Formulation and biopharmaceutical evaluation of osmotic matrix tablets of diclofenac sodium

Abstract

The objective of our study was to prepare and evaluate osmotic matrix (OM) tablets of diclofenac sodium (DS). In vitro studies were done on USPXXIV dissolution apparatus II in different release medium. Surface characteristics of coating films and osmotic contribution of OM tablets also were studied. In vivo evaluation was carried out in 6 healthy human volunteers using HPLC method to assay plasma samples, and the results were compared with the performance of fabricated matrix and two commercial tablets of DS. Through in vitro drug release kinetics, using regression coefficient analysis and Peppas equation, different pharmacokinetic parameters and relative bioavailability were determined. OM tablets were found to provide more prolonged and controlled therapeutic plasma DS levels and also showed improved bioavailability in comparison to fabricated matrix and commercial tablets studied.