博特佐米布溶液的物理化学稳定性用于皮下注射
Ángela Gómez1, Mª Cristina Benéitez García2, Nélida Barrueco3
1Department of Pharmaceutical and Food Technology, Complutense University of Madrid, 28040, Madrid, Spain.
Scientific reports
|April 18, 2024
概括
在溶解后,伯特佐米布在冷藏7天和室温24小时保持稳定. 这项研究提供了博特佐米布的关键物理化学稳定性数据,有助于节省成本和减少浪费.
科学领域:
- 制药科学 制药科学
- 药物的稳定性 药物的稳定性
- 瘤学 治疗学 治疗学
背景情况:
- 细胞毒药物制剂,如博特佐米布,往往缺乏单位剂量信息和开封后稳定性数据.
- 这种信息缺口影响了患者的管理,连续的访问,以及每位患者的成本效益.
- 了解物理化学稳定性对于安全高效的药物处理至关重要.
研究的目的:
- 为了确定在冷藏和临床使用条件下复制的博特佐米布的保质期.
- 为了评估博特佐米布在瓶子和预填注射器中的稳定性.
- 建立一个评估药物稳定性和降低医疗保健成本的协议.
主要方法:
- 在瓶子和注射器中测试复制的博特佐米布 (2.5毫克/毫升在0.9%的化中) 的稳定性.
- 监测关键的物理化学参数,包括杂质,纯度 (光二极管阵列),质量平衡和微可见粒子 (激光衍射).
- 使用稳定性指示HPLC方法进行化学稳定性评估和物理检查与pH监测.
主要成果:
- 博尔特佐米布在5±3°C (冷藏) 的情况下,在两瓶和注射器中保存7天的稳定性被证明是安全的,免受光线的影响.
- 在模拟的临床使用条件下 (20-30°C,免受光线影响) 药物在24小时内保持稳定.
- 该研究确定了复制的博特佐米布的稳定性规格.
结论:
- 复制的博特佐米布在冷藏下稳定7天,在室温下稳定24小时,可灵活施用.
- 开发的协议支持在瓶子和预填注射器中使用复制的博特佐米布,这可能会减少浪费.
- 这些稳定性数据可以在博特佐米布治疗方案中大幅节省成本.
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