Formulation Design and Characterization of Kollidon SR Based Trimetazidine Dihydrochloride Matrix Tablets

Abstract:

The purpose of the present study was to formulate sustained release Trimetazidine Dihydrochloride matrix tablets by using Kollidon SR as rate controlling polymer. Each of the formulated tablet contains 35 mg of Trimetazidine Dihydrochloride. The tablets were prepared by direct compression method. The granules were evaluated for angle of repose, bulk density, tapped density and compressibility index. The formulated tablets were evaluated for weight variation, thickness, diameter, hardness, friability and drug content and also in-vitro dissolution studies. Drug content in formulation was determined by UV method. The granules showed satisfactory flow properties. All the tablet formulations showed acceptable pharmacotechnical properties and complied for tested parameters. The in-vitro release study of matrix tablets were carried out in phosphate buffer with pH 7.4 for 7 hours. The drug release from each formulation was analyzed by using release kinetic theories. The results of dissolution studies indicated that all the formulations exhibited drug release pattern very close to theoretical release profile. Applying kinetic equation models, the mechanism of release of the drug from all the formulations were found to be followed Higuchi model, as the plots showed high linearity, with correlation coefficient (r²) value of 0.93 or more. The 'n' value lies between 0.45 <n<0.89 (Korsmeyer-Peppas model) demonstrating that the mechanism controlling the drug release was the anomalous non-Fickian or anomalous release. The mean dissolution time (MDT) was calculated for all the formulations and the highest MDT value was obtained with formulation 1. Therefore, the results generated in this study showed that the formulated sustained release matrix tablets deliver the drug through a combination of both diffusion and erosion controlled mechanism.
Keywords: Trimetazidine Dihydrochloride, Kollidon SR, Matrix Tablet