Stability of Captisol-Enabled Melphalan (Evomela) in 0.9% Sodium Chloride Solution in IV Bags and Glass Vials at Room Temperature and Refrigeration

Background Melphalan is an alkylating agent, which is used in intensive treatment of hematological malignancies and solid tumors. The older melphalan formulation (Alkeran) has very limited ( Methods Lyophilized CE melphalan was reconstituted to 5mg/ml with 0.9% sodium chloride (in glass vials), diluted to 2 mg/ml with 0.9% sodium chloride, in IV (PVC) bags. They were then stored at RT (23°C) and under refrigeration. Aliquots (1ml) were removed at 0, 2, 4, 6, 8, 12 and 24hr. after preparation of 2mg/ml IV bags and the concentration was analyzed by using a validated high performance liquid chromatography method. Since 5 mg/ml reconstituted vials were previously found to be stable for 24 hr., we determined its stability after 24 hr. at RT and under refrigeration. The 2 mg/ml or 5 mg/ml CE melphalan was considered stable if the concentration at a given time-point was greater than 90% of the initial concentration at time zero. Results The percent concentration at various time points compared to time zero, is presented in Table 1. The percent concentration after 24 hr. of 2 mg/ml CE melphalan in an IV bag was 93.77% at RT, and 95.87% under refrigeration. The percent concentration of 5 mg/ml CE melphalan solution in a glass vials at 24 hr. was 99.44% at RT and 99.84 % under refrigeration. Conclusion The results indicate that both 2 mg/ml CE melphalan in IV bags, and 5 mg/ml in glass vials are both stable at RT and under refrigeration for 24 hr. after preparation.