Taxotere 1-vial (docetaxel 20 mg/mL) physical and chemical stability over 28 days in infusion bags containing 0.9% saline solution and 5% glucose solution

The physical and chemical stability of Taxotere (docetaxel) 1-vial infusion solutions was determined at a range of concentrations in 0.9% saline and 5% glucose.The chemical stability part of the study was carried out in the sanofi-aventis Analytical Development Laboratories, Dagenham, UK. A series of saline and glucose infusion bags were prepared containing Taxotere 1-vial such that the equivalent docetaxel concentrations were equal to 60 mg/250 mL, 80 mg/250 mL, 200 mg/250 mL and 250 mg/250 mL of infusion solution. The prepared infusion bags (five of each concentration/infusion solution combination) were stored at 5°C and room temperature (about 20°C) and examined using a stability-indicating high performance liquid chromatography procedure initially and again after storage for 14 or 28 days.No significant change was observed in the docetaxel content or impurity profile after storage for up to 28 days.The physical stability part of the study was carried out by Fannin Compounding Limited, Dublin, Ireland. A ‘one shot’ method of infusion bag preparation was used: when more than one vial of Taxotere was needed to prepare the required dose the drug was drawn up into a single syringe before being introduced into the infusion bag. A series of saline and glucose infusion bags were prepared containing Taxotere 1-vial such that the equivalent docetaxel concentrations were 60 mg/250 mL, 80 mg/250 mL, 200 mg/250 mL and 250 mg/250 mL of infusion solution (six bags of each concentration/infusion solution combination giving a total of 48 infusion bags). Half of the bags were stored at 2°C–8°C and the remainder at 15°C–25°C. The bags were visually examined for evidence of crystallisation initially and after storage for 24 hours, 48 hours, 7 days, 14 days and 28 days.No crystals or other particles were observed in any of the bags after storage for up to 28 days.