Stabilité physico-chimique des solutions injectables de bésilate de cisatracurium dans les conditions cliniques d’utilisation

Objectives

To assess the stability of cisatracurium besilate solution stored at 5 °C and 25 °C.

Materials and methods

Cisatracurium 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.

Results

Cisatracurium 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.

Conclusion

Cisatracurium 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.