Stabilité physico-chimique des solutions injectables de bésilate de cisatracurium dans les conditions cliniques d’utilisation |
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Authors: | J. Pignard D. Bourdeaux S. Kauffmann J.M. Constantin V. Sautou |
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Affiliation: | 1. Pôle pharmacie, CHU G.-Montpied, rue Montalembert, 63003 Clermont-Ferrand, France;2. Université d’Auvergne, EA 4676C-Biosenss, UFR médecine-pharmacie, place Henri-Dunant, 63001 Clermont-Ferrand, France;3. Pôle bloc chirurgical, chirurgie et anesthésie-réanimation, CHU G.-Montpied, rue Montalembert, 63000 Clermont-Ferrand, France;4. Pôle ressources interventionnelles – anesthésie-réanimation, CHU Estaing, rue Lucie-Aubrac, 63100 Clermont-Ferrand, France |
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Abstract: | ObjectivesTo assess the stability of cisatracurium besilate solution stored at 5 °C and 25 °C.Materials and methodsCisatracurium solutions at 2, 5 and 0.1 mg/mL in 0.9 % sodium chloride or 5 % glucose were exposed to 5 °C and 25 °C under 60 % relative humidity for seven days. The physicochemical stability was assessed at 24, 48 hours and seven days with dosage of the active substance, detection of degradation products and a possible racemization, measuring pH, osmolality and turbidity, assessment of coloration, visible particles and invisible particles count.ResultsCisatracurium besilate present good stability for 24 hours at 5 °C and 25 °C for concentrations between 0.1 and 5 mg/mL. Beyond 24 hours, the solutions at 2 and 5 mg/mL remained stable for seven days at 5 °C. At 25 °C, potentially toxic degradation products appear in solutions of 0.1 mg/mL between 24 and 48 hours. No racemization was detected, the drug remains in its active form cis.ConclusionCisatracurium solutions at 2 and 5 mg/mL may be stored at 5 °C or 25 °C for seven days. It's advisable to keep the solutions in a dilution of 0.1 mg/mL in 0.9 % sodium chloride or 5 % glucose in the refrigerator. No diluted solution should be stored at room temperature beyond 24 hours. |
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Keywords: | Cisatracurium Stabilité Conservation Dé gradation Racé misation Particules |
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