Leachables and Extractables Handbook: Safety Evaluation, Qualification, and Best Practices Applied to Inhalation Drug Products

Leachables and Extractables Handbook: Safety Evaluation, Qualification, and Best Practices Applied to Inhalation Drug Products

Editor(s): Douglas J. Ball, Daniel L. Norwood, Cheryl L. M. Stults, Lee M. Nagao

Published Online: 28 FEB 2012 03:23AM EST

Print ISBN: 9780470173657

Online ISBN: 9781118147672

DOI: 10.1002/9781118147672

About this Book

A practical and science-based approach for addressing toxicological concerns related to leachables and extractables associated with inhalation drug products

Packaging and device components of Orally Inhaled and Nasal Drug Products (OINDP)—such as metered dose inhalers, dry powder inhalers, and nasal sprays—pose potential safety risks from leachables and extractables, chemicals that can be released or migrate from these components into the drug product. Addressing the concepts, background, historical use, and development of safety thresholds and their utility for qualifying leachables and extractables in OINDP, the Leachables and Extractables Handbook takes a practical approach to familiarize readers with the recent recommendations for safety and risk assessment established through a joint effort of scientists from the FDA, academia, and industry. Coverage includes best practices for the chemical evaluation and management of leachables and extractables throughout the pharmaceutical product life cycle, as well as:

  • Guidance for pharmaceutical professionals to qualify and risk-assess container closure system leachables and extractables in drug products

  • Principles for defining toxicological safety thresholds that are applicable to OINDP and potentially applicable to other drug products

  • Regulatory perspectives, along with an appendix of key terms and definitions, case studies, and sample protocols

Analytical chemists, packaging and device engineers, formulation development scientists, component suppliers, regulatory affairs specialists, and toxicologists will all benefit from the wealth of information offered in this important text.

Table of contents

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  1. Part I: Development of Safety Thresholds, Safety Evaluation, and Qualification of Extractables and Leachables in Orally Inhaled and Nasal Drug Products

  2. Part II: Best Practices for Evaluation and Management of Extractables and Leachables in Orally Inhaled and Nasal Drug Products

    1. Chapter 14

      Extractables: The Controlled Extraction Study (pages 289–329)

      Thomas N. Feinberg, Daniel L. Norwood, Alice T. Granger and Dennis Jenke

    2. Chapter 15

      Extractables: Case Study of a Sulfur-Cured Elastomer (pages 331–386)

      Daniel L. Norwood, Fenghe Qiu, James R. Coleman, James O. Mullis, Alice T. Granger, Keith McKellop, Michelle Raikes and John A. Robson

    3. Chapter 20

      Inorganic Leachables (pages 549–571)

      Diane Paskiet, Ernest L. Lippert, Brian D. Mitchell and Diego Zurbriggen

  3. Appendixes

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