Multivitamin (8.45 ± 1.08 µm), while the lowest loss was observed for Actilife-Multivitamin (5.61 ± 1.08 µm) after 20 cycles. Some of the tested effervescent tablets showed a considerable erosive potential and patients should be informed accordingly.

  17. 21 CFR 520.2150a - Stanozolol tablets.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ...) Administered orally to cats and small breeds of dogs, 1/2 to 1 tablet twice daily for several weeks; to large breeds of dogs, 1 to 2 tablets twice daily for several weeks. The tablets may be crushed and...

  18. Effect of geometry on drug release from 3D printed tablets.

    PubMed

    Goyanes, Alvaro; Robles Martinez, Pamela; Buanz, Asma; Basit, Abdul W; Gaisford, Simon

    2015-10-30

    The aim of this work was to explore the feasibility of combining hot melt extrusion (HME) with 3D printing (3DP) technology, with a view to producing different shaped tablets which would be otherwise difficult to produce using traditional methods. A filament extruder was used to obtain approx. 4% paracetamol loaded filaments of polyvinyl alcohol with characteristics suitable for use in fused-deposition modelling 3DP. Five different tablet geometries were successfully 3D-printed-cube, pyramid, cylinder, sphere and torus. The printing process did not affect the stability of the drug. Drug release from the tablets was not dependent on the surface area but instead on surface area to volume ratio, indicating the influence that geometrical shape has on drug release. An erosion-mediated process controlled drug release. This work has demonstrated the potential of 3DP to manufacture tablet shapes of different geometries, many of which would be challenging to manufacture by powder compaction. PMID:25934428

  19. Coherent anti-Stokes Raman scattering (CARS) microscopy visualizes pharmaceutical tablets during dissolution.

    PubMed

    Fussell, Andrew L; Kleinebudde, Peter; Herek, Jennifer; Strachan, Clare J; Offerhaus, Herman L

    2014-01-01

    Traditional pharmaceutical dissolution tests determine the amount of drug dissolved over time by measuring drug content in the dissolution medium. This method provides little direct information about what is happening on the surface of the dissolving tablet. As the tablet surface composition and structure can change during dissolution, it is essential to monitor it during dissolution testing. In this work coherent anti-Stokes Raman scattering microscopy is used to image the surface of tablets during dissolution while UV absorption spectroscopy is simultaneously providing inline analysis of dissolved drug concentration for tablets containing a 50% mixture of theophylline anhydrate and ethyl cellulose. The measurements showed that in situ CARS microscopy is capable of imaging selectively theophylline in the presence of ethyl cellulose. Additionally, the theophylline anhydrate converted to theophylline monohydrate during dissolution, with needle-shaped crystals growing on the tablet surface during dissolution. The conversion of theophylline anhydrate to monohydrate, combined with reduced exposure of the drug to the flowing dissolution medium resulted in decreased dissolution rates. Our results show that in situ CARS microscopy combined with inline UV absorption spectroscopy is capable of monitoring pharmaceutical tablet dissolution and correlating surface changes with changes in dissolution rate. PMID:25045833

  20. Design, Development and Optimization of S (-) Atenolol Floating Sustained Release Matrix Tablets Using Surface Response Methodology

    PubMed Central

    Gunjal, P. T.; Shinde, M. B.; Gharge, V. S.; Pimple, S. V.; Gurjar, M. K.; Shah, M. N.

    2015-01-01

    The objective of this present investigation was to develop and formulate floating sustained release matrix tablets of s (-) atenolol, by using different polymer combinations and filler, to optimize by using surface response methodology for different drug release variables and to evaluate the drug release pattern of the optimized product. Floating sustained release matrix tablets of various combinations were prepared with cellulose-based polymers: Hydroxypropyl methylcellulose, sodium bicarbonate as a gas generating agent, polyvinyl pyrrolidone as a binder and lactose monohydrate as filler. The 32 full factorial design was employed to investigate the effect of formulation variables on different properties of tablets applicable to floating lag time, buoyancy time, % drug release in 1 and 6 h (D1 h,D6 h) and time required to 90% drug release (t90%). Significance of result was analyzed using analysis of non variance and P < 0.05 was considered statistically significant. S (-) atenolol floating sustained release matrix tablets followed the Higuchi drug release kinetics that indicates the release of drug follows anomalous (non-Fickian) diffusion mechanism. The developed floating sustained release matrix tablet of improved efficacy can perform therapeutically better than a conventional tablet. PMID:26798171

  1. Design, Development and Optimization of S (-) Atenolol Floating Sustained Release Matrix Tablets Using Surface Response Methodology.

    PubMed

    Gunjal, P T; Shinde, M B; Gharge, V S; Pimple, S V; Gurjar, M K; Shah, M N

    2015-01-01

    The objective of this present investigation was to develop and formulate floating sustained release matrix tablets of s (-) atenolol, by using different polymer combinations and filler, to optimize by using surface response methodology for different drug release variables and to evaluate the drug release pattern of the optimized product. Floating sustained release matrix tablets of various combinations were prepared with cellulose-based polymers: Hydroxypropyl methylcellulose, sodium bicarbonate as a gas generating agent, polyvinyl pyrrolidone as a binder and lactose monohydrate as filler. The 3(2) full factorial design was employed to investigate the effect of formulation variables on different properties of tablets applicable to floating lag time, buoyancy time, % drug release in 1 and 6 h (D1 h,D6 h) and time required to 90% drug release (t90%). Significance of result was analyzed using analysis of non variance and P < 0.05 was considered statistically significant. S (-) atenolol floating sustained release matrix tablets followed the Higuchi drug release kinetics that indicates the release of drug follows anomalous (non-Fickian) diffusion mechanism. The developed floating sustained release matrix tablet of improved efficacy can perform therapeutically better than a conventional tablet. PMID:26798171

  2. Accuracy of tablet splitting: Comparison study between hand splitting and tablet cutter

    PubMed Central

    Habib, Walid A.; Alanizi, Abdulaziz S.; Abdelhamid, Magdi M.; Alanizi, Fars K.

    2013-01-01

    Background Tablet splitting is often used in pharmacy practice to adjust the administered doses. It is also used as a method of reducing medication costs. Objective To investigate the accuracy of tablet splitting by comparing hand splitting vs. a tablet cutter for a low dose drug tablet. Methods Salbutamol tablets (4 mg) were chosen as low dose tablets. A randomly selected equal number of tablets were split by hand and a tablet cutter, and the remaining tablets were kept whole. Weight variation and drug content were analysed for salbutamol in 0.1 N HCl using a validated spectrophotometric method. The percentages by which each whole tablet’s or half-tablet’s drug content and weight difference from sample mean values were compared with USP specification ranges for drug content. The %RSD was also calculated in order to determine whether the drugs met USP specification for %RSD. The tablets and half tablets were scanned using electron microscopy to show any visual differences arising from splitting. Results 27.5% of samples differed from sample mean values by a percentage that fell outside of USP specification for weight, of which 15% from the tablet cutter and 25% from those split by hand fell outside the specifications. All whole tablets and half tablets met the USP specifications for drug content but the variation of content between the two halves reached 21.3% of total content in case of hand splitting, and 7.13% only for the tablet cutter. The %RSDs for drug content and weight met the USP specification for whole salbutamol tablets and the half tablets which were split by tablet cutter. The halves which were split by hand fell outside the specification for %RSD (drug content = 6.43%, weight = 8.33%). The differences were visually clear in the electron microscope scans. Conclusion Drug content variation in half-tablets appeared to be attributable to weight variation occurring during the splitting process. This could have serious clinical consequences for

  3. Considerations about the theoretically expected crushing strength of tablets from binary powder mixtures: double layer tablets versus arithmetic additivity rule.

    PubMed

    Belda, Petra M; Mielck, Jobst B

    2006-11-01

    The theoretically expected breaking strength of tablets from powder mixtures is often calculated by the weighted arithmetic mean from the breaking strength of the single components, which corresponds to a linear interpolation. The validity of this additivity of fracture strength shall be evaluated by the underlying model of parallel couplings. It assumes the components linked in parallel with respect to the direction of loading during diametrical strength testing. Parallel couplings were experimentally realised by the preparation of double layer tablets from crystalline and spray-dried lactose on the one hand and from maltitol and metamizol-sodium on the other. Constant total true volumes of the single substances and of layered powders in varying ratios of true volume were compressed on an eccentric tabletting machine to constant geometric mean punch force. Simulated crushing profiles of parallel couplings were derived from force-displacement profiles measured during diametrical compression of the one-component tablets. At given finely graded deformation levels, the forces exerted by the components during loading were added in the proportion of the true volume fractions of the components in the coupling. The results from the experiments and from the simulations are in good accordance. They demonstrate that a linear change of the crushing strength in dependence on the true volume fraction of the components can only be assumed if the single components deform to the same extent up to the point of fracture. This behaviour was approximately found with the parallel lactose system. In all other cases it must be expected that the crushing strength of parallel systems will be lowered beneath the weighted arithmetic mean values or even below the crushing strength of the single components. The latter was observed with the maltitol-metamizol combinations. Thus, if tablets from binary powder mixtures exhibit a crushing strength depression, this is not necessarily an indication

  4. Prediction of dissolution profiles by non-destructive near infrared spectroscopy in tablets subjected to different levels of strain.

    PubMed

    Hernandez, Eduardo; Pawar, Pallavi; Keyvan, Golshid; Wang, Yifan; Velez, Natasha; Callegari, Gerardo; Cuitino, Alberto; Michniak-Kohn, Bozena; Muzzio, Fernando J; Romañach, Rodolfo J

    2016-01-01

    This study describes how the strain on formulation components affects dissolution and how near infrared spectroscopy can be used to predict dissolution. Strain (exposure to shear stress) applied during powder mixing affects the interaction between formulation components. Particles experience shear strain when they move relative to each other in a process affecting the properties of the final product. This stress affects the dissolution of oral solid dosages forms. However, dissolution testing destroys the entire tablet, making it impossible to further evaluate tablet properties when an out of specification result is obtained. Thus, a nondestructive technique such as near infrared spectroscopy is desirable to predict dissolution. The aim of this study was to predict dissolution on tablets with different levels of strain (shear) using near infrared spectroscopy in combination with multivariate data analysis. Shear was induced using a modified Couette cell on the powder mixture and tablets from these mixtures were produced using a tablet press emulator. Tablets produced with different strain levels were measured using near infrared spectroscopy. Spectra were obtained in diffuse reflectance mode and pretreated with baseline correction to maintain the physical and chemical information of the tablets. Dissolution profiles were obtained using USP Apparatus 2 as a reference method. Principal component analysis was used to study the sources of variation in the spectra obtained. Partial least squares 2 was used to predict dissolution on tablets with different levels of strain.

  5. Audio podcasting in a tablet PC-enhanced biochemistry course.

    PubMed

    Lyles, Heather; Robertson, Brian; Mangino, Michael; Cox, James R

    2007-11-01

    This report describes the effects of making audio podcasts of all lectures in a large, basic biochemistry course promptly available to students. The audio podcasts complement a previously described approach in which a tablet PC is used to annotate PowerPoint slides with digital ink to produce electronic notes that can be archived. The fundamentals of this approach are described, and data from student attitudinal and informational surveys are presented. The survey data suggest that the students have a positive attitude toward the combination of tablet-based instruction and audio podcasting. In addition, three students provide testimonials on how these technological tools allowed them to utilize their preferred learning styles to succeed in the course. Possible negative consequences of this approach, in terms of class attendance and note taking, are also analyzed and discussed.

  6. 21 CFR 520.1510 - Nitenpyram tablets.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ...) Specifications. Each tablet contains 11.4 or 57 milligrams (mg) nitenpyram. (b) Sponsor. See No. 058198 in § 510...) Cats—(i) Amount—(A) One 11.4-mg tablet, as needed, for use as in paragraph (d)(2)(ii)(A) of this... section. (ii) Indications for use—(A) For the treatment of flea infestations on cats and kittens 4...

  7. 21 CFR 520.1510 - Nitenpyram tablets.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ...) Specifications. Each tablet contains 11.4 or 57 milligrams (mg) nitenpyram. (b) Sponsor. See No. 058198 in § 510...) Cats—(i) Amount—(A) One 11.4-mg tablet, as needed, for use as in paragraph (d)(2)(ii)(A) of this... section. (ii) Indications for use—(A) For the treatment of flea infestations on cats and kittens 4...

  8. Putting Tablet PCs to the Test

    ERIC Educational Resources Information Center

    Amirian, Susan

    2004-01-01

    Like many educators, the author and her colleagues (five faculty members and two IT techs) in the department of Media Communications and Technology at East Stroudsburg University in Pennsylvania were interested to find out the status of tablet PCs in education. Microsoft listed 10 manufacturers of tablet PCs following two forms: the slate and the…

  9. 21 CFR 520.2088 - Roxarsone tablets.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ...) Amount. Dissolve 8 tablets in each gallon of drinking water (0.008 percent roxarsone). (b) Indications... animals must consume enough medicated water to provide a therapeutic dose. Withdraw 5 days before... chickens and growing turkeys—(i) Amount. 1 tablet in each gallon of drinking water (0.002 percent...

  10. 21 CFR 520.2088 - Roxarsone tablets.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... period. Withdraw 5 days before slaughter. Use as sole source of organic arsenic. (ii) Growing chickens—(a.... Withdraw 5 days before slaughter. Use as sole source of organic arsenic. (b)(1) Specifications. Each tablet... slaughter. Use as sole source of organic arsenic. (ii) (c)(1) Specifications. Each tablet contains...

  11. 21 CFR 520.2088 - Roxarsone tablets.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... period. Withdraw 5 days before slaughter. Use as sole source of organic arsenic. (ii) Growing chickens—(a.... Withdraw 5 days before slaughter. Use as sole source of organic arsenic. (b)(1) Specifications. Each tablet... slaughter. Use as sole source of organic arsenic. (ii) (c)(1) Specifications. Each tablet contains...

  12. Tablet PCs: A Physical Educator's New Clipboard

    ERIC Educational Resources Information Center

    Nye, Susan B.

    2010-01-01

    Computers in education have come a long way from the abacus of 5,000 years ago to the desktop and laptop computers of today. Computers have transformed the educational environment, and with each new iteration of smaller and more powerful machines come additional advantages for teaching practices. The Tablet PC is one. Tablet PCs are fully…

  13. How Tablets Are Utilized in the Classroom

    ERIC Educational Resources Information Center

    Ditzler, Christine; Hong, Eunsook; Strudler, Neal

    2016-01-01

    New technologies are a large part of the educational landscape in the 21st century. Emergent technologies are implemented in the classroom at an exponential rate. The newest technology to be added to the daily classroom is the tablet computer. Understanding students' and teachers' perceptions about the role of tablet computers is important as this…

  14. Enhancing Student Performance Using Tablet Computers

    ERIC Educational Resources Information Center

    Enriquez, Amelito G.

    2010-01-01

    Tablet PCs have the potential to change the dynamics of classroom interaction through wireless communication coupled with pen-based computing technology that is suited for analyzing and solving engineering problems. This study focuses on how tablet PCs and wireless technology can be used during classroom instruction to create an Interactive…

  15. 21 CFR 520.1870 - Praziquantel tablets.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 6 2011-04-01 2011-04-01 false Praziquantel tablets. 520.1870 Section 520.1870 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS ORAL DOSAGE FORM NEW ANIMAL DRUGS § 520.1870 Praziquantel tablets....

  16. 21 CFR 520.1510 - Nitenpyram tablets.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) ANIMAL... order of a licensed veterinarian. (d) Conditions of use—(1) Dogs—(i) Amount—(A) One 11.4-mg tablet for dogs weighing less than 25 pounds (lb) or one 57-mg tablet for dogs weighing more than 25 lb, as...

  17. 21 CFR 520.1510 - Nitenpyram tablets.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) ANIMAL... order of a licensed veterinarian. (d) Conditions of use—(1) Dogs—(i) Amount—(A) One 11.4-mg tablet for dogs weighing less than 25 pounds (lb) or one 57-mg tablet for dogs weighing more than 25 lb, as...

  18. 21 CFR 520.581 - Dichlorophene tablets.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 6 2010-04-01 2010-04-01 false Dichlorophene tablets. 520.581 Section 520.581 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) ANIMAL.... Dogs—(1) Amount. Single dose of 1 tablet (1 gram of dichlorophene) for each 10 pounds of body...

  19. 21 CFR 520.312 - Carnidazole tablets.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... this chapter. (c) Conditions of use—(1) Amount. Adult pigeons: 1 tablet (10 milligrams); newly weaned pigeons: 1/2 tablet (5 milligrams). (2) Indications for use. For treating trichomoniasis (canker) in ornamental and homing pigeons. (3) Limitations. Not for use in pigeons intended for human food. Consult...

  20. 21 CFR 520.312 - Carnidazole tablets.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... this chapter. (c) Conditions of use—(1) Amount. Adult pigeons: 1 tablet (10 milligrams); newly weaned pigeons: 1/2 tablet (5 milligrams). (2) Indications for use. For treating trichomoniasis (canker) in ornamental and homing pigeons. (3) Limitations. Not for use in pigeons intended for human food. Consult...

  1. 21 CFR 520.312 - Carnidazole tablets.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... this chapter. (c) Conditions of use—(1) Amount. Adult pigeons: 1 tablet (10 milligrams); newly weaned pigeons: 1/2 tablet (5 milligrams). (2) Indications for use. For treating trichomoniasis (canker) in ornamental and homing pigeons. (3) Limitations. Not for use in pigeons intended for human food. Consult...

  2. 21 CFR 520.312 - Carnidazole tablets.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... this chapter. (c) Conditions of use—(1) Amount. Adult pigeons: 1 tablet (10 milligrams); newly weaned pigeons: 1/2 tablet (5 milligrams). (2) Indications for use. For treating trichomoniasis (canker) in ornamental and homing pigeons. (3) Limitations. Not for use in pigeons intended for human food. Consult...

  3. 21 CFR 520.312 - Carnidazole tablets.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... this chapter. (c) Conditions of use(1) Amount. Adult pigeons: 1 tablet (10 milligrams); newly weaned pigeons: 1/2 tablet (5 milligrams). (2) Indications for use. For treating trichomoniasis (canker) in ornamental and homing pigeons. (3) Limitations. Not for use in pigeons intended for human food. Consult...

  4. Polymeric mucoadhesive tablets for topical or systemic buccal delivery of clonazepam: Effect of cyclodextrin complexation.

    PubMed

    Mura, P; Cirri, M; Mennini, N; Casella, G; Maestrelli, F

    2016-11-01

    Two kinds of mucoadhesive buccal tablets of clonazepam (CLZ) were developed to provide, a prolonged local or systemic delivery respectively. Tablets prepared by direct compression of combinations of different polymers were tested for swelling, erosion and residence time properties. Carbopol 971P/hydroxypropylmethylcellulose and Poloxamer/chitosan mixtures were the best and were selected for drug loading. The effect of CLZ complexation with different cyclodextrins was investigated. Randomly-methylated-βCD (RAMEßCD) was the most effective, allowing 100% drug released increase from local-delivery buccal tablets. Kollicoat was the best among the tested backing-layers, assuring a unidirectional release from systemic-delivery buccal tablets (<0.8% drug released in simulated saliva after 24h). In vitro permeation studies from coated-tablets showed that CLZ loading as RAMEßCD-coground enabled a 5-times increase in drug flux and permeability. Therefore, complexation with RAMEßCD was a successful strategy to improve the CLZ performance from buccal tablets for both local or systemic action. PMID:27516327

  5. Development and Characterization of Novel Floating-Mucoadhesive Tablets Bearing Venlafaxine Hydrochloride

    PubMed Central

    Misra, Raghvendra

    2016-01-01

    The present investigation is concerned about the development of floating bioadhesive drug delivery system of venlafaxine hydrochloride which after oral administration exhibits a unique combination of floating and bioadhesion to prolong gastric residence time and increase drug bioavailability within the stomach. The floating bioadhesive tablets were prepared by the wet granulation method using different ratios of hydroxypropyl methyl cellulose (HPMC K4MCR) and Carbopol 934PNF as polymers. Sodium bicarbonate (NaHCO3) and citric acid were used as gas (CO2) generating agents. Tablets were characterized for floating properties, in vitro drug release, detachment force, and swelling index. The concentration of hydroxypropyl methyl cellulose and Carbopol 934PNF significantly affects the in vitro drug release, floating properties, detachment force, and swelling properties of the tablets. The optimized formulation showed the floating lag time 72 ± 2.49 seconds and duration of floating 24.50 ± 0.74 hr. The in vitro release studies and floating behavior were studied in simulated gastric fluid (SGF) at pH 1.2. Different drug release kinetics models were also applied. The in vitro drug release from tablets was sufficiently sustained (more than 18 hr) and the Fickian transports of the drug from the tablets were confirmed. The radiological evidence suggests that the tablets remained buoyant and altered position in the stomach of albino rabbit and mean gastric residence time was prolonged (more than > 6 hr). PMID:27274884

  6. A novel ketoconazole bioadhesive effervescent tablet for vaginal delivery: design, in vitro and 'in vivo' evaluation.

    PubMed

    Wang, Lei; Tang, Xing

    2008-02-28

    Bioadhesive tablet formulations of ketoconazole for vaginal delivery were studied. Carbomer (Carbopol 974P, Carbopol 934P), hydroxypropylmethyl cellulose (HPMC) and hydroxypropyl cellulose (HPC) were used as candidate bioadhesive polymers. Effervescent was incorporated into the formulations as a disintegration agent. The swelling behavior and bioadhesive strength of the drug-free tablets were investigated. Carbopol 934P was selected as biopolymer in combination with HPMC or HPC at different ratios to develop five drug-loaded formulations. The swellings, tackiness and in vitro release were studied on the tablets. A good sustained effect and a moderate bioadhesion were obtained with the tablets. The formulation containing 100mg of effervescent, with the Carbopol 934P:HPC ratio of 1:9, seemed to be the optimum one for the tablet. In vivo drug residence tests were carried out by administering the preferred formulation to female rats. The results showed that the drug remaining followed a one-order model. Even after 24h of administration in vagina of rats, 17% of the original employed drug was retained on the vaginal tissue. Our study may provide a potential vaginal tablet formulation of ketoconazole against Candida albicans. PMID:17920795

  7. A novel ketoconazole bioadhesive effervescent tablet for vaginal delivery: design, in vitro and 'in vivo' evaluation.

    PubMed

    Wang, Lei; Tang, Xing

    2008-02-28

    Bioadhesive tablet formulations of ketoconazole for vaginal delivery were studied. Carbomer (Carbopol 974P, Carbopol 934P), hydroxypropylmethyl cellulose (HPMC) and hydroxypropyl cellulose (HPC) were used as candidate bioadhesive polymers. Effervescent was incorporated into the formulations as a disintegration agent. The swelling behavior and bioadhesive strength of the drug-free tablets were investigated. Carbopol 934P was selected as biopolymer in combination with HPMC or HPC at different ratios to develop five drug-loaded formulations. The swellings, tackiness and in vitro release were studied on the tablets. A good sustained effect and a moderate bioadhesion were obtained with the tablets. The formulation containing 100mg of effervescent, with the Carbopol 934P:HPC ratio of 1:9, seemed to be the optimum one for the tablet. In vivo drug residence tests were carried out by administering the preferred formulation to female rats. The results showed that the drug remaining followed a one-order model. Even after 24h of administration in vagina of rats, 17% of the original employed drug was retained on the vaginal tissue. Our study may provide a potential vaginal tablet formulation of ketoconazole against Candida albicans.

  8. Development and Characterization of Novel Floating-Mucoadhesive Tablets Bearing Venlafaxine Hydrochloride.

    PubMed

    Misra, Raghvendra; Bhardwaj, Peeyush

    2016-01-01

    The present investigation is concerned about the development of floating bioadhesive drug delivery system of venlafaxine hydrochloride which after oral administration exhibits a unique combination of floating and bioadhesion to prolong gastric residence time and increase drug bioavailability within the stomach. The floating bioadhesive tablets were prepared by the wet granulation method using different ratios of hydroxypropyl methyl cellulose (HPMC K4MCR) and Carbopol 934PNF as polymers. Sodium bicarbonate (NaHCO3) and citric acid were used as gas (CO2) generating agents. Tablets were characterized for floating properties, in vitro drug release, detachment force, and swelling index. The concentration of hydroxypropyl methyl cellulose and Carbopol 934PNF significantly affects the in vitro drug release, floating properties, detachment force, and swelling properties of the tablets. The optimized formulation showed the floating lag time 72 ± 2.49 seconds and duration of floating 24.50 ± 0.74 hr. The in vitro release studies and floating behavior were studied in simulated gastric fluid (SGF) at pH 1.2. Different drug release kinetics models were also applied. The in vitro drug release from tablets was sufficiently sustained (more than 18 hr) and the Fickian transports of the drug from the tablets were confirmed. The radiological evidence suggests that the tablets remained buoyant and altered position in the stomach of albino rabbit and mean gastric residence time was prolonged (more than > 6 hr). PMID:27274884

  9. Mathematical Model-Based Accelerated Development of Extended-release Metformin Hydrochloride Tablet Formulation.

    PubMed

    Chen, W; Desai, D; Good, D; Crison, J; Timmins, P; Paruchuri, S; Wang, J; Ha, K

    2016-08-01

    A computational fluid dynamic (CFD) model was developed to predict metformin release from a hydroxypropylmethylcellulose (HPMC) matrix-based extended-release formulation that took into consideration the physical and chemical properties of the drug substance, composition, as well as size and shape of the tablet. New high dose strength (1000 mg) tablet geometry was selected based on the surface area/volume (SA/V) approach advocated by Lapidus/Lordi/Reynold to obtain the desired equivalent metformin release kinetics. Maintaining a similar SA/V ratio across all extended-release metformin hydrochloride (Met XR) tablet strengths that had different geometries provided similar simulations of dissolution behavior. Experimental dissolution profiles of three lots of high-strength tablets agreed with the simulated release kinetics. Additionally, a pharmacokinetic absorption model was developed using GastroPlus™ software and known physicochemical, pharmacokinetic, and in vitro dissolution properties of metformin to predict the clinical exposure of the new high strength (1000 mg) tablet prior to conducting a human clinical bioequivalence study. In vitro metformin release kinetics were utilized in the absorption model to predict exposures in humans for new 1000-mg Met XR tablets, and the absorption model correctly projected equivalent in vivo exposure across all dose strengths. A clinical bioequivalence study was pursued based on the combined modeling results and demonstrated equivalent exposure as predicted by the simulations. PMID:26729531

  10. Comparison of febantel tablets and Vercom paste against gastrointestinal nematodes of dogs.

    PubMed

    Greiner, E C; Brenner, D G; Cox, D D; Heaton-Jones, D L

    1992-02-01

    Thirty adult dogs with naturally acquired gastrointestinal nematode infections were assigned at random to ten replicates and treated daily for 3 days with either a combination febantel/praziquantel (Vercom) paste, febantel tablets or placebo tablets. Numbers of hookworm and whipworm eggs after treatment were reduced similarly for both drug formulations when compared with pretreatment egg counts, whereas these counts increased in the controls. Vercom paste reduced the hookworm egg count by 99.9% and the whipworm egg count by 99.6%. The febantel tablet decreased the hookworm egg count by 99.9% and the whipworm egg count by 100%. As determined at necropsy, the controlled test efficacy against adult hookworms and whipworms was similar for the Vercom paste and the febantel tablets. The controlled test efficacies of Vercom paste against Ancylostoma caninum, Ancylostoma braziliense, and Trichuris vulpis were, respectively, 99.7%, 100% and 95.8% and those of febantel tablets were 98.2%, 100% and 99.7%. These results indicate that the nematocidal efficacy of febantel against these nematodes remains unchanged in these two formulations. No adverse reactions to either febantel tablets or to Vercom paste were observed. PMID:1561756

  11. Preparation and evaluation of sustained release calcium alginate beads and matrix tablets of acetazolamide.

    PubMed

    Barzegar-Jalali, M; Hanaee, J; Omidi, Y; Ghanbarzadeh, S; Ziaee, S; Bairami-Atashgah, R; Adibkia, K

    2013-02-01

    The aim of this study was to develop sustained release dosage forms of acetazolamide (ACZ) preparing its calcium alginate beads and matrix tablets. ACZ was incorporated into calcium alginate beads using microencapsulation method. Two methods were applied to prolong ACZ release rate. In the first method, the drug was incorporated into calcium alginate beads either alone or with various polymers in internal phase. The second method involved the preparation of matrix tablet from the beads benefiting direct compression method with or without various polymers in external phase. The release rate of these prepared formulations and an innovator's sustained-release capsule (Diamox®) were assessed. In-vitro dissolution studies revealed that the matrix tablets prepared by the second method containing NaCMC could sustain ACZ release properly and the drug released until 9 h. It was also found that several parameters such as concentration of sodium alginate, calcium chloride and ACZ; type and concentration of polymers; syringe needle size as well as distance between needle tip and surface of the calcium chloride could affect the properties of beads, matrix tablets and subsequently release profile. Preparation of polymer free beads, incorporation of polymers in internal phase of the beads and direct compression of the beads did not give sustained release property. Whereas, incorporation of NaCMC in the external phase of the beads in matrix tablets or in combination with alginate powder in directly compressed conventional tablets could produce dosage form with sustained release property similar to reference formulation. PMID:23447074

  12. The impact of hot-melt extrusion on the tableting behaviour of polyvinyl alcohol.

    PubMed

    Grymonpré, W; De Jaeghere, W; Peeters, E; Adriaensens, P; Remon, J P; Vervaet, C

    2016-02-10

    There is evidence that processing techniques like hot-melt extrusion (HME) could alter the mechanical properties of pharmaceuticals, which may impede further processability (e.g. tableting). The purpose of this study was to evaluate if HME has an impact on the tableting behaviour of polyvinyl alcohol (PVA)-formulations. Mixtures of partially hydrolysed PVA grades (with a hydroxylation degree of 75 and 88%) and sorbitol (0, 10 and 40%) were extruded, (cryo-) milled and compressed into compacts of 350 ± 10 mg. Before compression all intermediate products were characterized for their solid-state (Tg, Tm, crystallinity) and material properties (particle size, moisture content, moisture sorption). Because both PVA-grades required higher extrusion temperatures (i.e. 180 °C), sorbitol was added to PVA as plasticizing agent to allow extrusion at 140 °C. Compaction experiments were performed on both physical mixtures and cryo-milled extrudates of PVA-sorbitol. By measuring tablet tensile strength and porosity in function of compaction pressure, tableting behaviour was compared before and after HME by means of the CTC-profiles (compressibility, tabletability, compactibility). A higher amorphous content in the formulation (as a result of HME) negatively influenced the tableting behaviour (i.e. lower tablet tensile strength). HME altered the mechanical properties towards more elastically deforming materials, thereby increasing tablet elastic recovery during decompression. The lower tensile strengths resulted from a combined effect of less interparticulate bonding areas (because of higher elastic recovery) and weaker bonding strengths per unit bonding area (between glassy particles).

  13. Effects of plantain and corn starches on the mechanical and disintegration properties of paracetamol tablets.

    PubMed

    Akin-Ajani, Olufunke D; Itiola, Oludele A; Odeku, Oluwatoyin A

    2005-10-22

    The effects of plantain starch obtained from the unripe fruit of the plant Musa paradisiaca L. (Musaceae) on the mechanical and disintegration properties of paracetamol tablets have been investigated in comparison with the effects of corn starch BP using a 2(3) factorial experimental design. The individual and combined effects of nature of starch binder (N), concentration of starch binder (C), and the relative density of tablet (RD) on the tensile strength (TS), brittle fracture index (BFI), and disintegration time (DT) of the tablets were investigated. The ranking of the individual effects on TS was RD > C > N, on BFI was C > RD > N and on DT was N > C > RD. The ranking for the interaction effects on TS and DT was N-C > N-RD > C-RD, while that on BFI was N-C > C-RD > N-RD. Changing nature of starch from a "low" (plantain starch) to a "high" (corn starch) level, increasing the concentration of starch binding agent from 2.5% to 10.0% wt/wt, and increasing relative density of the tablet from 0.80 to 0.90, led to increase in the values of TS and DT, but a decrease in BFI. Thus, tablets containing plantain starch had lower tensile strength and disintegration time values than those containing corn starch, but showed better ability to reduce the lamination and capping tendency in paracetamol tablet formulation. The interaction between N and C was significantly (P < .001) higher than those between N and RD and between C and RD. There is therefore the need to carefully choose the nature (N) and concentration (C) of starch used as binding agent in tablet formulations to obtain tablets of desired bond strength and disintegration properties. Furthermore, plantain starch could be useful as an alternative binding agent to cornstarch, especially where faster disintegration is required and the problems of lamination and capping are of particular concern.

  14. Smartphones and tablets: Reshaping radiation oncologists’ lives

    PubMed Central

    Gomez-Iturriaga, Alfonso; Bilbao, Pedro; Casquero, Francisco; Cacicedo, Jon; Crook, Juanita

    2012-01-01

    Background Smartphones and tablets are new handheld devices always connected to an information source and capable of providing instant updates, they allow doctors to access the most updated information and provide decision support at the point of care. Aim The practice of radiation oncology has always been a discipline that relies on advanced technology. Smartphones provide substantial processing power, incorporating innovative user interfaces and applications. Materials and methods The most popular smartphone and tablet app stores were searched for “radiation oncology” and “oncology” related apps. A web search was also performed searching for smartphones, tablets, oncology, radiology and radiation oncology. Results Smartphones and tablets allow rapid access to information in the form of podcasts, apps, protocols, reference texts, recent research and more. Conclusion With the rapidly changing advances in radiation oncology, the trend toward accessing resources via smartphones and tablets will only increase, future will show if this technology will improve clinical care. PMID:24669308

  15. Teachers' Attitudes to Using iPads or Tablet Computers; Implications for Developing New Skills, Pedagogies and School-Provided Support

    ERIC Educational Resources Information Center

    Young, Keith

    2016-01-01

    This study examined the attitudes of teachers towards using tablet computers, predominantly Apple's iPad, across 22 post primary-schools in Ireland. The study also questions some previous research and assumptions on the educational use of tablet computers. The majority of schools were using devices with students and teachers; the combined size of…

  16. 21 CFR 520.1284 - Sodium liothyronine tablets.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 6 2012-04-01 2012-04-01 false Sodium liothyronine tablets. 520.1284 Section 520...) ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS ORAL DOSAGE FORM NEW ANIMAL DRUGS § 520.1284 Sodium liothyronine tablets. (a) Specifications. Sodium liothyronine tablets consist of tablets intended for...

  17. Xylan--a possible filler and disintegrant for tablets.

    PubMed

    Juslin, M; Paronen, P

    1984-04-01

    Xylan, a novel possible adjuvant for tablets was tested and compared with modified starch, Sta-Rx 1500, for weight variation, strength and disintegration of tablets. There was no remarkable difference in weight variation between the tablets of the corresponding compositions. The tablets containing xylan were stronger and disintegrated more rapidly than those containing modified starch. PMID:6144774

  18. Physicochemical and tablet properties of Cyperus alulatus rhizomes starch granules.

    PubMed

    Paramakrishnan, N; Jha, S; Kumar, K Jayaram

    2015-05-01

    The starch extracted from rhizomes of Cyperus alulatus (CA) was characterized for its physicochemical, morphological and tableting properties. Rhizomes of CA yield a significant quantity of starch granules (CASG) i.e., 11.93%. CASG was characterized in terms of moisture, ash and amylose contents, solubility and swelling power, paste clarity and water retention capacity. The swelling power was found to be significantly improved with the increase in temperature. Scanning electron micrographs revealed that the granule's surface was smooth, the granules were spherical, mostly round, disc like, and the size range was 6.65-12.13 μm. Finger print region in FTIR spectra confirmed its carbohydrate nature. The evaluated micromeritic properties of extracted granule's bulk density, tapped density, Carr's index, Hausner ratio, true density and porosity render unique practicability of CASG being used as an adjuvant in pharmaceutical solid dosage forms. Tablets prepared by using CASG showed higher mechanical strength and more disintegration time, which depicted the characteristic binding nature of the starch granules. As CASG is imparting better binding properties in less concentration and also it can be used in combination with the established starches to get the synergistic effect; this starch can be used commercially in the tablet preparation. PMID:25769783

  19. Formulation and development of orodispersible sustained release tablet of domperidone.

    PubMed

    Patil, Hemlata G; Tiwari, Roshan V; Repka, Michael A; Singh, Kamalinder K

    2016-01-01

    Commercially available domperidone orodispersible tablets (ODT) are intended for immediate release of the drug, but none of them have been formulated for sustained action. The aim of the present research work was to develop and evaluate orodispersible sustained release tablet (ODT-SR) of domperidone, which has the convenience of ODT and benefits of controlled release product combined in one. The technology comprised of developing sustained release microspheres (MS) of domperidone, followed by direct compression of MS along with suitable excipients to yield ODT-SR which rapidly disperses within 30 seconds and yet the dispersed MS maintain their integrity to have a sustained drug release. The particle size of the MS was optimized to be less than 200 μm to avoid the grittiness in the mouth. The DSC thermograms of MS showed the absence of drug-polymer interaction within the microparticles, while SEM confirmed their spherical shape and porous nature. Angle of repose, compressibility and Hausner's ratio of the blend for compression showed good flowability and high percent compressibility. The optimized ODT-SR showed disintegration time of 21 seconds and matrix controlled drug release for 9 h. In-vivo pharmacokinetic studies in Wistar rats showed that the ODT-SR had a prolonged MRT of 11.16 h as compared 3.86 h of conventional tablet. The developed technology is easily scalable and holds potential for commercial exploitation. PMID:26472165

  20. Terahertz Technology: A Boon to Tablet Analysis

    PubMed Central

    Wagh, M. P.; Sonawane, Y. H.; Joshi, O. U.

    2009-01-01

    The terahertz gap has a frequency ranges from ∼0.3 THz to ∼10 THz in the electromagnetic spectrum which is in between microwave and infrared. The terahertz radiations are invisible to naked eye. In comparison with x-ray they are intrinsically safe, non-destructive and non-invasive. Terahertz spectroscopy enables 3D imaging of structures and materials, and the measurement of the unique spectral fingerprints of chemical and physical forms. Terahertz radiations are produced by a dendrimer based high power terahertz source and spectroscopy technologies. It resolves many of the questions left unanswered by complementary techniques, such as optical imaging, Raman and infrared spectra. In the pharmaceutical industries it enables nondestructive, internal, chemical analysis of tablets, capsules, and other dosage forms. Tablet coatings are a major factor in drug bioavailability. Therefore tablet coatings integrity and uniformity are of crucial importance to quality. Terahertz imaging gives an unparalleled certainty about the integrity of tablet coatings and the matrix performance of tablet cores. This article demonstrates the potential of terahertz pulse imaging for the analysis of tablet coating thickness by illustrating the technique on tablets. PMID:20490288

  1. Quality of chloroquine tablets available in Africa

    PubMed Central

    SAWADOGO, C W; AMOOD AL-KAMARANY, M; AL-MEKHLAFI, H M; ELKARBANE, M; AL-ADHROEY, A H; CHERRAH, Y; BOUKLOUZE, A

    2011-01-01

    Malaria is the biggest killer of African children, yet it is cheaply preventable and curable with insecticides spraying, impregnated bednets and effective drugs. This study aimed to evaluate the quality of Chloroquine (CQ) tablets available in selected African countries. Twenty-six samples of antimalarial CQ tablet of 100, 150 and 250 mg were collected from 12 African countries and evaluated for their quality in the Drugs Quality Control Laboratory of Rabat, Morocco. The identification and dosage of active pharmaceutical ingredients in the tablets, dissolution rate, hardness and the friability of CQ tablets were performed according to the United States Pharmacopeia (USP) and European Pharmacopoeia (Eur.Ph.) recommended methods. The results showed that 7.7% of the sampled CQ tablets available in Burkina Faso were of low quality. Failure in dissolution profile was found in 50% of CQ tablets sampled from Benin, Burkina Faso, Comoros Union, Mali and Senegal. The findings showed poor quality of CQ tablets available in the African market. This problem may affect the efforts to control malaria in Africa. Efficient regulatory systems of drugs quality control should be implemented. PMID:22117854

  2. NMR imaging of density distributions in tablets.

    PubMed

    Djemai, A; Sinka, I C

    2006-08-17

    This paper describes the use of (1)H nuclear magnetic resonance (NMR) for 3D mapping of the relative density distribution in pharmaceutical tablets manufactured under controlled conditions. The tablets are impregnated with a compatible liquid. The technique involves imaging of the presence of liquid which occupies the open pore space. The method does not require special calibration as the signal is directly proportional to the porosity for the imaging conditions used. The NMR imaging method is validated using uniform density flat faced tablets and also by direct comparison with X-ray computed tomography. The results illustrate (1) the effect of die wall friction on density distribution by compressing round, curved faced tablets using clean and pre-lubricated tooling, (2) the evolution of density distribution during compaction for both clean and pre-lubricated die wall conditions, by imaging tablets compressed to different compaction forces, and (3) the effect of tablet image on density distribution by compressing two complex shape tablets in identical dies to the same average density using punches with different geometries.

  3. Dependence of tablet brittleness on tensile strength and porosity.

    PubMed

    Gong, Xingchu; Chang, Shao-Yu; Osei-Yeboah, Frederick; Paul, Shubhajit; Perumalla, Sathyanarayana Reddy; Shi, Limin; Sun, Wei-Jhe; Zhou, Qun; Sun, Changquan Calvin

    2015-09-30

    An analysis of data collected from 25 sets of diverse pharmaceutical powders has identified that an exponential growth function satisfactorily describes the relationship between tablet brittleness and tablet porosity while a power law function well describes the relationship between tablet brittleness and tensile strength. These equations have the potential to facilitate better characterization of tablet mechanical properties and to guide the design and optimization of pharmaceutical tablet products. PMID:26226338

  4. Comparison of the halving of tablets prepared with eccentric and rotary tablet presses.

    PubMed

    Sovány, T; Kása, P; Pintye-Hódi, K

    2009-01-01

    The aim of this study was to compare the densification of powder mixtures on eccentric and rotary tablet presses and to establish relationships with the halving properties of the resulting scored tablets. This is an important problem because the recent guidelines of EU require verification of the equal masses of tablet halves. The models of Walker, Heckel, and Kawakita were used to describe the powder densification on the two machines. The calculated parameters revealed that the shorter compression cycle of rotary machines results in poorer densification and lower tablet hardness at a given compression force. This is manifested in poorer halving properties, which are influenced mainly by the hardness. Better densification improves the halving even at lower tablet hardness. This demonstrates that these parameters can be good predictors of tablet halving properties. PMID:19381830

  5. Performance of tablet disintegrants: impact of storage conditions and relative tablet density.

    PubMed

    Quodbach, Julian; Kleinebudde, Peter

    2015-01-01

    Tablet disintegration can be influenced by several parameters, such as storage conditions, type and amount of disintegrant, and relative tablet density. Even though these parameters have been mentioned in the literature, the understanding of the disintegration process is limited. In this study, water uptake and force development of disintegrating tablets are analyzed, as they reveal underlying processes and interactions. Measurements were performed on dibasic calcium phosphate tablets containing seven different disintegrants stored at different relative humidities (5-97%), and on tablets containing disintegrants with different mechanisms of action (swelling and shape recovery), compressed to different relative densities. Disintegration times of tablets containing sodium starch glycolate are affected most by storage conditions, which is displayed in decreased water uptake and force development kinetics. Disintegration times of tablets with a swelling disintegrant are only marginally affected by relative tablet density, whereas the shape recovery disintegrant requires high relative densities for quick disintegration. The influence of relative tablet density on the kinetics of water uptake and force development greatly depends on the mechanism of action. Acquired data allows a detailed analysis of the influence of storage conditions and mechanisms of action on disintegration behavior. PMID:24848093

  6. 21 CFR 520.2330 - Sulfisoxazole tablets.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    .... (a) Specifications. Each tablet contains 260 milligrams (4 grains) of sulfisoxazole. (b) Sponsor. See... may require bioequivalency and safety information. (2) Indications for use. Use in dogs and cats as...

