Evaluation of Dissolution of Osmotic-Controlled Release Paliperidone Tablets Using the Reciprocating Cylinder Method

概要

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The dissolution profiles of paliperidone from INVEGA® 3-mg tablets, osmotic-controlled release tablets, were evaluated by using the reciprocating cylinder method (RC method). We used 4 different compositions of the dissolution fluids, by considering the environment of the tablet in the gastrointestinal tract. After a lag time of 2 to 4 h, paliperidone was approximately dissolved to 24 h by zero-order release. The dissolution characteristics of paliperidone were not affected by the kind of the test medium, pH, and surfactant. In addition, the dissolution of the tablets was evaluated using the paddle method in distilled water, Japanese Pharmacopoeia (JP) 1st test fluid, and JP 2nd test fluid. The dissolution profiles of paliperidone obtained using the RC method and the paddle method were very similar. Further, the dispersion of the percentage of the dissolved paliperidone obtained using the RC method and the paddle method was small.