Original ArticleFavorable Acceptance of Mini-Tablets Compared with Syrup: A Randomized Controlled Trial in Infants and Preschool Children
Section snippets
Methods
This trial was a single-center, randomized, open (unblinded) cross-over study. Participants sequentially received 3 oral drug-free formulations (uncoated and coated mini-tablets and syrup) and were randomized to one of 6 possible sequences. The study was conducted according to the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use guideline for Good Clinical Practice with a risk-adapted level of monitoring, adequate patient
Results
Participants were recruited between February and June 2011. Data of all 306 participants were evaluated; 127 of 306 (41.5%) participants were female, ranging from 29.4% (age 1 to 2 years) to 54.9% (age 2 to 3 years).
As primary endpoint of this study, the acceptability of the uncoated 2 mm mini-tablet was significantly higher compared with glucose syrup (difference in proportions 14.8%, 95% CI 10.2-19.4; P < .0001) for the entire study population. All following data are secondary endpoints. The
Discussion
The study was designed as a confirmatory (uncoated mini-tablets) trial but also as an exploratory (film-coated mini-tablets) trial to assess the use of mini-tablets as an alternative drug dosage form for preschool children. Based on the significantly higher acceptability of uncoated mini-tablets compared with syrup in this study, which was greater than expected from our pilot study, we conclude that uncoated mini-tablets are a new therapeutic alternative to liquid formulations for infants and
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2023, International Journal of PharmaceuticsCitation Excerpt :To avoid unintended chewing, which can lead to noncompliance with medication due to unpleasant taste, safety concerns, and decreased drug product efficacy, the maximum size of multiparticulate must be determined. Numerous studies have shown that children in preschool (up to the age of six) and even infants (up to the age of six months) can safely swallow particles smaller than three millimetres (Klingmann et al., 2013; Kluk et al., 2015; Spomer et al., 2012). On the other hand, newborns allow swallowing only liquids before the age of five months.
The authors declare no conflicts of interest.
Registered with the German Clinical Trials Register: DRKS00000432.