Abstract

DEVELOPMENT AND EVALUATION OF MUCOADHESIVE BUCCAL TABLETS OF VALSARTAN

B. Kranthi Kumar*, S. B. Bhanja, Ashwini K. Chauhan, D. Pooja Reddy, Sridhar Siddiraju and B. B. Panigrahi

ABSTRACT

The present investigation is concerned with formulation and evaluation of mucoadhesive buccal tablets containing antihypertensive drug i.e. Valsartan to circumvent the first pass effect and to improve its bioavailability with reduction in dosing frequency and also dose related side effects. The half life of Valsartan is approximately 5hrs. The tablets were prepared by direct compression method. Eight formulations were developed with varying concentrations of polymers. The formulations containing polymers like Carbopol 934p and HPMC K4M were used as a polymer because of its excellent mucoadhesive property. The tablets were tested for weight variation, hardness, surface pH, Drug Content Uniformity, Swelling index, bioadhesive strength and in-vitro drug dissolution study. FTIR studies showed no evidence on interactions between drug, polymers, and excipients. The in-vitro release of Valsartan was performed under sink conditions (Phosphate buffer pH 6.8, 37±0.5 0C, rpm50) using UP-XXIV dissolution apparatus type II. The best in-vitro drug release profile was achieved with the formulation F7 which contain the drug with HPMC K4M (1:1.5). The surface pH, bioadhesive strength and swelling index of formulation F7 was found to be (6.1±0.0070), (36.81±0.386 gm) and (134±0.451) respectively. The tablets containing 40 mg of Valsartan exhibited 5 hrs sustained release i.e. (98.12±0.461) % with desired therapeutic concentration. The dissolution data of all formulations were correlated with various drug release kinetics, such as zero-order, first order, higuchi, korsemeyer-peppas. From the data of regression R2, it was concluded that our formulations followed zero order kinetics with non-fickian diffusion mechanism.

Keywords: Valsartan, Buccal tablet, Surface pH, Bioadhesive strength and Swelling Index.