Good Cascade Impactor Practices, AIM and EDA for Orally Inhaled Products

  • Terrence P. Tougas
  • Jolyon P. Mitchell
  • Svetlana A. Lyapustina

Table of contents

  1. Front Matter
    Pages i-xii
  2. Terrence P. Tougas, Jolyon P. Mitchell, Beth Morgan, Helen Strickland
    Pages 1-13
  3. Jolyon P. Mitchell, Daryl L. Roberts
    Pages 15-55
  4. Helen Strickland, Beth Morgan, Jolyon P. Mitchell
    Pages 57-81
  5. Jolyon P. Mitchell
    Pages 83-117
  6. Jolyon P. Mitchell, Terrence P. Tougas
    Pages 119-133
  7. Richard Bauer, J. David Christopher, Volker Glaab, Svetlana A. Lyapustina, Jolyon P. Mitchell, Terrence P. Tougas
    Pages 135-149
  8. Terrence P. Tougas, Jolyon P. Mitchell
    Pages 151-171
  9. J. David Christopher, Helen Strickland, Beth Morgan, Monisha Dey, Alan Silcock, Terrence P. Tougas et al.
    Pages 173-249
  10. Helen Strickland, Beth Morgan, J. David Christopher, Volker Glaab, Adrian Goodey, Keyur Joshi et al.
    Pages 251-282
  11. Mark Copley, Jolyon P. Mitchell, Mårten Svensson, J. David Christopher, Jorge Quiroz, Geoffrey Daniels et al.
    Pages 283-357
  12. Steven C. Nichols, Jolyon P. Mitchell, Terrence P. Tougas, J. David Christopher, Susan Holmes
    Pages 359-374
  13. Terrence P. Tougas, Jolyon P. Mitchell
    Pages 401-410
  14. Terrence P. Tougas, Svetlana A. Lyapustina, Jolyon P. Mitchell
    Pages 411-417
  15. Back Matter
    Pages 419-442

About this book

Introduction

Aerodynamic particle size characteristics of orally inhaled products (OIPs) are critical to their performance.  Testing based on cascade impaction has been the primary tool used to characterize this critical quality attribute and is a regulatory expectation for Quality Control purposes.  In recent years, there have been substantial efforts directed at improving aerodynamic particle size determinations.

 

Good Cascade Impactor Practices, AIM and EDA for Orally Inhaled Products brings together for the first time a review of best practices for performing cascade impactor testing with a thorough discussion of the recently introduced concepts of abbreviated impactor measurements (AIM) and efficient data analysis (EDA).  

 

Topics covered include:

 

·         Review of pharmacopeial methods (US and European) for assessment of aerodynamic particle size distribution (APSD) of OIPs.

·         Physical processes that underlie aerosol formation from OIPs and the mechanisms that affect the APSD.

·         Good cascade impactor practice (GCIP) related to either full resolution or abbreviated impactor measurements. 

·         Introduction of the AIM and EDA concepts.

·         Selection of the type of testing through the development lifecycle of an OIP.

·         Theoretical basis for EDA.

·         Performance evaluation of EDA as a quality control element.

·         Case studies related to the application of  EDA. 

·         Experimental studies validating the AIM concept conducted by European Pharmaceutical Aerosol Group (EPAG) and the Cascade Impaction Working Group of the International Pharmaceutical Aerosol Consortium on Regulation and Science (IPAC-RS). 

·         Regulatory and compendial pathways to adoption of AIM and EDA.

·         Exploration and extension of AIM as a potential approach to measures that could be more predictive of particle deposition in the human respiratory tract. 

 

This comprehensive volume was written by a group of prominent international experts in aerosol testing led by members of the Cascade Impaction Working Group of IPAC-RS.  IPAC-RS is an international association of pharmaceutical companies committed to advancing consensus-based, scientifically driven standards and regulations for orally inhaled and nasal drug products.

Keywords

AIM Inhale Lyapustina Oral Product

Editors and affiliations

  • Terrence P. Tougas
    • 1
  • Jolyon P. Mitchell
    • 2
  • Svetlana A. Lyapustina
    • 3
  1. 1., Analytical DevelopmentBoehringer Ingelheim Pharmaceutical, IncRidgefieldUSA
  2. 2.Trudell Medical InternationalLondonCanada
  3. 3.Drinker Biddle & Reath LLPWashington, D.C.USA

Bibliographic information

  • DOI https://doi.org/10.1007/978-1-4614-6296-5
  • Copyright Information Springer Science+Business Media New York 2013
  • Publisher Name Springer, Boston, MA
  • eBook Packages Biomedical and Life Sciences
  • Print ISBN 978-1-4614-6295-8
  • Online ISBN 978-1-4614-6296-5
  • About this book