Dextromethorphan [Dissolution / BCS / IVIVC]

posted by Sridhar.E – India, 2020-10-08 14:59 (1731 d 11:04 ago) – Posting: # 21981
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❝ I read papers where it has classified as Class II, but also I found several publications that describe Dextromehorphan HBr as very high soluble substance.


I gone through reviews, I found Dextromehorphan Practically insoluble in water.

The Waiver request of in-vivo testing: 30 mg/600 mg based on acceptable bioequivalence studies on the 60 mg/1200 strength, acceptable dissolution testing across all strengths.


Edit: Full quote removed. Please delete everything from the text of the original poster which is not necessary in understanding your answer; see also this post #5! [Ohlbe]

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