  7. 21 CFR 520.816 - Epsiprantel tablets.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ...) Specifications. Each tablet contains either 12.5, 25, 50, or 100 milligrams of epsiprantel. (b) Sponsor. See No... pisiformis. (2) Cats—(i) Amount. 1.25 milligrams per pound of body weight. (ii) Indications for use....

  8. 21 CFR 520.816 - Epsiprantel tablets.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ...) Specifications. Each tablet contains either 12.5, 25, 50, or 100 milligrams of epsiprantel. (b) Sponsor. See No... pisiformis. (2) Cats—(i) Amount. 1.25 milligrams per pound of body weight. (ii) Indications for use....

  9. Formulation design and optimization of fast dissolving clonazepam tablets by sublimation method.

    PubMed

    Shirsand, S B; Suresh, Sarasija; Kusumdevi, V; Swamy, P V

    2011-09-01

    Fast dissolving tablets of clonazepam were prepared by sublimation method with a view to enhance patient compliance. A 3(2) full factorial design was applied to investigate the combined effect of two formulation variables: amount of croscarmellose sodium and camphor. Croscarmellose sodium (2-8% w/w) was used as superdisintegrant and camphor (20-40% w/w) was used as subliming agent, to increase the porosity of the tablets, since it helps water to penetrate into the tablets, along with directly compressible mannitol to enhance mouth feel. The tablets were evaluated for hardness, friability, thickness, drug content uniformity, in vitro dispersion time, wetting time and water absorption ratio. Based on in vitro dispersion time (approximately 11 s); the formulation containing 5% w/w croscarmellose sodium and 40% w/w camphor was found to be promising and tested for in vitro drug release pattern (in pH 6.8 phosphate buffer). Short-term stability (at 40°/75% relative humidity for 3 mo) and drug-excipient interaction. Surface response plots are presented to graphically represent the effect of independent variables on the in vitro dispersion time. The validity of the generated mathematical model was tested by preparing two extra-design checkpoints. The optimized tablet formulation was compared with conventional commercial tablet formulation for drug release profiles. This formulation showed nearly nine-fold faster drug release (t(50%) 1.8 min) compared to the conventional commercial tablet formulation (t(50%) 16.4 min). Short-term stability studies on the formulation indicated that there are no significant changes in drug content and in vitro dispersion time (P<0.05). PMID:22923860

  10. Electronic acquisition of OSCE performance using tablets

    PubMed Central

    Hochlehnert, Achim; Schultz, Jobst-Hendrik; Möltner, Andreas; Tımbıl, Sevgi; Brass, Konstantin; Jünger, Jana

    2015-01-01

    Background: Objective Structured Clinical Examinations (OSCEs) often involve a considerable amount of resources in terms of materials and organization since the scores are often recorded on paper. Computer-assisted administration is an alternative with which the need for material resources can be reduced. In particular, the use of tablets seems sensible because these are easy to transport and flexible to use. Aim: User acceptance concerning the use of tablets during OSCEs has not yet been extensively investigated. The aim of this study was to evaluate tablet-based OSCEs from the perspective of the user (examiner) and the student examinee. Method: For two OSCEs in Internal Medicine at the University of Heidelberg, user acceptance was analyzed regarding tablet-based administration (satisfaction with functionality) and the subjective amount of effort as perceived by the examiners. Standardized questionnaires and semi-standardized interviews were conducted (complete survey of all participating examiners). In addition, for one OSCE, the subjective evaluation of this mode of assessment was gathered from a random sample of participating students in semi-standardized interviews. Results: Overall, the examiners were very satisfied with using tablets during the assessment. The subjective amount of effort to use the tablet was found on average to be “hardly difficult”. The examiners identified the advantages of this mode of administration as being in particular the ease of use and low rate of error. During the interviews of the examinees, acceptance for the use of tablets during the assessment was also detected. Discussion: Overall, it was found that the use of tablets during OSCEs was well accepted by both examiners and examinees. We expect that this mode of assessment also offers advantages regarding assessment documentation, use of resources, and rate of error in comparison with paper-based assessments; all of these aspects should be followed up on in further studies

  11. Formulation and optimization of potassium iodide tablets

    PubMed Central

    Al-Achi, Antoine; Patel, Binit

    2014-01-01

    The use of potassium iodide (KI) as a protective agent against accidental radioactive exposure is well established. In this study, we aimed to prepare a KI tablet formulation using a direct compression method. We utilized Design of Experiment (DoE)/mixture design to define the best formulation with predetermined physical qualities as to its dissolution, hardness, assay, disintegration, and angle of repose. Based on the results from the DoE, the formulation had the following components (%w/w): Avicel 48.70%, silicon dioxide 0.27%, stearic acid (1.00%), magnesium stearate 2.45%, and dicalcium phosphate 18.69%, in addition to potassium iodide 28.89% (130 mg/tablet). This formulation was scaled-up using two tablet presses, a single-punch press and a rotary mini tablet press. The final scaled-up formulation was subjected to a variety of quality control tests, including photo-stability testing. The results indicate that potassium iodide tablets prepared by a rotary mini tablet press had good pharmaceutical characteristics and a shelf-life of 25 days when stored at room temperature protected from light. PMID:25685048

  12. Formulation and optimization of potassium iodide tablets.

    PubMed

    Al-Achi, Antoine; Patel, Binit

    2015-01-01

    The use of potassium iodide (KI) as a protective agent against accidental radioactive exposure is well established. In this study, we aimed to prepare a KI tablet formulation using a direct compression method. We utilized Design of Experiment (DoE)/mixture design to define the best formulation with predetermined physical qualities as to its dissolution, hardness, assay, disintegration, and angle of repose. Based on the results from the DoE, the formulation had the following components (%w/w): Avicel 48.70%, silicon dioxide 0.27%, stearic acid (1.00%), magnesium stearate 2.45%, and dicalcium phosphate 18.69%, in addition to potassium iodide 28.89% (130 mg/tablet). This formulation was scaled-up using two tablet presses, a single-punch press and a rotary mini tablet press. The final scaled-up formulation was subjected to a variety of quality control tests, including photo-stability testing. The results indicate that potassium iodide tablets prepared by a rotary mini tablet press had good pharmaceutical characteristics and a shelf-life of 25 days when stored at room temperature protected from light. PMID:25685048

  13. Erosive potential of vitamin and vitamin+mineral effervescent tablets.

    PubMed

    Wegehaupt, Florian J; Lunghi, Nancy; Hogger, Vanessa M G; Attin, Thomas

    2016-01-01

    The extrinsic sources for erosion-causing acids are primarily acidic beverages and foodstuffs. Effervescent tablets also contain organic acids (e.g. citric, tartaric, malic) in order to form carbon dioxide by contact with water – with the help of the carbonate salts of the tablets. To adequately inform patients about the possible erosive potential of effervescent tablets, this study was undertaken in order to investigate the erosive potential of effervescent tablets (ET), containing either a combination of vitamins and minerals or vitamins only, commercially available in Switzerland. One hundred and ninety-two bovine enamel samples were prepared and allocated to 16 groups (A–H and 1–8; n = 12/group). Samples were eroded (120 s/erosive cycle) in freshly prepared solutions (200 ml/12 samples) comprised of tap water and a supplement as follows: none (control groups, A and 1); vitamin+mineral ET: Qualite and Prix (B), Optisana (C), Well and Active (D), Actilife All in One (E), Berocca (F), Isostar (G) and Qualite and Prix Mg + Vit C (H); vitamin ET: Actilife-Multivitamin (2), Sunlife Vitamin C (3), Optisana Vitamin C (4), Optisana Multivitamin (5), Well and Active Multivitamin (6), Kneipp Vitamin C+Zink (7) and Sunlife Multivitamin (8). Enamel loss was measured using profilometry after 10 and 20 erosive cycles. For the vitamin+mineral ET, no loss was observed in groups B–E. Significantly highest enamel loss (mean ± SD) after 20 cycles was observed for Isostar (5.26 ± 0.76 µm) and Qualite and Prix Mg + Vit C (5.12 ± 0.67 µm). All vitamine ET showed erosive enamel loss. Significantly highest loss was observed for Sunlife Multivitamin (8.45 ± 1.08 µm), while the lowest loss was observed for Actilife-Multivitamin (5.61 ± 1.08 µm) after 20 cycles. Some of the tested effervescent tablets showed a considerable erosive potential and patients should be informed accordingly. PMID:27278776

  14. Investigation of the composition of anabolic tablets using near infrared spectroscopy and Raman chemical imaging.

    PubMed

    Rebiere, Hervé; Ghyselinck, Céline; Lempereur, Laurent; Brenier, Charlotte

    2016-01-01

    The use of performance enhancing drugs is a widespread phenomenon in professional and leisure sports. A spectroscopic study was carried out on anabolic tablets labelled as 5 mg methandienone tablets provided by police departments. The analytical approach was based on a two-step methodology: a fast analysis of tablets using near infrared (NIR) spectroscopy to assess sample homogeneity based on their global composition, followed by Raman chemical imaging of one sample per NIR profile to obtain information on sample formulation. NIR spectroscopy assisted by a principal components analysis (PCA) enabled fast discrimination of different profiles based on the excipient formulation. Raman hyperspectral imaging and multivariate curve resolution - alternating least square (MCR-ALS) provided chemical images of the distribution of the active substance and excipients within tablets and facilitated identification of the active compounds. The combination of NIR spectroscopy and Raman chemical imaging highlighted dose-to-dose variations and succeeded in the discrimination of four different formulations out of eight similar samples of anabolic tablets. Some samples contained either methandienone or methyltestosterone whereas one sample did not contain an active substance. Other ingredients were sucrose, lactose, starch or talc. Both techniques were fast and non-destructive and therefore can be carried out as exploratory methods prior to destructive screening methods. Copyright © 2015 John Wiley & Sons, Ltd.

  15. Matrix mini-tablets based on starch/microcrystalline wax mixtures.

    PubMed

    De Brabander, C; Vervaet, C; Fiermans, L; Remon, J P

    2000-04-20

    Matrix mini-tablets based on a combination of microcrystalline waxes and starch derivatives were prepared using ibuprofen as a model drug. The production of mini-tablets was preferred over the production of pellets, as up-scaling of the pelletisation process seemed problematic. Prior to tabletting, melt granulation in a hot stage screw extruder and milling were required. The in vitro drug release was varied using microcrystalline waxes with a different melting range, the slowest drug release being obtained with a formulation containing a microcrystalline wax with a melting range between 68 and 72 degrees C. Generally speaking increasing the wax concentration resulted in a slower drug release. In vitro drug release profiles were also modified using different starches and mixtures of starches. Increasing the ibuprofen concentration to 70% resulted in a faster drug release rate.

  16. Press-coating of immediate release powders onto coated controlled release tablets with adhesives.

    PubMed

    Waterman, Kenneth C; Fergione, Michael B

    2003-05-20

    A novel adhesive coating was developed that allows even small quantities of immediate-release (IR) powders to be press-coated onto controlled-release (CR), coated dosage forms without damaging the CR coating. The process was exemplified using a pseudoephedrine osmotic tablet (asymmetric membrane technology, AMT) where a powder weighing less than 25% of the core was pressed onto the osmotic tablet providing a final combination tablet with low friability. The dosage form with the adhesive plus the press-coated powder showed comparable sustained drug release rates to the untreated dosage form after an initial 2-h lag. The adhesive layer consisted of an approximately 100- microm coating of Eudragit RL, polyethylene glycol (PEG) and triethyl citrate (TEC) at a ratio of 5:3:1.2. This coating provides a practical balance between handleability before press-coating and good adhesion.

  17. Spectrophotometric estimation of ambroxol and cetirizine hydrochloride from tablet dosage form.

    PubMed

    Gowekar, N M; Pande, V V; Kasture, A V; Tekade, A R; Chandorkar, J G

    2007-07-01

    Fixed dose combination tablets containing ambroxol HCl and cetirizine HCl are clinically used as mucolytic and antiallergic. Several spectrophotometric and HPLC methods have been reported for simultaneous estimation of these drugs with other drugs. The drugs individually and in mixture obeys Beer's law over conc. range 1.2-4.4 microg/mL for cetirizine HCL and for ambroxol HCL 15-52 microg/mL at all five sampling wavelengths (correlation coeff. well above 0.995). The mean recoveries from tablet by standard addition method were 100.18% (+/-2.4) and 100.66 % (+/-2.31). The present work reports simple, accurate and precise spectrophotometric methods for their simultaneous estimation from tablet dosage form.

  18. Whispering-gallery-mode resonance sensor for dielectric sensing of drug tablets

    NASA Astrophysics Data System (ADS)

    Neshat, Mohammad; Chen, Huanyu; Gigoyan, Suren; Saeedkia, Daryoosh; Safavi-Naeini, Safieddin

    2010-01-01

    We propose, for the first time, the application of whispering gallery mode (WGM) perturbation technique in dielectric analysis of disk shape pharmaceutical tablets. Based on WGM resonance, a low-cost high sensitivity sensor in milllimeter-wave frequency range is presented. A comprehensive sensitivity analysis was performed to show that a change in the order of 10-4 in the sample permittivity can be detected by the proposed sensor. The results of various experiments carried out on drug tablets are reported to demonstrate the potential multifunctional capabilities of the sensor in moisture sensing, counterfeit drug detection and contamination screening. Analytically, two sample placement configurations, i.e. a tablet placed on top of a dielectric disk resonator and inside a dielectric ring resonator, have been studied to predict the resonance frequency and Q-factor of the combined sample-resonator structure. The accuracy of the analytical model was tested against full-wave simulations and experimental data.

  19. Etilefrinhydrochloride tablet ingestion: successful therapy by endoscopic removal of tablet conglomerate.

    PubMed

    Schwerk, C; Schulz, M; Schwerk, N; Blüher, S; Kiess, W; Siekmeyer, W

    2009-01-01

    We report here on a case of etilefrinhydrochloride tablet intoxication in suicidal intention in a female adolescent. Tablet ingestion resulted in the formation of a tablet conglomerate in the stomach, which could neither be effectively treated with activated charcoal nor by gastric lavage. Endoscopic dissemination and removal of the fragments finally led to the elimination of the tables and the symptoms of intoxication resolved completely. The case presented here offers an explanation as to why the use of activated charcoal and/or a gastric lavage may not be successful in some cases of ingestion/intoxication. Endoscopic removal of ingested fragments of the toxic substance, such as etilefrinhydrochloride tablets, may be useful even hours following ingestion and should be considered when treatment with activated charcoal or gastric lavage fail to eliminate toxic substances in cases of tablet ingestion. PMID:19199226

  20. Young HIV-Infected Children and Their Adult Caregivers Prefer Tablets to Syrup Antiretroviral Medications in Africa

    PubMed Central

    Nahirya-Ntege, Patricia; Cook, Adrian; Vhembo, Tichaona; Opilo, Wilfred; Namuddu, Rachel; Katuramu, Richard; Tezikyabbiri, Jessica; Naidoo-James, Bethany; Gibb, Diana

    2012-01-01

    Background Provision of anti-retroviral therapy (ART) for HIV-infected children is complicated using syrup formulations, which are costlier than tablets, harder to transport and store and difficult for health-workers to prescribe and caregivers to administer. Dispersible/crushable tablets may be more appropriate. We studied the acceptability of syrups and scored tablets among young children who used both in the AntiRetroviral Research fOr Watoto (ARROW) trial. Methods ARROW is an ongoing randomized trial of paediatric ART monitoring and treatment strategies in 1206 children in Uganda and Zimbabwe. 405 children initially received syrups of combination ART including Nevirapine, Zidovudine, Abacavir and Lamivudine before changing, when reaching the 12-<15 kg weightband, to scored adult-dose tablets prescribed according to WHO weightband tables. Caregiver expectations and experiences were collected in questionnaires at their last visit on syrups and after 8 and 24 weeks on tablets. Results Questionnaires were completed by caregivers of 267 children (median age 2.9 years (IQR 2.5, 3.4)). At last visit on syrups, 79% caregivers reported problems with syrups, mostly related to number, weight, transportation and conspicuousness of bottles. Difficulties taking tablets were expected by 127(48%) caregivers; however, after 8 and 24 weeks, only 26% and 18% reported their children had problems with tablets and no problems were reported with transportation/conspicuousness. Taste, swallowing or vomiting were reported as problems ‘sometimes/often’ for 14%, 9%, 22% children on syrups and 16%, 9%, 8% on tablets. At last visit on syrups, 74% caregivers expected to prefer tablets but only 27% thought their child would. After 8/24 weeks, 94%/97% caregivers preferred tablets and 57%/59% reported their child did. Conclusions Most children at about 3 years can take tablets; caregivers and children themselves generally prefer tablets to liquid formulations of HIV medications above this

  1. Effect of repeated compaction of tablets on tablet properties and work of compaction using an instrumented laboratory tablet press.

    PubMed

    Gamlen, Michael John Desmond; Martini, Luigi G; Al Obaidy, Kais G

    2015-01-01

    The repeated compaction of Avicel PH101, dicalcium phosphate dihydrate (DCP) powder, 50:50 DCP/Avicel PH101 and Starch 1500 was studied using an instrumented laboratory tablet press which measures upper punch force, punch displacement and ejection force and operates using a V-shaped compression profile. The measurement of work compaction was demonstrated, and the test materials were ranked in order of compaction behaviour Avicel PH101 > DCP/Avicel PH101 > Starch > DCP. The behaviour of the DCP/Avicel PH101 mixture was distinctly non-linear compared with the pure components. Repeated compaction and precompression had no effect on the tensile fracture strength of Avicel PH101 tablets, although small effects on friability and disintegration time were seen. Repeated compaction and precompression reduced the tensile strength and the increased disintegration time of the DCP tablets, but improved the strength and friability of Starch 1500 tablets. Based on the data reported, routine laboratory measurement of tablet work of compaction may have potential as a critical quality attribute of a powder blend for compression. The instrumented press was suitable for student use with minimal supervisor input.

  2. Fast-melting tablets based on highly plastic granules.

    PubMed

    Fu, Yourong; Jeong, Seong Hoon; Park, Kinam

    2005-12-01

    Highly plastic granules that can be compressed into tablets at low pressure were developed to make fast-melting tablets (FMTs) by compression method. The highly plastic granules are composed of three components: a plastic material, a material enhancing water penetration, and a wet binder. One of the unique properties of the highly plastic granules is that they maintain a porous structure even after compression into tablets. The porous and plastic nature of the granules allows fast absorption of water into the compressed tablet for fast melting/dissolution of the tablet. The prepared tablets possess tablet strength and friability that are suitable for multi-tablet packages. The three-component highly plastic granules provide an effective way of making FMTs by compression.

  3. 21 CFR 520.2150b - Stanozolol chewable tablets.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... treatment in dogs. (2) Administered orally to small breeds of dogs, 1/2 to 1 tablet twice daily for several weeks; to large breeds of dogs, 1 to 2 tablets twice daily for several weeks. (3) Federal law...

  4. 21 CFR 520.2150b - Stanozolol chewable tablets.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... treatment in dogs. (2) Administered orally to small breeds of dogs, 1/2 to 1 tablet twice daily for several weeks; to large breeds of dogs, 1 to 2 tablets twice daily for several weeks. (3) Federal law...

  5. [Modern polymers in matrix tablets technology].

    PubMed

    Zimmer, Łukasz; Kasperek, Regina; Poleszak, Ewa

    2014-01-01

    Matrix tablets are the most popular method of oral drug administration, and polymeric materials have been used broadly in matrix formulations to modify and modulate drug release rate. The main goal of the system is to extend drug release profiles to maintain a constant in vivo plasma drug concentration and a consistent pharmacological effect. Polymeric matrix tablets offer a great potential as oral controlled drug delivery systems. Cellulose derivatives, like hydroxypropyl methylcellulose (HPMC) are often used as matrix formers. However, also other types of polymers can be used for this purpose including: Kollidon SR, acrylic acid polymers such as Eudragits and Carbopols. Nevertheless, polymers of natural origin like: carragens, chitosan and alginates widely used in the food and cosmetics industry are now coming to the fore of pharmaceutical research and are used in matrix tablets technology. Modern polymers allow to obtain matrix tablets by 3D printing, which enables to develop new formulation types. In this paper, the polymers used in matrix tablets technology and examples of their applications were described.

  6. Stability study of losartan/hydrochlorothiazide tablets.

    PubMed

    Lusina, Maja; Cindrić, Tanja; Tomaić, Jadranka; Peko, Marijana; Pozaić, Lidija; Musulin, Nenad

    2005-03-01

    The purpose of stability testing is to investigate how the quality of a drug product changes with time under the influence of environmental factors, to establish a shelf life for the product and to recommend storage conditions. Stability study of losartan/hydrochlorothiazide tablets is presented in this paper. Losartan (angiotensin II receptor antagonist) and hydrochlorothiazide (diuretic) are successfully used in association in the treatment of hypertension. Stability study of losartan/hydrochlorothiazide tablets consisted of three steps: stress test (forced degradation study), preliminary testing (selection of packaging) and formal stability testing. The results of stress test suggested that losartan/hydrochlorothiazide tablets are sensitive to moisture. It was demonstrated that the developed analytical methods are stability indicating. Additional preliminary testing was performed in order to select appropriate packaging for losartan/hydrochlorothiazide tablets. OPA/Al/PVC//Al blisters were found to provide adequate protection for the product. Based on the first 12 months of the formal stability study, a shelf life of 24 months was proposed. Losartan/hydrochlorothiazide tablets in OPA/Al/PVC//Al blisters are demonstrated to be chemically, physically and microbiologically stable.

  7. Investigations into the tensile failure of doubly-convex cylindrical tablets under diametral loading using finite element methodology.

    PubMed

    Podczeck, Fridrun; Drake, Kevin R; Newton, J Michael

    2013-09-15

    In the literature various solutions exist for the calculation of the diametral compression tensile strength of doubly-convex tablets and each approach is based on experimental data obtained from single materials (gypsum, microcrystalline cellulose) only. The solutions are represented by complex equations and further differ for elastic and elasto-plastic behaviour of the compacts. The aim of this work was to develop a general equation that is applicable independently of deformation behaviour and which is based on simple tablet dimensions such as diameter and total tablet thickness only. With the help of 3D-FEM analysis the tensile failure stress of doubly-convex tables with central cylinder to total tablet thickness ratios W/D between 0.06 and 0.50 and face-curvature ratios D/R between 0.25 and 1.85 were evaluated. Both elastic and elasto-plastic deformation behaviour were considered. The results of 80 individual simulations were combined and showed that the tensile failure stress σt of doubly-convex tablets can be calculated from σt=(2P/πDW)(W/T)=2P/πDT with P being the failure load, D the diameter, W the central cylinder thickness, and T the total thickness of the tablet. This equation converts into the standard Brazilian equation (σt=2P/πDW) when W equals T, i.e. is equally valid for flat cylindrical tablets. In practice, the use of this new equation removes the need for complex measurements of tablet dimensions, because it only requires values for diameter and total tablet thickness. It also allows setting of standards for the mechanical strength of doubly-convex tablets. The new equation holds both for elastic and elasto-plastic deformation behaviour of the tablets under load. It is valid for all combinations of W/D-ratios between 0.06 and 0.50 with D/R-ratios between 0.00 and 1.85 except for W/D=0.50 in combination with D/R-ratios of 1.85 and 1.43 and for W/D-ratios of 0.40 and 0.30 in combination with D/R=1.85. FEM-analysis indicated a tendency to

  8. Evaluation of the tablets' surface flow velocities in pan coaters.

    PubMed

    Dreu, Rok; Toschkoff, Gregor; Funke, Adrian; Altmeyer, Andreas; Knop, Klaus; Khinast, Johannes; Kleinebudde, Peter

    2016-09-01

    The tablet pan coating process involves various types of transverse tablet bed motions, ranging from rolling to cascading. To preserve satisfactory results in terms of coating quality after scale-up, understanding the dynamics of pan coating process should be achieved. The aim of this study was to establish a methodology of estimating translational surface velocities of the tablets in a pan coater and to assess their dependence on the drum's filling degree, the pan speed, the presence of baffles and the selected tablet properties in a dry bed system and during coating while varying the drum's filling degree and the pan speed. Experiments were conducted on the laboratory scale and on the pilot scale in side-vented pan coaters. Surface movement of biconvex two-layer tablets was assessed before, during and after the process of active coating. In order to determine the tablets' surface flow velocities, a high-speed video of the tablet surface flow was recorded via a borescope inserted into the coating drum and analysed via a cross-correlation algorithm. The obtained tablet velocity data were arranged in a linear fashion as a function of the coating drum's radius and frequency. Velocity data obtained during coating were close to those of dry tablets after coating. The filling degree had little influence on the tablet velocity profile in a coating drum with baffles but clearly affected it in a coating drum without baffles. In most but not all cases, tablets with a lower static angle of repose had tablet velocity profiles with lower slopes than tablets with higher inter-tablet friction. This particular tablet velocity response can be explained by case specific values of tablet bed's dynamic angle of repose.

  9. [The production of tablets with diethylaminoethanol p-acetylaminobenzoate].

    PubMed

    Verbuţă, A; Cojocaru, I

    1989-01-01

    A formulation for tablets with diethylaminoethanol p-acetylaminobenzoate was set. The obtained tablets are adequate from the point of view of organoleptic qualities, mean weight weight variations, mechanical strength and disaggregation, both after processing and one year storage. The kinetics of water and artificial gastric juice, determined with the help of a Nogami device, by tablets capillarity reveals a homogeneous porosity, fact that determines the complete disintegration of the tablets in due time, and thus a good availability.

  10. Deformation of the Stokes B2 rotary tablet press: quantitation and influence on tablet compaction.

    PubMed

    Altaf, S A; Hoag, S W

    1995-03-01

    Deformations that affect the vertical punch displacement of a Stokes B2 rotary tablet press were characterized with a cathetometer. The press deformation was found to be elastic for both the upper and lower compression roller assemblies. However, the upper and lower compression roller assemblies have different Hookian spring constants: 8.58 x 10(4) and 5.18 x 10(4) kN/m for the upper and lower assemblies, respectively. Using two-way analysis of variance, the Hookian spring constants were shown to be independent of compaction phases and lower punch penetration setting. To study the influence of press deformation on tablet compaction, the Hookian spring constants were factored into the caculation of the incremental work of compaction for dibasic calcium phosphate dihydrate and microcrystalline cellulose. As the peak compression pressure increases, the force-displacement work done on the tablet during the loading phase decreases relative to calculations that neglect press deformation. This decrease in force-displacement work was attributed to elastic press deformation, which absorbs energy during the loading phase and then releases this energy later in the compaction cycle, altering the punch-displacement profile. The rate at which the press stores and releases elastic energy depends in part upon the viscoelastic properties of the tablet. Based upon these results, the coupling between press elasticity and a tablet's viscoelastic properties should be accounted for when analyzing tablet compaction or trying to simulate the punch-displacement profile of a tablet press that deforms during compaction.

  11. Detection of the breakage of pharmaceutical tablets in pneumatic transport.

    PubMed

    Albion, Katherine; Briens, Lauren; Briens, Cedric; Berruti, Franco

    2006-09-28

    Pneumatic transport of pharmaceutical tablets is very convenient, compact and greatly reduces contamination. A potential problem, however, is the breakage of a significant fraction of the transported tablets, causing serious product quality problems. Since the flowrate of tablets transported through a given pneumatic transport line increases with gas velocity, lines are often operated at gas velocities slightly below the velocity at which tablets break. Minor changes in operating conditions can have a large effect on the impact resistance of tablets and on the observed tablet breakage rate. Therefore, maintaining a constant gas velocity is not sufficient to keep the tablet breakage rate below an acceptable level. The objective of the present study was to develop a reliable and non-invasive on-line method for the detection of tablet breakage. Pharmaceutical acetaminophen tablets were transported pneumatically in a 0.1 m diameter pipeline consisting of a 5 m vertical and a 4.0 m horizontal section made of either re-enforced PVC or steel. The pipeline flow regime was determined by visual observation through clear pipeline sections. Tablet breakage was quantified by screening tablet samples. Acoustic measurements were recorded at different locations along the pipeline. Analysis of the signals from microphones attached to the wall of the elbow and horizontal section provided a reliable detection of conditions leading to tablet breakage.

  12. 21 CFR 529.400 - Chlorhexidine tablets and suspension.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 6 2013-04-01 2013-04-01 false Chlorhexidine tablets and suspension. 529.400... Chlorhexidine tablets and suspension. (a) Specification. Each tablet and each 28-milliliter syringe of suspension contain 1 gram of chlorhexidine dihydrochloride.1 1 These conditions are NAS/NRC reviewed...

  13. 21 CFR 529.400 - Chlorhexidine tablets and suspension.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 6 2010-04-01 2010-04-01 false Chlorhexidine tablets and suspension. 529.400... Chlorhexidine tablets and suspension. (a) Specification. Each tablet and each 28-milliliter syringe of suspension contain 1 gram of chlorhexidine dihydrochloride.1 1 These conditions are NAS/NRC reviewed...

  14. 21 CFR 529.400 - Chlorhexidine tablets and suspension.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 6 2011-04-01 2011-04-01 false Chlorhexidine tablets and suspension. 529.400... Chlorhexidine tablets and suspension. (a) Specification. Each tablet and each 28-milliliter syringe of suspension contain 1 gram of chlorhexidine dihydrochloride.1 1 These conditions are NAS/NRC reviewed...

  15. 21 CFR 529.400 - Chlorhexidine tablets and suspension.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 6 2012-04-01 2012-04-01 false Chlorhexidine tablets and suspension. 529.400... Chlorhexidine tablets and suspension. (a) Specification. Each tablet and each 28-milliliter syringe of suspension contain 1 gram of chlorhexidine dihydrochloride.1 1 These conditions are NAS/NRC reviewed...

  16. 21 CFR 529.400 - Chlorhexidine tablets and suspension.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 6 2014-04-01 2014-04-01 false Chlorhexidine tablets and suspension. 529.400... Chlorhexidine tablets and suspension. (a) Specification. Each tablet and each 28-milliliter syringe of suspension contain 1 gram of chlorhexidine dihydrochloride.1 1 These conditions are NAS/NRC reviewed...

  17. 21 CFR 520.1696d - Penicillin V tablets.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 6 2014-04-01 2014-04-01 false Penicillin V tablets. 520.1696d Section 520.1696d... DRUGS, FEEDS, AND RELATED PRODUCTS ORAL DOSAGE FORM NEW ANIMAL DRUGS § 520.1696d Penicillin V tablets. (a) Specifications. Each tablet contains penicillin V potassium equivalent to 125 milligrams...

  18. 21 CFR 520.1696d - Penicillin V potassium tablets.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 6 2012-04-01 2012-04-01 false Penicillin V potassium tablets. 520.1696d Section... Penicillin V potassium tablets. (a) Specifications. Each tablet contains penicillin V potassium equivalent to 125 milligrams (200,000 units) or 250 milligrams (400,000 units) of penicillin V. (b) Sponsors....

  19. 21 CFR 520.1696d - Penicillin V tablets.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 6 2013-04-01 2013-04-01 false Penicillin V tablets. 520.1696d Section 520.1696d... DRUGS, FEEDS, AND RELATED PRODUCTS ORAL DOSAGE FORM NEW ANIMAL DRUGS § 520.1696d Penicillin V tablets. (a) Specifications. Each tablet contains penicillin V potassium equivalent to 125 milligrams...

  20. 21 CFR 520.1331 - Meclofenamic acid tablets.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 6 2010-04-01 2010-04-01 false Meclofenamic acid tablets. 520.1331 Section 520...) ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS ORAL DOSAGE FORM NEW ANIMAL DRUGS § 520.1331 Meclofenamic acid tablets. (a) Specifications. Each tablet contains either 10 or 20 milligrams of meclofenamic acid....

  1. 21 CFR 520.1331 - Meclofenamic acid tablets.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 6 2012-04-01 2012-04-01 false Meclofenamic acid tablets. 520.1331 Section 520...) ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS ORAL DOSAGE FORM NEW ANIMAL DRUGS § 520.1331 Meclofenamic acid tablets. (a) Specifications. Each tablet contains either 10 or 20 milligrams of meclofenamic acid....

  2. 21 CFR 520.1331 - Meclofenamic acid tablets.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 6 2011-04-01 2011-04-01 false Meclofenamic acid tablets. 520.1331 Section 520...) ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS ORAL DOSAGE FORM NEW ANIMAL DRUGS § 520.1331 Meclofenamic acid tablets. (a) Specifications. Each tablet contains either 10 or 20 milligrams of meclofenamic acid....

  3. 21 CFR 520.1446 - Milbemcyin oxime and lufenuron tablets.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 6 2012-04-01 2012-04-01 false Milbemcyin oxime and lufenuron tablets. 520.1446... oxime and lufenuron tablets. (a) Specifications—(1) Tablets containing: 2.3 milligrams (mg) milbemycin oxime and 46 mg lufenuron, 5.75 mg milbemycin oxime and 115 mg lufenuron, 11.5 mg milbemycin oxime...

  4. 21 CFR 520.1409 - Methylprednisolone, aspirin tablets.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 6 2010-04-01 2010-04-01 false Methylprednisolone, aspirin tablets. 520.1409... Methylprednisolone, aspirin tablets. (a) Specifications. Each tablet contains 0.5 milligram of methylprednisolone and 300 milligrams of aspirin. (b) Sponsor. See No. 000009 in § 510.600(c) of this chapter. (c)...

  5. 21 CFR 520.1409 - Methylprednisolone, aspirin tablets.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 6 2013-04-01 2013-04-01 false Methylprednisolone, aspirin tablets. 520.1409... Methylprednisolone, aspirin tablets. (a) Specifications. Each tablet contains 0.5 milligram of methylprednisolone and 300 milligrams of aspirin. (b) Sponsor. See No. 000009 in § 510.600(c) of this chapter. (c)...

  6. 21 CFR 520.1409 - Methylprednisolone, aspirin tablets.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 6 2011-04-01 2011-04-01 false Methylprednisolone, aspirin tablets. 520.1409... Methylprednisolone, aspirin tablets. (a) Specifications. Each tablet contains 0.5 milligram of methylprednisolone and 300 milligrams of aspirin. (b) Sponsor. See No. 000009 in § 510.600(c) of this chapter. (c)...

  7. 21 CFR 520.1409 - Methylprednisolone, aspirin tablets.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 6 2014-04-01 2014-04-01 false Methylprednisolone, aspirin tablets. 520.1409... Methylprednisolone, aspirin tablets. (a) Specifications. Each tablet contains 0.5 milligram of methylprednisolone and 300 milligrams of aspirin. (b) Sponsor. See No. 000009 in § 510.600(c) of this chapter. (c)...

  8. 21 CFR 520.1409 - Methylprednisolone, aspirin tablets.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 6 2012-04-01 2012-04-01 false Methylprednisolone, aspirin tablets. 520.1409... Methylprednisolone, aspirin tablets. (a) Specifications. Each tablet contains 0.5 milligram of methylprednisolone and 300 milligrams of aspirin. (b) Sponsor. See No. 000009 in § 510.600(c) of this chapter. (c)...

  9. Design and In-vitro Evaluation of Sustained Release Floating Tablets of Metformin HCl Based on Effervescence and Swelling.

    PubMed

    Senjoti, Faria Gias; Mahmood, Syed; Jaffri, Juliana Md; Mandal, Uttam Kumar

    2016-01-01

    An oral sustained-release floating tablet formulation of metformin HCl was designed and developed. Effervescence and swelling properties were attributed on the developed tablets by sodium bicarbonate and HPMC-PEO polymer combination, respectively. Tablet composition was optimized by response surface methodology (RSM). Seventeen (17) trial formulations were analyzed according to Box-Behnken design of experiment where polymer content of HPMC and PEO at 1: 4 ratio (A), amount of sodium bi-carbonate (B), and amount of SSG (C) were adopted as independent variables. Floating lag time in sec (Y1), cumulative percent drug released at 1 h (Y2) and 12 h (Y3) were chosen as response variables. Tablets from the optimized formulation were also stored at accelerated stability condition (40°C and 75% RH) for 3 months to assess their stability profile. RSM could efficiently optimize the tablet composition with excellent prediction ability. In-vitro drug release until 12 h, floating lag time, and duration of floating were dependent on the amount of three selected independent variables. Optimized tablets remained floating for more than 24 h with a floating lag time of less than 4 min. Based on best fitting method, optimized formulation was found to follow Korsmeyer-Peppas release kinetic. Accelerated stability study revealed that optimized formulation was stable for three months without any major changes in assay, dissolution profile, floating lag time and other physical properties. PMID:27610147

  10. Design and In-vitro Evaluation of Sustained Release Floating Tablets of Metformin HCl Based on Effervescence and Swelling

    PubMed Central

    Senjoti, Faria Gias; Mahmood, Syed; Jaffri, Juliana Md; Mandal, Uttam Kumar

    2016-01-01

    An oral sustained-release floating tablet formulation of metformin HCl was designed and developed. Effervescence and swelling properties were attributed on the developed tablets by sodium bicarbonate and HPMC-PEO polymer combination, respectively. Tablet composition was optimized by response surface methodology (RSM). Seventeen (17) trial formulations were analyzed according to Box-Behnken design of experiment where polymer content of HPMC and PEO at 1: 4 ratio (A), amount of sodium bi-carbonate (B), and amount of SSG (C) were adopted as independent variables. Floating lag time in sec (Y1), cumulative percent drug released at 1 h (Y2) and 12 h (Y3) were chosen as response variables. Tablets from the optimized formulation were also stored at accelerated stability condition (40°C and 75% RH) for 3 months to assess their stability profile. RSM could efficiently optimize the tablet composition with excellent prediction ability. In-vitro drug release until 12 h, floating lag time, and duration of floating were dependent on the amount of three selected independent variables. Optimized tablets remained floating for more than 24 h with a floating lag time of less than 4 min. Based on best fitting method, optimized formulation was found to follow Korsmeyer-Peppas release kinetic. Accelerated stability study revealed that optimized formulation was stable for three months without any major changes in assay, dissolution profile, floating lag time and other physical properties.

  11. Design and In-vitro Evaluation of Sustained Release Floating Tablets of Metformin HCl Based on Effervescence and Swelling

    PubMed Central

    Senjoti, Faria Gias; Mahmood, Syed; Jaffri, Juliana Md; Mandal, Uttam Kumar

    2016-01-01

    An oral sustained-release floating tablet formulation of metformin HCl was designed and developed. Effervescence and swelling properties were attributed on the developed tablets by sodium bicarbonate and HPMC-PEO polymer combination, respectively. Tablet composition was optimized by response surface methodology (RSM). Seventeen (17) trial formulations were analyzed according to Box-Behnken design of experiment where polymer content of HPMC and PEO at 1: 4 ratio (A), amount of sodium bi-carbonate (B), and amount of SSG (C) were adopted as independent variables. Floating lag time in sec (Y1), cumulative percent drug released at 1 h (Y2) and 12 h (Y3) were chosen as response variables. Tablets from the optimized formulation were also stored at accelerated stability condition (40°C and 75% RH) for 3 months to assess their stability profile. RSM could efficiently optimize the tablet composition with excellent prediction ability. In-vitro drug release until 12 h, floating lag time, and duration of floating were dependent on the amount of three selected independent variables. Optimized tablets remained floating for more than 24 h with a floating lag time of less than 4 min. Based on best fitting method, optimized formulation was found to follow Korsmeyer-Peppas release kinetic. Accelerated stability study revealed that optimized formulation was stable for three months without any major changes in assay, dissolution profile, floating lag time and other physical properties. PMID:27610147

  12. Resveratrol cocrystals with enhanced solubility and tabletability.

    PubMed

    Zhou, Zhengzheng; Li, Wanying; Sun, Wei-Jhe; Lu, Tongbu; Tong, Henry H Y; Sun, Changquan Calvin; Zheng, Ying

    2016-07-25

    Two new 1:1 cocrystals of resveratrol (RES) with 4-aminobenzamide (RES-4ABZ) and isoniazid (RES-ISN) were synthesized by liquid assisted grinding (LAG) and rapid solvent removal (RSR) methods using ethanol as solvent. Their physiochemical properties were characterized using PXRD, DSC, solid state and solution NMR, FT-IR, and HPLC. Pharmaceutically relevant properties, including tabletability, solubility, intrinsic dissolution rate, and hygroscopicity, were evaluated. Temperature-composition phase diagram for RES-ISN cocrystal system was constructed from DSC data. Both cocrystals show higher solubility than resveratrol over a broad range of pH. They are phase stable and non-hygroscopic even under high humidity conditions. Importantly, both cocrystals exhibit improved solubility and tabletability compared with RES, which make them more suitable candidates for tablet formulation development. PMID:27282539

  13. Physicochemical equivalence of chloroquine phosphate tablets.

    PubMed

    Bamiro, O A; Odeniyi, M A; Idowu, O B; Jaiyeoba, K T

    2004-12-01

    Seven brands of chloroquine phosphate tablets sourced from different retail outlets in the South-West Nigerian market were analysed in order to determine their physicochemical equivalence. The assessment parameters included uniformity of weight, friability, crushing strength, disintegration and dissolution tests and chemical assay of the tablets. All the brands passed the British Pharmacopoeia tests for weight uniformity, disintegration time and dissolution rate. Two brands, C and E passed the minimum criterion for crushing strength, four brands passed the friability test and two brands exceeded the specified amount of active drug content for chloroquine tablets. Only one brand C out of the seven brands that were analysed passed all the BP quality specifications. Hence none of the seven brands analysed could said to be physically and chemically equivalent. This study highlights the need for constant market monitoring of new products in order to ascertain their quality. PMID:15977447

  14. Damage-tolerance strategies for nacre tablets.

    PubMed

    Wang, Shengnan; Zhu, Xinqiao; Li, Qiyang; Wang, Rizhi; Wang, Xiaoxiang

    2016-05-01

    Nacre, a natural armor, exhibits prominent penetration resistance against predatory attacks. Unraveling its hierarchical toughening mechanisms and damage-tolerance design strategies may provide significant inspiration for the pursuit of high-performance artificial armors. In this work, relationships between the structure and mechanical performance of nacre were investigated. The results show that other than their brick-and-mortar structure, individual nacre tablets significantly contribute to the damage localization of nacre. Affected by intracrystalline organics, the tablets exhibit a unique fracture behavior. The synergistic action of the nanoscale deformation mechanisms increases the energy dissipation efficiency of the tablets and contributes to the preservation of the structural and functional integrity of the shell. PMID:26892674

  15. Formulation and in vitro evaluation of Eudragit S-100 coated naproxen matrix tablets for colon-targeted drug delivery system

    PubMed Central

    Mehta, Rohit; Chawla, Anuj; Sharma, Pooja; Pawar, Pravin

    2013-01-01

    The purpose of the present investigation was to prepare matrix tablets of naproxen using a hydrophobic polymer, i.e., Eudragit RLPO, RSPO, and combination of both, by wet granulation method. The tablets were further coated with different concentrations of Eudragit S-100, a pH-sensitive polymer, by dip immerse method. In vitro drug release studies of tablets were carried out in different dissolution media, i.e., 0.1 N HCl (pH 1.2), phosphate buffers pH 6.8 and 7.4, with or without rat cecal content. The swelling studies of the optimized formulation were carried out. The physicochemical parameters of all the formulations were found to be in compliance with the pharmacopoeial standards. The effect of dissolution medium on the surface of matrix tablet was determined by using Scanning Electron Microscopy technique. The stability studies of all formulations were performed as per ICH guidelines. The results demonstrated that the tablets coated with Eudragit S-100 (2% w/v) showed a sustained release of 94.67% for 24 h, but drug release increased to about 98.60% for 24 h in the presence of rat cecal content while the uncoated tablets released the drug within 5 h. With regard to release kinetics, the data were best fitted with the Higuchi model with non-Fickian drug release kinetics mechanism. The stability studies of tablets showed less degradation during accelerated and room temperature storage conditions for 6 months. The enteric-coated Eudragit S-100 coated matrix tablets of naproxen showed promising site-specific drug delivery in the colon region. PMID:23662280

  16. Pharmacokinetics and safety of posaconazole delayed-release tablets for invasive fungal infections

    PubMed Central

    Wiederhold, Nathan P

    2016-01-01

    Posaconazole is a broad-spectrum triazole antifungal agent with potent activity against various pathogenic fungi, including yeast and moulds. Clinical studies have demonstrated that this agent is efficacious as prophylaxis against invasive fungal infections in patients at high risk, and may also be useful as salvage therapy against invasive aspergillosis and mucormycosis. However, the bioavailability of posaconazole following administration by oral suspension, which was the only formulation clinically available for many years, is highly variable and negatively influenced by several factors. Because of this, many patients had subtherapeutic or undetectable posaconazole levels when the oral suspension was used. To overcome this limitation, a delayed-release tablet was developed and is now available for clinical use. Hot-melt extrusion technology is used to combine a pH-sensitive polymer with posaconazole to produce a formulation that releases the drug in the elevated pH of the intestine where absorption occurs rather than in the low-pH environment of the stomach. This results in enhanced bioavailability and increased posaconazole exposure. Studies in healthy volunteers have demonstrated significantly higher and more consistent exposures with the tablet formulation compared to the oral suspension. In addition, pharmacokinetic parameters following administration of the tablets were not significantly affected by medications that raise gastric pH or increase gastric motility, and the tablets could also be administered without regard to food. Similar results have also been found in patients at high risk for invasive fungal infections who have received posaconazole tablets. The tablet formulation also appears to be well tolerated to date, although data regarding clinical efficacy are needed. PMID:26730212

  17. 3D printing of tablets containing multiple drugs with defined release profiles.

