Patel Parmi, Shah Jigna
Department of Pharmacology, Institute of Pharmacy, Nirma University, Ahmedabad, Gujrat, 382481, India.
Curr Clin Pharmacol. 2017;12(2):73-82. doi: 10.2174/1574884712666170509161252.
Nanomedicine, an emerging nanotechnology, imparts special biological features due to its quantum size and is a promising candidate for targeted drug delivery. At present, in spite of its novel applications in medical sciences, certain existing gaps still need to be addressed such as fate of nanoparticles and its toxicity assessment on human health. Behaviour of the entities post human body exposure and its deposition up to certain extent are some of the crucial factors to be considered for a successful treatment approach. Also, safety evaluation applicable for nanomedicine would be drastically different from bulk of drugs due to variation in size and they may respond differently depending upon their property. Due to inadequacy of data, multidisciplinary studies are being encouraged to understand toxicity of nanomedicines and adopt specific testing procedures or modifications in nanomaterials for safe design of nanomedicines. The current review offers a comprehensive understanding on the pressing need of toxicological assessment of nanomedicines, underlying challenges, future prospects followed by regulatory aspects. In a nutshell, the present review aims to provide a thorough compilation and regressive analysis onto safety and toxicity considerations of nanomedicines.
Extensive review of literature was conducted from electronic databases such as Medline and EMBASE and other bibliographies. The database was searched for articles from 1974-2017 using search terms "nanomedicines, toxicological assessment, and physicochemical parameters." Various regulatory websites (USFDA, EMA, MHRA, NANoREG, NNI) were also referred regarding the current updates on regulatory framework for nanomedicine.
Over 200 articles were identified and referred from which relevant data was selected to be included in the current review. The outcome of the review suggests the presence of existing gaps in the knowledge of toxicity assessment of nanomedicines and it also defines specific areas which should be addressed in the near future.
While nanotechnology has gained immense popularity in the research industry due to its improved efficacy compared to traditional counterparts, toxicological considerations and their regulations need to be elucidated. A strategic approach towards toxicological assessment of nanomedicine within the standard set of framework will not only motivate more research on the technology but it will also stir up the conventional drug delivery system.
纳米医学作为一种新兴的纳米技术，因其量子尺寸而具有特殊的生物学特性，是靶向药物递送的一个有前景的候选者。目前，尽管其在医学科学中有新颖的应用，但仍存在一些现有差距需要解决，例如纳米颗粒的命运及其对人类健康的毒性评估。人体暴露后这些实体的行为及其在一定程度上的沉积是成功治疗方法需要考虑的一些关键因素。此外，由于尺寸的变化，适用于纳米医学的安全性评估与大多数药物将有很大不同，并且它们可能因其性质而有不同反应。由于数据不足，鼓励进行多学科研究以了解纳米医学的毒性，并采用特定的测试程序或对纳米材料进行改性以实现纳米医学的安全设计。本综述全面阐述了纳米医学毒理学评估的迫切需求、潜在挑战、未来前景以及监管方面。简而言之，本综述旨在对纳米医学的安全性和毒性考量进行全面的汇编和回归分析。
从电子数据库如Medline、EMBASE及其他参考文献中进行广泛的文献综述。使用搜索词“纳米医学、毒理学评估和物理化学参数”在数据库中搜索1974 - 2017年的文章。还参考了各种监管网站（美国食品药品监督管理局、欧洲药品管理局、英国药品和健康产品管理局、纳米监管、纳米技术创新网络）关于纳米医学监管框架的当前更新情况。
识别并参考了200多篇文章，从中选择相关数据纳入本综述。综述结果表明，在纳米医学毒性评估知识方面存在现有差距，并且还确定了近期应解决的特定领域。
虽然纳米技术因其与传统技术相比提高的疗效而在研究行业中获得了极大的普及，但毒理学考量及其监管需要阐明。在标准框架内对纳米医学进行毒理学评估的战略方法不仅将推动对该技术的更多研究，还将搅动传统药物递送系统。
