Evaluation of the stability of vancomycin solutions at concentrations used in clinical services

• Published in: European journal of hospital pharmacy. Science and practice Vol. 27; no. e1; pp. e87 - e92
• Main Authors: Masse, Morgane, Genay, Stéphanie, Martin Mena, Anthony, Carta, Natacha, Lannoy, Damien, Barthélémy, Christine, Décaudin, Bertrand, Odou, Pascal
• Format: Journal Article
• Language: English
• Published: England BMJ Publishing Group LTD 01-03-2020; BMJ Group; BMJ Publishing Group
• Series: European Journal of Hospital Pharmacy
• Subjects: Antibiotics; Chromatography; Hydrochloric acid; Life Sciences; Original Research; Polyvinyl chloride; Sodium; Solvents; France; particulate contamination; drug stability-indicating method; chromatography, high pressure liquid; infusion, intravenous; vancomycin hydrochloride; intravenous; infusion; chromatography; high pressure liquid
• ISSN: 2047-9956; 2047-9964
• DOI: 10.1136/ejhpharm-2019-002076

Solutions at 5 and 10 mg/mL were stable for 58 days at +4°C in 100 mL polyvinyl chloride (PVC) infusion bags with no specification with regard to protection from light.8 Vancomycin was stable at 5 mg/mL in PVC bags for 48 hours at +22°C without protection from light and for 7 days at +4°C with protection from light.9 Raverdy et al 10 examined the stability of vancomycin diluted in 5% dextrose at high concentration (83 mg/mL) and was stable for 72 hours at +37°C. However, none of these studies reflects real infusion conditions as vancomycin is usually administered at 30 mg/kg/day.11 12 In practice, clinical services infuse vancomycin into electric syringe pumps using 50 mL (for adults) or 20 mL (for children) syringes. The aim of this work was therefore to study vancomycin stability in syringes and assess its use (pH, osmolality, number of particles) during a continuous 24-hour infusion with and without inline filters at four concentrations—25, 40, 60 and 80 mg/mL—reconstituted in two solvents (WFI and saline solution) and diluted in saline solution. To perform the mobile phase, acetonitrile (high-performance liquid chromatography (HPLC) gradient grade; VWR Chemicals, Fontenay-sous-Bois, France), phosphate buffer (potassium dihydrogen phosphate; Merck, Calais, France), ultrapure water (Purelab Classic Elga System, Veolia, Wasquehal, France) and orthophosphoric acid (Merck) were used. The number of particles ≥10 µm and ≥25 µm should not exceed 6000 and 600 particles per syringe, respectively.18 Statistical analysis The Mann-Whitney U test compared the following filtered and unfiltered measurements: cumulative amount with both reconstitution solvents at T24, and the number of particles, pH and osmolality at T0 and T24.