Testing exemestane solubility and dissolution in biorelevant media

Drug: exemestane tablet
Therapeutic category: anti-cancer
Release: immediate
Type: neutral
Food effect: positive
BCS classification: class 2                   

In vitro biorelevant solubility and dissolution tests were conducted on the steroidal anticancer molecule exemestane (reference drug product Aromasin) and a generic formulation widely marketed in Europe. These biorelevant tests were able to detect a significant difference in vitro between originator and test formulation. This difference was also translated in vivo when the bioavailability of the two exemestane tablets was tested.

If you would like to discuss how biorelevant tests can help you match the dissolution release profile of your test product to the originator before you start your human bioequivalence clinical trials, feel free to contact our Technical Support team here.