National Chemistry Week 2000: JCE Resources in Food Chemistry

NASA Astrophysics Data System (ADS)

Jacobsen, Erica K.

2000-10-01

November brings another National Chemistry Week, and this year's theme is food chemistry. I was asked to collect and evaluate JCE resources for use with this theme, a project that took me deep into past issues of JCE and yielded many treasures. Here we present the results of searches for food chemistry information and activities. While the selected articles are mainly at the high school and college levels, there are some excellent ones for the elementary school level and some that can be adapted for younger students. The focus of all articles is on the chemistry of food itself. Activities that only use food to demonstrate a principle other than food chemistry are not included. Articles that cover household products such as cleansers and pharmaceuticals are also not included. Each article has been characterized as a demonstration, experiment, calculation, activity, or informational item; several fit more than one classification. Also included are keywords and an evaluation as to which levels the article may serve.

Linking a Pharmaceutical Chemistry Workshop to Pharmacy Practice

PubMed Central

Morral, Jordi; Culshaw, Margaret; Morral, Kim; Conway, Barbara; Adams, Sylvia; Adams, Andrew

2015-01-01

This paper describes the design and implementation of a workshop to enhance pharmacy students’ appreciation of the importance of chemistry for pharmacy practice. The workshop was designed to form part of the practical work of two modules taught in the second year of the MPharm degree. In this mandatory workshop, second year pharmacy students were required to spot in the dispensary drugs based on their chemical properties like chirality, their origin and chemical structure. The lecturers involved in the workshop showed examples of the application of chemistry in the day to day work of the dispensary (e.g. calculating the dose for a patient in millimoles or how small modifications from a natural product can change its ability to cross the blood-brain-barrier). Feedback from participating students was collected via two survey instruments to examine the impact of the intervention. The survey results showed a clear shift towards a more positive perception by students of the chemistry taught in the MPharm curriculum. PMID:26839806

Cross-Linked Hydrogel for Pharmaceutical Applications: A Review

PubMed Central

2017-01-01

Hydrogels are promising biomaterials because of their important qualities such as biocompatibility, biodegradability, hydrophilicity and non-toxicity. These qualities make hydrogels suitable for application in medical and pharmaceutical field. Recently, a tremendous growth of hydrogel application is seen, especially as gel and patch form, in transdermal drug delivery. This review mainly focuses on the types of hydrogels based on cross-linking and; secondly to describe the possible synthesis methods to design hydrogels for different pharmaceutical applications. The synthesis and chemistry of these hydrogels are discussed using specific pharmaceutical examples. The structure and water content in a typical hydrogel have also been discussed. PMID:29399542

The application of structure-based assessment to support safety and chemistry diligence to manage genotoxic impurities in active pharmaceutical ingredients during drug development.

PubMed

Dobo, Krista L; Greene, Nigel; Cyr, Michelle O; Caron, Stéphane; Ku, Warren W

2006-04-01

Starting materials and intermediates used to synthesize pharmaceuticals are reactive in nature and may be present as impurities in the active pharmaceutical ingredient (API) used for preclinical safety studies and clinical trials. Furthermore, starting materials and intermediates may be known or suspected mutagens and/or carcinogens. Therefore, during drug development due diligence need be applied from two perspectives (1) to understand potential mutagenic and carcinogenic risks associated with compounds used for synthesis and (2) to understand the capability of synthetic processes to control genotoxic impurities in the API. Recently, a task force comprised of experts from pharmaceutical industry proposed guidance, with recommendations for classification, testing, qualification and assessing risk of genotoxic impurities. In our experience the proposed structure-based classification, has differentiated 75% of starting materials and intermediates as mutagenic and non-mutagenic with high concordance (92%) when compared with Ames results. Structure-based assessment has been used to identify genotoxic hazards, and prompted evaluation of fate of genotoxic impurities in API. These two assessments (safety and chemistry) culminate in identification of genotoxic impurities known or suspected to exceed acceptable levels in API, thereby triggering actions needed to assure appropriate control and measurement methods are in place. Hypothetical case studies are presented demonstrating this multi-disciplinary approach.

Upon Further Review: A Commodity Chemist on Green Chemistry

NASA Astrophysics Data System (ADS)

Carroll, William F.

2016-09-01

Green chemistry is most often thought of in the context of specialty or pharmaceutical chemicals where many synthetic chemistry approaches are in play. However, principles similar to those of green chemistry and engineering were employed over the years in reducing cost and increasing volume of chemicals that became commodities. This paper considers some of those principles, their impact, and some perspectives on the potential and limits associated with green chemistry for commodity chemicals.

Pharmaceutical Cocrystals: Regulatory and Strategic Aspects, Design and Development

PubMed Central

Gadade, Dipak Dilip; Pekamwar, Sanjay Sudhakar

2016-01-01

Cocrystal is a concept of the supramolecular chemistry which is gaining the extensive interest of researchers from pharmaceutical and chemical sciences and of drug regulatory agencies. The prominent reason of which is its ability to modify physicochemical properties of active pharmaceutical ingredients. During the development of the pharmaceutical product, formulators have to optimize the physicochemical properties of active pharmaceutical ingredients. Pharmaceutical cocrystals can be employed to improve vital physicochemical characteristics of a drug, including solubility, dissolution, bioavailability and stability of pharmaceutical compounds while maintaining its therapeutic activity. It is advantageous being a green synthesis approach for production of pharmaceutical compounds. The formation polymorphic forms, solvates, hydrates and salts of cocrystals during the synthesis reported in the literature which can be a potential issue in the development of pharmaceutical cocrystals. The approaches like hydrogen bonding rules, solubility parameters, screening through the CSD database or thermodynamic characteristics can be utilized for the rational design of cocrystals and selection of coformers for synthesis multi-component cocrystals. Considering the significance of pharmaceutical cocrystals pharmaceutical regulatory authorities in the United States and Europe issued guidance documents which may be helpful for pharmaceutical product registration in these regions. In this article, we deal with the design, synthesis, strategic aspects and characteristics of cocrystals along perspectives on its regulatory and intellectual property considerations. PMID:28101455

Pharmaceutical Cocrystals: Regulatory and Strategic Aspects, Design and Development.

PubMed

Gadade, Dipak Dilip; Pekamwar, Sanjay Sudhakar

2016-12-01

Cocrystal is a concept of the supramolecular chemistry which is gaining the extensive interest of researchers from pharmaceutical and chemical sciences and of drug regulatory agencies. The prominent reason of which is its ability to modify physicochemical properties of active pharmaceutical ingredients. During the development of the pharmaceutical product, formulators have to optimize the physicochemical properties of active pharmaceutical ingredients. Pharmaceutical cocrystals can be employed to improve vital physicochemical characteristics of a drug, including solubility, dissolution, bioavailability and stability of pharmaceutical compounds while maintaining its therapeutic activity. It is advantageous being a green synthesis approach for production of pharmaceutical compounds. The formation polymorphic forms, solvates, hydrates and salts of cocrystals during the synthesis reported in the literature which can be a potential issue in the development of pharmaceutical cocrystals. The approaches like hydrogen bonding rules, solubility parameters, screening through the CSD database or thermodynamic characteristics can be utilized for the rational design of cocrystals and selection of coformers for synthesis multi-component cocrystals. Considering the significance of pharmaceutical cocrystals pharmaceutical regulatory authorities in the United States and Europe issued guidance documents which may be helpful for pharmaceutical product registration in these regions. In this article, we deal with the design, synthesis, strategic aspects and characteristics of cocrystals along perspectives on its regulatory and intellectual property considerations.

Protein Chemistry: A Graduate Course in Pharmaceutical Biotechnology at the University of Kansas.

ERIC Educational Resources Information Center

Manning, Mark C.; Mitchell, James W.

1991-01-01

The University of Kansas course in pharmaceutical biotechnology aims at providing students with an understanding of the basic chemical and structural characteristics making protein pharmaceuticals unique and distinct. In addition, stability and analysis of proteins are emphasized. Attention given to molecular biology, drug delivery, and…

Scientific Knowledge and Technology, Animal Experimentation, and Pharmaceutical Development.

PubMed

Kinter, Lewis B; DeGeorge, Joseph J

2016-12-01

Human discovery of pharmacologically active substances is arguably the oldest of the biomedical sciences with origins >3500 years ago. Since ancient times, four major transformations have dramatically impacted pharmaceutical development, each driven by advances in scientific knowledge, technology, and/or regulation: (1) anesthesia, analgesia, and antisepsis; (2) medicinal chemistry; (3) regulatory toxicology; and (4) targeted drug discovery. Animal experimentation in pharmaceutical development is a modern phenomenon dating from the 20th century and enabling several of the four transformations. While each transformation resulted in more effective and/or safer pharmaceuticals, overall attrition, cycle time, cost, numbers of animals used, and low probability of success for new products remain concerns, and pharmaceutical development remains a very high risk business proposition. In this manuscript we review pharmaceutical development since ancient times, describe its coevolution with animal experimentation, and attempt to predict the characteristics of future transformations. © The Author 2016. Published by Oxford University Press on behalf of the Institute for Laboratory Animal Research. All rights reserved. For permissions, please email: journals.permissions@oup.com.

Pharmaceuticals Exposed to the Space Environment: Problems and Prospects

NASA Technical Reports Server (NTRS)

Jaworske, Donald A.; Myers, Jerry G.

2016-01-01

The NASA Human Research Program (HRP) Health Countermeasures Element maintains ongoing efforts to inform detailed risks, gaps, and further questions associated with the use of pharmaceuticals in space. Most recently, the Pharmacology Risk Report, released in 2010, illustrates the problems associated with maintaining pharmaceutical efficacy. Since the report, one key publication includes evaluation of pharmaceutical products stored on the International Space Station (ISS). This study shows that selected pharmaceuticals on ISS have a shorter shelf-life in space than corresponding terrestrial controls. The HRP Human Research Roadmap for planetary exploration identifies the risk of ineffective or toxic medications due to long-term storage during missions to Mars. The roadmap also identifies the need to understand and predict how pharmaceuticals will behave when exposed to radiation for long durations. Terrestrial studies of returned samples offer a start for predictive modeling. This paper shows that pharmaceuticals returned to Earth for post-flight analyses are amenable to a Weibull distribution analysis in order to support probabilistic risk assessment modeling. The paper also considers the prospect of passive payloads of key pharmaceuticals on sample return missions outside of Earth's magnetic field to gather additional statistics. Ongoing work in radiation chemistry suggests possible mitigation strategies where future work could be done at cryogenic temperatures to explore methods for preserving the strength of pharmaceuticals in the space radiation environment, perhaps one day leading to an architecture where pharmaceuticals are cached on the Martian surface and preserved cryogenically.

MICROWAVE-ASSISTED GREENER SYNTHESIS OF PHARMACEUTICALLY ACTIVE HETEROCYCLES UNDER BENIGN CONDITIONS

EPA Science Inventory

Green chemistry is a rapidly developing new field that provides us a proactive avenue for the sustainable development of future science and technologies. Environmentally benign protocols have been developed for the synthesis of various pharmaceutically active heterocycles namely ...

Pharmaceutical product development: A quality by design approach

PubMed Central

Pramod, Kannissery; Tahir, M. Abu; Charoo, Naseem A.; Ansari, Shahid H.; Ali, Javed

2016-01-01

The application of quality by design (QbD) in pharmaceutical product development is now a thrust area for the regulatory authorities and the pharmaceutical industry. International Conference on Harmonization and United States Food and Drug Administration (USFDA) emphasized the principles and applications of QbD in pharmaceutical development in their guidance for the industry. QbD attributes are addressed in question-based review, developed by USFDA for chemistry, manufacturing, and controls section of abbreviated new drug applications. QbD principles, when implemented, lead to a successful product development, subsequent prompt regulatory approval, reduce exhaustive validation burden, and significantly reduce post-approval changes. The key elements of QbD viz., target product quality profile, critical quality attributes, risk assessments, design space, control strategy, product lifecycle management, and continual improvement are discussed to understand the performance of dosage forms within design space. Design of experiments, risk assessment tools, and process analytical technology are also discussed for their role in QbD. This review underlines the importance of QbD in inculcating science-based approach in pharmaceutical product development. PMID:27606256

Pharmaceutical product development: A quality by design approach.

PubMed

Pramod, Kannissery; Tahir, M Abu; Charoo, Naseem A; Ansari, Shahid H; Ali, Javed

2016-01-01

The application of quality by design (QbD) in pharmaceutical product development is now a thrust area for the regulatory authorities and the pharmaceutical industry. International Conference on Harmonization and United States Food and Drug Administration (USFDA) emphasized the principles and applications of QbD in pharmaceutical development in their guidance for the industry. QbD attributes are addressed in question-based review, developed by USFDA for chemistry, manufacturing, and controls section of abbreviated new drug applications. QbD principles, when implemented, lead to a successful product development, subsequent prompt regulatory approval, reduce exhaustive validation burden, and significantly reduce post-approval changes. The key elements of QbD viz., target product quality profile, critical quality attributes, risk assessments, design space, control strategy, product lifecycle management, and continual improvement are discussed to understand the performance of dosage forms within design space. Design of experiments, risk assessment tools, and process analytical technology are also discussed for their role in QbD. This review underlines the importance of QbD in inculcating science-based approach in pharmaceutical product development.

The route from problem to solution in multistep continuous flow synthesis of pharmaceutical compounds.

PubMed

Bana, Péter; Örkényi, Róbert; Lövei, Klára; Lakó, Ágnes; Túrós, György István; Éles, János; Faigl, Ferenc; Greiner, István

2017-12-01

Recent advances in the field of continuous flow chemistry allow the multistep preparation of complex molecules such as APIs (Active Pharmaceutical Ingredients) in a telescoped manner. Numerous examples of laboratory-scale applications are described, which are pointing towards novel manufacturing processes of pharmaceutical compounds, in accordance with recent regulatory, economical and quality guidances. The chemical and technical knowledge gained during these studies is considerable; nevertheless, connecting several individual chemical transformations and the attached analytics and purification holds hidden traps. In this review, we summarize innovative solutions for these challenges, in order to benefit chemists aiming to exploit flow chemistry systems for the synthesis of biologically active molecules. Copyright © 2016 Elsevier Ltd. All rights reserved.

Inkjet printing for pharmaceutics - A review of research and manufacturing.

PubMed

Daly, Ronan; Harrington, Tomás S; Martin, Graham D; Hutchings, Ian M

2015-10-30

Global regulatory, manufacturing and consumer trends are driving a need for change in current pharmaceutical sector business models, with a specific focus on the inherently expensive research costs, high-risk capital-intensive scale-up and the traditional centralised batch manufacturing paradigm. New technologies, such as inkjet printing, are being explored to radically transform pharmaceutical production processing and the end-to-end supply chain. This review provides a brief summary of inkjet printing technologies and their current applications in manufacturing before examining the business context driving the exploration of inkjet printing in the pharmaceutical sector. We then examine the trends reported in the literature for pharmaceutical printing, followed by the scientific considerations and challenges facing the adoption of this technology. We demonstrate that research activities are highly diverse, targeting a broad range of pharmaceutical types and printing systems. To mitigate this complexity we show that by categorising findings in terms of targeted business models and Active Pharmaceutical Ingredient (API) chemistry we have a more coherent approach to comparing research findings and can drive efficient translation of a chosen drug to inkjet manufacturing. Copyright © 2015 Elsevier B.V. All rights reserved.

Computational chemistry in pharmaceutical research: at the crossroads.

PubMed

Bajorath, Jürgen

2012-01-01

Computational approaches are an integral part of pharmaceutical research. However, there are many of unsolved key questions that limit the scientific progress in the still evolving computational field and its impact on drug discovery. Importantly, a number of these questions are not new but date back many years. Hence, it might be difficult to conclusively answer them in the foreseeable future. Moreover, the computational field as a whole is characterized by a high degree of heterogeneity and so is, unfortunately, the quality of its scientific output. In light of this situation, it is proposed that changes in scientific standards and culture should be seriously considered now in order to lay a foundation for future progress in computational research.

Drug discovery chemistry: a primer for the non-specialist.

PubMed

Jordan, Allan M; Roughley, Stephen D

2009-08-01

Like all scientific disciplines, drug discovery chemistry is rife with terminology and methodology that can seem intractable to those outside the sphere of synthetic chemistry. Derived from a successful in-house workshop, this Foundation Review aims to demystify some of this inherent terminology, providing the non-specialist with a general insight into the nomenclature, terminology and workflow of medicinal chemists within the pharmaceutical industry.

The 10th Joint Meeting on Medicinal Chemistry (JMMC 2017) Held in Dubrovnik, Croatia.

PubMed

Perković, Ivana; Stepanić, Višnja; Marković, Vesna Gabelica

2018-01-08

The Croatian Chemical Society was established in 1926 and has developed over the decades into a society that actively supports all chemical activities in Croatia. The Society has eight divisions, the youngest of which, the Division of Medicinal and Pharmaceutical Chemistry, was established in 2012 and immediately became a member of the European Federation of Medicinal Chemistry (EFMC). The mission of the Medicinal and Pharmaceutical Chemistry Division is the promotion and development of scientific, professional, and educational activities within the medicinal chemistry community in Croatia, as well as to build partnerships and collaborations with other primarily EU-based medicinal chemistry societies. In Croatia, medicinal chemistry research is ongoing at several institutes, including the University of Zagreb (Faculty of Science, Faculty of Pharmacy and Biochemistry, and Faculty of Chemical Engineering and Technology), national institutes of science (Ruđer Bošković Institute), and private-sector drug discovery companies (CRO Fidelta Ltd.). In order to effectively exchange knowledge, ideas, and scientific results, Croatian medicinal chemists meet twice annually. © 2018 Wiley-VCH Verlag GmbH & Co. KGaA, Weinheim.

Recent trends in laboratory automation in the pharmaceutical industry.

PubMed

Rutherford, M L; Stinger, T

2001-05-01

The impact of robotics and automation on the pharmaceutical industry over the last two decades has been significant. In the last ten years, the emphasis of laboratory automation has shifted from the support of manufactured products and quality control of laboratory applications, to research and development. This shift has been the direct result of an increased emphasis on the identification, development and eventual marketing of innovative new products. In this article, we will briefly identify and discuss some of the current trends in laboratory automation in the pharmaceutical industry as they apply to research and development, including screening, sample management, combinatorial chemistry, ADME/Tox and pharmacokinetics.

Pharmaceutical structure montages as catalysts for design and discovery.

PubMed

Njarðarson, Jon T

2012-05-01

Majority of pharmaceuticals are small molecule organic compounds. Their structures are most effectively described and communicated using the graphical language of organic chemistry. A few years ago we decided to harness this powerful language to create new educational tools that could serve well for data mining and as catalysts for discovery. The results were the Top 200 drug posters, which we have posted online for everyone to enjoy and update yearly. This article details the origin and motivation for our design and highlights the value of this graphical format by presenting and analyzing a new pharmaceutical structure montage (poster) focused on US FDA approved drugs in 2011.

Pharmaceutical sciences' manpower supply and internal rate of return.

PubMed

Hartzema, A G; Perfetto, E

1991-06-01

A pharmacy student has many career options upon graduation. These options include graduate education in one of the pharmaceutical sciences and a retail pharmacy position. The attractive salaries offered by chain pharmacies play an important role in the recent graduate's career decision-making process. The purpose of this study is to provide a comparative assessment of the internal rate of return (IRR) for different pharmaceutical science career options as related to chain-store pharmacist earnings. Additionally, this study analyzes the effect of the IRR on the applicant pool size and composition for graduate study in pharmaceutical sciences. Income/age profiles were developed using public domain income data derived from salary surveys sponsored by professional associations. Based on these income/age profiles, IRRs were estimated for the pharmaceutical science disciplines, clinical pharmacy, pharmaceutics, medicinal chemistry, and pharmacy administration, and further differentiated for industry versus academic careers. The IRRs are the highest for Pharm.D.'s in academic careers (16.0%), followed by pharmaceutical scientists employed by pharmaceutical industry (8.13%). The IRR of pharmaceutical scientists in academia is lower than the return of other financial investment vehicles. Other authors have established a relationship between the IRR of a profession and a rise or decline in the applicant pool. The IRRs calculated here imply that this association can also be observed for the pharmaceutical scientist applicant pool. Low IRRs should result in a declining applicant pool. However, the last decade has shown an increase of 66% in the number of Ph.D.'s granted, while the percentage of Ph.D.'s granted to nonpharmacists or non-Americans has not increased significantly over the same time period.(ABSTRACT TRUNCATED AT 250 WORDS)

Combinatorial nanodiamond in pharmaceutical and biomedical applications.

PubMed

Lim, Dae Gon; Prim, Racelly Ena; Kim, Ki Hyun; Kang, Eunah; Park, Kinam; Jeong, Seong Hoon

2016-11-30

One of the newly emerging carbon materials, nanodiamond (ND), has been exploited for use in traditional electric materials and this has extended into biomedical and pharmaceutical applications. Recently, NDs have attained significant interests as a multifunctional and combinational drug delivery system. ND studies have provided insights into granting new potentials with their wide ranging surface chemistry, complex formation with biopolymers, and combination with biomolecules. The studies that have proved ND inertness, biocompatibility, and low toxicity have made NDs much more feasible for use in real in vivo applications. This review gives an understanding of NDs in biomedical engineering and pharmaceuticals, focusing on the classified introduction of ND/drug complexes. In addition, the diverse potential applications that can be obtained with chemical modification are presented. Copyright © 2016 Elsevier B.V. All rights reserved.

Pharmaceutical quality by design: product and process development, understanding, and control.

PubMed

Yu, Lawrence X

2008-04-01

The purpose of this paper is to discuss the pharmaceutical Quality by Design (QbD) and describe how it can be used to ensure pharmaceutical quality. The QbD was described and some of its elements identified. Process parameters and quality attributes were identified for each unit operation during manufacture of solid oral dosage forms. The use of QbD was contrasted with the evaluation of product quality by testing alone. The QbD is a systemic approach to pharmaceutical development. It means designing and developing formulations and manufacturing processes to ensure predefined product quality. Some of the QbD elements include: Defining target product quality profile; Designing product and manufacturing processes; Identifying critical quality attributes, process parameters, and sources of variability; Controlling manufacturing processes to produce consistent quality over time. Using QbD, pharmaceutical quality is assured by understanding and controlling formulation and manufacturing variables. Product testing confirms the product quality. Implementation of QbD will enable transformation of the chemistry, manufacturing, and controls (CMC) review of abbreviated new drug applications (ANDAs) into a science-based pharmaceutical quality assessment.

Early drug discovery and the rise of pharmaceutical chemistry.

PubMed

Jones, Alan Wayne

2011-06-01

Studies in the field of forensic pharmacology and toxicology would not be complete without some knowledge of the history of drug discovery, the various personalities involved, and the events leading to the development and introduction of new therapeutic agents. The first medicinal drugs came from natural sources and existed in the form of herbs, plants, roots, vines and fungi. Until the mid-nineteenth century nature's pharmaceuticals were all that were available to relieve man's pain and suffering. The first synthetic drug, chloral hydrate, was discovered in 1869 and introduced as a sedative-hypnotic; it is still available today in some countries. The first pharmaceutical companies were spin-offs from the textiles and synthetic dye industry and owe much to the rich source of organic chemicals derived from the distillation of coal (coal-tar). The first analgesics and antipyretics, exemplified by phenacetin and acetanilide, were simple chemical derivatives of aniline and p-nitrophenol, both of which were byproducts from coal-tar. An extract from the bark of the white willow tree had been used for centuries to treat various fevers and inflammation. The active principle in white willow, salicin or salicylic acid, had a bitter taste and irritated the gastric mucosa, but a simple chemical modification was much more palatable. This was acetylsalicylic acid, better known as Aspirin®, the first blockbuster drug. At the start of the twentieth century, the first of the barbiturate family of drugs entered the pharmacopoeia and the rest, as they say, is history. Copyright © 2011 John Wiley & Sons, Ltd.

Chemistry in the Time of the Pharaohs

ERIC Educational Resources Information Center

Loyson, Peter

2011-01-01

The Egyptians were known in the ancient world as experts in many applied chemistry fields such as metallurgy, wine and beer making, glass making, paper manufacture, paint pigments, dyes, cosmetics, perfumes, and pharmaceuticals. They made significant developments in the extraction of metals from their ores, especially copper and gold. The…

Consumer Chemistry in the Classroom. Science from the Supermarket.

ERIC Educational Resources Information Center

Sumrall, William J.; Brown, Fred W.

1991-01-01

Activities that show students a practical use for chemistry using common items such as food products, pharmaceuticals, and household products as sources of chemical compounds are presented. The importance of having adequate resource materials available for students is emphasized. (KR)

New insights into liquid chromatography for more eco-friendly analysis of pharmaceuticals.

PubMed

Shaaban, Heba

2016-10-01

Greening the analytical methods used for analysis of pharmaceuticals has been receiving great interest aimed at eliminating or minimizing the amount of organic solvents consumed daily worldwide without loss in chromatographic performance. Traditional analytical LC techniques employed in pharmaceutical analysis consume tremendous amounts of hazardous solvents and consequently generate large amounts of waste. The monetary and ecological impact of using large amounts of solvents and waste disposal motivated the analytical community to search for alternatives to replace polluting analytical methodologies with clean ones. In this context, implementing the principles of green analytical chemistry (GAC) in analytical laboratories is highly desired. This review gives a comprehensive overview on different green LC pathways for implementing GAC principles in analytical laboratories and focuses on evaluating the greenness of LC analytical procedures. This review presents green LC approaches for eco-friendly analysis of pharmaceuticals in industrial, biological, and environmental matrices. Graphical Abstract Green pathways of liquid chromatography for more eco-friendly analysis of pharmaceuticals.

Challenges in Chemistry Graduate Education: A Workshop Summary

ERIC Educational Resources Information Center

National Academies Press, 2012

2012-01-01

Chemistry graduate education is under considerable pressure. Pharmaceutical companies, long a major employer of synthetic organic chemists, are drastically paring back their research divisions to reduce costs. Chemical companies are opening new research and development facilities in Asia rather than in the United States to take advantage of…

Connecting Acids and Bases with Encapsulation... and Chemistry with Nanotechnology

ERIC Educational Resources Information Center

Criswell, Brett

2007-01-01

The features and the development of various new acids and bases activity sets that combines chemistry with nanotechnology are being described. These sets lead to the generation of many nanotechnology-based pharmaceuticals for the treatment of various diseases.

On being green: can flow chemistry help?

PubMed

Ley, Steven V

2012-08-01

The principles of Green Chemistry are important but challenging drivers for most modern synthesis programs. To meet these challenges new flow chemistry tools are proving to be very effective by providing improved heat/mass transfer opportunities, lower solvent usage, less waste generation, hazardous compound containment, and the possibility of a 24/7 working regime. This machine-assisted approach can be used to effect repetitive or routine scale-up steps or when combined with reagent and scavenger cartridges, to achieve multi-step synthesis of complex natural products and pharmaceutical agents. Copyright © 2012 The Japan Chemical Journal Forum and Wiley Periodicals, Inc.

[Historical sketch of modern pharmaceutical science and technology (Part 3). From the second half of the 19th century to World War II].

PubMed

Yamakawa, K

1995-01-01

The history of modern pharmaceutical science and technology, from the second half of the 19th century to the end of World War II, is divided into nine sections for the purpose of discussion. 1. The European medical and pharmaceutical science and technology at the end of the 19th century is reviewed. Pharmacology, bacteriology and biochemistry were built in this period. 2. The Meiji Government accepted Western medicine and medical law and regulations in 1883. Consequently, the Japanese physician changed from Eastern (Kanpooi) to Western (Seiyooi). 3. Modern scientific and engineering education had been accepted in America, England, Germany, and France etc. Foreign scientists and engineers (Oyatoi-gai-kokujin) were educated by practice and theory. The Faculty of Engineering was established in the universities in Japan. This fact is one of the differences in the history of universities in Europe and America. 4. Pharmaceutical education in the Meiji period (1873-1911). Twenty-nine schools of pharmacy were built in this period. However, 20 schools of pharmacy had been closed. Pharmacy and pharmaceutical industry was not established in the Meiji era. 5. The profession of pharmacist in 1873-1944. The policy of medicine was changed by the Meiji Government in 1889, when Western physicians were allowed to prepare medicines for patients, and this practice continues today. Political and technological power of Japanese pharmacists was weak, so their role was not estimated. 6. Consequences of world War I, and the establishment of the pharmaceutical industry. The Sino-Japanese War (1894-95) and Russo-Japanese War (1904-05) were won fortunately. The first pharmaceutical company was established in 1885. At this times, many pharmaceutical manufacturing companies, which were converted from whole sale merchants, were built. Then started the manufacturing of commercial drugs. 7. Hygienic chemistry and some problems of public hygiene. The causes of diseses unique to Japan, such as

Effects of soil properties on the uptake of pharmaceuticals into earthworms.

PubMed

Carter, Laura J; Ryan, Jim J; Boxall, Alistair B A

2016-06-01

Pharmaceuticals can enter the soil environment when animal slurries and sewage sludge are applied to land as a fertiliser or during irrigation with contaminated water. These pharmaceuticals may then be taken up by soil organisms possibly resulting in toxic effects and/or exposure of organisms higher up the food chain. This study investigated the influence of soil properties on the uptake and depuration of pharmaceuticals (carbamazepine, diclofenac, fluoxetine and orlistat) in the earthworm Eisenia fetida. The uptake and accumulation of pharmaceuticals into E. fetida changed depending on soil type. Orlistat exhibited the highest pore water based bioconcentration factors (BCFs) and displayed the largest differences between soil types with BCFs ranging between 30.5 and 115.9. For carbamazepine, diclofenac and fluoxetine BCFs ranged between 1.1 and 1.6, 7.0 and 69.6 and 14.1 and 20.4 respectively. Additional analysis demonstrated that in certain treatments the presence of these chemicals in the soil matrices changed the soil pH over time, with a statistically significant pH difference to control samples. The internal pH of E. fetida also changed as a result of incubation in pharmaceutically spiked soil, in comparison to the control earthworms. These results demonstrate that a combination of soil properties and pharmaceutical physico-chemical properties are important in terms of predicting pharmaceutical uptake in terrestrial systems and that pharmaceuticals can modify soil and internal earthworm chemistry which may hold wider implications for risk assessment. Copyright © 2016 The Authors. Published by Elsevier Ltd.. All rights reserved.

High-Resolution Solid-State NMR Spectroscopy: Characterization of Polymorphism in Cimetidine, a Pharmaceutical Compound

ERIC Educational Resources Information Center

Pacilio, Julia E.; Tokarski, John T.; Quiñones, Rosalynn; Iuliucci, Robbie J.

2014-01-01

High-resolution solid-state NMR (SSNMR) spectroscopy has many advantages as a tool to characterize solid-phase material that finds applications in polymer chemistry, nanotechnology, materials science, biomolecular structure determination, and others, including the pharmaceutical industry. The technology associated with achieving high resolution…

Using an innovative combination of quality-by-design and green analytical chemistry approaches for the development of a stability indicating UHPLC method in pharmaceutical products.

PubMed

Boussès, Christine; Ferey, Ludivine; Vedrines, Elodie; Gaudin, Karen

2015-11-10

An innovative combination of green chemistry and quality by design (QbD) approach is presented through the development of an UHPLC method for the analysis of the main degradation products of dextromethorphan hydrobromide. QbD strategy was integrated to the field of green analytical chemistry to improve method understanding while assuring quality and minimizing environmental impacts, and analyst exposure. This analytical method was thoroughly evaluated by applying risk assessment and multivariate analysis tools. After a scouting phase aimed at selecting a suitable stationary phase and an organic solvent in accordance with green chemistry principles, quality risk assessment tools were applied to determine the critical process parameters (CPPs). The effects of the CPPs on critical quality attributes (CQAs), i.e., resolutions, efficiencies, and solvent consumption were further evaluated by means of a screening design. A response surface methodology was then carried out to model CQAs as function of the selected CPPs and the optimal separation conditions were determined through a desirability analysis. Resulting contour plots enabled to establish the design space (DS) (method operable design region) where all CQAs fulfilled the requirements. An experimental validation of the DS proved that quality within the DS was guaranteed; therefore no more robustness study was required before the validation. Finally, this UHPLC method was validated using the concept of total error and was used to analyze a pharmaceutical drug product. Copyright © 2015 Elsevier B.V. All rights reserved.

A Laboratory Experiment in Pharmaceutical Analysis: Analysis of Diazepam Tablets by High Pressure Liquid Chromatography

ERIC Educational Resources Information Center

Bailey, Leonard

1978-01-01

The experiment described was developed for the third-year course in inorganic and analytical pharmaceutical chemistry to provide students with "hands-on" experience with high pressure liquid chromatography. Assay procedures are given along with experimental parameters and student results. (LBH)

The Impact of Biotechnology upon Chemistry in Pharmacy Schools.

ERIC Educational Resources Information Center

Henkel, James G.; And Others

1990-01-01

Applications of biotechnology to the pharmaceutical industry are examined, and its impact on the research and practical domains of medicinal and natural products chemistry is discussed. Specific curricular implications for undergraduate and graduate study in pharmacy are outlined, and suggestions for faculty development in biotechnology are made.…

Continuous Manufacturing in Pharmaceutical Process Development and Manufacturing.

PubMed

Burcham, Christopher L; Florence, Alastair J; Johnson, Martin D

2018-06-07

The pharmaceutical industry has found new applications for the use of continuous processing for the manufacture of new therapies currently in development. The transformation has been encouraged by regulatory bodies as well as driven by cost reduction, decreased development cycles, access to new chemistries not practical in batch, improved safety, flexible manufacturing platforms, and improved product quality assurance. The transformation from batch to continuous manufacturing processing is the focus of this review. The review is limited to small, chemically synthesized organic molecules and encompasses the manufacture of both active pharmaceutical ingredients (APIs) and the subsequent drug product. Continuous drug product is currently used in approved processes. A few examples of production of APIs under current good manufacturing practice conditions using continuous processing steps have been published in the past five years, but they are lagging behind continuous drug product with respect to regulatory filings.

Recent Trends on the Future of Graduate Education in the Pharmaceutical Sciences and Research

PubMed Central

Kushwaha, KSS; Kushwaha, N; Rai, AK

2010-01-01

Harmonization of pharmacy education has to be made a global agenda that will encompass the developments that have taken place in basic, medical, pharmaceutical sciences in serving the needs and expectations of the society. The professional pharmacy curriculum is designed to produce pharmacists who have the abilities and skills to provide drug information, education, and pharmaceutical care to patients; manage the pharmacy and its medication distribution and control systems; and promote public health. Required coursework for all pharmacy students includes pharmaceutical chemistry; pharmaceutics (drug dosage forms, delivery, and disposition in the human body) pharmacology; therapeutics (the clinical use of drugs and dietary supplements in patients); drug information and analysis; pharmacy administration (including pharmacy law, bioethics, health systems, pharmacoeconomics, medical informatics); clinical skills (physical assessment, patient counseling, drug therapy monitoring for appropriate selection, dose, effect, interactions, use); and clinical pharmacy practice in pharmacies, industry, health maintenance organizations, hospital wards, and ambulatory care clinics. PMID:21264127

High-Throughput Synthetic Chemistry Enabled by Organic Solvent Disintegrating Tablet.

PubMed

Li, Tingting; Xu, Lei; Xing, Yanjun; Xu, Bo

2017-01-17

Synthetic chemistry remains a time- and labor-intensive process of inherent hazardous nature. Our organic solvent disintegrating tablet (O-Tab) technology has shown potential to make industrial/synthetic chemistry more efficient. As is the case with pharmaceutical tablets, our reagent-containing O-Tabs are mechanically strong, but disintegrate rapidly when in contact with reaction media (organic solvents). For O-Tabs containing sensitive chemicals, they can be further coated to insulate them from air and moisture. © 2017 Wiley-VCH Verlag GmbH & Co. KGaA, Weinheim.

Using a Thematic Laboratory-Centered Curriculum to Teach General Chemistry

ERIC Educational Resources Information Center

Hopkins, Todd A.; Samide, Michael

2013-01-01

This article describes an approach to general chemistry that involves teaching chemical concepts in the context of two thematic laboratory modules: environmental remediation and the fate of pharmaceuticals in the environment. These modules were designed based on active-learning pedagogies and involve multiple-week projects that dictate what…

[Investigation of biologically active compounds at the Department of Organic Chemistry of University of Debrecen 1992-2009. Part III].

PubMed

Antus, Sándor

2010-01-01

The author briefly reviews the beginning of the carbohydrate chemistry in Hungary with special regard to the results achieved at the Department of Organic Chemistry of University of Debrecen and summarizes the most important synthetic and pharmaceutical results obtained in this field between 1992-2009, part III.

'Big data' in pharmaceutical science: challenges and opportunities.

PubMed

Dossetter, Al G; Ecker, Gerhard; Laverty, Hugh; Overington, John

2014-05-01

Future Medicinal Chemistry invited a selection of experts to express their views on the current impact of big data in drug discovery and design, as well as speculate on future developments in the field. The topics discussed include the challenges of implementing big data technologies, maintaining the quality and privacy of data sets, and how the industry will need to adapt to welcome the big data era. Their enlightening responses provide a snapshot of the many and varied contributions being made by big data to the advancement of pharmaceutical science.

Halogenase engineering and its utility in medicinal chemistry.

PubMed

Fraley, Amy E; Sherman, David H

2018-06-15

Halogenation is commonly used in medicinal chemistry to improve the potency of pharmaceutical leads. While synthetic methods for halogenation present selectivity and reactivity challenges, halogenases have evolved over time to perform selective reactions under benign conditions. The optimization of halogenation biocatalysts has utilized enzyme evolution and structure-based engineering alongside biotransformation in a variety of systems to generate stable site-selective variants. The recent improvements in halogenase-catalyzed reactions has demonstrated the utility of these biocatalysts for industrial purposes, and their ability to achieve a broad substrate scope implies a synthetic tractability with increasing relevance in medicinal chemistry. Copyright © 2018 Elsevier Ltd. All rights reserved.

Pharmaceutical cocrystals, salts and multicomponent systems; intermolecular interactions and property based design.

PubMed

Berry, David J; Steed, Jonathan W

2017-08-01

As small molecule drugs become harder to develop and less cost effective for patient use, efficient strategies for their property improvement become increasingly important to global health initiatives. Improvements in the physical properties of Active Pharmaceutical Ingredients (APIs), without changes in the covalent chemistry, have long been possible through the application of binary component solids. This was first achieved through the use of pharmaceutical salts, within the last 10-15years with cocrystals and more recently coamorphous systems have also been consciously applied to this problem. In order to rationally discover the best multicomponent phase for drug development, intermolecular interactions need to be considered at all stages of the process. This review highlights the current thinking in this area and the state of the art in: pharmaceutical multicomponent phase design, the intermolecular interactions in these phases, the implications of these interactions on the material properties and the pharmacokinetics in a patient. Copyright © 2017 Elsevier B.V. All rights reserved.

Development of Taiwan's strategies for regulating nanotechnology-based pharmaceuticals harmonized with international considerations.

PubMed

Guo, Jiun-Wen; Lee, Yu-Hsuan; Huang, Hsiau-Wen; Tzou, Mei-Chyun; Wang, Ying-Jan; Tsai, Jui-Chen

2014-01-01

Nanotechnology offers potential in pharmaceuticals and biomedical developments for improving drug delivery systems, medical imaging, diagnosis, cancer therapy, and regenerative medicine. Although there is no international regulation or legislation specifically for nanomedicine, it is agreed worldwide that considerably more attention should be paid to the quality, safety, and efficacy of nanotechnology-based drugs. The US Food and Drug Administration and the European Medicines Agency have provided several draft regulatory guidance and reflection papers to assist the development of nanomedicines. To cope with the impact of nanotechnology and to foster its pharmaceutical applications and development in Taiwan, this article reviews the trends of regulating nanotechnology-based pharmaceuticals in the international community and proposes strategies for Taiwan's regulation harmonized with international considerations. The draft regulatory measures include a chemistry, manufacturing, and controls (CMC) review checklist and guidance for CMC review of liposomal products. These have been submitted for discussion among an expert committee, with membership comprised of multidisciplinary academia, research institutions, the pharmaceutical industry, and regulators, and are currently approaching final consensus. Once a consensus is reached, these mechanisms will be recommended to the Taiwan Food and Drug Administration for jurisdiction and may be initiated as the starting point for regulating nanotechnology-based pharmaceuticals in Taiwan.

Mechanisms of removal of three widespread pharmaceuticals by two clay materials.

PubMed

Dordio, A V; Miranda, S; Prates Ramalho, J P; Carvalho, A J Palace

2017-02-05

Pharmaceutical residues presence in the environment is among nowadays top emergent environmental issues. For removal of such pollutants, adsorption is a generally efficient process that can be complementary to conventional treatment. Research of cheap, widely available adsorbents may make this process economically attractive. The aim of the present work was to evaluate the capacity of two clay materials (exfoliated vermiculite, LECA) to adsorb gemfibrozil, mefenamic acid and naproxen in lab-scale batch assays. Results show that both adsorbents are able to remove the pharmaceuticals from aqueous medium. Although vermiculite exhibited higher adsorption capacities per unit mass of adsorbent, LECA yielded higher absolute removals of the pharmaceuticals due to the larger mass of adsorbent. Quantum chemistry calculations predicted that the forms of binding of the three molecules to the vermiculite surface are essentially identical, but the adsorption isotherm of naproxen differs substantially from the other two's. The linear forms of the latter impose limits at lower concentrations to the removal efficiencies of these pharmaceuticals by vermiculite, thereby electing LECA as more efficient. Notwithstanding, vermiculite's high specific adsorption capacity and also its much faster adsorption kinetics suggest that there may be some benefits in combining both materials as a composite adsorbent solution. Copyright © 2016 Elsevier B.V. All rights reserved.

Chromatographic resolution of closely related species in pharmaceutical chemistry: dehalogenation impurities and mixtures of halogen isomers.

PubMed

Regalado, Erik L; Zhuang, Ping; Chen, Yadan; Makarov, Alexey A; Schafer, Wes A; McGachy, Neil; Welch, Christopher J

2014-01-07

In recent years, the use of halogen-containing molecules has proliferated in the pharmaceutical industry, where the incorporation of halogens, especially fluorine, has become vitally important for blocking metabolism and enhancing the biological activity of pharmaceuticals. The chromatographic separation of halogen-containing pharmaceuticals from associated isomers or dehalogenation impurities can sometimes be quite difficult. In an attempt to identify the best current tools available for addressing this important problem, a survey of the suitability of four chromatographic method development platforms (ultra high-performance liquid chromatography (UHPLC), core shell HPLC, achiral supercritical fluid chromatography (SFC) and chiral SFC) for separating closely related mixtures of halogen-containing pharmaceuticals and their dehalogenated isosteres is described. Of the 132 column and mobile phase combinations examined for each mixture, a small subset of conditions were found to afford the best overall performance, with a single UHPLC method (2.1 × 50 mm, 1.9 μm Hypersil Gold PFP, acetonitrile/methanol based aqueous eluents containing either phosphoric or perchloric acid with 150 mM sodium perchlorate) affording excellent separation for all samples. Similarly, a survey of several families of closely related halogen-containing small molecules representing the diversity of impurities that can sometimes be found in purchased starting materials for synthesis revealed chiral SFC (Chiralcel OJ-3 and Chiralpak IB, isopropanol or ethanol with 25 mM isobutylamine/carbon dioxide) as well as the UHPLC (2.1 × 50 mm, 1.8 μm ZORBAX RRHD Eclipse Plus C18 and the Gold PFP, acetonitrile/methanol based aqueous eluents containing phosphoric acid) as preferred methods.

Recent Advances of Metallocenes for Medicinal Chemistry.

PubMed

Santos, Miguel M; Bastos, Pedro; Catela, Isabelle; Zalewska, Karolina; Branco, Luis C

2017-01-01

The recent advances for the synthesis and application of different metallocenes for Medicinal Chemistry is reviewed. This manuscript presents the different metallocene scaffolds, with special emphasis on ferrocene derivatives, and their potential pharmaceutical application. Over the last years, the synthesis of new metallocene compounds and their biological and medicinal effects against some types of diseases (e.g. anti-tumoral, antibiotics, anti-viral) have been reported. From the medicinal point of view, the attractive properties of metallocene derivatives, such as their high stability, low toxicity and appealing redox behaviors are particularly relevant. This area has attracted many researchers as well as the pharmaceutical industry due to the promising results of some metallocenes, in particular ferrocene compounds, in breast cancer and malaria. Copyright© Bentham Science Publishers; For any queries, please email at epub@benthamscience.org.

Second International Electronic Conference on Medicinal Chemistry (ECMC-2)

PubMed Central

Mayence, Annie; Vanden Eynde, Jean Jacques

2017-01-01

The second International Electronic Conference on Medicinal Chemistry, organized and sponsored by the publisher MDPI AG and the Journal Pharmaceuticals, took place in November 2016 on the SciForum website (www.sciforum.net/conference/ecmc-12). More than 150 authors from 22 countries participated in the event. Selected works presented during the scientific meeting are disclosed in this report. PMID:28146112

Polysaccharide based nanogels in the drug delivery system: Application as the carrier of pharmaceutical agents.

PubMed

Debele, Tilahun Ayane; Mekuria, Shewaye Lakew; Tsai, Hsieh-Chih

2016-11-01

Polysaccharide-based nanoparticles have fascinated attention as a vesicle of different pharmaceutical agents due to their unique multi-functional groups in addition to their physicochemical properties, including biocompatibility and biodegradability. The existence of multi-functional groups on the polysaccharide backbone permits facile chemical or biochemical modification to synthesize polysaccharide based nanoparticles with miscellaneous structures. Polysaccharide-based nanogels have high water content, large surface area for multivalent bioconjugation, tunable size, and interior network for the incorporation of different pharmaceutical agents. These unique properties offer great potential for the utilization of polysaccharide-based nanogels in the drug delivery systems. Hence, this review describes chemistry of certain common polysaccharides, several methodologies used to synthesize polysaccharide nanoparticles and primarily focused on the polysaccharide (or polysaccharide derivative) based nanogels as the carrier of pharmaceutical agents. Copyright © 2016 Elsevier B.V. All rights reserved.

Enabling continuous-flow chemistry in microstructured devices for pharmaceutical and fine-chemical production.

PubMed

Kockmann, Norbert; Gottsponer, Michael; Zimmermann, Bertin; Roberge, Dominique M

2008-01-01

Microstructured devices offer unique transport capabilities for rapid mixing, enhanced heat and mass transfer and can handle small amounts of dangerous or unstable materials. The integration of reaction kinetics into fluid dynamics and transport phenomena is essential for successful application from process design in laboratory to chemical production. Strategies to implement production campaigns up to tons of pharmaceutical chemicals are discussed, based on Lonza projects.

Development of Taiwan’s strategies for regulating nanotechnology-based pharmaceuticals harmonized with international considerations

PubMed Central

Guo, Jiun-Wen; Lee, Yu-Hsuan; Huang, Hsiau-Wen; Tzou, Mei-Chyun; Wang, Ying-Jan; Tsai, Jui-Chen

2014-01-01

Nanotechnology offers potential in pharmaceuticals and biomedical developments for improving drug delivery systems, medical imaging, diagnosis, cancer therapy, and regenerative medicine. Although there is no international regulation or legislation specifically for nanomedicine, it is agreed worldwide that considerably more attention should be paid to the quality, safety, and efficacy of nanotechnology-based drugs. The US Food and Drug Administration and the European Medicines Agency have provided several draft regulatory guidance and reflection papers to assist the development of nanomedicines. To cope with the impact of nanotechnology and to foster its pharmaceutical applications and development in Taiwan, this article reviews the trends of regulating nanotechnology-based pharmaceuticals in the international community and proposes strategies for Taiwan’s regulation harmonized with international considerations. The draft regulatory measures include a chemistry, manufacturing, and controls (CMC) review checklist and guidance for CMC review of liposomal products. These have been submitted for discussion among an expert committee, with membership comprised of multidisciplinary academia, research institutions, the pharmaceutical industry, and regulators, and are currently approaching final consensus. Once a consensus is reached, these mechanisms will be recommended to the Taiwan Food and Drug Administration for jurisdiction and may be initiated as the starting point for regulating nanotechnology-based pharmaceuticals in Taiwan. PMID:25342901

Structurally Based Therapeutic Evaluation: A Therapeutic and Practical Approach to Teaching Medicinal Chemistry.

ERIC Educational Resources Information Center

Alsharif, Naser Z.; And Others

1997-01-01

Explains structurally based therapeutic evaluation of drugs, which uses seven therapeutic criteria in translating chemical and structural knowledge into therapeutic decision making in pharmaceutical care. In a Creighton University (Nebraska) medicinal chemistry course, students apply the approach to solve patient-related therapeutic problems in…

Kent and Riegel's Handbook of industrial chemistry and biotechnology. 11th ed.

DOE Office of Scientific and Technical Information (OSTI.GOV)

Kent, James A.

2007-07-01

This handbook provides extensive information on plastics, rubber, adhesives, textile fibers, pharmaceutical chemistry, synthetic organic chemicals, soaps and detergents, as well as various other major classes of industrial chemistry. There is detailed coverage of coal utilization technology, dyes and dye intermediates, chlor-alkali and heavy chemicals, paints and pigments, chemical explosives, propellants, petroleum and petrochemicals, natural gas, industrial gases, synthetic nitrogen products, fats and oils, sulfur and sulfuric acid, phosphorous and phosphates, wood products, and sweeteners. The chapter on coal is entitled: coal technology for power, liquid fuels and chemicals. 100 ills.

Organic chemistry on solid surfaces

NASA Astrophysics Data System (ADS)

Ma, Zhen; Zaera, Francisco

2006-07-01

Chemistry on solid surfaces is central to many areas of practical interest such as heterogeneous catalysis, tribology, electrochemistry, and materials processing. With the development of many surface-sensitive analytical techniques in the past decades, great advances have been possible in our understanding of such surface chemistry at the molecular level. Earlier studies with model systems, single crystals in particular, have provided rich information about the adsorption and reaction kinetics of simple inorganic molecules. More recently, the same approach has been expanded to the study of the surface chemistry of relatively complex organic molecules, in large measure in connection with the selective synthesis of fine chemicals and pharmaceuticals. In this report, the chemical reactions of organic molecules and fragments on solid surfaces, mainly on single crystals of metals but also on crystals of metal oxides, carbides, nitrides, phosphides, sulfides and semiconductors as well as on more complex models such as bimetallics, alloys, and supported particles, are reviewed. A scheme borrowed from the organometallic and organic chemistry literature is followed in which key examples of representative reactions are cited first, and general reactivity trends in terms of both the reactants and the nature of the surface are then identified to highlight important mechanistic details. An attempt has been made to emphasize recent advances, but key earlier examples are cited as needed. Finally, correlations between surface and organometallic and organic chemistry, the relevance of surface reactions to applied catalysis and materials functionalization, and some promising future directions in this area are briefly discussed.

Perception of the Relevance of Organic Chemistry in a German Pharmacy Students’ Course

PubMed Central

Wehle, Sarah

2016-01-01

Objective. To investigate German pharmacy students’ attitudes toward the relevance of organic chemistry training in Julius Maximilian University (JMU) of Würzburg with regard to subsequent courses in the curricula and in later prospective career options. Methods. Surveys were conducted in the second-year organic chemistry course (50 participants) as well as during the third-year and fourth-year lecture cycle on medicinal and pharmaceutical chemistry (66 participants) in 2014. Results. Students’ attitudes were surprisingly consistent throughout the progress of the degree course. Students considered organic chemistry very relevant to the pharmacy study program (95% junior and 97% senior students), and of importance for their future pharmacy program (88% junior and 94% senior students). With regard to prospective career options, the perceived relevance was considerably lower and attitudes were less homogenous. Conclusions. German pharmacy students at JMU Würzburg consider organic chemistry of high relevance for medicinal chemistry and other courses in JMU’s pharmacy program. PMID:27170811

Perception of the Relevance of Organic Chemistry in a German Pharmacy Students' Course.

PubMed

Wehle, Sarah; Decker, Michael

2016-04-25

Objective. To investigate German pharmacy students' attitudes toward the relevance of organic chemistry training in Julius Maximilian University (JMU) of Würzburg with regard to subsequent courses in the curricula and in later prospective career options. Methods. Surveys were conducted in the second-year organic chemistry course (50 participants) as well as during the third-year and fourth-year lecture cycle on medicinal and pharmaceutical chemistry (66 participants) in 2014. Results. Students' attitudes were surprisingly consistent throughout the progress of the degree course. Students considered organic chemistry very relevant to the pharmacy study program (95% junior and 97% senior students), and of importance for their future pharmacy program (88% junior and 94% senior students). With regard to prospective career options, the perceived relevance was considerably lower and attitudes were less homogenous. Conclusions. German pharmacy students at JMU Würzburg consider organic chemistry of high relevance for medicinal chemistry and other courses in JMU's pharmacy program.

Peptide chemistry toolbox - Transforming natural peptides into peptide therapeutics.

PubMed

Erak, Miloš; Bellmann-Sickert, Kathrin; Els-Heindl, Sylvia; Beck-Sickinger, Annette G

2018-06-01

The development of solid phase peptide synthesis has released tremendous opportunities for using synthetic peptides in medicinal applications. In the last decades, peptide therapeutics became an emerging market in pharmaceutical industry. The need for synthetic strategies in order to improve peptidic properties, such as longer half-life, higher bioavailability, increased potency and efficiency is accordingly rising. In this mini-review, we present a toolbox of modifications in peptide chemistry for overcoming the main drawbacks during the transition from natural peptides to peptide therapeutics. Modifications at the level of the peptide backbone, amino acid side chains and higher orders of structures are described. Furthermore, we are discussing the future of peptide therapeutics development and their impact on the pharmaceutical market. Copyright © 2018 Elsevier Ltd. All rights reserved.

[Techniques of mediation. Chemistry as a combination of work, teaching and research: the case of J. F. A. Göttling].

PubMed

Frercks, Jan

2008-01-01

Atypical career of a chemist in Germany around 1800 consisted of being trained as an apothecary, followed by an occupation as a professor at a university or another institution of higher education. These conditions deeply influenced the concept and the practice of chemistry as a science. Johann Friedrich August Göttling is an intriguing example for merging education and daily duties of teaching with the self-image of a scientific chemist. He linked chemical teaching, work, and research by using different hybrid media, such as the Almanach oder Taschenbuch für Scheidekünstler und Apotheker, a stove specifically designed for the narrow student's room, portable laboratories, a pharmaceutical boarding school and textbooks. This allowed him to practice three different forms of chemistry as a science. A "socio-epistemological diagram" of German chemistry around 1800 shows that these forms neatly corresponded to the then predominant three-level epistemology. In particular, the concept of a chemical fact served to link pharmaceutical practice with teaching practice, while granting only the chemistry done by professors the status of a science.

Chemistry and Pharmacology of Citrus sinensis.

PubMed

Favela-Hernández, Juan Manuel J; González-Santiago, Omar; Ramírez-Cabrera, Mónica A; Esquivel-Ferriño, Patricia C; Camacho-Corona, María del Rayo

2016-02-22

Presently the search for new drugs from natural resources is of growing interest to the pharmaceutical industry. Natural products have been the source of new drugs since ancient times. Plants are a good source of secondary metabolites which have been found to have beneficial properties. The present study is a review of the chemistry and pharmacology of Citrus sinensis. This review reveals the therapeutic potential of C. sinensis as a source of natural compounds with important activities that are beneficial for human health that could be used to develop new drugs.

An automated synthesis-purification-sample-management platform for the accelerated generation of pharmaceutical candidates.

PubMed

Sutherland, J David; Tu, Noah P; Nemcek, Thomas A; Searle, Philip A; Hochlowski, Jill E; Djuric, Stevan W; Pan, Jeffrey Y

2014-04-01

A flexible and integrated flow-chemistry-synthesis-purification compound-generation and sample-management platform has been developed to accelerate the production of small-molecule organic-compound drug candidates in pharmaceutical research. Central to the integrated system is a Mitsubishi robot, which hands off samples throughout the process to the next station, including synthesis and purification, sample dispensing for purity and quantification analysis, dry-down, and aliquot generation.

Ranking of pharmaceuticals detected in the environment: aggregation and weighting procedures.

PubMed

Voigt, Kristina; Brüggemann, Rainer

2008-12-01

Pharmaceuticals are omnipresent in waste-water world-wide. Research has shown that many pharmaceuticals are not completely removed during wastewater treatment, and as a result, this has led to their occurrence being reported in waste water treatment plant effluents, rivers and lakes, and more rarely in groundwater and in drinking water. Hence, it is only logical that pharmaceutical residues in the environment and their potential toxic effects have been recognized as one of the emerging research areas in environmental chemistry. A lack of data, especially ecotoxicological and fate data on pharmaceuticals, is evident. The extent to which data are missing should therefore be looked upon in more detail in order to trigger further political steps in performing studies concerning the risk assessment of pharmaceuticals in the environment. In this investigation, we evaluate the data-availability of 16 pharmaceuticals in 17 Internet databases which means we examine a 16 (objects) x 17 (attributes) data-matrix. The consideration of the chosen pharmaceutical in databases is coded 0 = not available, or 1 = available. For the evaluation of the data-matrix, we apply the multi-criteria decision method named METEOR (Method of Evaluation by Order Theory). In contrast to conventional multi-criteria decision aids, like the well-known PROMETHEE, AHP, SMART, ORESTE as well as different versions of ELECTRE, we support the basic consideration of environmetrics: let first the data speak and let us then include subjective preferences in order to get a unique decision. The basis of METEOR is a data-matrix in which the objects are characterized by a set of attributes (indicators). By means of the attributes, a partial order is derived. In the subsequent steps, attributes are aggregated by a weighting procedure, allowing a high degree of involvement of experts, stakeholders and other participants. All conducted approaches show that the data-situation on the chosen test-set of 16 well

Ask the experts: the challenges and benefits of flow chemistry to optimize drug development.

PubMed

Anderson, Neal; Gernaey, Krist V; Jamison, Timothy F; Kircher, Manfred; Wiles, Charlotte; Leadbeater, Nicholas E; Sandford, Graham; Richardson, Paul

2012-09-01

Against a backdrop of a struggling economic and regulatory climate, pharmaceutical companies have recently been forced to develop new ways to provide more efficient technology to meet the demands of a competitive drug industry. This issue, coupled with an increase in patent legislation and a rising generics market, makes these themes common issues in the growth of drug development. As a consequence, the importance of process chemistry and scale-up has never been more under the spotlight. Future Medicinal Chemistry wishes to share the thoughts and opinions of a variety of experts from this field, discussing issues concerning the use of flow chemistry to optimize drug development, the potential regulatory and environmental challenges faced with this, and whether the academic and industrial sectors could benefit from a more harmonized system relevant to process chemistry.

Comparative study on pharmaceuticals adsorption in reclaimed water desalination concentrate using biochar: Impact of salts and organic matter.

PubMed

Lin, Lu; Jiang, Wenbin; Xu, Pei

2017-12-01

The synergistic impact of salts and organic matter on adsorption of ibuprofen and sulfamethoxazole by three types of biochar and an activated carbon was investigated using reclaimed water reverse osmosis (RO) concentrate and synthetic solutions spiked with target organic compounds and non-target water constituents (e.g., Na + , Ca 2+ , Mg 2+ , K + , Cl - , SO 4 2- , alkalinity, humic acid (HA), and bovine serum albumin (BSA)). Kinetic modeling was used to better understand the adsorption process between the carbon adsorbents and pharmaceuticals and to elucidate the impact of water chemistry on pharmaceuticals adsorption. The adsorption capacity of pharmaceuticals by biochar was affected by their physicochemical properties including ash content, specific surface area, charge, pore volume, as well as hydrophobicity, π-energy, and speciation of pharmaceuticals. The adsorption of pharmaceuticals in concentrate was pH-dependent, the kinetic rate constant increased with deceasing pH due to the electrical interactions between pharmaceutical molecules and adsorbents. High salinity and electrolyte ions in RO concentrate improved adsorption, whereas the presence of carbonate species, HA, and BSA hindered the removal of ibuprofen and sulfamethoxazole. This study revealed the correlation of concentrate water quality on adsorption of pharmaceuticals by biochar and activated carbon. Biochar provides a promising alternative to activated carbon for removal of organic contaminants of emerging concerns in various wastewater and concentrate streams. Copyright © 2017 Elsevier B.V. All rights reserved.

