Failed fasting but passed fed study [Dissolution / BCS / IVIVC]

posted by Bhupesh  – India, 2008-03-13 12:00  – Posting: # 1686
Views: 5,022

Dear Friends
Regards :-)
We are working on a BCS class two molecule which is enteric coated. We are getting very good results in Fed pilot study but getting lower T/R% ratios in Fasting study. We checked release in ph 1.2, 2.98 and 4.5 buffer, the drug is not getting released in these media and this is shown in the biostudy also where we are getting a lag time of 1-3 hr.
What may be the reason of this failure in fasting biostudy and how to solve it? :ponder:
Thanks a lot.............

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