Fornaguera Cristina, García-Celma Maria José
Sagetis Biotech, 08017 Barcelona, Spain.
Department of Pharmacy and Pharmaceutic Technology and Physicochemistry, R + D Associated Unit to CSIC, Faculty of Pharmacy and Food Sciences and Institute of Nanosciences and Nanotechnology (IN2UB), University of Barcelona, 08028 Barcelona, Spain; Centro de Investigación Biomédica en Red (CIBER) of Bioengineering, Biomaterials and Nanomedicine (CIBER-BBN), 08028 Barcelona, Spain.
J Pers Med. 2017 Oct 12;7(4):12. doi: 10.3390/jpm7040012.
Nanomedicine is an interdisciplinary research field that results from the application of nanotechnology to medicine and has the potential to significantly improve some current treatments. Specifically, in the field of personalized medicine, it is expected to have a great impact in the near future due to its multiple advantages, namely its versatility to adapt a drug to a cohort of patients. In the present review, the properties and requirements of pharmaceutical dosage forms at the nanoscale, so-called nanomedicines, are been highlighted. An overview of the main current nanomedicines in pre-clinical and clinical development is presented, detailing the challenges to the personalization of these therapies. Next, the process of development of novel nanomedicines is described, from their design in research labs to their arrival on the market, including considerations for the design of nanomedicines adapted to the requirements of the market to achieve safe, effective, and quality products. Finally, attention is given to the point of view of the pharmaceutical industry, including regulation issues applied to the specific case of personalized medicine. The authors expect this review to be a useful overview of the current state of the art of nanomedicine research and industrial production, and the future opportunities of personalized medicine in the upcoming years. The authors encourage the development and marketing of novel personalized nanomedicines.
纳米医学是一个跨学科研究领域，它源于将纳米技术应用于医学，并且有潜力显著改善当前的一些治疗方法。具体而言，在个性化医疗领域，由于其具有多种优势，即能够使药物适应一群患者，预计在不久的将来会产生重大影响。在本综述中，重点介绍了纳米级药物剂型（即所谓的纳米药物）的特性和要求。概述了目前处于临床前和临床开发阶段的主要纳米药物，详细阐述了这些疗法个性化面临的挑战。接下来，描述了新型纳米药物的开发过程，从其在研究实验室的设计到上市，包括在设计适应市场需求的纳米药物时应考虑的因素，以实现安全、有效和高质量的产品。最后，关注制药行业的观点，包括适用于个性化医疗具体案例的监管问题。作者期望本综述能成为纳米医学研究和工业生产当前技术水平以及未来几年个性化医疗未来机遇的有用概述。作者鼓励新型个性化纳米药物的开发和上市。
