Pharmaceutics (Sep 2024)

Pharmacometrics to Evaluate Dosing of the Patient-Friendly Ivermectin CHILD-IVITAB in Children ≥ 15 kg and <15 kg

  • Klervi Golhen,
  • Michael Buettcher,
  • Jörg Huwyler,
  • John van den Anker,
  • Verena Gotta,
  • Kim Dao,
  • Laura E. Rothuizen,
  • Kevin Kobylinski,
  • Marc Pfister

DOI
https://doi.org/10.3390/pharmaceutics16091186
Journal volume & issue
Vol. 16, no. 9
p. 1186

Abstract

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The antiparasitic drug ivermectin is approved for persons > 15 kg in the US and EU. A pharmacometric (PMX) population model with clinical PK data was developed (i) to characterize the effect of the patient-friendly ivermectin formulation CHILD-IVITAB on the absorption process and (ii) to evaluate dosing for studies in children ®. A total of 448 ivermectin concentrations were available from 16 healthy adults. The absorption rate constant was 2.41 h−1 (CV 19%) for CHILD-IVITAB vs. 1.56 h−1 (CV 43%) for STROMECTOL®. Simulations indicated that 250 µg/kg of CHILD-IVITAB is associated with exposure coverage in children ®. Performed analysis confirmed that CHILD-IVITAB is associated with faster and more controlled absorption than STROMECTOL®. Simulations indicate that 250 µg/kg of CHILD-IVITAB achieves equivalent ivermectin exposure coverage in children < 15 kg as seen in children ≥ 15 kg and adults.

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