    PubMed

    Khaled, Shaban A; Burley, Jonathan C; Alexander, Morgan R; Yang, Jing; Roberts, Clive J

    2015-10-30

    We have employed three-dimensional (3D) extrusion-based printing as a medicine manufacturing technique for the production of multi-active tablets with well-defined and separate controlled release profiles for three different drugs. This 'polypill' made by a 3D additive manufacture technique demonstrates that complex medication regimes can be combined in a single tablet and that it is viable to formulate and 'dial up' this single tablet for the particular needs of an individual. The tablets used to illustrate this concept incorporate an osmotic pump with the drug captopril and sustained release compartments with the drugs nifedipine and glipizide. This combination of medicines could potentially be used to treat diabetics suffering from hypertension. The room temperature extrusion process used to print the formulations used excipients commonly employed in the pharmaceutical industry. Attenuated Total Reflectance Fourier Transform Infrared Spectroscopy (ATR-FTIR) and X-ray powder diffraction (XRPD) were used to assess drug-excipient interaction. The printed formulations were evaluated for drug release using USP dissolution testing. We found that the captopril portion showed the intended zero order drug release of an osmotic pump and noted that the nifedipine and glipizide portions showed either first order release or Korsmeyer-Peppas release kinetics dependent upon the active/excipient ratio used.

  18. 3D printing of tablets containing multiple drugs with defined release profiles.

    PubMed

    Khaled, Shaban A; Burley, Jonathan C; Alexander, Morgan R; Yang, Jing; Roberts, Clive J

    2015-10-30

    We have employed three-dimensional (3D) extrusion-based printing as a medicine manufacturing technique for the production of multi-active tablets with well-defined and separate controlled release profiles for three different drugs. This 'polypill' made by a 3D additive manufacture technique demonstrates that complex medication regimes can be combined in a single tablet and that it is viable to formulate and 'dial up' this single tablet for the particular needs of an individual. The tablets used to illustrate this concept incorporate an osmotic pump with the drug captopril and sustained release compartments with the drugs nifedipine and glipizide. This combination of medicines could potentially be used to treat diabetics suffering from hypertension. The room temperature extrusion process used to print the formulations used excipients commonly employed in the pharmaceutical industry. Attenuated Total Reflectance Fourier Transform Infrared Spectroscopy (ATR-FTIR) and X-ray powder diffraction (XRPD) were used to assess drug-excipient interaction. The printed formulations were evaluated for drug release using USP dissolution testing. We found that the captopril portion showed the intended zero order drug release of an osmotic pump and noted that the nifedipine and glipizide portions showed either first order release or Korsmeyer-Peppas release kinetics dependent upon the active/excipient ratio used. PMID:26235921

  19. Formulation and stability evaluation of immediate release antioxidant tablet.

    PubMed

    Sultana, Abida; Hassan, Fouzia; Israr, Fozia; Hasan, S M Farid; Haque, Naheed

    2014-09-01

    Oxidative stress plays an important part in the development of human diseases. Pharmaceutical strategies are required to be work out in order to fight against such oxidative damages. Designing of new formulations that can protect human beings from the undesirable effects, consequence of oxidative stress, the crucial cellular and molecular processes, along with recurring oxidative damage and diseases is to be expedited. The main objective of present work was to design a rapidly releasing synthetic antioxidant tablet dosage form comprising of vitamin A, vitamin C, vitamin E and zinc in combination with lecithin (a phospho-lipid) that can fulfill human health and nutritional requirement and to perform stability studies. Beside active ingredients, the excipients used in present formulation were; Avicel pH 102, starch pregelatinized, silicon dioxide colloidal and polyethylene glycol 8000 milled magnesium stearate, acid stearic fine powder and aq.opa dry coating material. The immediate release formulation of antioxidant was prepared by wet granulation method. Three different trials were developed. Vitamin C was selected as tracer for detection and evaluation of tablet dosage form. When the resulting formulation was evaluated by USP 24 / NF 19, 2000 guidelines and later by stability studies, it was found that their quality can be maintained over a storage period of 24 months. PMID:25176233

  20. Integrating artificial and human intelligence into tablet production process.

    PubMed

    Gams, Matjaž; Horvat, Matej; Ožek, Matej; Luštrek, Mitja; Gradišek, Anton

    2014-12-01

    We developed a new machine learning-based method in order to facilitate the manufacturing processes of pharmaceutical products, such as tablets, in accordance with the Process Analytical Technology (PAT) and Quality by Design (QbD) initiatives. Our approach combines the data, available from prior production runs, with machine learning algorithms that are assisted by a human operator with expert knowledge of the production process. The process parameters encompass those that relate to the attributes of the precursor raw materials and those that relate to the manufacturing process itself. During manufacturing, our method allows production operator to inspect the impacts of various settings of process parameters within their proven acceptable range with the purpose of choosing the most promising values in advance of the actual batch manufacture. The interaction between the human operator and the artificial intelligence system provides improved performance and quality. We successfully implemented the method on data provided by a pharmaceutical company for a particular product, a tablet, under development. We tested the accuracy of the method in comparison with some other machine learning approaches. The method is especially suitable for analyzing manufacturing processes characterized by a limited amount of data.

  1. Formulation and stability evaluation of immediate release antioxidant tablet.

    PubMed

    Sultana, Abida; Hassan, Fouzia; Israr, Fozia; Hasan, S M Farid; Haque, Naheed

    2014-09-01

    Oxidative stress plays an important part in the development of human diseases. Pharmaceutical strategies are required to be work out in order to fight against such oxidative damages. Designing of new formulations that can protect human beings from the undesirable effects, consequence of oxidative stress, the crucial cellular and molecular processes, along with recurring oxidative damage and diseases is to be expedited. The main objective of present work was to design a rapidly releasing synthetic antioxidant tablet dosage form comprising of vitamin A, vitamin C, vitamin E and zinc in combination with lecithin (a phospho-lipid) that can fulfill human health and nutritional requirement and to perform stability studies. Beside active ingredients, the excipients used in present formulation were; Avicel pH 102, starch pregelatinized, silicon dioxide colloidal and polyethylene glycol 8000 milled magnesium stearate, acid stearic fine powder and aq.opa dry coating material. The immediate release formulation of antioxidant was prepared by wet granulation method. Three different trials were developed. Vitamin C was selected as tracer for detection and evaluation of tablet dosage form. When the resulting formulation was evaluated by USP 24 / NF 19, 2000 guidelines and later by stability studies, it was found that their quality can be maintained over a storage period of 24 months.

  2. Measurement uncertainty of lactase-containing tablets analyzed with FTIR.

    PubMed

    Paakkunainen, Maaret; Kohonen, Jarno; Reinikainen, Satu-Pia

    2014-01-01

    Uncertainty is one of the most critical aspects in determination of measurement reliability. In order to ensure accurate measurements, results need to be traceable and uncertainty measurable. In this study, homogeneity of FTIR samples is determined with a combination of variographic and multivariate approach. An approach for estimation of uncertainty within individual sample, as well as, within repeated samples is introduced. FTIR samples containing two commercial pharmaceutical lactase products (LactaNON and Lactrase) are applied as an example of the procedure. The results showed that the approach is suitable for the purpose. The sample pellets were quite homogeneous, since the total uncertainty of each pellet varied between 1.5% and 2.5%. The heterogeneity within a tablet strip was found to be dominant, as 15-20 tablets has to be analyzed in order to achieve <5.0% expanded uncertainty level. Uncertainty arising from the FTIR instrument was <1.0%. The uncertainty estimates are computed directly from FTIR spectra without any concentration information of the analyte.

  3. Tramadol and acetaminophen tablets for dental pain.

    PubMed Central

    Medve, R. A.; Wang, J.; Karim, R.

    2001-01-01

    The purpose of this work was to compare the efficacy and time to analgesia of a new tramadol/acetaminophen combination tablet to those of tramadol or acetaminophen (APAP) alone. A meta-analysis was performed of 3 separate single-dose, double-blind, parallel-group trials in patients with moderate or severe pain following extraction of 2 or more third molars. Patients in each study were evenly randomized to a single dose of tramadol/APAP (75 mg/650 mg), tramadol 75 mg, APAP 650 mg, ibuprofen 400 mg, or placebo. Active control with ibuprofen was used to determine model sensitivity. Pain relief (scale, 0-4) and pain intensity (scale, 0-3) were reported at 30 minutes after the dose and then hourly for 8 hours. Total pain relief over 8 hours (TOTPAR8) and the sum of pain intensity differences (SPID8) were calculated from the hourly scores. Time to onset of pain relief was determined by the double-stopwatch technique, and patients were advised to wait at least 2 hours before taking supplemental analgesia. Patients assessed overall efficacy (scale, 1-5) upon completion. In all, 1197 patients (age range, 16-46 years) were evaluable for efficacy; treatment groups in each study were similar at baseline. Pain relief was superior to placebo (P < or = .0001) for all treatments. Pain relief provided by tramadol/ APAP was superior to that of tramadol or APAP alone, as shown by mean TOT-PAR8 (12.1 vs 6.7 and 8.6, respectively, P < or = .0001) and SPID8 (4.7 vs 0.9 and 2.7, respectively, P < or = .0001). Estimated onset of pain relief was 17 minutes (95% CI, 15-20 minutes) for tramadol/APAP compared with 51 minutes (95% CI, 40-70 minutes) for tramadol, 18 minutes (95% CI, 16-21 minutes) for APAP, and 34 minutes (95% CI, 28-44 minutes) for ibuprofen. Median time to supplemental analgesia and mean overall assessment of efficacy were greater (P < .05) for the tramadol/APAP group (302 minutes and 3.0, respectively) than for the tramadol (122 minutes and 2.0) or APAP (183 minutes and 2

  4. Dissolution of tablet-in-tablet formulations studied with ATR-FTIR spectroscopic imaging.

    PubMed

    Wray, Patrick S; Clarke, Graham S; Kazarian, Sergei G

    2013-03-12

    This work uses ATR-FTIR spectroscopic imaging to study the dissolution of delayed release and pH resistant compressed coating pharmaceutical tablets. Tablets with an inner core and outer shell were constructed using a custom designed compaction cell. The core of the delayed release tablets consisted of hydroxypropyl methylcellulose (HPMC) and caffeine. The shell consisted of microcrystalline cellulose (MCC) and glucose. The core of the pH resistant formulations was an ibuprofen and PEG melt and the shell was constructed from HPMC and a basic buffer. UV/vis spectroscopy was used to monitor the lag-time of drug release and visible optical video imaging was used as a complementary imaging technique with a larger field of view. Two delayed release mechanisms were established. For tablets with soluble shell sections, lag-time was dependent upon rapid shell dissolution. For tablets with less soluble shells, the lag-time was controlled by the rate of dissolution medium ingress through the shell and the subsequent expansion of the wet HPMC core. The pH resistant formulations prevented crystallization of the ibuprofen in the core during dissolution despite an acidic dissolution medium. FTIR imaging produced important information about the physical and chemical processes occurring at the interface between tablet sections during dissolution. PMID:23291036

  5. Analysis of tablet compaction. II. Finite element analysis of density distributions in convex tablets.

    PubMed

    Sinka, I C; Cunningham, J C; Zavaliangos, A

    2004-08-01

    A Drucker-Prager/cap constitutive model, where the elastic and plastic model parameters are expressed as a function of relative density (RD), was presented in a companion article together with experimental calibration procedures. Here, we examine the RD distribution in curved-faced tablets with special reference to the die wall lubrication conditions. The compaction of powders is examined using finite element analysis, which involves the following factors: constitutive behavior of powder, friction between powder and tooling, geometry of die and punches, sequence of punch motions, and initial conditions that result from die fill. The predictions of the model are validated using experimental RD maps. It is shown that different die wall lubrication conditions induce opposite density distribution trends in identical tablets (weight, height, and material). The importance of the internal tablet structure is illustrated with respect to break force, failure mode, and friability: it is demonstrated that for a given average tablet density the break force and failure mode are not unique. Also, tablet regions having lower density locally have higher propensity for damage. The applicability of finite element analysis for optimizations of formulation design, process development, tablet image, and tool design is discussed.

  6. 21 CFR 520.1288 - Lufenuron tablets.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... § 520.1510(d)(1) of this chapter is indicated to kill adult fleas and prevent flea eggs from hatching... tablets as in § 520.1510(d)(2) of this chapter is indicated to kill adult fleas and prevent flea eggs...

  7. 21 CFR 520.1288 - Lufenuron tablets.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... § 520.1510(d)(1) of this chapter is indicated to kill adult fleas and prevent flea eggs from hatching... tablets as in § 520.1510(d)(2) of this chapter is indicated to kill adult fleas and prevent flea eggs...

  8. 21 CFR 520.1288 - Lufenuron tablets.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... § 520.1510(d)(1) of this chapter is indicated to kill adult fleas and prevent flea eggs from hatching... tablets as in § 520.1510(d)(2) of this chapter is indicated to kill adult fleas and prevent flea eggs...

  9. 21 CFR 520.1288 - Lufenuron tablets.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... § 520.1510(d)(1) of this chapter is indicated to kill adult fleas and prevent flea eggs from hatching... tablets as in § 520.1510(d)(2) of this chapter is indicated to kill adult fleas and prevent flea eggs...

  10. 21 CFR 520.1408 - Methylprednisolone tablets.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 6 2013-04-01 2013-04-01 false Methylprednisolone tablets. 520.1408 Section 520.1408 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED... presence of active tuberculosis, diabetes, osteoporosis, chronic psychotic reactions, predisposition...

  11. 21 CFR 520.1880 - Prednisolone tablets.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 6 2012-04-01 2012-04-01 false Prednisolone tablets. 520.1880 Section 520.1880 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) ANIMAL... Cushingoid syndrome. The presence of diabetes, osteoporosis, predisposition to thrombophlebitis,...

  12. 21 CFR 520.1408 - Methylprednisolone tablets.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 6 2012-04-01 2012-04-01 false Methylprednisolone tablets. 520.1408 Section 520.1408 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED... presence of active tuberculosis, diabetes, osteoporosis, chronic psychotic reactions, predisposition...

  13. 21 CFR 520.1880 - Prednisolone tablets.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 6 2014-04-01 2014-04-01 false Prednisolone tablets. 520.1880 Section 520.1880 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) ANIMAL... Cushingoid syndrome. The presence of diabetes, osteoporosis, predisposition to thrombophlebitis,...

  14. 21 CFR 520.1880 - Prednisolone tablets.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 6 2013-04-01 2013-04-01 false Prednisolone tablets. 520.1880 Section 520.1880 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) ANIMAL... Cushingoid syndrome. The presence of diabetes, osteoporosis, predisposition to thrombophlebitis,...

  15. 21 CFR 520.1408 - Methylprednisolone tablets.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 6 2014-04-01 2014-04-01 false Methylprednisolone tablets. 520.1408 Section 520.1408 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED... ulcer, acute psychoses, or cushingoid syndrome. The presence of active tuberculosis,...

  16. Research on Mobile Learning Activities Applying Tablets

    ERIC Educational Resources Information Center

    Kurilovas, Eugenijus; Juskeviciene, Anita; Bireniene, Virginija

    2015-01-01

    The paper aims to present current research on mobile learning activities in Lithuania while implementing flagship EU-funded CCL project on application of tablet computers in education. In the paper, the quality of modern mobile learning activities based on learning personalisation, problem solving, collaboration, and flipped class methods is…

  17. How to Transform Teaching with Tablets

    ERIC Educational Resources Information Center

    Daccord, Tom; Reich, Justin

    2015-01-01

    Without a change in our technology integration strategies, there's no reason to expect that a new device will magically create new teaching practices. In some iPad classrooms, students are engaged in truly innovative work. On the whole, however, tablets are most often used to reproduce existing practices. To make the most of their investment in…

  18. 21 CFR 520.816 - Epsiprantel tablets.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 6 2013-04-01 2013-04-01 false Epsiprantel tablets. 520.816 Section 520.816 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) ANIMAL... pound of body weight. (ii) Indications for use. Removal of canine cestodes Dipylidium caninum and...

  19. Touch Tablet Surprises: A Preschool Teacher's Story

    ERIC Educational Resources Information Center

    Shifflet, Rena; Toledo, Cheri; Mattoon, Cassandra

    2012-01-01

    A year and a half ago, Rena, Cheri, and Cassandra were introduced to each other by a colleague because they shared an interest in exploring the impact newer technologies have on learning in early childhood classrooms. They meet regularly to share ideas and information on how to incorporate tablets using best practices. Cassandra's preschool…

  20. 21 CFR 520.804 - Enalapril tablets.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 6 2014-04-01 2014-04-01 false Enalapril tablets. 520.804 Section 520.804 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) ANIMAL... mild, moderate, and severe (modified New York Heart Association Class II, III, IV) heart failure...

  1. Using Tablet Technology for University Lectures

    ERIC Educational Resources Information Center

    Chester, Victoria

    2008-01-01

    Tablet PCs provide numerous benefits over traditional electronically projected lectures that use software such as PowerPoint. Flexibility and spontaneity can be achieved by editing or creating notes in real-time. The input pen or stylus is a very useful tool, especially for courses that involve the extensive use of equations or mathematical…

  2. 21 CFR 520.531 - Cythioate tablets.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... DRUGS, FEEDS, AND RELATED PRODUCTS ORAL DOSAGE FORM NEW ANIMAL DRUGS § 520.531 Cythioate tablets. (a) (b...) Limitations. For oral use in dogs only. Do not use in greyhounds or in animals that are pregnant, sick, under stress, or recovering from surgery. Federal law restricts this drug to use by or on the order of...

  3. GRAPHIC INPUT TABLETS FOR PROGRAMMED INSTRUCTION.

    ERIC Educational Resources Information Center

    BOOKER, C.A., JR.; AND OTHERS

    TO FACILITATE STUDENT-COMPUTER COMMUNICATION IN PROGRAMED INSTRUCTION, A MODIFICATION OF THE RAND TABLET, WHICH CONVERTS POSITION INFORMATION INTO ELECTRICAL SIGNALS, IS PROPOSED. MANUFACTURE OF THE DEVICE WOULD BE MORE ECONOMICAL, AND THE ELECTRONICS PACKAGE, REDESIGNED WITH INTEGRATED CIRCUITS, WOULD BE SMALLER AND MORE FLEXIBLE. MODIFICATION OF…

  4. 21 CFR 520.2330 - Sulfisoxazole tablets.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 6 2010-04-01 2010-04-01 false Sulfisoxazole tablets. 520.2330 Section 520.2330 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) ANIMAL... may require bioequivalency and safety information. (2) Indications for use. Use in dogs and cats as...

  5. 21 CFR 520.816 - Epsiprantel tablets.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 6 2010-04-01 2010-04-01 false Epsiprantel tablets. 520.816 Section 520.816 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) ANIMAL... pisiformis. (2) Cats—(i) Amount. 1.25 milligrams per pound of body weight. (ii) Indications for use....

  6. 21 CFR 520.816 - Epsiprantel tablets.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 6 2011-04-01 2011-04-01 false Epsiprantel tablets. 520.816 Section 520.816 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) ANIMAL... pisiformis. (2) Cats—(i) Amount. 1.25 milligrams per pound of body weight. (ii) Indications for use....

  7. 21 CFR 520.1310 - Marbofloxacin tablets.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 6 2011-04-01 2011-04-01 false Marbofloxacin tablets. 520.1310 Section 520.1310 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) ANIMAL...) Indications for use. For the treatment of infections in dogs and cats associated with bacteria susceptible...

  8. 21 CFR 520.1380 - Methocarbamol tablets.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 6 2010-04-01 2010-04-01 false Methocarbamol tablets. 520.1380 Section 520.1380 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) ANIMAL...) Conditions of use. (1) The drug is administered to dogs and cats as an adjunct to therapy for...

  9. 21 CFR 520.1310 - Marbofloxacin tablets.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 6 2010-04-01 2010-04-01 false Marbofloxacin tablets. 520.1310 Section 520.1310 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) ANIMAL...) Indications for use. For the treatment of infections in dogs and cats associated with bacteria susceptible...

  10. 21 CFR 520.1380 - Methocarbamol tablets.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 6 2011-04-01 2011-04-01 false Methocarbamol tablets. 520.1380 Section 520.1380 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) ANIMAL...) Conditions of use. (1) The drug is administered to dogs and cats as an adjunct to therapy for...

  11. 21 CFR 520.2330 - Sulfisoxazole tablets.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 6 2011-04-01 2011-04-01 false Sulfisoxazole tablets. 520.2330 Section 520.2330 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) ANIMAL... may require bioequivalency and safety information. (2) Indications for use. Use in dogs and cats as...

  12. 21 CFR 520.2088 - Roxarsone tablets.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... organic arsenic. Overdosage or the lack of water intake may result in weakness or paralysis of legs. ... water (0.002 percent roxarsone). (b) Indications for use. For increased rate of weight gain, improved...) Amount. Dissolve 8 tablets in each gallon of drinking water (0.008 percent roxarsone). (b)...

  13. 21 CFR 520.455 - Clomipramine tablets.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 6 2010-04-01 2010-04-01 false Clomipramine tablets. 520.455 Section 520.455 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) ANIMAL... comprehensive behavioral management program to treat separation anxiety in dogs greater than 6 months of age....

  14. You May Now Open Your Test Tablets...

    ERIC Educational Resources Information Center

    Schaffhauser, Dian

    2012-01-01

    Tony Alpert, chief operating officer for the Smarter Balanced Assessment Consortium (SBAC), ponders whether to allow tablet computers--and particularly iPads--to be used for summative testing online. As Alpert points out, not only would student cheating compromise the validity of the individual student's test event, "worse yet, it could expose…

  15. Relationship between Age and the Ability to Break Scored Tablets

    PubMed Central

    Notenboom, Kim; Vromans, Herman; Schipper, Maarten; Leufkens, Hubert G. M.; Bouvy, Marcel L.

    2016-01-01

    Background: Practical problems with the use of medicines, such as difficulties with breaking tablets, are an often overlooked cause for non-adherence. Tablets frequently break in uneven parts and loss of product can occur due to crumbling and powdering. Health characteristics, such as the presence of peripheral neuropathy, decreased grip strength and manual dexterity, can affect a patient's ability to break tablets. As these impairments are associated with aging and age-related diseases, such as Parkinson's disease and arthritis, difficulties with breaking tablets could be more prevalent among older adults. The objective of this study was to investigate the relationship between age and the ability to break scored tablets. Methods: A comparative study design was chosen. Thirty-six older adults and 36 young adults were systematically observed with breaking scored tablets. Twelve different tablets were included. All participants were asked to break each tablet by three techniques: in between the fingers with the use of nails, in between the fingers without the use of nails and pushing the tablet downward with one finger on a solid surface. It was established whether a tablet was broken or not, and if broken, whether the tablet was broken accurately or not. Results: The older adults experienced more difficulties to break tablets compared to the young adults. On average, the older persons broke 38.1% of the tablets, of which 71.0% was broken accurately. The young adults broke 78.2% of the tablets, of which 77.4% was broken accurately. Further analysis by mixed effects logistic regression revealed that age was associated with the ability to break tablets, but not with the accuracy of breaking. Conclusions: Breaking scored tablets by hand is less successful in an elderly population compared to a group of young adults. Health care providers should be aware that tablet breaking is not appropriate for all patients and for all drugs. In case tablet breaking is unavoidable, a

  16. Formulation and Evaluation of Multilayered Tablets of Pioglitazone Hydrochloride and Metformin Hydrochloride

    PubMed Central

    Chowdary, Y. Ankamma; Raparla, Ramakrishna; Madhuri, Muramshetty

    2014-01-01

    In the treatment of type 2 diabetes mellitus a continuous therapy is required which is a more complex one. As in these patients there may be a defect in both insulin secretion and insulin action exists. Hence, the treatment depends on the pathophysiology and the disease state. In the present study, multilayered tablets of pioglitazone hydrochloride 15 mg and metformin hydrochloride 500 mg were prepared in an attempt for combination therapy for the treatment of type 2 diabetes mellitus. Pioglitazone HCl was formulated as immediate release layer to show immediate action by direct compression method using combination of superdisintegrants, namely, crospovidone and avicel PH 102. Crospovidone at 20% concentration showed good drug release profile at 2 hrs. Metformin HCl was formulated as controlled release layer to prolong the drug action by incorporating hydrophilic polymers such as HPMC K4M by direct compression method and guar gum by wet granulation method in order to sustain the drug release from the tablets and maintain its integrity so as to provide a suitable formulation. The multilayered tablets were prepared after carrying out the optimization of immediate release layer and were evaluated for various precompression and postcompression parameters. Formulation F13 showed 99.97% of pioglitazone release at 2 hrs in 0.1 N HCl and metformin showed 98.81% drug release at 10 hrs of dissolution in 6.8 pH phosphate buffer. The developed formulation is equivalent to innovator product in view of in vitro drug release profile. The results of all these evaluation tests are within the standards. The procedure followed for the formulation of these tablets was found to be reproducible and all the formulations were stable after accelerated stability studies. Hence, multilayered tablets of pioglitazone HCl and metformin HCl can be a better alternative way to conventional dosage forms. PMID:26556204

  17. Formulation and Evaluation of Multilayered Tablets of Pioglitazone Hydrochloride and Metformin Hydrochloride.

    PubMed

    Chowdary, Y Ankamma; Raparla, Ramakrishna; Madhuri, Muramshetty

    2014-01-01

    In the treatment of type 2 diabetes mellitus a continuous therapy is required which is a more complex one. As in these patients there may be a defect in both insulin secretion and insulin action exists. Hence, the treatment depends on the pathophysiology and the disease state. In the present study, multilayered tablets of pioglitazone hydrochloride 15 mg and metformin hydrochloride 500 mg were prepared in an attempt for combination therapy for the treatment of type 2 diabetes mellitus. Pioglitazone HCl was formulated as immediate release layer to show immediate action by direct compression method using combination of superdisintegrants, namely, crospovidone and avicel PH 102. Crospovidone at 20% concentration showed good drug release profile at 2 hrs. Metformin HCl was formulated as controlled release layer to prolong the drug action by incorporating hydrophilic polymers such as HPMC K4M by direct compression method and guar gum by wet granulation method in order to sustain the drug release from the tablets and maintain its integrity so as to provide a suitable formulation. The multilayered tablets were prepared after carrying out the optimization of immediate release layer and were evaluated for various precompression and postcompression parameters. Formulation F13 showed 99.97% of pioglitazone release at 2 hrs in 0.1 N HCl and metformin showed 98.81% drug release at 10 hrs of dissolution in 6.8 pH phosphate buffer. The developed formulation is equivalent to innovator product in view of in vitro drug release profile. The results of all these evaluation tests are within the standards. The procedure followed for the formulation of these tablets was found to be reproducible and all the formulations were stable after accelerated stability studies. Hence, multilayered tablets of pioglitazone HCl and metformin HCl can be a better alternative way to conventional dosage forms. PMID:26556204

  18. Formulation and in vitro release studies of pegylated mucin based matrix tablets.

    PubMed

    Eraga, Sylvester Okhuelegbe; Arhewoh, Matthew Ikhuoria; Iwuagwu, Magnus Amara; Ukponahiusi, Oyenmwen Enoma

    2015-01-01

    The effects of polymer concentration on the flow properties of granules and in-vitro release profiles from matrix tablets of three model drugs formulated from pegylated mucin base was investigated. Mucin was extracted from the African giant snail and in combination with PEG was used to produce a copolymer matrix base, which was mixed with the model drugs using wet granulation method. The granules and tablets were evaluated according to official and unofficial requirements. Results showed best flow with Acetylsalicylic acid (ASA) and Chloroquine Phosphate (CQ) granules with Hausner ratio of 1.04-1.2, Carr's index of 4.2-17.5% and angle of repose between 19°-26°. The tablets met B.P specifications with respect to tablet weights, friability and drug content. The release profiles showed faster release of the drug with high content of PEG and a slower release with high concentration of mucin. Pegylated mucin base will find useful application in the development of a wide range of formulations. PMID:25553689

  19. Formulation and optimization of mucoadhesive bilayer buccal tablets of atenolol using simplex design method

    PubMed Central

    Shirsand, SB; Suresh, Sarasija; Keshavshetti, GG; Swamy, PV; Reddy, P Vijay Prakash

    2012-01-01

    Introduction: In the present study, mucoadhesive buccal bilayer tablets of atenolol were fabricated with the objective of avoiding first pass metabolism and to improve its bioavailability with reduction in dosing frequency. Hence, the aim of this work was to design oral controlled release mucoadhesive tablets of atenolol and to optimize the drug release profile and bioadhesion. Materials and Methods: Bilayer buccal tablets of atenolol were prepared by direct compression method using simplex method of optimization to investigate the combined effect of hydroxypropyl methylcellulose 15 cps (X1), Carbopol (X2) and mannitol (X3); the in vitro drug release (Y1) and mucoadhesive strength (Y2) were taken as responses. The designed tablets were evaluated for various physical and biological parameters like drug content uniformity, in vitro drug release, short-term stability, and drug- excipient interactions (FTIR). Results: The formulation C containing hydroxypropyl methylcellulose 15 cps (10% w/w of matrix layer), Carbopol 934p (10% w/w of matrix layer) and mannitol (channeling agent, 40% w/w of matrix layer) was found to be promising. This formulation exhibited an in vitro drug release of 89.43% in 9 h along with satisfactory bioadhesion strength (7.20 g). Short-term stability studies on the promising formulation indicated that there are no significant changes in drug content and in vitro dissolution characteristics (P<0.05). IR spectroscopic studies indicated that there are no drug-excipient interactions. PMID:23071958

  20. In vitro characterization and release study of Ambroxol hydrochloride matrix tablets prepared by direct compression.

    PubMed

    Abd-Elbary, A; Haider, M; Sayed, S

    2012-01-01

    A series of either hydrophilic or hydrophobic polymers were used to prepare controlled release Ambroxol hydrochloride (AMX) matrix tablets by direct compression. Both the compatibility and flow properties of AMX/polymer mixtures were investigated. The effect of the amount and type of polymer on the physical properties and in vitro drug release was studied and compared to commercially available Ambroxol(®) SR capsules. A kinetic study of the release profile of AMX from the prepared matrix tablets was performed. All excipients used in the study were compatible with the model drug. AMX/drug mixtures containing sodium alginate (NA) and hydroxypropylmethyl cellulose (HPMC) showed better flow properties than other polymers used in the study. The in vitro drug release studies showed that matrix tablets formulae containing 10% HPMC (S7) or a combination of 30% NA and 5% HPMC (Ah) exhibited a higher ability to control the release of AMX. The kinetic study revealed that a diffusion controlled mechanism prevailed except when carbopol was used. Formula Ah followed a non-fickian diffusion mechanism similar to Ambroxol(®) SR capsules. Both formulae S7 and Ah could be considered as potential candidates for formulation of AMX controlled release matrix tablets.

  1. In vitro characterization and release study of Ambroxol hydrochloride matrix tablets prepared by direct compression.

    PubMed

    Abd-Elbary, A; Haider, M; Sayed, S

    2012-01-01

    A series of either hydrophilic or hydrophobic polymers were used to prepare controlled release Ambroxol hydrochloride (AMX) matrix tablets by direct compression. Both the compatibility and flow properties of AMX/polymer mixtures were investigated. The effect of the amount and type of polymer on the physical properties and in vitro drug release was studied and compared to commercially available Ambroxol(®) SR capsules. A kinetic study of the release profile of AMX from the prepared matrix tablets was performed. All excipients used in the study were compatible with the model drug. AMX/drug mixtures containing sodium alginate (NA) and hydroxypropylmethyl cellulose (HPMC) showed better flow properties than other polymers used in the study. The in vitro drug release studies showed that matrix tablets formulae containing 10% HPMC (S7) or a combination of 30% NA and 5% HPMC (Ah) exhibited a higher ability to control the release of AMX. The kinetic study revealed that a diffusion controlled mechanism prevailed except when carbopol was used. Formula Ah followed a non-fickian diffusion mechanism similar to Ambroxol(®) SR capsules. Both formulae S7 and Ah could be considered as potential candidates for formulation of AMX controlled release matrix tablets. PMID:21428699

  2. Formulation and evaluation of taste-masked levocetirizine dihydrochloride orally disintegrating tablets.

    PubMed

    Devireddy, Srinivas Reddy; Gonugunta, Chandra Sekhara Rao; Veerareddy, Prabhakar Reddy

    2009-01-01

    Orally disintegrating tablets of levocetirizine dihydrochloride were formulated with different superdisintegrants (sodium starch glycollate, croscarmellose sodium, and crospovidone) using mannitol as a diluent. Tulsion-335, Indion-204, and poly kyron T-134 cation exchange resins were used as taste-masking agents. The drug and resin complex was prepared by the kneading method. Ten formulations were prepared with varying combinations of superdisintegrants and ion-exchange resins by the wet granulation technique, using polyvinylpyrrolidone K-30 as the binder. The prepared tablets were evaluated for degree of taste masking, weight variation, hardness, friability, in vitro and in vivo disintegration time, content uniformity, and water absorption ratio. Dissolution studies were performed in two dissolution media: 0.1N HCl and distilled water. The corresponding dissolution rates were compared with the marketed formulation. Differential scanning calorimetry studies were carried out on the drug-resin complexes. Prepared tablets were good in appearance and showed acceptable results for hardness and friability. In vitro and in vivo disintegration times for the optimum formulation (F-1) were found to be 22 and 55 s, respectively. Relatively acceptable taste was achieved with both Indion-204 and Tulsion-335. Rapid disintegration time was achieved in tablets containing crosspovidone as the superdisintegrant. Dissolution studies indicated the formation of the complex of drug and resin. Differential scanning calorimetry studies indicated the formation of drug-resin complex.

  3. Development and evaluation of the tablets coated with the novel formulation termed thin-layer sugarless coated tablets.

    PubMed

    Ohmori, Shinji; Ohno, Yasuo; Makino, Tadashi; Kashihara, Toshio

    2004-07-01

    The purpose of this study was to develop and evaluate the thin-layer sugarless coated tablets containing Vitamin C, Vitamin E, Vitamin B2, calcium pantothenate, and L-cysteine. As a result of the formulation study, three coating layers, 2% under coating (UC), 38% build-up coating (BC), and 5% syrup coating (SC) were necessary for sufficient impact toughness, elegant appearance, and improvement of appearance stability after storage at 25 degrees C/75% RH for 6 months under open conditions. We demonstrated that the thin-layer sugarless coated tablets are superior to the sugar-coated tablets in terms of small tablet size and stability of calcium pantothenate. It was due to the coating method, the continuous spray mist method, which can minimize the thicknesses of coating layers and the moisture content in the tablets. We also demonstrated that the thin-layer sugarless coated tablets are superior to the film-coated tablets in terms of masking ability of the unpleasant odor and the appearance, stability of the appearance, and low hygroscopicity. It was due to the dense, opaque, and stable coating layers mainly consist of erythritol. We revealed that thin-layer sugarless coated tablets have both advantages of film-coated tablets and sugar-coated tablets. PMID:15196649

  4. Biocidal Efficacy of a Flocculating Emergency Water Purification Tablet

    PubMed Central

    Powers, Edmund M.; Hernandez, C.; Boutros, S. N.; Harper, B. G.

    1994-01-01

    Chlor-Floc (CF) emergency water purification tablets were tested for bactericidal, virucidal, and cysticidal efficacy in water at temperatures ranging from 5 to 25°C. The minimal required log reduction was achieved for bacteria, Giardia muris, and rotavirus, but CF did not achieve the required log reduction of poliovirus at any of the temperatures or times investigated. The biocidal properties of the CF tablet were equivalent to if not greater than those of the Globaline iodine tablet, and the CF tablet was a more rapid cysticide under several potential use conditions. Therefore, it is a suitable substitute for iodine tablets for emergency purification of drinking water. Clarification of turbid waters was effective, but filtration through a cloth is necessary to prevent flocculated sediment from entering the canteen. The CF tablets met military requirements for emergency water purification and are safe and acceptable for use by the military. PMID:16349318

  5. The variability of ecstasy tablets composition in Brazil.

    PubMed

    Togni, Loraine R; Lanaro, Rafael; Resende, Rodrigo R; Costa, Jose L

    2015-01-01

    The content of ecstasy tablets has been changing over the years, and nowadays 3,4-methylenedioxymethamphetamine (MDMA) is not always present in the tablets. The aim of this study was to investigate the chemical composition in the seized tablets labeled as ecstasy. We analyzed samples from 150 different seizures made by Sao Paulo's State Police by gas chromatography-mass spectrometry. MDMA was present in 44.7% of the analyzed samples, and another twenty different active substances were identified in these tablets, such as caffeine, 2C-B, piperazines, amphetamines, phencyclidine, and others. Methamphetamine was present in 22% of these samples. The results demonstrate a huge shift in the pattern of trafficking of synthetic drugs, where MDMA has been replaced in tablets mostly by illicit psychoactive substances, in a clear attempt to bypass the law. The great variability in the tablets composition may lead to an increased risk of drug poisoning.

  6. The variability of ecstasy tablets composition in Brazil.

    PubMed

    Togni, Loraine R; Lanaro, Rafael; Resende, Rodrigo R; Costa, Jose L

    2015-01-01

    The content of ecstasy tablets has been changing over the years, and nowadays 3,4-methylenedioxymethamphetamine (MDMA) is not always present in the tablets. The aim of this study was to investigate the chemical composition in the seized tablets labeled as ecstasy. We analyzed samples from 150 different seizures made by Sao Paulo's State Police by gas chromatography-mass spectrometry. MDMA was present in 44.7% of the analyzed samples, and another twenty different active substances were identified in these tablets, such as caffeine, 2C-B, piperazines, amphetamines, phencyclidine, and others. Methamphetamine was present in 22% of these samples. The results demonstrate a huge shift in the pattern of trafficking of synthetic drugs, where MDMA has been replaced in tablets mostly by illicit psychoactive substances, in a clear attempt to bypass the law. The great variability in the tablets composition may lead to an increased risk of drug poisoning. PMID:25125149

  7. Dissolution test for silymarin tablets and capsules.

    PubMed

    Campodónico, A; Collado, E; Ricci, R; Pappa, H; Segall, A; Pizzorno, M T

    2001-01-01

    Silybine (SBN), isosilybine (ISBN), silycristine (SCN), silydianine (SDN), and taxifoline (TXF) are the main active flavonoids commonly found in the dried fruits of Silybum marianum, Gaertner (Compositae). Concentrations of these compounds, except TXF, are usually expressed together as silymarin content. This paper describes a simple dissolution test developed to estimate silymarin (Sl) in pharmaceutical formulations. Five commercial products were tested using this new method (including tablets, sugar tablets, and capsules): two from Argentina, one from Brazil, one from Spain, and one from Italy. Results demonstrated that, provided the dosage form disintegrates, amounts dissolved range from 50 to 90% of the labeled value. Products were analyzed by high performance liquid chromatography (HPLC) and UV spectrophotometry.

  8. Fatal overdose of iron tablets in adults.

    PubMed

    Abhilash, Kundavaram P P; Arul, J Jonathan; Bala, Divya

    2013-09-01

    Acute iron toxicity is usually seen in children with accidental ingestion of iron-containing syrups. However, the literature on acute iron toxicity with suicidal intent in adults is scant. We report, the first instance of two adults with fatal ingestion of a single drug overdose with iron tablets from India. Two young adults developed severe gastro-intestinal bleeding and fulminant hepatic failure 48 h after deliberate consumption of large doses of iron tablets. Serum iron levels measured 36 h after ingestion were normal presumably due to the redistribution of iron to the intracellular compartment. Despite aggressive supportive management in medical intensive care unit of a tertiary care hospital, the patients succumbed to the toxic doses of iron.

  9. Fatal overdose of iron tablets in adults.

    PubMed

    Abhilash, Kundavaram P P; Arul, J Jonathan; Bala, Divya

    2013-09-01

    Acute iron toxicity is usually seen in children with accidental ingestion of iron-containing syrups. However, the literature on acute iron toxicity with suicidal intent in adults is scant. We report, the first instance of two adults with fatal ingestion of a single drug overdose with iron tablets from India. Two young adults developed severe gastro-intestinal bleeding and fulminant hepatic failure 48 h after deliberate consumption of large doses of iron tablets. Serum iron levels measured 36 h after ingestion were normal presumably due to the redistribution of iron to the intracellular compartment. Despite aggressive supportive management in medical intensive care unit of a tertiary care hospital, the patients succumbed to the toxic doses of iron. PMID:24339645

  10. [Dissolution study of the gentin tablets].

    PubMed

    Tsagareishvili, N T; Bakuridze, A D; Kurdiani, N G; Murtazashvili, T Zh

    2006-04-01

    To establish individual dissolution test for the tablets gentin, which have a marked influence on the secretory function of the stomach (increase the free acidity of the gastric juice and stimulate enzymoproduction function of the stomach), and gastroprotective functioning, the conditions for the test realization were studied and specified, using apparatus "Rotating Basket" (Dissolution test, apparatus 1, p.1791, USP XXIII, 1995). For the quantification of the active ingredients in buffer solutions chromatospectrophotometric method was used. The same conditions were used for the accomplishment of the dissolution test using apparatus "Rotating Paddle" (Dissolution test, apparatus 2, p.1791, USP XXIII, 1995). Metrologic characteristics were compared for the evaluation of the reproducibility of the results. Obtained data showed better reproducibility of the results for the apparatus "Rotating Paddle" compare to the apparatus "Rotating Basket". Estimated conditions are useful for the routine control of the tablets "Gentin" in the case of manufacturing.

