Applications, challenges, and outlook for PBPK modeling and simulation: a regulatory, industrial and academic perspective

W Lin, Y Chen, JD Unadkat, X Zhang, D Wu… - Pharmaceutical …, 2022 - Springer
Several regulatory guidances on the use of physiologically based pharmacokinetic (PBPK)
analyses and physiologically based biopharmaceutics model (s)(PBBM (s)) have been …

Pharmaceutical approaches for enhancing solubility and oral bioavailability of poorly soluble drugs

I Nyamba, CB Sombie, M Yabre… - European Journal of …, 2024 - Elsevier
High solubility in water and physiological fluids is an indispensable requirement for the
pharmacological efficacy of an active pharmaceutical ingredient. Indeed, it is well …

Selective COX-2 inhibitors after bariatric surgery: Celecoxib, etoricoxib and etodolac post-bariatric solubility/dissolution and pharmacokinetics

D Porat, O Dukhno, M Partook-Maccabi… - International Journal of …, 2023 - Elsevier
Anatomical/physiological gastrointestinal changes after bariatric surgery may influence the
fate of orally administered drugs. Since non-selective NSAIDs are not well-tolerated post …

Antiallergic treatment of bariatric patients: Potentially hampered solubility/dissolution and bioavailability of loratadine, but not desloratadine, post-bariatric surgery

D Porat, O Dukhno, E Vainer, S Cvijic… - Molecular …, 2022 - ACS Publications
Gastrointestinal anatomical/physiological changes after bariatric surgery influence variables
affecting the fate of drugs after ingestion, and medication management of these patients …

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 …

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 …

Use of gastrointestinal simulator, mass transport analysis, and absorption simulation to investigate the impact of pH modifiers in mitigating weakly basic drugs' …

G Kuminek, N Salehi, NM Waltz, DC Sperry… - Molecular …, 2022 - ACS Publications
It is well known that reduced gastric acidity, for example with concomitant administration of
acid reducing agents, can result in variable pharmacokinetics and decreased absorption of …

Development and optimization of curcumin-nanosuspensions with improved wound healing effect

KC Aye, T Rojanarata, T Ngawhirunpat… - Journal of Drug Delivery …, 2023 - Elsevier
Curcumin (Cur) is a beneficial compound, but its efficacy is limited due to its poor aqueous
solubility. The objective of this study was to develop and optimize Cur-nanosuspensions …

[HTML][HTML] Novel analytical solutions for convolution in compartmental pharmacokinetic models and application to non-bioequivalent formulations

MA García, PM González, A Aceituno… - European Journal of …, 2024 - Elsevier
Deconvolution and convolution are powerful tools that allow decomposition and
reconstruction, respectively, of plasma versus time profiles from input and impulse functions …

Amorphous solid dispersion to facilitate the delivery of poorly water-soluble drugs: recent advances on novel preparation processes and technology coupling

C Luo, R Li, M Tang, Y Gao, J Zhang… - Expert Opinion on …, 2024 - Taylor & Francis
Introduction Amorphous solid dispersion (ASD) technique has recently been used as an
effective formulation strategy to significantly improve the bioavailability of insoluble drugs …