Department of Medical Nanotechnology, Faculty of Advanced Medical Science, Tabriz University of Medical Sciences, Tabriz 51664, Iran.
Nanoscale Res Lett. 2013 Feb 22;8(1):102. doi: 10.1186/1556-276X-8-102.
Liposomes, sphere-shaped vesicles consisting of one or more phospholipid bilayers, were first described in the mid-60s. Today, they are a very useful reproduction, reagent, and tool in various scientific disciplines, including mathematics and theoretical physics, biophysics, chemistry, colloid science, biochemistry, and biology. Since then, liposomes have made their way to the market. Among several talented new drug delivery systems, liposomes characterize an advanced technology to deliver active molecules to the site of action, and at present, several formulations are in clinical use. Research on liposome technology has progressed from conventional vesicles to 'second-generation liposomes', in which long-circulating liposomes are obtained by modulating the lipid composition, size, and charge of the vesicle. Liposomes with modified surfaces have also been developed using several molecules, such as glycolipids or sialic acid. This paper summarizes exclusively scalable techniques and focuses on strengths, respectively, limitations in respect to industrial applicability and regulatory requirements concerning liposomal drug formulations based on FDA and EMEA documents.
脂质体是一种由一个或多个磷脂双层组成的球形囊泡,于 60 年代中期首次被描述。如今,它们在包括数学和理论物理、生物物理、化学、胶体科学、生物化学和生物学在内的多个科学领域中是一种非常有用的复制物、试剂和工具。自那时以来,脂质体已经进入市场。在几种有前途的新型药物输送系统中,脂质体是一种将活性分子递送到作用部位的先进技术,目前有几种制剂正在临床使用。脂质体技术的研究已经从传统囊泡发展到“第二代脂质体”,通过调节脂质组成、囊泡的大小和电荷,可以获得长循环脂质体。还使用几种分子(如糖脂或唾液酸)开发了具有修饰表面的脂质体。本文仅总结可扩展技术,并根据 FDA 和 EMEA 文件,重点介绍基于脂质体药物制剂的工业适用性和监管要求方面的各自优势、局限性。
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