[HTML][HTML] Successful oral delivery of poorly water-soluble drugs both depends on the intraluminal behavior of drugs and of appropriate advanced drug delivery systems

BJ Boyd, CAS Bergström, Z Vinarov, M Kuentz… - European Journal of …, 2019 - Elsevier
Poorly water-soluble drugs continue to be a problematic, yet important class of
pharmaceutical compounds for treatment of a wide range of diseases. Their prevalence in …

[HTML][HTML] Impact of regional differences along the gastrointestinal tract of healthy adults on oral drug absorption: An UNGAP review

M Vertzoni, P Augustijns, M Grimm, M Koziolek… - European journal of …, 2019 - Elsevier
Oral administration is the most common route of drug delivery. The absorption of a drug from
the gut into the bloodstream involves disintegration of the solid dosage form, dissolution of …

The biopharmaceutics classification system (BCS) and the biopharmaceutics drug disposition classification system (BDDCS): beyond guidelines

A Charalabidis, M Sfouni, C Bergström… - International journal of …, 2019 - Elsevier
The recent impact of the Biopharmaceutics Classification System (BCS) and the
Biopharmaceutics Drug Disposition Classification System (BDDCS) on relevant scientific …

[HTML][HTML] In vitro models for the prediction of in vivo performance of oral dosage forms: recent progress from partnership through the IMI OrBiTo collaboration

J Butler, B Hens, M Vertzoni, J Brouwers… - European Journal of …, 2019 - Elsevier
The availability of in vitro tools that are constructed on the basis of a detailed knowledge of
key aspects of gastrointestinal (GI) physiology and their impact on formulation performance …

Navigating the human gastrointestinal tract for oral drug delivery: Uncharted waters and new frontiers

M Koziolek, M Grimm, F Schneider, P Jedamzik… - Advanced Drug Delivery …, 2016 - Elsevier
Many concepts of oral drug delivery are based on our comprehension of human
gastrointestinal physiology. Unfortunately, we tend to oversimplify the complex interplay …

Intragastric pH and pressure profiles after intake of the high-caloric, high-fat meal as used for food effect studies

M Koziolek, F Schneider, M Grimm, C Modeβ… - Journal of controlled …, 2015 - Elsevier
The intraluminal conditions of the fed stomach are critical for drug release from solid oral
dosage forms and thus, often associated with the occurrence of food effects on oral …

Parameterization of physiologically based biopharmaceutics models: workshop summary report

X Pepin, S Arora, L Borges, M Cano-Vega… - Molecular …, 2024 - ACS Publications
This Article shares the proceedings from the August 29th, 2023 (day 1) workshop
“Physiologically Based Biopharmaceutics Modeling (PBBM) Best Practices for Drug Product …

Selection of In Vivo Predictive Dissolution Media Using Drug Substance and Physiological Properties

DM Mudie, N Samiei, DJ Marshall, GE Amidon… - The AAPS journal, 2020 - Springer
The rate and extent of drug dissolution in the gastrointestinal (GI) tract are highly dependent
upon drug physicochemical properties and GI fluid properties. Biorelevant dissolution media …

[HTML][HTML] Oral delivery of non-viral nucleic acid-based therapeutics-do we have the guts for this?

CM O'Driscoll, A Bernkop-Schnürch, JD Friedl… - European Journal of …, 2019 - Elsevier
Gene therapy with RNA and pDNA-based drugs is limited by poor enzymatic stability and
poor cellular permeation. The delivery of nucleic acids, in particular by the oral route …

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 …