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A critical review on the particle generation and other applications of rapid expansion of supercritical solution
International Journal of Pharmaceutics ( IF 5.8 ) Pub Date : 2021-09-14 , DOI: 10.1016/j.ijpharm.2021.121089
Rahul Kumar 1 , Amit K Thakur 1 , Nilanjana Banerjee 1 , Pranava Chaudhari 1
Affiliation  

The novel particle generation processes of Active Pharmaceutical Ingredient (API)/drug have been extensively explored in recent decades due to their wide-range applications in the pharmaceutical industry. The Rapid Expansion of Supercritical Solutions (RESS) is one of the promising techniques to obtain the fine particles (micro to nano-size) of APIs with narrow particle size distribution (PSD). In RESS, supercritical carbon dioxide (SC CO2) and API are used as solvent and solute respectively. In this literature survey, the application of RESS in the formation of fine particles is critically reviewed. Solubility of API in SC CO2 and supersaturation are the key factors in tuning the particle size. The different approaches to model and predict the solubility of API in SC CO2 are discussed. Then, the effect of process parameters on mean particle size and the particle size distribution are interpreted in the context of solubility and supersaturation. Furthermore, the less-explored applications of RESS in preparation of solid-lipid nanoparticles, liposome, polymorphic conversion, cocrystallization and inclusion complexation are compared with traditional processes. The solubility enhancement of API in SC CO2 using co-solvent and its applications in particle generation are explored in published literature. The development and modifications in the conventional RESS process to overcome the limitations of RESS are presented. Finally, the perspective on RESS with special attention to its commercial operation is highlighted.



中文翻译:

超临界溶液快速膨胀的粒子产生及其他应用的批判性评论

近几十年来,活性药物成分 (API)/药物的新型颗粒生成过程因其在制药行业的广泛应用而得到广泛探索。超临界溶液的快速膨胀 (RESS) 是获得具有窄粒度分布 (PSD) 的 API 细颗粒(微米到纳米级)的有前途的技术之一。在RESS中,超临界二氧化碳(SC CO 2)和API分别用作溶剂和溶质。在这篇文献调查中,对RESS在细颗粒形成中的应用进行了批判性回顾。API 在 SC CO 2 中的溶解度和过饱和度是调节粒径的关键因素。模拟和预测 API 在 SC CO 2 中的溶解度的不同方法进行了讨论。然后,在溶解度和过饱和度的背景下解释工艺参数对平均粒度和粒度分布的影响。此外,与传统工艺相比,RESS 在制备固体脂质纳米颗粒、脂质体、多晶型转化、共结晶和包合络合方面的应用较少。已发表的文献中探讨了使用共溶剂增强 API 在 SC CO 2 中的溶解度及其在颗粒生成中的应用。介绍了传统 RESS 工艺的发展和改进,以克服 RESS 的局限性。最后,强调了RESS的观点,特别关注其商业运营。

更新日期:2021-09-24
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