Pharmacometrics to Evaluate Dosing of the Patient-Friendly Ivermectin CHILD-IVITAB in Children ≥ 15 kg and <15 kg.
Details
Serval ID
serval:BIB_28526707336D
Type
Article: article from journal or magazin.
Collection
Publications
Institution
Title
Pharmacometrics to Evaluate Dosing of the Patient-Friendly Ivermectin CHILD-IVITAB in Children ≥ 15 kg and <15 kg.
Journal
Pharmaceutics
ISSN
1999-4923 (Print)
ISSN-L
1999-4923
Publication state
Published
Issued date
07/09/2024
Peer-reviewed
Oui
Volume
16
Number
9
Language
english
Notes
Publication types: Journal Article
Publication Status: epublish
Publication Status: epublish
Abstract
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 < 15 kg. Simulations were performed to identify dosing with CHILD-IVITAB associated with similar exposure coverage in children ≥ 15 kg and < 15 kg as observed in adults receiving the reference formulation STROMECTOL <sup>®</sup> . A total of 448 ivermectin concentrations were available from 16 healthy adults. The absorption rate constant was 2.41 h <sup>-1</sup> (CV 19%) for CHILD-IVITAB vs. 1.56 h <sup>-1</sup> (CV 43%) for STROMECTOL <sup>®</sup> . Simulations indicated that 250 µg/kg of CHILD-IVITAB is associated with exposure coverage in children < 15 kg consistent with that observed in children ≥ 15 kg and adults receiving 200 µg/kg of STROMECTOL <sup>®</sup> . Performed analysis confirmed that CHILD-IVITAB is associated with faster and more controlled absorption than STROMECTOL <sup>®</sup> . 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.
Keywords
Stromectol®, TIP-based technology, absorption, dosing, ivermectin, novel delivery systems, oral drug delivery, orodispersible tablet (ODT), pharmacometrics, variability, STROMECTOL®
Pubmed
Web of science
Open Access
Yes
Create date
04/10/2024 15:38
Last modification date
31/10/2024 7:13