Physical and chemical stability of docetaxel infusions

Study objectives: To investigate the long-term physical and chemical stability of 0.3 mg/mL and 0.7 mg/mL infusions of docetaxel (Teva) in polyolefin bags containing either 0.9% sodium chloride or 5% glucose, stored under refrigerated (2°C-8°C) and room temperature (25°C) conditions protected from the light. Methods: The infusions were prepared aseptically and stored at the two temperatures for 56 days. At various time points, chemical stability was determined using a validated stability-indicating, high performance liquid chromatography (HPLC) assay. Physical stability was ascertained in terms of visual appearance, pH, weight change of infusions, and sub-visual particulate counts. Results: Irrespective of drug concentration, diluent type, or storage temperature, docetaxel infusions were compliant with both physical and chemical acceptance criteria over the 56-day study period. Conclusion: This study has demonstrated the extended stability of docetaxel (Teva) infusions over the concentration range 0.3-0.7 mg/mL in polyolefin bags containing either 0.9% sodium chloride or 5% glucose and stored at either 2°C-8°C or 25°C. These findings will enable pre-preparation and storage of these infusions by Centralised Intravenous Additive Services (CIVAS) units and the application of dose-banding schemes. As with all infusions where physical stability is potentially limited, docetaxel infusions should be carefully inspected for precipitation both before and during administration irrespective of the storage period before use.