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Abbreviated Impactor Measurement (AIM) and Efficient Data Analysis (EDA) Concepts: A partnership for the assurance of Oral Inhaled Product (OIP) quality

  • Publication Date: 12/01/2010
  • Author(s):
    Bauer, Richard Christopher, David Church, Tanya Dey, Monisha Glaab, Volker Goodey, Adrian Holmes, Sue Iley, Teresa Lyapustina, Svetlana Mitchell, Jolyon P. Patel, Rajni Quiroz, Jorge Russell-Graham, David Strickland, Helen Svensson, Mårten Tougas, Terrence Van Oort, Michiel Wu, Zecai
  • Organization(s):
    AstraZeneca Boehringer Ingelheim Cascade Impaction Working Group (CI-WG) Chiesi Drinker Biddle & Reath GlaxoSmithKline International Pharmaceutical Aerosol Consortium on Regulation & Science (IPAC-RS) MannKind Corporation Merck Pfizer Teva Trudell Medical International Vectura
  • Article Type: Technical Articles
  • Subjects: Device Design, Devices and Components, Industry Issues and Trends, Product Development/Formulation, Testing, Validation, and Regulatory Compliance
AIM-EDA continues to evolve, changing the ways OIPs are evaluated throughout their life cycles.

AIM: Proof of Concept
The present version of the Abbreviated Impactor Measurement (AIM) Concept was born three years ago, initially as a way of improving productivity in the course of making in vitro measurements of Oral Inhaled Products (OIPs) and related add-on devices, such as spacers and valved holding chambers that are used with pressurized metered dose inhalers (pMDIs). The core idea was to eliminate unnecessary components of a full resolution cascade impactor (CI) so that only those fractions having meaning in the context of product performance were determined. The Cascade Impactor Working Group (CI-WG) of the International Pharmaceutical Consortium on Regulation and Science (IPAC-RS) later spearheaded the idea of using AIM in conjunction with alternate data analysis approaches. The initial goal was to address the issue that full resolution CI measurements are highly complex, with many opportunities for measurement variability to enter into the determination of OIP aerosol aerodynamic particle size distribution (APSD).

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