Bioequivalence and Bioavailability Forum

begoña ☆ Spain, 2020-10-08 14:14 (2064 d 14:30 ago) Posting: # 21976 Views: 9,483	Dextromethorphan [Dissolution / BCS / IVIVC] Post reply
	I am trying to find information about BCS classification of Dexthrometorphan BrH Thank you

Sridhar.E ☆ India, 2020-10-08 14:27 (2064 d 14:16 ago) @ begoña Posting: # 21978 Views: 8,305	Dextromethorphan Post reply
	❝ I am trying to find information about BCS classification of Dexthrometorphan BrH Hai Dextromethorphan hydrobromide belongs to the class II of biopharmaceutics classification system (BCS), exhibits low solubility and high permeability.

begoña
☆

Spain,
2020-10-08 14:35
(2064 d 14:08 ago)

@ Sridhar.E
Posting: # 21979
Views: 8,278

Dextromethorphan

Post reply

❝ Dextromethorphan hydrobromide belongs to the class II of biopharmaceutics classification system (BCS), exhibits low solubility and high permeability.

Thanks
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 was wondering if I could ask for a biowaiver, during the evaluation of an oral product containig dexthrometorphan.

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! [Helmut]

Sridhar.E
☆

India,
2020-10-08 14:59
(2064 d 13:44 ago)

@ begoña
Posting: # 21981
Views: 8,196

Dextromethorphan

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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]

Helmut
★★★