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Excipient Development for Pharmaceutical, Biotechnology, and Drug Delivery Systems

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This book serves as a comprehensive source to improve understanding of excipients and forge new avenues to promote independent regulatory review and development of novel excipients. And presents in-depth information on various aspects of excipient development, safety/toxicology testing, regulatory processes, quality, manufacturability, and the utility of excipients for various drug delivery system. The book divided 23 chapters. Chapter 1 discuss excipients: background/introduction. Chapter 2 discuss food and drug administration perspective on regulation of pharmaceutical excipients. Chapter 3 discuss pharmaceutical excipients development preclinical challenge. Chapter 4 discuss regulation of pharmaceutical excipients. Chapter 5 discuss cyclodextrins-enabling excipients: a case study of the development of a new excipient-sulfobutylether ?-cyclodextrin (CAPTISOL). Chapter 6 discuss the use of food additive safety evaluation procedures as a basic for evaluation the safety of new pharmaceutical excipients. Chapter 7 discuss pharmacopeial harmonization. Chapter 8 discuss excipient interaction. Chapter 9 discuss improved excipient functionality by coprocessing. Chapter 10 discuss a comparison of physical and mechanical properties of common tableting diluents. Chapter 11 discuss excipients for oral liquid formulations. Chapter 12 discuss use of nonactive pharmaceutical excipients in oral drug formulations: biopharmaceutical classification system considerations. Chapter 13 discuss excipients for semisolid formulations. Chapter 14 discuss excipients for pulmonary formulations. Chapter 15 discuss synergistic combinations of penetration enhancers and their discovery by high-throughput screening. Chapter 16 discuss excipient selection and criteria for injectable dosage forms. Chapter 17 discuss excipients for protein drugs. Chapter 18 discuss excipients used in vaccines. Chapter 19 discuss polymeric excipients for controlled release applications. Chapter 20 discuss emerging excipients in parenteral medications: the new paradigm. Chapter 21 discuss excipient manufacturing and good manufacturing practices. Chapter 22 discuss excipient quality assurance: handling, sampling, and regulatory issues. Chapetr 23 discuss excipient distribution.

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Detail Information

Series Title

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Call Number

615.1-1 Kat E

Publisher

New York : Informa Healthcare., 2006

Collation

xvii, 452 hal. Ilus. ; 26 cm Index. Hlm 437 - 452

Language

Indonesia

ISBN/ISSN

978-0-8493-2706-7

Classification

615.1-1 Kat E

Content Type

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Media Type

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Carrier Type

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Edition

NULL

Subject(s)

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Specific Detail Info

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Statement of Responsibility

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