How can Biorelevant Media be discriminatory?

When selected and used correctly, Biorelevant Media are perfect discriminatory dissolution tools for evaluating a Test formulation against the Originator. This is because the interaction of the formulations with physiological components of the Biorelevant Media mimic wetting and dissolution processes that occur in vivo. This means relevant formulation differences (for example polymorph and particle size) influencing the release from Test and Reference Products into the intestinal fluids can be identified. If the Test and Reference Product have the same in vivo dissolution profile under all luminal conditions, they will have the same rate and extent of absorption and will be bioequivalent.

Selecting the appropriate Biorelevant Media is crucial. You must select media that will reveal differences. For example, FaSSGF can often mask differences of water insoluble bases and FaSSIF may be inappropriate for a high dose drug as drug release may be limited.  

Download our Biorelevant Dissolution Guides here.