Table 5

Novel types of oral dosage forms for young children: type of dosage form, age group and main user advantages and disadvantages*

Novel types of oral dosage forms
Dosage formFormulation characteristicsLikely to be used fromMain (user) advantagesMain (user) disadvantages
Medicated spoon that forms oral pulpImmediate release†Probably 4–6 monthsEasy to swallow
Easy handling
Various strength may be required
Need for clean water by patient
20
Multiple scored tabletIMMEDIATE release†1 monthAs tablet but
  • Better dosing flexibility

As tablet but
  • Need for dosing accuracy upon breaking

  • Acceptability parts depend on size/shape

34
Milk-based oral liquid formulationImmediate release†(Term) birthAs liquid formulationAs liquid formulation, but
  • Solubility and compatibility need attention

35
Nipple-shield drug delivery deviceImmediate release†(Term) birthFor use in breastfed children only36
Robot system using microencapsulated drugImmediate† or modified‡ release6 months, possibly youngerAs for granules, but
  • Swallowed as a pulp

  • One dosage unit contains all drugs prescribed

Cost only acceptable if adopted on a wide scale37
  • *Recommendations on age are based on the reflected literature, considerations of the European Medicines Agency (EMA) guideline on the pharmaceutical development of medicines for paediatric use16 and expert knowledge of marketing authorisations.

  • †Immediate release administration implies the general disadvantage that dosing frequencies may be high. Although not intended, immediate release formulations may normally be chewed, crumbled or crushed. However, this may affect taste.

  • ‡Modified release administration implies the general advantage that dosing frequencies may be reduced. Depending on the type of modified release, these formulations may sometimes be chewed or crumbled; however, they may never be crushed to powder.