locally acting / diss. similarity mandatory [Dissolution / BCS / IVIVC]
❝ 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
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]
Complete thread:
- Dissolution profie matching Kiran 2017-06-24 18:25 [Dissolution / BCS / IVIVC]
- in vivo data before tweaking in vitro Helmut 2017-06-24 19:30
- in vivo data before tweaking in vitro Kiran 2017-06-24 20:19
- locally acting / diss. similarity mandatory Helmut 2017-06-25 12:48
- locally acting / diss. similarity mandatoryKiran 2017-06-25 16:40
- locally acting / diss. similarity mandatory Helmut 2017-06-25 12:48
- in vivo data before tweaking in vitro Kiran 2017-06-24 20:19
- Dissolution profie matching ElMaestro 2017-06-25 20:21
- Dissolution profie matching Kiran 2017-06-26 05:11
- in vivo data before tweaking in vitro Helmut 2017-06-24 19:30