Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Review
. 2018 Aug 20:6:360.
doi: 10.3389/fchem.2018.00360. eCollection 2018.

Nanomedicine: Principles, Properties, and Regulatory Issues

Affiliations
Review

Nanomedicine: Principles, Properties, and Regulatory Issues

Sara Soares et al. Front Chem. .

Abstract

Several scientific areas have benefited significantly from the introduction of nanotechnology and the respective evolution. This is especially noteworthy in the development of new drug substances and products. This review focuses on the introduction of nanomedicines in the pharmaceutical market, and all the controversy associated to basic concepts related to these nanosystems, and the numerous methodologies applied for enhanced knowledge. Due to the properties conferred by the nanoscale, the challenges for nanotechnology implementation, specifically in the pharmaceutical development of new drug products and respective regulatory issues are critically discussed, mainly focused on the European Union context. Finally, issues pertaining to the current applications and future developments are presented.

Keywords: nanomaterials; nanomedicine; nanotechnology; nanotoxicology; pharmaceutical development.

PubMed Disclaimer

Figures

Figure 1
Figure 1
Schematic representation of the different forms of particles: primary particle, aggregate, and agglomerate (reproduced with permission from Oberdörster, 2010).
Figure 2
Figure 2
Schematic representation of the several “barriers” found throughout the development of a nanomedicine product.
Figure 3
Figure 3
Nanotoxicological classification (reproduced with permission from Keck and Müller, 2013).

References

    1. Adabi M., Naghibzadeh M., Adabi M., Zarrinfard M. A., Esnaashari S., Seifalian A. M., et al. . (2017). Biocompatibility and nanostructured materials: applications in nanomedicine. Artif. Cells Nanomed. Biotechnol. 45, 833–842. 10.1080/21691401.2016.1178134 - DOI - PubMed
    1. Agrahari V., Hiremath P. (2017). Challenges associated and approaches for successful translation of nanomedicines into commercial products. Nanomedicine 12, 819–823. 10.2217/nnm-2017-0039 - DOI - PubMed
    1. Albanese A., Tang P. S., Chan W. C. (2012). The effect of nanoparticle size, shape, and surface chemistry on biological systems. Annu. Rev. Biomed. Eng.14, 1–16. 10.1146/annurev-bioeng-071811-150124 - DOI - PubMed
    1. Arora S., Rajwade J. M., Paknikar K. M. (2012). Nanotoxicology and in vitro studies: the need of the hour. Toxicol. Appl. Pharmacol. 258, 151–165. 10.1016/j.taap.2011.11.010 - DOI - PubMed
    1. Arts J. H., Hadi M., Keene A. M., Kreiling R., Lyon D., Maier M., et al. . (2014). A critical appraisal of existing concepts for the grouping of nanomaterials. Regul. Toxicol. Pharmacol. 70, 492–506. 10.1016/j.yrtph.2014.07.025 - DOI - PubMed

LinkOut - more resources