Acceptability of multiple coated mini-tablets in comparison to syrup in infants and toddlers: a randomised controlled study

Abstract

ObjectivesDrug treatment of children is often limited to liquid formulations or manipulation of adult solid oral dosage forms because of the lack of age-appropriate formulations, concerns around particle aspiration and paediatric acceptability. Recent research revealed that the administration of mini-tablets has substantial advantages in improving dose accuracy and avoiding issues related to drug stability, storage conditions, potentially toxic excipients and taste masking (especially effective when the mini-tablets are coated). Most trials were performed with single and multipleuncoatedmini-tablets. This study here aimed to investigate young children’s acceptability and swallowability of multiplecoatedplacebo mini-tablets compared with glucose syrup.DesignThis clinical trial was conducted as a single-centre randomised cross-over study.SettingProspective cross-over study performed at the Children′s University Hospital Düsseldorf.PatientsThis study was conducted on 50 children in five age groups from 1 to <6 years.InterventionsAn age-adapted amount of 16–28 mini-tablets and 3–6 mL syrup was administered in randomised order.Main outcome measuresAcceptability and swallowability of multiple coated mini-tablets and syrup.ResultsIn all age groups, administration of multiple coated mini-tablets and syrup showed good acceptability (mini-tablets 80%–100%, syrup 90%–100%) and swallowability (mini-tablets 30%–70%, syrup 20%–80%) without any clinically meaningful difference. This is consistent with results from large studies with uncoated mini-tablets.ConclusionMultiple coated mini-tablets are a suitable age-appropriate alternative to liquid formulations in the paediatric population. No safety concerns with the use of coated mini-tablets were observed in the study.Trial registration numberDRKS00010395.