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基于模型的纳米粒子和溶解形式比率的预测使用总度数据:SNB-101的案例研究

Jinha Park^1,2, Soo Hyeon Bae¹, Sangil Jeon¹

¹AIMS BioScience, Co., Ltd., Seoul, Republic of Korea.

Frontiers in pharmacology

|September 8, 2025

概括

在SNB-101纳米颗粒配方中,SN-38主要以纳米颗粒的形式产生,导致SN-38总暴露率更高,但与传统的义诺太干相比,系统毒性降低. 这种纳米粒子药物递送系统可以提高安全性和疗效的预测.

科学领域:

药理学药理学是指药理学的学科.
纳米技术纳米技术
临床药理学临床药理学

背景情况:

氨酸 (CPT-11) 是SN-38的前药物,但其临床使用受到转化不良,瘤向和毒性限制.
像SNB-101这样的纳米颗粒配方旨在通过EPR效应改善虹素的输送并降低毒性.

研究的目的:

开发一种药理动力学 (PK) 模型,以区分纳米粒子 (NP) 和溶解 (S) 形式的虹素和SN-38.
从SNB-101. 描述NP-to-S转换及其对SNB-101. 总药物暴露的贡献.

主要方法:

利用了SNB-101.1的第一阶段临床试验的血总度数据.
开发了一个11个部件的PK模型,整合了先前的知识和新的临床数据.

主要成果:

SNB-101主要提供纳米粒子形式的SN-38 (NP-SN-38),占SN-38总暴露量的80%以上.
尽管总SN-38水平增加,但高NP-SN-38暴露与系统毒性降低相关.

结论:

减少暴露于溶解的SN-38和氨基酸有助于SNB-101的安全性.
这种基于模型的方法强调了区分NP和S形式的价值,以预测纳米粒子治疗药物的疗效和毒性.

关键词:

标签:SN-38 标签: 美国增强的透性和保留效应.纳米颗粒药物输送方法药物动力学建模药物动力学建模瘤向向的目标

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