A Review of Liposomes as a Drug Delivery System: Current Status of Approved Products, Regulatory Environments, and Future Perspectives
Open accessAbstract
Liposomes have been considered promising and versatile drug vesicles. Compared with traditional drug delivery systems, liposomes exhibit better properties, including site-targeting, sustained or controlled release, protection of drugs from degradation and clearance, superior therapeutic effects, and lower toxic side effects. Given these merits, several liposomal drug products have been successfully approved and used in clinics over the last couple of decades. In this review, the liposomal drug products approved by the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) are discussed. Based on the published approval package in the FDA and European public assessment report (EPAR) in EMA, the critical chemistry information and mature pharmaceutical technologies applied in the marketed liposomal products, including the lipid excipient, manufacturing methods, nanosizing technique, drug loading methods, as well as critical quality attributions (CQAs) of products, are introduced. Additionally, the current regulatory guidance and future perspectives related to liposomal products are summarized. This knowledge can be used for research and development of the liposomal drug candidates under various pipelines, including the laboratory bench, pilot plant, and commercial manufacturing.
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Liposomes can encapsulate both hydrophilic and hydrophobic molecules while offering biocompatibility, biodegradability, and protection against enzymatic degradation.
“Liposomes, composed of phospholipid bilayers surrounding an aqueous core, can encapsulate both hydrophilic and hydrophobic molecules while offering biocompatibility, biodegradability, and protection against enzymatic degradation [28].”
From Statins as Antifungal Agents: A Review on Drug Repurposing and Nanotechnology-Driven Delivery Strategies (2025) · cites this paper as [28]
The Introduction describes phospholipid bilayers enclosing an aqueous compartment and says liposomes are biocompatible and protect encapsulated substances from physiological degradation. Section 4.3 gives examples of drugs carried in the lipid bilayer and aqueous core. Our copy does not specifically describe liposomes as biodegradable or identify enzymatic degradation as the process they protect against. (LLM, conf=0.86)
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- Authors
- Liu, P., Chen, G., & Zhang, J.
- Affiliations
- Shanghai Center for Drug Evaluation and Inspection, Haiqu Road 58, Shanghai 201210, China
- Corresponding author
- Liu, Peng
- Zhang, Jingchen
- Venue
- Molecules
- Publisher
- MDPI AG
- Published
- 2022-02-17
- Volume
- 27
- Issue
- 4
- Pages
- 1372
- ISSN
- 1420-3049 (ISSN-L)
- PMC
- PMC8879473
- OpenAlex
- W4212801432
- Cited by
- 1,334
- References
- 130
- Citations by year
- 2026: 243 · 2025: 455 · 2024: 361 · 2023: 222 · 2022: 52
- FWCI
- 18.74
- Type
- journal article
- Language
- en
- Open access
- gold
- doi.org
- Licence
- Locations
- Molecules (publishedVersion, cc-by)
- PubMed Central (publishedVersion, cc-by)
- PubMed (publishedVersion)
- DOAJ (DOAJ: Directory of Open Access Journals) (submittedVersion, cc-by-sa)
- Topics
- Physical Sciences › Materials Science › Biomaterials › Nanoparticle-Based Drug Delivery
- Life Sciences › Pharmacology, Toxicology and Pharmaceutics › Pharmaceutical Science › Advanced Drug Delivery Systems
- Life Sciences › Pharmacology, Toxicology and Pharmaceutics › Pharmaceutical Science › Drug Solubulity and Delivery Systems
- Keywords
- liposomes, liposomal drug delivery, regulatory guidelines, lipid excipients, nanosizing, drug loading methods, critical quality attributes, pharmaceutical manufacturing, sustained drug release
- MeSH terms
- Consumer Product Safety, Drug and Narcotic Control, Drug Carriers, Europe, Humans, Liposomes, United States, United States Food and Drug Administration, Molecular Structure, Drug Delivery Systems, Drug Approval
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