ABSTRACT

The in vivo solubilisation of a drug fundamentally impacts on its ability to exert a pharmacological effect as dissolution is the first stage that controls the bioavailability of an oral dosage form. This entry briefly touches on the theoretical background of drug dissolution and presents the various compendial and non-compendial apparatuses which have been developed for the testing of simple, immediate-release and more complicated modified-release oral dosage forms, and also discusses issues such as choice of medium, sample collection and analysis, and data presentation and specifications.