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Safety and Toxicological Considerations of Nanomedicines: The Future Directions

[ Vol. 12 , Issue. 2 ]


Parmi Patel and Jigna Shah* Pages 73-82 (10)


Background: 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.

Method: 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.

Results: 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.

Conclusion: 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.


Nanomedicine, nanoparticles, toxicity, toxicological assessment, physicochemical, parameters, regulatory.


Department of Pharmacology, Institute of Pharmacy, Nirma University, Ahmedabad, Gujrat, 382481, Department of Pharmacology, Institute of Pharmacy, Nirma University, Ahmedabad, Gujrat, 382481

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