Department of Pharmaceutics, Pratiksha Institute of Pharmaceutical Sciences, Guwahati, India.
J Appl Toxicol. 2021 Oct;41(10):1494-1517. doi: 10.1002/jat.4157. Epub 2021 Feb 28.
Nanotechnology, with its continuous advancement, leads to the development of nanoscale-level therapeutics to mitigate many complex diseases. This results in the emergence of numerous novel nanomaterials and its composite products into the market such as liposome, polymeric nanoparticles, dendrimers, and nanostructured lipid carrier. However, their application is always determined by a high benefit to risk ratio. Very few research have been done on the toxicity assessment of nanoparticles in the biological system; therefore, the limited knowledge regarding the toxicity profile of nanotherapeutics is available leading to the ignorance of its side effects. Nanoparticles can distribute in the whole body through translocating in the bloodstream by crossing membrane barriers efficiently and shows effect in organs and tissues at cellular and molecular levels. The interaction of nanoparticle with cell may consequences into nanotoxicity. The narrow size distribution, large surface area to mass ratio and surface properties of nanoparticle are significantly associated with nanotoxicity. Nanoparticles can enter into the tissue and cell by invading the membranes and cause cellular injury as well as toxicity. Therefore, the exploration of mechanisms of nanotoxicity has prime importance now a day. The toxicity assessment should be an integral part of the development of nanotherapeutics using various toxicity evaluation models. This review has focused on the exploration of different nanostructures for therapeutic delivery system along with its physicochemical characteristics responsible for adverse effects on human biology, various toxicity evaluation models, and environmental and regulatory hurdles.
纳米技术的不断进步，推动了纳米级疗法的发展，以减轻许多复杂疾病。这导致了许多新型纳米材料及其复合材料如脂质体、聚合物纳米粒子、树枝状大分子和纳米结构脂质载体进入市场。然而，它们的应用始终取决于高收益与风险的比率。关于纳米颗粒在生物系统中的毒性评估，很少有研究；因此，对于纳米治疗药物的毒性概况的了解有限，导致其副作用被忽视。纳米颗粒可以通过有效地穿过细胞膜屏障在血液中迁移而分布在全身，并在器官和组织中显示出细胞和分子水平的作用。纳米颗粒与细胞的相互作用可能导致纳米毒性。纳米颗粒的窄粒径分布、大的表面积与质量比和表面性质与纳米毒性显著相关。纳米颗粒可以通过侵入细胞膜进入组织和细胞，引起细胞损伤和毒性。因此，现在探索纳米毒性的机制至关重要。毒性评估应该是使用各种毒性评估模型开发纳米治疗药物的一个组成部分。本综述重点探讨了不同的纳米结构作为治疗性递药系统的应用，以及其对人类生物学产生不良影响的物理化学特性、各种毒性评估模型以及环境和监管障碍。
