Titre
Pharmacokinetic Evaluation of Oral Viscous Budesonide in Paediatric Patients with Eosinophilic Oesophagitis in Repaired Oesophageal Atresia.
Type
article
Institution
Externe
Périodique
Auteur(s)
Simeoli, R.
Co-première auteure/Co-premier auteur
Lava, SAG
Co-première auteure/Co-premier auteur
Di Deo, A.
Auteure/Auteur
Roversi, M.
Auteure/Auteur
Cairoli, S.
Auteure/Auteur
Tambucci, R.
Auteure/Auteur
Rea, F.
Auteure/Auteur
Malamisura, M.
Auteure/Auteur
Angelino, G.
Auteure/Auteur
Biondi, I.
Auteure/Auteur
Simonetti, A.
Auteure/Auteur
De Angelis, P.
Auteure/Auteur
Dionisi Vici, C.
Auteure/Auteur
Rossi, P.
Auteure/Auteur
Pontrelli, G.
Auteure/Auteur
Della Pasqua, O.
Auteure/Auteur
Goffredo, B.M.
Auteure/Auteur
Liens vers les personnes
ISSN
1999-4923
Statut éditorial
Publié
Date de publication
2024-06-28
Volume
16
Numéro
7
Peer-reviewed
Oui
Langue
anglais
Notes
Publication types: Journal Article
Publication Status: epublish
Publication Status: epublish
Résumé
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.
PID Serval
serval:BIB_29C95FFD246E
PMID
Open Access
Oui
Date de création
2025-03-10T20:52:19.765Z
Date de création dans IRIS
2025-05-20T18:45:16Z
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Nom
Simeoli R (2024), Published - pharmaceutics-16-00872-v2.pdf
Version du manuscrit
published
Licence
https://creativecommons.org/licenses/by/4.0
Taille
1.09 MB
Format
Adobe PDF
PID Serval
serval:BIB_29C95FFD246E.P001
Somme de contrôle
(MD5):e8e2ad9135ab8d01f1c57fc737af27fb