FORMULATION AND IN-VITRO CHARACTERISATION OF CONTROLLED RELEASE LAFUTIDINE SUPER PORUS HYDROGEL TABLETS

The aim is to design, develop & characterize a desired gastro retentive super porous hydrogel (SPH) formulations containing lafutidine is histamine H2-receptor antagonist that may be used alone or with other agents to treat inhibits stomach acid production. SPH‘s synthesized employing various composite agents viz., sodium alginate, pectin, Carbopol, and chitosan were subjected to density and swelling property (swelling time, swelling ratio) characterization. Pectin, Carbapol, and chitosan have shown the best results; they were optimized for further characterization. As a hybrid agent is responsible for maintaining the capillary structure required for fast swelling of SPH, the effect of optimized hybrid on mechanical characters and swelling behavior of SPH was assessed. As the hybrid chitosan concentration increased, there was an extensive variation in swelling properties. Swelling time was gradually decreased from 45 to 16 min. SPHH-CN1 to SPH-CN7 lafutidine combined formulations were developed with dried SPH-CN5 powder. Drug release studies for formulations F1- F7 was carried out, and based upon release and retarding capacity, the effect of sodium bicarbonate F4 is the optimized formulation for present work. No prominent difference was observed in the principal IR peaks of lafutidine optimized polymer (chitosan), no prominent enthalpy changes were observed in the DSC endotherms of lafutidine, optimized polymer (chitosan), physical mixture formulations upon comparison with the peaks of drug and polymer alone, which may be considered that  lafutidine and chitosan are compatible enough without any interactions. SEM photograph clearly reveals the presence of the swollen pores on the surface of the super porous hydrogel hybrid drug delivery systems.