This book reviews the history, regulatory status, pharmacopeial specifications, and harmonization of pharmaceutical excipients in the United States and Europe, and provides a comprehensive understanding of the current scientific basis for safety evaluation and risk assessment.
Examines excipients as a unique class of products and explores new procedures for determining toxicity!
A timely and unique addition to the pharmaceutical literature, containing over 570 citations that support and enhance the text, Excipient Toxicity and Safety
identifies the differences between excipients (inactive ingredients), food ingredients, and drug products
evaluates issues of dose administration, species selection, and study design for various routes of exposure
provides detailed information on the historical uses of excipients in drug formulations
clarifies the Safety Committee of the International Pharmaceutical Excipients Council's (IPEC) guidelines and technical specifications for conducting tests for each route of exposure
explains how data generated in toxicity models are applied to identify hazards in drug formulations
details exposure assessment to link hazard identification with risk
considers the requirements and importance of purity specifications
and much more!
Excipient Toxicity and Safety is a blue-ribbon reference ideal for pharmacists; toxicologists; pharmacologists; analytical chemists; quality control, quality assurance, and regulatory compliance managers; and upper-level undergraduate and graduate students in these disciplines.
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
David J. George and Annette M. Shipp
Risk Assessment and Risk Communication
Anthony D. Dayan
Harmonization of Excipient Standards
Zak T. Chowhan
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
...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