Testing amiodarone HCl solubility and dissolution in biorelevant media

Drug: amiodarone HCl tablet
Therapeutic category: anti-arrhythmic
Release: immediate
Type: basic salt
Food effect: positive
BCS classification: class 2                   

In vitro biorelevant dissolution tests were conducted on a generic formulation of the cardiovascular molecule amiodarone HCl (Reference drug product: Cordarone X®) which is marketed in the UK. In vivo this lipophilic drug has a relatively narrow therapeutic index, variable absorption and therefore it is recommended to take amiodarone tablets consistently with meals. The biorelevant tests were able to give clear insights into the mechanism of the food effect on amiodarone HCl absorption and identify how to test and develop bioequivalent test formulations to match the dissolution release profile to the originator.

If you would like to find out how biorelevant tests can help you during the development of your test product before you start your human bioequivalence clinical trials, contact our Technical Support team and they will happy to discuss this with you.