Physiological Dynamics in the Upper Gastrointestinal Tract and the Development of Gastrointestinal Absorption Models for the Immediate-Release Oral Dosage Forms …

K Wang, GL Amidon, DE Smith - Pharmaceutical Research, 2023 - Springer
This review is a revisit of various oral drug absorption models developed in the past
decades, focusing on how to incorporate the physiological dynamics in the upper …

[HTML][HTML] Unraveling the behavior of oral drug products inside the human gastrointestinal tract using the aspiration technique: history, methodology and applications

P Augustijns, M Vertzoni, C Reppas, P Langguth… - European Journal of …, 2020 - Elsevier
Fluid sampling from the gastrointestinal (GI) tract has been applied as a valuable tool to gain
more insight into the fluids present in the human GI tract and to explore the dynamic …

Establishing virtual bioequivalence and clinically relevant specifications using in vitro biorelevant dissolution testing and physiologically-based population …

I Loisios-Konstantinidis, R Cristofoletti, N Fotaki… - European Journal of …, 2020 - Elsevier
Background Physiologically-based population pharmacokinetic modeling (popPBPK)
coupled with in vitro biopharmaceutics tools such as biorelevant dissolution testing can …

[HTML][HTML] A mechanistic physiologically-based biopharmaceutics modeling (PBBM) approach to assess the in vivo performance of an orally administered drug product …

M Bermejo, B Hens, J Dickens, D Mudie, P Paixão… - Pharmaceutics, 2020 - mdpi.com
The application of in silico modeling to predict the in vivo outcome of an oral drug product is
gaining a lot of interest. Fully relying on these models as a surrogate tool requires …

Bridging the gap between food effects under clinical trial conditions and real life: modeling delayed gastric emptying of drug substances and gastric content volume …

F Winter, P Schick, W Weitschies - Molecular Pharmaceutics, 2022 - ACS Publications
Delayed gastric emptying is known to have a major impact on drug absorption. While the test
meal recommended by the FDA and EMA to study food effects represents a worst-case …

Application of a dynamic fluid and pH model to simulate intraluminal and systemic concentrations of a weak base in GastroPlus™

B Hens, MB Bolger - Journal of pharmaceutical sciences, 2019 - Elsevier
The application of preclinical in vitro and in silico models can help formulation scientists to
predict the in vivo performance of a drug in an early stage of oral drug product development …

A fully resolved multiphysics model of gastric peristalsis and bolus emptying in the upper gastrointestinal tract

S Acharya, S Halder, W Kou, PJ Kahrilas… - Computers in biology …, 2022 - Elsevier
Over the past few decades, in silico modeling of organ systems has significantly furthered
our understanding of their physiology and biomechanical function. In spite of the relative …

Mechanistic analysis and experimental verification of bicarbonate-controlled enteric coat dissolution: Potential in vivo implications

J Al-Gousous, H Ruan, JA Blechar, KX Sun… - European Journal of …, 2019 - Elsevier
Enteric coatings have shown in vivo dissolution rates that are poorly predicted by traditional
in vitro tests, with the in vivo dissolution being considerably slower than in vitro. To provide a …

Digitalizing the TIM-1 Model Using Computational Approaches─ Part Two: Digital TIM-1 Model in GastroPlus

B Hens, I Sarcevica, I Tomaszewska… - Molecular …, 2023 - ACS Publications
A TIM-1 model is an in vitro gastrointestinal (GI) simulator considering crucial physiological
parameters that will affect the in vivo drug release process. The outcome of these …

Stochastic differential equation-based mixed effects model of the fluid volume in the fasted stomach in healthy adult human

K Wang, L Marciani, GL Amidon, DE Smith, D Sun - The AAPS Journal, 2023 - Springer
The rate and extent of drug dissolution and absorption from a solid oral dosage form depend
largely on the fluid volume along the gastrointestinal tract. Hence, a model built upon the …