Solutions (T) vs Tablets (R) or Vice Versa= Invivo BE Study [Dissolution / BCS / IVIVC]

posted by Obinoscopy  – USA, 2018-07-01 04:06 (2214 d 11:59 ago) – Posting: # 19003
Views: 32,703

❝ Hello everyone. Hope the weather is better where you are than where I am.

It's 26°C here with light rain showers. I guess mine is better ;-).

❝ Am I correct in assuming that the guideline seems to imply that a solid dosage form (T) can obtain a BCS-based biowaiver versus an oral solution (R), but somehow an oral solution claiming a BCS-based biowaiver versus a tablet is not covered?

Personally I think BCS-based biowaiver is ruled out the moment the dosage form of the test and reference products are different. So whether its a solid dosage form (T) versus an oral solution (R) or vice versa, BCS-based biowaiver is to be ruled out.

❝ Personally, I think I have room to justify trying to submit a BCS-based biowaiver for an oral solution when the only option is a tablet reference product, both from a regulatory viewpoint and a scientific one.

From a scientific stand point, I think its better both the test and reference product are in the same dosage form before one can waive an invivo BE study and deduce bioequivalence from dissolution studies. This is because excipients play a very important role in BE.

It's possible for a BCS class I tablet (R) that is rapidly dissolving to have a different AUC and Cmax in plasma when compared to an oral solution (T) of same API and vice versa. This is because the different excipients in the two formulations might affect the absorption of the API differently. Its safer to apply BCS-based biowaiver on a product with a same dosage form as the reference product since the absorption of that dosage form has already been "validated". This is my thinking.

❝ Of course all this hypothesizing is moot if anyone of you already has experience with this situation. Thanks in advance.

I am also hypothesizing :-D. Also waiting for those with relevant experience on this :-).


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