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From paediatric formulations development to access: Advances made and remaining challenges.

Catherine Litalien1,2, Sophie Bérubé2, Catherine Tuleu3

  • 1Division of General Pediatrics, Department of Pediatrics, Centre Hospitalier Universitaire Sainte-Justine, Montréal, Québec, Canada.

British Journal of Clinical Pharmacology
|March 1, 2022
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Summary

Developing pediatric formulations is crucial for children's health. Current progress shows improved oral dosage forms, but global access and unified prioritization remain key challenges for optimal pharmacotherapy.

Keywords:
accessflexible solid oral formsliquid oral formsminitabletsmultiparticulatespaediatric formulations

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Area of Science:

  • Pharmaceutical Science
  • Paediatric Medicine
  • Drug Delivery Systems

Background:

  • Optimal pharmacotherapy for children requires suitable paediatric formulations and equitable global access.
  • The last two decades have seen progress in paediatric oral formulations, focusing on acceptability and dosing flexibility.

Purpose of the Study:

  • To review advancements in paediatric oral formulations over the past two decades.
  • To discuss clinical needs, access, and challenges in developing age-appropriate medicines for children.
  • To propose actions for improved global development and access to paediatric formulations.

Main Methods:

  • Literature review of paediatric oral formulations (liquid and solid).
  • Analysis of evidence for acceptability and dosing flexibility.
  • Discussion of clinical needs, access, and regulatory pathways.

Main Results:

  • Growing evidence supports the acceptability of solid oral dosage forms, including multiparticulates and minitablets.
  • Gaps in research for certain paediatric formulations persist.
  • International prioritization of medicines needing age-appropriate formulations is lacking.
  • Access to paediatric formulations is fragmented and unequal globally.

Conclusions:

  • While solid oral dosage forms show promise, further research is needed.
  • International collaboration and a unified priority list are essential for developing impactful paediatric formulations.
  • Aligning development, approval, pricing, and reimbursement processes is critical for equitable global access.