Development and Characterization of Osmotically Controlled Self Pore Forming Tablet Dosage Form

Abstract

The goal of the current research was to develop osmotically controlled self-pore forming tablet of drug candidates Vildagliptin and Carvedilol. Self-pore forming osmotic control drug delivery system can provide continuous delivery of drug at predictable and reproducible kinetics throughout the GIT. Carvedilol with Vildagliptin in a bilayer tablet represents a new era in the successful development of a controlled release osmotic tablet formulation with a number of features to ensure effective drug delivery. Preformulation studies for Carvedilol and Vildagliptin drug and excipients revealed that the drugs and newlineexcipients used in present investigation are compatible with each other. Formulation for newlineboth layers was developed successfully using 32 full factorial design of experiments. Data newlineanalysis and statistical significance was determined successfully which revealed that the variables and models selected during study were significant. In-vitro Drug release study of self- pore forming osmotic controlled release bilayer tablet was performed for CV1 to CV9 batches from that CV6 shows 100.49 ±1.7 drug release and it considered as the optimized one because of uniform drug release in control manner. Stability study protocol performed on optimized formulation and stored at 40° C / 75 % RH and 60°C, 80% RH for 3 month and result shows 99±1.5 and 99±1.0 drug release accordingly. The formulation was discovered to be stable for the designated study period, according to a stability study. In-vivo study performed on rabbit shown that the developed formulation was found to have significant antihypertensive activity and antihyperglycemic activity. Moreover, a comparison of test with marketed formulation also shown that test formulation has got comparative activity with the marketed formulation.