Long-term physico-chemical stability of 5-fluorouracile at standardised rounded doses (SRD) in MyFuser® portable infusion pump

Abstract

Management of chemotherapies is a strategic issue for european healthcare. Dose-banding enables to reduce waiting time of patients in day care units and drug wastage. The aim of this study was to assess the stability of 5-Fluorouracile (5-FU) at standardised rounded doses of 4 and 5 g in MyFuser® portable infusion pump for in-advance preparation. Ten MyFuser® (4 and 5 gr 5-FU added to NaCl 0.9%) were prepared under aseptic conditions and stored at room temperature (23 ± 2 °C) for 28 days then at 30 °C for three days. Physical stability tests were periodically performed: visual and microscopic inspection, pH measurements and optical densities. The concentration of solutions was measured by High Performance Liquid Chromatography/UV detector. Results confirm the stability of 5-FU at selected SRD of 4 g and 5 g with NaCl 0.9% in MyFuser® for at least 28 days at room temperature and three days at 30 °C, allowing in-advance preparation.

Keywords:

• Dose-Banding
• 5-FU
• Chromatography
• stability study
• portable infusion pump
• CIVAS

Notes on contributor

Mélanie Closset is a medical doctor (2009) with a master degree in ethic (2015). She’s in charge of the department of clinical biochemistry of the medicine laboratory at CHU UCL Namur. She’s PhD student since 2018 and she is collaborating with the department of pharmacy on stability studies about injectable drugs.

Sabrina Onorati is a laboratory technologist since 2016. She's working at the department of clinical biochemistry of the medicine laboratory at CHU UCL Namur. She collaborated with the department of pharmacy on stability studies about injectable.

Marie-Lise Colsoul is a Bioengineer. PhD student at the Catholic University of Louvain since 2018, she is also in charge of the chromatographic department of the medicine laboratory at CHU UCL Namur. She is collaborating with the department of pharmacy on stability studies about injectable.

Nicolas Goderniaux is a laboratory technologist. He's working at the department of clinical biochemistry of the medicine laboratory at CHU UCL Namur and is collaborating with the department of pharmacy on stability studies about injectable.

Benoît Bihin is biologist. PhD Student at the university of Namur since 2011, he is also lecturer of biostatistics courses. He works at the CHU UCL Namur as biostatistician since 2014 and is a member of the Drug Stability Research Group.

Jacques Jamart is medical doctor (1972) and surgeon (1978) then received a master degree in statistics (1984). He worked in experimental surgery mainly in the field of organ preservation for transplantation and more recently as biostatistician and head of Scientific Support Unit (1993) of University Hospital of Mont-Godinne. He is also emeritus professor at Catholic University of Louvain(2009) and at University of Namur (2010).

Laura Soumoy is hospital pharmacist. She has been working at the CHU UCL Namur since 2014 and is now chief of the department of Pharmacy since 2019. Since 2017, she is also a member of the Drug Stability Research Group in the same CHU.

Professor Jean-Daniel Hecq is Hospital pharmacist and doctor in pharmaceutical sciences. He worked at the CHU UCL Namur from 1979 to 2019 and was chief of the department of Pharmacy from 1989 to 2019. He is also the coordinator of the Drug Stability Research Group in the same CHU and the author since 39 years of a Belgian electronic database so entitled “Stability of injectable drugs in infusion”.

Pascal Odou is professor at the Faculty of Pharmacy of Lille (2004) in hospital pharmaceutical technologies. He is also the director (2015) of the Research Group on injectable forms and associated technologies (ULR 7365). In addition to these academic functions, he is since 2010, also the pharmacist in charge of the pharmaceutical department of the University Hospital of Lille.

Professor Laurence Galanti, MD, PhD is co-director of the department of laboratory medicine at CHU UCL Namur, in charge of clinical biochemistry on the site of Mont-Godinne. She holds several positions in national and international scientific organizations. Her research focused on clinical application of biomarkers of exposition to tobacco smoke and on the stability of injectable drugs in collaboration with the department of pharmacy.