Science.gov

Sample records for active ingredient isolated

  1. Development of a solvate as an active pharmaceutical ingredient: Developability, crystallisation and isolation challenges

    NASA Astrophysics Data System (ADS)

    Douillet, Julien; Stevenson, Neil; Lee, Mei; Mallet, Franck; Ward, Richard; Aspin, Peter; Dennehy, Daniel Robert; Camus, Laure

    2012-03-01

    The preclinical development of an active pharmaceutical ingredient (API) begins with the selection of a solid state form. A solvate may be selected for development if it is sufficiently stable and if the solvent quantity administered to the patient is lower than the tolerated potential daily exposure (PDE). The selection and process development of a solvate is presented here. The initial crystallisation process gave poor control over the particle size distribution (PSD) and inclusion of additional crystallisation solvent in the crystal lattice. These two API attributes were controlled using micronised seeds and optimising the crystallisation conditions. After filtration, slurry washing with a second solvent was used to replace the high boiling point crystallisation solvent to improve the drying efficiency. The slurry washing was modelled and studied in the laboratory to control the level of unbound crystallisation solvent in the API. The API desolvation during slurry washing was studied by considering thermodynamics, by construction of the ternary phase diagram, and kinetics aspects. This work provides useful approaches and considerations to assess the risks specific to the controlled production of a solvate that are rarely presented in the literature.

  2. Encapsulation of new active ingredients

    Technology Transfer Automated Retrieval System (TEKTRAN)

    The organic construct consumed as food comes packaged in units that carry the active components, protects the entrapped active materials until delivered to targeted human organ. The packaging and delivery role is mimicked in the microencapsulation tools used to deliver active ingredients in process...

  3. 21 CFR 347.20 - Permitted combinations of active ingredients.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ...) Combinations of skin protectant and sunscreen active ingredients. Any one (two when required to be in... single sunscreen active ingredient, or any permitted combination of these ingredients, provided...

  4. 21 CFR 347.20 - Permitted combinations of active ingredients.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ...) Combinations of skin protectant and sunscreen active ingredients. Any one (two when required to be in... single sunscreen active ingredient, or any permitted combination of these ingredients, provided...

  5. 21 CFR 347.20 - Permitted combinations of active ingredients.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ...) Combinations of skin protectant and sunscreen active ingredients. Any one (two when required to be in... single sunscreen active ingredient, or any permitted combination of these ingredients, provided...

  6. 21 CFR 347.20 - Permitted combinations of active ingredients.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ...) Combinations of skin protectant and sunscreen active ingredients. Any one (two when required to be in... single sunscreen active ingredient, or any permitted combination of these ingredients, provided...

  7. 21 CFR 347.20 - Permitted combinations of active ingredients.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ...) Combinations of skin protectant and sunscreen active ingredients. Any one (two when required to be in... single sunscreen active ingredient, or any permitted combination of these ingredients, provided...

  8. Rapid isolation and identification of active antioxidant ingredients from Gongju using HPLC-DAD-ESI-MS(n) and postcolumn derivatization.

    PubMed

    Cui, Gang; Niu, Yaru; Wang, Hong; Dong, Jing; Yuki, Hashi; Chen, Shizhong

    2012-05-30

    Flos Chrysanthemi (Gongju, GJ) is used to prepare a herbal tea that is commonly consumed as a health beverage in Asia and is believed to contain abundant beneficial antioxidants. To rapidly identify the chemical constituents and to obtain the profile related to antioxidant activity, an online analytical method combining high-performance liquid chromatography-diode-array detector-electrospray ionization-ion-trap time-of-flight mass spectrometry (HPLC-DAD-ESI-IT-TOF-MS(n)) and postcolumn derivatization (PCD) has been applied for a precise and thorough identification of the chemical constituents. Meanwhile, the antioxidant profile has also been characterized by directly measuring the scavenging activity of each compound for the free radical produced by DPPH. As a result, 13 compounds have been identified in GJ, 7 of which account for its antioxidant activity. The established LC-MS(n)-PCD system has proved to offer a useful strategy for correlating the chemical profile with the bioactivities of the components without their isolation and purification, and may be used for multicomponent analysis of active substances in other foods and herbs. PMID:22540938

  9. Active Pharmaceutical Ingredients and Aquatic Organisms

    EPA Science Inventory

    The presence of active pharmaceuticals ingredients (APIs) in aquatic systems in recent years has led to a burgeoning literature examining environmental occurrence, fate, effects, risk assessment, and treatability of these compounds. Although APIs have received much attention as ...

  10. PTSD: A Search for "Active Ingredients."

    ERIC Educational Resources Information Center

    Huber, Charles H.

    1997-01-01

    Family counselors working with individuals suffering the effects of trauma are encouraged to consider the "active ingredients" found by Charles Figley and Joyce Carbonell at Florida State University and reported in the two articles reviewed. (Author/MKA)

  11. Choleretic Activity of Turmeric and its Active Ingredients.

    PubMed

    Wang, Yonglu; Wang, Liyao; Zhu, Xinyi; Wang, Dong; Li, Xueming

    2016-07-01

    Turmeric, a rhizome of Curcumin longa L. is widely used as both a spice and an herbal medicine. The traditional use of turmeric in gastroenterology is mainly based on its choleretic activity. The aim of this study is to determine the effects of turmeric on bile flow (BF) and total bile acids (TBAs) excretion in a bile fistula rat model after acute duodenal administration. A significant dose-dependent enhancement in both BF and TBAs was detected after treatment with the turmeric decoctions which suggested the choleretic activity was bile acid-dependent secretion. In order to direct the active group of compounds, aqueous (AE), ethyl acetate (EtOAc), and petroleum ether (PE) extracts were investigated. The EtOAc and PE extracts showing high effects were purified to locate the active ingredients. Three curcuminoids (curcumin, demethoxycurcumin, and bisdemethoxycurcumin) and 2 sesquiterpenes (bisacurone B and ar-turmerone) were isolated. It was found Bisacurone B was the most potent choleretic ingredient followed by ar-turmerone, bisdemethoxycurcumin demethoxycurcumin, and then curcumin. The amounts of the active ingredients were quantitatively analyzed by high-performance liquid chromatography. The EtOAc and PE extracts had high sesquiterpenes and curcuminoids content, while the AE extract had poor content of sesquiterpenes and curcuminoids which affected neither BF nor TBAs. Based on the results of multiple linear regression analysis, the content of BIS and TUR were dominant factors (P < 0.01) of controlling BL and TBAs in EtOAC and PE extracts. PMID:27228476

  12. 21 CFR 352.10 - Sunscreen active ingredients.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 5 2012-04-01 2012-04-01 false Sunscreen active ingredients. 352.10 Section 352...) DRUGS FOR HUMAN USE SUNSCREEN DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE Active Ingredients § 352.10 Sunscreen active ingredients. The active ingredient of the product consists of any of the following,...

  13. 21 CFR 352.10 - Sunscreen active ingredients.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 5 2010-04-01 2010-04-01 false Sunscreen active ingredients. 352.10 Section 352...) DRUGS FOR HUMAN USE SUNSCREEN DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE Active Ingredients § 352.10 Sunscreen active ingredients. The active ingredient of the product consists of any of the following,...

  14. 21 CFR 352.10 - Sunscreen active ingredients.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 5 2011-04-01 2011-04-01 false Sunscreen active ingredients. 352.10 Section 352...) DRUGS FOR HUMAN USE SUNSCREEN DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE Active Ingredients § 352.10 Sunscreen active ingredients. The active ingredient of the product consists of any of the following,...

  15. 21 CFR 352.10 - Sunscreen active ingredients.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 5 2014-04-01 2014-04-01 false Sunscreen active ingredients. 352.10 Section 352...) DRUGS FOR HUMAN USE SUNSCREEN DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE Active Ingredients § 352.10 Sunscreen active ingredients. The active ingredient of the product consists of any of the following,...

  16. 21 CFR 352.10 - Sunscreen active ingredients.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 5 2013-04-01 2013-04-01 false Sunscreen active ingredients. 352.10 Section 352...) DRUGS FOR HUMAN USE SUNSCREEN DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE Active Ingredients § 352.10 Sunscreen active ingredients. The active ingredient of the product consists of any of the following,...

  17. 21 CFR 331.10 - Antacid active ingredients.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 5 2012-04-01 2012-04-01 false Antacid active ingredients. 331.10 Section 331.10... FOR HUMAN USE ANTACID PRODUCTS FOR OVER-THE-COUNTER (OTC) HUMAN USE Active Ingredients § 331.10 Antacid active ingredients. (a) The active antacid ingredients of the product consist of one or more...

  18. 21 CFR 331.10 - Antacid active ingredients.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 5 2013-04-01 2013-04-01 false Antacid active ingredients. 331.10 Section 331.10... FOR HUMAN USE ANTACID PRODUCTS FOR OVER-THE-COUNTER (OTC) HUMAN USE Active Ingredients § 331.10 Antacid active ingredients. (a) The active antacid ingredients of the product consist of one or more...

  19. 21 CFR 331.10 - Antacid active ingredients.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 5 2010-04-01 2010-04-01 false Antacid active ingredients. 331.10 Section 331.10... FOR HUMAN USE ANTACID PRODUCTS FOR OVER-THE-COUNTER (OTC) HUMAN USE Active Ingredients § 331.10 Antacid active ingredients. (a) The active antacid ingredients of the product consist of one or more...

  20. 21 CFR 331.10 - Antacid active ingredients.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 5 2011-04-01 2011-04-01 false Antacid active ingredients. 331.10 Section 331.10... FOR HUMAN USE ANTACID PRODUCTS FOR OVER-THE-COUNTER (OTC) HUMAN USE Active Ingredients § 331.10 Antacid active ingredients. (a) The active antacid ingredients of the product consist of one or more...

  1. 21 CFR 331.10 - Antacid active ingredients.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 5 2014-04-01 2014-04-01 false Antacid active ingredients. 331.10 Section 331.10... FOR HUMAN USE ANTACID PRODUCTS FOR OVER-THE-COUNTER (OTC) HUMAN USE Active Ingredients § 331.10 Antacid active ingredients. (a) The active antacid ingredients of the product consist of one or more...

  2. 21 CFR 343.12 - Cardiovascular active ingredients.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ...-COUNTER HUMAN USE Active Ingredients § 343.12 Cardiovascular active ingredients. (a) Aspirin. (b) Buffered aspirin. Aspirin identified in paragraph (a) of this section may be buffered with any antacid ingredient(s... milliequivalents of acid-neutralizing capacity per 325 milligrams of aspirin as measured by the procedure...

  3. 21 CFR 343.13 - Rheumatologic active ingredients.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ...-COUNTER HUMAN USE Active Ingredients § 343.13 Rheumatologic active ingredients. (a) Aspirin. (b) Buffered aspirin. Aspirin identified in paragraph (a) of this section may be buffered with any antacid ingredient(s... milliequivalents of acid-neutralizing capacity per 325 milligrams of aspirin as measured by the procedure...

  4. 21 CFR 343.12 - Cardiovascular active ingredients.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ...-COUNTER HUMAN USE Active Ingredients § 343.12 Cardiovascular active ingredients. (a) Aspirin. (b) Buffered aspirin. Aspirin identified in paragraph (a) of this section may be buffered with any antacid ingredient(s... milliequivalents of acid-neutralizing capacity per 325 milligrams of aspirin as measured by the procedure...

  5. 21 CFR 343.12 - Cardiovascular active ingredients.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ...-COUNTER HUMAN USE Active Ingredients § 343.12 Cardiovascular active ingredients. (a) Aspirin. (b) Buffered aspirin. Aspirin identified in paragraph (a) of this section may be buffered with any antacid ingredient(s... milliequivalents of acid-neutralizing capacity per 325 milligrams of aspirin as measured by the procedure...

  6. 21 CFR 343.13 - Rheumatologic active ingredients.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ...-COUNTER HUMAN USE Active Ingredients § 343.13 Rheumatologic active ingredients. (a) Aspirin. (b) Buffered aspirin. Aspirin identified in paragraph (a) of this section may be buffered with any antacid ingredient(s... milliequivalents of acid-neutralizing capacity per 325 milligrams of aspirin as measured by the procedure...

  7. 21 CFR 343.13 - Rheumatologic active ingredients.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ...-COUNTER HUMAN USE Active Ingredients § 343.13 Rheumatologic active ingredients. (a) Aspirin. (b) Buffered aspirin. Aspirin identified in paragraph (a) of this section may be buffered with any antacid ingredient(s... milliequivalents of acid-neutralizing capacity per 325 milligrams of aspirin as measured by the procedure...

  8. 21 CFR 343.13 - Rheumatologic active ingredients.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ...-COUNTER HUMAN USE Active Ingredients § 343.13 Rheumatologic active ingredients. (a) Aspirin. (b) Buffered aspirin. Aspirin identified in paragraph (a) of this section may be buffered with any antacid ingredient(s... milliequivalents of acid-neutralizing capacity per 325 milligrams of aspirin as measured by the procedure...

  9. 21 CFR 343.12 - Cardiovascular active ingredients.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ...-COUNTER HUMAN USE Active Ingredients § 343.12 Cardiovascular active ingredients. (a) Aspirin. (b) Buffered aspirin. Aspirin identified in paragraph (a) of this section may be buffered with any antacid ingredient(s... milliequivalents of acid-neutralizing capacity per 325 milligrams of aspirin as measured by the procedure...

  10. 21 CFR 343.13 - Rheumatologic active ingredients.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ...-COUNTER HUMAN USE Active Ingredients § 343.13 Rheumatologic active ingredients. (a) Aspirin. (b) Buffered aspirin. Aspirin identified in paragraph (a) of this section may be buffered with any antacid ingredient(s... milliequivalents of acid-neutralizing capacity per 325 milligrams of aspirin as measured by the procedure...

  11. 21 CFR 343.12 - Cardiovascular active ingredients.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ...-COUNTER HUMAN USE Active Ingredients § 343.12 Cardiovascular active ingredients. (a) Aspirin. (b) Buffered aspirin. Aspirin identified in paragraph (a) of this section may be buffered with any antacid ingredient(s... milliequivalents of acid-neutralizing capacity per 325 milligrams of aspirin as measured by the procedure...

  12. 21 CFR 346.14 - Protectant active ingredients.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 5 2014-04-01 2014-04-01 false Protectant active ingredients. 346.14 Section 346... Protectant active ingredients. (a) The following active ingredients may be used as the sole protectant active... solution so that the final product contains not less than 10 and not more than 45 percent glycerin...

  13. 21 CFR 333.120 - Permitted combinations of active ingredients.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... First Aid Antibiotic Drug Products § 333.120 Permitted combinations of active ingredients. The following... with a suitable filler. (b) Combinations of first aid antibiotic active ingredients and...

  14. 21 CFR 333.120 - Permitted combinations of active ingredients.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... First Aid Antibiotic Drug Products § 333.120 Permitted combinations of active ingredients. The following... with a suitable filler. (b) Combinations of first aid antibiotic active ingredients and...

  15. 21 CFR 333.120 - Permitted combinations of active ingredients.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... First Aid Antibiotic Drug Products § 333.120 Permitted combinations of active ingredients. The following... with a suitable filler. (b) Combinations of first aid antibiotic active ingredients and...

  16. 21 CFR 333.120 - Permitted combinations of active ingredients.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... First Aid Antibiotic Drug Products § 333.120 Permitted combinations of active ingredients. The following... with a suitable filler. (b) Combinations of first aid antibiotic active ingredients and...

  17. 21 CFR 344.12 - Ear drying aid active ingredient.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 5 2011-04-01 2011-04-01 false Ear drying aid active ingredient. 344.12 Section 344.12 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED....12 Ear drying aid active ingredient. The active ingredient of the product consists of...

  18. 21 CFR 344.12 - Ear drying aid active ingredient.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 5 2010-04-01 2010-04-01 false Ear drying aid active ingredient. 344.12 Section 344.12 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED....12 Ear drying aid active ingredient. The active ingredient of the product consists of...

  19. 21 CFR 344.12 - Ear drying aid active ingredient.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 5 2012-04-01 2012-04-01 false Ear drying aid active ingredient. 344.12 Section 344.12 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED....12 Ear drying aid active ingredient. The active ingredient of the product consists of...

  20. 21 CFR 344.12 - Ear drying aid active ingredient.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 5 2014-04-01 2014-04-01 false Ear drying aid active ingredient. 344.12 Section 344.12 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED....12 Ear drying aid active ingredient. The active ingredient of the product consists of...

  1. 21 CFR 344.12 - Ear drying aid active ingredient.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 5 2013-04-01 2013-04-01 false Ear drying aid active ingredient. 344.12 Section 344.12 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED....12 Ear drying aid active ingredient. The active ingredient of the product consists of...

  2. 21 CFR 347.10 - Skin protectant active ingredients.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 5 2013-04-01 2013-04-01 false Skin protectant active ingredients. 347.10 Section 347.10 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED... § 347.10 Skin protectant active ingredients. The active ingredients of the product consist of any of...

  3. 21 CFR 347.12 - Astringent active ingredients.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 5 2011-04-01 2011-04-01 false Astringent active ingredients. 347.12 Section 347.12 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED... § 347.12 Astringent active ingredients. The active ingredient of the product consists of any one of...

  4. 21 CFR 347.10 - Skin protectant active ingredients.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 5 2012-04-01 2012-04-01 false Skin protectant active ingredients. 347.10 Section 347.10 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED... § 347.10 Skin protectant active ingredients. The active ingredients of the product consist of any of...

  5. 21 CFR 347.12 - Astringent active ingredients.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 5 2013-04-01 2013-04-01 false Astringent active ingredients. 347.12 Section 347.12 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED... § 347.12 Astringent active ingredients. The active ingredient of the product consists of any one of...

  6. 21 CFR 347.12 - Astringent active ingredients.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 5 2010-04-01 2010-04-01 false Astringent active ingredients. 347.12 Section 347.12 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED... § 347.12 Astringent active ingredients. The active ingredient of the product consists of any one of...

  7. 21 CFR 347.10 - Skin protectant active ingredients.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 5 2011-04-01 2011-04-01 false Skin protectant active ingredients. 347.10 Section 347.10 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED... § 347.10 Skin protectant active ingredients. The active ingredients of the product consist of any of...

  8. 21 CFR 347.12 - Astringent active ingredients.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 5 2012-04-01 2012-04-01 false Astringent active ingredients. 347.12 Section 347.12 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED... § 347.12 Astringent active ingredients. The active ingredient of the product consists of any one of...

  9. 21 CFR 347.12 - Astringent active ingredients.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 5 2014-04-01 2014-04-01 false Astringent active ingredients. 347.12 Section 347.12 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED... § 347.12 Astringent active ingredients. The active ingredient of the product consists of any one of...

  10. 21 CFR 346.10 - Local anesthetic active ingredients.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 5 2010-04-01 2010-04-01 false Local anesthetic active ingredients. 346.10 Section 346.10 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES... § 346.10 Local anesthetic active ingredients. The active ingredient of the product consists of any...

  11. 21 CFR 346.10 - Local anesthetic active ingredients.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 5 2013-04-01 2013-04-01 false Local anesthetic active ingredients. 346.10 Section 346.10 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES... § 346.10 Local anesthetic active ingredients. The active ingredient of the product consists of any...

  12. 21 CFR 346.10 - Local anesthetic active ingredients.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 5 2012-04-01 2012-04-01 false Local anesthetic active ingredients. 346.10 Section 346.10 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES... § 346.10 Local anesthetic active ingredients. The active ingredient of the product consists of any...

  13. 21 CFR 346.10 - Local anesthetic active ingredients.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 5 2014-04-01 2014-04-01 false Local anesthetic active ingredients. 346.10 Section 346.10 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES... § 346.10 Local anesthetic active ingredients. The active ingredient of the product consists of any...

  14. 21 CFR 346.10 - Local anesthetic active ingredients.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 5 2011-04-01 2011-04-01 false Local anesthetic active ingredients. 346.10 Section 346.10 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES... § 346.10 Local anesthetic active ingredients. The active ingredient of the product consists of any...

  15. 21 CFR 333.310 - Acne active ingredients.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 5 2011-04-01 2011-04-01 false Acne active ingredients. 333.310 Section 333.310... FOR HUMAN USE TOPICAL ANTIMICROBIAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE Topical Acne Drug Products § 333.310 Acne active ingredients. The active ingredient of the product consists of any of...

  16. 21 CFR 333.310 - Acne active ingredients.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 5 2013-04-01 2013-04-01 false Acne active ingredients. 333.310 Section 333.310... FOR HUMAN USE TOPICAL ANTIMICROBIAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE Topical Acne Drug Products § 333.310 Acne active ingredients. The active ingredient of the product consists of any of...

  17. 21 CFR 333.310 - Acne active ingredients.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 5 2012-04-01 2012-04-01 false Acne active ingredients. 333.310 Section 333.310... FOR HUMAN USE TOPICAL ANTIMICROBIAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE Topical Acne Drug Products § 333.310 Acne active ingredients. The active ingredient of the product consists of any of...

  18. 21 CFR 333.310 - Acne active ingredients.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 5 2014-04-01 2014-04-01 false Acne active ingredients. 333.310 Section 333.310... FOR HUMAN USE TOPICAL ANTIMICROBIAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE Topical Acne Drug Products § 333.310 Acne active ingredients. The active ingredient of the product consists of any of...

  19. 21 CFR 333.310 - Acne active ingredients.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 5 2010-04-01 2010-04-01 false Acne active ingredients. 333.310 Section 333.310... FOR HUMAN USE TOPICAL ANTIMICROBIAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE Topical Acne Drug Products § 333.310 Acne active ingredients. The active ingredient of the product consists of any of...

  20. 21 CFR 341.40 - Permitted combinations of active ingredients.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... ingredients, or any aspirin and antacid combination provided that the product is labeled according to § 341.85... combination of acetaminophen with other analgesic-antipyretic active ingredients, or any aspirin and antacid... other analgesic-antipyretic active ingredients, or any aspirin and antacid combination provided that...

  1. 21 CFR 341.40 - Permitted combinations of active ingredients.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... ingredients, or any aspirin and antacid combination provided that the product is labeled according to § 341.85... combination of acetaminophen with other analgesic-antipyretic active ingredients, or any aspirin and antacid... other analgesic-antipyretic active ingredients, or any aspirin and antacid combination provided that...

  2. 21 CFR 341.40 - Permitted combinations of active ingredients.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... ingredients, or any aspirin and antacid combination provided that the product is labeled according to § 341.85... combination of acetaminophen with other analgesic-antipyretic active ingredients, or any aspirin and antacid... other analgesic-antipyretic active ingredients, or any aspirin and antacid combination provided that...

  3. 21 CFR 341.40 - Permitted combinations of active ingredients.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... ingredients, or any aspirin and antacid combination provided that the product is labeled according to § 341.85... combination of acetaminophen with other analgesic-antipyretic active ingredients, or any aspirin and antacid... other analgesic-antipyretic active ingredients, or any aspirin and antacid combination provided that...

  4. Polyphenols as active ingredients for cosmetic products.

    PubMed

    Zillich, O V; Schweiggert-Weisz, U; Eisner, P; Kerscher, M

    2015-10-01

    Polyphenols are secondary plant metabolites with antioxidant, anti-inflammatory and anti-microbial activity. They are ubiquitously distributed in the plant kingdom; high amounts contain, for example, green tea and grape seeds. Polyphenolic extracts are attractive ingredients for cosmetics and pharmacy due to their beneficial biological properties. This review summarizes the effects of polyphenols in the context of anti-ageing activity. We have explored in vitro studies, which investigate antioxidant activity, inhibition of dermal proteases and photoprotective activity, mostly studied using dermal fibroblasts or epidermal keratinocytes cell lines. Possible negative effects of polyphenols were also discussed. Further, some physicochemical aspects, namely the possible interactions with emulsifiers and the influence of the cosmetic formulation on the skin delivery, were reported. Finally, few clinical studies, which cover the anti-ageing action of polyphenols on the skin after topical application, were reviewed. PMID:25712493

  5. Evaporation drift of pesticides active ingredients.

    PubMed

    De Schampheleire, M; Nuyttens, D; De Keyser, D; Spanoghe, P

    2008-01-01

    Losses of pesticide active ingredients (a.i.) into the atmosphere can occur through several pathways. A main pathway is evaporation drift. The evaporation process of pesticide a.i., after application, is affected by three main factors: Physicochemical properties of the pesticide a.i., weather conditions and crop structure. The main physicochemical parameters are the Henry coefficient, which is a measure for the volatilization tendency of the pesticide a.i. from a dilute aqueous solution, and the vapour pressure, which is a measure for the volatilization tendency of the pesticide a.i. from the solid phase. Five pesticide a.i., with various Henry coefficients and various vapour pressures, were selected to conduct laboratory experiments: metalaxyl-m, dichlorovos, diazinon, Lindane and trifluralin. Evaporation experiments were conducted in a volatilization chamber. It was found that the evaporation tendencies significantly differed according to the physicochemical properties of the a.i. PMID:19226822

  6. 21 CFR 352.20 - Permitted combinations of active ingredients.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... SERVICES (CONTINUED) DRUGS FOR HUMAN USE SUNSCREEN DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE Active... measured by the testing procedures established in subpart D of this part. (a) Combinations of sunscreen active ingredients. (1) Two or more sunscreen active ingredients identified in § 352.10(a), (c), (e),...

  7. 21 CFR 352.20 - Permitted combinations of active ingredients.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... SERVICES (CONTINUED) DRUGS FOR HUMAN USE SUNSCREEN DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE Active... measured by the testing procedures established in subpart D of this part. (a) Combinations of sunscreen active ingredients. (1) Two or more sunscreen active ingredients identified in § 352.10(a), (c), (e),...

  8. 21 CFR 352.20 - Permitted combinations of active ingredients.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... SERVICES (CONTINUED) DRUGS FOR HUMAN USE SUNSCREEN DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE Active... measured by the testing procedures established in subpart D of this part. (a) Combinations of sunscreen active ingredients. (1) Two or more sunscreen active ingredients identified in § 352.10(a), (c), (e),...

  9. 21 CFR 352.20 - Permitted combinations of active ingredients.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... SERVICES (CONTINUED) DRUGS FOR HUMAN USE SUNSCREEN DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE Active... measured by the testing procedures established in subpart D of this part. (a) Combinations of sunscreen active ingredients. (1) Two or more sunscreen active ingredients identified in § 352.10(a), (c), (e),...

  10. 21 CFR 352.20 - Permitted combinations of active ingredients.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... SERVICES (CONTINUED) DRUGS FOR HUMAN USE SUNSCREEN DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE Active... measured by the testing procedures established in subpart D of this part. (a) Combinations of sunscreen active ingredients. (1) Two or more sunscreen active ingredients identified in § 352.10(a), (c), (e),...

  11. 21 CFR 347.10 - Skin protectant active ingredients.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 5 2014-04-01 2014-04-01 false Skin protectant active ingredients. 347.10 Section 347.10 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS FOR HUMAN USE SKIN PROTECTANT DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE Active Ingredients § 347.10 Skin protectant active...

  12. 21 CFR 333.110 - First aid antibiotic active ingredients.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 5 2010-04-01 2010-04-01 false First aid antibiotic active ingredients. 333.110... (CONTINUED) DRUGS FOR HUMAN USE TOPICAL ANTIMICROBIAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE First Aid Antibiotic Drug Products § 333.110 First aid antibiotic active ingredients. The product consists of any...

  13. 21 CFR 333.110 - First aid antibiotic active ingredients.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 5 2011-04-01 2011-04-01 false First aid antibiotic active ingredients. 333.110... (CONTINUED) DRUGS FOR HUMAN USE TOPICAL ANTIMICROBIAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE First Aid Antibiotic Drug Products § 333.110 First aid antibiotic active ingredients. The product consists of any...

  14. 21 CFR 333.110 - First aid antibiotic active ingredients.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 5 2013-04-01 2013-04-01 false First aid antibiotic active ingredients. 333.110... (CONTINUED) DRUGS FOR HUMAN USE TOPICAL ANTIMICROBIAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE First Aid Antibiotic Drug Products § 333.110 First aid antibiotic active ingredients. The product consists of any...

  15. 21 CFR 333.110 - First aid antibiotic active ingredients.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 5 2012-04-01 2012-04-01 false First aid antibiotic active ingredients. 333.110... (CONTINUED) DRUGS FOR HUMAN USE TOPICAL ANTIMICROBIAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE First Aid Antibiotic Drug Products § 333.110 First aid antibiotic active ingredients. The product consists of any...

  16. 21 CFR 331.15 - Combination with nonantacid active ingredients.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... SERVICES (CONTINUED) DRUGS FOR HUMAN USE ANTACID PRODUCTS FOR OVER-THE-COUNTER (OTC) HUMAN USE Active Ingredients § 331.15 Combination with nonantacid active ingredients. (a) An antacid may contain any generally... antacid. No labeling claim of the laxative effect may be used for such a product. (b) An antacid...

  17. 21 CFR 331.15 - Combination with nonantacid active ingredients.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... SERVICES (CONTINUED) DRUGS FOR HUMAN USE ANTACID PRODUCTS FOR OVER-THE-COUNTER (OTC) HUMAN USE Active Ingredients § 331.15 Combination with nonantacid active ingredients. (a) An antacid may contain any generally... antacid. No labeling claim of the laxative effect may be used for such a product. (b) An antacid...

  18. 21 CFR 331.15 - Combination with nonantacid active ingredients.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... SERVICES (CONTINUED) DRUGS FOR HUMAN USE ANTACID PRODUCTS FOR OVER-THE-COUNTER (OTC) HUMAN USE Active Ingredients § 331.15 Combination with nonantacid active ingredients. (a) An antacid may contain any generally... antacid. No labeling claim of the laxative effect may be used for such a product. (b) An antacid...

  19. 21 CFR 331.15 - Combination with nonantacid active ingredients.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... SERVICES (CONTINUED) DRUGS FOR HUMAN USE ANTACID PRODUCTS FOR OVER-THE-COUNTER (OTC) HUMAN USE Active Ingredients § 331.15 Combination with nonantacid active ingredients. (a) An antacid may contain any generally... antacid. No labeling claim of the laxative effect may be used for such a product. (b) An antacid...

  20. 21 CFR 331.15 - Combination with nonantacid active ingredients.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... SERVICES (CONTINUED) DRUGS FOR HUMAN USE ANTACID PRODUCTS FOR OVER-THE-COUNTER (OTC) HUMAN USE Active Ingredients § 331.15 Combination with nonantacid active ingredients. (a) An antacid may contain any generally... antacid. No labeling claim of the laxative effect may be used for such a product. (b) An antacid...

  1. 21 CFR 341.14 - Antitussive active ingredients.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 5 2011-04-01 2011-04-01 false Antitussive active ingredients. 341.14 Section 341.14 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS FOR HUMAN USE COLD, COUGH, ALLERGY, BRONCHODILATOR, AND ANTIASTHMATIC DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE Active Ingredients §...

  2. 75 FR 6386 - Pesticide Products; Registration Applications for a New Active Ingredient Chemical; Demiditraz

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-02-09

    ... AGENCY Pesticide Products; Registration Applications for a New Active Ingredient Chemical; Demiditraz.... Product name: Demiditraz Technical. Active ingredient: Insecticide and Demiditraz at 100%. Proposed...., Kalamazoo, MI 49001. Product name: CA Acaricide. Active ingredient: Insecticide and Demiditraz at...

  3. Antiproliferative activities of Garcinia bracteata extract and its active ingredient, isobractatin, against human tumor cell lines.

    PubMed

    Shen, Tao; Li, Wei; Wang, Yan-Yan; Zhong, Qing-Qing; Wang, Shu-Qi; Wang, Xiao-Ning; Ren, Dong-Mei; Lou, Hong-Xiang

    2014-03-01

    In our cell based screening of antitumor ingredients from plants, the EtOH extract of Garcinia bracteata displayed antiproliferative effect against human lung adenocarcinoma A549 cells, human breast cancer MCF-7 cells, and human prostate cancer PC3 cells. Phytochemical investigation of this active extract produced nine ingredients, and their structures were established by analysis of MS and NMR spectra. Antiproliferative evaluation of isolated ingredients on A549, MCF-7 and PC3 cells indicated that a xanthone named isobractatin (1) exhibited potent antiproliferative activity against the above three human cancer cell lines with IC50 values ranging from 2.90 to 4.15 μM. Treatment of PC3 cells with 1 led to an enhancement of the cell apoptosis, and arrested cell cycle in the G0/G1 phase. The G0/G1 phase cycle-related proteins analysis showed that the expressions of cyclins D1 and E were reduced by 1, whereas the protein level of cyclin dependent kinase (CDK) inhibitor P21 was induced. Additionally, 1 enhanced PC3 cell apoptosis by activations of Bax, caspases 3 and 9, and by inhibition of Bcl-2. Our combined data illustrated that isobractatin (1) was the antiproliferative ingredient of G. bracteata against three human cancer cell lines, which exerted its antiproliferatrive effect via cell cycle arrest and induction of apoptosis. PMID:23812779

  4. Study on THz spectra of the active ingredients in the TCM

    NASA Astrophysics Data System (ADS)

    Ma, ShiHua; Wang, WenFeng; Liu, GuiFeng; Ge, Min; Zhu, ZhiYong

    2008-03-01

    Terahertz spectroscopy has tremendous potential for applications to evaluate the quality of the drugs including the TCM. In this paper, the Terahertz Time-Domain Spectroscopy investigated two active ingredients: Andrographolide and Dehydroandrographoline, isolated from Andrographis paniculata (Burm. f.) Nees. We also measured the mixtures of two active ingredients at the different ratio and the quantitative analysis is also applied to determine the contents of compound. The Terahertz spectroscopy is a potential and promising technique in identifying the components, evaluating the drugs sanitation and inspecting the quality of medicine including TCM.

  5. 21 CFR 338.10 - Nighttime sleep-aid active ingredients.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 5 2012-04-01 2012-04-01 false Nighttime sleep-aid active ingredients. 338.10... (CONTINUED) DRUGS FOR HUMAN USE NIGHTTIME SLEEP-AID DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE Active Ingredients § 338.10 Nighttime sleep-aid active ingredients. The active ingredient of the product consists...

  6. 21 CFR 338.10 - Nighttime sleep-aid active ingredients.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 5 2010-04-01 2010-04-01 false Nighttime sleep-aid active ingredients. 338.10... (CONTINUED) DRUGS FOR HUMAN USE NIGHTTIME SLEEP-AID DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE Active Ingredients § 338.10 Nighttime sleep-aid active ingredients. The active ingredient of the product consists...

  7. 21 CFR 338.10 - Nighttime sleep-aid active ingredients.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 5 2014-04-01 2014-04-01 false Nighttime sleep-aid active ingredients. 338.10... (CONTINUED) DRUGS FOR HUMAN USE NIGHTTIME SLEEP-AID DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE Active Ingredients § 338.10 Nighttime sleep-aid active ingredients. The active ingredient of the product consists...

  8. 21 CFR 338.10 - Nighttime sleep-aid active ingredients.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 5 2013-04-01 2013-04-01 false Nighttime sleep-aid active ingredients. 338.10... (CONTINUED) DRUGS FOR HUMAN USE NIGHTTIME SLEEP-AID DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE Active Ingredients § 338.10 Nighttime sleep-aid active ingredients. The active ingredient of the product consists...

  9. 21 CFR 338.10 - Nighttime sleep-aid active ingredients.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 5 2011-04-01 2011-04-01 false Nighttime sleep-aid active ingredients. 338.10... (CONTINUED) DRUGS FOR HUMAN USE NIGHTTIME SLEEP-AID DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE Active Ingredients § 338.10 Nighttime sleep-aid active ingredients. The active ingredient of the product consists...

  10. Pharmacokinetics in the oral cavity: fluoride and other active ingredients.

    PubMed

    Duckworth, Ralph M

    2013-01-01

    Modern commercial toothpastes contain therapeutic ingredients to combat various oral conditions, for example, caries, gingivitis, calculus and tooth stain. The efficient delivery and retention of such ingredients in the mouth is essential for good performance. The aim of this chapter is to review the literature on the oral pharmacokinetics of, primarily, fluoride but also other active ingredients, mainly anti-plaque agents. Elevated levels of fluoride have been found in saliva, plaque and the oral soft tissues after use of fluoridated toothpaste, which persist at potentially active concentrations for hours. Both experiment and mathematical modelling suggest that the soft tissues are the main oral reservoir for fluoride. Qualitatively similar observations have been made for anti-plaque agents such as triclosan and metal cations, though their oral substantivity is generally greater. Scope for improved retention and subsequent efficacy exists. PMID:23817065

  11. 21 CFR 346.16 - Analgesic, anesthetic, and antipruritic active ingredients.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 5 2011-04-01 2011-04-01 false Analgesic, anesthetic, and antipruritic active ingredients. 346.16 Section 346.16 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN... Ingredients § 346.16 Analgesic, anesthetic, and antipruritic active ingredients. The active ingredient of...

  12. 21 CFR 346.16 - Analgesic, anesthetic, and antipruritic active ingredients.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 5 2012-04-01 2012-04-01 false Analgesic, anesthetic, and antipruritic active ingredients. 346.16 Section 346.16 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN... Ingredients § 346.16 Analgesic, anesthetic, and antipruritic active ingredients. The active ingredient of...

  13. 21 CFR 346.16 - Analgesic, anesthetic, and antipruritic active ingredients.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 5 2010-04-01 2010-04-01 false Analgesic, anesthetic, and antipruritic active ingredients. 346.16 Section 346.16 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN... Ingredients § 346.16 Analgesic, anesthetic, and antipruritic active ingredients. The active ingredient of...

  14. 21 CFR 346.16 - Analgesic, anesthetic, and antipruritic active ingredients.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 5 2013-04-01 2013-04-01 false Analgesic, anesthetic, and antipruritic active ingredients. 346.16 Section 346.16 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN... Ingredients § 346.16 Analgesic, anesthetic, and antipruritic active ingredients. The active ingredient of...

  15. 21 CFR 346.16 - Analgesic, anesthetic, and antipruritic active ingredients.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 5 2014-04-01 2014-04-01 false Analgesic, anesthetic, and antipruritic active ingredients. 346.16 Section 346.16 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN... Ingredients § 346.16 Analgesic, anesthetic, and antipruritic active ingredients. The active ingredient of...

  16. 21 CFR 341.20 - Nasal decongestant active ingredients.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 5 2010-04-01 2010-04-01 false Nasal decongestant active ingredients. 341.20 Section 341.20 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS FOR HUMAN USE COLD, COUGH, ALLERGY, BRONCHODILATOR, AND ANTIASTHMATIC DRUG PRODUCTS...

  17. 21 CFR 341.16 - Bronchodilator active ingredients.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 5 2010-04-01 2010-04-01 false Bronchodilator active ingredients. 341.16 Section 341.16 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS FOR HUMAN USE COLD, COUGH, ALLERGY, BRONCHODILATOR, AND ANTIASTHMATIC DRUG PRODUCTS FOR...

  18. 21 CFR 341.18 - Expectorant active ingredient.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 5 2010-04-01 2010-04-01 false Expectorant active ingredient. 341.18 Section 341.18 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS FOR HUMAN USE COLD, COUGH, ALLERGY, BRONCHODILATOR, AND ANTIASTHMATIC DRUG PRODUCTS FOR...

  19. 21 CFR 341.12 - Antihistamine active ingredients.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 5 2010-04-01 2010-04-01 false Antihistamine active ingredients. 341.12 Section 341.12 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS FOR HUMAN USE COLD, COUGH, ALLERGY, BRONCHODILATOR, AND ANTIASTHMATIC DRUG PRODUCTS FOR...

  20. 21 CFR 331.11 - Listing of specific active ingredients.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... ion; maximum daily dosage limit 200 mEq. for persons up to 60 years old and 100 mEq. for persons 60...., 8 grams calcium carbonate). (e) Citrate-containing active ingredients: Citrate ion, as citric acid... effervescent preparation); maximum daily dosage limit 200 mEq. of bicarbonate ion for persons up to 60...

  1. 21 CFR 331.11 - Listing of specific active ingredients.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... ion; maximum daily dosage limit 200 mEq. for persons up to 60 years old and 100 mEq. for persons 60...., 8 grams calcium carbonate). (e) Citrate-containing active ingredients: Citrate ion, as citric acid... effervescent preparation); maximum daily dosage limit 200 mEq. of bicarbonate ion for persons up to 60...

  2. 21 CFR 331.11 - Listing of specific active ingredients.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... ion; maximum daily dosage limit 200 mEq. for persons up to 60 years old and 100 mEq. for persons 60...., 8 grams calcium carbonate). (e) Citrate-containing active ingredients: Citrate ion, as citric acid... effervescent preparation); maximum daily dosage limit 200 mEq. of bicarbonate ion for persons up to 60...

  3. 21 CFR 331.11 - Listing of specific active ingredients.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... ion; maximum daily dosage limit 200 mEq. for persons up to 60 years old and 100 mEq. for persons 60...., 8 grams calcium carbonate). (e) Citrate-containing active ingredients: Citrate ion, as citric acid... effervescent preparation); maximum daily dosage limit 200 mEq. of bicarbonate ion for persons up to 60...

  4. 21 CFR 331.11 - Listing of specific active ingredients.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... ion; maximum daily dosage limit 200 mEq. for persons up to 60 years old and 100 mEq. for persons 60...., 8 grams calcium carbonate). (e) Citrate-containing active ingredients: Citrate ion, as citric acid... effervescent preparation); maximum daily dosage limit 200 mEq. of bicarbonate ion for persons up to 60...

  5. 21 CFR 358.720 - Permitted combinations of active ingredients.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 5 2014-04-01 2014-04-01 false Permitted combinations of active ingredients. 358.720 Section 358.720 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS FOR HUMAN USE MISCELLANEOUS EXTERNAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE Drug Products for the Control of...

  6. 21 CFR 358.720 - Permitted combinations of active ingredients.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 5 2010-04-01 2010-04-01 false Permitted combinations of active ingredients. 358.720 Section 358.720 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS FOR HUMAN USE MISCELLANEOUS EXTERNAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE Drug Products for the Control of...

  7. 21 CFR 358.310 - Ingrown toenail relief active ingredient.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 5 2010-04-01 2010-04-01 false Ingrown toenail relief active ingredient. 358.310 Section 358.310 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS FOR HUMAN USE MISCELLANEOUS EXTERNAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE Ingrown Toenail Relief Drug Products §...

  8. 21 CFR 333.110 - First aid antibiotic active ingredients.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 5 2014-04-01 2014-04-01 false First aid antibiotic active ingredients. 333.110 Section 333.110 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS FOR HUMAN USE TOPICAL ANTIMICROBIAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE First Aid Antibiotic Drug Products § 333.110...

  9. 21 CFR 333.120 - Permitted combinations of active ingredients.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 5 2014-04-01 2014-04-01 false Permitted combinations of active ingredients. 333.120 Section 333.120 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS FOR HUMAN USE TOPICAL ANTIMICROBIAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE First Aid Antibiotic Drug Products §...

  10. 21 CFR 358.720 - Permitted combinations of active ingredients.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 5 2013-04-01 2013-04-01 false Permitted combinations of active ingredients. 358.720 Section 358.720 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS FOR HUMAN USE MISCELLANEOUS EXTERNAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE Drug Products for the Control of...

  11. 21 CFR 358.720 - Permitted combinations of active ingredients.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 5 2012-04-01 2012-04-01 false Permitted combinations of active ingredients. 358.720 Section 358.720 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS FOR HUMAN USE MISCELLANEOUS EXTERNAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE Drug Products for the Control of...

  12. 21 CFR 358.110 - Wart remover active ingredients.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 5 2011-04-01 2011-04-01 false Wart remover active ingredients. 358.110 Section 358.110 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS FOR HUMAN USE MISCELLANEOUS EXTERNAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE Wart Remover Drug Products § 358.110 Wart remover...

  13. 21 CFR 358.720 - Permitted combinations of active ingredients.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 5 2011-04-01 2011-04-01 false Permitted combinations of active ingredients. 358.720 Section 358.720 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS FOR HUMAN USE MISCELLANEOUS EXTERNAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE Drug Products for the Control of...

  14. 21 CFR 341.16 - Bronchodilator active ingredients.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 5 2011-04-01 2011-04-01 false Bronchodilator active ingredients. 341.16 Section 341.16 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS FOR HUMAN USE COLD, COUGH, ALLERGY, BRONCHODILATOR, AND ANTIASTHMATIC DRUG PRODUCTS FOR...

  15. 21 CFR 341.16 - Bronchodilator active ingredients.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 5 2013-04-01 2013-04-01 false Bronchodilator active ingredients. 341.16 Section 341.16 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS FOR HUMAN USE COLD, COUGH, ALLERGY, BRONCHODILATOR, AND ANTIASTHMATIC DRUG PRODUCTS FOR...

  16. 21 CFR 341.20 - Nasal decongestant active ingredients.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 5 2014-04-01 2014-04-01 false Nasal decongestant active ingredients. 341.20 Section 341.20 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS FOR HUMAN USE COLD, COUGH, ALLERGY, BRONCHODILATOR, AND ANTIASTHMATIC DRUG PRODUCTS...

  17. 21 CFR 341.16 - Bronchodilator active ingredients.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 5 2012-04-01 2012-04-01 false Bronchodilator active ingredients. 341.16 Section 341.16 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS FOR HUMAN USE COLD, COUGH, ALLERGY, BRONCHODILATOR, AND ANTIASTHMATIC DRUG PRODUCTS FOR...

  18. 21 CFR 341.20 - Nasal decongestant active ingredients.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 5 2012-04-01 2012-04-01 false Nasal decongestant active ingredients. 341.20 Section 341.20 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS FOR HUMAN USE COLD, COUGH, ALLERGY, BRONCHODILATOR, AND ANTIASTHMATIC DRUG PRODUCTS...

  19. 21 CFR 341.12 - Antihistamine active ingredients.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 5 2012-04-01 2012-04-01 false Antihistamine active ingredients. 341.12 Section 341.12 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS FOR HUMAN USE COLD, COUGH, ALLERGY, BRONCHODILATOR, AND ANTIASTHMATIC DRUG PRODUCTS FOR...

  20. 21 CFR 341.12 - Antihistamine active ingredients.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 5 2014-04-01 2014-04-01 false Antihistamine active ingredients. 341.12 Section 341.12 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS FOR HUMAN USE COLD, COUGH, ALLERGY, BRONCHODILATOR, AND ANTIASTHMATIC DRUG PRODUCTS FOR...

  1. 21 CFR 341.16 - Bronchodilator active ingredients.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 5 2014-04-01 2014-04-01 false Bronchodilator active ingredients. 341.16 Section 341.16 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS FOR HUMAN USE COLD, COUGH, ALLERGY, BRONCHODILATOR, AND ANTIASTHMATIC DRUG PRODUCTS FOR...

  2. 21 CFR 341.12 - Antihistamine active ingredients.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 5 2011-04-01 2011-04-01 false Antihistamine active ingredients. 341.12 Section 341.12 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS FOR HUMAN USE COLD, COUGH, ALLERGY, BRONCHODILATOR, AND ANTIASTHMATIC DRUG PRODUCTS FOR...

  3. 21 CFR 341.12 - Antihistamine active ingredients.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 5 2013-04-01 2013-04-01 false Antihistamine active ingredients. 341.12 Section 341.12 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS FOR HUMAN USE COLD, COUGH, ALLERGY, BRONCHODILATOR, AND ANTIASTHMATIC DRUG PRODUCTS FOR...

  4. 21 CFR 341.20 - Nasal decongestant active ingredients.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 5 2011-04-01 2011-04-01 false Nasal decongestant active ingredients. 341.20 Section 341.20 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS FOR HUMAN USE COLD, COUGH, ALLERGY, BRONCHODILATOR, AND ANTIASTHMATIC DRUG PRODUCTS...

  5. 21 CFR 341.18 - Expectorant active ingredient.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 5 2014-04-01 2014-04-01 false Expectorant active ingredient. 341.18 Section 341.18 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS FOR HUMAN USE COLD, COUGH, ALLERGY, BRONCHODILATOR, AND ANTIASTHMATIC DRUG PRODUCTS FOR...

  6. 21 CFR 341.18 - Expectorant active ingredient.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 5 2012-04-01 2012-04-01 false Expectorant active ingredient. 341.18 Section 341.18 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS FOR HUMAN USE COLD, COUGH, ALLERGY, BRONCHODILATOR, AND ANTIASTHMATIC DRUG PRODUCTS FOR...

  7. 21 CFR 341.20 - Nasal decongestant active ingredients.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 5 2013-04-01 2013-04-01 false Nasal decongestant active ingredients. 341.20 Section 341.20 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS FOR HUMAN USE COLD, COUGH, ALLERGY, BRONCHODILATOR, AND ANTIASTHMATIC DRUG PRODUCTS...

  8. 21 CFR 341.18 - Expectorant active ingredient.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 5 2013-04-01 2013-04-01 false Expectorant active ingredient. 341.18 Section 341.18 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS FOR HUMAN USE COLD, COUGH, ALLERGY, BRONCHODILATOR, AND ANTIASTHMATIC DRUG PRODUCTS FOR...

  9. 21 CFR 341.18 - Expectorant active ingredient.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 5 2011-04-01 2011-04-01 false Expectorant active ingredient. 341.18 Section 341.18 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS FOR HUMAN USE COLD, COUGH, ALLERGY, BRONCHODILATOR, AND ANTIASTHMATIC DRUG PRODUCTS FOR...

  10. 21 CFR 357.210 - Cholecystokinetic active ingredients.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 5 2013-04-01 2013-04-01 false Cholecystokinetic active ingredients. 357.210 Section 357.210 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS FOR HUMAN USE MISCELLANEOUS INTERNAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE Cholecystokinetic Drug Products §...

  11. 21 CFR 350.10 - Antiperspirant active ingredients.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... any buffer component present in the compound, in an aerosol or nonaerosol dosage form. The..., omitting from the calculation any buffer component present in the compound, in a nonaerosol dosage form. The labeled declaration of the percentage of the active ingredient should exclude any water,...

  12. 21 CFR 350.10 - Antiperspirant active ingredients.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... any buffer component present in the compound, in an aerosol or nonaerosol dosage form. The..., omitting from the calculation any buffer component present in the compound, in a nonaerosol dosage form. The labeled declaration of the percentage of the active ingredient should exclude any water,...

  13. 21 CFR 350.10 - Antiperspirant active ingredients.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... any buffer component present in the compound, in an aerosol or nonaerosol dosage form. The..., omitting from the calculation any buffer component present in the compound, in a nonaerosol dosage form. The labeled declaration of the percentage of the active ingredient should exclude any water,...

  14. 21 CFR 350.10 - Antiperspirant active ingredients.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... any buffer component present in the compound, in an aerosol or nonaerosol dosage form. The..., omitting from the calculation any buffer component present in the compound, in a nonaerosol dosage form. The labeled declaration of the percentage of the active ingredient should exclude any water,...

  15. 21 CFR 350.10 - Antiperspirant active ingredients.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... any buffer component present in the compound, in an aerosol or nonaerosol dosage form. The..., omitting from the calculation any buffer component present in the compound, in a nonaerosol dosage form. The labeled declaration of the percentage of the active ingredient should exclude any water,...

  16. 21 CFR 333.320 - Permitted combinations of active ingredients.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 5 2011-04-01 2011-04-01 false Permitted combinations of active ingredients. 333.320 Section 333.320 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS FOR HUMAN USE TOPICAL ANTIMICROBIAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN...

  17. 21 CFR 333.320 - Permitted combinations of active ingredients.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 5 2010-04-01 2010-04-01 false Permitted combinations of active ingredients. 333.320 Section 333.320 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS FOR HUMAN USE TOPICAL ANTIMICROBIAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN...

  18. 21 CFR 333.210 - Antifungal active ingredients.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 5 2011-04-01 2011-04-01 false Antifungal active ingredients. 333.210 Section 333.210 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS FOR HUMAN USE TOPICAL ANTIMICROBIAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE...

  19. 21 CFR 333.320 - Permitted combinations of active ingredients.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 5 2013-04-01 2013-04-01 false Permitted combinations of active ingredients. 333.320 Section 333.320 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS FOR HUMAN USE TOPICAL ANTIMICROBIAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN...

  20. 21 CFR 333.210 - Antifungal active ingredients.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 5 2012-04-01 2012-04-01 false Antifungal active ingredients. 333.210 Section 333.210 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS FOR HUMAN USE TOPICAL ANTIMICROBIAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE...

  1. 21 CFR 333.320 - Permitted combinations of active ingredients.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 5 2014-04-01 2014-04-01 false Permitted combinations of active ingredients. 333.320 Section 333.320 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS FOR HUMAN USE TOPICAL ANTIMICROBIAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN...

