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Validating AIM-Based Instrumentation and Associated Measurement Techniques

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

Abstract

The validation of the wide variety of equipment capable of making abbreviated impactor measurements is a key component providing proof that the AIM concept works in practice. This chapter provides a comprehensive collection of validation experiments that have been provided by a variety of different laboratories, mainly through the support of the Cascade Impactor sub-team of the European Pharmaceutical Aerosol Group (EPAG), who held a Workshop on the topic in December 2010. These studies have involved the whole range of OIP formats, thereby increasing confidence in the wide applicability of the approach. A series of “learnings” are summarized at the end of the chapter as guidance for those planning on implementing an AIM-based method.

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Authors and Affiliations

  1. Copley Scientific Limited, Colwick Quays Business Park, Private Road No. 2, Colwick, Nottingham, NG4 2JY, UK

    Mark Copley

  2. Trudell Medical International, 725 Third Street, London, ON, N5V 5G4, Canada

    Jolyon P. Mitchell

  3. Emmace Consulting AB, Vinkelhaken 1D, Sodra Sandy, 247 32, Sweden

    Mårten Svensson

  4. Merck Research Laboratories, Nonclinical and Pharmaceutical Sciences Statistics, WP37C-305, 770 Sumneytown Pike, West Point, PA, 19486-0004, USA

    J. David Christopher

  5. Novartis Pharmaceuticals Corporation, One Health Plaza, Bldg. 438/2417B, East Hanover, NJ, 07936, USA

    Jorge Quiroz

  6. Inhaled Product & Device Technology, GlaxoSmithKline, Park Road, Ware, Hertfordshire, SG12 0DP, UK

    Geoffrey Daniels

  7. Inhaled Delivery Sciences, Inhaled Product & Device Technology, GSK R&D Park Road, Ware, Herts, SG12 0DP, UK

    Melanie Hamilton

  8. Mylan Global Respiratory Group, Mylan Inc., Discovery Park, Sandwich, CT13 9NJ, UK

    Dave Russell-Graham

Authors
  1. Mark Copley
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  2. Jolyon P. Mitchell
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  3. Mårten Svensson
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  4. J. David Christopher
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  5. Jorge Quiroz
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  6. Geoffrey Daniels
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  7. Melanie Hamilton
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  8. Dave Russell-Graham
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Corresponding author

Correspondence to Mark Copley .

Editor information

Editors and Affiliations

  1. , Analytical Development, Boehringer Ingelheim Pharmaceutical, Inc, Ridgebury Rd 900, Ridgefield, 06877, Connecticut, USA

    Terrence P. Tougas

  2. Trudell Medical International, Third Street 725, London, N5V 5G4, Ontario, Canada

    Jolyon P. Mitchell

  3. Drinker Biddle & Reath LLP, K Street, N.W. 1500, Washington, D.C., 20005, District of Columbia, USA

    Svetlana A. Lyapustina

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Copley, M. et al. (2013). Validating AIM-Based Instrumentation and Associated Measurement Techniques. In: Tougas, T., Mitchell, J., Lyapustina, S. (eds) Good Cascade Impactor Practices, AIM and EDA for Orally Inhaled Products. Springer, Boston, MA. https://doi.org/10.1007/978-1-4614-6296-5_10

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