Dhaval Mori, Dudhat Kiran, Gadoya Aastha, Shah Sunny, Pethani Trupesh, Jambukiya Nilesh, Patel Ajay, Kalsariya Chintan, Ansari Jainabparvin, Borkhataria Chetan
B.K. Mody Government Pharmacy College, Polytechnic Campus, Near Ajidam, Rajkot, Gujarat-360005, India.
R.K. School of Pharmacy, R.K. University, Rajkot, Gujarat, India.
AAPS PharmSciTech. 2025 Jan 16;26(1):36. doi: 10.1208/s12249-024-03020-4.
Pharmaceutical salts are a cornerstone in drug development, offering a robust, economical, and industry-friendly option for improving the crucial physicochemical properties of drugs, particularly solubility and dissolution. This review article explores all critical aspects of salt formation, including its importance, the basic chemistry involved, the principles governing counterion selection, the range of counterions used, and the methods for preparing salts along with their advantages and limitations. Additionally, it explores analytical techniques for confirming salt formation and the different approaches various countries adopt in considering new salts as intellectual property. Furthermore, the review sheds light on US FDA-approved salts from 2019 to 2023, providing a unique perspective by analyzing trends in counterion selection observed in FDA-approved salts during this period. Despite the extensive literature on pharmaceutical salts, a comprehensive review addressing all these critical aspects in a single article with a focus on current trends and particularly on US FDA-approved salts from 2019 to 2023 is lacking. This review bridges this gap by thoroughly exploring all mentioned facets of pharmaceutical salts and providing an up-to-date overview.
药用盐是药物研发的基石,为改善药物的关键物理化学性质,尤其是溶解度和溶出度,提供了一种强大、经济且对行业友好的选择。这篇综述文章探讨了盐形成的所有关键方面,包括其重要性、涉及的基础化学、反离子选择的指导原则、使用的反离子范围、制备盐的方法及其优缺点。此外,还探讨了确认盐形成的分析技术以及各国在将新盐视为知识产权方面采取的不同方法。此外,该综述还揭示了2019年至2023年美国食品药品监督管理局(FDA)批准的盐,通过分析在此期间FDA批准的盐中反离子选择的趋势提供了独特的视角。尽管有大量关于药用盐的文献,但缺乏一篇在一篇文章中全面涵盖所有这些关键方面、关注当前趋势且特别关注2019年至2023年美国FDA批准的盐的综述。本综述通过全面探讨药用盐的所有上述方面并提供最新概述来弥补这一差距。
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