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Pharmaceutical Excipients: Properties, Functionality, and Applications in Research and Industry

Pharmaceutical Excipients: Properties, Functionality, and Applications in Research and Industry

Otilia M. Y. Koo (Editor)

ISBN: 978-1-118-99242-5

Oct 2016

352 pages

$140.99

Description

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

List of Contributors vii

1 Excipient Characterization 1
David Good and Yongmei Wu

2 Excipients for Conventional Oral Solid Dosage Forms 51
Umesh Kestur and Divyakant Desai

3 Excipients and their Functionality for Enabling Technologies in Oral Dosage Forms 97
Kunnal Sharma, Shreya Thakkar, Sakshi Khurana, and Arvind Kumar Bansal

4 Excipients used in Biotechnology Products 145
Eva Y. Chi

5 Excipient Standards and Harmonization 199
R.C. Moreton

6 Regulatory Information for Excipients 241
Christopher C. DeMerlis, Alexa Smith, and David R. Schoneker

7 Development of New Excipients 269
Karl Kolter and Felicitas Guth

8 PATability of Excipients 303
Claudia Corredor

Index 329