Bioequivalence and Bioavailability Forum

❝ Hi Mr.Helmet,

Helmut, not Helmet.

❝ We have regulations in our country to perform a comparative dissolution test before bioequivalence…

Not uncommon.

❝ …and in these results I face this problem mainly in the actives with low solubility and low release profile without surfactant.

Add a surfactant.

❝ What could be done in this case ?

See above. Note that for BCS classes II/IV in vitro dissolution is rarely predictive of in vivo per­for­mance. Even if you find dissimilar dissolution, products might still be BE. If you are in doubt, run a pilot study. Most agencies require in vitro data, but in vivo BE overrules dissolution.
I’m not familiar with the Egyptian regulation: Do you mean that you are not allowed to per­form a BE study for products lacking dissolution similarity? That would be weird.