Nanomedicines: current status and future perspectives in aspect of drug delivery and pharmacokinetics

Нанолекарственные средства: современное состояние и перспективы в области доставки лекарств и фармакокинетики
Young Hee Choi, Hyo‐Kyung Han
2017-11-28

FDA and EMA guidelinesdrug deliveryliposomesnanomedicinespharmacokinetics
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.
1
Compared with conventional medicines, nanomedicines may improve efficacy, safety, physicochemical properties, and pharmacokinetic/pharmacodynamic profiles.
2
Nanomedicine formulations strongly influence their kinetic behavior and drug delivery characteristics within the body.
3
Nanomedicines have expanded into multiple platforms, including dendrimers, nanocrystals, emulsions, liposomes, solid lipid nanoparticles, micelles, and polymeric nanoparticles.
4
Recent FDA and EMA guidelines identify key regulatory and developmental issues that will shape future nanomedicine development.
5
The review analyzes FDA- and EMA-approved nanomedicines and summarizes their development processes and advantages.

Nanomedicines and their formulations, including dendrimers, nanocrystals, emulsions, liposomes, solid lipid nanoparticles, micelles, and polymeric nanoparticles

Drug-delivery performance and in-body pharmacokinetic/pharmacodynamic characteristics of nanomedicines, including formulation-dependent kinetic behavior, benefits, regulatory approval, and future development issues

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2017-11-28
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Young Hee Choi
Hyo‐Kyung Han
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