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Population Pharmacokinetics and Individualized Medication of Azithromycin for Injection in Children Under 6 Years Old

Yuwen Zhang1, Yinghui Wang2, Jiangshuo Li3

  • 1Department of Pharmacy, Beijing Friendship Hospital, Capital Medical University, 100050, Beijing China.

Journal of Pharmaceutical Sciences
|January 22, 2024
PubMed

Insights

Limited pharmacokinetic data for injectable azithromycin in children is now available. A new population pharmacokinetic model and optimized dosing regimen were developed for children under six, improving individualized therapy.

Area of Science:

  • Pharmacology
  • Pediatric Medicine
  • Drug Development

Background:

  • Pharmacokinetic data for injectable azithromycin in pediatric populations are scarce.
  • Accurate dosing is crucial for effective treatment and minimizing adverse effects in children.

Purpose of the Study:

  • To develop and validate a population pharmacokinetic (PPK) model for injectable azithromycin in children under six years old.
  • To optimize the azithromycin dosage regimen for this specific pediatric population.

Main Methods:

  • Prospective enrollment of pediatric patients (<6 years) receiving injectable azithromycin.
  • Collection of demographic, clinical data, and plasma samples for azithromycin concentration analysis via UPLC-MS/MS.
  • Population pharmacokinetic modeling using Phoenix NLME, validated with VPC and bootstrap analysis. Dosing regimen optimization via Monte Carlo simulations.

Main Results:

  • A robust PPK model was established using 254 plasma concentration data points from 148 pediatric patients.
  • Key pharmacokinetic parameters identified: clearance (1.27 L/h/kg) and volume of distribution (45.6 L/kg).
  • Weight and age were identified as significant covariates influencing azithromycin pharmacokinetics. A practical, optimized dosing scheme was derived.

Conclusions:

  • The developed population pharmacokinetic model for injectable azithromycin is reliable and robust for children under six.
  • The optimized dosing regimen provides a basis for individualized azithromycin therapy in this population.
  • This study enhances clinical decision-making and supports personalized treatment strategies for pediatric patients.

Keywords:
AzithromycinIndividualized drug therapyPediatricPharmacokinetic/pharmacodynamic (PK/PD) modelingPopulation pharmacokinetics

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