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Klingmann, Viviane; Hinder, Markus; Langenickel, Thomas H; Chen, Fabian; Khder, Yasser; Breitkreutz, Jörg; Bosse, Hans Martin

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

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  • Medientyp: E-Artikel
  • Titel: Acceptability of multiple coated mini-tablets in comparison to syrup in infants and toddlers: a randomised controlled study
  • Beteiligte: Klingmann, Viviane; Hinder, Markus; Langenickel, Thomas H; Chen, Fabian; Khder, Yasser; Breitkreutz, Jörg; Bosse, Hans Martin
  • Erschienen: BMJ, 2023
  • Erschienen in: Archives of Disease in Childhood
  • Sprache: Englisch
  • DOI: 10.1136/archdischild-2022-325264
  • ISSN: 0003-9888; 1468-2044
  • Entstehung:
  • Anmerkungen:
  • Beschreibung: <jats:sec><jats:title>Objectives</jats:title><jats:p>Drug 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 multiple<jats:italic>uncoated</jats:italic>mini-tablets. This study here aimed to investigate young children’s acceptability and swallowability of multiple<jats:italic>coated</jats:italic>placebo mini-tablets compared with glucose syrup.</jats:p></jats:sec><jats:sec><jats:title>Design</jats:title><jats:p>This clinical trial was conducted as a single-centre randomised cross-over study.</jats:p></jats:sec><jats:sec><jats:title>Setting</jats:title><jats:p>Prospective cross-over study performed at the Children′s University Hospital Düsseldorf.</jats:p></jats:sec><jats:sec><jats:title>Patients</jats:title><jats:p>This study was conducted on 50 children in five age groups from 1 to &lt;6 years.</jats:p></jats:sec><jats:sec><jats:title>Interventions</jats:title><jats:p>An age-adapted amount of 16–28 mini-tablets and 3–6 mL syrup was administered in randomised order.</jats:p></jats:sec><jats:sec><jats:title>Main outcome measures</jats:title><jats:p>Acceptability and swallowability of multiple coated mini-tablets and syrup.</jats:p></jats:sec><jats:sec><jats:title>Results</jats:title><jats:p>In 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.</jats:p></jats:sec><jats:sec><jats:title>Conclusion</jats:title><jats:p>Multiple 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.</jats:p></jats:sec><jats:sec><jats:title>Trial registration number</jats:title><jats:p>DRKS00010395.</jats:p></jats:sec>