Physicochemical stability of cabazitaxel and docetaxel solutions. Issue 3 (1st December 2014)

• Record Type: Journal Article
• Authors: Lazzarini, Renzo; Salvadori, Severo; Trapella, Claudio; Guerrini, Remo; Marzola, Erica; Pasini, Giada; Dalpiaz, Alessandro
• Is Part Of: European journal of hospital pharmacy. Volume 22:Issue 3(2015)
• Page Start: 150
• Page End: 155
• Publication Date: 2014-12-01
• Subjects: Pharmacy -- Periodicals; Hospital pharmacies -- Periodicals; 615.1
• DOI: 10.1136/ejhpharm-2014-000558
• Languages: English
• ISSNs: 2047-9956

Abstract

Abstract : Objectives: It is recommended that the Jevtana (current parenteral cabazitaxel formulation) final infusion solution should be used within 8 h when stored at ambient temperature or within 24 h if refrigerated. We determined the physical and chemical stability of cabazitaxel and docetaxel over prolonged periods after dilution in infusion solutions from their Jevtana and Hospira, respectively, parenteral formulations. Methods: The stability of these antineoplastic drugs was determined after (i) reconstitution of the injection concentrate and (ii) further dilution in 0.9% NaCl solution contained in PVC-free infusion bags. Chemical stability was determined using both high-performance liquid chromatography (HPLC) with ultraviolet detection and high-resolution (HR)-HPLC–mass spectrometry (MS) techniques. Physical stability was determined by visual inspection. Results: The stability tests revealed that reconstituted cabazitaxel solutions (premix solutions) stored at 4°C were physicochemically stable (at a level of ≥95% cabazitaxel) for a minimum of 4 weeks. Diluted infusion solutions in PVC-free infusion bags (docetaxel concentration 0.30 mg/mL; cabazitaxel concentration 0.15 mg/mL) were physicochemically stable (at a level of ≥95% cabazitaxel or docetaxel) for a minimum of 4 weeks, independently of storage temperature (4°C or 25°C). Diluted cabazitaxel infusion solutions appeared stable (at a level of ≥95% cabazitaxel) for a minimum of 4 weeks when stored in the presence of saturated oxygen at 25°C. Conclusions: Cabazitaxel and docetaxel are characterised by high stability in customary infusion fluids for at least 4 weeks.