Bioequivalence and Bioavailability Forum

HI,

Today I have seen BE recommendation of Levomilnacipran ER capsules, the dissolution medium to be used in in-vitro dose dumping in alcohol test is water in testing conditions and 0.1N HCl in the proposed method of test 1.

Dissolution media mentioned in OGD is water.

I believe that the in-vitro dose dumping in alcohol test compares the dissolution performance of the generic (test) product and the RLD by substituting various concentrations (0%, 5%, 20% and 40% (v/v)) of test medium [0.1N HCl] with Alcohol USP and 0.1N HCl is used as baseline medium to approximate conditions in the stomach, since most of a dose of alcohol is absorbed through the gastric mucosa.

I have seen almost all the BE recommendations which recommends to use 0.1N HCL for these studies. Then what might be the basis of water as test medium for this product. If it is water then what is the significance of using 0.1N HCl in test 1. These are the questions raised when i have seen this guideline.

Looking for other opinions too.

Regards,
Bharathi