begoña
☆    

Spain,
2020-10-08 14:14
(1266 d 23:43 ago)

Posting: # 21976
Views: 3,277
 

 Dextromethorphan [Dissolution / BCS / IVIVC]

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

Thank you
Sridhar.E
☆    

India,
2020-10-08 14:27
(1266 d 23:30 ago)

@ begoña
Posting: # 21978
Views: 2,864
 

 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 14:35
(1266 d 23:22 ago)

@ Sridhar.E
Posting: # 21979
Views: 2,872
 

 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 14:59
(1266 d 22:58 ago)

@ begoña
Posting: # 21981
Views: 2,841
 

 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 14:54
(1266 d 23:03 ago)

@ begoña
Posting: # 21980
Views: 2,890
 

 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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