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

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

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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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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: Liu, Peng
Chen, Guiliang
Zhang, Jingchen
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: gold
doi.org
Licence: cc-by
creativecommons.org/licenses/by/4.0/ (vor)
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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A Review of Liposomes as a Drug Delivery System: Current Status of Approved Products, Regulatory Environments, and Future Perspectives

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