Palatability Assessment of 3D-printed Chewable Tablets in Children and Adolescents
Conditions
Keywords
Palatability, 3D Printing, Chewable Tablet, Pediatric Formulation, Sensory Acceptability, Pharmaceutical Technology
Brief summary
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.
Interventions
None listed
Sponsors
University of Brasilia
Hospital da Criança de Brasília José Alencar
Study design
Observational model
OTHER
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
3 Years to 18 Years
Inclusion criteria
* 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).
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sensory acceptability score (5-point facial hedonic scale) | 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. |
Outcome results
None listed