Testing celecoxib solubility and dissolution in biorelevant media

Drug: celecoxib capsules
Therapeutic category: anti-inflammatory
Release: immediate
Type: neutral
Food effect: positive
BCS classification: class 2                   

A variety of in vitro biorelevant dissolution tests were conducted on celecoxib capsules (Reference drug product: Celebrex®) to understand how the drug product behaved in simulated gastrointestinal fluids. The biorelevant tests were developed to evaluate and identify bioequivalent test formulations of celecoxib to match the dissolution release profile of the originator. Additionally, when the results were coupled with the physiological parameters and biopharmaceutical properties of celecoxib, a relationship between the in vitro results and the in vivo pharmacokinetics of this poorly water-soluble drug was also achieved.

If you would like to discuss how such biorelevant tests will help you accelerate the development of your test product to maximise your chances of achieving bioequivalence in your pivotal clinical trials, please feel free to contact our Technical Support team here.