Physicochemical stability of carfilzomib (Kyprolis®) containing solutions in glass vials, ready-to-administer plastic syringes and infusion bags over a 28-day storage period.

Abstract

Centralized aseptic preparation of ready-to-administer carfilzomib containing parenteral solutions in plastic syringes and polyolefine (PO) infusion bags needs profound knowledge about the physicochemical stability in order to determine the beyond-use-date of the preparations. Therefore, the purpose of this study was to determine the physicochemical stability of carfilzomib solution marketed as Kyprolis® powder for solution for infusion. Reconstituted solutions and ready-to-administer preparations of Kyprolis® stored under refrigeration (2-8℃) or at room temperature (25℃) were analyzed at predetermined intervals over a maximum storage period of 28 days. Chemical stability of carfilzomib was planned to be determined with a stability-indicating reversed-phase high-performance liquid chromatography assay. Physicochemical stability was planned to be determined by visual inspection of clarity and color as well as pH measurement. The study results show that reconstituted carfilzomib containing parenteral solutions are stable in glass vials as well as diluted solutions in plastic syringes and PO infusion bags over a period of at least 28 days when stored light protected under refrigeration. When stored at room temperature, reconstituted and diluted carfilzomib solutions are physicochemically stable over 14 days and 10 days, respectively. The physicochemical stability of carfilzomib infusion solutions allows cost-saving pharmacy-based centralized preparation of ready-to-administer preparations.