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Formulation and Evaluation of Delayed Release Pantoprazole Tablets
Pantoprazole is a proton pump inhibitor, belongs to group of benzimidazole, used for the treatment of gastric and duodenum ulcers. Pantoprazole undergoes degradation in acid medium of the stomach, can be coated with enteric coating polymer that will safely deliver the drug in the small intestine. In this present study an attempt was made to formulate and evaluate pantoprazole as enteric coated tablet. Delayed release tablets of pantoprazole were prepared by wet granulation method using HPMC, Cassava starch and polyvinyl pyrrolidine as polymer, Avicel PH 102 (MCC) as filler and starch as binder. The prepared tablets were evaluated for hardness, weight variation, friability and drug content uniformity and it was found that the results comply with official standards. The prepared tablets were coated using enteric coating polymer such as cellulose acetate phthalate, Eudragit L100 and Drug coat L100 by dip coating method. The in vitro release was studied using pH 1.2 acidic buffer and pH 6.8 phosphate buffer. The in vitro release study revealed that the prepared tablets were able to sustain release drug in to the intestine. The release kinetics studies showed that the release was first order diffusion controlled and then values obtained from the Korsmeyer-Peppas model showed that the release mechanism was super case-II transport. Stability studies indicated that the developed tablets were stable and retained their pharmaceutical properties at room temperature and 40°C / 75% RH for a period of 1 month. The anti-ulcer activity was evaluated by water immersion stress induced ulcer model. The pantoprazole sodium sesquihydrate coated formulations ECF3 at a dose of 10 mg/kg body weight showed a protection index of 100%.
Pantoprazole, Delayed Release, HPMC, PVP, Cassava Starch.
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