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药物研发中的固体形态筛选:当前实践的视角

Solid Form Screenings in Pharmaceutical Development: a Perspective on Current Practices.

作者信息

Gui Yue

机构信息

China Innovation Center of Roche, Building 5, 371 Lishizhen Road, Shanghai, China.

出版信息

Pharm Res. 2023 Oct;40(10):2347-2354. doi: 10.1007/s11095-023-03573-2. Epub 2023 Aug 3.

Abstract

Solid form screening is a crucial step in new drug development because solid forms of a drug substance significantly affect stability, dissolution and manufacturing processes of its drug products. This perspective introduces solid-state science from a practical standpoint, aiming to reduce knowledge gaps and promote communications among scientists with diverse background. This perspective starts with a concise overview that followed by discussion on timeline and goals of solid form screening. Techniques for solid from identification and characterization are then discussed. Subsequently, the perspective presents commonly used methods in solid form screening and introduces criteria and strategies to effectively select a favorable solid form based on screening results. The last section summarizes current practices in pharmaceutical industries and suggests potential opportunities for future research and development.

摘要

固态筛选是新药开发中的关键步骤,因为药物物质的固态形式会显著影响其药品的稳定性、溶解性和生产工艺。本视角从实际角度介绍固态科学,旨在缩小知识差距并促进不同背景科学家之间的交流。本视角首先进行简要概述,随后讨论固态筛选的时间线和目标。接着讨论固态鉴定和表征技术。随后,本视角介绍固态筛选中常用的方法,并引入基于筛选结果有效选择有利固态形式的标准和策略。最后一部分总结了制药行业的当前实践,并提出了未来研发的潜在机会。

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