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Cited by 1,334Nanoparticle-Based Drug DeliveryAdvanced Drug Delivery SystemsDrug Solubulity and Delivery Systems

The DOI matches its Crossref record; 129 of the 131 references it cites were found in a registry or an index.

A Review of Liposomes as a Drug Delivery System: Current Status of Approved Products, Regulatory Environments, and Future Perspectives

Open access
Liu, Peng, Chen, Guiliang, Zhang, Jingchen·2022·Molecules
DOI 10.3390/molecules27041372PMC PMC8879473
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Abstract

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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  1. Sakamoto, K., Lochhead, R.Y., Maibach, H.I., and Yamashita, Y. (2017). Liposomes for Cosmetics. Cosmetic Science and Technology, Elsevier.

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Metadata

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
ORCID
Venue
Molecules
Publisher
MDPI AG
Published
2022-02-17
Volume
27
Issue
4
Pages
1372
ISSN
1420-3049 (ISSN-L)
DOI
10.3390/molecules27041372
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
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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