Bioequivalence and Bioavailability Forum

❝ OK, if you are bound to one of the FDA’s guidance (e.g., mesalamine where additionally to fasting/fed BE dissolution similarity is mandatory), there is nothing you can do. Find another supplier of the API.

Hello Mr Helmut,

Thanks for the response.

Yes you are true.

We cannot change the intrinsic nature of API (Intrinsic dissolution or solubility) by making formulation changes, but my my current situation is I have to work out with present API source or quit.

I am trying to make premix with insoluble excipient may be it can retard the release (Cmax may be affected) have to do trial and error.

Thanks and regards,
Hari Kiran

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Edit: Full quote removed. Please delete everything from the text of the original poster which is not necessary in understanding your answer; see also this post #5! [Helmut]