Alyami Hamad, Dahmash Eman, Alyami Fahad, Dahmash Dania, Huynh Chi, Terry David, Mohammed Afzal R
Aston Pharmacy School, School of Life and Health Sciences, Aston University, Birmingham, UK.
Najran Maternity and Children Hospital, Najran, Saudi Arabia.
Eur J Hosp Pharm. 2017 Nov;24(6):332-337. doi: 10.1136/ejhpharm-2016-001023. Epub 2016 Sep 2.
The current study aims to evaluate dosage form preferences in children and young adults together with identifying the key pragmatic dosage form characteristics that would enable appropriate formulation of orally disintegrating tablets (ODTs).
International, multisite, cross-sectional questionnaire of children and young adults aged from 6 to 18 years. Eligibility was based on age, ability to communicate and previous experience in taking medications. The study was carried out at three locations: the UK, Saudi Arabia and Jordan. The questionnaire instrument was designed for participant self-completion under supervision of the study team.
104 questionnaires were completed by the study cohort (n=120, response rate 87%). Results showed that ODTs were the most preferred oral dosage forms (58%) followed by liquids (20%), tablets (12%) and capsules (11%). The preferred colours were pink or white while the preferred size was small (<8 mm) with a round shape. With regard to flavour, strawberry was the most preferred (30.8%), while orange was the least preferred (5.8%). The results also showed that the most important physical characteristics of ODTs were disintegration time followed by taste, size and flavour, respectively.
The results of our study support the WHO's claim for a shift of paradigm from liquid towards ODTs dosage forms for drug administration to young children older than 6 years. Data from this study will also equip formulators to prioritise development of key physical/performance attributes within the delivery system.
本研究旨在评估儿童和青年对剂型的偏好，并确定有助于合理制备口腔崩解片（ODT）的关键实用剂型特征。
针对6至18岁儿童和青年开展国际多中心横断面问卷调查。入选标准基于年龄、沟通能力和既往用药经验。研究在三个地点进行：英国、沙特阿拉伯和约旦。问卷由研究团队监督参与者自行填写。
研究队列完成了104份问卷（n = 120，应答率87%）。结果显示，ODT是最受欢迎的口服剂型（58%），其次是液体制剂（20%）、普通片剂（12%）和胶囊剂（11%）。首选颜色为粉色或白色，首选尺寸为小尺寸（<8毫米）且为圆形。关于口味，草莓味最受欢迎（30.8%），而橙子味最不受欢迎（5.8%）。结果还表明，ODT最重要的物理特性分别是崩解时间，其次是味道、尺寸和口味。
我们的研究结果支持世界卫生组织的主张，即对于6岁以上儿童给药，剂型模式应从液体制剂向ODT转变。本研究数据还将帮助配方设计师确定给药系统中关键物理/性能属性的开发优先级。
