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Dissolution Testing of Orally Inhaled Drug Products - Challenges with Method Development and Specifications

Floroiu A, Klein M, Krämer J, Lehr C.

Respiratory Drug Delivery 2020. Volume 1, 2020: 147-154.


When it comes to predicting the in vivo performance of orally inhaled drug products (OIDPs), it is becoming increasingly evident that dissolution testing is an essential tool. Before reaching the stage of having a simple, standardized method for quality control testing, better understanding of the interaction between particles and the lung environment is needed in order to identify the critical attributes of this type of product not evaluated by other standard tests. The factors to be considered at every step of setting up a dissolution test for OIDPs are discussed. Meaningful dissolution testing should include sample determination, e.g. by a classification of the relevant fraction as provided by the drug product. Besides the design of apparatus, the composition of the in vitro dissolution media is of primary importance.

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