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PP-033 Physico-chemical stability of cabazitaxel-containing premix solution and ready-to-administer solutions

Background Extended stability data for recently approved cytotoxic drugs are often missing. However knowledge about the physico-chemical stability of concentrated and ready-to-use solutions is essential in a pharmacy-based centralised cytotoxic preparation unit. Purpose To investigate the extended physico-chemical stability of cabazitaxel-containing premix solution and diluted infusion solutions in either 0.9% sodium chloride (NaCl) or 5% glucose. Materials and methods A stability-indicating reversed-phase high-performance liquid chromatography (RP-HPLC) assay with ultraviolet detection was developed and validated. Premix solutions of cabazitaxel were prepared in the original vials. Infusion solutions were prepared in prefilled polypropylene/polyethylene (PP/PE) infusion bags (0.9% NaCl, 5% glucose) in order to achieve the recommended minimum and maximum cabazitaxel concentrations (0.1 mg/mL, 0.26 mg/mL). Test solutions were stored refrigerated (2 – 8°C) or at room temperature (25°C) protected from light. Samples were taken and assayed in triplicate over a 28 day storage period. Physical stability was determined by measuring the pH value and visual inspection at predetermined intervals. Results The premix solution containing cabazitaxel was found to be physico-chemically stable over a period of 28 days. Diluted cabazitaxel infusion solutions remained chemically stable over a period of 28 days. Precipitation of cabazitaxel occurred in particular infusion solutions at the end of the storage period. Conclusions Cabazitaxel premix solutions and infusion solutions prepared with 0.9% NaCl or G5 vehicle solution in PP/PE bags are chemically stable over storage a period of 28 days either refrigerated or stored at room temperature. Diluted infusion solutions should be visually checked prior to use as unpredictable crystallisation of cabazitaxel may occur. No conflict of interest.