European Commission, Joint Research Center (JRC), Directorate for Health, Consumers & Reference Materials, Via Enrico Fermi 2749, I-21027 Ispra, VA, Italy.
Univ. Grenoble Alpes, F38000 Grenoble, France.
Nanomedicine (Lond). 2018 Mar 1;13(5):539-554. doi: 10.2217/nnm-2017-0338. Epub 2018 Jan 30.
The use of nanotechnology in medical products has been demonstrated at laboratory scale, and many resulting nanomedicines are in the translational phase toward clinical applications, with global market trends indicating strong growth of the sector in the coming years. The translation of nanomedicines toward the clinic and subsequent commercialization may require the development of new or adaptation of existing standards to ensure the quality, safety and efficacy of such products. This work addresses some identified needs, and illustrates the shortcomings of currently used standardized methods when applied to medical-nanoparticles to assess particle size, drug loading, drug release and in vitro safety. Alternative physicochemical, and in vitro toxicology methods, with the potential to qualify as future standards supporting the evaluation of nanomedicine are provided.
纳米技术在医疗产品中的应用已经在实验室规模上得到了验证,许多由此产生的纳米药物正处于向临床应用转化的阶段,全球市场趋势表明,该领域在未来几年将强劲增长。纳米药物向临床的转化和随后的商业化可能需要开发新的标准或调整现有的标准,以确保这些产品的质量、安全性和疗效。这项工作解决了一些已确定的需求,并说明了当前用于评估粒径、药物负载、药物释放和体外安全性的标准化方法在应用于医疗纳米颗粒时的局限性。提供了一些替代的物理化学和体外毒理学方法,这些方法有可能成为未来支持纳米药物评估的标准。
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