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Criss ☆ 2014-05-09 01:17 (4425 d 16:21 ago) Posting: # 12929 Views: 7,604 |
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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. |
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Helmut ★★★   Vienna, Austria, 2014-05-09 12:51 (4425 d 04:46 ago) @ Criss Posting: # 12930 Views: 6,226 |
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Hi Criss, ❝ Could Deferasirox (BCS Class II) be qualified for biowaiver? Did you read the guidelines on the topic? FDA: Class I, EMA & WHO: Class I and Class III under certain circumstances. Some Class IIa drugs (weak acids with high permeability) may be accepted on a case-by-case basis (see especially WHO’s TRS 937, Annex 7). Though deferasirox is a weak acid, dissolution media with surfactants are not acceptable and its fraction absorbed is not ≥85% → no chance. — Dif-tor heh smusma 🖖🏼 Довге життя Україна! ![[image]](https://static.bebac.at/pics/Blue_and_yellow_ribbon_UA.png) Helmut Schütz ![[image]](https://static.bebac.at/img/CC by.png) The quality of responses received is directly proportional to the quality of the question asked. 🚮 Science Quotes |
Ing. Helmut Schütz