Formulation and Evaluation of Floating Tablets of Pantoprazole

Abstract

Background: Pantoprazole is a protein pump inhibitor (PPI) used to treat acute duodenal ulcers, acute benign gastric ulcers, gastroesophageal reflux disease (GERD), and as a preventative measure for duodenal ulcer. It has a local effect on the stomach and works by competitively inhibiting the enzyme H+/K+ ATP, which is found in the gastric parietal cells. For acute duodenal ulcers, acute benign gastric ulcers, and gastroesophageal reflux disease (GERD), the usual oral dosage recommendation is 45 mg, and it is taken for 8–12 weeks. 
 Objectives: The preparation of pantoprazole floating tablets was attempted in the current investigation and optimize the formulation using different excipients like Hydroxy ethyl cellulose (HEC), cyclodextrin, sodium bicarbonate, citric acid and microcrystalline cellulose were used in the direct compression method to create pantoprazole floating tablets (250 mg).
 Methods: The direct compression method has been used in the current effort to create floating tablets. The active ingredient, sodium bicarbonate, citric acid, microcrystalline cellulose, and hydroxy ethyl cellulose were sieved through sieve no. 60 and blended uniformly with a mortar and pestle. Using a Rotary tablet punch machine, the powder was compacted into tablets after talc and magnesium stearate were added as lubricants
 Results: Preformulation studies were conducted to select suitable excipients, drug/polymer interactions were validated by the FTIR investigation. The manufactured floating tablets were assessed for hardness, weight fluctuation, thickness, friability, drug content homogeneity, floating lag time, and in vitro dissolution experiment studies was conducted. The results were within the limit and were compared with the marketed formulation.
 Conclusion: According to the observations of the current investigation, a floating pantoprazole tablet increases the stomach residence time and bioavailability, increasing therapeutic efficacy. Formulations F1, F2, F4, F5, F7, and F8 showed good floating, but Formulations F3, and F6 showed moderate floating throughout all 8 formulations. The stability analyses that were done for all the formulations showed that the F7 and F8 formulations had good stability.
 Keywords: Pantoprazole, Floating tablet, Hydroxy ethyl cellulose (HEC), Cyclodextrin, In-vitro drug release studies.