In vitro bioequivalence studies for a metered dose inhaler formulation using the Morphologi automated particle imaging system

Characterization of the size and shape of API particles in Metered Dose Inhalation (MDI) formulations are data commonly required to demonstrate in vitro bioequivalence of a generic product to the reference drug. In this application note, we present a study comparing API particle size and shape in a generic and the innovator MDI formulations using the Morphologi® instrument. The comparison is extended to the API granules to investigate the effect of the formulation manufacturing process on the API material.

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