Liu Fang, Ranmal Sejal, Batchelor Hannah K, Orlu-Gul Mine, Ernest Terry B, Thomas Iwan W, Flanagan Talia, Kendall Richard, Tuleu Catherine
Department of Pharmacy, School of Life and Medical Sciences, University of Hertfordshire, Hatfield AL10 9AB, UK.
Department of Pharmaceutics, UCL School of Pharmacy, University College London, 29-39 Brunswick Square, London WC1N 1AX, UK.
Int J Pharm. 2015 Aug 15;492(1-2):341-3. doi: 10.1016/j.ijpharm.2015.05.013. Epub 2015 May 7.
Acceptability of medicines in children and caregivers affects safety and effectiveness of medicinal treatments. The pharmaceutical industry is required to demonstrate acceptability of new paediatric formulations in target age groups as an integrated part of the development of these products (Kozarewicz, 2014). Two questions arise when trying to tackle this task: "which dosage form to choose for each target age group?" and "how to formulate it once the dosage form is decided?". Inevitably, both the regulator and the developer turn to scientific evidence for answers. Research has emerged in recent years to demonstrate age-appropriateness and patient acceptability of different dosage forms; however, such information is still fragmented and far from satisfactory to define efficient formulation development strategies for a diverse patient subset (Ranmal and Tuleu, 2013). This paper highlights how formulation factors affect the acceptability of different oral medicines in children (Table 1), and it is based on a more extensive review article by Liu et al. (Liu et al., 2014). Gaps in knowledge are highlighted in order to stimulate further research. In some areas, findings from studies conducted in adult populations may provide useful guidance for paediatric development and this is also discussed.
药物在儿童及照护者中的可接受性会影响药物治疗的安全性和有效性。制药行业需要证明新的儿科制剂在目标年龄组中的可接受性，将其作为这些产品研发的一个组成部分（科扎雷维茨，2014年）。在试图解决这项任务时会出现两个问题：“针对每个目标年龄组应选择哪种剂型？”以及“一旦确定了剂型，应如何进行配方设计？”。不可避免地，监管机构和研发人员都要寻求科学证据来寻找答案。近年来已有研究表明不同剂型在年龄适宜性和患者可接受性方面的情况；然而，此类信息仍然零散，远不足以定义针对不同患者亚组的有效配方开发策略（兰马尔和图勒乌，2013年）。本文着重介绍配方因素如何影响不同口服药物在儿童中的可接受性（表1），其基于刘等人更全面的综述文章（刘等人，2014年）。文中强调了知识空白，以激励进一步的研究。在某些领域，在成年人群中开展的研究结果可能会为儿科研发提供有用的指导，本文也将对此进行讨论。
