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在体内表征Perseris和组成相等的配方

Xiaoyi Wang¹, Quanying Bao¹, Ruifeng Wang¹

¹Department of Pharmaceutical Sciences, University of Connecticut, Storrs, CT 06269, USA.

International journal of pharmaceutics

|June 24, 2023

概括

这项研究验证了评估RISPERIDONE植入物的子模型,显示了Perseris及其同等配方的可比体内性能. 这些发现支持未来开发类似的长效注射药物输送系统.

科学领域:

药理学药理学是指药理学的学科.
生物材料科学生物材料科学
药物输送系统药物输送系统

背景情况:

帕塞里斯是一种治疗成年精神分裂症的皮下延长释放的RISPERIDONE植入物,用于每月的药物输送,使用Poly-lactide-co-glycolide (PLGA).
基于Perseris的逆向工程开发了两个组成相等的配方 (F-1,F-2),在体外表现出类似的药物释放概况.

研究的目的:

在子模型中探索Perseris和两个同等配方 (F-1,F-2) 的体内性能.
为了评估与Perseris相比F-1和F-2的相同性,使用体内药理动力学和药物仓库行为分析.
评估子模型是否适合在体内对RISPERIDONE植入物进行评估.

主要方法:

在子中研究了体内药理动力学 (PK) 概况,药物吸收,相分离,宏观外观,体重减轻和水分吸收.
为了比较,使用了体外药物释放数据和现有的狗/人体体内数据.
分析的重点是比较Perseris,F-1和F-2以及体外与体外行为.

主要成果:

帕塞里斯的子PK概况与狗和人类临床数据相对相关,验证了子模型的相关性.
配方F-1和F-2表现出与Perseris相似的体内PK配置文件,药物吸收率,体重减轻和胀.
虽然侵蚀机制相似,但在药物释放动力学,相分离和胀方面观察到体外和体内差异.

结论:

子模型适用于研究RISPERIDONE植入物的体内性能.
开发的等效配方 (F-1,F-2) 在体内表现出与Perseris相比较的行为.
这项研究提供了全面的体外/体内理解,有利于开发通用和新型PLGA in situ形成植入物.

关键词:

在构成上相当的配方.在现场形成植入物.持续的持续的持续的药理动力学药理动力学聚乳酸合糖化物 (PLGA) (PLGA) 是一种聚乳酸合糖化物.一个子子.里斯佩里胺是一种素.

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