Dissolution challenges associated with the surface pH of drug particles: integration into mechanistic oral absorption modeling

B Hens, N Seegobin, M Bermejo, Y Tsume, N Clear… - The AAPS Journal, 2022 - Springer
The present work aimed to differentiate between in vitro dissolution profiles of ibuprofen as
input for GastroPlus™ and to see the impact on systemic exposure. In vitro dissolution …

Harmonizing biopredictive methodologies through the Product Quality Research Institute (PQRI) Part I: biopredictive dissolution of ibuprofen and dipyridamole tablets

Y Tsume, L Ashworth, M Bermejo, J Cheng, V Cicale… - The AAPS Journal, 2023 - Springer
Assessing in vivo performance to inform formulation selection and development decisions is
an important aspect of drug development. Biopredictive dissolution methodologies for oral …

Best practices for integration of dissolution data into physiologically based biopharmaceutics models (PBBM): a biopharmaceutics modeling scientist perspective

S Kollipara, AK Bhattiprolu, R Boddu, T Ahmed… - AAPS …, 2023 - Springer
Dissolution is considered as a critical input into physiologically based biopharmaceutics
models (PBBM) as it governs in vivo exposure. Despite many workshops, initiatives by …

Exploring clinically relevant dissolution specifications for oral solid dosage forms of weak acid drugs using an in silico modeling and simulation approach

A Kambayashi, C Yomota - European Journal of Pharmaceutical Sciences, 2021 - Elsevier
The aim of this study was to explore clinically relevant dissolution specifications for weak
acid drugs using an in silico drug absorption model. Loxoprofen sodium and ibuprofen were …

Current status and future opportunities for incorporation of dissolution data in PBPK modeling for pharmaceutical development and regulatory applications: OrBiTo …

M Jamei, B Abrahamsson, J Brown, J Bevernage… - European Journal of …, 2020 - Elsevier
In vitro dissolution experiments are used to qualitatively assess the impact of formulation
composition and process changes on the drug dosage form performance. However, the use …

Progressive tools and critical strategies for development of best fit PBPK model aiming better in vitro-in vivo correlation

A Golhar, M Pillai, P Dhakne, N Rajput, T Jadav… - International Journal of …, 2023 - Elsevier
Nowadays, conducting discriminative dissolution experiments employing physiologically
based pharmacokinetic modeling (PBPK) or physiologically based biopharmaceutical …

Drug dissolution in oral drug absorption: workshop report

K Raines, P Agarwal, P Augustijns, A Alayoubi, L Attia… - The AAPS Journal, 2023 - Springer
The in-person workshop “Drug Dissolution in Oral Drug Absorption” was held on May 23–
24, 2023, in Baltimore, MD, USA. The workshop was organized into lectures and breakout …

Mechanistic models for USP2 dissolution apparatus, including fluid hydrodynamics and sedimentation

X Pepin, M Goetschy, S Abrahmsén-Alami - Journal of Pharmaceutical …, 2022 - Elsevier
Drug product dissolution is a key input to Physiologically Based Biopharmaceutics Models
(PBBM) to be able to predict in vivo dissolution. The integration of product dissolution in …

Mechanistic deconvolution of oral absorption model with dynamic gastrointestinal fluid to predict regional rate and extent of GI drug dissolution

A Yu, MJ Koenigsknecht, B Hens, JR Baker, B Wen… - The AAPS journal, 2020 - Springer
Multiple approaches such as mathematical deconvolution and mechanistic oral absorption
models have been used to predict in vivo drug dissolution in the gastrointestinal (GI) tract …

Linking the gastrointestinal behavior of ibuprofen with the systemic exposure between and within humans—part 2: fed state

P Paixão, M Bermejo, B Hens, Y Tsume… - Molecular …, 2018 - ACS Publications
Exploring the intraluminal behavior of an oral drug product in the human gastrointestinal (GI)
tract remains challenging. Many in vivo techniques are available to investigate the impact of …