  11. Physiological relevant in vitro evaluation of polymer coats for gastroretentive floating tablets.

    PubMed

    Eisenächer, Friederike; Garbacz, Grzegorz; Mäder, Karsten

    2014-11-01

    Gastroretentive drug delivery systems are retained in the stomach for a sufficient time interval, releasing the drug in a controlled manner. According to literature, the floating principle is the most frequently used formulation approach for gastric retention. However, many publications lack information of the floating forces, the impact of different pH-values and almost no information exist concerning the resistance of the floating performance against physiological relevant stress. Therefore, we evaluated the performance of CO2-generating floating bilayer (drug and floating layer) tablets with respect to robustness, drug release profile, pH dependence and floating behaviour. Bilayer tablets were coated with a flexible and water permeable, but CO2-retaining polymer film of either polyvinyl acetate or ammonio-methacrylate copolymer type A. Metformin-HCl was used as a relevant model drug due to its dose-dependent and saturable absorption from the proximal part of the small intestine. To mimic physiological relevant mechanical stress conditions, recently developed dissolution stress tests with pulsed pressures were applied in addition to release studies according to the pharmacopeia. Bilayer tablets coated with polyvinyl acetate showed short floating lag times, reasonable floating strength values, floating durations of more than 24h in simulated gastric fluid and a robust and pH independent release of Metformin-HCl. Tablets coated with ammonio-methacrylate copolymer type A showed a higher permeability for the active ingredient combined with a decreased robustness of the inflated tablets. Both polymers can be used for balloon-like floating devices. The appropriate polymer has to be chosen dependent from the properties of the active ingredient and requested application of the delivery device. Furthermore, the dissolution stress test analysis is able to indicate possible safety issues of gastroretentive formulations as well as to characterise the robustness of

  12. [Efficacy of compound Xiatianwu tablets in elderly patients with osteoporotic distal radius fractures].

    PubMed

    Zhang, Bin; Chen, Gang; Li, Hai-long; Ren, Hai-peng; Yang, Tao; Chen, Min; Guo, Li-gang

    2015-06-01

    Xiatianwu tablet is based on the theory of traditional Chinese medicine (TCM), combined with modern TCM pharmacology and selected 33 famous traditional Chinese crude drugs to compose. Its recipe helps cure rheumatism, relax tendons, promote blood circulation to relieve pain, et al. Although Xiatianwu tablets are widely applied to clinical remedy such as rheumatic arthritis, lumbar disc hernia, osteoarthritis and so on, there is no report about its application in fracture. This article is to observe the efficacy of compound Xiatianwu tablets in elderly patients with osteoporotic distal radius fractures and its impact on the wrist function and complications. 180 elderly patients with osteoporotic distal radius fractures, from January 2011 to June 2014, were divided into observation group and control group by the method of random number table, each group had 90 cases. The control group were gave Caltrate D after manipulative reduction and plaster immobilization, observation group were treated with compound Xiatianwu tablets in the basis of the control group. Efficacy, wrist function and complication rates were observed in two groups after treatment. The excellent and good rate was 95.56% in observation group better than 77.78% in control group, the difference was statistically significant (χ2 = 4.712, P < 0.05). The complication rate in observation group was significantly lower compared with the control group (P < 0.05). This study shows that compound Xiatianwu tablets can improve the efficacy in elderly patients with osteoporotic distal radius fractures, reduce the incidence of complications and relieve the pain of patients which plays a significant role in improving the quality of life. PMID:26591540

  13. Formulation and evaluation of different floating tablets containing metronidazole to target stomach.

    PubMed

    Loh, Zhiao C; Elkordy, Amal A

    2015-01-01

    The purpose of this study is to formulate and develop tablets dosage form containing Metronidazole which has swelling and floating properties as a gastroretentive controlled-release drug delivery system to improve drug bioavailability. Fifteen different formulations of effervescence-forming floating systems were designed using HPMC K15M, xanthan gum, co-povidone, Eudragit® RL PO, pluronic® F-127 and/or polypropylene foam powder as swelling agents and sodium bicarbonate with/ without citric acid as gas-forming agents at different compositions. Six out of these 15 formulations which have satisfactory tablet floating behaviour were further studied with the incorporation of Metronidazole. The tablets were evaluated based on tablet physicochemical properties, floating behaviour, swelling ability and drug dissolution studies which were carried out using 0.1M HCl at 37°C for 8 hours. Furthermore, evaluation of the powder mixtures using Fourier transform infrared (FT-IR) spectroscopy, differential scanning calorimetry (DSC) and scanning electron microscope (SEM) were investigated. Most of the tablets show good physicochemical properties except for F11 which contains pluronic® F-127 as its release-retarding matrix-forming polymer. Other formulations show high swelling capacity, ability to float for at least 8 hours in vitro and have sustained drug release characteristics. Data obtained indicated that F3 which contains HPMC (12.5%w/w), xanthan gum (25%w/w), co-povidone (12.5%w/w) and sodium bicarbonate (31.7%w/w) is a suitable formulation with short floating lag time, good floating behaviour and sustained drug release for at least 8 hours in vitro with a zero order kinetic. Combinations of HPMC K15M and xanthan gum as swelling agents show synergistic effect in retarding drug release and are suitable in providing the most sustained drug release system.

  14. Physiological relevant in vitro evaluation of polymer coats for gastroretentive floating tablets.

    PubMed

    Eisenächer, Friederike; Garbacz, Grzegorz; Mäder, Karsten

    2014-11-01

    Gastroretentive drug delivery systems are retained in the stomach for a sufficient time interval, releasing the drug in a controlled manner. According to literature, the floating principle is the most frequently used formulation approach for gastric retention. However, many publications lack information of the floating forces, the impact of different pH-values and almost no information exist concerning the resistance of the floating performance against physiological relevant stress. Therefore, we evaluated the performance of CO2-generating floating bilayer (drug and floating layer) tablets with respect to robustness, drug release profile, pH dependence and floating behaviour. Bilayer tablets were coated with a flexible and water permeable, but CO2-retaining polymer film of either polyvinyl acetate or ammonio-methacrylate copolymer type A. Metformin-HCl was used as a relevant model drug due to its dose-dependent and saturable absorption from the proximal part of the small intestine. To mimic physiological relevant mechanical stress conditions, recently developed dissolution stress tests with pulsed pressures were applied in addition to release studies according to the pharmacopeia. Bilayer tablets coated with polyvinyl acetate showed short floating lag times, reasonable floating strength values, floating durations of more than 24h in simulated gastric fluid and a robust and pH independent release of Metformin-HCl. Tablets coated with ammonio-methacrylate copolymer type A showed a higher permeability for the active ingredient combined with a decreased robustness of the inflated tablets. Both polymers can be used for balloon-like floating devices. The appropriate polymer has to be chosen dependent from the properties of the active ingredient and requested application of the delivery device. Furthermore, the dissolution stress test analysis is able to indicate possible safety issues of gastroretentive formulations as well as to characterise the robustness of

  15. [Explore Xueshuan Xinmaining tablet effecting on treatment outcome of coronary heart disease based on propensity score].

    PubMed

    Li, Yuan; Xie, Yan-ming; Liu, Yan; Zhao, Wei

    2015-12-01

    Xueshuan Xinmaining tablet is a Chinese patent medicine for treating chest pain caused by blood stasis. It is widely used in clinical prevention and treatment of coronary heart disease. In order to understand the treatment effect of Xueshuan Xinmaining tablet in patients with coronary heart disease, we extracted electronic medical record data from 18 large hospitals nationwide. We matched the coronary artery disease patients with or without Xueshuan Xinmaining tablet treatment on gender, age, condition at admission and whether combined with cardiac insufficiency on a one to one ratio. After matching, both groups, patients using Xueshuan Xinmaining tablet (group A) and patients not using Xueshuan Xinmaining tablet (group B), ended up with 1,122 people. In order to evaluate the effectiveness of treatment, the endpoint of effective group was defined as "cure" and "better" while the endpoint of invalid group was defined as "invalid" and "death". Chi-square test showed a statistical significant difference (P < 0.05) between the two groups of patients with coronary heart disease, with a higher efficiency in Xueshuan Xinmaining group. Classic logistic regression analysis showed no statistical significant difference between the two groups on treatment outcome efficiency. Generalized boosted models (GBM) and propensity score (PS) weighted Logistic regression were then applied to balance 45 variables between the two groups. The results showed a regression coefficient greater than 0 and a statistical significant difference (P < 0.05) between the two groups. Based on the existing results of the analysis, we considered that coronary heart disease patients using Xueshuan Xinmaining tablet had a higher efficiency in clinical efficiency than the patients not using Xueshuan Xinmaining tablet. Since this study did not certainly eliminate all the possible confounders and patients from the hospitals included in this study were not yet well represent the overall situation of the source

  16. [Explore Xueshuan Xinmaining tablet effecting on treatment outcome of coronary heart disease based on propensity score].

    PubMed

    Li, Yuan; Xie, Yan-ming; Liu, Yan; Zhao, Wei

    2015-12-01

    Xueshuan Xinmaining tablet is a Chinese patent medicine for treating chest pain caused by blood stasis. It is widely used in clinical prevention and treatment of coronary heart disease. In order to understand the treatment effect of Xueshuan Xinmaining tablet in patients with coronary heart disease, we extracted electronic medical record data from 18 large hospitals nationwide. We matched the coronary artery disease patients with or without Xueshuan Xinmaining tablet treatment on gender, age, condition at admission and whether combined with cardiac insufficiency on a one to one ratio. After matching, both groups, patients using Xueshuan Xinmaining tablet (group A) and patients not using Xueshuan Xinmaining tablet (group B), ended up with 1,122 people. In order to evaluate the effectiveness of treatment, the endpoint of effective group was defined as "cure" and "better" while the endpoint of invalid group was defined as "invalid" and "death". Chi-square test showed a statistical significant difference (P < 0.05) between the two groups of patients with coronary heart disease, with a higher efficiency in Xueshuan Xinmaining group. Classic logistic regression analysis showed no statistical significant difference between the two groups on treatment outcome efficiency. Generalized boosted models (GBM) and propensity score (PS) weighted Logistic regression were then applied to balance 45 variables between the two groups. The results showed a regression coefficient greater than 0 and a statistical significant difference (P < 0.05) between the two groups. Based on the existing results of the analysis, we considered that coronary heart disease patients using Xueshuan Xinmaining tablet had a higher efficiency in clinical efficiency than the patients not using Xueshuan Xinmaining tablet. Since this study did not certainly eliminate all the possible confounders and patients from the hospitals included in this study were not yet well represent the overall situation of the source

  17. 77 FR 18860 - Certain Consumer Electronics, Including Mobile Phones and Tablets; Notice of Receipt of Complaint...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-03-28

    ... COMMISSION Certain Consumer Electronics, Including Mobile Phones and Tablets; Notice of Receipt of Complaint... complaint entitled Certain Consumer Electronics, Including Mobile Phones and Tablets, DN 2885; the... importation of certain consumer electronics, including mobile phones and tablets. The complaint names...

  18. 77 FR 34063 - Certain Electronic Devices, Including Mobile Phones and Tablet Computers, and Components Thereof...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-06-08

    ... COMMISSION Certain Electronic Devices, Including Mobile Phones and Tablet Computers, and Components Thereof... devices, including mobile phones and tablet computers, and components thereof by reason of infringement of... certain electronics devices, including mobile phones and tablet computers, and components thereof...

  19. 21 CFR 520.1616 - Orbifloxacin tablets.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 6 2011-04-01 2011-04-01 false Orbifloxacin tablets. 520.1616 Section 520.1616 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) ANIMAL... in § 510.600(c) of this chapter. (c) Conditions of use in dogs and cats—(1) Amount. 2.5 to 7.5 mg...

  20. A structure parameter for porous pharmaceutical tablets obtained with the aid of Wiener bounds for effective permittivity and terahertz time-delay measurement.

    PubMed

    Bawuah, Prince; Chakraborty, Mousumi; Ervasti, Tuomas; Zeitler, J Axel; Ketolainen, Jarkko; Gane, Patrick A C; Peiponen, Kai-Erik

    2016-06-15

    A structure parameter that can be used to predict the pattern of arrangement of porous inclusions in pharmaceutical tablets is introduced. By utilizing the effective refractive index of a pharmaceutical tablet obtained from terahertz time-domain measurements, we have shown that there exists a promising correlation between the calculated structural parameter and the porosity of training sets of pharmaceutical tablets, having well-defined characterization. Knowing of the structural arrangement, i.e. combined constituent skeletal-pore elements in series, parallel or mixed within porous media, could serve as a basis for understanding the ingress and permeation of liquids in such media. In the realm of pharmaceutical applications, such knowledge of the structural arrangement of air voids within a medicinal tablet could enable correlation with mechanical strength and dissolution behaviour in aqueous systems.

  1. A structure parameter for porous pharmaceutical tablets obtained with the aid of Wiener bounds for effective permittivity and terahertz time-delay measurement.

    PubMed

    Bawuah, Prince; Chakraborty, Mousumi; Ervasti, Tuomas; Zeitler, J Axel; Ketolainen, Jarkko; Gane, Patrick A C; Peiponen, Kai-Erik

    2016-06-15

    A structure parameter that can be used to predict the pattern of arrangement of porous inclusions in pharmaceutical tablets is introduced. By utilizing the effective refractive index of a pharmaceutical tablet obtained from terahertz time-domain measurements, we have shown that there exists a promising correlation between the calculated structural parameter and the porosity of training sets of pharmaceutical tablets, having well-defined characterization. Knowing of the structural arrangement, i.e. combined constituent skeletal-pore elements in series, parallel or mixed within porous media, could serve as a basis for understanding the ingress and permeation of liquids in such media. In the realm of pharmaceutical applications, such knowledge of the structural arrangement of air voids within a medicinal tablet could enable correlation with mechanical strength and dissolution behaviour in aqueous systems. PMID:27094355

  2. Microtomographic studies of subdivision of modified-release tablets.

    PubMed

    Wilczyński, Sławomir; Koprowski, Robert; Duda, Piotr; Banyś, Anna; Błońska-Fajfrowska, Barbara

    2016-09-25

    The uniformity of dosage units within a certain batch is ensured when each unit contains the active pharmaceutical ingredient (API) within a narrow range around the label claim. For tablets containing a score-line authorised for dose reductions, the European Pharmacopoeia (Ph. Eur.) considers that the uniformity of the tablet parts may be based on weight measurements regardless of the tablet type (immediate or modified release). This is because it is up to the regulatory authorities first to assess whether the tablet may contain a score-line for such use. X-ray microtomography was applied to assess the symmetry of 36 modified release tablets, containing 300mg of theophylline. The sum of the volume and surface area of the pellets in the subdivided tablets were compared. Simulations were carried out to identify the optimal amount of pellets in the tablet mass. The maximum difference in the API content between two subdivided halves was 165.18mg vs 133.83mg. If the amount of pellets in the tablet mass would drop below 13% on the basis of the pellet surface area, then the Ph. Eur. requirements would be exceeded. The amount of pellets in the tablet halves resulting in the greatest variability in API content was 38%. The results of this study indicate that the pellets were not distributed uniformly in the tablet mass. Thus, the uniformity of the dose in both halves of a tablet containing pellets cannot be based on the weight measurements i.e. it is necessary to develop further standards for tablet subdivision. Microtomographic methods are a very interesting alternative to expensive and time-consuming pharmacokinetic studies. PMID:27480395

  3. Posture, Musculoskeletal Activities, and Possible Musculoskeletal Discomfort Among Children Using Laptops or Tablet Computers for Educational Purposes: A Literature Review

    NASA Astrophysics Data System (ADS)

    Binboğa, Elif; Korhan, Orhan

    2014-10-01

    Educational ergonomics focuses on the interaction between educational performance and educational design. By improving the design or pointing out the possible problems, educational ergonomics can be utilized to have positive impacts on the student performance and thus on education process. Laptops and tablet computers are becoming widely used by school children and beginning to be used effectively for educational purposes. As the latest generation of laptops and tablet computers are mobile and lightweight compared to conventional personal computers, they support student-centred interaction-based learning. However, these technologies have been introduced into schools with minimal adaptations to furniture or attention to ergonomics. There are increasing reports of an association between increased musculoskeletal (MSK) problems in children and use of such technologies. Although children are among the users of laptops and tablet computers both in their everyday lives and at schools, the literature investigating MSK activities and possible MSK discomfort regarding children using portable technologies is limited. This study reviews the literature to identify published studies that investigated posture, MSK activities, and possible MSK discomfort among children using mobile technologies (laptops or tablet computers) for educational purposes. An electronic search of the literature published in English between January 1994 and January 2014 was performed in several databases. The literature search terms were identified and combined to search the databases. The search results that the resources investigating MSK outcomes of laptop or tablet use of children are very scarce. This review points out the research gaps in this field, and identifying areas for future studies.

  4. In vitro/in vivo evaluation of HPMC/alginate based extended-release matrix tablets of cefpodoxime proxetil.

    PubMed

    Mujtaba, Ali; Kohli, Kanchan

    2016-08-01

    The purpose of this research was to assessment of antimicrobial activity and in vitro/in vivo evaluation of cefpodoxime proxetil extended-release (ER) tablet for once daily administration. The tablets were prepared using combination of biodegradable polysaccharides including hydroxypropyl methylcellulose and sodium alginate as matrix material to achieve pH-independent ER release. The tablets were found within the permissible limits for various physicochemical parameters. The in vitro drug release showed that the drug was released over a period of 24h in a sustained release manner. The drug release followed Higuchi kinetics as these plots showed the highest linearity (R(2)=0.9833), but a close relationship was also observed with zero-order kinetics (R(2)=0.9088) and the drug release mechanism was found to be of anomalous or non-Fickian type. Further, in vitro drug release was assessed by antimicrobial assay and it revealed that drug release through 24h periods was above the MIC. In vivo investigation in rabbits showed ER pharmacokinetic profile of cefpodoxime from the matrix tablets. A good correlation of drug absorption in vivo and drug release in vitro (R(2)=0.9785) was observed. These results suggested that the investigated CFP matrix tablets have a potential for extended-release dosage forms. PMID:27155235

  5. Floating matrix tablets based on low density foam powder: effects of formulation and processing parameters on drug release.

    PubMed

    Streubel, A; Siepmann, J; Bodmeier, R

    2003-01-01

    The aim of this study was to develop and physicochemically characterize single unit, floating controlled drug delivery systems consisting of (i). polypropylene foam powder, (ii). matrix-forming polymer(s), (iii). drug, and (iv). filler (optional). The highly porous foam powder provided low density and, thus, excellent in vitro floating behavior of the tablets. All foam powder-containing tablets remained floating for at least 8 h in 0.1 N HCl at 37 degrees C. Different types of matrix-forming polymers were studied: hydroxypropyl methylcellulose (HPMC), polyacrylates, sodium alginate, corn starch, carrageenan, gum guar and gum arabic. The tablets eroded upon contact with the release medium, and the relative importance of drug diffusion, polymer swelling and tablet erosion for the resulting release patterns varied significantly with the type of matrix former. The release rate could effectively be modified by varying the "matrix-forming polymer/foam powder" ratio, the initial drug loading, the tablet geometry (radius and height), the type of matrix-forming polymer, the use of polymer blends and the addition of water-soluble or water-insoluble fillers (such as lactose or microcrystalline cellulose). The floating behavior of the low density drug delivery systems could successfully be combined with accurate control of the drug release patterns.

  6. Chocolate tablet aspects of cytherean Meshkenet Tessera

    NASA Technical Reports Server (NTRS)

    Raitala, J.

    1993-01-01

    Meshkenet Tessera structures were mapped from Magellan data and several resemblances to chocolate tablet boudinage were found. The complex fault sets display polyphase tectonic sequences of a few main deformation phases. Shear and tension have contributed to the areal deformation. Main faults cut the 1600-km long Meshkenet Tessera highland into bar-like blocks which have ridge and groove pattern oriented along or at high angles to the faults. The first approach to the surface block deformation is an assumption of initial parallel shear faulting followed by a chocolate tablet boudinage. Major faults which cut Meshkenet Tessera into rectangular blocks have been active repetitively while two progressive or superposed boudinage set formations have taken place at high angles during the relaxational or flattening type deformation of the area. Chocolate tablet boudinage is caused by a layer-parallel two-dimensional extension resulting in fracturing of the competent layer. Such structures, defined by two sets of boudin neck lines at right angles to each other, have been described by a number of authors. They develop in a flattening type of bulk deformation or during superposed deformation where the rock is elongated in two dimensions parallel to the surface. This is an attempt to describe and understand the formation and development of structures of Meshkenet Tessera which has complicated fault structures.

  7. Efficacy of afoxolaner plus milbemycin oxime chewable tablets against naturally acquired intestinal nematodes in dogs.

    PubMed

    Rehbein, Steffen; Dorr, Paul; Bowman, Dwight D; Crafford, Dionne; Kusi, Ilir; Postoli, Rezart; Yoon, Stephen; Chester, S Theodore; Dollhofer, Doris; Visser, Martin; Larsen, Diane L

    2016-02-15

    The efficacy of oral afoxolaner plus milbemycin oxime combination chewable tablets (NexGard Spectra, Merial) against naturally acquired intestinal nematode infections in dogs was evaluated in six negative control, blinded studies including a total of 114 dogs. Dogs were selected based on a pre-treatment fecal examination indicating patent infections with hookworms (two studies), Toxocara or Toxascaris ascarids (one study each) or Trichuris whipworms (two studies). In each study, dogs were assigned to blocks of two animals each, based on decreasing pre-treatment body weight and were randomly allocated to one of two groups consisting of eight, nine or 10 dogs: untreated (control) or treated with the combination chewable tablet formulation. Chewable tablets were combined to provide doses of actives as close as possible to the minimum effective dose of afoxolaner and milbemycin oxime, i.e., 2.5 mg/kg body weight and 0.5 mg/kg body weight, respectively, once on Day 0. For parasite recovery and count, dogs were euthanized humanely and necropsied seven or eight days after treatment. A single treatment with afoxolaner plus milbemycin oxime chewable tablets provided 94.8% and 90.9% efficacy against adult Ancylostoma braziliense and A. caninum, respectively, 97.8% and 99.4% efficacy against adult Toxocara canis and Toxascaris leonina, respectively, and ≥98.3% efficacy against adult Trichuris vulpis. Compared to untreated controls, nematode counts of the treated dogs were significantly reduced (F-test; p<0.002). In addition, analysis of the pooled data across studies revealed that treatment with afoxolaner plus milbemycin oxime chewable tablets reduced adult Uncinaria stenocephala burdens by 74.9% (p=0.002). All dogs tolerated the treatment well based on clinical observations post-treatment and daily clinical observations. No adverse experiences or other clinical problems related to the treatment were observed throughout the studies. The results of this series of controlled

  8. Preparation and in-vitro in-vivo evaluation of sustained release matrix diclofenac sodium tablets using PVP-K90 and natural gums.

    PubMed

    Iqbal, Zafar; Khan, Raza; Nasir, Fazli; Khan, Jamshaid Ali; Rashid, Abdur; Khan, Abbas; Khan, Abad

    2011-10-01

    Conventional dosage form is nowadays mostly replaced by sustained release formulation in order to increase drug efficacy and patient compliance. The sustained release properties of the PVP K90 alone and in combination with guar gum, xanthan gum and gum tragacanth were evaluated using diclofenac sodium (100 mg/tablet) as a model drug. Tablets were processed using wet granulation method and evaluated for sustained drug release properties. The drug release from the formulations was studied in relationship with Commercially available Diclofenac Sodium SR, used as a reference tablets and results were expressed as similarity (f1) and differential factor (f2). The tablets prepared using PVP K90 160 mg/tablet sustained the release of diclofenac sodium for 12 hours. Formulations where the PVP K90 was partially replaced with different gums also sustained the release of drug for 12 hours. The release of the drug from these formulations mainly followed Higuchi model and super case-II and Non-Fickian diffusion. The in-vivo drug release was studied in healthy human volunteers using non-blinded cross over, two period design using Diclofenac Sodium SR Tablets as a reference drug. The relative bioavailability of the formulation containing PVP K90 and gum tragacanth was 0.91. The studies showed that the use of the PVP K90 in combination with gum tragacanth both in-vitro and in-vivo sustained the release of the drug.

  9. Relative bioavailability of different oral sustained release oxprenolol tablets.

    PubMed

    Leucuta, S E; Follidis, M; Capalneanu, R; Mocan, A

    1998-01-01

    The bioequivalence of oral dosage forms of oxprenolol was assessed in a triple crossover study on two groups of 12 volunteers each. Single 160 mg doses of oxprenolol hydrochloride were given after an overnight fast of either oxprenolol sustained-release tablets in a megaloporous system, a hydrophil matrix and Slow-Trasicor (Ciba-Geigy) in the first group, or floating slow-release tablets administered with food or in absence of food, and rapid release Oxprenolol (Terapia, Cluj-Napoca) tablets, in the second group. Serum oxprenolol concentrations were measured by a gas chromatographic method. Pharmacokinetic parameters which describe bioavailability and general kinetic behavior of the drug were calculated from individual serum profiles. They were subjected to statistical analysis (paired Student's t test, p < 0.05). The customary bioequivalence criterion was used: 0.8 < parameter ratio(tested/standard) < 1.2. Megaloporous tablets showed bioequivalence with the reference sustained release product Slow-Trasicor. Hydrophil tablets showed moderate sustained-release characteristics. Floating tablets showed significantly greater oxprenolol absorption when taken with food and were non-bioequivalent with floating tablets without food, as well as with the reference rapid release tablets, of oxprenolol. However, fasting tablets were bioequivalent to the Slow-Trasicor product, when taken with food. PMID:9725478

  10. 21 CFR 520.443 - Chlortetracycline tablets and boluses.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... Klebsiella spp., susceptible to chlortetracycline. (ii) Limitations. Administer tablet directly by mouth or... pneumonia associated with Pasteurella spp., Hemophilus spp., and Klebsiella spp., susceptible...

  11. 21 CFR 520.443 - Chlortetracycline tablets and boluses.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... Klebsiella spp., susceptible to chlortetracycline. (ii) Limitations. Administer tablet directly by mouth or... pneumonia associated with Pasteurella spp., Hemophilus spp., and Klebsiella spp., susceptible...

  12. 21 CFR 520.443 - Chlortetracycline tablets and boluses.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... Klebsiella spp., susceptible to chlortetracycline. (ii) Limitations. Administer tablet directly by mouth or... pneumonia associated with Pasteurella spp., Hemophilus spp., and Klebsiella spp., susceptible...

  13. Placing wireless tablets in clinical settings for patient education

    PubMed Central

    Stribling, Judy C.; Richardson, Joshua E.

    2016-01-01

    Objective The authors explored the feasibility and possible benefit of tablet-based educational materials for patients in clinic waiting areas. Methods We distributed eight tablets preloaded with diagnosis-relevant information in two clinic waiting areas. Patients were surveyed about satisfaction, usability, and effects on learning. Technical issues were resolved. Results Thirty-seven of forty patients completed the survey. On average, the patients were satisfied in all categories. Conclusions Placing tablet-based educational materials in clinic waiting areas is relatively easy to implement. Patients using tablets reported satisfaction across three domains: usability, education, and satisfaction. PMID:27076806

  14. Drug tablet thickness estimations using air-coupled acoustics.

    PubMed

    Akseli, Ilgaz; Cetinkaya, Cetin

    2008-03-01

    A non-contact/non-destructive acoustic technique for predicting the coating layer thickness of a drug tablet is presented. Quality of tablet coatings can play a major role in the effectiveness of drug delivery. Many pharmaceutical tablets consist of a tablet core and a coated outer cover. Variations in the tablet coating can be indicative of various process problems and, therefore, is of a concern for quality assurance. In the current non-contact measurement system, an air-coupled excitation and laser interferometric detection for predicting the coating layer thickness of a drug tablet is introduced. Drug tablets with different coating thicknesses are vibrated via an acoustic field generated by an air-coupled transducer in a frequency range sufficiently high to excite their several vibrational modes. The tablet surface vibrational responses are acquired at a number of measurement points by a laser interferometer in a non-contact manner. An iterative computational procedure, based on the FE method and Newton's method, was developed and demonstrated to extract the coating layer thicknesses of the tablets from a subset of the measured resonance frequencies. PMID:18022335

  15. Biowaiver extension potential to BCS Class III high solubility-low permeability drugs: bridging evidence for metformin immediate-release tablet.

    PubMed

    Cheng, Ching-Ling; Yu, Lawrence X; Lee, Hwei-Ling; Yang, Chyun-Yu; Lue, Chang-Sha; Chou, Chen-Hsi

    2004-07-01

    The biopharmaceutics classification system (BCS) allows biowaiver for rapid dissolving immediate-release (IR) products of Class I drugs (high solubility and high permeability). The possibility of extending biowaivers to Class III high solubility and low permeability drugs is currently under scrutiny. In vivo bioequivalence data of different formulations of Class III drugs would support such an extension. The objective of this work was to demonstrate the bioequivalence of two marketed IR tablet products of a Class III drug, metformin hydrochloride, that are rapidly dissolving and have similar in vitro dissolution profiles. The effect of race on the systemic exposure of metformin was also explored. A randomized, open-label, two-period crossover study was conducted in 12 healthy Chinese male volunteers. Each subject received a single-dose of 500 mg of each product after an overnight fasting. The plasma concentrations of metformin were followed for 24 h. No significant formulation effect was found for the bioequivalence metrics: areas under concentration-time curve (AUC0-t, AUC0-infinity) and maximal concentration (Cmax). The 90% confidence intervals for the ratio of means were found within the acceptance range of 80-125% for the log-transformed data. Based on these results, it was concluded that the two IR products are bioequivalent. The pharmacokinetic parameters of metformin in Chinese for both products were similar and were in good agreement with those reported for metformin IR tablets in other ethnic populations. This study serves as an example for supporting biowaiver for BCS Class III drugs.

  16. Preparation and pharmaceutical evaluation of acetaminophen nano-fiber tablets: Application of a solvent-based electrospinning method for tableting.

    PubMed

    Hamori, Mami; Nagano, Kana; Kakimoto, Sayaka; Naruhashi, Kazumasa; Kiriyama, Akiko; Nishimura, Asako; Shibata, Nobuhito

    2016-03-01

    In this study, we developed nano-fiber-based tablets with acetaminophen (AAP; LogPow=0.51) for controlled-release delivery systems and evaluated in vitro drug dissolution and in vivo pharmacokinetics in rats. Nano-fibers made from methacrylic acid copolymer S (MAC; EUDRAGIT S100) and containing AAP were prepared using a solvent-based electrospinning (ES) method. In vitro dissolution rate profiles of AAP showed tableting pressure-dependent decreases and pH-dependent increases. The results of tablet tracking by X-ray irradiation showed tablets based on MAC nano-fibers did not disintegrate in the upper intestinal lumen and had the properties of a long-term-acting tablet. In addition, the in vitro release profiles of AAP from nano-fiber tablets prepared by dissolving MAC with AAP (NFT), nano-fiber tablets prepared by adsorbing AAP to drug-free MAC nano-fibers (NFTadso), and tablets prepared by adsorbing half the amount of AAP to MAC nano-fibers containing the remaining amount of AAP (NFThalf) showed independent controlled-release aspects of AAP compared with physical mixture tablets (PMT). In vivo pharmacokinetic studies in rats after intraduodenal administration of 14 mg/rat AAP in NFT, NFTadso, and NFThalf demonstrated that all these tablets based on MAC nano-fibers showed sustained-release profiles compared with PMT, and showed ultra-sustained release properties for AAP. These new tablets based on MAC nano-fibers did not disintegrate in the intestine in the lower pH region, and the tablets could regulate the release of AAP in a pH-dependent manner. The ES method is a useful technique to prepare nano-fibers and showed promising results as an oral delivery system for sustained-release regulation.

  17. Effect of diluents on tablet integrity and controlled drug release.

    PubMed

    Zhang, Y E; Schwartz, J B

    2000-07-01

    The objective of this study was to evaluate the effect of diluents and wax level on tablet integrity during heat treatment and dissolution for sustained-release formulations and the resultant effect on drug release. Dibasic calcium phosphate dihydrate (DCPD), microcrystalline cellulose (MCC), and lactose were evaluated for their effect on tablet integrity during drug dissolution and heat treatment in wax matrix formulations. A newly developed direct compression diluent, dibasic calcium phosphate anhydrous (DCPA), was also evaluated. Compritol 888 ATO was used as the wax matrix material, with phenylpropanolamine hydrochloride (PPA) as a model drug. Tablets were made by direct compression and then subjected to heat treatment at 80 degrees C for 30 min. The results showed that MCC, lactose, and DCPA could maintain tablets intact during heat treatment above the melting point of wax (70 degrees C-75 degrees C). However, DCPD tablets showed wax egress during the treatment. MCC tablets swelled and cracked during drug dissolution and resulted in quick release. DCPD and lactose tablets remained intact during dissolution and gave slower release than MCC tablets. DCPA tablets without heat treatment disintegrated very quickly and showed immediate release. In contrast, heat-treated DCPA tablets remained intact through the 24-hr dissolution test and only released about 80% PPA at 6 hr. In the investigation of wax level, DCPD was used as the diluent. The drug release rate decreased as the wax content increased from 15% to 81.25%. The dissolution data were best described by the Higuchi square-root-of-time model. Diluents showed various effects during heat treatment and drug dissolution. The integrity of the tablets was related to the drug release rate. Heat treatment retarded drug release if there was no wax egress.

  18. Development and Evaluation of Microbial Degradation Dependent Compression Coated Secnidazole Tablets for Colonic Delivery

    PubMed Central

    Sridhar, B. K.; Srinatha, A.; Zaman, B. B.; Ragunandan, H.

    2011-01-01

    The present paper describes development of a polysaccharide based compression coated tablets of secnidazole for colon delivery. Core tablet containing secnidazole was compression coated with various proportions of guar gum, xanthan gum and chitosan, either alone or in combinations. Drug release studies were performed in simulated gastric fluid (SGF) for 2 h followed by simulated intestinal fluid (SIF, pH 7.4) up to 24 h. Secnidazole release from the prepared formulations was dependent on the type and concentration of polymer used in the formulation. Tablets coating containing either guar gum or xanthan gum showed ~30-40% drug release in 8 h. Further, in vitro dissolution studies of selected formulations performed in the dissolution media with rat caecal contents showed 54.48±0.24 - 60.42±0.16% of drug release. Formulations with single polymer in coating layer were unsuitable for targeting secnidazole release to colon region. Combination of chitosan with guar gum or xanthan gum exhibited control over secnidazole release. PMID:23112398

  19. Development and evaluation of microbial degradation dependent compression coated secnidazole tablets for colonic delivery.

    PubMed

    Sridhar, B K; Srinatha, A; Zaman, B B; Ragunandan, H

    2011-11-01

    The present paper describes development of a polysaccharide based compression coated tablets of secnidazole for colon delivery. Core tablet containing secnidazole was compression coated with various proportions of guar gum, xanthan gum and chitosan, either alone or in combinations. Drug release studies were performed in simulated gastric fluid (SGF) for 2 h followed by simulated intestinal fluid (SIF, pH 7.4) up to 24 h. Secnidazole release from the prepared formulations was dependent on the type and concentration of polymer used in the formulation. Tablets coating containing either guar gum or xanthan gum showed ~30-40% drug release in 8 h. Further, in vitro dissolution studies of selected formulations performed in the dissolution media with rat caecal contents showed 54.48±0.24 - 60.42±0.16% of drug release. Formulations with single polymer in coating layer were unsuitable for targeting secnidazole release to colon region. Combination of chitosan with guar gum or xanthan gum exhibited control over secnidazole release. PMID:23112398

  20. Development and Validation of Simultaneous Spectrophotometric Methods for Drotaverine Hydrochloride and Aceclofenac from Tablet Dosage Form

    PubMed Central

    Shah, S. A.; Shah, D. R.; Chauhan, R. S.; Jain, J. R.

    2011-01-01

    Two simple spectrophotometric methods have been developed for simultaneous estimation of drotaverine hydrochloride and aceclofenac from tablet dosage form. Method I is a simultaneous equation method (Vierodt's method), wavelengths selected are 306.5 and 276 nm. Method II is the absorbance ratio method (Q-Analysis), which employs 298.5 nm as λ1 and 276 nm as λ2 (λmax of AF) for formation of equations. Both the methods were found to be linear between the range of 8-32 μg/ml for drotaverine and 10-40 μg/ml for aceclofenac. The accuracy and precision were determined and found to comply with ICH guidelines. Both the methods showed good reproducibility and recovery with % RSD in the desired range. The methods were found to be rapid, specific, precise and accurate and can be successfully applied for the routine analysis of drotaverine and aceclofenac in their combined tablet dosage form. PMID:22457554

  1. 21 CFR 520.540c - Dexamethasone chewable tablets.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ....25 to 1.25 milligrams per day.1 (2) Indications for use. Supportive therapy in nonspecific dermatosis... crumble over food. Administer 0.25 to 1.25 milligrams daily in single or two divided doses until response... Dexamethasone chewable tablets. (a) Specifications. Each half-scored tablet contains 0.25 milligram...

  2. 21 CFR 520.540c - Dexamethasone chewable tablets.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ....25 to 1.25 milligrams per day.1 (2) Indications for use. Supportive therapy in nonspecific dermatosis... crumble over food. Administer 0.25 to 1.25 milligrams daily in single or two divided doses until response... Dexamethasone chewable tablets. (a) Specifications. Each half-scored tablet contains 0.25 milligram...

  3. 21 CFR 520.540c - Dexamethasone chewable tablets.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ....25 to 1.25 milligrams per day.1 (2) Indications for use. Supportive therapy in nonspecific dermatosis... crumble over food. Administer 0.25 to 1.25 milligrams daily in single or two divided doses until response... Dexamethasone chewable tablets. (a) Specifications. Each half-scored tablet contains 0.25 milligram...

  4. 21 CFR 520.540c - Dexamethasone chewable tablets.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ....25 to 1.25 milligrams per day.1 (2) Indications for use. Supportive therapy in nonspecific dermatosis... crumble over food. Administer 0.25 to 1.25 milligrams daily in single or two divided doses until response... Dexamethasone chewable tablets. (a) Specifications. Each half-scored tablet contains 0.25 milligram...

  5. 21 CFR 520.540c - Dexamethasone chewable tablets.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ....25 to 1.25 milligrams per day.1 (2) Indications for use. Supportive therapy in nonspecific dermatosis... crumble over food. Administer 0.25 to 1.25 milligrams daily in single or two divided doses until response... Dexamethasone chewable tablets. (a) Specifications. Each half-scored tablet contains 0.25 milligram...

  6. 21 CFR 520.2362 - Thenium closylate tablets.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 6 2013-04-01 2013-04-01 false Thenium closylate tablets. 520.2362 Section 520.2362 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED...) Conditions of use. (1) The tablets are administered orally to dogs as a single day treatment of...

  7. 21 CFR 520.2362 - Thenium closylate tablets.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 6 2014-04-01 2014-04-01 false Thenium closylate tablets. 520.2362 Section 520.2362 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED...) Conditions of use. (1) The tablets are administered orally to dogs as a single day treatment of...

  8. 21 CFR 520.2362 - Thenium closylate tablets.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 6 2012-04-01 2012-04-01 false Thenium closylate tablets. 520.2362 Section 520.2362 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS ORAL DOSAGE FORM NEW ANIMAL DRUGS § 520.2362 Thenium closylate tablets. (a) Chemical name....

  9. 21 CFR 520.2098 - Selegiline hydrochloride tablets.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 6 2012-04-01 2012-04-01 false Selegiline hydrochloride tablets. 520.2098 Section 520.2098 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS ORAL DOSAGE FORM NEW ANIMAL DRUGS § 520.2098 Selegiline hydrochloride tablets. (a)...

  10. Tableau Economique: Teaching Economics with a Tablet Computer

    ERIC Educational Resources Information Center

    Scott, Robert H., III

    2011-01-01

    The typical method of instruction in economics is chalk and talk. Economics courses often require writing equations and drawing graphs and charts, which are all best done in freehand. Unlike static PowerPoint presentations, tablet computers create dynamic nonlinear presentations. Wireless technology allows professors to write on their tablets and…

  11. Equivalency of Paper versus Tablet Computer Survey Data

    ERIC Educational Resources Information Center

    Ravert, Russell D.; Gomez-Scott, Jessica; Donnellan, M. Brent

    2015-01-01

    Survey responses collected via paper surveys and computer tablets were compared to test for differences between those methods of obtaining self-report data. College students (N = 258) were recruited in public campus locations and invited to complete identical surveys on either paper or iPad tablet. Only minor homogeneity differences were found…

  12. 21 CFR 520.62 - Aminopentamide hydrogen sulphate tablets.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 6 2010-04-01 2010-04-01 false Aminopentamide hydrogen sulphate tablets. 520.62 Section 520.62 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES... Aminopentamide hydrogen sulphate tablets. (a) Chemical name. 4-(Dimethylamino)-2,2-diphenylvaleramide...

  13. Students' Opinions on the Use of Tablet Computers in Education

    ERIC Educational Resources Information Center

    Duran, Muharrem; Aytaç, Tufan

    2016-01-01

    One of the most important tools for the integration of ICT in education, especially with tablet computers, has been employed in Turkey through the FATIH Project. This study aimed to determine students' views on the use of tablet computers in learning and teaching processes. Eighty-four first-year high school students studying at three schools in…

  14. Active Reading Behaviors in Tablet-Based Learning

    ERIC Educational Resources Information Center

    Palilonis, Jennifer; Bolchini, Davide

    2015-01-01

    Active reading is fundamental to learning. However, there is little understanding about whether traditional active reading frameworks sufficiently characterize how learners study multimedia tablet textbooks. This paper explores the nature of active reading in the tablet environment through a qualitative study that engaged 30 students in an active…

  15. Commentary: Tablet PCs--Lightweights with a Teaching Punch

    ERIC Educational Resources Information Center

    Parslow, Graham R.

    2010-01-01

    Tablet (or slate) computers are a group of small portable computers that have two features in common, a touch screen and wireless connectivity to the web. At the 2010 Consumer Electronics show held in January in Las Vegas, this category of product caused the greatest interest ahead of the release of the Apple iPad (www.cesweb.org). The tablet PC…

  16. Beyond Migration: Preserving Electronic Documents with Digital Tablets.

    ERIC Educational Resources Information Center

    Kranch, Douglas A.

    1998-01-01

    Discusses electronic-document preservation and argues that digital tablets, storing both the documents and the software to use them, should be developed as a more permanent alternative to migration, currently the primary preservation strategy. Discusses technology that could be used to produce a digital tablet, lists life expectancy of digital…

  17. 21 CFR 520.622a - Diethylcarbamazine citrate tablets.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ..., 200, and 300 milligram tablets for prevention of heartworm disease in dogs and as an aid in the..., 200, 300, or 400 milligram tablets for prevention of heartworm disease in dogs, as an aid in the... cats. (4) (5) See No. 000061 in § 510.600(c) of this chapter for use of 60, 120, or 180...

  18. 21 CFR 520.622a - Diethylcarbamazine citrate tablets.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ..., 200, and 300 milligram tablets for prevention of heartworm disease in dogs and as an aid in the..., 200, 300, or 400 milligram tablets for prevention of heartworm disease in dogs, as an aid in the... cats. (4) (5) See No. 000061 in § 510.600(c) of this chapter for use of 60, 120, or 180...

  19. 21 CFR 520.622a - Diethylcarbamazine citrate tablets.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ..., 200, and 300 milligram tablets for prevention of heartworm disease in dogs and as an aid in the..., 200, 300, or 400 milligram tablets for prevention of heartworm disease in dogs, as an aid in the... cats. (4) (5) See No. 000061 in § 510.600(c) of this chapter for use of 60, 120, or 180...

