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
| Autor: | Natacha Carta, Pascal Odou, Bertrand Décaudin, Christine Barthélémy, Stéphanie Genay, Sixtine Gilliot, Héloïse Henry |
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| Rok vydání: | 2021 |
| Předmět: |
Cardiac output
Chromatography Chemistry medicine.medical_treatment 030226 pharmacology & pharmacy Diluent Vial Dilution 03 medical and health sciences 0302 clinical medicine Compounding Intensive care medicine Dobutamine 030212 general & internal medicine General Pharmacology Toxicology and Pharmaceutics Saline medicine.drug |
| Zdroj: | European Journal of Hospital Pharmacy. 30:153-159 |
| ISSN: | 2047-9964 2047-9956 |
| Popis: | 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. |
| Databáze: | OpenAIRE |
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