Pharmaceutical Excipients

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

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.

Considered essential to pharmaceutical drug product development, pharmaceutical excipients are materials, other than the active moiety, intentionally included in a drug product for the purpose of ensuring it is acceptable to regulatory authorities and patients in terms of manufacturability and performance. Pharmaceutical excipients are a very diverse group of materials, of either natural or synthetic origins, and can range from very simple molecules to complex high molecular weight polymers. Having a good foundation in the field of excipients, how they are developed, regulated and understanding their properties and effects is crucial for dosage formulation.

Pharmaceutical Excipients: Properties, Functionality, and Applications in Research and Industry provides a broad overview of excipients, their functionalities in pharmaceutical dosage forms, and how their selection can influence pharmaceutical products manufacture. Eight detailed chapters encompass the development, characterization, applications and case studies, harmonization, and research in the field of excipients.

Including up-to-date advancements of excipients used for pharmaceutical development; this valuable resource for scientists, researchers, regulatory personnel, and chemical engineers encompasses the overview, applications, and most current research. Pharmaceutical Excipients offers key benefits that include:

• Coverage of the sources, characterization, and harmonization of excipients: essential information for optimal excipients selection in pharmaceutical development
• Description of the physico-chemical properties and biological effects of excipients
• Discussion of chemical classes, safety and toxicity, and formulation
• Explanation of recent efforts in the standardization and harmonization of excipients
• Presentation of the development and regulatory considerations for new excipients