[Physicochemical stability study of injectable solutions of cisatracurium besilate in clinical conditions].
OBJECTIVE
To assess the stability of cisatracurium besilate solution stored at 5°C and 25°C.


METHODS
Cisatracurium solutions at 2, 5 and 0.1mg/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, 48hours 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.


RESULTS
Cisatracurium besilate present good stability for 24hours at 5°C and 25°C for concentrations between 0.1 and 5mg/mL. Beyond 24hours, the solutions at 2 and 5mg/mL remained stable for seven days at 5°C. At 25°C, potentially toxic degradation products appear in solutions of 0.1mg/mL between 24 and 48hours. No racemization was detected, the drug remains in its active form cis.


CONCLUSIONS
Cisatracurium solutions at 2 and 5mg/mL may be stored at 5°C or 25°C for seven days. It's advisable to keep the solutions in a dilution of 0.1mg/mL in 0.9 % sodium chloride or 5 % glucose in the refrigerator. No diluted solution should be stored at room temperature beyond 24hours.
Pôle pharmacie, CHU G.-Montpied, rue Montalembert, 63003 Clermont-Ferrand, France.
J
J
Pignard
Pôle pharmacie, CHU G.-Montpied, rue Montalembert, 63003 Clermont-Ferrand, France; Université d'Auvergne, EA 4676C-Biosenss, UFR médecine-pharmacie, place Henri-Dunant, 63001 Clermont-Ferrand, France.
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D
Bourdeaux
Pôle bloc chirurgical, chirurgie et anesthésie-réanimation, CHU G.-Montpied, rue Montalembert, 63000 Clermont-Ferrand, France.
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S
Kauffmann
Pôle ressources interventionnelles - anesthésie-réanimation, CHU Estaing, rue Lucie-Aubrac, 63100 Clermont-Ferrand, France.
J M
JM
Constantin
Pôle pharmacie, CHU G.-Montpied, rue Montalembert, 63003 Clermont-Ferrand, France; Université d'Auvergne, EA 4676C-Biosenss, UFR médecine-pharmacie, place Henri-Dunant, 63001 Clermont-Ferrand, France. Electronic address: vsautou@chu-clermontferrand.fr.
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V
Sautou
D001279:Atracurium / Q000031:analogs & derivatives* / Q000737:chemistry; D004349:Drug Packaging; D004355:Drug Stability; D004356:Drug Storage; D005947:Glucose; D006863:Hydrogen-Ion Concentration; D003473:Neuromuscular Nondepolarizing Agents / Q000737:chemistry*; D019999:Pharmaceutical Solutions; D012965:Sodium Chloride; D013594:Syringes
D003473:Neuromuscular Nondepolarizing Agents; D019999:Pharmaceutical Solutions; D001279:Atracurium; D012965:Sodium Chloride; D005947:Glucose; C101584:cisatracurium
Cisatracurium; Conservation; Degradation; Dégradation; Particles; Particules; Racemization; Racémisation; Stability; Stabilité