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Dear John
Highly soluble but poor in permeability => BCS class III drug. In Europe you have to show dissolution in three pH media: 1.2, 4.5 and 6.8. If your drug is highly soluble then the drug should be dissolved completely within 30 minutes in all three media. According to your question this is not the case. Could you please specify which dissolution media you use? With a tmax of 8 h the rate limiting factor will be the absorption, however, it would be useful to know more about the dissolution to make reasonable assumptions for PK.
Kind regards
Dr_Dan
Highly soluble but poor in permeability => BCS class III drug. In Europe you have to show dissolution in three pH media: 1.2, 4.5 and 6.8. If your drug is highly soluble then the drug should be dissolved completely within 30 minutes in all three media. According to your question this is not the case. Could you please specify which dissolution media you use? With a tmax of 8 h the rate limiting factor will be the absorption, however, it would be useful to know more about the dissolution to make reasonable assumptions for PK.
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:
- Dissolution jag009 2014-08-22 16:47
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- DissolutionDr_Dan 2014-08-22 19:27
- Dissolution jag009 2014-08-25 15:19
- Dissolution luvblooms 2014-08-26 06:41
- Dissolution jag009 2014-08-26 17:33
- Dissolution luvblooms 2014-08-28 08:21
- Dissolution Samaya B 2014-09-01 07:48
- Dissolution luvblooms 2014-09-01 14:09
- Dissolution Samaya B 2014-09-04 06:54
- Dissolution luvblooms 2014-09-01 14:09
- Dissolution Samaya B 2014-09-01 07:48
- Dissolution luvblooms 2014-08-28 08:21
- Dissolution jag009 2014-08-26 17:33
- DissolutionDr_Dan 2014-08-22 19:27
Ing. Helmut Schütz