discriminatory methods? [Dissolution / BCS / IVIVC]

posted by Dr_Dan  – Germany, 2014-04-04 12:43 (3763 d 04:44 ago) – Posting: # 12766
Views: 9,940

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

Kind regards and have a nice day

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