  2. 21 CFR 333.210 - Antifungal active ingredients.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 5 2014-04-01 2014-04-01 false Antifungal active ingredients. 333.210 Section 333.210 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS FOR HUMAN USE TOPICAL ANTIMICROBIAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE...

  3. 21 CFR 333.210 - Antifungal active ingredients.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 5 2013-04-01 2013-04-01 false Antifungal active ingredients. 333.210 Section 333.210 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS FOR HUMAN USE TOPICAL ANTIMICROBIAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE...

  4. 21 CFR 333.320 - Permitted combinations of active ingredients.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 5 2012-04-01 2012-04-01 false Permitted combinations of active ingredients. 333.320 Section 333.320 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS FOR HUMAN USE TOPICAL ANTIMICROBIAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN...

  5. 21 CFR 333.210 - Antifungal active ingredients.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 5 2010-04-01 2010-04-01 false Antifungal active ingredients. 333.210 Section 333.210 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS FOR HUMAN USE TOPICAL ANTIMICROBIAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE...

  6. 78 FR 10167 - Pesticide Products; Registration Applications for a New Active Ingredient

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-02-13

    ... AGENCY Pesticide Products; Registration Applications for a New Active Ingredient AGENCY: Environmental... products containing an active ingredient not included in any currently registered pesticide products... agricultural producer, food manufacturer, or pesticide manufacturer. The following list of North...

  7. 21 CFR 348.10 - Analgesic, anesthetic, and antipruritic active ingredients.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 5 2014-04-01 2014-04-01 false Analgesic, anesthetic, and antipruritic active ingredients. 348.10 Section 348.10 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN... Active Ingredients § 348.10 Analgesic, anesthetic, and antipruritic active ingredients. The...

  8. 21 CFR 348.10 - Analgesic, anesthetic, and antipruritic active ingredients.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 5 2010-04-01 2010-04-01 false Analgesic, anesthetic, and antipruritic active ingredients. 348.10 Section 348.10 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN... Active Ingredients § 348.10 Analgesic, anesthetic, and antipruritic active ingredients. The...

  9. 21 CFR 348.10 - Analgesic, anesthetic, and antipruritic active ingredients.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 5 2012-04-01 2012-04-01 false Analgesic, anesthetic, and antipruritic active ingredients. 348.10 Section 348.10 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN... Active Ingredients § 348.10 Analgesic, anesthetic, and antipruritic active ingredients. The...

  10. 21 CFR 348.10 - Analgesic, anesthetic, and antipruritic active ingredients.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 5 2011-04-01 2011-04-01 false Analgesic, anesthetic, and antipruritic active ingredients. 348.10 Section 348.10 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN... Active Ingredients § 348.10 Analgesic, anesthetic, and antipruritic active ingredients. The...

  11. 21 CFR 348.10 - Analgesic, anesthetic, and antipruritic active ingredients.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 5 2013-04-01 2013-04-01 false Analgesic, anesthetic, and antipruritic active ingredients. 348.10 Section 348.10 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN... Active Ingredients § 348.10 Analgesic, anesthetic, and antipruritic active ingredients. The...

  12. 78 FR 64937 - Pesticide Products; Registration Applications for New Active Ingredients

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-10-30

    ... 20240. Active ingredient: Male sea lamprey pheromone (3-ketopetromyzonol-24-sulfate). Product type: Biochemical pheromone. Proposed uses: Mating disruptor for sea lamprey control. (BPPD) 3. EPA File...

  13. Development of new polysilsesquioxane spherical particles as stabilized active ingredients for sunscreens

    NASA Astrophysics Data System (ADS)

    Tolbert, Stephanie Helene

    Healthy skin is a sign of positive self-worth, attractiveness and vitality. Compromises to this are frequently caused by extended periods of recreation in the sun and in turn exposure to the harmful effects of UV radiation. To maintain strength and integrity, protection of the skin is paramount. This can be achieved by implementing skin-care products which contain sunscreen active ingredients that provide UV protection. Unfortunately, photo-degradation, toxicity, and photo-allergies limit the effectiveness of present day sunscreen ingredients. Currently, this is moderated by physically embedding within inert silica particles, but leaching of the active ingredient can occur, thereby negating protective efforts. Alternatively, this research details the preparation and investigation of bridged silsesquioxane analogues of commercial ingredients which can be chemically grafted to the silica matrix. Studies with bridged salicylate particles detail facile preparation, minimized leaching, and enhanced UV stability over physically encapsulated and pendant salicylate counterparts. In terms of UVB protective ability, the highest maintenance of sun protection factor (SPF) after extended UV exposure was achieved with bridged incorporation, and has been attributed to corollary UV stability. Additionally, bridged salicylate particles can be classified as broad-spectrum, and rate from moderate to good in terms of UVA protective ability. Particles incorporated with a bridged curcuminoid silsesquioxane were also prepared and displayed comparable results. As such, an attractive method for sunscreen isolation and stabilization has been developed to eliminate the problems associated with current sunscreens, all while maintaining the established UV absorbance profiles of the parent compound. To appreciate the technology utilized in this research, a thorough understanding of sol-gel science as it pertains to hybrid organic/silica particles, including methods of organic fragment

  14. Impurity profile tracking for active pharmaceutical ingredients: case reports.

    PubMed

    Zhou, Lili; Mao, Bing; Reamer, Robert; Novak, Tom; Ge, Zhihong

    2007-06-28

    Tracking the impurity profile of an active pharmaceutical ingredient (API) is a very important task for all stages of drug development. A systematic approach for tracking impurity profile of API is described. Various real pharmaceutical applications are presented through successful examples of impurity profile tracking for three different novel APIs. These include MK-0969, an M3 antagonist; MK-0677, an oral-active growth hormone secretagogue and API-A, a cathepsin K inhibitor. A general strategy including selection of a reversed phase high performance liquid chromatographic (RP-HPLC) impurity profile method based on screening various stationary phases and changing the pH of the mobile phase and elucidation of impurity structures through the utilization of LC-MS, preparative-LC and NMR is demonstrated. A series of studies were conducted on the peak purity check by using the LC-UV diode-array and LC-MS detections. The advantages and disadvantages of each technique in the evaluation of peak purity are discussed. PMID:17142001

  15. The THz fingerprint spectra of the active ingredients of a TCM medicine: Herba Ephedrae

    NASA Astrophysics Data System (ADS)

    Ma, Shihua; Liu, Guifeng; Zhang, Peng; Song, Xiyu; Ji, Te; Wang, Wenfeng

    2008-12-01

    In this paper, THz-TDS has been used to measure the spectral properties of two active ingredients of Herba Ephedrae: ephedrine and pseudoephedrine, which exist in hydrochloride salts. The THz spectra of the sole-ingredient, twoingredient and three-ingredient compounds are studied. We obtained the finger-print spectra of the net active ingredients of the medicine, and also measured the mixtures of by two or three active ingredients at the different ratios. At the same time, theoretical analysis and quantitative analysis is applied to foretell the different THz spectra, identify the ingredients and infer the contents of principal components in samples. The THz spectroscopy is a potential and promising technique in evaluating and inspecting the quality of the drugs in the TCM field.

  16. 21 CFR 358.110 - Wart remover active ingredients.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... ingredient. (a) Salicylic acid 12 to 40 percent in a plaster vehicle. (b) Salicylic acid 5 to 17 percent in a collodion-like vehicle. (c) Salicylic acid 15 percent in a karaya gum, glycol plaster vehicle....

  17. 21 CFR 358.110 - Wart remover active ingredients.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... ingredient. (a) Salicylic acid 12 to 40 percent in a plaster vehicle. (b) Salicylic acid 5 to 17 percent in a collodion-like vehicle. (c) Salicylic acid 15 percent in a karaya gum, glycol plaster vehicle....

  18. 21 CFR 358.110 - Wart remover active ingredients.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... ingredient. (a) Salicylic acid 12 to 40 percent in a plaster vehicle. (b) Salicylic acid 5 to 17 percent in a collodion-like vehicle. (c) Salicylic acid 15 percent in a karaya gum, glycol plaster vehicle....

  19. 21 CFR 358.110 - Wart remover active ingredients.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... ingredient. (a) Salicylic acid 12 to 40 percent in a plaster vehicle. (b) Salicylic acid 5 to 17 percent in a collodion-like vehicle. (c) Salicylic acid 15 percent in a karaya gum, glycol plaster vehicle....

  20. Cordycepin is an immunoregulatory active ingredient of Cordyceps sinensis.

    PubMed

    Zhou, Xiaoxia; Luo, Liping; Dressel, Waike; Shadier, Gulibahaer; Krumbiegel, Doreen; Schmidtke, Peter; Zepp, Fred; Meyer, Claudius U

    2008-01-01

    We have reported that cordycepin, an adenosine derivative from the fungus Cordyceps, increased interleukin (IL)-10 expression, decreased IL-2 expression and suppressed T lymphocyte activity. In the present study, we further characterized the regulatory effects of cordycepin on human immune cells. Moreover, a traditional Chinese drug, Cordyceps sinensis (CS) that contains cordycepin, was also investigated. Cytometric Bead Array (CBA) was used to determine the concentrations of IL-1beta, IL-2, IL-4, IL-5, IL-6, IL-8, IL-10, IL-12, TNF-alpha and IFN-gamma in culture of peripheral blood mononuclear cells (PBMCs). The results showed that both cordycepin and CS up-regulated IL-10, IL-1beta, IL-6, IL-8 and TNF-alpha; at the same time, they suppressed phytohemagglutinin (PHA)-induced production of IL-2, IL-4, IL-5, IFN-gamma and IL-12. As compared to cordycepin, CS displayed its regulatory effects on IL-2 and IL-10 in a similar dose-dependent manner even with higher efficiency. The binding activity of transcription factors in a human monocytic cell line THP-1 was tested by the trans-AM method, and a higher binding activity of SP1 and SP3 was observed in cordycepin or CS treated cells compared to the control. These results led to the opinion that cordycepin and CS pleiotropically affected the actions of immune cells and cytokine network in a similar fashion. Cordycepin could be an important immunoregulatory active ingredient in Cordyceps sinensis. In addition, CS may contain substances which possess synergism with cordycepin, as CS showed a higher efficiency in the production of IL-10 and IL-2 than cordycepin. However, merits of these effects in pharmacology and clinical medicine have yet to be proven and the precise mechanism of these immune regulatory actions should be researched. PMID:19051361

  1. Quality investigation of hydroxyprogesterone caproate active pharmaceutical ingredient and injection

    PubMed Central

    Chollet, John L.; Jozwiakowski, Michael J.

    2012-01-01

    The purpose of this study was to investigate the quality of hydroxyprogesterone caproate (HPC) active pharmaceutical ingredient (API) sources that may be used by compounding pharmacies, compared to the FDA-approved source of the API; and to investigate the quality of HPC injection samples obtained from compounding pharmacies in the US, compared to the FDA-approved product (Makena®). Samples of API were obtained from every source confirmed to be an original manufacturer of the drug for human use, which were all companies in China that were not registered with FDA. Eight of the ten API samples (80%) did not meet the impurity specifications required by FDA for the API used in the approved product. One API sample was found to not be HPC at all; additional laboratory testing showed that it was glucose. Thirty samples of HPC injection obtained from com pounding pharmacies throughout the US were also tested, and eight of these samples (27%) failed to meet the potency requirement listed in the USP monograph for HPC injection and/or the HPLC assay. Sixteen of the thirty injection samples (53%) exceeded the impurity limit setforthe FDA-approved drug product. These results confirm the inconsistency of compounded HPC Injections and suggest that the risk-benefit ratio of using an unapproved compounded preparation, when an FDA-approved drug product is available, is not favorable. PMID:22329865

  2. 21 CFR 358.510 - Corn and callus remover active ingredients.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 5 2010-04-01 2010-04-01 false Corn and callus remover active ingredients. 358.510 Section 358.510 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN... USE Corn and Callus Remover Drug Products § 358.510 Corn and callus remover active ingredients....

  3. 21 CFR 358.510 - Corn and callus remover active ingredients.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 5 2013-04-01 2013-04-01 false Corn and callus remover active ingredients. 358.510 Section 358.510 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN... USE Corn and Callus Remover Drug Products § 358.510 Corn and callus remover active ingredients....

  4. 21 CFR 358.510 - Corn and callus remover active ingredients.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 5 2012-04-01 2012-04-01 false Corn and callus remover active ingredients. 358.510 Section 358.510 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN... USE Corn and Callus Remover Drug Products § 358.510 Corn and callus remover active ingredients....

  5. 21 CFR 358.510 - Corn and callus remover active ingredients.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 5 2014-04-01 2014-04-01 false Corn and callus remover active ingredients. 358.510 Section 358.510 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN... USE Corn and Callus Remover Drug Products § 358.510 Corn and callus remover active ingredients....

  6. Using Indices of Fidelity to Intervention Core Components to Identify Program Active Ingredients

    ERIC Educational Resources Information Center

    Abry, Tashia; Hulleman, Chris S.; Rimm-Kaufman, Sara E.

    2015-01-01

    Identifying the active ingredients of an intervention--intervention-specific components serving as key levers of change--is crucial for unpacking the intervention black box. Measures of intervention fidelity can be used to identify specific active ingredients, yet such applications are rare. We illustrate how fidelity measures can be used to…

  7. 40 CFR Table 1 to Part 455 - List of Organic Pesticide Active Ingredients

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... 40 Protection of Environment 30 2011-07-01 2011-07-01 false List of Organic Pesticide Active Ingredients 1 Table 1 to Part 455 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) EFFLUENT GUIDELINES AND STANDARDS PESTICIDE CHEMICALS Pt. 455, Table 1 Table 1 to Part 455—List of Organic Pesticide Active Ingredients EPA census...

  8. Research on the immunosuppressive activity of ingredients contained in sunscreens.

    PubMed

    Frikeche, Jihane; Couteau, Céline; Roussakis, Christos; Coiffard, Laurence J M

    2015-04-01

    The immunosuppressive properties of Benzophenone-4, an UV-filter and three ingredients, Allantoin, Bisabolol and Enoxolon used in sunscreen formulation, previously characterized as anti-inflammatory compounds, are studied. The results of this study demonstrate that four tested molecules have effects on DCs and T cells which are the most important cells of the immune system. The impact is also visible on keratinocyte cells which are in the direct contact with skin sunscreens. Each ingredient should be used with caution at reduced doses or even removed from some cosmetic preparations, such as sunscreens. PMID:25556843

  9. 21 CFR 341.14 - Antitussive active ingredients.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... and 21 CFR 1308.15(c). (i) Codeine. (ii) Codeine phosphate. (iii) Codeine sulfate. (3...) DRUGS FOR HUMAN USE COLD, COUGH, ALLERGY, BRONCHODILATOR, AND ANTIASTHMATIC DRUG PRODUCTS FOR OVER-THE... established for each ingredient in § 341.74(d): (a) Oral antitussives. (1) Chlophedianol hydrochloride....

  10. 21 CFR 341.14 - Antitussive active ingredients.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... and 21 CFR 1308.15(c). (i) Codeine. (ii) Codeine phosphate. (iii) Codeine sulfate. (3...) DRUGS FOR HUMAN USE COLD, COUGH, ALLERGY, BRONCHODILATOR, AND ANTIASTHMATIC DRUG PRODUCTS FOR OVER-THE... established for each ingredient in § 341.74(d): (a) Oral antitussives. (1) Chlophedianol hydrochloride....

  11. 21 CFR 341.14 - Antitussive active ingredients.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... and 21 CFR 1308.15(c). (i) Codeine. (ii) Codeine phosphate. (iii) Codeine sulfate. (3...) DRUGS FOR HUMAN USE COLD, COUGH, ALLERGY, BRONCHODILATOR, AND ANTIASTHMATIC DRUG PRODUCTS FOR OVER-THE... established for each ingredient in § 341.74(d): (a) Oral antitussives. (1) Chlophedianol hydrochloride....

  12. 21 CFR 341.14 - Antitussive active ingredients.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... and 21 CFR 1308.15(c). (i) Codeine. (ii) Codeine phosphate. (iii) Codeine sulfate. (3...) DRUGS FOR HUMAN USE COLD, COUGH, ALLERGY, BRONCHODILATOR, AND ANTIASTHMATIC DRUG PRODUCTS FOR OVER-THE... established for each ingredient in § 341.74(d): (a) Oral antitussives. (1) Chlophedianol hydrochloride....

  13. 78 FR 75343 - Pesticide Products; Registration Applications for New Active Ingredients

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-12-11

    .... Applicant: Novozymes BioAg, Inc., 13100 W. Lisbon Road, Suite 600, Brookfield, WI 53005. Active ingredient... (represented by Technology Sciences Group, Inc., 712 Fifth St., Suite A, Davis CA 95616). Active...

  14. Effects of active pharmaceutical ingredients mixtures in mussel Mytilus galloprovincialis.

    PubMed

    Gonzalez-Rey, M; Mattos, J J; Piazza, C E; Bainy, A C D; Bebianno, M J

    2014-08-01

    Active pharmaceutical ingredients (APIs) are emergent environmental contaminants widely detected in surface waters as result of incomplete waste water treatment plant (WWTP) removal processes and improper disposal. The assessment of potential effects of APIs on non-target organisms is still scarce since besides presenting multiple chemical structures, properties and modes of action, these compounds occur as complex mixtures. This study comprises a 15-day exposure of mussels Mytilus galloprovincialis to mixtures (at environmentally relevant nominal concentrations) of non-steroidal inflammatory drugs ibuprofen (IBU) and diclofenac (DCF) (250 ng L(-1) each) and selective serotonin reuptake inhibitor (SSRI) fluoxetine (FLX) (75 ng L(-1)) (MIX 1) along with the addition of classical pro-oxidant copper (Cu) (5 μg L(-1)) (MIX 2). The goals included the assessment of oxidative stress, neurotoxic and endocrine effects on this sentinel species applying both a multibiomarker and gene expression (here and later gene expression is taken as synonym to gene transcription, although it is acknowledged that it is also affected by, e.g. translation, and mRNA and protein stability) analysis approaches. The results revealed a swifter antioxidant response in digestive glands than in gills induced by MIX 1, nevertheless the presence of Cu in MIX 2 promoted a higher lipid peroxidation (LPO) induction. Neither mixture altered acetylcholinesterase (AChE) activity, while both triggered the formation of vitellogenin-like proteins in females confirming the xenoestrogenic effect of mixtures. All these results varied with respect to those obtained in previous single exposure essays. Moreover, RT-PCR analysis revealed a catalase (CAT) and CYP4Y1 gene expression down- and upregulation, respectively, with no significant changes in mRNA levels of genes encoding superoxide dismutase (SOD) and glutathione-S-transferase (GST). Finally, this study highlights variable tissue and time-specific biomarker

  15. [Simulation of the Baird-Parker media formula based on Soviet ingredients for the isolation of Staphylococcus aureus].

    PubMed

    Petrushina, L I; Kolosnitsyna, N V; Sheveleva, S A

    1989-01-01

    A medium has been prepared based on Soviet nutrient agar and reagents supplemented by ingredients from Baird-Parker's medium. Its growth and selective properties are close to those of Baird-Parker's medium. The new selective medium has been recommended for isolation of S. aureus from food products and environment objects. PMID:2718421

  16. 78 FR 70043 - Pesticide Product Registration; Receipt of an Application for a New Active Ingredient

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-11-22

    ... name: DAS-81419-2 Soybean. Active ingredients: Bacillus thuringiensis Cry1Ac protein expressed in soybean and Bacillus thuringiensis Cry1F protein expressed in soybean. Proposed classification/Use:...

  17. Source characterization of nervous system active pharmaceutical ingredients in healthcare wastewaters

    EPA Science Inventory

    Nervous system active pharmaceutical ingredients (APIs), including anti-depressants and opioids, are important clinically administered pharmaceuticals within healthcare facilities. Concentrations and mass loadings of ten nervous system APIs and three nervous system API metaboli...

  18. [Effect of Guizhi Fuling capsule and combination of active ingredients on rats with uterine myoma].

    PubMed

    Heng, Qing-qing; Cao, Liang; Li, Na; Ding, Gang; Wang, Zhen-zhong; Xiao, Wei

    2015-06-01

    It is to observe the therapeutic action of Guizhi Fuling capsule and the combination of active ingredients on model rats with uterine leiomyoma. The hysteromyoma rats models was established in rats by loading eatrogen, to observe the effect on pathological condition of uterus, uterus wet weight, the content of estradiol and progesterone. Guizhi Fuling capsule and the combination of active ingredients remarkably decreased uterus weight, restrained the excess proliferation of the smooth muscle of uterus, decreased the estraiol and progesterone in blood serum. Guizhi Fuling capsule and the combination of active ingredients can restrain the formation of hysteromyoma in a dose-dependent manner. Perhaps the combination of active ingredients is the material foundation of antihysteromyoma. PMID:26552182

  19. Fixed-Dose Combination Drug Approvals, Patents and Market Exclusivities Compared to Single Active Ingredient Pharmaceuticals

    PubMed Central

    Hao, Jing; Rodriguez-Monguio, Rosa; Seoane-Vazquez, Enrique

    2015-01-01

    Introduction Fixed-dose combinations (FDC) contain two or more active ingredients. The effective patent and exclusivity life of FDC compared to single active ingredient has not been assessed. Objectives Trends in FDA approved FDC in the period 1980–2012 and time lag between approval of FDC and single active ingredients in the combination were assessed, and the effective patent and exclusivity life of FDC was compared with their single active ingredients. Materials and Methods New molecular entities (NMEs), new therapeutic biologics license applications (BLAs) and FDC data were collected from the FDA Orange Book and Drugs@FDA. Analysis included FDC containing one or more NMEs or BLAs at first FDA approval (NMEs-FDC) and only already marketed drugs (Non-NMEs-FDC). Descriptive, Kruskal-Wallis and Wilcoxon Rank Sum analyses were performed. Results During the study period, the FDA approved 28 NMEs-FDC (3.5% of NMEs) and 117 non-NMEs-FDC. FDC approvals increased from 12 in the 1980s to 59 in the 2000s. Non-NMEs-FDC entered the market at a median of 5.43 years (interquartile range 1.74, 10.31) after first FDA approval of single active ingredients in the combination. The Non-NMEs-FDC entered the market at a median of 2.33 years (-7.55, 2.39) before approval of generic single active ingredient. Non-NME-FDC added a median of 9.70 (2.75, 16.24) years to the patent and exclusivity life of the single active ingredients in the combination. Conclusion FDC approvals significantly increased over the last twenty years. Pharmaceutical companies market FDC drugs shortly before the generic versions of the single ingredients enter the market extending the patent and exclusivity life of drugs included in the combination. PMID:26469277

  20. On the novel action of melanolysis by a leaf extract of Aloe vera and its active ingredient aloin, potent skin depigmenting agents.

    PubMed

    Ali, Sharique A; Galgut, Jyoti M; Choudhary, Ram K

    2012-05-01

    The present study was carried out to investigate the effects of an Aloe vera leaf extract, along with its standard active ingredient aloin, on the isolated tail melanophores of Bufo melanostictus tadpoles, which are a type of disguised smooth muscle cells offering excellent in vitro opportunities for studying the effects of pharmacological and pharmaceutical agents. It was found that the leaf extract of A. vera and its active ingredient aloin induced powerful, dose-dependent, physiologically significant melanin aggregating effects in the isolated tail melanophores of B. melanostictus similar to those of adrenaline per se. These preliminary findings clearly demonstrate that the extract of A. vera and its active ingredient aloin cause melanin aggregation leading to skin lightening via alpha adrenergic receptor stimulation. The present study opens new vistas for the use of A. vera regarding its clinical application as a new nontoxic melanolytic agent for the treatment of hyperpigmentation. PMID:22495441

  1. Terpinen-4-ol is the Most Active Ingredient of Tea Tree Oil to Kill Demodex Mites

    PubMed Central

    Tighe, Sean; Gao, Ying-Ying; Tseng, Scheffer C. G.

    2013-01-01

    Purpose To determine the active ingredient in tea tree oil (TTO) responsible for its reported killing effect on Demodex mites, the most common ectoparasite found in the human skin extending to the eye. Methods Using a reported in vitro killing assay to measure the survival time of adult Demodex folliculorum up to 150 minutes, we have screened serial concentrations of 13 of the 15 known ingredients of TTO (ISO4730:2004) that were soluble in mineral oil and examined their synergistic relationships in killing mites. The most potent ingredient was then tested for its efficacy in killing Demodex in vivo. Results All ingredients exhibited a dose-dependent killing effect. Besides Terpinen-4-ol, the order of relative potency did not correlate with the order of relative abundance in TTO for the remaining 12 ingredients. Terpinen-4-ol was the most potent ingredient followed by α-Terpineol, 1,8-Cineole and Sabinene. Terpinen-4-ol, the most abundant ingredient in TTO, was more potent than TTO at equivalent concentrations and its killing effect was even observable at a mere concentration of 1%. Terpinen-4-ol exhibited a significant synergistic effect with Terpinolene, but an antagonistic effect with α-Terpineol in killing mites (both P < 0.05). In vivo, Terpinen-4-ol was shown to eradicate mites. Conclusions The above finding suggests that deployment of Terpinen-4-ol alone should enhance its potency in killing Demodex mites by reducing the adverse and antagonistic effects from other ingredients in TTO. Translational Relevance Terpinen-4-ol can be adopted in future formulations of acaricides to treat a number of ocular and cutaneous diseases caused by demodicosis. PMID:24349880

  2. Data-mining of potential antitubercular activities from molecular ingredients of traditional Chinese medicines

    PubMed Central

    Jamal, Salma

    2014-01-01

    Background. Traditional Chinese medicine encompasses a well established alternate system of medicine based on a broad range of herbal formulations and is practiced extensively in the region for the treatment of a wide variety of diseases. In recent years, several reports describe in depth studies of the molecular ingredients of traditional Chinese medicines on the biological activities including anti-bacterial activities. The availability of a well-curated dataset of molecular ingredients of traditional Chinese medicines and accurate in-silico cheminformatics models for data mining for antitubercular agents and computational filters to prioritize molecules has prompted us to search for potential hits from these datasets. Results. We used a consensus approach to predict molecules with potential antitubercular activities from a large dataset of molecular ingredients of traditional Chinese medicines available in the public domain. We further prioritized 160 molecules based on five computational filters (SMARTSfilter) so as to avoid potentially undesirable molecules. We further examined the molecules for permeability across Mycobacterial cell wall and for potential activities against non-replicating and drug tolerant Mycobacteria. Additional in-depth literature surveys for the reported antitubercular activities of the molecular ingredients and their sources were considered for drawing support to prioritization. Conclusions. Our analysis suggests that datasets of molecular ingredients of traditional Chinese medicines offer a new opportunity to mine for potential biological activities. In this report, we suggest a proof-of-concept methodology to prioritize molecules for further experimental assays using a variety of computational tools. We also additionally suggest that a subset of prioritized molecules could be used for evaluation for tuberculosis due to their additional effect against non-replicating tuberculosis as well as the additional hepato-protection offered by

  3. 40 CFR Table 1 to Part 455 - List of Organic Pesticide Active Ingredients

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 40 Protection of Environment 29 2010-07-01 2010-07-01 false List of Organic Pesticide Active...) EFFLUENT GUIDELINES AND STANDARDS PESTICIDE CHEMICALS Pt. 455, Table 1 Table 1 to Part 455—List of Organic Pesticide Active Ingredients EPA census code Pesticide code Pesticide name CAS No. 1 10501 Dicofol...

  4. 21 CFR 331.20 - Determination of percent contribution of active ingredients.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... SERVICES (CONTINUED) DRUGS FOR HUMAN USE ANTACID PRODUCTS FOR OVER-THE-COUNTER (OTC) HUMAN USE Testing... contribution of an antacid active ingredient, place an accurately weighed amount of the antacid active... United States Pharmacopeia 23/National Formulary 18 and calculate the percent contribution of the...

  5. 21 CFR 331.20 - Determination of percent contribution of active ingredients.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... SERVICES (CONTINUED) DRUGS FOR HUMAN USE ANTACID PRODUCTS FOR OVER-THE-COUNTER (OTC) HUMAN USE Testing... contribution of an antacid active ingredient, place an accurately weighed amount of the antacid active... United States Pharmacopeia 23/National Formulary 18 and calculate the percent contribution of the...

  6. 21 CFR 331.20 - Determination of percent contribution of active ingredients.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... SERVICES (CONTINUED) DRUGS FOR HUMAN USE ANTACID PRODUCTS FOR OVER-THE-COUNTER (OTC) HUMAN USE Testing... contribution of an antacid active ingredient, place an accurately weighed amount of the antacid active... United States Pharmacopeia 23/National Formulary 18 and calculate the percent contribution of the...

  7. 21 CFR 331.20 - Determination of percent contribution of active ingredients.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... SERVICES (CONTINUED) DRUGS FOR HUMAN USE ANTACID PRODUCTS FOR OVER-THE-COUNTER (OTC) HUMAN USE Testing... contribution of an antacid active ingredient, place an accurately weighed amount of the antacid active... United States Pharmacopeia 23/National Formulary 18 and calculate the percent contribution of the...

  8. 21 CFR 331.20 - Determination of percent contribution of active ingredients.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... SERVICES (CONTINUED) DRUGS FOR HUMAN USE ANTACID PRODUCTS FOR OVER-THE-COUNTER (OTC) HUMAN USE Testing... contribution of an antacid active ingredient, place an accurately weighed amount of the antacid active... United States Pharmacopeia 23/National Formulary 18 and calculate the percent contribution of the...

  9. [Active ingredients in rhubarb with anti-proliferative effects on scar fibroblasts].

    PubMed

    Wang, Qian; Zhang, Nan-Nan; Li, Hong-Yan; Jiang, Min; Gao, Jie; Bai, Gang

    2012-12-01

    This study is to explore the active ingredients of traditional Chinese medicine rhubarb with antiproliferative activity on hypertrophic scar fibroblasts (HSF). Rhubarb was extracted with Soxhlet extraction method by different polar solvents. MTS method was used to screen rhubarb solvent extracts (25 microg x mL(-1)) with anti-proliferative activity on HSF, and flow cytometry was used to detect their influences on cell cycle. Then, the active ingredients were analyzed by HPLC. The components with high activity were identified by UPLC-Q/TOF and verified by HE staining. The results showed that the ethyl acetate extract of rhubarb had higher anti-proliferative activity (P < 0.01), increased significantly the proportion of cells in G0/G1 phase (P < 0.01), and reduced the proliferation index (PI) (P < 0.01). The main active ingredients were anthraquinones. The results of confirming experiment showed that emodin, rhein and gallic acid could inhibit cell proliferation in a dose-dependent manner. In conclusion, the ethyl acetate extract of rhubarb showed anti-proliferative activity on HSF, and the anti-proliferative ingredients might be anthraquinones. PMID:23460967

  10. 21 CFR 358.710 - Active ingredients for the control of dandruff, seborrheic dermatitis, or psoriasis.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... to be applied and left on the skin or scalp. (4) Salicylic acid, 1.8 to 3 percent. (5) Selenium sulfide, 1 percent. (6) Selenium sulfide, micronized, 0.6 percent. (7) Sulfur, 2 to 5 percent. (b) Active...) Salicylic acid, 1.8 to 3 percent. (5) Selenium sulfide, 1 percent. (c) Active ingredients for the control...

  11. 21 CFR 358.710 - Active ingredients for the control of dandruff, seborrheic dermatitis, or psoriasis.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... to be applied and left on the skin or scalp. (4) Salicylic acid, 1.8 to 3 percent. (5) Selenium sulfide, 1 percent. (6) Selenium sulfide, micronized, 0.6 percent. (7) Sulfur, 2 to 5 percent. (b) Active...) Salicylic acid, 1.8 to 3 percent. (5) Selenium sulfide, 1 percent. (c) Active ingredients for the control...

  12. 21 CFR 358.710 - Active ingredients for the control of dandruff, seborrheic dermatitis, or psoriasis.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... to be applied and left on the skin or scalp. (4) Salicylic acid, 1.8 to 3 percent. (5) Selenium sulfide, 1 percent. (6) Selenium sulfide, micronized, 0.6 percent. (7) Sulfur, 2 to 5 percent. (b) Active...) Salicylic acid, 1.8 to 3 percent. (5) Selenium sulfide, 1 percent. (c) Active ingredients for the control...

  13. 21 CFR 358.710 - Active ingredients for the control of dandruff, seborrheic dermatitis, or psoriasis.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... to be applied and left on the skin or scalp. (4) Salicylic acid, 1.8 to 3 percent. (5) Selenium sulfide, 1 percent. (6) Selenium sulfide, micronized, 0.6 percent. (7) Sulfur, 2 to 5 percent. (b) Active...) Salicylic acid, 1.8 to 3 percent. (5) Selenium sulfide, 1 percent. (c) Active ingredients for the control...

  14. 21 CFR 358.710 - Active ingredients for the control of dandruff, seborrheic dermatitis, or psoriasis.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... to be applied and left on the skin or scalp. (4) Salicylic acid, 1.8 to 3 percent. (5) Selenium sulfide, 1 percent. (6) Selenium sulfide, micronized, 0.6 percent. (7) Sulfur, 2 to 5 percent. (b) Active...) Salicylic acid, 1.8 to 3 percent. (5) Selenium sulfide, 1 percent. (c) Active ingredients for the control...

  15. Encapsulation of cosmetic active ingredients for topical application--a review.

    PubMed

    Casanova, Francisca; Santos, Lúcia

    2016-02-01

    Microencapsulation is finding increasing applications in cosmetics and personal care markets. This article provides an overall discussion on encapsulation of cosmetically active ingredients and encapsulation techniques for cosmetic and personal care products for topical applications. Some of the challenges are identified and critical aspects and future perspectives are addressed. Many cosmetics and personal care products contain biologically active substances that require encapsulation for increased stability of the active materials. The topical and transdermal delivery of active cosmetic ingredients requires effective, controlled and safe means of reaching the target site within the skin. Preservation of the active ingredients is also essential during formulation, storage and application of the final cosmetic product. Microencapsulation offers an ideal and unique carrier system for cosmetic active ingredients, as it has the potential to respond to all these requirements. The encapsulated agent can be released by several mechanisms, such as mechanical action, heat, diffusion, pH, biodegradation and dissolution. The selection of the encapsulation technique and shell material depends on the final application of the product, considering physical and chemical stability, concentration, required particle size, release mechanism and manufacturing costs. PMID:26612271

  16. Effect of penetration modifiers on the dermal and transdermal delivery of drugs and cosmetic active ingredients.

    PubMed

    Otto, A; Wiechers, J W; Kelly, C L; Hadgraft, J; du Plessis, J

    2008-01-01

    In this study the effect of 2 penetration modifiers, dimethyl isosorbide (DMI) and diethylene glycol monoethyl ether (DGME) on the skin delivery of hydroquinone (HQ), salicylic acid (SA) and octadecenedioic acid (DIOIC) was investigated. Ten percent DMI and DGME were separately formulated into oil-in-water emulsions containing 1.8% HQ, SA and DIOIC, respectively. Skin delivery and the flux across split-thickness human skin of the active ingredients were determined using Franz diffusion cells. An emulsion with 10% water incorporated instead of the water-soluble penetration modifiers served as a control. The study showed that neither 10% DMI nor 10% DGME significantly enhanced the skin permeation of the various lipophilic active ingredients or the uptake into the skin. It was hypothesized that the addition of the penetration modifiers to the emulsions not only enhanced the solubility of the various active ingredients in the skin but also in the formulation, resulting in a reduced thermodynamic activity and hence a weaker driving force for penetration. Therefore, the effect of DMI and DGME on the solubility of the active ingredients in the skin was counteracted by a simultaneous reduction in the thermodynamic activity in the formulation. PMID:18832865

  17. FRUIT CANNERY WASTE ACTIVATED SLUDGE AS A CATTLE FEED INGREDIENT

    EPA Science Inventory

    The feasibility of sludge disposal, from a fruit processing waste activated sludge treatment system, by dewatering and using the dewatered biological sludge solids as cattle feed was evaluated by Snokist Growers at Yakima, Washington. Dewatering of the biological sludge utilizing...

  18. [In vitro microdialysis recoveries of nine active ingredients in Mahuang decoction].

    PubMed

    Tang, Ying-hong; Wan, Hai-tong; Chen, Jian-zhen; Zhou, Hui-fen; Tian, Yan-fang; He, Yu

    2015-09-01

    To detect the in vitro probe microdialysis recoveries based on an HPLC-DAD method for simultaneous quantification of nine active ingredients (ephedrine, pseudoephedrine, methylephedrine, amygdalin, liquiritin, cinnamyl alcohol, cinnamic acid, cinnamaldehyde and glycyrrhizic acid) in Mahuang decoction, which provides reference for in vivo pharmacokinetic study. The concentrations of nine active ingredients in dialysate were detected by HPLC-DAD, to investigate the effect of flow rates (incremental method and subtraction method) and intraday stability of the probe recoveries and medium concentrations on the recoveries. Nine active ingredients could be well separated in 52 min. At the perfusion rate of 1.0 μL x min(-1), the relative recoveries of ephedrine, pseudoephedrine, methylephedrine, amygdalin, liquiritin, cinnamyl alcohol, cinnamic acid, cinnamaldehyde and glycyrrhizic acid were (50.95 ± 0.82)%, (52.74 ± 1.13)%, (51.29 ± 0.51)%, (32.56 ± 0.84)%, (45.36 ± 0.83)%, (70.94 ± 0.99)%, (69.98 ± 2.30)%, (71.68 ± 0.63)%, and (22.14 ± 0.48)%, respectively. And the probe kept steady in 7 hours. At the same medium concentration, the probe recoveries decreased exponentially with the increase in flow rates. The recoveries of seven ingredients detected by these two methods were similar at certain flow rates, except for amygdalin and cinnamaldehyde. At the same flow rate, the relative recoveries of cinnamyl alcohol, cinnamic acid and cinnamaldehyde changed greatly (9.55%-16.2%) and the others six ingredients had less change (3.27%-5.71%) with the changes in medium concentrations. Microdialysis method could be used to detect the in vitro recoveries of nine ingredients in Mahuang decoction. Reverse dialysis method could be used for the in vivo probe recovery calibration of ephedrine, pseudoephedrine, methylephedrine, liquiritin, cinnamyl alcohol and cinnamic acid at the flow rate of 2.0 μL x min(-1). PMID:26983219

  19. 21 CFR 349.30 - Permitted combinations of active ingredients.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ....30 Section 349.30 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS FOR HUMAN USE OPHTHALMIC DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE Active... § 349.14 may be combined as necessary to give the product proper consistency for application to the eye....

  20. 77 FR 48519 - Registration Applications for Pesticide Products Containing New Active Ingredients

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-08-14

    ... products pursuant to the provisions of section 3(c)(4) of the Federal Insecticide, Fungicide, and.... israelensis, Strain SUM-6218 at 100.0%. Product Type: microbial insecticide. Proposed Use: Manufacturing use..., Kalamazoo, MI 49008. Active Ingredient: GS-U-ACTX-Hv1a-SEQ2 at 30.00%. Product Type: Insecticide....

  1. 21 CFR 347.60 - Labeling of permitted combinations of active ingredients.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ...) Combinations of skin protectant and sunscreen active ingredients in § 347.20(d). In addition to any or all of... sunscreen drug products should be used and any or all of the additional indications for sunscreen drug... a skin protectant and a sunscreen identified in §§ 347.20(d) and 352.20(b). The warnings...

  2. 21 CFR 347.60 - Labeling of permitted combinations of active ingredients.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ...) Combinations of skin protectant and sunscreen active ingredients in § 347.20(d). In addition to any or all of... sunscreen drug products should be used and any or all of the additional indications for sunscreen drug... a skin protectant and a sunscreen identified in §§ 347.20(d) and 352.20(b). The warnings...

  3. 21 CFR 347.60 - Labeling of permitted combinations of active ingredients.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ...) Combinations of skin protectant and sunscreen active ingredients in § 347.20(d). In addition to any or all of... sunscreen drug products should be used and any or all of the additional indications for sunscreen drug... a skin protectant and a sunscreen identified in §§ 347.20(d) and 352.20(b). The warnings...

  4. 21 CFR 347.60 - Labeling of permitted combinations of active ingredients.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ...) Combinations of skin protectant and sunscreen active ingredients in § 347.20(d). In addition to any or all of... sunscreen drug products should be used and any or all of the additional indications for sunscreen drug... a skin protectant and a sunscreen identified in §§ 347.20(d) and 352.20(b). The warnings...

  5. 21 CFR 347.60 - Labeling of permitted combinations of active ingredients.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ...) Combinations of skin protectant and sunscreen active ingredients in § 347.20(d). In addition to any or all of... sunscreen drug products should be used and any or all of the additional indications for sunscreen drug... a skin protectant and a sunscreen identified in §§ 347.20(d) and 352.20(b). The warnings...

  6. 21 CFR 333.160 - Labeling of permitted combinations of active ingredients.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 5 2014-04-01 2014-04-01 false Labeling of permitted combinations of active ingredients. 333.160 Section 333.160 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS FOR HUMAN USE TOPICAL ANTIMICROBIAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE First Aid Antibiotic Drug...

  7. 21 CFR 358.510 - Corn and callus remover active ingredients.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 5 2011-04-01 2011-04-01 false Corn and callus remover active ingredients. 358.510 Section 358.510 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS FOR HUMAN USE MISCELLANEOUS EXTERNAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE Corn and Callus Remover Drug Products §...

  8. 21 CFR 341.85 - Labeling of permitted combinations of active ingredients.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 5 2014-04-01 2014-04-01 false Labeling of permitted combinations of active ingredients. 341.85 Section 341.85 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS FOR HUMAN USE COLD, COUGH, ALLERGY, BRONCHODILATOR, AND ANTIASTHMATIC...

  9. Bacteriological effects of dentifrices with and without active ingredients of natural origin.

    PubMed

    Ledder, Ruth G; Latimer, Joe; Humphreys, Gavin J; Sreenivasan, Prem K; McBain, Andrew J

    2014-10-01

    Compounds of natural origin are increasingly used as adjuncts to oral hygiene. We have adopted four distinct approaches to assess the antibacterial activity of dentifrices containing natural active ingredients against oral bacteria in several test systems. Corsodyl Daily (CD), Kingfisher Mint (KM), and Parodontax fluoride (PF) were compared to a dentifrice containing fluoride (Colgate Cavity Protection [CCP]) and one containing triclosan (Colgate Total [CT]). The growth inhibitory and bactericidal potency of the formulations were determined for 10 isolated oral bacteria. Effects of single exposures of simulated supragingival plaques were then determined by epifluorescence and confocal microscopy, while the effects of repeated exposures were quantified by viable counting. Additionally, dense plaques, maintained in continuous culture, were repeatedly dosed, and the outcome was assessed by viable counting and eubacterial DNA profiling. The test dentifrices exhibited variable specificity and potency against oral bacteria in axenic culture. Of the herbal formulations, KM caused the largest viability reductions in simulated supragingival plaques, with CT causing the greatest reductions overall. Following single exposures, CD caused moderate reductions, while PF had no effect. After multiple dosing, all formulations significantly reduced numbers of total, facultative, and Gram-negative anaerobes, but only KM and CT caused greater reductions than the fluoride control. KM also reduced counts of streptococci (rank order of effectiveness: CT > KM > CCP > PF > CD). Marked changes in eubacterial DNA profiles were not detected for any herbal formulation in dense plaques, although KM markedly reduced viable counts of streptococci, in agreement with supragingival data. While both nonherbal comparators displayed antibacterial activity, the triclosan-containing formulation caused greater viability reductions than the herbal and nonherbal formulations. PMID:25107974

  10. Bacteriological Effects of Dentifrices with and without Active Ingredients of Natural Origin

    PubMed Central

    Latimer, Joe; Humphreys, Gavin J.; Sreenivasan, Prem K.; McBain, Andrew J.

    2014-01-01

    Compounds of natural origin are increasingly used as adjuncts to oral hygiene. We have adopted four distinct approaches to assess the antibacterial activity of dentifrices containing natural active ingredients against oral bacteria in several test systems. Corsodyl Daily (CD), Kingfisher Mint (KM), and Parodontax fluoride (PF) were compared to a dentifrice containing fluoride (Colgate Cavity Protection [CCP]) and one containing triclosan (Colgate Total [CT]). The growth inhibitory and bactericidal potency of the formulations were determined for 10 isolated oral bacteria. Effects of single exposures of simulated supragingival plaques were then determined by epifluorescence and confocal microscopy, while the effects of repeated exposures were quantified by viable counting. Additionally, dense plaques, maintained in continuous culture, were repeatedly dosed, and the outcome was assessed by viable counting and eubacterial DNA profiling. The test dentifrices exhibited variable specificity and potency against oral bacteria in axenic culture. Of the herbal formulations, KM caused the largest viability reductions in simulated supragingival plaques, with CT causing the greatest reductions overall. Following single exposures, CD caused moderate reductions, while PF had no effect. After multiple dosing, all formulations significantly reduced numbers of total, facultative, and Gram-negative anaerobes, but only KM and CT caused greater reductions than the fluoride control. KM also reduced counts of streptococci (rank order of effectiveness: CT > KM > CCP > PF > CD). Marked changes in eubacterial DNA profiles were not detected for any herbal formulation in dense plaques, although KM markedly reduced viable counts of streptococci, in agreement with supragingival data. While both nonherbal comparators displayed antibacterial activity, the triclosan-containing formulation caused greater viability reductions than the herbal and nonherbal formulations. PMID:25107974

  11. Are pharmaceuticals potent environmental pollutants? Part I: environmental risk assessments of selected active pharmaceutical ingredients.

    PubMed

    Carlsson, Carina; Johansson, Anna-Karin; Alvan, Gunnar; Bergman, Kerstin; Kühler, Thomas

    2006-07-01

    As part of achieving national environmental goals, the Swedish Government commissioned an official report from the Swedish Medical Products Agency on environmental effects of pharmaceuticals. Considering half-lives/biodegradability, environmental occurrence, and Swedish sales statistics, 27 active pharmaceutical ingredients were selected for environmental hazard and risk assessments. Although there were large data gaps for many of the compounds, nine ingredients were identified as dangerous for the aquatic environment. Only the sex hormones oestradiol and ethinyloestradiol were considered to be associated with possible aquatic environmental risks. We conclude that risk for acute toxic effects in the environment with the current use of active pharmaceutical ingredients is unlikely. Chronic environmental toxic effects, however, cannot be excluded due to lack of chronic ecotoxicity data. Measures to reduce potential environmental impact posed by pharmaceutical products must be based on knowledge on chronic ecotoxic effects of both active pharmaceutical ingredients as well as excipients. We believe that the impact pharmaceuticals have on the environment should be further studied and be given greater attention such that informed assessments of hazards as well as risks can be done. PMID:16257037

  12. 40 CFR Table 3 to Part 455 - Organic Pesticide Active Ingredient New Source Performance Standards (NSPS) and Pretreatment...

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... 40 Protection of Environment 30 2011-07-01 2011-07-01 false Organic Pesticide Active Ingredient... STANDARDS PESTICIDE CHEMICALS Pt. 455, Table 3 Table 3 to Part 455—Organic Pesticide Active Ingredient New Source Performance Standards (NSPS) and Pretreatment Standards for New Sources (PSNS) Pesticide...

  13. 40 CFR Table 2 to Part 455 - Organic Pesticide Active Ingredient Effluent Limitations Best Available Technology Economically...

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... 40 Protection of Environment 30 2011-07-01 2011-07-01 false Organic Pesticide Active Ingredient... (CONTINUED) EFFLUENT GUIDELINES AND STANDARDS PESTICIDE CHEMICALS Pt. 455, Table 2 Table 2 to Part 455—Organic Pesticide Active Ingredient Effluent Limitations Best Available Technology Economically...

  14. 40 CFR Table 2 to Part 455 - Organic Pesticide Active Ingredient Effluent Limitations Best Available Technology Economically...

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... 40 Protection of Environment 30 2014-07-01 2014-07-01 false Organic Pesticide Active Ingredient... (CONTINUED) EFFLUENT GUIDELINES AND STANDARDS (CONTINUED) PESTICIDE CHEMICALS Pt. 455, Table 2 Table 2 to Part 455—Organic Pesticide Active Ingredient Effluent Limitations Best Available...

  15. 40 CFR Table 2 to Part 455 - Organic Pesticide Active Ingredient Effluent Limitations Best Available Technology Economically...

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... 40 Protection of Environment 31 2013-07-01 2013-07-01 false Organic Pesticide Active Ingredient... (CONTINUED) EFFLUENT GUIDELINES AND STANDARDS (CONTINUED) PESTICIDE CHEMICALS Pt. 455, Table 2 Table 2 to Part 455—Organic Pesticide Active Ingredient Effluent Limitations Best Available...

  16. 40 CFR Table 2 to Part 455 - Organic Pesticide Active Ingredient Effluent Limitations Best Available Technology Economically...

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... 40 Protection of Environment 31 2012-07-01 2012-07-01 false Organic Pesticide Active Ingredient... (CONTINUED) EFFLUENT GUIDELINES AND STANDARDS (CONTINUED) PESTICIDE CHEMICALS Pt. 455, Table 2 Table 2 to Part 455—Organic Pesticide Active Ingredient Effluent Limitations Best Available...

  17. 40 CFR Table 2 to Part 455 - Organic Pesticide Active Ingredient Effluent Limitations Best Available Technology Economically...

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 40 Protection of Environment 29 2010-07-01 2010-07-01 false Organic Pesticide Active Ingredient... (CONTINUED) EFFLUENT GUIDELINES AND STANDARDS PESTICIDE CHEMICALS Pt. 455, Table 2 Table 2 to Part 455—Organic Pesticide Active Ingredient Effluent Limitations Best Available Technology Economically...

  18. 40 CFR Table 3 to Part 455 - Organic Pesticide Active Ingredient New Source Performance Standards (NSPS) and Pretreatment...

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 40 Protection of Environment 29 2010-07-01 2010-07-01 false Organic Pesticide Active Ingredient... STANDARDS PESTICIDE CHEMICALS Pt. 455, Table 3 Table 3 to Part 455—Organic Pesticide Active Ingredient New Source Performance Standards (NSPS) and Pretreatment Standards for New Sources (PSNS) Pesticide...

  19. 21 CFR 201.322 - Over-the-counter drug products containing internal analgesic/antipyretic active ingredients...

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... analgesic/antipyretic active ingredients; required alcohol warning. 201.322 Section 201.322 Food and Drugs... containing internal analgesic/antipyretic active ingredients; required alcohol warning. (a) People who regularly consume large quantities of alcohol (three or more drinks every day) have an increased risk...

  20. A brief review on anti diabetic plants: Global distribution, active ingredients, extraction techniques and acting mechanisms

    PubMed Central

    Chan, Chung-Hung; Ngoh, Gek-Cheng; Yusoff, Rozita

    2012-01-01

    A study has been conducted with the aim to provide researchers with general information on anti diabetic extracts based on relevant research articles collected from 34 reliable medical journals. The study showed that Asian and African continents have 56% and 17% share of the worldwide distribution of therapeutic herbal plants, respectively. In Asia, India and China are the leading countries in herbal plants research, and there has been an increase in medicinal research on plants extract for diabetes treatment since 1995 in these regions. The information collected shows that plant leaves are about 20% more favorable for storing active ingredients, as compared to other parts of herbal plants. A brief review on the extraction techniques for the mentioned parts is also included. Furthermore, the acting mechanisms for the anti diabetic activity were described, and the related active ingredients were identified. The findings reveal that most of the anti diabetic research is focused on the alteration of glucose metabolism to prevent diabetes. PMID:22654401

  1. Research Advances in the Intervention of Inflammation and Cancer by Active Ingredients of Traditional Chinese Medicine.

