Infections of the respiratory tract with Pseudomonas aeruginosa in cystic fibrosis patients are frequently treated with colistimethate sodium (CMS). For the intravenous administration of CMS a disposable elastomeric pump is a convenient option. To date, there are no data available on the chemical stability of CMS solutions stored in elastomeric pumps. We evaluated the chemical stability of 0.8 mg/mL solutions of CMS by measuring the degradation over a period of 7 days. Test samples were prepared by diluting CMS with saline solution (0.9%). The preparations were transferred to 100-mL elastomeric pumps and stored at 4 °C. The chemical stability was measured by a high-performance liquid chromatography method with UV detection. There was no degradation of CMS (<0.5% of CMS present as colistin) for at least 3 day at 4°C, and after 7 days all test samples remained chemically stable (<5% of CMS present as colistin). Since colistin formed in pharmacy-compounded CMS solutions prior to administration may cause toxicity, we advise that the solution should be used before the hydrolysis of CMS occurs. Therefore, we recommend that the 0.8 mg/mL solution of CMS can be stored for up to 3 days at 4°C in an elastomeric pump.

Colistimethate sodium, Colistin, Elastomeric pump, Stability,
International Journal of Pharmaceutics
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Department of Medical Oncology

Abdulla, A, van Leeuwen, R.W.F, De Vries Schultink, A.H.M, & Koch, B.C.P. (2015). Stability of colistimethate sodium in a disposable elastomeric infusion device. International Journal of Pharmaceutics, 486(1-2), 367–369. doi:10.1016/j.ijpharm.2015.04.008