1st Edition

Excipient Toxicity and Safety

By Myra L. Weiner, Lois A. Kotkoskie Copyright 2007
    392 Pages
    by CRC Press

    392 Pages
    by CRC Press

    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.
  • 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


    Weiner, Myra L.; Kotkoskie, Lois A.