Statistical evaluation of influence of viscosity of polymer and types of filler on dipyridamole release from floating matrix tablets

Abstract

Present investigation describes statistically the influence of viscosity of hydroxypropyl methylcellulose and types of filler on dipyridamole release from floating matrix tablets using 3 2 full factorial design. Tablets were prepared using direct compression technique. Tablets were evaluated for in vitro floating ability and drug release study using USP 24 types II paddle apparatus using 0.1 N HCl (pH 1.2) at rotation of 100 rpm and temperature of 37±0.5°. Multiple regression analysis was performed for dependent variables studied and to evaluate contribution of factors with their levels two way ANOVA was performed followed by Tukey test. Polynomial equations and response surface plots were generated for all dependent variables. It was observed that both the factors had significant influence on all dependent variable studied (p<0.05). It was observed that as viscosity of polymer increases the release rate constant was decreased. Release rate obtained was highest when microcrystalline cellulose was employed as filler followed by dicalcium phosphate and lactose. Mechanism of drug release was anomalous types and depends upon viscosity of polymer and types of filler used. Microcrystalline cellulose gave release mechanism nearer to diffusion mechanism while dicalcium phosphate and lactose gave anomalous release. It was observed that both the factors had significant contribution on all dependent variables studied. A major controlling factor for kinetics of drug release was viscosity of polymer and it can be modified by incorporation of different types of filler. In initial phase of drug release viscosity of polymer and types of filler both governs the drug release while in later phase only the viscosity of polymer predominates