Abstract
Although oral drug delivery is the preferred administration route and has been used for centuries, modern drug discovery and development pipelines challenge conventional formulation approaches and highlight the insufficient mechanistic understanding of processes critical to oral drug absorption. This review presents the opinion of UNGAP scientists on four key themes across the oral absorption landscape: (1) specific patient populations, (2) regional differences in the gastrointestinal tract, (3) advanced formulations and (4) food-drug interactions. The differences of oral absorption in pediatric and geriatric populations, the specific issues in colonic absorption, the formulation approaches for poorly water-soluble (small molecules) and poorly permeable (peptides, RNA etc.) drugs, as well as the vast realm of food effects, are some of the topics discussed in detail. The identified controversies and gaps in the current understanding of gastrointestinal absorption-related processes are used to create a roadmap for the future of oral drug absorption research.
Highlights
Oral absorption is the cornerstone of oral drug delivery, which is the most convenient and widely used administration route
This review presents the opinion of UNGAP scientists on four key themes across the oral absorption landscape: (1) specific patient populations, (2) regional differences in the gastrointestinal tract, (3) advanced formulations and (4) food-drug interactions
The UNGAP programme is an example of a vehicle in which information relevant to oral drug absorption and nutrition is freely exchanged, scientists find ways to advance and disseminate knowledge and training for the generation and discoveries are made
Summary
Oral absorption is the cornerstone of oral drug delivery, which is the most convenient and widely used administration route. The realization that peptides, proteins and nucleic acids can be potent medicinal agents has split modern drug discovery pipelines in two separate streams: classical, small-molecule therapeutics [5] and high molecular weight biologicals [4,6,7] These two directions in the development of therapeutic entities have strikingly different (even completely opposite) physicochemical and biopharmaceutical properties, which pose specific challenges to their oral delivery. There is poor availability of GIT physiology and clinical PK data for specific patient populations These knowledge gaps result in substantial limitations in the development and validation of in vitro and in silico tools representative of special populations, which is a critical gap in the development of new medicines [42,43].
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