The gut lumen is a complex and dynamic environment presenting several barriers to oral drug delivery. The variable pH range, plethora of intestinal and bacterial enzymes, and presence of numerous transporters has a significant impact on the solubility, stability, and absorption of drug compounds. Assessing drug behavior throughout the GI tract is a critical pre-formulation step to support candidate selection, and to help design optimal drug delivery systems.
Assess drug solubility, stability, and permeability in the GI tract (stomach, small intestine, and colon)
Drug profiling using biological fluids and tissues from human subjects (in healthy and diseased states)
Profiling using biological fluids and tissues from relevant animal species
Comprehensive knowledge of human and animal GI physiology
Cutting-edge experience with biologics, including peptides and monocolonal antibodies
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Intract has developed unique models as a rapid and cost-effective means to evaluate drugs in the GI compartments of both animals and humans. Our strategic clinical collaborations provide unique access to biological fluids and tissue samples from healthy subjects, as well as patients with GI diseases.
The models have been used to evaluate numerous small molecules and biologics with distinct physicochemical and biopharmaceutical properties. Our comprehensive knowledge and capabilities can support both preclinical animal studies and advanced product development for greater clinical success.
Our GI models can determine if limited solubility or intestinal degradation will impact drug bioavailability and efficacy.
We have unique access to human gastric fluids (HGF) and small intestinal fluids (HIF) from healthy and diseased subjects providing unparalleled in vivo predictions.
For over a decade, our CSM has provided unique insights into the colonic behavior of both drug compounds and product formulations.
Using bio-relevant inoculum, proprietary media, and a specialist anaerobic work-station, our model accurately mimics the conditions of the large intestine.
We can assess drug behavior in specific regions of GI tissue from humans and animals including:
Mucosal stability
Localization by laser microscopy and quantification by ELISA
Permeation and bioavailability
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