开发一种基于旋转器的加速药物释放方法,用于评估布皮瓦卡因多胞体脂质体
Ziyun Xia1,2, Minzhi Yu1,2, Yayuan Liu1,2
1Department of Pharmaceutical Sciences, College of Pharmacy, University of Michigan, NCRC, 2800 Plymouth Road, Ann Arbor, MI, 48109, USA.
Pharmaceutical research
|January 11, 2024
概括
使用旋转器的新体外释放测试 (IVRT) 方法有效测量布皮瓦卡因多胞体脂质体 (MVLs) 的释放. 这种方法有助于通过区分质量差异来开发通用MVL配方.
科学领域:
- 制药科学 制药科学
- 药物输送系统 药物输送系统
- 分析化学 分析化学
背景情况:
- 多胞体脂质体 (MVL) 旨在持续释放药物,特别是具有短半衰期的药物.
- 布皮瓦卡因MVL配方已被批准用于止痛,但开发复杂配方的体外释放测试 (IVRT) 方法存在挑战.
- 强大的IVRT方法对于仿制药的开发和监管批准至关重要.
研究的目的:
- 开发一种基于旋转器的加速IVRT方法,用于布皮瓦卡因MVLs.
- 建立一种能够区分不同质量属性的布皮瓦卡因MVL的方法.
- 支持复杂的脂质体配方的通用开发.
主要方法:
- 选了三种IVRT设置 (网状管,水平动器,垂直旋转器),以在24小时内实现至少50%的布皮瓦卡因释放.
- 优化了IVRT的样本稀释系数,化温度和释放介质pH.
- 验证了与商业布皮瓦卡因MVL的方法可复制性,并评估了使用受损配方的歧视能力.
主要成果:
- 基于旋转器的释放设置因其在24小时内达到70%的药物释放能力而被选择.
- 优化的条件包括50倍的稀释系数,37°C的化温度和pH 7.4的释放介质.
- 该方法证明了可重复性和能够区分配方的能力.
结论:
- 成功开发了一种基于旋转器的加速IVRT方法,用于bupivacaine MVLs.
- 该方法表现出区分能力,可以根据质量属性区分配方.
- 这种IVRT方法作为一种强大的工具,用于开发基于MVL的通用配方.
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