What is FEDGAS?
FEDGAS (Fed Gastric Fluid) biorelevant media are analytical laboratory test solutions that simulate different types of stomach fluids after eating an FDA meal. This standardized, high-fat meal is used in human bioequivalence clinical studies to trigger a significant digestive response, enabling the effect of food on the bioavailability of a co-administered drug to be examined.
The solubilization power of these fed state media allows developers of BCS Class 2 drugs to compare in vitro dissolution profiles of Test and Reference products to see if there are differences in release rates within a gastrointestinal environment. Different in vitro release rates will help discriminate and spot relevant differences between the Test and Reference formulation.
What is in FEDGAS?
FEDGAS contains the full level of fat of an FDA meal along with carbohydrates, water soluble fibre and the low level of bile salts that is present in actual fed state stomach fluid due to intestinal reflux.
How do I make FEDGAS?
FEDGAS dissolution media can be prepared in less than a couple of minutes with FEDGAS Gel and the appropriate diluted FEDGAS Buffer Concentrate (Early, Mid or Late).