Table of Contents

Introduction to Excipients

What Are Excipients?
Thomas A. Wheatley
Purity of Excipients
Dankward Jäkel and Martin Keck
History of Excipient Safety and Toxicity
Charles L. Winek
Regulation of Pharmaceutical Excipients
Christopher C. DeMerlis
Safety Evaluation of Pharmaceutical Excipients

Development of Safety Evaluation Guidelines
Joseph F. Borzelleca and Myra L. Weiner
Routes of Exposure: Oral
Lois A. Kotkoskie
Routes of Exposure: Topical and Transdermal
Matthew J. Cukierski and Alice E. Loper
Routes of Exposure: Inhalation and Intranasal
Charmille B. Tamulinas and Chet L. Leach
Routes of Exposure: Parenteral
David B. Mitchell
Routes of Exposure: Other
Carol S. Auletta

Risk Assessment of Excipients

Toxicokinetics and Hazard Identification
Frank M. Sullivan and Susan M. Barlow
Exposure Assessment
David J. George and Annette M. Shipp
Risk Assessment and Risk Communication
Anthony D. Dayan

Future Issues

Harmonization of Excipient Standards
Zak T. Chowhan

About the Author

Weiner, Myra L.; Kotkoskie, Lois A.

Reviews

"From the foreword This book meets a need at all levels of the Pharmaceutical Industry from undergraduate student through senior management, including regulators and regulatory scientists....This book provides a pragmatic overview of the excipient and excipient safety in pharmaceuticals. My thanks to the contributors for a very needed and valuable book. "-Louis Blecher, Chairman, The International Pharmaceutical Excipients Council Arlington, Virginia ...full of useful information and...thoroughly recommend[ed]. - British Toxicology Society Newsletter Because safety and toxicity questions are of primary concern to those seeking to promote the development of new excipients, those workers will find this volume to be a valuable source of summarized information. The book is also highly recommended to all formulators seeking to use the high-technology excipients in new formations, since they will need to know the expeditious routes to regulatory approval. -Pharmaceutical Development and Technology, 2001