Etablierung patientenspezifischer In-vitro-Freisetzungsmodelle für perorale Darreichungsformen unter Berücksichtigung gastrointestinaler Besonderheiten

Media type: E-Book; Thesis

Title: Etablierung patientenspezifischer In-vitro-Freisetzungsmodelle für perorale Darreichungsformen unter Berücksichtigung gastrointestinaler Besonderheiten

Contributor: Wollmer, Erik [Author]; Klein, Sandra [Degree supervisor]; Breitkreutz, Jörg [Degree supervisor]

Corporation: Universität Greifswald

Published: Greifswald, 07.12.2022

Extent: 1 Online-Ressource (PDF-Datei: 139 Seiten, 24394 Kilobyte); Illustrationen (teilweise farbig), Diagramme (teilweise farbig)

Language: German; English

Identifier:

RVK notation: VX 8557 : Dissertationen, Habilitationsschriften, wertvollere und umfangreichere Sonderdrucke

Keywords: Gastrointestinaltrakt > Feste Arzneiform > Hydrocortison > L-Dopa > Wirkstofffreisetzung > Parkinson-Krankheit > Patient > Pharmakokinetik > Biopharmazie > In vitro > In silico-Methode

Origination:

University thesis: Dissertation, Mathematisch-Naturwissenschaftliche Fakultät der Universität Greifswald, 2023

Footnote: Literaturverzeichnis: Seite 39-54. - Literaturangaben
Text deutsch, Publikationen englisch

Description: Pharmazeutische Technologie, Biopharmazie, Wirkstofffreisetzung, in vitro, in silico, Gastrointestinaltrakt, Patient, Feste Arzneiform, Hydrocortison, Levodopa, PBPK, Parkinson-Patienten, Pädiatrische Patienten, biorelevante Wirkstofffreisetzung, feste Arzneiformen, individualisierte Wirkstofffreisetzung, biorelevant dissolution, patient specific in vitro models

This work focused on establishing patient-specific, biopredictive in vitro drug release models for orally administered dosage forms with consideration of specific gastrointestinal characteristics of two patient populations: paediatric patients and Parkinson's disease (PD) patients. Paediatric in vitro drug release models were designed to evaluate the stability and in vivo drug release behaviour of the novel Alkindi® formulation after co-administration with typical paediatric dosing vehicles using physiology-based in vitro models based on the mini-paddle apparatus. In the first study, in vitro drug release was investigated after administration of the Alkindi® formulation with typical dosing vehicles for children under six years of age, i.e., breast milk, formula milk and whole milk. In the second study, the age range of the addressed patient population was expanded to 2-16 years and several other liquid and semi-solid dosing vehicles, such as orange juice and yogurt, were used. The results of both studies demonstrated robust drug release behaviour of the Alkindi® formulation and good compatibility with the dosing matrices. Based on the results of the in vitro studies, it was concluded that in vivo drug release and bioavailability of the investigated dosage form are not affected by the investigated dosing vehicles, and consequently, these vehicles are suitable for co-administration with the Alkindi® formulation. The second part of the presented work addressed the establishment ...

Access State: Open Access

Search in field:

Recently searched for: