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Researcher Department of Pharmacy Pitié-Salpêtrière Hospital (Assistance Publique-Hopitaux de Paris) Paris, France
Analyst Department of Pharmacy Pitié-Salpêtrière Hospital (Assistance Publique-Hopitaux de Paris)
Pharmacist Department of Pharmacy Pitié-Salpêtrière Hospital (Assistance Publique-Hopitaux de Paris)
Pharmacist Department of Pharmacy Pitié-Salpêtrière Hospital (Assistance Publique-Hopitaux de Paris)
Pharmacist Department of Pharmacy Pitié-Salpêtrière Hospital (Assistance Publique-Hopitaux de Paris)
Pharmacist Department of Pharmacy Pitié-Salpêtrière Hospital (Assistance Publique-Hopitaux de Paris)
Assistant Professor and Pharmacist Department of Pharmacy Pitié-Salpêtrière Hospital (Assistance Publique-Hopitaux de Paris) 47 boulevard de l'hopital 75013 Paris, France fax 33 1-42-16-22-86 christine.fernandez{at}psl.aphp.fr
Professor and Director Department of Pharmacy Pitié-Salpêtrière Hospital (Assistance Publique-Hopitaux de Paris)
Published Online, February 3, 2009. www.theannals.com, DOI 10.1345/aph.1L122
Methods. Nine 50-mL polyolefine Freeflex, bags containing 5% dextrose injection (Fresenius Kabi, France) were prepared from a commercial solution of oxaliplatin 5 mg/mL (Eloxatin, Aventis Pharma, UK) to obtain a diluted oxaliplatin concentration of 0.25 mg/mL. Bags were stored at 4 °C (n = 3) or at room temperature either protected (n = 3) or unprotected (n = 3) from light. The solutions were assayed immediately after preparation (day 0) and thereafter on days 1, 2, 3, 4, 7, 10, 14, 22, 28, and 90.
Oxaliplatin concentrations were determined by liquid chromatography. The system consisted of a Waters analytical instrument (Waters, France) equipped with a photodiode array detector 2996 set at 205 nm. The separation was carried out on a C18 Atlantis column (250 x 4.6 mm i.d., 5 µm). An acetonitrile–orthophosphoric acid solution (0.001 M; pH = 3.0) eluent (1:99, v/v) was used as mobile phase (1.2 mL/min). The stability of oxaliplatin was defined as not less than 90% of the initial drug concentration remaining in the solutions. The physical stability of oxaliplatin solutions was assessed by visual examination.
Results. After 90 days of storage, oxaliplatin remained stable under the 3 conditions: mean concentrations in the infusion bags were 97.8%, 96.4%, and 97.8% of the initial concentration (Figure 1). Neither precipitate nor discoloration was observed throughout the study period. Minor peaks appeared in all chromatograms and increased over the course of the study, but no major degradation was observed. Some of these impurities were already present in the commercial product before the solution was diluted. The peak area of these compounds represented 0.20% and 0.13% of the main compound on day 0 and increased up to 0.87% and 0.35% on day 90 after being stored at room temperature and not protected from light.
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The assay was conducted on PVC-free infusion bags, as many interactions have been described between drugs and PVC containers.3 A working concentration of 0.25 mg/mL was chosen, as it is the minimal concentration prescribed by physicians.
As described by Andre et al,2 oxaliplatin's shelf life is up to 30 days under refrigeration or at room temperature. Our results allow this stability period to be extended to 90 days in PVC-free bags at a low concentration (0.25 mg/mL). Consequently, the extended stability of 90 days allows oxaliplatin 0.25 mg/mL solutions in 5% dextrose PVC-free bags to be prepared in advance under sterile conditions in our pharmacy departments and to be stored at room temperature until their administration to patients.
References
This article has been cited by other articles:
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  C. Eiden, L. Philibert, K. Bekhtari, S. Poujol, F. Malosse, and F. Pinguet Physicochemical stability of oxaliplatin in 5% dextrose injection stored in polyvinyl chloride, polyethylene, and polypropylene infusion bags Am. J. Health Syst. Pharm., November 1, 2009; 66(21): 1929 - 1933. [Abstract] [Full Text] [PDF]
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= +4 °C; •
= room temperature; 
= room temperature, protected from light.