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RegisterDeferasirox qualified for biowaiver? [Dissolution / BCS / IVIVC]
Could Deferasirox (BCS Class II) be qualified for biowaiver?
The molecule has a low solubility and the QC dissolution medium contains SDS as surfactant (in pH 6.8).
For the lowest strength is enough a comparison between the dissolution profiles of highest strength and the lowest one as support for biowaiver? Since the molecule is almost insoluble in water, these dissolution profiles could be performed in 0.1 N HCl, pH 4.5 and pH 6.8 containing the same amount of surfactant as QC medium?
Thank you in advance.
The molecule has a low solubility and the QC dissolution medium contains SDS as surfactant (in pH 6.8).
For the lowest strength is enough a comparison between the dissolution profiles of highest strength and the lowest one as support for biowaiver? Since the molecule is almost insoluble in water, these dissolution profiles could be performed in 0.1 N HCl, pH 4.5 and pH 6.8 containing the same amount of surfactant as QC medium?
Thank you in advance.
Complete thread:
- Deferasirox qualified for biowaiver?Criss 2014-05-08 23:17
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- F ≥85%, no surfactants Helmut 2014-05-09 10:51
Ing. Helmut Schütz