Chewable Tablets Produced by Three-Dimensional Printing: A Sensory Acceptability Study in Children and Adolescents
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 主要终点
- Sensory acceptability score (5-point facial hedonic scale)
研究概览
简要总结
The lack of appropriate pediatric formulations compromises adherence and the effectiveness of oral treatment in children, mainly due to the splitting of adult tablets and low sensory acceptability. This observational, analytical, and cross-sectional study aims to evaluate the acceptability of a novel pediatric dosage form consisting of placebo chewable tablets produced by 3D printing, with a focus on palatability and feasibility for dose personalization. Children and adolescents aged 3 to 18 years receiving care at the Nutrition Outpatient Clinic of the Hospital da Criança de Brasília José Alencar will be invited to participate. The study will be conducted in two stages. In the first stage, acceptability of a bear-shaped chewable tablet will be assessed, as well as preference among different flavors. In the second stage, preference for chewable tablets with or without xylitol will be investigated, in addition to dysgeusia associated with diseases or chronic medication use. Acceptability will be measured using a 5-point facial hedonic scale, evaluator observation, and age-appropriate questionnaires. The study is expected to identify the most accepted flavors and sweetness intensities, as well as to evaluate the acceptability of the 3D-printed dosage form, contributing to the development of safer, more attractive, and personalized pediatric medicines.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 3 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children and adolescents aged 3 to 18 years receiving care at the Nutrition Outpatient Clinic of the Hospital da Criança de Brasília José Alencar (HCB).
- •Written informed consent provided by the legal guardian through the signing of the Informed Consent Form (ICF).
- •Assent from the child or adolescent, when applicable, expressed through the signing of the Informed Assent Form (IAF).
排除标准
- •Children or adolescents with dietary restrictions or known allergies to any component present in the formulations used in the study.
- •Children or adolescents with glucose-6-phosphate dehydrogenase (G6PD) deficiency.
- •Children or adolescents diagnosed with severe neurological, cognitive, or behavioral disorders that impair communication, comprehension, or response to the sensory scale.
- •Oral conditions, mucosal lesions, or dysphagia that prevent or significantly impair proper chewing or swallowing of the tablet (e.g., mucositis).
- •Refusal of the child/adolescent or legal guardian to participate in the study at any time, even after prior consent has been provided.
结局指标
主要结局
Sensory acceptability score (5-point facial hedonic scale)
时间窗: Immediately after tablet administration (single assessment per stage)
Sensory acceptability will be assessed using a 5-point Facial Hedonic Scale ranging from 1 (disliked very much) to 5 (liked very much), with higher scores indicating better acceptability.
次要结局
未报告次要终点
研究者
Marcílio Sérgio Soares da Cunha Filho
Doctor
University of Brasilia