The purpose of present investigation is to formulate and optimize the sustained release matrix tablet containing Trimetazidine dihydrochloride as a model drug. A 32 full factorial design were applied to carry out systematic studies. The concentration of HPMC K 100 (X1) and Eudragit RSPO (X2) were chosen as independent variables while percentage drug release at 2 hrs, 6 hrs and 12 hrs (Q2, Q6 and Q12) was taken as dependent variables. The dissolution profile of all nine factorial formulations was fitted to zero-order, first-order, Higuchi and Korsemeyer-Peppas models to ascertain the kinetic modeling of drug release. A response surface plot is presented to show the effects of X1 and X2 on % drug releases after 2 hrs, after 6 % and at the end of 12 hrs. The drug was released by diffusion of anomalous type. A model was validated for accurate prediction of drug release profile. Acceptable batches were identified in the experimental design with constraints on percentage drug released in 2, 6 and 12 hrs. From this study, it was observed that the concentration of HPMC K 100 and Eudragit RSPO have distinct effect on in-vitro drug release profile. The release rate of Trimetazidine dihydrochloride decreased proportionally with increased polymer concentration. Also the concentration of pH independent polymer Eudragit RSPO increases resulted decrease in initial burst release. The study helped in finding the optimum formulation with excellent sustained drug release.
Loading....