Expert Consensus on Technical Practice for the in Vitro Release Test of Topical Semisolid Dosage Forms for Skin and Mucous Membrane Preparations

The in vitro release test (IVRT) is critical to quality evaluation and control of topical semisolid dosage forms. The drug regulatory authorities of some countries have issued guidelines on the research of topical semisolid dosage forms. However, there is still a lack of description about operating details for IVRT. In order to standardize the IVRT of semisolid preparations for skin and mucosa, based on international and domestic practice, The Transdermal Drug Delivery Committee of the World Federation of Chinese Medicine Societies organized experts to discuss and form the consensus for reference by industry colleagues and regulators.