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

• Published in: Molecules (Basel, Switzerland) Vol. 27; no. 4; p. 1372
• Main Authors: Liu, Peng, Chen, Guiliang, Zhang, Jingchen
• Format: Journal Article
• Language: English
• Published: Switzerland MDPI AG 17.02.2022; MDPI
• Subjects: Cancer therapies; Consumer Product Safety; Drug and Narcotic Control; Drug Approval; Drug Carriers - chemistry; drug delivery; Drug Delivery Systems; drug loading; Europe; Fatty acids; FDA approval; Growth factors; Humans; Ligands; lipid excipient; Lipids; liposomes; Liposomes - chemistry; marketed products; Molecular Structure; Molecular weight; Particle size; Phase transitions; Physiology; Review; United States; United States Food and Drug Administration; United States; Europe; drug loading; drug delivery; liposomes; lipid excipient; marketed products
• ISSN: 1420-3049; 1420-3049
• DOI: 10.3390/molecules27041372

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.