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[Formulation Design that Contributes to the Development of Pediatric-friendly Drugs].

Tsutomu Harada1

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Summary

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.

Keywords:
acceptabilitycomposite endpointmini-tabletpalatabilitypediatric formulationswallowability

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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.