用途中的稳定性 塑料注射器中的daratumumab皮下注射溶液即用
Laura Knoll1, Judith Thiesen2, Martin D Klassen3
1Pharmacy, University Medical Center of the Johannes Gutenberg University, Mainz, Germany Laura.knoll@unimedizin-mainz.de.
European journal of hospital pharmacy : science and practice
|October 25, 2023
概括
达拉图穆马布皮下注射液在冷藏或室温的塑料注射器中稳定28天. 这一发现支持这种多发性骨髓瘤治疗的长期储存,确保其对患者的有效性和安全性.
科学领域:
- 药理学 药理学是指药理学的学科.
- 生物化学 生物化学
- 药物稳定性研究研究药物稳定性研究.
背景情况:
- 达拉图穆马布是治疗多发性骨髓瘤的关键疗法,可以用皮下注射.
- 目前的指导方针规定了daratumumab注射器的有限稳定性 (冷藏24小时,室温12小时).
- 扩展在使用中的稳定性数据对于优化患者治疗物流至关重要.
研究的目的:
- 为了评估daratumumab皮下注射溶液准备使用的物理化学稳定性.
- 为了评估不同类型的注射器和存储条件在28天内的稳定性.
- 提供证据,以延长daratumumab注射器的使用稳定期.
主要方法:
- 达拉图穆马布皮下注射溶液是在20mL和50mL三件式卢尔-洛克注射器中制备的.
- 这些注射器在2-8°C或室温 (22±2°C) 保护下,在28天的时间内被保护免受光线的影响.
- 使用IE-HPLC,SE-HPLC,pH测量和视觉检查来评估稳定性.
主要成果:
- 通过IE-HPLC,没有观察到峰值区域或比率的显著变化,这表明没有充电变体退化.
- SE-HPLC证实没有聚合物或碎片形成.
- 达拉图穆马布单体度保持在95%以上,pH值稳定,没有视觉变化 (清晰度,颜色,颗粒).
- 在不同储存条件下,结果一致.
结论:
- 达拉图穆马布皮下注射液在封闭的塑料注射器中物理化学稳定,在冷藏和室温下保存28天.
- 建议在微生物安全性方面进行无菌制备和冷藏储存.
- 准备注射的达拉图穆马布注射器在无菌地制备时可以保持28天的稳定性.
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