impact of excipients [Dissolution / BCS / IVIVC]

posted by Dr_Dan  – Germany, 2013-09-27 14:35 (4652 d 18:54 ago) – Posting: # 11569
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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

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