    PubMed

    Huang, Yinghong; Cai, Tiange; Xia, Xi; Cai, Y; Wu, Xiao Yu

    2016-01-01

    A large body of evidence has shown that inflammation and cancer are strongly related. Thus anti-inflammatory agents have been investigated for cancer prevention and treatment in preclinical and clinical studies, including the nonsteroidal anti-inflammatory drugs (NSAIDs) and traditional Chinese medicine (TCM). In TCM, there exist a wide range of biologically active substances, such as saponins, flavonoids, alkaloids, polysaccharides, polyphenols, phenylpropanoids, and quinones. Many of these active ingredients have been reported to inhibit inflammation, activate inflammatory immune response, and/or inhibit cancer cell proliferation and tumor growth. Given the potential role of inflammation in cancer initiation and progression, the inflammatory tumor microenvironment, the cross-talks between inflammatory and cancer cells, and multitargeting activities of some TCM compounds, we summarize the current knowledge on the anti-inflammatory and anti-cancer properties of ingredients of TCM together with their underlying mechanisms in an integrated way. We hope to provide a reliable basis and useful information for the development of new treatment strategies of inflammation and cancer comprehensively using TCM and their active ingredients. This article is open to POST-PUBLICATION REVIEW. Registered readers (see "For Readers") may comment by clicking on ABSTRACT on the issue's contents page. PMID:27096696

  2. A slow-release system of bacterial cellulose gel and nanoparticles for hydrophobic active ingredients.

    PubMed

    Numata, Yukari; Mazzarino, Leticia; Borsali, Redouane

    2015-01-01

    A combination of bacterial cellulose (BC) gel and amphiphilic block copolymer nanoparticles was investigated as a drug delivery system (DDS) for hydrophobic active ingredients. Poly(ethylene oxide)-b-poly(caprolactone) (PEO-b-PCL) and retinol were used as the block copolymer and hydrophobic active ingredient, respectively. The BC gel was capable of incorporating copolymer nanoparticles and releasing them in an acetic acid-sodium acetate buffer solution (pH 5.2) at 37 °C. The percentage of released copolymer reached a maximum value of approximately 60% after 6h and remained constant after 24h. The percentage of retinol released from the copolymer-containing BC gel reached a maximum value at 4h. These results show that the combination of BC gel and nanoparticles is a slow-release system that may be useful in the cosmetic and biomedical fields for skin treatment and preparation. PMID:25840273

  3. An active ingredient of Cat's Claw water extracts identification and efficacy of quinic acid.

    PubMed

    Sheng, Yezhou; Akesson, Christina; Holmgren, Kristin; Bryngelsson, Carl; Giamapa, Vincent; Pero, Ronald W

    2005-01-15

    Historic medicinal practice has defined Cat's Claw, also known as Una de Gato or Uncaria tomentosa, as an effective treatment for several health disorders including chronic inflammation, gastrointestinal dysfunction such as ulcers, tumors and infections. The efficacy of Cat's Claw was originally believed, as early as the 1960s, to be due to the presence of oxindole alkaloids. However, more recently water-soluble Cat's Claw extracts were shown not to contain significant amounts of alkaloids (<0.05%), and yet still were shown to be very efficacious. Here we characterize the active ingredients of a water-soluble Cat's Claw extract called C-Med-100 as inhibiting cell growth without cell death thus providing enhanced opportunities for DNA repair, and the consequences thereof, such as immune stimulation, anti-inflammation and cancer prevention. The active ingredients were chemically defined as quinic acid esters and could also be shown to be bioactive in vivo as quinic acid. PMID:15619581

  4. 21 CFR 310.532 - Drug products containing active ingredients offered over-the-counter (OTC) to relieve the...

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... offered over-the-counter (OTC) to relieve the symptoms of benign prostatic hypertrophy. 310.532 Section... products containing active ingredients offered over-the-counter (OTC) to relieve the symptoms of benign... the ingredient sabal have been present in over-the-counter (OTC) drug products to relieve the...

  5. 21 CFR 310.532 - Drug products containing active ingredients offered over-the-counter (OTC) to relieve the...

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... offered over-the-counter (OTC) to relieve the symptoms of benign prostatic hypertrophy. 310.532 Section... products containing active ingredients offered over-the-counter (OTC) to relieve the symptoms of benign... the ingredient sabal have been present in over-the-counter (OTC) drug products to relieve the...

  6. The role of degradant profiling in active pharmaceutical ingredients and drug products.

    PubMed

    Alsante, Karen M; Ando, Akemi; Brown, Roland; Ensing, Janice; Hatajik, Todd D; Kong, Wei; Tsuda, Yoshiko

    2007-01-10

    Forced degradation studies are used to facilitate the development of analytical methodology, to gain a better understanding of active pharmaceutical ingredient (API) and drug product (DP) stability, and to provide information about degradation pathways and degradation products. In order to fulfill development and regulatory needs, this publication provides a roadmap for when and how to perform studies, helpful tools in designing rugged scientific studies, and guidance on how to record and communicate results. PMID:17187892

  7. Soil sorption and leaching of active ingredients of Lumax® under mineral or organic fertilization.

    PubMed

    Pinna, Maria Vittoria; Roggero, Pier Paolo; Seddaiu, Giovanna; Pusino, Alba

    2014-09-01

    The study describes the soil sorption of the herbicide Lumax®, composed of S-metolachlor (MTC), terbuthylazine (TBZ), and mesotrione (MST), as influenced by mineral and organic fertilizers. The investigation was performed on a sandy soil of an agricultural area designated as a Nitrate Vulnerable Zone, where mineral and organic fertilizers were applied for many years. Two organic fertilizers, cattle manure and slurry, respectively, and a mineral fertilizer with a nitrification inhibitor, Entec®, were compared. According to the experiments, performed with a batch method, the sorption conformed to Freundlich model. The extent of sorption of Lumax® ingredients was closely related to their octanol-water partition coefficient Kow. The respective desorption was hysteretic. Leaching trials were carried out by using water or solutions of DOM or Entec® as the eluants. Only the elution with the mineral fertilizer promoted the leaching of Lumax® active ingredients. PMID:24997942

  8. Supercritical carbon dioxide fractionation of whey protein isolate for new food-grade ingredients

    Technology Transfer Automated Retrieval System (TEKTRAN)

    A new, environmentally benign whey protein fractionation process was developed using supercritical CO2 (SCO2) as an acid aggregating agent to separate a-lactalbumin (a-LA) aggregates from soluble beta-lactoglobulin (beta-LG) protein in concentrated whey protein isolate (WPI) solutions. The process e...

  9. Evaluation of the fate of the active ingredients of insecticide sprays used indoors.

    PubMed

    Leva, Paolo; Katsoyiannis, Athanasios; Barrero-Morero, Josefa; Kephalopoulos, Stylianos; Kotzias, Dimitrios

    2009-01-01

    The fate of the active ingredients of insecticide sprays after use in indoor environments was investigated. Indoor air sampling was performed through two types of adsorbents, namely, TENAX TA and XAD-2 (10 L). After sampling, both adsorbents were ultrasonically extracted and analyzed by Gas Chromatography coupled to Mass Spectroscopy. The separation and analysis of the selected compounds were satisfactory and fast (duration of the chromatographic run: 40 min). The method was linear for all examined chemicals over the tested range (2 to 50 ng of absolute compound); limits of detection ranged from 0.42 to 1.32 ng of absolute compound. The method was then applied in the determination of the active ingredients of three commercially available insecticide sprays that were separately used in a full-scale environmental chamber (30 m(3)). After spraying, the fate of the active ingredients [propoxur, piperonyl butoxide (PBO) and pyrethrin insecticides] was monitored over 40 minutes, with and without ventilation. Both adsorbent materials were proven to be efficient and the differences in the concentrations deriving from sampling with both materials were in almost all cases less than 10%. All chemicals were removed in rates that exceeded 80%, after the 40 minutes of monitoring, exhibiting different decay rates. The removal of insecticides was not significantly affected by the ventilation of the chamber. The correlation analysis of propoxur, PBO and pyrethrins with the aerosols of various sizes (15 fractions, from 0.3 to > 20 microm) showed that propoxur and PBO mainly associated with the medium size aerosols (3-7.5 microm) while pyrethrins seem to link more with heavier particles (> 10 microm). PMID:19089715

  10. Stability Assessment of 10 Active Pharmaceutical Ingredients Compounded in SyrSpend SF.

    PubMed

    Geiger, Christine M; Sorenson, Bridget; Whaley, Paul

    2015-01-01

    The stability of 10 active pharmaceutical ingredients was studied in SyrSpend SF PH4 or SyrSpend SF Alka at room and/or refrigerated temperature (2°C to 8°C). An oral suspension of each active pharmaceutical ingredient was compounded in low actinic plastic bottles at a specific concentration in SyrSpend SF PH4 or SyrSpend SF Alka. Samples were assessed for stability immediately after preparation (day 0) followed by storage at room temperature and/or at refrigerated temperature. At set time points, the samples were removed from storage and assayed using a high-performance liquid chromatographic stability- indicating method. The active pharmaceutical ingredient was considered stable if the suspension retained 90% to 110% of the initial concentration. Furosemide was stable for at least 14 days in SyrSpend SF Alka at refrigerated conditions. Prednisolone sodium phosphate in SyrSpend SF PH4 was stable for at least 30 days at room temperature and refrigerated conditions. Ranitidine hydrochloride suspensions in SyrSpend SF PH4 at room temperature and refrigerated conditions were stable for at least 30 days and 58 days, respectively. Hydrocortisone hemisuccinate and sodium phosphate retained greater than 90% for at least 60 days at both room temperature and refrigerated samples in SyrSpend SF PH4. Amiodarone hydrochloride and nifedipine suspensions at both room temperature and refrigerated conditions retained greater than 90% of the initial concentrations for at least 90 days in SyrSpend SF PH4. Refrigerated samples of simvastatin in SyrSpend SF PH4 were stable for at least 90 days. Spironolactone in SyrSpend SF PH4 at room temperature retained more than 90% of the initial concentration for at least 90 days. Phenobarbital in SyrSpend SF PH4 retained above 90% of initial concentration for at least 154 days at room temperature. This study demonstrated the stability of a wide range of frequently used active pharmaceutical ingredients, tested in SyrSpend SF PH4 and Syr

  11. A target analogue imprinted polymer for the recognition of antiplatelet active ingredients in Radix Salviae Miltiorrhizae by LC/MS/MS.

    PubMed

    Huang, Meixia; Pang, Wensheng; Zhang, Jing; Lin, Siding; Hu, Juan

    2012-01-25

    The purpose of this study was to prepare a propyl gallate (PrG) molecular imprinted polymer as a cartridge stuffing material to isolate antiplatelet active ingredients. A macroporous polymer was synthesized utilizing ethylene glycol dimethacrylate (EDMA) as the crosslinking agent, PrG as the template molecule and 4-vinylpyridine (4-Vpy) as the functional monomer. Subsequently, PrG was removed by washing with methanol-glacial acetic acid (9:1, v/v). The molecular imprinted polymer recognized an active ingredient, protocatechuic acid, from a crude extract of the Chinese herbal medicine, Radix Salviae Miltiorrhizae (Danshen), using an on-line column switching solid phase extraction process. Pharmacological experiments showed that protocatechuic acid inhibits arachidonic acid (10 mg/kg) induced aggregation of rat platelets in vivo. This study provides an example of an application of separation-analysis technique for screening potentially bioactive compounds. PMID:21978827

  12. Active ingredients in Chinese medicines promoting blood circulation as Na+/K+-ATPase inhibitors

    PubMed Central

    Chen, Ronald JY; Jinn, Tzyy-rong; Chen, Yi-ching; Chung, Tse-yu; Yang, Wei-hung; Tzen, Jason TC

    2011-01-01

    The positive inotropic effect of cardiac glycosides lies in their reversible inhibition on the membrane-bound Na+/K+-ATPase in human myocardium. Steroid-like compounds containing a core structure similar to cardiac glycosides are found in many Chinese medicines conventionally used for promoting blood circulation. Some of them are demonstrated to be Na+/K+-ATPase inhibitors and thus putatively responsible for their therapeutic effects via the same molecular mechanism as cardiac glycosides. On the other hand, magnesium lithospermate B of danshen is also proposed to exert its cardiac therapeutic effect by effectively inhibiting Na+/K+-ATPase. Theoretical modeling suggests that the number of hydrogen bonds and the strength of hydrophobic interaction between the effective ingredients of various medicines and residues around the binding pocket of Na+/K+-ATPase are crucial for the inhibitory potency of these active ingredients. Ginsenosides, the active ingredients in ginseng and sanqi, substantially inhibit Na+/K+-ATPase when sugar moieties are attached only to the C-3 position of their steroid-like structure, equivalent to the sugar position in cardiac glycosides. Their inhibitory potency is abolished, however, when sugar moieties are linked to C-6 or C-20 position of the steroid nucleus; presumably, these sugar attachments lead to steric hindrance for the entrance of ginsenosides into the binding pocket of Na+/K+-ATPase. Neuroprotective effects of cardiac glycosides, several steroid-like compounds, and magnesium lithospermate B against ischemic stroke have been accordingly observed in a cortical brain slice-based assay model, and cumulative data support that effective inhibitors of Na+/K+-ATPase in the brain could be potential drugs for the treatment of ischemic stroke. PMID:21293466

  13. Co-Crystals: A Novel Approach to Modify Physicochemical Properties of Active Pharmaceutical Ingredients

    PubMed Central

    Yadav, A. V.; Shete, A. S.; Dabke, A. P.; Kulkarni, P. V.; Sakhare, S. S.

    2009-01-01

    Crystal form can be crucial to the performance of a dosage form. This is especially true for compounds that have intrinsic barriers to drug delivery, such as low aqueous solubility, slow dissolution in gastrointestinal media, low permeability and first-pass metabolism. The nature of the physical form and formulation tends to exhibit the greatest effect on bioavailability parameters of water insoluble compounds that need to be given orally in high doses. An alternative approach available for the enhancement of drug solubility, dissolution and bioavailability is through the application of crystal engineering of co-crystals. The physicochemical properties of the active pharmaceutical ingredients and the bulk material properties can be modified, whilst maintaining the intrinsic activity of the drug molecule. This article covers the advantages of co-crystals over salts, solvates (hydrates), solid dispersions and polymorphs, mechanism of formation of co-crystals, methods of preparation of co-crystals and application of co-crystals to modify physicochemical characteristics of active pharmaceutical ingredients along with the case studies. The intellectual property implications of creating co-crystals are also highly relevant. PMID:20502540

  14. After-brush rinsing protocols, frequency of toothpaste use: fluoride and other active ingredients.

    PubMed

    Parnell, C; O'Mullane, D

    2013-01-01

    The intra-oral retention or substantivity of active ingredients in toothpastes is important for their effectiveness, and this is influenced by product-related and user-related factors. Product-related factors include the formulation and the compatibility of active and other agents in the toothpaste and the concentration of the active ingredient. User-related factors include biological aspects such as salivary flow and salivary clearance, and behavioural aspects, such as frequency and duration of brushing, amount of toothpaste used and post-brushing rinsing behaviour. To date, product-related factors have dominated the research agenda for toothpastes, but user-related factors have the potential to significantly enhance or reduce the effectiveness of toothpaste. In this chapter, we will focus on two of the user-related factors that have been most widely studied: (1) frequency of toothbrushing and (2) post-brushing rinsing behaviour. We will then provide an overview of how evidence on these two behaviours has been used to produce guidance both for the profession and for the public, and make suggestions for the future direction of research in this area. PMID:23817066

  15. Determination of active ingredients of Rhododendron dauricum L. by capillary electrophoresis with electrochemical detection.

    PubMed

    Cao, Yuhua; Lou, Changgang; Fang, Yuzhi; Ye, Jiannong

    2002-01-11

    High-performance capillary electrophoresis with electrochemical detection was employed to analyse active ingredients of Rhododendron dauricum L., an important crude herb frequently used in Chinese medicines. Farrerol, quercetin, syringic acid, vanillic acid, 4-hydroxybenzoic acid, protocatechuic acid are major important active ingredients. Operated in a wall-jet configuration, a 300-microm diameter carbon-disk electrode was used as the working electrode, which exhibits a good response at +950 mV (vs. saturated calomel electrodes) for six analytes. Under the optimum conditions, the analytes were baseline separated within 16 min in a borax buffer (pH 8.7). Notably, excellent linearity was obtained over two orders of magnitude with detection limits (S/N=3) ranged from 9 x 10(-7) to 3.0 x 10(-6) M for all analytes. This method was successfully used in the analysis of Rhododendron dauricum L. with relatively simple extraction procedures, and the assay results were satisfactory. PMID:11820277

  16. Integration of active pharmaceutical ingredient solid form selection and particle engineering into drug product design.

    PubMed

    Ticehurst, Martyn David; Marziano, Ivan

    2015-06-01

    This review seeks to offer a broad perspective that encompasses an understanding of the drug product attributes affected by active pharmaceutical ingredient (API) physical properties, their link to solid form selection and the role of particle engineering. While the crucial role of active pharmaceutical ingredient (API) solid form selection is universally acknowledged in the pharmaceutical industry, the value of increasing effort to understanding the link between solid form, API physical properties and drug product formulation and manufacture is now also being recognised. A truly holistic strategy for drug product development should focus on connecting solid form selection, particle engineering and formulation design to both exploit opportunities to access simpler manufacturing operations and prevent failures. Modelling and predictive tools that assist in establishing these links early in product development are discussed. In addition, the potential for differences between the ingoing API physical properties and those in the final product caused by drug product processing is considered. The focus of this review is on oral solid dosage forms and dry powder inhaler products for lung delivery. PMID:25677227

  17. Determination of nickel in active pharmaceutical ingredients by electrothermal atomic absorption spectrometry.

    PubMed

    Bubnič, Zoran; Urleb, Uroš; Kreft, Katjuša; Veber, Marjan

    2010-03-01

    An electrothermal atomic absorption spectrometric procedure for the determination of nickel in active pharmaceutical ingredients was developed. Since the recoveries of nickel by the direct dissolution of samples in diluted nitric acid were low and caused errors in the determination of Ni in pharmaceutical samples, different approaches for sample pre-treatment were examined. It was found that the microwave digestion was the most suitable way for sample preparation. Various combinations of digestion agents and different microwave conditions were tested. The combination of nitric acid and hydrogen peroxide was found to be the most appropriate. The validity of the method was evaluated by recovery studies of spiked samples and by the comparison of the results obtained by inductively coupled plasma mass spectrometry (ICP-MS). The recovery ranged from 87.5 to 104.0% and a good agreement was achieved between both methods. The detection limit and the limit of quantification were 0.6 and 2.1 µg g-1 respectively. The precision of the method was confirmed by the determination of Ni in the spiked samples and was below 4%, expressed in terms of a relative standard deviation. The method was applied to the determination of nickel in production samples of active pharmaceutical ingredients and intermediates. PMID:24061653

  18. A Comprehensive and System Review for the Pharmacological Mechanism of Action of Rhein, an Active Anthraquinone Ingredient.

    PubMed

    Sun, Hao; Luo, Guangwen; Chen, Dahui; Xiang, Zheng

    2016-01-01

    Rhein is a major medicinal ingredient isolated from several traditional Chinese medicines, including Rheum palmatum L., Aloe barbadensis Miller, Cassia angustifolia Vahl., and Polygonum multiflorum Thunb. Rhein has various pharmacological activities, such as anti-inflammatory, antitumor, antioxidant, antifibrosis, hepatoprotective, and nephroprotective activities. Although more than 100 articles in PubMed are involved in the pharmacological mechanism of action of rhein, only a few focus on the relationship of crosstalk among multiple pharmacological mechanisms. The mechanism of rhein involves multiple pathways which contain close interactions. From the overall perspective, the pathways which are related to the targets of rhein, are initiated by the membrane receptor. Then, MAPK and PI3K-AKT parallel signaling pathways are activated, and several downstream pathways are affected, thereby eventually regulating cell cycle and apoptosis. The therapeutic effect of rhein, as a multitarget molecule, is the synergistic and comprehensive result of the involvement of multiple pathways rather than the blocking or activation of a single signaling pathway. We review the pharmacological mechanisms of action of rhein by consulting literature published in the last 100 years in PubMed. We then summarize these pharmacological mechanisms from a comprehensive, interactive, and crosstalk perspective. In general, the molecular mechanism of action of drug must be understood from a systematic and holistic perspective, which can provide a theoretical basis for precise treatment and rational drug use. PMID:27582705

  19. A Comprehensive and System Review for the Pharmacological Mechanism of Action of Rhein, an Active Anthraquinone Ingredient

    PubMed Central

    Sun, Hao; Luo, Guangwen; Chen, Dahui; Xiang, Zheng

    2016-01-01

    Rhein is a major medicinal ingredient isolated from several traditional Chinese medicines, including Rheum palmatum L., Aloe barbadensis Miller, Cassia angustifolia Vahl., and Polygonum multiflorum Thunb. Rhein has various pharmacological activities, such as anti-inflammatory, antitumor, antioxidant, antifibrosis, hepatoprotective, and nephroprotective activities. Although more than 100 articles in PubMed are involved in the pharmacological mechanism of action of rhein, only a few focus on the relationship of crosstalk among multiple pharmacological mechanisms. The mechanism of rhein involves multiple pathways which contain close interactions. From the overall perspective, the pathways which are related to the targets of rhein, are initiated by the membrane receptor. Then, MAPK and PI3K-AKT parallel signaling pathways are activated, and several downstream pathways are affected, thereby eventually regulating cell cycle and apoptosis. The therapeutic effect of rhein, as a multitarget molecule, is the synergistic and comprehensive result of the involvement of multiple pathways rather than the blocking or activation of a single signaling pathway. We review the pharmacological mechanisms of action of rhein by consulting literature published in the last 100 years in PubMed. We then summarize these pharmacological mechanisms from a comprehensive, interactive, and crosstalk perspective. In general, the molecular mechanism of action of drug must be understood from a systematic and holistic perspective, which can provide a theoretical basis for precise treatment and rational drug use. PMID:27582705

  20. Identification of Medicinally Active Ingredient in Ultradiluted Digitalis purpurea: Fluorescence Spectroscopic and Cyclic-Voltammetric Study

    PubMed Central

    Sharma, Anup; Purkait, Bulbul

    2012-01-01

    Serially diluted and agitated (SAD) drugs available commercially are in use with great faith because of the astonishing results they produce. The scientific viewpoint attached to the centuries-old therapy with SAD drugs, as in homeopathy, remained doubtful for want of appropriate research and insufficient evidence base. The conflicting points related to SAD drug mostly related to the level of concentrations/dilutions, use of drug in contradictory clinical conditions compared to the modern system of medicine, identification of medicinally active ingredient in concentrations and dilutions used in commercially available SAD drugs, and lack of laboratory-based pharmacological data vis-à-vis modern medicine. Modus operandi of SAD drug is also unknown. To address some of these issues an analytical study was carried out wherein commercially available SAD drug Digitalis purpurea, commonly used in different systems of medicine, was put to test. Various concentrations of commercially available Digitalis purpurea were analyzed using analytical methods: cyclic voltammetry, emission spectroscopy, and UV-VIS spectroscopy. These analytical methods apparently identified the medicinal ingredients and effect of serial dilution in commercial preparation of the drugs. PMID:22606641

  1. Peculiar surface behavior of some ionic liquids based on active pharmaceutical ingredients

    NASA Astrophysics Data System (ADS)

    Restolho, José; Mata, José Luis; Saramago, Benilde

    2011-02-01

    The ionic liquids based on biologically active cations and anions, commonly designated by ionic liquids based on active pharmaceutical ingredients (ILs-APIs), are interesting compounds for use in pharmaceutical applications. Lidocaine docusate, ranitidine docusate, and didecyldimethylammonium ibuprofen are examples of promising ILs-APIs that were recently synthesized. They were submitted to biological testing and calorimetric measurements, but nothing is known about their surface properties. In this work, we measured the surface tension and the contact angles on both hydrophilic and hydrophobic surfaces in a temperature range as wide as possible. Based on the wettability data, the polarity fractions were estimated using the Fowkes theory. The peculiar surface behavior observed was tentatively attributed to the presence of mesophases.

  2. Peculiar surface behavior of some ionic liquids based on active pharmaceutical ingredients.

    PubMed

    Restolho, José; Mata, José Luis; Saramago, Benilde

    2011-02-21

    The ionic liquids based on biologically active cations and anions, commonly designated by ionic liquids based on active pharmaceutical ingredients (ILs-APIs), are interesting compounds for use in pharmaceutical applications. Lidocaine docusate, ranitidine docusate, and didecyldimethylammonium ibuprofen are examples of promising ILs-APIs that were recently synthesized. They were submitted to biological testing and calorimetric measurements, but nothing is known about their surface properties. In this work, we measured the surface tension and the contact angles on both hydrophilic and hydrophobic surfaces in a temperature range as wide as possible. Based on the wettability data, the polarity fractions were estimated using the Fowkes theory. The peculiar surface behavior observed was tentatively attributed to the presence of mesophases. PMID:21341864

  3. Multiple Comparisons of Glucokinase Activation Mechanisms of Five Mulberry Bioactive Ingredients in Hepatocyte.

    PubMed

    He, Hao; Yu, Wan-Guo; Yang, Jun-Peng; Ge, Sheng; Lu, Yan-Hua

    2016-03-30

    Glucokinase (GK) activity, which is rapidly regulated by glucokinase regulatory protein (GKRP) in the liver, is crucial for blood glucose homeostasis. In this paper, the GK activation mechanisms of 1-deoxynojrimycin (DNJ), resveratrol (RES), oxyresveratrol (OXY), cyanidin-3-glucoside (C3G), and cyanidin-3-rutinoside (C3R) were compared. The results revealed that DNJ, RES, C3G, and C3R could differently improve glucose consumption and enhance intracellular GK activities. DNJ and RES significantly promoted GK translocation at 12.5 μM, whereas other ingredients showed moderate effects. DNJ, C3G, and C3R could rupture intramolecular hydrogen bonds of GK to accelerate its allosteric activation at early stage. RES and OXY could bind to a "hydrophobic pocket" on GK to stabilize the active GK at the final stage. Otherwise, RES, OXY, C3G, and C3R could interact with GKRP at the F1P binding site to promote GK dissociation and translocation. Enzymatic assay showed that RES (15-50 μM) and OXY (25-50 μM) could significantly enhance GK activities, which was caused by their binding properties with GK. Moreover, the most dramatic up-regulation effects on GK expression were observed in C3G and C3R groups. This work expounded the differences between GK activation mechanisms, and the new findings would help to develop new GK activators. PMID:26292150

  4. Transparent gels: study of their formation and assimilation of active ingredients through phase diagrams.

    PubMed

    Comelles, F; Caelles, J; Parra, J L; Leal, J S

    1992-08-01

    Synopsis Multicomponent gel formulations capable of assimilating, simultaneously, several active ingredients of potential application in the cosmetic field were studied. The possibility of formation of a transparent gel was determined using a method which consisted in the optimization of several lipophilic basic compositions, composed of oil, a mixture of surfactants, a sunscreen agent, several vitamins and antioxidants situated in the base of a regular tetrahedron that symbolized the considered system. To this, a polar phase made of water, a cosolvent and urea in appropriate proportions and situated in the fourth vertex, was progressively added. It may be concluded, that the use of phase diagrams on cosmetic systems, constitutes a useful way to select the components and their mutual ratios, allowing an adaptation to the specific requested conditions of formulation. PMID:19272106

  5. Application of instrumented nanoindentation in preformulation studies of pharmaceutical active ingredients and excipients.

    PubMed

    Egart, Mateja; Janković, Biljana; Srčič, Stane

    2016-09-01

    Nanoindentation allows quantitative determination of a material's response to stress such as elastic and plastic deformation or fracture tendency. Key instruments that have enabled great advances in nanomechanical studies are the instrumented nanoindenter and atomic force microscopy. The versatility of these instruments lies in their capability to measure local mechanical response, in very small volumes and depths, while monitoring time, displacement and force with high accuracy and precision. This review highlights the application of nanoindentation for mechanical characterization of pharmaceutical materials in the preformulation phase (primary investigation of crystalline active ingredients and excipients). With nanoindentation, mechanical response can be assessed with respect to crystal structure. The technique is valuable for mechanical screening of a material at an early development phase in order to predict and better control the processes in which a material is exposed to stress such as milling and compression. PMID:27383883

  6. A risk-based approach to managing active pharmaceutical ingredients in manufacturing effluent.

    PubMed

    Caldwell, Daniel J; Mertens, Birgit; Kappler, Kelly; Senac, Thomas; Journel, Romain; Wilson, Peter; Meyerhoff, Roger D; Parke, Neil J; Mastrocco, Frank; Mattson, Bengt; Murray-Smith, Richard; Dolan, David G; Straub, Jürg Oliver; Wiedemann, Michael; Hartmann, Andreas; Finan, Douglas S

    2016-04-01

    The present study describes guidance intended to assist pharmaceutical manufacturers in assessing, mitigating, and managing the potential environmental impacts of active pharmaceutical ingredients (APIs) in wastewater from manufacturing operations, including those from external suppliers. The tools are not a substitute for compliance with local regulatory requirements but rather are intended to help manufacturers achieve the general standard of "no discharge of APIs in toxic amounts." The approaches detailed in the present study identify practices for assessing potential environmental risks from APIs in manufacturing effluent and outline measures that can be used to reduce the risk, including selective application of available treatment technologies. These measures either are commonly employed within the industry or have been implemented to a more limited extent based on local circumstances. Much of the material is based on company experience and case studies discussed at an industry workshop held on this topic. PMID:26183919

  7. Automated sample preparation for ICP analysis of active pharmaceutical ingredients and intermediates.

    PubMed

    Sims, Jonathan; Smith, Andrew; Patel, Dharmista; Batchelor, Richard; Carreira, Judith

    2011-10-01

    Routine testing of active pharmaceutical ingredients (APIs) for metal residues is an expectation of regulatory bodies such as the FDA (U.S. Food and Drug Administration). Sample preparation techniques are the rate-limiting step in the testing process and can be variable depending on the specific characteristics of the API under test. Simplification and standardization of the routine preparation of inductively coupled plasma spectroscopy sample solutions of organic compounds has been developed using a commercially available robotic workstation. Contamination from the metal components of the instrument and from sample tubes used in the methodology has been studied using a Design of Experiments approach. The optimized method described can be used for the measurement of trace metals in Pharmaceuticals at levels compliant with European and U.S. regulatory requirements. PMID:21906564

  8. Review article: health benefits of some physiologically active ingredients and their suitability as yoghurt fortifiers.

    PubMed

    Fayed, A E

    2015-05-01

    The article is concerned with health benefits of two main physiologically active ingredients namely, Isoflavones and γ-Aminobutyric acid, with emphasis on their fitness for fortification of yoghurt to be consumed as a functional food. Isoflavones (ISO) are part of the diphenol compounds, called "phytoestrogens," which are structurally and functionally similar to estradiol, the human estrogen, but much less potent. Because of this similarity, ISO were suggested to have preventive effects for many kinds of hormone-dependent diseases. In nature, ISO usually occur as glycosides and, once deconjugated by the intestinal microflora, the ISO can be absorbed into the blood. At present, it seems convincing their possible protective actions against various cancers, osteoporosis and menopausal symptoms and high levels of blood cholesterol as well as the epidemiological evidence. Γ-Aminobutyric acid (GABA), it is an amino acid that has long been reported to lower blood pressure by intravenous administration in experimental animals and in human subjects. GABA is present in many vegetables and fruits but not in dairy products. GABA was reported to lower blood pressure in people with mild hypertension. It was suggested that low-dose oral GABA has a hypotensive effect in spontaneously hypertensive. Yoghurt beyond its ability to be probiotic food via its culturing with the gut strains, it could further carry more healthy benefits when it was fortified with physiological active ingredients, especially GABA versus ISO preferring, whether, bacteriologically or biochemically, a fortification level of 50 mg ISO/kg or 200 mg GABA/kg. PMID:25892751

  9. Cotton defoliant runoff as a function of active ingredient and tillage.

    PubMed

    Potter, Thomas L; Truman, Clint C; Bosch, David D; Bednarz, Craig W

    2003-01-01

    Cotton (Gossypium hirsutum L.) defoliant runoff was recently identified as an ecological risk. However, assessments are not supported by field studies. Runoff potential of three defoliant active ingredients, dimethipin (2,3-dihydro-5,6-dimethyl-1,4-dithiin 1,1,4,4-tetraoxide), thidiazuron (N-phenyl-N-1,2,3-thidiazol-5-yl-urea), and tribufos (S,S,S-tributyl phosphorotrithioate) was investigated by rainfall simulation on strip (ST) and conventionally tilled (CT) cotton in south central Georgia. Simulated rainfall timing relative to defoliant application (1 h after) represented an extreme worst-case scenario; however, weather records indicate that it was not unrealistic for the region. Thidiazuron and tribufos losses were 12 to 15% of applied. Only 2 to 5% of the more water soluble dimethipin was lost. Although ST erosion rates were less, loss of tribufos, a strongly sorbing compound, was not affected. Higher sediment-water partition coefficients (kd) were measured in ST samples. This likely explains why no tillage related differences in loss rates were observed, but it is unknown whether this result can be generalized. The study was conducted in the first year following establishment of tillage treatments at the study site. As soil conditions stabilize, ST impacts may change. Data provide an estimate of the maximum amount of the defoliants that will run off during a single postapplication storm event. Use of these values in place of the default value in runoff simulation models used in pesticide risk assessments will likely improve risk estimate accuracy and enhance evaluation of comparative risk among these active ingredients. PMID:14674540

  10. 40 CFR Table 3 to Part 455 - Organic Pesticide Active Ingredient New Source Performance Standards (NSPS) and Pretreatment...

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... 40 Protection of Environment 31 2012-07-01 2012-07-01 false Organic Pesticide Active Ingredient... STANDARDS (CONTINUED) PESTICIDE CHEMICALS Pt. 455, Table 3 Table 3 to Part 455—Organic Pesticide Active...) Pesticide kg/kkg (lb/1,000 lb) pounds of pollutant per 1000 lbs product Daily maximum shall not...

  11. 40 CFR Table 3 to Part 455 - Organic Pesticide Active Ingredient New Source Performance Standards (NSPS) and Pretreatment...

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... 40 Protection of Environment 31 2013-07-01 2013-07-01 false Organic Pesticide Active Ingredient... STANDARDS (CONTINUED) PESTICIDE CHEMICALS Pt. 455, Table 3 Table 3 to Part 455—Organic Pesticide Active...) Pesticide kg/kkg (lb/1,000 lb) pounds of pollutant per 1000 lbs product Daily maximum shall not...

  12. 40 CFR Table 3 to Part 455 - Organic Pesticide Active Ingredient New Source Performance Standards (NSPS) and Pretreatment...

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... 40 Protection of Environment 30 2014-07-01 2014-07-01 false Organic Pesticide Active Ingredient... STANDARDS (CONTINUED) PESTICIDE CHEMICALS Pt. 455, Table 3 Table 3 to Part 455—Organic Pesticide Active...) Pesticide kg/kkg (lb/1,000 lb) pounds of pollutant per 1000 lbs product Daily maximum shall not...

  13. Identification of active ingredients in Wuzhuyu decoction improving migraine in mice by spectral efficiency association.

    PubMed

    Pan, Xueqiang; Wang, Manyuan; Wu, Yanchuan; Lu, Xuran; Shang, Yawen; Xu, Yongsong; Zhai, Yongsong; Li, Jing; Li, Zhaoxia; Gong, Muxin

    2015-07-01

    Wuzhuyu decoction is a traditional Chinese medicine used for the effective treatment of migraines, termed 'Jueyin headache', in China. However, there have been few investigations to clarify the composition of Wuzhuyu decoction for the treatment of migraines. In the present study, 10 types of Wuzhuyu decoction were analyzed by chromatograms. 5-hydroxytryptamine (5-HT)-depletion mouse models of migraine were prepared by subcutaneous injection of reserpine and placement of autologous blood clots in the cerebral cortex. The levels of 5-HT, noradrenaline (NE), dopamine (DA), nitric oxide (NO) and nitric oxide synthase (NOS) in the brain tissues and sera of the mice were determined. The ingredients and pharmacodynamic indices of the Wuzhuyu decoctions were analyzed using spectral efficiency association by partial least squares regression. The levels of 5-HT, NE and DA in the mouse brain tissues were reduced to 337.785 ± 84.504, 171.173 ± 65.172 and 242.075 ± 158.621 mg/g brain tissue, respectively. The level of NO in the brain tissues increased to 0.425 ± 0.184 µmol/g protein and the activities of NOS in the brain tissues and sera increased to 0.719 ± 0.477 U/mg and 50.688 ± 8.132 U/ml, respectively. Regarding the ingredients of the Wuzhuyu decoction, those with significant regression coefficients were ginsenoside-Rg1, Re, Rb1, rutaevine (Rv), limonin (Li), evodiamine (Ev), rutaecarpine (Ru) and substance X (awaiting identification). Rg1, Re, Rb1, Rv, Li, Ev, Ru and X in the Wuzhuyu decoction were observed to yield the pharmacological effects, whereas Rb1, Rv and Ev were important in index improvement. PMID:25815775

  14. Evaluation of teratogenic effects of crocin and safranal, active ingredients of saffron, in mice.

    PubMed

    Moallem, Seyed Adel; Afshar, Mohammad; Etemad, Leila; Razavi, Bibi Marjan; Hosseinzadeh, Hossein

    2016-02-01

    Saffron (Crocus sativus) is a widely used food additive for its color and taste. Crocin and safranal are two main components of this plant. Numerous studies are underway to introduce saffron and its active ingredients as pharmacological agents. Safety assessments of these compounds are important parts of this endeavor. In this study, the effects of crocin and safranal administrations during embryogenesis have been investigated in mice. A total of 75 BALB/c pregnant mice were divided into six experimental and control groups. Four experimental groups received intraperitoneal injection of crocin (200 mg/kg or 600 mg/kg) daily or safranal (0.075 ml/kg or 0.225 ml/kg) on gestational days (GDs) 6 to 15. Control groups received normal saline or paraffin as solvents of crocin and safranal. Dams were dissected on GD18 and embryos were collected. Routine maternal and fetal parameters were recorded. Macroscopic observation of external malformations was also performed. Fetuses were then selected for double skeletal staining with alizarin red and alcian blue. All experimental groups caused significant decrease in length and weight of fetuses when compared with the control groups and revealed malformations such as minor skeletal malformations, mandible and calvaria malformations, and growth retardation. Minor skeletal malformations were the most commonly observed abnormality, which were statistically significant when compared with the control groups (p < 0.05). The severities of malformations were comparable in the crocin- and safranal-treated groups. This study suggests that crocin or safranal can induce embryonic malformations when administered in pregnant mice. Due to the wide use of saffron, further elaborate studies to understand the malformation mechanisms of these ingredients are recommended. PMID:24097366

  15. Hypoglycemic effects of clove (Syzygium aromaticum flower buds) on genetically diabetic KK-Ay mice and identification of the active ingredients.

    PubMed

    Kuroda, Minpei; Mimaki, Yoshihiro; Ohtomo, Takayuki; Yamada, Junji; Nishiyama, Tozo; Mae, Tatsumasa; Kishida, Hideyuki; Kawada, Teruo

    2012-04-01

    Clove (Syzygium aromaticum flower buds) EtOH extract significantly suppressed an increase in blood glucose level in type 2 diabetic KK-A(y) mice. In-vitro evaluation showed the extract had human peroxisome proliferator-activated receptor (PPAR)-γ ligand-binding activity in a GAL4-PPAR-γ chimera assay. Bioassay-guided fractionation of the EtOH extract resulted in the isolation of eight compounds, of which dehydrodieugenol (2) and dehydrodieugenol B (3) had potent PPAR-γ ligand-binding activities, whereas oleanolic acid (4), a major constituent in the EtOH extract, had moderate activity. Furthermore, 2 and 3 were shown to stimulate 3T3-L1 preadipocyte differentiation through PPAR-γ activation. These results indicate that clove has potential as a functional food ingredient for the prevention of type 2 diabetes and that 2-4 mainly contribute to its hypoglycemic effects via PPAR-γ activation. PMID:21987283

  16. Dissolution enhancement of active pharmaceutical ingredients by therapeutic deep eutectic systems.

    PubMed

    Aroso, Ivo M; Silva, João C; Mano, Francisca; Ferreira, Ana S D; Dionísio, Madalena; Sá-Nogueira, Isabel; Barreiros, Susana; Reis, Rui L; Paiva, Alexandre; Duarte, Ana Rita C

    2016-01-01

    A therapeutic deep eutectic system (THEDES) is here defined as a deep eutectic solvent (DES) having an active pharmaceutical ingredient (API) as one of the components. In this work, THEDESs are proposed as enhanced transporters and delivery vehicles for bioactive molecules. THEDESs based on choline chloride (ChCl) or menthol conjugated with three different APIs, namely acetylsalicylic acid (AA), benzoic acid (BA) and phenylacetic acid (PA), were synthesized and characterized for thermal behaviour, structural features, dissolution rate and antibacterial activity. Differential scanning calorimetry and polarized optical microscopy showed that ChCl:PA (1:1), ChCl:AA (1:1), menthol:AA (3:1), menthol:BA (3:1), menthol:PA (2:1) and menthol:PA (3:1) were liquid at room temperature. Dissolution studies in PBS led to increased dissolution rates for the APIs when in the form of THEDES, compared to the API alone. The increase in dissolution rate was particularly noticeable for menthol-based THEDES. Antibacterial activity was assessed using both Gram-positive and Gram-negative model organisms. The results show that all the THEDESs retain the antibacterial activity of the API. Overall, our results highlight the great potential of THEDES as dissolution enhancers in the development of novel and more effective drug delivery systems. PMID:26586342

  17. Gallic Acid, the Active Ingredient of Terminalia bellirica, Enhances Adipocyte Differentiation and Adiponectin Secretion.

    PubMed

    Makihara, Hiroko; Koike, Yuka; Ohta, Masatomi; Horiguchi-Babamoto, Emi; Tsubata, Masahito; Kinoshita, Kaoru; Akase, Tomoko; Goshima, Yoshio; Aburada, Masaki; Shimada, Tsutomu

    2016-01-01

    Visceral obesity induces the onset of metabolic disorders such as insulin resistance and diabetes mellitus. Adipose tissue is considered as a potential pharmacological target for treating metabolic disorders. The fruit of Terminalia bellirica is extensively used in Ayurvedic medicine to treat patients with diseases such as diabetes mellitus. We previously investigated the effects of a hot water extract of T. bellirica fruit (TB) on obesity and insulin resistance in spontaneously obese type 2 diabetic mice. To determine the active ingredients of TB and their molecular mechanisms, we focused on adipocyte differentiation using mouse 3T3-L1 cells, which are widely used to study adipocyte physiology. We show here that TB enhanced the differentiation of 3T3-L1 cells to mature adipocytes and that one of the active main components was identified as gallic acid. Gallic acid (10-30 µM) enhanced the expression and secretion of adiponectin via adipocyte differentiation and also that of fatty acid binding protein-4, which is the target of peroxisome proliferator-activated receptor gamma (PPARγ), although it does not alter the expression of the upstream genes PPARγ and CCAAT enhancer binding protein alpha. In the PPARγ ligand assay, the binding of gallic acid to PPARγ was undetectable. These findings indicate that gallic acid mediates the therapeutic effects of TB on metabolic disorders by regulating adipocyte differentiation. Therefore, TB shows promise as a candidate for preventing and treating patients with metabolic syndrome. PMID:27374289

  18. Defining the Active Ingredients of Interactive Computer Play Interventions for Children with Neuromotor Impairments: A Scoping Review

    ERIC Educational Resources Information Center

    Levac, Danielle; Rivard, Lisa; Missiuna, Cheryl

    2012-01-01

    Rehabilitation researchers who investigate complex interventions are challenged to describe the "active ingredients" of their interventions: the reason(s) why a treatment is expected to be effective. Interactive Computer Play (ICP) is an emerging complex intervention in rehabilitation practice and research. The purpose of this scoping review is to…

  19. 21 CFR 310.532 - Drug products containing active ingredients offered over-the-counter (OTC) to relieve the...

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 5 2010-04-01 2010-04-01 false Drug products containing active ingredients offered over-the-counter (OTC) to relieve the symptoms of benign prostatic hypertrophy. 310.532 Section 310.532 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS FOR HUMAN USE NEW DRUGS Requirements...

  20. Effects of ginsenosides, the active ingredients of Panax ginseng, on development, growth, and life span of Caenorhabditis elegans

    Technology Transfer Automated Retrieval System (TEKTRAN)

    Ginsenosides, the active ingredients of Panax ginseng, are saponins derived from sterols. The free-living nematode Caenorhabditis elegans is a well-established model for biochemical and genetic studies in animals. Although cholesterol is an essential requirement for the growth and development of C. ...

  1. 21 CFR 310.527 - Drug products containing active ingredients offered over-the-counter (OTC) for external use as...

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 5 2014-04-01 2014-04-01 false Drug products containing active ingredients offered over-the-counter (OTC) for external use as hair growers or for hair loss prevention. 310.527 Section 310.527 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS FOR HUMAN USE NEW DRUGS...

  2. 21 CFR 310.532 - Drug products containing active ingredients offered over-the-counter (OTC) to relieve the...

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 5 2014-04-01 2014-04-01 false Drug products containing active ingredients offered over-the-counter (OTC) to relieve the symptoms of benign prostatic hypertrophy. 310.532 Section 310.532 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS FOR HUMAN USE NEW DRUGS Requirements...

  3. 21 CFR 310.542 - Over-the-counter (OTC) drug products containing active ingredients offered for use in the...

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 5 2010-04-01 2010-04-01 false Over-the-counter (OTC) drug products containing active ingredients offered for use in the treatment of hyperphosphatemia. 310.542 Section 310.542 Food...) Hyperphosphatemia is a condition in which an abnormally high plasma level of phosphate occurs in the blood....

  4. 21 CFR 310.541 - Over-the-counter (OTC) drug products containing active ingredients offered for use in the...

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 5 2010-04-01 2010-04-01 false Over-the-counter (OTC) drug products containing active ingredients offered for use in the treatment of hypophosphatemia. 310.541 Section 310.541 Food and...) Hypophosphatemia is a condition in which an abnormally low plasma level of phosphate occurs in the blood....

  5. 21 CFR 310.532 - Drug products containing active ingredients offered over-the-counter (OTC) to relieve the...

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 5 2011-04-01 2011-04-01 false Drug products containing active ingredients offered over-the-counter (OTC) to relieve the symptoms of benign prostatic hypertrophy. 310.532 Section 310.532 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS FOR HUMAN USE NEW DRUGS Requirements...

  6. 21 CFR 310.543 - Drug products containing active ingredients offered over-the-counter (OTC) for human use in...

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... offered over-the-counter (OTC) for human use in exocrine pancreatic insufficiency. 310.543 Section 310.543... containing active ingredients offered over-the-counter (OTC) for human use in exocrine pancreatic... potential for serious risk to patients using these drug products. The bioavailability of pancreatic...

  7. 21 CFR 310.543 - Drug products containing active ingredients offered over-the-counter (OTC) for human use in...

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... offered over-the-counter (OTC) for human use in exocrine pancreatic insufficiency. 310.543 Section 310.543... containing active ingredients offered over-the-counter (OTC) for human use in exocrine pancreatic... potential for serious risk to patients using these drug products. The bioavailability of pancreatic...

  8. 21 CFR 310.527 - Drug products containing active ingredients offered over-the-counter (OTC) for external use as...

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... offered over-the-counter (OTC) for external use as hair growers or for hair loss prevention. 310.527... products containing active ingredients offered over-the-counter (OTC) for external use as hair growers or for hair loss prevention. (a) Amino acids, aminobenzoic acid, ascorbic acid, benzoic acid, biotin...

  9. 21 CFR 310.527 - Drug products containing active ingredients offered over-the-counter (OTC) for external use as...

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... offered over-the-counter (OTC) for external use as hair growers or for hair loss prevention. 310.527... products containing active ingredients offered over-the-counter (OTC) for external use as hair growers or for hair loss prevention. (a) Amino acids, aminobenzoic acid, ascorbic acid, benzoic acid, biotin...

  10. 21 CFR 310.527 - Drug products containing active ingredients offered over-the-counter (OTC) for external use as...

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... offered over-the-counter (OTC) for external use as hair growers or for hair loss prevention. 310.527... products containing active ingredients offered over-the-counter (OTC) for external use as hair growers or for hair loss prevention. (a) Amino acids, aminobenzoic acid, ascorbic acid, benzoic acid, biotin...

  11. 21 CFR 310.527 - Drug products containing active ingredients offered over-the-counter (OTC) for external use as...

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... offered over-the-counter (OTC) for external use as hair growers or for hair loss prevention. 310.527... products containing active ingredients offered over-the-counter (OTC) for external use as hair growers or for hair loss prevention. (a) Amino acids, aminobenzoic acid, ascorbic acid, benzoic acid, biotin...

  12. 21 CFR 310.541 - Over-the-counter (OTC) drug products containing active ingredients offered for use in the...

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 5 2011-04-01 2011-04-01 false Over-the-counter (OTC) drug products containing active ingredients offered for use in the treatment of hypophosphatemia. 310.541 Section 310.541 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS FOR HUMAN USE NEW DRUGS Requirements for...

  13. 21 CFR 310.543 - Drug products containing active ingredients offered over-the-counter (OTC) for human use in...

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 5 2011-04-01 2011-04-01 false Drug products containing active ingredients offered over-the-counter (OTC) for human use in exocrine pancreatic insufficiency. 310.543 Section 310.543 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS FOR HUMAN USE NEW DRUGS Requirements...

  14. 21 CFR 310.538 - Drug products containing active ingredients offered over-the-counter (OTC) for use for ingrown...

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 5 2011-04-01 2011-04-01 false Drug products containing active ingredients offered over-the-counter (OTC) for use for ingrown toenail relief. 310.538 Section 310.538 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS FOR HUMAN USE NEW DRUGS Requirements for Specific New Drugs...

  15. 21 CFR 310.542 - Over-the-counter (OTC) drug products containing active ingredients offered for use in the...

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 5 2011-04-01 2011-04-01 false Over-the-counter (OTC) drug products containing active ingredients offered for use in the treatment of hyperphosphatemia. 310.542 Section 310.542 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS FOR HUMAN USE NEW DRUGS Requirements for...

  16. 21 CFR 310.536 - Drug products containing active ingredients offered over-the-counter (OTC) for use as a...

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 5 2011-04-01 2011-04-01 false Drug products containing active ingredients offered over-the-counter (OTC) for use as a nailbiting or thumbsucking deterrent. 310.536 Section 310.536 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS FOR HUMAN USE NEW DRUGS Requirements...

  17. Dampened neural activity and abolition of epileptic-like activity in cortical slices by active ingredients of spices

    PubMed Central

    Pezzoli, Maurizio; Elhamdani, Abdeladim; Camacho, Susana; Meystre, Julie; González, Stephanie Michlig; le Coutre, Johannes; Markram, Henry

    2014-01-01

    Active ingredients of spices (AIS) modulate neural response in the peripheral nervous system, mainly through interaction with TRP channel/receptors. The present study explores how different AIS modulate neural response in layer 5 pyramidal neurons of S1 neocortex. The AIS tested are agonists of TRPV1/3, TRPM8 or TRPA1. Our results demonstrate that capsaicin, eugenol, menthol, icilin and cinnamaldehyde, but not AITC dampen the generation of APs in a voltage- and time-dependent manner. This effect was further tested for the TRPM8 ligands in the presence of a TRPM8 blocker (BCTC) and on TRPM8 KO mice. The observable effect was still present. Finally, the influence of the selected AIS was tested on in vitro gabazine-induced seizures. Results coincide with the above observations: except for cinnamaldehyde, the same AIS were able to reduce the number, duration of the AP bursts and increase the concentration of gabazine needed to elicit them. In conclusion, our data suggests that some of these AIS can modulate glutamatergic neurons in the brain through a TRP-independent pathway, regardless of whether the neurons are stimulated intracellularly or by hyperactive microcircuitry. PMID:25359561

  18. The protective effect of the earthworm active ingredients on hepatocellular injury induced by endoplasmic reticulum stress.

    PubMed

    Wang, Qi; Duan, Leng-Xin; Xu, Zheng-Shun; Wang, Jian-Gang; Xi, Shou-Min

    2016-08-01

    The earthworm is a widely used Chinese herbal medicine. There are more than 40 prescriptions including earthworms in the "Compendium of Materia Medica". TCM theory holds that earthworms exert antispasmodic and antipyretic effects through the liver meridian to calm the liver. However, the clinical effect of earthworms on liver injury has not been clearly demonstrated. We have previously established a method to extract the active ingredients from earthworms (hereinafter referred to as EWAs) [1]. In the present study, we observed protective effect of the EWAs on tunicamycin-induced ERS (endoplasmic reticulum stress) model in human hepatic L02 cells. The results showed that the EWAs promote proliferation and reduced apoptosis of ERS model in L02 cells (P<0.01). The up-regulation of ERS-related proteins, including PERK (protein kinase RNA-like endoplasmic reticulum kinase), eIF2a (eukaryotic translation initiation factor 2a), ATF4 (activating transcription factor 4) and CHOP (CCAAT/enhancer binding protein homologous protein), in L02 cell under ERS was inhibited by treatment of the EWAs (P<0.01). In summary, our data suggest the EWAs can significant attenuate ERS-induced hepatocyte injury via PERK-eIF2a-ATF4 pathway. PMID:27470367

  19. 78 FR 23558 - Pesticide Products; Registration Applications for New Active Ingredients

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-04-19

    ... Ingredient: Bacillus thuringiensis subsp. galleriae strain SDS-502 at 85.0%. Proposed Use: For control of... February 29, 2012 (77 FR 12295)(FRL- 9332-8), EPA announced receipt of two other applications to...

