奥美拉唑肠溶微丸压片与稳定性研究.pdf

European Journal of Pharmaceutics and Biopharmaceutics 57 (2004) 279–286 /locate/ejpb Research paper Tableting and stability evaluation of enteric-coated omeprazole pellets ¨ ˘ * Murat Turkoglu , Hakan Varol, Mine C¸ elikok Pharmaceutical Technology Department, Faculty of Pharmacy, Marmara University, Istanbul, Turkey Received 7 March 2003; accepted in revised form 24 October 2003 Abstract In this study, fluidized-bed manufactured enteric-coated omeprazole pellets were compressed into tablets. The stability of the pellets and those of compressed tablets were evaluated for remaining omeprazole and for degradation products under an accelerated stability protocol. The data were analyzed using the artificial neural network (ANN) and analysis of variance (ANOVA). It was found that enteric-coated omeprazole pellets could be compressed into quickly disintegrating tablets using microcrystalline cellulose granules as the pressure absorbing matrix. The ANN, using the multilayer perceptron model, predicted that there was a positive correlation between tablet crushing strength and microcrystalline cellulose concentration. Microcrystalline cellulose matrix showed a strong plastic deformation and all the pellets inside the tablet maintained their integrity with no significant change in their surface properties. Omeprazole degradation in acid medium was mainly dependent on microcrystalline cellulose concentration. A 90-day accelerated stability test in brown glass bottles with a desiccant showed that all prototype formulations would result in an