Difference between tablet and film tablet [Regulatives / Guidelines]

posted by ElMaestro  – Denmark, 2015-11-24 23:01 (3368 d 08:28 ago) – Posting: # 15669
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Hi wienui,

❝ I have a question regarding to the Bioequivalence (BE) study of IR tablets vs IR Film coated (F.C.) tablets.


❝ if the BE study is done for the IR Tablets formulation and the manufacture want to register the IR Film coated tablets formulation, should he need to conduct a new BE study for this formulation?

❝ what I think is that the Pk behaviour for the two formulations ( especially the absorption process) will be totally different which could definitely different consequences of therapeutic effect. Please correct me if I'm wrong.


Since a film coat usually does not modify the release, this might be a situation where you can argue to use just dissolution. Show that the fc tablets behave like the ordinary tablet.

Pass or fail!
ElMaestro

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