Volume 3, Issue 6


Optimization and In vitro evaluation of verapamil hydrochloride floating bilayer tablet

Author: Bharat W. Tekade, Vinod M. Thakare, Umesh T. Jadhao, Fahim Kazi

Abstract: The main objective of this investigation was to optimize bilayer gastric floating drug delivery system of Verapamil hydrochloride to study the effect of formulation variables especially, combination of polymers on drug release showing prolonged gastric residence time and optimized by using mathematical and statistical techniques. Three ratios of drug to total polymer content and three ratios of HPMC K4M to CP934 were chosen for an optimal design.  In the preliminary trials the effect of sodium bicarbonate loading was studied on floating properties and 12% concentration was found to be optimum for floating buoyancy. Hardness of about 5 kg/cm2 was found to be optimum for floating buoyancy and to keep two layers intact. Other physical parameters like weight variation, thickness and friability were within pharmacopoeial limit. Percentage drug content in all BFT formulations was found to be 98.47% - 99.96% which were within pharmacopoeial limit. Drug-polymer ratio and the HPMC K4M-CP934 significantly affect the buoyancy and drug release. It was concluded on the basis of buoyancy and in-vitro release kinetics that an optimized formulation containing a ratio of Drug to polymer 1:1 and polymer to polymer 1:1 gave the best in-vitro release of 99.42% in 12 hrs while for 3:1 and 1:3 in-vitro release was 91.05% and 93.71% respectively. A comparative study was done with the marketed formulation of Verapamil hydrochloride (Calaptin – SR). FTIR studies show no evidence of interaction between drug, polymers and other excipients. The In vitro data were fitted to different kinetic models.

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