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.
摘要：
脂质体被认为是有前途的和通用的药物囊泡。与传统给药系统相比,脂质体表现出更好的性质，包括网站定位，持续或控制释放，保护药物免受降解和清除，优越的治疗效果，和较低的毒副作用。鉴于这些优点，在过去的几十年中，几种脂质体药物产品已被成功批准并用于临床。在这次审查中,讨论了美国食品和药物管理局(FDA)和欧洲药品管理局(EMA)批准的脂质体药物产品。根据FDA和EMA的欧洲公共评估报告（EPAR）中公布的批准包，在市售脂质体产品中应用的关键化学信息和成熟的制药技术，包括脂质赋形剂，制造方法，纳米尺寸技术，药物装载方法，以及产品的关键质量归因(CQA)，被介绍。此外,总结了与脂质体产品相关的当前监管指南和未来观点。这些知识可用于各种管道下的脂质体候选药物的研究和开发，包括实验台,中试工厂,和商业制造。
