Assessing and mitigating pH-mediated DDI risks in drug development–formulation approaches and clinical considerations

D Wu, J Liu, EM Paragas, J Yadav… - Drug Metabolism …, 2024 - Taylor & Francis
Abstract pH-mediated drug-drug interactions (DDI) is a prevalent DDI in drug development,
especially for weak base compounds with highly pH-dependent solubility. FDA has released …

Dissolution profiles of BCS class II drugs generated by the gastrointestinal simulator alpha has an edge over the compendial USP II method

MD Naing, Y Tsume - European Journal of Pharmaceutics and …, 2024 - Elsevier
The poor water solubility of orally administered drugs leads to low dissolution in the GI tract,
resulting to low oral bioavailability. Traditionally, in vitro dissolution testing using the …

Contribution of the Dynamic Intestinal Absorption Model (Diamod) to the Development of a Patient-Centric Drug Formulation

F Moens, A Larsson, A De Blaiser… - Molecular …, 2023 - ACS Publications
Compound X is a weak basic drug targeting the early stages of Parkinson's disease, for
which a theoretical risk assessment has indicated that elevated gastric pH conditions could …

Mechanistic Modeling of In Vitro Biopharmaceutic Data for a Weak Acid Drug: A Pathway Towards Deriving Fundamental Parameters for Physiologically Based …

VK Kowthavarapu, NB Charbe, C Gupta, T Iakovleva… - The AAPS Journal, 2024 - Springer
Mechanistic modeling of in vitro experiments using metabolic enzyme systems enables the
extrapolation of metabolic clearance for in vitro-in vivo predictions. This is particularly …

[HTML][HTML] New mathematical model from dynamic dissolution rate tests

A Ruiz-Picazo, I Gonzalez-Alvarez, M Bermejo… - European Journal of …, 2024 - Elsevier
In vitro dissolution experiments are becoming increasingly complex attempting to replicate in
vivo behavior. The objective of these new methods is to explore the behavior of low …

Molecular Insights into the Mechanism of Modulatory Effects of Proton Pump Inhibitors on P-glycoprotein Mediated Drug Transport of Palbociclib and Ribociclib

MP Desai, P Harish Patil, SKA Vullendula… - Current Drug …, 2023 - ingentaconnect.com
Background: Palbociclib and ribociclib are substrates of efflux transporter P-glycoprotein
which plays a key role in absorption and transport of these drugs. Proton pump inhibitors …