  20. 21 CFR 343.22 - Permitted combinations of active ingredients for cardiovascular-rheumatologic use.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... permitted: Aspirin identified in §§ 343.12 and 343.13 may be combined with any antacid ingredient identified in § 331.11 of this chapter or any combination of antacids permitted in accordance with §...

  1. 21 CFR 343.22 - Permitted combinations of active ingredients for cardiovascular-rheumatologic use.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... permitted: Aspirin identified in §§ 343.12 and 343.13 may be combined with any antacid ingredient identified in § 331.11 of this chapter or any combination of antacids permitted in accordance with §...

  2. 21 CFR 343.22 - Permitted combinations of active ingredients for cardiovascular-rheumatologic use.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... permitted: Aspirin identified in §§ 343.12 and 343.13 may be combined with any antacid ingredient identified in § 331.11 of this chapter or any combination of antacids permitted in accordance with §...

  3. 21 CFR 343.22 - Permitted combinations of active ingredients for cardiovascular-rheumatologic use.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... permitted: Aspirin identified in §§ 343.12 and 343.13 may be combined with any antacid ingredient identified in § 331.11 of this chapter or any combination of antacids permitted in accordance with §...

  4. 21 CFR 343.22 - Permitted combinations of active ingredients for cardiovascular-rheumatologic use.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... permitted: Aspirin identified in §§ 343.12 and 343.13 may be combined with any antacid ingredient identified in § 331.11 of this chapter or any combination of antacids permitted in accordance with §...

  5. Quantifying Amphibian Pesticide Body Burdens for Active Ingredients Versus Formulations Through Dermal Exposure

    EPA Science Inventory

    Widespread pesticide applications throughout agricultural landscapes pose a risk to post-metamorphic amphibians leaving or moving between breeding ponds in terrestrial habitats. Recent studies indicate that the inactive ingredients in pesticide formulations may be equally or more...

  6. Consequences of New Approach to Chemical Stability Tests to Active Pharmaceutical Ingredients

    PubMed Central

    Jamrógiewicz, Marzena

    2016-01-01

    There is a great need of broaden look on stability tests of active pharmaceutical ingredients (APIs) in comparison with current requirements contained in pharmacopeia. By usage of many modern analytical methods the conception of monitoring the changes of APIs during initial stage of their exposure to harmful factors has been developed. New knowledge must be acquired in terms of identification of each degradation products, especially volatile ones. Further research as toxicology prediction during in silico studies of determined and identified degradation products is necessary. In silico methods are known as computational toxicology or computer-assisted technologies which are used for predicting toxicology of pharmaceutical substances such as impurities or degradation products. This is a specialized software and databases intended to calculate probability of genotoxicity or mutagenicity of these substances through a chemical structure-based screening process and algorithm specific to a given software program. Applying of new analytical approach is proposed as the usage of PAT tools, XRD, HS-SPME GC-MS/MS, LC-MS/MS for stability testing. Described improvements should be taken into account in case of each drug existing already in the market as well as being implemented as new one. PMID:26955356

  7. Pharmacokinetics of hederacoside C, an active ingredient in AG NPP709, in rats.

    PubMed

    Kim, Ju Myung; Yoon, Ji Na; Jung, Ji Won; Choi, Hye Duck; Shin, Young June; Han, Chang Kyun; Lee, Hye Suk; Kang, Hee Eun

    2013-11-01

    1. Hederacoside C (HDC) is one of the active ingredients in Hedera helix leaf extract (Ivy Ex.) and AG NPP709, a new botanical drug to treat acute respiratory infection and chronic inflammatory bronchitis. However, information regarding its pharmacokinetic properties remains limited. 2. Here, we report the pharmacokinetics of HDC in rats after intravenous administration of HDC (3, 12.5, and 25 mg/kg) and after oral administration of HDC, Ivy Ex., and AG NPP709 (equivalent to 12.5, 25, and 50 mg/kg HDC). 3. Linear pharmacokinetics of HDC were identified upon its intravenous administration at doses of 3-25 mg/kg. Intravenous administration of HDC results in relatively slow clearance (1.46-2.08 mL/min/kg) and a small volume of distribution at steady state (138-222 mL/kg), while oral administration results in a low absolute oral bioavailability (F) of 0.118-0.250%. The extremely low F of HDC may be due to poor absorption of HDC from the gastrointestinal (GI) tract and/or its decomposition therein. 4. The oral pharmacokinetics of HDC did not differ significantly among pure HDC, Ivy Ex., and AG NPP709. PMID:23607546

  8. Consequences of New Approach to Chemical Stability Tests to Active Pharmaceutical Ingredients.

    PubMed

    Jamrógiewicz, Marzena

    2016-01-01

    There is a great need of broaden look on stability tests of active pharmaceutical ingredients (APIs) in comparison with current requirements contained in pharmacopeia. By usage of many modern analytical methods the conception of monitoring the changes of APIs during initial stage of their exposure to harmful factors has been developed. New knowledge must be acquired in terms of identification of each degradation products, especially volatile ones. Further research as toxicology prediction during in silico studies of determined and identified degradation products is necessary. In silico methods are known as computational toxicology or computer-assisted technologies which are used for predicting toxicology of pharmaceutical substances such as impurities or degradation products. This is a specialized software and databases intended to calculate probability of genotoxicity or mutagenicity of these substances through a chemical structure-based screening process and algorithm specific to a given software program. Applying of new analytical approach is proposed as the usage of PAT tools, XRD, HS-SPME GC-MS/MS, LC-MS/MS for stability testing. Described improvements should be taken into account in case of each drug existing already in the market as well as being implemented as new one. PMID:26955356

  9. Estimation of active pharmaceutical ingredients content using locally weighted partial least squares and statistical wavelength selection.

    PubMed

    Kim, Sanghong; Kano, Manabu; Nakagawa, Hiroshi; Hasebe, Shinji

    2011-12-15

    Development of quality estimation models using near infrared spectroscopy (NIRS) and multivariate analysis has been accelerated as a process analytical technology (PAT) tool in the pharmaceutical industry. Although linear regression methods such as partial least squares (PLS) are widely used, they cannot always achieve high estimation accuracy because physical and chemical properties of a measuring object have a complex effect on NIR spectra. In this research, locally weighted PLS (LW-PLS) which utilizes a newly defined similarity between samples is proposed to estimate active pharmaceutical ingredient (API) content in granules for tableting. In addition, a statistical wavelength selection method which quantifies the effect of API content and other factors on NIR spectra is proposed. LW-PLS and the proposed wavelength selection method were applied to real process data provided by Daiichi Sankyo Co., Ltd., and the estimation accuracy was improved by 38.6% in root mean square error of prediction (RMSEP) compared to the conventional PLS using wavelengths selected on the basis of variable importance on the projection (VIP). The results clearly show that the proposed calibration modeling technique is useful for API content estimation and is superior to the conventional one. PMID:22001843

  10. Challenges in the analytical method development and validation for an unstable active pharmaceutical ingredient.

    PubMed

    Sajonz, Peter; Wu, Yan; Natishan, Theresa K; McGachy, Neil T; Detora, David

    2006-03-01

    A sensitive high-performance liquid chromatography (HPLC) impurity profile method for the antibiotic ertapenem is developed and subsequently validated. The method utilizes an Inertsil phenyl column at ambient temperature, gradient elution with aqueous sodium phosphate buffer at pH 8, and acetonitrile as the mobile phase. The linearity, method precision, method ruggedness, limit of quantitation, and limit of detection of the impurity profile HPLC method are found to be satisfactory. The method is determined to be specific, as judged by resolving ertapenem from in-process impurities in crude samples and degradation products that arise from solid state thermal and light stress, acid, base, and oxidative stressed solutions. In addition, evidence is obtained by photodiode array detection studies that no degradate or impurity having a different UV spectrum coeluted with the major component in stressed or unstressed samples. The challenges during the development and validation of the method are discussed. The difficulties of analyzing an unstable active pharmaceutical ingredient (API) are addressed. Several major impurities/degradates of the API have very different UV response factors from the API. These impurities/degradates are synthesized or prepared by controlled degradation and the relative response factors are determined. PMID:16620508

  11. Towards integrated drug substance and drug product design for an active pharmaceutical ingredient using particle engineering.

    PubMed

    Kougoulos, Eleftherios; Smales, Ian; Verrier, Hugh M

    2011-03-01

    A novel experimental approach describing the integration of drug substance and drug production design using particle engineering techniques such as sonocrystallization, high shear wet milling (HSWM) and dry impact (hammer) milling were used to manufacture samples of an active pharmaceutical ingredient (API) with diverse particle size and size distributions. The API instability was addressed using particle engineering and through judicious selection of excipients to reduce degradation reactions. API produced using a conventional batch cooling crystallization process resulted in content uniformity issues. Hammer milling increased fine particle formation resulting in reduced content uniformity and increased degradation compared to sonocrystallized and HSWM API in the formulation. To ensure at least a 2-year shelf life based on predictions using an Accelerated Stability Assessment Program, this API should have a D [v, 0.1] of 55 μm and a D [v, 0.5] of 140 μm. The particle size of the chief excipient in the drug product formulation needed to be close to that of the API to avoid content uniformity and stability issues but large enough to reduce lactam formation. The novel methodology described here has potential for application to other APIs. PMID:21246419

  12. Use of prediction methods to estimate true density of active pharmaceutical ingredients.

    PubMed

    Cao, Xiaoping; Leyva, Norma; Anderson, Stephen R; Hancock, Bruno C

    2008-05-01

    True density is a fundamental and important property of active pharmaceutical ingredients (APIs). Using prediction methods to estimate the API true density can be very beneficial in pharmaceutical research and development, especially when experimental measurements cannot be made due to lack of material or sample handling restrictions. In this paper, two empirical prediction methods developed by Girolami and Immirzi and Perini were used to estimate the true density of APIs, and the estimation results were compared with experimentally measured values by helium pycnometry. The Girolami method is simple and can be used for both liquids and solids. For the tested APIs, the Girolami method had a maximum error of -12.7% and an average percent error of -3.0% with a 95% CI of (-3.8, -2.3%). The Immirzi and Perini method is more involved and is mainly used for solid crystals. In general, it gives better predictions than the Girolami method. For the tested APIs, the Immirzi and Perini method had a maximum error of 9.6% and an average percent error of 0.9% with a 95% CI of (0.3, 1.6%). PMID:18242023

  13. Prioritization methodology for the monitoring of active pharmaceutical ingredients in hospital effluents.

    PubMed

    Daouk, Silwan; Chèvre, Nathalie; Vernaz, Nathalie; Bonnabry, Pascal; Dayer, Pierre; Daali, Youssef; Fleury-Souverain, Sandrine

    2015-09-01

    The important number of active pharmaceutical ingredients (API) available on the market along with their potential adverse effects in the aquatic ecosystems, lead to the development of prioritization methods, which allow choosing priority molecules to monitor based on a set of selected criteria. Due to the large volumes of API used in hospitals, an increasing attention has been recently paid to their effluents as a source of environmental pollution. Based on the consumption data of a Swiss university hospital, about hundred of API has been prioritized following an OPBT approach (Occurrence, Persistence, Bioaccumulation and Toxicity). In addition, an Environmental Risk Assessment (ERA) allowed prioritizing API based on predicted concentrations and environmental toxicity data found in the literature for 71 compounds. Both prioritization approaches were compared. OPBT prioritization results highlight the high concern of some non steroidal anti-inflammatory drugs and antiviral drugs, whereas antibiotics are revealed by ERA as potentially problematic to the aquatic ecosystems. Nevertheless, according to the predicted risk quotient, only the hospital fraction of ciprofloxacin represents a risk to the aquatic organisms. Some compounds were highlighted as high-priority with both methods: ibuprofen, trimethoprim, sulfamethoxazole, ritonavir, gabapentin, amoxicillin, ciprofloxacin, raltegravir, propofol, etc. Analyzing consumption data and building prioritization lists helped choosing about 15 API to be monitored in hospital wastewaters. The API ranking approach adopted in this study can be easily transposed to any other hospitals, which have the will to look at the contamination of their effluents. PMID:26144564

  14. Quantitative determination of residual active pharmaceutical ingredients and intermediates on equipment surfaces by ion mobility spectrometry.

    PubMed

    Qin, C; Granger, A; Papov, V; McCaffrey, J; Norwood, D L

    2010-01-01

    Ion mobility spectrometry (IMS) is an analytical technique that separates ions based on their gas phase mobility at atmospheric pressure. Since gas phase ion mobility is a function of the shape and structure of the ion, this technique has the potential to provide unique specificity and selectivity. Furthermore, IMS is very sensitive (subnanogram detection limits for many small molecules), and a single analysis is typically completed within 1 min. In principle, these features of IMS should make it an ideal choice for use in cleaning verification analysis of pharmaceutical manufacturing equipment. This report describes the successful development and validation of three different equipment cleaning verification methods using IMS. The methods were developed for a specific intermediate (Compound A) in the synthetic route for a drug substance as well as for final drug substances (active pharmaceutical ingredients Compounds B and C). The cleaning verification methods were validated with respect to specificity, linearity, precision, accuracy, stability, and limit-of-quantitation. In all cases, the limits-of-quantitation were determined to be at the nanogram or sub-nanogram level. Both swab and rinse samples collected from the equipment surfaces were successfully analyzed and manufacturing equipment down-time was significantly minimized due to the reduction in cleaning verification analysis time (for example, the total analysis time for more than 30 samples using IMS was reduced to less than 2h). PMID:19758781

  15. Active Pharmaceutical Ingredients: Prediction of Physical-Chemical Properties from First Principles

    NASA Astrophysics Data System (ADS)

    Valenzano, Loredana

    2013-03-01

    Polymorphism in active pharmaceutical ingredients (APIs) plays a crucial role both for medical and intellectual property concerns but despite ongoing efforts, experimental and computational investigations of the existence and the physical-chemical properties of the same compound in different forms is still an open question.While comparison between computed and experimental values for properties derived from differences between states is often promising (such as bulk modulus), results are disappointing for absolute values (such as density). Quantum mechanical computational methods describe the systems at 0K, experimentally properties are often evaluated at room temperature. Therefore it is not surprising that results determined from first principles dramatically differ from those obtained experimentally. By applying a quantum mechanical periodic approach that takes into account long range London dispersion forces fitted for solid materials, and by imposing different cell volumes corresponding to different thermodynamic conditions, we show how results from calculations at 0K (structures, vibrational spectra, elastic constants) may be compared to experimental values at higher temperatures, helping to foster a stronger linkage between computational and experimental work on systems such as APIs. Where experimental results are not available, our work represents an innovative approach in addressing the properties of APIs. Our results can also serve as foundation for the developing of new force fields to be adopted within a multi-scale computational approach.

  16. Direct analysis of palladium in active pharmaceutical ingredients by anodic stripping voltammetry.

    PubMed

    Rosolina, Samuel M; Chambers, James Q; Xue, Zi-Ling

    2016-03-31

    Anodic stripping voltammetry, a classical electroanalytical method has been optimized to analyze trace Pd(II) in active pharmaceutical ingredient matrices. The electroanalytical approach with an unmodified glassy carbon electrode was performed in both aqueous and 95% DMSO/5% water (95/5 DMSO/H2O) solutions, without pretreatment such as acid digestion or dry ashing to remove the organics. Limits of detection (LODs) in the presence of caffeine and ketoprofen were determined to be 11 and 9.6 μg g(-1), with a relative standard deviation (RSD) of 5.7% and 2.3%, respectively. This method is simple, highly reproducible, sensitive, and robust. The instrumentation has the potential to be portable and the obviation of sample pretreatment makes it an ideal approach for determining lost catalytic metals in pharmaceutical-related industries. Furthermore, the simultaneous detection of Pd(II) with Cd(II) and Pb(II) in the low μg L(-1) range indicates that this system is capable of simultaneous multi-analyte analysis in a variety of matrices. PMID:26965326

  17. Core-Shell Composite Hydrogels for Controlled Nanocrystal Formation and Release of Hydrophobic Active Pharmaceutical Ingredients.

    PubMed

    Badruddoza, Abu Zayed Md; Godfrin, P Douglas; Myerson, Allan S; Trout, Bernhardt L; Doyle, Patrick S

    2016-08-01

    Although roughly 40% of pharmaceuticals being developed are poorly water soluble, this class of drugs lacks a formulation strategy capable of producing high loads, fast dissolution kinetics, and low energy input. In this work, a novel bottom-up approach is developed for producing and formulating nanocrystals of poorly water-soluble active pharmaceutical ingredients (APIs) using core-shell composite hydrogel beads. Organic phase nanoemulsion droplets stabilized by polyvinyl alcohol (PVA) and containing a model hydrophobic API (fenofibrate) are embedded in the alginate hydrogel matrix and subsequently act as crystallization reactors. Controlled evaporation of this composite material produces core-shell structured alginate-PVA hydrogels with drug nanocrystals (500-650 nm) embedded within the core. Adjustable loading of API nanocrystals up to 83% by weight is achieved with dissolution (of 80% of the drug) occurring in as little as 30 min. A quantitative model is also developed and experimentally validated that the drug release patterns of the fenofibrate nanocrystals can be modulated by controlling the thickness of the PVA shell and drug loading. Thus, these composite materials offer a "designer" drug delivery system. Overall, our approach enables a novel means of simultaneous controlled crystallization and formulation of hydrophobic drugs that circumvents energy intensive top-down processes in traditional manufacturing. PMID:27249402

  18. Terahertz study on porosity and mass fraction of active pharmaceutical ingredient of pharmaceutical tablets.

    PubMed

    Bawuah, Prince; Tan, Nicholas; Tweneboah, Samuel Nana A; Ervasti, Tuomas; Axel Zeitler, J; Ketolainen, Jarkko; Peiponen, Kai-Erik

    2016-08-01

    In this study, terahertz time-domain spectroscopic (THz-TDS) technique has been used to ascertain the change in the optical properties, as a function of changing porosity and mass fraction of active pharmaceutical ingredient (API), of training sets of pharmaceutical tablets. Four training sets of pharmaceutical tablets were compressed with microcrystalline cellulose (MCC) excipient and indomethacin API by varying either the porosity, height, and API mass fraction or all three tablet parameters. It was observed, as far as we know, for the first time, that the THz time-domain and frequency-domain effective refractive index, as well as, the frequency-domain effective absorption coefficient both show linear correlations with the porosity and API mass fraction for training sets of real pharmaceutical tablets. We suggest that, the observed linear correlations can be useful in basic research and quality inspection of pharmaceutical tablets. Additionally, we propose a novel optical strain parameter, based on THz measurement, which yields information on the conventional strain parameter of a tablet as well as on the change of fill fraction of solid material during compression of porous pharmaceutical tablets. We suggest that the THz measurement and proposed method of data analysis, in addition to providing an efficient tool for basic research of porous media, can serve as one of the novel quality by design (QbD) implementation techniques to predict critical quality attributes (CQA) such as porosity, API mass fraction and strain of flat-faced pharmaceutical tablets before production. PMID:27288937

  19. Identification of aroma active compounds of cereal coffee brew and its roasted ingredients.

    PubMed

    Majcher, Małgorzata A; Klensporf-Pawlik, Dorota; Dziadas, Mariusz; Jeleń, Henryk H

    2013-03-20

    Cereal coffee is a coffee substitute made mainly from roasted cereals such as barley and rye (60-70%), chicory (15-20%), and sugar beets (6-10%). It is perceived by consumers as a healthy, caffeine free, non-irritating beverage suitable for those who cannot drink regular coffee made from coffee beans. In presented studies, typical Polish cereal coffee brew has been subjected to the key odorants analysis with the application of gas chromatography-olfactometry (GC-O) and aroma extract dilution analysis (AEDA). In the analyzed cereal coffee extract, 30 aroma-active volatiles have been identified with FD factors ranging from 16 to 4096. This approach was also used for characterization of key odorants in ingredients used for the cereal coffee production. Comparing the main odors detected in GC-O analysis of roasted cereals brew to the odor notes of cereal coffee brew, it was evident that the aroma of cereal coffee brew is mainly influenced by roasted barley. Flavor compound identification and quantitation has been performed with application of comprehensive multidimentional gas chromatography and time-of-flight mass spectrometry (GCxGC-ToFMS). The results of the quantitative measurements followed by calculation of the odor activity values (OAV) revealed 17 aroma active compounds of the cereal coffee brew with OAV ranging from 12.5 and 2000. The most potent odorant was 2-furfurylthiol followed by the 3-mercapto-3-methylbutyl formate, 3-isobutyl-2-methoxypyrazine and 2-ethyl-3,5-dimethylpyrazine, 2-thenylthiol, 2,3-butanedione, 2-methoxy phenol and 2-methoxy-4-vinyl phenol, 3(sec-butyl)-2-methoxypyrazine, 2-acetyl-1-pyrroline, 3-(methylthio)-propanal, 2,3-pentanedione, 4-hydroxy-2,5-dimethyl-3-(2H)-furanone, (E,E)-2,4-decadienal, (Z)-4-heptenal, phenylacetaldehyde, and 1-octen-3-one. PMID:23414530

  20. Role of herbal bioactives as a potential bioavailability enhancer for Active Pharmaceutical Ingredients.

    PubMed

    Ajazuddin; Alexander, Amit; Qureshi, Azra; Kumari, Leena; Vaishnav, Pramudita; Sharma, Mukesh; Saraf, Swarnlata; Saraf, Shailendra

    2014-09-01

    The current review emphasizes on the herbal bioenhancers which themselves do not possess inherent pharmacological activity of their own but when co-administered with Active Pharmaceutical Ingredients (API), enhances their bioavailability and efficacy. Herbal bioenhancers play a crucial role in enhancing the bioavailability and bioefficacy of different classes of drugs, such as antihypertensives, anticancer, antiviral, antitubercular and antifungal drugs at low doses. This paper highlights various natural compounds that can be utilized as an efficient bioenhancer. Several herbal compounds including piperine, quercetin, genistein, naringin, sinomenine, curcumin, and glycyrrhizin have demonstrated capability to improve the pharmacokinetic parameters of several potent API. This article also focuses on various United States patents on herbal bioenhancers, which has proved to be beneficial in improving oral absorption of nutraceuticals like vitamins, minerals, amino acids and certain herbal compounds. The present paper also describes proposed mechanism of action, which mainly includes absorption process, drug metabolism, and action on drug target. The herbal bioenhancers are easily available, safe, free from side effects, minimizes drug toxicity, shortens the duration of treatment, lowers the drug resistance problems and minimizes the cost of treatment. Inspite of the fact that herbal bioenhancers provide an innovative concept for enhancing the bioavailability of several potent drugs, there are numerous bioenhancers of herbal origin that are yet to be explored in several vital areas. These bioenhancers must also be implied to enhance the bioavailability and bioefficacy through routes other than the oral route of drug delivery. There is a vast array of unexploited plants which can be investigated for their drug bioenhancing potency. The toxicity profiles of these herbal bioenhancers must not be overlooked. Researches must be carried out to solve these issues and to

  1. NASDA's activities on vibration isolation technology

    NASA Technical Reports Server (NTRS)

    1992-01-01

    The National Space Development Agency's (NASDA) activities in providing various vibration isolation technologies for the Space Station Mission are covered in viewgraph form. Technologies covered include an active vibration isolation system for extra sensitive missions in the low frequency range, a passive damping system consisting of a damping rack for the reduction of resonance amplification, and an isolator for vibration isolation from low frequencies. Information is given in viewgraph form on the active vibration isolation concept, voice coil type electromagnetic suspension, a profile of an active vibration isolation system, a three degree of freedom ground experiment, and acceleration feedback.

  2. Managing emissions of active pharmaceutical ingredients from manufacturing facilities: an environmental quality standard approach.

    PubMed

    Murray-Smith, Richard J; Coombe, Vyvyan T; Grönlund, Marie Haag; Waern, Fredrik; Baird, James A

    2012-04-01

    Active pharmaceutical ingredient (API) residues have been found to be widespread in the aquatic environment, albeit in most cases at trace levels, with the route to the environment predominantly being via therapeutic use and subsequent excretion to sewer. Although manufacturing discharges may be a low overall contributor to environmental concentrations, they need to be managed effectively so that they do not adversely affect the local receiving environment. In order to achieve this, a risk-based approach is proposed that identifies the long-term and short-term concentrations, referred to as environmental reference concentrations (ERCs) and maximum tolerable concentrations (MTCs), respectively, of an API which should not be exceeded in the aquatic environment receiving effluent from pharmaceutical manufacturing sites. The ERC approach is based on established environmental quality standard concepts currently used in much national and international legislation. Building on these concepts, the approach takes into account indirect exposure of potential consumers such as fish-eating mammals and humans, as well as primary producers (e.g., algae) and primary and secondary consumers (e.g., invertebrates and fish). Although chronic toxicity data are preferred for ERC derivation, acute data, with appropriate considerations of uncertainty, may be used when chronic data are not available. This approach takes all available information into account, particularly for older established medicines that may predate current regulatory requirements for environmental data, and consequently helps prioritize resources for environmental testing. The ERC approach has been applied to 30 of AstraZeneca's APIs. Merits of the approach are discussed together with opportunities for potential future refinement. PMID:22057894

  3. Investigations of the use of bioavailability data to adjust occupational exposure limits for active pharmaceutical ingredients.

    PubMed

    Naumann, Bruce D; Weideman, Patricia A; Sarangapani, Ramesh; Hu, Shu-Cheih; Dixit, Rakesh; Sargent, Edward V

    2009-11-01

    Occupational exposure limits (OELs) for active pharmaceutical ingredients have traditionally been established using no-observed-adverse-effect levels derived from clinical studies employing po and iv routes of administration and by applying default uncertainty factors or chemical-specific adjustment factors. However, exposure by the inhalation or dermal route is more relevant in terms of occupational safety. In this investigation, to explore new methods for route-to-route extrapolation, the bioavailability of MK-0679, a leukotriene D(4) receptor antagonist, was compared following iv, po, intranasal (in), or intratracheal (it) administration. The relative bioavailability of MK-0679 was iv congruent with it > po congruent with in. Bioavailability correction factors (BCFs) of 2.0 and 0.6 were derived from these data to adjust a hypothetical OEL of 0.1 mg/m(3) for MK-0679 with particle sizes of 10 and 50 mum, respectively. These BCFs were used to adjust the OEL established using po clinical data, to reflect the differences in bioavailability following deposition in different regions of the respiratory tract. To further investigate how bioavailability data could be used in setting OELs, a preliminary pharmacokinetic (PK) model was developed to describe the time course of plasma concentrations using the data from the route comparison study. An inhalation study was then performed to test the validity of using either empirical data or modeling approaches to derive BCFs when setting OELs. These investigations demonstrated how the use of route-specific PK data could reduce some of the uncertainties associated with route-to-route extrapolation and allow for improved precision and quantitative adjustments when establishing OELs. Further investigations are needed to better understand the factors responsible for differences in systemic uptake following deposition in different regions of the respiratory tract and how these can be generalized across different classes of soluble

  4. Dissolution study of active pharmaceutical ingredients using molecular dynamics simulations with classical force fields

    NASA Astrophysics Data System (ADS)

    Greiner, Maximilian; Elts, Ekaterina; Schneider, Julian; Reuter, Karsten; Briesen, Heiko

    2014-11-01

    The CHARMM, general Amber and OPLS force fields are evaluated for their suitability in simulating the molecular dynamics of the dissolution of the hydrophobic, small-molecule active pharmaceutical ingredients aspirin, ibuprofen, and paracetamol in aqueous media. The force fields are evaluated by comparison with quantum chemical simulations or experimental references on the basis of the following capabilities: accurately representing intra- and intermolecular interactions, appropriately reproducing crystal lattice parameters, adequately describing thermodynamic properties, and the qualitative description of the dissolution behavior. To make this approach easily accessible for evaluating the dissolution properties of novel drug candidates in the early stage of drug development, the force field parameter files are generated using online resources such as the SWISS PARAM servers, and the software packages ACPYPE and Maestro. All force fields are found to reproduce the intermolecular interactions with a reasonable degree of accuracy, with the general Amber and CHARMM force fields showing the best agreement with quantum mechanical calculations. A stable crystal bulk structure is obtained for all model substances, except for ibuprofen, where the reproductions of the lattice parameters and observed crystal stability are considerably poor for all force fields. The heat of solution used to evaluate the solid-to-solution phase transitions is found to be in qualitative agreement with the experimental data for all combinations tested, with the results being quantitatively optimum for the general Amber and CHARMM force fields. For aspirin and paracetamol, stable crystal-water interfaces were obtained. The (100), (110), (011) and (001) interfaces of aspirin or paracetamol and water were simulated for each force field for 30 ns. Although generally expected as a rare event, in some of the simulations, dissolution is observed at 310 K and ambient pressure conditions.

  5. Assessment of antifungal activity of herbal and conventional toothpastes against clinical isolates of Candida albicans

    PubMed Central

    Adwan, Ghaleb; Salameh, Yousef; Adwan, Kamel; Barakat, Ali

    2012-01-01

    Objective To detect the anticandidal activity of nine toothpastes containing sodium fluoride, sodium monofluorophosphate and herbal extracts as an active ingredients against 45 oral and non oral Candida albicans (C. albicans) isolates. Methods The antifungal activity of these toothpaste formulations was determined using a standard agar well diffusion method. Statistical analysis was performed using a statistical package, SPSS windows version 15, by applying mean values using one-way ANOVA with post-hoc least square differences (LSD) method. A P value of less than 0.05 was considered significant. Results All toothpastes studied in our experiments were effective in inhibiting the growth of all C. albicans isolates. The highest anticandidal activity was obtained from toothpaste that containing both herbal extracts and sodium fluoride as active ingredients, while the lowest activity was obtained from toothpaste containing sodium monofluorophosphate as an active ingredient. Antifungal activity of Parodontax toothpaste showed a significant difference (P< 0.001) against C. albicans isolates compared to toothpastes containing sodium fluoride or herbal products. Conclusions In the present study, it has been demonstrated that toothpaste containing both herbal extracts and sodium fluoride as active ingredients are more effective in control of C. albicans, while toothpaste that containing monofluorophosphate as an active ingredient is less effective against C. albicans. Some herbal toothpaste formulations studied in our experiments, appear to be equally effective as the fluoride dental formulations and it can be used as an alternative to conventional formulations for individuals who have an interest in naturally-based products. Our results may provide invaluable information for dental professionals. PMID:23569933

  6. One-pot β-cyclodextrin-assisted extraction of active ingredients from Xue-Zhi-Ning basing its encapsulated ability.

    PubMed

    Zhang, Hui-Jie; Liu, Ya-Nan; Wang, Meng; Wang, Yue-Fei; Deng, Yan-Ru; Cui, Ming-Lei; Ren, Xiao-Liang; Qi, Ai-Di

    2015-11-01

    Xue-Zhi-Ning (XZN) is a traditional Chinese medicine formula, containing active ingredients with poor solubility in water, which has been demonstrated to be helpful for patients with hyperlipidemia. One-pot β-cyclodextrin (β-CD)-assisted extraction of active ingredients from XZN has been carried out to develop an efficient and eco-friendly extraction process. Five active compounds--rubrofusarin gentiobioside, 2,3,5,4'-tetrahydroxy-stilbene-2-O-β-D-glucoside, emodin, nuciferine and quercetin--were identified by UPLC/DAD/MS and used as indexes to evaluate the process optimized by an orthogonal test. The results showed that addition of β-CD significantly enhanced the extraction ratios of all five components. The enhancement of extraction ratios was positively correlated with the apparent formation constants between β-CD and the compounds. The study also showed that the stabilities and dissolution rates of the active ingredients were improved in the presence of β-CD. This one-pot β-cyclodextrin-assisted extraction has the potential to be applied in pharmaceutical preparations directly. PMID:26256368

  7. Microwave-assisted digestion using nitric acid for heavy metals and sulfated ash testing in active pharmaceutical ingredients.

    PubMed

    Pluhácek, T; Hanzal, J; Hendrych, J; Milde, D

    2016-04-01

    The monitoring of inorganic impurities in active pharmaceutical ingredients plays a crucial role in the quality control of the pharmaceutical production. The heavy metals and residue on ignition/sulfated ash methods employing microwave-assisted digestion with concentrated nitric acid have been demonstrated as alternatives to inappropriate compendial methods recommended in United States Pharmacopoeia (USP) and European Pharmacopoeia (Ph. Eur.). The recoveries using the heavy metals method ranged between 89% and 122% for nearly all USP and Ph. Eur. restricted elements as well as the recoveries of sodium sulfate spikes were around 100% in all tested matrices. The proposed microwave-assisted digestion method allowed simultaneous decomposition of 15 different active pharmaceutical ingredients with sample weigh up to 1 g. The heavy metals and sulfated ash procedures were successfully applied to the determination of heavy metals and residue on ignition/sulfated ash content in mycophenolate mofetil, nicergoline and silymarin. PMID:27209695

  8. 21 CFR 341.85 - Labeling of permitted combinations of active ingredients.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ..., menthol, and eucalyptus oil identified in § 341.40(u). The labeling for antitussive ingredients in § 341... camphor, menthol, and eucalyptus oil identified in § 341.40(u). The labeling states the warnings for... containing camphor, menthol, and eucalyptus oil identified in § 341.40(u). The labeling states the...

  9. 21 CFR 341.85 - Labeling of permitted combinations of active ingredients.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ..., menthol, and eucalyptus oil identified in § 341.40(u). The labeling for antitussive ingredients in § 341... camphor, menthol, and eucalyptus oil identified in § 341.40(u). The labeling states the warnings for... containing camphor, menthol, and eucalyptus oil identified in § 341.40(u). The labeling states the...

  10. 21 CFR 341.85 - Labeling of permitted combinations of active ingredients.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... ingredients in part 356 of this chapter should be used. (5) For permitted combinations containing camphor... camphor, menthol, and eucalyptus oil identified in § 341.40(u). The labeling states the warnings for... containing camphor, menthol, and eucalyptus oil identified in § 341.40(u). The labeling states the...

  11. 78 FR 3900 - Generic Drug User Fee-Active Pharmaceutical Ingredient and Finished Dosage Form Facility Fee...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-01-17

    ...The Food and Drug Administration (FDA) is announcing the rate for the generic drug active pharmaceutical ingredient (API) and finished dosage form (FDF) facilities user fees for fiscal year (FY) 2013. The Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Generic Drug User Fee Amendments of 2012 (GDUFA), enacted the Food and Drug Administration Safety and Innovation Act, as......

  12. System-level Study on Synergism and Antagonism of Active Ingredients in Traditional Chinese Medicine by Using Molecular Imprinting Technology

    PubMed Central

    Chen, Tengfei; Gu, Jiangyong; Zhang, Xinzhuang; Ma, Yimin; Cao, Liang; Wang, Zhenzhong; Chen, Lirong; Xu, Xiaojie; Xiao, Wei

    2014-01-01

    In this work, synergism and antagonism among active ingredients of traditional Chinese medicine (TCM) were studied at system-level by using molecular imprinting technology. Reduning Injection (RDNI), a TCM injection, was widely used to relieve fever caused by viral infection diseases in China. Molecularly imprinted polymers (MIPs) synthesized by sol-gel method were used to separate caffeic acid (CA) and analogues from RDNI without affecting other compounds. It can realize the preparative scale separation. The inhibitory effects of separated samples of RDNI and sample combinations in prostaglandin E2 biosynthesis in lipopolysaccharide-induced RAW264.7 cells were studied. The combination index was calculated to evaluate the synergism and antagonism. We found that components which had different scaffolds can produce synergistic anti-inflammatory effect inside and outside the RDNI. Components which had similar scaffolds exhibited the antagonistic effect, and the antagonistic effects among components could be reduced to some extent in RDNI system. The results indicated MIPs with the characteristics of specific adsorption ability and large scale preparation can be an effective approach to study the interaction mechanism among active ingredients of complex system such as TCM at system-level. And this work would provide a new idea to study the interactions among active ingredients of TCM. PMID:25418048

  13. Content of Selected Minerals and Active Ingredients in Teas Containing Yerba Mate and Rooibos.

    PubMed

    Rusinek-Prystupa, Elżbieta; Marzec, Zbigniew; Sembratowicz, Iwona; Samolińska, Wioletta; Kiczorowska, Bożena; Kwiecień, Małgorzata

    2016-07-01

    The study aimed to determine the content of selected elements: sodium, potassium, copper, zinc, iron, manganese and active ingredients such as phenolic acids and tannins in teas containing Yerba Mate and Rooibos cultivated in various areas. The study material comprised six samples of Yerba Mate teas and of Rooibos teas, both tea bags and leaves, purchased in Puławy and online via Allegro. In total, 24 samples were tested. Yerba Mate was particularly abundant in Mn and Fe. The richest source of these elements was Yerba Mate Yer-Vita (2261.3 mg · kg(-1) d.m.) and (691.6 mg · kg(-1) d.m.). The highest content of zinc was determined in Yerba Mate Amanda with lime (106.0 mg · kg(-1) d.m.), while copper was most abundant in Yerba Mate Big-Active cocoa and vanilla (14.05 mg · kg(-1) d.m.). In Rooibos, the content of sodium was several times higher than in Yerba Mate. A clear difference was observed in the content of minerals in dry weight of the examined products, which could be a result of both the taxonomic distinctness and the origin of the raw material. Leaf teas turned out to be a better source of tannins; on the other hand, tea bags contained substantially more phenolic acids. The richest source of phenolic acids was Yer-Vita in bags (1.8 %), and the highest amount of tannins was recorded in the leaf tea Green Goucho caramel and dark chocolate (9.04 g · 100 g(-1) d.m.). In Rooibos products, the highest content of phenolic acids was recorded in tea bags (Savannah with honey and vanilla 0.96 %), and tannins in (Lord Nelson with strawberry and cream 7.99 g · 100 g (-1) d.m.). PMID:26686675

  14. Active pharmaceutical ingredients for antiretroviral treatment in low- and middle-income countries: a survey

    PubMed Central

    Fortunak, Joseph M; de Souza, Rodrigo OMA; Kulkarni, Amol A; King, Christopher L; Ellison, Tiffany; Miranda, Leandro SM

    2015-01-01

    Active pharmaceutical ingredients (APIs) are the molecular entities that exert the therapeutic effects of medicines. This article provides an overview of the major APIs that are entered into antiretroviral therapy (ART), outlines how APIs are manufactured, and examines the regulatory and cost frameworks of manufacturing ART APIs used in low- and middle-income countries (LMICs). Almost all APIs for ART are prepared by chemical synthesis. Roughly 15 APIs account for essentially all of the ARTs used in LMICs. Nearly all of the ART APIs purchased through the Global Fund for AIDS, TB and Malaria (GFATM) or the United States President’s Emergency Plan for AIDS Relief (PEPFAR) are produced by generic companies. API costs are very important because they are the largest contribution to the overall cost of ART. Efficient API production requires substantial investment in chemical manufacturing technologies and the ready availability of raw materials and energy at competitive prices. Generic API production is practiced in only a limited number of countries; the API market for ART is dominated by Indian companies. The quality of these APIs is ensured by manufacturing under good manufacturing practice (GMP), including process validation, testing against previously established specifications and the demonstration of clinical bioequivalence. The investment and personnel costs of a quality management system for GMP contribute significantly to the cost of API production. Chinese companies are the major suppliers for many advanced intermediates in API production. Improved chemistry of manufacturing, economies of scale and optimization of procurement have enabled drastic cost reductions for many ART APIs. The available capacity for global production of quality-assured APIs is likely adequate to meet forecasted demand for 2015. The increased use of ART for paediatric treatment, for second-line and salvage therapy, and the introduction of new APIs and combinations are important

  15. Anti-inflammaging and antiglycation activity of a novel botanical ingredient from African biodiversity (Centevita™)

    PubMed Central

    Maramaldi, Giada; Togni, Stefano; Franceschi, Federico; Lati, Elian

    2014-01-01

    Purpose The aim of this study was to investigate the topical efficacy of a new purified extract from Madagascar, Gotu Kola (Centella asiatica [L.] Urban), both on human explants and on human volunteers, in relation to skin wrinkling and skin protection against ultraviolet light exposure. The extract, with a peculiar content of biologically active molecules, was investigated as a novel anti-inflammaging and antiglycation agent. Its typical terpenes, known as collagen synthesis promoters, represent at least 45% of the extract. It also contains a polyphenolic fraction cooperating to the observed properties. Methods C. asiatica purified extract was assayed on human skin explants maintained alive, and several parameters were evaluated. Among the most relevant, the thymine dimerization was evaluated by immunostaining. Malondialdehyde formation was evaluated as free-radical scavenging marker by enzyme-linked immunosorbent assay. The expression of interleukin-1α was observed by enzyme-linked immunosorbent assay as well. The product was further evaluated as an antiglycation agent, being glycation quantified by the advanced glycation product carboxymethyl lysine. C. asiatica purified extract was also evaluated as an antiwrinkling agent in a single-blind, placebo-controlled study. Formulated in a simple oil-in-water emulsion, the extent of wrinkling was assessed by skin replicas, skin firmness, skin elasticity, and collagen density measurements. Results C. asiatica purified extract could protect DNA from ultraviolet light-induced damage, decreasing the thymine photodimerization by over 28% (P<0.05). A reduced (26%, P<0.01) expression of interleukin-1α was also observed, supporting its anti-inflammatory potential. C. asiatica purified extract showed in vitro a total inhibition of carboxymethyl lysine formation induced by the glycating agent methylglyoxal. A clear epidermal densification of collagen network in the papillary dermis was observed. These in vitro data have been

  16. The significance of different health institutions and their respective contributions of active pharmaceutical ingredients to wastewater.

    PubMed

    Herrmann, Manuel; Olsson, Oliver; Fiehn, Rainer; Herrel, Markus; Kümmerer, Klaus

    2015-12-01

    Active pharmaceutical ingredients (APIs) have been frequently found in the environment. It is, however, still not quite clear who is mainly responsible for API emissions. Hospitals have been considered to be the main contributing point sources for wastewater (WW) discharge of APIs. However, recent studies have shown that the contribution of hospitals to the input of APIs into the aquatic environment is quite low. Due to demographic change and the increase of psychiatric diseases, health institutions (HIs) such as psychiatric hospitals and nursing homes are likely to be important sources as well, but no data is available in this respect. This study aims to assess the impact of HIs and to provide a methodology to measure their respective contributions. Drawing on pharmaceutical consumption data for the years 2010, 2011, and 2012, this study identified API usage patterns for a psychiatric hospital (146 beds), a nursing home (286 inhabitants), and a general hospital (741 beds), the latter of which comprises three separate locations. All the HIs are located in two sub-regions of a county district with about 400,000 citizens in southwestern Germany. A selection of neurological drugs was quantified in the sewer of these facilities to evaluate the correlation between consumption and emission. The API contribution of HIs was assessed by comparing the specific consumption in the facilities with the consumption in households, expressed as the emission potential (IEP). The study shows that the usage patterns of APIs in the psychiatric hospital and the nursing home were different from the general hospital. Neurological drugs such as anticonvulsants, psycholeptics, and psychoanaleptics were mainly consumed in the psychiatric hospital and the nursing home (74% and 65%, respectively). Predicted and average measured concentrations in the effluent of the investigated HIs differed mostly by less than one order of magnitude. Therefore, the consumption-based approach is a useful method

  17. Active pharmaceutical ingredients for antiretroviral treatment in low- and middle-income countries: a survey.

    PubMed

    Fortunak, Joseph M; de Souza, Rodrigo O M A; Kulkarni, Amol A; King, Christopher L; Ellison, Tiffany; Miranda, Leandro S M

    2014-01-01

    Active pharmaceutical ingredients (APIs) are the molecular entities that exert the therapeutic effects of medicines. This article provides an overview of the major APIs that are entered into antiretroviral therapy (ART), outlines how APIs are manufactured, and examines the regulatory and cost frameworks of manufacturing ART APIs used in low- and middle-income countries (LMICs). Almost all APIs for ART are prepared by chemical synthesis. Roughly 15 APIs account for essentially all of the ARTs used in LMICs. Nearly all of the ART APIs purchased through the Global Fund for AIDS, TB and Malaria (GFATM) or the United States President's Emergency Plan for AIDS Relief (PEPFAR) are produced by generic companies. API costs are very important because they are the largest contribution to the overall cost of ART. Efficient API production requires substantial investment in chemical manufacturing technologies and the ready availability of raw materials and energy at competitive prices. Generic API production is practiced in only a limited number of countries; the API market for ART is dominated by Indian companies. The quality of these APIs is ensured by manufacturing under good manufacturing practice (GMP), including process validation, testing against previously established specifications and the demonstration of clinical bioequivalence. The investment and personnel costs of a quality management system for GMP contribute significantly to the cost of API production. Chinese companies are the major suppliers for many advanced intermediates in API production. Improved chemistry of manufacturing, economies of scale and optimization of procurement have enabled drastic cost reductions for many ART APIs. The available capacity for global production of quality-assured APIs is likely adequate to meet forecasted demand for 2015. The increased use of ART for paediatric treatment, for second-line and salvage therapy, and the introduction of new APIs and combinations are important factors

  18. Quantification of active pharmaceutical ingredient and impurities in sildenafil citrate obtained from the Internet

    PubMed Central

    Nutan, Mohammad T.; Dodla, Uday Krishna Reddy

    2014-01-01

    Background: The accessibility of prescription drugs produced outside of the United States, most notably sildenafil citrate (innovator product, Viagra®), has been made much easier by the Internet. Of greatest concern to clinicians and policymakers is product quality and patient safety. The US Food and Drug Administration (FDA) has issued warnings to potential buyers that the safety of drugs purchased from the Internet cannot be guaranteed, and may present a health risk to consumers from substandard products. Objective: The objective of this study was to determine whether generic sildenafil citrate tablets from international markets obtained via the Internet are equivalent to the US innovator product regarding major aspects of pharmaceutical quality: potency, accuracy of labeling, and presence and level of impurities. This will help identify aspects of drug quality that may impact public health risks. Methods: A total of 15 sildenafil citrate tablets were obtained for pharmaceutical analysis: 14 generic samples from international Internet pharmacy websites and the US innovator product. According to US Pharmacopeial guidelines, tablet samples were tested using high-performance liquid chromatography for potency of active pharmaceutical ingredient (API) and levels of impurities (impurities A, B, C, and D). Impurity levels were compared with International Conference on Harmonisation (ICH) limits. Results: Among the 15 samples, 4 samples possessed higher impurity B levels than the ICH qualification threshold, 8 samples possessed higher impurity C levels than the ICH qualification threshold, and 4 samples possessed more than 1% impurity quantity of maximum daily dose (MDD). For API, 6 of the samples failed to fall within the 5% assay limit. Conclusions: Quality assurance tests are often used to detect formulation defects of drug products during the manufacturing and/or storage process. Results suggest that manufacturing standards for sildenafil citrate generic drug

  19. Reproductive and developmental toxicity of the herbicide Betanal® Expert and corresponding active ingredients to Daphnia spp.

    PubMed

    Vidal, Tânia; Pereira, Joana Luísa; Abrantes, Nelson; Soares, Amadeu M V M; Gonçalves, Fernando

    2016-07-01

    The commercial herbicide formulation Betanal® Expert and its active ingredients (a.i.s) ethofumesate, phenmedipham and desmedipham were focused in this study. Following questions yielding from a previous study, an in-depth analysis of the reproductive toxicity of the pesticide was made. Long-term exposures of Daphnia magna and Daphnia longispina to Betanal® Expert, to each a.i. and to a customised mixture matching the a.i.s ratio within the commercial formulation were carried out, and deleterious effects in the offspring were recorded. This intended to clarify whether (1) the tested compounds induce reproductive injury; (2) there is interspecific variation in daphnids tolerance to the compounds; (3) there is an interaction between chemicals in combined treatments; and (4) the so-called inert ingredients added to the commercial formulation contribute to the toxicity of the herbicide. Generally, developmental impair was observed in both species (egg abortion and release of undeveloped embryos or dead offspring) at concentrations of any of the a.i.s below 1 mg L(-1). Ethofumesate was invariably the least toxic pesticide, and D. magna tended to be of slightly higher sensitivity to the exposures compared to D. longispina. Joint exposures indicated that the a.i.s can interact, inducing more than and less than additive effects for Betanal® Expert and the customised a.i. mixture, respectively. This indicates that inert ingredients co-formulating the commercial pesticide (which are absent from the customised a.i. mixture) actually contribute to its overall toxicity. This study constitutes an add-on to the discussion on the ecotoxicological framework required for authorisation of pesticide trade and usage. The results support the need to consider test species, long-term hazardous potential and toxicity of commercial formulations rather than solely that of active ingredients, as relevant variables in pesticide regulation. PMID:27023815

  20. Silver sucrose octasulfate (IASOS™) as a valid active ingredient into a novel vaginal gel against human vaginal pathogens: in vitro antimicrobial activity assessment.

    PubMed

    Marianelli, Cinzia; Petrucci, Paola; Comelli, Maria Cristina; Calderini, Gabriella

    2014-01-01

    This in vitro study assessed the antimicrobial properties of a novel octasilver salt of Sucrose Octasulfate (IASOS) as well as of an innovative vaginal gel containing IASOS (SilSOS Femme), against bacterial and yeast pathogens isolated from human clinical cases of symptomatic vaginal infections. In BHI and LAPT culture media, different ionic silver concentrations and different pHs were tested. IASOS exerted a strong antimicrobial activity towards all the pathogens tested in both culture media. The results demonstrated that salts and organic compounds present in the culture media influenced IASOS efficacy only to a moderate extent. Whereas comparable MBCs (Minimal Bactericidal Concentrations) were observed for G. vaginalis (10 mg/L Ag+), E. coli and E. aerogenes (25 mg/L Ag+) in both media, higher MBCs were found for S. aureus and S. agalactiae in LAPT cultures (50 mg/L Ag+ versus 25 mg/L Ag+). No minimal concentration totally inhibiting the growth of C. albicans was found. Nevertheless, in both media at the highest ionic silver concentrations (50-200 mg/L Ag+), a significant 34-52% drop in Candida growth was observed. pH differently affected the antimicrobial properties of IASOS against bacteria or yeasts; however, a stronger antimicrobial activity at pH higher than the physiological pH was generally observed. It can be therefore concluded that IASOS exerts a bactericidal action against all the tested bacteria and a clear fungistatic action against C. albicans. The antimicrobial activity of the whole vaginal gel SilSOS Femme further confirmed the antimicrobial activity of IASOS. Overall, our findings support IASOS as a valid active ingredient into a vaginal gel. PMID:24897299

  1. Artepillin C, a Major Ingredient of Brazilian Propolis, Induces a Pungent Taste by Activating TRPA1 Channels

    PubMed Central

    Hata, Taketoshi; Tazawa, Shigemi; Ohta, Shozo; Rhyu, Mee-Ra; Misaka, Takumi; Ichihara, Kenji

    2012-01-01

    Brazilian green propolis is a popular health supplement because of its various biological properties. The ethanol extract of Brazilian green propolis (EEBP) is characteristic for its herb-like smell and unique pungent taste. However, the ingredients responsible for its pungency have not yet been identified. This study provides the first evidence that artepillin C is the main pungent ingredient in EEBP and that it potently activates human transient receptor potential ankyrin 1 (TRPA1) channels. EEBP was fractionated using column chromatography with a step gradient elution of an ethanol-water solution, and the fractions having the pungent taste were determined by sensory tests. HPLC analysis revealed that the pungent fraction was composed primarily of artepillin C, a prenylated derivative of cinnamic acid. Artepillin C was also identified as the pungent compound of EEBP by organoleptic examiners. Furthermore, the effects of artepillin C and other cinnamic acids found in EEBP on TRPA1 channels were examined by calcium imaging and plate reader-based assays in human TRPA1-expressing cells to investigate the molecular mechanisms underlying their pungent tastes. Artepillin C and baccharin activated the TRPA1 channel strongly, whereas drupanin caused a slight activation and p-coumaric acid showed no activation. Because the EC50 values of artepillin C, baccharin, and allyl isothiocyanate were 1.8 µM, 15.5 µM, and 6.2 µM, respectively, artepillin C was more potent than the typical TRPA1 agonist allyl isothiocyanate. These findings strongly indicate that artepillin C is the main pungent ingredient in EEBP and stimulates a pungent taste by activating TRPA1 channels. PMID:23133611

  2. [Protective effect of combined administration of active ingredients of Danhong on cerebral micro-vascular endothelial cell injured by hypoxia].

