Department of Pharmacy Sciences, School of Pharmacy and Health Professions, Creighton University, 2500 California Plaza, Omaha, Nebraska, 68178, USA.
AAPS PharmSciTech. 2019 Apr 9;20(4):160. doi: 10.1208/s12249-019-1367-2.
Over the last several decades, nanoparticulate delivery systems have emerged as advanced drug and gene delivery tools for cancer therapy. However, their translation into clinical use still poses major challenges. Even though many innovative nanoparticulate approaches have shown very positive results both in vitro and in vivo, few of them have found a place in clinical practice. Possible factors responsible for the existing gap in the translation of nanomedicine to clinical practice may include oversimplification of enhanced permeability and retention effect, lack of correlation between the in vivo animal data vs their translation in human, and challenging multiple biological steps experienced during systemic delivery of nanomedicine. Understanding these challenges and coming up with solutions to overcome them is an important step in effective translation of nanomedicine into clinical practice. This review focuses on advancements in the field of nanomedicine used for anti-cancer therapy, including passive targeting, active targeting, and stimuli-controlled delivery. The review further reveals some of the challenges that are currently faced by pharmaceutical scientists in translation of nanomedicine; these include lack of adequate models for preclinical testing that can predict efficacy in humans, absence of appropriate regulatory guidelines for their approval processes, and difficulty in scale-up of the manufacturing of nanodrug delivery systems. A better understanding of these challenges will help us in filling the gap between the bench and bedside in cancer therapy.
在过去的几十年中,纳米颗粒给药系统已成为癌症治疗中先进的药物和基因传递工具。然而,将其转化为临床应用仍然面临重大挑战。尽管许多创新的纳米颗粒方法在体外和体内都显示出非常积极的结果,但其中很少有方法在临床实践中得到应用。导致纳米医学向临床转化存在差距的可能因素包括对增强的通透性和保留效应的过度简化、体内动物数据与人类转化之间缺乏相关性,以及在纳米药物全身给药过程中经历的多个生物学步骤具有挑战性。了解这些挑战并提出解决方案来克服它们是将纳米医学有效转化为临床实践的重要步骤。本综述重点介绍了用于癌症治疗的纳米医学领域的进展,包括被动靶向、主动靶向和刺激控制递药。综述进一步揭示了制药科学家在将纳米医学转化为临床实践方面目前面临的一些挑战;这些挑战包括缺乏能够预测人类疗效的临床前测试的适当模型、缺乏用于批准程序的适当监管指南,以及纳米药物递送系统制造的规模化困难。更好地了解这些挑战将有助于我们填补癌症治疗中从实验室到临床的差距。