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Excipients in the Paediatric Population: A Review

Khadija Rouaz1, Blanca Chiclana-Rodríguez1, Anna Nardi-Ricart1

  • 1Department of Pharmacy and Pharmaceutical Technology and Physical Chemistry, Faculty of Pharmacy and Food Sciences, University of Barcelona, Av. Joan XXIII, 27-31, 08028 Barcelona, Spain.

Pharmaceutics
|April 3, 2021
PubMed

Insights

This review examines excipient safety in pediatric medicines, identifying potentially harmful ingredients and emphasizing toxicity testing for children. Orally disintegrating tablets (ODTs) are also explored.

Area of Science:

  • Pharmaceutical Sciences
  • Pediatric Drug Development
  • Regulatory Science

Background:

  • Excipients are crucial in pediatric formulations but pose potential risks.
  • Regulatory guidelines from European and American agencies govern excipient use.
  • Identifying harmful excipients and ensuring safety is paramount for pediatric populations.

Purpose of the Study:

  • To critically review excipient use in pediatric medicine.
  • To identify frequently used excipients with potential adverse effects in children.
  • To highlight the importance of safety and toxicity assessments for pediatric excipients.

Main Methods:

  • Literature review of scientific publications and regulatory guidelines.
  • Analysis of excipients commonly found in pediatric drug formulations.
  • Examination of safety and toxicity data, referencing databases like STEP.
  • Exploration of Orally Disintegrating Tablets (ODTs) as a suitable pediatric dosage form.

Main Results:

  • Identification of specific excipients associated with adverse side effects in pediatric patients.
  • Emphasis on the necessity of rigorous safety and toxicity evaluations for all pediatric excipients.
  • Recognition of the STEP database as a model for compiling safety data.

Conclusions:

  • A critical need exists for comprehensive safety data on excipients used in pediatric medicines.
  • Regulatory compliance and thorough toxicity studies are essential for protecting children's health.
  • Orally Disintegrating Tablets (ODTs) show promise as a safe and effective dosage form for pediatric use.

Keywords:
STEP and ODTexcipientspaediatricssecuritytoxicology

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