Preparation of a stable amiodarone hydrochloride formulation using various nanotechnology methods and pharmaceutical studies

Xinyu You; Xianghua Gao; Bingbing Wu; Rongqiang Li; Luoting Yu; Qijie Xu

doi:10.2478/pjct-2026-0006

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Preparation of a stable amiodarone hydrochloride formulation using various nanotechnology methods and pharmaceutical studies

Green Sciences

Volume 28 (2026): Issue 1 (March 2026)

By: Xinyu You, Xianghua Gao, Bingbing Wu, Rongqiang Li, Luoting Yu and Qijie Xu

Open Access

|Jun 2026

Abstract

Amiodarone hydrochloride (AD), a Class II antiarrhythmic agent, is widely prescribed for ventricular and supraventricular arrhythmias. However, its limited aqueous solubility constrains its clinical application. In this study, two chemically stable AD nanosuspensions were prepared via the evaporative precipitation into aqueous solution (EPAS) method and the wet-milling technique. The nanosuspensions were characterised by transmission electron microscopy, photon correlation spectroscopy, differential scanning calorimetry (DSC), and X-ray powder diffraction (XRPD). DSC and XRPD analyses confirmed the maintenance of the crystalline state. In vitro dissolution assays demonstrated that both nanosuspensions exhibited significantly improved dissolution rates compared with their coarse suspension counterparts. Pharmacokinetic studies in rats showed that the oral bioavailability of AD in nanosuspensions (75.91 and 64.72%) was two to three times higher than that of coarse suspensions (33.31%).

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Articles in this issue

DOI: https://doi.org/10.2478/pjct-2026-0006 | Journal eISSN: 3072-0389 | Journal ISSN: 1509-8117

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Language: English

Page range: 88 - 101

Submitted on: Jul 24, 2025

Accepted on: May 11, 2026

Published on: Jun 12, 2026

Published by: West Pomeranian University of Technology, Szczecin

In partnership with: Paradigm Publishing Services

Publication frequency: Volume open

Keywords:

Amiodarone hydrochloride,

Evaporative precipitation into aqueous solution,

Pharmacokinetic studies,

Nanosuspensions,

Wet-milling

Related subjects:

Industrial chemistry,

Biotechnology,

Chemical engineering,

Process engineering

© 2026 Xinyu You, Xianghua Gao, Bingbing Wu, Rongqiang Li, Luoting Yu, Qijie Xu, published by West Pomeranian University of Technology, Szczecin
This work is licensed under the Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 License.

Volume 28 (2026): Issue 1 (March 2026)