Choi Young Hee, Han Hyo-Kyung
College of Pharmacy and Integrated Research Institute for Drug Development, Dongguk University-Seoul, 32 Dongguk-lo, Ilsandong-gu, Goyang, Gyonggi-do 10326 Republic of Korea.
J Pharm Investig. 2018;48(1):43-60. doi: 10.1007/s40005-017-0370-4. Epub 2017 Nov 28.
Nanomedicines have evolved into various forms including dendrimers, nanocrystals, emulsions, liposomes, solid lipid nanoparticles, micelles, and polymeric nanoparticles since their first launch in the market. Widely highlighted benefits of nanomedicines over conventional medicines include superior efficacy, safety, physicochemical properties, and pharmacokinetic/pharmacodynamic profiles of pharmaceutical ingredients. Especially, various kinetic characteristics of nanomedicines in body are further influenced by their formulations. This review provides an updated understanding of nanomedicines with respect to delivery and pharmacokinetics. It describes the process and advantages of the nanomedicines approved by FDA and EMA. New FDA and EMA guidelines will also be discussed. Based on the analysis of recent guidelines and approved nanomedicines, key issues in the future development of nanomedicines will be addressed.
自纳米药物首次投放市场以来,已发展出多种形式,包括树枝状大分子、纳米晶体、乳剂、脂质体、固体脂质纳米粒、胶束和聚合物纳米粒。与传统药物相比,纳米药物被广泛强调的优势包括药物成分具有卓越的疗效、安全性、物理化学性质以及药代动力学/药效学特征。特别是,纳米药物在体内的各种动力学特性会因其制剂而受到进一步影响。本综述提供了关于纳米药物递送和药代动力学的最新认识。它描述了获得美国食品药品监督管理局(FDA)和欧洲药品管理局(EMA)批准的纳米药物的过程和优势。还将讨论FDA和EMA的新指南。基于对近期指南和已批准纳米药物的分析,将探讨纳米药物未来发展中的关键问题。