Table 4

Solid formulations for young children: type of dosage form, age group and main user advantages and disadvantages*

Manufactured and administered and swallowed as a solid (eventually with a slug of water to ease swallowing)
Dosage form	Formulation characteristics	Likely to be used from	Main (user) advantages	Main (user) disadvantages
Powder	Immediate release†	From 6 months, probably younger	Easy to swallow Flexible dosing	Grittiness/taste may be an issue, may be given with food or drink even if food compatibility had not been shown, less accepted than mini-tablets	25
Granules/pellets/sprinkles	Immediate† or modified‡ release	From 6 months, probably younger	As powder, but ▸ Suitable for coating and taste masking ▸ May be combined with novel sipping administration modality	As powder, but ▸ Potential need for packaging/dispensing system ▸ Better accepted than drops	26 27
Mini-tablet (1–4 mm)	2-mm coated or uncoated (placed on tongue); immediate release†	6 months, possibly younger	Easy to swallow Flexible dosing Can be stored outside refrigerator Good portability Several tablets can be taken with a jelly as a single dose Tablet better accepted than syrup	Possible need for tablet dispenser Acceptability in domiciliary setting not yet confirmed	6 28–30
Mini-tablet (1–4 mm)	4-mm (given at home by parents); immediate release†	1 year, possibly younger	As 2 mm tablet Better accepted than syrup, suspension, powder Long experience with vitamin D and fluoride tablets	As 2 mm tablet, but ▸ No need for tablet dispenser	25
Tablets (conventional size)	5–8 mm Immediate release	2 years	As granules/pellets/sprinkles, but ▸ Reduced dosing flexibility ▸ Reduced swallowability; can beimproved by training	Acceptability will depend on size, shape, coating, child characteristics ▸ Reduced dosing flexibility; various strengths may be requiredPotential risk of choking	31
Chewable tablets	Immediate release†	2 years, possibly younger	Easier to swallow than conventional tablets Water is not required	Reduced dosing flexibility; various strengths may be required Mouth feel and taste may be an issue Controlled release is challenging Potential need of excipients of unknown safety profile Risk of overdose if used as candy Risk of choking in young children	32 33
Capsules	Hard or soft	Probably 2 years	In case of swallowing difficulties, sometimes contents can be taken as such	Various dose strengths may be required No data on child acceptability in relation to size/shape available	7

*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.