Design and evaluation of Esomeprazole mucoadhesive buccal tablets

Abstract

The present investigation is to formulate and evaluate mucoadhesive buccal tablets containing antiulcer drug i.e. Esomeprazole to circumvent the first pass effect, to avoid gastric degradation and to improve its bioavailability with reduction in dose related side effects. The tablets were prepared by direct compression method. Twelve for- mulations were developed with varying concentrations of polymers like Carbopol 934, Hydroxy Propyl Methyl Cel- lulose (HPMC) and Sodium Carboxy Methyl Cellulose (SCMC). The tablets were tested for weight variation, hard- ness, surface pH, drug Content Uniformity, swelling index, and bioadhesive strength and in-vitro drug dissolution study. FTIR studies showed no interactions between drug, polymers and excipients. The Invitro release of Esomeprazole was performed under sink conditions (Phosphate buffer pH 6.8, 37±0.5 ºC, rpm 50) using USP disso- lution apparatus type II. The best in-vitro drug release profile was attained with the formulation F4 which contain Carbopol 934 and HPMC K 100 in the ratio of 31.The surface pH, bioadhesive strength and swelling index of for- mulation F4 was found to be 6.79, 0.289 and 127.2. Formulation F4 showed 8 hrs sustained drug release i.e.97.54 % with desired therapeutic concentration. The dissolution data of all formulations were correlated with various drug release kinetics, such as Zero order, Higuchi & Korsemeyer-Peppas. From the data, it was concluded that all the formulations followed non-Fickian type diffusion with zero order release kinetics.