    PubMed

    Zhou, Hui-fen; He, Yu; Zhang, Yu-yan; Yang, Jie-hong; Zhao, Tao; Fu, Wei; Zhou, Peng; Wan, Hai-tong

    2014-11-01

    To study the protective effect of combined administration of active ingredients of Danhong on cultured primary mice's brain microvascular endothelial cells (rBMECs) injured by hypoxia. Primary mice's brain micro-vascular endothelial cells were cultured to establish the 4 h hypoxia model. Meanwhile, active ingredients (protocatechuic aldehyde, salvianolic acid B, hydroxysafflor yellow A and tanshinol) of Danhong were administered in rBMECs. The non-toxic dosage was determined by MTT. The leakage of lactate dehydrogenase(LDH), cell superoxide dismutase (SOD) activity and MDA level were detected by the colorimetric method. The expressions of ICAM-1, MMP-9, P53 mRNA were detected by RT-PCR method. Changes in rBMECs cell cycle and early apoptosis were detected by flow cytometry. Danhong's active ingredients and prescriptions 1, 2, 3, 7, 8, 9 could be combined to significantly restrain LDH in hypoxic cells supernatant. Prescriptions 1, 2, 3, 7, 8, 9 could significantly enhance SOD activity in anoxic cells; Prescriptions 1, 2, 3, 8, 9 could significantly decrease the MDA level; Prescriptions 1, 2, 6, 7, 9 could significantly inhibit the early rB-MECs apoptosis induced by hypoxia. After hypoxia, the up-regulated P53 mRNA expression could cause retardation in G, phase and promote cell apoptosis. This proved that the regulatory function of P53 gene lay in monitoring of calibration points in G, phase. Prescriptions 1, 2, 5, 6, 7, 8, 9 could significantly down-regulate the P53 mRNA expression; Prescriptions 1, 4, 7, 8, 9 could significantly down-regulate the ICAM-1 mRNA expression; Prescriptions 1, 3, 6, 9 could significantly down-regulate the MMP-9 mRNA expression. The combined administration of Danhong's active ingredients showed a significant protective effect on primary cultured rBMECs injury induced by hypoxia Its mechanism may be related to the enhancement of cellular antioxidant capacity and the inhibition of inflammatory response and cell apoptosis. This study could

  3. [Efficiency in the prescription of drugs. Impact of a health policy: automatic change to prescription by active ingredient].

    PubMed

    López de Landache, Isabel Elizondo; Braceras Izaguirre, Leire; Echeto García, Ainara; Gardeazabal Romillo, Maria José; Acevedo Heranz, Paloma

    2013-11-01

    In the Basque Country in June 2010 were changed in the electronic prescription system the treatments prescribed by a brand by active ingredients, all the patients who had prescribed these molecules: atorvastatin, clopidogrel, weekly risedronate and losartan-hydrochlorothiazide. The aim of this study was to evaluate the economic impact of this change automated done in June 2010. Retrospective study of the prescriptions made in the Basque Country of the selected active ingredients. The use of generics of these molecules from May to December 2010 increased from 64 points to 87. Particularly clopidogrel increased from 6.25% in generic prescriptions to 93.76%, losartan + hydrochlorothiazide from 17.94% to 93.83%, 18.92% for atorvastatin acid and 96.03% risedronic 1.76% to 65.97%. If we make the estimation of the amount of active ingredient in generic containers that have been dispensed from June to December 2010. If they had dispensed brand drugs you get this quantity of total savings: 8 104 762.22 euros. This work suggests that a program to promote use of generics increased efficiency in the use of drugs. To promote the use of generic drugs is an efficiency measure implemented in the NHS and in the neighboring countries, in recent figures are reached 40% in securities of U.S.A packaging and around 65% in the Basque Country the consume in early 2010 was much lower than these figures stand at 20% and at the end of the year stood at 27% thanks to the measures taken. PMID:24404717

  4. The ingredients in Saengshik, a formulated health food, inhibited the activity of α-amylase and α-glucosidase as anti-diabetic function

    PubMed Central

    Kim, Misook; Kim, Eunji; Kwak, Han Sub

    2014-01-01

    BACKGROUND/OBJECTIVES We investigated total 26 ingredients of Saengshik which will be commercially produced as an anti-diabetic dietary supplement. SUBJECTS/METHODS Thirteen vegetables, nine cereals, three legumes and one seed were extracted with aqueous ethanol for 2 h at 60℃, and evaluated for their inhibitory effects against α-amylase and α-glucosidase and for total phenolic and flavonoid contents. RESULTS All ingredients inhibited α-amylase activity except cabbage. Strong inhibitory activity of α-amylase was observed in leek, black rice, angelica and barley compared with acarbose as a positive control. Stronger inhibition of α-glucosidase activity was found in small water dropwort, radish leaves, sorghum and cabbage than acarbose. All Saengshik ingredients suppressed α-glucosidase activity in the range of 0.3-60.5%. Most ingredients contained total phenols which were in the range of 1.2-229.4 mg gallic acid equivalent/g dried extract. But, total phenolic contents were not observed in carrot, pumpkin and radish. All ingredients contained flavonoid in the range of 11.6-380.7 mg catechin equivalent/g dried extract. CONCLUSIONS Our results demonstrate that Saengshik containing these ingredients would be an effective dietary supplement for diabetes. PMID:25324943

  5. A Unique Combination of Nutritionally Active Ingredients Can Prevent Several Key Processes Associated with Atherosclerosis In Vitro

    PubMed Central

    Moss, Joe W. E.; Davies, Thomas S.; Garaiova, Iveta; Plummer, Sue F.; Michael, Daryn R.; Ramji, Dipak P.

    2016-01-01

    Introduction Atherosclerosis is the underlying cause of cardiovascular disease that leads to more global mortalities each year than any other ailment. Consumption of active food ingredients such as phytosterols, omega-3 polyunsaturated fatty acids and flavanols are known to impart beneficial effects on cardiovascular disease although the combined actions of such agents in atherosclerosis is poorly understood. The aim of this study was to screen a nutritional supplement containing each of these active components for its anti-atherosclerotic effect on macrophages in vitro. Results The supplement attenuated the expression of intercellular adhesion molecule-1 and macrophage chemoattractant protein-1 in human and murine macrophages at physiologically relevant doses. The migratory capacity of human monocytes was also hindered, possibly mediated by eicosapentaenoic acid and catechin, while the ability of foam cells to efflux cholesterol was improved. The polarisation of murine macrophages towards a pro-inflammatory phenotype was also attenuated by the supplement. Conclusion The formulation was able to hinder multiple key steps of atherosclerosis development in vitro by inhibiting monocyte recruitment, foam cell formation and macrophage polarisation towards an inflammatory phenotype. This is the first time a combination these ingredients has been shown to elicit such effects and supports its further study in preclinical in vivo models. PMID:26950833

  6. Evaluation of Essential Oil and its Three Main Active Ingredients of Chinese Chenopodium ambrosioides (Family: Chenopodiaceae) against Blattella germanica

    PubMed Central

    Zhu, Wei Xiang; Zhao, Kun; Chu, Sha Sha; Liu, Zhi Long

    2012-01-01

    Background: The efficacy of essential oil of Chenopodium ambrosioides flowering aerial parts and its three main active ingredients was evaluated against Blattella germanica male adults. Methods: Composition of essential oil was determined by GC-MS. Topical application bioassay was used to evaluate contact toxicity of essential oil and three main components. Fumigant toxicity of essential oil and its main components was measured using a sealed space method. Results: Twenty-two components were identified in the essential oil and the main components were (Z)-ascaridole (29.7%), isoascaridole (13.0%), ρ-cymene (12.7%) and piperitone (5.0%). The essential oil and (Z)-ascaridole, isoascaridole and ρ-cymene possessed fumigant toxicity against male German cockroaches with LC50 values of 4.13, 0.55, 2.07 and 6.92 mg/L air, respectively. Topical application bioassay showed that all the three compounds were toxic to male German cockroaches and (Z)-ascaridole was the strongest with a LD50 value of 22.02 μg/adult while the crude oil with a LD50 value of 67.46 μg/adult. Conclusion: The essential oil from Chinese C. ambrosioides and its three main active ingredients may be explored as natural potential insecticides in the control of cockroaches. PMID:23378965

  7. The use of green tea extract in cosmetic formulations: not only an antioxidant active ingredient.

    PubMed

    Gianeti, Mirela D; Mercurio, Daiane G; Campos, Patricia M B G Maia

    2013-01-01

    Green tea (GT) extracts contain polyphenols, known to be effective free radical scavengers, and other ingredients that could also provide benefits to the skin. This is a report on clinical studies using objective, noninvasive methods to evaluate the effects of cosmetic formulations containing GT. Experimental formulations were supplemented or not (vehicle) with 6% Camellia sinensis glycolic leaf extracts (GT). These formulations were applied to the forearm skin of 24 volunteers, and their effects were evaluated before and after 2 hours, 15 and 30 days according to the following parameters: stratum corneum water content, transepidermal water loss, skin viscoelastic-to-elastic ratio (Uv/Ue), and microrelief. The volunteers were instructed not to apply any formulation in an area of the forearm (control area). Experimental formulations (GT) increased skin moisture in the long-term study, indicating that GT has a prolonged moisturizing effect. The Uv/Ue was significantly enhanced after 30 days of topical application of the experimental formulation when compared with vehicle and control. After 15-30 days, skin microrelief was significantly improved due to a reduction in skin roughness. The results suggest that GT-containing cosmetic formulations have pronounced moisturizing effects and improve skin microrelief. PMID:23742288

  8. Risk of error estimated from Palestine pharmacists’ knowledge and certainty on the adverse effects and contraindications of active pharmaceutical ingredients and excipients

    PubMed Central

    2016-01-01

    Purpose: This study aimed to investigate community pharmacists’ knowledge and certainty of adverse effects and contraindications of pharmaceutical products to estimate the risk of error. Factors influencing their knowledge and certainty were also investigated. Methods: The knowledge of community pharmacists was assessed in a cross-sectional design using a multiple-choice questions test on the adverse effects and contraindications of active pharmaceutical ingredients and excipients from May 2014 to March 2015. Self-rated certainty scores were also recorded for each question. Knowledge and certainty scores were combined to estimate the risk of error. Results: Out of 315 subjects, 129 community pharmacists (41.0%) completed the 30 multiple-choice questions test on active ingredients and excipients. Knowledge on active ingredients was associated with the year of graduation and obtaining a licence to practice pharmacy. Knowledge on excipients was associated with the degree obtained. There was higher risk of error in items on excipients than those on ingredients (P<0.01). Conclusion: The knowledge of community pharmacists in Palestine was insufficient with high risk of errors. Knowledge of community pharmacists on the safety issues of active ingredients and excipients need to be improved. PMID:26743774

  9. Fucoxanthin: A Promising Medicinal and Nutritional Ingredient

    PubMed Central

    Zhang, Hui; Tang, Yibo; Zhang, Ying; Zhang, Shuofeng; Qu, Jing; Wang, Xu; Kong, Ran; Han, Chunchao; Liu, Zhenquan

    2015-01-01

    Fucoxanthin, an allenic carotenoid, can be isolated from edible brown seaweeds. Recent studies have reported that fucoxanthin has many physiological functions and biological properties, such as antiobesity, antitumor, antidiabetes, antioxidant, anti-inflammatory, and hepatoprotective activities, as well as cardiovascular and cerebrovascular protective effects. Therefore, fucoxanthin can be used as both medicinal and nutritional ingredient to prevent and treat chronic diseases. Although fucoxanthin possesses many medicinal ingredient and nutritional qualities, studies indicated that its structure was unstable. In this paper, we consulted the current documents and reviewed structural properties and factors affecting the stability of fucoxanthin. We also reported the metabolism, safety, pharmacological activities, and the methods of improving the bioavailability of fucoxanthin. Based on these studies providing essential background knowledge, fucoxanthin can be developed into marine drugs and nutritional products. PMID:26106437

  10. 21 CFR 310.528 - Drug products containing active ingredients offered over-the-counter (OTC) for use as an...

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ..., testosterone, vitamins, yohimbine, yohimbine hydrochloride, and yohimbinum have been present as ingredients in such drug products. Androgens (e.g., testosterone and methyltestosterone) and estrogens are...

  11. 21 CFR 310.528 - Drug products containing active ingredients offered over-the-counter (OTC) for use as an...

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ..., testosterone, vitamins, yohimbine, yohimbine hydrochloride, and yohimbinum have been present as ingredients in such drug products. Androgens (e.g., testosterone and methyltestosterone) and estrogens are...

  12. 21 CFR 310.528 - Drug products containing active ingredients offered over-the-counter (OTC) for use as an...

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ..., testosterone, vitamins, yohimbine, yohimbine hydrochloride, and yohimbinum have been present as ingredients in such drug products. Androgens (e.g., testosterone and methyltestosterone) and estrogens are...

  13. Quantitation of active ingredients and excipients in nasal sprays by high-performance liquid chromatography, capillary electrophoresis and UV spectroscopy.

    PubMed

    Bernal, J L; del Nozal, M J; Martín, M T; Diez-Masa, J C; Cifuentes, A

    1998-10-01

    A study on the use of different analytical methodologies to determine active ingredients and excipients found in commercial nasal sprays is presented. Two of the developed methodologies consisted of separation techniques, i.e. high-performance liquid chromatography and capillary electrophoresis, and the third one involved a UV-spectroscopic multicomponent procedure. The samples studied are characterized by a high viscosity and the existence of a large number of particles in suspension; therefore, special emphasis is paid on the sample preparation required by each methodology. Advantages and drawbacks of each analytical technique are also discussed in terms of speed of analysis, sensitivity and reproducibility. From this work it is observed that although the UV method needs the most laborious sample preparation, the total time required per analysis is the shortest one. The best reproducibility in terms of analysis time and quantitation of the analyzed compounds is obtained using HPLC. CE allows the determination of more components in the same sample. PMID:9818419

  14. Simultaneous determination of active ingredients in Erigeron breviscapus (Vant.) Hand-Mazz. by capillary electrophoresis with electrochemical detection.

    PubMed

    Chu, Qingcui; Wu, Ting; Fu, Liang; Ye, Jiannong

    2005-03-01

    A high-performance capillary electrophoresis (CE) with electrochemical detection (ED) method was developed for the determination of the pharmacologically active ingredients in Erigeron breviscapus (Vant.) Hand-Mazz. and its extract phytopharmaceuticals in this work. Under the optimum conditions, nine analytes, baicalein, naringenin, scopoletin, kaempferol, apigenin, scutellarin, luteolin, caffeic acid and protocatechuic acid were separated within 24 min in a borax buffer (pH 8.7). Notably, excellent linearity was obtained over two orders of magnitude with detection limits (S/N=3) ranged from 1.0 x 10(-7) g/mL to 5.6 x 10(-7) g/mL for all nine analytes. This method was successfully used in the analysis of E. breviscapus (Vant.) Hand-Mazz. and its phytopharmaceuticals with a relatively simple extraction procedure, and the assay results were satisfactory. PMID:15740914

  15. Optimization of HS-GC-FID-MS Method for Residual Solvent Profiling in Active Pharmaceutical Ingredients Using DoE.

    PubMed

    Poceva Panovska, Ana; Acevska, Jelena; Stefkov, Gjoshe; Brezovska, Katerina; Petkovska, Rumenka; Dimitrovska, Aneta

    2016-02-01

    Within this research, a headspace (HS) gas chromatography-flame ionization detector-mass spectrometry method was developed for profiling of residual solvents (RSs) in active pharmaceutical ingredients (APIs). Design of experiment was used for optimization of sample preparation, as well as for robustness testing of the method. HS equilibration temperature and dilution medium were detected as parameters with greater impact on the sensitivity, compared with the time used for equilibration of the samples. Regardless of the sample solubility, the use of water for sample preparation was found to be crucial for better sensitivity. The use of a well-designed strategy for method development and robustness testing, additional level of identification confidence, as well as use of internal standard provided a strong and reliable analytical tool for API fingerprinting, thus enabling the authentication of the substance based on the RS profile. PMID:26290585

  16. Water determination in active pharmaceutical ingredients using ionic liquid headspace gas chromatography and two different detection protocols.

    PubMed

    Frink, Lillian A; Weatherly, Choyce A; Armstrong, Daniel W

    2014-06-01

    A rapid, accurate, precise and versatile analytical method was developed for the detection and quantification of water in solid active pharmaceutical ingredients (APIs). The headspace gas chromatography (HSGC) method utilized an ionic liquid (IL) based open tubular capillary GC column to increase sensitivity and ruggedness of this method. ILs are also utilized as the headspace solvent because of their low vapor pressure, unique physiochemical properties and high thermal stability. This method is not affected by side reactions and solubility problems which are common with Karl Fischer Titration (KFT) methods. Nor is it as limited as weight loss on drying approaches. The ability to use either/both modern thermal conductivity or barrier ion discharge GC detection provides flexibility, different dynamic ranges and sensitivity. The developed method also was shown to be broadly applicable. PMID:24561336

  17. Peimine, a main active ingredient of Fritillaria, exhibits anti-inflammatory and pain suppression properties at the cellular level.

    PubMed

    Xu, Jianwei; Zhao, Wei; Pan, Lanying; Zhang, Ailian; Chen, Qingmao; Xu, Kai; Lu, Haiyin; Chen, Yuan

    2016-06-01

    Fritillaria is one of the most important herbs in Chinese traditional medicine and represents an annual ¥700 million industry. It is often used as an anti-inflammatory, pain relieving and antitussive medicine. However, the mechanisms of these effects are still unclear. Peimine is one of active ingredients of Fritillaria. Using the patch-clamp technique, we profiled the action of Peimine against selected ion channels stably expressed in HEK 293 cell lines. Our data indicated that Peimine was not only able to block the Nav1.7 ion channel but also preferably inhibited the Kv1.3 ion channel. Thus, the study suggested potential mechanisms of Fritillaria as a pain relieving and anti-inflammatory herb. PMID:27033404

  18. Effects of isolation on various lymphocyte activities

    SciTech Connect

    Jessop, J.J.

    1986-01-01

    Prolonged exposure of Sprague Dawley male rats to isolation, water scheduling, or their combination resulted in an enhanced lymphocyte proliferative response to mitogen. Time course studies of effects of isolation on mitogenic response of splenic and/or blood T and B lymphocytes and splenic NK cell activity demonstrated a suppression with short term exposure followed by an enhancement with prolonged exposure. Use of immunoperoxidase staining techniques to identify splenic T or T helper cells revealed that prolonged exposure to isolation had no significant effect on the proportion of these cell populations in the spleen. Examination of the data by Lineweaver-Burke plot and plot of the data as % maximum response showed that prolonged exposure to isolation did not alter the sensitivity of the lymphocytes to mitogen. Involvement of corticosteroids and opioid peptides in mediation of the effects of exposure to isolation on lymphocyte activity was assessed by measurement of plasma corticosterone by radioimmunoassay and by examination of the ability of the opioid antagonist naltrexone to alter the effects of isolation on lymphocyte proliferative response to mitogen. Attempts were made to mimic the effects of short-term isolation on lymphocyte activity by morphine sulfate administration.

  19. Isolated polypeptide having arabinofuranosidase activity

    DOEpatents

    Foreman, Pamela; Van Solingen, Pieter; Goedegebuur, Frits; Ward, Michael

    2010-02-23

    Described herein are novel gene sequences isolated from Trichoderma reesei. Two genes encoding proteins comprising a cellulose binding domain, one encoding an arabionfuranosidase and one encoding an acetylxylanesterase are described. The sequences, CIP1 and CIP2, contain a cellulose binding domain. These proteins are especially useful in the textile and detergent industry and in pulp and paper industry. TABLE-US-00001 cip1 cDNA sequence (SEQ ID NO: 1) GACTAGTTCA TAATACAGTA GTTGAGTTCA TAGCAACTTC 50 ACTCTCTAGC TGAACAAATT ATCTGCGCAA ACATGGTTCG CCGGACTGCT 100 CTGCTGGCCC TTGGGGCTCT CTCAACGCTC TCTATGGCCC AAATCTCAGA 150 CGACTTCGAG TCGGGCTGGG ATCAGACTAA ATGGCCCATT TCGGCACCAG 200 ACTGTAACCA GGGCGGCACC GTCAGCCTCG ACACCACAGT AGCCCACAGC 250 GGCAGCAACT CCATGAAGGT CGTTGGTGGC CCCAATGGCT ACTGTGGACA 300 CATCTTCTTC GGCACTACCC AGGTGCCAAC TGGGGATGTA TATGTCAGAG 350 CTTGGATTCG GCTTCAGACT GCTCTCGGCA GCAACCACGT CACATTCATC 400 ATCATGCCAG ACACCGCTCA GGGAGGGAAG CACCTCCGAA TTGGTGGCCA 450 AAGCCAAGTT CTCGACTACA ACCGCGAGTC CGACGATGCC ACTCTTCCGG 500 ACCTGTCTCC CAACGGCATT GCCTCCACCG TCACTCTGCC TACCGGCGCG 550 TTCCAGTGCT TCGAGTACCA CCTGGGCACT GACGGAACCA TCGAGACGTG 600 GCTCAACGGC AGCCTCATCC CGGGCATGAC CGTGGGCCCT GGCGTCGACA 650 ATCCAAACGA CGCTGGCTGG ACGAGGGCCA GCTATATTCC GGAGATCACC 700 GGTGTCAACT TTGGCTGGGA GGCCTACAGC GGAGACGTCA ACACCGTCTG 750 GTTCGACGAC ATCTCGATTG CGTCGACCCG CGTGGGATGC GGCCCCGGCA 800 GCCCCGGCGG TCCTGGAAGC TCGACGACTG GGCGTAGCAG CACCTCGGGC 850 CCGACGAGCA CTTCGAGGCC AAGCACCACC ATTCCGCCAC CGACTTCCAG 900 GACAACGACC GCCACGGGTC CGACTCAGAC ACACTATGGC CAGTGCGGAG 1000 GGATTGGTTA CAGCGGGCCT ACGGTCTGCG CGAGCGGCAC GACCTGCCAG 1050 GTCCTGAACC CATACTACTC CCAGTGCTTA TAAGGGGATG AGCATGGAGT 1100 GAAGTGAAGT GAAGTGGAGA GAGTTGAAGT GGCATTGCGC TCGGCTGGGT 1150 AGATAAAAGT CAGCAGCTAT GAATACTCTA TGTGATGCTC ATTGGCGTGT 1200 ACGTTTTAAA AAAAAAAAAA AAAAAAAAAA AAAAAAAAAA AAAAAAAAAA 1250 AAAAAAAAAA AAAAAAAAAG GGGGCGGCCG C 1271

  20. Functional ingredients from microalgae.

    PubMed

    Buono, Silvia; Langellotti, Antonio Luca; Martello, Anna; Rinna, Francesca; Fogliano, Vincenzo

    2014-08-01

    A wide variety of natural sources are under investigation to evaluate their possible use for new functional ingredient formulation. Some records attested the traditional and ancient use of wild harvested microalgae as human food but their cultivation for different purposes started about 40 years ago. The most popular species are Arthrospira (traditional name, Spirulina), Chlorella spp., Dunaliella spp. and Haematococcus spp. Microalgae provide a bewildering array of opportunities to develop healthier food products using innovative approaches and a number of different strategies. Compared to other natural sources of bioactive ingredients, microalgae have many advantages such as their huge biodiversity, the possibility to grow in arid land and with limited fresh water consumption and the flexibility of their metabolism, which could be adapted to produce specific molecules. All these factors led to very sustainable production making microalgae eligible as one of the most promising foods for the future, particularly as source of proteins, lipids and phytochemicals. In this work, a revision of the knowledge about the use of microalgae as food and as a source of functional ingredients has been performed. The most interesting results in the field are presented and commented upon, focusing on the different species of microalgae and the activity of the nutritionally relevant compounds. A summary of the health effects obtained together with pros and cons in the adoption of this natural source as functional food ingredients is also proposed. PMID:24957182

  1. Active thermal isolation for temperature responsive sensors

    NASA Technical Reports Server (NTRS)

    Martinson, Scott D. (Inventor); Gray, David L. (Inventor); Carraway, Debra L. (Inventor); Reda, Daniel C. (Inventor)

    1994-01-01

    A temperature responsive sensor is located in the airflow over the specified surface of a body and is maintained at a constant temperature. An active thermal isolator is located between this temperature responsive sensor and the specified surface of the body. The temperature of this isolator is controlled to reduce conductive heat flow from the temperature responsive sensor to the body. This temperature control includes: (1) operating the isolator at the same temperature as the constant temperature of the sensor and (2) establishing a fixed boundary temperature which is either less than or equal to or slightly greater than the sensor constant temperature.

  2. 21 CFR 333.160 - Labeling of permitted combinations of active ingredients.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... HUMAN USE First Aid Antibiotic Drug Products § 333.160 Labeling of permitted combinations of active... product may state, under the heading “Indications,” the following additional indication: “First aid...

  3. 21 CFR 333.160 - Labeling of permitted combinations of active ingredients.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... HUMAN USE First Aid Antibiotic Drug Products § 333.160 Labeling of permitted combinations of active... product may state, under the heading “Indications,” the following additional indication: “First aid...

  4. 21 CFR 333.160 - Labeling of permitted combinations of active ingredients.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... HUMAN USE First Aid Antibiotic Drug Products § 333.160 Labeling of permitted combinations of active... product may state, under the heading “Indications,” the following additional indication: “First aid...

  5. 21 CFR 333.160 - Labeling of permitted combinations of active ingredients.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... HUMAN USE First Aid Antibiotic Drug Products § 333.160 Labeling of permitted combinations of active... product may state, under the heading “Indications,” the following additional indication: “First aid...

  6. [Effect of different nitrogen forms and ratio on growth and active ingredient content of Platycodon grandiflorum].

    PubMed

    Duan, Yun-jing; Wang, Kang-cai; Niu, Ling-hui; Li, Ke; Su, Yun-yun

    2015-10-01

    To providing evidence about nitrogen adequate application of Platycodon grandiflorum, the pot culture experiment was conducted to study the effect of nitrogen on the growth, physiological metabolism and the quality of P. grandiflorum. The activity of NR, GS and SOD, POD and CAT were determined. And the nitrate and ammonium nitrogen content, photosynthetic characteristics, active components of P. grandiflorum were determined. The results showed that the nitrate nitrogen content and P. biomass reached its maximum value, when NH4(+)-N/NO3(-) -N was 0: 100, the activity of NR. The activity of GS was the highest at the NH4(+) -N/NO3(-) -N ratio of 25:75 and ammonium nitrogen content was the highest at 75:25. The activity of SOD decreased and then increased with the increasing of NO3(-) -N. At the NH4(+) -N/NO3(-) -N ratio of 25: 75, the activity of CAT had its maximum value and the content of MDA had the minimum value. At the same time, the content of platycodon D was the highest at this treatment. The studies had shown that different nitrogen forms and ratio had a significant effect on the characteristics of photosynthetic physiology, nitrogen metabolism and resistance adjustment, growth and the quality of P. grandiflorum. The NH4(+) -N/NO3(-) -N ratio of 25: 75 was a suitable ratio of nitrogen forms for the growth of P. Grandiflorum and accumulating the content of platycodon D. PMID:26975097

  7. Antibacterial activity of some triclosan-containing toothpastes and their ingredients.

    PubMed

    Wade, W G; Addy, M

    1992-04-01

    The antibacterial activity of 4 triclosan-containing toothpastes was compared to a conventional fluoride dentifrice and triclosan and sodium lauryl sulphate (SLS), both singly and in combination. A panel of 17 bacteria was tested by an agar dilution method. At concentrations typical of those found in toothpastes, triclosan and SLS displayed approximately equal antibacterial activity. A paste containing triclosan and zinc citrate appeared more active than the other triclosan pastes which, in general, showed marginal superiority over the conventional paste. SLS, although included in dentifrice formulations for its detergent properties, may significantly contribute to the antibacterial profile of a product. The need for appropriate controls when evaluating experimental toothpastes is emphasized. PMID:1345321

  8. Anti-inflammatory, antioxidant and antitumor activities of ingredients of Curcuma phaeocaulis Val.

    PubMed

    Hou, Yan; Lu, Chuan-Li; Zeng, Qiao-Hui; Jiang, Jian-Guo

    2015-01-01

    Curcuma phaeocaulis Val. is used in Chinese Pharmacopoeia as health food and folk medicine for removing blood stasis, alleviating pain and tumor therapy. This research was aimed to explore and compare three main bioactivities including anti-oxidant, antitumor and anti-inflammatory activities between the ethanol extract of C. Phaeocaulis and its fractions using different in vitro models. Firstly, 70 % ethanol was used to extract C. Phaeocaulis, and then the crude extract was re-extracted, resulting in petroleum ether (EZ-PE), ethyl acetate (EZ-EA), and water fractions (EZ-W), respectively, and then a series of index was detected. Results showed that all the extracts had medium DPPH radical scavenging activity when the concentration was 200 μg/ml and their DPPH radical scavenging activity was in a concentration-dependent manner. The extracts except ethanol extract of C. Phaeocaulis had almost no cytotoxicity to the survival of RAW264.7 cell when the concentration reached 80 μg/ml, and all of them had medium inhibitory effect on nitrite release. Extracts of C. Phaeocaulis had medium intensity antitumor activity, EZ-PE and EZ-EA fractions significantly inhibited the proliferation of four tumor cells (SMMC-7721 cell lines, HepG-2 cell lines, A549 cell lines and Hela cell lines). C. Phaeocaulis had antioxidant and anti-inflammatory activities, which did not carry out centralized phenomenon when re-extracted. EZ-PE and EZ-EA were active antitumor sites of C. Phaeocaulis. PMID:26648822

  9. Anti-inflammatory, antioxidant and antitumor activities of ingredients of Curcuma phaeocaulis Val

    PubMed Central

    Hou, Yan; Lu, Chuan-Li; Zeng, Qiao-Hui; Jiang, Jian-Guo

    2015-01-01

    Curcuma phaeocaulis Val. is used in Chinese Pharmacopoeia as health food and folk medicine for removing blood stasis, alleviating pain and tumor therapy. This research was aimed to explore and compare three main bioactivities including anti-oxidant, antitumor and anti-inflammatory activities between the ethanol extract of C. Phaeocaulis and its fractions using different in vitro models. Firstly, 70 % ethanol was used to extract C. Phaeocaulis, and then the crude extract was re-extracted, resulting in petroleum ether (EZ-PE), ethyl acetate (EZ-EA), and water fractions (EZ-W), respectively, and then a series of index was detected. Results showed that all the extracts had medium DPPH radical scavenging activity when the concentration was 200 μg/ml and their DPPH radical scavenging activity was in a concentration-dependent manner. The extracts except ethanol extract of C. Phaeocaulis had almost no cytotoxicity to the survival of RAW264.7 cell when the concentration reached 80 μg/ml, and all of them had medium inhibitory effect on nitrite release. Extracts of C. Phaeocaulis had medium intensity antitumor activity, EZ-PE and EZ-EA fractions significantly inhibited the proliferation of four tumor cells (SMMC-7721 cell lines, HepG-2 cell lines, A549 cell lines and Hela cell lines). C. Phaeocaulis had antioxidant and anti-inflammatory activities, which did not carry out centralized phenomenon when re-extracted. EZ-PE and EZ-EA were active antitumor sites of C. Phaeocaulis. PMID:26648822

  10. Developing a Passive Time-Activity Triage System In support of Consumer Ingredient Exposure Prioritization

    EPA Science Inventory

    Chemical Hazard/toxicity assessment of chemicals relies on droves of chemical-biological data at the organism, tissue, cell, and biomolecular level of resolution. Big data in the context of exposure science relies on a comprehensive knowledge of societies’ and community activity ...

  11. Attractive toxic sugar baits: Control of mosquitoes with the low risk active ingredient dinotefuran and potential impacts on non-target organisms in Morocco

    Technology Transfer Automated Retrieval System (TEKTRAN)

    We evaluated the efficacy of ATSB in the laboratory and the field with the low risk active ingredient dinotefuran against mosquito populations. Assays indicated that dinotefuran in solution with the sugar baits was ingested and resulted in high mortality of female Culex quinquefasciatus and Aedes a...

  12. 21 CFR 310.534 - Drug products containing active ingredients offered over-the-counter (OTC) for human use as oral...

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... offered over-the-counter (OTC) for human use as oral wound healing agents. 310.534 Section 310.534 Food... active ingredients offered over-the-counter (OTC) for human use as oral wound healing agents. (a... aqueous solution have been present in oral mucosal injury drug products for use as oral wound...

  13. 21 CFR 310.534 - Drug products containing active ingredients offered over-the-counter (OTC) for human use as oral...

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... offered over-the-counter (OTC) for human use as oral wound healing agents. 310.534 Section 310.534 Food... active ingredients offered over-the-counter (OTC) for human use as oral wound healing agents. (a... aqueous solution have been present in oral mucosal injury drug products for use as oral wound...

  14. 21 CFR 310.534 - Drug products containing active ingredients offered over-the-counter (OTC) for human use as oral...

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 5 2012-04-01 2012-04-01 false Drug products containing active ingredients offered over-the-counter (OTC) for human use as oral wound healing agents. 310.534 Section 310.534 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS FOR HUMAN USE NEW DRUGS Requirements for Specific...

  15. 21 CFR 310.534 - Drug products containing active ingredients offered over-the-counter (OTC) for human use as oral...

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... offered over-the-counter (OTC) for human use as oral wound healing agents. 310.534 Section 310.534 Food... active ingredients offered over-the-counter (OTC) for human use as oral wound healing agents. (a... aqueous solution have been present in oral mucosal injury drug products for use as oral wound...

  16. 21 CFR 310.534 - Drug products containing active ingredients offered over-the-counter (OTC) for human use as oral...

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... offered over-the-counter (OTC) for human use as oral wound healing agents. 310.534 Section 310.534 Food... active ingredients offered over-the-counter (OTC) for human use as oral wound healing agents. (a... aqueous solution have been present in oral mucosal injury drug products for use as oral wound...

  17. Understanding the Active Ingredients in an Effective Preschool Vocabulary Intervention: An Exploratory Study of Teacher and Child Talk during Book Reading

    ERIC Educational Resources Information Center

    Wasik, Barbara A.; Hindman, Annemarie H.

    2014-01-01

    Research Findings: In order to identify the active ingredients in an effective professional development intervention focused on enhancing preschool vocabulary instruction, this study examines the frequency with which teachers and children discussed theme-related vocabulary words during shared book reading. Head Start teachers received 1 year of…

  18. Efficacy of attractive toxic sugar baits (ATSB) against Aedes albopictus with garlic oil encapsulated in beta-Cyclodextrin as the active ingredient

    Technology Transfer Automated Retrieval System (TEKTRAN)

    We tested the efficacy of attractive toxic sugar bait (ATSB) with garlic oil microencapsulated in beta-cyclodextrin as active ingredient against Aedes albopictus in suburban Haifa, Israel. Two three-acre gardens with high numbers of Ae. albopictus were chosen for perimeter spray treatment with ATSB ...

  19. Intrinsic Motivation and Engagement as "Active Ingredients" in Garden-Based Education: Examining Models and Measures Derived from Self-Determination Theory

    ERIC Educational Resources Information Center

    Skinner, Ellen A.; Chi, Una

    2012-01-01

    Building on self-determination theory, this study presents a model of intrinsic motivation and engagement as "active ingredients" in garden-based education. The model was used to create reliable and valid measures of key constructs, and to guide the empirical exploration of motivational processes in garden-based learning. Teacher- and…

  20. Characterizing Active Pharmaceutical Ingredient Binding to Human Serum Albumin by Spin-Labeling and EPR Spectroscopy.

    PubMed

    Hauenschild, Till; Reichenwallner, Jörg; Enkelmann, Volker; Hinderberger, Dariush

    2016-08-26

    Drug binding to human serum albumin (HSA) has been characterized by a spin-labeling and continuous-wave (CW) EPR spectroscopic approach. Specifically, the contribution of functional groups (FGs) in a compound on its albumin-binding capabilities is quantitatively described. Molecules from different drug classes are labeled with EPR-active nitroxide radicals (spin-labeled pharmaceuticals (SLPs)) and in a screening approach CW-EPR spectroscopy is used to investigate HSA binding under physiological conditions and at varying ratios of SLP to protein. Spectral simulations of the CW-EPR spectra allow extraction of association constants (KA ) and the maximum number (n) of binding sites per protein. By comparison of data from 23 SLPs, the mechanisms of drug-protein association and the impact of chemical modifications at individual positions on drug uptake can be rationalized. Furthermore, new drug modifications with predictable protein binding tendency may be envisaged. PMID:27460503

  1. The synthesis of active pharmaceutical ingredients (APIs) using continuous flow chemistry

    PubMed Central

    2015-01-01

    Summary The implementation of continuous flow processing as a key enabling technology has transformed the way we conduct chemistry and has expanded our synthetic capabilities. As a result many new preparative routes have been designed towards commercially relevant drug compounds achieving more efficient and reproducible manufacture. This review article aims to illustrate the holistic systems approach and diverse applications of flow chemistry to the preparation of pharmaceutically active molecules, demonstrating the value of this strategy towards every aspect ranging from synthesis, in-line analysis and purification to final formulation and tableting. Although this review will primarily concentrate on large scale continuous processing, additional selected syntheses using micro or meso-scaled flow reactors will be exemplified for key transformations and process control. It is hoped that the reader will gain an appreciation of the innovative technology and transformational nature that flow chemistry can leverage to an overall process. PMID:26425178

  2. Identification and molecular docking analysis of active ingredients with medicinal properties from edible Baccaurea sapida.

    PubMed

    Mann, Sonia; Sharma, Ankita; Biswas, Sagarika; Gupta, Rajinder K

    2015-01-01

    Underutilized plant species has started changing the conception of plants by expanding the use well beyond from foods and fibers to rich source of medicinally important secondary metabolites. Bioactive compounds from natural sources are gaining importance as potential drug candidates towards many inflammatory conditions like Rheumatoid Arthritis (RA). The focus of the present study has been centred to reveal the anti-inflammatory potential of an underutilized fruits of B. sapida. Further efforts towards its medicinal significance may provide relieve from symptoms of RA by reducing the side effects that are observed in available medications. Total 10 compounds in fruit crude methanol extract were identified and quantified by LC-MS/MS analysis followed by the agar well diffusion method for their anti microbial activity. Among all studied micro organism S. aureus was found to surmount the inflammation in RA through domain B of surface protein A (Staphylococcal surface protein A). Identified compounds (having anti-inflammatory properties) were scrutinized for their toxicity and quantitative structure-activity relationship (QSAR) using lazer toxicity and Molinspiration servers respectively. Further, docking studies have been carried out between domain B and studied compounds using AutoDock. Out of 6 anti-inflammtory compounds, quercetin has been identified as the most potent compound in reference to its inhibitory constant (47.01) and binding energy (-5.90 kcal/mol) to bacterial protein. Our data suggest that methanol extract of B. sapida fruit posses medicinally significant anti-inflammatory compounds and thus justifies the use of this fruit as folklore medicine for preventing inflammation related diseases. PMID:26527853

  3. Identification and molecular docking analysis of active ingredients with medicinal properties from edible Baccaurea sapida

    PubMed Central

    Mann, Sonia; Sharma, Ankita; Biswas, Sagarika; Gupta, Rajinder K

    2015-01-01

    Underutilized plant species has started changing the conception of plants by expanding the use well beyond from foods and fibers to rich source of medicinally important secondary metabolites. Bioactive compounds from natural sources are gaining importance as potential drug candidates towards many inflammatory conditions like Rheumatoid Arthritis (RA). The focus of the present study has been centred to reveal the anti-inflammatory potential of an underutilized fruits of B. sapida. Further efforts towards its medicinal significance may provide relieve from symptoms of RA by reducing the side effects that are observed in available medications. Total 10 compounds in fruit crude methanol extract were identified and quantified by LC-MS/MS analysis followed by the agar well diffusion method for their anti microbial activity. Among all studied micro organism S. aureus was found to surmount the inflammation in RA through domain B of surface protein A (Staphylococcal surface protein A). Identified compounds (having anti-inflammatory properties) were scrutinized for their toxicity and quantitative structure–activity relationship (QSAR) using lazer toxicity and Molinspiration servers respectively. Further, docking studies have been carried out between domain B and studied compounds using AutoDock. Out of 6 anti-inflammtory compounds, quercetin has been identified as the most potent compound in reference to its inhibitory constant (47.01) and binding energy (-5.90 kcal/mol) to bacterial protein. Our data suggest that methanol extract of B. sapida fruit posses medicinally significant anti-inflammatory compounds and thus justifies the use of this fruit as folklore medicine for preventing inflammation related diseases. PMID:26527853

  4. Membrane treatment of Aqueous Film Forming Foam (AFFF) wastes for recovery of its active ingredients. Final report, Mar 79-Sep 80

    SciTech Connect

    Chian, E.S.K.; Wu, T.P.; Rowland, R.W.

    1980-10-01

    Ultrafiltration (UF) and Reverse Osmosis (RO) treatment of Aqueous Film Forming Foam (AFFF) solutions was investigated to determine the feasibility of employing membrane processes to separate and recover AFFF active ingredients for reuse. Studies were performed on both 6% AFFF in tap-water solutions and on actual wastewaters spiked with 3% or 6% AFFF. The AFFF materials used in this study consisted of Ansul, 3M FC-206, and 3M FC-780. Membrane employed for these studies included Abcor HFD, HFF, HFJ, and HFK tubular ultrafiltration (UF) membranes and a DuPont B-10 reverse osmosis (RO) module. Parameters monitored to represent AFFF ingredients were TOC, dissolved solids, surfactants, and % glycol. An attempt was also made to determine fluorocarbons as fluoride. Membrane fluxes were also determined. Results of this study demonstrate the feasibility of employing UF-RO processes to separate and recover the AFFF active ingredients for reuse. Approximately 75% recovery of the AFFF active ingredients as represented by the foam test was attained. An economic analysis of the membrane treatment processes indicates that it is extremely favorable in recovering the AFFF wastewater for reuse. Pilot-scale studies are, however, necessary to fully establish the process feasibilities and economics of the AFFF recovery system.

  5. Active thermal isolation for temperature responsive sensors

    NASA Technical Reports Server (NTRS)

    Martinson, Scott D. (Inventor); Gray, David L. (Inventor); Carraway, Debra L. (Inventor); Reda, Daniel C. (Inventor)

    1994-01-01

    The detection of flow transition between laminar and turbulent flow and of shear stress or skin friction of airfoils is important in basic research for validation of airfoil theory and design. These values are conventionally measured using hot film nickel sensors deposited on a polyimide substrate. The substrate electrically insulates the sensor and underlying airfoil but is prevented from thermally isolating the sensor by thickness constraints necessary to avoid flow contamination. Proposed heating of the model surface is difficult to control, requires significant energy expenditures, and may alter the basic flow state of the airfoil. A temperature responsive sensor is located in the airflow over the specified surface of a body and is maintained at a constant temperature. An active thermal isolator is located between this temperature responsive sensor and the specific surface of the body. The total thickness of the isolator and sensor avoid any contamination of the flow. The temperature of this isolator is controlled to reduce conductive heat flow from the temperature responsive sensor to the body. This temperature control includes (1) operating the isolator at the same temperature as the constant temperature of the sensor; and (2) establishing a fixed boundary temperature which is either less than or equal to, or slightly greater than the sensor constant temperature. The present invention accordingly thermally isolates a temperature responsive sensor in an energy efficient, controllable manner while avoiding any contamination of the flow.

  6. An active viscoelastic metamaterial for isolation applications

    NASA Astrophysics Data System (ADS)

    Reynolds, M.; Daley, S.

    2014-04-01

    Metamaterials are of interest due to their ability to produce novel acoustic behaviour beyond that seen in naturally occurring media. Of particular interest is the appearance of band gaps which lead to very high levels of attenuation within narrow frequency ranges. Resonant elements within metamaterials allow band gaps to form within the long wavelength limit at low frequencies where traditional passive isolation solutions suffer poor performance. Hence metamaterials may provide a path to high performance, low frequency isolation. Two metamaterials are presented here. An acoustic material consisting of an array of split hollow spheres is developed, and its performance is validated experimentally. The application of an acoustic/mechanical analogy allows the development of an elastodynamic metamaterial that could be employed as a high performance vibration isolator at low frequencies. A prototype isolator is manufactured, and its performance is measured. The passively occurring band gap is enhanced using an active control architecture. The use of the active control system in conjunction with the natural passive behaviour of the metamaterial enables high levels of isolation across a broad frequency range. An eventual goal of the work is to produce such materials on a small scale, and as such the metamaterials developed are designed for, and produced using, additive layer manufacturing techniques.

  7. [Antihyperlipidemic effect of iodine egg: search for active ingredients and their iodine contents].

    PubMed

    Kaji, K; Seyama, Y; Yamashita, S

    1984-04-01

    Active fractions that possess the hypocholesterolemic effect of iodine egg yolk lipid fraction have been investigated with male Wistar strain rats fed on a cholesterol-rich diet. Iodine egg yolk lipid was extracted by Folch's (chloroform: methanol) method and was refractionated into a neutral lipid (IEY-NL) fraction and a polar lipid (IEY-PL) fraction. The iodine content in each fraction was determined. The animals were kept on the cholesterol-rich diet for 5 days, and then they were fed the fractions in addition to the above diet for 10 more days. The hypocholesterolemic effect was seen most significantly with the IEY-NL fraction. The serum total cholesterol level in rats receiving this fraction was 70% as compared with that of the Ch group (fed on the cholesterol diet). However, the liver total cholesterol level was not affected or rather increased by the IEY-NL fraction. Another fraction (IEY-PL) showed no such effect. Iodine content in the IEY-NL fraction was quite low (0.2 ppm) compared with the other fractions. The daily dose in terms of iodine in the IEY-NL fraction was only the amount equivalent to 1/50 of the reported daily requirement for the rat. The IEY-NL fraction induced the hypocholesterolemic effect, though it contained only a trace of iodine. PMID:6540225

  8. Occurrence and behaviour of 105 active pharmaceutical ingredients in sewage waters of a municipal sewer collection system.

    PubMed

    Lindberg, Richard H; Östman, Marcus; Olofsson, Ulrika; Grabic, Roman; Fick, Jerker

    2014-07-01

    The concentrations and behaviour of 105 different active pharmaceutical ingredients (APIs) in the aqueous phase of sewage water within a municipal sewer collection system have been investigated. Sewage water samples were gathered from seven pump stations (one of which was located within a university hospital) and from sewage water treatment influent and effluent. The targeted APIs were quantified using a multi-residue method based on online solid phase extraction liquid chromatography tandem mass spectrometry. The method was thoroughly validated and complies with EU regulations on sample handling, limits of quantification, quality control and selectivity. 51 APIs, including antibiotics, antidepressants, hypertension drugs, analgesics, NSAIDs and psycholeptics, were found frequently within the sewer collection system. API concentrations and mass flows were evaluated in terms of their frequency of detection, daily variation, median/minimum/maximum/average concentrations, demographic dissimilarities, removal efficiencies, and mass flow profiles relative to municipal sales data. Our results suggest that some APIs are removed from, or introduced to, the aqueous phase of sewage waters within the studied municipal collection system. PMID:24768701

  9. Application of the KeratinoSens™ assay for assessing the skin sensitization potential of agrochemical active ingredients and formulations.

    PubMed

    Settivari, Raja S; Gehen, Sean C; Amado, Ricardo Acosta; Visconti, Nicolo R; Boverhof, Darrell R; Carney, Edward W

    2015-07-01

    Assessment of skin sensitization potential is an important component of the safety evaluation process for agrochemical products. Recently, non-animal approaches including the KeratinoSens™ assay have been developed for predicting skin sensitization potential. Assessing the utility of the KeratinoSens™ assay for use with multi-component mixtures such as agrochemical formulations has not been previously evaluated and is a significant need. This study was undertaken to evaluate the KeratinoSens™ assay prediction potential for agrochemical formulations. The assay was conducted for 8 agrochemical active ingredients (AIs) including 3 sensitizers (acetochlor, meptyldinocap, triclopyr), 5 non-sensitizers (aminopyralid, clopyralid, florasulam, methoxyfenozide, oxyfluorfen) and 10 formulations for which in vivo sensitization data were available. The KeratinoSens™ correctly predicted the sensitization potential of all the AIs. For agrochemical formulations it was necessary to modify the standard assay procedure whereby the formulation was assumed to have a common molecular weight. The resultant approach correctly predicted the sensitization potential for 3 of 4 sensitizing formulations and all 6 non-sensitizing formulations when compared to in vivo data. Only the meptyldinocap-containing formulation was misclassified, as a result of high cytotoxicity. These results demonstrate the promising utility of the KeratinoSens™ assay for evaluating the skin sensitization potential of agrochemical AIs and formulations. PMID:25981449

  10. Direct determination of ECD in ECD Kit: a solid sample quantitation method for active pharmaceutical ingredient in drug product.

    PubMed

    Chao, Ming-Yu; Liu, Kung-Tien; Hsia, Yi-Chih; Liao, Mei-Hsiu; Shen, Lie-Hang

    2011-01-01

    Technetium-99m ethyl cysteinate dimer (Tc-99m-ECD) is an essential imaging agent used in evaluating the regional cerebral blood flow in patients with cerebrovascular diseases. Determination of active pharmaceutical ingredient, that is, L-Cysteine, N, N'-1,2-ethanediylbis-, diethyl ester, dihydrochloride (ECD) in ECD Kit is a relevant requirement for the pharmaceutical quality control in processes of mass fabrication. We here presented a direct solid sample determination method of ECD in ECD Kit without sample dissolution to avoid the rapid degradation of ECD. An elemental analyzer equipped with a nondispersive infrared detector and a calibration curve of coal standard was used for the quantitation of sulfur in ECD Kit. No significant matrix effect was found. The peak area of coal standard against the amount of sulfur was linear over the range of 0.03-0.10 mg, with a correlation coefficient (r) of 0.9993. Method validation parameters were achieved to demonstrate the potential of this method. PMID:21687539

  11. Quantitation of active pharmaceutical ingredients and excipients in powder blends using designed multivariate calibration models by near-infrared spectroscopy.

    PubMed

    Li, Weiyong; Worosila, Gregory D

    2005-05-13

    This research note demonstrates the simultaneous quantitation of a pharmaceutical active ingredient and three excipients in a simulated powder blend containing acetaminophen, Prosolv and Crospovidone. An experimental design approach was used in generating a 5-level (%, w/w) calibration sample set that included 125 samples. The samples were prepared by weighing suitable amount of powders into separate 20-mL scintillation vials and were mixed manually. Partial least squares (PLS) regression was used in calibration model development. The models generated accurate results for quantitation of Crospovidone (at 5%, w/w) and magnesium stearate (at 0.5%, w/w). Further testing of the models demonstrated that the 2-level models were as effective as the 5-level ones, which reduced the calibration sample number to 50. The models had a small bias for quantitation of acetaminophen (at 30%, w/w) and Prosolv (at 64.5%, w/w) in the blend. The implication of the bias is discussed. PMID:15848006

  12. Towards medicinal mechanochemistry: evolution of milling from pharmaceutical solid form screening to the synthesis of active pharmaceutical ingredients (APIs).

    PubMed

    Tan, Davin; Loots, Leigh; Friščić, Tomislav

    2016-06-14

    This overview highlights the emergent area of mechanochemical reactions for making active pharmaceutical ingredients (APIs), and covers the latest advances in the recently established area of mechanochemical screening and synthesis of pharmaceutical solid forms, specifically polymorphs, cocrystals, salts and salt cocrystals. We also provide an overview of the most recent developments in pharmaceutical uses of mechanochemistry, including real-time reaction monitoring, techniques for polymorph control and approaches for continuous manufacture using twin screw extrusion, and more. Most importantly, we show how the overlap of previously unrelated areas of mechanochemical screening for API solid forms, organic synthesis by milling, and mechanochemical screening for molecular recognition, enables the emergence of a new research discipline in which different aspects of pharmaceutical and medicinal chemistry are addressed through mechanochemistry rather than through conventional solution-based routes. The emergence of such medicinal mechanochemistry is likely to have a strong impact on future pharmaceutical and medicinal chemistry, as it offers not only access to materials and reactivity that are sometimes difficult or even impossible to access from solution, but can also provide a general answer to the demands of the pharmaceutical industry for cleaner, safer and efficient synthetic solutions. PMID:27185190

  13. The application of atomic absorption spectrometry for the determination of residual active pharmaceutical ingredients in cleaning validation samples.

