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Age-Appropriate Pediatric Dosage Forms in Japan: Insights into End-User Perceptions From an Observational

Jumpei Saito1,2, Miki Akabane1,2, Makoto Komura1

  • 11 Pharmaceutical Department, National Center for Child Health and Development, Setagaya-ku, Tokyo, Japan.

Therapeutic Innovation & Regulatory Science
|August 31, 2018
PubMed

Insights

Pediatric formulation acceptability in Japan showed minor differences compared to Europe, with powders being more favored. These findings are crucial for developing globally appropriate pediatric drug formulations.

Area of Science:

  • Pharmaceutical Sciences
  • Pediatric Medicine
  • Drug Development

Background:

  • Global challenge in developing suitable pediatric drug formulations.
  • Urgent need for acceptability data to guide the creation of standard pediatric dosage forms.
  • Lack of age-appropriate formulations hinders effective pediatric treatment worldwide.

Purpose of the Study:

  • Assess the acceptability of various oral dosage forms among pediatric patients in Japan.
  • Gather insights into age-appropriate pediatric formulations to support global drug development.
  • Compare perceptions of oral formulation acceptability between community and hospital settings.

Main Methods:

  • Cross-sectional observational study involving caregivers and nursing staff.
  • Face-to-face interviews conducted in community pharmacies and a pediatric hospital.
  • Questionnaire assessed acceptability of tablets, capsules, powders, liquids, and orally disintegrating tablets by age.

Main Results:

  • Acceptability of oral dosage forms in Japan aligned closely with European guidelines.
  • Perceptions of powder formulation acceptability differed between community and hospital settings.
  • Hospital nursing staff found powder formulations acceptable from the neonatal period.

Conclusions:

  • Caregiver perceptions of oral formulation acceptability in Japan showed minimal divergence from European data.
  • Powder dosage forms were perceived as more acceptable in the Japanese context.
  • Further global intervention studies are recommended to determine worldwide pediatric formulation preferences.
Abstract

Keywords:
acceptabilityadministration devicesage-appropriate dosage formsoral dosage formspediatric patients

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