Amorphous solid dispersions: An update for preparation, characterization, mechanism on bioavailability, stability, regulatory considerations and marketed products

P Pandi, R Bulusu, N Kommineni, W Khan… - International journal of …, 2020 - Elsevier
Amorphous solid dispersions (ASDs) are being employed frequently to improve
bioavailability of poorly soluble molecules by enhancing the rate and extant of dissolution in …

[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] Current challenges and future perspectives in oral absorption research: An opinion of the UNGAP network

Z Vinarov, B Abrahamsson, P Artursson… - Advanced Drug Delivery …, 2021 - Elsevier
Although oral drug delivery is the preferred administration route and has been used for
centuries, modern drug discovery and development pipelines challenge conventional …

[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 role of functional excipients in solid oral dosage forms to overcome poor drug dissolution and bioavailability

J Van der Merwe, J Steenekamp, D Steyn, J Hamman - Pharmaceutics, 2020 - mdpi.com
Many active pharmaceutical ingredients (APIs) exhibit poor solubility and low dissolution
rates in aqueous environments such as the luminal fluids of the gastrointestinal tract. The …

Impact of gastric pH variations on the release of amorphous solid dispersion formulations containing a weakly basic drug and enteric polymers

HT Nguyen, T Van Duong, LS Taylor - Molecular Pharmaceutics, 2023 - ACS Publications
Enteric polymers are widely used in amorphous solid dispersion (ASD) formulations. The
aim of the current study was to explore ASD failure mechanisms across a wide range of pH …

Exploring gastrointestinal variables affecting drug and formulation behavior: methodologies, challenges and opportunities

B Hens, M Corsetti, R Spiller, L Marciani… - International Journal of …, 2017 - Elsevier
Various gastrointestinal (GI) factors affect drug and formulation behavior after oral
administration, including GI transfer, motility, pH and GI fluid volume and composition. An in …

Gastric water emptying under fed state clinical trial conditions is as fast as under fasted conditions

M Grimm, E Scholz, M Koziolek, JP Kühn… - Molecular …, 2017 - ACS Publications
The Magenstrasse (stomach road) describes the fast emptying of ingested liquids from the
postprandial stomach. The occurrence of the Magenstrasse has great importance for drugs …

Role of physiologically based biopharmaceutics modeling (PBBM) in fed bioequivalence study waivers: regulatory outlook, case studies and future perspectives

S Kollipara, FS Martins, M Sanghavi… - Journal of …, 2024 - Elsevier
Over the past few decades, physiologically based biopharmaceutics modeling (PBBM) has
demonstrated its utility in both new drug and generic product development. Applications of …

[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 …