Biological Activity of Ionic Liquids and Their Application in Pharmaceutics and Medicine.

PubMed

Egorova, Ksenia S; Gordeev, Evgeniy G; Ananikov, Valentine P

2017-05-24

Ionic liquids are remarkable chemical compounds, which find applications in many areas of modern science. Because of their highly tunable nature and exceptional properties, ionic liquids have become essential players in the fields of synthesis and catalysis, extraction, electrochemistry, analytics, biotechnology, etc. Apart from physical and chemical features of ionic liquids, their high biological activity has been attracting significant attention from biochemists, ecologists, and medical scientists. This Review is dedicated to biological activities of ionic liquids, with a special emphasis on their potential employment in pharmaceutics and medicine. The accumulated data on the biological activity of ionic liquids, including their antimicrobial and cytotoxic properties, are discussed in view of possible applications in drug synthesis and drug delivery systems. Dedicated attention is given to a novel active pharmaceutical ingredient-ionic liquid (API-IL) concept, which suggests using traditional drugs in the form of ionic liquid species. The main aim of this Review is to attract a broad audience of chemical, biological, and medical scientists to study advantages of ionic liquid pharmaceutics. Overall, the discussed data highlight the importance of the research direction defined as "Ioliomics", studies of ions in liquids in modern chemistry, biology, and medicine.

First International Electronic Conference on Medicinal Chemistry (ECMC-1)

PubMed Central

Mayence, Annie; Vanden Eynde, Jean Jacques

2016-01-01

The first International Electronic Conference on Medicinal Chemistry, organized and sponsored by MDPI AG, publisher, and the Journal Pharmaceuticals, took place in November 2015 on the SciForum website. More than 200 authors from 18 countries participated in the event and was attended by 25,000 visitors who had the opportunity to browse among 55 presentations, keynotes, and videos. A short description of some works presented during that scientific meeting is disclosed in this report.

Third International Electronic Conference on Medicinal Chemistry (ECMC-3)

PubMed Central

Mayence, Annie

2018-01-01

The third International Electronic Conference on Medicinal Chemistry, organized and sponsored by MDPI AG, publisher, and the journal Pharmaceuticals, took place in November 2017 on the SciForum website (www.sciforum.net/conference/ecmc-3). Around 300 authors from 34 different countries participated at the event, which hosted more than 70 presentations, keynotes, videos, and posters. A short description of some works presented during that scientific meeting is disclosed in this report. PMID:29425181

Ontologies in medicinal chemistry: current status and future challenges.

PubMed

Gómez-Pérez, Asunción; Martínez-Romero, Marcos; Rodríguez-González, Alejandro; Vázquez, Guillermo; Vázquez-Naya, José M

2013-01-01

Recent years have seen a dramatic increase in the amount and availability of data in the diverse areas of medicinal chemistry, making it possible to achieve significant advances in fields such as the design, synthesis and biological evaluation of compounds. However, with this data explosion, the storage, management and analysis of available data to extract relevant information has become even a more complex task that offers challenging research issues to Artificial Intelligence (AI) scientists. Ontologies have emerged in AI as a key tool to formally represent and semantically organize aspects of the real world. Beyond glossaries or thesauri, ontologies facilitate communication between experts and allow the application of computational techniques to extract useful information from available data. In medicinal chemistry, multiple ontologies have been developed during the last years which contain knowledge about chemical compounds and processes of synthesis of pharmaceutical products. This article reviews the principal standards and ontologies in medicinal chemistry, analyzes their main applications and suggests future directions.

Natural products and combinatorial chemistry: back to the future.

PubMed

Ortholand, Jean-Yves; Ganesan, A

2004-06-01

The introduction of high-throughput synthesis and combinatorial chemistry has precipitated a global decline in the screening of natural products by the pharmaceutical industry. Some companies terminated their natural products program, despite the unproven success of the new technologies. This was a premature decision, as natural products have a long history of providing important medicinal agents. Furthermore, they occupy a complementary region of chemical space compared with the typical synthetic compound library. For these reasons, the interest in natural products has been rekindled. Various approaches have evolved that combine the power of natural products and organic chemistry, ranging from the combinatorial total synthesis of analogues to the exploration of natural product scaffolds and the design of completely unnatural molecules that resemble natural products in their molecular characteristics.

[The effects of the success of the synthesis of Stovaïne in science and industry. Ernest Fourneau (1872-1949) and the transformation of the field of medicinal chemistry in France].

PubMed

Debue-Barazer, Christine

2007-01-01

The synthetic local anaesthetic Stovaine was commercialised in France in 1904. Its inventor, Ernest Fourneau, began his career as a pharmaceutical chemist in organic chemistry laboratories in Germany, where from 1899 to 1901 he discovered how basic research could benefit from the modern chemistry theories which had developed in Germany starting in the 1860s. Using the complex structure of cocaine, he invented an original molecule, with comparable activity, but less toxic. The knowledge and the know-how which he acquired in Germany nourished his reflection in the field of the chemistry of the relationships between structure and activity, and led him to the development of Stovaïne. Emile Roux, Director of the Pasteur Institute in Paris, was interested in his work and invited him to head the first French therapeutic chemistry laboratory, in which research on medicinal chemistry was organised scientifically. The industrial development of new medicines resulting from the Pasteur Institute's therapeutic chemistry laboratory was supported by the Etablissements Poulenc frères, France thus gaining international reputation in the domain of pharmaceutical chemistry.

Nickel-Catalyzed Suzuki-Miyaura Cross-Coupling in a Green Alcohol Solvent for an Undergraduate Organic Chemistry Laboratory.

PubMed

Hie, Liana; Chang, Jonah J; Garg, Neil K

2015-03-10

A modern undergraduate organic chemistry laboratory experiment involving the Suzuki-Miyaura coupling is reported. Although Suzuki-Miyaura couplings typically employ palladium catalysts in environmentally harmful solvents, this experiment features the use of inexpensive nickel catalysis, in addition to a "green" alcohol solvent. The experiment employs heterocyclic substrates, which are important pharmaceutical building blocks. Thus, this laboratory procedure exposes students to a variety of contemporary topics in organic chemistry, including transition metal-catalyzed cross-couplings, green chemistry, and the importance of heterocycles in drug discovery, none of which are well represented in typical undergraduate organic chemistry curricula. The experimental protocol uses commercially available reagents and is useful in both organic and inorganic instructional laboratories.

Student Perceptions of the Benefits of a Learner-Based Writing Assignment in Organic Chemistry

ERIC Educational Resources Information Center

Ablin, Lois

2008-01-01

A writing assignment to increase student understanding of and interest in practical applications of organic chemistry is described. Students were required to study a pharmaceutical or other organic compound and perform a qualitative risk assessment on the chemical. Student perceptions of the benefits of the paper were generally positive. (Contains…

The Evolution of Chemical High-Throughput Experimentation To Address Challenging Problems in Pharmaceutical Synthesis.

PubMed

Krska, Shane W; DiRocco, Daniel A; Dreher, Spencer D; Shevlin, Michael

2017-12-19

The structural complexity of pharmaceuticals presents a significant challenge to modern catalysis. Many published methods that work well on simple substrates often fail when attempts are made to apply them to complex drug intermediates. The use of high-throughput experimentation (HTE) techniques offers a means to overcome this fundamental challenge by facilitating the rational exploration of large arrays of catalysts and reaction conditions in a time- and material-efficient manner. Initial forays into the use of HTE in our laboratories for solving chemistry problems centered around screening of chiral precious-metal catalysts for homogeneous asymmetric hydrogenation. The success of these early efforts in developing efficient catalytic steps for late-stage development programs motivated the desire to increase the scope of this approach to encompass other high-value catalytic chemistries. Doing so, however, required significant advances in reactor and workflow design and automation to enable the effective assembly and agitation of arrays of heterogeneous reaction mixtures and retention of volatile solvents under a wide range of temperatures. Associated innovations in high-throughput analytical chemistry techniques greatly increased the efficiency and reliability of these methods. These evolved HTE techniques have been utilized extensively to develop highly innovative catalysis solutions to the most challenging problems in large-scale pharmaceutical synthesis. Starting with Pd- and Cu-catalyzed cross-coupling chemistry, subsequent efforts expanded to other valuable modern synthetic transformations such as chiral phase-transfer catalysis, photoredox catalysis, and C-H functionalization. As our experience and confidence in HTE techniques matured, we envisioned their application beyond problems in process chemistry to address the needs of medicinal chemists. Here the problem of reaction generality is felt most acutely, and HTE approaches should prove broadly enabling

Opportunities and Challenges of Multinational Pharmaceutical Enterprises in Transforming Pharmaceutical Market in China.

PubMed

Hu, Linfeng; Yu, Zhong; Yuan, Qingwen; Hu, Yuanjia; Ung, Carolina Oi Lam

2018-01-01

The surging costs of health care in China is highly related to the high expenses in pharmaceutical costs. Since the Government of China launched the health care reform in 2009, the issue of growing pharmaceutical expenditure continues to grasp policy makers' attention. Since 2015, an ongoing series of drug-related policies have been revised or developed, resulting in profound impact on the overall pharmaceutical market in China, and the dynamic is still evolving. As China has become the second largest pharmaceutical market in the world, any volatility in the Chinese pharmaceutical market may have great implications to multinational pharmaceutical markets that have had their products launched in China or plan to extend their business to the Chinese market. Based on a comprehensive analysis of the most recent health care reform policies in China, the objectives of this study were to identify the major opportunities appealed to and the challenges confronted by multinational pharmaceutical enterprises in the current Chinese pharmaceutical market.

Selected analytical challenges in the determination of pharmaceuticals in drinking/marine waters and soil/sediment samples.

PubMed

Białk-Bielińska, Anna; Kumirska, Jolanta; Borecka, Marta; Caban, Magda; Paszkiewicz, Monika; Pazdro, Ksenia; Stepnowski, Piotr

2016-03-20

Recent developments and improvements in advanced instruments and analytical methodologies have made the detection of pharmaceuticals at low concentration levels in different environmental matrices possible. As a result of these advances, over the last 15 years residues of these compounds and their metabolites have been detected in different environmental compartments and pharmaceuticals have now become recognized as so-called 'emerging' contaminants. To date, a lot of papers have been published presenting the development of analytical methodologies for the determination of pharmaceuticals in aqueous and solid environmental samples. Many papers have also been published on the application of the new methodologies, mainly to the assessment of the environmental fate of pharmaceuticals. Although impressive improvements have undoubtedly been made, in order to fully understand the behavior of these chemicals in the environment, there are still numerous methodological challenges to be overcome. The aim of this paper therefore, is to present a review of selected recent improvements and challenges in the determination of pharmaceuticals in environmental samples. Special attention has been paid to the strategies used and the current challenges (also in terms of Green Analytical Chemistry) that exist in the analysis of these chemicals in soils, marine environments and drinking waters. There is a particular focus on the applicability of modern sorbents such as carbon nanotubes (CNTs) in sample preparation techniques, to overcome some of the problems that exist in the analysis of pharmaceuticals in different environmental samples. Copyright © 2016 Elsevier B.V. All rights reserved.

Rapid Access to Phospholipid Analogs Using Thiol-yne Chemistry

DTIC Science & Technology

2015-05-19

MONITORING AGENCY NAME(S) AND ADDRESS (ES) U.S. Army Research Office P.O. Box 12211 Research Triangle Park, NC 27709-2211 lipids, membrane, self...functions and material and pharmaceutical applications, straightforward methods to synthesize phospholipids in high yield are limited.10 Phospholipid...This journal is © The Royal Society of Chemistry 2015 Chem. Sci., 2015, 6, 4365–4372 | 4365 Chemical Science EDGE ARTICLE O pe n A cc es s A rt ic le

Application of Emerging Pharmaceutical Technologies for Therapeutic Challenges of Space Exploration Missions

NASA Technical Reports Server (NTRS)

Putcha, Lakshmi

2011-01-01

An important requirement of therapeutics for extended duration exploration missions beyond low Earth orbit will be the development of pharmaceutical technologies suitable for sustained and preventive health care in remote and adverse environmental conditions. Availability of sustained, stable and targeted delivery pharmaceuticals for preventive health of major organ systems including gastrointestinal, hepato-renal, musculo-skeletal and immune function are essential to offset adverse effects of space environment beyond low Earth orbit. Specifically, medical needs may include multi-drug combinations for hormone replacement, radiation protection, immune enhancement and organ function restoration. Additionally, extended stability of pharmaceuticals dispensed in space must be also considered in future drug development. Emerging technologies that can deliver stable and multi-therapy pharmaceutical preparations and delivery systems include nanotechnology based drug delivery platforms, targeted-delivery systems in non-oral and non-parenteral formulation matrices. Synthetic nanomaterials designed with molecular precision offer defined structures, electronics, and chemistries to be efficient drug carriers with clear advantages over conventional materials of drug delivery matricies. Nano-carrier materials like the bottle brush polymers may be suitable for systemic delivery of drug cocktails while Superparamagnetic Iron Oxide Nanoparticles or (SPIONS) have great potential to serve as carriers for targeted drug delivery to a specific site. These and other emerging concepts of drug delivery and extended shelf-life technologies will be reviewed in light of their application to address health-care challenges of exploration missions. Innovations in alternate treatments for sustained immune enhancement and infection control will be also discussed.

Pharmaceutical science faculty publication records at research-intensive pharmacy colleges and schools.

PubMed

Thompson, Dennis F; Nahata, Milap C

2012-11-12

To determine yearly (phase 1) and cumulative (phase 2) publication records of pharmaceutical science faculty members at research-intensive colleges and schools of pharmacy. The publication records of pharmaceutical science faculty members at research-intensive colleges and schools of pharmacy were searched on Web of Science. Fifty colleges and schools of pharmacy were randomly chosen for a search of 1,042 individual faculty members' publications per year from 2005 to 2009. A stratified random sample of 120 faculty members also was chosen, and cumulative publication counts were recorded and bibliometric indices calculated. The median number of publications per year was 2 (range, 0-34). Overall, 22% of faculty members had no publications in any given year, but the number was highly variable depending on the faculty members' colleges or schools of pharmacy. Bibliometric indices were higher for medicinal chemistry and pharmaceutics, with pharmacology ranking third and social and administrative sciences fourth. Higher bibliometric indices were also observed for institution status (ie, public vs private) and academic rank (discipline chairperson vs non-chairperson and professor vs junior faculty member) (p<0.01 for each). The median number of cumulative publications per faculty member was 34 (range, 0-370). Significant differences exist in yearly and cumulative publication rates for faculty members and bibliometric indices among pharmaceutical science disciplines and academic ranks within research-intensive colleges and schools of pharmacy. These data may be important for benchmarking purposes.

Drug Synthesis and Analysis on a Dime: A Capstone Medicinal Chemistry Experience for the Undergraduate Biochemistry Laboratory

ERIC Educational Resources Information Center

Streu, Craig N.; Reif, Randall D.; Neiles, Kelly Y.; Schech, Amanda J.; Mertz, Pamela S.

2016-01-01

Integrative, research-based experiences have shown tremendous potential as effective pedagogical approaches. Pharmaceutical development is an exciting field that draws heavily on organic chemistry and biochemistry techniques. A capstone drug synthesis/analysis laboratory is described where biochemistry students synthesize azo-stilbenoid compounds…

Ovation Pharmaceuticals, Inc.

PubMed

Deutsch, Barry

2002-11-01

Ovation Pharmaceuticals, Inc. is a privately held specialty pharmaceutical company that focuses on products in central nervous system (CNS) disorders, oncology and other therapeutic areas where a small number of specialized physicians treat patients. Ovation serves unmet medical needs by acquiring underpromoted branded pharmaceutical products and promising late-stage development products no longer being actively promoted or developed by larger companies. Ovation supports acquired products through active sales and marketing activities and a clinical development program focused on new formulations, new indications and other product improvements. In April 2002, Ovation received a US$150 million commitment in private equity financing, believed to be the largest private equity investment received to date by an early-stage specialty pharmaceutical firm. Ovation used a portion of those funds to purchase its first two products from a major pharmaceutical company in August 2002.

Interview with Future Medicinal Chemistry's US Senior Editor, Iwao Ojima. Interview by Issac Bruce.

PubMed

Ojima, Iwao

2012-10-01

Professor Iwao Ojima studied at the University of Tokyo (Japan) before being appointed as a Senior Research Fellow and Group Leader at the Sagami Institute of Chemical Research. He is now Director of the Institute of Chemical Biology and Drug Discovery at State University of New York (USA) and has been a visiting professor in European, North American and Asian academic institutions. Professor Ojima agreed to serve as the US Senior Editor of Future Medicinal Chemistry when it launched in 2009 and continues to provide his expertise to the journal. Professor Ojima spoke to Future Medicinal Chemistry about why medicinal chemistry is such an exciting field to work in, the state of the pharmaceutical industry, and what features and issues make this journal unique.

ENVIRONMENTAL ANALYTICAL CHEMISTRY OF PHARMACEUTICAL AND PERSONAL CARE PRODUCTS: THE SEPARATIONS FOCUS TURNS TO POLAR ANALYTES

EPA Science Inventory

Within the scope of a number of emerging contaminant issues in environmental analysis, one area that has received a great deal of public interest has been the assessment of the role of pharmaceuticals and personal care products (PPCPs) as stressors and agents of change in ecosyst...

Does brand differentiate pharmaceuticals?

PubMed

Bednarik, Josef

2005-12-01

Role of marketing in pharmaceutical industry is increasing and inspiration by successful brands known from consumer goods market influenced pharmaceutical companies enough to switch their attention to branding initiatives. Still there is little evidence that pharmaceutical brands represent anything more than product only. This study aims to explore the area of branding in pharmaceutical industry. Central hypothesis of the research has been that brand and its emotional content differentiate pharmaceuticals as well as rational data derived from clinical studies. It has been tested by extensive review of available literature as well as by primary research focused on drivers of physicians' attitudes towards products and their influence on prescribing behavior. The research has been conducted in the sample of psychiatrists in the Czech Republic. No evidence about pharmaceutical brand exceeding value of product has been found in reviewed literature. Nevertheless, the primary research conducted in the sample of Czech psychiatrists indicates that emotional brand in pharmaceutical industry exists and enables author to draw a model of Customer/product life cycle that describes likely impact of functional, emotional and self-expressive benefits throughout pharmaceutical product's market presence. Pharmaceutical brand is likely to develop differently than the same of consumer goods products--it seems to be built predominantly on long-term positive experience. Marketing role in this process should lie in finding relevant product position and building brand identity compliant with real product capabilities.

Pharmaceutical manufacturing facility discharges can substantially increase the pharmaceutical load to U.S. wastewaters

USGS Publications Warehouse

Scott, Tia-Marie; Phillips, Patrick J.; Kolpin, Dana W.; Colella, Kaitlyn M.; Furlong, Edward T.; Foreman, William T.; Gray, James L.

2018-01-01

Discharges from pharmaceutical manufacturing facilities (PMFs) previously have been identified as important sources of pharmaceuticals to the environment. Yet few studies are available to establish the influence of PMFs on the pharmaceutical source contribution to wastewater treatment plants (WWTPs) and waterways at the national scale. Consequently, a national network of 13 WWTPs receiving PMF discharges, six WWTPs with no PMF input, and one WWTP that transitioned through a PMF closure were selected from across the United States to assess the influence of PMF inputs on pharmaceutical loading to WWTPs. Effluent samples were analyzed for 120 pharmaceuticals and pharmaceutical degradates. Of these, 33 pharmaceuticals had concentrations substantially higher in PMF-influenced effluent (maximum 555,000 ng/L) compared to effluent from control sites (maximum 175 ng/L). Concentrations in WWTP receiving PMF input are variable, as discharges from PMFs are episodic, indicating that production activities can vary substantially over relatively short (several months) periods and have the potential to rapidly transition to other pharmaceutical products. Results show that PMFs are an important, national-scale source of pharmaceuticals to the environment.

PHARMACEUTICALS IN THE ENVIRONMENT: OVERVIEW ...

EPA Pesticide Factsheets

Pharmaceuticals and personal care products (PPCPs) comprise a large and diverse array of unregulated pollutants that can occur in the environment from the combined activities and actions of multitudes of individuals as well as from veterinary and agricultural use (http://epa.gov/nerlesd1/chemistry/pharma/images/drawing.pdf). Concerted research that began in Europe about two decades ago, and in the u.s. in the late 1990s, has begun escalating in the last few years. Investigation that was originally limited to studying the sources, origins, and occurrence of PPCPs primarily in waters has now expanded to encompass occurrence in other matrices and to consider the complexities involved with the range of unanticipated and subtle effects that might occur from low-dose. chronic exposure of non-target organisms. Risk management options designed around the principles of pollution prevention and environmental stewardship are also under discussion in the healthcare community. This paper will focus on the efforts being coordinated by the U.S. Environmental Protection Agency, much of which is captured on the PPCPs web site: http://epa.gov/nerlesd1/chemistry/pharma/. The research focused on in the subtasks is the development and application of state-of the-art technologies to meet the needs of the public, Office of Water, and ORD in the area of Water Quality. Located In the subtasks are the various research projects being performed in support of this Task and more in-depth co

Enabling Chemistry Technologies and Parallel Synthesis-Accelerators of Drug Discovery Programmes.

PubMed

Vasudevan, A; Bogdan, A R; Koolman, H F; Wang, Y; Djuric, S W

There is a pressing need to improve overall productivity in the pharmaceutical industry. Judicious investments in chemistry technologies can have a significant impact on cycle times, cost of goods and probability of technical success. This perspective describes some of these technologies developed and implemented at AbbVie, and their applications to the synthesis of novel scaffolds and to parallel synthesis. © 2017 Elsevier B.V. All rights reserved.

Colloids as a sink for certain pharmaceuticals in the aquatic environment.

PubMed

Maskaoui, Khalid; Zhou, John L

2010-05-01

The occurrence and fate of pharmaceuticals in the aquatic environment is recognized as one of the emerging issues in environmental chemistry and as a matter of public concern. Existing data tend to focus on the concentrations of pharmaceuticals in the aqueous phase, with limited studies on their concentrations in particulate phase such as sediments. Furthermore, current water quality monitoring does not differentiate between soluble and colloidal phases in water samples, hindering our understanding of the bioavailability and bioaccumulation of pharmaceuticals in aquatic organisms. In this study, an investigation was conducted into the concentrations and phase association (soluble, colloidal, suspended particulate matter or SPM) of selected pharmaceuticals (propranolol, sulfamethoxazole, meberverine, thioridazine, carbamazepine, tamoxifen, indomethacine, diclofenac, and meclofenamic acid) in river water, effluents from sewage treatment works (STW), and groundwater in the UK. The occurrence and phase association of selected pharmaceuticals propranolol, sulfamethoxazole, meberverine, thioridazine, carbamazepine, tamoxifen, indomethacine, diclofenac, and meclofenamic acid in contrasting aquatic environments (river, sewage effluent, and groundwater) were studied. Colloids were isolated by cross-flow ultrafiltration (CFUF). Water samples were extracted by solid-phase extraction (SPE), while SPM was extracted by microwave. All sample extracts were analyzed by liquid chromatography-tandem mass spectrometry (LC-MS/MS) in the multiple reaction monitoring. Five compounds propranolol, sulfamethoxazole, carbamazepine, indomethacine, and diclofenac were detected in all samples, with carbamazepine showing the highest concentrations in all phases. The highest concentrations of these compounds were detected in STW effluents, confirming STW as a key source of these compounds in the aquatic environments. The calculation of partition coefficients of pharmaceuticals between SPM and

[Pharmaceutical logistic in turnover of pharmaceutical products of Azerbaijan].

PubMed

Dzhalilova, K I

2009-11-01

Development of pharmaceutical logistic system model promotes optimal strategy for pharmaceutical functioning. The goal of such systems is organization of pharmaceutical product's turnover in required quantity and assortment, at preset time and place, at a highest possible degree of consumption readiness with minimal expenses and qualitative service. Organization of the optimal turnover chain in the region is offered to start from approximate classification of medicaments by logistic characteristics. Supplier selection was performed by evaluation of timeliness of delivery, quality of delivered products (according to the minimum acceptable level of quality) and time-keeping of time spending for orders delivery.

THz spectroscopy: An emerging technology for pharmaceutical development and pharmaceutical Process Analytical Technology (PAT) applications

NASA Astrophysics Data System (ADS)

Wu, Huiquan; Khan, Mansoor

2012-08-01

As an emerging technology, THz spectroscopy has gained increasing attention in the pharmaceutical area during the last decade. This attention is due to the fact that (1) it provides a promising alternative approach for in-depth understanding of both intermolecular interaction among pharmaceutical molecules and pharmaceutical product quality attributes; (2) it provides a promising alternative approach for enhanced process understanding of certain pharmaceutical manufacturing processes; and (3) the FDA pharmaceutical quality initiatives, most noticeably, the Process Analytical Technology (PAT) initiative. In this work, the current status and progress made so far on using THz spectroscopy for pharmaceutical development and pharmaceutical PAT applications are reviewed. In the spirit of demonstrating the utility of first principles modeling approach for addressing model validation challenge and reducing unnecessary model validation "burden" for facilitating THz pharmaceutical PAT applications, two scientific case studies based on published THz spectroscopy measurement results are created and discussed. Furthermore, other technical challenges and opportunities associated with adapting THz spectroscopy as a pharmaceutical PAT tool are highlighted.

Functionalization of chitosan by click chemistry

NASA Astrophysics Data System (ADS)

Cheaburu-Yilmaz, Catalina Natalia; Karavana, Sinem Yaprak; Yilmaz, Onur

2017-12-01

Chitosan modification represents a challenge nowadays. The variety of compounds which can be obtained with various architectures and different functionalities made it attractive to be used in fields like pharmacy and material science. Presents study deals with the chemical modification of chitosan by using click chemistry technique. The study adopted the approach of clicking azidated chitosan with a synthesized alkyne terminated polymer i.e. poly N isopropylacrylamide with thermoresponsive properties. Structures were confirmed by the FT-IR and HNMR spectra. Thermal characterization was performed showing different thermal behaviour with the chemical modification. The final synthesized graft copolymer can play important role within pharmaceutical formulations carrying drugs for topical or oral treatments.

Evaluation of P-Listed Pharmaceutical Residues in Empty Pharmaceutical Containers

EPA Science Inventory

Under the Resource Conservation and Recovery Act (RCRA), some pharmaceuticals are considered acute hazardous wastes because their sole active pharmaceutical ingredients are P-listed commercial chemical products (40 CFR 261.33). Hospitals and other healthcare facilities have stru...

Kitchen chemistry: A scoping review of the diversionary use of pharmaceuticals for non-medicinal use and home production of drug solutions.

PubMed

Van Hout, Marie Claire

2014-01-01

Misuse of pharmaceuticals is of increasing drug policy and public health concern. A scoping review was conducted on the diversionary use of pharmaceuticals for non-medicinal use and home production of drug solutions. The research question was broad: What is known from the existing literature about the diversion of pharmaceuticals for non-medicinal use and for home production of drug solutions? The scoping process centred on the systematic selection, collection, and summarization of extant knowledge within this broad thematic remit. One hundred and thirty-four records were grouped into discrete thematic categories namely: non medicinal use and tampering with pharmaceuticals, oral misuse of codeine cough syrups, homemade drug solutions, and home-produced drug-related harms in the narrative review design. Forms of abuse of codeine cough syrup include mixtures with alcohol or soft drinks ('Purple Drank'), with kratom leaves ('Kratom cocktails'), or chemically altered to extract dextromorphan ('Lemon Drop'). Production of homemade opiates ('Cheornaya', 'Kolyosa', Himiya', 'Braun', 'Krokodil'), methamphetamine ('Vint', 'Pervitin'), methcathinone ('Jeff'), and cathinone ('Boltushka') are described. Displacement patterns between the non-medical use of pharmaceuticals, commercial, and homemade drugs appear dependent on availability of opiates, prescribing practices, supervision of substitution drug dosing, availability of cheap ingredients, policing, and awareness of harms. Adverse health and social consequences relate to the use of unknown and contaminated (end) substances, injecting practices, redosing, medical complications, and death. The review highlights a public health imperative requiring a multidisciplinary approach to quantify potential impact and required integrated policy responses incorporating international regulation, enforcement, health surveillance and service delivery. Copyright © 2014 John Wiley & Sons, Ltd.

Virtual pharmaceutical companies: collaborating flexibly in pharmaceutical development.

PubMed

Forster, Simon P; Stegmaier, Julia; Spycher, Rene; Seeger, Stefan

2014-03-01

Research and development (R&D) collaborations represent one approach chosen by the pharmaceutical industry to tackle current challenges posed by declining internal R&D success rates and fading of the blockbuster model. In recent years, a flexible concept to collaborate in R&D has emerged: virtual pharmaceutical companies (VPCs). These differ from other R&D companies, such as biotech start-ups, collaborating with big pharmaceutical companies, because they solely comprise experienced teams of managers. VPCs have only been described anecdotally in literature. Thus, we present here the characteristics of a VPC and suggest how big pharma can leverage the concept of VPCs by introducing five possible modes of collaboration. We find that one mode, investing, is particularly promising for big pharma. Copyright © 2013 Elsevier Ltd. All rights reserved.

Neotropics and natural ingredients for pharmaceuticals: why isn't South American biodiversity on the crest of the wave?

PubMed

Desmarchelier, Cristian

2010-06-01

Despite the advent of biotechnology and modern methods of combinatorial chemistry and rational drug design, nature still plays a surprisingly important role as a source of new pharmaceutical compounds. These are marketed either as herbal drugs or as single active ingredients. South American tropical ecosystems (or the Neotropics) encompass one-third of the botanical biodiversity of the planet. For centuries, indigenous peoples have been using plants for healing purposes, and scientists are making considerable efforts in order to validate these uses from a pharmacological/phytochemical point of view. However, and despite the unique plant diversity in the region, very few natural pharmaceutical ingredients from this part of the world have reached the markets in industrialized countries. The present review addresses the importance of single active ingredients and herbal drugs from South American flora as natural ingredients for pharmaceuticals; it highlights the most relevant cases in terms of species of interest; and discusses the key entry barriers for these products in industrialized countries. It explores the reasons why, in spite of the region's competitive advantages, South American biodiversity has been a poor source of natural ingredients for the pharmaceutical industry. (c) 2010 John Wiley & Sons, Ltd.

ANALYTICAL CHEMISTRY RESEARCH NEEDS FOR MAPPING TRENDS OF PHARMACEUTICAL AND PERSONAL CARE PRODUCT POLLUTION FROM PERSONAL USE

EPA Science Inventory

The consensus among environmental scientists and risk assessors is that the fate and effects of pharmaceutical and personal care products (PPCPS) in the environment are poorly understood. Many classes of PPCPs have yet to be investigated. Acquisition of trends data for a suite of...

Early pharmaceutical profiling to predict oral drug absorption: current status and unmet needs.

PubMed

Bergström, Christel A S; Holm, René; Jørgensen, Søren Astrup; Andersson, Sara B E; Artursson, Per; Beato, Stefania; Borde, Anders; Box, Karl; Brewster, Marcus; Dressman, Jennifer; Feng, Kung-I; Halbert, Gavin; Kostewicz, Edmund; McAllister, Mark; Muenster, Uwe; Thinnes, Julian; Taylor, Robert; Mullertz, Anette

2014-06-16

Preformulation measurements are used to estimate the fraction absorbed in vivo for orally administered compounds and thereby allow an early evaluation of the need for enabling formulations. As part of the Oral Biopharmaceutical Tools (OrBiTo) project, this review provides a summary of the pharmaceutical profiling methods available, with focus on in silico and in vitro models typically used to forecast active pharmaceutical ingredient's (APIs) in vivo performance after oral administration. An overview of the composition of human, animal and simulated gastrointestinal (GI) fluids is provided and state-of-the art methodologies to study API properties impacting on oral absorption are reviewed. Assays performed during early development, i.e. physicochemical characterization, dissolution profiles under physiological conditions, permeability assays and the impact of excipients on these properties are discussed in detail and future demands on pharmaceutical profiling are identified. It is expected that innovative computational and experimental methods that better describe molecular processes involved in vivo during dissolution and absorption of APIs will be developed in the OrBiTo. These methods will provide early insights into successful pathways (medicinal chemistry or formulation strategy) and are anticipated to increase the number of new APIs with good oral absorption being discovered. Copyright © 2013 Elsevier B.V. All rights reserved.

[Drugs and pharmaceutical episodes in "Sazae-San": Japanese comic strips in 1940s-1970s].

PubMed

Goino, Masahiko

2009-01-01

This is a report on episodes with references to drugs and pharmaceuticals in one of the most famous Japanese comic strips, "Sazae-san", in the period from 1945 to 1974. There were 111 episodes of "Sazae-san" including references to drugs and pharmaceuticals in this period. In the period from 1945 to 1954, there were some references to pharmacists and pharmacies but only a small number of references in the period from 1965 to 1974. In the period from 1945 to 1954, there were references to disinfectants and insecticides in the hygienic chemistry field. However, in the period from 1965 to 1974, there were references to environmental problems, food additives and agricultural chemicals. As drug development has progressed, the number of references to practical drugs in "Sazae-san" has decreased over the period from 1945-1974.

Role of Biocatalysis in Sustainable Chemistry.

PubMed

Sheldon, Roger A; Woodley, John M

2018-01-24

Based on the principles and metrics of green chemistry and sustainable development, biocatalysis is both a green and sustainable technology. This is largely a result of the spectacular advances in molecular biology and biotechnology achieved in the past two decades. Protein engineering has enabled the optimization of existing enzymes and the invention of entirely new biocatalytic reactions that were previously unknown in Nature. It is now eminently feasible to develop enzymatic transformations to fit predefined parameters, resulting in processes that are truly sustainable by design. This approach has successfully been applied, for example, in the industrial synthesis of active pharmaceutical ingredients. In addition to the use of protein engineering, other aspects of biocatalysis engineering, such as substrate, medium, and reactor engineering, can be utilized to improve the efficiency and cost-effectiveness and, hence, the sustainability of biocatalytic reactions. Furthermore, immobilization of an enzyme can improve its stability and enable its reuse multiple times, resulting in better performance and commercial viability. Consequently, biocatalysis is being widely applied in the production of pharmaceuticals and some commodity chemicals. Moreover, its broader application will be further stimulated in the future by the emerging biobased economy.

The argument for pharmaceutical policy.

PubMed

Traulsen, Janine Morgall; Almarsdóttir, Anna Birna

2005-02-01

Pharmaceutical policy is a global concern. It has become a hot political topic in most countries--developed as well as developing--and can be found on the agenda of international organizations such as WHO, OECD, EU, WTO and even the World Bank. Pharmaceutical policy affects everyone in the world of pharmacy and it is therefore imperative that it be understood, discussed and debated within the pharmacy profession and included in the curriculum of schools of pharmacy. This, the first article in a series, argues for the importance of the academic discipline of pharmaceutical policy analysis and the involvement of pharmacists in this endeavour. The aim of the authors is to stimulate an informed and critical appreciation of this field. The authors begin with an introduction to the field of pharmaceutical policy, introducing several important concepts and current trends including: medicines regulation; how pharmaceutical policy is made; pharmaceutical policy as a dynamic process; and the new public health as a global issue. The article ends with a short description of the remaining five articles in the series which will deal with important aspects of pharmaceutical policy. The topics include: economic pressures on health care systems; drug utilization from the clinical viewpoint (rational use of medicines); the impact of pharmaceutical policy on patients and the patient impact on pharmaceutical policy; the professional perspective; and finally the last article which deals with studying and evaluating pharmaceutical policy.

Direct analysis in real time--high resolution mass spectrometry as a valuable tool for the pharmaceutical drug development.

PubMed

Srbek, Jan; Klejdus, Bořivoj; Douša, Michal; Břicháč, Jiří; Stasiak, Pawel; Reitmajer, Josef; Nováková, Lucie

2014-12-01

In this study, direct analysis in real time-mass spectrometry (DART-MS) was assessed for the analysis of various pharmaceutical formulations with intention to summarize possible applications for the routine pharmaceutical development. As DART is an ambient ionization technique, it allows direct analysis of pharmaceutical samples in solid or liquid form without complex sample preparation, which is often the most time-consuming part of the analytical method. This makes the technique suitable for many application fields, including pharmaceutical drug development. DART mass spectra of more than twenty selected tablets and other common pharmaceutical formulations, i.e. injection solutions, ointments and suppositories developed in the pharmaceutical industry during several recent years are presented. Moreover, as thin-layer chromatography (TLC) is still very popular for the monitoring of the reactions in the synthetic chemistry, several substances were analyzed directly from the TLC plates to demonstrate the simplicity of the technique. Pure substance solutions were spotted onto a TLC plate and then analyzed with DART without separation. This was the first DART-MS study of pharmaceutical dosage forms using DART-Orbitrap combination. The duration of sample analysis by the DART-MS technique lasted several seconds, allowing enough time to collect sufficient number of data points for compound identification. The experimental setup provided excellent mass accuracy and high resolution of the mass spectra which allowed unambiguous identification of the compounds of interest. Finally, DART mass spectrometry was also used for the monitoring of the selected impurity distribution in the atorvastatin tablets. These measurements demonstrated DART to be robust ionization technique, which provided easy-to-interpret mass spectra for the broad range of compounds. DART has high-throughput potential for various types of pharmaceutical analyses and therefore eliminates the time for sample

Generic Pharmaceutical Association (GPhA) - 2015 CMC Workshop (June 9-10, 2015 - Bethesda, Maryland, USA).

PubMed

Komlos, D

2015-07-01

Nearly 400 professionals attended the 2-day Generic Pharmaceutical Association (GPhA) workshop dedicated to fostering discussions on the FDA's chemistry, manufacturing and controls (CMC) expectations for abbreviated new drug applications (ANDAs), enhanced regulatory filing requirements, and other topics, as CMC takes root in the Office of Pharmaceutical Quality (OPQ). Following the keynote address by Janet Woodcock, Director of the FDA's Center for Drug Evaluation and Research (CDER) and Acting Director of OPQ, and an update from the Office of Generic Drugs (OGD) by Ted Sherwood, Acting Director of the OGD's Office of Regulatory Operations, plenary sessions took place covering OPQ updates, management plans, Generic Drug User Fee Amendments of 2012 (GDUFA) backlog, year 1 and 2 cohorts, drug substance, defining starting materials, quality related refuse-to-receive standards, risk and team-based integrated quality assessment, deficiencies and information requests - CMC submissions, emerging technologies, compliance and inspection, lifecycle management of drug products, quality metrics, pharmaceutically relevant dissolution specifications, and communication and project management. This report will provide a summary of conference highlights. Copyright 2015 Prous Science, S.A.U. or its licensors. All rights reserved.

Genus Caulophyllum: An Overview of Chemistry and Bioactivity

PubMed Central

Xia, Yong-Gang; Li, Guo-Yu; Liang, Jun; Yang, Bing-You; Lü, Shao-Wa; Kuang, Hai-Xue

2014-01-01

Recently, some promising advances have been achieved in understanding the chemistry, pharmacology, and action mechanisms of constituents from genus Caulophyllum. Despite this, there is to date no systematic review of those of genus Caulophyllum. This review covers naturally occurring alkaloids and saponins and those resulting from synthetic novel taspine derivatives. The paper further discussed several aspects of this genus, including pharmacological properties, mechanisms of action, pharmacokinetics, and cell membrane chromatography for activity screening. The aim of this paper is to provide a point of reference for pharmaceutical researchers to develop new drugs from constituents of Caulophyllum plants. PMID:24876877

Genus caulophyllum: an overview of chemistry and bioactivity.

PubMed

Xia, Yong-Gang; Li, Guo-Yu; Liang, Jun; Yang, Bing-You; Lü, Shao-Wa; Kuang, Hai-Xue

2014-01-01

Recently, some promising advances have been achieved in understanding the chemistry, pharmacology, and action mechanisms of constituents from genus Caulophyllum. Despite this, there is to date no systematic review of those of genus Caulophyllum. This review covers naturally occurring alkaloids and saponins and those resulting from synthetic novel taspine derivatives. The paper further discussed several aspects of this genus, including pharmacological properties, mechanisms of action, pharmacokinetics, and cell membrane chromatography for activity screening. The aim of this paper is to provide a point of reference for pharmaceutical researchers to develop new drugs from constituents of Caulophyllum plants.

Strengthening High School Chemistry Education through Teacher Outreach Programs: A Workshop Summary to the Chemical Sciences Roundtable

ERIC Educational Resources Information Center

Olson, Steve

2009-01-01

A strong chemical workforce in the United States will be essential to the ability to address many issues of societal concern in the future, including demand for renewable energy, more advanced materials, and more sophisticated pharmaceuticals. High school chemistry teachers have a critical role to play in engaging and supporting the chemical…

Pharmaceutical Formulation Facilities as Sources of Opioids and Other Pharmaceuticals to Wastewater Treatment Plant Effluents

PubMed Central

2010-01-01

Facilities involved in the manufacture of pharmaceutical products are an under-investigated source of pharmaceuticals to the environment. Between 2004 and 2009, 35 to 38 effluent samples were collected from each of three wastewater treatment plants (WWTPs) in New York and analyzed for seven pharmaceuticals including opioids and muscle relaxants. Two WWTPs (NY2 and NY3) receive substantial flows (>20% of plant flow) from pharmaceutical formulation facilities (PFF) and one (NY1) receives no PFF flow. Samples of effluents from 23 WWTPs across the United States were analyzed once for these pharmaceuticals as part of a national survey. Maximum pharmaceutical effluent concentrations for the national survey and NY1 effluent samples were generally <1 μg/L. Four pharmaceuticals (methadone, oxycodone, butalbital, and metaxalone) in samples of NY3 effluent had median concentrations ranging from 3.4 to >400 μg/L. Maximum concentrations of oxycodone (1700 μg/L) and metaxalone (3800 μg/L) in samples from NY3 effluent exceeded 1000 μg/L. Three pharmaceuticals (butalbital, carisoprodol, and oxycodone) in samples of NY2 effluent had median concentrations ranging from 2 to 11 μg/L. These findings suggest that current manufacturing practices at these PFFs can result in pharmaceuticals concentrations from 10 to 1000 times higher than those typically found in WWTP effluents. PMID:20521847

American Foundation for Pharmaceutical Education Survey of Scientific Manpower Needs in the Pharmaceutical Industry.

ERIC Educational Resources Information Center

Fisher, Albert B., Jr.

1979-01-01

Those disciplines in the pharmaceutical sciences where critical manpower shortages now exist or will occur are identified by 34 pharmaceutical manufacturers in response to a request by the American Foundation for Pharmaceutical Education, which awarded fellowships in four critical areas. High priority needs are appended. (JMD)

Pharmaceutical advertising in emergency departments.

PubMed

Marco, Catherine A

2004-04-01

Promotion of prescription drugs represents a growing source of pharmaceutical marketing expenditures. This study was undertaken to identify the frequency of items containing pharmaceutical advertising in clinical emergency departments (EDs). In this observational study, emergency physician on-site investigators quantified a variety of items containing pharmaceutical advertising present at specified representative times and days, in clinical EDs. Measurements were obtained by 65 on-site investigators, representing 22 states. Most EDs in this study were community EDs (87% community and 14% university or university affiliate), and most were in urban settings (50% urban, 38% suburban, and 13% rural). Investigators measured 42 items per ED (mean = 42; median = 31; interquartile range of 14-55) containing pharmaceutical advertising in the clinical area. The most commonly observed items included pens (mean 15 per ED; median 10), product brochures (mean 5; median 3), stethoscope labels (mean 4; median 2), drug samples (mean 3; median 0), books (mean 3.4), mugs (mean 2.4), and published literature (mean 3.1). EDs with a policy restricting pharmaceutical representatives in the ED had significantly fewer items containing pharmaceutical advertising (median 7.5; 95% CI = 0 to 27) than EDs without such a policy (median 35; 95% CI = 27 to 47, p = 0.005, nonparametric Wilcoxon two-sample test). There were no differences in quantities of pharmaceutical advertising for EDs in community compared with university settings (p = 0.5), rural compared with urban settings (p = 0.3), or annual ED volumes (p = 0.9). Numerous items containing pharmaceutical advertising are frequently observed in EDs. Policies restricting pharmaceutical representatives in the ED are associated with reduced pharmaceutical advertising.

HPLC method development for evolving applications in the pharmaceutical industry and nanoscale chemistry

NASA Astrophysics Data System (ADS)

Castiglione, Steven Louis

As scientific research trends towards trace levels and smaller architectures, the analytical chemist is often faced with the challenge of quantitating said species in a variety of matricies. The challenge is heightened when the analytes prove to be potentially toxic or possess physical or chemical properties that make traditional analytical methods problematic. In such cases, the successful development of an acceptable quantitative method plays a critical role in the ability to further develop the species under study. This is particularly true for pharmaceutical impurities and nanoparticles (NP). The first portion of the research focuses on the development of a part-per-billion level HPLC method for a substituted phenazine-class pharmaceutical impurity. The development of this method was required due to the need for a rapid methodology to quantitatively determine levels of a potentially toxic phenazine moiety in order to ensure patient safety. As the synthetic pathway for the active ingredient was continuously refined to produce progressively lower amounts of the phenazine impurity, the approach for increasingly sensitive quantitative methods was required. The approaches evolved across four discrete methods, each employing a unique scheme for analyte detection. All developed methods were evaluated with regards to accuracy, precision and linear adherence as well as ancillary benefits and detriments -- e.g., one method in this evolution demonstrated the ability to resolve and detect other species from the phenazine class. The second portion of the research focuses on the development of an HPLC method for the quantitative determination of NP size distributions. The current methodology for the determination of NP sizes employs tunneling electron microscopy (TEM), which requires sample drying without particle size alteration and which, in many cases, may prove infeasible due to cost or availability. The feasibility of an HPLC method for NP size characterizations evolved

[The Korean Pharmaceutical Industry and the Expansion of the General Pharmaceuticals Market in the 1950-1960s].

PubMed

Sihn, Kyu-Hwan

2015-12-01

After the Liberation, the Korean economy was dependent on relief supplies and aid after the ruin of the colonial regime and war. The pharmaceutical business also searched for their share in the delivery of military supplies and the distribution of relief supplies. The supply-side pharmaceutical policy made the pharmaceutical market a wholesale business. The gravity of the situation led to an increased importation of medical supplies, and wholesalers took the lead in establishing the distribution structure, whereas consumers and pharmaceutical business were relatively intimidated. The aid provided by the International Cooperation Administration (ICA) marked a turning point in the Korean pharmaceutical industry after the middle of the 1950s. ICA supplied raw materials and equipment funds, while the pharmaceutical business imported advanced technology and capital. The government invited the local production of medical substances, whereas pharmaceutical businesses replaced imported medical substances with locally produced antibiotics. After the 1960s, the production of antibiotics reached saturation. Pharmaceutical businesses needed new markets to break through the stalemate, so they turned their attention to vitamins and health tonics as general pharmaceuticals, as these were suitable for mass production and mass consumption. The modernized patent medicine market after the Opening of Korea was transformed into the contemporized general pharmaceuticals market equipped with the up-to-date facilities and technology in 1960s. Pharmaceutical businesses had to advertise these new products extensively and reform the distribution structure to achieve high profits. With the introduction of TV broadcasting, these businesses invested in TV advertising and generated sizable sales figures. They also established retail pharmacy and chain stores to reform the distribution structure. The end result was a dramatic expansion of the general pharmaceuticals market. The market for

Inventory management and reagent supply for automated chemistry.

PubMed

Kuzniar, E

1999-08-01

Developments in automated chemistry have kept pace with developments in HTS such that hundreds of thousands of new compounds can be rapidly synthesized in the belief that the greater the number and diversity of compounds that can be screened, the more successful HTS will be. The increasing use of automation for Multiple Parallel Synthesis (MPS) and the move to automated combinatorial library production is placing an overwhelming burden on the management of reagents. Although automation has improved the efficiency of the processes involved in compound synthesis, the bottleneck has shifted to ordering, collating and preparing reagents for automated chemistry resulting in loss of time, materials and momentum. Major efficiencies have already been made in the area of compound management for high throughput screening. Most of these efficiencies have been achieved with sophisticated library management systems using advanced engineering and data handling for the storage, tracking and retrieval of millions of compounds. The Automation Partnership has already provided many of the top pharmaceutical companies with modular automated storage, preparation and retrieval systems to manage compound libraries for high throughput screening. This article describes how these systems may be implemented to solve the specific problems of inventory management and reagent supply for automated chemistry.

Evolution of Plant-Made Pharmaceuticals

PubMed Central

Thomas, David R.; Penney, Claire A.; Majumder, Amrita; Walmsley, Amanda M.

2011-01-01

The science and policy of pharmaceuticals produced and/or delivered by plants has evolved over the past twenty-one years from a backyard remedy to regulated, purified products. After seemingly frozen at Phase I human clinical trials with six orally delivered plant-made vaccines not progressing past this stage over seven years, plant-made pharmaceuticals have made a breakthrough with several purified plant-based products advancing to Phase II trials and beyond. Though fraught with the usual difficulties of pharmaceutical development, pharmaceuticals made by plants have achieved pertinent milestones albeit slowly compared to other pharmaceutical production systems and are now at the cusp of reaching the consumer. Though the current economic climate begs for cautious investment as opposed to trail blazing, it is perhaps a good time to look to the future of plant-made pharmaceutical technology to assist in planning for future developments in order not to slow this technology’s momentum. To encourage continued progress, we highlight the advances made so far by this technology, particularly the change in paradigms, comparing developmental timelines, and summarizing the current status and future possibilities of plant-made pharmaceuticals. PMID:21686181

Purity Analysis of the Pharmaceuticals Naproxen and Propranolol: A Guided-Inquiry Laboratory Experiment in the Analytical Chemistry Laboratory

ERIC Educational Resources Information Center

Fakayode, Sayo O.

2015-01-01

Counterfeiting and adulteration of prescription drugs, herbal products, and food supplements are a global challenge, causing serious economic loss to drug marketers and health implications for humans. Accordingly, accurate determination of the purity of pharmaceuticals is critical for the quality assurance of prescription drugs. Herein, the first…

RP-HPLC×HILIC chromatography for quantifying ertapenem sodium with a look at green chemistry.

PubMed

Pedroso, Tahisa M; Medeiros, Ana C D; Salgado, Herida R N

2016-11-01

Ertapenem sodium is a polar and ionizable compound; therefore, it has little retention on traditional C18 columns in reverse-phase high-performance liquid chromatography, even using a highly-aqueous mobile phase that can result in dewetting in the stationary phase. Thus, the most coherent process for ERTM is to develop a method for Hydrophilic Interaction Chromatography. However, for the traditional methods in HILIC, the use of a highly organic mobile phase is necessary; usually an amount exceeding 80% acetonitrile is necessary. On the other hand, the RP-HPLC mode is considered for the analysis technique, which is more often used for quantification of substances, and new columns are often introduced to analyze different groups of compounds. Two new analytical methods have been developed for routine analysis. The proposed chromatographic method was adequate and advantageous by presenting simplicity, linearity, precision, accuracy, robustness, detection limits, and satisfactory quantification. Analytical methods are constantly undergoing changes and improvements. Researchers worldwide are rapidly adopting Green Chemistry. The development of new pharmaceutical methods based in Green chemistry has been encouraged by universities and the pharmaceutical industry. Issues related to green chemistry are in evidence and they have been featured in international journals of high impact. The methods described here have economic advantages and they feature an eco-friendly focus, which is discussed in this work. This work was developed with an environmental conscience, always looking to minimize the possible generated organic waste. Therefore, discussion on this aspect is included. Copyright © 2016 Elsevier B.V. All rights reserved.

Fabrication of Chromatographic Devices for Screening Cosmetics for Hydroquinone and Retinoic Acid as a Chemistry Project to Connect with the Community

ERIC Educational Resources Information Center

Rojanarata, Theerasak; Waewsa-nga, Kwanrutai; Muangchang, Thanawit; Ratanakreethakul, Pudinan; Plianwong, Samarwadee; Winotapun, Weerapath; Opanasopit, Praneet; Ngawhirunpat, Tanasait

2016-01-01

This article demonstrates how a student research project could connect classroom and community. Using local citizens' concerns about the adulteration of cosmetics by prohibited substances as a research problem, fifth-year pharmaceutical chemistry students were challenged to use their knowledge to create cost-effective and environmentally friendly…

[Hospital pharmaceutical practice in prison].

PubMed

Harcouët, L

2010-09-01

Since 1994, hospital pharmaceutical teams have been in charge of pharmaceutical tasks in "unités de consultation et de soins ambulatoires" (UCSA), which are hospital consulting care units in French prisons. In 2008, pharmaceutical team in Parisian prisons received 6500 prescriptions and prepared 85,000 nominative bags containing drugs. Prisoners were 1.3% to receive treatments against HIV, 8.2% cardiovascular drugs, 7.2% opioid substitution treatments, and 52.9% psychoactive drugs, including 39.3% hypnotics, 40.5% anxiolytics, 11.3% antidepressants and 12.2% neuroleptics. In prison, the dichotomy between somatic and mental care is marked, attitudes of prisoners about their medicines are complex (important claims, embezzlement, etc.) and it is difficult for law defendants to maintain treatment confidentiality and to prepare prison outing in terms of health. To attenuate the heterogeneity of drug distribution systems in French prisons, we propose pharmaceutical analysis of prescriptions and nominative dispensation, computerization in UCSA in coordination with hospitals, a better contribution of prison medical and pharmaceutical staff in hospital "drug committees" and the redaction of pharmaceutical guidelines. Acting in concert with multidisciplinary medical staff in UCSA, pharmaceutical teams have to develop epidemiological studies to improve knowledge in prisoner's health and also prevention and health care in prison. Copyright © 2010 Elsevier Masson SAS. All rights reserved.

The reasons behind medicine shortages from the perspective of pharmaceutical companies and pharmaceutical wholesalers in Finland.

PubMed

Heiskanen, Kati; Ahonen, Riitta; Kanerva, Risto; Karttunen, Pekka; Timonen, Johanna

2017-01-01

The aim of this study was to explore the reasons behind medicine shortages from the perspective of pharmaceutical companies and pharmaceutical wholesalers in Finland. The study took the form of semi-structured interviews. Forty-one pharmaceutical companies and pharmaceutical wholesalers were invited to participate in the study. The pharmaceutical companies were the member organizations of Pharma Industry Finland (PIF) (N = 30) and the Finnish Generic Pharmaceutical Association (FGPA) (N = 7). One company which is a central player in the pharmaceutical market in Finland but does not belong to PIF or FGPA was also invited. The pharmaceutical wholesalers were those with a nationwide distribution network (N = 3). A total of 30 interviews were conducted between March and June 2016. The data were subjected to qualitative thematic analysis. The most common reasons behind medicine shortages in Finland were the small size of the pharmaceutical market (29/30), sudden or fluctuating demand (28/30), small stock sizes (25/30), long delivery time (23/30) and a long or complex production chain (23/30). The reasons for the medicine shortages were supply-related more often than demand-related. However, the reasons were often complex and there was more than one reason behind a shortage. Supply-related reasons behind shortages commonly interfaced with the country-specific characteristics of Finland, whereas demand-related reasons were commonly associated with the predictability and attractiveness of the market. Some reasons, such as raw material shortages, were considered global and thus had similar effects on other countries.

Pharmaceutical cocrystals: an overview.

PubMed

Qiao, Ning; Li, Mingzhong; Schlindwein, Walkiria; Malek, Nazneen; Davies, Angela; Trappitt, Gary

2011-10-31

Pharmaceutical cocrystals are emerging as a new class of solid drugs with improved physicochemical properties, which has attracted increased interests from both industrial and academic researchers. In this paper a brief and systematic overview of pharmaceutical cocrystals is provided, with particular focus on cocrystal design strategies, formation methods, physicochemical property studies, characterisation techniques, and recent theoretical developments in cocrystal screening and mechanisms of cocrystal formations. Examples of pharmaceutical cocrystals are also summarised in this paper. Copyright © 2011 Elsevier B.V. All rights reserved.

Current trends in green liquid chromatography for the analysis of pharmaceutically active compounds in the environmental water compartments.

PubMed

Shaaban, Heba; Górecki, Tadeusz

2015-01-01

Green analytical chemistry is an aspect of green chemistry which introduced in the late nineties. The main objectives of green analytical chemistry are to obtain new analytical technologies or to modify an old method to incorporate procedures that use less hazardous chemicals. There are several approaches to achieve this goal such as using environmentally benign solvents and reagents, reducing the chromatographic separation times and miniaturization of analytical devices. Traditional methods used for the analysis of pharmaceutically active compounds require large volumes of organic solvents and generate large amounts of waste. Most of them are volatile and harmful to the environment. With the awareness about the environment, the development of green technologies has been receiving increasing attention aiming at eliminating or reducing the amount of organic solvents consumed everyday worldwide without loss in chromatographic performance. This review provides the state of the art of green analytical methodologies for environmental analysis of pharmaceutically active compounds in the aquatic environment with special emphasis on strategies for greening liquid chromatography (LC). The current trends of fast LC applied to environmental analysis, including elevated mobile phase temperature, as well as different column technologies such as monolithic columns, fully porous sub-2 μm and superficially porous particles are presented. In addition, green aspects of gas chromatography (GC) and supercritical fluid chromatography (SFC) will be discussed. We pay special attention to new green approaches such as automation, miniaturization, direct analysis and the possibility of locating the chromatograph on-line or at-line as a step forward in reducing the environmental impact of chromatographic analyses. Copyright © 2014 Elsevier B.V. All rights reserved.

Synthesis of a drug-like focused library of trisubstituted pyrrolidines using integrated flow chemistry and batch methods.

PubMed

Baumann, Marcus; Baxendale, Ian R; Kuratli, Christoph; Ley, Steven V; Martin, Rainer E; Schneider, Josef

2011-07-11

A combination of flow and batch chemistries has been successfully applied to the assembly of a series of trisubstituted drug-like pyrrolidines. This study demonstrates the efficient preparation of a focused library of these pharmaceutically important structures using microreactor technologies, as well as classical parallel synthesis techniques, and thus exemplifies the impact of integrating innovative enabling tools within the drug discovery process.

Elemental Impurities in Pharmaceutical Excipients.

PubMed

Li, Gang; Schoneker, Dave; Ulman, Katherine L; Sturm, Jason J; Thackery, Lisa M; Kauffman, John F

2015-12-01

Control of elemental impurities in pharmaceutical materials is currently undergoing a transition from control based on concentrations in components of drug products to control based on permitted daily exposures in drug products. Within the pharmaceutical community, there is uncertainty regarding the impact of these changes on manufactures of drug products. This uncertainty is fueled in part by a lack of publically available information on elemental impurity levels in common pharmaceutical excipients. This paper summarizes a recent survey of elemental impurity levels in common pharmaceutical excipients as well as some drug substances. A widely applicable analytical procedure was developed and was shown to be suitable for analysis of elements that are subject to United States Pharmacopoeia Chapter <232> and International Conference on Harmonization's Q3D Guideline on Elemental Impurities. The procedure utilizes microwave-assisted digestion of pharmaceutical materials and inductively coupled plasma mass spectrometry for quantitative analysis of these elements. The procedure was applied to 190 samples from 31 different excipients and 15 samples from eight drug substances provided through the International Pharmaceutical Excipient Council of the Americas. The results of the survey indicate that, for the materials included in the study, relatively low levels of elemental impurities are present. © 2015 The Authors. Journal of Pharmaceutical Sciences published by Wiley Periodicals, Inc. and the American Pharmacists Association.

The reasons behind medicine shortages from the perspective of pharmaceutical companies and pharmaceutical wholesalers in Finland

PubMed Central

Ahonen, Riitta; Kanerva, Risto; Karttunen, Pekka; Timonen, Johanna

2017-01-01

The aim of this study was to explore the reasons behind medicine shortages from the perspective of pharmaceutical companies and pharmaceutical wholesalers in Finland. The study took the form of semi-structured interviews. Forty-one pharmaceutical companies and pharmaceutical wholesalers were invited to participate in the study. The pharmaceutical companies were the member organizations of Pharma Industry Finland (PIF) (N = 30) and the Finnish Generic Pharmaceutical Association (FGPA) (N = 7). One company which is a central player in the pharmaceutical market in Finland but does not belong to PIF or FGPA was also invited. The pharmaceutical wholesalers were those with a nationwide distribution network (N = 3). A total of 30 interviews were conducted between March and June 2016. The data were subjected to qualitative thematic analysis. The most common reasons behind medicine shortages in Finland were the small size of the pharmaceutical market (29/30), sudden or fluctuating demand (28/30), small stock sizes (25/30), long delivery time (23/30) and a long or complex production chain (23/30). The reasons for the medicine shortages were supply-related more often than demand-related. However, the reasons were often complex and there was more than one reason behind a shortage. Supply-related reasons behind shortages commonly interfaced with the country-specific characteristics of Finland, whereas demand-related reasons were commonly associated with the predictability and attractiveness of the market. Some reasons, such as raw material shortages, were considered global and thus had similar effects on other countries. PMID:28658307

Basics of Compounding: Clinical Pharmaceutics, Part 2.

