Are existing standard methods suitable for the evaluation of nanomedicines: some case studies

作者：Gioria Sabrina^*; Caputo Fanny; Urban Patricia; Maguire Ciaran Manus; Bremer Hoffmann Susanne; Prina Mello Adriele; Calzolai Luigi; Mehn Dora

来源：Nanomedicine, 2018, 13(5): 539-554.

DOI：10.2217/nnm-2017-0338

• analytical ultracentrifugation
• cytotoxicity
• drug release
• field flow fractionation
• high content screening
• nanomedicine
• nanoparticle tracking analysis
• particle size distribution
• regulatory
• safety assessment

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.

• 出版日期2018-3
• 单位中国地震局