BSC approach at each strength? [Dissolution / BCS / IVIVC]

posted by Ohlbe – France, 2019-07-22 23:58  – Posting: # 20431
Views: 291

Dear Mauricio,

» For example: three strength of 80 mg, 40 mg and 20 mg and the drug is class 1.

I'm absolutely not a specialist of dissolution testing and BCS... But my understanding is that you need to demonstrate the BCS classification not only for the active substance, but also for the formulation. If your 3 strengths have a different composition, you could theoretically have a slower or lower dissolution for a lower strength and not meet the criteria for class 1 at 20 mg even if the 80 mg formulation is class 1.

Regards
Ohlbe

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