Application of USP Apparatus 7 to In Vitro Drug Release in Scopolamine Transdermal Systems

Abstract

Introduction For a transdermal system,the drug release test is important for monitoring batch-to-batch reproducibility and manufacturing deviations for quality control (QC) purposes. However,the approach and purpose of performing the drug release test may not necessarily be the same between Research and Development and QC (1), particularly for a transdermal system. To obtain a reliable prediction of bioavailability for a new drug application or bioequivalence for an abbreviated new drug application,the Franz diffusion cell with human cadaver skin is often used,which is desirable for the prediction of in vivo performance of the drug product. For QC purposes and a more economical