    PubMed

    Bubnič, Zoran; Urleb, Uroš; Kreft, Katjuša; Veber, Marjan

    2011-03-01

    The objective of this work was the development and validation of atomic absorption spectrometric (AAS) methods for the determination of residual active pharmaceutical ingredients (API) in rinse samples for cleaning validation. AAS as an indirect method for the determination of API in rinse samples can be applied when it is in the form of salt with metal ions or when the metal ion is a part of the API's structure. The electrothermal AAS methods (aqueous and ethanol medium) for the determination of magnesium in esomeprazole magnesium and the flame AAS method for the determination of lithium in lithium carbonate in rinse samples were developed. Various combinations of solvents were tested and a combination of 1% aqueous or ethanol solution of nitric acid for esomeprazole magnesium and 0.1% aqueous solution of nitric acid for lithium carbonate were found to be the most suitable. The atomization conditions in the graphite furnace and in the flame were carefully studied to avoid losses of analyte and to achieve suitable sensitivity. The cleaning verification methods were validated with respect to accuracy, precision, linearity, limit of detection, and quantification. In all the cases, the limits of detection were at the microgram level. The methods were successfully applied for the determination of esomeprazole magnesium and lithium carbonate in rinse samples from cleaning procedures. PMID:20923390

  14. Supramolecular hydrogen-bonding patterns of co-crystals containing the active pharmaceutical ingredient (API) phloroglucinol and N-heterocycles.

    PubMed

    Cvetkovski, Aleksandar; Bertolasi, Valerio; Ferretti, Valeria

    2016-06-01

    The active pharmaceutical ingredient phloroglucinol (PHL) has been taken as an illustrative molecule to explore the intermolecular interactions which can be established with other molecular entities to build PHL pharmaceutical co-crystals. The crystal structures of five newly synthesized co-crystals are reported, where PHL is crystallized with N-heterocycles, namely 2-hydroxy-6-methylpyridine (1), 2,4-dimethyl-6-hydroxypyrimidine (2), 4-phenylpyridine (3), 2-hydroxypyridine (4) and 2,3,5,6-tetramethylpyrazine (5). The structural characteristics of these co-crystals, as far as the hydrogen-bonding networks and the crystalline architectures are concerned, are strongly dependent on the chemical features of the coformer molecules, as well as on their size and shape. A detailed analysis of the intermolecular interactions established in all the PHL co-crystals of known structures has allowed the recognition of some regularities in the packing modes that can be useful in the design of new supramolecular adducts forming predictable structural motifs. PMID:27240764

  15. Solubilization of active ingredients of different polarity in Pluronic® micellar solutions - Correlations between solubilizate polarity and solubilization site.

    PubMed

    Nguyen-Kim, Viet; Prévost, Sylvain; Seidel, Karsten; Maier, Walter; Marguerre, Ann-Kathrin; Oetter, Günter; Tadros, Tharwat; Gradzielski, Michael

    2016-09-01

    The solubilization of two pharmaceutically active ingredients (AI) with significantly different water solubility, namely carbamazepine and fenofibrate (solubility of 150ppm and 10ppm, respectively), has been investigated using a series of Pluronics® (Poloxamers) containing different ethylene oxide and propylene oxide (EO/PO) units in the molecule. The results show largely enhanced solubilization of fenofibrate by Pluronic® micelles that increases with the PPO chain length provided the temperature is above the critical micelle temperature (cmt). In contrast the more water-soluble carbamazepine only shows a moderate increase in solubilization upon addition of Pluronics®. Small angle neutron scattering (SANS) and pulsed field gradient (PFG) NMR experiments show that the solubilization of fenofibrate occurs in the core of the micelles, whereas carbamazepine shows no direct association with the micelles. These clearly different solubilization mechanisms for the two AIs were confirmed by Nuclear Overhauser Enhancement Spectroscopy (NOESY) experiments, which show that fenofibrate interacts only with the PPO core of the micelle, whereas carbamazepine interacts with both PPO and PEO similarly. Accordingly, the large enhancement of the solubilization of fenofibrate is related to the fact that it is solubilized within the PPO core of the Pluronic® micelles, while the much more moderate increase of carbamazepine solubility is attributed to the change of solvent quality due to the presence of the amphiphilic copolymer and the interaction with the EO and PO units in solution. PMID:27244594

  16. A Tape Method for Fast Characterization and Identification of Active Pharmaceutical Ingredients in the 2-18 THz Spectral Range

    NASA Astrophysics Data System (ADS)

    Kissi, Eric Ofosu; Bawuah, Prince; Silfsten, Pertti; Peiponen, Kai-Erik

    2015-03-01

    In order to find counterfeit drugs quickly and reliably, we have developed `tape method' a transmission spectroscopic terahertz (THz) measurement technique and compared it with a standard attenuated total reflection (ATR) THz spectroscopic measurement. We used well-known training samples, which include commercial paracetamol and aspirin tablets to check the validity of these two measurement techniques. In this study, the spectral features of some active pharmaceutical ingredients (APIs), such as aspirin and paracetamol are characterized for identification purpose. This work covers a wide THz spectral range namely, 2-18 THz. This proposed simple but novel technique, the tape method, was used for characterizing API and identifying their presence in their dosage forms. By comparing the spectra of the APIs to their dosage forms (powder samples), all distinct fingerprints present in the APIs are also present in their respective dosage forms. The positions of the spectral features obtained with the ATR techniques were akin to that obtained from the tape method. The ATR and the tape method therefore, complement each other. The presence of distinct fingerprints in this spectral range has highlighted the possibility of developing fast THz sensors for the screening of pharmaceuticals. It is worth noting that, the ATR method is applicable to flat faced tablets whereas the tape method is suitable for powders in general (e.g. curved surface tablets that require milling before measurement). Finally, we have demonstrated that ATR techniques can be used to screen counterfeit antimalarial tablets.

  17. Determination of platinum group metal catalyst residues in active pharmaceutical ingredients by means of total reflection X-ray spectrometry

    NASA Astrophysics Data System (ADS)

    Marguí, Eva; Queralt, Ignasi; Hidalgo, Manuela

    2013-08-01

    The control of metal catalyst residues (i.e., platinum group metals (PGMs)) in different stages of the manufacturing processes of the active pharmaceutical ingredients (APIs) and, especially, in the final product is crucial. For API specimens, there are strict guidelines to limit the levels of metal residues based on their individual levels of safety concern. For PGMs the concentration limit has been established at 10 mg/kg in the API. Therefore great effort is currently being devoted to the development of new and simple procedures to control metals in pharmaceuticals. In the present work, an analytical methodology based on benchtop total reflection X-ray fluorescence spectrometry (TXRF) has been developed for the rapid and simple determination of some PGM catalyst impurities (Rh, Pd, Ir and Pt) in different types of API samples. An evaluation of different sample treatments (dissolution and digestion of the solid pharmaceutical samples) has been carried out and the developed methodologies have been validated according to the analytical parameters to be considered and acceptance criteria for PGM determination according to the United States Pharmacopeia (USP). Limits of quantification obtained for PGM metals were in the range of 2-4 mg/kg which are satisfactory according to current legislation. From the obtained results it is shown that the developed TXRF method can be implemented in the pharmaceutical industries to increase productivity of the laboratory; offering an interesting and complementary analytical tool to other atomic spectroscopic methods.

  18. Contact Lenses Wettability In Vitro: Effect of Surface-Active Ingredients

    PubMed Central

    Lin, Meng C.; Svitova, Tatyana F.

    2010-01-01

    Purpose To investigate the release of surface-active agents (surfactants) from unworn soft contact lenses and their influence on the lens surface wettability in vitro. Methods Surface tension (ST) of blister pack solutions was measured by pendant-drop technique. STs at the air-aqueous interface and contact angles (CAs) of four conventional and seven silicone hydrogel (SiH) soft contact lenses (SCLs) were evaluated in a dynamic-cycling regime using a modified captive-bubble tensiometer-goniometer. Measurements were performed immediately after removal from blister packs, and after soaking in a glass vial filled with a surfactant-free solution, which was replaced daily for one week. Lens surface wettability was expressed as adhesion energy (AE) according to Young’s equation. Results STs of all blister pack solutions were lower than the reference ST of pure water (72.5 mN/m), indicating the presence of surfactants. When lenses were depleted of surfactants by soaking, the STs of all studied lenses and advancing CAs of selected lenses increased (p < 0.001). Receding CAs of all studied lenses were 12° ± 5° and were not affected by the presence of surfactants. For most of the conventional lenses, the surface wettability was largely dependent on surfactants, and reduced significantly after surfactant depletion. In contrast, most SiH lenses exhibited stable and self-sustained surface wettability in vitro. Conclusions The manufacturer-added surfactants affected wetting properties of all studied SCLs, although to different degrees. PMID:20400924

  19. Disk-driven hydromagnetic winds as a key ingredient of active galactic nuclei unification schemes

    NASA Technical Reports Server (NTRS)

    Konigl, Arieh; Kartje, John F.

    1994-01-01

    Centrifugally driven winds from the surfaces of magnetized accretion disks have been recognized as an attractive mechanism of removing the angular momentum of the accreted matter and of producing the bipolar outflows and jets that are often associated with compact astronomical objects. As previously suggested in the context of young stellar objects, such winds have unique observational manifestations stemming from their highly stratified density and velocity structure and from their exposure to the strong continuum radiation field of the compact object. We have applied this scenario to active galactic nuclei (AGNs) and investigated the properties of hydromagnetic outflows that originate within approximately 10(M(sub 8)) pc of the central 10(exp 8)(M(sub 8)) solar mass black hole. On the basis of our results, we propose that hydromagnetic disk-driven winds may underlie the classification of broad-line and narrow-line AGNs (e.g., the Seyfert 1/Seyfert 2 dichotomy) as well as the apparent dearth of luminous Seyfert 2 galaxies. More generally, we demonstrate that such winds could strongly influence the spectral characteristics of Seyfert galaxies, QSOs, and BL Lac objects (BLOs). In our picture, the torus is identified with the outer regions of the wind where dust uplifted from the disk surfaces by gas-grain collisions is embedded in the outflow. Using an efficient radiative transfer code, we show that the infrared emission of Seyfert galaxies and QSOs can be attributed to the reprocessing of the UV/soft X-ray AGN continuum by the dust in the wind and the disk. We demonstrate that the radiation pressure force flattens the dust distribution in objects with comparatively high (but possibly sub-Eddington) bolometric luminosities, and we propose this as one likely reason for the apparent paucity of narrow-line objects among certain high-luminosity AGNs. Using the XSTAR photoionization code, we show that the inner regions of the wind could naturally account for the warm

  20. Khaya grandifoliola C.DC: a potential source of active ingredients against hepatitis C virus in vitro.

    PubMed

    Galani, Borris Rosnay Tietcheu; Sahuc, Marie-Emmanuelle; Sass, Gabriele; Njayou, Frédéric Nico; Loscher, Christine; Mkounga, Pierre; Deloison, Gaspard; Brodin, Priscille; Rouillé, Yves; Tiegs, Gisa; Séron, Karin; Moundipa, Paul Fewou

    2016-05-01

    In this study, we examined the antiviral properties of Khaya grandifoliola C.DC (Meliaceae) on the hepatitis C virus (HCV) life cycle in vitro and identified some of the chemical constituents contained in the fraction with the most antiviral activity. Dried bark powder was extracted by maceration in a methylene chloride/methanol (MCM) system (50:50; v/v) and separated on silica gel by flash chromatography. Infection and replication rates in Huh-7 cells were investigated by luciferase reporter assay and indirect immunofluorescence assay using subgenomic replicons, HCV pseudotyped particles, and cell-culture-derived HCV (HCVcc), respectively. Cell viability was assessed by MTT assay, and cellular gene expression was analysed by qRT-PCR. The chemical composition of the fraction with the most antiviral activity was analysed by coupled gas chromatography and mass spectrometry (GC-MS). Five fractions of different polarities (F0-F100) were obtained from the MCM extract. One fraction (KgF25) showed the strongest antiviral effect on LucUbiNeoET replicons at nontoxic concentrations. Tested at 100 µg/mL, KgF25 had a high inhibitory effect on HCV replication, comparable to that of 0.01 µM daclatasvir or 1 µM telaprevir. This fraction also inhibited HCVcc infection by mostly targeting the entry step. KgF25 inhibited HCV entry in a pan-genotypic manner by directly inactivating free viral particles. Its antiviral effects were mediated by the transcriptional upregulation of the haem oxygenase-1 gene and interferon antiviral response. Three constituents, namely, benzene, 1,1'-(oxydiethylidene)bis (1), carbamic acid, (4-methylphenyl)-, 1-phenyl (2), and 6-phenyl, 4-(1'-oxyethylphenyl) hexene (3), were identified from the active fraction KgF25 by GC-MS. Khaya grandifoliola contains ingredients capable of acting on different steps of the HCV life cycle. PMID:26843184

  1. A Special Ingredient (VtR) Containing Oligostilbenes Isolated from Vitis thunbergii Prevents Bone Loss in Ovariectomized Mice: In Vitro and In Vivo Study

    PubMed Central

    Huang, Yu-Ling; Liu, Yen-Wenn; Huang, Yu-Jou; Chiou, Wen-Fei

    2013-01-01

    Vitis thunbergii is used in Taiwan as a botanical supplement for inflammatory bone diseases. This study aims to examine its direct effect on bone metabolism. Three-month-old female mice were randomly divided into ovariectomized control (OVX), sham operated (SHAM), and ovariectomy treated with either 17β-estradiol or a special ingredient (VtR) fractionated from an ethanol extract of V. thunbergii started two weeks after ovariectomy. VtR treatment for 8 weeks significantly ameliorated the deterioration of bone mineral density and reversed all the ovariectomy-induced changes in  μ-CT parameters. The antiosteoporotic effect of VtR accompanied decrease in serum levels of C-terminal telopeptides of type I collagen (CTx), interleukin-7, and ration of RANKL/osteoprotegerin (OPG) but rise in osteocalcin concentration. Sparse calcified microarchitecture and less alkaline-phosphatase- (ALP-) positive cells were observed at the femur and vertebral sites in OVX mice while VtR remarkably restored such variation. HPLC analysis showed (+)-vitisin-A, (−)-vitisin-B, and ampelopsin C predominated in VtR. Both (−)-vitisin B and ampelopsin C increased ALP activity and bone nodule formation in cultured osteoblasts. Instead of stimulating osteoblastogenesis, (+)-vitisin A dramatically repressed osteoclasts differentiation and bone resorption. The results suggested VtR composed of diverse components to reciprocally drive osteoblastogenesis and interdict osteoclastogenesis may serve as a potential botanic drug for osteoporosis therapy. PMID:23662133

  2. Electrochemical flow injection analysis of hydrazine in an excess of an active pharmaceutical ingredient: achieving pharmaceutical detection limits electrochemically.

    PubMed

    Channon, Robert B; Joseph, Maxim B; Bitziou, Eleni; Bristow, Anthony W T; Ray, Andrew D; Macpherson, Julie V

    2015-10-01

    The quantification of genotoxic impurities (GIs) such as hydrazine (HZ) is of critical importance in the pharmaceutical industry in order to uphold drug safety. HZ is a particularly intractable GI and its detection represents a significant technical challenge. Here, we present, for the first time, the use of electrochemical analysis to achieve the required detection limits by the pharmaceutical industry for the detection of HZ in the presence of a large excess of a common active pharmaceutical ingredient (API), acetaminophen (ACM) which itself is redox active, typical of many APIs. A flow injection analysis approach with electrochemical detection (FIA-EC) is utilized, in conjunction with a coplanar boron doped diamond (BDD) microband electrode, insulated in an insulating diamond platform for durability and integrated into a two piece flow cell. In order to separate the electrochemical signature for HZ such that it is not obscured by that of the ACM (present in excess), the BDD electrode is functionalized with Pt nanoparticles (NPs) to significantly shift the half wave potential for HZ oxidation to less positive potentials. Microstereolithography was used to fabricate flow cells with defined hydrodynamics which minimize dispersion of the analyte and optimize detection sensitivity. Importantly, the Pt NPs were shown to be stable under flow, and a limit of detection of 64.5 nM or 0.274 ppm for HZ with respect to the ACM, present in excess, was achieved. This represents the first electrochemical approach which surpasses the required detection limits set by the pharmaceutical industry for HZ detection in the presence of an API and paves the wave for online analysis and application to other GI and API systems. PMID:26302058

  3. The effects of UV-B radiation intensity on biochemical parameters and active ingredients in flowers of Qi chrysanthemum and Huai chrysanthemum.

    PubMed

    Yao, Xiao-Qin; Chu, Jian-Zhou; He, Xue-Li; Si, Chao

    2014-01-01

    The article studied UV-B effects on biochemical parameters and active ingredients in flowers of Qi chrysanthemum and Huai chrysanthemum during the bud stage. The experiment included four UV-B radiation levels (CK, ambient UV-B; T1, T2 and T3 indicated a 5%, 10% and 15% increase in ambient UV-BBE, respectively) to determine the optimal UV-B radiation intensity in regulating active ingredients level in flowers of two chrysanthemum varieties. Flower dry weight of two cultivars was not affected by UV-B radiation under experimental conditions reported here. UV-B treatments significantly increased the rate of superoxide radical production, hydrogen peroxide (H2O2) (except for T1) and malondialdehyde concentration in flowers of Huai chrysanthemum and H2O2 concentration in flowers of Qi chrysanthemum. T2 and T3 treatments induced a significant increase in phenylalanine ammonia lyase enzyme (PAL) activity, anthocyanins, proline, ascorbic acid, chlorogenic acid and flavone content in flowers of two chrysanthemum varieties, and there were no significant differences in PAL activity, ascorbic acid, flavone and chlorogenic acid content between the two treatments. These results indicated that appropriate UV-B radiation intensity did not result in the decrease in flower yield, and could regulate PAL activity and increase active ingredients content in flowers of two chrysanthemum varieties. PMID:25112378

  4. Active Inertial Vibration Isolators And Dampers

    NASA Technical Reports Server (NTRS)

    Laughlin, Darren; Blackburn, John; Smith, Dennis

    1994-01-01

    Report describes development of active inertial vibration isolators and dampers in which actuators electromagnet coils moving linearly within permanent magnetic fields in housings, somewhat as though massive, low-frequency voice coils in loudspeakers. Discusses principle of operation, electrical and mechanical considerations in design of actuators, characteristics of accelerometers, and frequency responses of control systems. Describes design and performance of one- and three-degree-of-freedom vibration-suppressing system based on concept.

  5. Effects of enhanced UV-B radiation on the nutritional and active ingredient contents during the floral development of medicinal chrysanthemum.

    PubMed

    Ma, Chun Hui; Chu, Jian Zhou; Shi, Xiao Fei; Liu, Cun Qi; Yao, Xiao Qin

    2016-05-01

    The paper mainly studied the effects of enhanced UV-B radiation on the nutritional and active ingredient contents during the floral development of medicinal chrysanthemum. The experiment included two levels of UV-B radiation (0 and 400μWcm(-2)). The contents of hydrogen peroxide (H2O2), anthocyanin, UV-B absorbing compounds, total chlorophyll and carotenoids, and the activities of phenylalanine ammonia lyase enzyme (PAL) and cinnamic acid-4-hydroxylase enzyme (C4H) in flowers significantly decreased with the floral development. However, the contents of soluble sugar, amino acid and total vitamin C in flowers significantly increased with the floral development. The contents of flavonoid and chlorogenic acid were significantly different in the four stages of floral development, and their highest contents were found in the bud stage (stage 2). In the four stages of floral development, enhanced UV-B radiation significantly increased the contents of H2O2, UV-B absorbing compounds, chlorophyll, carotenoids, soluble sugar, amino acid, vitamin C, flavonoid and chlorogenic acid, and the activities of PLA and C4H in flowers. The results indicated that the highest contents of active and nutrient ingredients in flowers were found not to be in the same developmental stages of flowers. Comprehensive analysis revealed that the best harvest stage of chrysanthemum flowers was between the bud stage and the young flower stage (stage 2 and stage 3), which could simultaneously gain the higher contents of active and nutritional ingredients in flowers. PMID:26985737

  6. Rosmarinus officinalis L. extract and some of its active ingredients as potential emulsion stabilizers: a new approach to the formation of multiple (W/O/W) emulsion.

    PubMed

    Cizauskaite, Ugne; Ivanauskas, Liudas; Jakštas, Valdas; Marksiene, Ruta; Jonaitiene, Laimute; Bernatoniene, Jurga

    2016-09-01

    Nowadays, novel topical formulations loaded with natural functional actives are under intense investigations. Therefore, the aim of our study was to evaluate how the rosemary extract and some of its active ingredients [rosmarinic acid (RA), ursolic acid (UA) and oleanolic acid (OA)] affect technological characteristics of multiple emulsion. Formulation has been prepared by adding investigated solutions (10%) in water/oil/water (W/O/W) multiple emulsion consisting of different lipophilic phases: olive oil and liquid paraffin, with 0.5% emulsifying agent (complex of sodium polyacrylate and polysorbate 20) under constant stirring with mechanical stirrer at room temperature. The emulsion parameters were evaluated using centrifugation test, freeze-thaw cycle test, microscopical and texture analyses. Rosemary's triterpenic saponins UA and OA showed the highest emulsion stabilizing properties: they decreased CI from 3.26% to 10.23% (p < 0.05). According to obtained interfacial tension data, the effect of rosemary active ingredients is not surfactant-like. Even though emulsifier itself at low concentration intends to form directly the multiple emulsion, the obtained results indicate that rosemary extract containing active ingredients does not only serve as functional cosmetic agent due to a number of biological activities, but also offer potential advantages as a stabilizer and an enhancer of W/O/W emulsions formation for dermopharmaceutical and cosmetic preparations. PMID:26000558

  7. Measurement of low amounts of amorphous content in hydrophobic active pharmaceutical ingredients with dynamic organic vapor sorption.

    PubMed

    Müller, Thorsten; Schiewe, Jörg; Smal, Rüdiger; Weiler, Claudius; Wolkenhauer, Markus; Steckel, Hartwig

    2015-05-01

    Today, a variety of devices for dry powder inhalers (DPIs) is available and many different formulations for optimized deposition in the lung are developed. However, during the production of powder inhalers, processing steps may induce changes to both, the carrier and active pharmaceutical ingredients (APIs). It is well known that standard pharmaceutical operations may lead to structural changes, crystal defects and amorphous regions. Especially operations such as milling, blending and even sieving generate these effects. These disorders may induce re-crystallization and particle size changes post-production which have a huge influence on drug delivery and product stability. In this study, pilot tests with a polar solvent (water) and hydrophilic drug (Salbutamol sulfate) were performed to receive a first impression on further possible implementation of hydrophobic samples with organic solvents. Thereafter, a reliable method for the accurate detection of low amounts of amorphous content is described up to a limit of quantification (LOQ) of 0.5% for a hydrophobic model API (Ciclesonide). The organic vapor sorption method which is a gravimetric method quantifies exactly these low amounts of amorphous content in the hydrophobic powder once the suitable solvent (isopropanol), the correct p/p0 value (0.1) and the exact temperature (25°C) have been found. Afterward it was possible to quantitate low amorphous amounts in jet-milled powders (0.5-17.0%). In summary, the data of the study led to a clearer understanding in what quantity amorphous parts were generated in single production steps and how variable these parts behave to fully crystalline material. Nevertheless it showed how difficult it was to re-crystallize hydrophobic material with water vapor over a short period. For the individual samples it was possible to determine the single humidity at which the material starts to re-crystallize, the behavior against different nonpolar solvents and the calculation of the

  8. Impact of alternative solid state forms and specific surface area of high-dose, hydrophilic active pharmaceutical ingredients on tabletability.

    PubMed

    Paluch, Krzysztof J; Tajber, Lidia; Corrigan, Owen I; Healy, Anne Marie

    2013-10-01

    In order to investigate the effect of using different solid state forms and specific surface area (TBET) of active pharmaceutical ingredients on tabletability and dissolution performance, the mono- and dihydrated crystalline forms of chlorothiazide sodium and chlorothiazide potassium (CTZK) salts were compared to alternative anhydrous and amorphous forms, as well as to amorphous microparticles of chlorothiazide sodium and potassium which were produced by spray drying and had a large specific surface area. The tablet hardness and tensile strength, porosity, and specific surface area of single-component, convex tablets prepared at different compression pressures were characterized. Results confirmed the complexity of the compressibility mechanisms. In general it may be concluded that factors such as solid-state form (crystalline vs amorphous), type of hydration (presence of interstitial molecules of water, dehydrates), or specific surface area of the material have a direct impact on the tabletability of the powder. It was observed that, for powders of the same solid state form, those with a larger specific surface area compacted well, and better than powders of a lower surface area, even at relatively low compression pressures. Compacts prepared at lower compression pressures from high surface area porous microparticles presented the shortest times to dissolve, when compared with compacts made of equivalent materials, which had to be compressed at higher compression pressures in order to obtain satisfactory compacts. Therefore, materials composed of nanoparticulate microparticles (NPMPs) may be considered as suitable for direct compaction and possibly for inclusion in tablet formulations as bulking agents, APIs, carriers, or binders due to their good compactibility performance. PMID:23961942

  9. Potential ecological footprints of active pharmaceutical ingredients: an examination of risk factors in low-, middle- and high-income countries

    PubMed Central

    Kookana, Rai S.; Williams, Mike; Boxall, Alistair B. A.; Larsson, D. G. Joakim; Gaw, Sally; Choi, Kyungho; Yamamoto, Hiroshi; Thatikonda, Shashidhar; Zhu, Yong-Guan; Carriquiriborde, Pedro

    2014-01-01

    Active pharmaceutical ingredients (APIs) can enter the natural environment during manufacture, use and/or disposal, and consequently public concern about their potential adverse impacts in the environment is growing. Despite the bulk of the human population living in Asia and Africa (mostly in low- or middle-income countries), limited work relating to research, development and regulations on APIs in the environment have so far been conducted in these regions. Also, the API manufacturing sector is gradually shifting to countries with lower production costs. This paper focuses mainly on APIs for human consumption and highlights key differences between the low-, middle- and high-income countries, covering factors such as population and demographics, manufacture, prescriptions, treatment, disposal and reuse of waste and wastewater. The striking differences in populations (both human and animal), urbanization, sewer connectivity and other factors have revealed that the environmental compartments receiving the bulk of API residues differ markedly between low- and high-income countries. High sewer connectivity in developed countries allows capture and treatment of the waste stream (point-source). However, in many low- or middle-income countries, sewerage connectivity is generally low and in some areas waste is collected predominantly in septic systems. Consequently, the diffuse-source impact, such as on groundwater from leaking septic systems or on land due to disposal of raw sewage or septage, may be of greater concern. A screening level assessment of potential burdens of APIs in urban and rural environments of countries representing low- and middle-income as well as high-income has been made. Implications for ecological risks of APIs used by humans in lower income countries are discussed. PMID:25405973

  10. Thermal, mechanical and drug release characteristics of an acrylic film using active pharmaceutical ingredient as non-traditional plasticizer.

    PubMed

    Wiranidchapong, Chutima; Kieongarm, Waraporn; Managit, Chittima; Phrompittayarat, Watoo

    2016-01-01

    The objective of this study was to investigate thermal and mechanical properties as well as in vitro drug release of Eudragit® RL (ERL) film using chlorpheniramine maleate (CPM) as either active pharmaceutical ingredient or non-traditional plasticizer. Differential scanning calorimeter was used to measure the glass transition temperature (Tg) of 0-100% w/w CPM in ERL physical mixture. Instron testing machine was used to investigate Young's modulus, tensile stress and tensile strain (%) of ERL film containing 20-60% w/w CPM. Finally, a Franz diffusion cell was used to study drug release from ERL films obtained from four formulations, i.e. CRHP0/0, CRHP0/5, CRHP2/0 and CRHP2/5. The Tg of ERL was decreased when the weight percentage of CPM increased. The reduction of the Tg could be described by Kwei equation, indicating the interaction between CPM and ERL. Modulus and tensile stress decreased whereas tensile strain (%) increased when weight percentage of CPM increased. The change of mechanical properties was associated with the reduction of the Tg when weight percentage of CPM increased. ERL films obtained from four formulations could release the drug in no less than 10 h. Cumulative amount of drug release per unit area of ERL film containing only CPM (CRHP0/0) was lower than those obtained from the formulations containing traditional plasticizer (CRHP0/5), surfactant (CRHP2/0) or both of them (CRHP2/5). The increase of drug release was a result of the increase of drug permeability through ERL film and drug solubility based on traditional plasticizer and surfactant, respectively. PMID:26133082

  11. Potential ecological footprints of active pharmaceutical ingredients: an examination of risk factors in low-, middle- and high-income countries.

    PubMed

    Kookana, Rai S; Williams, Mike; Boxall, Alistair B A; Larsson, D G Joakim; Gaw, Sally; Choi, Kyungho; Yamamoto, Hiroshi; Thatikonda, Shashidhar; Zhu, Yong-Guan; Carriquiriborde, Pedro

    2014-11-19

    Active pharmaceutical ingredients (APIs) can enter the natural environment during manufacture, use and/or disposal, and consequently public concern about their potential adverse impacts in the environment is growing. Despite the bulk of the human population living in Asia and Africa (mostly in low- or middle-income countries), limited work relating to research, development and regulations on APIs in the environment have so far been conducted in these regions. Also, the API manufacturing sector is gradually shifting to countries with lower production costs. This paper focuses mainly on APIs for human consumption and highlights key differences between the low-, middle- and high-income countries, covering factors such as population and demographics, manufacture, prescriptions, treatment, disposal and reuse of waste and wastewater. The striking differences in populations (both human and animal), urbanization, sewer connectivity and other factors have revealed that the environmental compartments receiving the bulk of API residues differ markedly between low- and high-income countries. High sewer connectivity in developed countries allows capture and treatment of the waste stream (point-source). However, in many low- or middle-income countries, sewerage connectivity is generally low and in some areas waste is collected predominantly in septic systems. Consequently, the diffuse-source impact, such as on groundwater from leaking septic systems or on land due to disposal of raw sewage or septage, may be of greater concern. A screening level assessment of potential burdens of APIs in urban and rural environments of countries representing low- and middle-income as well as high-income has been made. Implications for ecological risks of APIs used by humans in lower income countries are discussed. PMID:25405973

  12. Characterization of solid polymer dispersions of active pharmaceutical ingredients by 19F MAS NMR and factor analysis

    NASA Astrophysics Data System (ADS)

    Urbanova, Martina; Brus, Jiri; Sedenkova, Ivana; Policianova, Olivia; Kobera, Libor

    In this contribution the ability of 19F MAS NMR spectroscopy to probe structural variability of poorly water-soluble drugs formulated as solid dispersions in polymer matrices is discussed. The application potentiality of the proposed approach is demonstrated on a moderately sized active pharmaceutical ingredient (API, Atorvastatin) exhibiting extensive polymorphism. In this respect, a range of model systems with the API incorporated in the matrix of polvinylpyrrolidone (PVP) was prepared. The extent of mixing of both components was determined by T1(1H) and T1ρ(1H) relaxation experiments, and it was found that the API forms nanosized domains. Subsequently it was found out that the polymer matrix induces two kinds of changes in 19F MAS NMR spectra. At first, this is a high-frequency shift reaching 2-3 ppm which is independent on molecular structure of the API and which results from the long-range polarization of the electron cloud around 19F nucleus induced by electrostatic fields of the polymer matrix. At second, this is broadening of the signals and formation of shoulders reflecting changes in molecular arrangement of the API. To avoid misleading in the interpretation of the recorded 19F MAS NMR spectra, because both the contributions act simultaneously, we applied chemometric approach based on multivariate analysis. It is demonstrated that factor analysis of the recorded spectra can separate both these spectral contributions, and the subtle structural differences in the molecular arrangement of the API in the nanosized domains can be traced. In this way 19F MAS NMR spectra of both pure APIs and APIs in solid dispersions can be directly compared. The proposed strategy thus provides a powerful tool for the analysis of new formulations of fluorinated pharmaceutical substances in polymer matrices.

  13. 21 CFR 310.540 - Drug products containing active ingredients offered over-the-counter (OTC) for use as stomach...

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... offered over-the-counter (OTC) for use as stomach acidifiers. 310.540 Section 310.540 Food and Drugs FOOD... ingredients offered over-the-counter (OTC) for use as stomach acidifiers. (a) Betaine hydrochloride, glutamic...-counter (OTC) drug products for use as stomach acidifiers. Because of the lack of adequate data...

  14. 21 CFR 310.540 - Drug products containing active ingredients offered over-the-counter (OTC) for use as stomach...

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... offered over-the-counter (OTC) for use as stomach acidifiers. 310.540 Section 310.540 Food and Drugs FOOD... ingredients offered over-the-counter (OTC) for use as stomach acidifiers. (a) Betaine hydrochloride, glutamic...-counter (OTC) drug products for use as stomach acidifiers. Because of the lack of adequate data...

  15. 21 CFR 310.540 - Drug products containing active ingredients offered over-the-counter (OTC) for use as stomach...

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... offered over-the-counter (OTC) for use as stomach acidifiers. 310.540 Section 310.540 Food and Drugs FOOD... ingredients offered over-the-counter (OTC) for use as stomach acidifiers. (a) Betaine hydrochloride, glutamic...-counter (OTC) drug products for use as stomach acidifiers. Because of the lack of adequate data...

  16. 21 CFR 310.540 - Drug products containing active ingredients offered over-the-counter (OTC) for use as stomach...

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... offered over-the-counter (OTC) for use as stomach acidifiers. 310.540 Section 310.540 Food and Drugs FOOD... ingredients offered over-the-counter (OTC) for use as stomach acidifiers. (a) Betaine hydrochloride, glutamic...-counter (OTC) drug products for use as stomach acidifiers. Because of the lack of adequate data...

  17. 21 CFR 310.540 - Drug products containing active ingredients offered over-the-counter (OTC) for use as stomach...

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... offered over-the-counter (OTC) for use as stomach acidifiers. 310.540 Section 310.540 Food and Drugs FOOD... ingredients offered over-the-counter (OTC) for use as stomach acidifiers. (a) Betaine hydrochloride, glutamic...-counter (OTC) drug products for use as stomach acidifiers. Because of the lack of adequate data...

  18. 21 CFR 310.531 - Drug products containing active ingredients offered over-the-counter (OTC) for the treatment of...

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS FOR HUMAN USE NEW DRUGS..., petrolatum, phenol, pine tar, rosin, rosin cerate, sassafras oil, sulfur, thymol, triclosan, and zinc oxide... general recognition of the safety and effectiveness of these or any other ingredient for OTC use for...

  19. 21 CFR 310.531 - Drug products containing active ingredients offered over-the-counter (OTC) for the treatment of...

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS FOR HUMAN USE NEW DRUGS..., petrolatum, phenol, pine tar, rosin, rosin cerate, sassafras oil, sulfur, thymol, triclosan, and zinc oxide... general recognition of the safety and effectiveness of these or any other ingredient for OTC use for...

  20. 21 CFR 310.531 - Drug products containing active ingredients offered over-the-counter (OTC) for the treatment of...

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS FOR HUMAN USE NEW DRUGS..., petrolatum, phenol, pine tar, rosin, rosin cerate, sassafras oil, sulfur, thymol, triclosan, and zinc oxide... general recognition of the safety and effectiveness of these or any other ingredient for OTC use for...

  1. 21 CFR 310.531 - Drug products containing active ingredients offered over-the-counter (OTC) for the treatment of...

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS FOR HUMAN USE NEW DRUGS..., petrolatum, phenol, pine tar, rosin, rosin cerate, sassafras oil, sulfur, thymol, triclosan, and zinc oxide... general recognition of the safety and effectiveness of these or any other ingredient for OTC use for...

  2. Capillary-induced Homogenization of Matrix in Paper: A Powerful Approach for the Quantification of Active Pharmaceutical Ingredients Using Mass Spectrometry Imaging

    PubMed Central

    de Menezes, Maico; de Oliveira, Diogo Noin; Catharino, Rodrigo Ramos

    2016-01-01

    Herein we present a novel approach for the quantification of active pharmaceutical ingredients (APIs) using mass spectrometry imaging. This strategy uses a filter paper previously “eluted” with a MALDI matrix solution as a support for analyte application. Samples are submitted to mass spectrometry imaging (MSI) and quantification through characteristic fingerprints is ultimately performed. Results for the content of rosuvastatin from a known formulation are comparable to those obtained with a validated HPLC method. PMID:27439589

  3. Capillary-induced Homogenization of Matrix in Paper: A Powerful Approach for the Quantification of Active Pharmaceutical Ingredients Using Mass Spectrometry Imaging

    NASA Astrophysics Data System (ADS)

    de Menezes, Maico; de Oliveira, Diogo Noin; Catharino, Rodrigo Ramos

    2016-07-01

    Herein we present a novel approach for the quantification of active pharmaceutical ingredients (APIs) using mass spectrometry imaging. This strategy uses a filter paper previously “eluted” with a MALDI matrix solution as a support for analyte application. Samples are submitted to mass spectrometry imaging (MSI) and quantification through characteristic fingerprints is ultimately performed. Results for the content of rosuvastatin from a known formulation are comparable to those obtained with a validated HPLC method.

  4. Participant report of therapist-delivered active ingredients in a telephone-delivered brief motivational intervention predicts taking steps towards change

    PubMed Central

    Lee, Christina S.; Longabaugh, Richard; Baird, Janette; Streszak, Val; Nirenberg, Ted; Mello, Michael

    2015-01-01

    Objective Given the widespread potential for disseminating Motivational Interviewing (MI) through technology, the question of whether MI active ingredients are present when not delivered in person is critical to assure high treatment quality. The Participant Rating Form (PRF) was developed and used to evaluate therapist-delivered active ingredients in phone-delivered MI with hazardous drinking Emergency Department patients. Method A factor analysis of all PRFs completed after receiving one call (n=256) was conducted. Multiple regression analysis was used to examine whether PRF factors predicted a measure of motivation to change -- taking steps—at the second call (n=214). Results The majority of participants were male (65%), with a mean age of 32 years and with an average alcohol ASSIST (Alcohol, Smoking, and Substance Involvement Screening Test) score of 20.5 (SD = 7.1). Results of the factor analysis for the PRF revealed Relational (working collaboration) and Technical (MI behaviors) factors. After controlling for demographics, alcohol severity, and baseline readiness, the technical factor predicted self-report of increased taking steps towards change while the relational factor did not explain any additional variance. Conclusions Our study adds to the growing literature investigating patient perspectives of therapist skill as a source of information to better understand MI active ingredients. The PRF is a feasible instrument for measuring the patient’s experience of phone-based MI. Results indicate that MI active ingredients of change (relational and technical components) were present in the telephone intervention as hypothesized. Clinical Trial Registration # 01326169. PMID:26441490

  5. Capillary-induced Homogenization of Matrix in Paper: A Powerful Approach for the Quantification of Active Pharmaceutical Ingredients Using Mass Spectrometry Imaging.

    PubMed

    de Menezes, Maico; de Oliveira, Diogo Noin; Catharino, Rodrigo Ramos

    2016-01-01

    Herein we present a novel approach for the quantification of active pharmaceutical ingredients (APIs) using mass spectrometry imaging. This strategy uses a filter paper previously "eluted" with a MALDI matrix solution as a support for analyte application. Samples are submitted to mass spectrometry imaging (MSI) and quantification through characteristic fingerprints is ultimately performed. Results for the content of rosuvastatin from a known formulation are comparable to those obtained with a validated HPLC method. PMID:27439589

  6. p-Hydroxybenzyl Alcohol, an Active Phenolic Ingredient of Gastrodia elata, Reverses the Cycloheximide-Induced Memory Deficit by Activating the Adrenal Gland in Rats.

    PubMed

    Wu, Lung-Yuan; Chen, Wang-Chuan; Tsai, Fan-Shiu; Tsai, Chin-Chuan; Wu, Chi-Rei; Lin, Li-Wei

    2015-01-01

    The present study investigated the ameliorating effects of p-hydroxybenzyl alcohol (HBA), an active phenolic ingredient of Gastrodia elata, on cycloheximide (CXM)-induced impairment of passive avoidance response and clarified the role of adrenal glands on the effect of HBA in rats. An adrenalectomy (ADX) caused the memory deficit from 1 to 3 days after surgery. Administration of corticosterone (CORT) plus glucose completely recovered the memory deficit caused by ADX, and this effect was better than that of glucose or CORT alone. HBA ameliorated the memory deficit induced by CXM in sham and ADX rats, but ADX partially blocked it. Furthermore, plasma glucose, epinephrine and adrenal steroid levels of ADX rats significantly decreased. Sham rats who received HBA had an increase in plasma glucose and adrenal steroid levels. Therefore, we suggest that the reversal of CXM-induced memory deficit by HBA was partially dependent on adrenal glands through the increase of the levels of plasma adrenal steroids. PMID:26621444

  7. Non-Hodgkin Lymphoma and Occupational Exposure to Agricultural Pesticide Chemical Groups and Active Ingredients: A Systematic Review and Meta-Analysis

    PubMed Central

    Schinasi, Leah; Leon, Maria E.

    2014-01-01

    This paper describes results from a systematic review and a series of meta-analyses of nearly three decades worth of epidemiologic research on the relationship between non-Hodgkin lymphoma (NHL) and occupational exposure to agricultural pesticide active ingredients and chemical groups. Estimates of associations of NHL with 21 pesticide chemical groups and 80 active ingredients were extracted from 44 papers, all of which reported results from analyses of studies conducted in high-income countries. Random effects meta-analyses showed that phenoxy herbicides, carbamate insecticides, organophosphorus insecticides and the active ingredient lindane, an organochlorine insecticide, were positively associated with NHL. In a handful of papers, associations between pesticides and NHL subtypes were reported; B cell lymphoma was positively associated with phenoxy herbicides and the organophosphorus herbicide glyphosate. Diffuse large B-cell lymphoma was positively associated with phenoxy herbicide exposure. Despite compelling evidence that NHL is associated with certain chemicals, this review indicates the need for investigations of a larger variety of pesticides in more geographic areas, especially in low- and middle-income countries, which, despite producing a large portion of the world’s agriculture, were missing in the literature that were reviewed. PMID:24762670

  8. The simultaneous determination of active ingredients in cough-cold mixtures by isocratic reversed-phase ion-pair high-performance liquid chromatography.

    PubMed

    Lau, O W; Chan, K; Lau, Y K; Wong, W C

    1989-01-01

    A simple, rapid and accurate method for the simultaneous determination of active ingredients in cough-cold mixtures using isocratic reversed-phase ion-pair high-performance liquid chromatography has been developed. It involves the use of an octadecylsilane column as the stationary phase with methanol, water, tetrahydrofuran, phosphoric acid mixtures as mobile phase including sodium dioctylsulphosuccinate as the ion-pair agent. The pH of the mobile phase was adjusted to 4.6 by means of phosphoric acid and ammonium hydroxide solutions. The proposed method involves the simple dilution of the samples with the mobile phase and the addition of metoclopramide hydrochloride as the internal standard. The active ingredients under investigation were chlorpheniramine, codeine, diphenhydramine, ephedrine, ethylmorphine, phenylephrine, phenylpropanolamine and pholcodine, which exist as various combinations in cough-cold mixtures. The optimum composition of the mobile phase and the optimum flow rate were determined and are reported. The method was applied to the determination of active ingredients in seven commercially available cough-cold mixtures. PMID:2577452

  9. Lactose in dairy ingredients: Effect on processing and storage stability.

    PubMed

    Huppertz, Thom; Gazi, Inge

    2016-08-01

    Lactose is the main carbohydrate in the milk of most species. It is present in virtually all dry dairy ingredients, with levels ranging from <2% (e.g., caseinates, milk protein isolates) to 100% in lactose powders. The presence of lactose has a strong effect on ingredient processing and stability. Lactose can negatively influence powder properties and lead to undesirable effects, such as the stickiness of powder resulting in fouling during drying, or caking and related phenomena during storage. In addition, being a reducing carbohydrate, lactose can also participate in the Maillard reaction with free amino groups of proteins, peptides, and free AA. In this review, the influence of the presence (or absence) of lactose on physiochemical properties of dairy ingredients is reviewed, with particular emphasis on behavior during processing and storage. Particularly important features in this respect are whether lactose is in the (glassy) amorphous phase or in the crystalline phase, which is strongly affected by precrystallization conditions (e.g., in lactose, permeate, and whey powders) and by drying conditions. Furthermore, the moisture content and water activity of the ingredients are important parameters to consider, as they determine both mobility and reactivity, influencing Maillard reactions and concomitant browning, the crystallization of amorphous lactose during storage of dairy ingredients, glass transitions temperatures, and associated stickiness and caking phenomena. For the stickiness and caking, a crucial aspect to take into account is powder particle surface composition in relation to the bulk powder. Lactose is typically underrepresented at the powder surface, as a result of which deviations between observed lactose-induced caking and stickiness temperatures, and determined glass transition temperatures arise. By considering lactose as an integral part of ingredient composition along with all other compositional and environmental properties, lactose

  10. Active ingredients of ginger as potential candidates in the prevention and treatment of diseases via modulation of biological activities

    PubMed Central

    Rahmani, Arshad H; shabrmi, Fahad M Al; Aly, Salah M

    2014-01-01

    The current mode of treatment based on synthetic drugs is expensive and also causes genetic and metabolic alterations. However, safe and sound mode of treatment is needed to control the diseases development and progression. In this regards, medicinal plant and its constituents play an important role in diseases management via modulation of biological activities. Ginger, the rhizome of the Zingiber officinale, has shown therapeutic role in the health management since ancient time and considered as potential chemopreventive agent. Numerous studies based on clinical trials and animal model has shown that ginger and its constituents shows significant role in the prevention of diseases via modulation of genetic and metabolic activities. In this review, we focused on the therapeutics effects of ginger and its constituents in the diseases management, and its impact on genetic and metabolic activities. PMID:25057339

  11. "Natural" ingredients in cosmetic dermatology.

    PubMed

    Baumann, Leslie; Woolery-Lloyd, Heather; Friedman, Adam

    2009-06-01

    Recently, both clinical and bench research has begun to provide scientific validation for the use of certain botanical ingredients. Related findings regarding proposed biological mechanisms of action have translated into clinical practice. Botanical compounds for which dermatologic and cosmetic applications have emerged include: olive oil, chamomile, colloidal oatmeal, oat kernal extract, feverfew, acai berry, coffee berry, curcumin, green tea, pomegranate, licorice, paper mulberry, arbutin, and soy. Many of these botanical sources offer biologically active components that require further in vitro and in vivo investigation in order for us to properly educate ourselves, and our patients, regarding over-the-counter products based on these ingredients. PMID:19562883

  12. Litchi flavonoids: isolation, identification and biological activity.

    PubMed

    Li, Jiangrong; Jiang, Yueming

    2007-01-01

    The current status of the isolation, identification, biological activity, utilization and development prospects of flavonoids found in litchi fruit pericarp (LFP) tissues is reviewed. LFP tissues account for approximately 15% by weight of the whole fresh fruit and are comprised of significant amount of flavonoids. The major flavonoids in ripe LFP include flavonols and anthocyanins. The major flavanols in the LFP are reported to be procyanidin B4, procyanidin B2 and epicatechin, while cyanindin-3-rutinside, cyanidin-3-glucoside, quercetin-3-rutinosde and quercetin-3-glucoside are identified as the important anthocyanins. Litchi flavanols and anthocyanins exhibit good potential antioxidant activity. The hydroxyl radical and superoxide anion scavenging activities of procyanidin B2 are greater than those of procyanidin B4 and epicatechin, while epicatechin has the highest alpha,alpha-diphenyl-beta-picrylhydrazyl radical (DPPH*) scavenging activity. In addition to the antioxidant activity, LFP extract displays a dose- and time-dependent inhibitory effect on human breast cancer, which could be attributed, in part, to its inhibition of proliferation and induction of apoptosis in cancer cells through upregulation and down-regulation of multiple genes. Furthermore, various anticancer activities are observed for epicatechin, procyanidin B2, procyanidin B4 and the ethyl acetate fraction of LFP tissue extracts. Procyanidin B4 and the ethyl acetate fraction show a stronger inhibitory effect on HELF than MCF-7 proliferation, while epicatechin and procyanidin B2 have lower cytotoxicities towards MCF-7 and HELF than paclitaxel. It is therefore suggested that flavonoids from LFP might be potentially useful components for functional foods and/or anti-breast cancer drugs. PMID:17851427

  13. A survey of the syntheses of active pharmaceutical ingredients for antiretroviral drug combinations critical to access in emerging nations.

    PubMed

    Pinheiro, Eloan Dos Santos; Antunes, Octavio Augusto Ceva; Fortunak, Joseph M D

    2008-09-01

    irrelevant, except for "advanced salvage" drugs such as enfuvirtide. In resource-poor settings cost is a huge factor that limits drug access, resulting in high rates of new infection and subsequent mortality. IP coverage, where granted, can keep access prices for essential ARVs higher than would otherwise be the case. Large, innovator companies have made drugs available at prices very close to the cost of manufacturing for "lowest income" countries. Generic providers in India and elsewhere provide the largest supply of drugs for the developing world. The recent issuance of Voluntary and Compulsory Licenses (VLs, CLs) through the World Trade Organization's TRIP (Treaty Respecting Intellectual Property) provisions arguably contribute to bringing down access prices. The utilization of improved science, pooled purchasing and intelligent procurement practices all definitely contribute to access. This work surveys the production processes for several critical ARVs. These are discussed in terms of scale up, raw material/intermediates and active pharmaceutical ingredient (API) costs. In some cases new routes to APIs or critical intermediates are needed. Based on potential new chemistries, there are significant opportunities to reduce cost for a number of critical ARVs. PMID:18571246

  14. Active isolation of vibrations with adaptive structures

    NASA Technical Reports Server (NTRS)

    Guigou, C.; Fuller, C. R.; Wagstaff, P. R.

    1991-01-01

    Vibration transmission in structures is controlled by means of a technique which employs distributed arrays of piezoelectric transducers bonded to the supporting structure. Distributed PVDF piezoelectric strips are employed as error sensors, and a two-channel feedforward adaptive LMS algorithm is used for minimizing error signals and thereby controlling the structure. A harmonic force input excites a thick plate, and a receiving plate is configured with three pairs of piezoelectric actuators. Modal analyses are performed to determine the resonant frequencies of the system, and a scanning laser vibrometer is used to study the shape of the response of the receiving plate during excitation with and without the control algorithm. Efficient active isolation of the vibrations is achieved with modal suppression, and good control is noted in the on-resonance cases in which increased numbers of PVDF sensors and piezoelectric actuators are employed.

  15. [Antimicrobial activity of cefodizime against clinical isolates].

    PubMed

    Suzuki, Y; Ishihara, R; Ishii, Y; Nakazawa, A; Deguchi, K; Matsumoto, Y; Nishinari, C; Nakane, Y; Fukumoto, T

    1996-10-01

    In order to evaluate antimicrobial activity of cefodizime (CDZM), minimum inhibitory concentrations (MICs) of CDZM and control drugs were determined against clinical isolates collected from nation-wide medical institutions and in our laboratory from September to December of 1992 and from September to December of 1995. The results are summarized as follows: 1. Bacterial species with no or few strains resistant to CDZM included Streptococcus pyogenes, Haemophilus influenzae, Citrobacter koseri, Proteus mirabilis and Neisseria gonorrhoeae. The range of MIC values of CDZM against Klebsiella pneumoniae was spread. Other strains, Streptococcus pneumoniae, Moraxella subgenus Branhamella catarrhalis, Escherichia coli, Citrobacter freundii, Enterobacter spp., Serratia marcescens, Proteus vulgaris, Morganella morganii, Providencia spp., Peptostreptococcus spp. and Bacteroides fragilis group were resistant to cephems including CDZM. 2. The MIC90's of CDZM were 0.05 approximately 3.13 micrograms/ml against Streptococcus spp., H. influenzae, M. (B.) catarrhalis, E. coli, Klebsiella spp., P. mirabilis, N. gonorrhoeae and Peptostreptococcus spp. obtained in 1995 that were frequently found in daily treatment of infections. It appears that the effectiveness of CDZM was still relatively high against community-acquired infections. 3. Among H. influenzae isolates included imipenem (IPM)-resistant and norfloxacin (NFLX)-resistant strains. The MIC-range of CDZM against strains collected in 1995 including IPM-resistant and NFLX-resistant strains was < or = 0.025 approximately 0.1 microgram/ml, and MIC90 against these strains was 0.05 microgram/ml. CDZM showed strong antimicrobial activities against H. influenzae strains resistant to carbapenems and new-quinolones. PMID:8986558

  16. A Survey of Active Vibration Isolation Systems for Microgravity Applications

    NASA Technical Reports Server (NTRS)

    Grodsinsky, Carlos M.; Whorton, Mark S.

