Dissolution profie matching [Dissolution / BCS / IVIVC]
Hello Kiran,
I only ever heard of generic companies going for anther crystal morph when they had to work around an IP issue. Noone that I have ever met would ever accept it for any other reason.
Try and look up, if you can, Potassium Chloride SR in EU. The API is othwerwise dissolving insanely fast. It's one of them resin-wax-oral-semi-solid-rubber-sponge thingies. I do apologise if that is not exactly what the formulation principle is actually called but I feel I am pretty close.
If I got it right the dissolution in that ...errrmmm... thing... is controlled simply by exposing some but very little API to the solvent at any and all times.
I only ever heard of generic companies going for anther crystal morph when they had to work around an IP issue. Noone that I have ever met would ever accept it for any other reason.
❝ Any suggestions???
Try and look up, if you can, Potassium Chloride SR in EU. The API is othwerwise dissolving insanely fast. It's one of them resin-wax-oral-semi-solid-rubber-sponge thingies. I do apologise if that is not exactly what the formulation principle is actually called but I feel I am pretty close.
If I got it right the dissolution in that ...errrmmm... thing... is controlled simply by exposing some but very little API to the solvent at any and all times.
—
Pass or fail!
ElMaestro
Pass or fail!
ElMaestro
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 mandatory Kiran 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 matchingElMaestro 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