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

Author:

Kawedia Jitesh D1,Ramchandran Sumankalai2,Liu Xiaoqian1,Gulbis Alison M1,Titus Mark2,Bashir Qaiser3,Qazilbash Muzaffar H3,Champlin Richard E3,Ciurea Stefan O4

Affiliation:

1. Department of Pharmacy Clinical Services, The University of Texas MD Anderson Cancer Center , Houston, TX , USA

2. Department of Genitourinary Medical Oncology, The University of Texas MD Anderson Cancer Center , Houston, TX , USA

3. Department of Stem Cell Transplantation and Cellular Therapy, The University of Texas MD Anderson Cancer Center , Houston, TX , USA

4. Division of Hematology/Oncology, Department of Medicine, Chao Family Comprehensive Cancer Center, University of California , Irvine, Irvine, CA , USA

Abstract

Abstract Purpose 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. Methods 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 Aliquots were withdrawn from the bags and reconstituted vials of CE-melphalan and PG-melphalan immediately after preparation and at predetermined time intervals.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. Results 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. Conclusion 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.

Publisher

Oxford University Press (OUP)

Subject

Health Policy,Pharmacology

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