  20. Tablets in English Class: Students' Activities Surrounding Online Dictionary Work

    ERIC Educational Resources Information Center

    Bunting, Leona

    2015-01-01

    Tablets have become increasingly popular among young people in Sweden and this rapid increase also resonates in school, especially in classrooms for younger children. The aim of the present study is to analyze and describe how the students deal with the open instructions for a task of using online dictionaries on tablets. Specific focus is on how…

  1. Tablet-Based Education to Reduce Depression-Related Stigma

    ERIC Educational Resources Information Center

    Lu, Catherine; Winkelman, Megan; Wong, Shane Shucheng

    2016-01-01

    Objectives: This study investigated the efficacy of a tablet-based multimedia education application, the Project Not Alone Depression Module, in improving depression literacy and reducing depression stigma among a community-based mental health clinic population. Methods: A total of 93 participants completed either a tablet-based multimedia…

  2. Protecting Investments: Third-Party Warranty Coverage for Tablets

    ERIC Educational Resources Information Center

    Sands, Austin

    2012-01-01

    A year ago, only a handful of K-12 schools and universities had integrated tablets into their curricula. Today, not one week passes with out another iPad rollout announcement. The reasons that schools use tablets are as varied as the schools themselves. Hawaii Preparatory Academy uses iPads to encourage budding physicists, linguists, and…

  3. Frosta: a new technology for making fast-melting tablets.

    PubMed

    Jeong, Seong Hoon; Fu, Yourong; Park, Kinam

    2005-11-01

    The fast-melting tablet (FMT) technology, which is known to be one of the most innovated methods in oral drug delivery systems, is a rapidly growing area of drug delivery. The initial success of the FMT formulation led to the development of various technologies. These technologies, however, still have some limitations. Recently, a new technology called Frosta (Akina) was developed for making FMTs. The Frosta technology utilises the conventional wet granulation process and tablet press for cost-effective production of tablets. The Frosta tablets are mechanically strong with friability of < 1% and are stable in accelerated stability conditions when packaged into a bottle container. They are robust enough to be packaged in multi-tablet vials. Conventional rotary tablet presses can be used for the production of the tablets and no other special instruments are required. Thus, the cost of making FMTs is lower than that of other existing technologies. Depending on the size, Frosta tablets can melt in < 10 s after placing them in the oral cavity for easy swallowing. The Frosta technology is ideal for wide application of FMTs technology to various drug and nutritional formulations.

  4. Some physical properties of tabletted seed of Garcinia kola (HECKEL).

    PubMed

    Onunkwo, G C; Egeonu, H C; Adikwu, M U; Ojile, J E; Olowosulu, A K

    2004-06-01

    The formulation of Garcinia kola seeds into tablet dosage form and evaluation of some physical properties of the tablets are presented. A chemical assay was conducted on the dry, powdered seeds as well as the crude aqueous extract of the seeds. The dry powdered seeds contain 0.003% of flavonoids while the crude extract contained 0.007% of flavonoids based on rutin used as the standard. The powdered material (50 mg) and crude extract (10 mg) were formulated into tablets using the wet granulation method. Named binders were evaluated in these formulations. The various tablet parameters were evaluated, namely: weight variation, thickness and diameter, hardness, friability, disintegration time, dissolution profile and content uniformity. The results indicated that the tablets had good disintegration time, dissolution and hardness/friability profiles. Tablets formulated with starch had the best disintegration properties but were consequently very friable. Tablets formulated from 10 mg of the crude extract needed a larger proportion of diluents, which affected the tablet properties.

  5. 21 CFR 520.2150b - Stanozolol chewable tablets.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ....2150b Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED... treatment in dogs. (2) Administered orally to small breeds of dogs, 1/2 to 1 tablet twice daily for several weeks; to large breeds of dogs, 1 to 2 tablets twice daily for several weeks. (3) Federal law...

  6. 21 CFR 520.2362 - Thenium closylate tablets.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ....2362 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED...) Conditions of use. (1) The tablets are administered orally to dogs as a single day treatment of canine... Uncinaria stenocephala (hookworms). Dogs weighing 10 pounds and over are administered 1 tablet as a...

  7. 21 CFR 520.2362 - Thenium closylate tablets.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ....2362 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED...) Conditions of use. (1) The tablets are administered orally to dogs as a single day treatment of canine... Uncinaria stenocephala (hookworms). Dogs weighing 10 pounds and over are administered 1 tablet as a...

  8. 21 CFR 520.2150b - Stanozolol chewable tablets.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ....2150b Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED... treatment in dogs. (2) Administered orally to small breeds of dogs, 1/2 to 1 tablet twice daily for several weeks; to large breeds of dogs, 1 to 2 tablets twice daily for several weeks. (3) Federal law...

  9. 21 CFR 520.62 - Aminopentamide hydrogen sulphate tablets.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 6 2011-04-01 2011-04-01 false Aminopentamide hydrogen sulphate tablets. 520.62 Section 520.62 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES... Aminopentamide hydrogen sulphate tablets. (a) Chemical name. 4-(Dimethylamino)-2,2-diphenylvaleramide...

  10. 21 CFR 520.62 - Aminopentamide hydrogen sulphate tablets.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 6 2012-04-01 2012-04-01 false Aminopentamide hydrogen sulphate tablets. 520.62 Section 520.62 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES... Aminopentamide hydrogen sulphate tablets. (a) Chemical name. 4-(Dimethylamino)-2,2-diphenylvaleramide...

  11. 21 CFR 520.62 - Aminopentamide hydrogen sulphate tablets.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 6 2014-04-01 2014-04-01 false Aminopentamide hydrogen sulphate tablets. 520.62 Section 520.62 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES... Aminopentamide hydrogen sulphate tablets. (a) Chemical name. 4-(Dimethylamino)-2,2-diphenylvaleramide...

  12. 21 CFR 520.62 - Aminopentamide hydrogen sulphate tablets.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 6 2013-04-01 2013-04-01 false Aminopentamide hydrogen sulphate tablets. 520.62 Section 520.62 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES... Aminopentamide hydrogen sulphate tablets. (a) Chemical name. 4-(Dimethylamino)-2,2-diphenylvaleramide...

  13. Changes in key constituents of clonally propagated Artemisia annua L. during preparation of compressed leaf tablets for possible therapeutic use

    PubMed Central

    Weathers, Pamela J.; Towler, Melissa J.

    2014-01-01

    Artemisia annua L., long used as a tea infusion in traditional Chinese medicine, produces artemisinin. Although artemisinin is currently used as artemisinin-based combination therapy (ACT) against malaria, oral consumption of dried leaves from the plant showed efficacy and will be less costly than ACT. Many compounds in the plant have some antimalarial activity. Unknown, however, is how these plant components change as leaves are processed into tablets for oral consumption. Here we compared extracts from fresh and dried leaf biomass with compressed leaf tablets of A. annua. Using GC-MS, nineteen endogenous compounds, including artemisinin and several of its pathway metabolites, nine flavonoids, three monoterpenes, a coumarin, and two phenolic acids, were identified and quantified from solvent extracts to determine how levels of these compounds changed during processing. Results showed that compared to dried leaves, artemisinin, arteannuin B, artemisinic acid, chlorogenic acid, scopoletin, chrysoplenetin, and quercetin increased or remained stable with powdering and compression into tablets. Dihydroartemisinic acid, monoterpenes, and chrysoplenol-D decreased with tablet formation. Five target compounds were not detectable in any of the extracts of this cultivar. In contrast to the individually measured aglycone flavonoids, using the AlCl3 method, total flavonoids increased nearly fivefold during the tablet formation. To our knowledge this is the first study documenting changes that occurred in processing dried leaves of A. annua into tablets. These results will improve our understanding of the potential use of not only this medicinal herb, but also others to afford better quality control of intact plant material for therapeutic use. PMID:25228784

  14. Using a Virtual Tablet Machine to Improve Student Understanding of the Complex Processes Involved in Tablet Manufacturing

    PubMed Central

    Sjöström, Hans-Erik; Englund, Claire

    2016-01-01

    Objective. To develop and implement a virtual tablet machine simulation to aid distance students’ understanding of the processes involved in tablet production. Design. A tablet simulation was created enabling students to study the effects different parameters have on the properties of the tablet. Once results were generated, students interpreted and explained them on the basis of current theory. Assessment. The simulation was evaluated using written questionnaires and focus group interviews. Students appreciated the exercise and considered it to be motivational. Students commented that they found the simulation, together with the online seminar and the writing of the report, was beneficial for their learning process. Conclusion. According to students’ perceptions, the use of the tablet simulation contributed to their understanding of the compaction process. PMID:27402990

  15. Using a Virtual Tablet Machine to Improve Student Understanding of the Complex Processes Involved in Tablet Manufacturing.

    PubMed

    Mattsson, Sofia; Sjöström, Hans-Erik; Englund, Claire

    2016-06-25

    Objective. To develop and implement a virtual tablet machine simulation to aid distance students' understanding of the processes involved in tablet production. Design. A tablet simulation was created enabling students to study the effects different parameters have on the properties of the tablet. Once results were generated, students interpreted and explained them on the basis of current theory. Assessment. The simulation was evaluated using written questionnaires and focus group interviews. Students appreciated the exercise and considered it to be motivational. Students commented that they found the simulation, together with the online seminar and the writing of the report, was beneficial for their learning process. Conclusion. According to students' perceptions, the use of the tablet simulation contributed to their understanding of the compaction process. PMID:27402990

  16. 21 CFR 520.82b - Aminopropazine fumarate, neomycin sulfate tablets.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 6 2010-04-01 2010-04-01 false Aminopropazine fumarate, neomycin sulfate tablets... Aminopropazine fumarate, neomycin sulfate tablets. (a) Specifications. The drug is in tablet form. Each tablet contains both aminopropazine fumarate equivalent to 25 milligrams of aminopropazine base and...

  17. Pharmacokinetics and Bioequivalence Evaluation of Cyclobenzaprine Tablets

    PubMed Central

    Brioschi, Tatiane Maria de Lima Souza; Schramm, Simone Grigoleto; Kano, Eunice Kazue; Koono, Eunice Emiko Mori; Ching, Ting Hui; Serra, Cristina Helena dos Reis

    2013-01-01

    The purpose of this study was to investigate cyclobenzaprine pharmacokinetics and to evaluate bioequivalence between two different tablet formulations containing the drug. An open, randomized, crossover, single-dose, two-period, and two-sequence design was employed. Tablets were administered to 23 healthy subjects after an overnight fasting and blood samples were collected up to 240 hours after drug administration. Plasma cyclobenzaprine was quantified by means of an LC-MS/MS method. Pharmacokinetic parameters related to absorption, distribution, and elimination were calculated. Cyclobenzaprine plasma profiles for the reference and test products were similar, as well as absorption pharmacokinetic parameters AUC (reference: 199.4 ng∗h/mL; test: 201.6 ng∗h/mL), Cmax (reference: 7.0 ng/mL; test: 7.2 ng/mL), and Tmax (reference: 4.5 h; test: 4.6 h). Bioequivalence was evaluated by means of 90% confidence intervals for the ratio of AUC (93%–111%) and Cmax (93%–112%) values for test and reference products, which were within the 80%–125% interval proposed by FDA. Cyclobenzaprine pharmacokinetics can be described by a multicompartment open model with an average rapid elimination half-life (t(1/2)β) of 3.1 hours and an average terminal elimination half-life (t(1/2)γ) of 31.9 hours. PMID:24151591

  18. Tamarindus indica pectin blend film composition for coating tablets with enhanced adhesive force strength.

    PubMed

    Khurana, Rajneet; Singh, Kuldeep; Sapra, Bharti; Tiwary, A K; Rana, Vikas

    2014-02-15

    Tablet coating is the most useful method to improve tablet texture, odour and mask taste. Thus, the present investigation was aimed at developing an industrially acceptable aqueous tablet coating material. The physico-chemical, electrical and SEM investigations ensures that blending of Tamarindus indica (Linn.) pectin (TP) with chitosan gives water resistant film texture. Therefore, CH-TP (60:40) spray coated tablets were prepared. The evaluation of CH-TP coated tablets showed enhanced adhesive force strength (between tablet surface to coat) and negligible cohesive force strength (between two tablets) both evaluated using texture analyzer. The comparison of CH-TP coated tablets with Eudragit coated tablets further supported superiority of the former material. Thus, the findings pointed towards the potential of CH-TP for use as a tablet coating material in food as well as pharmaceutical industry.

  19. On the Correlation of Effective Terahertz Refractive Index and Average Surface Roughness of Pharmaceutical Tablets

    NASA Astrophysics Data System (ADS)

    Chakraborty, Mousumi; Bawuah, Prince; Tan, Nicholas; Ervasti, Tuomas; Pääkkönen, Pertti; Zeitler, J. Axel; Ketolainen, Jarkko; Peiponen, Kai-Erik

    2016-08-01

    In this paper, we have studied terahertz (THz) pulse time delay of porous pharmaceutical microcrystalline compacts and also pharmaceutical tablets that contain indomethacin (painkiller) as an active pharmaceutical ingredient (API) and microcrystalline cellulose as the matrix of the tablet. The porosity of a pharmaceutical tablet is important because it affects the release of drug substance. In addition, surface roughness of the tablet has much importance regarding dissolution of the tablet and hence the rate of drug release. Here, we show, using a training set of tablets containing API and with a priori known tablet's quality parameters, that the effective refractive index (obtained from THz time delay data) of such porous tablets correlates with the average surface roughness of a tablet. Hence, THz pulse time delay measurement in the transmission mode provides information on both porosity and the average surface roughness of a compact. This is demonstrated for two different sets of pharmaceutical tablets having different porosity and average surface roughness values.

  20. Hydration induced material transfer in membranes of osmotic pump tablets measured by synchrotron radiation based FTIR.

    PubMed

    Wu, Li; Yin, Xianzhen; Guo, Zhen; Tong, Yajun; Feng, Jing; York, Peter; Xiao, Tiqiao; Chen, Min; Gu, Jingkai; Zhang, Jiwen

    2016-03-10

    Osmotic pump tablets are reliable oral controlled drug delivery systems based on their semipermeable membrane coating. This research used synchrotron radiation-based Fourier transform infrared (SR-FTIR) microspectroscopy and imaging to investigate the hydration induced material transfer in the membranes of osmotic pump tablets. SR-FTIR was applied to record and map the chemical information of a micro-region of the membranes, composed of cellulose acetate (CA, as the water insoluble matrix) and polyethylene glycol (PEG, as the soluble pore forming agent and plasticizing agent). The microstructure and chemical change of membranes hydrated for 0, 5, 10 and 30min were measured using SR-FTIR, combined with scanning electronic microscopy and atom force microscopy. The SR-FTIR microspectroscopy results indicated that there was a major change at the absorption range of 2700-3100cm(-1) in the membranes after different periods of hydration time. The absorption bands at 2870-2880cm(-1) and 2950-2960cm(-1) were assigned to represent CA and PEG, respectively. The chemical group signal distribution illustrated by the ratio of PEG to CA demonstrated that the trigger of drug release in the preliminary stage was due to the rapid transfer of PEG into liquid medium with a sharp decrease of PEG in the membranes. The SR-FTIR mapping results have demonstrated the hydration induced material transfer in the membranes of osmotic pump tablets and enabled reassessment of the drug release mechanism of membrane controlled osmotic pump systems. PMID:26802550

  1. Hydration induced material transfer in membranes of osmotic pump tablets measured by synchrotron radiation based FTIR.

    PubMed

    Wu, Li; Yin, Xianzhen; Guo, Zhen; Tong, Yajun; Feng, Jing; York, Peter; Xiao, Tiqiao; Chen, Min; Gu, Jingkai; Zhang, Jiwen

    2016-03-10

    Osmotic pump tablets are reliable oral controlled drug delivery systems based on their semipermeable membrane coating. This research used synchrotron radiation-based Fourier transform infrared (SR-FTIR) microspectroscopy and imaging to investigate the hydration induced material transfer in the membranes of osmotic pump tablets. SR-FTIR was applied to record and map the chemical information of a micro-region of the membranes, composed of cellulose acetate (CA, as the water insoluble matrix) and polyethylene glycol (PEG, as the soluble pore forming agent and plasticizing agent). The microstructure and chemical change of membranes hydrated for 0, 5, 10 and 30min were measured using SR-FTIR, combined with scanning electronic microscopy and atom force microscopy. The SR-FTIR microspectroscopy results indicated that there was a major change at the absorption range of 2700-3100cm(-1) in the membranes after different periods of hydration time. The absorption bands at 2870-2880cm(-1) and 2950-2960cm(-1) were assigned to represent CA and PEG, respectively. The chemical group signal distribution illustrated by the ratio of PEG to CA demonstrated that the trigger of drug release in the preliminary stage was due to the rapid transfer of PEG into liquid medium with a sharp decrease of PEG in the membranes. The SR-FTIR mapping results have demonstrated the hydration induced material transfer in the membranes of osmotic pump tablets and enabled reassessment of the drug release mechanism of membrane controlled osmotic pump systems.

  2. Defusing the population bomb in the 1950s: foam tablets in India.

    PubMed

    Löwy, Ilana

    2012-09-01

    After the World War II era, Western experts explained that the progress of medicine, which had led to a decrease in mortality in developing countries ('control of death') was not accompanied by a parallel decrease in birth rates ('control of life'). This conjunction, they warned, would lead inexorably to population explosion and its terrifying consequences: famines, riots, political instability, expansion of Communism, wars. A heterogenous coalition of demographers, public health experts and politicians was urgently looking for an effective means to curb population growth. In the 1950s, many of them considered that mass distribution of foam tablets, a local contraceptive presented as simple to use, cheap and efficient, was a possible solution for the population crisis. At the same time, a potential opening of huge markets for this product generated intense competition among manufacturers and attempts to disqualify competing preparations as inefficient and dangerous for health. Struggles around the marketing of foam tablets, especially in India, reveal a unique combination of science, medicine, cold war politics, philanthropy and business. The presumed commercial and social potential of foam tablets was never fulfilled, due to the unreliability both of the product itself and of its 'backward' users, who either refused this contraceptive mean, or abandoned it promptly.

  3. Quality by design approach for formulation development: a case study of dispersible tablets.

    PubMed

    Charoo, Naseem A; Shamsher, Areeg A A; Zidan, Ahmed S; Rahman, Ziyaur

    2012-02-28

    The focus of the current investigations was to apply quality by design (QbD) approach to the development of dispersible tablets. Critical material and process parameters are linked to the critical quality attributes of the product. Variability is reduced by product and process understanding which translates into quality improvement, risk reduction and productivity enhancement. The risk management approach further leads to better understanding of the risks, ways to mitigate them and control strategy is proposed commensurate with the level of the risk. Design space in combination with pharmaceutical quality management system provide for flexible regulatory approaches with opportunity for continuous improvement that benefit patient and manufacturer alike. The development of dispersible tablet was proposed in the current study through a QbD paradigm for a better patient compliance and product quality. The quality target product profile of a model biopharmaceutical class II drug was identified. Initial risk analysis led to the identification of the critical quality attributes. Physicochemical characterization and compatibility studies of the drug with commonly used excipients were performed. Experiments were designed with focus on critical material and process attributes. Design space was identified and risk factors for all the possible failure modes were below critical levels after the implementation of control strategy. Compliance to the design space provides an opportunity to release batches in a real time. In conclusion, QbD tools together with risk and quality management tools provided an effective and efficient paradigm to build the quality into dispersible tablet. PMID:22209997

  4. Defusing the population bomb in the 1950s: foam tablets in India.

    PubMed

    Löwy, Ilana

    2012-09-01

    After the World War II era, Western experts explained that the progress of medicine, which had led to a decrease in mortality in developing countries ('control of death') was not accompanied by a parallel decrease in birth rates ('control of life'). This conjunction, they warned, would lead inexorably to population explosion and its terrifying consequences: famines, riots, political instability, expansion of Communism, wars. A heterogenous coalition of demographers, public health experts and politicians was urgently looking for an effective means to curb population growth. In the 1950s, many of them considered that mass distribution of foam tablets, a local contraceptive presented as simple to use, cheap and efficient, was a possible solution for the population crisis. At the same time, a potential opening of huge markets for this product generated intense competition among manufacturers and attempts to disqualify competing preparations as inefficient and dangerous for health. Struggles around the marketing of foam tablets, especially in India, reveal a unique combination of science, medicine, cold war politics, philanthropy and business. The presumed commercial and social potential of foam tablets was never fulfilled, due to the unreliability both of the product itself and of its 'backward' users, who either refused this contraceptive mean, or abandoned it promptly. PMID:22580021

  5. Composition profiling of seized ecstasy tablets by Raman spectroscopy.

    PubMed

    Bell, S E; Burns, D T; Dennis, A C; Matchett, L J; Speers, J S

    2000-10-01

    Raman spectroscopy with far-red excitation has been investigated as a simple and rapid technique for composition profiling of seized ecstasy (MDMA, N-methyl-3,4-methylenedioxyamphetamine) tablets. The spectra obtained are rich in vibrational bands and allow the active drug and excipient used to bulk the tablets to be identified. Relative band heights can be used to determine drug/excipient ratios and the degree of hydration of the drug while the fact that 50 tablets per hour can be analysed allows large numbers of spectra to be recorded. The ability of Raman spectroscopy to distinguish between ecstasy tablets on the basis of their chemical composition is illustrated here by a sample set of 400 tablets taken from a large seizure of > 50,000 tablets that were found in eight large bags. The tablets are all similar in appearance and carry the same logo. Conventional analysis by GC-MS showed they contained MDMA. Initial Raman studies of samples from each of the eight bags showed that despite some tablet-to-tablet variation within each bag the contents could be classified on the basis of the excipients used. The tablets in five of the bags were sorbitol-based, two were cellulose-based and one bag contained tablets with a glucose excipient. More extensive analysis of 50 tablets from each of a representative series of sample bags have distribution profiles that showed the contents of each bag were approximately normally distributed about a mean value, rather than being mixtures of several discrete types. Two of the sorbitol-containing sample sets were indistinguishable while a third was similar but not identical to these, in that it contained the same excipient and MDMA with the same degree of hydration but had a slightly different MDMA/sorbitol ratio. The cellulose-based samples were badly manufactured and showed considerable tablet-to-tablet variation in their drug/excipient ratio while the glucose-based tablets had a tight distribution in their drug/excipient ratios

  6. Chitosan-based mucoadhesive tablets for oral delivery of ibuprofen.

    PubMed

    Sogias, Ioannis A; Williams, Adrian C; Khutoryanskiy, Vitaliy V

    2012-10-15

    Chitosan and its half-acetylated derivative have been compared as excipients in mucoadhesive tablets containing ibuprofen. Initially the powder formulations containing the polymers and the drug were prepared by either co-spray drying or physical co-grinding. Polymer-drug interactions and the degree of drug crystallinity in these formulations were assessed by infrared spectroscopy and differential scanning calorimetry. Tablets were prepared and their swelling and dissolution properties were studied in media of various pHs. Mucoadhesive properties of ibuprofen-loaded and drug-free tablets were evaluated by analysing their detachment from pig gastric mucosa over a range of pHs. Greater polymer-drug interactions were seen for spray-dried particles compared to co-ground samples and drug loading into chitosan-based microparticles (41%) was greater than the corresponding half-acetylated samples (32%). Swelling and drug release was greater with the half-acetylated chitosan tablets than tablets containing the parent polymer and both tablets were mucoadhesive, the extent of which was dependent on substrate pH. The results illustrate the potential sustained drug delivery benefits of both chitosan and its half-acetylated derivative as mucoadhesive tablet excipients. PMID:22842627

  7. Continuous melt granulation: Influence of process and formulation parameters upon granule and tablet properties.

    PubMed

    Monteyne, Tinne; Vancoillie, Jochem; Remon, Jean-Paul; Vervaet, Chris; De Beer, Thomas

    2016-10-01

    The pharmaceutical industry has a growing interest in alternative manufacturing models allowing automation and continuous production in order to improve process efficiency and reduce costs. Implementing a switch from batch to continuous processing requires fundamental process understanding and the implementation of quality-by-design (QbD) principles. The aim of this study was to examine the relationship between formulation-parameters (type binder, binder concentration, drug-binder miscibility), process-parameters (screw speed, powder feed rate and granulation temperature), granule properties (size, size distribution, shape, friability, true density, flowability) and tablet properties (tensile strength, friability, dissolution rate) of four different drug-binder formulations using Design of experiments (DOE). Two binders (polyethylene glycol (PEG) and Soluplus®) with a different solid state, semi-crystalline vs amorphous respectively, were combined with two model-drugs, metoprolol tartrate (MPT) and caffeine anhydrous (CAF), both having a contrasting miscibility with the binders. This research revealed that the granule properties of miscible drug-binder systems depended on the powder feed rate and barrel filling degree of the granulator whereas the granule properties of immiscible systems were mainly influenced by binder concentration. Using an amorphous binder, the tablet tensile strength depended on the granule size. In contrast, granule friability was more important for tablet quality using a brittle binder. However, this was not the case for caffeine-containing blends, since these phenomena were dominated by the enhanced compression properties of caffeine Form I, which was formed during granulation. Hence, it is important to gain knowledge about formulation behavior during processing since this influences the effect of process parameters onto the granule and tablet properties. PMID:27449628

  8. Continuous melt granulation: Influence of process and formulation parameters upon granule and tablet properties.

    PubMed

    Monteyne, Tinne; Vancoillie, Jochem; Remon, Jean-Paul; Vervaet, Chris; De Beer, Thomas

    2016-10-01

    The pharmaceutical industry has a growing interest in alternative manufacturing models allowing automation and continuous production in order to improve process efficiency and reduce costs. Implementing a switch from batch to continuous processing requires fundamental process understanding and the implementation of quality-by-design (QbD) principles. The aim of this study was to examine the relationship between formulation-parameters (type binder, binder concentration, drug-binder miscibility), process-parameters (screw speed, powder feed rate and granulation temperature), granule properties (size, size distribution, shape, friability, true density, flowability) and tablet properties (tensile strength, friability, dissolution rate) of four different drug-binder formulations using Design of experiments (DOE). Two binders (polyethylene glycol (PEG) and Soluplus®) with a different solid state, semi-crystalline vs amorphous respectively, were combined with two model-drugs, metoprolol tartrate (MPT) and caffeine anhydrous (CAF), both having a contrasting miscibility with the binders. This research revealed that the granule properties of miscible drug-binder systems depended on the powder feed rate and barrel filling degree of the granulator whereas the granule properties of immiscible systems were mainly influenced by binder concentration. Using an amorphous binder, the tablet tensile strength depended on the granule size. In contrast, granule friability was more important for tablet quality using a brittle binder. However, this was not the case for caffeine-containing blends, since these phenomena were dominated by the enhanced compression properties of caffeine Form I, which was formed during granulation. Hence, it is important to gain knowledge about formulation behavior during processing since this influences the effect of process parameters onto the granule and tablet properties.

  9. Comparison of tablet-based strategies for incision planning in laser microsurgery

    NASA Astrophysics Data System (ADS)

    Schoob, Andreas; Lekon, Stefan; Kundrat, Dennis; Kahrs, Lüder A.; Mattos, Leonardo S.; Ortmaier, Tobias

    2015-03-01

    Recent research has revealed that incision planning in laser surgery deploying stylus and tablet outperforms state-of-the-art micro-manipulator-based laser control. Providing more detailed quantitation regarding that approach, a comparative study of six tablet-based strategies for laser path planning is presented. Reference strategy is defined by monoscopic visualization and continuous path drawing on a graphics tablet. Further concepts deploying stereoscopic or a synthesized laser view, point-based path definition, real-time teleoperation or a pen display are compared with the reference scenario. Volunteers were asked to redraw and ablate stamped lines on a sample. Performance is assessed by measuring planning accuracy, completion time and ease of use. Results demonstrate that significant differences exist between proposed concepts. The reference strategy provides more accurate incision planning than the stereo or laser view scenario. Real-time teleoperation performs best with respect to completion time without indicating any significant deviation in accuracy and usability. Point-based planning as well as the pen display provide most accurate planning and increased ease of use compared to the reference strategy. As a result, combining the pen display approach with point-based planning has potential to become a powerful strategy because of benefiting from improved hand-eye-coordination on the one hand and from a simple but accurate technique for path definition on the other hand. These findings as well as the overall usability scale indicating high acceptance and consistence of proposed strategies motivate further advanced tablet-based planning in laser microsurgery.

  10. Xanthan and galactomannan (from M. scabrella) matrix tablets for oral controlled delivery of theophylline.

    PubMed

    Vendruscolo, C W; Andreazza, I F; Ganter, J L M S; Ferrero, C; Bresolin, T M B

    2005-05-30

    Directly compressed theophylline tablets, containing commercial xanthan (X) (Keltrol) and a highly hydrophilic galactomannan (G) from the seeds of Mimosa scabrella (a brazilian leguminous tree called bracatinga) as release-controlling agents, were obtained. Gums were used at 4, 8, 12.5 and 25% (w/w), either alone or in mixture (X:G 1:1). During galactomannan extraction process, the biopolymer was dried in a scale up, by vacuum oven (VO) or spray dryer (SD). The in vitro drug release was evaluated at different time intervals during 8 h using apparatus 1 (USP 26) at 100 rpm. The pH of the dissolution medium (1.4) was changed to 4.0 and 6.8 after 2 and 3 h, respectively. Tablets containing G(SD) resulted in more uniform drug release than G(VO) ones, due to their smaller particle size. The drug release decreased with the increase of polymer concentration and all formulations at 25% w/w of gums showed excessive sustained release effect. The matrices made with alone X showed higher drug retention for all concentrations, compared with G matrices that released the drug too fast. The XG matrices were able to produce near zero-order drug release. The XG(SD) 8% tablets provided the required release rate (about 90% at the end of 8 h), with zero-order release kinetics. Tablets containing G(VO) in low concentration showed a complete erosion, while the others demonstrated fast hydration and swelling in contact with the dissolution medium. The release mechanism was a combination of diffusion and relaxation. The relative importance of these two processes varied with matrix composition. The XG(SD) 8% matrix showed higher contribution of polymer relaxation.

  11. Ginger Orally Disintegrating Tablets to Improve Swallowing in Older People.

    PubMed

    Hirata, Ayumu; Funato, Hiroki; Nakai, Megumi; Iizuka, Michiro; Abe, Noriaki; Yagi, Yusuke; Shiraishi, Hisashi; Jobu, Kohei; Yokota, Junko; Hirose, Kahori; Hyodo, Masamitsu; Miyamura, Mitsuhiko

    2016-01-01

    We previously prepared and pharmaceutically evaluated ginger orally disintegrating (OD) tablets, optimized the base formulation, and carried out a clinical trial in healthy adults in their 20 s and 50s to measure their effect on salivary substance P (SP) level and improved swallowing function. In this study, we conducted clinical trials using the ginger OD tablets in older people to clinically evaluate the improvements in swallowing function resulting from the functional components of the tablet. The ginger OD tablets were prepared by mixing the excipients with the same amount of mannitol and sucrose to a concentration of 1% ginger. Eighteen healthy older adult volunteers aged 63 to 90 were included in the swallowing function test. Saliva was collected before and 15 min after administration of the placebo and ginger OD tablets. Swallowing endoscopy was performed by an otolaryngologist before administration and 15 min after administration of the ginger OD tablets. A scoring method was used to evaluate the endoscopic swallowing. Fifteen minutes after taking the ginger OD tablets, the salivary SP amount was significantly higher than prior to ingestion or after taking the placebo (p<0.05). Among 10 subjects, one scored 1-3 using the four evaluation criteria. Overall, no aspiration occurred and a significant improvement in the swallowing function score was observed (p<0.05) after taking the ginger OD tablets. Our findings showed that the ginger OD tablets increased the salivary SP amount and improved swallowing function in older people with appreciably reduced swallowing function. PMID:27374286

  12. Gravimetric and spectrophotometric determination of some phenothiazine and imidazole derivatives in coated tablets and tablets.

    PubMed

    Iliaszenko, J; Sokołowska, M; Paruszewski, R

    2001-01-01

    Two drugs in the form of coated tablets: Promazin (promazine hydrochloride) (1) and Thioridazin (thioridazine hydrochloride) (2), and tablets Clotrimazolum (clotrimazole) (3) were assayed gravimetrically and spectrophotometrically in the same process using complexes with ammonium molybdate. Stoichiometry of these complexes was established by elemental analysis and analysis of the incineration residue (MoO3). The complexes were subsequently characterized using their IR and UV spectra and melting points. The active substances of the complexes were also determined spectrophotometrically. Using this method Beers Law was found to hold for the concentration ranges of 5-40 microg/ml (complex of 1), 5-60 (microg/ml (complex of 2) and 2-10 microg/ml (complex of 3). The method was validated in terms of precision, linearity, detection limit and quantification limit. The two methods of drug determination, used in a single analytical process verify each other.

  13. Stability of freeze-dried tablets at different relative humidities.

    PubMed

    Corveleyn, S; Remon, J P

    1999-09-01

    The purpose of the study was to evaluate the stability of two different freeze-dried tablet formulations at different relative humidities (RHs). The tablets contained 25 mg hydrochlorothiazide (HCT) as a model drug and were prepared by freeze-drying a suspension and an oil-in-water (o/w) emulsion. Formulation A was a rapidly disintegrating tablet and consisted of 80 mg of maltodextrine DE38; 8 mg of polyethyleneglycol (PEG 6000), 8 mg of xanthan gum, and 25 mg of HCT. Formulation B was a lyophilized dry emulsion tablet that consisted of 160 mg of Miglyol 812, 80 mg of maltodextrin DE38, 16 mg of methylcellulose (Methocel) A15LV, and 25 mg of HCT. Tablets were packaged in different packing materials: polyvinylchloride (PVC)/aluminum blister packs, PVC-polyvinylidenechloride (PVDC)/aluminum blister packs, closed containers with a dessicant tablet, and open containers. The tablets were stored at three relative humidities (45%, 60%, and 85% RH) and were characterized on mechanical strength, residual moisture, porosity, content uniformity, and scanning electron microscopy (SEM) during a period of 6 months. After 1 month at 60% and 85% RH, a strong increase in moisture content (from 2.7% to 6.8%) was seen for the tablets packed in the open and closed containers and for the PVC/aluminum blistered tablets. This increase was higher for formulation A compared to formulation B since B contained 160 mg of triglycerides and was more hydrophobic. This increase in water content was correlated with a decrease in mechanical strength. The tablets also showed a change in microstructure and porosity. At a moisture content of 7.2%, formulation A showed a structural "collapse" since water acts as a plasticizer for the amorphous glass, lowering the glass transition temperature Tg. This phenomenon even occurred in PVC/aluminum blister packs at 85% RH. The structural collapse was associated with a complete loss of microstructure as detected by porosimetric analysis and SEM. For the PVC

  14. Formulation and evaluation of dried yeast tablets using different techniques.

    PubMed

    Al-Mohizea, Abdullah M; Ahmed, Mahrous O; Al-jenoobi, Fahad I; Mahrous, Gamal M; Abdel-Rahman, Aly A

    2007-08-01

    The aim of this study was to prepare and evaluate dried yeast tablets using both direct compression and dry granulation techniques in comparison with the conventional wet granulation as well as commercial product. Wet granulation technique is not favorable for producing the yeast tablets due to the problems of color darkening and the reduction of the fermentation power of the yeast as a result of the early start of the fermentation process due to the presence of moisture. Twenty six formulae of dried yeast tablets were prepared and evaluated. Certain directly compressible vehicles were employed for preparing these tablets. The quality control tests (weight uniformity, friability, disintegration time and hardness) of the prepared dried yeast tablets were performed according to B.P. 1998 limits. All batches of the prepared tablets complied with the B.P. limits of weight uniformity. Moreover, small values of friability % (1% or less) were obtained for all batches of dried yeast tablets with acceptable hardness values, indicating good mechanical properties which can withstand handling. On the other hand, not all batches complied with the limit of disintegration test which may be attributed to various formulation component variables. Therefore, four disintegrating agents were investigated for their disintegrating effect. It was found that the method of preparation, whether it is direct compression, dry granulation or wet granulation, has an effect on disintegration time of these dried yeast tablets and short disintegration times were obtained for some of the formulae. The shortest disintegration time was obtained with those tablets prepared by direct compression among the other techniques. Therefore, the direct compression is considered the best technique for preparation of dried yeast tablets and the best formula (which showed shorter disintegration time and better organoleptic properties than the available commercial yeast tablets) was chosen. Drug content for dried

  15. Standardization of Unani Antidiabetic Tablet - Qurse Tabasheer

    PubMed Central

    Ali, Waris; Shaikh, Hamiduddin; Ansari, Abdullah; Khanam, Salma

    2016-01-01

    Background: Quality control of Unani polyherbal formulations is the need of the day for better acceptance of Unani medicine. Qurse Tabasheer (QT) is a Unani polyherbal formulation containing six ingredients, Tabasheer (Siliceous concretions) (Bambosa arundinaceae Retz.), Gule Surkh (Rosa damascena Mill. flower), Gulnar (Punica granatum Linn. flower), Tukhme kahu (Lactuca sativa Linn. seed), Tukhme khurfa (Portulaca oleraceae Linn. seed), and Gile Armani (bole) widely used in treatment of diabetes. The present study was taken up to scientifically evaluate the various physicochemical parameters to standardize the formulation. Objective: To evaluate various physicochemical parameters including ash values, moisture content, extractive values, thin layer chromatography (TLC) and high-performance TLC (HPTLC), friability, disintegration, uniformity, and weight variation for standardization of QT. Materials and Methods: Ingredients were identified by the experts. The method mentioned in national formulary of Unani Medicine with modification was followed for preparation of the tablets. Physicochemical standards were established for ideal batch of tablets on the basis of set parameters regarding friability, hardness, and disintegration. Various parameters such as organoleptic characters, extractive values for the extract and HPTLC fingerprinting postcompression were carried out for evaluation of QT. Results: Parameters for loss of weight on drying, pH, ash values, extractive values documented. Qualitative chemical tests indicated the presence of alkaloid, glycoside, tannins, and steroids. TLC and HPTLC fingerprinting studies showing the presence of major peaks were documented. Friability, hardness, and disintegration time of ideal batch was 0.09 ± 0.0057, 4.03 ± 0.087, and 25.57 ± 0.4860 min, respectively, and it was found to be within the set limit. Weight variation was <5%. Total fungal and bacterial counts were found to be within the limit. Conclusion: Standards were

  16. Seismic Wave Propagation on the Tablet Computer

    NASA Astrophysics Data System (ADS)

    Emoto, K.

    2015-12-01

    Tablet computers widely used in recent years. The performance of the tablet computer is improving year by year. Some of them have performance comparable to the personal computer of a few years ago with respect to the calculation speed and the memory size. The convenience and the intuitive operation are the advantage of the tablet computer compared to the desktop PC. I developed the iPad application of the numerical simulation of the seismic wave propagation. The numerical simulation is based on the 2D finite difference method with the staggered-grid scheme. The number of the grid points is 512 x 384 = 196,608. The grid space is 200m in both horizontal and vertical directions. That is the calculation area is 102km x 77km. The time step is 0.01s. In order to reduce the user waiting time, the image of the wave field is drawn simultaneously with the calculation rather than playing the movie after the whole calculation. P and S wave energies are plotted on the screen every 20 steps (0.2s). There is the trade-off between the smooth simulation and the resolution of the wave field image. In the current setting, it takes about 30s to calculate the 10s wave propagation (50 times image updates). The seismogram at the receiver is displayed below of the wave field updated in real time. The default medium structure consists of 3 layers. The layer boundary is defined by 10 movable points with linear interpolation. Users can intuitively change to the arbitrary boundary shape by moving the point. Also users can easily change the source and the receiver positions. The favorite structure can be saved and loaded. For the advance simulation, users can introduce the random velocity fluctuation whose spectrum can be changed to the arbitrary shape. By using this application, everyone can simulate the seismic wave propagation without the special knowledge of the elastic wave equation. So far, the Japanese version of the application is released on the App Store. Now I am preparing the

  17. Formulation and in vitro evaluation of floating tablets of hydroxypropyl methylcellulose and polyethylene oxide using ranitidine hydrochloride as a model drug

    PubMed Central

    Gharti, KP; Thapa, P; Budhathoki, U; Bhargava, A

    2012-01-01

    The present study was carried out with an objective of preparation and in vitro evaluation of floating tablets of hydroxypropyl methyl cellulose (HPMC) and polyethylene oxide (PEO) using ranitidine hydrochloride as a model drug. The floating tablets were based on effervescent approach using sodium bicarbonate a gas generating agent. The tablets were prepared by dry granulation method. The effect of polymers concentration and viscosity grades of HPMC on drug release profile was evaluated. The effect of sodium bicarbonate and stearic acid on drug release profile and floating properties were also investigated. The result of in vitro dissolution study showed that the drug release profile could be sustained by increasing the concentration of HPMC K15MCR and Polyox WSR303. The formulation containing HPMC K15MCR and Polyox WSR303 at the concentration of 13.88% showed 91.2% drug release at the end of 24 hours. Changing the viscosity grade of HPMC from K15MCR to K100MCR had no significant effect on drug release profile. Sodium bicarbonate and stearic acid in combination showed no significant effect on drug release profile. The formulations containing sodium bicarbonate 20 mg per tablet showed desired buoyancy (floating lag time of about 2 minutes and total floating time of >24 hours). The present study shows that polymers like HPMC K15MCR and Polyox WSR303 in combination with sodium bicarbonate as a gas generating agent can be used to develop sustained release floating tablets of ranitidine hydrochloride. PMID:23493037

  18. Comparison of salivary fluoride concentrations after administration of a bioadhesive slow-release tablet and a conventional fluoride tablet.

    PubMed

    Bottenberg, P; Cleymaet, R; de Muynck, C; Remon, J P; Coomans, D; Slop, D

    1992-08-01

    The in-vitro and in-vivo fluoride release of bioadhesive, slow-release tablets prepared from a mixture of polyethylene glycol polymers, containing 0.1 mg of fluoride as NaF was studied, and their ability to sustain fluoride levels in saliva were compared with conventional fluoride tablets with the same fluoride content. In-vitro release experiments showed that the bioadhesive tablets needed 8 h to release all their fluoride compared with less than 1 h for the conventional fluoride tablets. In-vivo, the bioadhesive tablets had a retention period of 6 h and could sustain a salivary fluoride level of more than 10 microM above the baseline for 7 h. The conventional fluoride tablets achieved a peak concentration of 0.5 mM directly after dissolution in the mouth, but the fluoride level could not be sustained for longer than 1 h. A good agreement was found between the in-vitro swelling behaviour of the bioadhesive tablets and their in-vitro and in-vivo release characteristics and their in-vivo retention time. PMID:1359097

  19. Synthesis and Characterization of Sodium Alginate Conjugate and Study of Effect of Conjugation on Drug Release from Matrix Tablet.

    PubMed

    Satheeshababu, B K; Mohamed, I

    2015-01-01

    The aim of the present research work to study the effect of conjugation of the polymer on drug release from the matrix tablets. Sodium alginate L-cysteine conjugate was achieved by covalent attachment of thiol group of L-cysteine with the primary amino group of sodium alginate through the amide bonds formed by primary amino groups of the sodium alginate and the carboxylic acid group of L-cysteine. The synthesised sodium alginate L-cysteine conjugate was characterised by determining of charring point, Fourier transmission-infrared and differential scanning calorimetric analysis. To study the effect of conjugation on drug release pattern, the matrix tablets were prepared using various proportions of sodium alginate and sodium alginate L-cysteine conjugate along with atorvastatin calcium as model drug. The wet granulation technique was adopted and prepared matrix tablets were evaluated for various physical parameters. The in vitro drug release study results suggested that tablet formulated in combination of sodium alginate and sodium alginate L-cysteine conjugate S4 showed 100% after 8 h drug release whereas formulated with only sodium alginate S0 released 40% in 8 h. PMID:26798173

  20. [The investigation of short term efficiency of oxfendazole + oxyclozanide paste and tablet formulations against gastrointestinal nematodes in sheep].

    PubMed

    Yildirim, Alparslan; Güneş, Vehbi; Iça, Anil; Sariözkan, Savaş; Düzlü, Onder; Inci, Abdullah; Albasan, Hasan

    2008-01-01

    The aim of this study was to investigate the effectiveness of tablet and paste formulations of Oxfendazole and Oxyclozanide combinations against subclinical gastrointestinal nematode infections and to compare the advantages and/or disadvantages of their use. Seventy-five infected sheep were selected from an enterprise located in Kayseri in 2006. The sheep were divided into 3 equal groups as paste, tablet and control groups. Fecal samples were collected from each group before drug administration. While the paste and tablet groups were administered drugs orally, no drugs were given to the controls. Fecal samples were collected on the 7th, 14th, 21st, and 28th days after drug application and the EPG values were determined. The parasitological examination revealed that the most prevalent species was Ostertagia spp., followed by Nematodirus spp. and Trichostrongylus spp. While the mean EPG value of the control group increased up to a ratio of 7.8% at day 28, the mean EPG values of drug groups decreased to 0%. Although the unit dose of paste formulation is more expensive, it was found that it could be an alternative to tablet formulation and has some advantages such as being easier to give, effective utilizing, shorter application period, fewer complications and death risk, no application failure and requires fewer personnel.

