Design and Evaluation of Controlled Release Gastric Floating Drug Delivery System of Proton Pump Inhibitor

The purpose of this research was to prepare and evaluate a floating drug delivery system of a proton pump inhibitor (pantoprazole sodium). Pantoprazole is a proton pump inhibitor, belongs to group of benzimidazole, used for the treatment of gastric and duodenum ulcers. The core tablets were prepared by direct compression method (effervescent method) by using microcrystalline cellulose, sodium bicarbonate, citric acid, magnesium stearate and HPMC K100 and HPMC K15. The physicochemical parameters like pre-compression and post compression evaluation were performed as per Pharmacopoeial standard and the compatibility study was performed by FTIR and DSC methods. The release data were subjected to different models in order to evaluate their release kinetics and mechanisms. The compatibility study of the prepared Pantoprazole sodium tablets implies the information about no interaction between drug and polymer. The drug release kinetics was observed by Non-Fickian diffusion mechanism. HPMC K100 shows better release properties than HPMC K15. The floating lag time were found to be significantly increased with the increasing concentration of the gas generating agent. After the dissolution study of prepared Pantoprazole sodium floating tablet, it was concluded that the formulations with HPMC K100 shows better controlled release effect than HPMC K15. The release kinetics data implies that the release mechanism of the all formulation was Non-Fickian. The developed floating tablets of pantoprazole sodium may be used in clinic for prolonged drug release for at least 12h, thereby improving the bioavailability and patient compliance.