工程制药结晶固体的挑战:晶体结构设计和预测的科学和法规事务观点

A. Cvetkovski
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引用次数: 0

摘要

固态研究的突破已经成为测定活性药物成分(api)和赋形剂结构的新兴方法,从而影响其物理化学性质、生物制药和药代动力学特征。传统药用盐的概念已经扩展到多组分晶体,其非共价分子间相互作用的多样性决定了结构内的晶体排列模式,从而调节了原料药的天然性质。因此,本文的目的是强调分子晶体的晶体学研究成果如何影响其分类,以及这些新的固相是如何被监管机构认可的。探索一种原料药的药物结晶固体的优势意味着选择具有有利性质的形式用于开发药物剂型的制剂。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
The Challenge for Engineering Pharmaceutical Crystalline Solids: Scientific and Regulatory Affairs Perspectives for Crystal Structure Design and Prediction
The Breakthrough into solid-state research has become emerging approach for structure determination of Active Pharmaceutical Ingredients (APIs) and excipeents that consequently influence their physic-chemical properties, biopharmaceutical and pharmacokinetic profiles. The concept of conventional pharmaceutical salts has been extended to multicomponent crystals which diversity in nature of the non-covalent intermolecular interactions determine the crystal packing patterns within the structures, and thus modulate the native properties of APIs. Therefore, the aim of this review is to highlight how accomplishments in crystallographic research on molecular crystal have influenced their classification and how these new solid phases have been recognized by the regulatory bodies. The advantage to explore the pharmaceutical crystalline solids of one API implies the selection of the form with favorable properties for the development of formulations for pharmaceutical dosage forms.
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