  1. Susceptibility testing of Actinobacillus pleuropneumoniae in Denmark. Evaluation of three different media of MIC-determinations and tablet diffusion tests.

    PubMed

    Aarestrup, F M; Jensen, N E

    1999-02-12

    This study was conducted to compare the applicability of three different media in sensitivity testing of Actinobacillus pleuropneumoniae by means of MIC and tablet diffusion tests. The media used were: modified PPLO agar, chocolatized Mueller-Hinton-II and Columbia agar supplemented with NAD. Seven antimicrobial agents were tested: ceftiofur, enrofloxacin, penicillin, spectinomycin, tiamulin, trimethoprim + sulfadiazine and tylosin, against 40 randomly selected A. pleuropneumoniae isolates. In general, good agreement was found between results obtained with all combinations of media, most antimicrobials tested and the two-test systems. Some variations between media were observed for spectinomycin, tiamulin and tylosin. For ceftiofur and trimethoprim + sulfadiazine some isolates with low MIC-values were classified as resistant using tablet diffusion, indicating that the break points of resistance for these antimicrobials using the tablet diffusion tests need adjustment. Using current break points for resistance with MIC-determinations, all isolates tested susceptible to ceftiofur, enrofloxacin, penicillin, tiamulin and trimethoprim + sulfadiazine. A larger number of isolates tested resistant to spectinomycin and tylosin on all three media using both MIC determinations and tablet diffusion. PMID:10063535

  2. Synthesis and Characterization of Sodium Alginate Conjugate and Study of Effect of Conjugation on Drug Release from Matrix Tablet

    PubMed Central

    Satheeshababu, B. K.; Mohamed, I.

    2015-01-01

    The aim of the present research work to study the effect of conjugation of the polymer on drug release from the matrix tablets. Sodium alginate L-cysteine conjugate was achieved by covalent attachment of thiol group of L-cysteine with the primary amino group of sodium alginate through the amide bonds formed by primary amino groups of the sodium alginate and the carboxylic acid group of L-cysteine. The synthesised sodium alginate L-cysteine conjugate was characterised by determining of charring point, Fourier transmission-infrared and differential scanning calorimetric analysis. To study the effect of conjugation on drug release pattern, the matrix tablets were prepared using various proportions of sodium alginate and sodium alginate L-cysteine conjugate along with atorvastatin calcium as model drug. The wet granulation technique was adopted and prepared matrix tablets were evaluated for various physical parameters. The in vitro drug release study results suggested that tablet formulated in combination of sodium alginate and sodium alginate L-cysteine conjugate S4 showed 100% after 8 h drug release whereas formulated with only sodium alginate S0 released 40% in 8 h. PMID:26798173

  3. Solid dispersions in the development of a nimodipine floating tablet formulation and optimization by artificial neural networks and genetic programming.

    PubMed

    Barmpalexis, Panagiotis; Kachrimanis, Kyriakos; Georgarakis, Emanouil

    2011-01-01

    The present study investigates the use of nimodipine-polyethylene glycol solid dispersions for the development of effervescent controlled release floating tablet formulations. The physical state of the dispersed nimodipine in the polymer matrix was characterized by differential scanning calorimetry, powder X-ray diffraction, FT-IR spectroscopy and polarized light microscopy, and the mixture proportions of polyethylene glycol (PEG), polyvinyl-pyrrolidone (PVP), hydroxypropylmethylcellulose (HPMC), effervescent agents (EFF) and nimodipine were optimized in relation to drug release (% release at 60 min, and time at which the 90% of the drug was dissolved) and floating properties (tablet's floating strength and duration), employing a 25-run D-optimal mixture design combined with artificial neural networks (ANNs) and genetic programming (GP). It was found that nimodipine exists as mod I microcrystals in the solid dispersions and is stable for at least a three-month period. The tablets showed good floating properties and controlled release profiles, with drug release proceeding via the concomitant operation of swelling and erosion of the polymer matrix. ANNs and GP both proved to be efficient tools in the optimization of the tablet formulation, and the global optimum formulation suggested by the GP equations consisted of PEG=9%, PVP=30%, HPMC=36%, EFF=11%, nimodipine=14%.

  4. Application of water-insoluble polymers to orally disintegrating tablets treated by high-pressure carbon dioxide gas.

    PubMed

    Ito, Yoshitaka; Maeda, Atsushi; Kondo, Hiromu; Iwao, Yasunori; Noguchi, Shuji; Itai, Shigeru

    2016-09-10

    The phase transition of pharmaceutical excipients that can be induced by humidifying or heating is well-known to increase the hardness of orally disintegrating tablets (ODTs). However, these conditions are not applicable to drug substances that are chemically unstable against such stressors. Here, we describe a system which enhances the hardness of tablets containing water-insoluble polymers by using high-pressure carbon dioxide (CO2). On screening of 26 polymeric excipients, aminoalkyl methacrylate copolymer E (AMCE) markedly increased tablet hardness (+155N) when maintained in a high-pressure CO2 environment. ODTs containing 10% AMCE were prepared and treatment with 4.0MPa CO2 gas at 25°C for 10min increased the hardness to +30N, whose level corresponded to heating at 70°C for 720min. In addition, we confirmed the effects of CO2 pressure, temperature, treatment time, and AMCE content on the physical properties of ODTs. Optimal pressure of CO2 gas was considered to be approximately 3.5MPa for an AMCE formula, as excessive pressure delayed the disintegration of ODTs. Combination of high-pressure CO2 gas and AMCE is a prospective approach for increasing the tablet hardness for ODTs, and can be conducted without additional heat or moisture stress using a simple apparatus. PMID:27374202

  5. The opacity of tablet film coatings.

    PubMed

    Rowe, R C

    1984-09-01

    The opacity of tablet film coatings containing a variety of pigments and fillers has been assessed using a contrast ratio defined as the ratio of the measured reflectance of the incident light when the film is placed on a black substrate to the measured reflectance of the incident light when the film is placed on a white substrate. Films pigmented with calcium carbonate, calcium sulphate or talc had very low contrast ratios and only the inclusion of titanium dioxide imparted opacity. Films pigmented with the coloured lake pigments had contrast ratios dependent on both the parent dye and the dye concentration with the contrast ratios decreasing blue greater than red greater than orange greater than yellow. Films pigmented with the synthetic iron oxides all had very high contrast ratios. The results are consistent with the known theories of light scattering and absorption and illustrate the potential of this accurate, rapid and simple technique in the optimization of film formulations during product development.

  6. 21 CFR 520.2150a - Stanozolol tablets.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... chapter. (c) Conditions of use. (1) Used as an anabolic steroid treatment in dogs and cats. (2) Administered orally to cats and small breeds of dogs, 1/2 to 1 tablet twice daily for several weeks; to...

  7. GETTYSBURG ADDRESS TABLET BESIDE ENTRANCE GATE AT MEMORIAL WALK. VIEW ...

    Library of Congress Historic Buildings Survey, Historic Engineering Record, Historic Landscapes Survey

    GETTYSBURG ADDRESS TABLET BESIDE ENTRANCE GATE AT MEMORIAL WALK. VIEW TO EAST. - Rock Island National Cemetery, Rock Island Arsenal, 0.25 mile north of southern tip of Rock Island, Rock Island, Rock Island County, IL

  8. 21 CFR 520.2123a - Spectinomycin tablets.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    .... (a) Specifications. Each tablet contains spectinomycin dihydrochloride pentahydrate equivalent to 100... use in dogs—(1) Amount. Administer orally to provide 10 mg per pound (lb) of body weight twice...

  9. To evaluate efficacy and safety of fixed dose combination of aceclofenac + paracetamol + thiocolchicoside (acenac-MR) in the treatment of acute low back pain.

    PubMed

    Lahoti, Govind

    2012-01-01

    Low back pain is very common complaint in all age groups. Paracetamol, non-steroidal anti-inflammatory drugs and muscle relaxants are commonly prescribed in combination for the treatment of back pain. The aim of the study was to evaluate efficacy and safety of fixed dose combination of aceclofenac + paracetamol + thiocolchicoside (acenac-MR) in the treatment of acute low back pain. Thirty-five patients, age being 18 to 76 years suffering from acute low back pain were enrolled in the study. Study drug acenac-MR tablet, (Medley pharmaceutical, Mumbai) containing aceclofenac 100 mg + thiocolchicoside 4 mg + paracetamol 500 mg was prescribed twice daily for a duration of 7 days. Intensity of pain was evaluated at the start of the therapy and on day 3 and day 7 with the help of visual analogue scale. Mobility assessment in low back patients was evaluated at the start of the therapy and on day 3 and day 7. A simple graduated bar (0 value at floor) evaluated hand-to-floor distance. Tolerability and efficacy was evaluated based on the global assessment by the investigator based on a 3-point scale marked as excellent/good/poor. There were 20 males and 10 females who were included for final analysis, 5 patients lost to follow-up. Intensity of pain at rest (p< or =0.0014 at day 3, p< or =0.0001 at day 7), during movement (p< or =0.0001 at day 3, p< or =0.0001 at day 7) and at night (p< or =0.0001 at day 3, p< or =0.0001 at day 7) was significantly reduced by acenac-MR compared to baseline. The mobility assessment revealed a statistically significant improvement in hand-to-floor distance on the 3rd (< or =0.0001) and 7th day (< or =0.0001) as compared to baseline with acenac-MR. As per investigators' assessment about efficacy of trial drug, 70% of patients reported excellent, 26.66 % good and 3.33 % reported poor efficacy. As per investigators' assessment about tolerability, 60 % of patients reported excellent, 36.66 % good and 3.33 % reported poor tolerability. None of the

  10. Controlled porosity solubility modulated osmotic pump tablets of gliclazide.

    PubMed

    Banerjee, Arti; Verma, P R P; Gore, Subhash

    2015-06-01

    A system that can deliver drug at a controlled rate is very important for the treatment of various chronic diseases such as diabetes, asthma, and heart disease. Poorly water-soluble drug with pH-dependent solubility such as gliclazide (GLZ) offers challenges in the controlled-release formulation because of low dissolution rate and poor bioavailability. Solid dispersion (SD) of GLZ consisted of hydroxypropyl cellulose (HPC-SSL) as a polymeric solubilizer was manufactured by hot melt extrusion (HME) technology. Then, controlled porosity osmotic pump (CPOP) tablet of gliclazide was designed to deliver drug in a controlled manner up to 16 h. The developed formulation was optimized for type and level of pore former and coating weight gain. The optimized formulation was found to exhibit zero order kinetics independent of pH and agitation speed but depends on osmotic pressure of dissolution media indicated that mechanism of drug release was osmotic pressure. The in vivo performance prediction of developed formulation using convolution approach revealed that the developed formulation was superior to the existing marketed extended-release formulation in terms of attaining steady state plasma levels and indicated adequate exposure in translating hypoglycemic response. The prototype solubilization method combined with controlled porosity osmotic pump based technique could provide a unique way to increase dissolution rate and bioavailability of many poorly water-soluble, narrow therapeutic index drugs used in diabetes, cardiovascular diseases, etc.

  11. A Novel Multilayered Multidisk Oral Tablet for Chronotherapeutic Drug Delivery

    PubMed Central

    Khan, Zaheeda; Choonara, Yahya E.; du Toit, Lisa C.; Ndesendo, Valence M. K.; Pillay, Viness

    2013-01-01

    A Multilayered Multidisk Tablet (MLMDT) comprising two drug-loaded disks enveloped by three drug-free barrier layers was developed for use in chronotherapeutic disorders, employing two model drugs, theophylline and diltiazem HCl. The MLMDT was designed to achieve two pulses of drug release separated by a lag phase. The polymer disk comprised hydroxyethylcellulose (HEC) and ethylcellulose (EC) granulated using an aqueous dispersion of EC. The polymeric barrier layers constituted a combination of pectin/Avicel (PBL) (1st barrier layer) and hydroxypropylmethylcellulose (HPMC) (HBL1 and HBL2) as the 2nd and 3rd barrier layers, respectively. Sodium bicarbonate was incorporated into the diltiazem-containing formulation for delayed drug release. Erosion and swelling studies confirmed the manner in which the drug was released with theophylline formulations exhibiting a maximum swelling of 97% and diltiazem containing formulations with a maximum swelling of 119%. FTIR spectra displayed no interactions between drugs and polymers. Molecular mechanics simulations were undertaken to predict the possible orientation of the polymer morphologies most likely affecting the MLMDT performance. The MLMDT provided two pulses of drug release, separated by a lag phase, and additionally it displayed desirable friability, hardness, and uniformity of mass indicating a stable formulation that may be a desirable candidate for chronotherapeutic drug delivery. PMID:24024200

  12. Formulation and evaluation of bilayer tablet for bimodal release of venlafaxine hydrochloride.

    PubMed

    Momin, Munira M; Kane, Snehal; Abhang, Pooja

    2015-01-01

    The aim of the present research was to develop a bilayer tablet of venlafaxine hydrochloride for bimodal drug release. In the present investigation authors have tried to explore fenugreek mucilage (FNM) for bioadhesive sustained release layer. The attempt has been made to combine FNM with well studied bioadhesive polymers like hydroxy propyl methyl cellulose (HPMC), Carbopol, and Xanthan Gum. The formulations were evaluated for swelling Index, ex vivo bioadhesion, water uptake studies, in vitro drug release and dissolution kinetics was studied. Substantial bioadhesion force (2.4 ± 0.023 g) and tablet adhesion retention time (24 ± 2 h) was observed with FNM and HPMC combination at 80:20 ratio. The dissolution kinetics followed the Higuchi model (R (2) = 0.9913) via a non-Fickian diffusion controlled release mechanism after the initial burst. The 3(2) full factorial design was employed in the present study. The type of polymers used in combination with FNM (X1) and percent polymer replaced with FNM (X2) were taken as independent formulations variables. The selected responses, bioadhesion force (0.11-0.25 ± 0.023 g), amount of drug released in 10 h, Y10 (78.20-95.78 ± 1.24%) and bioadhesive strength, (19-24 ± 2 h) presented good correlation with the selected independent variables. Statistical analysis (ANOVA) of the optimized bilayer formulations showed no significant difference in the cumulative amount of drug release after 15 min, but significant difference (p < 0.05) in the amount of drug released after 1 hr till 12 h from optimized formulations was observed. The natural mucilage like FNM could be successfully incorporated into tablet with only 20% replacement with HPMC and it showed good bioadhesiveness and sustained drug release. PMID:26217229

  13. Formulation and evaluation of bilayer tablet for bimodal release of venlafaxine hydrochloride

    PubMed Central

    Momin, Munira M.; Kane, Snehal; Abhang, Pooja

    2015-01-01

    The aim of the present research was to develop a bilayer tablet of venlafaxine hydrochloride for bimodal drug release. In the present investigation authors have tried to explore fenugreek mucilage (FNM) for bioadhesive sustained release layer. The attempt has been made to combine FNM with well studied bioadhesive polymers like hydroxy propyl methyl cellulose (HPMC), Carbopol, and Xanthan Gum. The formulations were evaluated for swelling Index, ex vivo bioadhesion, water uptake studies, in vitro drug release and dissolution kinetics was studied. Substantial bioadhesion force (2.4 ± 0.023 g) and tablet adhesion retention time (24 ± 2 h) was observed with FNM and HPMC combination at 80:20 ratio. The dissolution kinetics followed the Higuchi model (R2 = 0.9913) via a non-Fickian diffusion controlled release mechanism after the initial burst. The 32 full factorial design was employed in the present study. The type of polymers used in combination with FNM (X1) and percent polymer replaced with FNM (X2) were taken as independent formulations variables. The selected responses, bioadhesion force (0.11–0.25 ± 0.023 g), amount of drug released in 10 h, Y10 (78.20–95.78 ± 1.24%) and bioadhesive strength, (19–24 ± 2 h) presented good correlation with the selected independent variables. Statistical analysis (ANOVA) of the optimized bilayer formulations showed no significant difference in the cumulative amount of drug release after 15 min, but significant difference (p < 0.05) in the amount of drug released after 1 hr till 12 h from optimized formulations was observed. The natural mucilage like FNM could be successfully incorporated into tablet with only 20% replacement with HPMC and it showed good bioadhesiveness and sustained drug release. PMID:26217229

  14. 21 CFR 520.1720a - Phenylbutazone tablets and boluses.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... Section 520.1720a Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES...-mg or 1-g tablets, or 2- or 4-g boluses, in dogs and horses. (2) Nos. 000010 and 059130 for use of 100- or 200-mg or 1-g tablets in dogs and horses. (3) Nos. 000856 and 061623 for use of 100-mg or...

  15. 21 CFR 520.1720a - Phenylbutazone tablets and boluses.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... Section 520.1720a Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES...-mg or 1-g tablets, or 2- or 4-g boluses, in dogs and horses. (2) Nos. 000010 and 059130 for use of 100- or 200-mg or 1-g tablets in dogs and horses. (3) Nos. 000856 and 061623 for use of 100-mg or...

  16. Tablet Computers on Trial: A Transformative Force in Education?

    ERIC Educational Resources Information Center

    Kjartansdóttir, Skúlína Hlíf; Jakobsdóttir, Sólveig

    2013-01-01

    In this paper we present the results of an evaluation study of a development project for the introduction and use of tablet computers (iPads) at the lower secondary level in Nordlinga school, a compulsory school in Reykjavík. In the study, we assess the impact of the use of tablet computers on instruction and students' learning in grades 9 to 10,…

  17. Formulation and Evaluation of Alstonia boonei Stem Bark Powder Tablets

    PubMed Central

    Chime, Salome A.; Ugwuoke, E. C.; Onyishi, I. V.; Brown, S. A.; Onunkwo, G. C.

    2013-01-01

    The aim of this work was to formulate Alstonia boonei dried stem bark powder into tablets by wet granulation method using acacia, gelatine and sodium carboxymethyl cellulose as binders at concentrations of 1, 2, 4 and 8% w/w. The phytochemistry of the stem bark of Alstonia boonei was evaluated. The micromeritic properties of the granules prepared were studied. The tablets were evaluated using the necessary official and unofficial tests. The results of the phytochemical analysis showed that alkaloids, tannins, steroids, saponins, glycosides, flavonoids and terpenoids were present while anthroquinones and acidcompounds were absent. Micromeritic studies showed that Alstonia boonei granules had good flowability. The formulated tablets complied with British Pharmacopoeial specification for weight uniformity, hardness (≥5 kgf) and tablet friability (<1%). For disintegration test, tablets formulated with gelatine and acacia at concentrations of 1, 2 and 4% w/w complied with Pharmacopoeial specification. However, tablets formulated with SCMC (1-8% w/w) and 8% w/w of acacia and gelatine failed the disintegration tests (Disintegration time more than 15 min). PMID:24019574

  18. Desktop 3D printing of controlled release pharmaceutical bilayer tablets.

    PubMed

    Khaled, Shaban A; Burley, Jonathan C; Alexander, Morgan R; Roberts, Clive J

    2014-01-30

    Three dimensional (3D) printing was used as a novel medicine formulation technique for production of viable tablets capable of satisfying regulatory tests and matching the release of standard commercial tablets. Hydroxypropyl methylcellulose (HPMC 2208) (Methocel™ K100M Premium) and poly(acrylic acid) (PAA) (Carbopol(®) 974P NF) were used as a hydrophilic matrix for a sustained release (SR) layer. Hypromellose(®) (HPMC 2910) was used as a binder while microcrystalline cellulose (MCC) (Pharmacel(®) 102) and sodium starch glycolate (SSG) (Primojel(®)) were used as disintegrants for an immediate release (IR) layer. Commercial guaifenesin bi-layer tablets (GBT) were used as a model drug (Mucinex(®)) for this study. There was a favourable comparison of release of the active guaifenesin from the printed hydrophilic matrix compared with the commercially available GBT. The printed formulations were also evaluated for physical and mechanical properties such as weight variation, friability, hardness and thickness as a comparison to the commercial tablet and were within acceptable range as defined by the international standards stated in the United States Pharmacopoeia (USP). All formulations (standard tablets and 3D printed tablets) showed Korsmeyer-Peppas n values between 0.27 and 0.44 which indicates Fickian diffusion drug release through a hydrated HPMC gel layer. PMID:24280018

  19. Crystal coating via spray drying to improve powder tabletability.

    PubMed

    Vanhoorne, V; Peeters, E; Van Snick, B; Remon, J P; Vervaet, C

    2014-11-01

    A continuous crystal coating method was developed to improve both flowability and tabletability of powders. The method includes the introduction of solid, dry particles into an atomized spray during spray drying in order to coat and agglomerate individual particles. Paracetamol was used as a model drug as it exhibits poor flowability and high capping tendency upon compaction. The particle size enlargement and flowability were evaluated by the mean median particle size and flow index of the resulting powders. The crystal coating coprocessing method was successful for the production of powders containing 75% paracetamol with excellent tableting properties. However, the extent of agglomeration achieved during coprocessing was limited. Tablets compressed on a rotary tablet press in manual mode showed excellent compression properties without capping tendency. A formulation with 75% paracetamol, 5% PVP and 20% amorphous lactose yielded a tensile strength of 1.9 MPa at a compression pressure of 288 MPa. The friability of tablets compressed at 188 MPa was only 0.6%. The excellent tabletability of this formulation was attributed to the coating of paracetamol crystals with amorphous lactose and PVP through coprocessing and the presence of brittle and plastic components in the formulation. The coprocessing method was also successfully applied for the production of directly compressible lactose showing improved tensile strength and friability in comparison to a spray dried direct compression lactose grade. PMID:25445306

  20. Crystal coating via spray drying to improve powder tabletability.

    PubMed

    Vanhoorne, V; Peeters, E; Van Snick, B; Remon, J P; Vervaet, C

    2014-11-01

    A continuous crystal coating method was developed to improve both flowability and tabletability of powders. The method includes the introduction of solid, dry particles into an atomized spray during spray drying in order to coat and agglomerate individual particles. Paracetamol was used as a model drug as it exhibits poor flowability and high capping tendency upon compaction. The particle size enlargement and flowability were evaluated by the mean median particle size and flow index of the resulting powders. The crystal coating coprocessing method was successful for the production of powders containing 75% paracetamol with excellent tableting properties. However, the extent of agglomeration achieved during coprocessing was limited. Tablets compressed on a rotary tablet press in manual mode showed excellent compression properties without capping tendency. A formulation with 75% paracetamol, 5% PVP and 20% amorphous lactose yielded a tensile strength of 1.9 MPa at a compression pressure of 288 MPa. The friability of tablets compressed at 188 MPa was only 0.6%. The excellent tabletability of this formulation was attributed to the coating of paracetamol crystals with amorphous lactose and PVP through coprocessing and the presence of brittle and plastic components in the formulation. The coprocessing method was also successfully applied for the production of directly compressible lactose showing improved tensile strength and friability in comparison to a spray dried direct compression lactose grade.

  1. Formulation and Characterization of Cetylpyridinium Chloride Bioadhesive Tablets

    PubMed Central

    Akbari, Jafar; Saeedi, Majid; Morteza-Semnani, Katayoun; Kelidari, Hamidreza; Lashkari, Maryam

    2014-01-01

    Purpose: Bioadhesive polymers play an important role in biomedical and drug delivery applications. The aim of this study is to develop a sustained- release tablet for local application of Cetylpyridinium Chloride (CPC). This delivery system would supply the drug at an effective level for a long period of time, and thereby overcome the problem of the short retention time of CPC and could be used for buccal delivery as a topical anti-infective agent. Methods: CPC bioadhesive tablets were directly prepared using 7 mm flat-faced punches on a hydraulic press. The materials for each tablet were weighted, introduced into the die and compacted at constant compression pressure. The dissolution tests were performed to the rotation paddle method and the bioadhesive strength of the tablets were measured. Results: The results showed that as the concentration of polymer increased, the drug release rate was decreased. Also the type and ratio of polymers altered the release kinetic of Cetylpyridinium Chloride from investigated tablets. The bioadhesion strength increased with increasing the concentration of polymer and maximum bioadhesion strength was observed with HPMC K100M. Conclusion: The selected formulation of CPC bioadhesive tablet can be used as a suitable preparation for continuous release of CPC with appropriate bioadhesion strength. PMID:25436196

  2. Desktop 3D printing of controlled release pharmaceutical bilayer tablets.

    PubMed

    Khaled, Shaban A; Burley, Jonathan C; Alexander, Morgan R; Roberts, Clive J

    2014-01-30

    Three dimensional (3D) printing was used as a novel medicine formulation technique for production of viable tablets capable of satisfying regulatory tests and matching the release of standard commercial tablets. Hydroxypropyl methylcellulose (HPMC 2208) (Methocel™ K100M Premium) and poly(acrylic acid) (PAA) (Carbopol(®) 974P NF) were used as a hydrophilic matrix for a sustained release (SR) layer. Hypromellose(®) (HPMC 2910) was used as a binder while microcrystalline cellulose (MCC) (Pharmacel(®) 102) and sodium starch glycolate (SSG) (Primojel(®)) were used as disintegrants for an immediate release (IR) layer. Commercial guaifenesin bi-layer tablets (GBT) were used as a model drug (Mucinex(®)) for this study. There was a favourable comparison of release of the active guaifenesin from the printed hydrophilic matrix compared with the commercially available GBT. The printed formulations were also evaluated for physical and mechanical properties such as weight variation, friability, hardness and thickness as a comparison to the commercial tablet and were within acceptable range as defined by the international standards stated in the United States Pharmacopoeia (USP). All formulations (standard tablets and 3D printed tablets) showed Korsmeyer-Peppas n values between 0.27 and 0.44 which indicates Fickian diffusion drug release through a hydrated HPMC gel layer.

  3. Validation and applications of an expedited tablet friability method.

    PubMed

    Osei-Yeboah, Frederick; Sun, Changquan Calvin

    2015-04-30

    The harmonized monograph on tablet friability test in United States Pharmacopeia (USP), European Pharmacopeia (Pharm. Eur.), and Japanese Pharmacopeia (JP) is designed to assess adequacy of mechanical strength of a batch of tablets. Currently, its potential applications in formulation development have been limited due to the batch requirement that is both labor and material intensive. To this end, we have developed an expedited tablet friability test method, using the existing USP test apparatus. The validity of the expedited friability method is established by showing that the friability data from the expedited method is not statistically different from those from the standard pharmacopeia method using materials of very different mechanical properties, i.e., microcrystalline cellulose and dibasic calcium phosphate dihydrate. Using the expedited friability method, we have shown that the relationship between tablet friability and tablet mechanical strength follows a power law expression. Furthermore, potential applications of this expedited friability test in facilitating systematic and efficient tablet formulation and tooling design are demonstrated with examples.

  4. Release Kinetics of Papaverine Hydrochloride from Tablets with Different Excipients

    PubMed Central

    Kasperek, Regina; Polski, Andrzej; Zimmer, Łukasz; Poleszak, Ewa

    2014-01-01

    Abstract The influence of excipients on the disintegration times of tablets and the release of papaverine hydrochloride (PAP) from tablets were studied. Ten different formulations of tablets with PAP were prepared by direct powder compression. Different binders, disintegrants, fillers, and lubricants were used as excipients. The release of PAP was carried out in the paddle apparatus using 0.1 N HCl as a dissolution medium. The results of the disintegration times of tablets showed that six formulations can be classified as fast dissolving tablets (FDT). FDT formulations contained Avicel PH 101, Avicel PH 102, mannitol, (3-lactose, PVP K 10, gelatinized starch (CPharmGel), Prosolv Easy Tab, Prosolv SMCC 90, magnesium stearate, and the addition of disintegrants such as AcDiSol and Kollidon CL. Drug release kinetics were estimated by the zero- and first-order, Higuchi release rate, and Korsmeyer-Peppas models. Two formulations of the tablets containing PVP (K10) (10%), CPharmGel (10% and 25%), and Prosolv Easy Tab (44% and 60%) without the addition of a disintegrant were well-fitted to the kinetics models such as the Higuchi and zero-order, which are suitable for controlled- or sustained-release. PMID:25853076

  5. Evaluation of citrus fibers as a tablet excipient.

    PubMed

    Cespi, Marco; Bonacucina, Giulia; Roberts, Matthew; Hanson, Samuel; Jones, Stephen; Makevica, Elina; Casettari, Luca; Palmieri, Giovanni Filippo

    2014-04-01

    The consumption of fibers is associated with many health benefits, such as a reduction of cardiovascular and gastrointestinal diseases, control of body weight, and prevention of diabetes. Despite the widespread use of fiber supplements such as capsules or tablets, there is an almost complete lack of information concerning the technological properties of functional fibers used in nutraceutical formulations. The aim of this work was to characterize the technological properties of citrus fibers necessary for their use as a processing aid in tableting. The results obtained showed that citrus fibers share many properties of other polysaccharides used as tableting excipients, such as thermal behavior and compaction mechanism, together with an appreciable tabletability. However, the most interesting properties resulted from their disintegration power. Citrus fibers behaved in a similar manner to the well-known super disintegrant croscarmellose sodium and resulted to be little susceptible to their concentration, to lubricant type, and lubricant concentration. Thus, this work supports the idea of a potential use of citrus fibers as "active" substances and processing aid in the tableting of nutraceutical products and also as functional excipient in pharmaceutical tablets formulation.

  6. Evaluation of citrus fibers as a tablet excipient.

    PubMed

    Cespi, Marco; Bonacucina, Giulia; Roberts, Matthew; Hanson, Samuel; Jones, Stephen; Makevica, Elina; Casettari, Luca; Palmieri, Giovanni Filippo

    2014-04-01

    The consumption of fibers is associated with many health benefits, such as a reduction of cardiovascular and gastrointestinal diseases, control of body weight, and prevention of diabetes. Despite the widespread use of fiber supplements such as capsules or tablets, there is an almost complete lack of information concerning the technological properties of functional fibers used in nutraceutical formulations. The aim of this work was to characterize the technological properties of citrus fibers necessary for their use as a processing aid in tableting. The results obtained showed that citrus fibers share many properties of other polysaccharides used as tableting excipients, such as thermal behavior and compaction mechanism, together with an appreciable tabletability. However, the most interesting properties resulted from their disintegration power. Citrus fibers behaved in a similar manner to the well-known super disintegrant croscarmellose sodium and resulted to be little susceptible to their concentration, to lubricant type, and lubricant concentration. Thus, this work supports the idea of a potential use of citrus fibers as "active" substances and processing aid in the tableting of nutraceutical products and also as functional excipient in pharmaceutical tablets formulation. PMID:24306677

  7. Gastroretentive Matrix Tablets of Boswellia Oleogum Resin: Preparation, Optimization, In Vitro Evaluation, and Cytoprotective Effect on Indomethacin-Induced Gastric Ulcer in Rabbits.

    PubMed

    Yusif, Rehab Mohammad; Abu Hashim, Irhan Ibrahim; Mohamed, Elham Abdelmonem; Badria, Farid Abd-Elreheim

    2016-04-01

    Currently available anti-ulcer drugs suffer from serious side effects which limited their uses and prompted the need to search for a safe and efficient new anti-ulcer agent. Boswellia gum resin (BR) emerged as a safe, efficient, natural, and economic potential cytoprotective agent. Thus, it is of medical importance to develop gastroretentive (GR) formulations of BR to enhance its bioavailability and anti-ulcer efficacy. Early attempts involved the use of organic solvents and non-applicability to large-scale production. In this study, different tablet formulations were prepared by simple direct compression combining floating and bioadhesion mechanisms employing hydroxypropyl methylcellulose (HPMC), sodium carboxymethyl cellulose (SCMC), pectin (PC), and/or carbopol (CP) as bioadhesive polymers and sodium bicarbonate (SB) as a gas former. The prepared tablets were subjected for assessment of swelling, floating, bioadhesion, and drug release in 0.1 N HCl. The optimized GR formulation was examined for its protective effect on the gastric ulcer induced by indomethacin in albino rabbits compared with lactose tablets. The obtained results disclosed that swelling, floating, bioadhesion, and drug release of the GR tablets of BR depend mainly on the nature of the matrix and the ratio of polymer combinations. Moreover, a combination of SCMC-CP in a ratio of 2:1 (SCP21) exhibited desirable floating, bioadhesion, swelling, and extended drug release. Also, a 6-h pretreatment with SCP21 tablets decreased the severity of inflammation and number of bleeding spots among ulcer-induced rabbits in comparison to those treated with lactose tablets. PMID:26092303

  8. Acute ischaemia of the leg following accidental intra-arterial injection of dissolved flunitrazepam tablets.

    PubMed

    Leifert, J A; Bossaller, L; Uhl, M

    2008-11-01

    Accidental intra-arterial injection of drugs is a sporadic complication in i.v. drug addicts. A 22-year-old drug-abuser injected flunitrazepam tablets dissolved in tap water into her left femoral artery and presented with clinical signs of acute ischaemia of the left leg. Severe rhabdomyolysis developed within 5 hours after the injection. Selective arterial catheter angiography showed an acute occlusion of the posterior tibial artery. Combination therapy with i.a. urokinase, i.a. prostaglandines and i.v. anticoagulation resulted in re-opening of the obstructed distal artery and complete cessation of symptoms.

  9. Influence of binder type on interacting variables acting on mechanical properties of a sulfadimidine tablet formulation.

    PubMed

    Alebiowu, G; Ojeleye, O O

    2007-01-01

    A study of the quantitative effect of type of binder (N), applied pressure (P), and granular size (G) on two mechanical properties-tensile strength (TS) and brittle fracture index (BFI) - of a sulfadimidine tablet formulation has been carried out by using a 2(3) factorial experimental design. The results obtained from this work suggest that P exhibited the largest individual effect on TS and BFI. It is also seen from this work that the nature of binders in combination affects the influence that P and G had on the TS or BFI.

  10. Continuous manufacturing of tablets with PROMIS-line - Introduction and case studies from continuous feeding, blending and tableting.

    PubMed

    Simonaho, Simo-Pekka; Ketolainen, Jarkko; Ervasti, Tuomas; Toiviainen, Maunu; Korhonen, Ossi

    2016-07-30

    Drug manufacturing technology is in the midst of modernization and continuous manufacturing of drug products is especially the focus of great interest. The adoption of new manufacturing approaches requires extensive cooperation between industry, regulatory bodies, academics and equipment manufacturers. In this paper we introduce PROMIS-line which is a continuous tableting line built at the University of Eastern Finland, School of Pharmacy, PROMIS-centre. PROMIS-line is modular and tablets can be produced via dry granulation or direct compression. In three case studies, continuous feeding, blending and tablet performance is studied to illustrate some basic features of PROMIS-line. In conclusion, the PROMIS-line is an excellent tool for studying the fundamentals of continuous manufacturing of tablets. PMID:26879237

  11. Continuous manufacturing of tablets with PROMIS-line - Introduction and case studies from continuous feeding, blending and tableting.

    PubMed

    Simonaho, Simo-Pekka; Ketolainen, Jarkko; Ervasti, Tuomas; Toiviainen, Maunu; Korhonen, Ossi

    2016-07-30

    Drug manufacturing technology is in the midst of modernization and continuous manufacturing of drug products is especially the focus of great interest. The adoption of new manufacturing approaches requires extensive cooperation between industry, regulatory bodies, academics and equipment manufacturers. In this paper we introduce PROMIS-line which is a continuous tableting line built at the University of Eastern Finland, School of Pharmacy, PROMIS-centre. PROMIS-line is modular and tablets can be produced via dry granulation or direct compression. In three case studies, continuous feeding, blending and tablet performance is studied to illustrate some basic features of PROMIS-line. In conclusion, the PROMIS-line is an excellent tool for studying the fundamentals of continuous manufacturing of tablets.

  12. Terbutaline slow-release tablets in children with bronchial asthma. Effect and pharmacokinetics compared with plain terbutaline tablets.

    PubMed

    Wettrell, G; Anehus, S; Hattevig, G; Kjellman, B

    1986-08-01

    The effect of terbutaline sulphate in slow-release (SR) tablets (Bricanyl Depot), 5 mg twice daily, was compared with that of terbutaline sulphate in ordinary tablets (Bricanyl), 2.5 mg three times daily, in a double-blind, randomized, cross-over study during 2 consecutive weeks in 10 asthmatic children. Plasma concentrations and urinary excretion of terbutaline were measured at various times during both treatment periods. The SR tablets produced a higher mean plasma concentration in the morning and a smaller peak-trough variation over the day than the ordinary ones. No differences between the two treatments were observed concerning FEV1 (forced expiratory volume in 1 s). Tremor, measured with an opto-electronic tremorgraph, was about the same for two treatments and not significantly different from tremor seen in healthy children. The reported side effects were less frequent in the SR tablet period. PMID:3789327

  13. Comparison of high-pressure liquid chromatography and microbiological assay for determination of ciprofloxacin tablets in human plasma employed in bioequivalence and pharmacokinetics study.

    PubMed

    Khan, Muhammad Khalid; Khan, Muhammad Farid; Mustafa, Ghulam; Sualah, Mohammed

    2012-01-01

    Ciprofloxacin was given orally to 28 healthy male volunteers for single oral dose of 500mg; Plasma samples were collected at different time's interval between 0 and 12h and analyzed both by high pressure liquid chromatography and by a microbiological assay. The detection limits (LOD) were 0.02μg/ml and 0.1μg/ml, for both methods respectively. For each method, coefficients of variation (R(2)) were 0.9995 and 0.9918 in plasma and limit of quantitation (LOQ).02 and 0.5μg/ml. The Comparison of means maximum concentration 2.68 μg/ml at 1.5 hr for test and 2.43 μg/ml are attain in HPLC method of Reference at 2hrs respectively. The plasma concentrations measured by microbiological assay of reference tablet are 3.95μg/ml (mean ± SE) at 1 hour and 3.80μg/ml (mean ± SE) at 1 hour. The concentrations in plasma measured by microbiological method were markedly higher than the high-pressure liquid chromatography values which indicates the presence of antimicrobially active metabolites. The mean ± SE values of pharmacokinetic parameters calculated by HPLC method, for total area under the curve (AUC 0-oo) were 13.11, and 11.91 h.mg/l for both test and reference tablets respectively. The mean ± SE values of clearance measured in l/h were 44.91 and 48.42 respectively. The elimination rate constant Kel [l/h] showed 0.17 l/h for test and 0.15 l/h reference tablets and likewise, absorption half-life expressed in hours shown 0.67 h for test and 1.04 h for reference respectively. The Mean Residence Time for test is 5.48 h and 5.49 h for reference. The mean ± SE values of pharmacokinetic parameters (Microbiological assay) for total area under the curve (AUC 0-oo) were 22.11 and 19.33 h.mg/l for both test and reference tablets respectively. The mean ± SE values of clearance measured in l/h were 29.02 and 31.63 respectively. The elimination rate constant Kel [l/h] showed 0.21 l/h for test and 0.20 l/h reference tablets and likewise, absorption half-life expressed in hours shown

  14. Microspheres and tablet in capsule system: A novel chronotherapeutic system of ketorolac tromethamine for site and time specific delivery.

    PubMed

    Shahi, Priya; Kumari, Neeraj; Pathak, Kamla

    2015-01-01

    The objective of the present work was to develop a novel delivery system of ketorolac tromethamine (KT) for dual pulse release based on microspheres and tablet in capsule system (MATICS) as a treatment modality for rheumatoid arthritis. The design consisted of an impermeable hard gelatin capsule body, in which a core tablet was (second pulse) placed in the bottom and sealed with a hydrogel plug (HP2). The body was locked with enteric coated cap filled with KT microspheres (first pulse). The microspheres for first pulse were selected by screening the formulations (M1-M6), and M1 with least particle size of 96.38 ± 0.05 μm, highest drug loading of 25.10% ± 0.28% and maximum CDR of 89.32% ± 0.21% was adjudged as the best formulation. The HP2 tablet was selected based on its capability for maintaining a lag period of 6 h. The selection criterion of the second pulse (core tablet: T3) was its disintegration time of 4.02 ± 0.53 min and CDR of 99.10% ± 0.32% in 30 min. All the optimized formulations were assembled in accordance with the proposed design to form pulsatile MATICS and evaluated for in vitro release. MATICS displayed delayed sustained CDR of 80.15% in 8 h from the first pulse (microspheres) after a lag time of 2 h, followed by 97.05% KT release from second pulse (core tablet) in simulated colonic fluid within 10 h. Conclusively, in vitro pulsatile release was a rational combination of delayed sustained and immediate release of KT that has the potential to combat the pain at night and morning stiffness. Incorporation of two pulses in one system offers a reduction in dose frequency and better pain management.

  15. Development and Evaluation of a Novel Pellet-Based Tablet System for Potential Colon Delivery of Budesonide

    PubMed Central

    Varshosaz, Jaleh; Emami, Jaber; Tavakoli, Naser; Minaiyan, Mohsen; Rahmani, Nakisa; Dorkoosh, Farid

    2012-01-01

    Budesonide, a potent glucocorticoid, is used for the treatment of inflammatory bowel diseases. Current available oral formulations of budesonide have low efficacy against ulcerative colitis because of the premature drug release in the upper part of the gastrointestinal tract. In this paper a pH- and time-controlled colon-targeted pellet-based tablet of budesonide was established. Pellet cores were prepared by extrusion-spheronization method and further coated with xanthan gum (barrier layer), Eudragit NE30D and L30D55 combination (inner layer), and Eudragit FS30 (as enteric layer) sequentially to achieve the required release profile. The coated pellets then compressed into tablets using inert tabletting granules of Cellactose or Pearlitol. Release studies, performed in simulated gastric, intestinal, and colon pH were used in sequence to mimic the gastrointestinal transit. The influence of formulation variables like barrier layer thickness, inner layer composition, and enteric coat thickness on drug release were investigated and the coated pellets that contained 12% weight gain in xanthan gum layer, Eudragit L30D55 and Eudragit NE30D with a ratio of 3 : 7 in inner layer with 30% weight gain and 25% weight gain in Eudragit FS layer were found to protect the drug release in stomach and small intestine and 83.35 ± 2.4 of budesonide was released at 24 h. The drug release from the tablets prepared using 40% Cellactose 80 as tableting excipient was found to be closely similar to that of uncompressed pellets. PMID:22577558

  16. Microspheres and tablet in capsule system: A novel chronotherapeutic system of ketorolac tromethamine for site and time specific delivery

    PubMed Central

    Shahi, Priya; Kumari, Neeraj; Pathak, Kamla

    2015-01-01

    The objective of the present work was to develop a novel delivery system of ketorolac tromethamine (KT) for dual pulse release based on microspheres and tablet in capsule system (MATICS) as a treatment modality for rheumatoid arthritis. The design consisted of an impermeable hard gelatin capsule body, in which a core tablet was (second pulse) placed in the bottom and sealed with a hydrogel plug (HP2). The body was locked with enteric coated cap filled with KT microspheres (first pulse). The microspheres for first pulse were selected by screening the formulations (M1–M6), and M1 with least particle size of 96.38 ± 0.05 μm, highest drug loading of 25.10% ± 0.28% and maximum CDR of 89.32% ± 0.21% was adjudged as the best formulation. The HP2 tablet was selected based on its capability for maintaining a lag period of 6 h. The selection criterion of the second pulse (core tablet: T3) was its disintegration time of 4.02 ± 0.53 min and CDR of 99.10% ± 0.32% in 30 min. All the optimized formulations were assembled in accordance with the proposed design to form pulsatile MATICS and evaluated for in vitro release. MATICS displayed delayed sustained CDR of 80.15% in 8 h from the first pulse (microspheres) after a lag time of 2 h, followed by 97.05% KT release from second pulse (core tablet) in simulated colonic fluid within 10 h. Conclusively, in vitro pulsatile release was a rational combination of delayed sustained and immediate release of KT that has the potential to combat the pain at night and morning stiffness. Incorporation of two pulses in one system offers a reduction in dose frequency and better pain management. PMID:26258058

  17. Effect of filtration on morphine and particle content of injections prepared from slow-release oral morphine tablets

    PubMed Central

    2009-01-01

    Background Injections of mixtures prepared from crushed tablets contain insoluble particles which can cause embolisms and other complications. Although many particles can be removed by filtration, many injecting drug users do not filter due to availability, cost or performance of filters, and also due to concerns that some of the dose will be lost. Methods Injection solutions were prepared from slow-release morphine tablets (MS Contin®) replicating methods used by injecting drug users. Contaminating particles were counted by microscopy and morphine content analysed by liquid chromatography before and after filtration. Results Unfiltered tablet extracts contained tens of millions of particles with a range in sizes from < 5 μm to > 400 μm. Cigarette filters removed most of the larger particles (> 50 μm) but the smaller particles remained. Commercial syringe filters (0.45 and 0.22 μm) produced a dramatic reduction in particles but tended to block unless used after a cigarette filter. Morphine was retained by all filters but could be recovered by following the filtration with one or two 1 ml washes. The combined use of a cigarette filter then 0.22 μm filter, with rinses, enabled recovery of 90% of the extracted morphine in a solution which was essentially free of tablet-derived particles. Conclusions Apart from overdose and addiction itself, the harmful consequences of injecting morphine tablets come from the insoluble particles from the tablets and microbial contamination. These harmful components can be substantially reduced by passing the injection through a sterilizing (0.22 μm) filter. To prevent the filter from blocking, a preliminary coarse filter (such as a cigarette filter) should be used first. The filters retain some of the dose, but this can be recovered by following filtration with one or two rinses with 1 ml water. Although filtration can reduce the non-pharmacological harmful consequences of injecting tablets, this remains an unsafe practice due

  18. An investigation into the drug release from ibuprofen matrix tablets with ethylcellulose and some poly-acrylate polymers.

