Physicochemical stability of Oxaliplatin Accord 5 mg/mL in punctured original vials and after dilution with 5% glucose solution in polyethylene bottles and polyolefine bags

Study objectives: To determine the physicochemical stability of Oxaliplatin Accord 5 mg/mL in punctured original vials and after dilution with 5% glucose solution in polyethylene (PE) bottles and polyolefine (PO) bags at different concentrations and different storage conditions. Methods: Test solutions were prepared by dilution of Oxaliplatin Accord 5 mg/mL with 5% glucose solution either in 500 mL PE bottles or 100 mL PO bags to achieve two nominal oxaliplatin concentrations (0.1 mg/mL, 1.2 mg/mL) in each container type. Solutions were either stored at 2[degrees]C-8[degrees]C or at room temperature (20[degrees]C-25[degrees]C) with/without light protection. Test periods were 14 days in 40 mL original vials, 35 days in 100 mL PO bags and 84 days in 500 mL PE bottles. Samples were taken and analysed initially (Day 0) and at predetermined time points. Analyses comprised pH measurement, visual inspections and high-performance liquid chromatography (HPLC) assay. Results: Oxaliplatin Accord 5 mg/mL concentrate remained unchanged over the test period of two weeks when stored in the punctured original vials at room temperature under ambient light conditions. Diluted oxaliplatin solutions (0.1 mg/mL, 1.2 mg/mL) remained physicochemically stable over the whole study period (35 days in PO bags, 84 days in PE bottles), irrespective of temperature and light conditions. Conclusion: Punctured vials of Oxaliplatin Accord 5 mg/mL can be used for up to 14 days when stored at room temperature. Oxaliplatin Accord infusion solutions diluted with 5% glucose solution may be prepared in advance in pharmacy-based preparation units and used for 35 days (PO bags) and for 84 days (PE bottles). Keywords: concentrated solution, diluted infusion solution, oxaliplatin, physicochemical stability