Your browser doesn't support javascript.
loading
Pharmacokinetic Evaluation of Oral Viscous Budesonide in Paediatric Patients with Eosinophilic Oesophagitis in Repaired Oesophageal Atresia.
Simeoli, Raffaele; Lava, Sebastiano A G; Di Deo, Alessandro; Roversi, Marco; Cairoli, Sara; Tambucci, Renato; Rea, Francesca; Malamisura, Monica; Angelino, Giulia; Biondi, Isabella; Simonetti, Alessandra; De Angelis, Paola; Dionisi Vici, Carlo; Rossi, Paolo; Pontrelli, Giuseppe; Della Pasqua, Oscar; Goffredo, Bianca Maria.
Afiliación
  • Simeoli R; Division of Metabolic Diseases, Bambino Gesù Children's Hospital, IRCCS, 00165 Rome, Italy.
  • Lava SAG; Clinical Pharmacology & Therapeutics Group, University College London, London WC1N 3JH, UK.
  • Di Deo A; Clinical Pharmacology & Therapeutics Group, University College London, London WC1N 3JH, UK.
  • Roversi M; PhD Program in Immunology, Molecular Medicine and Applied Biotechnology, University of Rome Tor Vergata, 00133 Rome, Italy.
  • Cairoli S; Division of Metabolic Diseases, Bambino Gesù Children's Hospital, IRCCS, 00165 Rome, Italy.
  • Tambucci R; Digestive Endoscopy Unit, Bambino Gesù Children's Hospital, IRCCS, 00165 Rome, Italy.
  • Rea F; Digestive Endoscopy Unit, Bambino Gesù Children's Hospital, IRCCS, 00165 Rome, Italy.
  • Malamisura M; Digestive Endoscopy Unit, Bambino Gesù Children's Hospital, IRCCS, 00165 Rome, Italy.
  • Angelino G; Digestive Endoscopy Unit, Bambino Gesù Children's Hospital, IRCCS, 00165 Rome, Italy.
  • Biondi I; Centre of Excellence for the Development and Implementation of Medicines, Vaccines, and Medical Devices for Pediatric Use, Bambino Gesù Children's Hospital, IRCCS, 00165 Rome, Italy.
  • Simonetti A; Centre of Excellence for the Development and Implementation of Medicines, Vaccines, and Medical Devices for Pediatric Use, Bambino Gesù Children's Hospital, IRCCS, 00165 Rome, Italy.
  • De Angelis P; Digestive Endoscopy Unit, Bambino Gesù Children's Hospital, IRCCS, 00165 Rome, Italy.
  • Dionisi Vici C; Division of Metabolic Diseases, Bambino Gesù Children's Hospital, IRCCS, 00165 Rome, Italy.
  • Rossi P; Centre of Excellence for the Development and Implementation of Medicines, Vaccines, and Medical Devices for Pediatric Use, Bambino Gesù Children's Hospital, IRCCS, 00165 Rome, Italy.
  • Pontrelli G; Centre of Excellence for the Development and Implementation of Medicines, Vaccines, and Medical Devices for Pediatric Use, Bambino Gesù Children's Hospital, IRCCS, 00165 Rome, Italy.
  • Della Pasqua O; Clinical Pharmacology & Therapeutics Group, University College London, London WC1N 3JH, UK.
  • Goffredo BM; Division of Metabolic Diseases, Bambino Gesù Children's Hospital, IRCCS, 00165 Rome, Italy.
Pharmaceutics ; 16(7)2024 Jun 28.
Article en En | MEDLINE | ID: mdl-39065569
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.
Palabras clave
Texto completo
Añadir a Mi BVS
Imprimir
XML
PubMed Links
Buscar en Google

Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Idioma: En Revista: Pharmaceutics Año: 2024 Tipo del documento: Article País de afiliación: Italia Pais de publicación: Suiza
Texto completo
Añadir a Mi BVS
Imprimir
XML
PubMed Links
Buscar en Google

Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Idioma: En Revista: Pharmaceutics Año: 2024 Tipo del documento: Article País de afiliación: Italia Pais de publicación: Suiza