oral powder with water acceptable? [Regulatives / Guidelines]

posted by chris089 – Munich, Germany, 2018-04-16 13:43  – Posting: # 18687
Views: 1,808

Hello,

We have developed an oral powder for which we need to show BE to an existing tablet. I have inherited the results of a (narrowly) failed two-way BE study where the powder was administered without water and the reference with water. We have reasons to believe that the powder administered with water, would be bioequivalent to the tablet, and while it would not be as sexy marketing-wise as the intake without water, we are considering a second study where test and reference are taken with water.

Does anybody have experience, if the regulatory agencies (EU, free choice of RMS) would accept these results if only administration with water is claimed in the SmPC?

I know, that an oral powder is treated similarly to an ODT (PKWP Q&A). THE Guideline recommends a 3-period study (we would have 2x2, but should be OK), but there is no information on the consequence, if BE w/ water is demonstrated, but BE w/o water fails. Does this mean, that the whole product is considered not bioequvalent, or just that you cannot claim the application w/o water?
The famous last paragraph says "recommended use of the product", which I translate as "according to the SmPC".

Maybe it's a stupid question, but I'm new to the business. I have read the previous 1000 questions on water, but AFAIK this has not been discussed yet.

Best,
Christian

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