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Acceptability of Mini-Tablets in Young Children: Results from Three Prospective Cross-over Studies

Viviane Klingmann1

  • 1Department of General Paediatrics, Neonatology, and Paediatric Cardiology, University Children's Hospital Duesseldorf, Moorenstrasse 5, 40225, Duesseldorf, Germany. viviane.klingmann@med.uni-duesseldorf.de.

AAPS Pharmscitech
|October 8, 2016
PubMed

Insights

Pediatric patients found mini-tablets, both coated and uncoated, more acceptable and easier to swallow than syrup. This suggests mini-tablets are a viable alternative to liquid formulations for children.

Area of Science:

  • Pharmaceutical Sciences
  • Pediatric Drug Delivery
  • Formulation Development

Background:

  • Children often lack evidence-based therapeutic options, necessitating age-specific pharmaceutical formulations.
  • Regulatory bodies like the European Medicines Agency (EMA) require suitability evidence for pediatric dosage forms.
  • Solid dosage forms are generally recommended by the World Health Organization (WHO).

Purpose of the Study:

  • To review and discuss acceptability data of mini-tablets in pediatric patients.
  • To compare the suitability of coated and uncoated mini-tablets against a syrup formulation.
  • To evaluate pediatric acceptability and swallowing capability of different dosage forms.

Main Methods:

  • Review of acceptability studies involving coated and uncoated mini-tablets.
  • Comparison of mini-tablet formulations with a sweet syrup (gold standard).
  • Statistical analysis of predefined outcome parameters: acceptability and capability to swallow.

Main Results:

  • Both coated and uncoated mini-tablets demonstrated statistically significant higher acceptability than syrup.
  • Both mini-tablet formulations showed statistically significant higher capability to swallow compared to syrup.
  • Mini-tablets represent a potentially superior dosage form for pediatric administration.

Conclusions:

  • Mini-tablets are a suitable and preferred alternative to syrup for pediatric drug administration.
  • Improved acceptability and swallowing capability support the use of mini-tablets in pediatric populations.
  • Further development of mini-tablet formulations can address the need for evidence-based pediatric therapeutics.

Keywords:
acceptabilitydrug administrationmini-tabletspaediatric drug dosage formsswallowability

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