Storpirtis S, Rodrigues D
Pharmacy Department, School of Pharmaceutical Sciences, University of São Paulo, Brazil.
Drug Dev Ind Pharm. 1998 Nov;24(11):1101-7. doi: 10.3109/03639049809089956.
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 degrees 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.
本报告描述了一项体外研究的结果，该研究对来自不同巴西制造商的肠溶包衣微丸中含奥美拉唑的胶囊进行了评估。与三种类似产品（A、B和C）相比，原产品作为参照。将样品置于严苛条件下（40摄氏度和75%相对湿度，持续120天），所进行的测试包括奥美拉唑含量、微丸中溶解的奥美拉唑百分比以及其主要降解产物H 238/85的量。所获得的数据表明，这些产品不能被视为可互换的。产品A、B和C在物理和物理化学性质上的差异表明，它们未保持所需的稳定性，且奥美拉唑从微丸中的溶解不佳可能会影响生物利用度。
