IN-VITRO EVALUATION OF ORAL EXTENDED RELEASE DRUG DELIVERY SYSTEM FOR TRIMETAZIDINE DIHYDROCHLORIDE USING METHOCEL POLYMERS

Objective: In the present study an attempt has been made to evaluate the effect of hydrophilic, pH independent polymers on the release profile of drug from matrix system. Methods: Trimetazidine Dihydrochloride, an anti-anginal agent was used as model drug to evaluate their release characteristics from different matrices. Matrix tablets [1] of Trimetazidine Dihydrochloride were prepared by direct compression process using METHOCEL K15M CR, METHOCEL K4M CR and METHOCEL K100M CR. Release kinetics of Trimetazidine Dihydrochloride from these controlled extended release matrices at 0.1 N HCl using USP paddle method with sinker was conducted for 10 hours and examined. Results: Statistically significant differences were found among the drug release profile from different classes of polymeric matrices. Higher polymer content (50%) in the matrix decreased the rate of the drug due to increased tortuosity and decreased porosity. At lower polymeric level (25%), the rate of drug release [10] was elevated. METHOCEL K4M CR was found to cause the retardation of drug. On the other hand, highest release was found from METHOCEL K100M CR, while other formulations gave an intermediate release profile of Trimetazidine Dihydrochloride. METHOCEL K15M CR and METHOCEL K4M CR extended the release of Trimetazidine Dihydrochloride up to 10 hours. The release mechanism was explored and explained with zero order, first order, Higuchi and Korsmeyer equation. Conclusion: The result generated in this study showed that the profile and kinetics of drug release were functions of polymer type, polymer level and physicochemical properties of drug. A controlled plasma level profile of Trimetazidine Dihydrochloride drug can be obtained by exact combination of polymers [9] and modulation of polymer content in the matrix.