Physicochemical stability of Irinotecan Accord in punctured original vials and polypropylene syringes and after dilution with 0.9% sodium chloride or 5% glucose solution in polyolefine bags

Study objectives: To determine the physicochemical stability of undiluted Irinotecan Accord concentrate in punctured original glass vials, in polypropylene (PP) syringes, and after dilution with 0.9% sodium chloride solution or 5% glucose solution in polyolefine (PO) bags at different concentrations and storage conditions for up to 96 days. Methods: Test solutions were prepared with Irinotecan Accord 20 mg/mL and stored refrigerated with light protection and at room temperature under normal room light (undiluted solutions) or at room temperature (20[degrees]C-25[degrees]C) with light protection (diluted solutions). Samples were taken and analysed initially and at predetermined time points. Analysis comprised pH measurements, visual inspections and high-performance liquid chromatography (HPLC) assays. Results: Irinotecan concentrate in punctured vials remained physicochemically stable for 56 days and 14 days, when stored refrigerated under light protection or at room temperature under ambient light conditions, respectively. Irinotecan concentrate stored in PP syringes remained stable for up to 96 days when stored at room temperature. Diluted irinotecan solutions stored in PO bags at room temperature remained physicochemically stable for up to 84 days, independent from the vehicle solution. Conclusion: Irinotecan Accord 20 mg/mL residues in punctured vials can be used for up to 56 days when stored refrigerated and for 14 days when stored at room temperature or for 96 days in PP syringes, when stored at room temperature without light protection. Diluted solutions may be prepared in advance and used over a period of 84 days, when stored in PO bags at room temperature. Keywords: concentrated solution, diluted infusion solution, irinotecan, physicochemical stability