Table 2

Assumptions for assessing swallowability of formulations listed in the EMLc 2011–2019, for children under 5 years of age

FormulationAge from which considered appropriateAssumption/Rationale
Liquids
Oral powders and granules
Dispersible tablets
From birthEasy to swallow depending on the dose volume, with 10 mL considered the maximum acceptable for a child aged 5 years.*
Crushed tablets
Sprinkle capsules
6 months
6 months
Age from which child can swallow solids.39
Chewable tablets
Oro-dispersible tablets
2 years
2 years
Age from which child can safely chew and swallow tablets.40
Conventional tablets
Capsules
Not age-appropriate†‡
Not age-appropriate†‡
Incapacity (likely swallowing issues and safety).
Effervescent tablets§Not age-appropriate†Large volumes involved; typically, in excess of 100–200 mL suggested.
  • *10 mL was based on practice. For example, a child 2–4 years of age would be dosed 7.5 mL of a 120 mg/mL paracetamol suspension; hence, a maximum of 10 mL may be assumed ideal for a child aged 5 years. For children aged <2 years, 5 mL was assumed the ideal maximum. In all cases, minimum measurable volume assumed as 0.1 mL. The assessment recognised, though, that multiple doses of 10 mL could be administered, as with fractions. No limit on volume was placed on dispersible tablets as they can also be dispersed onto semi-solid food. The only other consideration for dispersible tablets was the dose adaptability, especially important if this required the tablet to be dispersed in any volume which is to be proportioned.

  • †Only age-appropriate from 6 years. The size of the tablet/capsule not taken into account, that is, whether tablets were intact or divided.

  • ‡A maximum pill burden of three (tablet or capsule required to administer a dose) was assumed.

  • §Soluble tablets, where these are intended to be dispersed in a smaller volume (5–10 mL) of fluid are considered as dispersible tablets.

  • ¶These assumptions do not take into account the individual variability which may be seen in practice.

  • **Oral liquid products were assumed to be swallowable; no attempt was made to assess palatability. Rectal preparations were assumed to be administrable and volume of the dose to be administered was not taken into consideration.