Age-appropriate and acceptable paediatric dosage forms: Insights into end-user perceptions, preferences and practices...

Area of Science:

• Paediatric Formulation Development
• Pharmaceutical Sciences
• Patient Acceptability Studies

Background:

• A significant knowledge gap exists in designing age-appropriate and acceptable paediatric dosage forms.
• Current paediatric formulation development lacks robust evidence guiding end-user preferences.
• Solid oral dosage forms are common, but their acceptability among children varies widely.

Purpose of the Study:

• To investigate children's and caregivers' perceptions of various solid oral dosage forms.
• To identify factors influencing the acceptability of different paediatric drug formulations.
• To provide evidence for rational design of paediatric dosage forms.

Main Methods:

• The Children's Acceptability of Oral Formulations (CALF) study utilized validated, age-adapted questionnaires.
• Surveys were administered to 590 school children/adolescents and 428 adult caregivers in diverse settings.
• Data collection focused on perceptions and practices related to tablets, capsules, chewables, orodispersibles, multiparticulates, and mini-tablets.

Main Results:

• Attitudes towards dosage forms varied by age and prior experience, with positive views on tablets/capsules increasing with age up to 14 years.
• Chewable and orodispersible formulations were generally preferred across age groups.
• Multiparticulate formulations were perceived as less favourable; willingness to take 10mm tablets was reported by 59.6% of children, but only 32.1% of caregivers found this size suitable.

Conclusions:

• Study findings offer evidence to support the rational design of paediatric oral dosage forms.
• Methodological approaches for evaluating drug formulation acceptability in paediatric populations were established.
• Further evaluation of acceptability is recommended to optimize paediatric medicine design.