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Back to the forum  Query: 2018-04-24 10:30 CEST (UTC+2h)

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

posted by Dr_Dan - 2017-06-08 16:57  - Posting: # 17461
Views: 4,643

Dear all
there are tons of literature describing how the bioavailability of certain drugs can be improved but AFAIK this seldom leads to new products. My question in this regard is: if I have a reference product with a 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?
I guess not, but I would like to learn your opinions.
IMHO in case dissolution is the time determining step you are confronted with the following dilemma: either you can reach the same Cmax but you would have a lower AUC and vice versa you can reach the same AUC but Cmax will be increased. The shorter t1/2 the more pronounced is this effect, right?
And if you can not demonstrate bioequivalence you are forced to conduct phase III studies for the registration of your new product and this makes the new product unattractive from a commercial point of view.
Do you have any experience in this field?

Kind regards and have a nice day

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