Shela Salsabila, Miski Aghnia Khairinisa, Nasrul Wathoni, Irna Sufiawati, Wan Ezumi Mohd Fuad, Nur Kusaira Khairul Ikram, Muchtaridi Muchtaridi
{"title":"<i>In vivo</i> toxicity of chitosan-based nanoparticles: a systematic review.","authors":"Shela Salsabila, Miski Aghnia Khairinisa, Nasrul Wathoni, Irna Sufiawati, Wan Ezumi Mohd Fuad, Nur Kusaira Khairul Ikram, Muchtaridi Muchtaridi","doi":"10.1080/21691401.2025.2462328","DOIUrl":null,"url":null,"abstract":"<p><p>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 <i>in vivo</i> 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.</p>","PeriodicalId":8736,"journal":{"name":"Artificial Cells, Nanomedicine, and Biotechnology","volume":"53 1","pages":"1-15"},"PeriodicalIF":4.5000,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Artificial Cells, Nanomedicine, and Biotechnology","FirstCategoryId":"5","ListUrlMain":"https://doi.org/10.1080/21691401.2025.2462328","RegionNum":3,"RegionCategory":"生物学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2025/2/9 0:00:00","PubModel":"Epub","JCR":"Q1","JCRName":"BIOTECHNOLOGY & APPLIED MICROBIOLOGY","Score":null,"Total":0}
引用次数: 0
Abstract
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.
期刊介绍:
Artificial Cells, Nanomedicine and Biotechnology covers the frontiers of interdisciplinary research and application, combining artificial cells, nanotechnology, nanobiotechnology, biotechnology, molecular biology, bioencapsulation, novel carriers, stem cells and tissue engineering. Emphasis is on basic research, applied research, and clinical and industrial applications of the following topics:artificial cellsblood substitutes and oxygen therapeuticsnanotechnology, nanobiotecnology, nanomedicinetissue engineeringstem cellsbioencapsulationmicroencapsulation and nanoencapsulationmicroparticles and nanoparticlesliposomescell therapy and gene therapyenzyme therapydrug delivery systemsbiodegradable and biocompatible polymers for scaffolds and carriersbiosensorsimmobilized enzymes and their usesother biotechnological and nanobiotechnological approachesRapid progress in modern research cannot be carried out in isolation and is based on the combined use of the different novel approaches. The interdisciplinary research involving novel approaches, as discussed above, has revolutionized this field resulting in rapid developments. This journal serves to bring these different, modern and futuristic approaches together for the academic, clinical and industrial communities to allow for even greater developments of this highly interdisciplinary area.