About The Book

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


Table of Contents

List of Contributors vii1 Excipient Characterization 1
David Good and
Yongmei Wu
2 Excipients for Conventional Oral Solid Dosage Forms 51
Umesh Kestur and Divyakant Desai3 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


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