Bioequivalence and Bioavailability Forum

❝ Because of difficulties with degradation of ivermectin at acidic pH the drug release rate was not measured at pH 1.2. But also at pH 7.0.

❝

Degradation is a substance specific characteristic. Once the tablet disintegrates and the drug dissolves the concentrations you measure both formulations should be affected in the same way. But it is very important to see if the profiles of test and reference are similar even if the shape of the curves are strange (no 100% dissolution, decline of curve etc.). In my opinion for IR formulations the results of comparable dissolution at pH 1.2 are more predictive for in vivo performance than the results of pH 6.8.
Kind regards
Dr_Dan