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Junior Pharmacist, Pharmacy Intern, Pharmacy Department, University Hospital of Jean Verdier, Bondy, France
Senior Pharmacist, Clinical Pharmacist, Pharmacy Department, University Hospital of Jean Verdier
Senior Pharmacist, Clinical Pharmacist, Pharmacy Department, University Hospital of Jean Verdier
Senior Pharmacist, Pharmacist in Chief, Pharmacy Department, University Hospital of Jean Verdier
Reprints: Joël Schlatter PharmD, avenue du 14 juillet, 93140 Bondy, France, FAX 33148026623, joel.schlatter{at}jvr.ap-hop-paris.fr
BACKGROUND: Cyclophosphamide (CYP) is used to treat cancers in combination with mesna to prevent cystitis. The use of extemporaneously prepared admixtures of these drugs must be supported by documentation of their chemical stability.
OBJECTIVE: To evaluate the chemical stability of CYP and mesna admixtures in dextrose 5% polyethylene infusion bags.
METHODS: The drugs were diluted in 100-mL dextrose 5% infusion bags to final concentrations of CYP 10.8 mg/mL with mesna 3.2 mg/mL (solution A) and CYP 1.8 mg/mL with mesna 0.54 mg/mL (solution B). Six infusion bags from each solution were stored at 4 °C and 6 were stored at room temperature. Triplicate HPLC determinations were performed on each bag to measure drug concentrations at 0, 1, 2, 4, 6, 12, 24, 48, and 96 hours.
RESULTS: At 96 hours, drug concentrations in all solutions stored at room temperature were found to be <80% compared with the initial concentrations. The solutions stored at 4 °C retained at least 90% of the initial drug concentrations at 48 hours. The pH of solutions A and B stored at room temperature decreased significantly by 4.44 and 4.31 units, respectively. The pH of the refrigerated infusion bags decreased significantly by 1.46 units for solution B.
CONCLUSIONS: Admixtures stored at 4 °C (pH 7.90 ± 0.004; mean ± SD) are stable for 48 hours. The CYP and mesna combination can be infused at room temperature over 6 hours without significant degradation of the drugs. Stabilities are dependent on pH, temperature, and/or concentration.
Key Words: admixtures, cyclophosphamide, mesna, stability
Published Online, October 15, 2003. www.theannals.com, DOI 10.1345/aph.1D200
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  R. Kennedy, D. Groepper, M. Tagen, R. Christensen, F. Navid, A. Gajjar, and C. F Stewart Stability of Cyclophosphamide in Extemporaneous Oral Suspensions Ann. Pharmacother., February 1, 2010; 44(2): 295 - 301. [Abstract] [Full Text] [PDF]
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H. Almoazen, H. Bhattacharjee, A. C Samsa, and S. Pate Stability of Mesna in ReadyMed Infusion Devices Ann. Pharmacother., January 1, 2010; 44(1): 224 - 225. [Full Text] [PDF]
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