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Evaluation of changes in oral drug absorption in preterm and term neonates for Biopharmaceutics Classification System

Amit A Somani1, Kirstin Thelen2, Songmao Zheng1

  • 1Center for Pharmacometrics and Systems Pharmacology, College of Pharmacy, University of Florida, Orlando, FL, USA.

British Journal of Clinical Pharmacology
|August 25, 2015
PubMed

Insights

Oral drug absorption in neonates reaches adult levels within one week after birth. This drug-independent maturation function, identified for paracetamol, applies to Biopharmaceutics Classification System (BCS) class I and II drugs.

Area of Science:

  • Pharmacokinetics
  • Paediatric pharmacotherapy
  • Drug absorption

Background:

  • Oral drug absorption rates vary in early childhood, with unclear clinical implications, especially for preterm neonates.
  • Understanding these changes is crucial for optimizing paediatric drug therapy.

Purpose of the Study:

  • To evaluate oral drug absorption changes after birth for Biopharmaceutics Classification System (BCS) class I and II compounds.
  • To inform paediatric pharmacotherapy by understanding drug absorption maturation in neonates.

Main Methods:

  • Population pharmacokinetic analysis using NONMEM® 7.2.
  • Comparative analysis of BCS class I (paracetamol, theophylline) and class II (indomethacin, ibuprofen) compounds.
  • Development of an age-dependent maturation function for oral drug absorption.

Main Results:

  • Oral drug absorption rate reaches adult levels within approximately one week post-birth.
  • A maturation function developed for paracetamol was applicable to theophylline and indomethacin, considering formulation-based solubility.
  • Excipient influence on solubility and bioavailability was confirmed for ibuprofen.

Conclusions:

  • Postnatal oral drug absorption changes are drug-independent.
  • The identified maturation function for paracetamol is likely generalizable to other BCS class I and II drugs.
  • This aids in characterizing drug absorption in both preterm and term neonates.
Abstract

Keywords:
BCS class I and IIoral drug absorptionpaediatricspharmacokineticspreterm neonates

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