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Pharmacokinetics of Budesonide Oral Suspension in Children and Adolescents With Eosinophilic Esophagitis

The pharmacokinetic (PK) profile of budesonide oral suspension (BOS) was evaluated during a phase 2, randomized, double-blind, placebo-controlled, dose-ranging study in pediatric patients with eosinophilic esophagitis (EoE) (MPI 101-01/NCT00762073). Non-compartmental methods were used to calculate P...

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Autores principales: Gupta, Sandeep K., Hill, Malcolm, Vitanza, Joanne M., Farber, Robert H., Desai, Nirav K., Williams, James, Song, Ivy H.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Lippincott Williams & Wilkins 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9278710/
https://www.ncbi.nlm.nih.gov/pubmed/35666852
http://dx.doi.org/10.1097/MPG.0000000000003482
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author Gupta, Sandeep K.
Hill, Malcolm
Vitanza, Joanne M.
Farber, Robert H.
Desai, Nirav K.
Williams, James
Song, Ivy H.
author_facet Gupta, Sandeep K.
Hill, Malcolm
Vitanza, Joanne M.
Farber, Robert H.
Desai, Nirav K.
Williams, James
Song, Ivy H.
author_sort Gupta, Sandeep K.
collection PubMed
description The pharmacokinetic (PK) profile of budesonide oral suspension (BOS) was evaluated during a phase 2, randomized, double-blind, placebo-controlled, dose-ranging study in pediatric patients with eosinophilic esophagitis (EoE) (MPI 101-01/NCT00762073). Non-compartmental methods were used to calculate PK parameters in 37 patients after receiving morning doses of BOS, with volume and dose adjusted for age (low dose: 0.35 or 0.5 mg; high dose: 1.4 or 2.0 mg [2–9 or 10–18 years old, respectively]). Relationships between apparent oral clearance and volume of distribution, and bodyweight and body mass index were also evaluated. Budesonide systemic exposure increased with BOS dose. After oral administration, time to maximum plasma budesonide concentration occurred ~1 hour post dose and the half-life of budesonide was 3.3–3.5 hours. PK parameters were similar between age groups for low- and high-dose BOS, indicating that volume and dose adjustments for age were appropriate for pediatric patients with EoE. BOS was well tolerated.
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spelling pubmed-92787102022-08-02 Pharmacokinetics of Budesonide Oral Suspension in Children and Adolescents With Eosinophilic Esophagitis Gupta, Sandeep K. Hill, Malcolm Vitanza, Joanne M. Farber, Robert H. Desai, Nirav K. Williams, James Song, Ivy H. J Pediatr Gastroenterol Nutr Short Communications: Gastroenterology: Eosinophilic Gastrointestinal Diseases The pharmacokinetic (PK) profile of budesonide oral suspension (BOS) was evaluated during a phase 2, randomized, double-blind, placebo-controlled, dose-ranging study in pediatric patients with eosinophilic esophagitis (EoE) (MPI 101-01/NCT00762073). Non-compartmental methods were used to calculate PK parameters in 37 patients after receiving morning doses of BOS, with volume and dose adjusted for age (low dose: 0.35 or 0.5 mg; high dose: 1.4 or 2.0 mg [2–9 or 10–18 years old, respectively]). Relationships between apparent oral clearance and volume of distribution, and bodyweight and body mass index were also evaluated. Budesonide systemic exposure increased with BOS dose. After oral administration, time to maximum plasma budesonide concentration occurred ~1 hour post dose and the half-life of budesonide was 3.3–3.5 hours. PK parameters were similar between age groups for low- and high-dose BOS, indicating that volume and dose adjustments for age were appropriate for pediatric patients with EoE. BOS was well tolerated. Lippincott Williams & Wilkins 2022-06-06 2022-08 /pmc/articles/PMC9278710/ /pubmed/35666852 http://dx.doi.org/10.1097/MPG.0000000000003482 Text en Copyright © 2022 The Author(s). Published by Wolters Kluwer on behalf of European Society for Pediatric Gastroenterology, Hepatology, and Nutrition and North American Society for Pediatric Gastroenterology, Hepatology, and Nutrition. https://creativecommons.org/licenses/by/4.0/This is an open access article distributed under the Creative Commons Attribution License 4.0 (CCBY) (https://creativecommons.org/licenses/by/4.0/) , which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
spellingShingle Short Communications: Gastroenterology: Eosinophilic Gastrointestinal Diseases
Gupta, Sandeep K.
Hill, Malcolm
Vitanza, Joanne M.
Farber, Robert H.
Desai, Nirav K.
Williams, James
Song, Ivy H.
Pharmacokinetics of Budesonide Oral Suspension in Children and Adolescents With Eosinophilic Esophagitis
title Pharmacokinetics of Budesonide Oral Suspension in Children and Adolescents With Eosinophilic Esophagitis
title_full Pharmacokinetics of Budesonide Oral Suspension in Children and Adolescents With Eosinophilic Esophagitis
title_fullStr Pharmacokinetics of Budesonide Oral Suspension in Children and Adolescents With Eosinophilic Esophagitis
title_full_unstemmed Pharmacokinetics of Budesonide Oral Suspension in Children and Adolescents With Eosinophilic Esophagitis
title_short Pharmacokinetics of Budesonide Oral Suspension in Children and Adolescents With Eosinophilic Esophagitis
title_sort pharmacokinetics of budesonide oral suspension in children and adolescents with eosinophilic esophagitis
topic Short Communications: Gastroenterology: Eosinophilic Gastrointestinal Diseases
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9278710/
https://www.ncbi.nlm.nih.gov/pubmed/35666852
http://dx.doi.org/10.1097/MPG.0000000000003482
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