儿童药物配方:稳定性,细胞毒性和成本效益研究
Guendalina Zuccari1, Carla Villa1, Valentina Iurilli2
1Department of Pharmacy, University of Genoa, Viale Benedetto XV, 16132 Genoa, Italy.
Pharmaceutics
|April 27, 2024
概括
在室温下稀释脂质体安二乙 (AmBisome®),特别是较低度,会增加药物聚合和细胞毒性. 在药房集中使用AmBisome®稀释剂可确保患者安全,减少药物浪费.
科学领域:
- 药理学 药理学是指药理学的学科.
- 药物输送系统是药物输送系统.
- 体科学是关于体的科学.
背景情况:
- 脂质体安波特 B (AmBisome®) 是成人和儿童的关键抗真菌剂.
- 医院工作人员的溶解和稀释存在挑战,这是由于安二B的聚合倾向.
- 二B聚合物的多样化的生物活性需要稳定性评估.
研究的目的:
- 在储存条件下,研究脂肪体安福特里辛B在时间上的合和化学稳定性.
- 评估不同度对脂质体稳定性和药物聚合的影响.
- 评估稳定性变化的临床相关性,特别是对于脆弱的患者群体.
主要方法:
- 准备和分析了三种脂质体安二B配方 (4.0,2.0和0.2毫克/毫升).
- 试验包括尺寸分布,泽塔潜力,药物聚合状态和副产品识别.
- 对不同配方和储存条件的细胞毒性进行了评估.
主要成果:
- 在室温下最稀释的配方 (0.2 mg/mL) 显示了药物聚合的显著变化.
- 药物聚合增加与稀释配方中更高的细胞毒性相关.
- 随着时间的推移,观察到稳定性问题,特别是在较低度和室温下.
结论:
- 在医院药房集中Ambisome®稀释对于确保患者安全至关重要.
- 基于药房的稀释方案可以减轻与药物聚合和细胞毒性相关的风险.
- 实施集中稀释可以通过减少药物浪费而大幅节省成本.
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