impact of excipients [Dissolution / BCS / IVIVC]
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
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
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Kind regards and have a nice day
Dr_Dan
Kind regards and have a nice day
Dr_Dan
Complete thread:
- impact of excipientsDr_Dan 2013-09-27 12:35
- impact of excipients jag009 2013-09-27 21:44
- impact of excipients luvblooms 2013-09-30 06:29
- impact of excipients Dr_Dan 2013-10-02 10:12
- impact of excipients luvblooms 2013-10-03 05:53
- impact of excipients Dr_Dan 2013-10-02 10:12
