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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Main Authors: 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
Format: Article
Language:English
Published: MDPI AG 2023-09-01
Series:International Journal of Molecular Sciences
Subjects:
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.
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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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