FORMULATION AND EVALUATION OF DICLOFENAC SODIUM SUSTAINED RELEASE TABLETS USING MELT GRANULATION TECHNIQUE

Abstract

Hydrophilic polymers alone are not quite efficient in controlling the release of highly water soluble drugs. Hydrophobic Polymer and pore forming agent have been extensively investigated for sustaining the release of drug. They provide several advantages include good stability at varying pH ranges and effectively retards the water soluble drug. In the present study it was a novel approach where the water soluble drug is first incorporate in polymer matrix by melt granulation technique and this matrix is subsequently granulated with pore forming agent. Here it was considered that the combination of hydrophobic polymer and Pore forming agent to prepare the matrix tablets will result in desired slow release profile. Diclofenac sodium is selected as a model drug as it is water soluble and having short half life of 1-2 hours. Sustained release matrix tablets were developed by using hydrophobic polymer like Cetyl alcohol and pore forming agent like Pharmagrade sugar .Tablets containing 100 mg of drug were formulated. Flow properties of granules were studied by determining bulk density, tapped density, Carr’s index, Hausner ratio for all the formulations were obtained in satisfactory range. Drug content, Weight variation, Hardness, Percent Friability, and Thickness and are within acceptable limits of pharmacopoeial requirement. To know the drug release kinetics Zero order, First order, Higuchi plot, Korsmeyer Peppa’s plot were constructed ^{3, 10, 11}