ABSTRACT
Performance testing is an integral part of any formulation development program and can be used strategically throughout the development process to mitigate development risks and failures due to inadequate product performance. When based on sound scientific principles, product performance tests can be used for pre- and post-manufacturing purposes such as during the product research and development phase, as a basic quality control tool, for demonstrating product similarity, or for demonstrating compliance with regulatory guidelines. Synthetic membranes have been investigated extensively as a readily available and easy-to-use tool to study the in vitro release profiles of drugs from topical formulations to assess and compare product performance and quality. In addition, like classical tablet dissolution testing, in vitro release testing has also been employed to demonstrate “sameness” under certain scale-up and post-approval changes for semi-solid products, and it is assumed that in vitro release testing can be used to characterise performance characteristics of a finished topical dosage form.
