Differences in Physico-Chemical Properties and Immunological Response in Nanosimilar Complex Drugs: The Case of Liposomal Doxorubicin
This study aims to highlight the impact of physicochemical properties on the behaviour of nanopharmaceuticals and how much carrier structure and physiochemical characteristics weigh on the effects of a formulation. For this purpose, two commercially available nanosimilar formulations of Doxil and th...
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Language: | English |
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MDPI AG
2023-09-01
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Online Access: | https://www.mdpi.com/1422-0067/24/17/13612 |
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author | Dorelia Lipsa Davide Magrì Giacomo Della Camera Rita La Spina Claudia Cella Irantzu Garmendia-Aguirre Dora Mehn Ana Ruiz-Moreno Francesco Fumagalli Luigi Calzolai Sabrina Gioria |
author_facet | Dorelia Lipsa Davide Magrì Giacomo Della Camera Rita La Spina Claudia Cella Irantzu Garmendia-Aguirre Dora Mehn Ana Ruiz-Moreno Francesco Fumagalli Luigi Calzolai Sabrina Gioria |
author_sort | Dorelia Lipsa |
collection | DOAJ |
description | This study aims to highlight the impact of physicochemical properties on the behaviour of nanopharmaceuticals and how much carrier structure and physiochemical characteristics weigh on the effects of a formulation. For this purpose, two commercially available nanosimilar formulations of Doxil and their respective carriers were compared as a case study. Although the two formulations were “similar”, we detected different toxicological effects (profiles) in terms of in vitro toxicity and immunological responses at the level of cytokines release and complement activation (iC3b fragment), that could be correlated with the differences in the physicochemical properties of the formulations. Shedding light on nanosimilar key quality attributes of liposome-based materials and the need for an accurate characterization, including investigation of the immunological effects, is of fundamental importance considering their great potential as delivery system for drugs, genes, or vaccines and the growing market demand. |
first_indexed | 2024-03-10T23:20:52Z |
format | Article |
id | doaj.art-c4b710bbea1e4a89829d9ce94e0013e6 |
institution | Directory Open Access Journal |
issn | 1661-6596 1422-0067 |
language | English |
last_indexed | 2024-03-10T23:20:52Z |
publishDate | 2023-09-01 |
publisher | MDPI AG |
record_format | Article |
series | International Journal of Molecular Sciences |
spelling | doaj.art-c4b710bbea1e4a89829d9ce94e0013e62023-11-19T08:19:49ZengMDPI AGInternational Journal of Molecular Sciences1661-65961422-00672023-09-0124171361210.3390/ijms241713612Differences in Physico-Chemical Properties and Immunological Response in Nanosimilar Complex Drugs: The Case of Liposomal DoxorubicinDorelia Lipsa0Davide Magrì1Giacomo Della Camera2Rita La Spina3Claudia Cella4Irantzu Garmendia-Aguirre5Dora Mehn6Ana Ruiz-Moreno7Francesco Fumagalli8Luigi Calzolai9Sabrina Gioria10European Commission, Joint Research Centre (JRC), 21027 Ispra, ItalyEuropean Commission, Joint Research Centre (JRC), 21027 Ispra, ItalyEuropean Commission, Joint Research Centre (JRC), 21027 Ispra, ItalyEuropean Commission, Joint Research Centre (JRC), 21027 Ispra, ItalyEuropean Commission, Joint Research Centre (JRC), 21027 Ispra, ItalyEuropean Commission, Joint Research Centre (JRC), 21027 Ispra, ItalyEuropean Commission, Joint Research Centre (JRC), 21027 Ispra, ItalyEuropean Commission, Joint Research Centre (JRC), 21027 Ispra, ItalyEuropean Commission, Joint Research Centre (JRC), 21027 Ispra, ItalyEuropean Commission, Joint Research Centre (JRC), 21027 Ispra, ItalyEuropean Commission, Joint Research Centre (JRC), 21027 Ispra, ItalyThis study aims to highlight the impact of physicochemical properties on the behaviour of nanopharmaceuticals and how much carrier structure and physiochemical characteristics weigh on the effects of a formulation. For this purpose, two commercially available nanosimilar formulations of Doxil and their respective carriers were compared as a case study. Although the two formulations were “similar”, we detected different toxicological effects (profiles) in terms of in vitro toxicity and immunological responses at the level of cytokines release and complement activation (iC3b fragment), that could be correlated with the differences in the physicochemical properties of the formulations. Shedding light on nanosimilar key quality attributes of liposome-based materials and the need for an accurate characterization, including investigation of the immunological effects, is of fundamental importance considering their great potential as delivery system for drugs, genes, or vaccines and the growing market demand.https://www.mdpi.com/1422-0067/24/17/13612Doxildoxorubicinsafety assessmentnanomedicinesparticle size distributionliposome |
spellingShingle | Dorelia Lipsa Davide Magrì Giacomo Della Camera Rita La Spina Claudia Cella Irantzu Garmendia-Aguirre Dora Mehn Ana Ruiz-Moreno Francesco Fumagalli Luigi Calzolai Sabrina Gioria Differences in Physico-Chemical Properties and Immunological Response in Nanosimilar Complex Drugs: The Case of Liposomal Doxorubicin International Journal of Molecular Sciences Doxil doxorubicin safety assessment nanomedicines particle size distribution liposome |
title | Differences in Physico-Chemical Properties and Immunological Response in Nanosimilar Complex Drugs: The Case of Liposomal Doxorubicin |
title_full | Differences in Physico-Chemical Properties and Immunological Response in Nanosimilar Complex Drugs: The Case of Liposomal Doxorubicin |
title_fullStr | Differences in Physico-Chemical Properties and Immunological Response in Nanosimilar Complex Drugs: The Case of Liposomal Doxorubicin |
title_full_unstemmed | Differences in Physico-Chemical Properties and Immunological Response in Nanosimilar Complex Drugs: The Case of Liposomal Doxorubicin |
title_short | Differences in Physico-Chemical Properties and Immunological Response in Nanosimilar Complex Drugs: The Case of Liposomal Doxorubicin |
title_sort | differences in physico chemical properties and immunological response in nanosimilar complex drugs the case of liposomal doxorubicin |
topic | Doxil doxorubicin safety assessment nanomedicines particle size distribution liposome |
url | https://www.mdpi.com/1422-0067/24/17/13612 |
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