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Registerregulatory authorities have a different view [Dissolution / BCS / IVIVC]
Dear Mauricio
in contrast to stable drugs the curve of the dissolution profile of a capecetabine formulation will not asymptotically approximate the 100% but decline after reaching a maximum which can not be 100%. It is reasonable to assume that everything is all right as Long as you can show similarity of the disso profile of your test formulation with the reference formulation, however, you have no proof. IMHO this is the reason why regulatory authorities have a different view (see this recent post of Helmut). In disso testing you regard two processes, disintegration and dissolution. In case of capecitabine there is a third process, degradation. It could be assumed that this third processes superimposes the first two processes and that therefore differences in formulation can not be detected.
I hope this helps.
Kind regards
Dr_Dan
in contrast to stable drugs the curve of the dissolution profile of a capecetabine formulation will not asymptotically approximate the 100% but decline after reaching a maximum which can not be 100%. It is reasonable to assume that everything is all right as Long as you can show similarity of the disso profile of your test formulation with the reference formulation, however, you have no proof. IMHO this is the reason why regulatory authorities have a different view (see this recent post of Helmut). In disso testing you regard two processes, disintegration and dissolution. In case of capecitabine there is a third process, degradation. It could be assumed that this third processes superimposes the first two processes and that therefore differences in formulation can not be detected.
I hope this helps.
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:
- Biowaiver for Capecitabine - FDA x EMA Mauricio Sampaio 2015-09-08 20:38
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Biowaiver for Capecitabine - FDA x EMA Dr_Dan 2015-09-09 09:00
- Biowaiver for Capecitabine - FDA x EMA Mauricio Sampaio 2015-09-09 18:42
- …as well as the solubility Dr_Dan 2015-09-10 08:52
- …as well as the solubility Mauricio Sampaio 2015-09-15 06:56
- regulatory authorities have a different viewDr_Dan 2015-09-15 08:53
- regulatory authorities have a different view Mauricio Sampaio 2015-09-17 06:44
- regulatory authorities have a different viewDr_Dan 2015-09-15 08:53
- …as well as the solubility Mauricio Sampaio 2015-09-15 06:56
- Biowaiver for Capecitabine - FDA x EMA Dr_Dan 2015-09-09 09:00
Ing. Helmut Schütz