Investigation of the Release Test Method for the Topical Application of Pharmaceutical Preparations: Release Test of Cataplasm Including Nonsteroidal Anti-inflammatory Drugs Using Artificial Sweat

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Abstract

A simple procedure for determining the in vitro release profile of a cataplasm for use in a quality control procedure has been developed. Since the disk assembly in the USP for patch dosage forms was unsuited for use in a release test due to penetration of the dissolution medium into the cataplasm from the screw part of the device and the cataplasm swelled, new holders were designed. In the new holder, a cataplasm is held in position by sandwiching it between a stainless-steel O-ring and a silicon O-ring on the stainless steel board, 2 acrylic boards hold the O-rings and the stainless steal board, and the entire assembly is placed at the bottom of the dissolution vessel. The release profile was determined using the “Paddle over Disk” method in USP26. Furthermore, in order to prevent the swelling of the cataplasm, artificial sweat was used as the dissolution medium. The release profiles of the nine marketed brands of cataplasm containing indomethacin, ketoprofen, and flurbiprofen, respectively, were determined over a 12-h period. By adjusting the ion concentration and volume of the media, and the release surface-area of the cataplasm exposed to each medium, the procedure was found to be reproducible for in vitro release characterization of nine marketed brands. This shows that this technique can be used as a quality control tool for assuring product uniformity.

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