Palani Shanmugasundaram1*and Kamarapu Sudheerkumar2
1Director, School of Pharmaceutical Sciences, VISTAS, VELS University, Chennai, Tamilnadu, India.
2Research Scholar, Department of Pharmaceutical analysis, School of Pharmaceutical Sciences, VISTAS, VELS University, Chennai, Tamilnadu, India.
A B S T R A C T
Dissolution testing is a valuable tool that provides key information about bioavailability or bioequivalency as well as batch to batch consistency of drug. Since the number of poorly soluble drug is increasing, the selection of adequate dissolution test for these becomes more and more important. Biorelevant is a term, used to describe a medium that has same relevance to the in vivo dissolution condition for the compound. The development of biorelevant dissolution medium includes simulation of gastrointestinal condition, hydrodynamic characteristics, and physicochemical parameters of drug, prediction of plasma profile and lastly the development of IVIVC. Simulation of gastrointestinal conditions is essential to adequately predict the in vivo behavior of drug formulations. To reduce the size and number of human studies required to identify a drug product with appropriate performance in both the fed and fasted states, it is advantageous to be able to pre-screen formulations in vitro. The choice of appropriate media for such in vitro tests is crucial to their ability to correctly forecast the food effect in pharmacokinetic studies.
Keywords: Biorelevant media, fasted state, fed state, simulated gastrointestinal condition, hydrodynamic, IVIVC.