Acceptability of Uncoated Mini-Tablets in Neonates--A Randomized Controlled Trial

J Pediatr. 2015 Oct;167(4):893-896.e2. doi: 10.1016/j.jpeds.2015.07.010. Epub 2015 Aug 7.


Objective: To evaluate the suitability of drug-free solid dosage forms (2 mm mini-tablets) as an alternative administration modality in neonates in comparison with syrup.

Study design: A total of 151 neonates (inpatients; aged 2-28 days; median 4 days) were recruited. An open, randomized, prospective cross-over study was conducted to compare the acceptability and swallowability of 2 mm uncoated mini-tablets compared with .5 mL syrup.

Results: All neonates (N = 151) accepted the uncoated mini-tablet as well as the syrup (both formulations 100%; 95% CI 97.6%-100.0%; primary objective). The level of swallowability of uncoated mini-tablets was not inferior (P < .0001), in fact even higher (difference in proportions 10.0%; 95% CI 1.37%-19.34%; P = .0315) compared with syrup. Both pharmaceutical formulations were well tolerated, and in none of the 151 neonates, serious adverse events occurred; particularly none of the neonates inhaled or coughed in either of the formulations.

Conclusions: The administration of uncoated mini-tablets proved to be a valuable alternative to syrup for term neonates. Our data on neonates close the age gap of prior findings in toddlers and infants: uncoated mini-tablets offer the potential of a single formulation for all age groups. These findings further shift the paradigm from liquid toward small-sized solid drug formulations for children of all age groups, as the World Health Organization proposes.

Trial registration: German Clinical Trials Register (Deutsches Register Klinischer Studien [DRKS;]): DRKS00005609.

Publication types

  • Randomized Controlled Trial

MeSH terms

  • Administration, Oral*
  • Area Under Curve
  • Cough
  • Cross-Over Studies
  • Deglutition
  • Female
  • Humans
  • Infant, Newborn
  • Male
  • Pharmaceutical Preparations
  • Prospective Studies
  • Reproducibility of Results
  • Tablets / administration & dosage*
  • Tablets / adverse effects*


  • Pharmaceutical Preparations
  • Tablets

Associated data

  • DRKS/DRKS00005609