title: In vitro toxicity assessment of oral nanocarriers.
abstract: The fascinating properties of nanomaterials opened new frontiers in medicine. Nanocarriers are useful systems in transporting drugs to site-specific targets. The unique physico-chemical characteristics making nanocarriers promising devices to treat diseases may also be responsible for potential adverse effects. In order to develop functional nano-based drug delivery systems, efficacy and safety should be carefully evaluated. To date, no common testing strategy to address nanomaterial toxicological challenges has been generated. Different cell culture models are currently used to evaluate nanocarrier safety using conventional in vitro assays, but overall they have generated a huge amount of conflicting data. In this review we describe state-of-the-art approaches for in vitro testing of orally administered nanocarriers, highlighting the importance of developing harmonized and validated standard operating procedures. These procedures should be applied in a safe-by-design context with the aim to reduce and/or eliminate the uncertainties and risks associated with nanomedicine development.
authors.affiliation: ECSIN-European Center for the Sustainable Impact of Nanotechnology, ECAMRICERT SRL, Viale Porta Adige 45, I-45100 Rovigo, Italy.
authors.forename: Silvia Gabriella
authors.initials: SG
authors.lastname: Ciappellano
authors.affiliation: ECSIN-European Center for the Sustainable Impact of Nanotechnology, ECAMRICERT SRL, Viale Porta Adige 45, I-45100 Rovigo, Italy.
authors.forename: Erik
authors.initials: E
authors.lastname: Tedesco
authors.affiliation: ECSIN-European Center for the Sustainable Impact of Nanotechnology, ECAMRICERT SRL, Viale Porta Adige 45, I-45100 Rovigo, Italy.
authors.forename: Marco
authors.initials: M
authors.lastname: Venturini
authors.affiliation: ECSIN-European Center for the Sustainable Impact of Nanotechnology, ECAMRICERT SRL, Viale Porta Adige 45, I-45100 Rovigo, Italy. Electronic address: f.benetti@ecamricert.com.
authors.forename: Federico
authors.initials: F
authors.lastname: Benetti
mesh_terms: D000818:Animals; D018929:Cell Culture Techniques / Q000379:methods; D004337:Drug Carriers / Q000008:administration & dosage* / Q000009:adverse effects / Q000633:toxicity*; D006801:Humans; D066298:In Vitro Techniques / Q000379:methods*; D050997:Nanomedicine / Q000379:methods* / Q000592:standards*; D049329:Nanostructures / Q000008:administration & dosage* / Q000009:adverse effects / Q000633:toxicity*
chemical_list: D004337:Drug Carriers
keywords: Drug delivery systems; In vitro assay interferences; In vitro models; In vitro testing; Nanomedicine; Nanotoxicology; Safe-by-Design; Standard operating procedures