Formulation, Development and Optimization of Propranolol Mucoadhesive Bilayer Tablets by Using Central Composite Design and its In Vitro Studies

The purpose of this research work was to establish mucoadhesive buccal tablets of propranolol in the form of bilayer tablets. Central composite design was used for optimization of bilayer buccal tablets. Optimized formulations were planned by using Design Expert (R) after using the bio-adhesive polymers like polyacrylic acid (PAA) and hydroxypropyl methyl cellulose (HPMC). Wet granulation was used in compression of bilayer buccal tablets. Micrometric tests like angle of repose, compressibility index, bulk and tapped densities, Hausner's ratio for powders and granules were performed. Compressed tablets were also evaluated for different quality control and physicochemical parameters like weight variation, friability, hardness, surface pH, content uniformity, swelling index, ex vivo mucoadhesive strength by using sheep buccal mucosa and dissolution studies. In vitro drug release kinetic studies were performed by using the DD Solver. Model dependent, i.e., zero order, first order, Higuchi, Korsmeyer and Peppas, Weibull models and model independent approaches like similarity (f(2)) and dissimilarity (f(1)) factors were applied. Mucoadhesive tablets by following novel design for buccal drug delivery having appropriate mucoadhesion strength were successfully developed to detour hepatic degradation and enhancement of propranolol bioavailability. It was also observed that HPMC K15 can be successfully utilized to control the release of drug in sustained manner for extended period.