    2000-01-01

    In view of the utility of space vehicles as orbiting science laboratories, the need for vibration isolation systems for acceleration sensitive experiments has gained increasing visibility. To date, three active microgravity vibration isolation systems have successfully been demonstrated in flight. This paper provides a tutorial discussion of the microgravity vibration isolation problem including a description of the acceleration environment of the International Space Station and attenuation requirements as well as a comparison of the dynamics of passive isolation, active rack-level isolation, and active payload-level isolation. This paper also surveys the flight test results of the three demonstrated systems: Suppression of Transient Accelerations By Levitation (STABLE); the Microgravity Vibration Isolation Mount (MIM); and the Active Rack Isolation System (ARIS).

  17. Survey of Active Vibration Isolation Systems for Microgravity Applications

    NASA Technical Reports Server (NTRS)

    Grodsinsky, Carlos M.; Whorton, Mark S.

    2000-01-01

    In view of the utility of space vehicles as orbiting science laboratories, the need for vibration isolation systems for acceleration-sensitive experiments has gained increasing visibility. To date, three active microgravity vibration isolation systems have successfully been demonstrated in flight. A tutorial discussion of the microgravity vibration isolation problem, including a description of the acceleration environment of the International Space Station and attenuation requirements, as well as a comparison or the dynamics of passive isolation, active rack-level isolation, and active payload-level isolation is provided. The flight test results of the three demonstrated systems: suppression of transient accelerations by levitation, the microgravity vibration isolation mount, and the active rack isolation system are surveyed.

  18. Genotoxicity evaluation of the herbicide Garlon(®) and its active ingredient (triclopyr) in fish (Anguilla anguilla L.) using the comet assay.

    PubMed

    Guilherme, Sofia; Santos, Maria A; Gaivão, Isabel; Pacheco, Mário

    2015-09-01

    Triclopyr-based herbicides are broadly used worldwide for site preparation and forest vegetation management. Thus, following application, these agrochemicals can inadvertently reach the aquatic ecosystems. Garlon(®) is one of the most popular commercial denominations of this group of herbicides, considered as highly toxic to fish, even by its manufacturer. Although DNA is frequently regarded as a target of pesticide toxicity, the genotoxic potential of Garlon(®) to fish remains completely unknown. Hence, the main goal of this study was to evaluate the genotoxicity of Garlon(®) and its active ingredient (triclopyr), clarifying the underlying mechanisms. Therefore, the comet assay, implemented as the standard procedure, with an extra step involving DNA lesion-specific repair enzymes (formamidopyrimidine DNA glycosylase and endonuclease III), was used to identify DNA damage in blood cells of Anguilla anguilla L. Short-term exposures (1 and 3 days) to Garlon(®) and triclopyr were carried out, adopting environmentally realistic concentrations (67.6 and 270.5 µg L(-1) Garlon(®) and 30 and 120 µg L(-1) triclopyr). The results concerning the nonspecific DNA damage proved the risk of the herbicide Garlon(®) and its active ingredient triclopyr in both tested concentrations and exposure lengths. In addition, the higher genotoxic potential of the formulation, in comparison with the active ingredient, was demonstrated. When the additional breaks corresponding to net enzyme-sensitive sites were considered, none of the conditions revealed significant levels of oxidative damage. This identification of the genotoxic properties of triclopyr-based herbicides to fish highlights the need to develop less hazardous formulations, as well as the adoption of mitigation measures related to the application of these agrochemicals in the framework of forestry and agriculture sustainable management. PMID:24623388

  19. Homeopathy – what are the active ingredients? An exploratory study using the UK Medical Research Council's framework for the evaluation of complex interventions

    PubMed Central

    Thompson, Trevor DB; Weiss, Marjorie

    2006-01-01

    Background Research in homeopathy has traditionally addressed itself to defining the effectiveness of homeopathic potencies in comparison to placebo medication. There is now increasing awareness that the homeopathic consultation is in itself a therapeutic intervention working independently or synergistically with the prescribed remedy. Our objective was to identify and evalute potential "active ingredients" of the homeopathic approach as a whole, in a prospective formal case series, which draws on actual consultation data, and is based on the MRC framework for the evaluation of complex interventions. Methods Following on from a theoretical review of how homeopathic care might mediate its effects, 18 patients were prospectively recruited to a case series based at Bristol Homeopathic Hospital. Patients, who lived with one of three index conditions, were interviewed before and after a five visit "package of care". All consultations were recorded and transcribed verbatim. Additional data, including generic and condition-specific questionnaires, artwork and "significant other" reports were collected. Textual data was subject to thematic analysis and triangulated with other sources. Results We judged that around one third of patients had experienced a major improvement in their health over the study period, a third had some improvement and a third had no improvement. Putative active ingredients included the patients' "openness to the mind-body connection", consultational empathy, in-depth enquiry into bodily complaints, disclosure, the remedy matching process and, potentially, the homeopathic remedies themselves. Conclusion This study has has identified, using primary consultation and other data, a range of factors that might account for the effectiveness of homeopathic care. Some of these, such as empathy, are non-specific. Others, such as the remedy matching process, are specific to homeopathy. These findings counsel against the use of placebo-controlled RCT designs in

  20. Comparative analysis of the effects of locally used herbicides and their active ingredients on a wild-type wine Saccharomyces cerevisiae strain.

    PubMed

    Braconi, Daniela; Sotgiu, Michele; Millucci, Lia; Paffetti, Alessandro; Tasso, Flavia; Alisi, Chiara; Martini, Silvia; Rappuoli, Roberto; Lusini, Paola; Sprocati, Anna Rosa; Rossi, Claudio; Santucci, Annalisa

    2006-04-19

    Herbicides are released to the environment with potential ecotoxicological risks for mammals. Yeast is a good model to elucidate toxicity mechanisms. We investigated how three commercial herbicides (Proper Energy, Pointer, and Silglif) and their active ingredients (respectively, fenoxaprop-P-ethyl, tribenuron methyl, and glyphosate) can affect biological activities of an oenological Saccharomyces cerevisiae strain, which may be resident on grape vineyards of the same geographical areas where herbicides are used. The use of commercial grade herbicides employed in Italy allowed us to reproduce the same conditions applied in crops; at the same time, assaying pure single active compounds made it possible to compare the effects obtained with commercial formulations. Interestingly, we found that while pure active compounds affect cell growth and metabolism at a lower extent, commercial preparations have a significant major negative influence on yeast biology. PMID:16608247

  1. Atmospheric identification of active ingredients in over-the-counter pharmaceuticals and drugs of abuse by atmospheric pressure glow discharge mass spectrometry (APGD-MS).

    PubMed

    Brewer, Tim M; Verkouteren, Jennifer R

    2011-09-15

    Atmospheric pressure glow discharge mass spectrometry was used to characterize the active ingredients in pharmaceutical over-the-counter (OTC) drug formulations (Tylenol Allergy, Alka-Seltzer Plus Nighttime, Sudafed, Aleve and Mucinex DM) and drugs of abuse (crack cocaine, methamphetamine, MDMA (ecstasy) and hydrocodone). Material was desorbed and directly ionized under atmospheric conditions by allowing the substance to come in direct contact with the plasma followed by mass spectrometric detection. With this technique, controlled substances and OTC medications were readily distinguished from one another. Characteristic mass spectra were identified for the active ingredients in the OTC and drugs of abuse. Importantly, all drug compounds studied here, both OTC and illicit, demonstrated signals for either molecular ions or protonated molecules as well as fragmentation patterns that are readily identified in the National Institute of Standards and Technology (NIST) electron ionization (EI) mass spectral library. It is believed that this technique holds promise for forensic and law enforcement communities for real-time atmospheric analysis of drugs with database-searchable spectra of controlled substances. PMID:21818799

  2. Creation of a tablet database containing several active ingredients and prediction of their pharmaceutical characteristics based on ensemble artificial neural networks.

    PubMed

    Takagaki, Keisuke; Arai, Hiroaki; Takayama, Kozo

    2010-10-01

    A tablet database containing several active ingredients for a standard tablet formulation was created. Tablet tensile strength (TS) and disintegration time (DT) were measured before and after storage for 30 days at 40 degrees C and 75% relative humidity. An ensemble artificial neural network (EANN) was used to predict responses to differences in quantities of excipients and physical-chemical properties of active ingredients in tablets. Most classical neural networks involve a tedious trial and error approach, but EANNs automatically determine basal key parameters, which ensure that an optimal structure is rapidly obtained. We compared the predictive abilities of EANNs in which the following kinds of training algorithms were used: linear, radial basis function, general regression (GR), and multilayer perceptron. The GR EANN predicted pharmaceutical responses such as TS and DT most accurately, as evidenced by high correlation coefficients in a leave-some-out cross-validation procedure. When used in conjunction with a tablet database, the GR EANN is capable of identifying acceptable candidate tablet formulations. PMID:20310024

  3. The effect of microcrystalline cellulose crystallinity on the hydrophilic property of tablets and the hydrolysis of acetylsalicylic acid as active pharmaceutical ingredient inside tablets.

    PubMed

    Awa, Kimie; Shinzawa, Hideyuki; Ozaki, Yukihiro

    2015-08-01

    The crystal structures of active pharmaceutical ingredients and excipients should be strictly controlled because they influence pharmaceutical properties of products which cause the change in the quality or the bioavailability of the products. In this study, we investigated the effects of microcrystalline cellulose (MCC) crystallinity on the hydrophilic properties of tablets and the hydrolysis of active pharmaceutical ingredient, acetylsalicylic acid (ASA), inside tablets by using tablets containing 20% MCC as an excipient. Different levels of grinding were applied to MCC prior to tablet formulation, to intentionally cause structural variation in the MCC. The water penetration and moisture absorbability of the tablets increased with decreasing the crystallinity of MCC through higher level of grinding. More importantly, the hydrolysis of ASA inside tablets was also accelerated. These results indicate that the crystallinity of MCC has crucial effects on the pharmaceutical properties of tablets even when the tablets contain a relatively small amount of MCC. Therefore, controlling the crystal structure of excipients is important for controlling product qualities. PMID:25583304

  4. Pharmacokinetics and tissue distribution of five active ingredients of Eucommiae cortex in normal and ovariectomized mice by UHPLC-MS/MS.

    PubMed

    An, Jing; Hu, Fangdi; Wang, Changhong; Zhang, Zijia; Yang, Li; Wang, Zhengtao

    2016-09-01

    1. Pinoresinol di-O-β-d-glucopyranoside (PDG), geniposide (GE), geniposidic acid (GA), aucubin (AN) and chlorogenic acid (CA) are the representative active ingredients in Eucommiae cortex (EC), which may be estrogenic. 2. The ultra high-performance liquid chromatography/tandem mass spectrometry (UHPLC-MS/MS) method for simultaneous determination of the five ingredients showed good linearity, low limits of quantification and high extraction recoveries, as well as acceptable precision, accuracy and stability in mice plasma and tissue samples (liver, spleen, kidney and uterus). It was successfully applied to the comparative study on pharmacokinetics and tissue distribution of PDG, GE, GA, AN and CA between normal and ovariectomized (OVX) mice. 3. The results indicated that except CA, the plasma and tissue concentrations of PDG, GE, GA in OVX mice were all greater than those in normal mice. AN could only be detected in the plasma and liver homogenate of normal mice, which was poorly absorbed in OVX mice and low in other measured tissues. PDG, GE and GA seem to be better absorbed in OVX mice than in normal mice proved by the remarkable increased value of AUC0-∞ and Cmax. It is beneficial that PDG, GE, GA have better plasma absorption and tissue distribution in pathological state. PMID:27232980

  5. Organic Pesticide Ingredients

    MedlinePlus

    ... Control a pest Integrated Pest Management What are pesticides? Herbicides Disinfectants Fungicides Insecticides Natural and Biological Pesticides ... Other types of pesticides Disponible en español Organic Pesticide Ingredients Organic foods are not necessarily pesticide-free. ...

  6. A "Kanes's Dynamics" Model for the Active Rack Isolation System

    NASA Technical Reports Server (NTRS)

    Hampton, R. David; Beech, Geoffrey

    1999-01-01

    Many microgravity space-science experiments require vibratory acceleration levels unachievable without active isolation. The Boeing Corporation's Active Rack Isolation System (ARIS) employs a novel combination of magnetic actuation and mechanical linkages, to address these isolation requirements on the International Space Station (ISS). ARIS provides isolation at the rack (international Standard Payload Rack, or ISPR) level. Effective model-based vibration isolation requires (1) an appropriate isolation device, (2) an adequate dynamic (i.e., mathematical) model of that isolator, and (3) a suitable, corresponding controller. ARIS provides the ISS response to the first requirement. This paper presents one response to the second, in a state-space framework intended to facilitate an optimal-controls approach to the third. The authors use "Kane's Dynamics" to develop an state-space, analytical (algebraic) set of linearized equations of motion for ARIS.

  7. A "Kane's Dynamics" Model for the Active Rack Isolation System

    NASA Technical Reports Server (NTRS)

    Hampton, R. D.; Beech, G. S.; Rao, N. N. S.; Rupert, J. K.; Kim, Y. K.

    2001-01-01

    Many microgravity space science experiments require vibratory acceleration levels unachievable without active isolation. The Boeing Corporation's Active Rack Isolation System (ARIS) employs a novel combination of magnetic actuation and mechanical linkages to address these isolation requirements on the International Space Station (ISS). ARIS provides isolation at the rack (International Standard Payload Rack (ISPR)) level. Effective model-based vibration isolation requires: (1) an appropriate isolation device, (2) an adequate dynamic (i.e., mathematical) model of that isolator, and (3) a suitable, corresponding controller. ARIS provides the ISS response to the first requirement. This paper presents one response to the second, in a state space framework intended to facilitate an optimal-controls approach to the third. The authors use "Kane's Dynamics" to develop a state-space, analytical (algebraic) set of linearized equations of motion for ARIS.

  8. Activity of faropenem against resistant isolates of Streptococcus pneumoniae.

    PubMed

    Black, J A; Moland, E S; Chartrand, S A; Thomson, K S

    2001-01-01

    An in vitro study of the activity of 9 agents against 181 US pediatric isolates of Streptococcus pneumoniae identified imipenem and faropenem as the most active agents. Overall, faropenem was the most potent oral agent inhibiting 98% of isolates at 1 microg/mL. PMID:11687320

  9. Allergy to ingredients of vehicles.

    PubMed

    Hannuksela, M; Kousa, M; Pirilä, V

    1976-04-01

    Common ingredients of vehicles such as perfumes, antibacterial agents, emulsifiers and other surface active agents, propylene glycol, lanolin and wool alcohols were tested in eczema patients over a three-year period. Perfume allergy was detected in 3.6% of the cases, sensitivity to thiomersal in 2%, to sorbic acid in 0.8%, to parabens in only 0.3%, and to wool alcohols in 1.2%. Reactions to emulsifiers were seen over 1% of those tested. PMID:1037096

  10. Isolation, characterization, and NO inhibitory activities of sesquiterpenes from Blumea balsamifera.

    PubMed

    Xu, Jing; Jin, Da-qing; Liu, Cuizhou; Xie, Chunfeng; Guo, Yuanqiang; Fang, Lingzhi

    2012-08-15

    Blumea balsamifera belongs to the family Compositae, and its leaves have been used as a flavoring ingredient and a tea. A phytochemical investigation of the aerial parts of B. balsamifera led to the isolation of 10 new (1-10) and 1 known (11) sesquiterpenes. Their structures were elucidated on the basis of extensive one- and two-dimensional nuclear magnetic resonance (heteronuclear multiple-quantum coherence, heteronuclear multiple-bond correlation, (1)H-(1)H correlation spectroscopy, and nuclear Overhauser effect spectrometry) spectroscopic data analyses, and the structure of compound 1 was confirmed by X-ray crystallography. The inhibitory activities on lipopolysaccharide-induced NO production in murine microglial BV-2 cells of these sesquiterpenes were evaluated, and all of the compounds showed inhibitory effects. PMID:22823402

  11. Antimicrobial activity of endophytic fungi isolated from Swietenia macrophylla leaves.

    PubMed

    Ibrahim, Darah; Lee, Chong Chai; Sheh-Hong, Lim

    2014-02-01

    The endophytic fungi isolated from leaves of Swietenia macrophylla of different ages were examined for antimicrobial activity. The agar plug diffusion assay was used for primary screening, followed by the disc diffusion method. A total of 461 filamentous endophytic fungi were isolated and cultured to examine their antimicrobial properties. In the primary screen, 315 isolates (68.3%) exhibited activity against at least one of the test pathogenic microorganisms. The percentage of isolates exhibiting antimicrobial activity increased with leaf age. Endophytic fungal assemblages, as well as those isolates exhibiting antimicrobial properties appeared to increase with leaf age. The main antimicrobial compounds were produced extracellularly by the endophytic fungi. The results suggest that healthy leaves at older stages of growth can be a potential source for the isolation of endophytic fungi with antimicrobial properties. PMID:24689302

  12. Cell-Based Screening Identifies the Active Ingredients from Traditional Chinese Medicine Formula Shixiao San as the Inhibitors of Atherosclerotic Endothelial Dysfunction

    PubMed Central

    Wang, Xiaofan; Zhang, Ruowen; Gu, Liqiang; Zhang, Yuanyuan; Zhao, Xu; Bi, Kaishun; Chen, Xiaohui

    2015-01-01

    In this study, we performed a phenotypic screening in human endothelial cells exposed to oxidized low density lipoprotein (an in vitro model of atherosclerotic endothelial dysfunction) to identify the effective compounds in Shixiao San. After investigating the suitability and reliability of the cell-based screening method using atorvastatin as the positive control drug, this method was applied in screening Shixiao San and its extracts. The treatment of n-butanol fraction on endothelial cells exhibited stronger healing effects against oxidized low density lipoprotein-induced insult when compared with other fractions. Cell viability, the level of nitric oxide, endothelial nitric oxide synthase and endothelin-1 were measured, respectively. The assays revealed n-butanol fraction significantly elevated the survival ratio of impaired cells in culture. In parallel, n-butanol fraction exhibited the highest inhibition of inflammation. The generation of prostaglandin-2 and adhesion molecule (soluble intercellular adhesion molecule-1) was obviously declined. Furthermore, n-butanol fraction suppressed the production of reactive oxygen species and malondialdehyde, and restored the activity of superoxide dismutase. Compounds identification of the n-butanol fraction was carried out by ultra high liquid chromatography coupled to quadrupole time-of-flight tandem mass spectrometry. The active ingredients including quercetin-3-O-(2G-α-l-rhamnosyl)-rutinoside, quercetin-3-O-neohesperidoside, isorhamnetin-3-O-neohesperidoside and isorhamnetin-3-O-rutinoside revealed the ability of anti-atherosclerosis after exposing on endothelial cells. The current work illustrated the pharmacology effect of Shixiao San and clearly indicated the major active components in Shixiao San. More importantly, the proposed cell-based screening method might be particularly suitable for fast evaluating the anti-atherosclerosis efficacy of Traditional Chinese Medicines and screening out the interesting

  13. Fractionation of whey protein isolate with supercritical carbon dioxide to produce enriched alpha-lactalbumin and beta-lactoglobulin food ingredients

    Technology Transfer Automated Retrieval System (TEKTRAN)

    A potentially economical and environmentally friendly whey protein fractionation process was developed using supercritical carbon dioxide (SCO2) as an acid to produce enriched fractions of alpha-lactalbumin (a-LA) and beta-lactoglobulin (b-LG) from whey protein isolate. To prepare the fractions, so...

  14. Highly sensitive solid forms discrimination on the whole tablet of the active ingredients in quercetin dietary supplements by NMR crystallography approaches.

    PubMed

    Miclaus, Maria O; Filip, Xenia; Filip, Claudiu; Martin, Flavia A; Grosu, Ioana G

    2016-05-30

    Similarly to synthetic drugs, the exact crystalline form of active ingredients in solid formulations of dietary supplements may directly influence the dissolution rate, bioavailability, and stability of the final product, but this information is usually not provided by manufacturers. Working on the examples of two commercial quercetin dietary supplements a quick, reliable, and sensitive method is introduced for quercetin solid forms discrimination directly on the marketed products, without the need for prior sample preparation. It exploits the complementarity between solid-state Nuclear Magnetic Resonance (ss-NMR) and Powder X-Ray Diffraction (PXRD), which proved essential for performing a complete and accurate solid-state characterization of the two commercial products, and for obtaining new insights into the complex quercetin solid-forms landscape. The method can be readily generalized also to other dietary supplements based on bio-flavonoids/polyphenols. PMID:26970982

  15. Efficacy of attractive toxic sugar baits (ATSB) against Aedes albopictus with garlic oil encapsulated in beta-cyclodextrin as the active ingredient

    PubMed Central

    Junnila, Amy; Revay, Edita E.; Müller, Gunter C.; Kravchenko, Vasiliy; Qualls, Whitney A.; Xue, Rui-de; Allen, Sandra A.; Beier, John C.; Schlein, Yosef

    2016-01-01

    We tested the efficacy of attractive toxic sugar bait (ATSB) with garlic oil microencapsulated in beta-cyclodextrin as active ingredient against Aedes albopictus in suburban Haifa, Israel. Two three-acre gardens with high numbers of Ae. albopictus were selected for perimeter spray treatment with ATSB and ASB (bait containing no active ingredient). Baits were colored with food dye to verify feeding of the mosquitoes. The mosquito population was monitored by human landing catches and sweep net catches in the surrounding vegetation. Experiments lasted for 44 days. Treatment occurred on day 13. The mosquito population collapsed about 4 days after treatment and continued to drop steadily for 27 days until the end of the study. At the experimental site the average pre-treatment landing rate was 17.2 per 5 mins. Two days post-treatment, the landing rate dropped to 11.4, and continued to drop to an average of 2.6 during the following 26 days. During the same period, the control population was stable. Few sugar fed females (8–10%) approached a human bait and anthrone tests showed relatively small amounts of sugar within their crop/gut. Around 60–70 % of males caught near our human bait were sugar positive which may indicate that the males were feeding on sugar for mating related behavior. From the vegetation treated with the toxic bait, we recovered significantly fewer (about 10–14%) males and females stained by ATSB than at the ASB-treated control. This may indicate that the toxic baits alter the resting behavior of the poisoned mosquitoes within the vegetation. Almost no Ae. albopictus females (5.2 ± 1.4) approached human bait after treatment with ATSB. It therefore appears that microencapsulated garlic oil is an effective pesticide against Ae. albopictus when used in an ATSB system. PMID:26403337

  16. Efficacy of attractive toxic sugar baits (ATSB) against Aedes albopictus with garlic oil encapsulated in beta-cyclodextrin as the active ingredient.

    PubMed

    Junnila, Amy; Revay, Edita E; Müller, Gunter C; Kravchenko, Vasiliy; Qualls, Whitney A; Xue, Rui-de; Allen, Sandra A; Beier, John C; Schlein, Yosef

    2015-12-01

    We tested the efficacy of attractive toxic sugar bait (ATSB) with garlic oil microencapsulated in beta-cyclodextrin as active ingredient against Aedes albopictus in suburban Haifa, Israel. Two three-acre gardens with high numbers of Ae. albopictus were selected for perimeter spray treatment with ATSB and ASB (bait containing no active ingredient). Baits were colored with food dye to verify feeding of the mosquitoes. The mosquito population was monitored by human landing catches and sweep net catches in the surrounding vegetation. Experiments lasted for 44 days. Treatment occurred on day 13. The mosquito population collapsed about 4 days after treatment and continued to drop steadily for 27 days until the end of the study. At the experimental site the average pre-treatment landing rate was 17.2 per 5mins. Two days post-treatment, the landing rate dropped to 11.4, and continued to drop to an average of 2.6 during the following 26 days. During the same period, the control population was stable. Few sugar fed females (8-10%) approached a human bait and anthrone tests showed relatively small amounts of sugar within their crop/gut. Around 60-70 % of males caught near our human bait were sugar positive which may indicate that the males were feeding on sugar for mating related behavior. From the vegetation treated with the toxic bait, we recovered significantly fewer (about 10-14%) males and females stained by ATSB than at the ASB-treated control. This may indicate that the toxic baits alter the resting behavior of the poisoned mosquitoes within the vegetation. Almost no Ae. albopictus females (5.2±1.4) approached human bait after treatment with ATSB. It therefore appears that microencapsulated garlic oil is an effective pesticide against Ae. albopictus when used in an ATSB system. PMID:26403337

  17. Botanical ingredients in cosmeceuticals.

    PubMed

    Baumann, Leslie

    2007-11-01

    During the last 10 to 15 years, complementary and alternative medicine (CAM) has become increasingly popular in the US. Within this realm of health care, oral and topical herbal supplements have become some of the most frequently used alternative therapies. Most herbal supplements are based on, or include, several botanical ingredients with long histories of traditional or folk medicine usage. Among the numerous botanical ingredients available on the market today, several are believed to confer dermatologic benefits. This article will focus on a select group of botanical compounds, many of which have long traditions in Asian medicine, with potential or exhibited dermatologic applications, including curcumin, Ginkgo biloba, ginseng, silymarin, soy, and tea tree oil. Other botanical agents, such as arnica, bromelain, chamomile, pomegranate, caffeine, green tea, licorice, and resveratrol, are also briefly considered. Some of these ingredients have been incorporated into topical formulations. PMID:18038494

  18. 21 CFR 310.533 - Drug products containing active ingredients offered over-the-counter (OTC) for human use as an...

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... in cough-cold drug products. (a) Atropine sulfate, belladonna alkaloids, and belladonna alkaloids as... ingredient. The belladonna alkaloids, which contain atropine (d, dl hyoscyamine) and scopolamine (l- hyoscine... ingredients as an anticholinergic for cough-cold use. Belladonna alkaloids for inhalation use, as contained...

  19. 21 CFR 310.533 - Drug products containing active ingredients offered over-the-counter (OTC) for human use as an...

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... in cough-cold drug products. (a) Atropine sulfate, belladonna alkaloids, and belladonna alkaloids as... ingredient. The belladonna alkaloids, which contain atropine (d, dl hyoscyamine) and scopolamine (l- hyoscine... ingredients as an anticholinergic for cough-cold use. Belladonna alkaloids for inhalation use, as contained...

  20. 21 CFR 310.533 - Drug products containing active ingredients offered over-the-counter (OTC) for human use as an...

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... in cough-cold drug products. (a) Atropine sulfate, belladonna alkaloids, and belladonna alkaloids as... ingredient. The belladonna alkaloids, which contain atropine (d, dl hyoscyamine) and scopolamine (l- hyoscine... ingredients as an anticholinergic for cough-cold use. Belladonna alkaloids for inhalation use, as contained...

  1. 21 CFR 310.533 - Drug products containing active ingredients offered over-the-counter (OTC) for human use as an...

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... in cough-cold drug products. (a) Atropine sulfate, belladonna alkaloids, and belladonna alkaloids as... ingredient. The belladonna alkaloids, which contain atropine (d, dl hyoscyamine) and scopolamine (l- hyoscine... ingredients as an anticholinergic for cough-cold use. Belladonna alkaloids for inhalation use, as contained...

  2. 21 CFR 310.533 - Drug products containing active ingredients offered over-the-counter (OTC) for human use as an...

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... in cough-cold drug products. (a) Atropine sulfate, belladonna alkaloids, and belladonna alkaloids as... ingredient. The belladonna alkaloids, which contain atropine (d, dl hyoscyamine) and scopolamine (l- hyoscine... ingredients as an anticholinergic for cough-cold use. Belladonna alkaloids for inhalation use, as contained...

  3. Biochemical analyses of the antioxidative activity and chemical ingredients in eight different Allium alien monosomic addition lines.

    PubMed

    Yaguchi, Shigenori; Matsumoto, Misato; Date, Rie; Harada, Kazuki; Maeda, Toshimichi; Yamauchi, Naoki; Shigyo, Masayoshi

    2013-01-01

    We measured the antioxidant contents and antioxidative activities in eight Allium fistulosum-shallot monosomic addition lines (MAL; FF+1A-FF+8A). The high antioxidative activity lines (FF+2A and FF+6A) showed high polyphenol accumulation. These additional chromosomes (2A and 6A) would therefore have anonymous genes related to the upregulation of polyphenol production, the antioxidative activities consequently being increased in these MALs. PMID:24317054

  4. Anti-inflammatory Activity of Constituents Isolated from Aerial Part of Angelica acutiloba Kitagawa.

    PubMed

    Uto, Takuhiro; Tung, Nguyen Huu; Taniyama, Risa; Miyanowaki, Tosihide; Morinaga, Osamu; Shoyama, Yukihiro

    2015-12-01

    Recently, the resources of medicinal plants have been exhausting. The root of Angelica acutiloba is one of the most important ingredients in Japanese Kampo medicine for the treatment of gynecological diseases. In our search for alternative medicinal plant resources of the root of A. acutiloba, we found that its aerial part has the anti-inflammatory potency as well as the root. Phytochemical investigation of the aerial part resulted in the isolation of four compounds including a new dimeric phthalide, namely tokiaerialide (2), along with Z-ligustilide (1), falcarindiol (3), and bergaptol (4). Next, we investigated the in vitro anti-inflammatory activity of 1-4 in lipopolysaccharide-stimulated RAW264 macrophages. Among the isolated compounds, 1 exhibited the most potent inhibition against lipopolysaccharide-induced production of prostaglandin E2 , nitric oxide, and pro-inflammatory cytokines (interleukin-6 and tumor necrosis factor-α). Compounds 3 and 4 also inhibited all inflammatory mediators, but their inhibitory abilities were weaker than those of 1. Furthermore, 1, 3, and 4 strongly also induced heme oxygenase-1. These results suggest that 1, 3, and 4 potentially exert anti-inflammatory activity, and the aerial part of A. acutiloba may be considered to be a useful medicinal resource for inflammatory diseases. PMID:26463105

  5. Brooding and Pondering: Isolating the Active Ingredients of Depressive Rumination with Exploratory Factor Analysis and Structural Equation Modeling

    ERIC Educational Resources Information Center

    Armey, Michael F.; Fresco, David M.; Moore, Michael T.; Mennin, Douglas S.; Turk, Cynthia L.; Heimberg, Richard G.; Kecmanovic, Jelena; Alloy, Lauren B.

    2009-01-01

    Depressive rumination, as assessed by Nolen-Hoeksema's Response Styles Questionnaire (RSQ), predicts the onset, chronicity, and duration of depressed mood. However, some RSQ items contain depressive content and result in a heterogeneous factor structure. After the a priori elimination of items potentially confounded with depressed item content,…

  6. Structural and Immunological Activity Characterization of a Polysaccharide Isolated from Meretrix meretrix Linnaeus

    PubMed Central

    Li, Li; Li, Heng; Qian, Jianying; He, Yongfeng; Zheng, Jialin; Lu, Zhenming; Xu, Zhenghong; Shi, Jinsong

    2015-01-01

    Polysaccharides from marine clams perform various biological activities, whereas information on structure is scarce. Here, a water-soluble polysaccharide MMPX-B2 was isolated from Meretrix meretrix Linnaeus. The proposed structure was deduced through characterization and its immunological activity was investigated. MMPX-B2 consisted of d-glucose and d-galctose residues at a molar ratio of 3.51:1.00. The average molecular weight of MMPX-B2 was 510 kDa. This polysaccharide possessed a main chain of (1→4)-linked-α-d-glucopyranosyl residues, partially substituted at the C-6 position by a few terminal β-d-galactose residues or branched chains consisting of (1→3)-linked β-d-galactose residues. Preliminary immunological tests in vitro showed that MMPX-B2 could stimulate the murine macrophages to release various cytokines, and the structure-activity relationship was then established. The present study demonstrated the potential immunological activity of MMPX-B2, and provided references for studying the active ingredients in M. meretrix. PMID:26729136

  7. 40 CFR 180.940 - Tolerance exemptions for active and inert ingredients for use in antimicrobial formulations (Food...

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... (Tartrazine) (conforming to 21 CFR 74.705) 1934-21-0 None D-Gluconic acid, monosodium salt 527-07-1 When ready... exceed 66 ppm FD&C Yellow No. 5 (Tartrazine) (conforming to 21 CFR 74.705) 1934-21-0 None D-Gluconic acid... of active quaternary ammonium compound Silver ions resulting from the use of...

  8. 40 CFR 180.940 - Tolerance exemptions for active and inert ingredients for use in antimicrobial formulations (Food...

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... (Tartrazine) (conforming to 21 CFR 74.705) 1934-21-0 None D-Gluconic acid, monosodium salt 527-07-1 When ready... exceed 66 ppm FD&C Yellow No. 5 (Tartrazine) (conforming to 21 CFR 74.705) 1934-21-0 None D-Gluconic acid... of active quaternary ammonium compound Silver ions resulting from the use of...

  9. Effective Teachers for Students with Emotional/Behavioral Disorders: Active Ingredients Leading to Positive Teacher and Student Outcomes

    ERIC Educational Resources Information Center

    Conroy, Maureen A.; Sutherland, Kevin S.

    2012-01-01

    Teachers of students with emotional/behavioral disorders (E/BD) have varied skills and abilities. Within the field there are some teachers, who teach students with E/BD by actively engaging them in learning tasks and who have few behavior problems in comparison to other teachers, who struggle with classroom management. Many researchers have found…

  10. Antagonistic Activity of Lactobacillus Isolates against Salmonella typhi In Vitro

    PubMed Central

    Abdel-Daim, Amira; Hassouna, Nadia; Hafez, Mohamed; Ashor, Mohamed Seif Aldeen; Aboulwafa, Mohammad M.

    2013-01-01

    Background. Enteric fever is a global health problem, and rapidly developing resistance to various drugs makes the situation more alarming. The potential use of Lactobacillus to control typhoid fever represents a promising approach, as it may exert protective actions through various mechanisms. Methods. In this study, the probiotic potential and antagonistic activities of 32 Lactobacillus isolates against Salmonella typhi were evaluated. The antimicrobial activity of cell free supernatants of Lactobacillus isolates, interference of Lactobacillus isolates with the Salmonella adherence and invasion, cytoprotective effect of Lactobacillus isolates, and possibility of concurrent use of tested Lactobacillus isolates and antibiotics were evaluated by testing their susceptibilities to antimicrobial agents, and their oxygen tolerance was also examined. Results. The results revealed that twelve Lactobacillus isolates could protect against Salmonella typhi infection through interference with both its growth and its virulence properties, such as adherence, invasion, and cytotoxicity. These Lactobacillus isolates exhibited MIC values for ciprofloxacin higher than those of Salmonella typhi and oxygen tolerance and were identified as Lactobacillus plantarum. Conclusion. The tested Lactobacillus plantarum isolates can be introduced as potential novel candidates that have to be subjected for in vivo and application studies for treatment and control of typhoid fever. PMID:24191248

  11. 40 CFR 180.940 - Tolerance exemptions for active and inert ingredients for use in antimicrobial formulations (Food...

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... 1400 ppm FD&C Yellow No. 5 (Tartrazine) (conforming to 21 CFR 74.705) 1934-21-0 None D-Gluconic acid... 21 CFR 74.705) 1934-21-0 None D-Gluconic acid, monosodium salt 527-07-1 When ready for use, the end... compounds is not to exceed 400 ppm of active quaternary ammonium compound Silver ions resulting from the...

  12. Design of optimal solvent for extraction of bio–active ingredients from six varieties of Medicago sativa

    PubMed Central

    2012-01-01

    Background Extensive research has been performed worldwide and important evidences were collected to show the immense potential of plants used in various traditional therapeutic systems. The aim of this work is to investigate the different extracting solvents in terms of the influence of their polarity on the extracting ability of bioactive molecules (phenolic compounds) from the M. sativa flowers. Results The total phenolic content of samples was determined using the Folin Ciocalteu (FC) procedure and their antioxidant activity was assayed through in vitro radical decomposing activity using the radical DPPH° assay (IUPAC name for DPPH is (phenyl)–(2,4,6–trinitrophenyl) iminoazanium). The results showed that water was better than methanol and acetic acid for extracting bioactive compounds, in particular for total phenolic compounds from the flowers of alfalfa. The average content of bioactive molecules in methanol extract was 263.5±1.02 mg GAE/100g of dry weight lyophilized extract. The total phenolic content of the tested plant extracts was highly correlated with the radical decomposing activity. However, all extracts were free–radical inhibitors, but the water extract was more potent than the acetic and the methanol ones. The order of inhibitor effectiveness (expressed by IC50) proved to be: water extract (0.924mg/mL) > acetic acid extract (0.154mg/mL) > methanol (0.079mg/mL). The profiles of each extract (fingerprint) were characterized by FT–MIR spectroscopy. Conclusions The present study compares the fingerprint of different extracts of the M. sativa flowers, collected from the wild flora of Romania. The total phenolic content of the tested plant extracts was highly correlated with the radical decomposing activity. The dependence of the extract composition on the solvent polarity (acetic acid vs. methanol vs. water) was revealed by UV–VIS spectrometry and Infrared fingerprint. PMID:23098128

  13. Quantitative HPLC analysis of active pharmaceutical ingredients in syrup vehicle using centrifugal filter devices and determination of xanthan gum in syrup vehicle using rheometry.

    PubMed

    Chen, Yong; Tadey, Tanya; Hu, Mougang; Carr, Geoff; Guo, Junan

    2010-02-01

    Using rapid centrifugal filtration (active pharmaceutical ingradients of interest. Two model active pharmaceutical ingredients, L-arginine and amphotericin B, were quantitatively recovered from the diluted syrup vehicle after centrifugation with the filter devices. The reproducibility [% relative standard deviation (RSD), peak area] of the filtered samples was less than 0.5%. For amphotericin B samples. The linear range was 0.28 microg/mL to 28.2 microg/mL. The limit of detection was 0.06 microg/mL. The limit of quantification was 0.28 microg/mL. The viscosity of a syrup vehicle changed linearly with the concentration of xanthan gum. A method was thus developed to determine xanthan gum in the syrup vehicle. The accuracy was within 95.0% to 105.0% at different concentration levels. PMID:20109286

  14. Implementation of a nurse-led behaviour change intervention to support medication taking in type 2 diabetes: beyond hypothesised active ingredients (SAMS Consultation Study)

    PubMed Central

    2014-01-01

    Background Implementation of trial interventions is rarely assessed, despite its effects on findings. We assessed the implementation of a nurse-led intervention to facilitate medication adherence in type 2 diabetes (SAMS) in a trial against standard care in general practice. The intervention increased adherence, but not through the hypothesised psychological mechanism. This study aimed to develop a reliable coding frame for tape-recorded consultations, assessing both a priori hypothesised and potential active ingredients observed during implementation, and to describe the delivery and receipt of intervention and standard care components to understand how the intervention might have worked. Methods 211 patients were randomised to intervention or comparison groups and 194/211 consultations were tape-recorded. Practice nurses delivered standard care to all patients and motivational and action planning (implementation intention) techniques to intervention patients only. The coding frame was developed and piloted iteratively on selected tape recordings until a priori reliability thresholds were achieved. All tape-recorded consultations were coded and a random subsample double-coded. Results Nurse communication, nurse-patient relationship and patient responses were identified as potential active ingredients over and above the a priori hypothesised techniques. The coding frame proved reliable. Intervention and standard care were clearly differentiated. Nurse protocol adherence was good (M (SD) = 3.95 (0.91)) and competence of intervention delivery moderate (M (SD) = 3.15 (1.01)). Nurses frequently reinforced positive beliefs about taking medication (e.g., 65% for advantages) but rarely prompted problem solving of negative beliefs (e.g., 21% for barriers). Patients’ action plans were virtually identical to current routines. Nurses showed significantly less patient-centred communication with the intervention than comparison group. Conclusions It is feasible to

  15. Antimicrobial activity of a traditionally used complex essential oil distillate (Olbas(®) Tropfen) in comparison to its individual essential oil ingredients.

    PubMed

    Hamoud, Razan; Sporer, Frank; Reichling, Jürgen; Wink, Michael

    2012-08-15

    Plant extracts and essential oils have been widely studied and used as antimicrobial agents in the last decades. In our study we investigated the antimicrobial activities of Olbas(®) Tropfen (in the following named Olbas), a traditionally used complex essential oil distillate, in comparison to its individual essential oil ingredients. Olbas (10 g) consists of three major components such as peppermint oil (5.3 g), eucalyptus oil (2.1 g), and cajuput oil (2.1 g) and of two minor constituents like juniper berry oil (0.3 g) and wintergreen oil (0.2 g). The composition of Olbas and the five individual essential oils were characterized by GLC-MS. According to GLC-MS analysis 1,8-cineol is the main component of the complex essential oil distillate followed by menthol and menthone. The minimum inhibitory and minimum microbicidal concentrations of Olbas and each of the single essential oils were evaluated in 17 species/strains of bacteria and fungi. Time-kill assay was performed to compare the microbicidal activity of Olbas and peppermint oil during several time intervals. Olbas displayed a high antimicrobial activity against all test strains used in this study, among them antibiotic resistant MRSA (methicillin-resistant Staphylococcus aureus) and VRE (vancomycin-resistant Enterococcus). Its antimicrobial activity was comparable to that of peppermint oil which was the most potent one of all individual essential oils tested. In the time kill assay Olbas as well as peppermint oil demonstrated similar microbicidal activities. Based on its wide antimicrobial properties Olbas can be a useful agent for the treatment of uncomplicated infections of skin and respiratory tract. PMID:22739414

  16. Extraction and Separation of Active Ingredients in Schisandra chinensis (Turcz.) Baill and the Study of their Antifungal Effects

    PubMed Central

    Liu, Jun; Zhang, Jie; Guo, Wei; Xiao, Weilie; Yao, Yuncong

    2016-01-01

    Schisandra chinensis extracts (SEs) have traditionally been used as an oriental medicine for the treatment of various human diseases, however, their further application in the biocontrol of plant disease remains poorly understood. This study was conducted to develop eco-friendly botanical pesticides from extracts of S. chinensis and assess whether they could play a key role in plant disease defense. Concentrated active fractions (SE-I, SE-II, and SE-III) were obtained from S. chinensis via specific extraction and separation. Then, lignan-like substances, such as Schisanhenol B, were detected via High-Performance Liquid Chromatography-ElectroSpray Ionization-Mass Spectrometry (HPLC-ESI-MS) analyses of the active fractions. Moreover, the results from biological tests on colony growth inhibition and spore germination indicated that SE-I, SE-II, and SE-III could inhibit hyphal growth and spore generation of three important plant pathogenic fungi (Monilinia fructicola, Fusarium oxysporum, and Botryosphaeria dothidea). The study of the mechanisms of resistant fungi revealed that the oxidation resistance system, including reactive oxygen species (ROS), malondialdehyde (MDA), catalase (CAT), and superoxide dismutase (SOD), was activated. The expression of genes related to defense, such as pathogenesis-related protein (PR4), α-farnesene synthase (AFS), polyphenol oxidase (PPO), and phenylalanine ammonia lyase (PAL) were shown to be up-regulated after treatment with SEs, which suggested an increase in apple immunity and that fruits were induced to effectively defend against the infection of pathogenic fungi (B. dothidea). This study revealed that SEs and their lignans represent promising resources for the development of safe, effective, and multi-targeted agents against pathogenic fungi. PMID:27152614

  17. Perylenequinones: Isolation, Synthesis, and Biological Activity

    PubMed Central

    Mulrooey, Carol A.; O'Brien, Erin M.; Morgan, Barbara J.

    2013-01-01

    The perylenequinones are a novel class of natural products characterized by pentacyclic conjugated chromophore giving rise to photoactivity. Potentially useful light-activated biological activity, targeting protein kinase C (PKC), has been identified for several of the natural products. Recently discovered new members of this class of compound, as well as several related phenanthroperylenequinones, are reviewed. Natural product modifications that improve biological profiles, and avenues for the total synthesis of analogs, which are not available from the natural product series, are outlined. An overview of structure/function relationships is provided. PMID:24039544

  18. Antimetastatic activity isolated from Colocasia esculenta (taro).

    PubMed

    Kundu, Namita; Campbell, Patricia; Hampton, Brian; Lin, Chen-Yong; Ma, Xinrong; Ambulos, Nicholas; Zhao, X Frank; Goloubeva, Olga; Holt, Dawn; Fulton, Amy M

    2012-02-01

    Breast cancer mortality is primarily due to the occurrence of metastatic disease. We have identified a novel potential therapeutic agent derived from an edible root of the plant Colocasia esculenta, commonly known as taro, which has demonstrable activity in a preclinical model of metastatic breast cancer and that should have minimal toxicity. We have shown for the first time that a water-soluble extract of taro (TE) potently inhibits lung-colonizing ability and spontaneous metastasis from mammary gland-implanted tumors, in a murine model of highly metastatic estrogen receptor, progesterone receptor and Her-2/neu-negative breast cancer. TE modestly inhibits the proliferation of some, but not all, breast and prostate cancer cell lines. Morphological changes including cell rounding were observed. Tumor cell migration was completely blocked by TE. TE treatment also inhibited prostaglandin E2 (PGE2) synthesis and downregulated cyclooxygenase 1 and 2 mRNA expression. We purified the active compound(s) to near homogeneity with antimetastatic activity comparable with stock TE. The active compound with a native size of approximately 25 kDa contains two fragments of nearly equal size. The N-terminal amino acid sequencing of both fragments reveals that the active compound is highly related to three taro proteins: 12-kDa storage protein, tarin and taro lectin. All are similar in terms of amino acid sequence, posttranslational processing and all contain a carbohydrate-binding domain. This is the first report describing compound(s) derived from taro that potently and specifically inhibits tumor metastasis. PMID:21934603

  19. Ceftaroline versus isolates from animal bite wounds: comparative in vitro activities against 243 isolates, including 156 Pasteurella species isolates.

    PubMed

    Goldstein, Ellie J C; Citron, Diane M; Merriam, C Vreni; Tyrrell, Kerin L

    2012-12-01

    More than 5 million Americans are bitten by animals, usually dogs, annually. Bite patients comprise ∼1% of all patients who visit emergency departments (300,000/year), and approximately 10,000 require hospitalization and intravenous antibiotics. Ceftaroline is the bioactive component of the prodrug ceftaroline fosamil, which is FDA approved for the treatment of acute bacterial skin and skin structure infections (ABSSSIs), including those containing methicillin-resistant Staphylococcus aureus (MRSA). There are no in vitro data about the activity of ceftaroline against Pasteurella multocida subsp. multocida and Pasteurella multocida subsp. septica, other Pasteurella spp., or other bite wound isolates. We therefore studied the in vitro activity of ceftaroline against 243 animal bite isolates. MICs were determined using the broth microdilution method according to CLSI guidelines. Comparator drugs included cefazolin, ceftriaxone, ertapenem, ampicillin-sulbactam, azithromycin, doxycycline, and sulfamethoxazole-trimethoprim (SMX-TMP). Ceftaroline was the most active agent against all 5 Pasteurella species, including P. multocida subsp. multocida and P. multocida subsp. septica, with a maximum MIC of ≤0.008 μg/ml; more active than ceftriaxone and ertapenem (MIC(90)s, ≤0.015 μg/ml); and more active than cefazolin (MIC(90), 0.5 μg/ml) doxycycline (MIC(90), 0.125 μg/ml), azithromycin (MIC(90), 0.5 μg/ml), ampicillin-sulbactam (MIC(90), 0.125 μg/ml), and SMX-TMP (MIC(90), 0.125 μg/ml). Ceftaroline was also very active against all S. aureus isolates (MIC(90), 0.125 μg/ml) and other Staphylococcus and Streptococcus species, with a maximum MIC of 0.125 μg/ml against all bite isolates tested. Ceftaroline has potential clinical utility against infections involving P. multocida, other Pasteurella species, and aerobic Gram-positive isolates, including S. aureus. PMID:23027193

  20. Ceftaroline versus Isolates from Animal Bite Wounds: Comparative In Vitro Activities against 243 Isolates, Including 156 Pasteurella Species Isolates

    PubMed Central

    Citron, Diane M.; Merriam, C. Vreni; Tyrrell, Kerin L.

    2012-01-01

    More than 5 million Americans are bitten by animals, usually dogs, annually. Bite patients comprise ∼1% of all patients who visit emergency departments (300,000/year), and approximately 10,000 require hospitalization and intravenous antibiotics. Ceftaroline is the bioactive component of the prodrug ceftaroline fosamil, which is FDA approved for the treatment of acute bacterial skin and skin structure infections (ABSSSIs), including those containing methicillin-resistant Staphylococcus aureus (MRSA). There are no in vitro data about the activity of ceftaroline against Pasteurella multocida subsp. multocida and Pasteurella multocida subsp. septica, other Pasteurella spp., or other bite wound isolates. We therefore studied the in vitro activity of ceftaroline against 243 animal bite isolates. MICs were determined using the broth microdilution method according to CLSI guidelines. Comparator drugs included cefazolin, ceftriaxone, ertapenem, ampicillin-sulbactam, azithromycin, doxycycline, and sulfamethoxazole-trimethoprim (SMX-TMP). Ceftaroline was the most active agent against all 5 Pasteurella species, including P. multocida subsp. multocida and P. multocida subsp. septica, with a maximum MIC of ≤0.008 μg/ml; more active than ceftriaxone and ertapenem (MIC90s, ≤0.015 μg/ml); and more active than cefazolin (MIC90, 0.5 μg/ml) doxycycline (MIC90, 0.125 μg/ml), azithromycin (MIC90, 0.5 μg/ml), ampicillin-sulbactam (MIC90, 0.125 μg/ml), and SMX-TMP (MIC90, 0.125 μg/ml). Ceftaroline was also very active against all S. aureus isolates (MIC90, 0.125 μg/ml) and other Staphylococcus and Streptococcus species, with a maximum MIC of 0.125 μg/ml against all bite isolates tested. Ceftaroline has potential clinical utility against infections involving P. multocida, other Pasteurella species, and aerobic Gram-positive isolates, including S. aureus. PMID:23027193

  1. Active transmission isolation/rotor loads measurement system

    NASA Technical Reports Server (NTRS)

    Kenigsberg, I. J.; Defelice, J. J.

    1973-01-01

    Modifications were incorporated into a helicopter active transmission isolation system to provide the capability of utilizing the system as a rotor force measuring device. These included; (1) isolator redesign to improve operation and minimize friction, (2) installation of pressure transducers in each isolator, and (3) load cells in series with each torque restraint link. Full scale vibration tests performed during this study on a CH-53A helicopter airframe verified that these modifications do not degrade the systems wide band isolation characteristics. Bench tests performed on each isolator unit indicated that steady and transient loads can be measured to within 1 percent of applied load. Individual isolator vibratory load measurement accuracy was determined to be 4 percent. Load measurement accuracy was found to be independent of variations in all basic isolator operating characteristics. Full scale system load calibration tests on the CH-53A airframe established the feasibility of simultaneously providing wide band vibration isolation and accurate measurement of rotor loads. Principal rotor loads (lift, propulsive force, and torque) were measured to within 2 percent of applied load.

  2. Mugineic acid, active ingredient of wheat grass: an oral novel hexadentate iron chelator in iron overloaded diseases.

    PubMed

    Das, Priyabrata; Mukhopadhyay, Soma; Kumar Sarkar, Nirmal; Mandal, Suvra; Kar, Manoj; Mukhopadhyay, Ashis

    2016-09-01

    Iron chelation therapies are required for the treatment of iron overloaded patients; nonetheless, their side effects are also well known. We have evaluated iron-chelating activity of wheat grass extract (WHE) and its purified compound, mugineic acid in murine model with phenylhydrazine (PHZ) and dextran induced acute and chronic iron overload conditions. PHZ and dextran treatment induced acute and chronic iron overload condition in mice, respectively, as indicated by increased serum and tissue iron in both cases. Iron overload was also accompanied with haemosiderosis in tissues (liver and spleen). These PHZ and dextran -: treated mice were orally treated with either crude WHE or purified mugineic acid. The efficacy of mugineic acid and WHE was compared with the potent oral iron chelator ICL670 (Exjade). PHZ and dextran treatment followed by oral administration of WHE or mugineic acid significantly checked the rise of serum/plasma levels of iron as well as tissue iron and also, haemosiderosis in tissues. The results are highly comparable with known iron chelator ICL670. WHE and purified mugineic acid, both seem to have significant prospect to be the cheap, non-toxic, hexadentate and oral therapeutic agents to prevent or alleviate toxic iron overload in patients. PMID:27008864

  3. Comparison of reversed-phase/cation-exchange/anion-exchange trimodal stationary phases and their use in active pharmaceutical ingredient and counterion determinations.

