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Register…as well as the solubility [Dissolution / BCS / IVIVC]
Dear Dan, thank you for clarification! Now I understood your last position about intrinsic property of Capecitabine. You are totally correct!
By the way, if capecitabine is unstable in acidic medium and this unstability is gradative in accordance with the passage of time, I think that is possible to conclude what is the BCS classification from Capecitabine. For example, in 30 minutes almost 30% of capecitabine is degraded. On the other hand, 70% at this moment is not degraded. Therefore, is possible to determinate if the drug (70% of capecitabine is not degraded) has high or low solubility.
Do you have an opinion about my comment? Could you share about that with your experience?
Thank you in advance!
By the way, if capecitabine is unstable in acidic medium and this unstability is gradative in accordance with the passage of time, I think that is possible to conclude what is the BCS classification from Capecitabine. For example, in 30 minutes almost 30% of capecitabine is degraded. On the other hand, 70% at this moment is not degraded. Therefore, is possible to determinate if the drug (70% of capecitabine is not degraded) has high or low solubility.
Do you have an opinion about my comment? Could you share about that with your experience?
Thank you in advance!
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 solubilityMauricio Sampaio 2015-09-15 06:56
- regulatory authorities have a different view Dr_Dan 2015-09-15 08:53
- regulatory authorities have a different view Mauricio Sampaio 2015-09-17 06:44
- regulatory authorities have a different view Dr_Dan 2015-09-15 08:53
- …as well as the solubilityMauricio Sampaio 2015-09-15 06:56
- Biowaiver for Capecitabine - FDA x EMA Dr_Dan 2015-09-09 09:00
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