    PubMed

    Tabandeh, Hosseinali; Mortazavi, Seyed Alireza

    2014-05-01

    This study was performed to achieve sustained-release Ibuprofen matrix tablets with a zero-order release kinetic while most of the previous formulations have shown Higuchi release kinetic. Considering the results from previous studies, ethyl cellulose, Carbopol 934P, Carbopol 974P, and Pemulen TR-1 were used at different amounts for preparation of the tablets by direct compression. The release profiles were studied in a two-stage release test using non-linear regression analysis. Carbopols 934P and 974P could not sustain the release adequately while Pemulen TR-1 had too strong sustaining effect. Therefore, combination formulations were considered and studied. The release profiles of ethyl cellulose formulation and the combination formulation consisting Carbopol 934P and Pemulen TR-1 best fitted in Higuchi model, although the zero-order model was not completely rejected. However, the kinetic model of release from the combination formulation consisting Carbopol 974P and Pemulen TR-1 changed to zero-order indicating the most constant release rate among formulations. This was speculated to be due to some erosion of the gel, as well as some interaction of the hydrophobic chain of Pemulen TR-1 with Ibuprofen. Therefore, this formulation is suggested for directly compressed sustained-release matrix tablets of Ibuprofen with a more constant release rate. PMID:24811808

  19. Noncontact photo-acoustic defect detection in drug tablets.

    PubMed

    Varghese, Ivin; Cetinkaya, Cetin

    2007-08-01

    Quality assurance monitoring is of great importance in the pharmaceutical industry for the reason that if defects such as coating layer irregularities, internal cracks, and delamination are present in a drug tablet, the desired dose delivery and bioavailability can be compromised. The U.S. Food and Drug Administration (FDA) established the Process Analytical Technology (PAT) initiative, in order to ensure efficient quality monitoring at each stage of the manufacturing process by the integration of analysis systems into the evaluation procedure. Improving consistency and predictability of tablet action by improving quality and uniformity of tablet coatings as well as ensuring core integrity is required. An ideal technique for quality monitoring would be noninvasive, nondestructive, have a short measurement time, intrinsically safe, and relatively inexpensive. In the proposed acoustic system, a pulsed laser is utilized to generate noncontact mechanical excitations and interferometric detection of transient vibrations of the drug tablets is employed for sensing. Two novel methods to excite vibrational modes in drug tablets are developed and employed: (i) a vibration plate excited by a pulsed-laser and (ii) pulsed laser-induced plasma generated shockwave expansion. Damage in coat and/or core of a tablet weakens its mechanical stiffness and, consequently, affects its acoustic response to an external dynamic force field. From the analysis of frequency spectra and the time-frequency spectrograms obtained under both mechanisms, it can be concluded that defective tablets can be effectively differentiated from the defect-free ones and the proposed proof-of-concept techniques have potential to provide a technology platform to be used in the greater PAT effort.

  20. Validation of tablet-based evaluation of color fundus images

    PubMed Central

    Christopher, Mark; Moga, Daniela C.; Russell, Stephen R.; Folk, James C.; Scheetz, Todd; Abràmoff, Michael D.

    2012-01-01

    Purpose To compare diabetic retinopathy (DR) referral recommendations made by viewing fundus images using a tablet computer to recommendations made using a standard desktop display. Methods A tablet computer (iPad) and a desktop PC with a high-definition color display were compared. For each platform, two retinal specialists independently rated 1200 color fundus images from patients at risk for DR using an annotation program, Truthseeker. The specialists determined whether each image had referable DR, and also how urgently each patient should be referred for medical examination. Graders viewed and rated the randomly presented images independently and were masked to their ratings on the alternative platform. Tablet- and desktop display-based referral ratings were compared using cross-platform, intra-observer kappa as the primary outcome measure. Additionally, inter-observer kappa, sensitivity, specificity, and area under ROC (AUC) were determined. Results A high level of cross-platform, intra-observer agreement was found for the DR referral ratings between the platforms (κ=0.778), and for the two graders, (κ=0.812). Inter-observer agreement was similar for the two platforms (κ=0.544 and κ=0.625 for tablet and desktop, respectively). The tablet-based ratings achieved a sensitivity of 0.848, a specificity of 0.987, and an AUC of 0.950 compared to desktop display-based ratings. Conclusions In this pilot study, tablet-based rating of color fundus images for subjects at risk for DR was consistent with desktop display-based rating. These results indicate that tablet computers can be reliably used for clinical evaluation of fundus images for DR. PMID:22495326

  1. Evaluating Tablet Computers as a Survey Tool in Rural Communities

    PubMed Central

    Newell, Steve M.; Logan, Henrietta L.; Guo, Yi; Marks, John G.; Shepperd, James A.

    2015-01-01

    Purpose Although tablet computers offer advantages in data collection over traditional paper-and-pencil methods, little research has examined whether the 2 formats yield similar responses, especially with underserved populations. We compared the 2 survey formats and tested whether participants’ responses to common health questionnaires or perceptions of usability differed by survey format. We also tested whether we could replicate established paper-and-pencil findings via tablet computer. Methods We recruited a sample of low-income community members living in the rural southern United States. Participants were 170 residents (black = 49%; white = 36%; other races and missing data = 15%) drawn from 2 counties meeting Florida’s state statutory definition of rural with 100 persons or fewer per square mile. We randomly assigned participants to complete scales (Center for Epidemiologic Studies Depression Inventory and Regulatory Focus Questionnaire) along with survey format usability ratings via paper-and-pencil or tablet computer. All participants rated a series of previously validated posters using a tablet computer. Finally, participants completed comparisons of the survey formats and reported survey format preferences. Findings Participants preferred using the tablet computer and showed no significant differences between formats in mean responses, scale reliabilities, or in participants’ usability ratings. Conclusions Overall, participants reported similar scales responses and usability ratings between formats. However, participants reported both preferring and enjoying responding via tablet computer more. Collectively, these findings are among the first data to show that tablet computers represent a suitable substitute among an underrepresented rural sample for paper-and-pencil methodology in survey research. PMID:25243953

  2. simuwatt - A Tablet Based Electronic Auditing Tool

    SciTech Connect

    Macumber, Daniel; Parker, Andrew; Lisell, Lars; Metzger, Ian; Brown, Matthew

    2014-05-08

    'simuwatt Energy Auditor' (TM) is a new tablet-based electronic auditing tool that is designed to dramatically reduce the time and cost to perform investment-grade audits and improve quality and consistency. The tool uses the U.S. Department of Energy's OpenStudio modeling platform and integrated Building Component Library to automate modeling and analysis. simuwatt's software-guided workflow helps users gather required data, and provides the data in a standard electronic format that is automatically converted to a baseline OpenStudio model for energy analysis. The baseline energy model is calibrated against actual monthly energy use to ASHRAE Standard 14 guidelines. Energy conservation measures from the Building Component Library are then evaluated using OpenStudio's parametric analysis capability. Automated reporting creates audit documents that describe recommended packages of energy conservation measures. The development of this tool was partially funded by the U.S. Department of Defense's Environmental Security Technology Certification Program. As part of this program, the tool is being tested at 13 buildings on 5 Department of Defense sites across the United States. Results of the first simuwatt audit tool demonstration are presented in this paper.

  3. 78 FR 1247 - Certain Electronic Devices, Including Wireless Communication Devices, Tablet Computers, Media...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-01-08

    ... COMMISSION Certain Electronic Devices, Including Wireless Communication Devices, Tablet Computers, Media... United States after importation of certain electronic devices, including wireless communication devices... importation of certain electronic devices, including wireless communication devices, tablet computers,...

  4. 77 FR 27078 - Certain Electronic Devices, Including Mobile Phones and Tablet Computers, and Components Thereof...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-05-08

    ... COMMISSION Certain Electronic Devices, Including Mobile Phones and Tablet Computers, and Components Thereof... Trade Commission has received a complaint entitled Certain Electronic Devices, Including Mobile Phones... electronic devices, including mobile phones and tablet computers, and components thereof. The complaint...

  5. The Determination of Calcium in Dietary Supplement Tablets by Ion-Exchange.

    ERIC Educational Resources Information Center

    Dietz, Mark L.

    1986-01-01

    An experimental simple ion-exchange experiment in which the amount of calcium present in dietary supplement tablets has been developed is described and some typical student results for several brands of tablets are presented. (JN)

  6. Enabling the Tablet Product Development of 5-Fluorocytosine by Conjugate Acid Base Cocrystals.

    PubMed

    Perumalla, Sathyanarayana R; Paul, Shubhajit; Sun, Changquan C

    2016-06-01

    5-Fluorocytosine (FC) is a high-dose antifungal drug that challenges the development of a tablet product due to poor solid-state stability and tabletability. Using 2 pharmaceutically acceptable conjugate acid base (CAB) cocrystals of FC with HCl and acesulfame, we have developed commercially viable high loading FC tablets. The tablets were prepared by direct compression using nano-coated microcrystalline cellulose Avicel PH105 as a tablet binder, which provided both excellent tabletability and good flowability. Commercial manufacturability of formulations based on both CAB cocrystals was verified on a compaction simulator. The results from an expedited friability study were used to set the compaction force, which yielded tablets with sufficient mechanical strength and rapid tablet disintegration. This work demonstrates the potential value of CAB cocrystals in drug product development. PMID:27238493

  7. Fast disintegrating tablets: Opportunity in drug delivery system

    PubMed Central

    Parkash, Ved; Maan, Saurabh; Deepika; Yadav, Shiv Kumar; Hemlata; Jogpal, Vikas

    2011-01-01

    Fast disintegrating tablets (FDTs) have received ever-increasing demand during the last decade, and the field has become a rapidly growing area in the pharmaceutical industry. Oral drug delivery remains the preferred route for administration of various drugs. Recent developments in the technology have prompted scientists to develop FDTs with improved patient compliance and convenience. Upon introduction into the mouth, these tablets dissolve or disintegrate in the mouth in the absence of additional water for easy administration of active pharmaceutical ingredients. The popularity and usefulness of the formulation resulted in development of several FDT technologies. FDTs are solid unit dosage forms, which disintegrate or dissolve rapidly in the mouth without chewing and water. FDTs or orally disintegrating tablets provide an advantage particularly for pediatric and geriatric populations who have difficulty in swallowing conventional tablets and capsules. This review describes various formulations and technologies developed to achieve fast dissolution/dispersion of tablets in the oral cavity. In particular, this review describes in detail FDT technologies based on lyophilization, molding, sublimation, and compaction, as well as approaches to enhancing the FDT properties, such as spray drying and use of disintegrants. In addition, taste-masking technologies, experimental measurements of disintegration times, and dissolution are also discussed. PMID:22247889

  8. Frictional work in double-sided tablet compression.

    PubMed

    Muñoz-Ruiz, A; Wihervaara, M; Hakkinen, M; Juslin, M; Paronen, P

    1997-04-01

    The aim of this study was to evaluate the friction during double-sided tablet compression. Dicalcium phosphate dihydrate and lactose were tabletted with a compaction simulator with symmetrical and asymmetrical double-sided sawtooth punch displacement profiles. The estimation of force transmission in a powder column was based on an exponential equation, including the material parameter consisting of both the friction coefficient and Poisson's ratio. This parameter was predetermined from a single-sided compression. A novel equation was derived from a previously presented equation for friction work in single-sided tablet compression. The basic assumption was drawn from the linearly decreasing movement of infinitely thin particle layers, which are produced as the compressing punch surface approaches the other punch. This calculation was also based on the assumption that the equilibrium point, where the particles do not move, is halfway between the punches in the symmetrical profile and at a distance proportional to the amplitudes of the asymmetrical upper and lower sawtooth profiles. The tensile strength of tablets compressed with single-double-sided profiles was identical, and thus the behavior of the materials studied under compression was independent of the compression profiles. The friction work values that were calculated with the proposed expression for double-sided profiles were close to the theoretical values, as estimated by calculations based on compressions with single-sided profiles. In conclusion, the novel mathematical expression opens new possibilities for the evaluation of friction in double-sided compression; for example, in rotary press tabletting. PMID:9109053

  9. In vivo bioavailability studies of sumatriptan succinate buccal tablets

    PubMed Central

    Shivanand, K; Raju, SA; Nizamuddin, S; Jayakar, B

    2011-01-01

    Back ground and the purpose of study Sumatriptan succinate is a Serotonin 5- HT1 receptor agonist, used in treatment of migraine. It is absorbed rapidly but incompletely when given orally and undergoes first-pass metabolism, resulting in a low absolute bioavailability of about 15%. The aim of this work was to design mucoadhesive bilayered buccal tablets of sumatriptan succinate to improve its bioavailability. Methods Mucoadhesive polymers carbopol 934 (Carbopol), HPMC K4M, HPMC K15M along with ethyl cellulose as an impermeable backing layer were used for the preparation of mucoadhesive bilayered tablets. In vivo bioavailability studies was also conducted in rabbits for optimized formulation using oral solution of sumatriptan succinate as standard. Results Bilayered buccal tablets (BBT) containing the mixture of Carbopol and HPMC K4M in the ratio 1:1 (T1) had the maximum percentage of in vitro drug release within 6 hrs. The optimized formulation (T1) followed non-Fickian release mechanism. The percentage relative bioavailability of sumatriptan succinate from selected bilayered buccal tablets (T1) was found to be 140.78%. Conclusions Bilayered buccal tablets of sumatriptan succinate was successfully prepared with improved bioavailability. PMID:22615661

  10. Formulation and evaluation of mouth dissolving tablets of the Etoricoxib.

    PubMed

    Chandira, R Margret; Venkataeswarlu, B S; Kumudhavalli, M V; Debjitbhowmik; Jayakar, B

    2010-04-01

    The demand for mouth dissolving tablets has been growing during the last decade especially for elderly and children who have swallowing difficulties. Etoricoxib is a new non-steroidal anti-inflammatory drug (NSAID) with selective cox-2 inhibitory activity, selective inhibition of cox-2 provides anti-inflammatory and analgesic activity it is commonly used for osteo-arthritis, rheumatoid arthritis, primary dysmenorrhoea, post operative dental pain and acute gout. The main criteria for mouth dissolving tablets are to disintegrate or dissolve rapidly in oral cavity with saliva in 15 sec to 60 sec with need of water. The disintegrants used should fulfill the criteria by disintegrating the tablets in specified time limit.in the present investigation variety of super disintegrants like primogel, kollidone, Ac-Di-sol, L-HPMC, L-HPC, were selected and tablets were prepared by direct compression method in different concentration like 4% and 8%. The prepared tablets were evaluated for weight variation, hardness, friability, in vitro disintegration time, wetting time, in vitro dissolution study, etc. formulation f-9 shows the lowest disintegration time (44 sec) and wetting time (52 sec). In vitro dissolution studies revealed that formulation F-9 containing 8% L-HPC showed 97% drug release at the end of 20 min. PMID:20363696

  11. Key Formulation Variables in Tableting of Coated Pellets

    PubMed Central

    Murthy Dwibhashyam, V. S. N.; Ratna, J. Vijaya

    2008-01-01

    Multiple unit controlled release dosage forms offer various advantages over their single unit counterparts. Most of these advantages are associated with the uniform distribution of multiparticulates throughout the gastrointestinal tract. Though coated pellets can be filled into hard gelatin capsules, tablet formulation is the preferred one because of various advantages associated with it. However, compression of coated pellets is a challenging task necessitating the optimization of various formulation and process variables. The key formulation variables include composition, porosity, size, shape and density of the pellets; type and amount of polymer coating; nature, size and amount of tableting excipients. The pellet core should be strong with some degree of plasticity. It should be highly porous, small, with an irregular shape. The critical density to achieve prolonged release was reported to lie between 2.4 and 2.8 g/cm3. Acrylic polymer films are more flexible and more suitable for the coating of pellets to be compressed into tablets. Thicker coatings offer better resistance to frictional forces. Solvent based coatings are more flexible and have a higher degree of mechanical stability than the aqueous based ones. The tableting excipients should have cushioning property. They should not be significantly different in size and density from those of the pellet cores in order to avoid segregation. Addition of 30%-60% of tableting excipients is necessary to avoid any damage to the polymer coat and to retain its functional property. PMID:21394249

  12. A validated high performance liquid chromatographic method for estimation of bromhexine and terbutaline in bulk and tablet dosage forms

    PubMed Central

    Kumar, Amit; Nanda, Sanju

    2011-01-01

    Introduction: Bromhexine (BH) is a mucolytic agent used in the treatment of respiratory disorders marketed in combination with terbutaline (TB), a β2-adrenergic receptor agonist used as a fast-acting bronchodilator. Materials and Methods: BH and TB were estimated at 270 nm by using ODS C8 column (length 250 mm and internal diameter 4.6 mm) as a stationary phase and a premix of phosphate buffer (0.05 M, pH 3): Acetonitrile (70:30 v/v) as a mobile phase. The total run time of this method was less than 20 min and the retention time for BH was found to be at 15.50 min while that of TB was 9.85 min at a flow rate of 1.0 ml/min, respectively. Results: Percentage label claim of tablet formulation using this method was found to be 99.35% for BH and 99.70% for TB, respectively. The standard deviation was found to be 0.225–0.351 for BH and 0.0.236–0.264 for TB for two different batches of tablet formulation. Conclusion: The results of analysis of two drugs from their tablet formulation using a developed method were found close to 100%. The low values of standard deviation indicate accuracy and reproducibility of the method. Thus developed methods can be used for the routine analysis of two drugs from a combined dosage form. PMID:23781460

  13. Usefulness and preference for tablet personal computers by medical students: are the features worth the money?

    PubMed

    Wiese, Dawn; Atreja, Ashish; Mehta, Neil

    2008-11-06

    Tablet Personal Computers (PCs) have a huge potential in medical education due to their interactive human- computer interface and the need for anatomical diagrams, annotations, biochemistry flow charts etc. We conducted an online survey of medical students to determine their pattern of usage of the tablet features. The results revealed that the majority of medical students use the tablet features infrequently and most do not place a high value on the tablet features.

  14. Successful Thrombolysis and Spasmolysis of Acute Leg Ischemia after Accidental Intra-arterial Injection of Dissolved Flunitrazepam Tablets

    SciTech Connect

    Radeleff, B. Stampfl, U.; Sommer, C.-M.; Bellemann, N.; Hyhlik-Duerr, A.; Weber, M.-A.; Boeckler, D.; Kauczor, H.-U.

    2011-10-15

    A 37-year-old man with known intravenous drug abuse presented in the surgical ambulatory care unit with acute leg ischemia after accidental intra-arterial injection of dissolved flunitrazepam tablets into the right femoral artery. A combination of anticoagulation, vasodilatation, and local selective and superselective thrombolysis with urokinase was performed to salvage the leg. As a result of the severe ischemia-induced pain, the patient had to be monitored over the complete therapy period on the intensive care unit with permanent administration of intravenous fluid and analgetics. We describe the presenting symptoms and the interventional technique, and we discuss the recent literature regarding the management of accidental intra-arterial injection of dissolved flunitrazepam tablets.

  15. In-line monitoring of the drug content of powder mixtures and tablets by near-infrared spectroscopy during the continuous direct compression tableting process.

    PubMed

    Järvinen, Kristiina; Hoehe, Wolfgang; Järvinen, Maiju; Poutiainen, Sami; Juuti, Mikko; Borchert, Sven

    2013-03-12

    Continuous manufacturing methods offer economic and quality advantages when compared with batch manufacturing methods. In continuous manufacturing, one requires real time assurance of quality of product via the implementation of PAT tools. This study focuses on an in-line near-infrared (NIR) spectroscopic method for determining the drug content of powder mixtures and tablets during a continuous tableting process. Tablets consisting of acetaminophen (20-30%), lactose (69.07-78.93%) and magnesium stearate (0.93-1.07%) were prepared in a continuous direct compression line that consisted of two loss-in-weight feeders, one for acetaminophen and one for premixed lactose and magnesium stearate, and a continuous mixer followed by a rotary tablet press. NIR spectroscopy was applied to the continuous mixer and tablet press to perform a 100% product check at full tableting speed. The UV-spectrophotometric method was used as an off-line reference method to determine the acetaminophen content in the samples. The powder mixture and tablet samples were taken during the process for the calibration of continuous mixer and tablet press, respectively. For the continuous mixer, model creation with the PLS method yielded R-Square and RMSEC (root mean square error of calibration) values of 0.975% and 0.56%, respectively. For the tablet press, the corresponding R-Square and RMSEC values were 0.943% and 0.75%, respectively. A test run demonstrated good predictability in the estimation of the API content in the powder mixtures and tablets during the continuous tableting process. For the continuous mixer and tablet press, the RMSEP (root mean square error of prediction) values were 0.96% and 1.37%, respectively. This study demonstrates that an NIR instrument capable of fast spectra acquisition can be a valuable tool for the in-line monitoring of the continuous mixing and tableting processes. PMID:23313622

  16. 78 FR 40171 - Certain Wireless Devices, Including Mobile Phones and Tablets; Notice Of Receipt of Complaint...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-07-03

    ... COMMISSION Certain Wireless Devices, Including Mobile Phones and Tablets; Notice Of Receipt of Complaint... complaint entitled Certain Wireless Devices, Including Mobile Phones and Tablets, DN 2964; the Commission is... importation of certain wireless devices, including mobile phones and tablets. The complaint names...

  17. 77 FR 24514 - Certain Consumer Electronics, Including Mobile Phones and Tablets; Institution of Investigation...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-04-24

    ... COMMISSION Certain Consumer Electronics, Including Mobile Phones and Tablets; Institution of Investigation... consumer electronics, including mobile phones and tablets, by reason of infringement of certain claims of U... mobile phones and tablets, that infringe one or more of claims 13, 15, and 16 of the `893 patent;...

  18. 76 FR 19997 - Determination That FENTORA (Fentanyl Citrate) Buccal Tablet, 300 Micrograms, Was Not Withdrawn...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-04-11

    ... HUMAN SERVICES Food and Drug Administration Determination That FENTORA (Fentanyl Citrate) Buccal Tablet... determined that FENTORA (fentanyl citrate) buccal tablet, 300 micrograms (mcg), was not withdrawn from sale... drug applications (ANDAs) for fentanyl citrate buccal tablet, 300 mcg, if all other legal...

  19. A Tablet Computer for Young Children? Exploring Its Viability for Early Childhood Education

    ERIC Educational Resources Information Center

    Couse, Leslie J.; Chen, Dora W.

    2010-01-01

    This study explored the viability of tablet computers in early education by investigating preschool children's ease in acclimating to tablet technology and its defectiveness in engaging them to draw. A total of 41 three- to six-year-old children were videotaped while they used the tablets. The study found significant differences in level of tablet…

  20. An investigation into the kinetic (sliding) friction of some tablets and capsules.

    PubMed

    Hancock, Bruno C; Mojica, Nestor; St John-Green, Kimberley; Elliott, James A; Bharadwaj, Rahul

    2010-01-15

    The kinetic (or sliding) friction of pharmaceutical tablets and capsules influences how they will behave during the conveying, coating, and packaging operations that are used for drug product manufacturing. In order to logically design equipment for manufacturing and packaging operations, and to simulate manufacturing and packaging performance (for example, using discrete or finite element modeling approaches), it is necessary to quantify the magnitude of the kinetic friction. In this work, the coefficient of kinetic friction of a range of pharmaceutical tablets and capsules has been measured for the first time using a pin-on-disk tribometer. Binary tablet-tablet contacts and the contacts between tablets or capsules and common equipment surfaces were studied. The range of the friction coefficients was large (between 0.00 and 0.74), and the values depended strongly on the identity of both contacting materials. Tablet-tablet contacts generally exhibited lower friction coefficients than tablet-polymer or tablet-metal contacts. Polymeric surfaces were generally less frictional than metal surfaces, even those that were highly polished. Tablet coatings appeared to have a marked effect on the kinetic friction coefficient between tablets and equipment surfaces, with the hardest coatings tending to be the least frictional. The surface roughness of the tablets and contacting surfaces did not contribute to the coefficient of kinetic friction in a consistent manner. The implications of the results for the design of conveying, processing and packaging operations are discussed.

  1. Student Perceptions of Using Tablet Technology in Post-Secondary Classes

    ERIC Educational Resources Information Center

    Mang, Colin F.; Wardley, Leslie J.

    2013-01-01

    This paper assesses students' attitudes towards using tablets, such as the Apple iPad, in university classes. Tablets are found to be a substitute for laptop computers. Students initially expressed a great deal of optimism regarding the technology, and, although their views diminished slightly as they gained experience with using a tablet,…

  2. Tablet Computer Literacy Levels of the Physical Education and Sports Department Students

    ERIC Educational Resources Information Center

    Hergüner, Gülten

    2016-01-01

    Education systems are being affected in parallel by newly emerging hardware and new developments occurring in technology daily. Tablet usage especially is becoming ubiquitous in the teaching-learning processes in recent years. Therefore, using the tablets effectively, managing them and having a high level of tablet literacy play an important role…

  3. Learner-Centred Mathematics and Statistics Education Using Netbook Tablet PCs

    ERIC Educational Resources Information Center

    Loch, Birgit; Galligan, Linda; Hobohm, Carola; McDonald, Christine

    2011-01-01

    Tablet technology has been shown to support learner-centred mathematics education when this technology is available to both the lecturer and the students. However, cost is often the barrier to students' use of tablet PCs for their university studies. This article argues that more affordable netbook PCs with tablet capabilities can be viable…

  4. 21 CFR 520.88a - Amoxicillin trihydrate film-coated tablets.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 6 2010-04-01 2010-04-01 false Amoxicillin trihydrate film-coated tablets. 520.88a Section 520.88a Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN... Amoxicillin trihydrate film-coated tablets. (a) Specifications. Each tablet contains amoxicillin...

  5. Development of Corn Starch-Neusilin UFL2 Conjugate as Tablet Superdisintegrant: Formulation and Evaluation of Fast Disintegrating Tablets.

    PubMed

    Juneja, Prateek; Kaur, Birender; Odeku, Oluwatoyin A; Singh, Inderbir

    2014-01-01

    In the present study, corn Starch-Neusilin UFL2 conjugates were prepared by physical, chemical, and microwave methods with the aim of using the conjugates as tablet superdisintegrant. Various powder tests, namely, angle of repose, bulk density, tapped density, Hausner's ratio, Carr's index, swelling index, and powder porosity were conducted on the samples. The conjugates were characterized by ATR-FTIR, XRD, DSC, and SEM techniques. Heckel and Kawakita models were applied to carry out compression studies for the prepared conjugates. Fast disintegrating tablets of domperidone were prepared using corn starch and corn Starch-Neusilin UFL2 conjugates as tablet superdisintegrants in different concentrations. Conjugates were found to possess good powder flow and tabletting properties. Heckel analysis indicated that the conjugates prepared by microwave method showed the slowest onset of plastic deformation while Kawakita analysis indicated that the conjugates prepared by microwave method exhibited the highest amount of total plastic deformation. The study revealed that the corn Starch-Neusilin UFL2 conjugates possess improved powder flow properties and could be a promising superdisintegrant for preparing fast disintegrating tablet. Also, the results sugessted that the microwave method was found to be most effective for the preparation of corn Starch-Neusilin UFL2 conjugates.

  6. Development of Corn Starch-Neusilin UFL2 Conjugate as Tablet Superdisintegrant: Formulation and Evaluation of Fast Disintegrating Tablets

    PubMed Central

    Juneja, Prateek; Kaur, Birender; Odeku, Oluwatoyin A.; Singh, Inderbir

    2014-01-01

    In the present study, corn Starch-Neusilin UFL2 conjugates were prepared by physical, chemical, and microwave methods with the aim of using the conjugates as tablet superdisintegrant. Various powder tests, namely, angle of repose, bulk density, tapped density, Hausner's ratio, Carr's index, swelling index, and powder porosity were conducted on the samples. The conjugates were characterized by ATR-FTIR, XRD, DSC, and SEM techniques. Heckel and Kawakita models were applied to carry out compression studies for the prepared conjugates. Fast disintegrating tablets of domperidone were prepared using corn starch and corn Starch-Neusilin UFL2 conjugates as tablet superdisintegrants in different concentrations. Conjugates were found to possess good powder flow and tabletting properties. Heckel analysis indicated that the conjugates prepared by microwave method showed the slowest onset of plastic deformation while Kawakita analysis indicated that the conjugates prepared by microwave method exhibited the highest amount of total plastic deformation. The study revealed that the corn Starch-Neusilin UFL2 conjugates possess improved powder flow properties and could be a promising superdisintegrant for preparing fast disintegrating tablet. Also, the results sugessted that the microwave method was found to be most effective for the preparation of corn Starch-Neusilin UFL2 conjugates. PMID:25328710

  7. The application of solid dispersion technique in the preparation of therapeutic tablets. Part 1: Paracetamol, amylobarbitone, and caffeine tablets.

    PubMed

    El-Banna, H M; Eshra, A G; Hammouda, Y

    1977-01-01

    A trial was made to study the possibility of preparing high-quality therapeutic tablets by direct compression of the solidified drugcarrier melt via solid dispersion technique. Paracetamol-mannitol, amylobarbitone-urea and caffeine-nicotinamide systems were investigated. Phase diagrams of the first two systems were found to be of the simple eutectic type, while that of the third system was a peritectic type. Solubility studies were also carried out. Dissolution rate studies showed that the fused mannitol/paracetamol (80:20), urea/amylobarbitone (80:20) and nicotinamide/caffeine (50:50 and 70:30) solid dispersions exhibited better rates of dissolution than those of the pure drugs. Comparative studies were carried on with tablets prepared by direct compression of the drug-carrier solidified melt exhibiting the highest dissolution rate and by slugging the pure drug and the drug-carrier physical mixture of corresponding composition. The physical properties and dissolution rate data showed the superiority of the tablets prepared by the solid dispersion technique. The drug release from these tablets was 4.5, 7.6 and 3.7 times greater than that from tablets prepared from pure paracetamol, amylobarbitone and caffeine respectively. PMID:145597

  8. Tablet potency of Tianeptine in coated tablets by near infrared spectroscopy: model optimisation, calibration transfer and confidence intervals.

    PubMed

    Boiret, Mathieu; Meunier, Loïc; Ginot, Yves-Michel

    2011-02-20

    A near infrared (NIR) method was developed for determination of tablet potency of active pharmaceutical ingredient (API) in a complex coated tablet matrix. The calibration set contained samples from laboratory and production scale batches. The reference values were obtained by high performance liquid chromatography (HPLC) and partial least squares (PLS) regression was used to establish a model. The model was challenged by calculating tablet potency of two external test sets. Root mean square errors of prediction were respectively equal to 2.0% and 2.7%. To use this model with a second spectrometer from the production field, a calibration transfer method called piecewise direct standardisation (PDS) was used. After the transfer, the root mean square error of prediction of the first test set was 2.4% compared to 4.0% without transferring the spectra. A statistical technique using bootstrap of PLS residuals was used to estimate confidence intervals of tablet potency calculations. This method requires an optimised PLS model, selection of the bootstrap number and determination of the risk. In the case of a chemical analysis, the tablet potency value will be included within the confidence interval calculated by the bootstrap method. An easy to use graphical interface was developed to easily determine if the predictions, surrounded by minimum and maximum values, are within the specifications defined by the regulatory organisation.

  9. Gamma scintigraphic study of the hydrodynamically balanced matrix tablets of Metformin HCl in rabbits

    PubMed Central

    Razavi, Mahboubeh; Karimian, Hamed; Yeong, Chai Hong; Sarji, Sazilah Ahmad; Chung, Lip Yong; Nyamathulla, Shaik; Noordin, Mohamed Ibrahim

    2015-01-01

    The purpose of this study is to evaluate the in vitro and in vivo performance of gastro-retentive matrix tablets having Metformin HCl as model drug and combination of natural polymers. A total of 16 formulations were prepared by a wet granulation method using xanthan, tamarind seed powder, tamarind kernel powder and salep as the gel-forming agents and sodium bicarbonate as a gas-forming agent. All the formulations were evaluated for compendial and non-compendial tests and in vitro study was carried out on a USP-II dissolution apparatus at a paddle speed of 50 rpm. MOX2 formulation, composed of salep and xanthan in the ratio of 4:1 with 96.9% release, was considered as the optimum formulation with more than 90% release in 12 hours and short floating lag time. In vivo study was carried out using gamma scintigraphy in New Zealand White rabbits, optimized formulation was incorporated with 10 mg of 153Sm for labeling MOX2 formulation. The radioactive samarium oxide was used as the marker to trace transit of the tablets in the gastrointestinal tract. The in vivo data also supported retention of MOX2 formulation in the gastric region for 12 hours and were different from the control formulation without a gas and gel forming agent. It was concluded that the prepared floating gastro-retentive matrix tablets had a sustained-release effect in vitro and in vivo, gamma scintigraphy played an important role in locating the oral transit and the drug-release pattern. PMID:26124637

  10. Ubiquitous Presenter: A Tablet PC-based System to Support Instructors and Students

    NASA Astrophysics Data System (ADS)

    Price, Edward; Simon, Beth

    2009-12-01

    Digital lecturing systems (computer and projector, often with PowerPoint) offer physics instructors the ability to incorporate graphics and the power to share and reuse materials. But these systems do a poor job of supporting interaction in the classroom. For instance, with digital presentation systems, instructors have limited ability to spontaneously respond to student questions. This limitation is especially acute during classroom activities such as problem solving, Peer Instruction, and Interactive Lecture Demonstrations (ILDs).2 A Tablet PC, a laptop computer with a stylus that can be used to "write" on the screen, provides a way for instructors to add digital ink spontaneously to a presentation in progress. The Tablet PC can be a powerful tool for teaching,3,4 especially when combined with software systems specifically designed to leverage digital ink for pedagogical uses. Ubiquitous Presenter (UP) is one such freely available system.5 Developed at the University of California, San Diego, and based on Classroom Presenter,6 UP allows the instructor to ink prepared digital material (such as exported PowerPoint slides) in real time in class. Ink is automatically archived stroke by stroke and can be reviewed through a web browser (by both students and instructors). The system also supports spontaneous in-class interaction through a web interface—students with web-enabled devices (Tablet PCs, regular laptops, PDAs, and cell phones) can make text-, ink-, or image-based submissions on the instructor's slides. The instructor can review and then project submitted slides to the class and add additional ink, so that material generated by students can be a focus for discussion. A brief video showing UP in action is at http://physics.csusm.edu/UP. In this article, we describe UP and give examples of how UP can support the physics classroom.

  11. Gamma scintigraphic study of the hydrodynamically balanced matrix tablets of Metformin HCl in rabbits.

    PubMed

    Razavi, Mahboubeh; Karimian, Hamed; Yeong, Chai Hong; Sarji, Sazilah Ahmad; Chung, Lip Yong; Nyamathulla, Shaik; Noordin, Mohamed Ibrahim

    2015-01-01

    The purpose of this study is to evaluate the in vitro and in vivo performance of gastro-retentive matrix tablets having Metformin HCl as model drug and combination of natural polymers. A total of 16 formulations were prepared by a wet granulation method using xanthan, tamarind seed powder, tamarind kernel powder and salep as the gel-forming agents and sodium bicarbonate as a gas-forming agent. All the formulations were evaluated for compendial and non-compendial tests and in vitro study was carried out on a USP-II dissolution apparatus at a paddle speed of 50 rpm. MOX2 formulation, composed of salep and xanthan in the ratio of 4:1 with 96.9% release, was considered as the optimum formulation with more than 90% release in 12 hours and short floating lag time. In vivo study was carried out using gamma scintigraphy in New Zealand White rabbits, optimized formulation was incorporated with 10 mg of (153)Sm for labeling MOX2 formulation. The radioactive samarium oxide was used as the marker to trace transit of the tablets in the gastrointestinal tract. The in vivo data also supported retention of MOX2 formulation in the gastric region for 12 hours and were different from the control formulation without a gas and gel forming agent. It was concluded that the prepared floating gastro-retentive matrix tablets had a sustained-release effect in vitro and in vivo, gamma scintigraphy played an important role in locating the oral transit and the drug-release pattern. PMID:26124637

  12. DISSOLUTION PROPERTIES AND KINETIC STUDY OF SULFADIMIDINE AND TRIMETHOPRIM TABLETS CONTAINING FOUR DIFFERENT SUPERDISINTEGRANTS.

    PubMed

    Zimmer, Łukasz; Kasperek, Regina; Poleszak, Ewa

    2015-01-01

    The objective of this study was to evaluate and compare the effect of four superdisintegrants such as croscarmellose sodium (Ac-Di-Sol), crospovidone (Kollidon CL and with smaller particle sizes Kollidon CL-F), sodium starch glycolate (Explotab) in combination with β-lactose and microcrystalline cellulose (Avicel PH-102) as base excipients exhibiting properties of directly compressed tablets and increasing the disintegration and the dissolution rate of sulfadimidine sodium (SDD-Na) and trimethoprim (TMP). All tablets were prepared by direct compression method and superdisintegrants were used at 2% for all formulations. The tablets were evaluated with regard to uniformity of weight, hardness, friability, drug content, disintegration time and dissolution properties. Dissolution properties such as t50% and t80% (time to release 50 and 80% of drug), DP3045 (percent of drug dissolved in 30 and 45 min) and the dissolution rate constant value (K) were considered in comparing the dissolution results. The results showed that crospovidone (Kollidon CL) provides the shortest disintegration time and the fastest rate of dissolution for both TMP and SDD-Na. The kinetic study of the dissolution data reveals that in vitro release profiles of TMP and SDD-Na can be best explained by first order model or by Higuchi model. The obtained data were plotted into Korsmeyer-Peppas equation to find out the confirmed diffusion mechanism. For TMP release, the values of the release exponent are beyond the limits of Korsmeyer model, so-called, power law. For SDD-Na release, exponent values are characteristic for anomalous transport (non-Fickian) or the value of the release exponent is beyond the limits of Korsmeyer model. PMID:26642686

  13. When color fails: illicit blue tablets containing anabolic androgen steroids.

    PubMed

    Favretto, Donata; Castagna, Franca; Maietti, Sergio; Boscolo-Berto, Rafael; Ferrara, Santo Davide

    2013-09-01

    The necessity of specific, confirmatory tests in the identification of seized illicit products was highlighted by the analysis of eighteen heart shaped, blue tablets confiscated by Police at a street control in the North East of Italy. The tablets responded as amphetamines to a preliminary color test (Marquis); a subsequent, confirmatory assay by gas chromatography-mass spectrometry revealed the presence of two anabolic androgen steroids (AAS), methandienone and methyltestosterone, in concentration of 1.7 and 1.5mg respectively per tablet; no trace of amphetamine-like or nitrogen containing compounds was found. The observed orange coloration was due to the reaction of concentrated sulphuric acid, contained in the Marquis reagent, with the Δ(4) C-3 keto group of steroids. The two AAS, banned under the world antidoping code, are not considered as psychoactive drugs of abuse in most countries, although their trafficking may entangle severe public health concerns. PMID:23770638

  14. Preparation and evaluation of gastroretentive floating tablets of acyclovir.

    PubMed

    Garg, Rajeev; Gupta, G D

    2009-10-01

    The present study performed by preparation and evaluation of floating tablets of Acyclovir as model drug for prolongation of gastric residence time. Floating effervescent tablets were formulated by various materials like hydroxypropyl methylcellulose K 4M, K 15M, psyllium husk, swelling agent as crospovidone and microcrystalline cellulose and gas generating agent like sodium bicarbonate and citric acid and evaluated for floating properties, swelling characteristics and in vitro drug release studies. Floating noneffervescent tablets were prepared by polypropylene foam powder and different matrix forming polymers like HPMC K 4M, Carbopol 934P, xanthan gum and sodium alginate. In vitro drug release studies were performed and drug release kinetics evaluated using the linear regression method was found to follow both the Higuchi and the Korsmeyer and Peppas equation. The drug release mechanism was found fickian type in most of the formulations.

  15. When color fails: illicit blue tablets containing anabolic androgen steroids.

    PubMed

    Favretto, Donata; Castagna, Franca; Maietti, Sergio; Boscolo-Berto, Rafael; Ferrara, Santo Davide

    2013-09-01

    The necessity of specific, confirmatory tests in the identification of seized illicit products was highlighted by the analysis of eighteen heart shaped, blue tablets confiscated by Police at a street control in the North East of Italy. The tablets responded as amphetamines to a preliminary color test (Marquis); a subsequent, confirmatory assay by gas chromatography-mass spectrometry revealed the presence of two anabolic androgen steroids (AAS), methandienone and methyltestosterone, in concentration of 1.7 and 1.5mg respectively per tablet; no trace of amphetamine-like or nitrogen containing compounds was found. The observed orange coloration was due to the reaction of concentrated sulphuric acid, contained in the Marquis reagent, with the Δ(4) C-3 keto group of steroids. The two AAS, banned under the world antidoping code, are not considered as psychoactive drugs of abuse in most countries, although their trafficking may entangle severe public health concerns.

  16. Formulation and evaluation of Cetirizine dihydrochloride orodispersible tablet.

    PubMed

    Subramanian, S; Sankar, V; Manakadan, Asha Asokan; Ismail, Sareena; Andhuvan, G

    2010-04-01

    Cetirizine orodispersible tablets were prepared to achieve quick onset of action and for maximum bioavailability. Tablets were prepared using cetirizine along with camphor and mannitol in the proportion of 1:1:1, 1:1:3, and 1:1:6. The flow property of granules was found to be good for the formulation CZ2 (1:1:3). The hardness and friability of all the formulations were found to be within the standard limit for orodispersible tablets. Disintegration time was found to be rapid in formulation CZ2 (1:1:3).The in vitro dissolution time was found to be 100% in 11 minutes for the formulation CZ2 (1:1:3).

