title: Nanotoxicological classification system (NCS) - a guide for the risk-benefit assessment of nanoparticulate drug delivery systems.
abstract: 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.
authors: Department of Pharmaceutics, Biopharmaceutics & NutriCosmetics, Freie Universität Berlin, Berlin, Germany. ck@ckc-berlin.de
authors: Cornelia M
authors: CM
authors: Keck
authors: Rainer H
authors: RH
authors: Müller
mesh_terms: D002626:Chemistry, Pharmaceutical / Q000379:methods; D016503:Drug Delivery Systems / Q000145:classification*; D015195:Drug Design; D006801:Humans; D050997:Nanomedicine / Q000379:methods*; D053758:Nanoparticles / Q000737:chemistry* / Q000145:classification* / Q000633:toxicity; D036103:Nanotechnology / Q000379:methods*; D010316:Particle Size; D018570:Risk Assessment; D013499:Surface Properties