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市售的纳米药物和纳米医药:挑战与机遇。

Nanopharmaceuticals and nanomedicines currently on the market: challenges and opportunities.

机构信息

Pharmaceutical Sciences Research Center, Shiraz University of Medical Sciences, Shiraz 71468-64685, Iran.

Department of Materials Science & Engineering, Sharif University of Technology, Tehran 11365-9466, Iran.

出版信息

Nanomedicine (Lond). 2019 Jan;14(1):93-126. doi: 10.2217/nnm-2018-0120. Epub 2018 Nov 19.

Abstract

There has been a revolution in nanotechnology and nanomedicine. Since 1980, there has been a remarkable increase in approved nano-based pharmaceutical products. These novel nano-based systems can either be therapeutic agents themselves, or else act as vehicles to carry different active pharmaceutical agents into specific parts of the body. Currently marketed nanostructures include nanocrystals, liposomes and lipid nanoparticles, PEGylated polymeric nanodrugs, other polymers, protein-based nanoparticles and metal-based nanoparticles. A range of issues must be addressed in the development of these nanostructures. Ethics, market size, possibility of market failure, costs and commercial development, are some topics which are on the table to be discussed. After passing all the ethical and biological assessments, and satisfying the investors as to future profitability, only a handful of these nanoformulations, successfully obtained marketing approval. We survey the range of nanomedicines that have received regulatory approval and are marketed. We discuss ethics, costs, commercial development and possible market failure. We estimate the global nanomedicine market size and future growth. Our goal is to summarize the different approved nanoformulations on the market, and briefly cover the challenges and future outlook.

摘要

纳米技术和纳米医学已经发生了一场革命。自 1980 年以来,已批准的基于纳米的药物产品数量显著增加。这些新型纳米系统本身可以是治疗剂,也可以作为载体将不同的活性药物成分输送到体内的特定部位。目前上市的纳米结构包括纳米晶体、脂质体和脂质纳米粒、聚乙二醇化聚合物纳米药物、其他聚合物、基于蛋白质的纳米颗粒和基于金属的纳米颗粒。在开发这些纳米结构时,必须解决一系列问题。伦理问题、市场规模、市场失灵的可能性、成本和商业开发,是一些正在讨论的话题。在通过所有伦理和生物评估,并使投资者对未来盈利能力感到满意后,只有少数这些纳米制剂成功获得了市场批准。我们调查了已获得监管批准并上市的各种纳米药物。我们讨论了伦理、成本、商业开发和可能的市场失灵。我们估计了全球纳米医学市场规模和未来增长。我们的目标是总结市场上已批准的不同纳米制剂,并简要介绍所面临的挑战和未来展望。

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