Abstract

FORMULATION, DEVELOPMENT AND IN-VITRO EVALUATION OF FIXED DOSE COMBINATION OF ANTIHYPERTENSIVE DRUGS THROUGH BILAYER APPROACH

Sameeran V. Kapadi*, Laxmikant T. Gadhe, Ajaykumar Vishwakarma, R.T.Mogal, Swati talele, Dr.G.N.Chaudhari

Abstract

The objective of the present study was to formulate, optimize and evaluate the bilayer tablet of telmisartan and Hydrochlorothiazide (HCTZ) both as immediate release layers for the effective management of patients with severe hypertention. Telmisartan layer (460 mg) and HCTZ (340mg) was prepared by wet granulation using superdisintegrant (Kyron-T314) and binder(PVP K30). On the basis of preliminary trials Kyron-T314 was optimized as superdisintegrant and PVP K30 as binder for Telmisartan layer and HCTZ layer respectively. Both Telmisartan and HCTZ layers were optimized using 32 factorial design. For both telmisartan layer and HCTZ layerPVP K30(X1) and Kyron-T314(X2) were selected as independent variable and In both the layers, 90% Drug release in 60 minutes (Y1) were selected as dependent variables. All formulations were evaluated for in vitrodrug release analyzed according to various release kinetic models. The optimize batch of Bilayer Tablet shows Result inthat, Telmisartan layer which contained PVP K3012.91 mg and Kyron-T314 5.73 % gives predicted % drug release by DE.7.0.0 is 96.03%, but actual experimental % drug release of telmisartan is obtaining 98.70% & % error is +2.67 and HCTZ layer which contained PVP K30 11.38 mg and Kyron-T314 3.05% gives predicted % drug release by DE.7.0.0 is 95.68%, but actual experimental % drug release of HCTZ is obtain 96.37% & % error is +2.67.The study indicate that telmisartan and HCTZ can be used in combination effectively for the treatment of severe hypertention.

Keywords: Bilayer tablet, wet granulation, Kyron-T314, PVP K 30, 32 factorial design.