浅谈在药物发现和产品开发过程中确定合适的固体形式的意义

Nishadh A. Patel
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引用次数: 1

摘要

近年来,固体形式筛选已成为药物开发中不可或缺的一部分。固体形式筛选通常包括产生和表征潜在候选药物的最大可能的固体形式。未来药物产品开发的不同类型的固体形态包括盐筛选、共晶筛选、结晶工艺开发、多晶筛选以及非晶固体分散筛选。固体形式的筛选研究是一套精心设计的实验,需要使用先进的分析技术来收集分析数据,然后进行深思熟虑的数据分析。这种固体形态筛选研究指导了铅固体形态的重要决策,这可能在药品开发生命周期中起着至关重要的作用。选择标准包括药学相关性质,如治疗功效和工艺特性,以及理化性质(即溶解度、溶出率、吸湿性、物理稳定性和化学纯度)在药品开发中的作用。一种选定的固体形式,如果热力学不稳定,则在暴露于环境条件(如温度和相对湿度)以及制药装置操作期间的制造应力时可能发生固体形式变化。在本工作中,讨论了固体形态筛选的基本原理,包括实验筛选方法以及固体形态的表征和分析。这里还讨论了与所需固体形式有关的药品风险评估的重要性。
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A Review on Significance of Identifying an Appropriate Solid Form Duringdrug Discovery and Product Development
In recent years, solid form screening has become an integral and mandatory part of drug development. Solid form screening typically involves producing and characterizingmaximum possible solid forms of a potential drug candidate. Different types of solid forms for future drug product development includes salt screening, co-crystal screening, crystallization process development, polymorph screening as well as amorphous solid dispersion screening.Screening studies of a solid form is a set of carefully designed experiments that requires use of advanced analytical techniques to collect analytical data followed by a thoughtful data analysis.This solid form screening studies guide an important decision-making of lead solid form whichis likely to play a vital role during the pharmaceutical product development lifecycle. The selection criteria include pharmaceutically relevant properties, such as therapeutic efficacy and processing characteristics as well as role of physicochemical properties (i.e. solubility, dissolution rate, hygroscopicity, physical stability and chemical purity) in drug product development. A selected solid form, if thermodynamically unstable, it may undergo solid form changes upon exposure to environmental conditions such as temperature and relative humidity as well as manufacturing stress during the pharmaceutical unit operations. In thepresent work, fundamentals of solid form screening are discussed, including the experimental screening methodologies as well as characterization and analysis of solid forms. The importance of drug product risk assessment pertaining to the desired solid form are also discussed here.
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