Additional strength Biowaiver [Dissolution / BCS / IVIVC]

posted by wienui  – Germany/Oman, 2020-07-18 20:00 (923 d 03:01 ago) – Posting: # 21742
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Dear dshah & All,

❝ I believe 2.5X8 tab Vs 20 mg, 10X2 tab vs 20 mg and 15 vs 20 mg strength using 0.4% SDS media is one of the option, but is there any other options for dissolution comparision?


Yes, I think your suggestion for the in vitro comparative dissolution testing for the other additional strength biowaivers is correct. ( take care of the sink conditions).

Beside the dissolution, the followings have to be fulfilled (EMA):

- Amount of API must be < 5% of tablet core weight in the BE strength and the biowaiver strength, and
- Amounts of excipients are same per strength, or
- Only the amount of a filler is changed to account for changes in API weight.

Cheers,
Osama

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