A fixed dose combination dissolution evaluation [Dissolution / BCS / IVIVC]
Dear Mahonny
As said, you should look for some more solubility and dissolution tests. With the current data I would be worried for my BE out come.
Regards
❝ Any more comments from different point of views are highly appreciated...
- Was there any heap formation at 50 rpm? The difference between 50 and 75 rpm points towards.
- Why not trying basket apparatus and check?
- Is there any impact of DT or any formulation excipients on solubility or release? As the end release is different in different media, this could be because of differential solubility of some excipient in different pH conditions. For class I and III drug, particle size will not have major effect but excipients will have.
As said, you should look for some more solubility and dissolution tests. With the current data I would be worried for my BE out come.
Regards
—
~A happy Soul~
~A happy Soul~
Complete thread:
- A fixed dose combination dissolution evaluation mahonny 2014-04-04 09:00 [Dissolution / BCS / IVIVC]
- discriminatory methods? Dr_Dan 2014-04-04 10:43
- discriminatory methods? mahonny 2014-04-04 11:12
- discriminatory methods? Dr_Dan 2014-04-04 12:43
- discriminatory methods? mahonny 2014-04-04 11:12
- A fixed dose combination dissolution evaluation mahonny 2014-04-04 13:29
- A fixed dose combination dissolution evaluationluvblooms 2014-04-07 08:28
- A fixed dose combination dissolution evaluation mahonny 2014-04-14 15:22
- A fixed dose combination dissolution evaluationluvblooms 2014-04-07 08:28
- A fixed dose combination dissolution evaluation susan dong 2018-11-26 08:35
- A fixed dose combination dissolution evaluation snow2020 2018-12-05 06:27
- discriminatory methods? Dr_Dan 2014-04-04 10:43