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A comparison of immunotoxic effects of nanomedicinal products with regulatory immunotoxicity testing requirements
Nanomaterials (NMs) are attractive for biomedical and pharmaceutical applications because of their unique physicochemical and biological properties. A major application area of NMs is drug delivery. Many nanomedicinal products (NMPs) currently on the market or in clinical trials are most often based...
Autores principales: | , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
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Dove Medical Press
2016
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4922791/ https://www.ncbi.nlm.nih.gov/pubmed/27382281 http://dx.doi.org/10.2147/IJN.S102385 |
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author | Giannakou, Christina Park, Margriet VDZ de Jong, Wim H van Loveren, Henk Vandebriel, Rob J Geertsma, Robert E |
author_facet | Giannakou, Christina Park, Margriet VDZ de Jong, Wim H van Loveren, Henk Vandebriel, Rob J Geertsma, Robert E |
author_sort | Giannakou, Christina |
collection | PubMed |
description | Nanomaterials (NMs) are attractive for biomedical and pharmaceutical applications because of their unique physicochemical and biological properties. A major application area of NMs is drug delivery. Many nanomedicinal products (NMPs) currently on the market or in clinical trials are most often based on liposomal products or polymer conjugates. NMPs can be designed to target specific tissues, eg, tumors. In virtually all cases, NMPs will eventually reach the immune system. It has been shown that most NMs end up in organs of the mononuclear phagocytic system, notably liver and spleen. Adverse immune effects, including allergy, hypersensitivity, and immunosuppression, have been reported after NMP administration. Interactions of NMPs with the immune system may therefore constitute important side effects. Currently, no regulatory documents are specifically dedicated to evaluate the immunotoxicity of NMs or NMPs. Their immunotoxicity assessment is performed based on existing guidelines for conventional substances or medicinal products. Due to the unique properties of NMPs when compared with conventional medicinal products, it is uncertain whether the currently prescribed set of tests provides sufficient information for an adequate evaluation of potential immunotoxicity of NMPs. The aim of this study was therefore, to compare the current regulatory immunotoxicity testing requirements with the accumulating knowledge on immunotoxic effects of NMPs in order to identify potential gaps in the safety assessment. This comparison showed that immunotoxic effects, such as complement activation-related pseudoallergy, myelosuppression, inflammasome activation, and hypersensitivity, are not readily detected by using current testing guidelines. Immunotoxicity of NMPs would be more accurately evaluated by an expanded testing strategy that is equipped to stratify applicable testing for the various types of NMPs. |
format | Online Article Text |
id | pubmed-4922791 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2016 |
publisher | Dove Medical Press |
record_format | MEDLINE/PubMed |
spelling | pubmed-49227912016-07-05 A comparison of immunotoxic effects of nanomedicinal products with regulatory immunotoxicity testing requirements Giannakou, Christina Park, Margriet VDZ de Jong, Wim H van Loveren, Henk Vandebriel, Rob J Geertsma, Robert E Int J Nanomedicine Review Nanomaterials (NMs) are attractive for biomedical and pharmaceutical applications because of their unique physicochemical and biological properties. A major application area of NMs is drug delivery. Many nanomedicinal products (NMPs) currently on the market or in clinical trials are most often based on liposomal products or polymer conjugates. NMPs can be designed to target specific tissues, eg, tumors. In virtually all cases, NMPs will eventually reach the immune system. It has been shown that most NMs end up in organs of the mononuclear phagocytic system, notably liver and spleen. Adverse immune effects, including allergy, hypersensitivity, and immunosuppression, have been reported after NMP administration. Interactions of NMPs with the immune system may therefore constitute important side effects. Currently, no regulatory documents are specifically dedicated to evaluate the immunotoxicity of NMs or NMPs. Their immunotoxicity assessment is performed based on existing guidelines for conventional substances or medicinal products. Due to the unique properties of NMPs when compared with conventional medicinal products, it is uncertain whether the currently prescribed set of tests provides sufficient information for an adequate evaluation of potential immunotoxicity of NMPs. The aim of this study was therefore, to compare the current regulatory immunotoxicity testing requirements with the accumulating knowledge on immunotoxic effects of NMPs in order to identify potential gaps in the safety assessment. This comparison showed that immunotoxic effects, such as complement activation-related pseudoallergy, myelosuppression, inflammasome activation, and hypersensitivity, are not readily detected by using current testing guidelines. Immunotoxicity of NMPs would be more accurately evaluated by an expanded testing strategy that is equipped to stratify applicable testing for the various types of NMPs. Dove Medical Press 2016-06-22 /pmc/articles/PMC4922791/ /pubmed/27382281 http://dx.doi.org/10.2147/IJN.S102385 Text en © 2016 Giannakou et al. This work is published and licensed by Dove Medical Press Limited The full terms of this license are available at https://www.dovepress.com/terms.php and incorporate the Creative Commons Attribution – Non Commercial (unported, v3.0) License (http://creativecommons.org/licenses/by-nc/3.0/). By accessing the work you hereby accept the Terms. Non-commercial uses of the work are permitted without any further permission from Dove Medical Press Limited, provided the work is properly attributed. |
spellingShingle | Review Giannakou, Christina Park, Margriet VDZ de Jong, Wim H van Loveren, Henk Vandebriel, Rob J Geertsma, Robert E A comparison of immunotoxic effects of nanomedicinal products with regulatory immunotoxicity testing requirements |
title | A comparison of immunotoxic effects of nanomedicinal products with regulatory immunotoxicity testing requirements |
title_full | A comparison of immunotoxic effects of nanomedicinal products with regulatory immunotoxicity testing requirements |
title_fullStr | A comparison of immunotoxic effects of nanomedicinal products with regulatory immunotoxicity testing requirements |
title_full_unstemmed | A comparison of immunotoxic effects of nanomedicinal products with regulatory immunotoxicity testing requirements |
title_short | A comparison of immunotoxic effects of nanomedicinal products with regulatory immunotoxicity testing requirements |
title_sort | comparison of immunotoxic effects of nanomedicinal products with regulatory immunotoxicity testing requirements |
topic | Review |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4922791/ https://www.ncbi.nlm.nih.gov/pubmed/27382281 http://dx.doi.org/10.2147/IJN.S102385 |
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