FORMULATION AND COMPARATIVE EVALUATION OF PANTOPRAZOLE BUCCAL PATCHES USING NATURAL AND SYNTHETIC POLYMER

Gastro-oesophageal reflux disease is a chronic condition of mucosal damage. GERD is caused by the regurgitation of stomach acid into the esophagus. Pantoprazole is a proton pump inhibitor which acts against GERD. This proposed work is to formulate and evaluate pantoprazole buccal patches using synthetic (HPMC K100) and natural (sodium alginate) film forming polymers. Solvent casting method was used for the preparation of patches. Polyethylene glycol and glycerol were used as plasticizers. Pantoprazole is a highly potent proton pump inhibitor used in treatment of erosion and ulceration of the esophagus caused by gastro esophageal reflux disease and it acts systemically. Preformulation studies were performed. FT-IR analysis showed the drug and polymers were compatible. Six formulations were prepared, F1, F2 and F3 using different concentration of sodium alginate. F4, F5 and F6 were formulated using different concentrations of HPMC k100. In vitro dissolution studies were done. It was seen that the formulation F4 showed maximum drug release (97.42%). Surface pH of the formulated patches was found to be around 7. Folding endurance, disintegration and dissolving time, moisture content, swelling index also were performed and all the tests showed a satisfactory results. From all the evaluation parameters, F4 formulation was found to be better showing sustained release when compared to other formulations. The kinetic study of F4 formulation was done and it was found that the formulation follows zero order. Key words: Pantoprazole; HPMC K100; Sodium alginate; FT-IR; GERD.