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

posted by ElMaestro  – Denmark, 2017-06-08 19:24 (2844 d 01:10 ago) – Posting: # 17465
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Dear Dr_Dan,


❝ (...) low soluble drug substance and developed a test product with an increased solubility of the same drug would it then be possible to achieve bioequivalence even if the dose of the new product can be adjusted?


Not understood.
You mean an injectable in two different solvents for T and R?
Usually formulations do not increase solubility. It is intrinsic. I probably got your basic message a bit wrong here?


❝ (...) same AUC but Cmax will be increased.

❝ Do you have any experience in this field?


It is common in the intra-nasal and inaled field to see matching AUCt and non-matching Cmax or vice versa. Sometimes -quite often even- this can be negotiated with an agency. But it requires dialogue and most important of all the right agency and the right attitude from the guys in the Armani suits who otherwise want to decide which countries to include in the first wave of DCPs.

There are no rules. Case by case, weight of evidence, yada yada yada :-):-)
—
Pass or fail!
ElMaestro

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