Acceptability of Prednisolone in an Open-Label Randomised Cross-Over Study-Focus on Formulation in Children

Area of Science:

• Pediatric pharmacology
• Pharmaceutical formulation
• Clinical acceptability studies

Background:

• Developing acceptable pediatric medicines is complex, considering factors like age, physiology, and formulation.
• Established medications, such as prednisolone, still present challenges in pediatric acceptability.
• Lack of suitable formulations impacts long-term adherence and treatment efficacy in children.

Purpose of the Study:

• To evaluate the acceptability of different prednisolone formulations in pediatric patients.
• To compare the acceptability of crushed tablets, whole tablets, and oral solutions.
• To identify formulation preferences in children with asthma and asthma-like symptoms.

Main Methods:

• Open-label, randomized, three-arm, cross-over study design.
• Inclusion of 41 pediatric patients (mean age 4.7 years) with asthma or similar conditions.
• Acceptability assessed using a modified Wong Baker Face scale for each formulation.

Main Results:

• Overall low acceptability observed, with only 32% of scores indicating high acceptance.
• Significant difference in acceptability between crushed tablets and whole tablets (p < 0.003).
• Crushed tablets had the least favorable mean acceptability score (3.9), compared to oral solution (3.1), oro-dispersible tablet (2.8), and whole tablets (2.4).

Conclusions:

• Current prednisolone formulations show low acceptability in pediatric patients.
• Crushed tablets are particularly unacceptable, posing challenges for long-term treatment.
• Development of age-appropriate and acceptable pediatric drug formulations is essential.