Stability of colistimethate sodium in a disposable elastomeric infusion device

Abstract

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.

Keywords: Colistimethate sodium; Colistin; Elastomeric pump; Stability.