Dissolution Test : Limitations
We all studied dissolution test as the important thing that mimic the in-vivo fate of drug/dosage form.
Despite the fact that dissolution testing is a fundamental part of drug product development and regulatory approval process, it has been a subject of frequent criticism for its limitations of sometimes being non-discriminating, over-discriminating, and formulation specific IVIVC.
But beside all these limitations it is the method that satisfy almost all the requirement for the regulatory approval.
Dissolution itself is a complex procedure & need to be modified depending upon various parameters that we studied. But these limitations is also required to evaluate the dosage form or for IVIVC.