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• W3035812912 startingPage "578" @default.
• W3035812912 abstract "Buprenorphine plays a crucial role in the therapeutic management of pain in adults, adolescents and pediatric subpopulations. However, only few pharmacokinetic studies of buprenorphine in children, particularly neonates, are available as conducting clinical trials in this population is especially challenging. Physiologically-based pharmacokinetic (PBPK) modeling allows the prediction of drug exposure in pediatrics based on age-related physiological differences. The aim of this study was to predict the pharmacokinetics of buprenorphine in pediatrics with PBPK modeling. Moreover, the drug-drug interaction (DDI) potential of buprenorphine with CYP3A4 and P-glycoprotein perpetrator drugs should be elucidated. A PBPK model of buprenorphine and norbuprenorphine in adults has been developed and scaled to children and preterm neonates, accounting for age-related changes. One-hundred-percent of the predicted AUClast values in adults (geometric mean fold error (GMFE): 1.22), 90% of individual AUClast predictions in children (GMFE: 1.54) and 75% in preterm neonates (GMFE: 1.57) met the 2-fold acceptance criterion. Moreover, the adult model was used to simulate DDI scenarios with clarithromycin, itraconazole and rifampicin. We demonstrate the applicability of scaling adult PBPK models to pediatrics for the prediction of individual plasma profiles. The novel PBPK models could be helpful to further investigate buprenorphine pharmacokinetics in various populations, particularly pediatric subgroups." @default.
• W3035812912 created "2020-06-25" @default.
• W3035812912 creator A5023520269 @default.
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• W3035812912 creator A5080845006 @default.
• W3035812912 date "2020-06-23" @default.
• W3035812912 modified "2023-09-30" @default.
• W3035812912 title "Physiologically-Based Pharmacokinetic (PBPK) Modeling of Buprenorphine in Adults, Children and Preterm Neonates" @default.
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• W3035812912 doi "https://doi.org/10.3390/pharmaceutics12060578" @default.
• W3035812912 hasPubMedCentralId "https://www.ncbi.nlm.nih.gov/pmc/articles/7355427" @default.
• W3035812912 hasPubMedId "https://pubmed.ncbi.nlm.nih.gov/32585880" @default.
• W3035812912 hasPublicationYear "2020" @default.
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