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RegisterSolubility based Biowaiver [Dissolution / BCS / IVIVC]
Thank you very much for your reply!
Basically it is an additional strength biowaiver. The molecule is classified as BCS Class II. However we were advised that considering solely the lowest strength, it is very close to being considered as highly soluble. As per the Guideline of BE "the drug substance i considered highly soluble if the highest single dose administered as immediate release formulation is completely dissolved in 250ml of buffers within certain pH range". In other words for a highly soluble drug, the dose number (D0) is equal or lower than 1.
Therefore, my question here is whether the solubility test should be done at the API or the final formulation (lowest strength) in order to support a biowaiver for the lowest stength.
I hope I have not confused you more!
Awaiting your response!
Thank you in advance,
Amalia
Basically it is an additional strength biowaiver. The molecule is classified as BCS Class II. However we were advised that considering solely the lowest strength, it is very close to being considered as highly soluble. As per the Guideline of BE "the drug substance i considered highly soluble if the highest single dose administered as immediate release formulation is completely dissolved in 250ml of buffers within certain pH range". In other words for a highly soluble drug, the dose number (D0) is equal or lower than 1.
Therefore, my question here is whether the solubility test should be done at the API or the final formulation (lowest strength) in order to support a biowaiver for the lowest stength.
I hope I have not confused you more!
Awaiting your response!
Thank you in advance,
Amalia
Complete thread:
- Solubility based Biowaiver Amalia 2018-10-01 11:04 [Dissolution / BCS / IVIVC]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
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- Solubility based Biowaiver The Outlaw Torn 2018-10-02 08:56
- Solubility based Biowaiver Obinoscopy 2018-10-01 19:05
- Solubility based BiowaiverAmalia 2018-10-01 15:59
- Solubility based Biowaiver lukamar 2018-10-05 09:30
- Solubility based Biowaiver Obinoscopy 2018-10-01 15:03
Ing. Helmut Schütz