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开发一种生物相关溶解试验,使用二碳酸缓冲和顶峰容器来预测临床生物等价性

Masahiro Fushimi^1,2, Katsuki Nakamichi¹, Masatoshi Nakatani¹

¹Sawai Pharmaceutical Co., Ltd., 5-2-30 Miyahara, Yodogawa-ku, Osaka 532-0003, Japan.

Chemical & pharmaceutical bulletin

|February 1, 2026

概括

使用二碳酸盐缓冲器和顶部容器的新生物相关溶解试验准确地预测了肠膜涂层埃索梅普拉颗粒的临床生物等价性 (BE). 这种方法克服了综合测试的局限性,改善了配方开发.

科学领域:

制药科学制药科学
药物运输药物运输药物运输
分析化学分析化学

背景情况:

目前的溶解测试往往无法预测临床生物等价性 (BE).
肠膜涂层药物配方需要专门的溶解测试.
治疗等效的可靠预测对于药物开发至关重要.

研究的目的:

开发一种生物相关的溶解试验,能够预测临床生物等价性 (BE).
为了评估ES和非BE (NBE) 状态的ESomeprazole三水合物 (ECP-ESO) 的肠涂层颗粒.
将生物相关条件与综合溶解方法进行比较.

主要方法:

在各种条件下使用式方法对ECP-ESO进行溶解测试.
使用具有生物相关性的二碳酸盐缓冲器 (BCB) 与浮动盖来模拟肠液.
使用顶部容器 (Apex-V) 来抑制工件形 (形).
将BCB/Apex-V与综合酸盐缓冲器 (PPB) 和圆底容器 (RB-V) 进行比较.

主要成果:

补充条件 (PPB/RB-V) 没有区分BE和NBE配方.
阿佩克斯-V 消除了共,但仅用PPB或BCB缺乏歧视力.
生物相关的BCB和Apex-V的组合成功地将BE与NBE ECP-ESO区分开来.
结果与临床生物等价性数据相关.

结论:

使用BCB和Apex-V的生物相关溶解测试可以准确预测临床BE/NBE.
这种简单,生物相关的方法提高了配方开发中的预测能力.
开发的测试提供了评估治疗等效性的实用方法.

关键词:

顶部船只的顶部船只碳酸的缓冲器碳酸的缓冲器生物等价性生物等价性浮动盖子浮动盖子在体内可预测溶解.

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