Technical requirements of in vitro release test studies for topical drug products
Due to the complex delivery of topical drug products,involving local action,and complexity of certain formulations,small differences in prescription compositions and preparation parameters may lead to different quality characteristics of products,thus affecting the safety and effectiveness of drugs.In vitro release test(IVRT)can be used to characterize the steady-state drug release rate of a product batch,and the influence of certain processes,formulations,and/or manufacturing changes on a drug product.Comparing the steady-state drug release rate of the postchange(test)and prechange(reference)products,typically in the context of scale-up or post-approval changes for an approved drug product,helps demonstrate equivalence of drugs in certain situations.Though IVRT does not simulate the in vivo performance,as a critical quality attribute,the release rate should be specified in the approval of finished products and shelf life specification,unless otherwise justified.This paper reviews the technical requirements of IVRT studies of topical drug products by referring to relevant technical guidelines and literatures.
topical drug producttransdermal drug deliveryin vitro release test(IVRT)consistency evaluation
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