Novel Approach for Optimisation of Gastroretentive Formulation

Swati      Jagdale; Swapnil      Ghorpade; Aniruddha      Chabukswar; Bhanudas      Kuchekar

doi:10.2174/2210304x11101010085

Abstract

Gastroretentive drug delivery system is employed for the controlled release of drug in stomach. Present study was performed to develop an optimized floating formulation comprising tramadol hydrochloride as a model drug, employing 32 full factorial design. Sodium bicarbonate and citric acid were used as gas forming agent that forms carbon dioxide with aqueous solution. Combination of various polymers such as hydroxy propyl methylcellulose grade K4M, eudragit L- 100 and guar gum were used to achieve sustained release effect. The concentration of polymers was considered as independent variables whereas floating time, drug content of formulation, % drug release, swelling index and hardness of the tablets were utilised as dependent variables. The drug-excipient compatibility was studied with the help of IR spectroscopy. The tablets containing 50mg HPMC K4M/60mg eudragit L-100 and 75mg of HPMC K4M/50mg guar gum showed the optimum results. Gastric retention of optimised formulation was confirmed by in-vivo X-ray studies.

Keywords: Eudragit L-100, floating, guar gum, HPMC K4M, optimization, sodium bicarbonate, tramadol hydrochloride, tramadol, Carr's Compressibility Index, HCl Tablets