Pandey Ramendra Pati, Vidic Jasmina, Mukherjee Riya, Chang Chung-Ming
Centre for Drug Design Discovery and Development (C4D), SRM University, Delhi-NCR, Rajiv Gandhi Education City, Sonepat 131 029, Haryana, India.
AgroParisTech, The Institut National de la Recherche Agronomique (INRAE), Micalis Institute, Université Paris-Saclay, 78350 Jouy-en-Josas, France.
Pharmaceutics. 2023 Feb 11;15(2):612. doi: 10.3390/pharmaceutics15020612.
Many novel medical therapies use nanoparticle-based drug delivery systems, including nanomaterials through drug delivery systems, diagnostics, or physiologically active medicinal products. The approval of nanoparticles with advanced therapeutic and diagnostic potentials for applications in medication and immunization depends strongly on their synthesizing procedure, efficiency of functionalization, and biological safety and biocompatibility. Nanoparticle biodistribution, absorption, bioavailability, passage across biological barriers, and biodistribution are frequently assessed using bespoke and biological models. These methods largely rely on in vitro cell-based evaluations that cannot predict the complexity involved in preclinical and clinical studies. Therefore, assessing the nanoparticle risk has to involve pharmacokinetics, organ toxicity, and drug interactions manifested at multiple cellular levels. At the same time, there is a need for novel approaches to examine nanoparticle safety risks due to increased constraints on animal exploitation and the demand for high-throughput testing. We focus here on biological evaluation methodologies that provide access to nanoparticle interactions with the organism (positive or negative via toxicity). This work aimed to provide a perception regarding the risks associated with the utilization of nanoparticle-based formulations with a particular focus on assays applied to assess the cytotoxicity of nanomaterials.
许多新型医学疗法使用基于纳米颗粒的药物递送系统，包括通过药物递送系统、诊断或生理活性药物产品使用纳米材料。具有先进治疗和诊断潜力的纳米颗粒在药物治疗和免疫接种中的应用批准，在很大程度上取决于其合成过程、功能化效率以及生物安全性和生物相容性。纳米颗粒的生物分布、吸收、生物利用度、穿越生物屏障以及生物分布情况，通常使用定制模型和生物模型进行评估。这些方法很大程度上依赖于基于体外细胞的评估，而这种评估无法预测临床前和临床研究中所涉及的复杂性。因此，评估纳米颗粒风险必须涉及药代动力学、器官毒性以及在多个细胞水平上表现出的药物相互作用。与此同时，由于对动物实验的限制增加以及对高通量测试的需求，需要新的方法来检测纳米颗粒的安全风险。我们在此重点关注能够提供纳米颗粒与生物体相互作用（通过毒性表现为正向或负向）的生物评估方法。这项工作旨在让人们了解使用基于纳米颗粒的制剂所带来的风险，尤其关注用于评估纳米材料细胞毒性的检测方法。
