Mini-tablets, films and dispersibles are reshaping paediatric dosage forms
The liquid medicine is losing its monopoly. Flexible solid formats promise better stability, more accurate dosing and lower costs, especially outside rich countries.
In brief
Mini-tablets, orodispersible films and dispersible tablets are replacing liquids in children’s medicines. How they work and what regulators expect.
For decades, the default answer to “how do we give this to a child?” was a liquid. That is changing. A new generation of solid dosage forms designed with children in mind is moving from academic interest to standard practice.
Mini-tablets
Mini-tablets are small enough for young children to swallow, often from around six months of age, and can be dosed by count to match a child’s weight. They can be coated for taste-masking and packed in dose-dispensing devices or capsules that are opened and sprinkled on food. For manufacturers they offer the stability advantages of a tablet without forcing a choice between a handful of fixed strengths.
Orodispersible films and tablets
Films that dissolve on the tongue within seconds avoid swallowing altogether and need no water. They suit children who resist tablets and settings where clean water is unreliable. Their limitation is drug load: films can only carry relatively small doses.
Dispersible tablets
Tablets that disperse in a small amount of water or milk before being given combine the stability of a solid with the ease of a liquid. They have been especially important in global health, where liquids are expensive to ship, bulky to store and prone to spoilage in heat. The World Health Organization has favoured flexible solid oral dosage forms for many children’s medicines for this reason.
What regulators expect
The EMA’s guideline on the pharmaceutical development of medicines for paediatric use asks developers to justify the chosen dosage form for each age group, including acceptability to children and carers. In practice that means palatability and swallowability studies, as well as conventional stability and bioavailability work.
The commercial angle
New formats can also extend the life of an existing medicine. An age-appropriate formulation developed as part of a paediatric plan can earn regulatory rewards, and in some cases open a market that the adult product never reached.
