Lopez Felipe L, Ernest Terry B, Tuleu Catherine, Gul Mine Orlu
a 1 University College London, School of Pharmacy, Department of Pharmaceutics , 29-39 Brunswick Square, London WC1N 1AX, UK
b 2 GlaxoSmithKline, Product Development , New Frontiers Science Park, Third Avenue, Harlow, Essex CM19 5AW, UK.
Expert Opin Drug Deliv. 2015;12(11):1727-40. doi: 10.1517/17425247.2015.1060218. Epub 2015 Jul 13.
Most conventional drug delivery systems are not acceptable for pediatric patients as they differ in their developmental status and dosing requirements from other subsets of the population. Technology platforms are required to aid the development of age-appropriate medicines to maximize patient acceptability while maintaining safety, efficacy, accessibility and affordability.
The current approaches and novel developments in the field of age-appropriate drug delivery for pediatric patients are critically discussed including patient-centric formulations, administration devices and packaging systems.
Despite the incentives provided by recent regulatory modifications and the efforts of formulation scientists, there is still a need for implementation of pharmaceutical technologies that enable the manufacture of licensed age-appropriate formulations. Harmonization of endeavors from regulators, industry and academia by sharing learning associated with data obtained from pediatric investigation plans, product development pathways and scientific projects would be the way forward to speed up bench-to-market age appropriate formulation development. A collaborative approach will benefit not only pediatrics, but other patient populations such as geriatrics would also benefit from an accelerated patient-centric approach to drug delivery.
大多数传统药物递送系统并不适合儿科患者,因为他们在发育状态和给药要求方面与其他人群子集不同。需要技术平台来辅助开发适合不同年龄段的药物,以在保持安全性、有效性、可及性和可负担性的同时,最大限度地提高患者接受度。
对儿科患者适用年龄药物递送领域的当前方法和新进展进行了批判性讨论,包括以患者为中心的制剂、给药装置和包装系统。
尽管近期监管调整提供了激励措施,且制剂科学家也做出了努力,但仍需要实施制药技术,以生产获得许可的适合不同年龄段的制剂。监管机构、行业和学术界通过分享与从儿科研究计划、产品开发途径和科研项目中获得的数据相关的经验,协调各方努力,将是加快从实验室到市场的适合不同年龄段制剂开发的前进方向。合作方法不仅将使儿科受益,其他患者群体,如老年患者,也将从以患者为中心的加速药物递送方法中受益。