An Overview of Dissolution Method Development and Validation for Semisolid Dosage Forms

When most of us think of drug product dissolution testing, images of solid oral dosage forms like capsules and tablets using Apparatus 1 or 2 come to mind. But other dosage forms are also characterized by dissolution, including semisolid forms often used for topical drug delivery. It’s worthwhile to look at some of the things specific to those forms in dissolution testing.

Dissolution testing of solid oral dosage forms has been the dominant United States Pharmacopeia (USP) dissolution test for more than four decades. Dissolution is used to understand the effect of changes to the physical characteristics of drug substances and drug products throughout the drug development life-cycle.

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