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- Title
Stability study of concentrate-solvent mixture & infusion solutions of Jevtana® cabazitaxel for extended multi-dosing.
- Authors
Hedvig Arnamo, A; Huitema, Alwin D.R; Beijnen, Jos H; Nuijen, Bastiaan
- Abstract
Aim/Background: In this study, the prolonged physical and chemical stability of the anticancer agent cabazitaxel, commercially available as Jevtana®, was examined. Both concentrate-solvent mixture and infusion solution were examined with the aim to extend the use of multidose left-over cabazitaxel and infusion solutions and with that reduce financial and environmental waste. Methods: A validated stability-indicating high-pressure liquid chromatography (HPLC) method with ultraviolet (UV) and photodiode array (PDA) detection was used to examine the purity and any degradation of cabazitaxel. The concentrate-solvent mixture and infusion solution samples that were tested had been stored out of the range of the criteria stated in the summary of product characteristics (SmPC). The concentrate-solvent mixtures were stored at 3–5°C, 18–21°C, and 40 °C, whereas the infusion solution was stored at 3–5°C. All samples were tested at t = 0, t = 1 week and t = 2 weeks. Results: All samples showed that purity and concentration had remained within the criteria of <5% as stated in the European Pharmacopoeia. However, the concentrate-solvent mixtures stored at 18-21°C and 40 °C showed a degradation product forming in all the samples lowering the purity of the samples from 100% to 99.91% and 98.20% respectively, whereas all samples stored at 3–5°C remained at 100%. Conclusion: Concentrate-solvent mixture and infusion solution of cabazitaxel, Jevtana®, can be used up to 2 weeks after preparation if stored at 3–5°C and prepared under aseptic conditions.
- Subjects
SOLVENTS; INTRAVENOUS therapy; HIGH performance liquid chromatography; CLINICAL drug trials; POLYPHARMACY; CABAZITAXEL; ANTINEOPLASTIC agents; DRUG stability; DESCRIPTIVE statistics; SOLUTION (Chemistry); DRUG storage; DRUG development; PHARMACEUTICAL chemistry; ULTRAVIOLET radiation; MEDICAL equipment reuse; PATIENT safety
- Publication
Journal of Oncology Pharmacy Practice, 2022, Vol 28, Issue 5, p1035
- ISSN
1078-1552
- Publication type
Article
- DOI
10.1177/10781552211016079