PubMed

Allen, Loyd V

2016-01-01

This article represents part 2 of a 2-part article on the topic of clinical pharmaceutics. Pharmaceutics is relevant far beyond the pharmaceutical industry, compounding, and the laboratory. Pharmaceutics can be used to solve many clinical problems in medication therapy. A pharmacists' knowledge of the physicochemical aspects of drugs and drug products should help the patient, physician, and healthcare professionals resolve issues in the increasingly complex world of modern medicine. Part 1 of this series of articles discussed incompatibilities which can directly affect a clinical outcome and utilized pharmaceutics case examples of the application and importance of clinical pharmaceutics covering different characteristics. Part 2 continues to illustrate the scientific principles and clinical effects involved in clinical pharmaceutics. Also covered in this article are many of the scientific principles in typical to patient care. Copyright© by International Journal of Pharmaceutical Compounding, Inc.

Ziziphus spinosa seeds for insomnia: A review of chemistry and psychopharmacology.

PubMed

Shergis, Johannah Linda; Ni, Xiaojia; Sarris, Jerome; Zhang, Anthony Lin; Guo, Xinfeng; Xue, Charlie C; Lu, Chuanjian; Hugel, Helmut

2017-10-15

In Chinese medicine, Ziziphus jujuba Mill. var. spinosa (Bunge) Hu ex H. F. Chou is widely used for the treatment of insomnia. This paper summarises the chemistry, psychopharmacology, and compares the pharmaceutical effects of the seeds of Ziziphus jujuba plant, Ziziphus spinosa (ZS) seeds, with benzodiazepines. Whole extracts and constituent compounds have been evaluated in preclinical and clinical studies. ZS secondary metabolites modulate GABAergic activity and the serotonergic system. The actual therapeutic agents require further confirmation/identification so that new insomnia phytomedicines can be discovered. Copyright © 2017 Elsevier GmbH. All rights reserved.

Herbicide and pharmaceutical relationships

USDA-ARS?s Scientific Manuscript database

For many years, virtually all pharmaceutical companies had an agrochemical division. This was partly to maximize the benefits of expensive chemical synthesis efforts by searching for many types of useful biological activities. Leads for pharmaceuticals and pesticides often overlap, in some cases l...

Pharmaceutical Education in Nigeria.

ERIC Educational Resources Information Center

Oyegbile, F. Rachel

1988-01-01

Nigeria has six pharmacy schools, most offering graduate programs. The undergraduate program is being expanded from four to five years. Although behavioral and clinical sciences are offered, emphasis is on the pharmaceutical sciences. Overall, pharmaceutical education is oriented toward hospice practice. (Author/MSE)

Airborne chemistry: acoustic levitation in chemical analysis.

PubMed

Santesson, Sabina; Nilsson, Staffan

2004-04-01

This review with 60 references describes a unique path to miniaturisation, that is, the use of acoustic levitation in analytical and bioanalytical chemistry applications. Levitation of small volumes of sample by means of a levitation technique can be used as a way to avoid solid walls around the sample, thus circumventing the main problem of miniaturisation, the unfavourable surface-to-volume ratio. Different techniques for sample levitation have been developed and improved. Of the levitation techniques described, acoustic or ultrasonic levitation fulfils all requirements for analytical chemistry applications. This technique has previously been used to study properties of molten materials and the equilibrium shape()and stability of liquid drops. Temperature and mass transfer in levitated drops have also been described, as have crystallisation and microgravity applications. The airborne analytical system described here is equipped with different and exchangeable remote detection systems. The levitated drops are normally in the 100 nL-2 microL volume range and additions to the levitated drop can be made in the pL-volume range. The use of levitated drops in analytical and bioanalytical chemistry offers several benefits. Several remote detection systems are compatible with acoustic levitation, including fluorescence imaging detection, right angle light scattering, Raman spectroscopy, and X-ray diffraction. Applications include liquid/liquid extractions, solvent exchange, analyte enrichment, single-cell analysis, cell-cell communication studies, precipitation screening of proteins to establish nucleation conditions, and crystallisation of proteins and pharmaceuticals.

Virtual drug discovery: beyond computational chemistry?

PubMed

Gilardoni, Francois; Arvanites, Anthony C

2010-02-01

This editorial looks at how a fully integrated structure that performs all aspects in the drug discovery process, under one company, is slowly disappearing. The steps in the drug discovery paradigm have been slowly increasing toward virtuality or outsourcing at various phases of product development in a company's candidate pipeline. Each step in the process, such as target identification and validation and medicinal chemistry, can be managed by scientific teams within a 'virtual' company. Pharmaceutical companies to biotechnology start-ups have been quick in adopting this new research and development business strategy in order to gain flexibility, access the best technologies and technical expertise, and decrease product developmental costs. In today's financial climate, the term virtual drug discovery has an organizational meaning. It represents the next evolutionary step in outsourcing drug development.

Pharmaceutical Industry in Syria

PubMed Central

2010-01-01

The aim of this article is to present the development of the pharmaceutical industry in Syria using national and international public data sources. At the end of the 80ies, the pharmaceutical industry in Syria was very poor, covering 6% of the national needs. In less than 20 years, with the government support in terms of legal frame and strategic political engagement, the Syrian pharmaceutical industry finally covered almost 90% of the national needs, in terms of drugs, and exported drugs in around 52 Arabian countries. Beyond covering the local market, the main added values of this huge development consisted in exporting drugs in amount of 150 million dollars per year and providing jobs for 17000 Syrian people, out of which around 85% are women. Strong and weak points of the pharmaceutical sector are taken into consideration in the article and further interventions to support a sustainable development are proposed by the author. PMID:20945828

In Silico Models for Ecotoxicity of Pharmaceuticals.

PubMed

Roy, Kunal; Kar, Supratik

2016-01-01

Pharmaceuticals and their active metabolites are one of the significantly emerging environmental toxicants. The major routes of entry of pharmaceuticals into the environment are industries, hospitals, or direct disposal of unwanted or expired drugs made by the patient. The most important and distinct features of pharmaceuticals are that they are deliberately designed to have an explicit mode of action and designed to exert an effect on humans and other living systems. This distinctive feature makes pharmaceuticals and their metabolites different from other chemicals, and this necessitates the evaluation of the direct effects of pharmaceuticals in various environmental compartments as well as to living systems. In this background, the alarming situation of ecotoxicity of diverse pharmaceuticals have forced government and nongovernment regulatory authorities to recommend the application of in silico methods to provide quick information about the risk assessment and fate properties of pharmaceuticals as well as their ecological and indirect human health effects. This chapter aims to offer information regarding occurrence of pharmaceuticals in the environment, their persistence, environmental fate, and toxicity as well as application of in silico methods to provide information about the basic risk management and fate prediction of pharmaceuticals in the environment. Brief ideas about toxicity endpoints, available ecotoxicity databases, and expert systems employed for rapid toxicity predictions of ecotoxicity of pharmaceuticals are also discussed.

Russian-American pharmaceutical relations, 1900-1945.

PubMed

Conroy, Mary Schaeffer

2004-01-01

Many books and articles have focused on Soviet health-care. But there are no studies of the Soviet pharmaceutical industry, which was a lynch-pin of Soviet medicine, for without therapies physicians and health-care personnel can only diagnose, not treat. The present paper, part of such a study, opens a window onto one small aspect of the Soviet pharmaceutical industry - points of congruence, divergence, and reconvergence in the pharmaceutical sector with an on-again, off-again political and economic rival. This paper briefly reviews the Russian and the Soviet pharmaceutical systems, so that American audiences can make a comparison of them with our own. It then examines American-Russian/Soviet interaction in trade, joint ventures, research and development, product mix, and connections during World War II to illustrate similarities and differences. During the last decade, although the Soviet and American pharmaceutical systems each had a different trajectory of development, ironically their pharmaceutical industries again are finding points in common.

Extending Halogen-based Medicinal Chemistry to Proteins

PubMed Central

El Hage, Krystel; Pandyarajan, Vijay; Phillips, Nelson B.; Smith, Brian J.; Menting, John G.; Whittaker, Jonathan; Lawrence, Michael C.; Meuwly, Markus; Weiss, Michael A.

2016-01-01

Insulin, a protein critical for metabolic homeostasis, provides a classical model for protein design with application to human health. Recent efforts to improve its pharmaceutical formulation demonstrated that iodination of a conserved tyrosine (TyrB26) enhances key properties of a rapid-acting clinical analog. Moreover, the broad utility of halogens in medicinal chemistry has motivated the use of hybrid quantum- and molecular-mechanical methods to study proteins. Here, we (i) undertook quantitative atomistic simulations of 3-[iodo-TyrB26]insulin to predict its structural features, and (ii) tested these predictions by X-ray crystallography. Using an electrostatic model of the modified aromatic ring based on quantum chemistry, the calculations suggested that the analog, as a dimer and hexamer, exhibits subtle differences in aromatic-aromatic interactions at the dimer interface. Aromatic rings (TyrB16, PheB24, PheB25, 3-I-TyrB26, and their symmetry-related mates) at this interface adjust to enable packing of the hydrophobic iodine atoms within the core of each monomer. Strikingly, these features were observed in the crystal structure of a 3-[iodo-TyrB26]insulin analog (determined as an R6 zinc hexamer). Given that residues B24–B30 detach from the core on receptor binding, the environment of 3-I-TyrB26 in a receptor complex must differ from that in the free hormone. Based on the recent structure of a “micro-receptor” complex, we predict that 3-I-TyrB26 engages the receptor via directional halogen bonding and halogen-directed hydrogen bonding as follows: favorable electrostatic interactions exploiting, respectively, the halogen's electron-deficient σ-hole and electronegative equatorial band. Inspired by quantum chemistry and molecular dynamics, such “halogen engineering” promises to extend principles of medicinal chemistry to proteins. PMID:27875310

Pharmaceutical virtue.

PubMed

Martin, Emily

2006-06-01

In the early history of psychopharmacology, the prospect of developing technologically sophisticated drugs to alleviate human ills was surrounded with a fervor that could be described as religious. This paper explores the subsequent history of the development of psychopharmacological agents, focusing on the ambivalent position of both the industry and its employees. Based on interviews with retired pharmaceutical employees who were active in the industry in the 1950s and 1960s when the major breakthroughs were made in the development of MAOIs and SSRIs, the paper explores the initial development of educational materials for use in sales campaigns. In addition, based on interviews with current employees in pharmaceutical sales and marketing, the paper describes the complex perspective of contemporary pharmaceutical employees who must live surrounded by the growing public vilification of the industry as rapacious and profit hungry and yet find ways to make their jobs meaningful and dignified. The paper will contribute to the understudied problem of how individuals function in positions that require them to be part of processes that on one description constitute a social evil, but on another, constitute a social good.

Paying for On-Patent Pharmaceuticals

PubMed Central

Goldfield, Norbert

2016-01-01

In this article we propose a new approach to pricing for patent-protected (on-patent) pharmaceuticals. We describe and define limit pricing as a method for drug companies to maximize revenue for their investment by offering budget-neutral pricing to encourage early adoption by payers. Under this approach, payers are incentivized to adopt innovative but expensive drugs more quickly if drug companies provide detailed analyses of the net impact of the new pharmaceutical upon total health budgets. For payers to adopt use of a new pharmaceutical, they would require objective third-party evaluation and pharmaceutical manufacturer accountability for projected outcomes efficacy of their treatments on population health. The pay for outcomes underpinning of this approach falls within the wider aspirations of health reform. PMID:26945298

Recognizing misleading pharmaceutical marketing online.

PubMed

De Freitas, Julian; Falls, Brian A; Haque, Omar S; Bursztajn, Harold J

2014-01-01

In light of decision-making psychology, this article details how drug marketing operates across established and novel web domains and identifies some common misleading trends and influences on prescribing and patient-initiated medication requests. The Internet has allowed pharmaceutical marketing to become more salient than ever before. Although the Internet's growth has improved the dissemination of pharmaceutical information, it has also led to the increased influence of misleading pharmaceutical marketing. Such mismarketing is of concern, especially in psychiatry, since psychotropics generate considerable revenue for drug companies. In a climate of resource-limited drug regulation and time-strapped physicians, we recommend improving both independent monitoring and consumer awareness of Internet-enabled, potentially misleading, pharmaceutical marketing influences. © 2014 American Academy of Psychiatry and the Law.

[PICS: pharmaceutical inspection cooperation scheme].

PubMed

Morénas, J

2009-01-01

The pharmaceutical inspection cooperation scheme (PICS) is a structure containing 34 participating authorities located worldwide (October 2008). It has been created in 1995 on the basis of the pharmaceutical inspection convention (PIC) settled by the European free trade association (EFTA) in1970. This scheme has different goals as to be an international recognised body in the field of good manufacturing practices (GMP), for training inspectors (by the way of an annual seminar and experts circles related notably to active pharmaceutical ingredients [API], quality risk management, computerized systems, useful for the writing of inspection's aide-memoires). PICS is also leading to high standards for GMP inspectorates (through regular crossed audits) and being a room for exchanges on technical matters between inspectors but also between inspectors and pharmaceutical industry.

Pharmaceutical applications using NIR technology in the cloud

NASA Astrophysics Data System (ADS)

Grossmann, Luiz; Borges, Marco A.

2017-05-01

NIR technology has been available for a long time, certainly more than 50 years. Without any doubt, it has found many niche applications, especially in the pharmaceutical, food, agriculture and other industries due to its flexibility. There are a number of advantages over other existing analytical technologies we can list, for example virtually no need for sample preparation; usually NIR does not demand sample destruction and subsequent discard; NIR provides fast results; NIR does not require extensive operator training and carries small operating costs. However, the key point about NIR technology is the fact that it's more related to statistics than chemistry or, in other words, we are more concerned about analyzing and distinguishing features within the data than looking deep into the chemical entities themselves. A simple scan reading in the NIR range usually involves huge inflows of data points. Usually we decompose the signals into hundreds of predictor variables and use complex algorithms to predict classes or quantify specific content. NIR is all about math, especially by converting chemical information into numbers. Easier said than done. A NIR signal is a very complex one. Usually the signal responses are not specific to a particular material, rather, each grouṕs responses add up, thus providing low specificity of a spectral reading. This paper proposes a simple and efficient method to analyze and compare NIR spectra for the purpose of identifying the presence of active pharmaceutical ingredients in finished products using low cost NIR scanning devices connected to the internet cloud.

Radiation treatment of pharmaceuticals

NASA Astrophysics Data System (ADS)

Dám, A. M.; Gazsó, L. G.; Kaewpila, S.; Maschek, I.

1996-03-01

Product specific doses were calculated for pharmaceuticals to be radiation treated. Radio-pasteurization dose were determined for some heat sensitive pharmaceutical basic materials (pancreaton, neopancreatin, neopancreatin USP, duodenum extract). Using the new recommendation (ISO standards, Method 1) dose calculations were performed and radiation sterilization doses were determined for aprotinine and heparine Na.

Specialty pharmaceuticals: developing a management plan.

PubMed

Willcutts, Dave

2002-01-01

This is the first in a series of articles that address the complex issues associated with specialty pharmaceuticals in the development of a successful specialty pharmaceutical program, a critical component of managing this high-cost and highly fragmented sector. This article focuses on how to define specialty pharmaceuticals. Other articles in this series will explore such topics as the mechanics of developing and managing a specialty pharmaceutical program, how and when to establish clinical protocols and authorizations, the importance of data management, and the benefits from automated processes.

The institutionalization of pharmaceutical administration after the korean liberation: focusing on regulating the pharmaceutical affairs law(yaksabeop) in 1953.

PubMed

Sihn, Kyu-Hwan

2013-12-01

The pharmaceutical administration under U.S Military Government in Korea and government of the Republic of Korea aimed at cleaning up the vestiges of Japanese imperialism which the pharmaceutical administration attached police administration and preparing with legal and systemic basis after the Korean liberation. The pharmaceutical bureau under U.S Military Government in Korea was reorganized as the independent division. The pharmaceutical bureau focused on preserving order, narcotics control and the distribution of relief drug. U.S Military Government proceeded supply side pharmaceutical policy for the distribution of relief drug without constructing human and material infrastructure. After the Korean War, Korean society asked the construction of system for nation building. Korean national assembly regulated National Medical Law(Gukmin uiryobeop) for promotion of public health in 1951. The Pharmaceutical Affairs Law(Yaksabeop) was regulated in 1953, and it prescribed the job requirement of pharmacist, apothecary, and drug maker and seller, and presented the frame of managing medical supplies. The Pharmaceutical Law originally planned the ideal pharmaceutical administration, but it rather secured the status of traditional apothecary, and drug maker and seller. On the contrary, though the Pharmaceutical Law guaranteed the traditional druggists, it did not materialize reproduction system such as educational and license system. It means that the traditional druggists would be degenerated in the near future. After the armistice agreement in 1953, Korean was in medical difficulties. Korean government was suffered from the deficiency of medical resources. Because of destruction of pharmaceutical facilities, Korean had to depend on United States and international aid. The Pharmaceutical Affairs Law did not cleaned up the vestiges of Japanese imperialism, and compromised with reality lacked human and material infrastructure. As a result, the law became the origin of

Effects of Repeated Intraperitoneal Injection of Pharmaceutical-grade and Nonpharmaceutical-grade Corn Oil in Female C57BL/6J Mice.

PubMed

Hubbard, Jennifer S; Chen, Patty H; Boyd, Kelli L

2017-11-01

Due to potential adverse effects on animal wellbeing, the use of nonpharmaceutical-grade substances in animal research must be scientifically justified in cases where a pharmaceutical-grade version of the substance exists. This requirement applies to all substances, including vehicles used to solubilize experimental drugs. To date, no studies have evaluated the direct effect of the pharmaceutical classification of a compound on animal wellbeing. In this study, we evaluated intraperitoneal administration of pharmaceutical-grade corn oil, nonpharmaceutical-grade corn oil, and saline in female C57BL/6J mice. Compounds were administered every 48 h for a total of 4 injections. Mice were evaluated clinically by using body weight, body condition score, visual assessment score, CBC, and serum chemistries. Animals were euthanized at 24 h and 14 d after the final injection. Inflammation of the peritoneal wall and mesenteric fat was assessed microscopically by using a semiquantitative scoring system. Saline-dosed groups had lower pathology scores at both time points. At day 21, pharmaceutical-grade corn oil had a significantly higher pathology score compared with nonpharmaceutical-grade corn oil. No other significant differences between the corn oil groups were observed. The use of nonpharmaceutical grade corn oil did not result in adverse clinical consequences and is presumed safe to use for intraperitoneal injection in mice. Differences in inflammation between the 2 groups suggest that the use of either pharmaceutical-grade or nonpharmaceutical-grade corn oil should be consistent within a study.

Effects of Repeated Intraperitoneal Injection of Pharmaceutical-grade and Nonpharmaceutical-grade Corn Oil in Female C57BL/6J Mice

PubMed Central

Hubbard, Jennifer S; Chen, Patty H; Boyd, Kelli L

2017-01-01

Due to potential adverse effects on animal wellbeing, the use of nonpharmaceutical-grade substances in animal research must be scientifically justified in cases where a pharmaceutical-grade version of the substance exists. This requirement applies to all substances, including vehicles used to solubilize experimental drugs. To date, no studies have evaluated the direct effect of the pharmaceutical classification of a compound on animal wellbeing. In this study, we evaluated intraperitoneal administration of pharmaceutical-grade corn oil, nonpharmaceutical-grade corn oil, and saline in female C57BL/6J mice. Compounds were administered every 48 h for a total of 4 injections. Mice were evaluated clinically by using body weight, body condition score, visual assessment score, CBC, and serum chemistries. Animals were euthanized at 24 h and 14 d after the final injection. Inflammation of the peritoneal wall and mesenteric fat was assessed microscopically by using a semiquantitative scoring system. Saline-dosed groups had lower pathology scores at both time points. At day 21, pharmaceutical-grade corn oil had a significantly higher pathology score compared with nonpharmaceutical-grade corn oil. No other significant differences between the corn oil groups were observed. The use of nonpharmaceutical grade corn oil did not result in adverse clinical consequences and is presumed safe to use for intraperitoneal injection in mice. Differences in inflammation between the 2 groups suggest that the use of either pharmaceutical-grade or nonpharmaceutical-grade corn oil should be consistent within a study. PMID:29256373

EMERGING POLLUTANTS, AND COMMUNICATING THE SCIENCE OF ENVIRONMENTAL CHEMISTRY AND MASS SPECTROMETRY: PHARMACEUTICALS IN THE ENVIRONMENT

EPA Science Inventory

This paper weaves a rnulti-dimensioned perspective of mass spectrometry as a career against the backdrop of mass spectrometry's key role in the past and future of environmental chemistry. Along the way, some insights are offered for better focusing the spotlight on the discipline...

"EMERGING" POLLUTANTS, AND COMMUNICATING THE SCIENCE OF ENVIRONMENTAL CHEMISTRY AND MASS SPECTROMETRY: PHARMACEUTICALS IN THE ENVIRONMENT

EPA Science Inventory

This paper weaves a rnulti-dimensioned perspective of mass spectrometry as a career against the backdrop of mass spectrometry's key role in the past and future of environmental chemistry. Along the way, some insights are offered for better focusing the spotlight on the discipline...

AN INFORMATIC APPROACH TO ESTIMATING ECOLOGICAL RISKS POSED BY PHARMACEUTICAL USE: HUMAN PRESCRIPTION PHARMACEUTICALS

EPA Science Inventory

Pharmaceuticals are often excreted from patients as the parent compound or as active metabolites. Some of these compounds have been found in the environment. However, the environmental concentrations of the majority of pharmaceuticals and their metabolites are not known. The re...

Considerations in pharmaceutical conversion: focus on antihistamines.

PubMed

Garbus, S B; Moulton, B W; Meltzer, E O; Reich, P R; Weinreb, L F; Friedman, J A; Orland, B I

1997-04-01

The practice of pharmaceutical conversion, which encompasses three types of drug interchange (generic, brand, and therapeutic substitution), is increasing in managed care settings. Pharmaceutical conversion has numerous implications for managed care organizations, their healthcare providers, and their customers. Although drug cost may be a driving consideration in pharmaceutical conversion, a number of other considerations are of equal or greater importance in the decision-making process may affect the overall cost of patient care. Among these considerations are clinical, psychosocial, and safety issues; patient adherence; patient satisfaction; and legal implications of pharmaceutical conversion. Patient-centered care must always remain central to decisions about pharmaceutical conversion. This article discusses the issues related to, and implications of, pharmaceutical conversion utilizing the antihistamines class of drugs as the case situation.

Pharmaceutical patents and price controls.

PubMed

Vogel, Ronald J

2002-07-01

Since 1995, every member-country of the World Trade Organization (WTO) has agreed to honor a 20-year patent-life, from the date of a pharmaceutical company's application for the patent, in the country of application. Patent protection retards competitive imitation of an invented product. This kind of protection is particularly important for pharmaceuticals, because pharmaceuticals that are not derived from biotechnology can be imitated easily and inexpensively. The economic function of a patent is to allow a period of above-normal profits for a technically and commercially successful product; these profits stimulate further investment and invention. However, direct price controls, or permutations of direct price controls on pharmaceutical compounds, can fully or partially circumvent the economic intent of patent agreements. This paper formulates an economic model that takes into account demand and cost/supply dimensions of the output and pricing of a hypothetical pharmaceutical, extrapolating about the respective effects of direct price controls and lack of price controls, and describing permutations of direct price controls in different countries. The pharmaceutical industry depends on patents to fund the development and introduction of new products. A country can indirectly circumvent the economic logic of a patent by using price controls, but it cannot shift the economic costs of such a policy to another country that does not use price controls. Instead, less money is available for research and development (R&D). Pharmaceutical price controls allow some countries to avoid the constraints of patent agreements without breaking those agreements outright. This, in turn, reduces the amount of profit available for further R&D, which is a detriment to consumers worldwide.

[Assessment of the pharmaceutical expenditure in Hungary].

PubMed

Inotai, András; Merész, Gergo; Kaló, Zoltán

2010-01-01

Scarcity of health care resources draws attention to the expenditure on pharmaceuticals, as drugs are considered to be one of the major growth drivers of health care spending. This article assesses the Hungarian expenditure on pharmaceuticals by taking into account the economic status of the country and benchmarks from other OECD countries with special focus on indicators of Visegrad V4 countries (Czech Republic, Slovakia, Poland and Hungary). Our results highlight the heterogeneity of pharmaceutical expenditure data derived from different indicators among observed countries. Pharmaceutical spending is relatively higher in middle-income countries, mainly due the price convergence of innovative drug's, on contrary manpower cost of health care services are adjusted to local price levels, therefore the price differential of health care services between middle income and developed countries is greater. International trends of the global pharmaceutical market are also valid in Hungary. Increased private funding, mainly out of pocket payments above the average of V4 countries, has been the major growth driver of pharmaceutical expenditure recently in Hungary. Increased private pharmaceutical expenditure was mainly derived from the severe cost-containment measures in 2006. The annual growth rate of the National Health Insurance Fund's pharmaceutical budget for drug reimbursement was 1.37% in real terms between 1994 and 2009. This is much beneath the expansion of global pharmaceutical market. Consequently, cost-containment of public pharmaceutical spending was very successful in the last fifteen years, and the burden of market growth has been shifted to households. Public health programmes, investment into preventive care, with consideration on unfavourable Hungarian morbidity and mortality indicators, however, necessitate the increase of public pharmaceutical budget. In order to improve the allocative efficiency of health care spending, available resources should be spent

Defining pharmaceutical systems strengthening: concepts to enable measurement

PubMed Central

Hafner, Tamara; Lee, David; Aboagye-Nyame, Francis

2017-01-01

Abstract Pharmaceutical products are indispensable for improving health outcomes. An extensive body of work on access to and use of medicines has resulted in an assortment of tools measuring various elements of pharmaceutical systems. Until now however, there has been little attempt to conceptualize a pharmaceutical system as an entity and define its strengthening in a way that allows for measuring systems strengthening. The narrow focus of available tools limits their value in ascertaining which interventions result in stronger, more resilient systems. We sought to address this shortcoming by revisiting the current definitions, frameworks and assessment tools related to pharmaceutical systems. We conducted a comprehensive literature review and consulted with select pharmaceutical experts. On the basis of our review, we propose that a pharmaceutical system consists of all structures, people, resources, processes, and their interactions within the broader health system that aim to ensure equitable and timely access to safe, effective, quality pharmaceutical products and related services that promote their appropriate and cost-effective use to improve health outcomes. We further propose that pharmaceutical systems strengthening is the process of identifying and implementing strategies and actions that achieve coordinated and sustainable improvements in the critical components of a pharmaceutical system to make it more responsive and resilient and to enhance its performance for achieving better health outcomes. Finally, we established that, in addition to system performance and resilience, seven components of the pharmaceutical system are critical for measuring pharmaceutical systems strengthening: pharmaceutical products and related services; policy, laws and governance; regulatory systems; innovation, research and development, manufacturing, and trade; financing; human resources; and information. This work adds clarity to the concept of pharmaceutical systems and

The role of cocrystals in pharmaceutical science.

PubMed

Shan, Ning; Zaworotko, Michael J

2008-05-01

Pharmaceutical cocrystals, a subset of a long known but little-studied class of compounds, represent an emerging class of crystal forms in the context of pharmaceutical science. They are attractive to pharmaceutical scientists because they can significantly diversify the number of crystal forms that exist for a particular active pharmaceutical ingredient (API), and they can lead to improvements in physical properties of clinical relevance. In this article we address pharmaceutical cocrystals from the perspective of design (crystal engineering) and present a series of case studies that demonstrate how they can enhance the solubility, bioavailability, and/or stability of API crystal forms.

Entrepreneurial patent management in pharmaceutical startups.

PubMed

Holgersson, Marcus; Phan, Tai; Hedner, Thomas

2016-07-01

Startups fill an increasingly important role as innovators in the pharmaceutical industry, and patenting is typically central to their success. This article aims to explore patent management in pharmaceutical startups. The results show that startups need to deal with several challenges related to patenting and an 'entrepreneurial' approach to patent management is called for. Resource constraints, venture capital provision, exits and other conditions and events must be readily considered in the patent management process to build a successful pharmaceutical venture, something that could benefit the pharmaceutical industry as a whole. Copyright © 2016 Elsevier Ltd. All rights reserved.

Introduction: Institutional corruption and the pharmaceutical policy.

PubMed

Rodwin, Marc A

2013-01-01

Today, the goals of pharmaceutical policy and medical practice are often undermined due to institutional corruption - that is, widespread or systemic practices, usually legal, that undermine an institution's objectives or integrity. In this symposium, 16 articles investigate the corruption of pharmaceutical policy, each taking a different look at the sources of corruption, how it occurs, and what is corrupted. We will see that the pharmaceutical industry's own purposes are often undermined. Furthermore, pharmaceutical industry funding of election campaigns and lobbying skews the legislative process that sets pharmaceutical policy. Moreover, certain practices have corrupted medical research, the production of medical knowledge, the practice of medicine, drug safety, the Food and Drug Administration's oversight of the pharmaceutical market, and the trustworthiness of patient advocacy organizations. © 2013 American Society of Law, Medicine & Ethics, Inc.

Iron-catalysed tritiation of pharmaceuticals

NASA Astrophysics Data System (ADS)

Pony Yu, Renyuan; Hesk, David; Rivera, Nelo; Pelczer, István; Chirik, Paul J.

2016-01-01

A thorough understanding of the pharmacokinetic and pharmacodynamic properties of a drug in animal models is a critical component of drug discovery and development. Such studies are performed in vivo and in vitro at various stages of the development process—ranging from preclinical absorption, distribution, metabolism and excretion (ADME) studies to late-stage human clinical trials—to elucidate a drug molecule’s metabolic profile and to assess its toxicity. Radiolabelled compounds, typically those that contain 14C or 3H isotopes, are one of the most powerful and widely deployed diagnostics for these studies. The introduction of radiolabels using synthetic chemistry enables the direct tracing of the drug molecule without substantially altering its structure or function. The ubiquity of C-H bonds in drugs and the relative ease and low cost associated with tritium (3H) make it an ideal radioisotope with which to conduct ADME studies early in the drug development process. Here we describe an iron-catalysed method for the direct 3H labelling of pharmaceuticals by hydrogen isotope exchange, using tritium gas as the source of the radioisotope. The site selectivity of the iron catalyst is orthogonal to currently used iridium catalysts and allows isotopic labelling of complementary positions in drug molecules, providing a new diagnostic tool in drug development.

[Gutiérrez Bueno (1745-1822), textbooks and a new public for chemistry in the last third of the 18th century].

PubMed

García Belmar, A; Bertomeu Sánchez, J R

2001-01-01

This paper is a part of a general research project on the role that chemistry played in the transition of materia medica to experimental pharmacology during 19th century Spain. Within this general framework, the paper deals with the main characteristics of Spanish textbooks aimed at pharmaceutical and medical students. In a former study, published in this journal, we outlined the institutional context in which these books were read, written and published. Some of these issues are developed in the present paper through analysis of the "Curso de química" written by Pedro Gutiérrez Bueno. New light is shed on the public for chemistry during the late XVIII century Spain and their role in shaping the contents and organisation of chemistry textbooks.

[The recent research progress of chemistry of marine natural products].

PubMed

Shi, Qing-wen; Li, Li-geng; Wang, Yu-fang; Huo, Chang-hong; Zhang, Man-li

2010-10-01

Ocean is a unique and excellent resource that provides a diverse array of intriguing natural products. Marine natural products have demonstrated significant and extremely potent biological activities and have captured the attention of natural products chemists in the past few decades. It is increasingly recognized that a wealth of fascinating natural products and novel chemical entities will play a dominant role in the discovery of useful leads for the development of pharmaceutical agents and provide useful probes to lead to breakthroughs in a variety of life-science fields. This article focused on the research progress of chemistry of marine natural products in recent five years.

National transparency assessment of Kuwait's pharmaceutical sector.

PubMed

Badawi, Dalia A; Alkhamis, Yousif; Qaddoumi, Mohammad; Behbehani, Kazem

2015-09-01

Corruption is one of several factors that may hinder the access to pharmaceuticals. Since Kuwait has the highest per-capita spending on pharmaceuticals in the region, we wanted to evaluate the level of transparency in its pharmaceutical sector using an established assessment tool adapted by the World Health Organization. Standardized questionnaires were conducted via semi-structured interviews with key informants to measure the level of transparency in eight functions of the public pharmaceutical sector. The scores for the degree of vulnerability to corruption reflected marginal to moderate venerability to corruption for most pharmaceutical sectors. The perceived strengths included availability of appropriate laws, the presence of clear standard operating procedures, and the use of an efficient registration/distribution system. Weaknesses included lack of conflict of interest guidelines and written terms of reference, absence of pharmacoeconomic studies, and inconsistencies in law enforcement. Findings reveal that few functions of Kuwait pharmaceutical sector remain fairly vulnerable to corruption. However, the willingness of Kuwait Ministry of Health to adopt the assessment study and the acknowledgement of the weaknesses of current processes of the pharmaceutical sector may assist to achieve a transparent pharmaceutical system in the near future. Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.

[Chinese medicine industry 4.0：advancing digital pharmaceutical manufacture toward intelligent pharmaceutical manufacture].

PubMed

Cheng, Yi-Yu; Qu, Hai-Bin; Zhang, Bo-Li

2016-01-01

A perspective analysis on the technological innovation in pharmaceutical engineering of Chinese medicine unveils a vision on "Future Factory" of Chinese medicine industry in mind. The strategy as well as the technical roadmap of "Chinese medicine industry 4.0" is proposed, with the projection of related core technology system. It is clarified that the technical development path of Chinese medicine industry from digital manufacture to intelligent manufacture. On the basis of precisely defining technical terms such as process control, on-line detection and process quality monitoring for Chinese medicine manufacture, the technical concepts and characteristics of intelligent pharmaceutical manufacture as well as digital pharmaceutical manufacture are elaborated. Promoting wide applications of digital manufacturing technology of Chinese medicine is strongly recommended. Through completely informationized manufacturing processes and multi-discipline cluster innovation, intelligent manufacturing technology of Chinese medicine should be developed, which would provide a new driving force for Chinese medicine industry in technology upgrade, product quality enhancement and efficiency improvement. Copyright© by the Chinese Pharmaceutical Association.

Bid purchasing of pharmaceuticals.

PubMed

Swift, R G; Ryan, M R

1978-11-01

The effects of bid purchasing of drug products by hospitals and the factors to consider in bid purchasing of pharmaceuticals are reviewed; further, the prices available with bid purchasing to a specific hospital in 1974 and 1977 are presented. Factors important for a successful bid purchasing system of pharmaceuticals are: (1) use of a formulary policy, (2) an effective procedure for handling bid purchasing and (3) criteria for evaluation of drug products. Significant differences were found between prices available with and without bid purchasing for 50 nonproprietary drug products in 1974 and for 19 products in 1977. Although monetary savings to hospitals do exist with bid purchasing of pharmaceuticals, the degree of savings is dependent upon the drug usage for that hospital.

Novel Electrosorption-Enhanced Solid-Phase Microextraction Device for Ultrafast In Vivo Sampling of Ionized Pharmaceuticals in Fish.

PubMed

Qiu, Junlang; Wang, Fuxin; Zhang, Tianlang; Chen, Le; Liu, Yuan; Zhu, Fang; Ouyang, Gangfeng

2018-01-02

Decreasing the tedious sample preparation duration is one of the most important concerns for the environmental analytical chemistry especially for in vivo experiments. However, due to the slow mass diffusion paths for most of the conventional methods, ultrafast in vivo sampling remains challenging. Herein, for the first time, we report an ultrafast in vivo solid-phase microextraction (SPME) device based on electrosorption enhancement and a novel custom-made CNT@PPY@pNE fiber for in vivo sampling of ionized acidic pharmaceuticals in fish. This sampling device exhibited an excellent robustness, reproducibility, matrix effect-resistant capacity, and quantitative ability. Importantly, the extraction kinetics of the targeted ionized pharmaceuticals were significantly accelerated using the device, which significantly improved the sensitivity of the SPME in vivo sampling method (limits of detection ranged from 0.12 ng·g -1 to 0.25 ng·g -1 ) and shorten the sampling time (only 1 min). The proposed approach was successfully applied to monitor the concentrations of ionized pharmaceuticals in living fish, which demonstrated that the device and fiber were suitable for ultrafast in vivo sampling and continuous monitoring. In addition, the bioconcentration factor (BCF) values of the pharmaceuticals were derived in tilapia (Oreochromis mossambicus) for the first time, based on the data of ultrafast in vivo sampling. Therefore, we developed and validated an effective and ultrafast SPME sampling device for in vivo sampling of ionized analytes in living organisms and this state-of-the-art method provides an alternative technique for future in vivo studies.

WHO Expert Committee on specifications for pharmaceutical preparations.

PubMed

2010-01-01

The Expert Committee on Specifications for Pharmaceutical Preparations works towards clear, independent and practical standards and guidelines for the quality assurance of medicines. Standards are developed by the Committee through worldwide consultation and an international consensus-building process. The following new guidelines were adopted and recommended for use: good practices for pharmaceutical quality control laboratories; supplementary guidelines for active pharmaceutical ingredients; good manufacturing practices for pharmaceutical products containing hazardous substances; good manufacturing practices for sterile pharmaceutical products; good distribution practices for pharmaceutical products; guidelines on the requalification of prequalified dossiers: and guidelines for the preparation of a contract research organization master file.

WHO Expert Committee on Specifications for Pharmaceutical Preparations.

PubMed

2009-01-01

The Expert Committee on Specifications for Pharmaceutical Preparations works towards clear, independent and practical standards and guidelines for the quality assurance of medicines. Standards are developed by the Committee through worldwide consultation and an international consensus-building process. The following new standards and guidelines were adopted and recommended for use: the current list of available International Chemical Reference Substances and International Infrared Reference Spectra; guidelines on stability testing of active pharmaceutical ingredients and finished pharmaceutical products; procedure for prequalification of pharmaceutical products; and the procedure for assessing the acceptability, in principle, of active pharmaceutical ingredients for use in pharmaceutical products.

Basics of Compounding: Clinical Pharmaceutics, Part 1.

PubMed

Allen, Loyd V

2016-01-01

Pharmaceutics is relevant far beyond the pharmaceutical industry, compounding, and the laboratory. Pharmaceutics can be used to solve many clinical problems in medication therapy. A pharmacists' knowledge of the physicochemical aspects of drugs and drug products should help the patient, physician, and healthcare professionals resolve issues in the increasingly complex world of modern medicine. Pharmacy is unique as it contains a knowledge base significantly different from that of physicians, nurses, and other health-related practitioners. The separation of the science and the practice of pharmacy have prevented the complete utilization of pharmaceutical sciences in the clinical environment far too long. Copyright© by International Journal of Pharmaceutical Compounding, Inc.

A rational approach to selecting and ranking some pharmaceuticals of concern for the aquatic environment and their relative importance compared with other chemicals.

PubMed

Donnachie, Rachel L; Johnson, Andrew C; Sumpter, John P

2016-04-01

Aquatic organisms can be exposed to thousands of chemicals discharged by the human population. Many of these chemicals are considered disruptive to aquatic wildlife, and the literature on the impacts of these chemicals grows daily. However, because time and resources are not infinite, research must focus on the chemicals that represent the greatest threat. One group of chemicals of increasing concern is pharmaceuticals, for which the primary challenge is to identify which represent the greatest threat. In the present study, a list of 12 pharmaceuticals was compiled based on scoring the prevalence of different compounds from previous prioritization reviews. These included rankings based on prescription data, environmental concentrations, predicted environmental concentration/predicted no-effect concentration (PEC/PNEC) ratios, persistency/bioaccumulation/(eco)toxicity (PBT), and fish plasma model approaches. The most frequently cited were diclofenac, paracetamol, ibuprofen, carbamazepine, naproxen, atenolol, ethinyl estradiol, aspirin, fluoxetine, propranolol, metoprolol, and sulfamethoxazole. For each pharmaceutical, literature on effect concentrations was compiled and compared with river concentrations in the United Kingdom. The pharmaceuticals were ranked by degree of difference between the median effect and median river concentrations. Ethinyl estradiol was ranked as the highest concern, followed by fluoxetine, propranolol, and paracetamol. The relative risk of these pharmaceuticals was compared with those of metals and some persistent organic pollutants. Pharmaceuticals appear to be less of a threat to aquatic organisms than some metals (Cu, Al, Zn) and triclosan, using this ranking approach. © 2015 The Authors. Environmental Toxicology and Chemistry Published by Wiley Periodicals, Inc. on behalf of SETAC.

Behavior of selected pharmaceuticals in topsoil of Greyic Phaeozem

NASA Astrophysics Data System (ADS)

Kodesova, Radka; Klement, Ales; Kocarek, Martin; Fer, Miroslav; Golovko, Oksana; Grabic, Roman; Jaksik, Ondrej

2014-05-01

It has been documented in several studies that soil may be contaminated by human or veterinary pharmaceuticals. Some of pharmaceutical ingredient may be retained in soils. The rest can be transported to the surface and groundwater through surface runoff and infiltration. Mobility of contaminants in soils is dependent on many soil and pharmaceutical properties (e.g. pharmaceutical adsorption on soil particles and pharmaceutical degradation). The goals of this study were: (1) to measure adsorption isotherms of selected pharmaceuticals in one soil; (2) to evaluate degradation of selected pharmaceuticals in this soil, and (3) to evaluate impact of applied pharmaceuticals on biological activity in soil, which influences pharmaceutical decomposition. Batch sorption tests were performed for 7 selected pharmaceuticals (beta blockers Atenolol and Metoprolol, anticonvulsant Carbamazepin, and antibiotics Clarithromycin, Clindamycin, Trimetoprim and Sulfamethoxazol) and one soil (topsoil of Greyic Phaeozem from Čáslav). The same concentrations (0.5, 1, 2.5, 5 and 10 mg/l) were used for almost all pharmaceuticals except Clarithromycin (0.033, 0.08, 0.165, 0.25, 0.33 mg/l). The Freundlich equations were used to describe adsorption isotherms. Degradation of all 7 pharmaceuticals was also studied. Solutes of different pharmaceuticals (concentration of 8.3 mg/l) were added into the plastic bottles (one pharmaceutical per bottle) with soil. Concentrations of pharmaceuticals remaining in soil 1, 2, 5, 12, 23, 40 and 61 days after the pharmaceutical application were analyzed. Colony forming unites were evaluated to describe microbial activity in time affected by different pharmaceuticals. Adsorption of studied pharmaceuticals on soil particles decreasing as follows: Clarithromycin, Trimetoprim, Metoprolol, Clindamycin, Atenolol, Carbamazepin, Sulfamethoxazol. Degradation rates in some degree reflected adsorption of studied pharmaceuticals on soil particles and increased with

Understanding the solution phase chemistry and solid state thermodynamic behavior of pharmaceutical cocrystals

NASA Astrophysics Data System (ADS)

Maheshwari, Chinmay

Cocrystals have drawn a lot of research interest in the last decade due to their potential to favorably alter the physicochemical and biopharmaceutical properties of active pharmaceutical ingredients. This dissertation focuses on the thermodynamic stability and solubility of pharmaceutical cocrystals. Specifically, the objectives are to; (i) investigate the influence of coformer properties such as solubility and ionization characteristics on cocrystal solubility and stability as a function of pH, (ii) to measure the thermodynamic solubility of metastable cocrystals, and study the solubility differences measured by kinetic and equilibrium methods, (iii) investigate the role of surfactants on the solubility and synthesis of cocrystals, (iv) investigate the solid state phase transformation of reactants to cocrystals and the factors that influence the reaction kinetics and, (v) provide models that enable the prediction of cocrystal formation by calculating the free energy of formation for a solid to solid transformation of reactants to cocrystals. Cocrystal solubilities were measured directly when cocrystals were thermodynamically stable, while solubilities were calculated from eutectic concentration measurements when cocrystals were of higher solubility than its components. Cocrystal solubility was highly dependent on coformer solubilities for gabapentin-lactam and lamotrigine cocrystals. It was found that melting point is not a good indicator of cocrystal solubility as solute-solvent interactions quantified by the activity coefficient play a huge role in the observed solubility. Similar to salts, cocrystals also exhibit pHmax, however the salts and cocrystals have different dependencies on the parameters that govern the value of pHmax. It is also shown that cocrystals could provide solubility advantage over salts as lamotrigine-nicotinamide cocrystal hydrate has about 6 fold higher solubility relative to lamotrigine-saccharin salt. In the case of mixtures of solid

[The reference pricing of pharmaceuticals in European countries].

PubMed

Gildeyeva, G N; Starykh, D A

2013-01-01

The article presents the analysis of various approaches to estimation of pharmaceuticals prices in conditions of actual systems of pharmaceuticals support. The pricing is considered in pegging to actual systems of pharmaceuticals support based on the principles of insurance and co-financing. The detailed analysis is presented concerning the methodology of estimation of reference prices of pharmaceuticals in different countries of Europe. The experience of European countries in evaluation of interchangeability of pharmaceuticals is discussed.

Pharmaceutical Cocrystals and Their Physicochemical Properties

PubMed Central

2009-01-01

Over the last 20 years, the number of publications outlining the advances in design strategies, growing techniques, and characterization of cocrystals has continued to increase significantly within the crystal engineering field. However, only within the last decade have cocrystals found their place in pharmaceuticals, primarily due to their ability to alter physicochemical properties without compromising the structural integrity of the active pharmaceutical ingredient (API) and thus, possibly, the bioactivity. This review article will highlight and discuss the advances made over the last 10 years pertaining to physical and chemical property improvements through pharmaceutical cocrystalline materials and, hopefully, draw closer the fields of crystal engineering and pharmaceutical sciences. PMID:19503732

Defining pharmaceutical systems strengthening: concepts to enable measurement.

PubMed

Hafner, Tamara; Walkowiak, Helena; Lee, David; Aboagye-Nyame, Francis

2017-05-01

Pharmaceutical products are indispensable for improving health outcomes. An extensive body of work on access to and use of medicines has resulted in an assortment of tools measuring various elements of pharmaceutical systems. Until now however, there has been little attempt to conceptualize a pharmaceutical system as an entity and define its strengthening in a way that allows for measuring systems strengthening. The narrow focus of available tools limits their value in ascertaining which interventions result in stronger, more resilient systems. We sought to address this shortcoming by revisiting the current definitions, frameworks and assessment tools related to pharmaceutical systems. We conducted a comprehensive literature review and consulted with select pharmaceutical experts. On the basis of our review, we propose that a pharmaceutical system consists of all structures, people, resources, processes, and their interactions within the broader health system that aim to ensure equitable and timely access to safe, effective, quality pharmaceutical products and related services that promote their appropriate and cost-effective use to improve health outcomes. We further propose that pharmaceutical systems strengthening is the process of identifying and implementing strategies and actions that achieve coordinated and sustainable improvements in the critical components of a pharmaceutical system to make it more responsive and resilient and to enhance its performance for achieving better health outcomes. Finally, we established that, in addition to system performance and resilience, seven components of the pharmaceutical system are critical for measuring pharmaceutical systems strengthening: pharmaceutical products and related services; policy, laws and governance; regulatory systems; innovation, research and development, manufacturing, and trade; financing; human resources; and information. This work adds clarity to the concept of pharmaceutical systems and their

From Medicinal Chemistry to Human Health: Current Approaches to Drug Discovery for Cancer and Neglected Tropical Diseases.

PubMed

Ferreira, Leonardo G; Oliva, Glaucius; Andricopulo, Adriano D

2018-01-01

Scientific and technological breakthroughs have compelled the current players in drug discovery to increasingly incorporate knowledge-based approaches. This evolving paradigm, which has its roots attached to the recent advances in medicinal chemistry, molecular and structural biology, has unprecedentedly demanded the development of up-to-date computational approaches, such as bio- and chemo-informatics. These tools have been pivotal to catalyzing the ever-increasing amount of data generated by the molecular sciences, and to converting the data into insightful guidelines for use in the research pipeline. As a result, ligand- and structure-based drug design have emerged as key pathways to address the pharmaceutical industry's striking demands for innovation. These approaches depend on a keen integration of experimental and molecular modeling methods to surmount the main challenges faced by drug candidates - in vivo efficacy, pharmacodynamics, metabolism, pharmacokinetics and safety. To that end, the Laboratório de Química Medicinal e Computacional (LQMC) of the Universidade de São Paulo has developed forefront research on highly prevalent and life-threatening neglected tropical diseases and cancer. By taking part in global initiatives for pharmaceutical innovation, the laboratory has contributed to the advance of these critical therapeutic areas through the use of cutting-edge strategies in medicinal chemistry.

[Tracking study to improve basic academic ability in chemistry for freshmen].

PubMed

Sato, Atsuko; Morone, Mieko; Azuma, Yutaka

2010-08-01

The aims of this study were to assess the basic academic ability of freshmen with regard to chemistry and implement suitable educational guidance measures. At Tohoku Pharmaceutical University, basic academic ability examinations are conducted in chemistry for freshmen immediately after entrance into the college. From 2003 to 2009, the examination was conducted using the same questions, and the secular changes in the mean percentage of correct response were statistically analyzed. An experience survey was also conducted on 2007 and 2009 freshmen regarding chemical experiments at senior high school. Analysis of the basic academic ability examinations revealed a significant decrease in the mean percentage of correct responses after 2007. With regard to the answers for each question, there was a significant decrease in the percentage of correct answers for approximately 80% of questions. In particular, a marked decrease was observed for calculation questions involving percentages. A significant decrease was also observed in the number of students who had experiences with chemical experiments in high school. However, notable results have been achieved through the implementation of practice incorporating calculation problems in order to improve calculation ability. Learning of chemistry and a lack of experimental experience in high school may be contributory factors in the decrease in chemistry academic ability. In consideration of the professional ability demanded of pharmacists, the decrease in calculation ability should be regarded as a serious issue and suitable measures for improving calculation ability are urgently required.

Imidazopyridines as a source of biological activity and their pharmacological potentials-Infrared and Raman spectroscopic evidence of their content in pharmaceuticals and plant materials.

PubMed

Dymińska, Lucyna

2015-09-15

Derivatives of imidazopyridine are used in medicinal chemistry due to their biological and pharmaceutical properties. This review article presents imidazopyridine pharmacological activity as antiinflammatory, anticancer, antiviral, antiosteoporotic, antiparasitic, and antihypertensive agents by studying its various synthesized derivatives. Some of compounds with imidazopyridine skeleton are used in psychiatry and autoimmune disorders. The presented data suggest that IR and Raman spectra measurements are a good methods for identification and characterization of the compounds containing imidazopyridine core. Two stretching vibrations: νas(Φ) and νs(Φ) are of a diagnostic importance. The appearance of these bands in the IR and Raman spectra of some plants, tissues and pharmaceuticals confirms the presence of imidazopyridine skeleton in these substances. Copyright © 2015 Elsevier Ltd. All rights reserved.

China: current trends in pharmaceutical drug discovery.

PubMed

Luo, Ying

2008-04-01

Pharmaceutical discovery and development is expensive and highly risky, even for multinational corporations. As a developing country with limited financial resources, China has been seeking the most cost-effective means to reach the same level of innovation and productivity as Western countries in the pharmaceutical industry sector. After more than 50 years of building up talent and experience, the time for China to become a powerhouse in pharmaceutical innovation is finally approaching. Returnee scientists to China are one of the reasons for the wave of new discovery and commercialization occurring within the country. The consolidation of local Chinese pharmaceutical companies and foreign investment is also providing an agreeable environment for the evolution of a new generation of biotechnology. The opportunity for pharmaceutical innovation is also being expedited by the entry of multinational companies into the Chinese pharmaceutical market, and by the outsourcing of research from these companies to China.

ANALYSIS OF TRENDS IN LIFE EXPECTANCIES AND PER CAPITA GROSS DOMESTIC PRODUCT AS WELL AS PHARMACEUTICAL AND NON-PHARMACEUTICAL HEALTHCARE EXPENDITURES.

PubMed

Hermanowski, Tomasz; Bystrov, Victor; Staszewska-Bystrova, Anna; Szafraniec-Buryło, Sylwia I; Rabczenko, Daniel; Kolasa, Katarzyna; Orlewska, Ewa

2015-01-01

Life expectancy is a common measure of population health. Macro-perspective based on aggregated data makes it possible to approximate the impact of different levels of pharmaceutical expenditure on general population health status and is often used in cross-country comparisons. The aim of the study was to determine whether there are long-run relations between life expectancy, total healthcare expenditures, and pharmaceutical expenditures in OECD countries. Common trends in per capita gross domestic products (GDPs) (excluding healthcare expenditures), per capita healthcare expenditures (excluding pharmaceutical expenditures), per capita pharmaceutical expenditures, and life expectancies of women and men aged 60 and 65 were analyzed across OECD countries. Short-term effect of pharmaceutical expenditure onto life expectancy was also estimated by regressing the deviations of life expectancies from their long-term trends onto the deviations of pharmaceutical and non-pharmaceutical health expenditures, as well as GDP from their trends. The dataset was created on the basis of OECD Health Data for 34 countries and the years 1991-2010. Life expectancy variables were used as proxies for the health outcomes, whereas the pharmaceutical and healthcare expenditures represented drug and healthcare consumption, respectively. In general, both expenditures and life expectancies tended to increase in all of the analyzed countries; however, the growth rates differed across the countries. The analysis of common trends indicated the existence of common long-term trends in life expectancies and per capita GDP as well as pharmaceutical and non-pharmaceutical healthcare expenditures. However, there was no evidence that pharmaceutical expenditures provided additional information about the long-term trends in life expectancies beyond that contained in the GDP series. The analysis based on the deviations of variables from their long-term trends allowed concluding that pharmaceutical

Sulfite-containing Canadian pharmaceutical products available in 1991.

PubMed Central

Miyata, M; Schuster, B; Schellenberg, R

1992-01-01

OBJECTIVE: To compile an inclusive list of Canadian pharmaceutical products available in 1991 that contained sulfites. DATA SOURCES: Written and oral responses from 94 pharmaceutical companies selected from the 1989 Compendium of Pharmaceuticals and Specialties. RESULTS: A list of sulfite-containing pharmaceutical products was compiled from data supplied by the 90 responding companies. Companies whose products contained no sulfites were separately identified. CONCLUSIONS: Sulfites are present in many pharmaceutical products and are one of many excipients and additives that have been reported to cause severe adverse reactions. The provided list should be a useful aid for health care practitioners when prescribing pharmaceutical products for sulfite-sensitive patients. PMID:1483237

[Fundamentals of plasma chemistry and its application to drug engineering].

PubMed

Kuzuya, M

1996-04-01

In this review, our novel research works in both low temperature plasma chemistry and solid state plasma chemistry were described. As for low temperature plasma, the ESR study on plasma-induced radicals of several selected conventional polymers was shown including the detailed analyses of the radical structure and the mechanism by which the radicals were formed on typical degradable methacrylic polymers and cross-linkable polystyrene. One of the pharmaceutical applications of the plasma processing for drug delivery system (DDS) was also described, which includes the preparations of double-compressed tablet consisting of drugs as a core material and various types of polymers as a wall material followed by plasma-irradiation on such a tablet. As for solid state plasma, the detailed reaction mechanism of solid state mechanochemical polymerization was shown including the solid state single electron transfer and the special feature of the resulting polymers. The structural criteria for polymerizable monomer derived from the quantum chemical considerations were also established. Based on the above findings, we synthesized various polymeric prodrugs by mechanochemical polymerization and studied the nature of hydrolyses (drug release).

From supramolecular chemistry towards constitutional dynamic chemistry and adaptive chemistry.

PubMed

Lehn, Jean-Marie

2007-02-01

Supramolecular chemistry has developed over the last forty years as chemistry beyond the molecule. Starting with the investigation of the basis of molecular recognition, it has explored the implementation of molecular information in the programming of chemical systems towards self-organisation processes, that may occur either on the basis of design or with selection of their components. Supramolecular entities are by nature constitutionally dynamic by virtue of the lability of non-covalent interactions. Importing such features into molecular chemistry, through the introduction of reversible bonds into molecules, leads to the emergence of a constitutional dynamic chemistry, covering both the molecular and supramolecular levels. It considers chemical objects and systems capable of responding to external solicitations by modification of their constitution through component exchange or reorganisation. It thus opens the way towards an adaptive and evolutive chemistry, a further step towards the chemistry of complex matter.

Patients' willingness to pay for pharmaceutical care.

PubMed

Larson, R A

2000-01-01

To determine the level at which patients receive pharmaceutical care services and their willingness to pay for comprehensive pharmaceutical care services. A mail survey was sent to 2,500 adults in the United States. Surveys were mailed to subjects' homes. Subjects were randomly selected from a marketing database that included representation from each of the 50 states of the United States. The survey provided a description of comprehensive pharmaceutical care, and survey items asked about the level of care subjects were receiving and their willingness to pay for these services. Level of various pharmacy services subjects reported receiving, and the dollar amount subjects were willing to pay for comprehensive pharmaceutical care. The majority of the subjects were not receiving pharmaceutical care services. The average amount all respondents were willing to pay for these services was $13 for a one-time consultation and $28 for this plus 1 year of monitoring. Looking only at those respondents willing to pay (56%), the means rise to $23 and $50, respectively. A majority of patients are willing to pay for pharmaceutical care services, even if they are not now receiving this level of care. Direct payment from patients who recognize the therapeutic benefits of pharmaceutical care may be a more viable option than is generally believed, at least until the profession can prove pharmaceutical care's utility and cost-effectiveness to third party payers.

Contribution of hospital effluents to the load of pharmaceuticals in urban wastewaters: identification of ecologically relevant pharmaceuticals.

PubMed

Santos, Lúcia H M L M; Gros, Meritxell; Rodriguez-Mozaz, Sara; Delerue-Matos, Cristina; Pena, Angelina; Barceló, Damià; Montenegro, M Conceição B S M

2013-09-01

The impact of effluent wastewaters from four different hospitals: a university (1456 beds), a general (350 beds), a pediatric (110 beds) and a maternity hospital (96 beds), which are conveyed to the same wastewater treatment plant (WWTP), was evaluated in the receiving urban wastewaters. The occurrence of 78 pharmaceuticals belonging to several therapeutic classes was assessed in hospital effluents and WWTP wastewaters (influent and effluent) as well as the contribution of each hospital in WWTP influent in terms of pharmaceutical load. Results indicate that pharmaceuticals are widespread pollutants in both hospital and urban wastewaters. The contribution of hospitals to the input of pharmaceuticals in urban wastewaters widely varies, according to their dimension. The estimated total mass loadings were 306 g d(-1) for the university hospital, 155 g d(-1) for the general one, 14 g d(-1) for the pediatric hospital and 1.5 g d(-1) for the maternity hospital, showing that the biggest hospitals have a greater contribution to the total mass load of pharmaceuticals. Furthermore, analysis of individual contributions of each therapeutic group showed that NSAIDs, analgesics and antibiotics are among the groups with the highest inputs. Removal efficiency can go from over 90% for pharmaceuticals like acetaminophen and ibuprofen to not removal for β-blockers and salbutamol. Total mass load of pharmaceuticals into receiving surface waters was estimated between 5 and 14 g/d/1000 inhabitants. Finally, the environmental risk posed by pharmaceuticals detected in hospital and WWTP effluents was assessed by means of hazard quotients toward different trophic levels (algae, daphnids and fish). Several pharmaceuticals present in the different matrices were identified as potentially hazardous to aquatic organisms, showing that especial attention should be paid to antibiotics such as ciprofloxacin, ofloxacin, sulfamethoxazole, azithromycin and clarithromycin, since their hazard quotients

Vulnerabilities to misinformation in online pharmaceutical marketing.

