Acceptability of small-sized oblong tablets in comparison to syrup and mini-tablets in infants and toddlers: A randomized controlled trial

Münch, Juliane; Meißner, Thomas; Mayatepek, Ertan; Wargenau, Manfred; Breitkreutz, Jörg; Bosse, Hans Martin; Klingmann, Viviane

doi:10.1016/j.ejpb.2021.06.007

Cited by 21 publications

(13 citation statements)

References 15 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…The results of a previous study suggested that mini-tablets may only be suitable for children from 4 years old [ 11 ]. However, the present results suggest that mini-tablets could be a feasible and safe method of drug administration for children as young as 2 years old and are in line with the findings of other studies, including studies that have demonstrated the acceptance of mini-tablets by very young children, including newborns and infants 6 months to 1 year old [ 10 , 12 , 13 , 14 , 15 ].…”

Section: Discussionsupporting

confidence: 91%

Acceptability, Swallowability, Palatability, and Safety of Multiple Film-Coated Mini-Tablets in Children Aged ≥2–<7 Years: Results of an Open-Label Randomised Study

et al. 2023

Self Cite

View full text Add to dashboard Cite

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).

show abstract

Section: Discussionsupporting

confidence: 91%

Acceptability, Swallowability, Palatability, and Safety of Multiple Film-Coated Mini-Tablets in Children Aged ≥2–<7 Years: Results of an Open-Label Randomised Study

et al. 2023

Self Cite

View full text Add to dashboard Cite

show abstract

“…In terms of safety, no adverse events were observed in children who took minitablets in this or previous studies conducted in Europe. Münch et al reported that one oblong tablet (2.5 × 6 mm), which is larger than minitablets of 2 mm, can be taken by children aged 1 to 5 years as a safe alternative to liquid formulations [16]. This suggests that minitablets with a diameter of 2 mm can be administered safely to Japanese children aged 6 months and older.…”

Section: Discussionmentioning

confidence: 99%

Swallowability of Minitablets among Children Aged 6–23 Months: An Exploratory, Randomized Crossover Study

et al. 2022

View full text Add to dashboard Cite

Minitablets have garnered interest as a new paediatric formulation that is easier to swallow than liquid formulations. In Japan, besides the latter, fine granules are frequently used for children. We examined the swallowability of multiple drug-free minitablets and compared it with that of fine granules and liquid formulations in 40 children of two age groups (n = 20 each, aged 6–11 and 12–23 months). We compared the percentage of children who could swallow minitablets without chewing with that of children who could swallow fine granules or liquid formulations without leftover. The children who visited the paediatric department of Showa University Hospital were enrolled. Their caregivers were allowed to choose the administration method. In total, 37 out of 40 caregivers dispersed the fine granules in water. Significantly more children (80%, 95% CI: 56–94%) aged 6–11 months could swallow the minitablets than those who could swallow all the dispersed fine granules and liquid formulations (22%, 95% CI: 6–47% and 35%, 95% CI: 15–59%, respectively). No significant differences were observed in children aged 12–23 months. Hence, minitablets may be easier to swallow than dispersed fine granules and liquid formulations in children aged 6–11 months.

show abstract

“…Evaluation and validation of acceptability as a composite endpoint was performed using the data from two previous studies: “Acceptability of small-sized oblong tablets in comparison to syrup and mini-tablets in infants and toddlers: A randomized controlled trial”, Münch et al [ 10 ]. In total, 280 children stratified into 5 age groups were included (1 to < 2 years, 2 to < 3 years, 3 to < 4 years, 4 to < 5 years, 5 to < 6 years).…”

Section: Resultsmentioning

confidence: 99%

“…This gap is intended to be closed with the proposed composite endpoint based on swallowability and palatability. Its suitability was demonstrated by evaluating data of two published studies [ 9 , 10 ] in children aged newborn to 6 years old. The data of the underlying studies were based on validated, standardized assessment methods, and followed the existing regulatory guidance’s and requirements.…”

Section: Discussionmentioning

confidence: 99%

See 1 more Smart Citation

A Composite Endpoint for Acceptability Evaluation of Oral Drug Formulations in the Pediatric Population

Wargenau¹,

Reidemeister

Klingmann

et al. 2022

Ther Innov Regul Sci

Self Cite

View full text Add to dashboard Cite

Introduction A medicine’s acceptability is likely to have significant impact on pediatric adherence. The importance is underlined in EMA and FDA guidance on this topic where investigation of acceptability is stated as a regulatory expectation. Demonstrating acceptability can be challenging given there is no globally recognized definition and no standardized testing methodology or assessment criteria. Palatability and swallowability are generally recognized as important elements of acceptability, and this work proposes a definition of acceptability using these elements to give a composite endpoint for acceptability for pediatric subjects across all age ranges. Methods This composite acceptability endpoint is based on validated assessment methods for swallowability and palatability in children of different age groups using different galenic placebo formulations, in line with criteria proposed by EMA for assessing acceptability in children from newborn to 18 years of age. Data from two studies investigating mini-tablets, oblong tablets, orodispersible films, and syrup were analyzed to establish the validity, expediency, and applicability of the suggested composite acceptability assessment tool. Results The new composite endpoint is an efficient and suitable way to distinguish preferences of oral formulations: Mini-tablets and oblong tablets had significantly better acceptability than syrups and orodispersible films. Conclusion Since the suggested acceptability criteria takes both swallowability and palatability into account as composite endpoint, it is highly sensitive to detect acceptability differences between oral formulations. It is a well-defined valid approach, which meets regulatory requirements in an appropriate and comprehensive manner and may in future serve as a pragmatic, standardized method to assess and compare acceptability of pediatric formulations with active substances.

show abstract

Acceptability of small-sized oblong tablets in comparison to syrup and mini-tablets in infants and toddlers: A randomized controlled trial

Cited by 21 publications

References 15 publications

Acceptability, Swallowability, Palatability, and Safety of Multiple Film-Coated Mini-Tablets in Children Aged ≥2–<7 Years: Results of an Open-Label Randomised Study

Acceptability, Swallowability, Palatability, and Safety of Multiple Film-Coated Mini-Tablets in Children Aged ≥2–<7 Years: Results of an Open-Label Randomised Study

Swallowability of Minitablets among Children Aged 6–23 Months: An Exploratory, Randomized Crossover Study

A Composite Endpoint for Acceptability Evaluation of Oral Drug Formulations in the Pediatric Population

Contact Info

Product

Resources

About