ビソプロロール・テープ剤の放出挙動の評価

抄録

In recent years, transdermal therapeutic systems have been widely used, while information regarding the release of drugs from such preparations and their pharmacokinetics remains insufficient. A “release test for preparations for cutaneous application” was recently published in the 17th edition of The Japanese Pharmacopoeia (JP17). In an effort to evaluate the release test method described in JP17 and its usefulness, we compared the release behavior of a bisoprolol patch preparation determined using the paddle-over-disk method described in JP17 with the results obtained in our reported clinical study. Several types of release fluids with pH values from 4.5 to 8 and salt concentrations from 10 to 100 mM were used in the release test. No influence of either the pH or the salt concentration of the release fluid on the release behavior was observed. The time required for 100％ release was approximately 6 hours, which was consistent with the results obtained in the clinical study. The results suggest that the patch preparation exhibited a consistent release behavior that can be used to evaluate pharmacokinetic profiles in clinical studies. Consequently, the release test method described in JP17 represents a useful method for determining drug release from patch preparations.