Formulation and Evaluation of Oral Floating Dexlansoprazole in situ Gel for Gastroesophageal reflux disease by pH triggered method

In the present study an attempt was made to formulation and evaluation of oral floating Dexlansoprazole in situ gel for Gastroesophageal reflux disease (GERD). GERD is a chronic symptom of mucosal damage caused by stomach acid coming up from the stomach into the oesophagus. The preformulation studies for the drugs included API characterization, solubility, melting point, determination of λmax, standard calibrate curve, drug and excipient compatibility study was carried out. Oral floating in situ gel of Dexlansoprazole was formulated by pH triggered method. In pH triggered method, various formulations (F1-F6) were developed using excipients in various concentration of Sodium alginate and HPMC K100M. Formulations were evaluated for various physicochemical parameters like appearance, clarity, pH, gel strength, viscosity, in-vitro gelling capacity, gelling time, in-vitro floating behaviour, drug content and in-vitro drug release studies. As the concentration of the polymer increases properties like gel strength, viscosity found to increasing but whereas the percentage of cumulative drug release from the formulation was decreased. F5 was selected as best formulation because of its good gelling capacity and optimum viscosity. Drug content was found to be 97.25 ± 0.20%. It showed 92.88 ± 0.1% in vitro drug release for 8h. The F5 formulation follows first order kinetic which describes that the rate of drug release is dependent of its concentration and which is best fit for higuchi kinetic model. Stability studies were carried out for F5 formulations as per ICH guidelines for a period of 90 days and the stability was confirmed as there were no significant changes observed in physicochemical parameters.