begoña
☆    

Spain,
2020-10-08 12:14
(19 d 22:02 ago)

Posting: # 21976
Views: 244
 

 Dextromethorphan [Dissolution / BCS / IVIVC]

I am trying to find information about BCS classification of Dexthrometorphan BrH

Thank you
Sridhar.E
☆    

India,
2020-10-08 12:27
(19 d 21:49 ago)

@ begoña
Posting: # 21978
Views: 227
 

 Dextromethorphan

» 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 12:35
(19 d 21:41 ago)

@ Sridhar.E
Posting: # 21979
Views: 226
 

 Dextromethorphan

» 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 12:59
(19 d 21:17 ago)

@ begoña
Posting: # 21981
Views: 214
 

 Dextromethorphan

» 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
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Vienna, Austria,
2020-10-08 12:54
(19 d 21:22 ago)

@ begoña
Posting: # 21980
Views: 220
 

 Dextromethorphan: Class II?

Hi begoña,

» I am trying to find information about BCS classification of Dexthrometorphan BrH

doi:10.14499/indonesianjpharm25iss3pp181
https://etd.ohiolink.edu/!etd.send_file?accession=mco1470340367&disposition=attachment

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