Journal
EUROPEAN JOURNAL OF PHARMACEUTICS AND BIOPHARMACEUTICS
Volume 84, Issue 3, Pages 445-448Publisher
ELSEVIER SCIENCE BV
DOI: 10.1016/j.ejpb.2013.01.001
Keywords
Nanoparticles; Nanotoxicity; Nanotoxicology; Nanotoxicological classification system; NCS
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There is an increasing discussion about potential toxicity of nanoparticles (nanotoxicity). A classification system is proposed classifying the nanoparticles in four classes (I to IV) from low/no risk to high risk. It is based on the nanoparticle size (>/<100 nm) and size-related differences in interaction with human cells, and on biodegradability/non-biodegradability in the body. This classification is superimposed by biocompatibility (B) and non-biocompatibility (NB) of the nanoparticle surface, resulting in a total of eight classes from I-B (best tolerated) to IV-NB (highest potential risk). The classification should help as a guideline in pharmaceutical formulation development, but also as a guide for risk assessment in other product areas and environmental exposure. (C) 2013 Elsevier B.V. All rights reserved.
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