  17. Noninvasive porosity measurement of biconvex tablets using terahertz pulses.

    PubMed

    Bawuah, Prince; Ervasti, Tuomas; Tan, Nicholas; Zeitler, J Axel; Ketolainen, Jarkko; Peiponen, Kai-Erik

    2016-07-25

    Biconvex pharmaceutical microcrystalline cellulose (MCC) compacts were investigated by the detection of terahertz (THz) pulse delay in the transmission measurement mode. The dimensions of the tablets were kept as constants but the porosity was a priori known variable. It is shown that the porosity of the biconvex compact has a linear correlation with the THz pulse delay. By constructing a calibration line between these two parameters (i.e. porosity and THz pulse delay), it is possible to non-invasively detect porosity of biconvex tablets. We suggest that this preliminary study could be the starting point of in-depth future studies on the screening of porosity and related properties of real biconvex pharmaceutical tablets using terahertz sensing techniques. PMID:27289013

  18. PREDICTIVE PHARMACOKINETICS OF TRAMADOL HYDROCHLORIDE FLOATING TABLETS.

    PubMed

    Wang, Jianming; Zhang, Yanzhen; Guo, Zhiling; Tao, Qingwen; Wang, Yongjun; Zhou, Wei; Ma, Xiao; Li, Zhihong

    2016-01-01

    The purpose of this study was to propose the effectiveness of convolution approach to predict pharmacokinetics of tramadol hydrochloride floating tablets, prepared by using various ratios of carbopol, HPMC K100M, and Hibiscus rosa Sinensis as excipient. The in vitro dissolution test was conducted using paddle method in 900 mL of HCl buffer with pH 1.2 to simulate the gastric condition. The stirring speed of paddles was set at 70 rpm. Temperature of dissolution medium was adjusted at 37 ± 5 °C. At predetermined time points, 5 mL of dissolution samples were taken with a replacement of same volume using fresh medium. The obtained samples were analyzed at 271 nm using UV visible spectrophotometer. The values of predicted pharmacokinetic parameters like Cmax (maximum blood drug level), Tmax (time required to attain maximum blood drug level), and AUC (area under blood drug concentration curve) ranged between 80.8 ± 3.2-119.6 ± 4.7 ng/mL, 11.4 ± 0.2-12.2 ± 0.2 h, and 1430.5 ± 209.5-1970.6 ± 287.4 ng.h/mL, respectively. This certainly is a desired feature required at the formulation development step, where the formulator requires the development of a formulation using desired in vivo features on the basis of only accessible in vitro data. It can be concluded from the results that convolution method is a practical method for the prediction of drug concentration in blood and for quality control. PMID:27476294

  19. Quantification of Niacin and Its Metabolite Nicotinuric Acid in Human Plasma by LC-MS/MS: Application to a Clinical Trial of a Fixed Dose Combination Tablet of Niacin Extended-Release/Simvastatin (500 mg/10 mg) in Healthy Chinese Volunteers

    PubMed Central

    Zhang, Pingping; Sun, Yantong; Shi, Guobing; Sui, Yin; Li, Qiuying; Tang, Yunbiao; Gu, Jingkai

    2015-01-01

    Our paper aimed to develop rapid, sensitive, and specific LC-MS/MS method for the quantification of niacin (NA) and its metabolite nicotinuric acid (NUA) in human plasma. Following protein precipitation with acetonitrile, the NA, NUA, and internal standard (5-fluorouracil) were separated on a Zorbax 300SB-C8 column (250 mm × 4.6 mm, 5 μm) with a mobile phase consisting of methanol-2 mM ammonium acetate (3 : 97, v/v) at a flow rate of 1 mL/min (split 1 : 1). A tandem mass spectrometer equipped with electrospray ionization source was used as the detector and operated in negative ion mode. The linear concentration ranges of the calibration curves were 5–800 ng/mL for NA and NUA. The intra-assay RSD for quality control (QC) samples were from 5.0% to 8.7% for NA, and 5.5% to 7.6% for NUA. The interassay RSD for QC samples were from 2.8% to 9.4% for NA, and 3.7% to 5.8% for NUA. The relative errors for QC samples were from −2.2% to 2.3% for NA, and −0.6% to 3.2% for NUA. The method was successfully applied to the investigation of the pharmacokinetic profiles of NA, NUA in human after single dose administration of Niacin extended-release/Simvastatin tablet (500 mg/10 mg). PMID:26345166

  20. Formulation and evaluation of aceclofenac mouth-dissolving tablet.

    PubMed

    Solanki, Shailendra Singh; Dahima, Rashmi

    2011-04-01

    Aceclofenac has been shown to have potent analgesic and anti-inflammatory activities similar to indomethacin and diclofenac, and due to its preferential Cox-2 blockade, it has a better safety than conventional Non steroidal anti-inflammatory drug (NSAIDs) with respect to adverse effect on gastrointestinal and cardiovascular systems. Aceclofenac is superior from other NSAIDs as it has selectivity for Cox-2, a beneficial Cox inhibitor is well tolerated, has better Gastrointestinal (GI) tolerability and improved cardiovascular safety when compared with other selective Cox-2 inhibitor. To provide the patient with the most convenient mode of administration, there is need to develop a fast-disintegrating dosage form, particularly one that disintegrates and dissolves/disperses in saliva and can be administered without water, anywhere, any time. Such tablets are also called as "melt in mouth tablet." Direct compression, freeze drying, sublimation, spray drying, tablet molding, disintegrant addition, and use of sugar-based excipients are technologies available for mouth-dissolving tablet. Mouth-dissolving tablets of aceclofenac were prepared with two different techniques, wet granulation and direct compression, in which different formulations were prepared with varying concentration of excipients. These tablets were evaluated for their friability, hardness, wetting time, and disintegration time; the drug release profile was studied in buffer Phosphate buffered Saline (PBS) pH 7.4. Direct compression batch C3 gave far better dissolution than the wet granulation Batch F2, which released only 75.37% drug, and C3, which released 89.69% drug in 90 minutes.

  1. [The delivery mechanism of micro-porous osmotic pump tablets].

    PubMed

    Zhao, Xue-ling; Li, Qiang; Gong, Xian-feng; Li, San-ming

    2007-02-01

    To investigate the delivery mechanism of micro-porous osmotic pump tablets ( MPOP), taking tramadol hydrochloride ( TR) as the model drug, tramadol hydrochloride micro-porous osmotic pump tablets (TR MPOP) were prepared with compressible starch as diluent, cellulose acetate as coating material, polyethylene glycol 400 as pore-forming agents. The equilibrium solubility and osmolality of TR were determined. The effects of fillers in tablet cores, coating levels, and osmotic pressures of release media on expansion behavior of preparations were described. The influences of the category, osmolality, and pH value of release media, release methods, and release conditions on release curves of tablets were evaluated. Based on several models, the delivery pattern of TR MPOP was fitted. The equilibrium solubility in water and osmolality of TR were (775.8 +/- 17.7) g x L(-1) and 4.036 Osmol x kg(-1), respectively. During the drug-release period, it was observed that the tablets expanded markedly in response to the expansion characteristics of compressible starch and the osmotic pressure difference across the membrane. When osmotic pressure of release media increased, the significant change of the equilibrium solubility of TR was not found, but the release rates of TR MPOP decreased significantly. The delivery rate was not influenced by the pH of release mediums, dissolution methods and paddle stirring rates. The drug release profile conformed to the model of zero order in 8 h. The pore-forming agents were dissolved in release medium, which caused micro-pores. The expansion of tablets made the size of micropores bigger, and then the drug-releasing pores were obtained. It was proved that the drivers of drug delivering from TR MPOP were mainly the difference of osmotic pressure, and secondly the difference of solubility. TR MPOP were the controlled-release preparation.

  2. Monitoring of the manufacturing process for ambroxol hydrochloride tablet using NIR-chemometric methods: compression effect on content uniformity model and relevant process parameters testing.

    PubMed

    Yang, Hongqin; Liao, Xiaoxiang; Peng, Feng; Wang, Wan; Liu, Yanxin; Yan, Jin; Li, Hui

    2015-01-01

    This study aimed at using near-infrared (NIR) spectroscopy to monitor compaction pressure for simultaneously determining the tensile strength and content uniformity, as well as moisture and mean particle size of ambroxol hydrochloride tablets. The content uniformity, compression force and tensile strength of the laboratory samples were obtained by pressing a mixture of active principle and excipient components into tablets. To reduce the spectral baseline shift of the laboratory samples, the compaction pressure applied to the mixture was assessed by a variable pressure test. Production samples were added to the test and subjected to principal component analysis. The expanded partial least-squares (PLS) calibration model used to quantify the active content was more accurate than the model constructed from laboratory samples using the production tablets included in the calibration set. The model showed good predictability, with correlation coefficient (R) 0.9977. The validation and reliability of the content model were evaluated to determine trueness and reliability for the measurement of individual production tablets and the laboratory tablets with drug content ranging from 24 to 36 mg. The PLS calibration models for compression force and tensile strength were constructed using the same spectral set assuming both were highly related. These models yielded high R values (0.9955 and 0.9910). The R values of the moisture and mean particle size were 0.9994 and 0.9919, respectively. This study demonstrated that NIR spectroscopy combined with chemometric techniques can be successfully used to quantitatively monitor the tablet manufacturing process in the pharmaceutical industry.

  3. Monitoring of the manufacturing process for ambroxol hydrochloride tablet using NIR-chemometric methods: compression effect on content uniformity model and relevant process parameters testing.

    PubMed

    Yang, Hongqin; Liao, Xiaoxiang; Peng, Feng; Wang, Wan; Liu, Yanxin; Yan, Jin; Li, Hui

    2015-01-01

    This study aimed at using near-infrared (NIR) spectroscopy to monitor compaction pressure for simultaneously determining the tensile strength and content uniformity, as well as moisture and mean particle size of ambroxol hydrochloride tablets. The content uniformity, compression force and tensile strength of the laboratory samples were obtained by pressing a mixture of active principle and excipient components into tablets. To reduce the spectral baseline shift of the laboratory samples, the compaction pressure applied to the mixture was assessed by a variable pressure test. Production samples were added to the test and subjected to principal component analysis. The expanded partial least-squares (PLS) calibration model used to quantify the active content was more accurate than the model constructed from laboratory samples using the production tablets included in the calibration set. The model showed good predictability, with correlation coefficient (R) 0.9977. The validation and reliability of the content model were evaluated to determine trueness and reliability for the measurement of individual production tablets and the laboratory tablets with drug content ranging from 24 to 36 mg. The PLS calibration models for compression force and tensile strength were constructed using the same spectral set assuming both were highly related. These models yielded high R values (0.9955 and 0.9910). The R values of the moisture and mean particle size were 0.9994 and 0.9919, respectively. This study demonstrated that NIR spectroscopy combined with chemometric techniques can be successfully used to quantitatively monitor the tablet manufacturing process in the pharmaceutical industry. PMID:25738811

  4. Retail pharmacy activities and their automation by bar code recorder, tablet counter and remote computer. A feasibility trial.

    PubMed

    Preece, J F; Finch, J D; Macdonald, A H

    1977-07-01

    The advent of mechanical tablet counters in retail pharmacy, and the development of methods of stock control involving mechanical code reading in other forms of retailing have prompted the trail of a machine which combines both these functions with support from a computer. The wide range of activities over which the combined machine can provide assistance to the pharmacist has been explored. An extension of the system utilising the same data would provide the basis for automation of the pharmaceutical wholesaler and manufacturer, and of the prescription pricing bureau. PMID:885641

  5. Combinational effects of sulfomethoxazole and copper on soil microbial community and function.

    PubMed

    Liu, Aiju; Cao, Huansheng; Yang, Yan; Ma, Xiaoxuan; Liu, Xiao

    2016-03-01

    Sulfonamides and Cu are largely used feed additives in poultry farm. Subsequently, they are spread onto agricultural soils together with contaminated manure used as fertilizer. Both sulfonamides and Cu affect the soil microbial community. However, an interactive effect of sulfonamides and Cu on soil microorganisms is not well understood. Therefore, a short-time microcosm experiment was conducted to investigate the interaction of veterinary antibiotic sulfomethoxazole (SMX) and Cu on soil microbial structure composition and functions. To this end, selected concentrations of SMX (0, 5, and 50 mg kg(-1)) and Cu (0, 300, and 500 mg kg(-1)) were combined, respectively. Clear dose-dependent effects of SMX on microbial biomass and basal respiration were determined, and these effects were amplified in the presence of additional Cu. For activities of soil enzymes including β-glucosidase, urease, and protease, clear reducing effects were determined in soil samples containing 5 or 50 mg kg(-1) of SMX, and the interaction of SMX and Cu was significant, particularly in soil samples containing 50 mg kg(-1) SMX or 500 mg kg(-1) Cu. SMX amendments, particularly in combination with Cu, significantly reduced amounts of the total, bacterial, and fungal phospholipid fatty acids (PLFAs) in soil. Moreover, the derived ratio of bacteria to fungi decreased significantly with incremental SMX and Cu, and principal component analysis of the PLFAs showed that soil microbial composition was significantly affected by SMX interacted with Cu at 500 mg kg(-1). All of these results indicated that the interaction of SMX and Cu was synergistic to amplify the negative effect of SMX on soil microbial biomass, structural composition, and even the enzymatic function. PMID:26122574

  6. Investigation and Evaluation of an in Situ Interpolymer Complex of Carbopol with Polyvinylpyrrolidone as a Matrix for Gastroretentive Tablets of Ranitidine Hydrochloride.

    PubMed

    Yusif, Rehab Mohammad; Abu Hashim, Irhan Ibrahim; Mohamed, Elham Abdelmonem; El Rakhawy, Mohamed Magdy

    2016-01-01

    Carbopol (CP) is a biocompatible bioadhesive polymer used as a matrix for gastroretentive (GR) tablets, however, its rapid hydration shortens its bioadhesion and floating when incorporated in effervescent formulae. The interpolymer complexation of CP with polyvinylpyrrolidone (PVP) significantly reduced the excessive hydration of CP, prolonging floating and maintaining the mucoadhesiveness. In early attempts, a lengthy process was followed to prepare such an interpolymer complex. In this study, an in situ interpolymer complexation between CP and two grades of PVP (K25 and K90) in 0.1 N HCl was investigated and characterized by Fourier transform infrared spectroscopy (FT-IR) and differential scanning calorimetry (DSC). Hence, directly compressed GR tablets of different combinations of PVP and CP with sodium bicarbonate (SB) as an effervescent agent were examined for prolonged gastroretention and sustained release of ranitidine hydrochloride (RHCl) as a model drug. Tablets were evaluated for in vitro buoyancy, bioadhesiveness, swelling, and drug release in 0.1 N HCl. All GR tablets containing PVP-CP combinations achieved more prolonged floating (>24 h) than CP tablets (5.2 h). Their bioadhesiveness, swelling, and drug release were dependent on the PVP molecular weight and its ratio to CP. Drug release profiles of all formulae followed non-Fickian diffusion. Formula containing the PVP K90-CP combination at a respective ratio of 1 : 3 (P90C13) was a promising system, exhibiting good floating and bioadhesive properties as well as sustained drug release. Abdominal X-ray imaging of P90C13 formula, loaded with barium sulfate, in six healthy volunteers showed a mean gastric retention period of 6.8±0.3 h.

  7. Effect of some additives on the properties of phenazopyridine hydrochloride granules and their corresponding tablets.

    PubMed

    el-Sabbagh, H M; Meshali, M; Ghanem, A; Abdel-Aleem, H

    1984-06-01

    The effect of the diluents, lactose and calcium carbonate and of the binders, syrup, gelatin, methylcellulose and Eudragit E on the physical properties of phenazopyridine hydrochloride (PNHCl) granules was evaluated. A correlation existed between the granules' physical properties and those of their compressed tablets. With regard to drug release, lactose-syrup 30% was the best of all diluent-binder combinations, followed by lactose-methylcellulose 4%. Also lactose was found to be superior to calcium carbonate in drug release when gelatin and methylcellulose were used as binders. Eudragit E was the best binder with calcium carbonate in this respect. On the other hand, the bioavailability of PNHCl in humans was the same when lactose was used with either gelatin, syrup or methylcellulose, but higher than that obtained with a combination of calcium carbonate and Eudragit E 15%.

  8. Evaluation of roll compaction as a preparation method for hydroxypropyl cellulose-based matrix tablets.

    PubMed

    Jeon, Imjak; Gilli, Tiziana; Betz, Gabriele

    2011-04-01

    Roll compaction was applied for the preparation of hydroxypropyl cellulose (HPC)-based sustained-release matrix tablets. Matrix tablets made via roll compaction exhibited higher dosage uniformity and faster drug release than direct-compacted tablets. HPC viscosity grade, roll pressure, and milling speed affected tablet properties significantly. Roll compaction seems to be an adequate granulation method for the preparation of HPC-based matrix tablets due to the simplicity of the process, less handling difficulty from HPC tackiness as well as easier particle size targeting. Selecting the optimum ratio of plastic excipients and the particle size of starting materials can however be critical issues in this method. PMID:21687348

  9. Evaluation of roll compaction as a preparation method for hydroxypropyl cellulose-based matrix tablets

    PubMed Central

    Jeon, Imjak; Gilli, Tiziana; Betz, Gabriele

    2011-01-01

    Roll compaction was applied for the preparation of hydroxypropyl cellulose (HPC)-based sustained-release matrix tablets. Matrix tablets made via roll compaction exhibited higher dosage uniformity and faster drug release than direct-compacted tablets. HPC viscosity grade, roll pressure, and milling speed affected tablet properties significantly. Roll compaction seems to be an adequate granulation method for the preparation of HPC-based matrix tablets due to the simplicity of the process, less handling difficulty from HPC tackiness as well as easier particle size targeting. Selecting the optimum ratio of plastic excipients and the particle size of starting materials can however be critical issues in this method. PMID:21687348

  10. Evaluation of roll compaction as a preparation method for hydroxypropyl cellulose-based matrix tablets.

    PubMed

    Jeon, Imjak; Gilli, Tiziana; Betz, Gabriele

    2011-04-01

    Roll compaction was applied for the preparation of hydroxypropyl cellulose (HPC)-based sustained-release matrix tablets. Matrix tablets made via roll compaction exhibited higher dosage uniformity and faster drug release than direct-compacted tablets. HPC viscosity grade, roll pressure, and milling speed affected tablet properties significantly. Roll compaction seems to be an adequate granulation method for the preparation of HPC-based matrix tablets due to the simplicity of the process, less handling difficulty from HPC tackiness as well as easier particle size targeting. Selecting the optimum ratio of plastic excipients and the particle size of starting materials can however be critical issues in this method.

  11. The moderating roles of gender and age in tablet computer adoption.

    PubMed

    Hur, Won-Moo; Kim, Hanna; Kim, Wan-Min

    2014-01-01

    This study aims to examine the relationship between perceived usefulness, ease of use, and enjoyment and attitude toward tablet computers, and between social influence and use intentions for such devices, as moderated by gender and age. Results from a partial least squares analysis using a sample of 482 consumers in South Korea showed that perceived usefulness and enjoyment have a positive effect on attitude toward tablets, while social influence and attitude toward tablet computers have a positive influence on intention to use tablets. Furthermore, gender and age moderated the relationship between perceived ease of use and attitude toward tablets.

  12. Characterising the disintegration properties of tablets in opaque media using texture analysis.

    PubMed

    Scheuerle, Rebekah L; Gerrard, Stephen E; Kendall, Richard A; Tuleu, Catherine; Slater, Nigel K H; Mahbubani, Krishnaa T

    2015-01-01

    Tablet disintegration characterisation is used in pharmaceutical research, development, and quality control. Standard methods used to characterise tablet disintegration are often dependent on visual observation in measurement of disintegration times. This presents a challenge for disintegration studies of tablets in opaque, physiologically relevant media that could be useful for tablet formulation optimisation. This study has explored an application of texture analysis disintegration testing, a non-visual, quantitative means of determining tablet disintegration end point, by analysing the disintegration behaviour of two tablet formulations in opaque media. In this study, the disintegration behaviour of one tablet formulation manufactured in-house, and Sybedia Flashtab placebo tablets in water, bovine, and human milk were characterised. A novel method is presented to characterise the disintegration process and to quantify the disintegration end points of the tablets in various media using load data generated by a texture analyser probe. The disintegration times in the different media were found to be statistically different (P<0.0001) from one another for both tablet formulations using one-way ANOVA. Using the Tukey post-hoc test, the Sybedia Flashtab placebo tablets were found not to have statistically significant disintegration times from each other in human versus bovine milk (adjusted P value 0.1685). PMID:25791759

  13. Gastrointestinal transit of model mini-tablet controlled release oral dosage forms in fasted human volunteers.

    PubMed

    Podczeck, F; Course, N; Newton, J M; Short, M B

    2007-07-01

    The aim of this study was to compare the gastrointestinal transit of multiple unit, small diameter (3.2 mm), non-disintegrating tablets of differing densities with results previously reported in the same volunteers in the fasted state for larger diameter (6.6 and 12.2 mm) tablets. The gastrointestinal transit was observed with gamma-scintigraphy at various intervals over a 9-h period to give an accurate assessment of the transit characteristics. The value for the median emptying time of the first light tablet was significantly shorter than that for the dense tablet, but the total emptying time and the time for the last tablet to empty for both sets of tablets were not statistically different. The value of the median time for initial and final emptying of the small tablets from the stomach was significantly longer than that for the larger diameter tablets. The 9-h time limit of the observations limited the estimation of the time taken to enter the caecum and consequently the small intestine transit times. There was clear evidence that for the dense tablets of all sizes, the value for the small intestine transit time was longer than the 3-4 h reported in the literature. The only tablet system to enter the caecum within the time limit of the study was the normal density 12.2-mm tablets. PMID:17637188

  14. Formulation and Evaluation of Cefixime Trihydrate Matrix Tablets Using HPMC, Sodium CMC, Ethyl Cellulose

    PubMed Central

    Sirisolla, Janakidevi; Ramanamurthy, K. V.

    2015-01-01

    The objective of the present work is to design sustained release matrix tablets of cefixime trihydrate by incorporating drug in a matrix made up of release retardant polymers, which prolong drug release leading to minimization of the peak and valley effect in the plasma and provide patient convenience. The effect of combination of polymers on parameters like release pattern, release mechanism of the drug were studied. Total nine formulations each containing 200 mg of drug were prepared by direct compression method. The formulations F-1, F-2, F-3 were prepared with a 1:1 drug to polymer ratio using hydroxypropyl methylcellulose, carboxymethyl cellulose sodium and ethyl cellulose. F-4 was prepared with a 1:1 ratio of hydroxypropyl methylcellulose, carboxymethyl cellulose sodium, F-5 as prepared with a 1:1 ratio of hydroxypropyl methylcellulose and ethyl cellulose, F-6 was prepared with a 1:1 ratio of carboxymethyl cellulose sodium and ethyl cellulose, F-7, F-8, F-9 were prepared by using polymers hydroxypropyl methylcellulose, carboxymethyl cellulose sodium and ethyl cellulose in the ratios of 0.5:0.5:1, 0.5:1:0.5, and 1:0.5:0.5. Designed matrix tablets were evaluated for various pre-compression and post-compression parameters. Formulation F-5 showed 102.15 % release at the end of 12 h and it is selected as the best formulation. All Formulations followed zero order with non-Fickian diffusion method. PMID:26180278

  15. Formulation and Evaluation of Mouth Disintegrating Tablets of Atenolol and Atorvastatin

    PubMed Central

    Sarfraz, R. M.; Khan, H. U.; Mahmood, A.; Ahmad, M.; Maheen, S.; Sher, M.

    2015-01-01

    In this study, mouth-disintegrating tablets of atenolol and atorvastatin combination were formulated using superdisintegrants to impart fast disintegration. Fifteen formulations were prepared based on different concentrations of two superdisintegrants, croscarmellose sodium and Kyron-T134. Three different techniques such as direct compression, effervescent and sublimation were used to study the effect of manufacturing processes, nature and concentration of superdisintegrants on various features of these tablets. Five formulations were made using each method. Precompression studies like bulk density, tapped density, angle of repose, Carr's compressibility index, Hausner's ratio and compatibility studies such as Fourier transform infrared spectroscopy and differential scanning calorimetry were performed. Various features such as hardness, thickness, diameter, weight variation, friability, disintegration time, dissolution studies, wetting time, wetting volume, water absorption ratio, modified disintegration, uniformity of contents and stability were evaluated. Finally results were statistically analyzed by the application of one way ANOVA test. Formulation F13 containing Kyron-T134 (6%) and croscarmellose sodium (2%) was found to be the best among all fifteen formulations prepared in all aspects evaluated. Sublimation method is found to be the best among three methods of preparation used. PMID:25767322

  16. Formulation Development and Stability Studies of Norfloxacin Extended-Release Matrix Tablets

    PubMed Central

    Oliveira, Paulo Renato; Klein, Lilian; Sangoi, Maximiliano da Silva; Bernardi, Larissa Sakis; Silva, Marcos Antônio Segatto

    2013-01-01

    The aim of this research was to develop a new hydrophilic matrix system containing norfloxacin (NFX). Extended-release tablets are usually intended for once-a-day administration with benefits to the patient and lower discontinuation of the therapy. Formulations were developed with hydroxypropylmethylcellulose or poly(ethylene oxide) as hydrophilic polymers, with different molecular weights (MWs) and concentrations (20 and 30%). The tablets were found to be stable (6 months at 40 ± 2°C and 75 ± 5% relative humidity), and the film-coating process is recommended to avoid NFX photodegradation. The dissolution profiles demonstrated an extended-release of NFX for all developed formulations. Dissolution curves analyzed using the Korsmeyer exponential equation showed that drug release was controlled by both drug diffusion and polymer relaxation or erosion mechanisms. A more erosion controlled system was obtained for the formulations containing lower MW and amount of polymer. With the increase in both MW and amount of polymer in the formulation, the gel layer became stronger, and the dissolution was more drug-diffusion dependent. Formulations containing intermediate MW polymers or high concentration (30%) of low MW polymers demonstrated a combination of extended and complete in vitro drug release. This way, these formulations could provide an increased bioavailability in vivo. PMID:24083235

  17. Standardization and quality control parameters of Dashanga Kwatha ghana tablet: An Ayurvedic formulation

    PubMed Central

    Baragi, Umapati C.; Baragi, Pramod C.; Vyas, Mahesh K.; Shukla, Vinay J.

    2011-01-01

    Herbal medicines have a long therapeutic history and are still serving many of the health needs of a large population of the world. However, the quality control and quality assurance still remains a challenge because of the high variability of chemical components involved. Herbal drugs, singularly and in combinations, contain numerous compounds in complex matrices in which no single active constituent is responsible for the overall efficacy. This creates a challenge in establishing quality control standards and standardization of finished herbal drugs. Many preparations have been mentioned in Ayurvedic text books for the treatment of Urdhwaga Amlapitta (non-ulcer dyspepsia). Dashanga Kwatha is one such known formulation. In this study, Dashanga Kwatha was converted into tablet form to increase the shelf life, make it easy to dispense, for dose fixation, etc. The Dashanga Kwatha Ghana tablet was subjected to organoleptic analysis, phytochemical analysis, and qualitative analysis to detect the presence of various functional groups, and to high performance thin layer chromatography (HPTLC) examination by optimizing the solvent systems. The investigation revealed the presence of tannins, mucilage, ascorbic acid, alkaloids, saponins, glycosides, flavonoids and carbohydrates mainly. PMID:21897642

  18. Compatibility studies of acyclovir and lactose in physical mixtures and commercial tablets.

    PubMed

    Monajjemzadeh, Farnaz; Hassanzadeh, Davoud; Valizadeh, Hadi; Siahi-Shadbad, Mohammad R; Mojarrad, Javid Shahbazi; Robertson, Thomas A; Roberts, Michael S

    2009-11-01

    This study documents drug-excipient incompatibility studies of acyclovir in physical mixtures with lactose and in different tablet brands. Differential scanning calorimetry (DSC) was initially used to assess compatibility of mixtures. The Fourier-transform infrared (FTIR) spectrum was also compared with the spectra of pure drug and excipient. Although DSC results indicated incompatibility with lactose, FTIR spectra were mostly unmodified due to overlapping peaks. Samples of isothermally stressed physical mixture were stored at 95 degrees C for 24 h. The residual drug was monitored using a validated high-performance liquid chromatography (HPLC) assay and data fitting to solid-state kinetic models was performed. The drug loss kinetics followed a diffusion model. The aqueous mixture of drug and excipient was heated in order to prepare an adduct mixture. HPLC analysis revealed one extra peak that was fractionated and subsequently injected into the liquid chromatography-mass spectrometry/mass spectrometry (LC-MS/MS) system. The MRM (Multiple Reaction Monitoring) chromatograms characterized the peak with molecular mass corresponding to an acyclovir-lactose Maillard reaction product. The presence of lactose in commercial tablets was checked using a new TLC method. Overall, the incompatibility of acyclovir with lactose was successfully evaluated using a combination of thermal methods and LC-MS/MS. PMID:19631740

  19. Formulation and evaluation of gastroretentive controlled release tablets of alfuzosin hydrochloride.

    PubMed

    Rudraswamy-Math, Nijaguni Revansiddayya; Gupta, Vankdari Rama-Mohan

    2015-11-01

    Alfuzosin hydrochloride is a novel drug used in the treatment of urinary incontinency. The purpose of this research was to develop controlled release floating matrix formulations of Alfuzosin HCl. Floating matrix tablets of Alfuzosin HCl were prepared using hydroxypropyl methylcellulose (HPMC), Polyethylene oxide (PEO), Carbopol 971P NF polymer (Direct compressible) and Blend of Polyvinyl Acetate and Povidone 30 (80:19:1(0.8% sodium laury sulfate and 0.2% silica)). Combination of citric acid and sodium bicarbonate were also used as gas forming agent. Matrix formulations were prepared by direct compression method and evaluated for floating, in vitro drug release profile and swelling characteristics. The mechanism of drug release was found to follow non-Fickian or anomalous type. The data obtained from the invitro release studies demonstrated that the floating matrix tablets containing HPMC 100K CR (controlled-release) and carbopol along with sodium CMC were found to sustain the release of drug over a period of 12 hours. Formulations containing 25% PEO 303WSR was also capable of sustaining delivery the release of Alfuzosin HCl. PMID:26639508

  20. A study of compressibility and compactibility of directly compressible tableting materials containing tramadol hydrochloride.

    PubMed

    Mužíková, Jitka; Kubíčková, Alena

    2016-09-01

    The paper evaluates and compares the compressibility and compactibility of directly compressible tableting materials for the preparation of hydrophilic gel matrix tablets containing tramadol hydrochloride and the coprocessed dry binders Prosolv® SMCC 90 and Disintequik™ MCC 25. The selected types of hypromellose are Methocel™ Premium K4M and Methocel™ Premium K100M in 30 and 50 % concentrations, the lubricant being magnesium stearate in a 1 % concentration. Compressibility is evaluated by means of the energy profile of compression process and compactibility by the tensile strength of tablets. The values of total energy of compression and plasticity were higher in the tableting materials containing Prosolv® SMCC 90 than in those containing Disintequik™ MCC 25. Tramadol slightly decreased the values of total energy of compression and plasticity. Tableting materials containing Prosolv® SMCC 90 yielded stronger tablets. Tramadol decreased the strength of tablets from both coprocessed dry binders.

  1. Security approaches in using tablet computers for primary data collection in clinical research.

    PubMed

    Wilcox, Adam B; Gallagher, Kathleen; Bakken, Suzanne

    2013-01-01

    Next-generation tablets (iPads and Android tablets) may potentially improve the collection and management of clinical research data. The widespread adoption of tablets, coupled with decreased software and hardware costs, has led to increased consideration of tablets for primary research data collection. When using tablets for the Washington Heights/Inwood Infrastructure for Comparative Effectiveness Research (WICER) project, we found that the devices give rise to inherent security issues associated with the potential use of cloud-based data storage approaches. This paper identifies and describes major security considerations for primary data collection with tablets; proposes a set of architectural strategies for implementing data collection forms with tablet computers; and discusses the security, cost, and workflow of each strategy. The paper briefly reviews the strategies with respect to their implementation for three primary data collection activities for the WICER project.

  2. Effect of tablet structure on controlled release from supersaturating solid dispersions containing glyceryl behenate.

    PubMed

    Keen, Justin M; Hughey, Justin R; Bennett, Ryan C; Jannin, Vincent; Rosiaux, Yvonne; Marchaud, Delphine; McGinity, James W

    2015-01-01

    The objective of this study was to evaluate the use of glyceryl behenate as a plasticizer and release modifier in solid dispersion systems containing itraconazole and carbamazepine. Amorphous solid dispersions of high molecular weight polyvinylpyrrolidone were prepared by hot-melt extrusion, the processing of which was improved by the inclusion of glyceryl behenate. Dispersions were milled and subsequently compressed into tablets. Solid dispersions were also prepared by KinetiSol Dispersing, which allowed for the manufacture of monolithic tablets of the same composition and shape as compressed tablets. Tablets without glyceryl behenate and all compressed tablets were observed to have an incomplete release profile likely due to drug crystallization within the tablet as this occurred at conditions in which dissolution concentrations were below saturation. Monolithic tablets formulated to be more hydrophobic, by including glyceryl behenate, allowed for sustained release below and above saturation conditions.

  3. Formulation and Evaluation of Cephalexin Extended-release Matrix Tablets Using Hydroxy Propyl Methyl Cellulose as Rate-controlling Polymer

    PubMed Central

    Vijay, J; Sahadevan, JT; Prabhakaran, R; Gilhotra, R Mehra

    2012-01-01

    The present investigation reports the design and evaluation of six-hour extended release film-coated matrix tablets of cephalexin using different grades of hydrophilic polymer hydroxypropylmethylcellulose (HPMC) employing direct compression method. The preformulation studies performed included the physical compatibility studies, Differential Scanning Calorimetry analysis, drug characterization using Fourier Transform Infra Red spectroscopic analysis and particle size analysis using sieve method. The tablets were evaluated for weight variation, hardness, thickness and friability. Results of the studies indicate that the polymers used have significant release-retarding effect on the formulation. The dissolution profile comparison of the prepared batches P1 to P8 and market preparation (Sporidex AF 375) was done by using Food and Drug Administration-recommended similarity factor (f2) determination. The formulation P8 (10% HPMC K4M, 15% HPMC 15cps) with a similarity factor (f2) of 77.75 was selected as the optimized formulae for scale-up batches. The dissolution data of the best formulation P8 was fitted into zero order, first order, Higuchi and Korsemeyer-Peppas models to identify the pharmacokinetics and mechanism of drug release. The results of the accelerated stability study of best formulation P8 for three months revealed that storage conditions were not found to have made any significant changes in final formulation F3. The release of cephalexin was prolonged for 6 h by using polymer combinations of HPMC and a twice daily matrix tablet was formulated. PMID:22523453

  4. The Virtual Tablet: Virtual Reality as a Control System

    NASA Technical Reports Server (NTRS)

    Chronister, Andrew

    2016-01-01

    In the field of human-computer interaction, Augmented Reality (AR) and Virtual Reality (VR) have been rapidly growing areas of interest and concerted development effort thanks to both private and public research. At NASA, a number of groups have explored the possibilities afforded by AR and VR technology, among which is the IT Advanced Concepts Lab (ITACL). Within ITACL, the AVR (Augmented/Virtual Reality) Lab focuses on VR technology specifically for its use in command and control. Previous work in the AVR lab includes the Natural User Interface (NUI) project and the Virtual Control Panel (VCP) project, which created virtual three-dimensional interfaces that users could interact with while wearing a VR headset thanks to body- and hand-tracking technology. The Virtual Tablet (VT) project attempts to improve on these previous efforts by incorporating a physical surrogate which is mirrored in the virtual environment, mitigating issues with difficulty of visually determining the interface location and lack of tactile feedback discovered in the development of previous efforts. The physical surrogate takes the form of a handheld sheet of acrylic glass with several infrared-range reflective markers and a sensor package attached. Using the sensor package to track orientation and a motion-capture system to track the marker positions, a model of the surrogate is placed in the virtual environment at a position which corresponds with the real-world location relative to the user's VR Head Mounted Display (HMD). A set of control mechanisms is then projected onto the surface of the surrogate such that to the user, immersed in VR, the control interface appears to be attached to the object they are holding. The VT project was taken from an early stage where the sensor package, motion-capture system, and physical surrogate had been constructed or tested individually but not yet combined or incorporated into the virtual environment. My contribution was to combine the pieces of

  5. Future Scenarios Regarding Tablet Computer Usage in Education and Writing

    ERIC Educational Resources Information Center

    Karadag, Ruhan; Kayabasi, Bekir

    2013-01-01

    Today, one of the most important sources forcing the educational institutions to alteration is the developments in informatics and communication technologies. Among these alterations, the internet and the tablet computers, which may cause a vital transformation in the history of education, are of importance. Making assumptions, based on today,…

  6. 21 CFR 520.1242e - Levamisole hydrochloride effervescent tablets.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... water from pigs before treatment is not necessary. Add one tablet for each 21/2 gallons of water; mix thoroughly. Allow 1 gallon of medicated water for each 100 pounds body weight of pigs to be treated. No other source of water should be offered. After pigs have consumed medicated water, resume use of regular...

  7. 21 CFR 520.1242e - Levamisole hydrochloride effervescent tablets.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... water from pigs before treatment is not necessary. Add one tablet for each 21/2 gallons of water; mix thoroughly. Allow 1 gallon of medicated water for each 100 pounds body weight of pigs to be treated. No other source of water should be offered. After pigs have consumed medicated water, resume use of regular...

  8. 21 CFR 520.2098 - Selegiline hydrochloride tablets.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 6 2014-04-01 2014-04-01 false Selegiline hydrochloride tablets. 520.2098 Section 520.2098 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES... the control of clinical signs associated with canine cognitive dysfunction syndrome. (ii)...

  9. 21 CFR 520.1199 - Ivermectin, pyrantel, and praziquantel tablets.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 6 2012-04-01 2012-04-01 false Ivermectin, pyrantel, and praziquantel tablets. 520.1199 Section 520.1199 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS ORAL DOSAGE FORM NEW ANIMAL DRUGS § 520.1199 Ivermectin, pyrantel, and...

  10. 21 CFR 520.2098 - Selegiline hydrochloride tablets.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 6 2013-04-01 2013-04-01 false Selegiline hydrochloride tablets. 520.2098 Section 520.2098 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES... the control of clinical signs associated with canine cognitive dysfunction syndrome. (ii)...

  11. Stability of Crushed Tedizolid Phosphate Tablets for Nasogastric Tube Administration.

    PubMed

    Kennedy, Gerard; Osborn, Jim; Flanagan, Shawn; Alsayed, Najy; Bertolami, Shellie

    2015-12-01

    Tedizolid phosphate is approved for the treatment of acute bacterial skin and skin structure infections. To determine whether the expected dose of tedizolid phosphate can be delivered via nasogastric tube in patients who have difficulty swallowing and in whom venous access is not suitable, this in vitro study evaluated the recovery of tedizolid phosphate 200-mg tablets after crushing, dispersion in water, and passage through a nasogastric tube. To analyze the chemical stability of the crushed tablet dispersed in water, the aqueous preparation was assayed initially after dispersion and again after 4 h at room temperature. Recovery of tedizolid phosphate after the crushed tablets were dispersed in water and passed through nasogastric tubes ranged from 92.5 to 97.1 %, which is within the specified acceptance criteria of 90 to 110 %. There was no significant change in recovery values after 4 h of storage at room temperature (93.9 % initially and 94.7 % after 4 h). The stability and recovery findings support the feasibility of administering an aqueous dispersion of crushed tedizolid phosphate tablets through a nasogastric tube in patients who have difficulty swallowing and in whom intravenous administration is not possible.

  12. Through the Lens of a Tetrad: Visual Storytelling on Tablets

    ERIC Educational Resources Information Center

    McEwen, Rhonda; Zbitnew, Anne; Chatsick, Jennifer

    2016-01-01

    What are the boundaries between traditional and new media, between ability and disability, and between the artist and the processes for making art? This article reports findings from a study of tablet devices as media for self-expression and visual storytelling by adults with intellectual disabilities and examined whether or not art-making…

  13. Can Tablet Computers Enhance Learning in Further Education?

    ERIC Educational Resources Information Center

    Butcher, John

    2016-01-01

    Interest in the potential benefits of providing tablet computers to students has grown in recent years, both in UK institutions, and across the world. Limited research studies have been reported in higher education (HE), and primary and secondary school settings, tentatively suggesting a range of positive impacts on learners, but little conclusive…

  14. Liquisolid Tablets for Dissolution Enhancement of a Hypolipidemic Drug

    PubMed Central

    Patel, D. S.; Pipaliya, R. M.; Surti, Naazneen

    2015-01-01

    This investigation was aimed to improve the dissolution rate of the poorly soluble drug lovastatin, by formulating it as a liquisolid compact. Different liquisolid compacts were prepared using mathematical formulae to calculate the required quantities of powder and liquid ingredients to produce acceptably flowable and compressible admixture. Avicel PH 200, Cab-O-Sil, sodium starch glycolate and PEG 400 were employed as carrier, coating material, disintegrant and non-volatile liquid vehicle, respectively. The various drug to liquid and carrier to coating ratio were used to prepare liquisolid compacts. The formulated liquisolid tablets were evaluated for weight variation, hardness, drug content, friability and disintegration time. The in vitro release characteristics of the drug from tablets formulated by direct compression and liquisolid technique were compared in two different dissolution media. The tableting properties of the liquisolid compacts were within the acceptable limits and drug release rates were distinctly higher as compared to directly compressed tablets. The FTIR spectra showed no interaction between drug-excipient and disappearance of the characteristic absorption band of lovastatin in liquisolid formulations could be attributed to the formation of hydrogen bonding between the drug and liquid vehicle, which resulted in dissolution enhancement. Thus, the liquisolid technique was found to be a promising approach for improving the dissolution of a poorly soluble drug like lovastatin. PMID:26180274

  15. 21 CFR 520.1331 - Meclofenamic acid tablets.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 6 2014-04-01 2014-04-01 false Meclofenamic acid tablets. 520.1331 Section 520.1331 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED...) Limitations. For oral use only. Should not be administered to animals with congestive heart failure or...

  16. 21 CFR 520.445c - Chlortetracycline tablets and boluses.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 6 2010-04-01 2010-04-01 false Chlortetracycline tablets and boluses. 520.445c Section 520.445c Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES...) Related tolerances. See § 556.150 of this chapter. (d) National Academy of Sciences/National...

  17. 21 CFR 520.1696d - Penicillin V potassium tablets.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 6 2010-04-01 2010-04-01 false Penicillin V potassium tablets. 520.1696d Section 520.1696d Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES... Nos. 017144, 050604, and 053501 in § 510.600(c) of this chapter. (c) National Academy of...

  18. 21 CFR 520.445c - Chlortetracycline tablets and boluses.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 6 2011-04-01 2011-04-01 false Chlortetracycline tablets and boluses. 520.445c Section 520.445c Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES...) Related tolerances. See § 556.150 of this chapter. (d) National Academy of Sciences/National...

  19. 21 CFR 520.1696d - Penicillin V potassium tablets.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 6 2011-04-01 2011-04-01 false Penicillin V potassium tablets. 520.1696d Section 520.1696d Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES... Nos. 017144, 050604, and 053501 in § 510.600(c) of this chapter. (c) National Academy of...

  20. Bioadhesive Mini-Tablets for Vaginal Drug Delivery

    PubMed Central

    Hiorth, Marianne; Nilsen, Susanne; Tho, Ingunn

    2014-01-01

    Different non-ionic cellulose ethers (methyl cellulose, MC; hydroxyethyl cellulose, HEC; hydroxypropyl cellulose, HPC; hydroxypropylmethyl cellulose, HPMC) and microcrystalline cellulose (MCC) were investigated as matrix formers for preparation of mini-tablets targeting vaginal drug delivery. Hexyl aminolevulinat hydrochloridum (HAL) was used as a model drug. The mini-tablets were characterized with respect to their mechanical strength, bioadhesion towards cow vaginal tissue in two independent tests (rotating cylinder test, detachment test using texture analyzer), and dissolution rate in two media mimicking the pH levels of fertile, healthy and post-menopausal women (vaginal fluid simulant pH 4.5, phosphate buffer pH 6.8). Mini-tablets with a matrix of either HPMC or HPC were found to possess adequate mechanical strength, superior bioadhesive behavior towards vaginal tissue, and pH independent controlled release of the model drug, suggesting that both systems would be suited for the treatment of women regardless of age, i.e., respective of their vaginal pH levels. Bioadhesive mini-tablets offer a potential for improved residence time in the vaginal cavity targeting contact with mucosal tissue and prolonged release of the drug. PMID:25166286