In vitro comparative evaluation of dissolution profile of omeprazole enteric coated pellets to development of similar medicine

Abstract

The omeprazole is a proton pump inhibitor drug widely used in the treatment of gastroesophageal reflux disease, Zollinger-Ellisson syndrome and peptic ulcer. Since it´s unstable in acid pH, the raw material omeprazole is usually marketed as enteric-coated pellets. Differences in the quality of the coated granules can be source of in vitro variability in the drug dissolution with consequent changes in the product’s bioavailability. The aim of this study was to assess the quality, through in vitro dissolution profile assays, of different batches of
omeprazole enteric-coated pellets, available in the Brazilian market. The products were tested according to Test 2 of omeprazole delayed-release capsule monograph in the U.S. Pharmacopeia. None of the manufacturers presented satisfactory dissolution profiles results when compared to the reference product. Data obtained from dissolution profiles indicate that the batches may have their bioavailability affected by the poor dissolution of omeprazole in the tested conditions.