• Publication Date: 08/01/2021
  • Author(s):
    Carter, Ian Christopher, J. David Doub, William H. Goodey, Adrian Mitchell, Jolyon P.
  • Organization(s):
    Jolyon Mitchell Inhaler Consulting Services, Inc. Merck OINDP In Vitro Analysis PPD Inc.
  • Article Type: Technical Articles
  • Subjects: Industry Issues and Trends, Particle Characterization, Product Development/Formulation, Testing, Validation, and Regulatory Compliance
The third in a series of articles from the IPAC-RS Cascade Impaction Working Group concerning the limitations of metrics commonly used in the assessment of aerodynamic particle size distributions (APSDs) of orally inhaled products (OIPs). The current article takes a broader view to discuss why we make quality control measurements such as inhaler APSD.

The authors believe that the decision-making framework used to demonstrate product quality consists of both the metrics themselves and the way they are used to make the decision. In the context of inhaler APSD, they contend that good decision-making requires independent assessments of each dimension of the APSD, namely size and mass, which they propose can be achieved via Efficient Data Analysis (EDA).

Read part one – The liability of fine particle dose (FPD)

Read part two – Cascade impactor stage groupings: Poor decisions from degraded data

Read an interview with the authors about reactions to these articles

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