Author byline as per print journal: Professor Irene Krämer, PhD; Frank Erdnuess, PhD; Judith Thiesen, PhD, Germany

Study objectives: To determine the physicochemical stability of undiluted Cabazitaxel Accord in punctured original vials and after dilution with 0.9% sodium chloride solution or 5% glucose solution in non-PVC bottles at the concentrations 0.1 mg/mL and 0.26 mg/mL.
Methods: Punctured original vials of Cabazitaxel Accord 20 mg/mL were stored at room temperature without light protection for 56 days. Diluted test solutions of Cabazitaxel Accord were stored for 28 days either refrigerated with light protection or at 15°C‒30°C under normal room lighting. Samples were taken from test solutions and analysed at predetermined time points. Analysis comprised pH measurements, visual inspections and high-performance liquid chromatography (HPLC) analysis.
Results: Cabazitaxel Accord 20 mg/mL concentrate in punctured original vials and diluted infusion solutions (0.1 mg/mL, 0.26 mg/mL) in non-PVC bottles pre-filled with 0.9% sodium chloride solution or 5% glucose solution remained physicochemically stable over the entire test periods of 56 days and 28 days, respectively.
Conclusion: Cabazitaxel Accord 20 mg/mL residues in punctured vials can be used for up to 56 days when stored at room temperature. Diluted Cabazitaxel Accord infusion solutions 0.1 mg/mL to 0.26 mg/mL in non-PVC bottles may be prepared in advance and used over a period of 28 days, irrespective of the type of vehicle solution and storage temperature.

Submitted: 4 March 2024; Revised: 15 April 2024; Accepted: 26 April 2024; Published online first: 6 May 2024

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This manuscript has been accepted for publication and undergone full peer review but has not been through the copyediting, typesetting, pagination and proofreading process, which may lead to differences between this version and the Version of Record.