Digital Image Segmentation Analysis Enables High-Throughput Next-Generation Impactor Analysis.

PURPOSE Aerodynamic particle size distribution (APSD) determination is a key quality attribute for inhaled therapeutics. The next-generation impactor is the gold standard for APSD determination; however, it suffers from lengthy analysis times due to the need for high-performance liquid chromatography (HPLC)-based quantitation. In this work, a novel method employing image analysis is developed to derive APSD metrics from dry powder inhalers.

MAJOR FINDINGS Analysis of neat active pharmaceutical ingredient (API), API/lactose blends, and stressed blend samples is demonstrated. The method shows sufficient resolution to differentiate between different sizes of neat API and within lactose blends. In addition, the results obtained from image analysis are comparable to the HPLC derived results.

CONCLUSIONS This study establishes the feasibility of image analysis for faster APSD determination.