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FORMULATION AND EVALUATION OF ACECLOFENAC SUSTAINED RELEASE TABLETS USING EC AND HPMC POLYMERS

The present work focuses on preparation of Aceclofenac sustained release tablets in order to reduce the dosing frequency, there by improve patient compliance and to produce uniform drug release for a prolonged period of time compared to the conventional Aceclofenac tablets. Six formulations were prepared by wet granulation method using HPMC E15 and Ethyl cellulose 22N as release retardant polymers in the concentration of 5%, 6% and 7%. The prepared granules were evaluated for various pre-compression parameters like angle of repose, bulk density, tapped density, compressibility index and Hausner’s ratio. The FT-IR studies concluded that there was no drug-polymer interaction. The post compression parameters like appearance, thickness, hardness, weight variation, friability, drug content, in-vitro drug release and order of kinetics were studied. The drug release of best formulation F6 was found to be 56.8±0.65% at the end of 10 hours. The overall results revealed that as the concentration of polymer was increased, the drug release decreased. Plots of log cumulative Percentage drug remaining Vs Time were found to be linear with all the formulations indicating that the drug release from these formulations was according to the first order kinetics. Stability studies of Formulation F6 revealed that the drug was stable even after stored at 40±2 o C/75±5% RH for 45 days. From all the above observations, the formulation F6 was found to be a better one which satisfied all the criteria for sustained release tablets.