Solubility based Biowaiver [Dissolution / BCS / IVIVC]

posted by Amalia – Greece, 2018-10-01 13:59 (882 d 15:07 ago) – Posting: # 19354
Views: 4,458

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

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