PubMed

De Freitas, Julian; Falls, Brian A; Haque, Omar S; Bursztajn, Harold J

2013-05-01

Given the large percentage of Internet users who search for health information online, pharmaceutical companies have invested significantly in online marketing of their products. Although online pharmaceutical marketing can potentially benefit both physicians and patients, it can also harm these groups by misleading them. Indeed, some pharmaceutical companies have been guilty of undue influence, which has threatened public health and trust. We conducted a review of the available literature on online pharmaceutical marketing, undue influence and the psychology of decision-making, in order to identify factors that contribute to Internet users' vulnerability to online pharmaceutical misinformation. We find five converging factors: Internet dependence, excessive trust in the veracity of online information, unawareness of pharmaceutical company influence, social isolation and detail fixation. As the Internet continues to change, it is important that regulators keep in mind not only misinformation that surrounds new web technologies and their contents, but also the factors that make Internet users vulnerable to misinformation in the first place. Psychological components are a critical, although often neglected, risk factor for Internet users becoming misinformed upon exposure to online pharmaceutical marketing. Awareness of these psychological factors may help Internet users attentively and safely navigate an evolving web terrain.

Pharmaceutical policies in European countries.

PubMed

Barros, Pedro Pita

2010-01-01

Pharmaceutical expenditures have an important role in Europe. The attempts to control expenditure have used a wide range of policy measures. We reviewed the main measures adopted by the European Union countries, especially in countries where governments are the largest third-party payers. To complement a literature review on the topic, data was gathered from national reviews of health systems and direct inquiries to several government bodies. Almost all countries regulate prices of pharmaceutical products. Popular policy measures include international referencing to set prices (using as benchmark countries that have set lower prices), internal reference pricing systems to promote price competition in domestic markets, and positive lists for reimbursement to promote consumption of generics (including in some cases substitution by pharmacists of drugs prescribed by physicians). Despite the wide range of policy measures, it is not possible to identify a "silver bullet" to control pharmaceutical expenditures. We also identified two main policy challenges: policy coordination among countries within the European Union to maintain incentives for R&D at the global level, and the development of new relationships with the pharmaceutical industry; namely, the so-called risk-sharing agreements between the pharmaceutical industry and governments/regulators (or large third-party payers).

Contribution of Surface Chemistry to the Shear Thickening of Silica Nanoparticle Suspensions.

PubMed

Yang, Wufang; Wu, Yang; Pei, Xiaowei; Zhou, Feng; Xue, Qunji

2017-01-31

Shear thickening is a general process crucial for many processed products ranging from food and personal care to pharmaceuticals. Theoretical calculations and mathematical simulations of hydrodynamic interactions and granular-like contacts have proved that contact forces between suspended particles dominate the rheological characteristic of colloidal suspensions. However, relevant experimental studies are very rare. This study was conducted to reveal the influence of nanoparticle (NP) interactions on the rheological behavior of shear-thickening fluids (STFs) by changing the colloidal surface chemistries. Silica NPs with various surface chemical compositions are fabricated and used to prepare dense suspensions. Rheological experiments are conducted to determine the influence of NP interactions on corresponding dense suspension systems. The results suggest that the surface chemistries of silica NPs determine the rheological behavior of dense suspensions, including shear-thickening behavior, onset stress, critical volume fraction, and jamming volume fraction. This study provides useful reference for designing effective STFs and regulating their characteristics.

Pharmacists' Perceptions of the Economic Value of Compounded Pharmaceuticals: A Comparison of Compounded and Commercial Pharmaceuticals in Select Disease States.

PubMed

Lobb, William B; Wilkin, Noel E; Holmes, Erin R

2015-01-01

Studies have been conducted to assess patient satisfaction with compounded pharmaceuticals and to directly compare compounded pharmaceuticals with their comparable commercial pharmaceuticals. Yet, the economic value of or potential for economic value derived from compounded pharmaceuticals relative to commercial pharmaceuticals is still not known. Therefore, the purpose of this study was to assess and compare compounding and non-compounding pharmacists' perceptions of the economic value of compounded preparations relative to commercial products. In-depth interviews with 10 compounding pharmacists and physicians who prescribe compounded prescription pharmaceutical preparations were conducted to help develop a self-administered questionnaire distributed to 50 compounding and 50 non-compounding pharmacists. Compounding and non-compounding pharmacists' perceptions differed most often in the context of compounded pharmaceuticals for pediatric patients. However, both groups responded with moderate agreement that compounded prescription treatments are more profitable for the pharmacy than commercial prescription treatments in most therapeutic areas. This research sought to understand the perception of pharmacists of areas for potential direct and indirect economic cost savings as a result of compounding. For all items whereby compounding and non-compounding pharmacists' ratings were significantly different, compounding pharmacists more strongly believed that compounding pharmaceuticals offered benefit and vice versa. The differences in ratings that were most common were those that directly compared the economic value of compounding and commercial pharmaceuticals, with compounding pharmacists more strongly agreeing with the potential cost savings associated with compounded pharmaceuticals. Based on these findings, prescription compounds are believed to have a benefit to the health system by those who provide them. Future research should proactively explore the economic

[History of pharmaceutical packaging in modern Japan. II--Package size of pharmaceuticals].

PubMed

Hattori, Akira

2014-01-01

When planning pharmaceutical packaging, the package size for the product is important for determining the basic package concept. Initially, the sales unit for herbal medicines was the weight; however in 1868, around the early part of the Meiji era, Japanese and Western units were being used and the sales unit was confusing. Since the Edo era, the packing size for OTC medicines was adopted using weight, numbers, dosage or treatment period. These were devised in various ways in consideration of convenience for the consumer, but the concept was not simple. In 1887, from the time that the first edition of the Japanese Pharmacopoeia came out, use of the metric system began to spread in Japan. Its use spread gradually for use in the package size of pharmaceutical products. At the time, the number of pharmaceutical units (i.e., tablets), became the sales unit, which is easy to understand by the purchaser.

Linked open drug data for pharmaceutical research and development

PubMed Central

2011-01-01

There is an abundance of information about drugs available on the Web. Data sources range from medicinal chemistry results, over the impact of drugs on gene expression, to the outcomes of drugs in clinical trials. These data are typically not connected together, which reduces the ease with which insights can be gained. Linking Open Drug Data (LODD) is a task force within the World Wide Web Consortium's (W3C) Health Care and Life Sciences Interest Group (HCLS IG). LODD has surveyed publicly available data about drugs, created Linked Data representations of the data sets, and identified interesting scientific and business questions that can be answered once the data sets are connected. The task force provides recommendations for the best practices of exposing data in a Linked Data representation. In this paper, we present past and ongoing work of LODD and discuss the growing importance of Linked Data as a foundation for pharmaceutical R&D data sharing. PMID:21575203

Nanocrystals Technology for Pharmaceutical Science.

PubMed

Cheng, Zhongyao; Lian, Yumei; Kamal, Zul; Ma, Xin; Chen, Jianjun; Zhou, Xinbo; Su, Jing; Qiu, Mingfeng

2018-05-17

Nanocrystals technology is a promising method for improving the dissolution rate and enhancing the bioavailability of poorly soluble drugs. In recent years, it has been developing rapidly and applied to drug research and engineering. Nanocrystal drugs can be formulated into various dosage forms. This review mainly focused on the nanocrystals technology and its application in pharmaceutical science. Firstly, different preparation methods of nanocrystal technology and the characterization of nanocrystal drugs are briefly described. Secondly, the application of nanocrystals technology in pharmaceutical science is mainly discussed followed by the introduction of sustained release formulations. Then, the scaling up process, marketed nanocrystal drug products and regulatory aspects about nanodrugs are summarized. Finally, the specific challenges and opportunities of nanocrystals technology for pharmaceutical science are summarized and discussed. This review will provide a comprehensive guide for scientists and engineers in the field of pharmaceutical science and biochemical engineering. Copyright© Bentham Science Publishers; For any queries, please email at epub@benthamscience.org.

Discovery of novel anti-HIV agents via Cu(I)-catalyzed azide-alkyne cycloaddition (CuAAC) click chemistry-based approach.

PubMed

Gao, Ping; Sun, Lin; Zhou, Junsu; Li, Xiao; Zhan, Peng; Liu, Xinyong

2016-09-01

In recent years, a variety of new synthetic methodologies and concepts have been proposed in the search for new pharmaceutical lead structures and optimization. Notably, the Cu(I)-catalyzed azide-alkyne cycloaddition (CuAAC) click chemistry approach has drawn great attention and has become a powerful tool for the generation of privileged medicinal skeletons in the discovery of anti-HIV agents. This is due to the high degree of reliability, complete specificity (chemoselectivity and regioselectivity), mild conditions, and the biocompatibility of the reactants. Herein, the authors describe the progress thus far on the discovery of novel anti-HIV agents via the CuAAC click chemistry-based approach. CuAAC click chemistry is a proven protocol for synthesizing triazole products which could serve as basic pharmacophores, act as replacements of traditional scaffold or substituent modification, be a linker of dual-target or dual-site inhibitors and more for the discovery of novel anti-HIV agents. What's more, it also provides convenience and feasibility for dynamic combinatorial chemistry and in situ screening. It is envisioned that click chemistry will draw more attention and make more contributions in anti-HIV drug discovery in the future.

Patent indicators: a window to pharmaceutical market success.

PubMed

Guo, Yang; Hu, Yuanjia; Zheng, Mingli; Wang, Yitao

2013-07-01

Pharmaceutical success in the market is the best reward for pharmaceutical investors undergoing the lengthy, costly and risky process of pharmaceutical Research and Development (R&D). Drugs with high market revenues trigger fierce competition between pharmaceutical enterprises, as is demonstrated by the increasing Mergers & Acquisitions (M&A) cases focusing on seizing the best-selling products. On the other hand, patents, as the best shield for innovative drugs against generic drugs, become a powerful weapon for pharmaceutical enterprises to win the substantial returns generated by market exclusivity. Patents seem to be directly responsible for the commercial success of new medicines. In this context, it is of great significance to find out the empirical associations between pharmaceutical commercial success and patents. By comprehensively analysing 127 drugs marketed in the USA and their 621 American patents, this article identifies the evidence to link various patent indicators with pharmaceutical sales in actual market.

Constitutional dynamic chemistry: bridge from supramolecular chemistry to adaptive chemistry.

PubMed

Lehn, Jean-Marie

2012-01-01

Supramolecular chemistry aims at implementing highly complex chemical systems from molecular components held together by non-covalent intermolecular forces and effecting molecular recognition, catalysis and transport processes. A further step consists in the investigation of chemical systems undergoing self-organization, i.e. systems capable of spontaneously generating well-defined functional supramolecular architectures by self-assembly from their components, thus behaving as programmed chemical systems. Supramolecular chemistry is intrinsically a dynamic chemistry in view of the lability of the interactions connecting the molecular components of a supramolecular entity and the resulting ability of supramolecular species to exchange their constituents. The same holds for molecular chemistry when the molecular entity contains covalent bonds that may form and break reversibility, so as to allow a continuous change in constitution by reorganization and exchange of building blocks. These features define a Constitutional Dynamic Chemistry (CDC) on both the molecular and supramolecular levels.CDC introduces a paradigm shift with respect to constitutionally static chemistry. The latter relies on design for the generation of a target entity, whereas CDC takes advantage of dynamic diversity to allow variation and selection. The implementation of selection in chemistry introduces a fundamental change in outlook. Whereas self-organization by design strives to achieve full control over the output molecular or supramolecular entity by explicit programming, self-organization with selection operates on dynamic constitutional diversity in response to either internal or external factors to achieve adaptation.The merging of the features: -information and programmability, -dynamics and reversibility, -constitution and structural diversity, points to the emergence of adaptive and evolutive chemistry, towards a chemistry of complex matter.

Adsorption of pharmaceuticals onto trimethylsilylated mesoporous SBA-15.

PubMed

Bui, Tung Xuan; Pham, Viet Hung; Le, Son Thanh; Choi, Heechul

2013-06-15

The adsorption of a complex mixture of 12 selected pharmaceuticals to trimethylsilylated mesoporous SBA-15 (TMS-SBA-15) has been investigated by batch adsorption experiments. The adsorption of pharmaceuticals to TMS-SBA-15 was highly dependent on the solution pH and pharmaceutical properties (i.e., hydrophobicity (logKow) and acidity (pKa)). Good log-log linear relationships between the adsorption (Kd) and pH-dependent octanol-water coefficients (Kow(pH)) were then established among the neutral, anionic, and cationic compounds, suggesting hydrophobic interaction as a primary driving force in the adsorption. In addition, the neutral species of each compound accounted for a major contribution to the overall compound adsorption onto TMS-SBA-15. The adsorption kinetics of pharmaceuticals was evaluated by the nonlinear first-order and pseudo-second-order models. The first-order model gave a better fit for five pharmaceuticals with lower adsorption capacity, whereas the pseudo-second-order model fitted better for seven pharmaceuticals having higher adsorption capacity. In the same group of properties, pharmaceuticals having higher adsorption capacity exhibited faster adsorption rates. The rate-limiting steps for adsorption of pharmaceuticals onto TMS-SBA-15 are boundary layer diffusion and intraparticle diffusion including diffusion in mesopores and micropores. In addition, the adsorption of pharmaceuticals to TMS-SBA-15 was not influenced by the change of initial pharmaceutical concentration (10-100μgL(-1)) and the presence of natural organic matter. Copyright © 2013 Elsevier B.V. All rights reserved.

Pharmaceutical technology management--profitable business avenue.

PubMed

Puthli, Shivanand P

2010-01-01

Growing research expenditure, regulatory framework and generic erosion have forced pharmaceutical companies globally to resort to pharmaceutical technology management (PTM). Indeed, the pharmaceutical industry has witnessed the impact of innovative drug delivery and device technologies and their influence on business. PTM has given a new business insight with greater profits and enhancement of product franchise. Promising breakthrough technologies have not been able to reach a commercial platform largely owing to lack of capital at the preliminary stages of the product development program. Intellectual property plays a considerable role in protecting innovative technologies. Joint ventures and strategic alliances also become important for commercializing a new technology. The synergy of PTM with options of in-licensing is expected to infuse newer opportunities to the pharmaceutical business.

Nanopharmaceuticals: Tiny challenges for the environmental risk assessment of pharmaceuticals.

PubMed

Berkner, Silvia; Schwirn, Kathrin; Voelker, Doris

2016-04-01

Many new developments and innovations in health care are based on nanotechnology. The field of nanopharmaceuticals is diverse and not as new as one might think; indeed, nanopharmaceuticals have been marketed for many years, and the future is likely to bring more nanosized compounds to the market. Therefore, it is time to examine whether the environmental risk assessment for human pharmaceuticals is prepared to assess the exposure, fate, and effects of nanopharmaceuticals in an adequate way. Challenges include the different definitions for nanomaterials and nanopharmaceuticals, different regulatory frameworks, the diversity of nanopharmaceuticals, the scope of current regulatory guidelines, and the applicability of test protocols. Based on the current environmental risk assessment for human medicinal products in the European Union, necessary adaptations for the assessment procedures and underlying study protocols are discussed and emerging solutions identified. © 2015 The Authors. Environmental Toxicology & Chemistry published by Wiley Periodicals, Inc. on behalf of SETAC.

WHO Expert Committee on Specifications for Pharmaceutical Preparations.

PubMed

2012-01-01

The Expert Committee on Specifications for Pharmaceutical Preparations works towards clear, independent and practical standards and guidelines for the quality assurance of medicines. Standards are developed by the Committee through worldwide consultation and an international consensus-building process. The following new guidelines were adopted and recommended for use: Development of monographs for The International Pharmacopoeia; WHO good manufacturing practices: water for pharmaceutical use; Pharmaceutical development of multisource (generic) pharmaceutical products--points to consider; Guidelines on submission of documentation for a multisource (generic) finished pharmaceutical product for the WHO Prequalification of Medicines Programme: quality part; Development of paediatric medicines: points to consider in formulation; Recommendations for quality requirements for artemisinin as a starting material in the production of antimalarial active pharmaceutical ingredients.

Active pharmaceutical ingredient (API) production involving continuous processes--a process system engineering (PSE)-assisted design framework.

PubMed

Cervera-Padrell, Albert E; Skovby, Tommy; Kiil, Søren; Gani, Rafiqul; Gernaey, Krist V

2012-10-01

A systematic framework is proposed for the design of continuous pharmaceutical manufacturing processes. Specifically, the design framework focuses on organic chemistry based, active pharmaceutical ingredient (API) synthetic processes, but could potentially be extended to biocatalytic and fermentation-based products. The method exploits the synergic combination of continuous flow technologies (e.g., microfluidic techniques) and process systems engineering (PSE) methods and tools for faster process design and increased process understanding throughout the whole drug product and process development cycle. The design framework structures the many different and challenging design problems (e.g., solvent selection, reactor design, and design of separation and purification operations), driving the user from the initial drug discovery steps--where process knowledge is very limited--toward the detailed design and analysis. Examples from the literature of PSE methods and tools applied to pharmaceutical process design and novel pharmaceutical production technologies are provided along the text, assisting in the accumulation and interpretation of process knowledge. Different criteria are suggested for the selection of batch and continuous processes so that the whole design results in low capital and operational costs as well as low environmental footprint. The design framework has been applied to the retrofit of an existing batch-wise process used by H. Lundbeck A/S to produce an API: zuclopenthixol. Some of its batch operations were successfully converted into continuous mode, obtaining higher yields that allowed a significant simplification of the whole process. The material and environmental footprint of the process--evaluated through the process mass intensity index, that is, kg of material used per kg of product--was reduced to half of its initial value, with potential for further reduction. The case-study includes reaction steps typically used by the pharmaceutical

Vulnerabilities to misinformation in online pharmaceutical marketing

PubMed Central

De Freitas, Julian; Falls, Brian A; Haque, Omar S; Bursztajn, Harold J

2013-01-01

Given the large percentage of Internet users who search for health information online, pharmaceutical companies have invested significantly in online marketing of their products. Although online pharmaceutical marketing can potentially benefit both physicians and patients, it can also harm these groups by misleading them. Indeed, some pharmaceutical companies have been guilty of undue influence, which has threatened public health and trust. We conducted a review of the available literature on online pharmaceutical marketing, undue influence and the psychology of decision-making, in order to identify factors that contribute to Internet users’ vulnerability to online pharmaceutical misinformation. We find five converging factors: Internet dependence, excessive trust in the veracity of online information, unawareness of pharmaceutical company influence, social isolation and detail fixation. As the Internet continues to change, it is important that regulators keep in mind not only misinformation that surrounds new web technologies and their contents, but also the factors that make Internet users vulnerable to misinformation in the first place. Psychological components are a critical, although often neglected, risk factor for Internet users becoming misinformed upon exposure to online pharmaceutical marketing. Awareness of these psychological factors may help Internet users attentively and safely navigate an evolving web terrain. PMID:23761527

QUALITY CONTROL OF PHARMACEUTICALS.

PubMed

LEVI, L; WALKER, G C; PUGSLEY, L I

1964-10-10

Quality control is an essential operation of the pharmaceutical industry. Drugs must be marketed as safe and therapeutically active formulations whose performance is consistent and predictable. New and better medicinal agents are being produced at an accelerated rate. At the same time more exacting and sophisticated analytical methods are being developed for their evaluation. Requirements governing the quality control of pharmaceuticals in accordance with the Canadian Food and Drugs Act are cited and discussed.

Electrostatic powder coating: Principles and pharmaceutical applications.

PubMed

Prasad, Leena Kumari; McGinity, James W; Williams, Robert O

2016-05-30

A majority of pharmaceutical powders are insulating materials that have a tendency to accumulate charge. This phenomenon has contributed to safety hazards and issues during powder handling and processing. However, increased understanding of this occurrence has led to greater understanding and control of processing and product performance. More recently, the charging of pharmaceutical powders has been employed to adopt electrostatic powder coating as a pharmaceutical process. Electrostatic powder coating is a mature technology used in the finishing industry and much of that knowledge applies to its use in pharmaceutical applications. This review will serve to summarize the principles of electrostatic powder coating and highlight some of the research conducted on its use for the preparation of pharmaceutical dosage forms. Copyright © 2016 Elsevier B.V. All rights reserved.

Multi-catalysis cascade reactions based on the methoxycarbonylketene platform: diversity-oriented synthesis of functionalized non-symmetrical malonates for agrochemicals and pharmaceuticals.

PubMed

Ramachary, Dhevalapally B; Venkaiah, Chintalapudi; Reddy, Y Vijayendar; Kishor, Mamillapalli

2009-05-21

In this paper we describe new multi-catalysis cascade (MCC) reactions for the one-pot synthesis of highly functionalized non-symmetrical malonates. These metal-free reactions are either five-step (olefination/hydrogenation/alkylation/ketenization/esterification) or six-step (olefination/hydrogenation/alkylation/ketenization/esterification/alkylation), and employ aldehydes/ketones, Meldrum's acid, 1,4-dihydropyridine/o-phenylenediamine, diazomethane, alcohols and active ethylene/acetylenes, and involve iminium-, self-, self-, self- and base-catalysis, respectively. Many of the products have direct application in agricultural and pharmaceutical chemistry.

Removal of Pharmaceutical Residues by Ferrate(VI)

PubMed Central

Jiang, JiaQian; Zhou, Zhengwei

2013-01-01

Background Pharmaceuticals and their metabolites are inevitably emitted into the waters. The adverse environmental and human health effects of pharmaceutical residues in water could take place under a very low concentration range; from several µg/L to ng/L. These are challenges to the global water industries as there is no unit process specifically designed to remove these pollutants. An efficient technology is thus sought to treat these pollutants in water and waste water. Methodology/Major Results A novel chemical, ferrate, was assessed using a standard jar test procedure for the removal of pharmaceuticals. The analytical protocols of pharmaceuticals were standard solid phase extraction together with various instrumentation methods including LC-MS, HPLC-UV and UV/Vis spectroscopy. Ferrate can remove more than 80% of ciprofloxacin (CIP) at ferrate dose of 1 mg Fe/L and 30% of ibuprofen (IBU) at ferrate dose of 2 mg Fe/L. Removal of pharmaceuticals by ferrate was pH dependant and this was in coordinate to the chemical/physical properties of pharmaceuticals. Ferrate has shown higher capability in the degradation of CIP than IBU; this is because CIP has electron-rich organic moieties (EOM) which can be readily degraded by ferrate oxidation and IBU has electron-withdrawing groups which has slow reaction rate with ferrate. Promising performance of ferrate in the treatment of real waste water effluent at both pH 6 and 8 and dose range of 1–5 mg Fe/L was observed. Removal efficiency of ciprofloxacin was the highest among the target compounds (63%), followed by naproxen (43%). On the other hand, n-acetyl sulphamethoxazole was the hardest to be removed by ferrate (8% only). Conclusions Ferrate is a promising chemical to be used to treat pharmaceuticals in waste water. Adjusting operating conditions in terms of the properties of target pharmaceuticals can maximise the pharmaceutical removal efficiency. PMID:23409029

Liquid chromatography coupled with inductively coupled plasma mass spectrometry in the pharmaceutical industry: selected examples.

PubMed

Marshall, Peter S; Leavens, Bill; Heudi, Olivier; Ramirez-Molina, Cesar

2004-11-12

Both LC and capillary LC (CapLC) have been successfully interfaced with inductively coupled plasma mass spectrometry (ICP-MS). Gradients of acetonitrile and aqueous based solvents have been employed to separate several compounds of pharmaceutical interest. This paper will describe four application areas in the pharmaceutical industry, and examples will be shown where CapLC, LC and gel electrophoresis via laser ablation have been coupled with ICP-MS. The four areas highlighted in this paper are: (1) the use of derivatisation reactions to "make the invisible visible". Methods involving derivatisations with copper and iron will be described that can be used for the analysis of amines and carboxylic acids by ICP-MS. (2) The profiling of metal ion content (in particular bromine) in biological samples such as human plasma, this study will focus on the metabolism of bromine-labelled peptides (e.g. substance P). (3) The analysis of materials derived from single, solid-phase beads used in combinatorial chemistry, and (4) also discussed will be our findings from investigations into the use of laser ablation ICP-MS on the determination of protein phosphorylation on electrophoresis gel blots.

Connecting biology and organic chemistry introductory laboratory courses through a collaborative research project.

PubMed

Boltax, Ariana L; Armanious, Stephanie; Kosinski-Collins, Melissa S; Pontrello, Jason K

2015-01-01

Modern research often requires collaboration of experts in fields, such as math, chemistry, biology, physics, and computer science to develop unique solutions to common problems. Traditional introductory undergraduate laboratory curricula in the sciences often do not emphasize connections possible between the various disciplines. We designed an interdisciplinary, medically relevant, project intended to help students see connections between chemistry and biology. Second term organic chemistry laboratory students designed and synthesized potential polymer inhibitors or inducers of polyglutamine protein aggregation. The use of novel target compounds added the uncertainty of scientific research to the project. Biology laboratory students then tested the novel potential pharmaceuticals in Huntington's disease model assays, using in vitro polyglutamine peptide aggregation and in vivo lethality studies in Drosophila. Students read articles from the primary literature describing the system from both chemical and biological perspectives. Assessment revealed that students emerged from both courses with a deeper understanding of the interdisciplinary nature of biology and chemistry and a heightened interest in basic research. The design of this collaborative project for introductory biology and organic chemistry labs demonstrated how the local interests and expertise at a university can be drawn from to create an effective way to integrate these introductory courses. Rather than simply presenting a series of experiments to be replicated, we hope that our efforts will inspire other scientists to think about how some aspect of authentic work can be brought into their own courses, and we also welcome additional collaborations to extend the scope of the scientific exploration. © 2015 The International Union of Biochemistry and Molecular Biology.

Occurrence of pharmaceuticals in Taiwan's surface waters: impact of waste streams from hospitals and pharmaceutical production facilities.

PubMed

Lin, Angela Yu-Chen; Tsai, Yu-Ting

2009-06-01

We investigated the occurrence and distribution of pharmaceuticals (including antibiotics, estrogens, non-steroidal anti-inflammatory drugs (NSAIDs), beta-blockers, and lipid regulators) in three rivers and in the waste streams of six hospitals and four pharmaceutical production facilities in Taiwan. The most frequently detected pharmaceuticals were acetaminophen, erythromycin-H(2)O, sulfamethoxazole, and gemfibrozil. NSAIDs were the next most-often detected compounds, with a detection frequency >60%. The other analytes were not detected or were seen in only a few samples at trace concentrations. The present study demonstrates a significant discharge of human medications from hospital and drug production facilities into surface waters in the Taipei district. The high concentrations of pharmaceuticals found in the Sindian and Dahan rivers demonstrate the alarming degree to which they have been impacted by urban drainage (waste effluents from hospitals, households, and pharmaceutical production facilities). The ubiquitous occurrence at extremely high concentrations of acetaminophen and erythromycin-H(2)O in both rivers (up to 15.7 and 75.5 microg/L) and in wastewater from hospitals and pharmaceutical production facilities (up to 417.5 and 7.84 microg/L) was unique. This finding, in combination with acetaminophen's status as the drug most often prescribed by Taiwan's dominant clinical institute, suggests the potential use of acetaminophen as a molecular indicator of contamination of Taiwan's aqueous environments with untreated urban drainage.

Quality Control of Pharmaceuticals

PubMed Central

Levi, Leo; Walker, George C.; Pugsley, L. I.

1964-01-01

Quality control is an essential operation of the pharmaceutical industry. Drugs must be marketed as safe and therapeutically active formulations whose performance is consistent and predictable. New and better medicinal agents are being produced at an accelerated rate. At the same time more exacting and sophisticated analytical methods are being developed for their evaluation. Requirements governing the quality control of pharmaceuticals in accordance with the Canadian Food and Drugs Act are cited and discussed. PMID:14199105

Gamma sterilization of pharmaceuticals--a review of the irradiation of excipients, active pharmaceutical ingredients, and final drug product formulations.

PubMed

Hasanain, Fatima; Guenther, Katharina; Mullett, Wayne M; Craven, Emily

2014-01-01

Sterilization by gamma irradiation has shown a strong applicability for a wide range of pharmaceutical products. Due to the requirement for terminal sterilization where possible in the pharmaceutical industry, gamma sterilization has proven itself to be an effective method as indicated by its acceptance in the European Pharmacopeia and the United States Pharmacopeia ( ). Some of the advantages of gamma over competitive procedures include high penetration power, isothermal character (small temperature rise), and no residues. It also provides a better assurance of product sterility than aseptic processing, as well as lower validation demands. Gamma irradiation is capable of killing microorganisms by breaking their chemical bonds, producing free radicals that attack the nucleic acid of the microorganism. Sterility by gamma irradiation is achieved mainly by the alteration of nucleic acid and preventing the cellular division. This review focuses on the extensive application of gamma sterilization to a wide range of pharmaceutical components including active pharmaceutical ingredients, excipients, final drug products, and combination drug-medical devices. A summary of the published literature for each class of pharmaceutical compound or product is presented. The irradiation conditions and various quality control characterization methodologies that were used to determine final product quality are included, in addition to a summary of the investigational outcomes. Based on this extensive literature review and in combination with regulatory guidelines and other published best practices, a decision tree for implementation of gamma irradiation for pharmaceutical products is established. This flow chart further facilitates the implementation of gamma irradiation in the pharmaceutical development process. The summary therefore provides a useful reference to the application and versatility of gamma irradiation for pharmaceutical sterilization. Many pharmaceutical products

Macro trends in pharmaceutical innovation.

PubMed

Cohen, Fredric J

2005-01-01

Critics decry the lack of 'truly innovative' new medicines and question the role of the pharmaceutical industry in creating the few that are developed. Is this an accurate portrayal of the state of pharmaceutical innovation? Does major pharma still innovate? If so, how? Must the industry innovate to survive? These and related issues are discussed.

A survey of reimbursement practices of private health insurance companies for pharmaceuticals not covered under the Pharmaceutical Benefits Scheme 2008.

PubMed

Lingaratnam, Senthil M; Kirsa, Sue W; Mellor, James D; Jackson, John; Crellin, Wallace; Fitzsimons, Michael; Zalcberg, John R

2011-05-01

To describe the current practices and policy of Australian private health insurance (PHI) companies with respect to cover for pharmaceuticals not subsidised under the Pharmaceutical Benefits Scheme (PBS). A 2008 review of web-published policy statements for top-level hospital and comprehensive general treatment insurance, and survey of reimbursement practices by way of questionnaire, of 31 Australian-registered, open-membership PHI companies. Description of the level of pharmaceutical cover and important considerations identified by PHI companies for funding non-PBS pharmaceuticals through benefit entitlements or ex-gratia payments. Nine of thirty-one PHI companies (29%) provided responses accounting for ~60% market share of PHI. The majority of smaller PHI firms either declined participation or did not respond. The maximum limits offered for non-PBS pharmaceuticals, under comprehensive general treatment insurance, varied significantly and typically did not adequately cover high-cost pharmaceuticals. Some companies occasionally offered ex-gratia payments (or discretionary payments in excess of the policyholder's entitlement benefits) for high cost-pharmaceuticals. Factors considered important in their decision to approve or reject ex-gratia requests were provided. All results were de-identified. There is little consistency across PHI companies in the manner in which they handle requests for high-cost pharmaceuticals in excess of the defined benefit limits. Such information and processes are not transparent to consumers.

Patrick Couvreur: inspiring pharmaceutical innovation.

PubMed

Stanwix, Hannah

2014-05-01

Patrick Couvreur speaks to Hannah Stanwix, Managing Comissioning Editor: Professor Patrick Couvreur received his pharmacy degree from the Université Catholique de Louvain (Louvain-la-Neuve, Belgium) in 1972. He holds a PhD in pharmaceutical technology from the same university and completed a postdoctoral fellowship at the Eidgenössische Technische Hochschule (Zürich, Switzerland). Since 1984, Professor Couvreur has been Full Professor of Pharmacy at the Paris-Sud University (Paris, France) and was holder of the Chair of Innovation Technologique at the prestigious Collège de France (Paris, France). He has published more than 450 peer-reviewed articles and has an H-index of 73, with over 19,000 citations. Professor Coureur has been recognized by numerous national and international awards, including the 2004 Pharmaceutical Sciences World Congress Award, the prestigious Host Madsen Medal, the Prix Galien, the European Pharmaceutical Scientist Award 2011 from the European Federation of Pharmaceutical Sciences, the Médaille de l'Innovation from the Centre National de la Recherche Scientifique, and recently the European Inventor Award 2013 from the European Patent Office.

PHARMACEUTICALS AND PERSONAL CARE PRODUCTS ...

EPA Pesticide Factsheets

Perhaps more so than with any other class of pollutants, the occurrence of pharmaceuticals and personal care products (PPCPS) in the environment highlights the immediate, intimate, and inseparable connection between the individual activities of consumers and their environment. In contrast to other types of pollutants, PPCPs owe their origins in the environment directly to their worldwide, universal, frequent, highly dispersed, and individually small but aggregate/cumulative usage and disposal by multitudes of individuals. An overview of this multi-faceted issue can be found at a U.S. EPA web site (http://www.epa.gov/nerlesdl/chemistry/pharma/index.htm), which also provides a reprint of a review article published in Environmental Health Perspectives. PPCPs can enter the environment following their ingestion or application by the user or administration to domestic animals. Disposal of unused/expired PPCPS in landfills and to domestic sewage are additional routes to the environment. Domestic sewage treatment plants are not specifically engineered to remove PPCPS; the efficiencies with which they are removed from sewage vary from nearly complete to ineffective. The aquatic environment serves as the major, ultimate receptacle for most PPCPS. Little is known with respect to actual or even potential adverse effects on non-target species; human exposure via drinking water is poorly defined. While PPCPs in the environment (or domestic drinking water) are not regulated

PHARMACEUTICALS AND PERSONAL CARE PRODUCTS ...

EPA Pesticide Factsheets

Perhaps more so than with any other class of pollutants, the occurrence of pharmaceuticals and personal care products (PPCPS) in the environment highlights the immediate, intimate, and inseparable connection between the individual activities of consumers and their environment. In contrast to other types of pollutants, PPCPs owe their origins in the environment directly to their worldwide, universal, frequent, highly dispersed, and individually small but aggregate/cumulative usage and disposal by multitudes of individuals. An overview of this multi-faceted issue can be found at a U.S. EPA web site (http://www.epa.gov/nerlesdl/chemistry/pharma/index.htm), which also provides a reprint of an Environmental Health Perspectives review article. PPCPs can enter the environment via excreta or wash water following their ingestion or application by the user or administration to domestic animals. Direct disposal of unused/expired PPCPs in landfills and domestic sewage is an additional route to the environment. Domestic sewage treatment plants are not specifically engineered to remove PPCPS; removal efficiencies vary from nearly complete to ineffective. The aquatic and groundwater environments serve as the major, ultimate receptacles for most PPCPS. Little is known with respect to actual or even potential adverse effects on non-target species; human exposure via drinking water is poorly defined. While PPCPs in the environment (or drinking water) are not regulated, and even t

PHARMACEUTICALS AND PERSONAL CARE PRODUCTS ...

EPA Pesticide Factsheets

Perhaps more so than with any other class of pollutants, the occurrence of pharmaceuticals and personal care products (PPCPS) in the environment highlights the immediate, intimate, and inseparable connection between the individual activities of consumers and their environment. In contrast to other types of pollutants, PPCPs owe their origins in the environment directly to their worldwide, universal, frequent, highly dispersed, and individually small but aggregate/cumulative usage and disposal by multitudes of individuals. An overview of this multi-faceted issue can be found at a U.S. EPA web site (http://www.epa.gov/nerlesdl/chemistry/pharma/index.htm), which also provides a reprint of a review article published in Environmental Health Perspectives as well as many other resources including several chapters from a new American Chemical Society book. PPCPs can enter the environment following their ingestion or application by the user or administration to domestic animals. Disposal of unused/expired PPCPs in landfills and to domestic sewage are additional routes to the environment. Domestic sewage treatment plants are not specifically engineered to remove PPCPS; the efficiencies with which they are removed from sewage vary from nearly complete to ineffective. The aquatic environment serves as the major, ultimate receptacle for most PPCPS. Little is known with respect to actual or even potential adverse effects on non-target species; human exposure via drinking wate

WHO Expert Committee on Specifications for Pharmaceutical Preparations.

PubMed

2011-01-01

The Expert Committee on Specifications for Pharmaceutical Preparations works towards clear, independent and practical standards and guidelines for the quality assurance of medicines. Standards are developed by the Committee through worldwide consultation and an international consensus-building process. The following new guidelines were adopted and recommended for use: procedure for adoption of International Chemical Reference Substances; WHO good practices for pharmaceutical microbiology laboratories; good manufacturing practices: main principles for pharmaceutical products; good manufacturing practices for blood establishments (jointly with the Expert Committee on Biological Standardization); guidelines on good manufacturing practices for heating, ventilation and air-conditioning systems for non-sterile pharmaceutical dosage forms; good manufacturing practices for sterile pharmaceutical products; guidelines on transfer of technology in pharmaceutical manufacturing; good pharmacy practice: standards for quality of pharmacy services (joint FIP/WHO); model guidance for the storage and transport of time- and temperature-sensitive pharmaceutical products (jointly with the Expert Committee on Biological Standardization); procedure for prequalification of pharmaceutical products; guide on submission of documentation for prequalification of innovator finished pharmaceutical products approved by stringent regulatory authorities; prequalification of quality control laboratories: procedure for assessing the acceptability, in principle, of quality control laboratories for use by United Nations agencies; guidelines for preparing a laboratory information file; guidelines for drafting a site master file; guidelines on submission of documentation for a multisource (generic) finished product: general format: preparation of product dossiers in common technical document format.

WHO Expert Committee on Specifications for Pharmaceutical Preparations.

PubMed

2003-01-01

This report presents the recommendations of an international group of experts convened by the World Health Organization to consider matters concerning the quality assurance of pharmaceuticals and specifications for drug substances and dosage forms. Of particular relevance to drug regulatory authorities and pharmaceutical manufacturers, the report discusses activities related to the development of The International Pharmacopoeia and basic tests for pharmaceutical substances and dosage forms, as well as quality control of reference materials, good manufacturing practices (GMP), stability studies, inspection, hazard analysis, procurement, storage and other aspects of quality assurance of pharmaceuticals, and regulatory issues. The report is complemented by a number of annexes, including recommendations on the risk of transmitting animal spongiform encephalopathy agents via medicinal products, guidelines on GMP for pharmaceutical products, a model certificate for GMP and guidance on a GMP inspection report. The final annexes provide guidance on the application of Hazard Analysis and Critical Control Point (HACCP) method to pharmaceuticals, good storage practices and a procedure for assessing acceptability of pharmaceutical products for purchase by United Nations agencies.

A Review on Advanced Treatment of Pharmaceutical Wastewater

NASA Astrophysics Data System (ADS)

Guo, Y.; Qi, P. S.; Liu, Y. Z.

2017-05-01

The composition of pharmaceutical wastewater is complex, which is high concentration of organic matter, microbial toxicity, high salt, and difficult to biodegrade. After secondary treatment, there are still trace amounts of suspended solids and dissolved organic matter. To improve the quality of pharmaceutical wastewater effluent, advanced treatment is essential. In this paper, the classification of the pharmaceutical technology was introduced, and the characteristics of pharmaceutical wastewater effluent quality were summarized. The methods of advanced treatment of pharmaceutical wastewater were reviewed afterwards, which included coagulation and sedimentation, flotation, activated carbon adsorption, membrane separation, advanced oxidation processes, membrane separation and biological treatment. Meanwhile, the characteristics of each process were described.

[Brief history of pharmaceutical standard system in China].

PubMed

Zhang, Jianwu; Xiao, Shiying; Dong, Guofeng; Liu, Wei; Di, Feng; Yang, Xujie

2010-03-01

Pharmaceutical standard system which belongs to an important part of national drug policies is an inevitable result of the development of pharmacy. There was a long standing of pharmaceutical standard system in China whose germination could be traced back to Qin and Han dynasties, and it had laid a solid foundation for the establishment and improvement of modern pharmaceutical standard system by continual accumulation from the past dynasties. Since the founding of new China, distinguished achievements had been obtained on pharmaceutical standardization working,and currently it is in a new developing stage. There was a brief description in this paper on the development history of pharmaceutical standard system in China.

Ecological risk assessment of pharmaceuticals in the receiving environment of pharmaceutical wastewater in Pakistan.

PubMed

Ashfaq, Muhammad; Nawaz Khan, Khujasta; Saif Ur Rehman, Muhammad; Mustafa, Ghulam; Faizan Nazar, Muhammad; Sun, Qian; Iqbal, Javed; Mulla, Sikandar I; Yu, Chang-Ping

2017-02-01

The pharmaceutical industry of Pakistan is growing with an annual growth rate of 10%. Besides this growth, this industry is not complying with environmental standards, and discharging its effluent into domestic wastewater network. Only limited information is available about the occurrence of pharmaceutical compounds (PCs) in the environmental matrices of Pakistan that has motivated us to aim at the occurrence and ecological risk assessment of 11 PCs of different therapeutic classes in the wastewater of pharmaceutical industry and in its receiving environmental matrices such as sludge, solid waste and soil samples near the pharmaceutical formulation units along Shiekhupura road, Lahore, Pakistan. Target PCs (paracetamol, naproxen, diclofenac, ibuprofen, amlodipine, rosuvastatin, ofloxacin, ciprofloxacin, moxifloxacin, sparfloxacin and gemifloxacin) were quantified using in-house developed HPLC-UV. Ibuprofen (1673µg/L, 6046µg/kg, 1229µg/kg and 610µg/kg), diclofenac (836µg/L, 4968µg/kg, 6632µg/kg and 257µg/kg) and naproxen (464µg/L, 7273µg/kg, 4819µg/kg and 199µg/kg) showed the highest concentrations among 11 target PCs in wastewater, sludge, solid waste and soil samples, respectively. Ecological risk assessment, in terms of risk quotient (RQ), was also carried out based on the maximum measured concentration of PCs in wastewater. The maximum RQ values obtained were with paracetamol (64 against daphnia), naproxen (177 against fish), diclofenac (12,600 against Oncorhynchus mykiss), ibuprofen (167,300 against Oryzias latipes), ofloxacin (81,000 against Pseudomonas putida) and ciprofloxacin (440 against Microcystis aeruginosa). These results show a high level of ecological risk due to the discharge of untreated wastewater from pharmaceutical units. This risk may further lead to food web contamination and drug resistance in pathogens. Thus, further studies are needed to detect the PCs in crops as well as the government should strictly enforce environmental

Pharmaceutical identifier confirmation via DART-TOF.

PubMed

Easter, Jacob L; Steiner, Robert R

2014-07-01

Pharmaceutical analysis comprises a large amount of the casework in forensic controlled substances laboratories. In order to reduce the time of analysis for pharmaceuticals, a Direct Analysis in Real Time ion source coupled with an accurate mass time-of-flight (DART-TOF) mass spectrometer was used to confirm identity. DART-TOF spectral data for pharmaceutical samples were analyzed and evaluated by comparison to standard spectra. Identical mass pharmaceuticals were differentiated using collision induced dissociation fragmentation, present/absent ions, and abundance comparison box plots; principal component analysis (PCA) and linear discriminant analysis (LDA) were used for differentiation of identical mass mixed drug spectra. Mass assignment reproducibility and robustness tests were performed on the DART-TOF spectra. Impacts on the forensic science community include a decrease in analysis time over the traditional gas chromatograph/mass spectrometry (GC/MS) confirmations, better laboratory efficiency, and simpler sample preparation. Using physical identifiers and the DART-TOF to confirm pharmaceutical identity will eliminate the use of GC/MS and effectively reduce analysis time while still complying with accepted analysis protocols. This will prove helpful in laboratories with large backlogs and will simplify the confirmation process. Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.

Critical assessment of inverse gas chromatography as means of assessing surface free energy and acid-base interaction of pharmaceutical powders.

PubMed

Telko, Martin J; Hickey, Anthony J

2007-10-01

Inverse gas chromatography (IGC) has been employed as a research tool for decades. Despite this record of use and proven utility in a variety of applications, the technique is not routinely used in pharmaceutical research. In other fields the technique has flourished. IGC is experimentally relatively straightforward, but analysis requires that certain theoretical assumptions are satisfied. The assumptions made to acquire some of the recently reported data are somewhat modified compared to initial reports. Most publications in the pharmaceutical literature have made use of a simplified equation for the determination of acid/base surface properties resulting in parameter values that are inconsistent with prior methods. In comparing the surface properties of different batches of alpha-lactose monohydrate, new data has been generated and compared with literature to allow critical analysis of the theoretical assumptions and their importance to the interpretation of the data. The commonly used (simplified) approach was compared with the more rigorous approach originally outlined in the surface chemistry literature. (c) 2007 Wiley-Liss, Inc.

Pharmaceutical care education in Kuwait: pharmacy students’ perspectives

PubMed Central

Katoue, Maram G.; Awad, Abdelmoneim I.; Schwinghammer, Terry L.; Kombian, Samuel B.

2014-01-01

Background Pharmaceutical care is defined as the responsible provision of medication therapy to achieve definite outcomes that improve patients’ quality of life. Pharmacy education should equip students with the knowledge, skills, and attitudes they need to practise pharmaceutical care competently. Objective To investigate pharmacy students’ attitudes towards pharmaceutical care, perceptions of their preparedness to perform pharmaceutical care competencies, opinions about the importance of the various pharmaceutical care activities, and the barriers to its implementation in Kuwait. Methods A descriptive, cross-sectional survey of pharmacy students (n=126) was conducted at Faculty of Pharmacy, Kuwait University. Data were collected via a pre-tested self-administered questionnaire. Descriptive statistics including percentages, medians and means Likert scale rating (SD) were calculated and compared using SPSS, version 19. Statistical significance was accepted at a p value of 0.05 or lower. Results The response rate was 99.2%. Pharmacy students expressed overall positive attitudes towards pharmaceutical care. They felt prepared to implement the various aspects of pharmaceutical care, with the least preparedness in the administrative/management aspects. Perceived pharmaceutical care competencies grew as students progressed through the curriculum. The students also appreciated the importance of the various pharmaceutical care competencies. They agreed/strongly agreed that the major barriers to the integration of pharmaceutical care into practice were lack of private counseling areas or inappropriate pharmacy layout (95.2%), lack of pharmacist time (83.3%), organizational obstacles (82.6%), and pharmacists’ physical separation from patient care areas (82.6%). Conclusion Pharmacy students’ attitudes and perceived preparedness can serve as needs assessment tools to guide curricular change and improvement. Student pharmacists at Kuwait University understand and

An overview of pharmaceutical cocrystals as intellectual property.

PubMed

Trask, Andrew V

2007-01-01

This review article focuses on the interaction among certain scientific, legal, and regulatory aspects of pharmaceutical crystal forms. The article offers an analysis of pharmaceutical cocrystals as patentable inventions by drawing upon recent scientific developments in the field. Several potential commercial advantages of pharmaceutical cocrystals are highlighted, and a number of recent court decisions involving salient issues are summarized. The article provides an outlook on how the developing field of cocrystallization may impact the pharmaceutical intellectual property landscape.

Endocrine-Active Pharmaceuticals: An Environmental Concern?

EPA Science Inventory

Recently, there has been growing interest in pharmaceuticals that are specifically designed to have endocrine activity, such as the estrogens used in birth control pills, exerting unintended effects on fish and other aquatic organisms. These pharmaceuticals may not be persistent...

Combinatorial chemistry has matured in the last three decades: dedicated to Professor Árpád Furka on the occasion of his 80th birthday.

PubMed

Dibó, Gábor

2012-02-01

Combinatorial chemistry was introduced in the 1980s. It provided the possibility to produce new compounds in practically unlimited number. New strategies and technologies have also been developed that made it possible to screen very large number of compounds and to identify useful components in mixtures containing millions of different substances. This dramatically changed the drug discovery process and the way of thinking of synthetic chemists. In addition, combinatorial strategies became useful in areas such as pharmaceutical research, agrochemistry, catalyst design, and materials research. Prof. Árpád Furka is one of the pioneers of combinatorial chemistry.

[Early achievements of the Danish pharmaceutical industry--2. The minor and almost forgotten pharmaceutical companies].

PubMed

Grevsen, Jørgen V; Kirkegaard, Hanne; Kruse, Edith; Kruse, Poul R

2009-01-01

The article series provides an account in words and pictures of the Danish pharmaceutical industry's products from the earliest times until about 1950. Part 2 deals with products from 16 minor pharmaceutical companies, founded in the last decades of the 19th century and the first decades of the 20th century. Mentioned in chronological order, according to year of foundation, the companies are: C.R. Evers & Co., Jensen & Langebek-Petersens chemisk-techniske Fabrik, Leerbeck & Holms kemiske Fabriker, A/S Skelskør Frugtplantage, Fabriken Ferrin, Chr. F. Petri, Erslevs kemiske Laboratorium, A/S Edward Jacobsen, Th. Fallesen-Schmidt, Fabriken Ferraton, Chemia, Fabriken Kemisan, Central-Laboratoriet, F.F. Gonget & Co., A/S Ejco, and M. Schultz chemiske Fabrik. None of these minor pharmaceutical companies exist today as independent firms. All of them are either closed down or merged into other firms after a number of years. The bigger pharmaceutical companies ensured their continued existence by research and development of new products. The minor companies were not innovative to the same extent, but they played a role at an early stage in the production of Danish copy medicine and in that way a role in the establishment of a Danish generic pharmaceutical industry. The earliest products included dietetic preparations as malt products and albumin maltose products, and iron preparations, often with an admixture of medicine substances. Real medicines such as sleeping, analgesic and antipyretic medicines as well as anesthetics followed later.

Nurse practitioners' perceptions and participation in pharmaceutical marketing.

PubMed

Crigger, Nancy; Barnes, Kristen; Junko, Autumn; Rahal, Sarah; Sheek, Casey

2009-03-01

This paper reports on a study conducted to describe family nurse practitioners' perceptions towards and participation in pharmaceutical marketing and to explore the relationships among related variables. The pharmaceutical industry's intense global marketing strategies have resulted in widespread concern in healthcare professionals and professional groups, sectors of the public in many countries, and in the World Health Organization. Research on healthcare providers' participation in pharmaceutical marketing indicates that these relationships are conflicts of interests and compromise healthcare providers' prescribing practices and trust. Nursing, as a discipline, appears to be slow to address the impact of pharmaceutical marketing on nursing practice. Questionnaires about perceptions and participation in pharmaceutical marketing were completed by a random sample of 84 licensed family nurse practitioners in the United States of America in 2007. Family nurse practitioners viewed pharmaceutical company marketing uncritically as educational and beneficial. They also perceived other providers but not themselves as influenced by pharmaceutical marketing. The findings supported those found in previous research with nurses and physicians. Lack of education, participation in marketing and psychological and social responses may impede family nurse practitioners' ability to respond critically and appropriately to marketing strategies and the conflict of interest it creates.

Fate and mobility of pharmaceuticals in solid matrices.

PubMed

Drillia, Panagiota; Stamatelatou, Katerina; Lyberatos, Gerasimos

2005-08-01

The sorption and mobility of six pharmaceuticals were investigated in two soil types with different organic carbon and clay content, and in bacterial biomass (aerobic and anaerobic). The pharmaceuticals examined were carbamazepine, propranolol, diclofenac sodium, clofibric acid, sulfamethoxazole and ofloxacin. The sorption experiments were performed according to the OECD test Guideline 106. The distribution coefficients determined by this batch equilibrium method varied with the pharmaceutical tested and the solid matrix type. Ofloxacin was particularly strongly adsorbed (except of the case of using anaerobic biomass for the solid matrix) while clofibric acid was found to be weakly adsorbed. The fate of pharmaceuticals in soil was also assessed using lysimeters. Important parameters that were studied were: the pharmaceutical loading rate and the hydraulic loading rate for adsorption and the rate and duration of a "rain" event for desorption. Major differences in the mobility of the six pharmaceuticals were observed and correlated with the adsorption/desorption properties of the compounds.

Modeling picking on pharmaceutical tablets

NASA Astrophysics Data System (ADS)

Swaminathan, Shrikant

Tablets are the most popular solid dosage form in the pharmaceutical industry because they are cheap to manufacture, chemically and mechanically stable and easy to transport and fairly easy to control dosage. Pharmaceutical tableting operations have been around for decades however the process is still not well understood. One of the common problems faced during the production of pharmaceutical tablets by powder compaction is sticking of powder to the punch face, This is known as 'sticking'. A more specialized case of sticking is picking when the powder is pulled away form the compact in the vicinity of debossed features. In the pharmaceutical industry, picking is solved by trial and error which is an expensive, labor intensive and time consuming affair. The objective of this work was to develop, validate, and implement a modeling framework for predicting picking in powder compacts. The model was developed in Abaqus a commercially available finite element package. The resulting model was used to investigate the influence of debossed feature geometry viz. the stroke angle and degree of pre-pick, and, influence of lubricant on picking. (Abstract shortened by ProQuest.).

EU pharmaceutical expenditure forecast.

PubMed

Urbinati, Duccio; Rémuzat, Cécile; Kornfeld, Åsa; Vataire, Anne-Lise; Cetinsoy, Laurent; Aballéa, Samuel; Mzoughi, Olfa; Toumi, Mondher

2014-01-01

With constant incentives for healthcare payers to contain their pharmaceutical budgets, forecasting has become critically important. Some countries have, for instance, developed pharmaceutical horizon scanning units. The objective of this project was to build a model to assess the net effect of the entrance of new patented medicinal products versus medicinal products going off-patent, with a defined forecast horizon, on selected European Union (EU) Member States' pharmaceutical budgets. This model took into account population ageing, as well as current and future country-specific pricing, reimbursement, and market access policies (the project was performed for the European Commission; see http://ec.europa.eu/health/healthcare/key_documents/index_en.htm). In order to have a representative heterogeneity of EU Member States, the following countries were selected for the analysis: France, Germany, Greece, Hungary, Poland, Portugal, and the United Kingdom. A forecasting period of 5 years (2012-2016) was chosen to assess the net pharmaceutical budget impact. A model for generics and biosimilars was developed for each country. The model estimated a separate and combined effect of the direct and indirect impacts of the patent cliff. A second model, estimating the sales development and the risk of development failure, was developed for new drugs. New drugs were reviewed individually to assess their clinical potential and translate it into commercial potential. The forecast was carried out according to three perspectives (healthcare public payer, society, and manufacturer), and several types of distribution chains (retail, hospital, and combined retail and hospital). Probabilistic and deterministic sensitivity analyses were carried out. According to the model, all countries experienced drug budget reductions except Poland (+€41 million). Savings were expected to be the highest in the United Kingdom (-€9,367 million), France (-€5,589 million), and, far behind them

EU pharmaceutical expenditure forecast

PubMed Central

Urbinati, Duccio; Rémuzat, Cécile; Kornfeld, Åsa; Vataire, Anne-Lise; Cetinsoy, Laurent; Aballéa, Samuel; Mzoughi, Olfa; Toumi, Mondher

2014-01-01

Background and Objectives With constant incentives for healthcare payers to contain their pharmaceutical budgets, forecasting has become critically important. Some countries have, for instance, developed pharmaceutical horizon scanning units. The objective of this project was to build a model to assess the net effect of the entrance of new patented medicinal products versus medicinal products going off-patent, with a defined forecast horizon, on selected European Union (EU) Member States’ pharmaceutical budgets. This model took into account population ageing, as well as current and future country-specific pricing, reimbursement, and market access policies (the project was performed for the European Commission; see http://ec.europa.eu/health/healthcare/key_documents/index_en.htm). Method In order to have a representative heterogeneity of EU Member States, the following countries were selected for the analysis: France, Germany, Greece, Hungary, Poland, Portugal, and the United Kingdom. A forecasting period of 5 years (2012–2016) was chosen to assess the net pharmaceutical budget impact. A model for generics and biosimilars was developed for each country. The model estimated a separate and combined effect of the direct and indirect impacts of the patent cliff. A second model, estimating the sales development and the risk of development failure, was developed for new drugs. New drugs were reviewed individually to assess their clinical potential and translate it into commercial potential. The forecast was carried out according to three perspectives (healthcare public payer, society, and manufacturer), and several types of distribution chains (retail, hospital, and combined retail and hospital). Probabilistic and deterministic sensitivity analyses were carried out. Results According to the model, all countries experienced drug budget reductions except Poland (+€41 million). Savings were expected to be the highest in the United Kingdom (−€9,367 million), France

Doctors and pharmaceutical industry.

PubMed

Beran, Roy G

2009-09-01

The pharmaceutical industry is seen as seducing doctors by providing expensive gifts, subsidising travel and underwriting practice expenses in return for those doctors prescribing products that otherwise they would not use. This paints doctors in a very negative light; suggests doctors are available to the highest bidder; implies doctors do not adequately act as independent agents; and that doctors are driven more by self-interest than by patient needs. Similar practices, in other industries, are accepted as normal business behaviour but it is automatically assumed to be improper if the pharmaceutical industry supports doctors. Should the pharmaceutical industry withdraw educational grants then there would be: fewer scientific meetings; reduced attendance at conferences; limited post graduate education; and a depreciated level of maintenance of professional standards. To suggest that doctors prescribe inappropriately in return for largesse maligns their integrity but where there is no scientific reason to choose between different treatments then there can be little argument against selecting the product manufactured by a company that has invested in the doctor and the question arises as to whether this represents bad medicine? This paper will examine what constitutes non-professional conduct in response to inducements by the pharmaceutical industry. It will review: conflict of interest; relationships between doctors and pharma and the consequences for patients; and the need for critical appraisal before automatically decrying this relationship while accepting that there remain those who do not practice ethical medicine.

The Impact of Biotechnology on Pharmaceutics.

ERIC Educational Resources Information Center

Block, Lawrence H.

1990-01-01

The emergence of bioactive peptides and proteins as new drug species poses formidable problems for the pharmaceutical scientist. Implications for revision or change in undergraduate and graduate pharmaceutics curricula derive from the biopharmaceutical, pharmacokinetic, and physiochemical aspects of the new drug species, which differ from…

Pharmaceutical counseling: Between evidence-based medicine and profits.

PubMed

Egorova, S N; Akhmetova, T

2015-01-01

The number of pharmacies, which produce drug formulations locally, has recently considerably reduced in Russia. Pharmacies mainly operate as retailers of industrially manufactured drugs.Pharmaceutical consultation of customers at pharmacies aimed at responsible self-medication is the most popular and accessible feature of pharmaceutical care. In Russia there is a significant list of medicines approved for sale in pharmacies on a non-prescription basis that is specified in the product label. In this regard, the role of pharmacists in public health in Russia increases. Pharmacist, working directly with population, is an important figure for the rational use of medicines. This type of work requires high level of professional training and appropriate ethics. To explore the current status of pharmaceutical counseling in Russia. Situation analysis, surveys of pharmacists. Our experience in the system of postgraduate professional education, the results of the survey of pharmacists, and the long-term dialogue with pharmacists allowed us to identify several unresolved issues in the work of a pharmacist selling non-prescription drugs.Lack of differentiation in the functions of a pharmacist with a higher education and pharmaceutical technologist: In production/industrial pharmacy technicians are engaged in manufacturing of pharmaceutical formulations. However, due to the loss of production functions technologists had to move away from production laboratories of apothecaries to the sales area. Currently, the apothecary's assignment to receive prescriptions and dispense medications can be fulfilled by either a pharmacist or a pharmaceutical technician. It significantly discerns the pharmacy from the medical organization with clearly delineated functions of doctors and nurses. Russian regulations should consider the level of education required for high-quality pharmaceutical counseling.Contradiction between the pharmacist's special functions and trade procedure with the lack of

[The aspects of pricing policy in Azerbaijan pharmaceutical sector].

PubMed

Dzhalilova, K I; Alieva, K Ia

2012-01-01

The effect of macro-, middle- and microeconomic factors on price formation in Azerbaijan pharmaceutical market has been studied. Worldwide pharmaceutical leaders have the goals to become leader on the pharmaceutical market of Azerbaijan and maximize their market share. Non-leaders pharmaceutical companies use different strategies of price formation: prime cost plus markup, or price formation on the base of current prices. It was revealed that domestic pharmaceutical market has high demand elasticity. Future market development is related to stimulation of product development, and hard penetration to the market through realization of price formation strategy. Non-state pharmaceutical organizations to achieve the purpose of survive in conditions of high competition should take in to account the factor perceptions of assortment by customers.

Implications of external price referencing of pharmaceuticals in Middle East countries.

