DEVELOPMENT AND IN VITRO EVALUATION OF SUSTAINED RELEASE MATRIX TABLETS OF DICLOFENAC SODIUM USING DIFFERENT GRADE HYDROPHILIC POLYMER & PEG 6000 AS RELEASE RETARDANT

摘要

Diclofenac Sodium, being NSAID, its oral administration restricted due to its inherent problems. Hence in the present study, attempt has been made to design oral sustained release once daily matrix tablets of Diclofenac Sodium using combination of hydroxyl propyl methyl cellulose (HPMC) & PEG 6000 and to study the effect of various process and formulation variables like polymer properties and polymer viscosity on in-vitro release of drug. Sustained release tablets of Diclofenac sodium were prepared using different proportion of HPMC 4000 cps and PEG 6000 (F1, F2, F3……..F6). The physical properties of prepared tablets like hardness, friability, weight variation, thickness and drug content were studied and were found to be within the acceptable limits. In-vitro release studies were performed in Simulated Gastric Fluid (SGF) pH-1.2 for two hours and Simulated Intestinal Fluid (SIF) pH-6.8 for subsequent 10 hours by USP-I dissolution apparatus, in 900 ml at 37.5±0.5oC (stirring speed was 70 rpm). As amount of HPMC was increased from 5% to 30%, released rate was decreased. However, no appreciable change occurred, when the amount of HPMC was increased to 30% matrix tablets containing 25% HPMC4000 cps and 5% PEG 6000 were found to show good initial release (32% in 2 hours) and extended the release upto 10 hours. The “n” value was found to be 0.89, indicating anomalous (non-fickian) behavior of the drug release.