Title
Clinical toxicities of nanocarrier systems
Date Issued
22 May 2008
Access level
metadata only access
Resource Type
review
Author(s)
Abstract
Toxicity of nanocarrier systems involves physiological, physicochemical, and molecular considerations. Nanoparticle exposures through the skin, the respiratory tract, the gastrointestinal tract and the lymphatics have been described. Nanocarrier systems may induce cytotoxicity and/or genotoxicity, whereas their antigenicity is still not well understood. Nanocarrier may alter the physicochemical properties of xenobiotics resulting in pharmaceutical changes in stability, solubility, and pharmacokinetic disposition. In particular, nanocarriers may reduce toxicity of hydrophobic cancer drugs that are solubilized. Nano regulation is still undergoing major changes to encompass environmental, health, and safety issues. The rapid commercialization of nanotechnology requires thoughtful environmental, health and safety research, meaningful, and an open discussion of broader societal impacts, and urgent toxicological oversight action. © 2008 Elsevier B.V. All rights reserved.
Start page
929
End page
938
Volume
60
Issue
8
Language
English
OCDE Knowledge area
Farmacología, Farmacia
Toxicología
Subjects
Scopus EID
2-s2.0-42649126357
PubMed ID
Source
Advanced Drug Delivery Reviews
ISSN of the container
0169409X
Sponsor(s)
The lack of toxicology data on nanocarrier systems hinders governmental regulation [2,3,11,34,62–64] . Currently, no regulatory requirement to test nanoparticles for health, safety, and environmental impacts has been formalized [65] . The Food and Drug Administration (FDA) was the main governmental entity entitled to regulate nanocarrier systems through the Center for Drug Evaluation and Research (CDER), the Center for Biologics Evaluation and Research (CBER), and the Center for Devices and Radiological Health (CDRH) since their appearance in the late 1990s [62] . The Environmental Protection Agency (EPA), the Department of Labor through the Occupational Safety and Health Administration (OSHA), the National Institute for Occupational Safety and Health (NIOSH), and the FDA have also participated since 2000 in the National Nanotechnology Initiative (NNI) approved by President Bill Clinton who nearly doubled governmental funding for nanotechnology [3,8,63,64] . The NNI is a federal research and development programme established in 1996 to coordinate governmental multiagency efforts in nanoscale science, engineering, and technology [3,8,65] . From 2000 to 2004, the NNI coordinated 3.2 billion dollars in grant money among the National Science Foundation (NSF), the Department of Defense (DOD), the Department of Energy (DOE), the National Institute of Health (NIH), the National Aeronautics and Space Administration (NASA), the National Institute of Standards and Technology (NIST), OSHA, FDA, EPA, and NIOSH for nanotechnology research [3,8,65] . The NNI budget request for 2008 is of 1.5 billion dollars, almost triple the estimated 464 million dollars spent in 2001 [3,8,65] . A substantial portion of the funding will go to the American Competitiveness Initiative (ACI), of which NSF, DOE, and NIST are all part of [3,8,65] . Currently, 26 federal agencies participate in the NNI, 13 of which have budgets for nanotechnology research and development coordinated through the Nanoscale Science, Engineering, and Technology (NSET) subcommittee of the National Science and Technology Council (NSTC) [65] . In addition to the departments and agencies previously listed, the Consumer Product Safety Commission (CPSC), the Department of Agriculture (USDA) through the Cooperative State, Research, Education, and Extension Service (CSREES), the Department of Commerce's Bureau of Industry and Security Technology Administration (BISTA), the Department of Education, the Department of Homeland Security (DHS), the Department of Justice (DOJ), the Department of Labor (DOL), the Department of State (DOS), the Department of Transportation (DOT), the Department of Treasury, the Intelligence Community, the International Trade Commission (ITC), the Nuclear Regulatory Commission (NRC), and the Patent and Trademark Office (PTO) participate in the NNI [3,8,65] .
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