PubMed

Kaló, Zoltán; Alabbadi, Ibrahim; Al Ahdab, Ola Ghaleb; Alowayesh, Maryam; Elmahdawy, Mahmoud; Al-Saggabi, Abdulaziz H; Tanzi, Vito Luigi; Al-Badriyeh, Daoud; Alsultan, Hamad S; Ali, Faleh Mohamed Hussain; Elsisi, Gihan H; Akhras, Kasem S; Vokó, Zoltán; Kanavos, Panos

2015-01-01

External price referencing (EPR) is applied frequently to control pharmaceutical prices. Our objective was to analyse how EPR is used in Middle Eastern (ME) countries and to compare the price corridor for original pharmaceuticals to non-pharmaceutical services not subjected to EPR. We conducted a survey on EPR regulations and collected prices of 16 patented pharmaceuticals and 14 non-pharmaceutical services in seven Middle Eastern (ME) countries. Maximum and minimum prices of each pharmaceutical and non-pharmaceutical technology were compared to mean prices in the countries studied by using market exchange rates. Influencing factors of pharmaceutical prices were assessed by multivariate linear regression analysis. The average price corridor is narrower for pharmaceuticals (-39.8%; +35.9%) than for outpatient and hospital services (-81.7%; +96.3%). Our analysis revealed the importance of population size and EPR implementation on drug price levels; however, EPR results in higher pharmaceutical prices in lower-income countries compared to non-pharmaceutical services.

Pharmaceutical and Medicine Manufacturing Sector (NAICS 3254)

EPA Pesticide Factsheets

Find environmental regulatory and compliance information for the pharmaceutical manufacturing sector, including essential uses of CFCs, NESHAP for pharmaceutical production, effluent guidelines for wastewater and management of hazardous waste.

New Zealand consumers' perceptions of private insurance for pharmaceuticals.

PubMed

Ragupathy, Rajan; Babar, Zaheer-Ud-Din; Mirza, Wasif; Daiya, Mitali; Chandra, Himesh; Yousif, Ali; Girn, Maninder

2014-01-01

Private insurance plays a minor role in paying for pharmaceuticals in New Zealand, despite controversy about access through the public health system. The present study examines New Zealand consumers' perceptions of private insurance for pharmaceuticals. A self-administered questionnaire was completed by 433 consumers at thirty pharmacies. The questionnaire included 18 questions on demographics, insurance status, perceptions of private insurance for pharmaceuticals and confidence in the public health system. Forty six percent of respondents had private health insurance. Respondents were more likely to have private health insurance as household income increased, and confidence in the public health system decreased. (Over two thirds of respondents were either confident or very confident in the public health system). Nineteen percent had private health insurance for pharmaceuticals, and the likelihood was not affected by household income or confidence in the public health system. Sixty one percent believed private insurance for pharmaceuticals would increase availability and affordability of pharmaceuticals. However, just over half were willing to pay for private insurance for pharmaceuticals. Of these, over two thirds were only willing to pay $20 per year or less. New Zealand pharmacy consumers' willingness to pay for private insurance for pharmaceuticals is very low.

Surface chemistry of gold nanorods: origin of cell membrane damage and cytotoxicity

NASA Astrophysics Data System (ADS)

Wang, Liming; Jiang, Xiumei; Ji, Yinglu; Bai, Ru; Zhao, Yuliang; Wu, Xiaochun; Chen, Chunying

2013-08-01

We investigated how surface chemistry influences the interaction between gold nanorods (AuNRs) and cell membranes and the subsequent cytotoxicity arising from them in a serum-free cell culture system. Our results showed that the AuNRs coated with cetyl trimethylammonium bromide (CTAB) molecules can generate defects in the cell membrane and induce cell death, mainly due to the unique bilayer structure of CTAB molecules on the surface of the rods rather than their charge. Compared to CTAB-capped nanorods, positively charged polyelectrolyte-coated, i.e. poly(diallyldimethyl ammonium chloride) (PDDAC), AuNRs show improved biocompatibility towards cells. Thus, the present results indicate that the nature of surface molecules, especially their packing structures on the surface of AuNRs rather than surface charge, play a more crucial role in determining cytotoxicity. These findings about interfacial interactions could also explain the effects of internalized AuNRs on the structures or functions of organelles. This study will help understanding of the toxic nature of AuNRs and guide rational design of the surface chemistry of AuNRs for good biocompatibility in pharmaceutical therapy.

Pharmaceutical experiment aboard STS-67 mission

NASA Technical Reports Server (NTRS)

1995-01-01

Astronaut William G. Gregory, pilot, works with a pharmaceutical experiment on the middeck of the Earth-orbiting Space Shuttle Endeavour during the STS-67 mission. Commercial Materials Dispersion Apparatus Instruments Technology Associates Experiments (CMIX-03) includes not only pharmaceutical, but also biotechnology, cell biology, fluids, and crystal growth investigation

Jordanian pharmaceutical companies: are their marketing efforts paying off?

PubMed

Al-Shaikh, Mustafa S; Torres, Ivonne M; Zuniga, Miguel A; Ghunaim, Ayman

2011-04-01

The pharmaceuticals industry is one of the main industries in Jordan. Jordanian pharmaceuticals rank third in the export industry of this country. This study aims to examine the strengths that Jordanian pharmaceutical companies have, which, in turn, form their competitiveness base. In addition, this study aims to identify their weaknesses and the effects of marketing their products in the local market. What is the relationship between Jordanian pharmaceutical product quality, price and value, and the competitiveness of pharmaceutical companies in the local market? Our study aims to answer this and other questions. Our results and practical implications are discussed.

Cost benefit of investment on quality in pharmaceutical manufacturing: WHO GMP pre- and post-certification of a Nigerian pharmaceutical manufacturer.

PubMed

Anyakora, Chimezie; Ekwunife, Obinna; Alozie, Faith; Esuga, Mopa; Ukwuru, Jonathan; Onya, Steve; Nwokike, Jude

2017-09-18

Pharmaceutical companies in Africa need to invest in both facilities and quality management systems to achieve good manufacturing practice (GMP) compliance. Compliance to international GMP standards is important to the attainment of World Health Organization (WHO) prequalification. However, most of the local pharmaceutical manufacturing companies may be deterred from investing in quality because of many reasons, ranging from financial constraints to technical capacity. This paper primarily evaluates benefits against the cost of investing in GMP, using a Nigerian pharmaceutical company, Chi Pharmaceuticals Limited, as a case study. This paper also discusses how to drive more local manufacturers to invest in quality to attain GMP compliance; and proffers practical recommendations for local manufacturers who would want to invest in quality to meet ethical and regulatory obligations. The cost benefit of improving the quality of Chi Pharmaceuticals Limited's facilities and system to attain WHO GMP certification for the production of zinc sulfate 20-mg dispersible tablets was calculated by dividing the annual benefits derived from quality improvement interventions by the annual costs of implementing quality improvement interventions, referred to as a benefit-cost ratio (BCR). Cost benefit of obtaining WHO GMP certification for the production of zinc sulfate 20-mg dispersible tablets was 5.3 (95% confidence interval of 5.0-5.5). Investment in quality improvement intervention is cost-beneficial for local manufacturing companies. Governments and regulators in African countries should support pharmaceutical companies striving to invest in quality. Collaboration of local manufacturing companies with global companies will further improve quality. Local pharmaceutical companies should be encouraged to key into development opportunities available for pharmaceutical companies in Africa.

Chemistry Rocks: Redox Chemistry as a Geologic Tool.

ERIC Educational Resources Information Center

Burns, Mary Sue

2001-01-01

Applies chemistry to earth science, uses rocks in chemistry laboratories, and teaches about transition metal chemistry, oxidation states, and oxidation-reduction reactions from firsthand experiences. (YDS)

A new e-beam application in the pharmaceutical industry

NASA Astrophysics Data System (ADS)

Sadat, Theo; Malcolm, Fiona

2005-10-01

The paper presents a new electron beam application in the pharmaceutical industry: an in-line self-shielded atropic transfer system using electron beam for surface decontamination of products entering a pharmaceutical filling line. The unit was developed by Linac Technologies in response to the specifications of a multi-national pharmaceutical company, to solve the risk of microbial contamination entering a filling line housed inside an isolator. In order to fit the sterilization unit inside the pharmaceutical plant, a "miniature" low-energy (200 keV) electron beam accelerator and e-beam tunnel were designed, all conforming to the pharmaceutical good manufacturing practice (GMP) regulations. Process validation using biological indicators is described, with reference to the regulations governing the pharmaceutical industry. Other industrial applications of a small-sized self-shielded electron beam sterilization unit are mentioned.

Incentives and pharmaceutical reimbursement reforms in Spain.

PubMed

Puig-Junoy, Jaume

2004-02-01

The aim of this paper is to assess whether cost containment has been affected by recent pharmaceutical reimbursement reforms that have been introduced in the Spanish health care system over the period 1996-2002, under the conservative Popular Party Government. Four main reimbursement policies can be observed in the Spanish pharmaceutical market after 1996, each of them largely unintegrated with the other three. First, a second supplementary negative list of excluded pharmaceutical products was introduced in 1998. Second, a reference pricing (RP) system was introduced in December 2000, with annual updating and enlargement. Third, the pharmacies' payment system has moved from the traditional set margin on the consumer price to a margin that varies according to the consumer price of the product, the generic status of the product, and the volume of sales by pharmacies. And fourth, general agreements between the government and the industry have been reached with cost containment objectives. In the final section of this paper, we present an overall assessment of the impact of these pharmaceutical reimbursement policies on the behaviour of the agents in the pharmaceutical market.

Near-infrared laboratory spectroscopy of mineral chemistry: A review

NASA Astrophysics Data System (ADS)

Meer, Freek van der

2018-03-01

Spectroscopy is the science concerned with the investigation and measurement of spectra produced when materials interacts with or emits electromagnetic radiation. Commercial infrared spectrometer were designed from the 1950's onward and found their way into the pharmaceutical and chemical industries. In the 1970's and 1980's also natural sciences notably mineralogy and vegetation science started systematically to measure optical properties of leaves and minerals/rocks with spectrometers. In the last decade spectroscopy has made the step from qualitative observations of mineral classes, soil type and vegetation biomass to quantitative estimates of mineral, soil and vegetation chemistry. This resulted in geothermometers used to characterize metamorphic and hydrothermal systems and to the advent of foliar biochemistry. More research is still needed to bridge the gap between laboratory spectroscopy and field spectroscopy. Empirical studies of minerals either as soil or rock constituents (and vegetation parameters) derived from regression analysis of spectra against chemistry is important in understanding the physics of the interaction of electromagnetic radiation and matter which in turn is important in the design of future satellite missions. Physics based models and retrievals are needed to operationalize these relationships and implement them in future earth observation missions as these are more robust and easy to transfer to other areas and data sets.

Pharmaceutical innovation: impact on expenditure and outcomes and subsequent challenges for pharmaceutical policy, with a special reference to Greece.

PubMed

Karampli, E; Souliotis, K; Polyzos, N; Kyriopoulos, J; Chatzaki, E

2014-04-01

Over the recent decades, advances in healthcare technology have led to significant improvements in the quality of healthcare and in population health. At the same time, technological change in healthcare, rising national income and expansion of insurance coverage have been acknowledged as the main determinants of the historical growth in health spending in industrialized countries. The pharmaceutical sector is of particular interest as it constitutes a market characterized by rapid technological change and high expenditure growth rates. The purpose of this article is to provide an overview of research findings on the impact of pharmaceutical innovation on pharmaceutical expenditure growth, total health expenditure and population health outcomes and to bring forward the challenges that arise for pharmaceutical policy in Greece.

Pharmaceutical regulation in 15 European countries review.

PubMed

Panteli, Dimitra; Arickx, Francis; Cleemput, Irina; Dedet, Guillaume; Eckhardt, Helen; Fogarty, Emer; Gerkens, Sophie; Henschke, Cornelia; Hislop, Jennifer; Jommi, Claudio; Kaitelidou, Daphne; Kawalec, Pawel; Keskimaki, Ilmo; Kroneman, Madelon; Lopez Bastida, Julio; Pita Barros, Pedro; Ramsberg, Joakim; Schneider, Peter; Spillane, Susan; Vogler, Sabine; Vuorenkoski, Lauri; Wallach Kildemoes, Helle; Wouters, Olivier; Busse, Reinhard

2016-10-01

In the context of pharmaceutical care, policy-makers repeatedly face the challenge of balancing patient access to effective medicines with affordability and rising costs. With the aim of guiding the health policy discourse towards questions that are important to actual and potential patients, this study investigates a broad range of regulatory measures, spanning marketing authorization to generic substitution and resulting price levels in a sample of 16 European health systems (Austria, Belgium, Denmark, England, Finland, France, Germany, Greece, Ireland, Italy, the Netherlands, Poland, Portugal, Scotland, Spain and Sweden). All countries employ a mix of regulatory mechanisms to contain pharmaceutical expenditure and ensure quality and efficiency in pharmaceutical care, albeit with varying configurations and rigour. This variation also influences the extent of publicly financed pharmaceutical costs. Overall, observed differences in pharmaceutical expenditure should be interpreted in conjunction with the differing volume and composition of consumption and price levels, as well as dispensation practices and their impact on measurement of pharmaceutical costs. No definitive evidence has yet been produced on the effects of different cost-containment measures on patient outcomes. Depending on the foremost policy concerns in each country, different levers will have to be used to enable the delivery of appropriate care at affordable prices. World Health Organization 2016 (acting as the host organization for, and secretariat of, the European Observatory on Health Systems and Policies).

The effect of radiation on a variety of pharmaceuticals and materials containing polymers.

PubMed

Silindir, Mine; Ozer, Yekta

2012-01-01

The interaction of radiation, whether it has natural or artificial, electromagnetic or particle-type characterizations, with materials causes different effects depending on the dose and type of radiation and physicochemical properties of the material. In the medical field, understanding the effect of radiation on a variety of materials including pharmaceuticals, medical devices, polymers as biomaterials, and packaging is crucial. Although there are many kinds of sterilization methods, the use of radiation in sterilization has many advantages such as being a substantially less toxic, safer terminal sterilization method. Radiosterilization is sterilization with an ionizing radiation such as gamma rays or electron beam (e-beam), the latter being a newer but less-frequently used technique. However, the need for large facilities with proper radiation protections for personnel and the environment from the effects of radiation and radioactive wastes makes this procedure highly costly. The effects of radiation on materials, especially pharmaceuticals and polymer-containing medical devices, cause degradation or chemical changes. The effects of radiation on a variety of different materials is a growing research area that can create safer techniques that reduce radiation damage and increase cost-effectiveness in the future. Radiation can be used for positive purposes such as medical applications and the sterilization of pharmaceutical products, medical devices, and food and agricultural products as well as clinical applications such as diagnosis and/or therapy of a variety of diseases. The dose rate, time, type and emitted energy of the radiation are critical issues for determining its benefit/damage ratio. The sterilization of pharmaceuticals and medical devices that contain polymers can be achieved safely and effectively by irradiation. The sterilization of materials at the terminal phase-that is, in its final packaging materials-and its suitability to a variety of

Selected Bibliographies for Pharmaceutical Supply Systems. Volume 5: Pharmaceutical Supply Systems Bibliographies. International Health Planning Reference Series.

ERIC Educational Resources Information Center

Schaumann, Leif

Intended as a companion piece to volume 7 in the Method Series, Pharmaceutical Supply System Planning (CE 024 234), this fifth of six volumes in the International Health Planning Reference Series is a combined literature review and annotated bibliography dealing with alternative methodologies for planning and analyzing pharmaceutical supply…

Significant steps in the evolution of analytical chemistry--is the today's analytical chemistry only chemistry?

PubMed

Karayannis, Miltiades I; Efstathiou, Constantinos E

2012-12-15

In this review the history of chemistry and specifically the history and the significant steps of the evolution of analytical chemistry are presented. In chronological time spans, covering the ancient world, the middle ages, the period of the 19th century, and the three evolutional periods, from the verge of the 19th century to contemporary times, it is given information for the progress of chemistry and analytical chemistry. During this period, analytical chemistry moved gradually from its pure empirical nature to more rational scientific activities, transforming itself to an autonomous branch of chemistry and a separate discipline. It is also shown that analytical chemistry moved gradually from the status of exclusive serving the chemical science, towards serving, the environment, health, law, almost all areas of science and technology, and the overall society. Some recommendations are also directed to analytical chemistry educators concerning the indispensable nature of knowledge of classical analytical chemistry and the associated laboratory exercises and to analysts, in general, why it is important to use the chemical knowledge to make measurements on problems of everyday life. Copyright © 2012 Elsevier B.V. All rights reserved.

Pharmaceutical laws and regulations in Iran: An overview

PubMed Central

Zaboli, Pardis; Hashemi-Meshkini, Amir; Varmaghani, Mehdi; Gholami, Hadi; Vazirian, Iman; Zekri, Hedieh-Sadat; Eslamitabar, Shahriar; Kebriaeezadeh, Abbas

2016-01-01

The pharmaceutical legal framework is a very important infrastructure in achieving predefined goals in pharmaceutical sector: Accessibility, quality, and rational use of medicine. This study aims to review the current pharmaceutical sector-related legal provisions in Iran where the Food and Drug Organization (FDO) is in charge of regulating all issues related to the pharmaceutical sector. The main laws and regulations enacted by parliament and cabinet and even internal regulations enacted by the Ministry of Health or Iran FDO are reviewed. Different laws and regulations are categorized according to the main goals of Iran national drug policy. PMID:27512704

Colloid-Mediated Transport of Pharmaceutical and Personal Care Products through Porous Media

NASA Astrophysics Data System (ADS)

Xing, Yingna; Chen, Xijuan; Chen, Xin; Zhuang, Jie

2016-10-01

Pharmaceutical and personal care products (PPCPs) enter soils through reclaimed water irrigation and biosolid land applications. Colloids, such as clays, that are present in soil may interact with PPCPs and thus affect their fate and transport in the subsurface environment. This study addresses the influence of soil colloids on the sorption and transport behaviors of PPCPs through laboratory column experiments. Results show that the affinities of PPCPs for colloids vary with their molecular chemistry and solution ionic strength. The presence of colloids promotes the breakthrough of ciprofloxacin (over 90% sorbed on colloids) from ~4% to 30-40%, and the colloid-facilitated effect was larger at lower ionic strength (e.g., 2 mM). In comparison, the net effect of colloids on the transport of tetracycline (~50% sorbed on colloids) could be facilitation or inhibition, depending on solution chemistry. This dual effect of colloids is primarily due to the opposite response of migration of dissolved and colloid-bound tetracycline to the change in solution ionic strength. Colloids could also facilitate the transport of ibuprofen (~10% sorbed on colloids) by ~50% due likely to exclusion of dispersion pathways by colloid straining. This study suggests that colloids are significant carriers or transport promoters of some PPCPs in the subsurface environment and could affect their off-site environmental risks.

Colloid-Mediated Transport of Pharmaceutical and Personal Care Products through Porous Media

PubMed Central

Xing, Yingna; Chen, Xijuan; Chen, Xin; Zhuang, Jie

2016-01-01

Pharmaceutical and personal care products (PPCPs) enter soils through reclaimed water irrigation and biosolid land applications. Colloids, such as clays, that are present in soil may interact with PPCPs and thus affect their fate and transport in the subsurface environment. This study addresses the influence of soil colloids on the sorption and transport behaviors of PPCPs through laboratory column experiments. Results show that the affinities of PPCPs for colloids vary with their molecular chemistry and solution ionic strength. The presence of colloids promotes the breakthrough of ciprofloxacin (over 90% sorbed on colloids) from ~4% to 30–40%, and the colloid-facilitated effect was larger at lower ionic strength (e.g., 2 mM). In comparison, the net effect of colloids on the transport of tetracycline (~50% sorbed on colloids) could be facilitation or inhibition, depending on solution chemistry. This dual effect of colloids is primarily due to the opposite response of migration of dissolved and colloid-bound tetracycline to the change in solution ionic strength. Colloids could also facilitate the transport of ibuprofen (~10% sorbed on colloids) by ~50% due likely to exclusion of dispersion pathways by colloid straining. This study suggests that colloids are significant carriers or transport promoters of some PPCPs in the subsurface environment and could affect their off-site environmental risks. PMID:27734948

Factors affecting the dissipation of pharmaceuticals in freshwater sediments.

PubMed

Al-Khazrajy, Omar S A; Bergström, Ed; Boxall, Alistair B A

2018-03-01

Degradation is one of the key processes governing the impact of pharmaceuticals in the aquatic environment. Most studies on the degradation of pharmaceuticals have focused on soil and sludge, with fewer exploring persistence in aquatic sediments. We investigated the dissipation of 6 pharmaceuticals from different therapeutic classes in a range of sediment types. Dissipation of each pharmaceutical was found to follow first-order exponential decay. Half-lives in the sediments ranged from 9.5 (atenolol) to 78.8 (amitriptyline) d. Under sterile conditions, the persistence of pharmaceuticals was considerably longer. Stepwise multiple linear regression analysis was performed to explore the relationships between half-lives of the pharmaceuticals, sediment physicochemical properties, and sorption coefficients for the compounds. Sediment clay, silt, and organic carbon content and microbial activity were the predominant factors related to the degradation rates of diltiazem, cimetidine, and ranitidine. Regression analysis failed to highlight a key property which may be responsible for observed differences in the degradation of the other pharmaceuticals. The present results suggest that the degradation rate of pharmaceuticals in sediments is determined by different factors and processes and does not exclusively depend on a single sediment parameter. Environ Toxicol Chem 2018;37:829-838. © 2017 SETAC. © 2017 SETAC.

Pharmaceutical drug marketing strategies and tactics: a comparative analysis of attitudes held by pharmaceutical representatives and physicians.

PubMed

Parker, R Stephen; Pettijohn, Charles E

2005-01-01

A variety of promotional strategies have been used to stimulate sales of pharmaceutical drugs. Traditionally, push techniques have been the predominant means used to encourage physicians to prescribe drugs and thus increase sales. Recently, the traditional push strategy has been supplemented by a pull strategy. Direct-to-consumer advertising is increasingly used to encourage consumers to request advertised drugs from their physicians. This research compares the attitudes of two of the most affected participants in the prescriptive sales processes; physicians and pharmaceutical sales representatives. The findings indicate differences between physicians and pharmaceutical sales representatives regarding the efficacy and ethical considerations of various promotional strategies.

The use of atomic spectroscopy in the pharmaceutical industry for the determination of trace elements in pharmaceuticals.

PubMed

Lewen, Nancy

2011-06-25

The subject of the analysis of various elements, including metals and metalloids, in the pharmaceutical industry has seen increasing importance in the last 10-15 years, as modern analytical instrumentation has afforded analysts with the opportunity to provide element-specific, accurate and meaningful information related to pharmaceutical products. Armed with toxicological data, compendial and regulatory agencies have revisited traditional approaches to the testing of pharmaceuticals for metals and metalloids, and analysts have begun to employ the techniques of atomic spectroscopy, such as flame- and graphite furnace atomic absorption spectroscopy (FAAS, Flame AA or FAA and GFAAS), inductively coupled plasma-atomic emission spectroscopy (ICP-AES) and inductively coupled plasma-mass spectrometry (ICP-MS), to meet their analytical needs. Newer techniques, such as laser-induced breakdown spectroscopy (LIBS) and Laser Ablation ICP-MS (LAICP-MS) are also beginning to see wider applications in the analysis of elements in the pharmaceutical industry.This article will provide a perspective regarding the various applications of atomic spectroscopy in the analysis of metals and metalloids in drug products, active pharmaceutical ingredients (API's), raw materials and intermediates. The application of atomic spectroscopy in the analysis of metals and metalloids in clinical samples, nutraceutical, metabolism and pharmacokinetic samples will not be addressed in this work. Copyright © 2010 Elsevier B.V. All rights reserved.

Recent Developments in Carbonylation Chemistry Using [13 C]CO, [11 C]CO and [14 C]CO.

PubMed

Nielsen, Dennis U; Neumann, Karoline T; Lindhardt, Anders T; Skrydstrup, Troels

2018-06-01

Carbon monoxide represents the most important C1-building block for the chemical industry, both for the production of bulk and fine chemicals, but also for synthetic fuels. Yet, its toxicity and subsequently its cautious handling has limited its applications in medicinal chemistry research and in particular for the synthesis of pharmaceutically relevant molecules. Recent years have nevertheless witnessed a considerable headway on the development of carbon monoxide surrogates and reactor systems, which provide an ideal setting for performing carbonylation chemistry with stoichiometric and sub-stoichiometric carbon monoxide. Such set-ups are particularly ideal for the introduction of isotope labels such as carbon-11, carbon-13 and carbon-14 into bioactive compounds. This review summarizes this growing field and examines the large number of carbonylation reactions that can be exploited for the introduction of a carbon isotope. This article is protected by copyright. All rights reserved.

PHARMACEUTICAL AND PERSONAL CARE PRODUCTS AS ...

EPA Pesticide Factsheets

Perhaps more so than with any other class of pollutants, the occurrence of pharmaceuticals and personal care products (PPCPS) in the environment highlights the immediate, intimate, and inseparable connection between the individual activities of consumers and their environment. In contrast to other types of pollutants, PPCPs owe their origins in the environment directly to their worldwide, universal, frequent, highly dispersed, and individually small but aggregate/cumulative usage and disposal by multitudes of individuals. An overview of this multi-faceted issue can be found at a U.S. EPA web site (http://www.epa.gov/neriesdl/chemistry/phanna/index.htm), which also provides a reprint of a review article published in Environmental Health Perspectives as well as many other resources including several chapters from a new American Chemical Society book. PPCPs can enter the environment following their ingestion or application by the user or administration to domestic animals. Disposal of unused/expired PPCPs in landfills and to domestic sewage are additional routes to the environment. Domestic sewage treatment plants are not specifically engineered to remove PPCPS; the efficiencies with which they are removed from sewage vary from nearly complete to ineffective. The aquatic environment serves as the major, ultimate receptacle for most PPCPS. Little is known with respect to actual or even potential adverse effects on non-target species; human exposure via drinking wate

Pharmaceutical new product development: the increasing role of in-licensing.

PubMed

Edwards, Nancy V

2008-12-01

Many pharmaceutical companies are facing a pipeline gap because of the increasing economic burden and uncertainty associated with internal research and development programs designed to develop new pharmaceutical products. To fill this pipeline gap, pharmaceutical companies are increasingly relying on in-licensing opportunities. New business development identifies new pharmaceuticals that satisfy unmet needs and are a good strategic fit for the company, completes valuation models and forecasts, evaluates the ability of the company to develop and launch products, and pursues in-licensing agreements for pharmaceuticals that cannot be developed internally on a timely basis. These agreements involve the transfer of access rights for patents, trademarks, or similar intellectual property from an outside company in exchange for payments. Despite the risks, in-licensing is increasingly becoming the preferred method for pharmaceutical companies with pipeline gaps to bring new pharmaceuticals to the clinician.

Metabolic engineering: the ultimate paradigm for continuous pharmaceutical manufacturing.

PubMed

Yadav, Vikramaditya G; Stephanopoulos, Gregory

2014-07-01

Research and development (R&D) expenditures by pharmaceutical companies doubled over the past decade, yet candidate attrition rates and development times rose markedly during this period. Understandably, companies have begun downsizing their pipelines and diverting investments away from R&D in favor of manufacturing. It is estimated that transitioning to continuous manufacturing could enable companies to compete for a share in emerging markets. Accordingly, the model for continuous manufacturing that has emerged commences with the conversion of late-stage intermediates into the active pharmaceutical ingredient (API) in a series of continuous flow reactors, followed by continuous solid processing to form finished tablets. The use of flow reactions for API synthesis will certainly generate purer products at higher yields in shorter times compared to equivalent batch reactions. However, transitioning from batch to flow configuration simply alleviates transport limitations within the reaction milieu. As the catalogue of reactions used in flow syntheses is a subset of batch-based chemistries, molecules such as natural products will continue to evade drug prospectors. Also, it is uncertain whether flow synthesis can deliver improvements in the atom and energy economies of API production at the scales that would achieve the levels of revenue growth targeted by companies. Instead, it is argued that implementing metabolic engineering for the production of oxidized scaffolds as gateway molecules for flow-based addition of electrophiles is a more effective and scalable strategy for accessing natural product chemical space. This new paradigm for manufacturing, with metabolic engineering as its engine, would also permit rapid optimization of production variables and allow facile scale-up from gram to ton scale to meet material requirements for clinical trials, thus recasting manufacturing as a tool for discovery. © 2014 WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim.

Care ideologies reflected in 4 conceptions of pharmaceutical care.

PubMed

Björkman, Ingeborg K; Bernsten, Cecilia B; Sanner, Margareta A

2008-12-01

Different ways to practice pharmaceutical care have been developed. One expression of this fact is the existence of many different classification systems to document drug-related problems (DRPs). Evidence suggests that classification systems have different characteristics and that these characteristics reflect different conceptions of pharmaceutical care. To increase the understanding of conceptions of pharmaceutical care, underlying values and beliefs (ideologies) can be explored. To explore various conceptions of pharmaceutical care to identify the care ideologies on which these conceptions are based. Representatives of 4 selected conceptions of pharmaceutical care were interviewed in face-to-face meetings. During the interviews, 4 basic questions were asked. Three were focused on pharmaceutical care and 1 on DRPs. Interview transcripts were analyzed by an inductive method inspired by grounded theory. The conceptions studied were Strand, Granada-II, PCNE v5.0, and Apoteket. In Strand, patients are given a more active role in the pharmaceutical care process, as compared to Granada-II, PCNE v5.0, and Apoteket. Pharmacists in all the conceptions of pharmaceutical care assume they have special knowledge that patients benefit from. However, they use their knowledge in different ways in the various pharmaceutical care conceptions. In Strand, individual goals of drug therapy are established together with the patient, whereas in Granada-II, PCNE, and Apoteket goals are not explicitly discussed. The identified differences correspond to different care ideologies. The pharmaceutical care conceptions are based on different care ideologies. The ideology is expressed in how therapy goals are set and patient needs defined. Strand is based on a patient-centered ideology; patient therapy goals and needs are defined by the patient together with the practitioners. Granada-II, PCNE, and Apoteket are based on an evidence-based medicine approach; patient therapy goals and needs are

Cell-Based Veterinary Pharmaceuticals - Basic Legal Parameters Set by the Veterinary Pharmaceutical Law and the Genetic Engineering Law of the European Union.

PubMed

Faltus, Timo; Brehm, Walter

2016-01-01

Cell-based therapies have been in use in veterinary medicine for years. However, the legal requirement of manufacturing, placing on the market and use of cell-based veterinary pharmaceuticals are not as well developed as the respective requirements of chemical pharmaceuticals. Cell-based veterinary pharmaceuticals are medicinal products in the sense of the pharmaceutical law of the European Union (EU). For that reason, such medicinal products principally require official approval for their manufacture and an official marketing authorization for their placement on the market before being used by the veterinarian. The manufacture, placing on the market, and use of cell-based veterinary pharmaceuticals without manufacturing approval and marketing authorization is permitted only in certain exceptional cases determined by EU and individual Member State law. Violations of this requirement may have consequences for the respective veterinarian under criminal law and under the code of professional conduct in the respective Member State. The regular use of cell-based veterinary pharmaceuticals within the scope of a therapeutic emergency as well as the import of such veterinary pharmaceuticals from non-European countries for use in the EU are currently out of the question in the EU because of a lack of legal bases. Here, we review the general legal requirement of manufacturing, placing on the market, and use of cell-based veterinary pharmaceuticals within the EU and point out different implementations of EU law within the different Member States.

Supercritical fluid technology: concepts and pharmaceutical applications.

PubMed

Deshpande, Praful Balavant; Kumar, G Aravind; Kumar, Averineni Ranjith; Shavi, Gopal Venkatesh; Karthik, Arumugam; Reddy, Meka Sreenivasa; Udupa, Nayanabhirama

2011-01-01

In light of environmental apprehension, supercritical fluid technology (SFT) exhibits excellent opportunities to accomplish key objectives in the drug delivery sector. Supercritical fluid extraction using carbon dioxide (CO(2)) has been recognized as a green technology. It is a clean and versatile solvent with gas-like diffusivity and liquid-like density in the supercritical phase, which has provided an excellent alternative to the use of chemical solvents. The present commentary provides an overview of different techniques using supercritical fluids and their future opportunity for the drug delivery industry. Some of the emerging applications of SFT in pharmaceuticals, such as particle design, drug solubilization, inclusion complex, polymer impregnation, polymorphism, drug extraction process, and analysis, are also covered in this review. The data collection methods are based on the recent literature related to drug delivery systems using SFT platforms. SFT has become a much more versatile and environmentally attractive technology that can handle a variety of complicated problems in pharmaceuticals. This cutting-edge technology is growing predominantly to surrogate conventional unit operations in relevance to the pharmaceutical production process. Supercritical fluid technology has recently drawn attention in the field of pharmaceuticals. It is a distinct conception that utilizes the solvent properties of supercritical fluids above their critical temperature and pressure, where they exhibit both liquid-like and gas-like properties, which can enable many pharmaceutical applications. For example, the liquid-like properties provide benefits in extraction processes of organic solvents or impurities, drug solubilization, and polymer plasticization, and the gas-like features facilitate mass transfer processes. It has become a much more versatile and environmentally attractive technology that can handle a variety of complicated problems in pharmaceuticals. This review is

Internet pharmaceutical sales: attributes, concerns, and future forecast.

PubMed

Bruckel, Katy; Capozzoli, Ernest A

2003-01-01

Internet pharmaceutical sales continue to skyrocket as healthcare providers and consumers are increasingly relying on the efficiencies and convenience that is available via such transactions. Managed care companies, increasing demands to reduce healthcare inefficiencies while maximizing the quality of patient care is a significant contributing factor to the expanding utilization and success of online pharmaceutical sales. However, with the expansion of Internet pharmaceutical sales, healthcare providers, pharmacy benefit management and insurance companies, and consumers realize new opportunities and risks. This paper will review the attributes and concerns associated with online pharmaceutical sales, discussing current and pending legislation intended to more effectively manage these parameters.

The ethics of the medical-pharmaceutical relationship.

PubMed

Vashi, Neelam A; Latkowski, Jo-Ann M

2012-01-01

Physician interaction with the pharmaceutical industry raises many ethical concerns. This relationship is complex, owing to a pluralism of beliefs held by physicians, patients, and third parties. As a result, determining whether physicians fulfill their responsibilities to both the professional and public communities is an arduous endeavor. In an effort to clarify the situation and provide transparency to this complex relationship, medical and pharmaceutical organizations have enacted their own respective codes and guidelines. Even with adherence to these guidelines, questions remain regarding the codependent relationship that interweaves the pharmaceutical industry with the medical community. Owing to the ever-changing landscape enmeshing product development, scientific advancement, corporate realities and patient care, the proper choice for physicians is rarely obvious; however, to operate to the highest standards, those in the medical community must be candid about relations with the pharmaceutical industry and transparent in their financial interests. Further undertakings should focus not on the eradication of physician-pharmaceutical interaction, but instead on the education of physicians about industry marketing strategies and the delineation of boundaries of these interactions to benefit not the individual physician, but our patients. Copyright © 2012. Published by Elsevier Inc.

Pharmaceutical Cocrystal: An Antique and Multifaceted Approach.

PubMed

Panzade, Prabhakar S; Shendarkar, Giridhar R

2017-01-01

Pharmaceutical cocrystal is an emerging approach to tailor physicochemical and mechanical properties of drug substances. Cocrystals are composed of API and pharmaceutically acceptable coformer. It is used to address the solubility, dissolution, mechanical properties and stability of drugs. This review discusses introduction to cocrystal, preparation, and characterization, what USFDA says on cocrystal and role of Hansen solubility parameter to predict cocrystal. The effect of cocrystal on drug properties, dependence of cocrystal solubility on pH, concept of drug-drug cocrystal, and aerosil 200 as novel cocrystal former and impact of cocrystal on drug pharmacokinetic has also been presented in this review along with highly selected examples of cocrystals. Finally, how cocrystal offers an opportunity for patents is also delineated. Pharmaceutical cocrystals have ability to tailor physichochemical and mechanical properties of drug substances. It also provides opportunity for patentable invention. Therapeutic efficacy of drugs may be improved via drug-drug cocrystal. The pharmaceutical cocrystals are not fully explored and have potential for future development. Successful drug delivery can be achieved through cocrystallization. Pharmaceutical industry will be beneficial through successful cocrystallization of drug substances. Copyright© Bentham Science Publishers; For any queries, please email at epub@benthamscience.org.

Pharmaceutical care: past, present and future.

PubMed

Berenguer, B; La Casa, C; de la Matta, M J; Martín-Calero, M J

2004-01-01

Since the concept of Pharmaceutical Care was introduced from United States about twenty years ago, this initiative has become a dominant form of practice for thousands of pharmacists around the world. Currently, pharmaceutical care is understood as the pharmacists' compromise to obtain the maximum benefit from the pharmacological treatments of the patients, being therefore responsible of monitoring their pharmacotherapy. As the profession has moved from a product orientation (dispensing medications) to a patient focus, clinical training requirements have expanded. This is a slow but ongoing process, which started from a philosophical point of view, in order to transform the concept of Pharmacy from commodity-based, mercantile operations into a clinical profession in the community pharmacies. Since its introduction, there has been an ample debate on the definition of pharmaceutical care due to differences in Pharmacy systems and in health care structure among the different countries. Moreover, several implementation barriers exist, which are attributable to problems in education, skills, resources and environment. Indeed, an awareness of the problem resulting from the use of medicines exists and numerous studies reflect that drug use control is necessary since there is an important relationship between morbidity / mortality and pharmacotherapy. Thus, it is possible to evaluate the benefits of pharmaceutical care on patients' health and ultimately on society. Many studies have been conducted, which show that the provision of pharmaceutical care has its value in common pathologies such as diabetes, hypertension, asthma, hyperlipidemia, chronic pain, rheumatic diseases or psychiatric disorders, as well as in polymedicated patients. A large amount of data is currently being published in biomedical journals, in an effort to establish the clinical, economic and humanistic viability of pharmaceutical care. Thus, the aim of this review is to study the evolution of this

Value of pharmaceuticals: ensuring the future of research and development.

PubMed

Serajuddin, Hamida K; Serajuddin, Abu T M

2006-01-01

To analyze the current situation under which the pharmaceutical industry is criticized for the production of drugs with potential adverse effects, the high prices of medicines, and aggressive marketing practices, and to provide a proposal to rectify the situation. Published books, pharmaceutical journals, Web of Science database using the search terms pharmaceutical, research, development, marketing, cost, and the Food and Drug Administration (FDA) Web site. Most breakthroughs in the treatment of diseases and prolongation of lives have come about through pharmaceuticals discovered and developed by the pharmaceutical industry. While the process of discovering and developing new pharmaceuticals is lengthy, costly, and lacking any assurance of success, investment in research and development by the U.S. pharmaceutical industry has increased progressively, reaching 51.3 billion dollars in 2005. Yet the annual number of FDA approvals of new molecular entities (NMEs) has gradually decreased over the past 10 years. Additionally, a large part of the patent life of a successful NME is consumed during this lengthy development phase. Few businesses, if any, have such long product gestation lives and risks. For these reasons, the pharmaceutical industry is often in a rush to recoup its investment before the product's patent expires, and this is the root cause of many criticisms against the pharmaceutical industry. To rectify the current situation, a new system is proposed under which innovator pharmaceutical companies would be allowed royalties for their products after the expiration of patents, in a manner similar to the way in which other intellectual properties (such as books, music, films) are protected by copyright. Such a system would allow pharmaceutical companies to continue research on new pharmaceutical products unimpeded by the patent clock. Given appropriate legislative or other facilitatory actions, a royalty-based system for the marketing of generic products after

[The pharmaceutical industry in the industrial chemical group: the National Union of Chemical-Pharmaceutical Laboratories (1919-1936)].

PubMed

Nozal, Raúl Rodríquez

2011-01-01

The pharmaceutical industry associations, as it happened with other businesses, had a significant rise during the dictatorship of Primo de Rivera and II Republic. The 'Cámara Nacional de Industrias Químicas', in Barcelona, represented the national chemical industry to its ultimate assimilation by the 'Organización Sindical' in 1939. In this association, matters relating to pharmaceutical products -- which we will especially deal with in this work -- were managed by the 'Unión Nacional de Laboratorios Químico-Farmacéuticos', which defended the interests of pharmaceutical companies in the presence of government authorities, using the resources and mechanisms also managed by business pressure groups. The inclusion of industrial pharmacy in the Chemical lobby separated the pharmaceutical industry from traditional exercise and its corporate environment. this created ups and downs, conflicts of interests and finally, love and hate relationships with their colleagues of the pharmacy work placement and, of course, with the association that represented them: the 'Unión Farmacéutica Nacional'.

Risk assessment for ecotoxicity of pharmaceuticals--an emerging issue.

PubMed

Kar, Supratik; Roy, Kunal

2012-03-01

Existence of a large amount of pharmaceuticals and their active metabolites in the environment has recently been considered as one of the most serious concerns in environmental sciences. Large diversity of pharmaceuticals has been found in the environmental domain in considerable amounts that are not only destructive to environment but also fatal for human and animal fraternity. There is a considerable lack of knowledge about the environmental fate and quantification of a large number of pharmaceuticals. This communication aims to review the literature information regarding occurrence of pharmaceuticals and their metabolites in the environment, their persistence, environmental fate and toxicity as well as application of theoretical, non-experimental, non-animal, alternative and, in particular, in silico methods to provide information about the basic physicochemical and fate properties of pharmaceuticals to the environment. The reader will gain an overview of risk assessment strategies for ecotoxicity of pharmaceuticals and advances in application of quantitative structure-toxicity relationship (QSTR) in this field. This review justifies the need to develop more QSTR models for prediction of ecotoxicity of pharmaceuticals in order to reduce time and cost involvement in such exercise.

Case histories in pharmaceutical risk management.

PubMed

McCormick, Cynthia G; Henningfield, Jack E; Haddox, J David; Varughese, Sajan; Lindholm, Anders; Rosen, Susan; Wissel, Janne; Waxman, Deborah; Carter, Lawrence P; Seeger, Vickie; Johnson, Rolley E

2009-12-01

The development and implementation of programs in the U.S. to minimize risks and assess unintended consequences of new medications has been increasingly required by the Food and Drug Administration (FDA) since the mid 1990s. This paper provides four case histories of risk management and post-marketing surveillance programs utilized recently to address problems associated with possible abuse, dependence and diversion. The pharmaceutical sponsors of each of these drugs were invited to present their programs and followed a similar template for their summaries that are included in this article. The drugs and presenting companies were OxyContin, an analgesic marketed by Purdue Pharma L.P., Daytrana and Vyvanse, ADHD medications marketed by Shire Pharmaceuticals, Xyrem for narcolepsy marketed by Jazz Pharmaceuticals, and Subutex and Suboxone for opioid dependence marketed by Reckitt Benckiser Pharmaceuticals Inc. These case histories and subsequent discussions provide invaluable real-world examples and illustrate both the promise of risk management programs in providing a path to market and/or for keeping on the market drugs with serious potential risks. They also illustrate the limitations of such programs in actually controlling unintended consequences, as well as the challenge of finding the right balance of reducing risks without posing undue barriers to patient access. These experiences are highly relevant as the FDA increasingly requires pharmaceutical sponsors to develop and implement the more formalized and enforceable versions of the risk management term Risk Evaluation and Mitigation Strategies (REMS).

Pharmaceutical care in smoking cessation

PubMed Central

Marín Armero, Alicia; Calleja Hernandez, Miguel A; Perez-Vicente, Sabina; Martinez-Martinez, Fernando

2015-01-01

As a determining factor in various diseases and the leading known cause of preventable mortality and morbidity, tobacco use is the number one public health problem in developed countries. Facing this health problem requires authorities and health professionals to promote, via specific programs, health campaigns that improve patients’ access to smoking cessation services. Pharmaceutical care has a number of specific characteristics that enable the pharmacist, as a health professional, to play an active role in dealing with smoking and deliver positive smoking cessation interventions. The objectives of the study were to assess the efficacy of a smoking cessation campaign carried out at a pharmaceutical care center and to evaluate the effects of pharmaceutical care on patients who decide to try to stop smoking. The methodology was an open, analytical, pre–post intervention, quasi-experimental clinical study performed with one patient cohort. The results of the study were that the promotional campaign for the smoking cessation program increased the number of patients from one to 22, and after 12 months into the study, 43.48% of the total number of patients achieved total smoking cessation. We can conclude that advertising of a smoking cessation program in a pharmacy increases the number of patients who use the pharmacy’s smoking cessation services, and pharmaceutical care is an effective means of achieving smoking cessation. PMID:25678779

[Written pharmaceutical advertising--still unreliable?].

PubMed

Gladsø, Kristin Haugen; Garberg, Hedda Rosland; Spigset, Olav; Slørdal, Lars

2014-09-02

Marketing by the pharmaceutical industry affects doctors' prescribing habits. All pharmaceutical advertising received by nine doctors in two GP offices over a period of three months was collected. The advertising material was sorted by compound. For each compound, the advert with the highest number of references was selected. The cited references were obtained, and the claims in the adverts were assessed in terms of their consistency with the source data based on the provisions in the Norwegian regulations on pharmaceuticals. The references were also assessed with regard to the incidence of conflicts of interest among authors. The doctors received a total of 270 shipments of advertising for 46 different compounds. Altogether 95% of the 173 references cited in the 46 selected adverts could be obtained. The adverts contained a total of 156 claims. Of these, 56% were assessed as correct when compared to the source data and as having clinical relevance. Altogether 75% of the journal articles reported relevant conflicts of interest for the authors. About half the claims in the adverts were found to be correct and clinically relevant. These results concur with those from a methodologically identical study based on advertising material collected in 2004. The cited literature was of varying quality and often funded by the pharmaceutical companies. The findings indicate that the target group should be sceptical of this type of marketing.

Pharmaceutical care in smoking cessation.

PubMed

Marín Armero, Alicia; Calleja Hernandez, Miguel A; Perez-Vicente, Sabina; Martinez-Martinez, Fernando

2015-01-01

As a determining factor in various diseases and the leading known cause of preventable mortality and morbidity, tobacco use is the number one public health problem in developed countries. Facing this health problem requires authorities and health professionals to promote, via specific programs, health campaigns that improve patients' access to smoking cessation services. Pharmaceutical care has a number of specific characteristics that enable the pharmacist, as a health professional, to play an active role in dealing with smoking and deliver positive smoking cessation interventions. The objectives of the study were to assess the efficacy of a smoking cessation campaign carried out at a pharmaceutical care center and to evaluate the effects of pharmaceutical care on patients who decide to try to stop smoking. The methodology was an open, analytical, pre-post intervention, quasi-experimental clinical study performed with one patient cohort. The results of the study were that the promotional campaign for the smoking cessation program increased the number of patients from one to 22, and after 12 months into the study, 43.48% of the total number of patients achieved total smoking cessation. We can conclude that advertising of a smoking cessation program in a pharmacy increases the number of patients who use the pharmacy's smoking cessation services, and pharmaceutical care is an effective means of achieving smoking cessation.

Trade, TRIPS, and pharmaceuticals.

PubMed

Smith, Richard D; Correa, Carlos; Oh, Cecilia

2009-02-21

The World Trade Organization's Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) set global minimum standards for the protection of intellectual property, substantially increasing and expanding intellectual-property rights, and generated clear gains for the pharmaceutical industry and the developed world. The question of whether TRIPS generates gains for developing countries, in the form of increased exports, is addressed in this paper through consideration of the importance of pharmaceuticals in health-care trade, outlining the essential requirements, implications, and issues related to TRIPS, and TRIPS-plus, in which increased restrictions are imposed as part of bilateral free-trade agreements. TRIPS has not generated substantial gains for developing countries, but has further increased pharmaceutical trade in developed countries. The unequal trade between developed and developing countries (ie, exporting and importing high-value patented drugs, respectively) raises the issue of access to medicines, which is exacerbated by TRIPS-plus provisions, although many countries have not even enacted provision for TRIPS flexibilities. Therefore this paper focuses on options that are available to the health community for negotiation to their advantage under TRIPS, and within the presence of TRIPS-plus.

Pharmaceuticals in the environment: scientific evidence of risks and its regulation

PubMed Central

Küster, Anette; Adler, Nicole

2014-01-01

During the past two decades scientists, regulatory agencies and the European Commission have acknowledged pharmaceuticals to be an emerging environmental problem. In parallel, a regulatory framework for environmental risk assessment (ERA) of pharmaceutical products has been developed. Since the regulatory guidelines came into force the German Federal Agency (UBA) has been evaluating ERAs for human and veterinary pharmaceutical products before they are marketed. The results show that approximately 10% of pharmaceutical products are of note regarding their potential environmental risk. For human medicinal products, hormones, antibiotics, analgesics, antidepressants and antineoplastics indicated an environmental risk. For veterinary products, hormones, antibiotics and parasiticides were most often discussed as being environmentally relevant. These results are in good correlation with the results within the open scientific literature of prioritization approaches for pharmaceuticals in the environment. UBA results revealed that prospective approaches, such as ERA of pharmaceuticals, play an important role in minimizing problems caused by pharmaceuticals in the environment. However, the regulatory ERA framework could be improved by (i) inclusion of the environment in the risk–benefit analysis for human pharmaceuticals, (ii) improvement of risk management options, (iii) generation of data on existing pharmaceuticals, and (iv) improving the availability of ERA data. In addition, more general and integrative steps of regulation, legislation and research have been developed and are presented in this article. In order to minimize the quantity of pharmaceuticals in the environment these should aim to (i) improve the existing legislation for pharmaceuticals, (ii) prioritize pharmaceuticals in the environment and (iii) improve the availability and collection of pharmaceutical data. PMID:25405974

Pharmaceutical penetration of new drug and pharmaceutical market structure in Taiwan: hospital-level prescription of thiazolidinediones for diabetes.

PubMed

Tsai, Yi-Wen; Wen, Yu-Wen; Huang, Weng-Foung; Kuo, Ken N; Chen, Pei-Fen; Shih, Hsin-Wei; Lee, Yue-Chune

2010-06-01

This study used Taiwan's National Health Insurance claim database (years 2000-2005) to examine how thiazolidinediones (TZD), a new class of drugs for diabetes, penetrated into Taiwan's hospitals, and its association with the concentration of all diabetes drugs at the hospital level. We collected 72 monthly summaries of diabetes prescriptions from all hospitals in Taiwan. Hospital-level pharmaceutical concentration was measured by penetration of TZD, defined as monthly market share of TZD in each hospital. Concentration of diabetes drugs was measured by Herfindahl-Hirschman indices. We found a negative association (coefficient = -0.3610) between TZD penetration and concentration of diabetes drug but a positive association between penetration of TZD and the volume of prescribed diabetes drugs (coefficient = 0.4088). In conclusion, hospital characteristics and volume of services determined the concentration of pharmaceuticals at the institution level, reflecting the heterogeneous competition between pharmaceutical companies within each hospital. Institution-level pharmaceutical concentration influences the adoption and penetration of new drugs.

Pharmaceutical industry exposure in our hospitals: the final frontier.

PubMed

Dean, Jessica; Loh, Erwin; Coleman, Justin J

2016-01-18

Despite recent changes in attitudes, most hospitals continue to experience pharmaceutical industry presence. Pharmaceutical industry presence may be necessary and beneficial in the context of sponsorship of clinical trials with appropriate governance. Doctors continue to hold positive attitudes towards market-oriented activities of the pharmaceutical and medical device industries. Despite evidence to the contrary, doctors believe they are able to effectively manage pharmaceutical sales representative interactions such that their own prescribing is not adversely impacted. Doctors also share a belief that small gifts and benefits are harmless. There may be significant financial burden associated with divestment of such sponsorship by hospitals. Change requires education and effective policies to manage pharmaceutical industry relationships and conflicts of interest. We discuss case studies involving students and public hospital doctors to show that divestment is possible without significant financial detriment. Health services need to be proactive in transitioning financial and cultural reliance on pharmaceutical industry sponsorship to other potentially less harmful sources.

Thick prescriptions: toward an interpretation of pharmaceutical sales practices.

PubMed

Oldani, Michael J

2004-09-01

Anthropologists of medicine and science are increasingly studying all aspects of pharmaceutical industry practices--from research and development to the marketing of prescription drugs. This article ethnographically explores one particular stage in the life cycle of pharmaceuticals: sales and marketing. Drawing on a range of sources-investigative journalism, medical ethics, and autoethnography--the author examines the day-to-day activities of pharmaceutical salespersons, or drug reps, during the 1990s. He describes in detail the pharmaceutical gift cycle, a three-way exchange network between doctors, salespersons, and patients and how this process of exchange is currently in a state of involution. This gift economy exists to generate prescriptions (scripts) and can mask and/or perpetuate risks and side effects for patients. With implications of pharmaceutical industry practices impacting everything from the personal-psychological to the global political economy, medical anthropologists can play a lead role in the emerging scholarly discourse concerned with critical pharmaceutical studies.

Prioritizing veterinary pharmaceuticals for aquatic environment in Korea.

PubMed

Kim, Younghee; Jung, Jinyong; Kim, Myunghyun; Park, Jeongim; Boxall, Alistair B A; Choi, Kyungho

2008-09-01

Pharmaceutical residues may have serious impacts on nontarget biological organisms in aquatic ecosystems, and have therefore precipitated numerous investigations worldwide. Many pharmaceutical compounds available on the market need to be prioritized based on their potential ecological and human health risks in order to develop sound management decisions. We prioritized veterinary pharmaceuticals in Korea by their usage, potential to enter the environment, and toxicological hazard. Twenty compounds were identified in the top priority class, most of which were antibiotics. Among these compounds, 8 were identified as deserving more immediate attention: amoxicillin, enramycin, fenbendazole, florfenicol, ivermectin, oxytetracycline, tylosin, and virginiamycin. A limitation of this study is that we initially screened veterinary pharmaceuticals by sales tonnage for veterinary use only. However, this is the first attempt to prioritize veterinary pharmaceuticals in Korea, and it provides important concepts for developing environmental risk management plans for such contaminants in aquatic systems. Copyright © 2008 Elsevier B.V. All rights reserved.

Membrane Bioprocesses for Pharmaceutical Micropollutant Removal from Waters

PubMed Central

de Cazes, Matthias; Abejón, Ricardo; Belleville, Marie-Pierre; Sanchez-Marcano, José

2014-01-01

The purpose of this review work is to give an overview of the research reported on bioprocesses for the treatment of domestic or industrial wastewaters (WW) containing pharmaceuticals. Conventional WW treatment technologies are not efficient enough to completely remove all pharmaceuticals from water. Indeed, these compounds are becoming an actual public health problem, because they are more and more present in underground and even in potable waters. Different types of bioprocesses are described in this work: from classical activated sludge systems, which allow the depletion of pharmaceuticals by bio-degradation and adsorption, to enzymatic reactions, which are more focused on the treatment of WW containing a relatively high content of pharmaceuticals and less organic carbon pollution than classical WW. Different aspects concerning the advantages of membrane bioreactors for pharmaceuticals removal are discussed, as well as the more recent studies on enzymatic membrane reactors to the depletion of these recalcitrant compounds. PMID:25295629

WHO Expert Committee on Specifications for Pharmaceutical Preparations.

PubMed

2005-01-01

This report presents the recommendations of an international group of experts convened by the World Health Organization to consider matters concerning the quality assurance of pharmaceuticals and specifications for drug substances and dosage forms. Of particular relevance to drug regulatory authorities and pharmaceutical manufacturers, this report discusses the monographs on antiretrovirals proposed for inclusion in The International Pharmacopoeia and specifications for radiopharmaceuticals, quality specifications for antituberculosis drugs and the revision of the monograph on artemisinin derivatives, as well as quality control of reference materials, good manufacturing practices (GMP), inspection, distribution and trade and other aspects of quality assurance of pharmaceuticals, and regulatory issues. The report is complemented by a number of annexes, including an amendment to good manufacturing practices: main principles regarding the requirement for the sampling of starting materials, guidelines on good manufacturing practices regarding water for pharmaceutical use, guidelines on the sampling of pharmaceutical products and related materials and draft guidelines for registration of fixed-dose combination medicinal products.

Synthetic biology advances for pharmaceutical production

PubMed Central

Breitling, Rainer; Takano, Eriko

2015-01-01

Synthetic biology enables a new generation of microbial engineering for the biotechnological production of pharmaceuticals and other high-value chemicals. This review presents an overview of recent advances in the field, describing new computational and experimental tools for the discovery, optimization and production of bioactive molecules, and outlining progress towards the application of these tools to pharmaceutical production systems. PMID:25744872

Review on Physicochemical, Chemical, and Biological Processes for Pharmaceutical Wastewater

NASA Astrophysics Data System (ADS)

Li, Zhenchen; Yang, Ping

2018-02-01

Due to the needs of human life and health, pharmaceutical industry has made great progress in recent years, but it has also brought about severe environmental problems. The presence of pharmaceuticals in natural waters which might pose potential harm to the ecosystems and humans raised increasing concern worldwide. Pharmaceuticals cannot be effectively removed by conventional wastewater treatment plants (WWTPs) owing to the complex composition, high concentration of organic contaminants, high salinity and biological toxicity of pharmaceutical wastewater. Therefore, the development of efficient methods is needed to improve the removal effect of pharmaceuticals. This review provides an overview on three types of treatment technologies including physicochemical, chemical and biological processes and their advantages and disadvantages respectively. In addition, the future perspectives of pharmaceutical wastewater treatment are given.

Organic solvents in the pharmaceutical industry.

PubMed

Grodowska, Katarzyna; Parczewski, Andrzej

2010-01-01

Organic solvents are commonly used in the pharmaceutical industry as reaction media, in separation and purification of synthesis products and also for cleaning of equipment. This paper presents some aspects of organic solvents utilization in an active pharmaceutical ingredient and a drug product manufacturing process. As residual solvents are not desirable substances in a final product, different methods for their removal may be used, provided they fulfill safety criteria. After the drying process, analyses need to be performed to check if amounts of solvents used at any step of the production do not exceed acceptable limits (taken from ICH Guideline or from pharmacopoeias). Also new solvents like supercritical fluids or ionic liquids are developed to replace "traditional" organic solvents in the pharmaceutical production processes.

Assessing the assessments: Pharmaceuticals in the environment

DOE Office of Scientific and Technical Information (OSTI.GOV)

Enick, O.V.; Moore, M.M.

2007-11-15

The relatively new issue of pharmaceutical contamination of the environment offers the opportunity to explore the application of values to the construction, communication and management of risk. The still-developing regulatory policies regarding environmental contamination with pharmaceuticals provide fertile ground for the introduction of values into the definition and management of risk. In this report, we summarize the current knowledge regarding pharmaceutical contamination of the environment and discuss specific attributes of pharmaceuticals that require special consideration. We then present an analysis showing that if values are incorporated into assessing, characterizing and managing risk, the results of risk assessments will more accuratelymore » reflect the needs of various stakeholders. Originating from an acknowledgement of the inherent uncertainty and value-laden nature of risk assessment, the precautionary principle (and later, the multi-criteria, integrated risk assessment), provides a direction for further research and policy development.« less

Pharmaceutical marketing research and the prescribing physician.

PubMed

Greene, Jeremy A

2007-05-15

Surveillance of physicians' prescribing patterns and the accumulation and sale of these data for pharmaceutical marketing are currently the subjects of legislation in several states and action by state and national medical associations. Contrary to common perception, the growth of the health care information organization industry has not been limited to the past decade but has been building slowly over the past 50 years, beginning in the 1940s when growth in the prescription drug market fueled industry interest in understanding and influencing prescribing patterns. The development of this surveillance system was not simply imposed on the medical profession by the pharmaceutical industry but was developed through the interactions of pharmaceutical salesmen, pharmaceutical marketers, academic researchers, individual physicians, and physician organizations. Examination of the role of physicians and physician organizations in the development of prescriber profiling is directly relevant to the contemporary policy debate surrounding this issue.

Information flow in the pharmaceutical supply chain.

PubMed

Yousefi, Nazila; Alibabaei, Ahmad

2015-01-01

Managing the supply chain plays an important role in creating competitive advantages for companies. Adequate information flow in supply chain is one of the most important issues in SCM. Therefore, using certain Information Systems can have a significant role in managing and integrating data and information within the supply chain. Pharmaceutical supply chain is more complex than many other supply chains, in the sense that it can affect social and political perspectives. On the other hand, managing the pharmaceutical supply chain is difficult because of its complexity and also government regulations in this field. Although, Iran has progressed a lot in pharmaceutical manufacturing, still there are many unsolved issues in managing the information flow in the pharmaceutical supply chain. In this study, we reviewed the benefits of using different levels of an integrated information system in the supply chain and the possible challenges ahead.

