FORMULATION AND EVALUATION OF CONTROLLED RELEASE OSMOTIC TABLET OF CARVEDILOL PHOSPHATE

Abstract

Carvedilol Phosphate Osmotic Tablets were prepared using a Direct Compression approach. A mixture of osmogens i.e. NaCl and Mannitol was used to achieve a desired osmotic pressure in the tablets which were then coated with Cellulose Acetate polymer with PEG as a plasticizer and Povidone K30 as a pore former. Early screening batches showed drastic effect of osmogens and pore former, as well as % weight gain on drug release of the tablets. The prepared tablets were evaluated for Weight variation, Thickness, Hardness, Dissolution, and the final optimized formulation was exposed to Accelerated Stability Study. A full factorial statistical optimization was carried out on the best optimized formulation to establish the design space for selected factors i.e., NaCl and Povidone K30 against Response Dissolution. A significant effect of both factors was found on Dissolution rate, which justifies the use and rationale of the excipients Key Words: Carvedilol Phosphate, Osmotic Tablets, Direct Compression, NaCl, Mannitol, Cellulose Acetate.