ArticlePharmaceutics2023
Acceptability, Swallowability, Palatability, and Safety of Multiple Film-Coated Mini-Tablets in Children Aged ≥2-<7 Years: Results of an Open-Label Randomised Study.
Article in Pharmaceutics, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 9 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
9 citing papers in PubMed.
- Population pharmacokinetics of selexipag for dose selection and confirmation in pediatric patients with pulmonary arterial hypertension.CPT: pharmacometrics & systems pharmacology · 2024Trial
- Targeting the Oral Mucosa: Emerging Drug Delivery Platforms and the Therapeutic Potential of Glycosaminoglycans.Pharmaceutics · 2025Review
- Article
- The Feasibility of the Repeated Administration of Acetylsalicylic Acid Mini-Tablets to Children with Kawasaki Disease: A Pilot Study.Pharmaceutics · 2025Article
- Acceptability and Palatability of Novel Orodispersible Minitablets of Enalapril in Children up to the Age of 6 with Heart Failure.Journal of clinical medicine · 2025Article
- Characteristics of pediatric interventional drug trials registered between 2015 and 2024 on ClinicalTrials.gov.Frontiers in pediatrics · 2025Article
- Acceptability of minitablets in soft food. A randomised cross-over study in children.Frontiers in pharmacology · 2025Article
- Application of Hydrophilic Polymers to the Preparation of Prolonged-Release Minitablets with Bromhexine Hydrochloride and Bisoprolol Fumarate.Pharmaceutics · 2024Article
- Questionnaire Study to Investigate the Preferences of Children, Parents, and Healthcare Professionals for Different Formulations of Oral Medicinal Products.Pharmaceutics · 2024Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
7 authors.
Funding
Abstract
This single-centre, open-label, randomised, parallel-group study assessed the acceptability, swallowability, palatability, and safety of film-coated, 3 mm diameter mini-tablets in children aged ≥2-<7 years. In total, 300 participants were randomised (2:2:1:1) to receive a single oral administration of 16 (group A) or 32 (group B) mini-tablets with soft food or 16 (group C) or 32 (group D) mini-tablets with water. Children in each group were stratified by age group (2-<3 years; 3-<4 years; 4-<5 years; 5-<6 years; and 6-<7 years). Groups C and D were pooled for statistical analyses. The rates of acceptability (swallowed ≥80% of the mini-tablets with or without chewing), swallowability (swallowed all mini-tablets without chewing or any leftover), and palatability (positive/neutral responses) were ≥80.0%, ≥42.0%, and ≥82.0%, respectively, across the study groups. No marked differences were observed between groups or across age groups. No adverse events or issues of clinical relevance with deglutition were reported. Mini-tablets taken with soft food or water provide a suitable method for administering medicines to children aged ≥2-<7 years. This study was registered in the German Clinical Trial Register (No. DRKS00024617).
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Registered trials
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