IN VITRO AND IN VIVO EVALUATION OF THE GASTRORETENTIVE FLOATING DOSAGE FORM

Abstract

The aim of the present investigation was to develop and optimize gastro retentive floating system of Pantoprazole for the efficient treatment of acid related disorders and H. Pylori infections. Floating tablets were developed using central composite design (CCD), and optimization was done by employing response surface methodology. The floating tablets were prepared with HPMC K4M/Ethyl cellulose and natural seed polymer of Delonix regia by wet granulation technique. Buoyancy was achieved by adding an effervescent mixture of sodium bicarbonate and anhydrous citric acid. The Optimized formulation (BS3) showed no significant change in physical appearance, drug content, total buoyancy time, or in vitro dissolution pattern after storage at 40°C/75 % relative humidity for 1 month. The best formulation was selected based on in vitro characteristics and was used for the in vivo radiographic studies by incorporating BaSO4. Evaluation of Gastric retention using x-Ray imaging studies were performed on rabbit to justify the increased gastric residence time of the dosage form in the stomach, based on the floating principle. Further the floating tablets were evaluated for its antiulcer activity in Male wristar rats by ethanol induced ulcer in comparison with standard. The floating formulation shows excellent buoyancy and better gastric cytoprotection when compared with standard drug.