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