Why to test your oral drug in fed state stomach fluids
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.
To understand the effect of food on drug absorption, complementary dissolution data in FeSSIF, FaSSIF and FaSSGF is also essential. All of these biorelevant media can be prepared from products available here.