Physicochemical stability of cabazitaxel and docetaxel solutions

Renzo Lazzarini, Severo Salvadori, Claudio Trapella, Remo Guerrini, Erica Marzola, Giada Pasini, Alessandro Dalpiaz

Research output: Contribution to journalArticle

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.

Original languageEnglish
Pages (from-to)150-155
Number of pages6
JournalEuropean Journal of Hospital Pharmacy
Volume22
Issue number3
DOIs
Publication statusPublished - 2015

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docetaxel
Polyvinyl Chloride
cabazitaxel
Temperature

ASJC Scopus subject areas

  • Pharmacology, Toxicology and Pharmaceutics(all)

Cite this

Lazzarini, R., Salvadori, S., Trapella, C., Guerrini, R., Marzola, E., Pasini, G., & Dalpiaz, A. (2015). Physicochemical stability of cabazitaxel and docetaxel solutions. European Journal of Hospital Pharmacy, 22(3), 150-155. https://doi.org/10.1136/ejhpharm-2014-000558

Physicochemical stability of cabazitaxel and docetaxel solutions. / Lazzarini, Renzo; Salvadori, Severo; Trapella, Claudio; Guerrini, Remo; Marzola, Erica; Pasini, Giada; Dalpiaz, Alessandro.

In: European Journal of Hospital Pharmacy, Vol. 22, No. 3, 2015, p. 150-155.

Research output: Contribution to journalArticle

Lazzarini, R, Salvadori, S, Trapella, C, Guerrini, R, Marzola, E, Pasini, G & Dalpiaz, A 2015, 'Physicochemical stability of cabazitaxel and docetaxel solutions', European Journal of Hospital Pharmacy, vol. 22, no. 3, pp. 150-155. https://doi.org/10.1136/ejhpharm-2014-000558
Lazzarini R, Salvadori S, Trapella C, Guerrini R, Marzola E, Pasini G et al. Physicochemical stability of cabazitaxel and docetaxel solutions. European Journal of Hospital Pharmacy. 2015;22(3):150-155. https://doi.org/10.1136/ejhpharm-2014-000558
Lazzarini, Renzo ; Salvadori, Severo ; Trapella, Claudio ; Guerrini, Remo ; Marzola, Erica ; Pasini, Giada ; Dalpiaz, Alessandro. / Physicochemical stability of cabazitaxel and docetaxel solutions. In: European Journal of Hospital Pharmacy. 2015 ; Vol. 22, No. 3. pp. 150-155.
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AU - Marzola, Erica

AU - Pasini, Giada

AU - Dalpiaz, Alessandro

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