ABSTRACT:
The purpose of this research work was to establish mucoadhesive buccal devices of esomeprazole magnesium bilayered buccal devices. The tablets were prepared by using carbpol-934 (CP), hydroxy propyl Methyl cellulose K4M (HPMC K 4M), hydroxy propyl Methyl cellulose E5 (HPMC E5) as bioadhesive polymers to impart mucoadhesion in drug: polymer ratio of 1:1, 1:1.25, 1:1.5 and ethyl cellulose to act as an impermeable backing layer. Buccal devices are evaluated by different parameters such as weight uniformity, hardness, thickness, content uniformity, surface pH, swelling index, ex-vivo mucoadhesion strength, ex-vivo mucoadhesion time, invitro drug release and invitro drug permeation. The buccal bilayered tablet showed slow release of drug along increased bioavailability. The ex-vivo drug release of F8 formulation showed 84.28±0.76 in 7hrs. The mechanism of drug release was found to be following zero order along obeying peppas and Hixson crowell release kinetics, which was perfectly suitable for a controlled release formulation, stability of the drug in the optimised buccal tablets found to be stable in human saliva for 6 hours. FTIR studies show no interaction between drug and polymers. The present study concludes that mucoadhesive buccal devices of esomeprazole can be a good way to bypass the extensive hepatic first-pass metabolism and to improve bioavailability of esomeprazole.