导航开发的干粉用于吸入:一个CDMO视角
Beatriz Noriega-Fernandes1, Mariam Ibrahim1, Rui Cruz1
1Small Molecules Product Development, Lonza Group AG, Bend, OR 97701, USA.
Pharmaceuticals (Basel, Switzerland)
|March 27, 2025
概括
本文提供了一个以CDMO为中心的路线图,用于开发吸入式干粉药物产品. 它指导新来者通过配方,粒子工程和封装来成功进行肺/鼻分泌.
科学领域:
- 制药科学 制药科学
- 药物运输 药物运输 药物运输
- 生物技术是生物技术.
背景情况:
- 对于具有挑战性的分子 (溶解性差,生物制剂) 的肺/鼻药物输送越来越感兴趣,以及进入该领域的新利益相关者.
- 合同开发和制造组织 (CDMO) 对于吸入产品的开发至关重要,但缺乏明确,综合的路线图.
- 现有的文献没有从CDMO的角度提供一个统一的框架来开发吸入性药物产品.
研究的目的:
- 为开发吸入式干粉药物产品提供一个以CDMO为中心,逐步的路线图.
- 突出产品开发的关键方面,为新手提供实用指导.
- 为了弥合临床前,配方,制造和封装方面的考虑.
主要方法:
- 为吸入性药物产品开发制定一种新的,逐步的战略.
- 分析关键方面,包括目标产品的定义和临床前剂量选择.
- 评估API特性 (小分子与生物) 和配方选择 (干粉重点).
主要成果:
- 关于选择颗粒工程技术 (喷射削,喷雾干燥) 的指导,包括利弊.
- 讨论喷雾干燥和喷射粉末封装的挑战和考虑因素.
- 介绍一个统一的框架,整合临床前,配方,制造和封装.
结论:
- 拟议的路线图促进了吸入干粉产品开发的决策.
- 本出版物是CDMO和该领域的新进入者的一种实用工具.
- 提供了一种全面的方法来应对肺/鼻药物产品开发的复杂性.
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