Micro and nanosizing of amiodarone hydrochloride drug via subcritical water anti-solvent technology

IF 4.4 3区工程技术 Q2 CHEMISTRY, PHYSICAL

Journal of Supercritical Fluids Pub Date : 2025-08-14 DOI:10.1016/j.supflu.2025.106752

Ali Haghighi Asl, Hadi Share Mohammadi, Maryam Khajenoori

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引用次数: 0

Abstract

As a green and bio-friendly technology, subcritical water (SW) processes have attracted considerable attention for micro and nanoparticle production in pharmaceutical applications. In this study, the solvent-antisolvent precipitation method was utilized for the first time to fabricate nanoparticles of amiodarone hydrochloride (AMD), an antiarrhythmic drug. The Design of Experiments (DOE) was applied to evaluate the simultaneous effects of three different variables, including SW temperature 373.15 K to 393.15 K, polyethylene glycol concentration 0.01 wt% to 0.03 wt%, and antisolvent temperature 273.15 K to 293.15 K, to discover the desirable conditions for achieving the smallest particle size. The desirable procedure conditions were determined as follows: SW temperature (393.15 K), polyethylene glycol concentration (0.03 wt%), and antisolvent temperature (283.15 K). Results indicated that under these conditions, the particle size was significantly reduced (average size of 28 nm) using green technology without requiring organic solvents or corresponding post-processing purification stages.

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亚临界水抗溶剂技术制备盐酸胺碘酮药物的微纳米化

亚临界水（SW）工艺作为一种绿色环保技术，在制药领域的微颗粒和纳米颗粒生产中受到了广泛的关注。本研究首次采用溶剂-抗溶剂沉淀法制备抗心律失常药物盐酸胺碘酮纳米颗粒。采用实验设计（DOE）方法，考察了SW温度（373.15 K ~ 393.15 K）、聚乙二醇浓度（0.01 wt% ~ 0.03 wt%）和抗溶剂温度（273.15 K ~ 293.15 K） 3个不同变量的同时影响，以确定实现最小粒径的理想条件。确定了理想的工艺条件：SW温度（393.15 K），聚乙二醇浓度（0.03 wt%），抗溶剂温度（283.15 K）。结果表明，在这些条件下，使用绿色技术，不需要有机溶剂或相应的后处理净化阶段，粒径显著减小（平均粒径为28 nm）。

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来源期刊

Journal of Supercritical Fluids 工程技术-工程：化工

CiteScore

7.60

自引率

10.30%

发文量

236

审稿时长

56 days

期刊介绍： The Journal of Supercritical Fluids is an international journal devoted to the fundamental and applied aspects of supercritical fluids and processes. Its aim is to provide a focused platform for academic and industrial researchers to report their findings and to have ready access to the advances in this rapidly growing field. Its coverage is multidisciplinary and includes both basic and applied topics. Thermodynamics and phase equilibria, reaction kinetics and rate processes, thermal and transport properties, and all topics related to processing such as separations (extraction, fractionation, purification, chromatography) nucleation and impregnation are within the scope. Accounts of specific engineering applications such as those encountered in food, fuel, natural products, minerals, pharmaceuticals and polymer industries are included. Topics related to high pressure equipment design, analytical techniques, sensors, and process control methodologies are also within the scope of the journal.