Long-term stability of an infusion containing paracetamol, alizapride, ketorolac and tramadol in glass bottles at 5±3°C
Autor: | Laurence Galanti, Océane Charles, Benoît Bihin, Jean-Daniel Hecq, Jacques Jamart, Nicolas Goderniaux, Laura Soumoy, Marie-Lise Colsoul |
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Přispěvatelé: | UCL - (MGD) Laboratoire de biologie clinique, UCL - (MGD) Département de pharmacie, UCL - (MGD) Unité de support scientifique, UCL - SSS/IREC/MONT - Pôle Mont Godinne |
Jazyk: | angličtina |
Rok vydání: | 2020 |
Předmět: |
Pyrrolidines
Time Factors Drug Storage 030226 pharmacology & pharmacy Toxicology and Pharmaceutics Absorbance 03 medical and health sciences 0302 clinical medicine Drug Stability General Pharmacology medicine Humans 030212 general & internal medicine General Pharmacology Toxicology and Pharmaceutics Infusions Intravenous Drug Packaging Tramadol Original Research Acetaminophen Chromatography Chemistry Anti-Inflammatory Agents Non-Steroidal Analgesics Non-Narcotic Diode array Ketorolac Anaesthesia unit Analgesics Opioid Pharmaceutical Solutions Antiemetics Alizapride Glass medicine.drug |
Zdroj: | European Journal of Hospital Pharmacy, Vol. 27, no. e1, p. e74-e78 (2020) Eur J Hosp Pharm |
Popis: | Background and objective Infusion containing paracetamol, alizapride, ketorolac and tramadol is used after a general anaesthesia in order to limit pain, fever and nausea. Currently, these infusions are prepared according to demand in the anaesthesia unit, but the preparation in advance could improve quality of preparation and time management. The aim of this study was to investigate the long-term stability of this infusion in glass bottles at 5°C ± 3 °C. Method Five bottles of infusion were stored at 5°C ± 3 °C for 60 days. A visual and microscope inspection were performed periodically to observe any particle appearance or colour change. pH and absorbance at three wavelengths were measured. The concentrations were measured by ultra-high performance liquid chromatography – diode array detection. Results Multiple verifications were performed during the first 35 days and no crystal, impurity or colour change were observed. At the next time point (42nd day), crystals were visible to the naked eye. pH and absorbance at 350 nm and 550 nm were stable. A slight increase in the absorbance at 410 nm was observed during the study, suggesting that a degradation product could be formed and absorb at this wavelength. The infusion was considered chemically stable while the lower one-sided prediction limit at 95% remains superior to 90% of the initial concentration. Concentration measurements demonstrated that ketorolac and alizapride remained stable in the infusion for 35 days. The stability of tramadol was 28 days. However, degradation of paracetamol was much faster given that concentration has fallen below 90% of the initial concentration after 7 days. Conclusion Infusion of paracetamol, alizapride, ketorolac and tramadol remains stable for 7 days in glass bottles at 5°C ± 3 °C and could be prepared in advance with these storage conditions. |
Databáze: | OpenAIRE |
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