Gastrointestinal Variables and Drug Absorption: Experimental, Computational and In Vitro Predictive Approaches, Volume II
A special issue of Pharmaceutics (ISSN 1999-4923). This special issue belongs to the section "Biopharmaceutics".
Deadline for manuscript submissions: closed (20 March 2024) | Viewed by 6707
Special Issue Editors
Interests: oral absorption; intestinal permeability methods; in vitro–in vivo correlations; PK modelling
Special Issues, Collections and Topics in MDPI journals
Interests: PBPK; biowaivers; pharmacokinetics; dissolution; absorption; drug solubility
Special Issues, Collections and Topics in MDPI journals
Special Issue Information
Dear Colleagues,
As more and more poorly soluble compounds (i.e., Biopharmaceutics Classification System (BCS) class 2 and 4 compounds) populate the pharmaceutical pipeline, developing a drug formulation that shows sufficient bioavailability (BA) after oral administration of the drug product is becoming tremendously challenging. Nevertheless, enabling formulations are gaining a lot of momentum as these strategies focus on increasing luminal concentrations along the human gastrointestinal (GI) tract in order to gain higher driving forces for intestinal absorption. Increasing luminal concentrations can be established by increasing the solubilization of the drug or by creating supersaturated concentrations. As GI physiology is extremely dynamic at the time of administration, predicting luminal behaviour for these drug compounds is challenging when formulated as an enabling formulation. Indeed, GI variables such as residual volumes, emptying and transit times may positively or negatively impact the luminal concentrations of drugs. What is even more challenging is demonstrating bioequivalence (BE) for generic drug candidates formulated as enabling formulations. From that perspective, significant attention is directed toward in silico modelling where virtual BE populations can be applied to study interindividual variability and to design a so-called safe space for dissolution in order to achieve the new candidate formulation. As these simulations are supported by the input of data derived from in vitro studies (e.g., solubility, dissolution and permeability), this is a promising strategy for establishing biowaivers for these formulations.
In this Special Issue, we will focus on studies that were performed to explore how in vivo, in vitro and in silico approaches can serve as a solid basis for predicting in vivo performances of enabling formulations in different populations (e.g., paediatrics, elderly and patients). This Special Issue is open for in vivo, in vitro and in silico investigations that were conducted to predict oral BA or BE for these formulations.
Prof. Dr. Marival Bermejo
Prof. Dr. Isabel Gonzalez-Alvarez
Dr. Bart Hens
Guest Editors
Manuscript Submission Information
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Keywords
- oral bioavailability
- in vitro dissolution testing
- in silico modeling
- in vivo techniques
- gastrointestinal
- PopPK
- PBPK modeling
- virtual bioequivalence
- oral drug absorption
- enabling formulations
- solid dispersions
- lipid-based formulations
- nanoparticles and microparticles
- in vivo dissolution
- human intubation studies
- MRI
- Manometry
- computational fluid dynamics
- oral absorption
- bioequivalence
- gastrointestinal motility
- human intestinal fluids
- BCS
- intestinal permeability
- in vitro dissolution methods
