Children are not small adults, and medicines for them need careful design. Hard gelatin capsules offer formulators several useful options for paediatric products, from small sizes that are easier to swallow to capsules designed to be opened and mixed with food. This guide is written for formulators and product developers.
The short answer
For paediatric products, formulators use smaller capsule sizes, mask unpleasant tastes, and sometimes design capsules to be opened and sprinkled on soft food, or filled with mini-tablets or pellets for flexible dosing. Whether a capsule may be opened is decided by the product's approved instructions, never by the user.
Why capsule design matters for children
Many young children cannot swallow large solid doses, many dislike bitter tastes, and doses often need to change as a child grows. A well-designed capsule product can address all three.
Smaller sizes
Sizes 3, 4 and 5 are much smaller than the adult-standard size 0, which can make swallowing easier for older children. See the size chart.
Taste masking
The capsule shell hides the taste of the contents. Coated pellets inside the capsule can mask taste even when the capsule is opened.
Capsules designed to be opened
Some products are developed and approved so that the capsule can be opened and its contents sprinkled on soft food. This must be stated in the product's instructions.
Mini-tablets and pellets
Filling small tablets or pellets into capsules gives formulators flexibility to create several strengths from the same building blocks.
Practical points for formulators
- Choose the smallest size that holds the dose comfortably, allowing for the bulk density of the blend.
- Use colour to separate strengths, so caregivers and pharmacists can tell them apart. See how to choose capsule colours.
- Check excipients for suitability in children, following the applicable regulatory guidance.
- Test release of opened-capsule designs with the foods recommended in the instructions.
- Design packaging and instructions with caregivers in mind.
This article is for product developers. Patients and parents should always follow the instructions of their doctor or pharmacist and the product label.
Frequently asked questions
Which capsule sizes are used for children?
Smaller sizes such as 3, 4 and 5 are often chosen for paediatric products because they are easier to swallow than size 0 or 00.
Can capsules be opened for children?
Only if the product is designed and approved for it and the instructions say so. Patients should always follow their doctor or pharmacist.
How do capsules help with bitter medicines?
The shell masks taste while it is swallowed, and coated pellets inside can mask taste even if the capsule is opened as directed.
Do you make small capsule sizes?
Yes. We make all sizes from 000 to 5; sizes other than 0 and 2 are made on request.
Developing a paediatric capsule product?
Tell us the size, colours and quantity you need for development, and we will supply samples.
Request samples