    PubMed

    Liu, Xiaodong; Pohl, Christopher A

    2012-04-01

    This study involved three commercial reversed-phase (RP)/anion-exchange (AEX)/cation-exchange (CEX) trimodal columns, namely Acclaim Trinity P1 (Thermo Fisher Scientific), Obelisc R (SIELC Technologies) and Scherzo SM-C18 (Imtakt). Their chromatographic properties were compared in details with respect to hydrophobicity, anion-exchange capacity, cation-exchange capacity, and selectivity, by studying retention behavior dependency on organic solvent, buffer concentration and pH. It was found that their remarkably different column chemistries resulted in distinctive chromatography properties. Trinity P1 exhibited strong anion-exchange and cation-exchange interactions but low RP retention while Scherzo SM-C18 showed strong reversed-phase retention with little cation-exchange and anion-exchange capacities. For Obelisc R, its reversed-phase capacity was weaker than Scherzo SM-C18 but slightly higher than Trinity P1, and its ion-exchange retentions were between Trinity P1 and Scherzo SM-C18. In addition, their difference in selectivity was demonstrated by examples of determining the active pharmaceutical ingredient (API) and counterion of drug products. PMID:22209548

  4. The Spectroscopy Study of the Binding of an Active Ingredient of Dioscorea Species with Bovine Serum Albumin with or without Co2+ or Zn2+

    PubMed Central

    Bian, He-Dong; Huang, Fu-Ping; Yao, Di; Yu, Qing; Liang, Hong

    2014-01-01

    Diosgenin (DIO) is the active ingredient of Dioscorea species. The interaction of DIO with bovine serum albumin (BSA) was investigated through spectroscopic methods under simulated physiological conditions. The fluorescence quenching data revealed that the binding of DIO to BSA without or with Co2+ or Zn2+ was a static quenching process. The presence of Co2+ or Zn2+ both increased the static quenching constants KSV and the binding affinity for the BSA-DIO system. In the sight of the competitive experiment and the negative values of ΔH0 and ΔS0, DIO bound to site I of BSA mainly through the hydrogen bond and Van der Waals' force. In addition, the conformational changes of BSA were studied by Raman spectra, which revealed that the secondary structure of BSA and microenvironment of the aromatic residues were changed by DIO. The Raman spectra analysis indicated that the changes of conformations, disulfide bridges, and the microenvironment of Tyr, Trp residues of BSA induced by DIO with Co2+ or Zn2+ were different from that without Co2+ or Zn2+. PMID:24991225

  5. Investigation of solubilising effects of bile salts on an active pharmaceutical ingredient with unusual pH dependent solubility by NMR spectroscopy.

    PubMed

    Vogtherr, M; Marx, A; Mieden, A-C; Saal, C

    2015-05-01

    The interaction between an ampholytic and amphiphilic Active Pharmaceutical Ingredient (API) showing unusual pH dependent solubility and Fasted State Simulated Intestinal Fluid (FaSSIF) was studied by NMR spectroscopy. Solubility in FaSSIF was drastically increased, about 30 fold, compared to simulated gastrointestinal fluid without bile salts. Our studies aimed at understanding the mechanisms that lead to this drastic enhancement. All species present in solution at various concentrations of API were characterised by Diffusion Ordered Spectroscopy (DOSY) NMR measurements. These indicated the presence of mixed taurocholate-lecithin and pure taurocholate micelles in pure FaSSIF, and formation of mixed taurocholate-API micelles after addition of API. The formation of taurocholate-API micelles was also supported by Nuclear Overhauser Effect/Enhancement (NOE) contacts between taurocholate and the API. Formation of mixed taurocholate-API micelles took place at the expense of pure taurocholate micelles, whereas mixed taurocholate-lecithin micelles remained uninfluenced by the presence of API. Our results showed that the increase in solubility was due to similar amphiphilic properties of the API and taurocholate which enabled formation of mixed taurocholate-API micelles. From results of determination of solubility as well as NMR experiments a phase diagram comprising several micellar species was derived. PMID:25720817

  6. Isotopic finger-printing of active pharmaceutical ingredients by 13C NMR and polarization transfer techniques as a tool to fight against counterfeiting.

    PubMed

    Bussy, Ugo; Thibaudeau, Christophe; Thomas, Freddy; Desmurs, Jean-Roger; Jamin, Eric; Remaud, Gérald S; Silvestre, Virginie; Akoka, Serge

    2011-09-30

    The robustness of adiabatic polarization transfer methods has been evaluated for determining the carbon isotopic finger-printing of active pharmaceutical ingredients. The short time stabilities of the adiabatic DEPT and INEPT sequences are very close to that observed with the one pulse sequence, but the DEPT long time stability is not sufficient for isotopic measurements at natural abundance or low enrichment. Using the INEPT sequence for (13)C isotopic measurements induces a dramatic reduction in the experimental time without deterioration in short time or long time stability. It appears, therefore, to be a method of choice for obtaining the isotopic finger-print of different ibuprofen samples in a minimum time. The results obtained on 13 commercial ibuprofen samples from different origins show that this strategy can be used effectively to determine (13)C distribution within a given molecule and to compare accurately differences in the isotopic distribution between different samples of the given molecule. The present methodology is proposed as a suitable tool to fight against counterfeiting. PMID:21872037

  7. Completeness assessment of type II active pharmaceutical ingredient drug master files under generic drug user fee amendment: review metrics and common incomplete items.

    PubMed

    Zhang, Huyi; Li, Haitao; Song, Wei; Shen, Diandian; Skanchy, David; Shen, Kun; Lionberger, Robert A; Rosencrance, Susan M; Yu, Lawrence X

    2014-09-01

    Under the Generic Drug User Fee Amendments (GDUFA) of 2012, Type II active pharmaceutical ingredient (API) drug master files (DMFs) must pay a user fee and pass a Completeness Assessment (CA) before they can be referenced in an Abbreviated New Drug Application (ANDA), ANDA amendment, or ANDA prior approval supplement (PAS). During the first year of GDUFA implementation, from October 1, 2012 to September 30, 2013, approximately 1,500 Type II API DMFs received at least one cycle of CA review and more than 1,100 Type II DMFs were deemed complete and published on FDA's "Available for Reference List". The data from CA reviews were analyzed for factors that influenced the CA review process and metrics, as well as the areas of DMF submissions which most frequently led to an incomplete CA status. The metrics analysis revealed that electronic DMFs appear to improve the completeness of submission and shorten both the review and response times. Utilizing the CA checklist to compile and proactively update the DMFs improves the chance for the DMFs to pass the CA in the first cycle. However, given that the majority of DMFs require at least two cycles of CA before being deemed complete, it is recommended that DMF fees are paid 6 months in advance of the ANDA submissions in order to avoid negatively impacting the filling status of the ANDAs. PMID:25034968

  8. Simultaneous determination of active ingredients in ethnomedicine Gaultheria leucocarpa var. yunnanensis and its medicinal preparation by capillary electrophoresis with electrochemical detection.

    PubMed

    Zeng, Yikun; Tang, Zhuxing; Wang, Qingjiang; He, Pingang; Fang, Yuzhi

    2007-10-01

    A simple and rapid capillary electrophoresis (CE) with electrcochemical detection (ED) method has been established for the simultaneous determination of seven active ingredients in the stems and roots of Gaultheria leucocarpa var. yunnanensis and its medicinal preparation, including (+)-catechin, rutin, gentisic acid, vallinic acid, salicylic acid, quercetin, and protocatechuic acid. The effects of working potential, pH, and concentration of running buffer, separation voltage, and injection time on CE-ED are systematically investigated. Under the optimum conditions, the seven analytes could be completely separated within 23 min in a borax running buffer (pH 8.7). A good linear relationship is obtained over three orders of magnitude with detection limits (signal-to-noise ratio=3) ranging from 5x10(-8) g/mL to 3x10(-7) g/mL for the analytes. The proposed method is successfully used in the analysis of real samples after a relatively simple extraction procedure, and the assay results are satisfactory. PMID:17988450

  9. Action of the insect growth regulator fluazuron, the active ingredient of the acaricide Acatak®, in Rhipicephalus sanguineus nymphs (Latreille, 1806) (Acari: Ixodidae).

    PubMed

    Calligaris, Izabela Braggião; De Oliveira, Patricia Rosa; Roma, Gislaine Cristina; Bechara, Gervásio Henrique; Camargo-Mathias, Maria Izabel

    2013-11-01

    The present study evaluated the efficacy of fluazuron (active ingredient of the acaricide Acatak®) and its effects on Rhipicephalus sanguineus nymphs fed on rabbits exposed to different doses of this insect growth regulator. Three different doses of fluazuron (20 mg/kg, 40 mg/kg, and 80 mg/kg) were applied on the back of hosts (via "pour on"), while distilled water was applied to the Control group. On the first day of treatment with fluazuron (24 h), hosts were artificially infested with R. sanguineus nymphs. Once fully engorged, nymphs were removed and placed in identified Petri dishes in Biochemical Oxygen Demand (BOD) incubator for 7 days. After this period, engorged nymphs were processed for ultramorphological analysis. The results revealed alterations in the ultramorphology of many chitinous structures (smaller hypostome and chelicerae, less sclerotized scutum, fewer sensilla, fewer pores, absence of grooves, marginal and cervical strips and festoons in the body, even the anal plaque was damaged) that play essential roles for the survivor of ticks and that can compromise the total or partial development of nymphs and emergence of adults after periodic molting. Our findings confirm the efficacy of fluazuron, a more specific and less aggressive chemical to the environment and human health, and that does not induce resistance, in nymphs of the tick R. sanguineus in artificially infested rabbits treated with this arthropod growth regulator (AGR), indicating that it could be used in the control of this stage of the biological cycle of the tick R. sanguineus. PMID:24000046

  10. Quantitative analysis of biologically active ingredients of Five Seeds Combo by liquid chromatography-quadrupole time-of-flight mass spectrometry for quality control of commercial herbal product.

    PubMed

    Chen, Meng-Li; Miao, Lan; Cao, Jin; Ip, Siu-Po; Che, Chun-Tao

    2012-07-01

    Five Seeds Combo (wu zi yan zong wan) is a traditional Chinese herbal formula composed of fructus Lycii, semen Cuscutae, fructus Rubi, semen Plantaginis, and fructus Schisandrae. This herbal prescription has been developed into herbal products by many pharmaceutical manufacturers for treating age-related symptoms. The present study aims to develop an analytical method for the quality control of this herbal drug. Nine active ingredients including schisantherin A, schisandrin B, schisandrin, schisandrin A, quercitrin, betaine, verbascoside, hyperoside, and kaempferol were selected as the targeted analytes for the analysis. By using liquid chromatogram/quadrupole time-of-flight mass spectrometry (MS), the nine chemical compounds were determined simultaneously from the chromatogram. The parameters for MS were optimized by orthogonal array testing and the best condition of the MS for the determination of the nine marker compounds was found to be 175, 75, and 700 V for fragmentor, skimmer, and voltage of capillary, respectively. The method validation showed that this analytical method had high precision and sensitivity (limit of quantitation was smaller than 10 ng/mL for most of the analytes). The method was found to be able to demonstrate the quality of Five Seeds Combo from different manufacturers. PMID:22761139

  11. Attractive Toxic Sugar Baits: Control of Mosquitoes With the Low-Risk Active Ingredient Dinotefuran and Potential Impacts on Nontarget Organisms in Morocco

    PubMed Central

    Khallaayoune, Khalid; Qualls, Whitney A.; Revay, Edita E.; Allan, Sandra A.; Arheart, Kristopher L.; Kravchenko, Vasiliy D.; Xue, Rui-De; Schlein, Yosef; Beier, John C.; Müller, Günter C.

    2014-01-01

    We evaluated the efficacy of attractive toxic sugar baits (ATSB) in the laboratory and field with the low-risk active ingredient dinotefuran against mosquito populations. Preliminary laboratory assays indicated that dinotefuran in solution with the sugar baits was ingested and resulted in high mortality of female Culex quinquefasciatus Say and Aedes aegypti Linnaeus. Field studies demonstrated >70% reduction of mosquito populations at 3 wk post-ATSB application. Nontarget feeding of seven insect orders—Hymenoptera, Lepidoptera, Coleoptera, Diptera, Hemiptera, Orthoptera, and Neuroptera—was evaluated in the field after application of attractive sugar baits (ASB) on vegetation by dissecting the guts and searching for food dye with a dissecting microscope. Nontargets were found stained with ASB 0.9% of the time when the application was applied on green nonflowering vegetation. Only two families were significantly impacted by the ASB application: Culicidae (mosquitoes) and Chironomidae (nonbiting midges) of the order Diptera. Pollinators of the other insect orders were not significantly impacted. No mortality was observed in the laboratory studies with predatory nontargets, wolf spiders or ground beetles, after feeding for 3 d on mosquitoes engorged on ATSB applied to vegetation. Overall, this novel control strategy had little impact on nontarget organisms, including pollinators and beneficial insects, and was effective at controlling mosquito populations, further supporting the development of ATSB for commercial use. PMID:24331613

  12. Isolation of biologically active nanomaterial (inclusion bodies) from bacterial cells

    PubMed Central

    2010-01-01

    Background In recent years bacterial inclusion bodies (IBs) were recognised as highly pure deposits of active proteins inside bacterial cells. Such active nanoparticles are very interesting for further downstream protein isolation, as well as for many other applications in nanomedicine, cosmetic, chemical and pharmaceutical industry. To prepare large quantities of a high quality product, the whole bioprocess has to be optimised. This includes not only the cultivation of the bacterial culture, but also the isolation step itself, which can be of critical importance for the production process. To determine the most appropriate method for the isolation of biologically active nanoparticles, three methods for bacterial cell disruption were analyzed. Results In this study, enzymatic lysis and two mechanical methods, high-pressure homogenization and sonication, were compared. During enzymatic lysis the enzyme lysozyme was found to attach to the surface of IBs, and it could not be removed by simple washing. As this represents an additional impurity in the engineered nanoparticles, we concluded that enzymatic lysis is not the most suitable method for IBs isolation. During sonication proteins are released (lost) from the surface of IBs and thus the surface of IBs appears more porous when compared to the other two methods. We also found that the acoustic output power needed to isolate the IBs from bacterial cells actually damages proteins structures, thereby causing a reduction in biological activity. High-pressure homogenization also caused some damage to IBs, however the protein loss from the IBs was negligible. Furthermore, homogenization had no side-effects on protein biological activity. Conclusions The study shows that among the three methods tested, homogenization is the most appropriate method for the isolation of active nanoparticles from bacterial cells. PMID:20831775

  13. Altered Gene Expression in the Schistosome-Transmitting Snail Biomphalaria glabrata following Exposure to Niclosamide, the Active Ingredient in the Widely Used Molluscicide Bayluscide

    PubMed Central

    Zhang, Si-Ming; Buddenborg, Sarah K.; Adema, Coen M.; Sullivan, John T.; Loker, Eric S.

    2015-01-01

    In view of the call by the World Health Organization (WHO) for elimination of schistosomiasis as a public health problem by 2025, use of molluscicides in snail control to supplement chemotherapy–based control efforts is likely to increase in the coming years. The mechanisms of action of niclosamide, the active ingredient in the most widely used molluscicides, remain largely unknown. A better understanding of its toxicology at the molecular level will both improve our knowledge of snail biology and may offer valuable insights into the development of better chemical control methods for snails. We used a recently developed Biomphalaria glabrata oligonucleotide microarray (31K features) to investigate the effect of sublethal exposure to niclosamide on the transcriptional responses of the snail B. glabrata relative to untreated snails. Most of the genes highly upregulated following exposure of snails to niclosamide are involved in biotransformation of xenobiotics, including genes encoding cytochrome P450s (CYP), glutathione S-transferases (GST), and drug transporters, notably multi-drug resistance protein (efflux transporter) and solute linked carrier (influx transporter). Niclosamide also induced stress responses. Specifically, six heat shock protein (HSP) genes from three super-families (HSP20, HSP40 and HSP70) were upregulated. Genes encoding ADP-ribosylation factor (ARF), cAMP response element-binding protein (CREB) and coatomer, all of which are involved in vesicle trafficking in the Golgi of mammalian cells, were also upregulated. Lastly, a hemoglobin gene was downregulated, suggesting niclosamide may affect oxygen transport. Our results show that snails mount substantial responses to sublethal concentrations of niclosamide, at least some of which appear to be protective. The topic of how niclosamide’s lethality at higher concentrations is determined requires further study. Given that niclosamide has also been used as an anthelmintic drug for decades and has

  14. Altered Gene Expression in the Schistosome-Transmitting Snail Biomphalaria glabrata following Exposure to Niclosamide, the Active Ingredient in the Widely Used Molluscicide Bayluscide.

    PubMed

    Zhang, Si-Ming; Buddenborg, Sarah K; Adema, Coen M; Sullivan, John T; Loker, Eric S

    2015-01-01

    In view of the call by the World Health Organization (WHO) for elimination of schistosomiasis as a public health problem by 2025, use of molluscicides in snail control to supplement chemotherapy-based control efforts is likely to increase in the coming years. The mechanisms of action of niclosamide, the active ingredient in the most widely used molluscicides, remain largely unknown. A better understanding of its toxicology at the molecular level will both improve our knowledge of snail biology and may offer valuable insights into the development of better chemical control methods for snails. We used a recently developed Biomphalaria glabrata oligonucleotide microarray (31K features) to investigate the effect of sublethal exposure to niclosamide on the transcriptional responses of the snail B. glabrata relative to untreated snails. Most of the genes highly upregulated following exposure of snails to niclosamide are involved in biotransformation of xenobiotics, including genes encoding cytochrome P450s (CYP), glutathione S-transferases (GST), and drug transporters, notably multi-drug resistance protein (efflux transporter) and solute linked carrier (influx transporter). Niclosamide also induced stress responses. Specifically, six heat shock protein (HSP) genes from three super-families (HSP20, HSP40 and HSP70) were upregulated. Genes encoding ADP-ribosylation factor (ARF), cAMP response element-binding protein (CREB) and coatomer, all of which are involved in vesicle trafficking in the Golgi of mammalian cells, were also upregulated. Lastly, a hemoglobin gene was downregulated, suggesting niclosamide may affect oxygen transport. Our results show that snails mount substantial responses to sublethal concentrations of niclosamide, at least some of which appear to be protective. The topic of how niclosamide's lethality at higher concentrations is determined requires further study. Given that niclosamide has also been used as an anthelmintic drug for decades and has been

  15. Systems pharmacology-based approach for dissecting the active ingredients and potential targets of the Chinese herbal Bufei Jianpi formula for the treatment of COPD

    PubMed Central

    Zhao, Peng; Li, Jiansheng; Li, Ya; Tian, Yange; Wang, Yonghua; Zheng, Chunli

    2015-01-01

    Background The Chinese herbal Bufei Jianpi formula (BJF) provides an effective treatment option for chronic obstructive pulmonary disease (COPD). However, the systems-level mechanism underlying the clinical effects of BJF on COPD remains unknown. Methods In this study, a systems pharmacology model based on absorption filtering, network targeting, and systems analyses was applied specifically to clarify the active compounds and therapeutic mechanisms of BJF. Then, a rat model of cigarette smoke- and bacterial infection-induced COPD was used to investigate the therapeutic mechanisms of BJF on COPD and its comorbidity. Results The pharmacological system successfully identified 145 bioactive ingredients from BJF and revealed 175 potential targets. There was a significant target overlap between the herbal constituents of BJF. These results suggested that each herb of BJF connected with similar multitargets, indicating potential synergistic effects among them. The integrated target–disease network showed that BJF probably was efficient for the treatment of not only respiratory tract diseases but also other diseases, such as nervous system and cardiovascular diseases. The possible mechanisms of action of BJF were related to activation of inflammatory response, immune responses, and matrix metalloproteinases, among others. Furthermore, we demonstrated that BJF treatment could effectively prevent COPD and its comorbidities, such as ventricular hypertrophy, by inhibition of inflammatory cytokine production, matrix metalloproteinases expression, and other cytokine production in vivo. Conclusion This study using the systems pharmacology method, in combination with in vivo experiments, helped us successfully dissect the molecular mechanism of BJF for the treatment of COPD and predict the potential targets of the multicomponent BJF, which provides a new approach to illustrate the synergetic mechanism of the complex prescription and discover more effective drugs against COPD

  16. Beta-glucuronidase activities of fecal isolates from healthy swine.

    PubMed Central

    Jackson, L; Langlois, B E; Dawson, K A

    1992-01-01

    Research has shown that various percentages of fecal Escherichia coli isolates obtained from healthy subjects may be beta-glucuronidase negative. The ability to detect beta-glucuronidase activity among fecal E. coli isolates from healthy subjects may be affected by assay conditions. A study was conducted in which agar and broth media containing 4-methylumbelliferyl-beta-D-glucuronide (MUG) were used to examine beta-glucuronidase activities of fecal isolates from healthy swine. Rectal swabs were plated on MacConkey agar plus 100 mg of MUG per liter (MAC-MUG) and incubated at 35 degrees C for 24 h. Each of 986 isolates picked from MAC-MUG was inoculated into duplicate tubes of lauryl tryptose broth plus 50 mg of MUG per liter (LT-MUG). One set of tubes was incubated at 35 degrees C and the other set of tubes was incubated at 44.5 degrees C. Gas production and hydrolysis of MUG, indicated by fluorescence when observed with UV light with a wavelength of 360 nm, were determined after incubation for 24 and 48 h. A higher percentage (P less than 0.01) of isolates was MUG positive at 44.5 degrees C than at 35 degrees C after 24 h of incubation in LT-MUG. A higher percentage (P less than 0.01) of isolates was MUG positive after 48 h than after 24 h of incubation at both 35 and 44.5 degrees C. A lower percentage of isolates (P less than 0.05) was observed to be MUG positive on MAC-MUG agar compared with their MUG reactions in LT-MUG at 35 and 44.5 degrees C. Approximately 89% of the isolates identified were beta-glucuronidase-positive E. coli. The largest proportion of MUG-positive E. coli was detected with LT-MUG at 35 degrees C after 48 h of incubation. PMID:1500519

  17. Active Rack Isolation System Program and Technical Status

    NASA Technical Reports Server (NTRS)

    Bushnell, Glenn; Fialho, Ian; Allen, James; Quraishi, Naveed

    2000-01-01

    The Boeing Active Rack Isolation System (ARIS) is one of the means used to isolate acceleration-sensitive scientific experiments from structurally transmitted disturbances aboard the International Space Station. The presentation provides an overview of ARIS and technical issues associated with the development of the active control system. An overview of ARIS analytical models is presented along with recent isolation performance predictions made using these models. Issues associated with commanding and capturing ARIS data are discussed and possible future options based on the ARIS ISS Characterization Experiment (ICE) Payload On-orbit Processor (POP) are outlined. An overview of the ARIS-ICE experiment scheduled to fly on ISS Flight 6A is presented. The presentation concludes with a discussion of recent- developmental work that includes passive rack damping, umbilical redesigns and advanced multivariable control design methods.

  18. Solophenols B-D and solomonin: new prenylated polyphenols isolated from propolis collected from the Solomon Islands and their antibacterial activity.

    PubMed

    Inui, Saori; Hosoya, Takahiro; Shimamura, Yuko; Masuda, Shuichi; Ogawa, Takeshi; Kobayashi, Hirokazu; Shirafuji, Kenichi; Moli, Reuben Toli; Kozone, Ikuko; Shin-ya, Kazuo; Kumazawa, Shigenori

    2012-11-28

    Three new prenylated flavonoids, namely, solophenols B (1), C (2), and D (3), as well as a new prenylated stilbene, solomonin (4), were isolated from propolis collected from the Solomon Islands. In addition, 17 known compounds were identified. The structures of the new compounds were determined by a combination of methods, including mass spectrometry and NMR. These new compounds and several known compounds were tested for antibacterial activity against Staphylococcus aureus, Bacillus subtilis, and Pseudomonas aeruginosa. Most of them exhibited potent antibacterial activity. These findings may indicate that propolis from the Solomon Islands has potential applications as an ingredient in food additives or pharmaceuticals. PMID:23067056

  19. Pharmacokinetic Profiles of Active Ingredients and Its Metabolites Derived from Rikkunshito, a Ghrelin Enhancer, in Healthy Japanese Volunteers: A Cross-Over, Randomized Study

    PubMed Central

    Kitagawa, Hiroyuki; Munekage, Masaya; Matsumoto, Takashi; Sadakane, Chiharu; Fukutake, Miwako; Aoki, Katsuyuki; Watanabe, Junko; Maemura, Kazuya; Hattori, Tomohisa; Kase, Yosio; Uezono, Yasuhito; Inui, Akio; Hanazaki, Kazuhiro

    2015-01-01

    Background Rikkunshito, a traditional Japanese (Kampo) medicine, has been used to treat upper gastrointestinal disorders such as functional dyspepsia and gastroesophageal reflux. This study investigated the exposure and pharmacokinetics of the ingredients of rikkunshito in healthy volunteers. Methods and Results First, an exploratory nonrandomized, open-label, one-period, noncrossover study using four healthy Japanese volunteers to detect 32 typical ingredients of rikkunshito in plasma and urine. As a result, 18 or 21 of 32 ingredients was detected in plasma or urine samples after oral administration of rikkunshito (7.5 g/day). Furthermore, a randomized, open-label, three-arm, three-period, crossover study using 21 subjects was conducted to determine the amounts of exposure and pharmacokinetic parameters of nine ingredients derived from rikkunshito (atractylodin, atractylodin carboxylic acid, pachymic acid, 3,3′,4′,5,6,7,8-heptamethoxyflavone, naringenin, nobiletin, liquiritigenin, isoliquiritigenin, and 18β-glycyrrhetinic acid) after oral administration of rikkunshito at three different doses (2.5, 5.0, or 7.5 g/day) during each period. The pharmacokinetic profiles of the nine ingredients in plasma were characterized. The geometric means (95% confidence interval) for the Cmax of the ingredients at a dose of 7.5 g were 1570 (1210–2040), 14,300 (12,200–16,800), 91.0 (71.8–115), 105 (75.6–144), 1150 (802–1650), 35.9 (24.6–52.5), 800 (672–952), 42.8 (30.4–60.3), and 55,600 (39,600–78,100) pg/mL, respectively, and for the AUC0–last were 1760 (1290–2390), 12700 (11,100–14,600), 1210 (882–1650), 225 (157–322), 4630 (2930–7320), 35.7 (20.4–62.7), 4040 (3260–5010), 122 (88.2–168), and 832,000 (628,000–1,100,000) pg·h/mL respectively. Conclusions We identified the ingredients of rikkunshito that are absorbed in humans. Furthermore, we determined the pharmacokinetics of nine ingredients derived from rikkunshito. This information

  20. Antioxidant activity of isolated ellagitannins from red raspberries and cloudberries.

    PubMed

    Kähkönen, Marja; Kylli, Petri; Ollilainen, Velimatti; Salminen, Juha-Pekka; Heinonen, Marina

    2012-02-01

    Ellagitannins from red raspberries (Rubus idaeus) and cloudberries (Rubus chamaemorus) were isolated by using column chromatography and preparative HPLC. The berry phenolic isolates consisted of 80% (cloudberry) and of 60% (raspberry) of ellagitannins, with raspberries also containing anthocyanins. The main ellagitannins of both raspberries and cloudberries were identified by ESI-MS to consist of the dimeric sanguiin H-6 and the trimeric lambertianin C. Monomeric ellagitannins such as casuarictin in raspberries and pedunculagin in cloudberries were also found. The antioxidant activity of the berry phenolic isolate, ellagitannin isolate (mixture), ellagitannin main fraction (dimer and trimer), and ellagic acid was studied in bulk and emulsified methyl linoleate, in human low-density lipoprotein in vitro, and the radical scavenging activity was studied in the 2,2-diphenyl-1-picrylhydrazyl (DPPH) test. Cloudberry and red raspberry ellagitannins were highly effective as radical scavengers. Berry ellagitannins also showed significant antioxidant activity toward oxidation of both human LDL and methyl linoleate emulsions. However, only weak or moderate antioxidant activity was exhibited by ellagitannins toward oxidation of bulk oil. Thus, ellagitannins contribute significantly to the antioxidant capacity of cloudberries and red raspberries in lipoprotein and lipid emulsion environments, the latter being more relevant for food applications. PMID:22229937

  1. Experiments on active precision isolation with a smart conical adapter

    NASA Astrophysics Data System (ADS)

    Li, H.; Li, H. Y.; Chen, Z. B.; Tzou, H. S.

    2016-07-01

    Based on a conical shell adaptor, an active vibration isolator for vibration control of precision payload is designed and tested in this study. Flexible piezoelectric sensors and actuators are bonded on the adaptor surface for active vibration monitoring and control. The mathematical model of a piezoelectric laminated conical shell is derived and then optimal design of the actuators is performed for the first axial vibration mode of the isolation system. A scaled conical adaptor is manufactured with four MFC actuators laminating on its outer surface. Active vibration isolation efficiency is then evaluated on a vibration shaker. The control model is built in Matlab/Simulink and programmed into the dSPACE control board. Experimental results show that, the proposed active isolator is effective in vibration suppression of payloads with the negative velocity feedback control. In contrast, the amplitude responses increase with positive feedback control. Furthermore, the amplitude responses increases when time delay is added into the control signals, and gets the maximum when the delay is close to one quarter of one cycle time.

  2. Glyceollin I, A Novel Antiestrogenic Phytoalexin Isolated from Activated Soy

    Technology Transfer Automated Retrieval System (TEKTRAN)

    Glyceollins, a group of novel phytoalexins isolated from activated soy, have recently been demonstrated to be a novel antiestrogen which bind to the estrogen receptor (ER) and inhibit estrogen-induced tumor progression. Our previous publications have focused specifically on inhibition of tumor form...

  3. Xanthone isolated from Securidaca longependunculata with activity against erectile dysfunction.

    PubMed

    Rakuambo, N C; Meyer, J J M; Hussein, A

    2004-07-01

    1,7-Dimethoxy-2-hydroxy-xanthone and 1,4-dihydroxy-7-methoxy-xanthone isolated from Securidaca longependunculata were tested for their activity on rabbit corpus cavernosum in vitro. Only the former relaxed the corpus cavernosum by 63% at 1.8 x 10(-5) mg/ml. PMID:15261388

  4. Potent inhibition of CYP1A2 by Frutinone A, an active ingredient of the broad spectrum antimicrobial herbal extract from P. fruticosa.

    PubMed

    Thelingwani, Roslyn S; Dhansay, Kariema; Smith, Peter; Chibale, Kelly; Masimirembwa, Collen M

    2012-10-01

    1. Frutinone is an active ingredient extracted from the lipophilic fraction of the Polygala Fruticosa demonstrating various antibacterial and fungal properties. The aim of this study was to characterize its metabolism in an effort to understand metabolism based drug-herb interactions. 2. In vitro metabolic clearance and metabolite identification studies were done using cryopreserved hepatocytes. Reaction phenotyping and inhibition studies were done using human liver microsomes and recombinant cytochrome P450s (CYPs). Frutinone A-CYP1A2 interactions were rationalized using docking simulations. 3. Hepatic clearance was predicted to be low (7.17 mL/min/kg), with reaction phenotyping studies indicating no clearance by the enzymes tested. Frutinone was identified as a potent inhibitor of CYP1A2 with moderate effects on CYP2C19, 2C9, 2D6 and 3A4. CYP1A2 inhibition was reversible and characterised by an IC(50) of 0.56 µM. Inhibition was differential showing mixed (K(i) = 0.48 µM) and competitive (K(i) = 0.31 µM) inhibition with 3-cyano-7-ethoxycoumarin and ethoxyresorufin, respectively. Two binding sites, one for inhibitors and the other for substrates were identified in silico. 4. The potent CYP1A2 inhibition by Frutinone A could be predictive of the potential drug-herb interaction risk in the use of herbal extracts from P. fruticosa. The data suggest future pharmacological research on this chromocoumarin should take metabolic properties into account. PMID:22533317

  5. Development and validation of a stability-indicating reverse phase ultra performance liquid chromatographic method for the estimation of nebivolol impurities in active pharmaceutical ingredients and pharmaceutical formulation.

    PubMed

    Thummala, Veera Raghava Raju; Lanka, Mohana Krishna

    2015-10-01

    A sensitive, stability-indicating gradient reverse phase ultra performance liquid chromatographic method has been developed for the quantitative estimation of nebivolol impurities in active pharmaceutical ingredient (API) and pharmaceutical formulation. Efficient chromatographic separation was achieved on an Acquity BEH C18 column (100 mm x 2.1 mm, 1.7 μm) with mobile phase of a gradient mixture. The flow rate of the mobile phase was 0.18 mL/min with column temperature of 30 degrees C and detection wavelength of 281 nm. The relative response factor values of (R*)-2-( benzylamino)-1-((S*)-6-fluorochroman-2-yl) ethanol ((R x S*) NBV-), (R)-1-((R)-6-fluorochroman-2-yl)-2-((S)-2-((S)-6-fluoro-chroman-2-yl)-2-hydroxyethyl-amino) ethanol ((RRSS) NBV-3), 1-(chroman-2-yl)-2-(2-(6-fluorochroman-2-yl)-2-hydroxyethyl amino) ethanol (monodesfluoro impurity), (S)-1-((R)-6-fluorochroman-2-yl)-2-((R)-2 (S*)-6-fluoro-chroman-2-yl)-2-hydroxyethylamino) ethanol hydrochloride ((RSRS) NBV-3) and (R*)-1-((S*)-6-fluorochroman-2-yl)-2-((S*)-2-((S*)-6-fluoro-chroman-2-yl)-2-hydroxyethylamino) ethanol ((R* S* S* S*) NBV-2) were 0.65, 0.91, 0.68, 0.92 and 0.91 respectively. Nebivolol formulation sample was subjected to the stress conditions of acid, base, oxidative, hydrolytic, thermal, humidity and photolytic degradation. Nebivolol was found to degrade significantly under peroxide stress condition. The degradation products were well resolved from nebivolol and its impurities. The peak purity test results confirmed that the nebivolol peak was homogenous and pure in all stress samples and the mass balance was found to be more than 98%, thus proving the stability-indicating power of the method. The developed method was validated according to International Conference on Hormonization (ICH) guidelines with respect to specificity, linearity, limits of detection and quantification, accuracy, precision and robustness. PMID:26930962

  6. Study and determination of elemental impurities by ICP-MS in active pharmaceutical ingredients using single reaction chamber digestion in compliance with USP requirements.

    PubMed

    Muller, Aline L H; Oliveira, Jussiane S S; Mello, Paola A; Muller, Edson I; Flores, Erico M M

    2015-05-01

    In this work a method for active pharmaceutical ingredients (APIs) digestion using the single reaction chamber (SRC-UltraWave™) system was proposed following the new recommendations of United States Pharmacopeia (USP). Levodope (LEVO), primaquine diphosphate (PRIM), propranolol hydrochloride (PROP) and sulfamethoxazole (SULF) were used to evaluate the digestion efficiency of the proposed method. A comparison of digestion efficiency was performed by measuring the carbon content and residual acidity in digests obtained using SRC and in digests obtained using conventional microwave-assisted digestion system (Multiwave(TM)). Three digestion solutions (concentrated HNO3, aqua regia or inverse aqua regia) were evaluated for digestion of APIs. The determination of Cd, Ir, Mn, Mo, Ni, Os, Pb, Pd, Pt, Rh, Ru was performed using inductively coupled plasma mass spectrometry (ICP-MS) in standard mode. Dynamic reaction cell (DRC) mode was used for the determination of (51)V, (52)Cr, (53)Cr, (63)Cu and (65)Cu in order to solve polyatomic ion interferences. Arsenic and Hg were determined using chemical vapor generation coupled to ICP-MS (FI-CVG-ICP-MS). Masses of 500mg of APIs were efficiently digested in a SRC-UltraWave™ system using only HNO3 and allowing a carbon content lower than 250mg L(-1) in final digests. Inverse aqua regia was suitable for digestion of sample masses up to 250mg allowing the determination of Ir, Pd, Pt, Rh and Ru. By using HNO3 or inverse aqua regia, suitable recoveries were obtained (between 91 and 109%) for all analytes (exception for Os). Limits of quantification were in agreement with USP requirements and they ranged from 0.001 to 0.015µg g(-1) for all elemental impurities (exception for Os). The proposed method was suitable for elemental impurities determination in APIs and it can be used in routine analysis for quality control in pharmaceutical industries. PMID:25702998

  7. Peroxidase and peroxidase-oxidase activities of isolated human myeloperoxidases.

    PubMed Central

    Svensson, B E; Domeij, K; Lindvall, S; Rydell, G

    1987-01-01

    Isolated neutrophils from healthy donors were used for the isolation of four highly purified forms of myeloperoxidase as determined by spectral (A430/A280 ratio 0.80-0.87) and enzyme-activity measurements. Although the myeloperoxidases exhibited different elution profiles on cation-exchange chromatography, gel filtration indicated similar relative molecular masses. When these forms were assayed for peroxidase and peroxidase-oxidase activities with several substrates, they all exhibited virtually the same specific activities. These results suggest that possible functional differences between the enzymes may be related to differences in their sites of action rather than to differences in enzyme activity. Myeloperoxidase from a patient with chronic myeloid leukaemia also revealed a similar heterogeneity on cation-exchange chromatography. However, this myeloperoxidase contained in addition one form with a lower and one form with a higher relative molecular mass, as indicated by gel-filtration chromatography. PMID:3036098

  8. Mechanisms of the Space Active Vibration Isolation (SAVI)

    NASA Technical Reports Server (NTRS)

    Schmitt, Frank

    1992-01-01

    The Space Active Vibration Isolation (SAVI) is a concept for vibration isolation of one body from another with simultaneous precise control in 6 Degrees Of Freedom (DOF). SAVI achieves this using a combination of electromechanical linear actuators and magnetic actuators. Other mechanisms of interest include a structure for simulating the body being pointed, an apparatus to simulate the body that is the vibration source, and mechanisms to off-load the weight of each of these two bodies from the experiment to approximate a zero-g condition. A SAVI was built and tested to demonstrate these capabilities.

  9. [Biologically Active Peptides Isolated from Dill Anethum graveolens L].

    PubMed

    Kulikova, O G; Maltsev, D I; Ilyina, A P; Burdina, A V; Yamskova, V P; Yamskov, I A

    2015-01-01

    Peptide mixtures with molecular weights of 1000-2000 Da and in vivo membrano-trophic activity against mouse hepatocyte culture at very low concentrations were isolated from dill Anethum graveolens L. leaves. It has been found that plant peptides in aqueous solution formed larger nanosized particles of approximately 90 nm with a secondary structure mainly composed of β-structures and random coil structures. We demonstrated that peptides isolated from A. graveolens in vitro at an ultra-low dosage affected the size of the area of pigmented cells of amphibian liver, which are analogous to Kupffer cells of the mammalian liver, using roller organotypic newt liver culture models. PMID:26204780

  10. 21 CFR 310.529 - Drug products containing active ingredients offered over-the-counter (OTC) for oral use as insect...

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... offered over-the-counter (OTC) for oral use as insect repellents. 310.529 Section 310.529 Food and Drugs... ingredients offered over-the-counter (OTC) for oral use as insect repellents. (a) Thiamine hydrochloride... insect repellent (an orally administered drug product intended to keep insects away). There is a lack...

  11. 21 CFR 310.529 - Drug products containing active ingredients offered over-the-counter (OTC) for oral use as insect...

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... offered over-the-counter (OTC) for oral use as insect repellents. 310.529 Section 310.529 Food and Drugs... ingredients offered over-the-counter (OTC) for oral use as insect repellents. (a) Thiamine hydrochloride... insect repellent (an orally administered drug product intended to keep insects away). There is a lack...

  12. 21 CFR 310.529 - Drug products containing active ingredients offered over-the-counter (OTC) for oral use as insect...

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... offered over-the-counter (OTC) for oral use as insect repellents. 310.529 Section 310.529 Food and Drugs... ingredients offered over-the-counter (OTC) for oral use as insect repellents. (a) Thiamine hydrochloride... insect repellent (an orally administered drug product intended to keep insects away). There is a lack...

  13. 21 CFR 310.529 - Drug products containing active ingredients offered over-the-counter (OTC) for oral use as insect...

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... offered over-the-counter (OTC) for oral use as insect repellents. 310.529 Section 310.529 Food and Drugs... ingredients offered over-the-counter (OTC) for oral use as insect repellents. (a) Thiamine hydrochloride... insect repellent (an orally administered drug product intended to keep insects away). There is a lack...

  14. 21 CFR 310.529 - Drug products containing active ingredients offered over-the-counter (OTC) for oral use as insect...

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... offered over-the-counter (OTC) for oral use as insect repellents. 310.529 Section 310.529 Food and Drugs... ingredients offered over-the-counter (OTC) for oral use as insect repellents. (a) Thiamine hydrochloride... insect repellent (an orally administered drug product intended to keep insects away). There is a lack...

  15. Acute toxic effects of the herbicide formulation and the active ingredient used in cycloxydim-tolerant maize cultivation on embryos and larvae of the African clawed frog, Xenopus laevis.

    PubMed

    Wagner, Norman; Lötters, Stefan; Veith, Michael; Viertel, Bruno

    2015-04-01

    Most genetically engineered herbicide-tolerant crops are still awaiting approval in Europe. There is, however, a recent trend for the cultivation of cycloxydim-tolerant maize hybrids for use in maize production. We studied the acute toxic effects of the complementary herbicide Focus(®) Ultra and its active ingredient cycloxydim on embryos and early-stage larvae of the African clawed frog (Xenopus laevis). The results indicate that the herbicide formulation is significantly more toxic than the active ingredient alone. Therefore, it is suggested that the added substances either solely or in a synergistic action with the active ingredient are responsible for adverse effects. The formulation was found to be moderately toxic to embryos but highly toxic to early larvae. Based on calculated teratogenic indices, both cycloxydim and Focus(®) Ultra seem to be non-teratogenic and also the minimum Focus(®) Ultra concentration to inhibit growth in embryos and larvae was close to the LC50 values. The data suggest that tests with the rainbow trout are not in all cases appropriate to assess the risk in aquatically developing anurans. This is demonstrated by 96-h LC50 values, which are for rainbow trout more than 50- to 20-fold higher than for early X. laevis larvae. However, based on worst-case predicted environmental concentrations for surface waters, there is apparently a large safety margin in field use of Focus(®) Ultra if buffer strips between the farm land and the amphibian habitats are regarded. PMID:25634323

  16. Detoxification of alpha- and beta-Thujones (the active ingredients of absinthe): site specificity and species differences in cytochrome P450 oxidation in vitro and in vivo.

    PubMed

    Höld, K M; Sirisoma, N S; Casida, J E

    2001-05-01

    Alpha- and beta-Thujones are active ingredients in the liqueur absinthe and in herbal medicines and seasonings for food and drinks. Our earlier study established that they are convulsants and have insecticidal activity, acting as noncompetitive blockers of the gamma-aminobutyric acid (GABA)-gated chloride channel, and identified 7-hydroxy-alpha-thujone as the major metabolite and 4-hydroxy-alpha- and -beta-thujones and 7,8-dehydro-alpha-thujone as minor metabolites in the mouse liver microsome-NADPH system. We report here unexpected site specificity and species differences in the metabolism of the thujone diastereomers in mouse, rat, and human liver microsomes and human recombinant P450 (P450 3A4), in orally treated mice and rats, and in Drosophila melanogaster. Major differences are apparent on comparing in vitro microsome-NADPH systems and in vivo urinary metabolites. Hydroxylation at the 2-position is observed only in mice where conjugated 2R-hydroxy-alpha-thujone is the major urinary metabolite of alpha-thujone. Hydroxylation at the 4-position gives one or both of 4-hydroxy-alpha- and -beta-thujones depending on the diastereomer and species studied with conjugated 4-hydroxy-alpha-thujone as the major urinary metabolite of alpha- and beta-thujones in rats. Hydroxylation at the 7-position of alpha- and beta-thujones is always a major pathway, but the conjugated urinary metabolite is minor except with beta-thujone in the mouse. Site specificity in glucuronidation favors excretion of 2R-hydroxy- and 4-hydroxy-alpha-thujone glucuronides rather than those of three other hydroxythujones. Two dehydro metabolites are observed from both alpha- and beta-thujones, the 7,8 in the P450 systems and the 4,10 in urine. Two types of evidence establish that P450-dependent oxidations of alpha- and beta-thujones are detoxification reactions: three P450 inhibitors block the metabolism of alpha- and beta-thujones and strongly synergize their toxicity in Drosophila; six metabolites

  17. Can We Identify the Active Ingredients of Behaviour Change Interventions for Coronary Heart Disease Patients? A Systematic Review and Meta-Analysis

    PubMed Central

    Goodwin, Laura; Ostuzzi, Giovanni; Khan, Nadia; Hotopf, Matthew H.; Moss-Morris, Rona

    2016-01-01

    Background The main behaviour change intervention available for coronary heart disease (CHD) patients is cardiac rehabilitation. There is little recognition of what the active ingredients of behavioural interventions for CHD might be. Using a behaviour change technique (BCT) framework to code existing interventions may help to identify this. The objectives of this systematic review are to determine the effectiveness of CHD behaviour change interventions and how this may be explained by BCT content and structure. Methods and Findings A systematic search of Medline, EMBASE and PsycInfo electronic databases was conducted over a twelve year period (2003–2015) to identify studies which reported on behaviour change interventions for CHD patients. The content of the behaviour change interventions was coded using the Coventry Aberdeen and London—Refined (CALO-RE) taxonomy. Meta-regression analyses examined the BCT content as a predictor of mortality. Twenty two papers met the criteria for this review, reporting data on 16,766 participants. The most commonly included BCTs were providing information, and goal setting. There was a small but significant effect of the interventions on smoking (risk ratio (RR) = 0.89, 95% CI 0.81–0.97). The interventions did not reduce the risk of CHD events (RR = 0.86, 95% CI 0.68, 1.09), but significantly reduced the risk of mortality (RR = 0.82, 95% CI 0.69, 0.97). Sensitivity analyses did not find that any of the BCT variables predicted mortality and the number of BCTs included in an intervention was not associated with mortality (β = -0.02, 95% CI -0.06–0.03). Conclusions Behaviour change interventions for CHD patients appear to have a positive impact on a number of outcomes. Using an existing BCT taxonomy to code the interventions helped us to understand which were the most commonly used techniques, providing information and goal setting, but not the active components of these complex interventions. PMID:27105435

  18. Quorum Sensing Inhibiting Activity of Streptomyces coelicoflavus Isolated from Soil.

    PubMed

    Hassan, Ramadan; Shaaban, Mona I; Abdel Bar, Fatma M; El-Mahdy, Areej M; Shokralla, Shadi

    2016-01-01

    Quorum sensing (QS) systems communicate bacterial population and stimulate microbial pathogenesis through signaling molecules. Inhibition of QS signals potentially suppresses microbial infections. Antimicrobial properties of Streptomyces have been extensively studied, however, less is known about quorum sensing inhibitory (QSI) activities of Streptomyces. This study explored the QSI potential of Streptomyces isolated from soil. Sixty-five bacterial isolates were purified from soil samples with morphological characteristics of Streptomyces. The three isolates: S6, S12, and S17, exhibited QSI effect by screening with the reporter, Chromobacterium violaceum. Isolate S17 was identified as Streptomyces coelicoflavus by sequencing of the hypervariable regions (V1-V6) of 16S rRNA and was assigned gene bank number KJ855087. The QSI effect of the cell-free supernatant of isolate S17 was not abolished by proteinase K indicating the non-enzymatic activity of QSI components of S17. Three major compounds were isolated and identified, using spectroscopic techniques (1D, 2D NMR, and Mass spectrometry), as behenic acid (docosanoic acid), borrelidin, and 1H-pyrrole-2-carboxylic acid. 1H-pyrrole-2-carboxylic acid inhibited QS and related virulence factors of Pseudomonas aeruginosa PAO1 including; elastase, protease, and pyocyanin without affecting Pseudomonas viability. At the molecular level, 1H-pyrrole-2-carboxylic acid suppressed the expression of QS genes (lasI, lasR, lasA, lasB, rhlI, rhlR, pqsA, and pqsR). Moreover, QSI activity of S17 was assessed under different growth conditions and ISP2 medium supplemented with glucose 0.4% w/v and adjusted at pH 7, showed the highest QSI action. In conclusion, 1H-pyrrole-2-carboxylic acid, one of the major metabolites of Streptomyces isolate S17, inhibited QS and virulence determinants of P. aeruginosa PAO1. The findings of the study open the scope to exploit the in vivo efficacy of this active molecule as anti-pathogenic and anti

  19. Quorum Sensing Inhibiting Activity of Streptomyces coelicoflavus Isolated from Soil

    PubMed Central

    Hassan, Ramadan; Shaaban, Mona I.; Abdel Bar, Fatma M.; El-Mahdy, Areej M.; Shokralla, Shadi

    2016-01-01

    Quorum sensing (QS) systems communicate bacterial population and stimulate microbial pathogenesis through signaling molecules. Inhibition of QS signals potentially suppresses microbial infections. Antimicrobial properties of Streptomyces have been extensively studied, however, less is known about quorum sensing inhibitory (QSI) activities of Streptomyces. This study explored the QSI potential of Streptomyces isolated from soil. Sixty-five bacterial isolates were purified from soil samples with morphological characteristics of Streptomyces. The three isolates: S6, S12, and S17, exhibited QSI effect by screening with the reporter, Chromobacterium violaceum. Isolate S17 was identified as Streptomyces coelicoflavus by sequencing of the hypervariable regions (V1–V6) of 16S rRNA and was assigned gene bank number KJ855087. The QSI effect of the cell-free supernatant of isolate S17 was not abolished by proteinase K indicating the non-enzymatic activity of QSI components of S17. Three major compounds were isolated and identified, using spectroscopic techniques (1D, 2D NMR, and Mass spectrometry), as behenic acid (docosanoic acid), borrelidin, and 1H-pyrrole-2-carboxylic acid. 1H-pyrrole-2-carboxylic acid inhibited QS and related virulence factors of Pseudomonas aeruginosa PAO1 including; elastase, protease, and pyocyanin without affecting Pseudomonas viability. At the molecular level, 1H-pyrrole-2-carboxylic acid suppressed the expression of QS genes (lasI, lasR, lasA, lasB, rhlI, rhlR, pqsA, and pqsR). Moreover, QSI activity of S17 was assessed under different growth conditions and ISP2 medium supplemented with glucose 0.4% w/v and adjusted at pH 7, showed the highest QSI action. In conclusion, 1H-pyrrole-2-carboxylic acid, one of the major metabolites of Streptomyces isolate S17, inhibited QS and virulence determinants of P. aeruginosa PAO1. The findings of the study open the scope to exploit the in vivo efficacy of this active molecule as anti-pathogenic and anti

  20. Antisickling activity of butyl stearate isolated from Ocimum basilicum (Lamiaceae)

    PubMed Central

    Tshilanda, Dorothée Dinangayi; Mpiana, Pius Tshimankinda; Onyamboko, Damase Nguwo Vele; Mbala, Blaise Mavinga; Ngbolua, Koto-te-Nyiwa; Tshibangu, Damien Sha Tshibey; Bokolo, Matthieu Kokengo; Taba, Kalulu Muzele; Kasonga, Teddy Kabeya

    2014-01-01

    Objective To perform phytochemical analyses on the leaves of Ocimum basilicum L. (O. basilicum), to elucidate the structure of isolate and then perform the antisickling activity on the crude extract and on the isolate. Methods The Emmel test performed on the acidified methanolic extract of this plant was used to evaluate the antisickling activity. The structure characterization of the active compound was performed using chromatographic techniques for the separation and the spectroscopic ones for structure elucidation (1H-NMR, 13C-NMR, COSY, HMBC). Results The chemical screening on the crude extract revealed the presence of polyphenols (flavonoids, anthocyanins, leucoanthocyanins, tannins, quinones) alkaloids, saponins, triterpenoids and steroids. The obtained extract after evaporation yielded 34.50 g (11.5%) out of 300 g of powdered leaves of O. basilicum. The acidified methanolic extract and butyl stearate showed an interesting antisickling activity. Conclusions The acidified methanolic extract and butyl stearate from O. basilicum displayed a good antisickling activity. To the best of our knowledge, this is the first time to report the antisickling activity of this compound in this plant. The synthesized compound presented the same spectroscopic characteristics than the natural one and the antisickling activities of its derivatives are understudying. PMID:25182725