The Quality by Design (QbD) initiative provides a significant opportunity for the pharmaceutical industry to re-appraise how it builds quality into orally inhaled products (OIPs). QbD involves rigorous definition of how critical quality attributes (CQAs) relate to the knowledge, design, and control spaces that map OIP performance. Aerodynamic particle size distribution (APSD) qualifies as a CQA for in vitro inhaler performance because of its relationship with
particle deposition in the respiratory tract. APSD measurements, therefore, serve an important purpose in the context of OIP quality control (QC). However, traditional multistage cascade impaction methods for measuring APSD require a great deal of labor, and operator inconsistency can make them subject to measurement variability.
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