Funding pharmaceutical innovation through direct tax credits.

PubMed

Lybecker, Kristina M; Freeman, Robert A

2007-07-01

Rising pharmaceutical prices, increasing demand for more effective innovative drugs and growing public outrage have heightened criticism of the pharmaceutical industry. The public debate has focused on drug prices and access. As a consequence, the patent system is being reexamined as an efficient mechanism for encouraging pharmaceutical innovation and drug development. We propose an alternative to the existing patent system, instead rewarding the innovating firm with direct tax credits in exchange for marginal cost pricing. This concept is based on the fundamental assumption that innovation that benefits society at large may be financed publicly. As an industry which produces a social good characterized by high fixed costs, high information and regulatory costs, and relatively low marginal costs of production, pharmaceuticals are well-suited to such a mechanism. Under this proposal, drug prices fall, consumer surplus increases, access is enhanced, and the incentives to innovate are preserved.

Information flow in the pharmaceutical supply chain

PubMed Central

Yousefi, Nazila; Alibabaei, Ahmad

2015-01-01

Managing the supply chain plays an important role in creating competitive advantages for companies. Adequate information flow in supply chain is one of the most important issues in SCM. Therefore, using certain Information Systems can have a significant role in managing and integrating data and information within the supply chain. Pharmaceutical supply chain is more complex than many other supply chains, in the sense that it can affect social and political perspectives. On the other hand, managing the pharmaceutical supply chain is difficult because of its complexity and also government regulations in this field. Although, Iran has progressed a lot in pharmaceutical manufacturing, still there are many unsolved issues in managing the information flow in the pharmaceutical supply chain. In this study, we reviewed the benefits of using different levels of an integrated information system in the supply chain and the possible challenges ahead. PMID:26664401

PHARMACEUTICALS AND PERSONAL CARE PRODUCTS ...

EPA Pesticide Factsheets

While the point-source emissions of pollutants from manufacturing waste streams have long been monitored and subject to controls, the environmental impact of the public's (i.e., the individual's) activities regarding the use of chemicals is more difficult to assess. Of particular question is the widespread release to sewage and surface/ground waters of pharmaceuticals and personal care products after their ingestion, external application, or disposal. Certain pharmaceutically active compounds (e.g., caffeine, nicotine, and aspirin) have been known for over 20 years to enter the environment by a variety of routes - primarily via treated and untreated sewage effluent. A larger picture, however, has emerged only more recently, where it is evident that numerous personal care products (such as fragrances and sunscreens) and drugs from a wide spectrum of therapeutic classes can occur in the environment and drinking water (albeit at very low concentrations), especially in natural waters receiving sewage. Nearly all ecological monitoring studies for pharmaceuticals and personal care products (informally referred to as

Microbiological testing of pharmaceuticals and cosmetics in Egypt.

PubMed

Zeitoun, Hend; Kassem, Mervat; Raafat, Dina; AbouShlieb, Hamida; Fanaki, Nourhan

2015-12-09

Microbial contamination of pharmaceuticals poses a great problem to the pharmaceutical manufacturing process, especially from a medical as well as an economic point of view. Depending upon the product and its intended use, the identification of isolates should not merely be limited to the United States Pharmacopeia (USP) indicator organisms. Eighty-five pre-used non-sterile pharmaceuticals collected from random consumers in Egypt were examined for the eventual presence of bacterial contaminants. Forty-one bacterial contaminants were isolated from 31 of the tested preparations. These isolates were subjected to biochemical identification by both conventional tests as well as API kits, which were sufficient for the accurate identification of only 11 out of the 41 bacterial contaminants (26.8%) to the species level. The remaining isolates were inconclusively identified or showed contradictory results after using both biochemical methods. Using molecular methods, 24 isolates (58.5%) were successfully identified to the species level. Moreover, polymerase chain reaction (PCR) assays were compared to standard biochemical methods in the detection of pharmacopoeial bacterial indicators in artificially-contaminated pharmaceutical samples. PCR-based methods proved to be superior regarding speed, cost-effectiveness and sensitivity. Therefore, pharmaceutical manufacturers would be advised to adopt PCR-based methods in the microbiological quality testing of pharmaceuticals in the future.

[Pharmaceutical product quality control and good manufacturing practices].

PubMed

Hiyama, Yukio

2010-01-01

This report describes the roles of Good Manufacturing Practices (GMP) in pharmaceutical product quality control. There are three keys to pharmaceutical product quality control. They are specifications, thorough product characterization during development, and adherence to GMP as the ICH Q6A guideline on specifications provides the most important principles in its background section. Impacts of the revised Pharmaceutical Affairs Law (rPAL) which became effective in 2005 on product quality control are discussed. Progress of ICH discussion for Pharmaceutical Development (Q8), Quality Risk Management (Q9) and Pharmaceutical Quality System (Q10) are reviewed. In order to reconstruct GMP guidelines and GMP inspection system in the regulatory agencies under the new paradigm by rPAL and the ICH, a series of Health Science studies were conducted. For GMP guidelines, product GMP guideline, technology transfer guideline, laboratory control guideline and change control system guideline were written. For the GMP inspection system, inspection check list, inspection memo and inspection scenario were proposed also by the Health Science study groups. Because pharmaceutical products and their raw materials are manufactured and distributed internationally, collaborations with other national authorities are highly desired. In order to enhance the international collaborations, consistent establishment of GMP inspection quality system throughout Japan will be essential.

Pharmaceuticals in the environment: scientific evidence of risks and its regulation.

PubMed

Küster, Anette; Adler, Nicole

2014-11-19

During the past two decades scientists, regulatory agencies and the European Commission have acknowledged pharmaceuticals to be an emerging environmental problem. In parallel, a regulatory framework for environmental risk assessment (ERA) of pharmaceutical products has been developed. Since the regulatory guidelines came into force the German Federal Agency (UBA) has been evaluating ERAs for human and veterinary pharmaceutical products before they are marketed. The results show that approximately 10% of pharmaceutical products are of note regarding their potential environmental risk. For human medicinal products, hormones, antibiotics, analgesics, antidepressants and antineoplastics indicated an environmental risk. For veterinary products, hormones, antibiotics and parasiticides were most often discussed as being environmentally relevant. These results are in good correlation with the results within the open scientific literature of prioritization approaches for pharmaceuticals in the environment. UBA results revealed that prospective approaches, such as ERA of pharmaceuticals, play an important role in minimizing problems caused by pharmaceuticals in the environment. However, the regulatory ERA framework could be improved by (i) inclusion of the environment in the risk-benefit analysis for human pharmaceuticals, (ii) improvement of risk management options, (iii) generation of data on existing pharmaceuticals, and (iv) improving the availability of ERA data. In addition, more general and integrative steps of regulation, legislation and research have been developed and are presented in this article. In order to minimize the quantity of pharmaceuticals in the environment these should aim to (i) improve the existing legislation for pharmaceuticals, (ii) prioritize pharmaceuticals in the environment and (iii) improve the availability and collection of pharmaceutical data. © 2014 The Author(s) Published by the Royal Society. All rights reserved.

Global risk of pharmaceutical contamination from highly populated developing countries.

PubMed

Rehman, Muhammad Saif Ur; Rashid, Naim; Ashfaq, Muhammad; Saif, Ameena; Ahmad, Nasir; Han, Jong-In

2015-11-01

Global pharmaceutical industry has relocated from the west to Asian countries to ensure competitive advantage. This industrial relocation has posed serious threats to the environment. The present study was carried out to assess the possible pharmaceutical contamination in the environment of emerging pharmaceutical manufacturing countries (Bangladesh, China, India and Pakistan). Although these countries have made tremendous progress in the pharmaceutical sector but most of their industrial units discharge wastewater into domestic sewage network without any treatment. The application of untreated wastewater (industrial and domestic) and biosolids (sewage sludge and manure) in agriculture causes the contamination of surface water, soil, groundwater, and the entire food web with pharmaceutical compounds (PCs), their metabolites and transformed products (TPs), and multidrug resistant microbes. This pharmaceutical contamination in Asian countries poses global risks via product export and international traveling. Several prospective research hypotheses including the development of new analytical methods to monitor these PCs/TPs and their metabolites, highly resistant microbial strains, and mixture toxicity as a consequence of pharmaceutical contamination in these emerging pharmaceutical exporters have also been proposed based on the available literature. Copyright © 2013 Elsevier Ltd. All rights reserved.

Human pharmaceutical products in the environment - the "problem" in perspective.

PubMed

Taylor, David; Senac, Thomas

2014-11-01

Concerns about the potential for significant environmental impact from residues of human pharmaceuticals emerged at the beginning of the 21st century. Since then there has been an exponential rise in the number of publications and conferences on this "problem". However, this intense focus on human pharmaceuticals is misplaced. Pharmaceuticals do not consist of a coherent group of substances with similar chemical, structural, biological or toxicological properties. Pharmaceuticals are only identifiable from their use: in other words substances can be divided into two classes, those that are used as pharmaceuticals and those for which a possible pharmaceutical use has not yet been discovered. For example, nitro-glycerine, Warfarin and dimethyl fumarate, initially sold respectively as an explosive, a rodenticide and a mould inhibitor have subsequently all been used as pharmaceuticals. As analytical science advances, an increasing range of environmental contaminants, including pharmaceuticals, is being identified at sub μgL(-1) concentrations. Although, human and environmental exposure to these contaminants will be low, all of them need to be subjected to risk assessment on a case by case basis. Many of these substances, including human pharmaceuticals, may have little, if any, impact on human health or the environment, however for some substances there may be a significant risk and in these cases appropriate action should be taken. However considering all human pharmaceuticals as a special case, isolated from the wider range of emerging contaminants, is scientifically unjustifiable and diverts resources away from the consideration of other substances that may be of considerably more significance. Copyright © 2014 Elsevier Ltd. All rights reserved.

Pharmaceuticals as indictors of sewage-influenced groundwater

NASA Astrophysics Data System (ADS)

Müller, Beate; Scheytt, Traugott; Asbrand, Martin; de Casas, Andrea Mross

2012-09-01

A set of human pharmaceuticals enables identification of groundwater that is influenced by sewage and provides information on the time of recharge. As the consumption rates of the investigated pharmaceuticals have changed over time, so too has the composition of the sewage. At the study area, south of Berlin (Germany), irrigation was performed as a method of wastewater clean-up at sewage irrigation farms until the early 1990s. Today, treated wastewater is discharged into the surface-water-stream Nuthegraben. Groundwater and surface-water samples were analyzed for the pharmaceutical substances clofibric acid, bezafibrate, diclofenac, carbamazepine and primidone, the main ions and organic carbon. The pharmaceutical substances were detected at concentrations up to microgram-per-liter level in groundwater and surface-water samples from the Nuthegraben Lowland area and from the former irrigation farms. Concentrations detected in groundwater are generally much lower than in surface water and there is significant variation in the distribution of pharmaceutical concentrations in groundwater. Groundwater influenced by the irrigation of sewage water shows higher primidone and clofibric-acid concentrations. Groundwater influenced by recent discharge of treated sewage water into the surface water shows high carbamazepine concentrations while concentrations of primidone and clofibric acid are low.

Removal of pharmaceuticals during drinking water treatment.

PubMed

Ternes, Thomas A; Meisenheimer, Martin; McDowell, Derek; Sacher, Frank; Brauch, Heinz-Jürgen; Haist-Gulde, Brigitte; Preuss, Gudrun; Wilme, Uwe; Zulei-Seibert, Ninette

2002-09-01

The elimination of selected pharmaceuticals (bezafibrate, clofibric acid, carbamazepine, diclofenac) during drinking water treatment processes was investigated at lab and pilot scale and in real waterworks. No significant removal of pharmaceuticals was observed in batch experiments with sand under natural aerobic and anoxic conditions, thus indicating low sorption properties and high persistence with nonadapted microorganisms. These results were underscored by the presence of carbamazepine in bank-filtrated water with anaerobic conditions in a waterworks area. Flocculation using iron(III) chloride in lab-scale experiments (Jar test) and investigations in waterworks exhibited no significant elimination of the selected target pharmaceuticals. However, ozonation was in some cases very effective in eliminating these polar compounds. In lab-scale experiments, 0.5 mg/L ozone was shown to reduce the concentrations of diclofenac and carbamazepine by more than 90%, while bezafibrate was eliminated by 50% with a 1.5 mg/L ozone dose. Clofibric acid was stable even at 3 mg/L ozone. Under waterworks conditions, similar removal efficiencies were observed. In addition to ozonation, filtration with granular activated carbon (GAC) was very effective in removing pharmaceuticals. Except for clofibric acid, GAC in pilot-scale experiments and waterworks provided a major elimination of the pharmaceuticals under investigation.

Forensic Chemistry

NASA Astrophysics Data System (ADS)

Bell, Suzanne

2009-07-01

Forensic chemistry is unique among chemical sciences in that its research, practice, and presentation must meet the needs of both the scientific and the legal communities. As such, forensic chemistry research is applied and derivative by nature and design, and it emphasizes metrology (the science of measurement) and validation. Forensic chemistry has moved away from its analytical roots and is incorporating a broader spectrum of chemical sciences. Existing forensic practices are being revisited as the purview of forensic chemistry extends outward from drug analysis and toxicology into such diverse areas as combustion chemistry, materials science, and pattern evidence.

Cell-Based Veterinary Pharmaceuticals – Basic Legal Parameters Set by the Veterinary Pharmaceutical Law and the Genetic Engineering Law of the European Union

PubMed Central

Faltus, Timo; Brehm, Walter

2016-01-01

Cell-based therapies have been in use in veterinary medicine for years. However, the legal requirement of manufacturing, placing on the market and use of cell-based veterinary pharmaceuticals are not as well developed as the respective requirements of chemical pharmaceuticals. Cell-based veterinary pharmaceuticals are medicinal products in the sense of the pharmaceutical law of the European Union (EU). For that reason, such medicinal products principally require official approval for their manufacture and an official marketing authorization for their placement on the market before being used by the veterinarian. The manufacture, placing on the market, and use of cell-based veterinary pharmaceuticals without manufacturing approval and marketing authorization is permitted only in certain exceptional cases determined by EU and individual Member State law. Violations of this requirement may have consequences for the respective veterinarian under criminal law and under the code of professional conduct in the respective Member State. The regular use of cell-based veterinary pharmaceuticals within the scope of a therapeutic emergency as well as the import of such veterinary pharmaceuticals from non-European countries for use in the EU are currently out of the question in the EU because of a lack of legal bases. Here, we review the general legal requirement of manufacturing, placing on the market, and use of cell-based veterinary pharmaceuticals within the EU and point out different implementations of EU law within the different Member States. PMID:27965965

Designing green derivatives of β-blocker Metoprolol: a tiered approach for green and sustainable pharmacy and chemistry.

PubMed

Rastogi, Tushar; Leder, Christoph; Kümmerer, Klaus

2014-09-01

The presences of micro-pollutants (active pharmaceutical ingredients, APIs) are increasingly seen as a challenge of the sustainable management of water resources worldwide due to ineffective effluent treatment and other measures for their input prevention. Therefore, novel approaches are needed like designing greener pharmaceuticals, i.e. better biodegradability in the environment. This study addresses a tiered approach of implementing green and sustainable chemistry principles for theoretically designing better biodegradable and pharmacologically improved pharmaceuticals. Photodegradation process coupled with LC-MS(n) analysis and in silico tools such as quantitative structure-activity relationships (QSAR) analysis and molecular docking proved to be a very significant approach for the preliminary stages of designing chemical structures that would fit into the "benign by design" concept in the direction of green and sustainable pharmacy. Metoprolol (MTL) was used as an example, which itself is not readily biodegradable under conditions found in sewage treatment and the aquatic environment. The study provides the theoretical design of new derivatives of MTL which might have the same or improved pharmacological activity and are more degradable in the environment than MTL. However, the in silico toxicity prediction by QSAR of those photo-TPs indicated few of them might be possibly mutagenic and require further testing. This novel approach of theoretically designing 'green' pharmaceuticals can be considered as a step forward towards the green and sustainable pharmacy field. However, more knowledge and further experience have to be collected on the full scope, opportunities and limitations of this approach. Copyright © 2014 Elsevier Ltd. All rights reserved.

Pharmaceutical care: the PCNE definition 2013.

PubMed

Allemann, Samuel S; van Mil, J W Foppe; Botermann, Lea; Berger, Karin; Griese, Nina; Hersberger, Kurt E

2014-06-01

Twenty-three years after Hepler and Strand published their well-known definition of Pharmaceutical Care (PhC), confusion remains about what the term includes and how to differentiate it from other terms. The board of the Pharmaceutical Care Network Europe (PCNE) felt the need to redefine PhC and to answer the question: "What is Pharmaceutical Care in 2013". The aims of this paper were to review existing definitions of PhC and to describe the process of developing a redefined definition. A literature search was conducted in the MEDLINE database (1964-January 2013). Keywords included "Pharmaceutical Care", "Medication (Therapy) Management", "Medicine Management", and "Pharmacist Care" in the title or abstract together with the term "defin*". To ease comparison between definitions, we developed a standardised syntax to paraphrase the definitions. During a dedicated meeting, a moderated discussion about the definition of PhC was organised. The initial literature search produced 186 hits, with eight unique PhC definitions. Hand searching identified a further 11 unique definitions. These 19 definitions were paraphrased using the standardised syntax (provider, recipient, subject, outcome, activities). Fourteen members of PCNE and 10 additional experts attended the moderated discussion. Working groups of increasing size developed intermediate definitions, which had similarities and differences to those retrieved in the literature search. At the end of the session, participants reached a consensus on a "PCNE definition of Pharmaceutical Care" reading: "Pharmaceutical Care is the pharmacist's contribution to the care of individuals in order to optimize medicines use and improve health outcomes". It was possible to paraphrase definitions of PhC using a standardised syntax focusing on the provider, recipient, subject, outcomes, and activities included in PhC practice. During a one-day workshop, experts in PhC research agreed on a definition, intended to be applicable for the

Mergers and innovation in the pharmaceutical industry.

PubMed

Comanor, William S; Scherer, F M

2013-01-01

Conflicting trends confound the pharmaceutical industry. The productivity of pharmaceutical innovation has declined in recent years. At the same time, the cohort of large companies who are the leading engines of pharmaceutical R&D has become increasingly concentrated. The concurrent presence of these trends is not sufficient to determine causation. In response to lagging innovation prospects, some companies have sought refuge in mergers and acquisitions to disguise their dwindling prospects or gain R&D synergies. On the other hand, the increased concentration brought on by recent mergers may have contributed to the declining rate of innovation. In this paper, we consider the second of these causal relationships: the likely impact of the recent merger wave among the largest pharmaceutical companies on the rate of innovation. In other words, have recent mergers, which may have been taken in response to lagging innovation, represented a self-defeating strategy that only made industry outcomes worse? Copyright © 2012 Elsevier B.V. All rights reserved.

Financing pharmaceuticals in transition economies.

PubMed

Kanavos, P

1999-06-01

This paper (a) provides a methodological taxonomy of pricing, financing, reimbursement, and cost containment methodologies for pharmaceuticals; (b) analyzes complex agency relationships and the health versus industrial policy tradeoff; (c) pinpoints financing measures to balance safety and effectiveness of medicines and their affordability by publicly funded systems in transition; and (d) highlights viable options for policy-makers for the financing of pharmaceuticals in transition. Three categories of measures and their implications for pharmaceutical policy cost containing are analyzed: supply-side measures, targeting manufacturers, proxy demand-side measures, targeting physicians and pharmacists, and demand-side measures, targeting patients. In pursuing supply side measures, we explore free pricing for pharmaceuticals, direct price controls, cost-plus and cost pricing, average pricing and international price comparisons, profit control, reference pricing, the introduction of a fourth hurdle, positive and negative lists, and other price control measures. The analysis of proxy-demand measures includes budgets for physicians, generic policies, practice guidelines, monitoring the authorizing behavior of physicians, and disease management schemes. Demand-side measures explore the effectiveness of patient co-payments, the impact of allowing products over-the-counter and health promotion programs. Global policies should operate simultaneously on the supply, the proxy demand, and the demand-side. Policy-making needs to have a continuous long-term planning. The importation of policies into transition economy may require extensive and expensive adaptation, and/or lead to sub-optimal policy outcomes.

Accelerated aging: prediction of chemical stability of pharmaceuticals.

PubMed

Waterman, Kenneth C; Adami, Roger C

2005-04-11

Methods of rapidly and accurately assessing the chemical stability of pharmaceutical dosage forms are reviewed with respect to the major degradation mechanisms generally observed in pharmaceutical development. Methods are discussed, with the appropriate caveats, for accelerated aging of liquid and solid dosage forms, including small and large molecule active pharmaceutical ingredients. In particular, this review covers general thermal methods, as well as accelerated aging methods appropriate to oxidation, hydrolysis, reaction with reactive excipient impurities, photolysis and protein denaturation.

Biotransformation of pharmaceuticals by ammonia oxidizing bacteria in wastewater treatment processes.

PubMed

Xu, Yifeng; Yuan, Zhiguo; Ni, Bing-Jie

2016-10-01

Pharmaceutical residues could potentially pose detrimental effects on aquatic ecosystems and human health, with wastewater treatment being one of the major pathways for pharmaceuticals to enter into the environment. Enhanced removal of pharmaceuticals by ammonia oxidizing bacteria (AOB) has been widely observed in wastewater treatment processes. This article reviews the current knowledge on the biotransformation of pharmaceuticals by AOB. The relationship between the pharmaceuticals removal and nitrification process was revealed. The important role of AOB-induced cometabolism on the biotransformation of pharmaceuticals as well as their transformation products and pathways was elucidated. Kinetics and mathematical models describing the biotransformation of pharmaceuticals by AOB were also reviewed. The results highlighted the high degradation capabilities of AOB toward some refractory pharmaceuticals, with their degradations being clearly related to the nitrification rate and their transformation products being identified, which may exhibit similar or higher ecotoxicological impacts compared to the parent compound. Copyright © 2016 Elsevier B.V. All rights reserved.

Assessing the Factors Associated With Iran's Intra-Industry Trade in Pharmaceuticals.

PubMed

Yusefzadeh, Hassan; Hadian, Mohammad; Abolghasem Gorji, Hassan; Ghaderi, Hossein

2015-03-30

Pharmaceutical industry is a sensitive and profitable industry. If this industry wants to survive, it should be able to compete well in international markets. So, study of Iran's intra-industry trade (IIT) in pharmaceuticals is essential in order to identify competitiveness potential of country and boost export capability in the global arena. This study assessed the factors associated with Iran's intra-industry trade in pharmaceuticals with the rest of the world during the 2001-2012 periods using seasonal time series data at the four-digit SITC level. The data was collected from Iran's pharmaceutical Statistics, World Bank and International Trade Center. Finally, we discussed a number of important policy recommendations to increase Iran's IIT in pharmaceuticals. The findings indicated that economies of scale, market structure and degree of economic development had a significantly positive impact on Iran's intra-industry trade in pharmaceuticals and tariff trade barriers were negatively related to IIT. Product differentiation and technological advancement didn't have the expected signs. In addition, we found that Iran's IIT in pharmaceuticals have shown an increasing trend during the study period. Thus, the composition of Iran trade in pharmaceuticals has changed from inter-industry trade to intra-industry trade. In order to get more prepared for integration into the global economy, the development of Iran's IIT in pharmaceuticals should be given priority. Therefore, paying attention to IIT could have an important role in serving pharmaceutical companies in relation to pharmaceutical trade.

Pharmaceutical and biomedical potential of surface engineered dendrimers.

PubMed

Satija, Jitendra; Gupta, Umesh; Jain, Narendra Kumar

2007-01-01

Dendrimers are hyperbranched, globular, monodisperse, nanometric polymeric architecture, having definite molecular weight, shape, and size (which make these an inimitable and optimum carrier molecule in pharmaceutical field). Dendritic architecture is having immense potential over the other carrier systems, particularly in the field of drug delivery because of their unique properties, such as structural uniformity, high purity, efficient membrane transport, high drug pay load, targeting potential, and good colloidal, biological, and shelf stability. Despite their enormous applicability in different areas, the inherent cytotoxicity, reticuloendothelial system (RES) uptake, drug leakage, immunogenicity, and hemolytic toxicity restricted their use in clinical applications, which is primarily associated with cationic charge present on the periphery due to amine groups. To overcome this toxic nature of dendrimers, some new types of nontoxic, biocompatible, and biodegradable dendrimers have been developed (e.g., polyester dendrimer, citric acid dendrimer, arginine dendrimer, carbohydrate dendrimers, etc.). The surface engineering of parent dendrimers is graceful and convenient strategy, which not only shields the positive charge to make this carrier more biomimetic but also improves the physicochemical and biological behavior of parent dendrimers. Thus, surface modification chemistry of parent dendrimers holds promise in pharmaceutical applications (such as solubilization, improved drug encapsulation, enhanced gene transfection, sustained and controlled drug release, intracellular targeting) and in the diagnostic field. Development of multifunctional dendrimer holds greater promise toward the biomedical applications because a number of targeting ligands determine specificity in the same manner as another type of group would secure stability in biological milieu and prolonged circulation, whereas others facilitate their transport through cell membranes. Therefore, as a

Pharmaceutical cocrystals, salts and polymorphs: Advanced characterization techniques.

PubMed

Pindelska, Edyta; Sokal, Agnieszka; Kolodziejski, Waclaw

2017-08-01

The main goal of a novel drug development is to obtain it with optimal physiochemical, pharmaceutical and biological properties. Pharmaceutical companies and scientists modify active pharmaceutical ingredients (APIs), which often are cocrystals, salts or carefully selected polymorphs, to improve the properties of a parent drug. To find the best form of a drug, various advanced characterization methods should be used. In this review, we have described such analytical methods, dedicated to solid drug forms. Thus, diffraction, spectroscopic, thermal and also pharmaceutical characterization methods are discussed. They all are necessary to study a solid API in its intrinsic complexity from bulk down to the molecular level, gain information on its structure, properties, purity and possible transformations, and make the characterization efficient, comprehensive and complete. Furthermore, these methods can be used to monitor and investigate physical processes, involved in the drug development, in situ and in real time. The main aim of this paper is to gather information on the current advancements in the analytical methods and highlight their pharmaceutical relevance. Copyright © 2017 Elsevier B.V. All rights reserved.

Approaches to education of pharmaceutical biotechnology in faculties of pharmacy.

PubMed

Calis, S; Oner, F; Kas, S; Hincal, A A

2001-06-01

Pharmaceutical biotechnology is developing rapidly both in academic institutions and in the biopharmaceutical industry. For this reason, FIP Special Interest Group of Pharmaceutical Biotechnology decided to develop a questionnaire concerning pharmaceutical biotechnology education. After preliminary studies were completed, questionnaires were sent to the leading scientists in academia and research directors or senior managers of various Pharmaceutical Biotechnology Companies in order to gather their views about how to create a satisfactory program. The objectives of this study were as follows: -To review all of the graduate and undergraduate courses which are presently available worldwide on pharmaceutical biotechnology in Faculties of Pharmacy. -To review all of the text books, references and scientific sources available worldwide in the area of pharmaceutical biotechnology. When replying to the questionnaires, the respondents were asked to consider the present status of pharmaceutical biotechnology education in academia and future learning needs in collaboration with the biotechnology industry. The data from various pharmacy faculties and biotechnology industry representatives from Asia, Europe and America were evaluated and the outcome of the survey showed that educational efforts in training qualified staff in the rapidly growing field of pharmaceutical biotechnology is promising. Part of the results of this questionnaire study have already been presented at the 57th International Congress of FIP Vancouver, Canada in 1997.

Defining the pharmaceutical system to support proactive drug safety.

PubMed

Lewis, Vicki R; Hernandez, Angelica; Meadors, Margaret

2013-02-01

The military, aviation, nuclear, and transportation industries have transformed their safety records by using a systems approach to safety and risk mitigation. This article creates a preliminary model of the U.S. pharmaceutical system using available literature including academic publications, policies, and guidelines established by regulatory bodies and drug industry trade publications. Drawing from the current literature, the goals, roles, and individualized processes of pharmaceutical subsystems will be defined. Defining the pharmaceutical system provides a vehicle to assess and address known problems within the system, and provides a means to conduct proactive risk analyses, which would create significant pharmaceutical safety advancement.

Indexing of Patents of Pharmaceutical Composition in Online Databases

NASA Astrophysics Data System (ADS)

Online searching of patents of pharmaceutical composition is generally considered to be very difficult. It is due to the fact that the patent databases include extensive technical information as well as legal information so that they are not likely to have index proper to the pharmaceutical composition or even if they have such index, the scope and coverage of indexing is ambiguous. This paper discusses how patents of pharmaceutical composition are indexed in online databases such as WPl, CA, CLAIMS, USP and PATOLIS. Online searching of patents of pharmaceutical composition are also discussed in some detail.

RFID in the pharmaceutical industry: addressing counterfeits with technology.

PubMed

Taylor, Douglas

2014-11-01

The use of Radio Frequency Identification (RFID) in the pharmaceutical industry has grown in recent years. The technology has matured from its specialized tracking and retail uses to a systemic part of supply chain management in international pharmaceutical production and distribution. Counterfeit drugs, however, remain a significant challenge for governments, pharmaceutical companies, clinicians, and patients and the use of RFID to track these compounds represents an opportunity for development. This paper discusses the medical, technological, and economic factors that support widespread adoption of RFID technology in the pharmaceutical industry in an effort to prevent counterfeit medicines from harming patients and brand equity.

Identifying new persistent and bioaccumulative organics among chemicals in commerce II: pharmaceuticals.

PubMed

Howard, Philip H; Muir, Derek C G

2011-08-15

The goal of this study was to identify commercial pharmaceuticals that might be persistent and bioaccumulative (P&B) and that were not being considered in current wastewater and aquatic environmental measurement programs. We developed a database of 3193 pharmaceuticals from two U.S. Food and Drug Administration (FDA) databases and some lists of top ranked or selling drugs. Of the 3193 pharmaceuticals, 275 pharmaceuticals have been found in the environment and 399 pharmaceuticals were, based upon production volumes, designated as high production volume (HPV) pharmaceuticals. All pharmaceuticals that had reported chemical structures were evaluated for potential bioaccumulation (B) or persistence (P) using quantitative structure property relationships (QSPR) or scientific judgment. Of the 275 drugs detected in the environment, 92 were rated as potentially bioaccumulative, 121 were rated as potentially persistent, and 99 were HPV pharmaceuticals. After removing the 275 pharmaceuticals previously detected in the environment, 58 HPV compounds were identified that were both P&B and 48 were identified as P only. Of the non-HPV compounds, 364 pharmaceuticals were identified that were P&B. This study has yielded some interesting and probable P&B pharmaceuticals that should be considered for further study.

Chemistry Notes.

ERIC Educational Resources Information Center

School Science Review, 1982

1982-01-01

Presents background information, laboratory procedures, classroom materials/activities, and experiments for chemistry. Topics include superheavy elements, polarizing power and chemistry of alkali metals, particulate carbon from combustion, tips for the chemistry laboratory, interesting/colorful experiments, behavior of bismuth (III) iodine, and…

NON-TRADITIONAL RESPONSES TO PHARMACEUTICALS IN AQUATIC ECOSYSTEMS

EPA Science Inventory

Quantitation of human and veterinary pharmaceuticals in environmental matrices has resulted in pharmaceuticals in the environment receiving unprecedented attention from the scientific community. Aquatic hazard assessments often use quantitative structure activity relationships an...

Ascorbic Acid as a Standard for Iodometric Titrations. An Analytical Experiment for General Chemistry

NASA Astrophysics Data System (ADS)

Silva, Cesar R.; Simoni, Jose A.; Collins, Carol H.; Volpe, Pedro L. O.

1999-10-01

Ascorbic acid is suggested as the weighable compound for the standardization of iodine solutions in an analytical experiment in general chemistry. The experiment involves an iodometric titration in which iodine reacts with ascorbic acid, oxidizing it to dehydroascorbic acid. The redox titration endpoint is determined by the first iodine excess that is complexed with starch, giving a deep blue-violet color. The results of the titration of iodine solution using ascorbic acid as a calibration standard were compared with the results acquired by the classic method using a standardized solution of sodium thiosulfate. The standardization of the iodine solution using ascorbic acid was accurate and precise, with the advantages of saving time and avoiding mistakes due to solution preparation. The colorless ascorbic acid solution gives a very clear and sharp titration end point with starch. It was shown by thermogravimetric analysis that ascorbic acid can be dried at 393 K for 2 h without decomposition. This experiment allows general chemistry students to perform an iodometric titration during a single laboratory period, determining with precision the content of vitamin C in pharmaceutical formulations.

Clinical chemistry through Clinical Chemistry: a journal timeline.

PubMed

Rej, Robert

2004-12-01

The establishment of the modern discipline of clinical chemistry was concurrent with the foundation of the journal Clinical Chemistry and that of the American Association for Clinical Chemistry in the late 1940s and early 1950s. To mark the 50th volume of this Journal, I chronicle and highlight scientific milestones, and those within the discipline, as documented in the pages of Clinical Chemistry. Amazing progress has been made in the field of laboratory diagnostics over these five decades, in many cases paralleling-as well as being bolstered by-the rapid pace in the development of computer technologies. Specific areas of laboratory medicine particularly well represented in Clinical Chemistry include lipids, endocrinology, protein markers, quality of laboratory measurements, molecular diagnostics, and general advances in methodology and instrumentation.

Polymers in life sciences: Pharmaceutical and biomedical applications

NASA Astrophysics Data System (ADS)

Barba, Anna Angela; Dalmoro, Annalisa; d'Amore, Matteo; Lamberti, Gaetano; Cascone, Sara; Titomanlio, Giuseppe

2015-12-01

This paper deals with the work done by prof. Titomanlio and his group in the fields of pharmaceutical and biomedical applications of polymers. In particular, the main topics covered are: i) controlled drug release from pharmaceuticals based on hydrogel for oral delivery of drugs; ii) production and characterization of micro and nanoparticles based on stimuli-responsive polymers; iii) use of polymers for coronary stent gel-paving; iv) design and realization of novel methods (in-vitro and in-silico) to test polymer-based pharmaceuticals.

The pharmaceutical sector inquiry: 'Hamlet' in a nutshell.

PubMed

den Exter, André

2010-03-01

In July 2009, the European Commission (DG Competition) published a Communication on the pharmaceutical sector. This inquiry was launched because there were some indications that competition in the pharmaceutical market in the European Union might not be working well. The report examines the reasons for the observed delay. This article analyses the outcomes from a critical standpoint, arguing in favour of enhanced 'soft law' accountability mechanisms in the pharmaceutical sector, defending conditional patenting and the introduction of a Community patent.

Life cycle analysis within pharmaceutical process optimization and intensification: case study of active pharmaceutical ingredient production.

PubMed

Ott, Denise; Kralisch, Dana; Denčić, Ivana; Hessel, Volker; Laribi, Yosra; Perrichon, Philippe D; Berguerand, Charline; Kiwi-Minsker, Lioubov; Loeb, Patrick

2014-12-01

As the demand for new drugs is rising, the pharmaceutical industry faces the quest of shortening development time, and thus, reducing the time to market. Environmental aspects typically still play a minor role within the early phase of process development. Nevertheless, it is highly promising to rethink, redesign, and optimize process strategies as early as possible in active pharmaceutical ingredient (API) process development, rather than later at the stage of already established processes. The study presented herein deals with a holistic life-cycle-based process optimization and intensification of a pharmaceutical production process targeting a low-volume, high-value API. Striving for process intensification by transfer from batch to continuous processing, as well as an alternative catalytic system, different process options are evaluated with regard to their environmental impact to identify bottlenecks and improvement potentials for further process development activities. © 2014 WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim.

DanceChemistry: Helping Students Visualize Chemistry Concepts through Dance Videos

ERIC Educational Resources Information Center

Tay, Gidget C.; Edwards, Kimberly D.

2015-01-01

A visual aid teaching tool, the DanceChemistry video series, has been developed to teach fundamental chemistry concepts through dance. These educational videos portray chemical interactions at the molecular level using dancers to represent chemical species. Students reported that the DanceChemistry videos helped them visualize chemistry ideas in a…

Environmental toxicology and risk assessment of pharmaceuticals from hospital wastewater.

PubMed

Escher, Beate I; Baumgartner, Rebekka; Koller, Mirjam; Treyer, Karin; Lienert, Judit; McArdell, Christa S

2011-01-01

In this paper, we evaluated the ecotoxicological potential of the 100 pharmaceuticals expected to occur in highest quantities in the wastewater of a general hospital and a psychiatric center in Switzerland. We related the toxicity data to predicted concentrations in different wastewater streams to assess the overall risk potential for different scenarios, including conventional biological pretreatment in the hospital and urine source separation. The concentrations in wastewater were estimated with pharmaceutical usage information provided by the hospitals and literature data on human excretion into feces and urine. Environmental concentrations in the effluents of the exposure scenarios were predicted by estimating dilution in sewers and with literature data on elimination during wastewater treatment. Effect assessment was performed using quantitative structure-activity relationships because experimental ecotoxicity data were only available for less than 20% of the 100 pharmaceuticals with expected highest loads. As many pharmaceuticals are acids or bases, a correction for the speciation was implemented in the toxicity prediction model. The lists of Top-100 pharmaceuticals were distinctly different between the two hospital types with only 37 pharmaceuticals overlapping in both datasets. 31 Pharmaceuticals in the general hospital and 42 pharmaceuticals in the psychiatric center had a risk quotient above 0.01 and thus contributed to the mixture risk quotient. However, together they constituted only 14% (hospital) and 30% (psychiatry) of the load of pharmaceuticals. Hence, medical consumption data alone are insufficient predictors of environmental risk. The risk quotients were dominated by amiodarone, ritonavir, clotrimazole, and diclofenac. Only diclofenac is well researched in ecotoxicology, while amiodarone, ritonavir, and clotrimazole have no or very limited experimental fate or toxicity data available. The presented computational analysis thus helps setting

Nanotechnology and pharmaceutical inhalation aerosols.

PubMed

Patel, A R; Vavia, P R

2007-02-01

Pharmaceutical inhalation aerosols have been playing a crucial role in the health and well being of millions of people throughout the world for many years. The technology's continual advancement, the ease of use and the more desirable pulmonary-rather-than-needle delivery for systemic drugs has increased the attraction for the pharmaceutical aerosol in recent years. But administration of drugs by the pulmonary route is technically challenging because oral deposition can be high, and variations in inhalation technique can affect the quantity of drug delivered to the lungs. Recent advances in nanotechnology, particularly drug delivery field have encouraged formulation scientists to expand their reach in solving tricky problems related to drug delivery. Moreover, application of nanotechnology to aerosol science has opened up a new category of pharmaceutical aerosols (collectively known as nanoenabled-aerosols) with added advantages and effectiveness. In this review, some of the latest approaches of nano-enabled aerosol drug delivery system (including nano-suspension, trojan particles, bioadhesive nanoparticles and smart particle aerosols) that can be employed successfully to overcome problems of conventional aerosol systems have been introduced.

Marketing concepts for pharmaceutical service development.

PubMed

Grauer, D W

1981-02-01

Marketing concepts as a mechanism to help pharmacy develop, communicate, and sell future pharmaceutical services to consumers are discussed. Pharmacy as a profession must define itself broadly to take advantage of future growth opportunities. These growth opportunities will be realized from unmet health-care needs and changing consumer life style trends and values. New services must therefore be oriented toward consumers (i.e., patients, health professionals, and third-party agencies) to gain acceptance. Dispensing and drug-knowledge-distribution pharmaceutical services are reviewed by a product life cycle analysis of sales profits versus time. A marketing mix for new pharmaceutical services is developed consisting of service, price, distribution, and promotion strategies. Marketing can encompass those key elements necessary to meet the organizational goals of pharmacy and provide a systematic, disciplined approach for presenting a new service to consumers.

Pharmaceuticals' sorptions relative to properties of thirteen different soils.

PubMed

Kodešová, Radka; Grabic, Roman; Kočárek, Martin; Klement, Aleš; Golovko, Oksana; Fér, Miroslav; Nikodem, Antonín; Jakšík, Ondřej

2015-04-01

Transport of human and veterinary pharmaceuticals in soils and consequent ground-water contamination are influenced by many factors, including compound sorption on soil particles. Here we evaluate the sorption isotherms for 7 pharmaceuticals on 13 soils, described by Freundlich equations, and assess the impact of soil properties on various pharmaceuticals' sorption on soils. Sorption of ionizable pharmaceuticals was, in many cases, highly affected by soil pH. The sorption coefficient of sulfamethoxazole was negatively correlated to soil pH, and thus positively related to hydrolytic acidity and exchangeable acidity. Sorption coefficients for clindamycin and clarithromycin were positively related to soil pH and thus negatively related to hydrolytic acidity and exchangeable acidity, and positively related to base cation saturation. The sorption coefficients for the remaining pharmaceuticals (trimethoprim, metoprolol, atenolol, and carbamazepine) were also positively correlated with the base cation saturation and cation exchange capacity. Positive correlations between sorption coefficients and clay content were found for clindamycin, clarithromycin, atenolol, and metoprolol. Positive correlations between sorption coefficients and organic carbon content were obtained for trimethoprim and carbamazepine. Pedotransfer rules for predicting sorption coefficients of various pharmaceuticals included hydrolytic acidity (sulfamethoxazole), organic carbon content (trimethoprimand carbamazepine), base cation saturation (atenolol and metoprolol), exchangeable acidity and clay content (clindamycin), and soil active pH and clay content (clarithromycin). Pedotransfer rules, predicting the Freundlich sorption coefficients, could be applied for prediction of pharmaceutical mobility in soils with similar soil properties. Predicted sorption coefficients together with pharmaceutical half-lives and other imputes (e.g., soil-hydraulic, geological, hydro-geological, climatic) may be used for

Adsorptive removal of selected pharmaceuticals by mesoporous silica SBA-15.

PubMed

Bui, Tung Xuan; Choi, Heechul

2009-09-15

The removal of five selected pharmaceuticals, viz., carbamazepine, clofibric acid, diclofenac, ibuprofen, and ketoprofen was examined by batch sorption experiments onto a synthesized mesoporous silica SBA-15. SBA-15 was synthesized and characterized by X-ray diffraction (XRD), transmission electron microscopy (TEM), N(2) adsorption-desorption measurement, and point of zero charge (PZC) measurement. Pharmaceutical adsorption kinetics was rapid and occurred on a scale of minutes, following a pseudo-second-order rate expression. Adsorption isotherms were best fitted by the Freundlich isotherm model. High removal rates of individual pharmaceuticals were achieved in acidic media (pH 3-5) and reached 85.2% for carbamazepine, 88.3% for diclofenac, 93.0% for ibuprofen, 94.3% for ketoprofen, and 49.0% for clofibric acid at pH 3 but decreased with increase in pH. SBA-15 also showed high efficiency for removal of a mixture of 5 pharmaceuticals. Except for clofibric acid (35.6%), the removal of pharmaceuticals in the mixture ranged from 75.2 to 89.3%. Based on adsorption and desorption results, the mechanism of the selected pharmaceuticals was found to be a hydrophilic interaction, providing valuable information for further studies to design materials for the purpose. The results of this study suggest that mesoporous-silica-based materials are promising adsorbents for removing pharmaceuticals from not only surface water but also wastewater of pharmaceutical industrial manufactures.

Price and welfare effects of a pharmaceutical substitution reform.

PubMed

Granlund, David

2010-12-01

The price effects of the Swedish pharmaceutical substitution reform are analyzed using data for a panel of all pharmaceutical product sold in Sweden in 1997-2007. The price reduction due to the reform was estimated to average 10% and was found to be significantly larger for brand-name pharmaceuticals than for generics. The results also imply that the reform amplified the effect that generic entry has on brand-name prices by a factor of 10. Results of a demand estimation imply that the price reductions increased total pharmaceutical consumption by 8% and consumer welfare by SEK 2.7 billion annually. Copyright © 2010 Elsevier B.V. All rights reserved.

Pharmaceutical cocrystals: walking the talk.

PubMed

Bolla, Geetha; Nangia, Ashwini

2016-06-28

Pharmaceutical cocrystals belong to a sub-class of cocrystals wherein one of the components is a drug molecule (or an active pharmaceutical ingredient, API) and the second is a benign food or drug grade additive (generally regarded as safe, GRAS). The two components are hydrogen-bonded in a fixed stoichiometric ratio in the crystal lattice. In the past decade, pharmaceutical cocrystals have demonstrated significant promise in their ability to modify the physicochemical and pharmacokinetic properties of drug substances, such as the solubility and dissolution rate, bioavailability, particle morphology and size, tableting and compaction, melting point, physical form, biochemical and hydration stability, and permeability. In this feature review, we highlight some prominent examples of drug cocrystals which exhibit variable hardness/softness and elasticity/plasticity depending on coformer selection, improvement of solubility and permeability in the same cocrystal, increase of the melting point for solid formulation, enhanced color performance, photostability and hydration stability, and a longer half-life. Cocrystals of flavanoids and polyphenols can make improved pharmaceuticals and also extend to the larger class of nutraceuticals. The application of crystal engineering to assemble ternary cocrystals expands this field to drug-drug cocrystals which may be useful in multi-drug resistance, mitigating side effects of drugs, or attenuating/enhancing drug action synergistically by rational selection. The advent of new techniques for structural characterization beyond the standard X-ray diffraction will provide a better understanding of drug phases which are at the borderline of crystalline-amorphous nature and even newer opportunities in the future.

Norwegian medical students' attitudes towards the pharmaceutical industry.

PubMed

Lea, Dordi; Spigset, Olav; Slørdal, Lars

2010-07-01

Whereas there is a considerable body of information on the interaction between physicians and the pharmaceutical industry, little is known about the pharmaceutical industry-medical student relationship. We have assessed the extent of contact between Norwegian medical students and the pharmaceutical industry as well as the attitudes of these students towards the pharmaceutical industry. A self-assessment questionnaire was distributed to fifth- and sixth-year students attending the four medical schools in Norway and to Norwegian medical students attending selected universities abroad. A total of 65.8% of all eligible students returned a completed questionnaire. Of these, 73.9% had been exposed to various levels of contact with the pharmaceutical industry, but only 17.5% reported having a generally positive attitude towards the industry. The level of exposure did not correlate in students' attitudes; rather, it correlated positively to a feeling of competence in terms of being able to handle such interactions. A majority of students responded that while they would decline accepting monetary gifts, they would welcome receiving reimbursements for meeting expenses, meals and educational material. Students favoured a practice of full disclosure of potential industry-related conflicts of interest among the university teaching staff. There were considerable differences in the students' attitudes between universities, suggesting that medical students are prone to influence from university lecturers. Norwegian medical students are opinionated, critical and curious with respect to pharmaceutical industry relations. This interest can be explored and probably also modified by educational initiatives.

Obstacles and opportunities in Chinese pharmaceutical innovation.

PubMed

Ni, Jingyun; Zhao, Junrui; Ung, Carolina Oi Lam; Hu, Yuanjia; Hu, Hao; Wang, Yitao

2017-03-24

Global healthcare innovation networks nowadays have expanded beyond developed countries with many developing countries joining the force and becoming important players. China, in particular, has seen a significant increase in the number of innovative firms and research organizations stepping up to the global network in recent years. Nevertheless, the intense Research and Development input has not brought about the expectable output. While China is ascending at a great speed to a leading position worldwide in terms of Research and Development investment, scientific publications and patents, the innovation capabilities in the pharmaceutical sector remain weak. This study discusses the challenges and opportunities for pharmaceutical innovation in China. One hand, academic, industrial, institutional and financial constraints were found to be the major and inevitable barriers hindering the development of drug innovation. On the other hand, unique advantages had been observed which included growing pharmaceutical market, Research and Development funding, distinctive source, and international cooperation. The most important thing for China's pharmaceutical sector to leap forward is to break though innovation barriers and integrate own advantages into global value-chain of healthcare product development.

Predicting variability of aquatic concentrations of human pharmaceuticals

EPA Science Inventory

Potential exposure to active pharmaceutical ingredients (APIs) in the aquatic environment is a subject of ongoing concern. We recently estimated maximum likely potency-normalized exposure rates at the national level for several hundred commonly used human prescription pharmaceut...

Investigating pharmaceutical marketing in Canada using American prosecutions.

PubMed

Shoucri, Rami; Persaud, Navindra

2014-01-01

Pharmaceutical companies are prohibited from marketing medications for off-label uses in both the United States and Canada. In the United States, there have been several recent multi-billion dollar settlements with pharmaceutical companies based, partly, on off-label promotion. Health Canada has not publicized any investigations into, or prosecutions of, pharmaceutical companies for off-label promotion in Canada even though many of the same medications are marketed here. The prohibition on off-label promotion is largely directed at preventing pharmaceutical companies from circumventing the drug licensing process and attendant safety checks. To determine if sanctions for off-label pharmaceutical promotion in one jurisdiction can be used to regulate marketing in another. We reviewed and compared the laws and regulatory bodies in Canada and the United States to determine if Canadian regulators could use the findings of American regulators. There were no important differences in the laws and regulatory bodies in Canada and the United States related to off-label promotion. Canadian regulators can use the findings of American regulators to investigate off-label promotion in Canada. All countries should consider using sanctions in other jurisdictions to direct the deployment of limited regulatory resources.

Occurrence of Pharmaceuticals in Calgary's Wastewater and Related Surface Water.

PubMed

Chen, M; Cooper, V I; Deng, J; Amatya, P L; Ambrus, D; Dong, S; Stalker, N; Nadeau-Bonilla, C; Patel, J

2015-05-01

The influents/effluents from Calgary's water resource recovery facilities and the surface water were analyzed for pharmaceuticals in the present study. The median concentrations in the effluents for the 15 targeted pharmaceuticals were within the range of 0.006 to 3.32 ppb. Although the wastewater treatment facilities were not designed to remove pharmaceuticals, this study indicates that the wastewater treatment processes are effective in removing some of the pharmaceuticals from the aqueous phase. The removal rate estimated can be 99.5% for caffeine, whereas little or no removal was observed for carbamazepine. Biodegradation, chemical degradation, and sorption could be some of the mechanisms responsible for the removal of pharmaceuticals. The drug residues in downstream surface water could be associated with incomplete removal of pharmaceuticals during the treatment process and may lead to concerns in terms of potential impacts on the aquatic ecosystem. However, this study does not indicate any immediate risks to the downstream aquatic environment.

WHO Expert Committee on Specifications for Pharmaceutical Preparations.

PubMed

2014-01-01

The Expert Committee on Specifications for Pharmaceutical Preparations works towards clear, independent and practical standards and guidelines for the quality assurance of medicines. Standards are developed by the Committee through worldwide consultation and an international consensus-building process. The following new guidelines were adopted and recommended for use, in addition to 20 monographs and general texts for inclusion in The International Pharmacopoeia and 11 new International Chemical Reference Substances. The International Pharmacopoeia--updating mechanism for the section on radiopharmaceuticals; WHO good manufacturing practices for pharmaceutical products: main principles; Model quality assurance system for procurement agencies; Assessment tool based on the model quality assurance system for procurement agencies: aide-memoire for inspection; Guidelines on submission of documentation for prequalification of finished pharmaceutical products approved by stringent regulatory authorities; and Guidelines on submission of documentation for a multisource (generic) finished pharmaceutical product: quality part.

Impacts of international sanctions on Iranian pharmaceutical market

PubMed Central

2013-01-01

Iran in recent decade faced several regional and international sanctions in foreign trade, financial and banking services. Iran national pharmaceutical industry has always played a major role in providing medicines to the Iranian patients. However, following the sanctions it has faced profound difficulties for importing of both finished products and pharmaceutical raw materials. Although medicines are exempted from sanctions, due to restriction on money transaction and proper insurance Iranian pharmaceutical companies have to pay cash in advance for imports of medicines and raw materials or to secure offshore funds at very high risks. Current situation in Iran pharmaceutical market confirms that the sanctions against Iran are affecting ordinary citizens and national health sector which resulted to reduction of availability of lifesaving medicines in the local market and has caused increasing pain and suffering for Iranian patients. PMID:23902642

Recent trends and future of pharmaceutical packaging technology

PubMed Central

Zadbuke, Nityanand; Shahi, Sadhana; Gulecha, Bhushan; Padalkar, Abhay; Thube, Mahesh

2013-01-01

The pharmaceutical packaging market is constantly advancing and has experienced annual growth of at least five percent per annum in the past few years. The market is now reckoned to be worth over $20 billion a year. As with most other packaged goods, pharmaceuticals need reliable and speedy packaging solutions that deliver a combination of product protection, quality, tamper evidence, patient comfort and security needs. Constant innovations in the pharmaceuticals themselves such as, blow fill seal (BFS) vials, anti-counterfeit measures, plasma impulse chemical vapor deposition (PICVD) coating technology, snap off ampoules, unit dose vials, two-in-one prefilled vial design, prefilled syringes and child-resistant packs have a direct impact on the packaging. The review details several of the recent pharmaceutical packaging trends that are impacting packaging industry, and offers some predictions for the future. PMID:23833515

Attitudes and beliefs regarding direct-to-consumer advertising of pharmaceutical drugs: an exploratory comparison of physicians and pharmaceutical sales representatives.

PubMed

Schulz, Steven A; Broekemier, Gregory M; Burkink, Tim J

2014-01-01

Even with many changes in regulation in recent years, direct-to-consumer advertising (DTCA) of pharmaceutical drugs remains a complicated and contentious issue. Many in our society argue for increased legislation of DTCA while others believe that DTCA serves a useful purpose and should not be overregulated. This study was designed to compare attitudes and beliefs regarding DTCA held by two key stakeholder groups, physicians and pharmaceutical sales representatives. A questionnaire was created, pretested, and administered to 30 physicians and 30 pharmaceutical sales representatives to investigate these issues. Significant differences between these two groups were found and implications for DTCA are discussed.

Method for the determination of Pd-catalyst residues in active pharmaceutical ingredients by means of high-energy polarized-beam energy dispersive X-ray fluorescence.

PubMed

Marguí, E; Van Meel, K; Van Grieken, R; Buendía, A; Fontàs, C; Hidalgo, M; Queralt, I

2009-02-15

In medicinal chemistry, Pd is perhaps the most-widely utilized precious metal, as catalyst in reactions which represent key transformations toward the synthesis of new active pharmaceutical ingredients (APIs). The disadvantage of this metal-catalyzed chemistry is that expensive and toxic metal residues are invariably left bound to the desired product. Thus, stringent regulatory guidelines exist for the amount of residual Pd that a drug candidate is allowed to contain. In this work, a rapid and simple method for the determination of Pd in API samples by high-energy polarized-beam energy dispersive X-ray fluorescence spectrometry has been developed and validated according to the specification limits of current legislation (10 mg kg(-1) Pd) and the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH guidelines). Sample and calibration standards preparation includes a first step of homogenization and then, in a second step, the pressing of the powdered material into pellets without any chemical treatment. The use of several synthetic calibration standards made of cellulose to simulate the API matrix appears to be an effective means to obtain reliable calibration curves with a good spread of data points over the working range. With the use of the best measuring conditions, the limit of detection (0.11 mg kg(-1) Pd) as well as the limit of quantitation (0.37 mg kg(-1) Pd) achieved meet rigorous requirements. The repeatability of the XRF measurement appeared to be less than 2%, while the precision of the whole method was around 7%. Trueness was evaluated by analyzing spiked API samples at the level of the specification limit and calculating the recovery factor, which was better than 95%. To study the applicability of the developed methodology for the intended purpose, three batches of the studied API were analyzed for their Pd content, and the attained results were comparable to those obtained by the

Pharmaceuticals as Groundwater Tracers - Applications and Limitations

NASA Astrophysics Data System (ADS)

Scheytt, T. J.; Mersmann, P.; Heberer, T.

2003-12-01

Pharmaceutically active substances and metabolites are found at concentrations up to the microgram/L-level in groundwater samples from the Berlin (Germany) area and from several other places world wide. Among the compounds detected in groundwater are clofibric acid, propyphenazone, diclofenac, ibuprofen, and carbamazepine. Clofibric acid, the active metabolite of clofibrate and etofibrate (blood lipid regulators) is detected in groundwater at maximum concentrations of 7300 ng/L. Among the most important input paths of drugs are excretion and disposal into the sewage system. Groundwater contamination is likely to be due to leaky sewage systems, influent streams, bank filtration, and irrigation with effluent water from sewage treatment plants. There are no known natural sources of the above mentioned pharmaceuticals. The use of pharmaceuticals as tracers may include: (a) Quantification of infiltration from underground septic tanks (b) Detection of leaky sewage systems / leaky sewage pipes (c) Estimation of the effectiveness of sewage treatment plants (d) Identification of transport pathways of other organic compounds (e) Quantification of surface water / groundwater interaction (f) Characterization of the biodegradation potential. The use of pharmaceuticals as tracers is limited by variations in input. These variations depend on the amount of drugs prescribed and used in the study area, the social structure of the community, the amount of hospital discharge, and temporal concentration variations. Furthermore, the analysis of trace amounts of pharmaceuticals is sophisticated and expensive and may therefore limit the applicability of pharmaceuticals as tracers. Finally, the transport and degradation behavior of pharmaceuticals is not fully understood. Preliminary experiments in the laboratory were conducted using sediment material and groundwater from the Berlin area to evaluate the transport and sorption behavior of selected drugs. Results of the column experiments

Unlicensed pharmaceutical preparations for clinical patient care: Ensuring safety.

PubMed

de Wilde, Sofieke; de Jong, Maria G H; Le Brun, Paul P H; Guchelaar, Henk-Jan; Schimmel, Kirsten J M

2018-01-01

Most medicinal products dispensed to patients have marketing authorization (MA) to ensure high quality of the product, safety, and efficacy. However, in daily practice, to treat patients adequately, there is a medical need for drugs that do not hold MA. To meet this medical need, medicinal products are used in clinical care without MA (unlicensed), such as products prepared by (local) pharmacies: the pharmaceutical preparations. Three types of pharmaceutical preparations are distinguished: (i) reconstitution in excess of summary of product characteristics; (ii) adaptation of a licensed medicinal product (outside its official labeling); (iii) medicinal products from an active pharmaceutical ingredient. Although unlicensed, patients may expect the same quality for these unlicensed pharmaceutical preparations as for the licensed medicinal products. To assure this quality, a proper risk-benefit assessment and proper documentation in (centralized) patient registries and linking to a national pharmacovigilance database should be in place. Based on a risk assessment matrix, requirements for quality assurance can be determined, which has impact on the level of documentation of a pharmaceutical preparation. In this paper, the approach for good documentation including quality assurance and benefit-risk assessment will be discussed and possibilities for patient registries are described to make these crucial preparations available for regular patient care. KEY POINTS Ensuring pharmaceutical quality and performing a proper benefit-risk assessment will guarantee safe use of pharmaceutical preparations. Good documentation of (ultra-)orphan treatments can be collected in centralized patient registries and should be combined with existing information in (inter)national databases and self-reflection of patients. Linking patient registries to a centralized database for adverse drug events is highly recommended as it increases safety control of the (ultra) orphan pharmaceutical

Chemistry for whom? Gender awareness in teaching and learning chemistry

NASA Astrophysics Data System (ADS)

Andersson, Kristina

2017-06-01

Marie Ståhl and Anita Hussénius have defined what discourses dominate national tests in chemistry for Grade 9 in Sweden by using feminist, critical didactic perspectives. This response seeks to expand the results in Ståhl and Hussénius's article Chemistry inside an epistemological community box!— Discursive exclusions and inclusions in the Swedish national tests in chemistry, by using different facets of gender awareness. The first facet—Gender awareness in relations to the test designers' own conceptions—highlighted how the gender order where women are subordinated men becomes visible in the national tests as a consequence of the test designers internalized conceptions. The second facet—Gender awareness in relation to chemistry—discussed the hierarchy between discourses within chemistry. The third facet—Gender awareness in relation to students—problematized chemistry in relation to the students' identity formation. In summary, I suggest that the different discourses can open up new ways to interpret chemistry and perhaps dismantle the hegemonic chemistry discourse.

Pharmaceutical advertising revenue and physician organizations: how much is too much?

