Pharmacokinetic Evaluation of Oral Viscous Budesonide in Paediatric Patients with Eosinophilic Oesophagitis in Repaired Oesophageal Atresia.

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State: Public
Version: Final published version
License: CC BY 4.0
Serval ID
serval:BIB_29C95FFD246E
Type
Article: article from journal or magazin.
Collection
Publications
Title
Pharmacokinetic Evaluation of Oral Viscous Budesonide in Paediatric Patients with Eosinophilic Oesophagitis in Repaired Oesophageal Atresia.
Journal
Pharmaceutics
Author(s)
Simeoli R. (co-first), Lava SAG (co-first), Di Deo A., Roversi M., Cairoli S., Tambucci R., Rea F., Malamisura M., Angelino G., Biondi I., Simonetti A., De Angelis P., Dionisi Vici C., Rossi P., Pontrelli G., Della Pasqua O., Goffredo B.M.
ISSN
1999-4923 (Print)
ISSN-L
1999-4923
Publication state
Published
Issued date
28/06/2024
Peer-reviewed
Oui
Volume
16
Number
7
Language
english
Notes
Publication types: Journal Article
Publication Status: epublish
Abstract
Eosinophilic oesophagitis is a long-term complication of oesophageal atresia (EA), an uncommon condition that affects approximately 1 in 3500 infants. An exploratory, open-label phase 2 clinical trial was conducted in paediatric eosinophilic oesophagitis after oesophageal atresia (EoE-EA) to assess the safety, pharmacokinetics, and efficacy of oral viscous budesonide (OVB). In total, eight patients were enrolled in the study and assigned to a twice-daily dosing regimen of either 0.8 or 1 mg OVB, depending on age and height, administered for 12 weeks. OVB was safe and effective in the treatment of EoE-EA. The current investigation focuses on the pharmacokinetics of budesonide and the impact of an oral viscous formulation on its absorption and bioavailability. Using a non-linear mixed effects approach, two distinct absorption profiles were identified, despite marked interindividual variability in drug concentrations. Budesonide exposure was higher than previously reported in children following oral inhalation. Even though no significant effect has been observed on serum cortisol levels, future studies should consider exploring different doses, schedules, and/or treatment durations, as there may be an opportunity to reduce the risk of cortisol suppression.
Keywords
Lc-ms/ms, eosinophilic oesophagitis (EoE), oesophageal atresia (EA), oral viscous budesonide, pharmacokinetics, population pharmacokinetic modelling, systemic absorption, LC-MS/MS
Pubmed
Web of science
Open Access
Yes
Create date
10/03/2025 22:52
Last modification date
12/04/2025 7:07
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