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首页> 外文期刊>Journal of oncology pharmacy practice: official publication of the International Society of Oncology Pharmacy Practitioners >Physicochemical stability of carfilzomib (Kyprolis (R)) containing solutions in glass vials, ready-to-administer plastic syringes and infusion bags over a 28-day storage period
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Physicochemical stability of carfilzomib (Kyprolis (R)) containing solutions in glass vials, ready-to-administer plastic syringes and infusion bags over a 28-day storage period

机译：玻璃瓶中含有溶液的Carfilzomib（Kyprois）的物理化学稳定性，即在28天的储存期内即可施用的塑料注射器和输液袋

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摘要

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 (R) powder for solution for infusion. Reconstituted solutions and ready-to-administer preparations of Kyprolis (R) stored under refrigeration (2-8celcius) or at room temperature (25celcius) 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.
机译：集中的无菌制剂在塑料注射器和聚烯烃（PO）输液袋中含有肠胃外溶液的即食肠外溶液的制剂需要关于物理化学稳定性的深刻知识，以确定制剂的超越使用日期。因此，本研究的目的是确定以kyprolis（r）粉末用于输注的kyprois（r）粉末的胭脂蓟马溶液的物理化学稳定性。在制冷（2-8celcius）下储存的kyprois（r）的重构解决方案和准备施用的制剂（2-8celcius）或在室温（25celcius）上以预定的间隔在28天的最大储存期间分析。计划用稳定性指示的反相高效液相色谱法测定Carfilzomib的化学稳定性。计划通过对清晰度和颜色以及pH测量的目视检查来确定物理化学稳定性。该研究结果表明，含有肠胃外溶液的重构Carfilzomib在玻璃瓶中稳定，以及在制冷中储存的光保护时至少28天的塑料注射器和PO输液袋中的稀释溶液。当在室温下储存时，重构和稀释的Carfilzomib溶液分别在14天和10天内物理学稳定。 Carfilzomib Infusion解决方案的物理化学稳定性允许节省成本的药房的集中制剂准备施用制剂。

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