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The pulmonary route of administration is used for both locally and systemically acting drugs. However, knowledge gaps about the fate of aerosol particles after deposition in the lung provide room for future elucidation. During pharmaceutical development as well as in quality control of oral inhalation products, in vitro performance tests are required for discriminating between formulations and to prove batch-to-batch consistency. Although the aerodynamic particle size distribution is widely recognized as the pivotal performance parameter, there is still no standardized test for in vitro dissolution testing. This review summarizes the in vitro performance testing methodologies developed for orally inhaled drug product (OIDP) evaluation, with a focus on dissolution testing of dry powders for inhalation. The dissolution setups used, together with the media, membranes, and methods employed for collecting the relevant particle fraction, are presented. With a clear focus on in vitro dissolution testing, particle size distribution is regarded as a physical reduction to the relevant moiety of the specimen to be sampled for subsequent testing.

Towards Standardized Dissolution Techniques for In Vitro Performance Testing of Dry Powder Inhalers