Article Text

other Versions

PDF
Physicochemical stability of cabazitaxel and docetaxel solutions
  1. Renzo Lazzarini1,
  2. Severo Salvadori2,
  3. Claudio Trapella2,
  4. Remo Guerrini2,
  5. Erica Marzola2,
  6. Giada Pasini2,
  7. Alessandro Dalpiaz2
  1. 1Pharmacy Department, CRO Aviano National Cancer Institute, Aviano (Pn), Italy
  2. 2Department of Chemical and Pharmaceutical Sciences, University of Ferrara, Ferrara, Italy
  1. Correspondence to Dr Alessandro Dalpiaz, Department of Chemical and Pharmaceutical Sciences, University of Ferrara, via Fossato di Mortara 19, Ferrara I-44121, Italy; dla{at}unife.it

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.

Statistics from Altmetric.com

Request permissions

If you wish to reuse any or all of this article please use the link below which will take you to the Copyright Clearance Center’s RightsLink service. You will be able to get a quick price and instant permission to reuse the content in many different ways.