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RegisterAdditional excipient justification [Dissolution / BCS / IVIVC]
Dear all
Some time ago I started a discussion about excipients (see this link) which faded out without result. So I thought this might be a good opportunity to restart. I would like to know if there is a chance to justify a different qualitative composition for a biowaiver if well established excipients are used (Lactose, Microcrystalline Cellulose, Magnesium Stearate, Croscarmellose Sodium, Colloidal Silicon Dioxide, Hydroxypropyl Cellulose Starch, Sodium Starch etc.). My Problem is that you will find an endless number of papers describing an impact of an excipient on a special drug substance. What I need is a rationale that at least for drugs considered for a biowaiver the difference in qualitative composition would not affect the in-vivo performance as long as in vitro dissolution tests show similarity between the test product and the reference.
Do you have an idea? I am looking Forward to your reply.
Kind regards
Dr_Dan
Some time ago I started a discussion about excipients (see this link) which faded out without result. So I thought this might be a good opportunity to restart. I would like to know if there is a chance to justify a different qualitative composition for a biowaiver if well established excipients are used (Lactose, Microcrystalline Cellulose, Magnesium Stearate, Croscarmellose Sodium, Colloidal Silicon Dioxide, Hydroxypropyl Cellulose Starch, Sodium Starch etc.). My Problem is that you will find an endless number of papers describing an impact of an excipient on a special drug substance. What I need is a rationale that at least for drugs considered for a biowaiver the difference in qualitative composition would not affect the in-vivo performance as long as in vitro dissolution tests show similarity between the test product and the reference.
Do you have an idea? I am looking Forward to your reply.
Kind regards
Dr_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:
- Additional excipient justification srinivasuk 2014-11-30 08:53
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Biowaiver for BCS Class II? Helmut 2014-11-30 14:24
- Additional excipient justification nobody 2014-11-30 20:44
- Additional excipient justificationDr_Dan 2014-12-02 09:34
- Additional excipient justification nobody 2014-12-02 10:38
- Additional excipient justificationDr_Dan 2014-12-02 09:34
Ing. Helmut Schütz