拟议的分类系统是指导长效,小分子和宏分子产品 (CS-BLAP) 的设计,开发,监管批准和缩放
Simone Perazzolo1, Danny D Shen1, Rodney Jy Ho2
1Department of Pharmaceutics, School of Pharmacy, University of Washington, Seattle, WA, USA.
Journal of pharmaceutical sciences
|November 8, 2025
概括
一个新的生物制药类别系统长效亲肠道产品 (CS-BLAP) 根据分子大小和吸收途径 (淋巴与血液) 将长效注射药物分类. 这个系统有助于开发和调节这些先进的疗法.
科学领域:
- 药理动力学和药物输送方法
- 生物制药生物制药公司
- 药物产品开发 药物产品开发
背景情况:
- 长效药物产品具有延长的治疗效果,但缺乏具体的监管指导和分类系统.
- 现有的生物制药分类系统 (BCS) 仅适用于口服小分子药物,而不是亲肠道LA产品.
- 大多数LA产品是通过皮下 (SC) 或肌内 (IM) 注射进行的.
研究的目的:
- 提出一种新的生物制药类别系统,用于长效亲肠道产品 (CS-BLAP).
- 建立基于药物特性和吸收机制的LA亲肠道产品分类框架.
- 引导各种LA亲肠道产品的开发,评估和监管,包括小分子和大分子.
主要方法:
- 开发了CS-BLAP专注于产品特征而不是药物物质.
- 使用淋巴或血液吸收通路的产品的综合分类.
- 利用药物和内源分子的数据集,建立基于分子大小的淋巴血液吸收分数的预测模型.
主要成果:
- CS-BLAP根据分子类型 (小分子/生物) 和主要吸收途径 (淋巴/血液) 将LA产品分为四类.
- 一个预测模型表明,淋巴与血液分布的过渡点约为35kDa,有利于淋巴增加分子大小.
- 时间到峰值血度 (Tmax) 被确定为非仓储产品中吸收动力学的替代标记.
结论:
- 拟议的CS-BLAP为LA亲肠道产品的分类提供了科学基础.
- 该框架支持科学家,监管机构和赞助商设计,开发和扩展LA产品.
- CS-BLAP容纳了广泛的LA产品,包括那些具有新的输送系统和吸收途径的产品.
关键词:
ADME ADME ADME ADME ADME ADME ADME ADME ADME ADME ADME ADME ADME ADME ADME ADME ADME ADME ADME ADME ADME ADME ADME ADME ADME ADME ADME ADME ADME ADME ADME ADME ADME ADME ADME ADME ADME吸收方式 吸收方式生物等价性 生物等价性生物制剂 生物制剂 生物制剂在CS-BLAP中使用.分类系统的分类系统.可以注射的注射剂.长效注射剂 长效注射剂长效药物 长效药物是一种长效药物.淋巴系统 淋巴系统药理动力学 药理动力学过境运输 过境运输是什么
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