Article Text

Download PDFPDF
Long-term stability of 10 mg/mL dobutamine injectable solutions in 5% dextrose and normal saline solution stored in polypropylene syringes and cyclic-oleofin-copolymer vials
  1. Sixtine Gilliot1,
  2. Héloïse Henry1,
  3. Natacha Carta1,
  4. Stéphanie Genay1,2,
  5. Christine Barthélémy1,
  6. Bertrand Décaudin1,2,
  7. Pascal Odou1
  1. 1ULR 7365 - GRITA - Groupe de Recherche sur les formes Injectables et les Technologies Associées, Univ. Lille, CHU Lille, Lille, France
  2. 2Institut of Pharmacy, CHRU Lille Pôle Spécialités Médicochirurgicales, Lille, France
  1. Correspondence to Sixtine Gilliot, ULR 7365 - GRITA - Groupe de Recherche sur les formes Injectables et les Technologies Associées, University of Lille, Lille 59000, France; sixtine.gilliot.etu{at}univ-lille.fr

Abstract

Objective Dobutamine is an inotropic agent given to patients with low cardiac output or undergoing cardiac surgery in intensive care units. Routine clinical care protocols recommend a target dilution concentration of 10 mg/mL dobutamine from the 250 mg/20 mL commercial solution.

This study aimed to assess the 1-year stability of ready-to-use 10 mg/mL diluted dobutamine solutions. Two types of 50 mL conditioning, polypropylene (PP) syringes or cyclic-oleofin-copolymer (COC) vials and two diluents (5% dextrose (D5W) and normal saline (NS)) were tested.

Methods Reversed-phase liquid chromatography coupled with an ultraviolet detection stability-indicating method was developed for dobutamine and validated according to selectivity, linearity, sensitivity, accuracy and precision. Chemical stability was considered to have been maintained if the measured concentrations were >90% of the initial concentration with no colour change. Physical stability was assessed through sterility tests, pH and osmolality monitoring, and subvisible particle counting. Containers were stored at −20±5°C, +5±3°C and +25±2°C with 60%±5% relative humidity in a dark, closed environment.

Results According to this study, the physicochemical stability of 10 mg/mL dobutamine solutions prepared with D5W or NS is constant throughout a 365-day period when stored in COC vials, at all the aforementioned temperatures, whereas solutions in PP syringes required a refrigerated temperature and should not be administered after 21 days or 3 months when prepared with D5W or NS, respectively, or after 1 month at ambient temperature whatever the diluent.

Conclusion Our results argue in favour of adopting the compounding of ready-to-use 10 mg/mL dobutamine solutions in COC vials in centralised intravenous additive services.

  • critical care
  • drug compounding
  • safety
  • analytic sample preparation methods
  • administration
  • intravenous

Data availability statement

Data are available in a public, open access repository: Gilliot, Sixtine; Henry, Héloïse; Carta, Natacha; Genay, Stéphanie; Barthélémy, Christine; Décaudin, Bertrand; Odou, Pascal (2020), “Long-term stability of 10 mg/mL dobutamine injectable solutions dataset”, Mendeley Data, V1, doi: 10.17632/cxs7y94kj8.1.

Statistics from Altmetric.com

Data availability statement

Data are available in a public, open access repository: Gilliot, Sixtine; Henry, Héloïse; Carta, Natacha; Genay, Stéphanie; Barthélémy, Christine; Décaudin, Bertrand; Odou, Pascal (2020), “Long-term stability of 10 mg/mL dobutamine injectable solutions dataset”, Mendeley Data, V1, doi: 10.17632/cxs7y94kj8.1.

View Full Text

Request Permissions

If you wish to reuse any or all of this article please use the link below which will take you to the Copyright Clearance Center’s RightsLink service. You will be able to get a quick price and instant permission to reuse the content in many different ways.