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
| As powder, but
| 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 |
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
| 25 | |
Tablets (conventional size) | 5–8 mm Immediate release | 2 years | As granules/pellets/sprinkles, but
| Acceptability will depend on size, shape, coating, child characteristics
| 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.