impact of excipients [Dissolution / BCS / IVIVC]

posted by Dr_Dan  – Germany, 2013-09-27 14:35 (4647 d 15:09 ago) – Posting: # 11569
Views: 7,706

Dear all
In general a generic product is a copy of the originator product. However, the quantitative composition of excipients is not known and sometimes the qualitative composition can not be copied due to patent issues. Applying for a BCS class biowaiver how can I demonstrate that the difference in quantitive and/or qualitative composition of my test product with regards to the the reference product does not:
modulate/alter permeability of the drug
influence intestinal residence time
alter GI motility and permeability
alter PK absorption profile
without performing respective in vivo or in vitro tests?
I am not talking about exotic exipients just the usual well established ones (Lactose, Microcrystalline Cellulose, Magnesium Stearate, Croscarmellose Sodium, Colloidal Silicon Dioxide, Hydroxypropyl Cellulose Starch, Sodium Starch etc.).
I am looking forward to your reply.
Kind regards
Dan

Kind regards and have a nice day
Dr_Dan

Complete thread:

UA Flag
Activity
 Admin contact
23,654 posts in 4,992 threads, 1,570 registered users;
171 visitors (0 registered, 171 guests [including 19 identified bots]).
Forum time: 05:44 CEST (Europe/Vienna)

Actually, science starts to become interesting
only where it ends.    Justus von Liebig

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