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Exploring Aerosolized Powder Behavior in Dry Powder Inhalers Using Advanced Imaging Techniques

Boc ST, Newman B.

Respiratory Drug Delivery 2026. Volume 1, 2026: 16-0.

Abstract:

As part of the US Food and Drug Administration’s (FDA) continued effort to enhance the efficiency of bioequivalence (BE) approaches for complex routes of delivery, research conducted under the Generic Drug User Fee Amendments (GDUFA) science and research program has explored the use of imaging techniques and analysis to characterize aerosolized powder emitted from dry powder inhaler (DPI) drug products. These techniques included the use of artificial intelligence (AI) to extract information on surface features (e.g., porosity) and particle size. Optical photothermal infrared (O-PTIR) microscopy was used to collect information on aerosolized powder at the sub-micron scale. Additionally, characterization of dynamic DPI powder dispersion was captured using high-speed imaging (HSI) and optical coherence tomography (OCT). This research reflects FDA’s commitment to support the development of innovative and efficient methodologies for evaluating the BE and quality of DPIs.