Long-term stability of 5-fluorouracil stored in PVC bags and in ambulatory pump reservoirs

• Published in: Journal of pharmaceutical and biomedical analysis Vol. 14; no. 4; pp. 395 - 399
• Main Authors: Martel, P., Petit, J., Pinguet, F., Poujol, S., Astre, C., Fabbro, M.
• Format: Journal Article
• Language: English
• Published: Amsterdam Elsevier B.V 01.02.1996; Elsevier Science
• Subjects: Ambulatory pump reservoir; Antimetabolites, Antineoplastic - chemistry; Antineoplastic agents; Biological and medical sciences; Chromatography, High Pressure Liquid; Drug Packaging; Drug Stability; Fluorouracil; Fluorouracil - chemistry; General aspects; High-performance liquid chromatography; Infusion Pumps; Medical sciences; Pharmacology. Drug treatments; Poly(vinyl chloride) bag; Temperature; Ambulatory pump reservoir; High-performance liquid chromatography; Poly(vinyl chloride) bag; Drug stability; Fluorouracil; Antineoplastic agent; Stability; Conservation; Reservoir; Long term; Pump; Perfusion; Pyrimidine derivatives; Ambulatory; Fluorine Organic compounds; Polyvinyl chloride; Comparative study; Physicochemical properties
• ISSN: 0731-7085; 1873-264X
• DOI: 10.1016/0731-7085(95)01635-X

Prolonged infusions of 5-fluorouracil (5FU) have been used since the early 1960s, but recently there has been a major resurgence of interest, partly because of the advent of electronically controlled portable infusion pumps. Admixtures of new formulation 5FU were subjected to stability studies to establish the feasability of continuous infusions. In the first study, the stability of 5FU, 1 or 10 mg ml −1, was determined in poly(vinyl chloride) (PVC) bags (0.9% sodium chloride injection or 5% dextrose injection) at 4 and 21°C after storage for 0, 1, 2, 3, 4, 7 and 14 days. In the second study, the stability of undiluted 5FU was tested at different temperatures (4 or 33°C) in ethylene vinyl acetate (EVA) or PVC ambulatory pump reservoirs after storage for 0, 3, 5, 7 and 14 days. For each condition, samples from each admixture were tested for drug concentration by stability-indicating high-performance liquid chromatography. The admixtures were also monitored for precipitation, colour change and pH. Evaporative water loss from the containers was measured. The stability of 5FU in PVC bags was unaffected by 14 days of storage at either 4 or 21°C. When stored in EVA reservoirs, 5FU was stable for at least 2 weeks at 33°C and for 3 days at 4°C (a precipitate was observed after 3 days). In PVC reservoirs, 5FU was stable for over 14 days at 33°C, but at 4°C a precipitate appeared after 5 days. Loss of water through the reservoirs was substantial only at 33°C for 14 days, and gave falsely high readings.