What are biorelevant media?
Biorelevant media simulate gut fluids more accurately than any other dissolution media. They contain components (bile salts, phospholipids and salts) which replicate conditions found in the gastrointestinal tract such as the solubilizing properties, pH and osmolality. Compositions of different biorelevant media (FaSSIF, FeSSIF and FaSSGF for example) vary depending upon the location and fed/fasted condition of the fluid they are simulating. By testing in them, you can investigate in vitro how your oral drug is likely to dissolve in vivo.
How can biorelevant media help develop new drugs (NCEs)?
Whether you're a chemist, biologist or pharmacist involved in the development a new oral drug (NCE: New Chemical Entity), biorelevant media are incredibly useful tools. Biorelevant tests provide important information on the amount of drug (solubility) and speed (dissolution) at which it will dissolve within different gastrointestinal fluids. Combined with a drug's biopharmaceutical data, these results can help identify potential developability problems related to absorption and food effects, enabling you to select the most appropriate oral formulation strategy for your drug. Because these in vitro media resemble gut fluids so closely, they are also useful for establishing in vitro in vivo correlations (IVIVCs). When coupled with physiological data, results can be correlated with the pharmacokinetics of an orally administered drug.
How can biorelevant media help develop bioequivalent generic drugs?
Testing in biorelevant media enables you to compare how closely your test drug product will match the dissolution of the Reference Listed Drug (RLD) in simulated gastrointestinal fluids. This is important because the results help you identify Test Formulations which will have the same absorption and be bioequivalent to the Reference Listed Drug. Biorelevant testing is most beneficial when carried out before you test your formulations in bioequivalence studies, so you can make any adjustments to your formulation before spending money on expensive human trials.