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Development of an intravenously injectable chemically stable aqueous omeprazole formulation using nanosuspension
Jan Möschwitzer1, Georg Achleitner, Herbert Pomper
1Department of Pharmaceutical Technology, Biotechnology and Quality Management, Free University of Berlin, Berlin, Germany.
Abstract:
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.
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