Anselmo Aaron C, Mitragotri Samir
David H. Koch Institute for Integrative Cancer Research, Massachusetts Institute of Technology Cambridge MA 02139.
Dept. of Chemical Engineering, Center for Bioengineering University of California Santa Barbara CA 93106.
Bioeng Transl Med. 2016 Jun 3;1(1):10-29. doi: 10.1002/btm2.10003. eCollection 2016 Mar.
Nanoparticle/microparticle-based drug delivery systems for systemic (i.e., intravenous) applications have significant advantages over their nonformulated and free drug counterparts. For example, nanoparticle systems are capable of delivering therapeutics and treating areas of the body that other delivery systems cannot reach. As such, nanoparticle drug delivery and imaging systems are one of the most investigated systems in preclinical and clinical settings. Here, we will highlight the diversity of nanoparticle types, the key advantages these systems have over their free drug counterparts, and discuss their overall potential in influencing clinical care. In particular, we will focus on current clinical trials for nanoparticle formulations that have yet to be clinically approved. Additional emphasis will be on clinically approved nanoparticle systems, both for their currently approved indications and their use in active clinical trials. Finally, we will discuss many of the often overlooked biological, technological, and study design challenges that impact the clinical success of nanoparticle delivery systems.
用于全身（即静脉内）应用的基于纳米颗粒/微粒的药物递送系统相对于未配制的游离药物同类物具有显著优势。例如，纳米颗粒系统能够递送治疗剂并治疗身体中其他递送系统无法到达的区域。因此，纳米颗粒药物递送和成像系统是临床前和临床环境中研究最多的系统之一。在此，我们将强调纳米颗粒类型的多样性、这些系统相对于游离药物同类物的关键优势，并讨论它们在影响临床护理方面的总体潜力。特别是，我们将重点关注尚未获得临床批准的纳米颗粒制剂的当前临床试验。还将额外强调已获得临床批准的纳米颗粒系统，包括其目前已批准的适应症以及在正在进行的临床试验中的应用。最后，我们将讨论许多常常被忽视的生物学、技术和研究设计挑战，这些挑战会影响纳米颗粒递送系统的临床成功。
