Elsevier

Drug Discovery Today

Volume 26, Issue 11, November 2021, Pages 2502-2507
Drug Discovery Today

Feature
Brain safety concerns of nanomedicines: The need for a specific regulatory framework

https://doi.org/10.1016/j.drudis.2021.06.011Get rights and content

Highlights

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    Nanocarriers used in nanomedicines can end up in the brain.

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    Protein corona influences the crossing of blood–brain barrier by nanomedicines.

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    Standardized criteria for assessing brain toxicity of nanomedicines are required.

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    Discussions on the FDA and EMA regulatory framework for nanomedicines.

Abstract

There is growing interest in using nanomaterials as carriers for the delivery of drugs in diseases such as cancers and central nervous system (CNS) disorders. Although several nanomaterial-based products have been approved, the regulatory framework for their use in humans remains limited. Nanomedicines (NMs) are usually not designed to cross the blood–brain barrier (BBB). Given the lack of a comprehensive set of standardized methods to assess their in vivo fate, there is an urgent need to characterize NM biodistribution as well as the toxicity that could result from their interaction with the CNS. Here, we discuss the risks of potential unwanted BBB crossing and brain toxicity of nanocarriers (NCs), along with the safety assessment and current regulatory challenges related to NMs.

Section snippets

Acknowledgments

The authors would like to thank Maena Le Borgne and Christine Janssen for the realization of the figure of the article.

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