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

• Year: 2012
• Tongue: English
• Leaves: 683
• Category: Library

✦ Synopsis

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.Content:
Chapter 1 Overview of Leachables and Extractables in Orally Inhaled and Nasal Drug Products (pages 1–19): Douglas J. Ball, Daniel L. Norwood and Lee M. Nagao
Chapter 2 A General Overview of the Suitability for Intended Use Requirements for Materials Used in Pharmaceutical Systems (pages 21–36): Dennis Jenke
Chapter 3 Concept and Application of Safety Thresholds in Drug Development (pages 37–44): David Jacobson?Kram and Ronald D. Snyder
Chapter 4 The Development of Safety Thresholds for Leachables in Orally Inhaled and Nasal Drug Products (pages 45–58): W. Mark Vogel
Chapter 5 The Analytical Evaluation Threshold (AET) and its Relationship to Safety Thresholds (pages 59–78): Daniel L. Norwood, James O. Mullis and Scott J. Pennino
Chapter 6 Safety Thresholds in the Pharmaceutical Development Process for OINDP: An Industry Perspective (pages 79–92): David Alexander and James Blanchard
Chapter 7 The Chemistry and Toxicology Partnership: Extractables and Leachables Information Sharing Among the Chemists and Toxicologists (pages 93–115): Cheryl L. M. Stults, Ronald Wolff and Douglas J. Ball
Chapter 8 Use of Safety Thresholds in the Pharmaceutical Development Process for OINDP: U.S. Regulatory Perspectives (pages 117–127): Timothy J. McGovern
Chapter 9 The Application of the Safety Thresholds to Qualify Leachables from Plastic Container Closure Systems Intended for Pharmaceutical Products: A Regulatory Perspective (pages 129–152): Kumudini Nicholas
Chapter 10 Analytical Best Practices for the Evaluation and Management of Extractables and Leachables in Orally Inhaled and Nasal Drug Products (pages 153–183): Daniel L. Norwood, Cheryl L. M. Stults and Lee M. Nagao
Chapter 11 Chemical and Physical Attributes of Plastics and Elastomers: Impact on the Extractables Profile of Container Closure Systems (pages 185–215): Michael A. Ruberto, Diane Paskiet and Kimberly Miller
Chapter 12 Pharmaceutical Container Closure Systems: Selection and Qualification of Materials (pages 217–240): Douglas J. Ball, William P. Beierschmitt and Arthur J. Shaw
Chapter 13 Analytical Techniques for Identification and Quantitation of Extractables and Leachables (pages 241–287): Daniel L. Norwood, Thomas N. Feinberg, James O. Mullis and Scott J. Pennino
Chapter 14 Extractables: The Controlled Extraction Study (pages 289–329): Thomas N. Feinberg, Daniel L. Norwood, Alice T. Granger and Dennis Jenke
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
Chapter 16 Case Study of a Polypropylene: Extractables Characterization, Quantitation, and Control (pages 387–415): Diane Paskiet, Laura Stubbs and Alan D. Hendricker
Chapter 17 Analytical Leachables Studies (pages 417–447): Andrew D. Feilden and Andy Rignall
Chapter 18 Development, Optimization, and Validation of Methods for Routine Testing (pages 449–506): Cheryl L. M. Stults and Jason M. Creasey
Chapter 19 Critical Component Quality Control and Specification Strategies (pages 507–548): Terrence Tougas, Suzette Roan and Barbara Falco
Chapter 20 Inorganic Leachables (pages 549–571): Diane Paskiet, Ernest L. Lippert, Brian D. Mitchell and Diego Zurbriggen
Chapter 21 Foreign Particulate Matter: Characterization and Control in a Quality?By?Design Environment (pages 573–615): James R. Coleman, John A. Robson, John A. Smoliga and Cornelia B. Field