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Pharmacokinetics of mesalazine pellets in children with inflammatory bowel disease

Heleen Wiersma1, Johanna C Escher, Karin Dilger

  • 1Department of Clinical Pharmacology and Pharmacotherapy, Academic Medical Center, Amsterdam, The Netherlands.

Inflammatory Bowel Diseases
|October 9, 2004
PubMed

Insights

This study provides key pharmacokinetic data for mesalazine pellets in children with inflammatory bowel disease (IBD). Results suggest similar drug absorption and elimination in children compared to adults, supporting current dosing strategies.

Area of Science:

  • Pharmacology
  • Pediatric Gastroenterology

Background:

  • Mesalazine is a primary treatment for pediatric inflammatory bowel disease (IBD).
  • Limited pharmacokinetic data exists for mesalazine in children, with dosages often based on adult studies.

Purpose of the Study:

  • To determine the pharmacokinetic profile of a novel mesalazine pellet formulation in pediatric patients with ulcerative colitis and Crohn's colitis.

Main Methods:

  • A single oral dose of 20 mg/kg mesalazine was given to 13 children (aged 6-16).
  • Blood and urine samples were collected over 24 hours to measure mesalazine and acetylmesalazine levels.

Main Results:

  • The maximum plasma concentration (Cmax) of mesalazine was 1332 ng/mL, reached at 3.7 hours (tmax).
  • Systemic exposure (AUC(0-infinity)) was 8712 ng/ml*h, with a terminal half-life (t(1/2)) of 3.5 hours.
  • Pharmacokinetics in children appeared similar to those observed in adult studies.

Conclusions:

  • This study offers comprehensive pharmacokinetic data for mesalazine pellets in children with mild-to-moderate IBD.
  • The findings support the similarity in mesalazine pharmacokinetics between pediatric and adult populations when administered as pellets.

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