Formulation and Evaluation of Pantoprazole Sodium Enteric Coated Tablets


Volume :

1

Issue :

2

Abstract :

Pantoprazole is a proton pump inhibitor belongs to group of benzimidazole which has been widely used in the treatment of gastric, duodenal ulcer and also in gastro-esophageal reflux disease (GERD), Zollinger Ellison syndrome. It suppresses the acid production by inhibiting the H+ K+ ATP’ase. Pantoprazole is an acid labile drug, which can be degraded in the stomach. In aqueous media more acidic than pH 4 it suffers a practically complete decomposition within a period shorter than 10 minutes. Pantoprazole which have an irritant effect on the stomach, can be coated with a substance that will only dissolve in the small intestine. For such types of drugs, enteric coating added to the formulation tends to avoid the stomachs acidic exposure, delivering them instead to a basic pH environment (intestines pH 5.5 and above) where they do not degrade, and give their desired action. The prepared tablets were evaluated for hardness, thickness, weight variation, friability & drug content uniformity and the results were found to comply with official standards. The prepared tablets were coated using an enteric coating polymers such as Eudragit L100, PVAP, Eudragit RS100 by the spray coating method. The in vitro release was studied using pH 1.2 acidic buffer and pH 6.8 phosphate buffer and the study revealed that the prepared tablets were able to release the drug in the intestine, from the Prepared all batch’s EC8 was found best, The optimized formulation EC8 shows the average thickness of 2.2 mm, average hardness of 3.52 (kg/cm2), average weight variation of 213 mg, friability of 0.46%, drug content 101.2 %, disintegration time 1min 10sec, cumulative % drug release 100.16% within 2hrs 45mins and acid resistance time of about 2hrs. 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 3 month.
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