Studies on dissolution tests for soft gelatin capsules by the rotating dialysis cell (RDC) method. VI. Preparation and evaluation of ibuprofen soft gelatin capsule.

We prepared soft gelatin capsules (SC) containing ibuprofen (IB), a widely used phenylpropionic acid-derived antiphlogistic-analgesic drug. To evaluate the SC, in vitro dissolution tests were performed both by the paddle (PD) method described in the Japanese Pharmacopoeia (JPXII) and by the rotating dialysis cell (RDC) method which we previously developed and evaluated for application. In vivo, the blood IB concentration was determined after administration to beagles. Higher bioavailability was observed after administration of the SC containing IB than after administration of the bulk IB powder. A higher correlation was observed between the in vitro dissolution behavior and in vivo results by the RDC method than by the PD method, suggesting the usefulness of the RDC method in the dissolution test of SC.