Stability and compatibility of 5-fluorouracil infusions in the Braun Easypump®

Abstract

Objective. The aim of this study was to determine the stability and compatibility of `high strength’ (50 mg/mL) and `normal strength’ (25 mg/mL) 5-fluorouracil (5-FU); the latter prepared from 50 mg/mL 5-FU in either 0.9% sodium chloride or 5% glucose diluents and filled into the Braun Easy-pumpÒ (also known as the Homepump Fresenius). Studies were conducted under storage (48C or 258C) and in-use (318C) conditions.

Methods. In the first study, the stability of 5-FU 50 mg/mL (undiluted) was determined in the EasypumpÒ at 258C and 318C over time intervals of 0, 1, 3, 5, 7, 14 and 21 days. In the second study, the stability of 25 mg/mL 5-FU diluted in 5% glucose and 0.9% sodium chloride for injection in the EasypumpÒ was determined after incubation at 48C for 0, 7 and 14 days and at 258C and 318C for 0, 1, 3, 5, 7, 14 and 21 days. For each time/temperature interval, the infusions were monitored for precipitation, colour change, pH, moisture loss, subvisual particulate levels (selected intervals) and chemical stability to assess for compatibility with the device.

Results. No significant changes in physical or chemical stability occurred in diluted solutions (25 mg/mL) over 14 days at 48C or 21 days at 258C and 318C or in the undiluted solutions (50 mg/mL) over 21 days at 258C and 318C, and 5-FU demonstrated suitable stability in the test devices.