PubMed

Glassman, P A; Hunter-Hayes, J; Nakamura, T

1999-10-01

To determine if revenue generated from pharmaceutical advertisements in medical journals creates potential financial conflicts of interest for nonprofit physician organizations that own those journals. Convenience sample of six professional medical societies and their respective journals. Calculation of pharmaceutical advertising revenue generated by these journals for their respective professional medical societies. Random selection of each journal for one month per quarter in calendar year 1996 and tabulation per edition of the average number of pharmaceutical advertising pages for each journal. Published advertising rates were used to estimate pharmaceutical advertising revenue for calendar year 1996 and compared with each organization's gross revenue and membership dues and assessments, based on Internal Revenue Service documents for the last available fiscal year (1995). Estimated pharmaceutical advertising revenue ranged from $715,000 to $18,630,000. Five organizations raised more than 10% of their gross income (range 2% to 30%) from a single journal's pharmaceutical advertising. Four organizations raised as much or more from pharmaceutical advertising as from members (range 17% to 790%). Potential financial conflicts of interest arising from pharmaceutical advertisements in medical journals may be substantial. The impact on professional societies' financial independence and behavior is unknown.

Chemometric analysis of correlations between electronic absorption characteristics and structural and/or physicochemical parameters for ampholytic substances of biological and pharmaceutical relevance.

PubMed

Judycka-Proma, U; Bober, L; Gajewicz, A; Puzyn, T; Błażejowski, J

2015-03-05

Forty ampholytic compounds of biological and pharmaceutical relevance were subjected to chemometric analysis based on unsupervised and supervised learning algorithms. This enabled relations to be found between empirical spectral characteristics derived from electronic absorption data and structural and physicochemical parameters predicted by quantum chemistry methods or phenomenological relationships based on additivity rules. It was found that the energies of long wavelength absorption bands are correlated through multiparametric linear relationships with parameters reflecting the bulkiness features of the absorbing molecules as well as their nucleophilicity and electrophilicity. These dependences enable the quantitative analysis of spectral features of the compounds, as well as a comparison of their similarities and certain pharmaceutical and biological features. Three QSPR models to predict the energies of long-wavelength absorption in buffers with pH=2.5 and pH=7.0, as well as in methanol, were developed and validated in this study. These models can be further used to predict the long-wavelength absorption energies of untested substances (if they are structurally similar to the training compounds). Copyright © 2014 Elsevier B.V. All rights reserved.

Pharmaceutical supply chain risks: a systematic review

PubMed Central

2013-01-01

Introduction Supply of medicine as a strategic product in any health system is a top priority. Pharmaceutical companies, a major player of the drug supply chain, are subject to many risks. These risks disrupt the supply of medicine in many ways such as their quantity and quality and their delivery to the right place and customers and at the right time. Therefore risk identification in the supply process of pharmaceutical companies and mitigate them is highly recommended. Objective In this study it is attempted to investigate pharmaceutical supply chain risks with perspective of manufacturing companies. Methods Scopus, PubMed, Web of Science bibliographic databases and Google scholar scientific search engines were searched for pharmaceutical supply chain risk management studies with 6 different groups of keywords. All results found by keywords were reviewed and none-relevant articles were excluded by outcome of interests and researcher boundaries of study within 4 steps and through a systematic method. Results Nine articles were included in the systematic review and totally 50 main risks based on study outcome of interest extracted which classified in 7 categories. Most of reported risks were related to supply and supplier issues. Organization and strategy issues, financial, logistic, political, market and regulatory issues were in next level of importance. Conclusion It was shown that the majority of risks in pharmaceutical supply chain were internal risks due to processes, people and functions mismanagement which could be managed by suitable mitigation strategies. PMID:24355166

Pharmaceutical supply chain risks: a systematic review.

PubMed

Jaberidoost, Mona; Nikfar, Shekoufeh; Abdollahiasl, Akbar; Dinarvand, Rassoul

2013-12-19

Supply of medicine as a strategic product in any health system is a top priority. Pharmaceutical companies, a major player of the drug supply chain, are subject to many risks. These risks disrupt the supply of medicine in many ways such as their quantity and quality and their delivery to the right place and customers and at the right time. Therefore risk identification in the supply process of pharmaceutical companies and mitigate them is highly recommended. In this study it is attempted to investigate pharmaceutical supply chain risks with perspective of manufacturing companies. Scopus, PubMed, Web of Science bibliographic databases and Google scholar scientific search engines were searched for pharmaceutical supply chain risk management studies with 6 different groups of keywords. All results found by keywords were reviewed and none-relevant articles were excluded by outcome of interests and researcher boundaries of study within 4 steps and through a systematic method. Nine articles were included in the systematic review and totally 50 main risks based on study outcome of interest extracted which classified in 7 categories. Most of reported risks were related to supply and supplier issues. Organization and strategy issues, financial, logistic, political, market and regulatory issues were in next level of importance. It was shown that the majority of risks in pharmaceutical supply chain were internal risks due to processes, people and functions mismanagement which could be managed by suitable mitigation strategies.

[Study thought of pharmaceutical preparations quality standards by dynamic quality control technology].

PubMed

Yu, Dan-Hong; Mao, Chen-Mei; Lv, Cheng-Zhe; Jin, Hui-Zhen; Yao, Xin; Jia, Xiao-Bin

2014-07-01

Pharmaceutical preparations, particularly as a "secret recipe" of traditional Chinese medicine in medical institutions, are the product of China's medical and health industry, and they are also an important means of competing of different medical institutions. Although pharmaceutical preparations have advantages and characteristics than institutes for drug and pharmaceutical companies, the quality standards of pharmaceutical preparations in medical institutions has not reached the desired level over the years. As we all know, the quality of pharmaceutical preparations is important to ensure the efficacy, especially under the environment of people pay more sttention on drug safety and effectiveness and contry increase emphasis on the stste of pharmaceutical preparations. In view of this, we will improve the grade, stability, and clinical efficacy of pharmaceutical preparations by the advanced equipment, testing instruments and the process dynamic quality control technology. Finally, we hope we can provide new ideas for the quality control of pharmaceutical preparations.

Medicating the environment: assessing risks of pharmaceuticals to wildlife and ecosystems

PubMed Central

Arnold, Kathryn E.; Brown, A. Ross; Ankley, Gerald T.; Sumpter, John P.

2014-01-01

Global pharmaceutical consumption is rising with the growing and ageing human population and more intensive food production. Recent studies have revealed pharmaceutical residues in a wide range of ecosystems and organisms. Environmental concentrations are often low, but pharmaceuticals typically are designed to have biological effects at low doses, acting on physiological systems that can be evolutionarily conserved across taxa. This Theme Issue introduces the latest research investigating the risks of environmentally relevant concentrations of pharmaceuticals to vertebrate wildlife. We take a holistic, global view of environmental exposure to pharmaceuticals encompassing terrestrial, freshwater and marine ecosystems in high- and low-income countries. Based on both field and laboratory data, the evidence for and relevance of changes to physiology and behaviour, in addition to mortality and reproductive effects, are examined in terms of the population- and community-level consequences of pharmaceutical exposure on wildlife. Studies on uptake, trophic transfer and indirect effects of pharmaceuticals acting via food webs are presented. Given the logistical and ethical complexities of research in this area, several papers focus on techniques for prioritizing which compounds are most likely to harm wildlife and how modelling approaches can make predictions about the bioavailability, metabolism and toxicity of pharmaceuticals in non-target species. This Theme Issue aims to help clarify the uncertainties, highlight opportunities and inform ongoing scientific and policy debates on the impacts of pharmaceuticals in the environment. PMID:25405959

Photoredox Catalysis in a Complex Pharmaceutical Setting: Toward the Preparation of JAK2 Inhibitor LY2784544

PubMed Central

2015-01-01

We report a detailed investigation into the application of visible light-mediated photocatalysis to a challenging bond construction in a complex pharmaceutical target. The optimized reaction allowed the direct coupling of N-methylmorpholine with an unfunctionalized pyridazine in good yield and selectivity, and with high purity of the product isolated via crystallization. The reaction also facilitated the expedient synthesis of a range of analogues via the use of other commercially available N-methyl substituted tertiary amines, and therefore it represents an attractive tool for medicinal chemistry. Furthermore, a number of other interesting photoredox reactions were discovered during the course of this investigation, such as a formal methylation reaction via C–N bond cleavage, functionalization of C–H bonds alpha to amides, and a visible light-mediated iminium ion reduction. PMID:25356724

Pharmaceutical expenditure forecast model to support health policy decision making.

PubMed

Rémuzat, Cécile; Urbinati, Duccio; Kornfeld, Åsa; Vataire, Anne-Lise; Cetinsoy, Laurent; Aballéa, Samuel; Mzoughi, Olfa; Toumi, Mondher

2014-01-01

With constant incentives for healthcare payers to contain their pharmaceutical budgets, modelling policy decision impact became critical. The objective of this project was to test the impact of various policy decisions on pharmaceutical budget (developed for the European Commission for the project 'European Union (EU) Pharmaceutical expenditure forecast' - http://ec.europa.eu/health/healthcare/key_documents/index_en.htm). A model was built to assess policy scenarios' impact on the pharmaceutical budgets of seven member states of the EU, namely France, Germany, Greece, Hungary, Poland, Portugal, and the United Kingdom. The following scenarios were tested: expanding the UK policies to EU, changing time to market access, modifying generic price and penetration, shifting the distribution chain of biosimilars (retail/hospital). Applying the UK policy resulted in dramatic savings for Germany (10 times the base case forecast) and substantial additional savings for France and Portugal (2 and 4 times the base case forecast, respectively). Delaying time to market was found be to a very powerful tool to reduce pharmaceutical expenditure. Applying the EU transparency directive (6-month process for pricing and reimbursement) increased pharmaceutical expenditure for all countries (from 1.1 to 4 times the base case forecast), except in Germany (additional savings). Decreasing the price of generics and boosting the penetration rate, as well as shifting distribution of biosimilars through hospital chain were also key methods to reduce pharmaceutical expenditure. Change in the level of reimbursement rate to 100% in all countries led to an important increase in the pharmaceutical budget. Forecasting pharmaceutical expenditure is a critical exercise to inform policy decision makers. The most important leverages identified by the model on pharmaceutical budget were driven by generic and biosimilar prices, penetration rate, and distribution. Reducing, even slightly, the prices of

Suspended biofilm carrier and activated sludge removal of acidic pharmaceuticals.

PubMed

Falås, P; Baillon-Dhumez, A; Andersen, H R; Ledin, A; la Cour Jansen, J

2012-03-15

Removal of seven active pharmaceutical substances (ibuprofen, ketoprofen, naproxen, diclofenac, clofibric acid, mefenamic acid, and gemfibrozil) was assessed by batch experiments, with suspended biofilm carriers and activated sludge from several full-scale wastewater treatment plants. A distinct difference between nitrifying activated sludge and suspended biofilm carrier removal of several pharmaceuticals was demonstrated. Biofilm carriers from full-scale nitrifying wastewater treatment plants, demonstrated considerably higher removal rates per unit biomass (i.e. suspended solids for the sludges and attached solids for the carriers) of diclofenac, ketoprofen, gemfibrozil, clofibric acid and mefenamic acid compared to the sludges. Among the target pharmaceuticals, only ibuprofen and naproxen showed similar removal rates per unit biomass for the sludges and biofilm carriers. In contrast to the pharmaceutical removal, the nitrification capacity per unit biomass was lower for the carriers than the sludges, which suggests that neither the nitrite nor the ammonia oxidizing bacteria are primarily responsible for the observed differences in pharmaceutical removal. The low ability of ammonia oxidizing bacteria to degrade or transform the target pharmaceuticals was further demonstrated by the limited pharmaceutical removal in an experiment with continuous nitritation and biofilm carriers from a partial nitritation/anammox sludge liquor treatment process. Copyright © 2011 Elsevier Ltd. All rights reserved.

Current Status and Issues in Basic Pharmaceutical Education.

PubMed

Yasuhara, Tomohisa

2017-01-01

Basic research in pharmaceutical sciences has a long and successful history. Researchers in this field have long given prime importance to the knowledge they have gained through their pharmaceutical education. The transition of pharmacy education to a 6-year course term has not only extended its duration but also placed more emphasis on practical clinical education. The School Education Act (in article 87, second paragraph) determines that "the term of the course, whose main purpose is to cultivate practical ability in clinical pharmacy, shall be six years" (excerpt). The 6-year pharmacy education is an exception to the general 4-year university term determined by the School Education Act. Therefore, the purpose of the 6-year course in pharmacy is clearly proscribed. This is true of the basic course in pharmaceutical education as well; hence, the basic course must be oriented toward developing "practical ability in clinical" education, too. The 6-year pharmacy course, starting from practice (Do), has evolved with the development of a syllabus that includes a model core curriculum (Plan). Furthermore, improvement in the course can be seen by the promoted development of faculty (Act). Now, evidence-based education research will be introduced (Check). This is how the Plan-Do-Check-Act cycle in pharmaceutical education is expected to work. Currently, pedagogy research in pharmacy education has just begun, so it is difficult to evaluate at this time whether basic pharmaceutical education does in fact contribute to enhancing the "practical clinical ability" component of pharmaceutical education.

Quality in the pharmaceutical industry - A literature review.

PubMed

Haleem, Reham M; Salem, Maissa Y; Fatahallah, Faten A; Abdelfattah, Laila E

2015-10-01

The aim of this study is to:a.Highlight the most important guidelines and practices of quality in the pharmaceutical industry.b.Organize such guidelines and practices to create a guide to pave the way for other researchers who would like to dig deeper into these guidelines and practices. A review was conducted of 102 publications; 56 publications were concerned with the pharmaceutical quality directly while 46 publications were concerned with the general quality practices. The content of those sources was analyzed and the following themes were identified:a.Research theme 1: Guidelines of the pharmaceutical quality.b.Research theme 2: General practices recently applied in the pharmaceutical industry. The following guidelines were identified and reviewed: WHO guidelines, FDA guidelines, EU guidelines and ICH guidelines in the research theme I. In research theme II; the following topics were identified and reviewed: quality risk management, quality by design, corrective actions and preventive actions, process capability analysis, Six Sigma, process analytical technology, lean manufacturing, total quality management, ISO series and HACCP. Upon reviewing the previously highlighted guidelines and the practices that are widely applied in the pharmaceutical industry, it was noticed that there is an abundant number of papers and articles that explain the general guidelines and practices but the literature lack those describing application; case studies of the pharmaceutical factories applying those guidelines and significance of those guidelines and practices. It is recommended that the literature would invest more in the area of application and significance of guidelines and practices. New case studies should be done to prove the feasibility of such practices.

The role of marketing in pharmaceutical research and development.

PubMed

Calfee, John E

2002-01-01

Pharmaceutical marketing, which is primarily targeted at physicians, has been criticised because it may distort physician prescribing and thus potentially raise costs and/or worsen health. An alternative view, presented in this paper, is that successful marketing of pharmaceuticals can improve consumer welfare by increasing incentives for research and development (R&D) investment and by providing guidance to R&D to make it more consistent with consumer preferences. There are a number of arguments that support this view, despite impediments to pharmaceutical marketing such as the prohibited dissemination of off-label information in the US, difficulties in estimating potential pharmaceutical demand, and the long time lag between demand assessment and the introduction of new drugs. For example, physicians are often slow to modify their prescribing practices, even when new evidence-based practice guidelines are issued by prestigious organisations. Pharmaceutical promotion is likely to be particularly valuable because information plays a key role, is highly technical, and can change rapidly. Even consumer advertising can potentially improve health, for example, by improving patient compliance with drug therapy. In addition to disseminating information about the benefits of new therapies, an essential (and perhaps unique) role for pharmaceutical promotion is to encourage physicians and payers to pay closer attention to consumer needs (i.e. willingness to pay) for new medical technology. Moreover, successful marketing of pharmaceuticals increases the returns from R&D, thus increasing incentives to explore consumer demand and to contribute to basic research on the role of drug therapy. Consumer benefits from this process may be very large.

Measuring US pharmaceutical industry R&D spending.

PubMed

Golec, Joseph; Vernon, John

2008-01-01

Government policy debates on pharmaceutical pricing often turn on whether higher drug prices fund greater company-financed R&D spending. In the US, debate breaks down because each side uses a different measure of R&D spending, and the measures are far apart. Government agencies, Congress and consumer groups use government-generated survey data from the National Science Foundation (NSF), and the pharmaceutical industry uses survey data from the Pharmaceutical Research and Manufacturers of America (PhRMA). This issue is also relevant to academic work because some studies use NSF data, and others use PhRMA data. This article illustrates the pros and cons of these survey data series, and offers a more reliable, comprehensive and replicable alternative series, based on Compustat data.

Peer Mentoring in the General Chemistry and Organic Chemistry Laboratories: The Pinacol Rearrangement--An Exercise in NMR and IR Spectroscopy for General Chemistry and Organic Chemistry Laboratories

ERIC Educational Resources Information Center

Arrington, Caleb A.; Hill, Jameica B.; Radfar, Ramin; Whisnant, David M.; Bass, Charles G.

2008-01-01

This article describes a discovery experiment for general chemistry and organic chemistry labs. Although the pinacol rearrangement has been employed in undergraduate organic laboratories before, in this application organic chemistry students act as mentors to students of general chemistry. Students work together using distillation--a new technique…

Fate of pharmaceuticals in full-scale source separated sanitation system.

PubMed

Butkovskyi, A; Hernandez Leal, L; Rijnaarts, H H M; Zeeman, G

2015-11-15

Removal of 14 pharmaceuticals and 3 of their transformation products was studied in a full-scale source separated sanitation system with separate collection and treatment of black water and grey water. Black water is treated in an up-flow anaerobic sludge blanket (UASB) reactor followed by oxygen-limited autotrophic nitrification-denitrification in a rotating biological contactor and struvite precipitation. Grey water is treated in an aerobic activated sludge process. Concentration of 10 pharmaceuticals and 2 transformation products in black water ranged between low μg/l to low mg/l. Additionally, 5 pharmaceuticals were also present in grey water in low μg/l range. Pharmaceutical influent loads were distributed over two streams, i.e. diclofenac was present for 70% in grey water, while the other compounds were predominantly associated to black water. Removal in the UASB reactor fed with black water exceeded 70% for 9 pharmaceuticals out of the 12 detected, with only two pharmaceuticals removed by sorption to sludge. Ibuprofen and the transformation product of naproxen, desmethylnaproxen, were removed in the rotating biological contactor. In contrast, only paracetamol removal exceeded 90% in the grey water treatment system while removal of other 7 pharmaceuticals was below 40% or even negative. The efficiency of pharmaceutical removal in the source separated sanitation system was compared with removal in the conventional sewage treatment plants. Furthermore, effluent concentrations of black water and grey water treatment systems were compared with predicted no-effect concentrations to assess toxicity of the effluent. Concentrations of diclofenac, ibuprofen and oxazepam in both effluents were higher than predicted no-effect concentrations, indicating the necessity of post-treatment. Ciprofloxacin, metoprolol and propranolol were found in UASB sludge in μg/g range, while pharmaceutical concentrations in struvite did not exceed the detection limits. Copyright © 2015

Examining pharmaceuticals using terahertz spectroscopy

NASA Astrophysics Data System (ADS)

Sulovská, Kateřina; Křesálek, Vojtěch

2015-10-01

Pharmaceutical trafficking is common issue in countries where they are under stricter dispensing regime with monitoring of users. Most commonly smuggled pharmaceuticals include trade names Paralen Plus, Modafen, Clarinase repetabs, Aspirin complex, etc. These are transported mainly from Eastern Europe (e.g. Poland, Ukraine, Russia) to countries like Czech Republic, which is said to have one of the highest number of methamphetamine producers in Europe. The aim of this paper is to describe the possibility of terahertz spectroscopy utilization as an examining tool to distinguish between pharmaceuticals containing pseudoephedrine compounds and those without it. Selected medicaments for experimental part contain as an active ingredient pseudoephedrine hydrochloride or pseudoephedrine sulphate. Results show a possibility to find a pseudoephedrine compound spectra in samples according to previously computed and experimentally found ones, and point out that spectra of same brand names pills may vary according to their expiration date, batch, and amount of absorbed water vapours from ambience. Mislead spectrum also occurs during experimental work in a sample without chosen active ingredient, which shows persistent minor inconveniences of terahertz spectroscopy. All measurement were done on the TPS Spectra 3000 instrument.

Exploration of fluorine chemistry at the multidisciplinary interface of chemistry and biology.

PubMed

Ojima, Iwao

2013-07-05

Over the last three decades, my engagement in "fluorine chemistry" has evolved substantially because of the multidisciplinary nature of the research programs. I began my research career as a synthetic chemist in organometallic chemistry and homogeneous catalysis directed toward organic synthesis. Then, I was brought into a very unique world of "fluorine chemistry" in the end of 1970s. I started exploring the interface of fluorine chemistry and transition metal homogeneous catalysis first, which was followed by amino acids, peptides, and peptidomimetics for medicinal chemistry. Since then, I have been exploring the interfaces of fluorine chemistry and multidisciplinary fields of research involving medicinal chemistry, chemical biology, cancer biology, and molecular imaging. This perspective intends to cover my fruitful endeavor in the exploration of fluorine chemistry at the multidisciplinary interface of chemistry and biology in a chronological order to show the evolution of my research interest and strategy.

E-detailing: information technology applied to pharmaceutical detailing.

PubMed

Montoya, Isaac D

2008-11-01

E-detailing can be best described as the use of information technology in the field of pharmaceutical detailing. It is becoming highly popular among pharmaceutical companies because it maximizes the time of the sales force, cuts down the cost of detailing and increases physician prescribing. Thus, the application of information technology is proving to be beneficial to both physicians and pharmaceutical companies. When e-detailing was introduced in 1996, it was limited to the US; however, numerous other countries soon adopted this novel approach to detailing and now it is popular in many developed nations. The objective of this paper is to demonstrate the rapid growth of e-detailing in the field of pharmaceutical marketing. A review of e-detailing literature was conducted in addition to personal conversations with physicians. E-detailing has the potential to reduce marketing costs, increase accessibility to physicians and offer many of the advantages of face-to-face detailing. E-detailing is gaining acceptance among physicians because they can access the information of a pharmaceutical product at their own time and convenience. However, the drug safety aspect of e-detailing has not been examined and e-detailing remains a supplement to traditional detailing and is not yet a replacement to it.

Pharmaceutical cocrystals: along the path to improved medicines.

PubMed

Duggirala, Naga K; Perry, Miranda L; Almarsson, Örn; Zaworotko, Michael J

2016-01-14

Cocrystals, a long known but understudied class of crystalline solids, have attracted interest from crystal engineers and pharmaceutical scientists in the past decade and are now an integral part of the preformulation stage of drug development. This is largely because cocrystals that contain a drug molecule, pharmaceutical cocrystals, can modify physicochemical properties without the need for covalent modification of the drug molecule. This review presents a brief history of cocrystals before addressing recent advances in design, discovery and development of pharmaceutical cocrystals that have occurred since an earlier review published in 2004. We address four aspects of cocrystals: nomenclature; design using hydrogen-bonded supramolecular synthons; methods of discovery and synthesis; development of pharmaceutical cocrystals as drug products. Cocrystals can be classified into molecular cocrystals (MCCs) that contain only neutral components (coformers) and ionic cocrystals (ICCs), which are comprised of at least one ionic coformer that is a salt. That cocrystals, especially ICCs, offer much greater diversity in terms of composition and properties than single component crystal forms and are amenable to design makes them of continuing interest. Seven recent case studies that illustrate how pharmaceutical cocrystals can improve physicochemical properties and clinical performance of drug substances, including a recently approved drug product based upon an ICC, are presented.

BIGCHEM: Challenges and Opportunities for Big Data Analysis in Chemistry.

PubMed

Tetko, Igor V; Engkvist, Ola; Koch, Uwe; Reymond, Jean-Louis; Chen, Hongming

2016-12-01

The increasing volume of biomedical data in chemistry and life sciences requires the development of new methods and approaches for their handling. Here, we briefly discuss some challenges and opportunities of this fast growing area of research with a focus on those to be addressed within the BIGCHEM project. The article starts with a brief description of some available resources for "Big Data" in chemistry and a discussion of the importance of data quality. We then discuss challenges with visualization of millions of compounds by combining chemical and biological data, the expectations from mining the "Big Data" using advanced machine-learning methods, and their applications in polypharmacology prediction and target de-convolution in phenotypic screening. We show that the efficient exploration of billions of molecules requires the development of smart strategies. We also address the issue of secure information sharing without disclosing chemical structures, which is critical to enable bi-party or multi-party data sharing. Data sharing is important in the context of the recent trend of "open innovation" in pharmaceutical industry, which has led to not only more information sharing among academics and pharma industries but also the so-called "precompetitive" collaboration between pharma companies. At the end we highlight the importance of education in "Big Data" for further progress of this area. © 2016 The Authors. Published by Wiley-VCH Verlag GmbH & Co. KGaA.

BIGCHEM: Challenges and Opportunities for Big Data Analysis in Chemistry

PubMed Central

Engkvist, Ola; Koch, Uwe; Reymond, Jean‐Louis; Chen, Hongming

2016-01-01

Abstract The increasing volume of biomedical data in chemistry and life sciences requires the development of new methods and approaches for their handling. Here, we briefly discuss some challenges and opportunities of this fast growing area of research with a focus on those to be addressed within the BIGCHEM project. The article starts with a brief description of some available resources for “Big Data” in chemistry and a discussion of the importance of data quality. We then discuss challenges with visualization of millions of compounds by combining chemical and biological data, the expectations from mining the “Big Data” using advanced machine‐learning methods, and their applications in polypharmacology prediction and target de‐convolution in phenotypic screening. We show that the efficient exploration of billions of molecules requires the development of smart strategies. We also address the issue of secure information sharing without disclosing chemical structures, which is critical to enable bi‐party or multi‐party data sharing. Data sharing is important in the context of the recent trend of “open innovation” in pharmaceutical industry, which has led to not only more information sharing among academics and pharma industries but also the so‐called “precompetitive” collaboration between pharma companies. At the end we highlight the importance of education in “Big Data” for further progress of this area. PMID:27464907

Chemistry: Experiments, Demonstrations and Other Activities Suggested for Chemistry.

ERIC Educational Resources Information Center

New York State Education Dept., Albany. Bureau of Secondary Curriculum Development.

This publication is a handbook used in conjunction with the course of study in chemistry developed through the New York State Education Department and The University of the State of New York. It contains experiments, demonstrations, and other activities for a chemistry course. Areas covered include the science of chemistry, the atomic structure of…

Publication bias in the pulmonary/allergy literature: effect of pharmaceutical company sponsorship.

PubMed

Liss, Howard

2006-07-01

A publication bias exists towards positive results in studies funded by pharmaceutical companies. To determine whether drug studies in the pulmonary/allergy literature also demonstrate a publication bias towards more favorable results when a pharmaceutical company funds the study. We reviewed all original articles published in seven pulmonary and allergy journals between October 2002 and September 2003. Included in the review were studies of inhaled corticosteroids (oral or nasal), long- or short-acting bronchodilators, or leukotriene receptor antagonists. Articles with funding from a pharmaceutical company and/or one or more authors employed by a pharmaceutical company were considered pharmaceutical company-sponsored studies. The remaining studies were considered not sponsored by a pharmaceutical company. Results were compared to ascertain whether positive results were obtained more frequently in the company-sponsored studies. Of the 100 articles included in this review 63 were considered pharmaceutical company-sponsored research. Results favorable for the drugs studies were significantly more common in those funded by a pharmaceutical company (98% vs. 32%). In the pulmonary and allergy literature, as in other fields, there is a publication bias towards positive results in pharmaceutical company-sponsored research.

Medicating the environment: assessing risks of pharmaceuticals to wildlife and ecosystems.

PubMed

Arnold, Kathryn E; Brown, A Ross; Ankley, Gerald T; Sumpter, John P

2014-11-19

Global pharmaceutical consumption is rising with the growing and ageing human population and more intensive food production. Recent studies have revealed pharmaceutical residues in a wide range of ecosystems and organisms. Environmental concentrations are often low, but pharmaceuticals typically are designed to have biological effects at low doses, acting on physiological systems that can be evolutionarily conserved across taxa. This Theme Issue introduces the latest research investigating the risks of environmentally relevant concentrations of pharmaceuticals to vertebrate wildlife. We take a holistic, global view of environmental exposure to pharmaceuticals encompassing terrestrial, freshwater and marine ecosystems in high- and low-income countries. Based on both field and laboratory data, the evidence for and relevance of changes to physiology and behaviour, in addition to mortality and reproductive effects, are examined in terms of the population- and community-level consequences of pharmaceutical exposure on wildlife. Studies on uptake, trophic transfer and indirect effects of pharmaceuticals acting via food webs are presented. Given the logistical and ethical complexities of research in this area, several papers focus on techniques for prioritizing which compounds are most likely to harm wildlife and how modelling approaches can make predictions about the bioavailability, metabolism and toxicity of pharmaceuticals in non-target species. This Theme Issue aims to help clarify the uncertainties, highlight opportunities and inform ongoing scientific and policy debates on the impacts of pharmaceuticals in the environment. © 2014 The Author(s) Published by the Royal Society. All rights reserved.

Analysis of molecular interactions in solid dosage forms; challenge to molecular pharmaceutics.

PubMed

Yamamoto, Keiji; Limwikrant, Waree; Moribe, Kunikazu

2011-01-01

The molecular states of active pharmaceutical ingredients (APIs) in pharmaceutical dosage forms strongly affect the properties and quality of a drug. Various important fundamental physicochemical studies were reviewed from the standpoint of molecular pharmaceutics. Mechanochemical effects were evaluated in mixtures of APIs and pharmaceutical additives. Amorphization, complex formation and nanoparticle formation are observed after grinding process depending on the combination of APIs and pharmaceutical additives. Sealed-heating method and mesoporous materials have been used to investigate drug molecular interactions in dosage forms. Molecular states have been investigated using powder X-ray diffraction, thermal analysis, IR, solid state fluorometry, and NMR. © 2011 Pharmaceutical Society of Japan

Pharmaceutical advertising revenue and physician organizations: how much is too much?

PubMed Central

Glassman, P A; Hunter-Hayes, J; Nakamura, T

1999-01-01

OBJECTIVE: To determine if revenue generated from pharmaceutical advertisements in medical journals creates potential financial conflicts of interest for nonprofit physician organizations that own those journals. DESIGN: Convenience sample of six professional medical societies and their respective journals. Calculation of pharmaceutical advertising revenue generated by these journals for their respective professional medical societies. METHODS: Random selection of each journal for one month per quarter in calendar year 1996 and tabulation per edition of the average number of pharmaceutical advertising pages for each journal. OUTCOME MEASURES: Published advertising rates were used to estimate pharmaceutical advertising revenue for calendar year 1996 and compared with each organization's gross revenue and membership dues and assessments, based on Internal Revenue Service documents for the last available fiscal year (1995). RESULTS: Estimated pharmaceutical advertising revenue ranged from $715,000 to $18,630,000. Five organizations raised more than 10% of their gross income (range 2% to 30%) from a single journal's pharmaceutical advertising. Four organizations raised as much or more from pharmaceutical advertising as from members (range 17% to 790%). CONCLUSIONS: Potential financial conflicts of interest arising from pharmaceutical advertisements in medical journals may be substantial. The impact on professional societies' financial independence and behavior is unknown. PMID:10578674

Do cost-sharing and entry deregulation curb pharmaceutical innovation?

PubMed

Grossmann, Volker

2013-09-01

This paper examines the role of both cost-sharing schemes in health insurance systems and the regulation of entry into the pharmaceutical sector for pharmaceutical R&D expenditure and drug prices. The analysis suggests that both an increase in the coinsurance rate and stricter price regulations adversely affect R&D spending in the pharmaceutical sector. In contrast, entry deregulation may lead to higher R&D spending of pharmaceutical companies. The relationship between R&D spending per firm and the number of firms may be hump-shaped. In this case, the number of rivals which maximizes R&D expenditure per firm is decreasing in the coinsurance rate and increasing in labor productivity. Copyright © 2013 Elsevier B.V. All rights reserved.

Institutional mistrust in the organization of pharmaceutical clinical trials

PubMed Central

2010-01-01

In this paper I explore the politics of trust in the clinical testing of pharmaceuticals in the US. Specifically, I analyze trust in terms of its institutional manifestations in the pharmaceutical clinical trials industry. In the process of testing new drugs, pharmaceutical companies must (1) protect their proprietary information from the clinicians who conduct their studies, and (2) find a way to ensure human subjects' compliance to study protocols. Concern with these two critical issues leads drug companies to approach clinicians and research subjects with an attitude of mistrust and the desire to exert control over their activities. This orientation results in an institutionalization of mistrust that structures the relationships and activities required for the clinical development of new pharmaceutical products. PMID:18633728

Systematic review of factors affecting pharmaceutical expenditures.

PubMed

Mousnad, Mohamed Awad; Shafie, Asrul Akmal; Ibrahim, Mohamed Izham

2014-06-01

To systematically identify the main factors contributing to the increase in pharmaceutical expenditures. A systematic search of published studies was conducted utilising major widely used electronic databases using the search terms 'factors,' 'financing,' 'pharmaceutical,' and 'expenditures.' To be included, the studies needed to: (1) measure at least one of the following outcomes: total growth in pharmaceutical expenditures, price growth or quantity growth; (2) mention a clear method for analysing the impact of factors affecting the increases in drug expenditures; (3) be written in English. Nonprimary articles that were published only as an abstract, a review, a commentary or a letter were excluded. From a total of 2039 studies, only 25 were included in the full review. The main determinant categories that were identified in the review were factors related to price, utilisation, therapeutic choice, demand and health care system. The major cost drivers were found to be changes in drug quantities and therapies as well as new drugs. It is important for policymakers to understand pharmaceutical spending trends and the factors that influence them in order to formulate effective cost containment strategies and design optimum drug policy. Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.

Pharmaceuticals Safety Practices-A Comparative Pilot Study

PubMed Central

Tawfik, Kamilia A.; Jabeen, Arshia

2013-01-01

Introduction The safety of medicine is essential for the safety of patients. Inappropriate drug storage, expiration dates, sharing prescription drugs, self medication habits and misuse of some drugs are contributing factors affecting medication safety. One or more of these factors may lead to serious health complications and even death. Objectives The purpose of this study was to highlight the common errors and pharmaceutical malpractices that people usually engage in on a daily basis and to correlate these to culture, gender and educational levels. This may spread awareness in an easy and understandable manner and provide certain guidelines to drug consumers ensuring that pharmaceutical preparations are used correctly and safely. Methods Two hundred questionnaires were randomly distributed in two countries; Saudi Arabia and India. The collected data were statistically analyzed. Outcomes and conclusion Results showed that alarming percentages of various participants were using pharmaceuticals inappropriately due to carelessness, unawareness or intentional mistakes. Therefore, active participation by health care professionals is essential for the prevention of drug misuse. Increasing population awareness about self medication, products expiration, pharmaceuticals labels and optimum storage conditions would minimize the adverse effects and may even be life saving. PMID:24533025

Environmental presence and persistence of pharmaceuticals: An overview

USGS Publications Warehouse

Glassmeyer, Susan T.; Koplin, Dana W.; Furlong, Edward T.; Focazio, M.

2008-01-01

Emerging contaminants (ECs) in the environment – that is, chemicals with domestic, municipal, industrial, or agricultural sources that are not commonly monitored but may have the potential for adverse environmental effects – is a rapidly growing field of research. The use of “emerging” is not intended to infer that the presence of these compounds in the environment is new. These chemicals have been released into the environment as long as they have been in production or, in the case of hormones and other endogenous compounds, since the rise of animal life. What is emerging is the interest by the scientific and lay communities in the presence of these chemicals in the environment, the analytical capabilities required for detection, and the subtle effects that very small concentrations of these chemicals appear to have on aquatic biota. In December 2006, Environmental Science & Technology devoted an entire special issue (volume 40, number 23) to the topic of ECs, illustrating the increased interest in the subject. Within the EGs, one particular class that has seen a substantial increase in research over the past 10 years is pharmaceuticals and personal-care products (PPCPs). This increased research interest can be demonstrated by several means, including requests for proposals from funding agencies, but the clearest indication of a focused effort to understand the introduction, transformation, and potential health and environmental effects of PPCPs and ECs, in general, is the number of published reports. This increase can be shown by examining six environmental journals that regularly publish PPCP-related papers – Chemosphere, Environmental Science & Technology, Environmental Toxicology and Chemistry, Science of the Total Environment, Water Research, and Water Science and Technology. In 1998 there were 22 papers published on pharmaceuticals, antibiotics, or drugs in these 6 journals; by 2006, this number increased sixfold to 132 papers (Figure 1.1).This

Assessing the Factors Associated With Iran’s Intra-Industry Trade in Pharmaceuticals

PubMed Central

Yusefzadeh, Hassan; Hadian, Mohammad; Gorji, Hassan Abolghasem; Ghaderi, Hossein

2015-01-01

Background: Pharmaceutical industry is a sensitive and profitable industry. If this industry wants to survive, it should be able to compete well in international markets. So, study of Iran’s intra-industry trade (IIT) in pharmaceuticals is essential in order to identify competitiveness potential of country and boost export capability in the global arena. Methods: This study assessed the factors associated with Iran’s intra-industry trade in pharmaceuticals with the rest of the world during the 2001–2012 periods using seasonal time series data at the four-digit SITC level. The data was collected from Iran’s pharmaceutical Statistics, World Bank and International Trade Center. Finally, we discussed a number of important policy recommendations to increase Iran’s IIT in pharmaceuticals. Results: The findings indicated that economies of scale, market structure and degree of economic development had a significantly positive impact on Iran’s intra-industry trade in pharmaceuticals and tariff trade barriers were negatively related to IIT. Product differentiation and technological advancement didn’t have the expected signs. In addition, we found that Iran’s IIT in pharmaceuticals have shown an increasing trend during the study period. Thus, the composition of Iran trade in pharmaceuticals has changed from inter-industry trade to intra-industry trade. Conclusions: In order to get more prepared for integration into the global economy, the development of Iran’s IIT in pharmaceuticals should be given priority. Therefore, paying attention to IIT could have an important role in serving pharmaceutical companies in relation to pharmaceutical trade. PMID:26156931

ENVIRONMENTAL ANALYTICAL CHEMISTRY OF ...

EPA Pesticide Factsheets

Within the scope of a number of emerging contaminant issues in environmental analysis, one area that has received a great deal of public interest has been the assessment of the role of pharmaceuticals and personal care products (PPCPs) as stressors and agents of change in ecosystems as well as their role in unplanned human exposure. The relationship between personal actions and the occurrence of PPCPs in the environment is clear-cut and comprehensible to the public. In this overview, we attempt to examine the separations aspect of the analytical approach to the vast array of potential analytes among this class of compounds. We also highlight the relationship between these compounds and endocrine disrupting compounds (EDCs) and between PPCPs and EDCs and the more traditional environmental analytes such as the persistent organic pollutants (POPs). Although the spectrum of chemical behavior extends from hydrophobic to hydrophilic, the current focus has shifted to moderately and highly polar analytes. Thus, emphasis on HPLC and LC/MS has grown and MS/MS has become a detection technique of choice with either electrospray ionization or atmospheric pressure chemical ionization. This contrasts markedly with the bench mark approach of capillary GC, GC/MS and electron ionization in traditional environmental analysis. The expansion of the analyte list has fostered new vigor in the development of environmental analytical chemistry, modernized the range of tools appli

[E-commerce of pharmaceuticals].

PubMed

Shani, Segev

2003-05-01

The emergence of the Internet as a new communications and information technology caused major social and cultural changes. The dramatic increase in accessibility and availability of information empowered the consumer by closing the information gap between the consumer and different suppliers. The objective of this article is to review many new internet-supported applications related to the pharmaceutical market. E-commerce is divided into two major components: Business to Consumer (B to C), and Business to Business (B to B). The main applications in B to C are dissemination of medical and drug information, and the sale of drugs through the Internet. Medical information on the Internet is vast and very helpful for patients, however, its reliability is not guaranteed. Online pharmacies increase the accessibility and availability of drugs. Nevertheless, several obstacles such as security of the data provided (both financial and clinical) prevent the widespread use of online pharmacies. Another risk is the health authorities' inability to regulate Internet sites effectively. Therefore, unregulated sale of prescription drugs, fake or substandard, often occurs on the Internet. B to B relates to physicians, clinics, hospitals, HMO's and pharmaceutical companies. There is a vast number of applications ranging from clinical research, marketing and sales promotion, to drug distribution and logistics. In conclusion, the Internet is dynamic and has contributed to the development of numerous new applications in the field of pharmaceuticals. Regulatory authorities should be active in developing new policies that will deal with those new Internet-based applications.

Introductory Level Problems Illustrating Concepts in Pharmaceutical Engineering

ERIC Educational Resources Information Center

McIver, Keith; Whitaker, Kathryn; De Delva, Vladimir; Farrell, Stephanie; Savelski, Mariano J.; Slater, C. Stewart

2012-01-01

Textbook style problems including detailed solutions introducing pharmaceutical topics at the level of an introductory chemical engineering course have been created. The problems illustrate and teach subjects which students would learn if they were to pursue a career in pharmaceutical engineering, including the unique terminology of the field,…

Pharmaceutical expenditure forecast model to support health policy decision making

PubMed Central

Rémuzat, Cécile; Urbinati, Duccio; Kornfeld, Åsa; Vataire, Anne-Lise; Cetinsoy, Laurent; Aballéa, Samuel; Mzoughi, Olfa; Toumi, Mondher

2014-01-01

Background and objective With constant incentives for healthcare payers to contain their pharmaceutical budgets, modelling policy decision impact became critical. The objective of this project was to test the impact of various policy decisions on pharmaceutical budget (developed for the European Commission for the project ‘European Union (EU) Pharmaceutical expenditure forecast’ – http://ec.europa.eu/health/healthcare/key_documents/index_en.htm). Methods A model was built to assess policy scenarios’ impact on the pharmaceutical budgets of seven member states of the EU, namely France, Germany, Greece, Hungary, Poland, Portugal, and the United Kingdom. The following scenarios were tested: expanding the UK policies to EU, changing time to market access, modifying generic price and penetration, shifting the distribution chain of biosimilars (retail/hospital). Results Applying the UK policy resulted in dramatic savings for Germany (10 times the base case forecast) and substantial additional savings for France and Portugal (2 and 4 times the base case forecast, respectively). Delaying time to market was found be to a very powerful tool to reduce pharmaceutical expenditure. Applying the EU transparency directive (6-month process for pricing and reimbursement) increased pharmaceutical expenditure for all countries (from 1.1 to 4 times the base case forecast), except in Germany (additional savings). Decreasing the price of generics and boosting the penetration rate, as well as shifting distribution of biosimilars through hospital chain were also key methods to reduce pharmaceutical expenditure. Change in the level of reimbursement rate to 100% in all countries led to an important increase in the pharmaceutical budget. Conclusions Forecasting pharmaceutical expenditure is a critical exercise to inform policy decision makers. The most important leverages identified by the model on pharmaceutical budget were driven by generic and biosimilar prices, penetration rate

PRINTING TECHNIQUES: RECENT DEVELOPMENTS IN PHARMACEUTICAL TECHNOLOGY.

PubMed

Jamroz, Witold; Kurek, Mateusz; Lyszczarz, Ewelina; Brniak, Witold; Jachowicz, Renata

2017-05-01

In the last few years there has been a huge progress in a development of printing techniques and their application in pharmaceutical sciences and particularly in the pharmaceutical technology. The variety of printing methods makes it necessary to systemize them, explain the principles of operation, and specify the possibilities of their use in pharmaceutical technology. This paper aims to review the printing techniques used in a drug development process. The growing interest in 2D and 3D printing methods results in continuously increasing number of scientific papers. Introduction of the first printed drug Spritam@ to the market seems to be a milestone of the 3D printing development. Thus, a particular aim of this review is to show the latest achievements of the researchers in the field of the printing medicines.

Occurrence, sources, and fate of pharmaceuticals in aquatic environment and soil.

PubMed

Li, W C

2014-04-01

With the rapid economic development, a better living condition leads to longer life expectancy, which increased the total population, in particular the elderly group. It may result in increase in the demand of pharmaceuticals for people in domestic use or in hospital. Although most sewage treatment plants or waste water treatment plantsmet the regulatory requirement, there are still many pharmaceuticals removed incompletely and thus discharged to the environment. Therefore, the pharmaceuticals residue draws the public concern because they might cause adverse effects on the organism even human beings. Recently, many studies have published on the source and occurrence as well as the fate of pharmaceuticals all over the world. This paper summarized and reviewed the recent studies on the sources, occurrence, fate and the effects of the most common pharmaceuticals. Finally, it gave the suggestion and risk management for controlling the pharmaceuticals. Copyright © 2014 Elsevier Ltd. All rights reserved.

99M-technetium labeled macroaggregated human serum albumin pharmaceutical

DOEpatents

Winchell, Harry S.; Barak, Morton; Van Fleet, III, Parmer

1977-05-17

A reagent comprising macroaggregated human serum albumin having dispersed therein particles of stannous tin and a method for instantly making a labeled pharmaceutical therefrom, are disclosed. The labeled pharmaceutical is utilized in organ imaging.

Extending Halogen-based Medicinal Chemistry to Proteins: IODO-INSULIN AS A CASE STUDY.

PubMed

El Hage, Krystel; Pandyarajan, Vijay; Phillips, Nelson B; Smith, Brian J; Menting, John G; Whittaker, Jonathan; Lawrence, Michael C; Meuwly, Markus; Weiss, Michael A

2016-12-30

Insulin, a protein critical for metabolic homeostasis, provides a classical model for protein design with application to human health. Recent efforts to improve its pharmaceutical formulation demonstrated that iodination of a conserved tyrosine (Tyr B26 ) enhances key properties of a rapid-acting clinical analog. Moreover, the broad utility of halogens in medicinal chemistry has motivated the use of hybrid quantum- and molecular-mechanical methods to study proteins. Here, we (i) undertook quantitative atomistic simulations of 3-[iodo-Tyr B26 ]insulin to predict its structural features, and (ii) tested these predictions by X-ray crystallography. Using an electrostatic model of the modified aromatic ring based on quantum chemistry, the calculations suggested that the analog, as a dimer and hexamer, exhibits subtle differences in aromatic-aromatic interactions at the dimer interface. Aromatic rings (Tyr B16 , Phe B24 , Phe B25 , 3-I-Tyr B26 , and their symmetry-related mates) at this interface adjust to enable packing of the hydrophobic iodine atoms within the core of each monomer. Strikingly, these features were observed in the crystal structure of a 3-[iodo-Tyr B26 ]insulin analog (determined as an R 6 zinc hexamer). Given that residues B24-B30 detach from the core on receptor binding, the environment of 3-I-Tyr B26 in a receptor complex must differ from that in the free hormone. Based on the recent structure of a "micro-receptor" complex, we predict that 3-I-Tyr B26 engages the receptor via directional halogen bonding and halogen-directed hydrogen bonding as follows: favorable electrostatic interactions exploiting, respectively, the halogen's electron-deficient σ-hole and electronegative equatorial band. Inspired by quantum chemistry and molecular dynamics, such "halogen engineering" promises to extend principles of medicinal chemistry to proteins. © 2016 by The American Society for Biochemistry and Molecular Biology, Inc.

Degradation of 40 selected pharmaceuticals by UV/H2O2.

PubMed

Wols, B A; Hofman-Caris, C H M; Harmsen, D J H; Beerendonk, E F

2013-10-01

The occurrence of pharmaceuticals in source waters is increasing. Although UV advanced oxidation is known to be an effective barrier against micropollutants, degradation rates are only available for limited amounts of pharmaceuticals. Therefore, the degradation of a large group of pharmaceuticals has been studied in this research for the UV/H2O2 process under different conditions, including pharmaceuticals of which the degradation by UV/H2O2 was never reported before (e.g., metformin, paroxetine, pindolol, sotalol, venlafaxine, etc.). Monochromatic low pressure (LP) and polychromatic medium pressure (MP) lamps were used for three different water matrices. In order to have well defined hydraulic conditions, all experiments were conducted in a collimated beam apparatus. Degradation rates for the pharmaceuticals were determined. For those compounds used in this research that are also reported in literature, measured degradation results are in good agreement with literature data. Pharmaceutical degradation for only photolysis with LP lamps is small, which is increased by using a MP lamp. Most of the pharmaceuticals are well removed when applying both UV (either LP or MP) and H2O2. However, differences in degradation rates between pharmaceuticals can be large. For example, ketoprofen, prednisolone, pindolol are very well removed by UV/H2O2, whereas metformin, cyclophosphamide, ifosfamide are very little removed by UV/H2O2. Copyright © 2013 Elsevier Ltd. All rights reserved.

Pharmaceuticals in settleable particulate material in urban and non-urban waters.

PubMed

Lahti, Marja; Oikari, Aimo

2011-10-01

Wastewater treatment plants (WWTP) are important sources of settleable particulate material (SPM), heading to sediments with natural suspended solids. To date, there is little information about the fate of pharmaceuticals in sediment systems. In this study, the objective was to determine if pharmaceuticals are detected in SPM at locations near WWTPs or even in rural areas, thus being susceptible for sedimentation. SPM samples were collected from 10 sites in Finland, grouped as reference, rural and wastewater effluent sites. SPM collectors were placed about 35 cm above bottom for about 2 months during summer. After extraction, a set of 17 pharmaceuticals was analyzed. Several pharmaceuticals were detected in SPM accumulated at sites next to WWTPs. The concentration of citalopram was notably high (300-1350 ng g⁻¹ dw). Also bisoprolol and ciprofloxacin were detected at high concentrations (6-325 and 9-390 ng g⁻¹ dw, respectively). In contrast, none of the pharmaceuticals were detected from reference sites and only two were found from a single rural site. There is no previous information about the presence of pharmaceuticals in SPM. The results showed that pharmaceuticals are sorbed to particles in WWTP and nearby, eventually ending up in sediments. These results also indicate that pharmaceuticals are not markedly contaminating sediments of rural areas in Finland. Copyright © 2011 Elsevier Ltd. All rights reserved.

Ways of Learning in the Pharmaceutical Sales Industry

ERIC Educational Resources Information Center

Hunter, Carrie Patricia

2010-01-01

Purpose: The purpose of this paper is to document the ways pharmaceutical representatives learn for work and report attributes of (in)formality and other characteristics of ways of learning perceived as effective and frequently used. Design/methodology/approach: A total of agents 20 from 11 pharmaceutical manufacturers across Canada participated…

American export control, technology spillover and innovation of Chinese pharmaceutical Industry.

PubMed

Hui, Jiang

2017-05-01

This paper was aimed to analyze whether the U.S. strict export control to China affects the technological innovation of Chinese pharmaceutical industry. This paper selected the data of technological innovation and the expenditure of high and new technology adoption in China's pharmaceutical industry from 1995 to 2014, created panel regression model to study the impact of export controls on technology spillovers and the impact of technology spillovers on innovation capacity. The results show that US export control has a significant impact on technology spillovers, but foreign technology spillovers have no significant impact on the innovation of Chinese pharmaceutical industry. Although the US export control prevented foreign technology spillovers to China, but indirectly stimulated the domestic technology spillovers to pharmaceutical manufacturing industry in China. Statistical analysis show that the correlation coefficient between innovation capacity and expenditure for high technology adoption is not significant, but the expenditure of purchasing domestic technical is essential to pharmaceutical innovation. This study shows that US export control indirectly, not directly, affected the technological innovation of China's pharmaceutical industry, affected the allocation of innovative resources, but failed to prevent the technological progress and competitiveness improvement of Chinese pharmaceutical industry.

Practices of pharmaceutical waste generation and discarding in households across Portugal.

PubMed

Dias-Ferreira, Celia; Valente, Susana; Vaz, João

2016-10-01

This work is the first nationwide study in Portugal on pharmaceutical waste generated at households, exploring people's attitudes and risk perception. The waste audit was carried out from September to November 2014, targeting pharmaceutical products kept by a sample of families (n = 244). This campaign was an assignment of VALORMED, the non-profit association that manages waste and packaging from expired and unused pharmaceutical products collected by the pharmacies. On average, each household kept at home 1097 g of pharmaceutical products, of which 20% were in use, 72% were not in use, and 8% were mostly expired products ready to discard. Face-to-face interviews with householders showed that 69% of the respondents claimed returning pharmaceutical waste to the local pharmacy. However, this figure is overrated, probably owing to a possible 'good answer' effect. The barriers identified to proper disposal were mainly established routines and lack of close disposal points. This study also provides an insight into the Portuguese awareness and daily practices concerning pharmaceutical waste, which is the cornerstone of any future strategy to reduce the release of active pharmaceutical ingredients into ecosystems. © The Author(s) 2016.

77 FR 16264 - Manufacturer of Controlled Substances, Notice of Registration; Johnson Matthey Pharmaceutical...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-03-20

..., Notice of Registration; Johnson Matthey Pharmaceutical Materials Inc. By Notice dated November 18, 2011... Pharmaceutical Materials Inc., Pharmaceutical Service, 25 Patton Road, Devens, Massachusetts 01434, made... Matthey Pharmaceutical Materials Inc. to manufacture the listed basic classes of controlled substances is...

An interactive lesson in acid/base and pro-drug chemistry using sodium gamma-hydroxybutyrate and commercial test coasters.

PubMed

Page, Nathaniel A; Paganelli, Meaghan; Boje, Kathleen M K; Fung, Ho-Leung

2007-06-15

To develop a classroom activity that applied pertinent pharmaceutical concepts to examine the use and limitations of a commercially available test drink coaster in detecting the presence of a date-rape drug, sodium gamma-hydroxybutyrate (NaGHB), in beverages. An activity exercise involving a combination of self-study, hands on participation, and classroom discussion was developed. Topics incorporated into the activity were drug-assisted rape, the concepts of false positives and negatives, and prodrug and pH chemistry. Based on questionnaires completed by the students, the intended concepts were reinforced and students demonstrated an increased awareness of the potential shortcomings of the commercial test devices. The activity was well received by the majority of students. The developed activity stimulated student awareness and interest in several principles relevant in pharmaceutical education, including drug-assisted rape, consumer-based drug testing of NaGHB, and the chemical basis for its limitations. The activity requires no special equipment other than the drink coasters and can be easily completed in one 2-hour classroom session.

Advanced oxidation process-mediated removal of pharmaceuticals from water: A review.

PubMed

Kanakaraju, Devagi; Glass, Beverley D; Oelgemöller, Michael

2018-08-01

Pharmaceuticals, which are frequently detected in natural and wastewater bodies as well as drinking water have attracted considerable attention, because they do not readily biodegrade and may persist and remain toxic. As a result, pharmaceutical residues pose on-going and potential health and environmental risks. To tackle these emerging contaminants, advanced oxidation processes (AOPs) such as photo-Fenton, sonolysis, electrochemical oxidation, radiation and ozonation etc. have been applied to remove pharmaceuticals. These processes utilize the high reactivity of hydroxyl radicals to progressively oxidize organic compounds to innocuous products. This review provides an overview of the findings from recent studies, which have applied AOPs to degrade pharmaceutical compounds. Included is a discussion that links various factors of TiO 2 -mediated photocatalytic treatment to its effectiveness in degrading pharmaceutical residues. This review furthermore highlights the success of AOPs in the removal of pharmaceuticals from different water matrices and recommendations for future studies are outlined. Copyright © 2018 Elsevier Ltd. All rights reserved.

Pharmaceutical high profits: the value of R&D, or oligopolistic rents?

PubMed

Spitz, Janet; Wickham, Mark

2012-01-01

Pharmaceutical firms attribute high prices and high profits to costs associated with researching and developing the next generation of life-saving drugs. Using data from annual reports, this article tests the validity of this claim. We find that while pharmaceutical firms do invest in R&D, they also enjoy strong rents; between 1988 and 2009, pharmaceuticals enjoyed profits of 3 to 37 times the all-industry average, depending on the years, while investing proportionately less in R&D than other high-R&D firms. Costs of pharmaceutical drugs have successfully flown below the radar in much of the current health care debate, with producers managing to obstruct alternative sourcing as well as payment cuts. While health care is examined for savings in other areas, sustained high pharmaceutical profits suggest that as a new health care policy develops in the U.S., the pharmaceutical industry should not be excluded from examination for significant savings in health care costs.

Novel methodology for pharmaceutical expenditure forecast.

PubMed

Vataire, Anne-Lise; Cetinsoy, Laurent; Aballéa, Samuel; Rémuzat, Cécile; Urbinati, Duccio; Kornfeld, Åsa; Mzoughi, Olfa; Toumi, Mondher

2014-01-01

The value appreciation of new drugs across countries today features a disruption that is making the historical data that are used for forecasting pharmaceutical expenditure poorly reliable. Forecasting methods rarely addressed uncertainty. The objective of this project was to propose a methodology to perform pharmaceutical expenditure forecasting that integrates expected policy changes and uncertainty (developed for the European Commission as the 'EU Pharmaceutical expenditure forecast'; see http://ec.europa.eu/health/healthcare/key_documents/index_en.htm). 1) Identification of all pharmaceuticals going off-patent and new branded medicinal products over a 5-year forecasting period in seven European Union (EU) Member States. 2) Development of a model to estimate direct and indirect impacts (based on health policies and clinical experts) on savings of generics and biosimilars. Inputs were originator sales value, patent expiry date, time to launch after marketing authorization, price discount, penetration rate, time to peak sales, and impact on brand price. 3) Development of a model for new drugs, which estimated sales progression in a competitive environment. Clinical expected benefits as well as commercial potential were assessed for each product by clinical experts. Inputs were development phase, marketing authorization dates, orphan condition, market size, and competitors. 4) Separate analysis of the budget impact of products going off-patent and new drugs according to several perspectives, distribution chains, and outcomes. 5) Addressing uncertainty surrounding estimations via deterministic and probabilistic sensitivity analysis. This methodology has proven to be effective by 1) identifying the main parameters impacting the variations in pharmaceutical expenditure forecasting across countries: generics discounts and penetration, brand price after patent loss, reimbursement rate, the penetration of biosimilars and discount price, distribution chains, and the time

Novel methodology for pharmaceutical expenditure forecast

PubMed Central

Vataire, Anne-Lise; Cetinsoy, Laurent; Aballéa, Samuel; Rémuzat, Cécile; Urbinati, Duccio; Kornfeld, Åsa; Mzoughi, Olfa; Toumi, Mondher

2014-01-01

Background and objective The value appreciation of new drugs across countries today features a disruption that is making the historical data that are used for forecasting pharmaceutical expenditure poorly reliable. Forecasting methods rarely addressed uncertainty. The objective of this project was to propose a methodology to perform pharmaceutical expenditure forecasting that integrates expected policy changes and uncertainty (developed for the European Commission as the ‘EU Pharmaceutical expenditure forecast’; see http://ec.europa.eu/health/healthcare/key_documents/index_en.htm). Methods 1) Identification of all pharmaceuticals going off-patent and new branded medicinal products over a 5-year forecasting period in seven European Union (EU) Member States. 2) Development of a model to estimate direct and indirect impacts (based on health policies and clinical experts) on savings of generics and biosimilars. Inputs were originator sales value, patent expiry date, time to launch after marketing authorization, price discount, penetration rate, time to peak sales, and impact on brand price. 3) Development of a model for new drugs, which estimated sales progression in a competitive environment. Clinical expected benefits as well as commercial potential were assessed for each product by clinical experts. Inputs were development phase, marketing authorization dates, orphan condition, market size, and competitors. 4) Separate analysis of the budget impact of products going off-patent and new drugs according to several perspectives, distribution chains, and outcomes. 5) Addressing uncertainty surrounding estimations via deterministic and probabilistic sensitivity analysis. Results This methodology has proven to be effective by 1) identifying the main parameters impacting the variations in pharmaceutical expenditure forecasting across countries: generics discounts and penetration, brand price after patent loss, reimbursement rate, the penetration of biosimilars and

Risks to aquatic organisms posed by human pharmaceutical use

EPA Science Inventory

In order to help prioritize future research efforts within the US, risks associated with exposure to human prescription pharmaceutical residues in wastewater were estimated from marketing and pharmacological data. Masses of 371 active pharmaceutical ingredients (APIs) dispensed ...

Water clusters in amorphous pharmaceuticals.

