Cold water reconstitution of Vidaza with subsequent refrigerated storage prolongs drug stability

Study Objectives: This study assessed whether the stability of azacitidine suspension can be prolonged when reconstituted with refrigerated water for injection followed by storage under refrigerated conditions.Methods: Two lots of azacitidine (Vidaza) were reconstituted with refrigerated (2–8oC) water for injection to form a suspension and immediately stored refrigerated (2–8oC). After storage for 16, 18, 20, or 22 hours, azacitidine suspension was then placed at a constant 25oC for 30 minutes then tested for potency, redispersibility time, and suspension appearance. Sterility testing was performed at the end of the study. Stability of azacitidine was defined as maintaining > 90% potency.Results: Azacitidine reconstituted with cold water (2–8oC) followed by refrigerated storage (2–8oC) and 30 minutes equilibration to 25oC remained stable from baseline to 22 hours with a maximum loss of potency of 2.7% for each of the two lots of drug evaluated. At the 16, 18, 20, and 22 hour study time points and 30 minutes equilibration to 25oC, redispersion time was 0.3 minutes with the appearance of fine white particles in suspension. All reconstituted vials stored refrigerated (2–8oC) passed sterility testing at the end of study. Reconstitution of azacitidine with cold water for injection together with subsequent refrigerated storage is associated with a threefold prolongation in the stability time of the drug from 8 to 22 hours.Conclusion: This substantial increase in the time of azacitidine maintaining > 90% potency allows for prolonged in-use time that may provide for more convenience for pharmacists.