A. R. Lee, B. R. Chae, S. H. Cho, S. W. Park, S. I. Sohn, S. Y. Baek

Daewon pharm Co. Ltd.

Pelubiprofen (PLB) is a propionic acid derivative with analgesic and anti-inflammatory properties and is widely used in t he treatment of inflammatory diseases. Because of the short half-life of PLB, it needs to be taken three times a day. Therefore, a controlled release(CR) formulation would benefit patients by elongating the dosing interval. Matrix system has many advantages such as effectiveness, wide range of drug loading and the utilization of conventional manufacturing equipment among CR system. In this study we employed the matrix system as controlled-release system to develop PLB-containing controlled release tablets (PLB-CRT) to improving patient compliance and efficacy.

PLB-CRT containing Kollidon SR showed gradual surface erosion during the dissolution test, resulting in the best fit to Hixon-Crowell model. Comparative PK studies of IR and K2 tablets using a multiple dosing, cross-over design in human volunteers showed bioequivalence in terms of the extent of bioavailability.