Stability of Captisol-enabled versus propylene glycol–based melphalan at room temperature and after refrigeration

梅尔法兰 小瓶 色谱法 化学 聚氯乙烯 制冷 材料科学 核化学 医学 外科 化疗 有机化学 机械工程 工程类
作者
Jitesh D. Kawedia,Sumankalai Ramchandran,Xiaoqian Liu,Alison Gulbis,Mark Titus,Qaiser Bashir,Muzaffar H. Qazilbash,Richard E. Champlin,Stefan O. Ciurea
出处
期刊:American Journal of Health-system Pharmacy [Oxford University Press]
卷期号:79 (12): 1011-1018
标识
DOI:10.1093/ajhp/zxac055
摘要

To compare the chemical stability of Captisol-enabled (CE) melphalan ("CE-melphalan"; Evomela, Acrotech Biopharma LLC) and propylene glycol (PG)-based melphalan ("PG-melphalan"; Alkeran, GlaxoSmithKline) admixtures prepared with 0.9% sodium chloride injection in polyvinyl chloride (PVC) bags or reconstituted vials stored at room temperature (RT) and under refrigeration.Lyophilized CE-melphalan and generic PG-melphalan were reconstituted to 5 mg/mL with 0.9% sodium chloride injection or manufacturer-supplied diluent, respectively. The reconstituted vials were then diluted to the desired concentrations with 0.9% sodium chloride injection in PVC bags and were stored at RT (23oC) or under refrigeration (4oC). Aliquots were withdrawn from the bags and reconstituted vials of CE-melphalan and PG-melphalan immediately after preparation and at predetermined time intervals. Melphalan concentrations were measured using a validated high-performance liquid chromatography method.CE-melphalan reconstituted in PVC bags at concentrations of 1 and 2 mg/mL was stable for 6 and 24 hours, respectively, at RT and for 8 and 24 hours, respectively, at 4oC. PG-melphalan reconstituted in bags at 1, 1.5, and 2 mg/mL was stable for 1, 2, and 2 hours, respectively, at RT and for 2, 4, and 4 hours, respectively, at 4oC. Reconstituted CE-melphalan vials were stable for 48 hours at both RT and 4oC, whereas PG-melphalan vials were stable for 6 hours at RT but formed precipitate within 2 hours at 4oC.CE-melphalan remained stable longer than generic PG-melphalan under the test conditions. CE-melphalan at 2 mg/mL has 24-hour stability at RT and can be used for extended infusion times or may be compounded ahead of time. Reconstituted CE-melphalan vials are stable for 48 hours at both RT and 4oC.

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