Physicochemical stability of cabazitaxel and docetaxel solutions

Objectives It is recommended that the Jevtana (current parenteral cabazitaxel formulation) final infusion solution should be used within 8h when stored at ambient temperature or within 24h if refrigerated. We determined the physical and chemical stability of cabazitaxel and docetaxel over prolonged periods after dilution in infusion solutions from their Jevtana and Hospira, respectively, parenteral formulations. Methods The stability of these antineoplastic drugs was determined after (i) reconstitution of the injection concentrate and (ii) further dilution in 0.9% NaCl solution contained in PVC-free infusion bags. Chemical stability was determined using both high-performance liquid chromatography (HPLC) with ultraviolet detection and high-resolution (HR)-HPLC-mass spectrometry (MS) techniques. Physical stability was determined by visual inspection. Results The stability tests revealed that reconstituted cabazitaxel solutions (premix solutions) stored at 4 degrees C were physicochemically stable (at a level of 95% cabazitaxel) for a minimum of 4weeks. Diluted infusion solutions in PVC-free infusion bags (docetaxel concentration 0.30mg/mL; cabazitaxel concentration 0.15mg/mL) were physicochemically stable (at a level of 95% cabazitaxel or docetaxel) for a minimum of 4weeks, independently of storage temperature (4 degrees C or 25 degrees C). Diluted cabazitaxel infusion solutions appeared stable (at a level of 95% cabazitaxel) for a minimum of 4weeks when stored in the presence of saturated oxygen at 25 degrees C. Conclusions Cabazitaxel and docetaxel are characterised by high stability in customary infusion fluids for at least 4weeks.