[Formulation Design that Contributes to the Development of Pediatric-friendly Drugs]
1Department of Pharmaceutics, Showa University Graduate School of Pharmacy.
Insights
Pediatric mini-tablets (MTs) were less swallowable than fine granules (FGs) and liquid formulations (LFs) in children aged 2-6 years. However, infants (6-11 months) showed better MT swallowability, indicating formulation-specific age considerations for medication adherence.
Area of Science:
- Pediatric pharmacology
- Pharmaceutical technology
- Drug delivery systems
Background:
- Optimal medication adherence in children requires age-appropriate formulations.
- Mini-tablets (MTs) are a novel pediatric formulation gaining traction in Europe and the US.
- Fine granules (FGs) and liquid formulations (LFs) are common pediatric dosage forms in Japan and elsewhere.
Purpose of the Study:
- To evaluate the acceptability of drug-free mini-tablets (MTs) compared to fine granules (FGs) and liquid formulations (LFs) in children.
- To assess the impact of age on the swallowability and palatability of different pediatric oral formulations.
- To determine the influence of formulation acceptability on pediatric medication adherence.
Main Methods:
- A comparative study involving drug-free mini-tablets (MTs), fine granules (FGs), and liquid formulations (LFs).
- Participants included children aged 6 months to 8 years visiting a pediatric department.
- Acceptability was primarily measured by healthcare professionals' observation of swallowability (without chewing) and parent-reported palatability.
Main Results:
- Mini-tablets (MTs) demonstrated lower swallowability compared to FGs and LFs in children aged 2-6 years, often due to chewing.
- Infants aged 6-11 months showed significantly better swallowability with MTs than with FGs or LFs.
- No significant differences in swallowability were found between MTs, FGs, and LFs in children aged 12-23 months.
Conclusions:
- Mini-tablet (MT) acceptability varies by age, with challenges in preschool-aged children but advantages in infants.
- Swallowability and palatability are critical factors influencing the overall acceptability of pediatric oral formulations.
- A combined acceptability analysis incorporating both swallowability and palatability provides valuable insights for developing effective pediatric drug delivery systems.
Abstract:
Age-appropriate pediatric formulations are needed to achieve optimal medication adherence in children. In Europe and the United States, mini-tablets (MTs) have garnered interest as a new pediatric formulation that is easier to swallow than liquid formulations (LFs). In Japan, fine granules (FGs) are also common for children. Acceptability of a medicine is likely to have significant impact on pediatric adherence. We examined the acceptability of drug-free MTs and compared it with that of FGs and LFs in children aged 6 months to 8 years who were visiting a pediatric department in Showa University Hospital. The primary endpoint was the measure of acceptability by observation of healthcare professionals according to pre-defined evaluation criteria. We compared the percentage of children who could swallow MTs without chewing with that of children who could swallow FGs or LFs without leftover. MTs showed lower swallowability compared to FGs and LFs in children aged 2-6 years, likely because children tend to chew on MTs. In contrast, significantly more children aged 6-11 months could swallow the MTs than those who could swallow all the FGs and LFs. No significant differences were observed in children aged 12-23 months. Palatability and swallowability are important for acceptability. Parents of children aged 6-23 months rated palatability after taking the three formulations. We combined the swallowability and palatability results into a new acceptability analysis. MTs did not differ significantly from FGs and LFs in acceptability for infants, but this new endpoint is useful for evaluating oral pediatric formulations.
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