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REVIEW ARTICLE

Innovative medicines by supercritical fluid particle design: Four decades of progress

Yongda Sun1,2*
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1 3S PharmaTech, (3SPT LLC), Newark, California, United States of America
2 3S PharmaEng Co., Ltd, Shenzhen, Guangdong, China
IMO, 025440059 https://doi.org/10.36922/IMO025440059
Received: 28 October 2025 | Revised: 10 March 2026 | Accepted: 12 March 2026 | Published online: 22 May 2026
© 2026 by the Author(s). This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution -Noncommercial 4.0 International License (CC-by the license) ( https://creativecommons.org/licenses/by-nc/4.0/ )
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Abstract

Innovative medicines are increasingly relying on advanced technologies spanning discovery, formulation, manufacturing, and regulation. Supercritical fluid particle design (SCF PD) is an emerging pharmaceutical platform that has evolved from laboratory research to industrial application over the past four decades. Transforming active pharmaceutical ingredients into innovative medicines requires coordinated optimization in aspects such as particle size, crystal form and morphology, solubility, absorption, bioactivity, functional structure, stability, and biocompatibility. In achieving this goal, SCF PD can not only produce pure drug particles but also manufacture composite particles with functional structures, such as hybrid nanoparticles, co-crystals, porous particles, and coated particles, which can be used in controlled-release, taste-masking, carrier-free inhalation, and other drug delivery system formulations. With the advancement of technology, equipment, and processes, innovative medicines developed through SCF PD have entered clinical trials and Good Manufacturing Practices production, such as StaniTab® sirolimus nanocrystal direct-compression tablets, Dasynoc® dasatinib hybrid nanodispersion tablets, Nano-enzalutamide 160 mg single-dose amorphous nanopowder tablets, and Zindol® ginger extract capsules. This narrative review focuses on the advances in innovative medicines for poorly soluble drugs, anticancer drugs, and inhalation drugs, emphasizing the simplification of complex manufacturing processes, dose reduction, improvement of medicine quality, enhancement of therapeutic efficacy, and increased patient adherence, providing important guidance for better utilization of SCF PD technology in the production of innovative medicines.

Keywords
Innovative medicines
Supercritical fluid particle design
3S-improved supercritical anti-solvent
Nanoparticles
Poorly soluble drugs
Anticancer drugs
Inhalation drugs
Funding
None.
Conflict of interest
Yongda Sun is an employee of 3S PharmaTech and 3S PharmaEng Co.; however, he was not involved in any activities that could constitute a conflict of interest in relation to this study.
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Innovative Medicines & Omics, Electronic ISSN: 3060-8740 Print ISSN: 3060-8910, Published by AccScience Publishing
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