An overview ofin vitrodissolution/release methods for novel mucosal drug delivery systems

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HighlightsMucosal delivery systems differ in physicochemical and release characteristics.Versatile in vitro release methods are currently used for their characterisation.Compendial methods are used as a first approach whenever applicable.Novel biorelevant methods are needed for the prediction of performance in vivo.In vitro dissolution/release tests are an important tool in the drug product development phase as well as in its quality control and the regulatory approval process. Mucosal drug delivery systems are aimed to provide both local and systemic drug action via mucosal surfaces of the body and exhibit significant differences in formulation design, as well as in their physicochemical and release characteristics. Therefore it is not possible to devise a single test system which would be suitable for release testing of such complex dosage forms. This article is aimed to provide a comprehensive review of both compendial and noncompendial methods used for in vitro dissolution/release testing of novel mucosal drug delivery systems aimed for ocular, nasal, oromucosal, vaginal and rectal administration.

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