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Age-Appropriate Pediatric Dosage Forms in Japan: Insights into End-User Perceptions From an Observational Cross-Sectional Survey Assessing the Acceptability of Oral Formulation

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Abstract

Background

The lack of appropriate pediatric formulations is a global issue and information on acceptability is urgently needed to develop standard pediatric formulations. This study aimed to assess perceptions of acceptability of several oral dosage forms among pediatric patients at a community and a pediatric hospital in Japan and collected information about age-appropriate pediatric formulations, aiming to contribute to drug development promotion worldwide

Methods

A cross-sectional observational study was performed. A convenience sample of caregivers was recruited from available chain-owned retail pharmacies and inpatient pediatric units. The questionnaire was composed of 3 parts: (1) acceptability of the 5 dosage forms (tablets, capsules, powders, liquids, and orally disintegrating tablet) by age; (2) acceptability of dosage size, amount, and volume by age; and (3) the actual method of administration. Face-to-face interviews were conducted at 3 independent community pharmacies (324 parents) and tertiary care pediatric hospital wards (112 nursing staff). Acceptability scores and acceptable dosages were then determined. The survey was conducted from October 1 to December 1, 2017, for the hospital setting and November 1 to 30, 2017, for the outpatient setting

Results

The acceptability of oral dosage forms was roughly similar to the matrix drafted by the European Medical Agency. Differences in perception of the powder forms between communities and hospitals were also observed, with the nursing staff perceiving powder as being acceptable from the neonatal period

Conclusions

The difference in caregivers’ perception of the acceptability of oral formulations between Japan and Europe was small. The powder form was found to be more acceptable in Japan. Further intervention studies are needed to assess the preferred pediatric formulation worldwide

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Authors and Affiliations

  1. Pharmaceutical Department, National Center for Child Health and Development, Okura 2-10-1, Setagaya-ku, Tokyo, 157-8535, Japan

    Jumpei Saito PhD, Miki Akabane MS, Makoto Komura BPharm & Yoichi Ishikawa BPharm

  2. Department of Clinical Research, Division of Clinical Pharmacology and Oral Formulation Development, National Center for Child Health and Development, Setagaya-ku, Tokyo, Japan

    Jumpei Saito PhD, Miki Akabane MS & Yoichi Ishikawa BPharm

  3. Department of Development Strategy, Division for Clinical Trials, Center for Social and Clinical Research, National Research Institute for Child Health and Development, National Center for Child Health and Development, Setagaya-ku, Tokyo, Japan

    Hidefumi Nakamura MD, PhD

Authors
  1. Jumpei Saito PhD
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  2. Miki Akabane MS
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  3. Makoto Komura BPharm
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  4. Hidefumi Nakamura MD, PhD
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  5. Yoichi Ishikawa BPharm
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Correspondence to Jumpei Saito PhD.

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Saito, J., Akabane, M., Komura, M. et al. Age-Appropriate Pediatric Dosage Forms in Japan: Insights into End-User Perceptions From an Observational Cross-Sectional Survey Assessing the Acceptability of Oral Formulation. Ther Innov Regul Sci 53, 455–471 (2019). https://doi.org/10.1177/2168479018791133

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  • DOI: https://doi.org/10.1177/2168479018791133

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