Pharma
ProDigest's in vitro SHIME® model serves as a valuable tool for pre-clinical development of lead Active Pharmaceutical Ingredients (APIs) as it provides quick insights into the solubility, the release, the stability and the bioavailability of pharmaceutical compounds under highly standardized and biologically relevant gastro-intestinal conditions. In particular, the validated SHIME® technology allows to predict and evaluate the stability of both APIs and drug formulations in the stomach and small intestine. In addition to classical dissolution assays, the SHIME® model offers the opportunity to evaluate the stability of APIs under colonic conditions, including the complete gut microbiota.
Application of
proDigest's
technology platform
in pharmaceutical research:
The extensive and integrated data set provided by the in vitro SHIME® technology platform has been shown very useful to elucidate the specific intestinal fate, metabolism and bioavailability of APIs in the different intestinal regions, allowing to better predict in vivo pharmacokinetics of the API, to develop the optimal formulation for targeted intestinal delivery and a straightforward set up of future clinical trials. Thanks to our broad knowledge and long-standing expertise in the field of gastrointestinal research, ProDigest is a reliable partner to address a wide array of fundamental scientific answers in the early pre-clinical phase, thereby significantly accelerating the process of product development.
The high flexibility of our technology platform allows multiple-endpoints studies.
Below is a non-exhaustive list of questions that can be answered using the SHIME® technology
What is the stability of an Active Pharmaceutical Ingredient (API) in the gastro-intestinal tract (GIT) of humans or animals?
What is the pH stability and solubility of my API?
Is there any effect of microbial metabolism on the API (i.e. degradation or inactivation)?
Is there any role of the gut microbiota in the activation of pro-drugs?
How can a specific drug formulation be improved to assure a high bioavailability, bioaccessability or protection from the physiological conditions of the upper GIT?
Is the designed targeted delivery approach (e.g. encapsulation) effective?
Can we predict the pharmacokinetic behavior of a specific API?
Is the API cytotoxic following ingestion?
What is the effect of a specific API on chronic inflammation under representative gastrointestinal conditions?
What is the efficacy of the API in diseased models?
What is the effect of antibiotics on the gut microbiota? What is the minimum inhibitory concentration?