Using f2 for compounds that never reach 85% dissolution [Dissolution / BCS / IVIVC]

posted by wligtenberg – The Netherlands, 2017-01-04 11:46 (2958 d 07:36 ago) – Posting: # 16928
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❝ As the experts are apparently still on holiday :-) I might start with some questions/remarks.

❝ Liposomes with doxorubicin (just wild guessing here ;-) ) are no oral formulation afaik. Why would you do dissolution testing (simulation GI tract, normally)?


Wrong guess. :)

❝ The fraction of dose you get into solution pretty much depends on the media you use for your testing, in my opinion.

❝ So maybe some more details on the kind of products/projects your on might be helpful to get more response. :-)


In this case it is for eye drops. So some medium that resembles tears would make sense, right? So I do think that comparing dissolution makes sense in this case, even though it is not the GI tract.

That still leaves the issue that we will not reach 85% dissolution in that medium. And I do think we should not keep many time points from the plateau phase.

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