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

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

Otilia M.Y. Koo, PhD, is currently Integrated Development Team Leader at Bristol-Myers Squibb Company. Her research interests and publications are in excipients characterization and the role of excipients in formulation development and processes. She serves on the 2015 - 2020 United States Pharmacopeia Expert Committee for Excipient Monographs and was lead guest editor of themed issues of the AAPS Journal and AAPS Pharm SciTech. She received her PhD in Pharmaceutics from the University of Illinois at Chicago and Masters/Bachelors from the National University of Singapore. She also is an adjunct assistant professor at University of Illinois at Chicago.

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