In Vitro Evaluation of Dissolution Properties and Degradation Products of Omeprazole in Enteric-Coated Pellets

Abstract

This report describes results of an in vitro study in which capsules containing omeprazole in enteric-coated pellets from different Brazilian manufacturers were evaluated. The original product was the reference in comparison to three similar products (A, B, and C). Samples were submitted to severe conditions (40° C and 75% relative humidity during 120 days), and the tests performed were the omeprazole content, the percentage of omeprazole dissolved from the pellets, and the amount of H 238/85, its main degradation product. The data obtained suggest that these products could not be considered interchangeable. Differences in physical and physicochemical properties of products A, B, and C indicated that they did not maintain the required stability and that bioavailability might be affected by the poor dissolution of omeprazole from the pellets.