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用于治疗和预防肺部感染性疾病的可吸入纳米药物的制剂与临床转化

Formulation and clinical translation of inhalable nanomedicines for the treatment and prevention of pulmonary infectious diseases.

作者信息

Ahmed Rami, Tewes Frederic, Aucamp Marique, Dube Admire

机构信息

School of Pharmacy, University of the Western Cape, Robert Sobukwe Road, Bellville, 7535, Cape Town, South Africa.

INSERM U1070, Pôle Biologie-Santé - B36, 1 Rue Georges Bonnet, 51106, 86073, POITIERS Cedex 9, TSA, France.

出版信息

Drug Deliv Transl Res. 2025 Apr 29. doi: 10.1007/s13346-025-01861-5.

DOI:10.1007/s13346-025-01861-5
PMID:40301249
Abstract

Pulmonary infections caused by bacteria, viruses and fungi are a significant global health issue. Inhalation therapies are gaining interest as an effective approach to directly target infected lung sites and nanoparticle-based pulmonary delivery systems are increasingly investigated for this purpose. In this review, we provide an overview of common pulmonary infectious diseases and review recent work on the application of inhalable nanoparticle-based formulations for pulmonary infectious diseases, the formulation strategies, and the current research for delivering inhalable nanomedicines. We also evaluate the current clinical development status, market landscape, and discuss challenges that impede clinical translation and propose solutions to overcome these obstacles, highlighting promising opportunities for future advancements in the field. Despite advancements made and products reaching the market, notable gap persists in translational research, with challenges in achieving the target product profile, availability of appropriate in vivo disease models, scale-up, and market related questions, likely hindering research translation to the clinic.

摘要

由细菌、病毒和真菌引起的肺部感染是一个重大的全球健康问题。吸入疗法作为一种直接针对感染肺部部位的有效方法正受到越来越多的关注,基于纳米颗粒的肺部给药系统也因此受到越来越多的研究。在这篇综述中,我们概述了常见的肺部感染性疾病,并回顾了基于可吸入纳米颗粒的制剂在肺部感染性疾病中的应用、制剂策略以及目前可吸入纳米药物递送的研究。我们还评估了当前的临床开发状况、市场格局,并讨论了阻碍临床转化的挑战,并提出克服这些障碍的解决方案,突出该领域未来进展的有前景的机会。尽管取得了进展且产品已投放市场,但转化研究仍存在显著差距,在实现目标产品概况、合适的体内疾病模型的可用性、扩大规模以及与市场相关的问题方面存在挑战,这可能会阻碍研究向临床的转化。

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