PP-018 Long term stability of 5-fluorouracile at standardised rounded doses in two types of portable infusion devices

Background The centralised intra-venous admixture service (CIVAS) of the hospital has started to implement dose banding for 5-fluorouracil (5-FU), a chemotherapeutic agent commonly used for colorectal cancer. The dose banding of this molecule includes polyolefin bags and portable infusion devices at standardised rounded doses (SRD). The portable infusion devices are of two types: Folfuser SV 2.5 mL/h Baxter and Myfuser XM 2.5 mL/h Canox. Purpose To prove the long term stability of 5-FU in portable infusion devices at selected SRD and to compare the two types of devices. Material and methods 20 infusion devices containing 5-FU in sodium chloride solution were prepared under aseptic conditions and stored at room temperature for 27 days: 5 Folfusor 4000 and 5000 mg and 5 Myfuser 4000 and 5000 mg. On days 0, 2, 4, 7, 9, 11, 15, 17, 22, 24 and 28 at room temperature, and on days 0, 1 and 2 at body surface temperature, two aliquots were withdrawn from each solution. The first was frozen for HPLC (Alliance, Waters Association) analyses and the second went through physical stability tests, including pH, spectrophotometric measurements at 350, 410 and 550 nm, and visual and microscopic inspection after centrifugation. All aliquots were defrosted at the same time to proceed to HPLC analyses to reduce technical variability. Results The concentration of the solution was considered stable for at least 28 days in MyFuser and for 27 days in Folfusor, because the lower limit of the 95% unilateral CI on the mean remained >90% of the theoretical concentration. There was no colour change, opacity or turbidity observed in the solutions. The pH measurements remained stable over the time and there were no changes in absorbance. The microscopic observations did not show any crystals. Conclusion Within the limits of our study, 5-FU can be considered stable for at 27 days in Folfusor and for at least 28 days in Myfuser. These results allow us to use portable infusion devices at selected SRD for ambulatory chemotherapy of 5-FU. References and/or acknowledgements Galanti L, et al. Can J Hosp Pharm2009; 62:34–8. No conflict of interest