Table 3

Solid formulations for young children that are liquid upon swallowing: type of dosage form, age group and main user advantages and disadvantages*

Manufactured and administered as a solid, but swallowed as a liquid
Dosage form	Formulation characteristics	Likely to be used from	Main (user) advantages	Main (user) disadvantages
Orodispersible granules in single dose packaging	Immediate release†	Birth	Easy swallowing Easy to use Water not required for intake Flexible dosing Good portability Can be stored outside refrigerator Likely to improve patient acceptability and adherence	Potential need of excipients of unknown safety profile Taste masking is challenging Fragile product, requires careful handling Critical packaging and storage conditions Risk for delayed market entry as technologies may be under patent	20 21
Orodispersible tablets	Mini-tablets (2–5 mm) Immediate release†	2 mm (pre)term birth; 3–4 mm probably at least from 6 months	As orodispersible granules, but ▸ limited risk for spillage Easy administration	As orodispersible granules, but Fixed dose Single dose may require several tablets Increased risk for accidental swallowing Acceptability in domiciliary setting not yet confirmed	20–22
Orodispersible tablets	Conventionally sized (>5 mm) immediate release†	5–8 mm at least 1 year, probably older	As orodispersible mini-tablets	As orodispersible mini-tablets, but May be accepted in older children only Reduced dosing flexibility; various strengths may be required	20 21 23
Orodispersible lyophilisate (=freeze dried solution/suspension)	Immediate release†	Possibly from birth	As orodispersible tablets	As orodispersible tablets, but Product damage upon handling Need for peel off blister packs Higher price than conventional dosage forms	20 21
Orodispersible films	Immediate release†	Possibly from birth	As orodispersible granules, but easy to manufacture in various strengths	As orodispersible tablets	20 21 24

*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.