FORMULATION, DEVELOPMENT AND EVALUATION OF AN IMMEDIATE RELEASE BUFFER TABLET OF OMEPRAZOLE

Darshna Mishra, Tripti Shukla, Neha Jain, Neeraj Upmanyu
Pharma Science Monitor   unpublished
Gastro-oesophageal reflux disease (GERD) patients on proton pump inhibitors before breakfast or dinner have acid recovery at night. Bedtime immediate-release buffer omeprazole tablet demonstrated better control of nocturnal pH than pantoprazole before dinner. Buffered omeprazole is an oral preparation consisting of an inner core of non-enteric-coated omeprazole with a shell of sodium bicarbonate. The buffer protects against acid degradation of omeprazole in addition to immediate antacid action.
more » ... ate antacid action. The aim of this study was to assess the efficacy of Buffered omeprazole for raising and maintaining an intragastric pH of more than 6 in comparison to i.v. pantoprazole in equivalent dosing. Omeprazole can be used in the treatment of gastroesophageal reflux disease (GERD), peptic ulcers, erosive esophagitis, and Zollinger-Ellison syndrome. Omeprazole, as well as other PPIs, are only effective on active H+/K+ ATPase pumps. These pumps are stimulated in the presence of food to aid in digestion. For this reason, patients should be advised to take omeprazole with a glass of water on an empty stomach about 30-60 minutes before a meal to allow the drug to reach peak levels once food is ingested. Additionally, most sources recommend that after taking omeprazole, at least 30 minutes should be allowed to elapse before eating. The formulation is designed as a way to have release as well as, to give protection to drug part against acid environment of stomach, for that the strategy was followed in such a way that buffer part of final tablet provide protection to drug part by mechanism of raising pH as well as by maintaining that pH range for a period of sufficient time so that total drug from inner tablet is released and absorb from that pH.
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