{"title":"开发长效可注射多囊脂质体(DepoFoam® 技术)的挑战。","authors":"Ji Li , Ziyun Xia , Minzhi Yu , Anna Schwendeman","doi":"10.1016/j.ejpb.2024.114577","DOIUrl":null,"url":null,"abstract":"<div><div>Multivesicular liposomes (DepoFoam® technology) are distinctive lipid-based sustained release drug delivery systems. Their non-concentric structure differentiates them from unilamellar and multilamellar liposomes. Several products using DepoFoam® technology have been successfully developed and translated into clinical and commercial applications. The unique composition and structure of these particles result in large drug-trap volumes, diverse loading capacities, variable release rates, and different administration routes. With all these advantages, DepoFoam® based products can achieve sustained release pharmacokinetics and significantly improved half-life in various subject species. However, the complexity of constituents and the manufacturing process, as well as the complicated structure and release mechanism, pose challenges to the translation and application of DepoFoam® technology. This review aims to summarize current approved commercial products based on DepoFoam® technology, their structures and components, large-scale manufacturing processes, release characteristics, <em>in vivo</em> pharmacokinetics and clinical outcomes. Challenges in the development and approval of multivesicular liposomes are also highlighted. The persistent academic and industrial research will be needed to overcome the difficulties in developing this unique drug delivery system and pave the path for successful DepoFoam® applications in the future.</div></div>","PeriodicalId":12024,"journal":{"name":"European Journal of Pharmaceutics and Biopharmaceutics","volume":"205 ","pages":"Article 114577"},"PeriodicalIF":4.4000,"publicationDate":"2024-11-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Challenges in the development of long acting injectable multivesicular liposomes (DepoFoam® technology)\",\"authors\":\"Ji Li , Ziyun Xia , Minzhi Yu , Anna Schwendeman\",\"doi\":\"10.1016/j.ejpb.2024.114577\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<div><div>Multivesicular liposomes (DepoFoam® technology) are distinctive lipid-based sustained release drug delivery systems. Their non-concentric structure differentiates them from unilamellar and multilamellar liposomes. Several products using DepoFoam® technology have been successfully developed and translated into clinical and commercial applications. The unique composition and structure of these particles result in large drug-trap volumes, diverse loading capacities, variable release rates, and different administration routes. With all these advantages, DepoFoam® based products can achieve sustained release pharmacokinetics and significantly improved half-life in various subject species. However, the complexity of constituents and the manufacturing process, as well as the complicated structure and release mechanism, pose challenges to the translation and application of DepoFoam® technology. This review aims to summarize current approved commercial products based on DepoFoam® technology, their structures and components, large-scale manufacturing processes, release characteristics, <em>in vivo</em> pharmacokinetics and clinical outcomes. Challenges in the development and approval of multivesicular liposomes are also highlighted. The persistent academic and industrial research will be needed to overcome the difficulties in developing this unique drug delivery system and pave the path for successful DepoFoam® applications in the future.</div></div>\",\"PeriodicalId\":12024,\"journal\":{\"name\":\"European Journal of Pharmaceutics and Biopharmaceutics\",\"volume\":\"205 \",\"pages\":\"Article 114577\"},\"PeriodicalIF\":4.4000,\"publicationDate\":\"2024-11-09\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"European Journal of Pharmaceutics and Biopharmaceutics\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://www.sciencedirect.com/science/article/pii/S093964112400403X\",\"RegionNum\":2,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q1\",\"JCRName\":\"PHARMACOLOGY & PHARMACY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"European Journal of Pharmaceutics and Biopharmaceutics","FirstCategoryId":"3","ListUrlMain":"https://www.sciencedirect.com/science/article/pii/S093964112400403X","RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"PHARMACOLOGY & PHARMACY","Score":null,"Total":0}
Challenges in the development of long acting injectable multivesicular liposomes (DepoFoam® technology)
Multivesicular liposomes (DepoFoam® technology) are distinctive lipid-based sustained release drug delivery systems. Their non-concentric structure differentiates them from unilamellar and multilamellar liposomes. Several products using DepoFoam® technology have been successfully developed and translated into clinical and commercial applications. The unique composition and structure of these particles result in large drug-trap volumes, diverse loading capacities, variable release rates, and different administration routes. With all these advantages, DepoFoam® based products can achieve sustained release pharmacokinetics and significantly improved half-life in various subject species. However, the complexity of constituents and the manufacturing process, as well as the complicated structure and release mechanism, pose challenges to the translation and application of DepoFoam® technology. This review aims to summarize current approved commercial products based on DepoFoam® technology, their structures and components, large-scale manufacturing processes, release characteristics, in vivo pharmacokinetics and clinical outcomes. Challenges in the development and approval of multivesicular liposomes are also highlighted. The persistent academic and industrial research will be needed to overcome the difficulties in developing this unique drug delivery system and pave the path for successful DepoFoam® applications in the future.
期刊介绍:
The European Journal of Pharmaceutics and Biopharmaceutics provides a medium for the publication of novel, innovative and hypothesis-driven research from the areas of Pharmaceutics and Biopharmaceutics.
Topics covered include for example:
Design and development of drug delivery systems for pharmaceuticals and biopharmaceuticals (small molecules, proteins, nucleic acids)
Aspects of manufacturing process design
Biomedical aspects of drug product design
Strategies and formulations for controlled drug transport across biological barriers
Physicochemical aspects of drug product development
Novel excipients for drug product design
Drug delivery and controlled release systems for systemic and local applications
Nanomaterials for therapeutic and diagnostic purposes
Advanced therapy medicinal products
Medical devices supporting a distinct pharmacological effect.