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Good Cascade Impactor Practices

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

Abstract

The CI-based methods for measuring the APSD properties of OIP-­produced aerosols are complex, exacting, and laborious to undertake. Yet they are the only accepted methods by regulatory agencies worldwide for determining particle aerodynamic size-related properties. In 2003, a group within the Product Quality Research Institute (PQRI), a body set up by pharmaceutical industry, the FDA, and academia to explore complex scientific and regulatory problems, developed a guide to good cascade impactor practices (GCIP). This chapter contains a review of the essence of their work, augmented by developments that have taken place since the original article was published.

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Authors and Affiliations

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

    Jolyon P. Mitchell

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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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Mitchell, J.P. (2013). Good Cascade Impactor Practices. 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_4

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