PubMed

Authelin, Jean-Rene; MacKenzie, Alan P; Rasmussen, Don H; Shalaev, Evgenyi Y

2014-09-01

Amorphous materials, although lacking the long-range translational and rotational order of crystalline and liquid crystalline materials, possess certain local (short-range) structure. This paper reviews the distribution of one particular component present in all amorphous pharmaceuticals, that is, water. Based on the current understanding of the structure of water, water molecules can exist in either unclustered form or as aggregates (clusters) of different sizes and geometries. Water clusters are reported in a range of amorphous systems including carbohydrates and their aqueous solutions, synthetic polymers, and proteins. Evidence of water clustering is obtained by various methods that include neutron and X-ray scattering, molecular dynamics simulation, water sorption isotherm, concentration dependence of the calorimetric Tg , dielectric relaxation, and nuclear magnetic resonance. A review of the published data suggests that clustering depends on water concentration, with unclustered water molecules existing at low water contents, whereas clusters form at intermediate water contents. The transition from water clusters to unclustered water molecules can be expected to change water dependence of pharmaceutical properties, such as rates of degradation. We conclude that a mechanistic understanding of the impact of water on the stability of amorphous pharmaceuticals would require systematic studies of water distribution and clustering, while such investigations are lacking. © 2014 Wiley Periodicals, Inc. and the American Pharmacists Association.

Informed consent: Enforcing pharmaceutical companies' obligations abroad.

PubMed

Lee, Stacey B

2010-06-15

The past several years have seen an evolution in the obligations of pharmaceutical companies conducting clinical trials abroad. Key players, such as international human rights organizations, multinational pharmaceutical companies, the United States government and courts, and the media, have played a significant role in defining these obligations. This article examines how such obligations have developed through the lens of past, present, and future recommendations for informed consent protections. In doing so, this article suggests that, no matter how robust obligations appear, they will continue to fall short of providing meaningful protection until they are accompanied by a substantive enforcement mechanism that holds multinational pharmaceutical companies accountable for their conduct. Issues of national sovereignty, particularly in the United States, will continue to prevent meaningful enforcement by an international tribunal or through one universally adopted code of ethics. This article argues that, rather than continuing to pursue an untenable international approach, the Alien Torts Statute (ATS) offers a viable enforcement mechanism, at least for US-based pharmaceutical companies. Recent federal appellate court precedent interpreting the ATS provides the mechanism for granting victims redress and enforcing accountability of sponsors (usually pharmaceutical companies and research and academic institutions) for informed consent misconduct. Substantive human rights protections are vital in order to ensure that every person can realize the "right to health." This article concludes that by building on the federal appellate court's ATS analysis, which grants foreign trial participants the right to pursue claims of human rights violations in US courts, a mechanism can be created for enforcing not only substantive informed consent, but also human rights protections.

A tool for corporate decision making about cognitive pharmaceutical services.

PubMed

Tipton, D J

2001-01-01

To present and discuss the models, theories, ideas, and frameworks that corporate decision makers would apply to the implementation of cognitive pharmaceutical services. Large chains and integrated delivery networks dominate the pharmacy marketplace. As a result, in many instances implementing cognitive pharmaceutical services, or expanding their delivery, first requires approval of a corporate decision maker, often not a pharmacist, who is schooled in marketing, management, and finance, and who necessarily views proposals for cognitive pharmaceutical services from those frames of reference. This article focuses on the following six marketing and management questions that corporate decision makers likely want answered before approving and funding the implementation of cognitive pharmaceutical services: (1) What is our product? (2) Who will pay, and what is the price? (3) Is there a market, and can it be reached? (4) What procedures must be put in place? (5) Who will deliver the service? (6) Where are the services to be delivered, and how is the facility to be presented? For a pharmacy manager charged with bringing cognitive pharmaceutical services to the marketplace, consideration of the issues detailed here meets a reasonable test of due diligence in committing human, financial, and organizational resources. It is natural for a pharmacist to look at cognitive pharmaceutical services through a professional lens. It is just as natural for a corporate decision marker to look at cognitive pharmaceutical services through a marketing and management lens. Unless both lenses are put together, one gets only half the picture.

Nano spray drying for encapsulation of pharmaceuticals.

PubMed

Arpagaus, Cordin; Collenberg, Andreas; Rütti, David; Assadpour, Elham; Jafari, Seid Mahdi

2018-05-17

Many pharmaceuticals such as pills, capsules, or tablets are prepared in a dried and powdered form. In this field, spray drying plays a critical role to convert liquid pharmaceutical formulations into powders. In addition, in many cases it is necessary to encapsulate bioactive drugs into wall materials to protect them against harsh process and environmental conditions, as well as to deliver the drug to the right place and at the correct time within the body. Thus, spray drying is a common process used for encapsulation of pharmaceuticals. In view of the rapid progress of nanoencapsulation techniques in pharmaceutics, nano spray drying is used to improve drug formulation and delivery. The nano spray dryer developed in the recent years provides ultrafine powders at nanoscale and high product yields. In this paper, after explaining the concept of nano spray drying and understanding the key elements of the equipment, the influence of the process parameters on the final powders properties, like particle size, morphology, encapsulation efficiency, drug loading and release, will be discussed. Then, numerous application examples are reviewed for nano spray drying and encapsulation of various drugs in the early stages of product development along with a brief overview of the obtained results and characterization techniques. Copyright © 2018 Elsevier B.V. All rights reserved.

[The pharmaceutical market in Mexico: size, value, and concentration].

PubMed

Torres Guerra, Sandra; Gutiérrez, Juan Pablo

2009-07-01

To describe the pharmaceutical drug market in Mexico in terms of its size, structure, business' market power, and consumer negotiating power. A descriptive study based on data from the 2004 Economics Census and the reports of IMS Health, Inc. (Norwalk, Connecticut, United States of America). Sales amounts and volumes of Mexico's pharmaceutical companies from 2002-2005 were obtained and the Herfindahl-Hirschman Index (HHI) and its inverse were calculated as indicators of the market's degree of concentration; also, price elasticity was determined by a product index. The total value of the products manufactured by the pharmaceutical sector was 115 billion in 2006 Mexican pesos, of which 99% pertained to companies categorized as large. This amount constituted 1.2% of the national gross domestic product that year (20.0% of the health sector's portion, estimated to be 6.0%) and 3.9% of the total value of manufactured goods. The HHI of Mexico's pharmaceutical market during the study period was about 0.04, albeit with a steady decline, and its inverse decreased from 23 to 26. The price elasticity of pharmaceutical products was minimal (0.007, 0.003, and -0.002). This study constitutes a preliminary description of Mexico's pharmaceutical market, one of the country's most dynamic economic sectors. It confirmed that the market is a rigid oligopoly, and thus supports enactment of firmer regulatory tools to reduce the power of the manufacturers in favor of that of the consumers.

Pharmaceuticals released from senior residences: occurrence and risk evaluation.

PubMed

Lacorte, Silvia; Luis, Silvia; Gómez-Canela, Cristian; Sala-Comorera, Teresa; Courtier, Audrey; Roig, Benoit; Oliveira-Brett, Ana Maria; Joannis-Cassan, Claire; Aragonés, Juan Ignacio; Poggio, Lucia; Noguer, Thierry; Lima, Luisa; Barata, Carlos; Calas-Blanchard, Carole

2018-03-01

One of the main pursuits, yet most difficult, in monitoring studies is to identify the sources of environmental pollution. In this study, we have identified health-care facilities from south European countries as an important source of pharmaceuticals in the environment. We have estimated that compounds consumed in by the elderly and released from effluents of senior residences can reach river waters at a concentration higher than 0.01 μg/L, which is the European Medicines Agency (EMA) threshold for risk evaluation of pharmaceuticals in surface waters. This study has been based on five health institutions in Portugal, Spain, and France, with 52 to 130 beds. We have compiled the pharmaceuticals dispensed on a daily base and calculated the consumption rates. From 54.9 to 1801 g of pharmaceuticals are consumed daily, with laxatives, analgesics, antiepileptics, antibiotics, and antidiabetic agents being the main drug families administered. According to excretion rates, dilution in the sewerage system, and elimination in wastewater treatment plants, macrogol, metformin, paracetamol, acetylcysteine, amoxicillin, and gabapentin, among others, are expected to reach river waters. Finally, we discuss the risk management actions related to the discharge of pharmaceuticals from senior residences to surface waters.

Effects of Glycosylation on the Stability of Protein Pharmaceuticals

PubMed Central

SOLÁ, RICARDO J.; GRIEBENOW, KAI

2008-01-01

In recent decades, protein-based therapeutics have substantially expanded the field of molecular pharmacology due to their outstanding potential for the treatment of disease. Unfortunately, protein pharmaceuticals display a series of intrinsic physical and chemical instability problems during their production, purification, storage, and delivery that can adversely impact their final therapeutic efficacies. This has prompted an intense search for generalized strategies to engineer the long-term stability of proteins during their pharmaceutical employment. Due to the well known effect that glycans have in increasing the overall stability of glycoproteins, rational manipulation of the glycosylation parameters through glycoengineering could become a promising approach to improve both the in vitro and in vivo stability of protein pharmaceuticals. The intent of this review is therefore to further the field of protein glycoengineering by increasing the general understanding of the mechanisms by which glycosylation improves the molecular stability of protein pharmaceuticals. This is achieved by presenting a survey of the different instabilities displayed by protein pharmaceuticals, by addressing which of these instabilities can be improved by glycosylation, and by discussing the possible mechanisms by which glycans induce these stabilization effects. PMID:18661536

The Purpose and Scope of Pedagogy in Pharmaceutical Education.

PubMed

Nakamura, Akihiro

2017-01-01

The WHO and International Pharmaceutical Federation (FIP) introduced the concept of the "seven-star pharmacist" in which a pharmacist is described as a caregiver, communicator, decision-maker, teacher, lifelong learner, leader and manager. In six-year pharmaceutical education programs, which have been provided in schools of pharmacy since 2006, 5th year students participate in on-site practice experiences in hospitals and community pharmacies. Thus, Japanese pharmacists also began to have a role in pharmaceutical education as teachers in clinical settings. Not only pharmacists in clinical settings, but also faculty members of pharmacy schools, had not previously been familiar with evidence-based education, and therefore they often teach in the way they were taught. Since research on teaching and learning has not been well developed in Japanese pharmaceutical education, both the model core curriculum for six-year programs and the subject benchmark statement for four-year programs are based on insufficient scientific evidence. We should promote the scholarship of teaching and learning, which promotes teaching as a scholarly endeavor and a worthy subject for research. In this review, I will summarize the needs and expectations for the establishment of pedagogy in pharmaceutical education.

Quantitative magnetic resonance micro-imaging methods for pharmaceutical research.

PubMed

Mantle, M D

2011-09-30

The use of magnetic resonance imaging (MRI) as a tool in pharmaceutical research is now well established and the current literature covers a multitude of different pharmaceutically relevant research areas. This review focuses on the use of quantitative magnetic resonance micro-imaging techniques and how they have been exploited to extract information that is of direct relevance to the pharmaceutical industry. The article is divided into two main areas. The first half outlines the theoretical aspects of magnetic resonance and deals with basic magnetic resonance theory, the effects of nuclear spin-lattice (T(1)), spin-spin (T(2)) relaxation and molecular diffusion upon image quantitation, and discusses the applications of rapid magnetic resonance imaging techniques. In addition to the theory, the review aims to provide some practical guidelines for the pharmaceutical researcher with an interest in MRI as to which MRI pulse sequences/protocols should be used and when. The second half of the article reviews the recent advances and developments that have appeared in the literature concerning the use of quantitative micro-imaging methods to pharmaceutically relevant research. Copyright © 2010 Elsevier B.V. All rights reserved.

In Defense of Pharmaceutically Enhancing Human Morality.

PubMed

Protopapadakis, Evangelos D

2017-01-01

I will discuss the prospect of pharmaceutically enhancing human morality and decision making in such a way as to eliminate morally unjustifiable choices and promote desirable ones. Our species in the relatively short period since it has emerged has enormously advanced in knowledge, science, and technical progress. When it comes to moral development, the distance it has covered is almost negligible. What if we could medically accelerate our moral development? What if we could once and for all render our species totally immune to certain vices? I will examine whether pharmaceutically intervening in human morality would compromise the autonomy of moral agents. I will argue that the argument from the autonomy of the moral agent is neither stable nor convincing. In the light of Kantian ethics we might consider moral enhancement by pharmaceutical means to be a perfect duty for moral agents.

Prioritizing human pharmaceuticals for ecological risks in the freshwater environment of Korea.

PubMed

Ji, Kyunghee; Han, Eun Jeong; Back, Sunhyoung; Park, Jeongim; Ryu, Jisung; Choi, Kyungho

2016-04-01

Pharmaceutical residues are potential threats to aquatic ecosystems. Because more than 3000 active pharmaceutical ingredients (APIs) are in use, identifying high-priority pharmaceuticals is important for developing appropriate management options. Priority pharmaceuticals may vary by geographical region, because their occurrence levels can be influenced by demographic, societal, and regional characteristics. In the present study, the authors prioritized human pharmaceuticals of potential ecological risk in the Korean water environment, based on amount of use, biological activity, and regional hydrologic characteristics. For this purpose, the authors estimated the amounts of annual production of 695 human APIs in Korea. Then derived predicted environmental concentrations, using 2 approaches, to develop an initial candidate list of target pharmaceuticals. Major antineoplastic drugs and hormones were added in the initial candidate list regardless of their production amount because of their high biological activity potential. The predicted no effect concentrations were derived for those pharmaceuticals based on ecotoxicity information available in the literature or by model prediction. Priority lists of human pharmaceuticals were developed based on ecological risks and availability of relevant information. Those priority APIs identified include acetaminophen, clarithromycin, ciprofloxacin, ofloxacin, metformin, and norethisterone. Many of these pharmaceuticals have been neither adequately monitored nor assessed for risks in Korea. Further efforts are needed to improve these lists and to develop management decisions for these compounds in Korean water. © 2015 SETAC.

An update on pharmaceutical film coating for drug delivery.

PubMed

Felton, Linda A; Porter, Stuart C

2013-04-01

Pharmaceutical coating processes have generally been transformed from what was essentially an art form in the mid-twentieth century to a much more technology-driven process. This review article provides a basic overview of current film coating processes, including a discussion on polymer selection, coating formulation additives and processing equipment. Substrate considerations for pharmaceutical coating processes are also presented. While polymeric coating operations are commonplace in the pharmaceutical industry, film coating processes are still not fully understood, which presents serious challenges with current regulatory requirements. Novel analytical technologies and various modeling techniques that are being used to better understand film coating processes are discussed. This review article also examines the challenges of implementing process analytical technologies in coating operations, active pharmaceutical ingredients in polymer film coatings, the use of high-solids coating systems and continuous coating and other novel coating application methods.

Boston Society's 11th Annual Applied Pharmaceutical Analysis conference.

PubMed

Lee, Violet; Liu, Ang; Groeber, Elizabeth; Moghaddam, Mehran; Schiller, James; Tweed, Joseph A; Walker, Gregory S

2016-02-01

Boston Society's 11th Annual Applied Pharmaceutical Analysis conference, Hyatt Regency Hotel, Cambridge, MA, USA, 14-16 September 2015 The Boston Society's 11th Annual Applied Pharmaceutical Analysis (APA) conference took place at the Hyatt Regency hotel in Cambridge, MA, on 14-16 September 2015. The 3-day conference affords pharmaceutical professionals, academic researchers and industry regulators the opportunity to collectively participate in meaningful and relevant discussions impacting the areas of pharmaceutical drug development. The APA conference was organized in three workshops encompassing the disciplines of regulated bioanalysis, discovery bioanalysis (encompassing new and emerging technologies) and biotransformation. The conference included a short course titled 'Bioanalytical considerations for the clinical development of antibody-drug conjugates (ADCs)', an engaging poster session, several panel and round table discussions and over 50 diverse talks from leading industry and academic scientists.

Urbanization gradient of selected pharmaceuticals in surface water at a watershed scale.

PubMed

Hong, Bing; Lin, Qiaoying; Yu, Shen; Chen, Yongshan; Chen, Yuemin; Chiang, Penchi

2018-04-06

Ubiquitous detection of pharmaceuticals in the aquatic environment around the world raises a great public concern. Aquatic residuals of pharmaceuticals have been assumed to relate to land use patterns and various human activities within a catchment or watershed. This study generated a gradient of human activity in the Jiulong River watershed, southeastern China by urban land use percentage in 20 research subwatersheds. Thirty-three compounds from three-category pharmaceuticals [26 compounds of 5 antibiotic groups, 6 compounds of non-steroidal anti-inflammatory drugs (NSAIDs), and 1 compound of respiratory system drugs (RSDs)] were quantified in stream water before the research subwatershed confluences with two sampling events in dry and wet seasons. In total, 27 out of the 33 pharmaceutical compounds of interest were found in stream waters. Seasonality of instream pharmaceuticals was observed, with less compounds and lower concentrations in the wet season sampling event than in the dry season one. Urban land use in the research subwatershed was identified as the main factor influencing in stream pharmaceutical concentrations and composition regardless of season. Rural land uses contributed a mixture of human and veterinary pharmaceuticals possibly from agricultural application of manure and sewage sludge and aquaculture in the research subwatersheds. Erythromycin in both sampling events showed medium to high risks to aquatic organisms. Results of this study suggest that urban pharmaceutical management, such as a strict prescription regulations and high-efficient removal of pharmaceuticals in wastewater treatment, is critical in reducing aquatic pharmaceutical loads. Copyright © 2018 Elsevier B.V. All rights reserved.

Recent advances in the application of transmission Raman spectroscopy to pharmaceutical analysis.

PubMed

Buckley, Kevin; Matousek, Pavel

2011-06-25

This article reviews recent advances in transmission Raman spectroscopy and its applications, from the perspective of pharmaceutical analysis. The emerging concepts enable rapid non-invasive volumetric analysis of pharmaceutical formulations and could lead to many important applications in pharmaceutical settings, including quantitative bulk analysis of intact pharmaceutical tablets and capsules in quality and process control. Crown Copyright © 2010. Published by Elsevier B.V. All rights reserved.

PNAUM: integrated approach to Pharmaceutical Services, Science, Technology and Innovation

PubMed Central

Gadelha, Carlos Augusto Grabois; Costa, Karen Sarmento; do Nascimento, José Miguel; Soeiro, Orlando Mário; Mengue, Sotero Serrate; da Motta, Márcia Luz; de Carvalho, Antônio Carlos Campos

2016-01-01

ABSTRACT This paper describes the development process of the Pesquisa Nacional sobre Acesso, Utilização e Promoção do Uso Racional de Medicamentos (PNAUM – National Survey on Access, Use and Promotion of Rational Use of Medicines) based on an integrated approach to pharmaceutical services, science, technology and innovation. It starts by contextualizing health and development in Brazil and features elements of the National Policy for Science, Technology and Innovation in Health in Brazil and the National Policy for Pharmaceutical Services. On presenting pharmaceutical policy guidelines, it stresses the lack of nationwide data. This survey, commissioned by the Brazilian Ministry of Health, has two components: household survey and evaluation of pharmaceutical services in primary care. The findings point to perspectives that represent, besides the enhancement of public policy for pharmaceutical services and public health, results of government action aimed at developing the economic and industrial health care complex to improve the health conditions of the Brazilian population. PMID:27982379

[Attitudes of general practitioners to pharmaceutical sales representatives in Sousse].

PubMed

Ben Abdelaziz, A; Harrabi, I; Rahmani, S; Ghedira, A; Gaha, K; Ghannem, H

2003-01-01

The therapeutic knowledge of physicians is the corner stone to the rational use of medicines; however information about medicines is generally obtained from the pharmaceutical industry via their sales representatives (reps). We aimed to identify general practitioners' (GPs) attitudes to pharmaceutical reps and the information they provide. We surveyed 140 GPs using a self-administered questionnaire. The response rate was 78% (72 GPs from the public sector and 68 from the private sector). About 10% of the GPs said they received daily visits from pharmaceutical reps; 84% of GPs considered them an efficient source of information and 31% said they might change their therapeutic prescribing following visits from these reps. Because of their positive perception of pharmaceutical reps, GPs are susceptible to the information they provide. Controlling the validity of the therapeutic information imparted by the pharmaceutical industry is thus a fundamental component of the programme for the rational use of medicines.

Prioritizing Environmental Risk of Prescription Pharmaceuticals

PubMed Central

Dong, Zhao; Senn, David B.; Moran, Rebecca E.

2015-01-01

Low levels of pharmaceutical compounds have been detected in aquatic environments worldwide, but their human and ecological health risks associated with low dose environmental exposure is largely unknown due to the large number of these compounds and a lack of information. Therefore prioritization and ranking methods are needed for screening target compounds for research and risk assessment. Previous efforts to rank pharmaceutical compounds have often focused on occurrence data and have paid less attention to removal mechanisms such as human metabolism. This study proposes a simple prioritization approach based on number of prescriptions and toxicity information, accounting for metabolism and wastewater treatment removal, and can be applied to unmeasured compounds. The approach was performed on the 200 most-prescribed drugs in the U.S. in 2009. Our results showed that under-studied compounds such as levothyroxine and montelukast sodium received the highest scores, suggesting the importance of removal mechanisms in influencing the ranking, and the need for future environmental research to include other less-studied but potentially harmful pharmaceutical compounds. PMID:22813724

[New distribution forms for pharmaceuticals--a logistic perspective].

PubMed

Grund, J; Vartdal, T E

1998-11-10

Pharmaceuticals are an important input in health care. As a complement to other modes of treatment and as a substitute for hospitalisation, they affect the health of individuals and populations. Enormous public financial resources are spent on pharmaceuticals, and halting the growth in expenditures is a political objective. Factors with room for improvement include drug use efficiency, cost-efficient prescription, purchasing prices and distribution. High distribution costs affect prices and, thus, the assessment of product cost vs. utility. Changes in the distribution system may be important, for three reasons: First, increased capital costs call for higher efficiency. Second, increased competition requires improved logistics. And third, information technology has opened up for new supply chain solutions. Direct sales solutions are being considered, and were discussed in a Norwegian public report on the matter, but no final conclusion has been reached. This article discusses changes in the supply of pharmaceuticals and the development of the market. Alternative supply chains are outlined, including what role the postal service may play in a deregulated pharmaceutical market.

Tackling corruption in the pharmaceutical systems worldwide with courage and conviction.

PubMed

Cohen, J C; Mrazek, M; Hawkins, L

2007-03-01

Poor drug access continues to be one of the main global health problems. Global inequalities in access to pharmaceuticals are caused by a number of variables including poverty, high drug prices, poor health infrastructure, and fraud and corruption--the latter being the subject of this article. There is growing recognition among policy makers that corruption in the pharmaceutical system can waste valuable resources allocated to pharmaceutical products and services. This, in turn, denies those most in need from life-saving or life-enhancing medicines. As a result, international organizations, including the World Health Organization and the World Bank are beginning to address the issue of corruption in the health sector broadly and the pharmaceutical system specifically. This is encouraging news for improving drug access for the global poor who are most harmed by corruption as they tend to purchase less expensive drugs from unqualified or illegal drug sellers selling counterfeit or sub-standard drugs. In our paper, we illuminate what are the core issues that relate to corruption in the pharmaceutical sector. We argue that corruption in the pharmaceutical system can be detrimental to a country's ability to improve the health of its population. Moreover, unless policy makers deal with the issue of corruption, funding allocated to the pharmaceutical system to treat health conditions may simply be wasted and the inequality between rich and poor in access to health and pharmaceutical products will be aggravated.

Pricing and reimbursement of pharmaceuticals in the Czech Republic and Sweden.

PubMed

Davidova, Jana; Praznovcova, Lenka; Lundborg, Cecilia Stålsby

2008-01-01

To describe and compare price regulation and reimbursement in the Czech Republic and Sweden. Legal documents, government reports, statutory information, annual reports and scientific articles were searched using the keywords: pharmaceutical market regulation, drug policy, drug pricing, drug reimbursement and patients' participation in costs concerning both countries. Approaches to regulation and regulatory steps concerning prices were compared between the countries. (i) Institutional responsibilities in pricing and reimbursement of pharmaceuticals; (ii) principles of patients' participation in costs on pharmaceuticals. Substantial differences were found in terms of pricing. In the Czech Republic, the Ministry of Finance sets maximal prices for pharmaceuticals whereas in Sweden there is a process of price regulation combined with reimbursement decisions taken by the Pharmaceutical Benefits Board. Together with a system of state-owned pharmacies, this ensures that drug prices in Sweden are fixed at the same level throughout the country. In the Czech Republic, prices may differ, since only maximal price levels are set. In both countries, decisions about reimbursement are taken at the national or state level whereas insurance funds or county councils are responsible for covering costs. The private share of pharmaceutical expenditures is substantially lower in the Czech Republic, even though there is no maximal level for patient's co-payment, as there is in Sweden. Differences in price setting and some other regulations of the pharmaceutical market were found. Both systems are designed to promote rational use of pharmaceuticals; and are based on social solidarity.

Pharmaceutical Concern and Prioritization Framework for Aquatic Life Effects

EPA Science Inventory

Human pharmaceuticals and veterinary drugs are being developed and used at an increasing rate world-wide. This, and increasingly sensitive analytical techniques, have lead to recurrent detection of pharmaceuticals as environmental pollutants. The goal of the present work was to d...

Chemistry in the Comics: Part 2. Classic Chemistry.

ERIC Educational Resources Information Center

Carter, Henry A.

1989-01-01

Describes topics in chemistry as related in the Classics Illustrated publications. Provides a list from "The Pioneers of Science" series with issue date, number, and biograhical topic. Lists references to topics in chemistry. Presents many pages from these comics. (MVL)

The Significance of the Origin of Physical Chemistry for Physical Chemistry Education: The Case of Electrolyte Solution Chemistry

ERIC Educational Resources Information Center

de Berg, Kevin Charles

2014-01-01

Physical Chemistry's birth was fraught with controversy, a controversy about electrolyte solution chemistry which has much to say about how scientific knowledge originates, matures, and responds to challenges. This has direct implications for the way our students are educated in physical chemistry in particular and science in general. The…

Code of ethics for the national pharmaceutical system: Codifying and compilation

PubMed Central

Salari, Pooneh; Namazi, Hamidreza; Abdollahi, Mohammad; Khansari, Fatemeh; Nikfar, Shekoufeh; Larijani, Bagher; Araminia, Behin

2013-01-01

Pharmacists as one of health-care providers face ethical issues in terms of pharmaceutical care, relationship with patients and cooperation with the health-care team. Other than pharmacy, there are pharmaceutical companies in various fields of manufacturing, importing or distributing that have their own ethical issues. Therefore, pharmacy practice is vulnerable to ethical challenges and needs special code of conducts. On feeling the need, based on a shared project between experts of the ethics from relevant research centers, all the needs were fully recognized and then specified code of conduct for each was written. The code of conduct was subject to comments of all experts involved in the pharmaceutical sector and thus criticized in several meetings. The prepared code of conduct is comprised of professional code of ethics for pharmacists, ethics guideline for pharmaceutical manufacturers, ethics guideline for pharmaceutical importers, ethics guideline for pharmaceutical distributors, and ethics guideline for policy makers. The document was compiled based on the principles of bioethics and professionalism. The compiling the code of ethics for the national pharmaceutical system is the first step in implementing ethics in pharmacy practice and further attempts into teaching the professionalism and the ethical code as the necessary and complementary effort are highly recommended. PMID:24174954

Between pharmaceutical patents and European patients: is a compromise still possible?

PubMed

Garattini, Livio; Padula, Anna

2017-10-01

Pharmaceutical regulation has always attempted to balance the public health objective to make safe and effective drugs available for patients while providing commercial incentives through patents. Here we discuss whether it is still possible to find a balance between the incentives on the supply side and the regulatory framework on the demand side. Areas covered: The current regulatory framework on pharmaceutical exclusivity has been harshly criticized by many experts, arguing about whether it is still fit for public purposes and needs. Here we envisage a different scenario without 'revolutionizing' the whole present system. The main radical change should concern the present management of pharmaceutical patents by introducing a specific agency dedicated to them. Secondly, specific pharmaceutical patents could be restricted to compounds for one (or more) declared indication(s). Thirdly, pharmaceutical patents should be kept only for compounds that start a first clinical trial within five years from the granting date. Expert opinion: We think it is time to reconsider the regulation of pharmaceutical patents in the light of their relevance in terms of public health. New models of enhancing research investments are required for long-term sustainability of public pharmaceutical expenditure and the EU can still play a leading role.

Chiral pharmaceuticals: A review on their environmental occurrence and fate processes.

PubMed

Sanganyado, Edmond; Lu, Zhijiang; Fu, Qiuguo; Schlenk, Daniel; Gan, Jay

2017-11-01

More than 50% of pharmaceuticals in current use are chiral compounds. Enantiomers of the same pharmaceutical have identical physicochemical properties, but may exhibit differences in pharmacokinetics, pharmacodynamics and toxicity. The advancement in separation and detection methods has made it possible to analyze trace amounts of chiral compounds in environmental media. As a result, interest on chiral analysis and evaluation of stereoselectivity in environmental occurrence, phase distribution and degradation of chiral pharmaceuticals has grown substantially in recent years. Here we review recent studies on the analysis, occurrence, and fate of chiral pharmaceuticals in engineered and natural environments. Monitoring studies have shown ubiquitous presence of chiral pharmaceuticals in wastewater, surface waters, sediments, and sludge, particularly β-receptor antagonists, analgesics, antifungals, and antidepressants. Selective sorption and microbial degradation have been demonstrated to result in enrichment of one enantiomer over the other. The changes in enantiomer composition may also be caused by biologically catalyzed chiral inversion. However, accurate evaluation of chiral pharmaceuticals as trace environmental pollutants is often hampered by the lack of identification of the stereoconfiguration of enantiomers. Furthermore, a systematic approach including occurrence, fate and transport in various environmental matrices is needed to minimize uncertainties in risk assessment of chiral pharmaceuticals as emerging environmental contaminants. Copyright © 2017 Elsevier Ltd. All rights reserved.

Hot-melt co-extrusion: requirements, challenges and opportunities for pharmaceutical applications.

PubMed

Vynckier, An-Katrien; Dierickx, Lien; Voorspoels, Jody; Gonnissen, Yves; Remon, Jean Paul; Vervaet, Chris

2014-02-01

Co-extrusion implies the simultaneous hot-melt extrusion of two or more materials through the same die, creating a multi-layered extrudate. It is an innovative continuous production technology that offers numerous advantages over traditional pharmaceutical processing techniques. This review provides an overview of the co-extrusion equipment, material requirements and medical and pharmaceutical applications. The co-extrusion equipment needed for pharmaceutical production has been summarized. Because the geometrical design of the die dictates the shape of the final product, different die types have been discussed. As one of the major challenges at the moment is shaping the final product in a continuous way, an overview of downstream solutions for processing co-extrudates into drug products is provided. Layer adhesion, extrusion temperature and viscosity matching are pointed out as most important requirements for material selection. Examples of medical and pharmaceutical applications are presented and some recent findings considering the production of oral drug delivery systems have been summarized. Co-extrusion provides great potential for the continuous production of fixed-dose combination products which are gaining importance in pharmaceutical industry. There are still some barriers to the implementation of co-extrusion in the pharmaceutical industry. The optimization of downstream processing remains a point of attention. © 2013 Royal Pharmaceutical Society.

Active methodology and blended learning: An experience in pharmaceutical care.

PubMed

Czepula, Alexandra Ingrid Dos Santos; Bottacin, Wallace Entringer; Júnior, Edson Hipólito; Pontarolo, Roberto; Correr, Cassyano Januário

The aim of this study was to analyze the implementation of an active methodology in a blended model of education in the teaching-learning processes of students enrolled in two disciplines: Pharmaceutical Care I and Pharmaceutical Care II, both part of the undergraduate Bachelor of Pharmacy program at the Federal University of Paraná. The study design was quasi-experimental, prospective, comparative, following a pre/posttest format, where Pharmaceutical Care classes were the intervention. Identical pre- and post-intervention tests were designed based on Anderson and Krathwohl's (2001) revision of Bloom's taxonomy, and according to the three levels of the cognitive domain: remember and understand; apply and analyze; evaluate and create. Participants were 133 students enrolled in the two Pharmaceutical Care classes. A significant difference between pre- and posttest results was observed, showing an increase in students' performance in the applied tests at all cognitive levels. This is the first study of its kind involving Pharmaceutical Care and Blended Learning. By comparing the results of the diagnostic and summative assessments based on Bloom's taxonomy at all levels of the cognitive domain, positive results were observed regarding the students' performance in the two disciplines (Pharmaceutical Care I and II). Copyright © 2017 Elsevier Inc. All rights reserved.

Use of atypical antipsychotics in nursing homes and pharmaceutical marketing.

PubMed

Pimentel, Camilla B; Donovan, Jennifer L; Field, Terry S; Gurwitz, Jerry H; Harrold, Leslie R; Kanaan, Abir O; Lemay, Celeste A; Mazor, Kathleen M; Tjia, Jennifer; Briesacher, Becky A

2015-02-01

To describe the current extent and type of pharmaceutical marketing in nursing homes (NHs) in one state and to provide preliminary evidence for the potential influence of pharmaceutical marketing on the use of atypical antipsychotics in NHs. Nested mixed-methods, cross-sectional study of NHs in a cluster randomized trial. Forty-one NHs in Connecticut. NH administrators, directors of nursing, and medical directors (n = 93, response rate 75.6%). Quantitative data, including prescription drug dispensing data (September 2009-August 2010) linked with Nursing Home Compare data (April 2011), were used to determine facility-level prevalence of atypical antipsychotic use, facility-level characteristics, NH staffing, and NH quality. Qualitative data, including semistructured interviews and surveys of NH leaders conducted in the first quarter of 2011, were used to determine encounters with pharmaceutical marketing. Leadership at 46.3% of NHs (n = 19) reported pharmaceutical marketing encounters, consisting of educational training, written and Internet-based materials, and sponsored training. No association was detected between level of atypical antipsychotic prescribing and reports of any pharmaceutical marketing by at least one NH leader. NH leaders frequently encounter pharmaceutical marketing through a variety of ways, although the impact on atypical antipsychotic prescribing is unclear. © 2015, Copyright the Authors Journal compilation © 2015, The American Geriatrics Society.

Chemistry on Stamps.

ERIC Educational Resources Information Center

Schreck, James O.

1986-01-01

Suggests how postage stamps can be incorporated into chemistry teaching. Categories considered include emergence of chemistry as a science, metric system, atoms (and molecules and ions), stoichiometry, energy relationships in chemical systems, chemical bonding, nuclear chemistry, biochemistry, geochemistry, matter (gases, liquids, and solids),…

Is Chemistry Attractive for Pupils? Czech Pupils' Perception of Chemistry

ERIC Educational Resources Information Center

Kubiatko, Milan

2015-01-01

Chemistry is an important subject due to understanding the composition and structure of the things around us. The main aim of the study was to find out the perception of chemistry by lower secondary school pupils. The partial aims were to find out the influence of gender, year of study and favorite subject on the perception of chemistry. The…

Global pharmaceutical regulation: the challenge of integration for developing states.

PubMed

Pezzola, Anthony; Sweet, Cassandra M

2016-12-20

This paper has set out to map the state of pharmaceutical regulation in the developing world through the construction of cross-national indices drawing from World Health Organization data. The last two decades have been characterized by deep changes for the pharmaceutical sector, including the complete transformation of intellectual property systems at the behest of the World Trade Organization and the consolidation of global active ingredient suppliers in China and India. Although the rules for ownership of medicine have been set and globally implemented, we know surprisingly little about how the standards for market entrance and regulation of pharmaceutical products have changed at the national level. How standardized are national pharmaceutical market systems? Do we find homogeneity or variation across the developing world? Are their patterns for understanding why some countries have moved closer to one global norm for pharmaceutical regulation and others have developed hybrid models for oversight of this sector? Access to medicine is a core tool in public health. This paper gauges the levels of standards in public and private generics markets for developing countries building on national-level pharmaceutical market surveys for 78 countries to offer three indicators of market oversight: State Regulatory Infrastructure, Monitoring the Private Market and Public Quality Control. Identifying the different variables that affect a state's institutional capacity and current standard level offers new insights to the state of pharmaceuticals in the developing world. It is notable that there are very few (none at the time of this paper) studies that map out the new global terrain for pharmaceutical regulation in the post-TRIPS context. This paper uses item response theory to develop original indicators of pharmaceutical regulation. We find remarkable resistance to the implementation of global pharmaceutical norms for quality standards in developing states and in

Interactions Between Pharmaceutical Representatives and Doctors in Training

PubMed Central

Zipkin, Daniella A; Steinman, Michael A

2005-01-01

Objective Medical school and residency are formative years in establishing patterns of prescribing. We aimed to review the literature regarding the extent of pharmaceutical industry contact with trainees, attitudes about these interactions, and effects on trainee prescribing behavior, with an emphasis on points of potential intervention and policy formation. Design We searched MEDLINE from 1966 until May 2004 for English language articles. All original articles were included if the abstract reported content relevant to medical training and the pharmaceutical industry. Editorials, guidelines, and policy recommendations were excluded. Measurements and Main Results Contact with pharmaceutical representatives was common among residents. The majority of trainees felt that the interactions were appropriate. A minority felt that their own prescribing could be influenced by contact or gifts, but were more likely to believe that others' prescribing could be influenced. Resident prescribing was associated with pharmaceutical representative visits and the availability of samples. A variety of policy and educational interventions appear to influence resident attitudes toward interactions with industry, although data on the long-term effects of these interventions are limited. Overall, residents reported insufficient training in this area. Conclusions The pharmaceutical industry has a significant presence during residency training, has gained the overall acceptance of trainees, and appears to influence prescribing behavior. Training programs can benefit from policies and curricula that teach residents about industry influence and ways in which to critically evaluate information that they are given. Recommendations for local and national approaches are discussed. PMID:16050893

Mitigating pharmaceutical waste exposures: policy and program considerations.

PubMed

Amster, Eric D

2016-01-01

Pharmaceutical disposal and the environmental fate of medication metabolites directly impacts the public's health in two significant ways: accidental medication ingestion of pharmaceuticals that were not disposed of properly results in inadvertent toxicity; and environmental health consequences of pharmaceuticals that were inappropriately disposed and which contaminate municipal water supply. In reviewing the effectiveness of medication disposal policy globally, it is crucial to not only determine which policies are effective but also to assess why they are effective. By assessing the root causes for a specific policy's effectiveness it can be determined if those successes could be translated to another country with a different health care system, unique culture and divergent policy ecosystem. Any intervention regarding pharmaceutical disposal would require a multifaceted approach beyond raising awareness and coordinating pharmaceutical disposal on a national level. While consumer participation is important, effective primary prevention would also include research on drug development that is designed to biodegrade in the environment as opposed to medications that persist and accumulate in the natural environment even when properly disposed. Countries that lack a nationalized disposal policy should leverage the resources and infrastructure already in place in the national health care system to implement a unified policy to address medication disposal in the short-term. In tandem, efforts should be made to recruit the biotechnology sector in high-tech and academia to develop new technologies in medication design and water filtration to decrease exposures in the long-term.

Pharmaceutical policies for the Third World--whose responsibility?

PubMed

1983-07-16

Several developing countries, such as Bangladesh, Cuba, India, and Mozambique, are currently formulating national pharmaceutical policies to reduce expenditures on drugs while increasing their availability to those in greatest need. 5 components of such national policies have been identified: 1) elimination of ineffective and inappropriate preparations through concentrating on a selection such as the World Health Organization's 200 "basic and essential drugs", coupled with national drug pricing policies that discriminate between essential drugs and non-essential or luxury drugs; 2) public systems of drug distribution which would reduce costs to the consumer; 3) importation of the limited number of drugs distributed through the public system in bulk, which might reduce costs by 20-25%; 4) use of generic rather than brand name drugs; and 5) establishment of domestic pharmaceutical industries within developing countries to encourage research into drugs for local health problems, reduce use of foreign exchange to import drugs, and increase local self-reliance in dealing with disease. In November 1982, Health Action International, a coordinating body for more than 50 publish interest groups seeking to promote rational use of pharmaceuticals, presented a draft internationl code on pharmaceuticals to the UN Conference on Trade and Development. A voluntary code produced in 1981 by the International Federation of Pharmaceutical Manufacturers' Associations paid little attention to monitoring and enforcement. Little progress has been made, and the need for sensible policy making at the international and national levels has long been apparent.

Medical student views on interactions with pharmaceutical representatives.

PubMed

Ganzini, Linda; Chen, Zunqiu; Peters, Dawn; Misra, Sahana; Macht, Madison; Osborne, Molly; Keepers, George

2012-05-01

In 2006, the Housestaff Association presented the Dean at Oregon Health and Science University (OHSU) with a proposal to effectively end the influence of the pharmaceutical industry on campus. The Dean convened a workgroup to examine the issue, and faculty, residents, and medical students were surveyed on their views and interactions. Authors present here the responses from medical students. A web-based, anonymous survey was sent to all OHSU medical students in 2007; 59% completed it. The survey included items measuring attitudes about the pharmaceutical industry and interactions with pharmaceutical representatives (PRs). Only 5% of clinical and 7% of preclinical students agreed that PRs have an important teaching role, and fewer than 1 in 6 believed that PRs provided useful and accurate information on either new or established drugs; 54% of clinical students indicated that PRs should be restricted from making presentations on campus, versus 32% of preclinical students, and only 30% of clinical students agreed that accepting gifts had no impact on their own prescribing, versus 50% of preclinical students. Students who acknowledged the influence of PRs and perceived less educational benefit were less likely to accept gifts such as textbooks; however, 84% of clinical students had attended an on-campus event sponsored by a pharmaceutical company in the previous year. Only a small proportion of OHSU medical students value interactions with PRs, but many still attend events sponsored by pharmaceutical companies.

Pharmaceuticals and Wastewater Tracers Along the Lower Hudson River

EPA Science Inventory

The behavior and fate of pharmaceutical residues in urbanized, coastal ecosystems is not well understood. In this study 16 highly prescribed pharmaceuticals were measured in the lower Hudson River and New York Harbor in order to elucidate factors and processes regulating their ...

Pharmaceutical logistics in the European theater.

PubMed

Spain, J

1999-10-01

This article describes the responsibilities and objectives of the pharmacy officer for the U.S. Army Medical Materiel Center, Europe. Pharmacists' experiences and knowledge offer advantages in the ordering, storage, and distribution of medical materiel. Exploitation of new technology and a customer-focused attitude encourage a working environment that capitalizes on pharmaceutical expertise. The use of temperature monitors, enhanced automation opportunities, expired drug return credits, and other customer-focused initiatives exemplify pharmacists' value to military medical logistics organizations. An overview of the pharmaceutical pipeline to U.S. military and State Department customers in the European theater is provided.

The view of the pharmaceutical industry.

PubMed

Roche, G; Helenport, J P

1994-06-01

Rhône-Poulenc Rorer has committed itself to the development of artemether because we believe the drug will be of considerable benefit to sufferers from severe falciparum malaria, and because it is a stable, effective and economical compound that can be given by intramuscular injection. The quality of the pharmaceutical product meets international regulatory standards. Artemether is unlikely to yield big profits, but we believe that major pharmaceutical companies have a responsibility to develop such much-needed products. To develop this project further, we will need the assistance of academic institutions, research organizations and international bodies.

[Major milestones for European pharmaceutical policy].

PubMed

Sauer, Fernand

2014-01-01

Under the 1985 White Paper on the completion of the single market, several pharmaceutical harmonisation measures were unanimously adopted, in favor of biotech products and on pricing transparency, legal status of prescription, wholesale distribution and advertising. The European pharmaceutical harmonisation was extended to Norway and Iceland, to new accession member states and through major international conferences with the US and Japan (ICH). Starting in 1995, the European medicines agency has produced an efficient marketing authorisation system for new human and veterinary medicines. The system was extended to pediatric medicines and advanced therapies. The monitoring of drug adverse effects (pharmacovigilance) has been gradually strengthened.

Aspects of research and development contract terms in the bio/pharmaceutical sector.

PubMed

Banerjee, Tannista

2012-01-01

The cost of new drug development is increasing every year. Pharmaceutical companies use R&D joint ventures, mergers, and outsource different stages of pharmaceutical R&D activities for a faster and cost minimizing method of innovation. Pharmaceutical companies outsource R&D activities to independent small biotech or pharmaceutical companies that specialize in different stages of pharmaceutical R&D. This chapter examines the determinants of the payment structure of research contracts between large bio/pharmaceutical companies and specialized research firms. Determinants of R&D contracts are analyzed using detailed R&D contract data between bio/pharmaceutical companies and independent research firms for 10 years. A multinomial logit model is used in order to understand the determinants of three different types of contracts; royalty contracts, fixed payment contracts, and the mixed contracts. Under uncertainty, the likelihood of a royalty contract rises for the early stages of the research and with the patent stock of the research firm. It is more likely to observe both royalty and fixed payment if the pharmaceutical client has past contracts with the same research firm. The results also suggest that if Food and Drug Administration (FDA) is more stringent in any disease area in reviewing the new drug application, then the likelihood of signing pure royalty contract decreases. Understanding the nature of R&D contracts and the effects of FDA's behavior on the pharmaceutical R&D contract is important because these contracts not only affect the cost of new drug invention but also the quality and the rate of invention. VALUE: Results are useful for both the pharmaceutical companies and the economic/business researchers.

Use of Atypical Antipsychotics in Nursing Homes and Pharmaceutical Marketing

PubMed Central

Pimentel, Camilla B.; Donovan, Jennifer L.; Field, Terry S.; Gurwitz, Jerry H.; Harrold, Leslie R.; Kanaan, Abir O.; Lemay, Celeste A.; Mazor, Kathleen M.; Tjia, Jennifer; Briesacher, Becky A.

2014-01-01

BACKGROUND Many nursing home (NH) residents are prescribed atypical antipsychotics despite US Food and Drug Administration warnings of increased risk of death in older adults with dementia. Aggressive pharmaceutical marketing has been cited as a potential cause, although data are scarce. The objectives of this study were to describe the current extent and type of pharmaceutical marketing in NHs in one state, and to provide preliminary evidence for the potential influence of pharmaceutical marketing on the use of atypical antipsychotics in NHs. DESIGN Nested mixed-methods, cross-sectional study of NHs in a cluster randomized trial. SETTING 41 NHs in Connecticut. PARTICIPANTS NH administrators, directors of nursing and medical directors (n = 93, response rate 75.6%). MEASUREMENTS Quantitative data, including prescription drug dispensing data (September 2009–August 2010) linked with Nursing Home Compare data (April 2011), were used to determine facility-level prevalence of atypical antipsychotic use, facility-level characteristics, NH staffing and NH quality. Qualitative data, including semi-structured interviews and surveys of NH leaders conducted in the first quarter of 2011, were used to determine encounters with pharmaceutical marketing. RESULTS Leadership at 46.3% of NHs (19/41) reported pharmaceutical marketing encounters, consisting of educational training, written/Internet-based materials and/or sponsored training. No association was detected between the level of atypical antipsychotic prescribing and reports of any pharmaceutical marketing by at least one NH leader. CONCLUSION NH leaders frequently encounter pharmaceutical marketing through a variety of ways, although the impact on atypical antipsychotic prescribing is unclear. PMID:25688605

Towards "Bildung"-Oriented Chemistry Education

ERIC Educational Resources Information Center

Sjöström, Jesper

2013-01-01

This paper concerns "Bildung"-oriented chemistry education, based on a reflective and critical discourse of chemistry. It is contrasted with the dominant type of chemistry education, based on the mainstream discourse of chemistry. "Bildung"-oriented chemistry education includes not only content knowledge in chemistry, but also…

42 CFR 88.16 - Reimbursement for medically necessary treatment, outpatient prescription pharmaceuticals...

Code of Federal Regulations, 2014 CFR

2014-10-01

..., outpatient prescription pharmaceuticals, monitoring, initial health evaluations, and travel expenses. 88.16... for medically necessary treatment, outpatient prescription pharmaceuticals, monitoring, initial health... pharmaceuticals. (1) The costs of providing medically necessary treatment or services for a WTC-related health...

42 CFR 88.16 - Reimbursement for medically necessary treatment, outpatient prescription pharmaceuticals...

Code of Federal Regulations, 2011 CFR

2011-10-01

..., outpatient prescription pharmaceuticals, monitoring, initial health evaluations, and travel expenses. 88.16... for medically necessary treatment, outpatient prescription pharmaceuticals, monitoring, initial health... pharmaceuticals. (1) The costs of providing medically necessary treatment or services for a WTC-related health...

42 CFR 88.16 - Reimbursement for medically necessary treatment, outpatient prescription pharmaceuticals...

Code of Federal Regulations, 2013 CFR

2013-10-01

..., outpatient prescription pharmaceuticals, monitoring, initial health evaluations, and travel expenses. 88.16... for medically necessary treatment, outpatient prescription pharmaceuticals, monitoring, initial health... pharmaceuticals. (1) The costs of providing medically necessary treatment or services for a WTC-related health...

42 CFR 88.16 - Reimbursement for medically necessary treatment, outpatient prescription pharmaceuticals...

Code of Federal Regulations, 2012 CFR

2012-10-01

..., outpatient prescription pharmaceuticals, monitoring, initial health evaluations, and travel expenses. 88.16... for medically necessary treatment, outpatient prescription pharmaceuticals, monitoring, initial health... pharmaceuticals. (1) The costs of providing medically necessary treatment or services for a WTC-related health...

Microcap pharmaceutical firms: linking drug pipelines to market value.

PubMed

Beach, Robert

2012-01-01

This article examines predictors of the future market value of microcap pharmaceutical companies. This is problematic since the large majority of these firms seldom report positive net income. Their value comes from the potential of a liquidity event such as occurs when a key drug is approved by the FDA. The typical scenario is one in which the company is either acquired by a larger pharmaceutical firm or enters into a joint venture with another pharmaceutical firm. Binary logistic regression is used to determine the impact of the firm's drug treatment pipeline and its investment in research and development on the firm's market cap. Using annual financial data from 2007 through 2010, this study finds that the status of the firm's drug treatment pipeline and its research and development expenses are significant predictors of the firm's future stock value relative to other microcap pharmaceutical firms.

Microbial Removal of the Pharmaceutical Compounds Ibuprofen and Diclofenac from Wastewater

PubMed Central

Inderfurth, Nadia; Schraa, Gosse; Kujawa-Roeleveld, Katarzyna; Rijnaarts, Huub

2013-01-01

Studies on the occurrence of pharmaceuticals show that the widely used pharmaceuticals ibuprofen and diclofenac are present in relevant concentrations in the environment. A pilot plant treating hospital wastewater with relevant concentrations of these pharmaceuticals was evaluated for its performance to reduce the concentration of the pharmaceuticals. Ibuprofen was completely removed, whereas diclofenac yielded a residual concentration, showing the necessity of posttreatment to remove diclofenac, for example, activated carbon. Successively, detailed laboratory experiments with activated sludge from the same wastewater treatment plant showed bioremediation potential in the treatment plant. The biological degradation pathway was studied and showed a mineralisation of ibuprofen and degradation of diclofenac. The present microbes were further studied in laboratory experiments, and DGGE analyses showed the enrichment and isolation of highly purified cultures that degraded either ibuprofen or diclofenac. This research illuminates the importance of the involved bacteria for the effectiveness of the removal of pharmaceuticals in a wastewater treatment plant. A complete removal of pharmaceuticals from wastewater will stimulate water reuse, addressing the worldwide increasing demand for clean and safe fresh water. PMID:24350260

Green Chemistry Metrics with Special Reference to Green Analytical Chemistry.

PubMed

Tobiszewski, Marek; Marć, Mariusz; Gałuszka, Agnieszka; Namieśnik, Jacek

2015-06-12

The concept of green chemistry is widely recognized in chemical laboratories. To properly measure an environmental impact of chemical processes, dedicated assessment tools are required. This paper summarizes the current state of knowledge in the field of development of green chemistry and green analytical chemistry metrics. The diverse methods used for evaluation of the greenness of organic synthesis, such as eco-footprint, E-Factor, EATOS, and Eco-Scale are described. Both the well-established and recently developed green analytical chemistry metrics, including NEMI labeling and analytical Eco-scale, are presented. Additionally, this paper focuses on the possibility of the use of multivariate statistics in evaluation of environmental impact of analytical procedures. All the above metrics are compared and discussed in terms of their advantages and disadvantages. The current needs and future perspectives in green chemistry metrics are also discussed.

Exploration of Fluorine Chemistry at the Multidisciplinary Interface of Chemistry and Biology

PubMed Central

Ojima, Iwao

2013-01-01

Over the last three decades, my engagement in “fluorine chemistry” has evolved substantially, because of the multidisciplinary nature of the research programs. I began my research career as a synthetic chemist in organometallic chemistry and homogeneous catalysis directed toward organic synthesis. Then, I was brought into a very unique world of “fluorine chemistry” in the end of 1970s. I started exploring the interface of fluorine chemistry and transition metal homogeneous catalysis first, which was followed by amino acids, peptides, and peptidomimetics for medicinal chemistry. Since then, I have been exploring the interfaces of fluorine chemistry and multidisciplinary fields of research involving medicinal chemistry, chemical biology, cancer biology and molecular imaging. This perspective intends to cover my fruitful endeavor in the exploration of fluorine chemistry at the multidisciplinary interface of chemistry and biology in a chronological order to show the evolution of my research interest and strategy. PMID:23614876

Quantitative Microbial Risk Assessment of Pharmaceutical Products.

PubMed

Eissa, Mostafa Essam

2017-01-01

Monitoring of microbiological quality in the pharmaceutical industry is an important criterion that is required to justify safe product release to the drug market. Good manufacturing practice and efficient control on bioburden level of product components are critical parameters that influence the microbiological cleanliness of medicinal products. However, because microbial dispersion through the samples follows Poisson distribution, the rate of detection of microbiologically defective samples lambda (λ) decreases when the number of defective units per batch decreases. When integrating a dose-response model of infection (P inf ) of a specific objectionable microbe with a contamination module, the overall probability of infection from a single batch of pharmaceutical product can be estimated. The combination of P inf with detectability chance of the test (P det ) will yield a value that could be used as a quantitative measure of the possibility of passing contaminated batch units of product with a certain load of a specific pathogen and infecting the final consumer without being detected in the firm. The simulation study can be used to assess the risk of contamination and infection from objectionable microorganisms for sterile and non-sterile products. LAY ABSTRACT: Microbial contamination of pharmaceutical products is a global problem that may lead to infection and possibly death. While reputable pharmaceutical companies strive to deliver microbiologically safe products, it would be helpful to apply an assessment system for the current risk associated with pharmaceutical batches delivered to the drug market. The current methodology may be helpful also in determining the degree of improvement or deterioration on the batch processing flow until reaching the final consumer. Moreover, the present system is flexible and can be applied to other industries such as food, cosmetics, or medical devices manufacturing and processing fields to assess the microbiological risk of

Premedical students' exposure to the pharmaceutical industry's marketing practices.

PubMed

Hodges, Laura E; Arora, Vineet M; Humphrey, Holly J; Reddy, Shalini T

2013-02-01

Physicians' exposure to pharmaceutical industry marketing raises concerns about their ability to make unbiased, evidence-based prescription decisions. This exposure begins early in medical education. The authors examined the frequency and context of such exposures for students before matriculation to medical school. The authors distributed two separate but related questionnaires to all 389 students who matriculated at the University of Chicago Pritzker School of Medicine between 2007 and 2010. The survey inquired about interactions with the pharmaceutical industry before entering medical school. Descriptive statistics and Wilcoxon rank sum tests were used to analyze data. Across four years, 282 (72.5%) students responded to the first survey; 219 (56.3%) responded to the follow-up survey. The majority of those (62.1%) had interacted with or were exposed to pharmaceutical marketing before medical school. The most common interactions were accepting a pen (50.2%) and attending a sponsored lunch (37.9%), which occurred most commonly while shadowing (33.6% and 42.2%, respectively). The next most common interactions were receiving a small gift (24.7%) and attending a sponsored dinner (20.6%), which occurred most commonly in "other" contexts, such as through family and while working in a medical setting (48.2% and 48.9%, respectively). The majority of students had interacted with the pharmaceutical industry before medical school. The differences in context indicate that students enter medical school with a heterogeneous set of exposures to pharmaceutical marketing. Medical schools should consider interventions to enhance students' knowledge of the impact of pharmaceutical marketing on physicians' prescribing practices.

Buddhism and neuroethics: the ethics of pharmaceutical cognitive enhancement.

PubMed

Fenton, Andrew

2009-08-01

This paper integrates some Buddhist moral values, attitudes and self-cultivation techniques into a discussion of the ethics of cognitive enhancement technologies - in particular, pharmaceutical enhancements. Many Buddhists utilize meditation techniques that are both integral to their practice and are believed to enhance the cognitive and affective states of experienced practitioners. Additionally, Mahāyāna Buddhism's teaching on skillful means permits a liberal use of methods or techniques in Buddhist practice that yield insight into our selfnature or aid in alleviating or eliminating duhkha (i.e. dissatisfaction). These features of many, if not most, Buddhist traditions will inform much of the Buddhist assessment of pharmaceutical enhancements offered in this paper. Some Buddhist concerns about the effects and context of the use of pharmaceutical enhancements will be canvassed in the discussion. Also, the author will consider Buddhist views of the possible harms that may befall human and nonhuman research subjects, interference with a recipient's karma, the artificiality of pharmaceutical enhancements, and the possible motivations or intentions of healthy individuals pursuing pharmacological enhancement. Perhaps surprisingly, none of these concerns will adequately ground a reflective Buddhist opposition to the further development and continued use of pharmaceutical enhancements, either in principle or in practice. The author argues that Buddhists, from at least certain traditions - particularly Mahāyāna Buddhist traditions - should advocate the development or use of pharmaceutical enhancements if a consequence of their use is further insight into our self-nature or the reduction or alleviation of duhkha.

What is your reasonable expectation of success in obtaining pharmaceutical or biotechnology patents having nonobvious claimed inventions that the courts will uphold? An overview of obviousness court decisions.

PubMed

Pereira, Daniel J; Kunin, Stephen G

2014-12-04

This article explores the legal basis for establishing the nonobviousness of patent claims in the life sciences fields of technology drawn from the guidance provided in published decisions of the U.S. Patent and Trademark Office's Patent Trial and Appeal Board, federal district courts, the Federal Circuit Court of Appeals, and the U.S. Supreme Court. Our analysis, although equally applicable to all disciplines and technologies, focuses primarily on decisions of greatest import affecting patents in the fields of pharmaceutical chemistry and biotechnology. Copyright © 2015 Cold Spring Harbor Laboratory Press; all rights reserved.

A Study of Comparative Advantage and Intra-Industry Trade in the Pharmaceutical Industry of Iran.

PubMed

Yusefzadeh, Hassan; Rezapour, Aziz; Lotfi, Farhad; Ebadifard Azar, Farbod; Nabilo, Bahram; Abolghasem Gorji, Hassan; Hadian, Mohammad; Shahidisadeghi, Niusha; Karami, Atiyeh

2015-04-23

Drug costs in Iran accounts for about 30% of the total health care expenditure. Moreover, pharmaceutical business lies among the world's greatest businesses. The aim of this study was to analyze Iran's comparative advantage and intra-industry trade in pharmaceuticals so that suitable policies can be developed and implemented in order to boost Iran's trade in this field. To identify Iran's comparative advantage in pharmaceuticals, trade specialization, export propensity, import penetration and Balassa and Vollrath indexes were calculated and the results were compared with other pharmaceutical exporting countries. The extent and growth of Iran's intra-industry trade in pharmaceuticals were measured and evaluated using the Grubel-Lloyd and Menon-Dixon indexes. The required data was obtained from Iran's Customs Administration, Iran's pharmaceutical Statistics, World Bank and International Trade Center. The results showed that among pharmaceutical exporting countries, Iran has a high level of comparative disadvantage in pharmaceutical products because it holds a small share in world's total pharmaceutical exports. Also, the low extent of bilateral intra-industry trade between Iran and its trading partners in pharmaceuticals shows the trading model of Iran's pharmaceutical industry is mostly inter-industry trade rather than intra-industry trade. In addition, the growth of Iran's intra-industry trade in pharmaceuticals is due to its shares of imports from pharmaceutical exporting countries to Iran and exports from Iran to its neighboring countries. The results of the analysis can play a valuable role in helping pharmaceutical companies and policy makers to boost pharmaceutical trade.