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Development Of An Intravenously Injectable Chemically Stable Aqueous Omeprazole Formulation Using Nanosuspension Technology.
Published 2004 · Medicine, Chemistry
Omeprazole is a proton pump inhibitor, which is used for the treatment of peptic ulcers, reflux esophagitis and Zollinger-Ellison syndrome. It is a poorly soluble, chemically labile drug with a high degradation rate in aqueous media. The aim of this study was to show the feasibility of omeprazole stabilization using the DissoCubes technology and to find optimal production parameters for a stable, highly concentrated omeprazole nanosuspension. The high performance liquid chromatography analysis has proved the predominance of the nanosuspension produced by high pressure homogenization in comparison to an aqueous solution. Even 1 month after production no discoloration or drug loss was recognizable when the nanosuspension was produced at 0 degree C. As a result it can be stated that the production of nanosuspensions by high pressure homogenization is suitable for preventing degradation of labile drugs.