Age appropriate formulations

What is the preferred route of administration for patients of all ages? Why?

Oral route

Because it’s more convenient and more stable

What are the major barriers of oral liquids?

• Taste masking

• Safe and acceptable excipients for children

Which excipients are not to be used in children’s medicines?

• Ethanol

• Propylene glycol

• Benzyl alcohol

• Parabens

When do you need to take into account electrolyte concetration?

In neonates - renal function may be immature

What are the advantages for using oral liquids?

• Provides maximal dosing flexibility

• Possible to use for a wide age range

What are the drawbacks to using oral liquids?

• Volume needs to be acceptable to the patient

• Dosing device must be fit for purpose

What are the EMA’s maximum single dose volumes?

• 5ml for children under 4

• 10ml for children 4-12

Does a liquid or solid have better stability when formulated in medicines?

Solid

What problems can you have if you don’t formulate dispersible products in appropriate volume of liquid?

• Risk of local tissue injury

• Delay in onset of action as drug needs to dissolve prior to absorption

What are the limitations of conventional tablets?

• limited by their rigid dose content

• limited by the ability of a child to swallow a tablet

What is the pH of gastric acid at birth?

Neutral (6-8)