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.

人们越来越关注使用纳米材料作为载体在癌症和中枢神经系统 (CNS) 疾病等疾病中递送药物。尽管已经批准了几种基于纳米材料的产品，但用于人类的监管框架仍然有限。纳米药物 (NM) 通常不设计用于穿过血脑屏障 (BBB)。鉴于缺乏一套全面的标准化方法来评估它们的体内命运，迫切需要描述 NM 的生物分布以及它们与 CNS 相互作用可能产生的毒性。在这里，我们讨论了纳米载体 (NCs) 潜在有害 BBB 交叉和脑毒性的风险，以及与 NMs 相关的安全性评估和当前监管挑战。