What is FEDGAS?
FEDGAS (Fed State Simulated Gastric Fluid AKA FeSSGF) is a very useful drug development tool. Tests in these dissolution media can help reveal how your oral drug is likely to dissolve in gastric fluids after eating a high-fat FDA meal during the early, mid and late stages of emptying. Although drugs are generally not absorbed in the stomach, the interaction with fed gastric fluids can have a big influence on the absorption of many lipophilic drugs when the contents are transferred to the intestines. The stability, solubility and dissolution data you generate from testing in FEDGAS can help identify critical factors influencing your drug’s behaviour and subsequent absorption in the fed state. These results also support your selection of the appropriate solid state and formulation approach for your drug. Experiments are performed using standard laboratory equipment (such as USP Dissolution Apparatus 1 or 2). Drug content is analysed using HPLC.
What’s the composition of FEDGAS?
FEDGAS in vitro test solutions simulate stomach fluids after consumption of a high-fat FDA meal. The FDA meal is frequently co-administered with drugs in human clinical trials to assess potential food effects on a drug’s pharmacokinetics by eliciting an extreme physiological response in the gut. 900mL of FEDGAS medium contains the same amount of fat present in this meal. The three different types of FEDGAS (early, mid and late) represent fluids from different stages of stomach emptying (pH 3, pH 4.5 and pH 6 respectively). FEDGAS also replicates the dietary fibre and carbohydrate content of the FDA meal. Bile salt that is refluxed back into the stomach from the upper section of the small intestine during digestion is mimicked too.
You can learn more about FEDGAS and purchase the product here.