In vivo toxicity of chitosan-based nanoparticles: a systematic review

Chitosan nanoparticles have been extensively utilised as polymeric drug carriers in nanoparticles formulations due to their potential to enhance drug delivery, efficacy, and safety. Numerous toxicity studies have been previously conducted to assess the safety profile of chitosan-based nanoparticles....

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Main Authors: Shela Salsabila, Miski Aghnia Khairinisa, Nasrul Wathoni, Irna Sufiawati, Wan Ezumi Mohd Fuad, Nur Kusaira Khairul Ikram, Muchtaridi Muchtaridi
Format: Article
Language:English
Published: Taylor & Francis Group 2025-12-01
Series:Artificial Cells, Nanomedicine, and Biotechnology
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Online Access:https://www.tandfonline.com/doi/10.1080/21691401.2025.2462328
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author Shela Salsabila
Miski Aghnia Khairinisa
Nasrul Wathoni
Irna Sufiawati
Wan Ezumi Mohd Fuad
Nur Kusaira Khairul Ikram
Muchtaridi Muchtaridi
author_facet Shela Salsabila
Miski Aghnia Khairinisa
Nasrul Wathoni
Irna Sufiawati
Wan Ezumi Mohd Fuad
Nur Kusaira Khairul Ikram
Muchtaridi Muchtaridi
author_sort Shela Salsabila
collection DOAJ
description Chitosan nanoparticles have been extensively utilised as polymeric drug carriers in nanoparticles formulations due to their potential to enhance drug delivery, efficacy, and safety. Numerous toxicity studies have been previously conducted to assess the safety profile of chitosan-based nanoparticles. These toxicity studies employed various methodologies, including test animals, interventions, and different routes of administration. This review aims to summarise research on the safety profile of chitosan-based nanoparticles in drug delivery, with a focus on general toxicity tests to determine LD50 and NOAEL values. It can serve as a repository and reference for chitosan-based nanoparticles, facilitating future research and further development of drugs delivery system using chitosan nanoparticles. Publications from 2014 to 2024 were obtained from PubMed, Scopus, Google Scholar, and ScienceDirect, in accordance with the inclusion and exclusion criteria.The ARRIVE 2.0 guidelines were employed to evaluate the quality and risk-of-bias in the in vivo toxicity studies. The results demonstrated favourable toxicity profiles, often exhibiting reduced toxicity compared to free drugs or substances. Acute toxicity studies consistently reported high LD50 values, frequently exceeding 5000 mg/kg body weight, while subacute studies typically revealed no significant adverse effects. Various routes of administration varied, including oral, intravenous, intraperitoneal, inhalation, and topical, each demonstrating promising safety profiles.
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spelling doaj-art-ed2ec4dc3d1848198e99ed7ccd7bcce12025-08-20T02:38:13ZengTaylor & Francis GroupArtificial Cells, Nanomedicine, and Biotechnology2169-14012169-141X2025-12-0153111510.1080/21691401.2025.2462328In vivo toxicity of chitosan-based nanoparticles: a systematic reviewShela Salsabila0Miski Aghnia Khairinisa1Nasrul Wathoni2Irna Sufiawati3Wan Ezumi Mohd Fuad4Nur Kusaira Khairul Ikram5Muchtaridi Muchtaridi6Department of Pharmaceutical Analysis and Medicinal Chemistry, Faculty of Pharmacy, Padjadjaran University, Sumedang, IndonesiaDepartment of Pharmacology and Clinical Pharmacy, Faculty of Pharmacy, Padjadjaran University, Sumedang, IndonesiaDepartment of Pharmaceutics and Pharmaceutical Technology, Faculty of Pharmacy, Universitas Padjadjaran, Sumedang, IndonesiaDepartment of Oral Medicine, Faculty of Dentistry, Universitas Padjadjaran, Sumedang, IndonesiaProgramme of Biomedicine, School of Health Sciences, USM Health Campus, Kubang Kerian, Kelantan, MalaysiaInstitute of Biological Sciences, Faculty of Science, Universiti Malaya, Kuala Lumpur, MalaysiaDepartment of Pharmaceutical Analysis and Medicinal Chemistry, Faculty of Pharmacy, Padjadjaran University, Sumedang, IndonesiaChitosan nanoparticles have been extensively utilised as polymeric drug carriers in nanoparticles formulations due to their potential to enhance drug delivery, efficacy, and safety. Numerous toxicity studies have been previously conducted to assess the safety profile of chitosan-based nanoparticles. These toxicity studies employed various methodologies, including test animals, interventions, and different routes of administration. This review aims to summarise research on the safety profile of chitosan-based nanoparticles in drug delivery, with a focus on general toxicity tests to determine LD50 and NOAEL values. It can serve as a repository and reference for chitosan-based nanoparticles, facilitating future research and further development of drugs delivery system using chitosan nanoparticles. Publications from 2014 to 2024 were obtained from PubMed, Scopus, Google Scholar, and ScienceDirect, in accordance with the inclusion and exclusion criteria.The ARRIVE 2.0 guidelines were employed to evaluate the quality and risk-of-bias in the in vivo toxicity studies. The results demonstrated favourable toxicity profiles, often exhibiting reduced toxicity compared to free drugs or substances. Acute toxicity studies consistently reported high LD50 values, frequently exceeding 5000 mg/kg body weight, while subacute studies typically revealed no significant adverse effects. Various routes of administration varied, including oral, intravenous, intraperitoneal, inhalation, and topical, each demonstrating promising safety profiles.https://www.tandfonline.com/doi/10.1080/21691401.2025.2462328Drug-coatedchitosan nanoparticlestoxicityLD50NOAEL
spellingShingle Shela Salsabila
Miski Aghnia Khairinisa
Nasrul Wathoni
Irna Sufiawati
Wan Ezumi Mohd Fuad
Nur Kusaira Khairul Ikram
Muchtaridi Muchtaridi
In vivo toxicity of chitosan-based nanoparticles: a systematic review
Artificial Cells, Nanomedicine, and Biotechnology
Drug-coated
chitosan nanoparticles
toxicity
LD50
NOAEL
title In vivo toxicity of chitosan-based nanoparticles: a systematic review
title_full In vivo toxicity of chitosan-based nanoparticles: a systematic review
title_fullStr In vivo toxicity of chitosan-based nanoparticles: a systematic review
title_full_unstemmed In vivo toxicity of chitosan-based nanoparticles: a systematic review
title_short In vivo toxicity of chitosan-based nanoparticles: a systematic review
title_sort in vivo toxicity of chitosan based nanoparticles a systematic review
topic Drug-coated
chitosan nanoparticles
toxicity
LD50
NOAEL
url https://www.tandfonline.com/doi/10.1080/21691401.2025.2462328
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