Pharmaceutical Excipients

by Otilia M. Y. Koo

Author	: Otilia M. Y. Koo
Publisher	: John Wiley & Sons
Total Pages	: 369
Release	: 2016-10-03
Genre	: Medical
ISBN	: 1118992423

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This book provides an overview of excipients, their functionalities in pharmaceutical dosage forms, regulation, and selection for pharmaceutical products formulation. It includes development, characterization methodology, applications, and up-to-date advances through the perspectives of excipients developers, users, and regulatory experts. Covers the sources, characterization, and harmonization of excipients: essential information for optimal excipients selection in pharmaceutical development Describes the physico-chemical properties and biological effects of excipients Discusses chemical classes, safety and toxicity, and formulation Addresses recent efforts in the standardization and harmonization of excipients

Handbook of Pharmaceutical Excipients

by Raymond C. Rowe

Author	: Raymond C. Rowe
Publisher	: Amer Pharmacists Assn
Total Pages	: 888
Release	: 2009-01-01
Genre	: Medical
ISBN	: 9781582121352

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An internationally acclaimed reference work recognized as one of the most authoritative and comprehensive sources of information on excipients used in pharmaceutical formulation with this new edition providing 340 excipient monographs. Incorporates information on the uses, and chemical and physical properties of excipients systematically collated from a variety of international sources including: pharmacopeias, patents, primary and secondary literature, websites, and manufacturers' data; extensive data provided on the applications, licensing, and safety of excipients; comprehensively cross-referenced and indexed, with many additional excipients described as related substances and an international supplier's directory and detailed information on trade names and specific grades or types of excipients commercially available.

Profiles of Drug Substances, Excipients and Related Methodology

by Harry G. Brittain

Author	: Harry G. Brittain
Publisher	: Academic Press
Total Pages	: 399
Release	: 2011-07-15
Genre	: Science
ISBN	: 0123877024

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Volumes in this widely revered series present comprehensive reviews of drug substances and additional materials, with critical review chapters that summarize information related to the characterization of drug substances and excipients. This organizational structure meets the needs of the pharmaceutical community and allows for the development of a timely vehicle for publishing review materials on this topic. The scope of the Profiles series encompasses review articles and database compilations that fall within one of the following six broad categories: Physical profiles of drug substances and excipients; Analytical profiles of drug substances and excipients; Drug metabolism and pharmacokinetic profiles of drug substances and excipients; Methodology related to the characterization of drug substances and excipients; Methods of chemical synthesis; and Reviews of the uses and applications for individual drug substances, classes of drug substances, or excipients. - Presents comprehensive reviews covering all aspects of drug development and formulation of drugs - Profiles creatine monohydrate and fexofenadine hydrochloride, as well as five others - Meets the information needs of the drug development community

Polyvinylpyrrolidone Excipients for Pharmaceuticals

by Volker Bühler

Author	: Volker Bühler
Publisher	: Springer Science & Business Media
Total Pages	: 272
Release	: 2005
Genre	: Medical
ISBN	: 9783540234128

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The book describes the properties, analytical methods and the applications of different polyvinylpyrrolidone excipients (povidone, crospovidone, copovidone etc.) for use in pharmaceutical preparations. This group of excipients is one of the most important excipients used in modern technology to produce drugs. The book is intended for all persons working in the research, development and quality control of drugs. It gives a survey of all applications in solid, liquid and semisolid dosage forms including many drug formulation examples and more than 600 references to the literature.

Excipient Development for Pharmaceutical, Biotechnology, and Drug Delivery Systems

by Ashok Katdare

Author	: Ashok Katdare
Publisher	: CRC Press
Total Pages	: 474
Release	: 2006-07-28
Genre	: Medical
ISBN	: 1420004131

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To facilitate the development of novel drug delivery systems and biotechnology-oriented drugs, the need for new, yet to be developed, and approved excipients continues to increase. Excipient Development for Pharmaceutical, Biotechnology, and Drug Delivery Systems serves as a comprehensive source to improve understanding of excipients and forge potential new avenues for regulatory approval. This book presents detailed, up-to-date information on various aspects of excipient development, testing, and technological considerations for their use. It addresses specific details such as historical perspective, preclinical testing, safety, and toxicology evaluation, as well as regulatory, quality, and utility aspects. The text also describes best practices for use of various functional excipients and extensive literature references for all topics.

Excipient Applications in Formulation Design and Drug Delivery

by Ajit S Narang

Author	: Ajit S Narang
Publisher	: Springer
Total Pages	: 700
Release	: 2015-10-07
Genre	: Medical
ISBN	: 3319202065

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In recent years, emerging trends in the design and development of drug products have indicated ever greater need for integrated characterization of excipients and in-depth understanding of their roles in drug delivery applications. This book presents a concise summary of relevant scientific and mechanistic information that can aid the use of excipients in formulation design and drug delivery applications. Each chapter is contributed by chosen experts in their respective fields, which affords truly in-depth perspective into a spectrum of excipient-focused topics. This book captures current subjects of interest – with the most up to date research updates – in the field of pharmaceutical excipients. This includes areas of interest to the biopharmaceutical industry users, students, educators, excipient manufacturers, and regulatory bodies alike.

Pharmaceutical Excipients

by David E. Bugay

Author	: David E. Bugay
Publisher	: CRC Press
Total Pages	: 688
Release	: 1999-02-23
Genre	: Medical
ISBN	: 9780824793739

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Meeting the need for a hands-on guide elucidating the role of molecular spectroscopy in the physical characterization of pharmaceutical solids, two experts from the industry gather theoretical discussions of infrared, Raman, and nuclear magnetic resonance spectroscopy. They provide recommendations on spectral data acquisition techniques and include 600 spectra for 300 of the most commonly used excipients. Complete with references, equations, tables, and a CAS registry number index, the book covers the drug development process, including chemical identification of substances, investigative studies, competitor analysis, problem solving activities, reproduction of spectral data, and more.

CRC Handbook of Food, Drug, and Cosmetic Excipients

by Susan C. Smolinske

Author	: Susan C. Smolinske
Publisher	: CRC Press
Total Pages	: 458
Release	: 1992-03-10
Genre	: Technology & Engineering
ISBN	: 9780849335853

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CRC Handbook of Food, Drug, and Cosmetic Excipients provides a comprehensive summary of toxicological issues regarding inactive ingredients in pharmaceutical products, cosmetic products, and food additives. Background information on regulations and labeling requirements for each type of product is provided, and 77 articles critically review human and animal data pertinent to a variety of agents and makes judgments regarding the clinical relevance. The book also identifies at-risk populations, such as neonates, patients with renal failure, and atopic patients. Inactive common pharmaceutical agents and/or foods containing certain ingredients are listed to help physicians counsel hypersensitive patients who must avoid products containing these excipients.

Analytical Profiles of Drug Substances and Excipients

by

Author	:
Publisher	: Academic Press
Total Pages	: 625
Release	: 1994-09-05
Genre	: Medical
ISBN	: 0080861180

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Although the official compendia define a drug substance as to identity, purity, strength, and quality, they normally do not provide other physical or chemical data, nor do they list methods of synthesis or pathways of physical or biological degradation and metabolism. Such information is scattered throughout the scientific literature and the files of pharmaceutical laboratories. Edited by the Associate Director of Analytical Research and Development for the AmericanAssociation of Pharmaceutical Scientists, Analytical Profiles of Drug Substances and Excipients brings this information together into one source. The scope of the series has recently been expanded to include profiles of excipient materials.