PP-013 Long term stability of 5-fluorouracil at standardised rounded doses in sodium chloride infusion polyolefin bags, stored at room temperature

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Abstract

Background

5-Fluorouracil (5-FU) is a chemotherapeutic agent commonly used by oncologists as the standard therapy for advanced colorectal cancer. The centralised intra-venous admixture service (CIVAS) of the hospital started to produce 5-FU at standardised rounded doses (SRD) in 2015 to implement dose banding.

Purpose

To assess the long term stability of 5-FU at selected standardised rounded doses.

Material and methods

10 polyolefin bags, 5 containing 700 mg and 5 containing 800 mg of 5-FU in sodium chloride solution (614 mg/100 mL and 689.7 mg/100mL respectively) were prepared under aseptic conditions and stored at room temperature for 24 days. At days 0, 2, 4, 7, 9, 11, 15, 17, 22 and 24, two aliquots were withdrawn from each solution. One aliquot was frozen for HPLC (Alliance, model 2695, Waters Association, Milford Massachusetts) analyses; the other aliquot went through physical stability tests, including pH (inoLab, WTW GmbH, Weilheim, Germany), spectrophotometric measurements (Genesys 10 UV, Spectronic Unican) at 350, 410 and 550 nm to detect turbidity, and visual and microscopic inspection at 10 fold magnification after centrifugation. On day 24, the frozen aliquots were defrosted and analysed by HPLC. Degradation tests were performed to evaluate the specificity of the analyses.

Results

Degradation tests proved that there were no interfering peaks with 5-FU. The concentration of the solution was considered stable for at least 24 days because the lower limit of the 95% unilateral CI on the mean remained >90% of the theoretical concentration. There were no colour changes, opacity or turbidity observed in the solutions over time. Microscopic observations did not show any crystals. The pH remained stable during the study and there were no changes in absorbance.

Conclusion

Within the limits of this study, 5-FU can be considered stable for 24 days at room temperature in polyolefin bags and at selected SRD of 700 mg and 800 mg/bag. These results allow us to use it in this way for dose banding.

References and/or acknowledgements

Soumoy L, et al. J Pharma Belg 2015; 97:24–35.

References and/or acknowledgements

Hecq JD, et al. J Pharma Belg 2015;97:36–44.

References and/or acknowledgements

No conflict of interest

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