RT Journal Article
SR Electronic
T1 Physicochemical stability of cabazitaxel and docetaxel solutions
JF European Journal of Hospital Pharmacy
JO Eur J Hosp Pharm
FD British Medical Journal Publishing Group
SP 150
OP 155
DO 10.1136/ejhpharm-2014-000558
VO 22
IS 3
A1 Renzo Lazzarini
A1 Severo Salvadori
A1 Claudio Trapella
A1 Remo Guerrini
A1 Erica Marzola
A1 Giada Pasini
A1 Alessandro Dalpiaz
YR 2015
UL http://ejhp.bmj.com/content/22/3/150.abstract
AB 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.