Kineticstudy of Diclofenac Sodium from Methocelk15mcr and Cetylalcohol : Using Model dependent and Independent Methods and Bioequivalence Study

Current study aimed at the development of a matrix type sustain release Diclofenac tablet, using hydrophilic HPMC and hydrophobic polymer Cetyl alcohol. It was found that hydrophilic Methocel K15 MCR matrices based tablets showed zero order and hydrophobic cetyl alcohol matrices based tablets were followed first-order kinetics except formulation six (F6 showed zero order profile). The result of dissolution study indicated that formulations containing cetyl alcohol showed better dissolution properties as compared to formulations containing Methocel K15 MCR in terms of similarity and difference factor. By comparing the dissolution profiles with Voltaren SR tablet in terms of difference factors and similarity factors, it was revealed that the formulation F-4, F-5 and F-6 exhibited similar drug release profile as that of Voltaren SR tablet which indicated that these formulations could be bioequivalent with Voltaren SR tablet in vitro. The present study demonstrated that Diclofenac could be successfully prepared using an appropriate amount of Methocel K15 MCR and cetyl alcohol in the form of matrix tablets with similar dissolution profile of patent product Voltaren SR.