School of Pharmacy, University College London, London, United Kingdom.
School of Pharmacy, Institute of Clinical Sciences, University of Birmingham, Birmingham, United Kingdom.
Sci Rep. 2018 Jun 15;8(1):9210. doi: 10.1038/s41598-018-27446-6.
Patient acceptability is an important consideration in the design of medicines for children. The aim of this study was to investigate acceptability of multiparticulates in healthy children and adults. A randomised, single-blind acceptability testing was performed involving 71 children (4-12 years) and 61 adults (18-37 years). Each participant received three 500 mg samples of microcrystalline cellulose pellets administered on a medicine spoon with water at 5-10 minutes intervals. Acceptability was measured based on voluntary intake of the samples, facial expressions, ratings on hedonic scales and reported willingness to take multiparticulates everyday as a medicine. Multiparticulates were voluntarily swallowed by 92% of children and 100% of adults. However, palatability issues were identified, with emphasis on textural aspects. Grittiness perception received negative ratings on hedonic scales by 60% of children and 51% of adults. Researcher observations revealed that 72% of children and 42% of adults displayed negative facial expressions towards the samples. Children reported their willingness to take multiparticulates as a medicine in 30% of the cases, compared to 74% in adults. This study demonstrates that multiparticulates may be a suitable formulation platform for children and adults, although palatability concerns have been highlighted. Additional work is required to define acceptability criteria and to standardise methodologies.
患者接受度是儿童用药设计中的一个重要考虑因素。本研究旨在调查多颗粒剂在健康儿童和成人中的接受度。进行了一项随机、单盲的接受度测试，涉及 71 名儿童（4-12 岁）和 61 名成人（18-37 岁）。每个参与者接受三个 500mg 的微晶纤维素丸剂，用勺子盛水，在 5-10 分钟间隔内服用。接受度基于自愿摄入样品、面部表情、愉悦度评分以及报告每天作为药物服用多颗粒剂的意愿来衡量。92%的儿童和 100%的成人自愿吞下多颗粒剂。然而，发现了适口性问题，重点是质地方面。60%的儿童和 51%的成人在愉悦度评分中对颗粒感给予负面评价。研究人员观察到，72%的儿童和 42%的成人对样品表现出负面的面部表情。儿童报告愿意在 30%的情况下将多颗粒剂作为药物服用，而成年人则有 74%愿意。这项研究表明，多颗粒剂可能是儿童和成人的一种合适的制剂平台，尽管适口性问题已经得到强调。需要进一步的工作来定义接受度标准并标准化方法。
