Towards more effective advanced drug delivery systems
Towards more effective advanced drug delivery systems
复制标题
DOI：
10.1016/j.ijpharm.2013.02.020
复制
发表时间：
2013-09-15
影响因子：
5.8
通讯作者：
Florence, Alexander T.
中科院分区：
文献类型：
--
作者：
Crommelin, Daan J. A.;Florence, Alexander T.
本立场文件讨论了所谓先进药物输送系统的进展，特别是但不限于纳米领域的进展。本文讨论结果与众多国际该领域的专家分享他们的意见方面的主题,从术语用于这种系统,有时过分劳累的主张在纳米技术的时代,针对运载系统的复杂本质特定目的地体内,需要制定标准的选择和描述细胞株用于体外研究,关注可制造性,系统的稳定性和分析概况以及更多相关的毒理学研究。强调了许多系统发展的历史背景。成功实现目标和采取行动的许多步骤的随机性也是如此。该领域的一个空白是缺乏在体外和体内使用标准对照使用相同模型的各种载体系统的可用数据。该论文断言，还必须更加重视在目标器官中达到的有效活性水平，因为没有这些关键数据，许多实验系统将难以进入临床。这意味着使用诊断/成像技术来监测靶向药物输送并对患者群体进行分层，确定最有可能成功治疗的患者。最后，讨论了发展科学基地对监管政策、监督该领域的科学平台和新的融资模式的至关重要性。(C) 2013 Elsevier B.V.版权所有
This position paper discusses progress made and to be made with so-called advanced drug delivery systems, particularly but not exclusively those in the nanometre domain. The paper has resulted from discussions with a number of international experts in the field who shared their views on aspects of the subject, from the nomenclature used for such systems, the sometimes overwrought claims made in the era of nanotechnology, the complex nature of targeting delivery systems to specific destinations in vivo, the need for setting standards for the choice and characterisation of cell lines used in in vitro studies, to attention to the manufacturability, stability and analytical profiling of systems and more relevant studies on toxicology. The historical background to the development of many systems is emphasised. So too is the stochastic nature of many of the steps to successful access to and action in targets. A lacuna in the field is the lack of availability of data on a variety of carrier systems using the same models in vitro and in vivo using standard controls. The paper asserts that greater emphasis must also be paid to the effective levels of active attained in target organs, for without such crucial data it will be difficult for many experimental systems to enter the clinic. This means the use of diagnostic/imaging technologies to monitor targeted drug delivery and stratify patient groups, identifying patients with optimum chances for successful therapy. Last, but not least, the critical importance of the development of science bases for regulatory policies, scientific platforms overseeing the field and new paradigms of financing are discussed. (C) 2013 Elsevier B.V. All rights reserved.