Biodegradation, biodistribution and toxicity of chitosan
Abstract
Chitosan is a natural polysaccharide that has attracted significant scientific interest during the last two decades. It is a potentially biologically compatible material that is chemically versatile (-NH2 groups and various M(w)). These two basic properties have been used by drug delivery and tissue engineering scientists to create a plethora of formulations and scaffolds that show promise in healthcare. Despite the high number of published studies, chitosan is not approved by the FDA for any product in drug delivery, and as a consequence very few biotech companies are using this material. This review will aim to provide information on these biological properties that affect chitosan's safe use in drug delivery. The term "Chitosan" represents a large group of structurally different chemical entities that may show different biodistribution, biodegradation and toxicological profiles. Here we aim to review research in this area and critically discuss chitosan's potential to be used as a generally regarded as safe (GRAS) material.
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Practical limitations of chitosan include variability in molecular weight and degree of deacetylation due to natural sourcing from shellfish, as well as regulatory hurdles.
“However, practical limitations include variability in molecular weight and degree of deacetylation due to its natural sourcing from shellfish, as well as regulatory hurdles.”
From Biomaterials in Postoperative Adhesion Barriers and Uterine Tissue Engineering (2025) · cites this paper as [149]
Although chitosan is classified as Generally Recognized as Safe by the U.S. FDA for certain food applications, its medical-grade use requires rigorous purification to meet endotoxin, sterility, and biocompatibility standards, which can complicate clinical translation.
“Although chitosan is classified as Generally Recognized as Safe (GRAS) by the U.S. FDA for certain food applications, its medical-grade use—especially in injectable or implantable products—requires rigorous purification to meet endotoxin, sterility, and biocompatibility standards, which can complicate its clinical translation [149].”
From Biomaterials in Postoperative Adhesion Barriers and Uterine Tissue Engineering (2025) · cites this paper as [149]
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- Authors
- Kean, T., & Thanou, M.
- Affiliations
- Case Western Reserve University (US)
- King's College London (GB)
- Corresponding author
- Thanou, M.
- ORCID
- Venue
- Advanced Drug Delivery Reviews
- Publisher
- Elsevier BV
- Published
- 2010-01
- Volume
- 62
- Issue
- 1
- Pages
- 3-11
- ISSN
- 0169-409X (ISSN-L)
- OpenAlex
- W2154899729
- Cited by
- 1,837
- References
- 93
- Citations by year
- 2026: 90 · 2025: 112 · 2024: 124 · 2023: 127 · 2022: 143 · 2021: 158 · 2020: 148 · 2019: 148 · 2018: 115 · 2017: 123 · 2016: 113 · 2015: 110 · 2014: 80 · 2013: 80 · 2012: 80
- FWCI
- 5.65
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- Advanced Drug Delivery Reviews (publishedVersion)
- PubMed (publishedVersion)
- Research Portal (King's College London) (submittedVersion)
- Topics
- Life Sciences › Pharmacology, Toxicology and Pharmaceutics › Pharmaceutical Science › Advanced Drug Delivery Systems
- Physical Sciences › Materials Science › Biomaterials › Nanocomposite Films for Food Packaging
- Health Sciences › Medicine › Surgery › Tissue Engineering and Regenerative Medicine
- Keywords
- chitosan, biodegradation, tissue distribution, toxicity, drug delivery, tissue engineering scaffolds, GRAS, FDA approval
- MeSH terms
- Animals, Biotransformation, Humans, Tissue Distribution, Drug Delivery Systems, Chitosan
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