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Pharmaceutics, Vol. 16, Pages 1186: Pharmacometrics to Evaluate Dosing of the Patient-Friendly Ivermectin CHILD-IVITAB in Children ≥ 15 kg and <15 kg
Pharmaceutics doi: 10.3390/pharmaceutics16091186
Authors: Klervi Golhen Michael Buettcher Jörg Huwyler John van den Anker Verena Gotta Kim Dao Laura E. Rothuizen Kevin Kobylinski Marc Pfister
The antiparasitic drug ivermectin is approved for persons &gt; 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 &lt; 15 kg. Simulations were performed to identify dosing with CHILD-IVITAB associated with similar exposure coverage in children &ge; 15 kg and &lt; 15 kg as observed in adults receiving the reference formulation STROMECTOL&reg;. A total of 448 ivermectin concentrations were available from 16 healthy adults. The absorption rate constant was 2.41 h&minus;1 (CV 19%) for CHILD-IVITAB vs. 1.56 h&minus;1 (CV 43%) for STROMECTOL&reg;. Simulations indicated that 250 &micro;g/kg of CHILD-IVITAB is associated with exposure coverage in children &lt; 15 kg consistent with that observed in children &ge; 15 kg and adults receiving 200 &micro;g/kg of STROMECTOL&reg;. Performed analysis confirmed that CHILD-IVITAB is associated with faster and more controlled absorption than STROMECTOL&reg;. Simulations indicate that 250 &micro;g/kg of CHILD-IVITAB achieves equivalent ivermectin exposure coverage in children &lt; 15 kg as seen in children &ge; 15 kg and adults.
