f2 (similarity factor) calculation for enteric coated tablets

Dear All,

Please advice the requirements for the f2 calcuation for different markets and different product, especially on the f2 (similarity factor) calculation for enteric coated tablets.
(reference guideline for the similarity factor calculation for Enteric Coated tablets)

thanks in advance

Santosh Yadav

Pls visit dissolutiondiscussiongroup.com

you will definately find your answer over there.

the f2 calculation is same for both. the different is occured in the test procedure. the immediate release dosage forms could use 3 media (acidic, intermediate, and neutral), while the modified release use 2 media sequentially (acid and buffered) and 3 different speeds. please read the ICH guidance.

Find the Attachment.

Dishant Sanghavi

F1 F2.pdf (787.4 KB)