一种自动化的电分析方法,用于对脂质体多克索鲁比HCl配方的药物释放概况
Fatma Yurtsever1, Wenlei Jiang2, Thilak Mudalige1
1Arkansas Laboratory, Office of Regulatory Affairs, U.S. Food and Drug Administration, Jefferson, AR 72079, USA.
Journal of pharmaceutical sciences
|December 10, 2023
概括
一种自动化的电分析方法为脂质体 doxorubicin 提供了持续的实时药物释放概况. 这种技术简化了质量控制,可能适用于其他氧化还原活性药物配方.
科学领域:
- 分析化学 分析化学
- 药品制造 药品制造 药品制造
- 电化学 电化学 电化学
背景情况:
- 脂质体是先进的药物递送系统,增强化疗生物可用性,降低毒性.
- 在体外药物释放分析对于脂质体配方的批准和质量控制至关重要.
- 药物释放量化的传统方法涉及复杂的分离步骤.
研究的目的:
- 开发一种自动化的电分析方法,用于脂质体中多克索鲁比的药物释放概况.
- 建立一个连续和高效的 in vitro 释放测试方法.
- 为了比较品牌和通用脂质体 doxorubicin 配方的药物释放概况.
主要方法:
- 开发一种使用正方形波电压测量的自动化电分析方法.
- 在特定的脉冲电位范围内测量释放的多克索鲁比辛电流.
- 在不同的pH值和温度条件下,在24小时内持续监测药物释放.
主要成果:
- 电分析方法提供了连续的药物释放测量24小时,没有先前分离.
- 药物释放随着pH值和温度的升高而显著增加.
- 在pH 6.5和52°C的情况下,在3小时内实现了完全的药物释放 (>80%).
- 品牌和通用脂质体 doxorubicin 配方表现出类似的释放特征.
结论:
- 开发的电分析方法提供了一个简化和高效的替代体脂体多克索鲁比辛在体外释放测试.
- 这种方法不需要传统的分离技术,如透析或固体相提取.
- 该技术有可能用于体外释放测试其他含有氧化还原活性药物的脂质体配方,如鲁素.
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