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Nanomedicinal products: a survey on specific toxicity and side effects.
Brand, Walter; Noorlander, Cornelle W; Giannakou, Christina; De Jong, Wim H; Kooi, Myrna W; Park, Margriet Vdz; Vandebriel, Rob J; Bosselaers, Irene Em; Scholl, Joep Hg; Geertsma, Robert E.
Afiliación
  • Brand W; Centre for Safety of Substances and Products.
  • Noorlander CW; Centre for Safety of Substances and Products.
  • Giannakou C; Centre for Health Protection, National Institute for Public Health and the Environment (RIVM), Bilthoven.
  • De Jong WH; Department of Toxicogenomics, Maastricht University, Maastricht.
  • Kooi MW; Centre for Health Protection, National Institute for Public Health and the Environment (RIVM), Bilthoven.
  • Park MV; Centre for Safety of Substances and Products.
  • Vandebriel RJ; Centre for Health Protection, National Institute for Public Health and the Environment (RIVM), Bilthoven.
  • Bosselaers IE; Centre for Health Protection, National Institute for Public Health and the Environment (RIVM), Bilthoven.
  • Scholl JH; Section Pharmacology, Toxicology and Pharmacokinetics, Medicines Evaluation Board (CBG-MEB), Utrecht.
  • Geertsma RE; Research & Analysis Department, Netherlands Pharmacovigilance Centre Lareb, 's-Hertogenbosch, the Netherlands.
Int J Nanomedicine ; 12: 6107-6129, 2017.
Article en En | MEDLINE | ID: mdl-28883724
Due to their specific properties and pharmacokinetics, nanomedicinal products (NMPs) may present different toxicity and side effects compared to non-nanoformulated, conventional medicines. To facilitate the safety assessment of NMPs, we aimed to gain insight into toxic effects specific for NMPs by systematically analyzing the available toxicity data on approved NMPs in the European Union. In addition, by comparing five sets of products with the same active pharmaceutical ingredient (API) in a conventional formulation versus a nanoformulation, we aimed to identify any side effects specific for the nano aspect of NMPs. The objective was to investigate whether specific toxicity could be related to certain structural types of NMPs and whether a nanoformulation of an API altered the nature of side effects of the product in humans compared to a conventional formulation. The survey of toxicity data did not reveal nanospecific toxicity that could be related to certain types of structures of NMPs, other than those reported previously in relation to accumulation of iron nanoparticles (NPs). However, given the limited data for some of the product groups or toxicological end points in the analysis, conclusions with regard to (a lack of) potential nanomedicine-specific effects need to be considered carefully. Results from the comparison of side effects of five sets of drugs (mainly liposomes and/or cytostatics) confirmed the induction of pseudo-allergic responses associated with specific NMPs in the literature, in addition to the side effects common to both nanoformulations and regular formulations, eg, with liposomal doxorubicin, and possibly liposomal daunorubicin. Based on the available data, immunotoxicological effects of certain NMPs cannot be excluded, and we conclude that this end point requires further attention.
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Nanoestructuras Tipo de estudio: Systematic_reviews Límite: Humans Idioma: En Revista: Int J Nanomedicine Año: 2017 Tipo del documento: Article Pais de publicación: Nueva Zelanda
Texto completo
Añadir a Mi BVS
Imprimir
XML
PubMed Links
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Nanoestructuras Tipo de estudio: Systematic_reviews Límite: Humans Idioma: En Revista: Int J Nanomedicine Año: 2017 Tipo del documento: Article Pais de publicación: Nueva Zelanda