Physical and chemical stability of Taxotere 1-vial 20 mg/1 mL infusion solution following refrigerated storage

Background: Taxotere 1-vial is expected to simplify preparation by no longer requiring the initial dilution step that was necessary with the 2-vial presentation, offering easier and quicker preparation and therefore improved convenience.Objective: The physical and chemical stability of a new 1-vial formulation of docetaxel (Taxotere 1-vial, sanofiaventis, Dagenham, UK) in a large number of infusion solutions was studied following refrigerated storage.Methods: Taxotere 1-vial infusion solutions were prepared by adding 200 mg of docetaxel, using a single introduction of 10 mL docetaxel concentrate (20 mg/mL), into 250 mL polyethylene bags filled with 0.9% saline. Infusion bags were stored under refrigeration at 5°C and removed after either two (n = 60 bags) or seven (n = 60 bags) days. The infusion bags were assessed immediately upon removal and then again at various time intervals, up to a maximum of 24 hours, following storage at ambient temperature (about 20°C). Physical stability, determined by crystallisation, was assessed by careful visual examination. The same solution from several of the infusion bags used to assess physical stability was used to assess chemical stability, and this was performed using HPLC to determine the docetaxel content and the presence or absence of degradation impurities.Results: No visible crystallisation was observed in any of the Taxotere 1-vial infusion bags following refrigerated storage for either two or seven days and subsequent storage for 24 hours at approximately 20°C. There were also no significant changes in pH or docetaxel content and no degradation impurities recorded in the infusion bags during this time.Conclusion: The new Taxotere 1-vial formulation is associated with a reduced risk of docetaxel precipitation due to elimination of the premix solution (required for the Taxotere 2-vial presentation) and a one-shot preparation technique (only one intervention into the infusion bag). Refrigerated storage also significantly extends the physico-chemical stability of the Taxotere 1-vial for up to seven days. However, only physico-chemical stability has been demonstrated in this study.