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Solubility based Biowaiver [Dissolution / BCS / IVIVC]

posted by Amalia - Greece, 2018-10-01 11:04  - Posting: # 19350
Views: 518

Dear all,

we are trying to built a biowaiver justification for the lowest strength of a products.
According to the guideline "The pH-solubility profile of the drug substance should be determined and discussed. The drug substance is considered highly soluble if the highest single dose administered as immediate release formulation(s) is completely dissolved in 250 ml of buffers within the range of pH 1 – 6.8 at 37±1 °C. This demonstration requires the investigation in at least three buffers within this range (preferably at pH 1.2, 4.5 and 6.8) and in addition at the pKa, if it is within the specified pH range. Replicate determinations at each pH condition may be necessary to achieve an unequivocal solubility classification (e.g. shake-flask method or other justified method). Solution pH should be verified prior and after addition of the drug substance to a buffer."

Could you please let me know whether the solubility studies refer to the API, or to the FDF?
If we demonstrate that the FDF of the lowest strength is highly soluble in all relevant media, will it be sufficient to claim a biowaiver?

Thank you in advance.

Kind Regards,
Amalia


Edit: Category changed; see also this post #1[Helmut]

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