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Registerdiscriminatory methods? [Dissolution / BCS / IVIVC]
Dear mahonny
Keeping in mind that both drugs are good soluble the results you present look rather strange and I would not draw any conclusion from these data. I suggest to evaluate if your method is discriminatory. In case of BCS class I and III substances you would expect dissolution profiles which show a rapid onset with more than 85% dissolution after 15 min. or at least after 30 min. and about 100% at the end for each pH level. If you show this for the reference product you can evaluate if your products is suitable.
I hope this helps
Dr_Dan
Keeping in mind that both drugs are good soluble the results you present look rather strange and I would not draw any conclusion from these data. I suggest to evaluate if your method is discriminatory. In case of BCS class I and III substances you would expect dissolution profiles which show a rapid onset with more than 85% dissolution after 15 min. or at least after 30 min. and about 100% at the end for each pH level. If you show this for the reference product you can evaluate if your products is suitable.
I hope this helps
Dr_Dan
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Kind regards and have a nice day
Dr_Dan
Kind regards and have a nice day
Dr_Dan
Complete thread:
- A fixed dose combination dissolution evaluation mahonny 2014-04-04 09:00
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- 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 evaluation luvblooms 2014-04-07 08:28
- A fixed dose combination dissolution evaluation mahonny 2014-04-14 15:22
- A fixed dose combination dissolution evaluation luvblooms 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
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