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Opportunities and Challenges in Mechanochemical Cocrystallization toward Scaled-Up Pharmaceutical Manufacturing
Organic Process Research & Development ( IF 3.1 ) Pub Date : 2023-02-13 , DOI: 10.1021/acs.oprd.2c00314
Sithmi Nimashi Madanayake 1 , Aruna Manipura 1 , Ranjit Thakuria 2 , Nadeesh M. Adassooriya 1, 3
Affiliation  

Recently, pharmaceutical cocrystals have gained immense interest because of their potential to tune mechanical, pharmacokinetic, and physicochemical properties of active pharmaceutical ingredients (APIs) while keeping their therapeutic action intact. In this review, cocrystallization is raised as a viable strategy toward commercialized pharmaceutical manufacturing, where attention has been paid to solid-state cocrystal preparation methods and their opportunities and challenges in overall product and process development. A comparative study of cocrystallization in the form of mechanical energy is demonstrated with the aid of SELECT criteria to qualitatively evaluate the synthetic route selection of scalable mechanochemical cocrystallization methods. Remedies and alternatives for the challenges that arise in mechanochemical synthesis of cocrystals are presented in this review, highlighting the commercial perspectives of sustainable, eco-friendly, and less toxic mechanochemical methods.

中文翻译:

机械化学共结晶对扩大制药生产的机遇和挑战

最近,药物共晶因其在保持其治疗作用不变的同时调节活性药物成分 (API) 的机械、药代动力学和物理化学特性的潜力而受到极大关注。在这篇综述中,共结晶被提出作为商业化药物制造的可行策略,其中关注了固态共晶制备方法及其在整体产品和工艺开发中的机遇和挑战。借助 SELECT 标准对机械能形式的共结晶进行了比较研究,以定性评估可扩展机械化学共结晶方法的合成路线选择。
更新日期:2023-02-13
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