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A Dried Blood Spot Analysis for Solithromycin in Adolescents, Children, and Infants: A Short Communication

Ryan J Beechinor1, Michael Cohen-Wolkowiez2,3, Theresa Jasion3

  • 1Division of Pharmacotherapy and Experimental Therapeutics, UNC Eshelman School of Pharmacy, The University of North Carolina at Chapel Hill, Chapel Hill, North Carolina.

Therapeutic Drug Monitoring
|July 19, 2019
PubMed

Insights

Dried blood spots (DBS) accurately measure solithromycin concentrations in children, simplifying pharmacokinetic studies. This method enhances pediatric enrollment for antibiotic research.

Area of Science:

  • Pharmacology
  • Clinical Pharmacy
  • Pediatric Infectious Diseases

Background:

  • Solithromycin, a novel macrolide antibiotic, shows promise for treating pediatric community-acquired bacterial pneumonia.
  • Limited pharmacokinetic (PK) data in children hinders solithromycin's clinical application.
  • Dried blood spots (DBS) offer a minimally invasive alternative for drug sampling in pediatric PK studies.

Purpose of the Study:

  • To compare solithromycin concentrations in DBS versus liquid plasma samples (LPS).
  • To assess the impact of using DBS concentrations on population PK modeling.
  • To determine if corrections for hematocrit or protein binding are necessary for DBS samples.

Main Methods:

  • Matched DBS and LPS samples from pediatric clinical trials were analyzed.
  • Solithromycin concentrations were compared using DBS:LPS ratios and prediction errors.
  • A population PK model (NONMEM) was used to evaluate parameter estimates from both sample types.

Main Results:

  • 672 paired DBS-LPS samples from 95 pediatric subjects were analyzed.
  • Median solithromycin concentrations were comparable between DBS (0.32 mcg/mL) and LPS (0.3 mcg/mL).
  • Population PK parameter estimates using DBS were largely within 15% of those from LPS.

Conclusions:

  • Solithromycin concentrations in DBS are comparable to LPS.
  • DBS sampling does not require correction for hematocrit or protein binding in pediatric PK studies.
  • DBS is a viable method to facilitate pediatric PK studies of solithromycin.
Abstract

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