increased solubility = different PK profile? [Dissolution / BCS / IVIVC]

posted by Kiran – 2017-06-24 13:02 (2496 d 21:06 ago) – Posting: # 17499
Views: 13,453

Hello everyone,

I am new to the group, found this topic interested, can we decrease the extent of release of test product containing highly soluble polymorphic form by varying formulation changes in order to match the dissolution profile with that of reference product containing low soluble polymorphic form ??.

I am asking thus because inorder to match the dissolution profile of low soluble polymorphic form of generic product with that of highly soluble polymorphic form of reference products we generally adopt methods such as micronisation, adding solubility enhancers, solid dispersion technology .

Any opinions???

Edit: Full quote removed. Please delete everything from the text of the original poster which is not necessary in understanding your answer; see also this post #5! [Helmut]

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