Bioequivalence and Bioavailability Forum • discriminatory methods?

discriminatory methods? [Dissolution / BCS / IVIVC]

posted by Dr_Dan – Germany, 2014-04-04 14:43 (3672 d 15:37 ago) – Posting: # 12768
Views: 9,657

Dear mahonny,
I do not believe that main reason for relatively low solubility at 50 rpm is the particle size of the API1 in reference product since large particles dissolve more slowly indeed but at the end completely so that you will get 100% dissolution even if the profile is different. But you show differences in the proportion of dissolved API between your test and the reference formulation. I suggest to perform some more solubility and dissolution tests. On basis of the presented data I would not dare to give advice.
Kind regards
Dr_Dan

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Kind regards and have a nice day
Dr_Dan

Complete thread:

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