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Pediatric orally disintegrating tablets: Overlook the future from multiple aspects

Zixi Yin1, Xiao Lin1, Yanlong Hong2

  • 1School of Pharmacy, Shanghai University of Traditional Chinese Medicine, No. 1200, Cai-Lun Road, Pudong District, Shanghai 201203, PR China; Engineering Research Center of Modern Preparation Technology of Traditional Chinese Medicine of Ministry of Education, Shanghai University of Traditional Chinese Medicine, No. 1200, Cai-Lun Road, Pudong District, Shanghai 201203, PR China.

European Journal of Pharmaceutics and Biopharmaceutics : Official Journal of Arbeitsgemeinschaft Fur Pharmazeutische Verfahrenstechnik E.V
|December 9, 2025
PubMed

Insights

Orally disintegrating tablets (ODTs) offer improved pediatric medication compliance. This review analyzes ODT manufacturing, quality control, and future applications for children, addressing drug shortages.

Area of Science:

  • Pharmaceutical Technology
  • Pediatric Drug Delivery
  • Formulation Science

Background:

  • Orally disintegrating tablets (ODTs) are increasingly popular due to ease of administration and rapid action.
  • Pediatric-specific medicines face global shortages and limited market scales, impacting treatment access.
  • ODTs present a significant opportunity to enhance medication compliance and broaden patient coverage in pediatric populations.

Purpose of the Study:

  • To review manufacturing technologies, excipients, and quality control challenges specific to pediatric ODTs.
  • To explore the future development trends and potential applications of pediatric ODTs.
  • To provide a reference for the development of pediatric ODTs by analyzing unique pediatric patient aspects.

Main Methods:

  • Analysis of existing literature on ODT manufacturing and pediatric considerations.
  • Review of quality control strategies and challenges in pediatric ODT development.
  • Prospective analysis of future trends, applications, and challenges based on Quality by Design (QbD) principles.

Main Results:

  • Pediatric ODTs require tailored manufacturing and quality control approaches due to unique patient factors.
  • Quality control optimization involves a continuous cycle across research, manufacturing, market, and clinical practice.
  • Future applications are anticipated in acute diseases, mental disorders, oral health, and pediatric respiratory conditions.

Conclusions:

  • ODTs hold substantial promise for improving pediatric medication adherence and addressing drug accessibility issues.
  • The Quality by Design (QbD) framework and personalized medicine trends will drive pediatric ODT quality optimization.
  • Further research and development in pediatric ODTs are crucial for expanding therapeutic options for children.

Keywords:
ExcipientManufactureOrally disintegrating tabletsPediatricQuality controls

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