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Development of propranolol hydrochloride extended-release lipid matrix tablets for pediatric use

Stefanie Broocks1, Melanie Gebhardt1, Sandra Klein1

  • 1Department of Pharmacy, University of Greifswald, 17489 Greifswald, Germany.

International Journal of Pharmaceutics
|July 24, 2026
PubMed

Insights

This study developed new extended-release tablets for children using safe, sustainable lipid-based materials. These novel pediatric formulations offer improved drug delivery and adherence for young patients.

Area of Science:

  • Pharmaceutical Sciences
  • Drug Delivery Systems
  • Pediatric Formulations

Background:

  • Limited availability of age-appropriate solid oral dosage forms for pediatric patients.
  • Challenges in pediatric formulation development include excipient safety, dose flexibility, and adherence.
  • Need for sustainable and safe excipients in pediatric drug development.

Purpose of the Study:

  • To develop a pediatric-appropriate extended-release matrix tablet using lipid matrix formers.
  • To evaluate the safety and sustainability of lipid-based excipients compared to conventional ones.
  • To assess the influence of physiological conditions and storage on drug release.

Main Methods:

  • Formulation screening of lipid-based and conventional matrix formers.
  • Evaluation of drug release kinetics after one hour and extended-release performance.
  • Assessment of manufacturability, tablet hardness, and drug release under physiological conditions (pH-gradient, bile salts) and long-term storage.

Main Results:

  • Several lipid-based matrix formulations demonstrated good manufacturability and uniformity.
  • Selected formulations exhibited sustained drug release profiles.
  • Drug release remained stable under simulated physiological conditions and long-term storage.

Conclusions:

  • Lipid-based matrix formulations are suitable for developing pediatric extended-release tablets.
  • This approach offers a promising foundation for creating safe, sustainable, and effective oral drug delivery systems for children.
  • The developed formulations address key challenges in pediatric drug formulation, potentially improving therapeutic outcomes.

Keywords:
Age-appropriate dosage formsChildrenGreen excipientsPropranolol HClSafe excipientsSustainabilitySustained release

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