An Integration of Absorption Chamber with USP II Dissolution Apparatus

Traditional (USP) dissolution tests have been used in the pharmaceutical industry to perform quality control of manufacturing process for drug products, and also to compare performance of different drug product formulations during the late stage of the drug development process. It has been a subject of multiple debates if differences in the dissolution profile would be biorelevant, i.e. would lead to the significant changes in the in vivo absorption properties of active pharmaceutical ingredients (API). The goal of this study was to develop a method enabling simultaneous monitoring of dissolution of the drug product in the compendial apparatus at the same time providing the means to assess kinetic of API penetration into the absorption chamber separated from the dissolution vessel by a lipophilic membrane.

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