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

posted by wligtenberg – The Netherlands, 2017-01-04 11:46 (3453 d 16:34 ago) – Posting: # 16928
Views: 8,003

❝ 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.

Complete thread:

UA Flag
Activity
 Admin contact
23,655 posts in 4,993 threads, 1,570 registered users;
160 visitors (0 registered, 160 guests [including 11 identified bots]).
Forum time: 05:20 CEST (Europe/Vienna)

I have finally come to the konklusion
that a good reliable set ov bowels
iz worth more to a man
than enny quantity of brains.    Josh Billings

The Bioequivalence and Bioavailability Forum is hosted by
BEBAC Ing. Helmut Schütz
HTML5