Abstract
As nanomedicines have the potential to address many currently unmet medical needs, the early identification of regulatory requirements that could hamper a smooth translation of nanomedicines from the laboratory environment to clinical applications is of utmost importance. The blood system is especially relevant as many nanomedicinal products that are currently under development are designed for intravenous administration and cells of the blood system will be among the first biological systems exposed to the injected nanomedicine. This review collects and summarizes the current knowledge related to the blood compatibility of nanomedicines and nanomaterials with a potential use in biomedical applications. Different types of nanomedicines were analyzed for their toxicity to the blood system, and the role of their physicochemical properties was further elucidated. Trends were identified related to: (a) the nature of the most frequently occurring blood incompatibilities such as thrombogenicity and complement activation, (b) the contribution of physicochemical properties to these blood incompatibilities, and (c) the similarities between data retrieved from in vivo and in vitro studies. Finally, we provide an overview of available standards that allow evaluating the compatibility of a material with the blood system.This article is categorized under: Toxicology and Regulatory Issues in Nanomedicine > Toxicology of NanomaterialsTherapeutic Approaches and Drug Discovery > Emerging TechnologiesToxicology and Regulatory Issues in Nanomedicine > Regulatory and Policy Issues in Nanomedicine
Highlights
The advantages of applying nanotechnology in the medical field have been extensively reviewed (Kaur et al, 2014) and the potential of nanomedicines raises many hopes to address unmet medical needs, as defined by the WHO in its report on priority medicines for Europe (Kaplan et al, 2013)
Our results indicate that some nanomaterials have more frequently been linked with specific blood incompatibilities in literature: the main toxicity associated with inorganic nanoparticles is thrombosis, whereas complement activation is the most reported blood toxicity linked to lipid-based nanoparticles
The use of some assays commonly used in literature, such as measuring activated partial thromboplastin time, prothrombin time, and thrombin time are not recommended by International Organization for Standardization (ISO) 10993-4; since they do have some limitations, for example, they assess coagulation in isolation, whereas in vivo these pathways are closely interlinked (Curry & Pierce, 2007)
Summary
A link between the physicochemical properties of the nanomaterial and the toxicological outcome at the cellular level has already been proposed in literature (Hall, Dobrovolskaia, Patri, & McNeil, 2007; Mayer et al, 2009); but only a limited amount of preclinical in vivo data with effects on the blood system has been published Different characteristics such as size, particle structure, shape, and surface chemistry have been suggested as drivers of the biological behaviour of nanoparticles (Nel, 2013; Fadeel, 2013; Fadeel & Garcia-Bennett, 2010). Thrombosis in vivo has been associated with NPs properties such as surface chemistry, size, surface charge, and chemical entity These properties were identified as key physicochemical parameters from in vitro data related to alterations in the coagulation and platelets. Methods proposed in these guidelines include: complete cell count, the evaluation of erythrocytes morphology, determination
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