开发和优化一种体外释放试验,用于评估脂质体内氨基酸氨基酸的配方
Vivian Juang1, Jingyao Gan1, Ziyun Xia1
1Department of Pharmaceutical Sciences, University of Michigan, Ann Arbor, MI 48109, United States; Biointerfaces Institute, University of Michigan, Ann Arbor, MI 48109, United States.
International journal of pharmaceutics
|October 23, 2024
概括
开发了一种新的体外释放试验 (IVRT),用于Onivyde® (pegylated irinotecan liposomal配方),以帮助开发仿制药. 这种优化的测定方法确保了脂质体里诺特干配方的质量控制和可比性.
科学领域:
- 制药科学 制药科学
- 药物输送系统 药物输送系统
- 瘤学 治疗学 治疗学
背景情况:
- 奥尼维德® (pegylated irinotecan liposomal配方) 是FDA批准用于转移性胰腺腺癌的药物.
- 开发复杂的脂质体配方的通用版本,如Onivyde®提出了重要的制造和质量控制挑战.
- 强大的体外释放试验 (IVRT) 对于评估仿制脂质体药物产品的质量和可比性至关重要.
研究的目的:
- 开发和优化一种可靠的体外释放试验 (IVRT) 对Onivyde® (pegylated irinotecan liposomal配方).
- 确定影响从脂质体配方中体外释放色素的关键参数.
- 提供一个验证的测试,以评估仿制的脂体配方的质量和体外可比性.
主要方法:
- 使用透析膜技术确定了Onivyde®的体外释放特征.
- 研究了释放介质组成,pH值,温度,初始度和透析袋规格 (材料,分子量切断) 对药物释放的影响.
- 优化了IVRT条件,包括5mM二碳酸/HEPES缓冲器 (pH7.4),4.6μg/mL初始度,50kDa透析袋,37°C和80rpm的动.
主要成果:
- 确定了影响Onivyde®释放的关键因素,包括介质成分,温度,度,透析袋特性和pH值.
- 开发了一种优化的IVRT方法,使用特定的缓冲器,度,透析袋大小,温度和调设置.
- 证明了优化的IVR测定可以有效地区分不同品质的体体配方.
结论:
- 开发的IVRT提供了一种可靠和可重复的方法来评估脂质体里诺特干配方.
- 这种测定对于确保Onivyde®通用产品的质量控制和体外可比性至关重要.
- 这些发现有助于开发和监管评估仿制的基化氨酸体配方.
相关概念视频
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