用于给药的脂质体:分类、治疗应用和局限性

Ramachandran Chelliah , Momna Rubab , Selvakumar Vijayalakshmi , Murugan Karuvelan , Kaliyan Barathikannan , Deog-Hwan Oh
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引用次数: 0

摘要

脂质体是一种基于脂质的囊泡,由于其能够增强各种药物的治疗效果,已成为一种用途广泛且被广泛研究的药物传递平台。多年来,脂质体技术的进步导致了许多基于脂质体的药物配方的开发和临床测试,其中一些获得了医疗用途的监管批准。通过改变治疗剂的生物分布,这些制剂显著提高了其治疗指标,并将脱靶效应降至最低。这篇综述深入探讨了脂质体在药物传递中的当前和潜在应用,重点介绍了临床批准的配方的关键例子以及它们在继续开发和利用中面临的挑战。特别关注可扩展的制造方法,脂质体药物产品的工业限制以及美国食品和药物管理局(FDA)和欧洲药品管理局(EMA)定义的监管指南。通过解决这些关键方面,本综述旨在为研究人员、行业专业人士和监管机构提供有价值的见解,强调基于脂质体的治疗方法在现代医学中的前景和障碍。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Liposomes for drug delivery: Classification, therapeutic applications, and limitations
Liposomes, lipid-based vesicles, have emerged as a versatile and extensively studied drug delivery platform due to their ability to enhance the therapeutic efficacy of various agents. Over the years, advancements in liposome technology have led to the development and clinical testing of numerous liposome-based drug formulations, with several achieving regulatory approval for medical use. By altering the bio-distribution of therapeutic agents, these formulations have significantly improved their therapeutic indices and minimized off-target effects. This review delves into the current and potential applications of liposomes in drug delivery, highlighting key examples of clinically approved formulations and the challenges faced in their continued development and utilization. A special focus is placed on scalable manufacturing methods, the industrial limitations of liposomal drug products, and regulatory guidelines as defined by the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA). By addressing these critical aspects, this review aims to provide valuable insights for researchers, industry professionals, and regulatory bodies, underscoring the promise and hurdles of liposome-based therapeutics in modern medicine.
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