Are existing standard methods suitable for the evaluation of nanomedicines: some case studies.
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.
['Gioria|Sabrina|S|', 'Caputo|Fanny|F|', 'Urbán|Patricia|P|', 'Maguire|Ciarán Manus|CM|', 'Bremer-Hoffmann|Susanne|S|', 'Prina-Mello|Adriele|A|', 'Calzolai|Luigi|L|', 'Mehn|Dora|D|']
D002626:Chemistry, Pharmaceutical D004337:Drug Carriers D065546:Drug Liberation D006801:Humans D050997:Nanomedicine D053758:Nanoparticles D010316:Particle Size D004364:Pharmaceutical Preparations
nanomedicine drug release analytical ultracentrifugation cytotoxicity field flow fractionation high content screening nanoparticle tracking analysis particle size distribution regulatory safety assessment