averroes1304
☆    

Morocco,
2018-11-19 21:14

Posting: # 19643
Views: 1,408
 

 BCS Biowaiver for oral suspension [Dissolution / BCS / IVIVC]

Dear all.

Is it possible to apply the biowaiver based on the BCS system for oral suspensions with systemic effect? Knowing that the guidlines announce that the BCS system is only for immediate release oral solid forms. And oral suspensions are not solid forms.

Kind regards.
Mauricio Sampaio
★    

Brazil,
2018-11-23 15:39

@ averroes1304
Posting: # 19646
Views: 1,311
 

 BCS Biowaiver for oral suspension

Dear averroes1304

The particles of the dispersed phase of a suspension are (generally) solid insoluble in the dispersing medium. Then, it is possible to apply the biowaiver based on the BCS system for oral suspensions with systemic effect!:ok:

In conclusion: Oral suspensions are solid forms.:yes:

Best regards.
wienui
★    

Germany, Oman,
2018-11-23 19:36

@ averroes1304
Posting: # 19648
Views: 1,136
 

 BCS Biowaiver for oral suspension

Dear averroes1304,

» Is it possible to apply the biowaiver based on the BCS system for oral suspensions with systemic effect?

Yes, if you apply for EU region ,WHO & some other countries
No for USA & some other countries

Please refer to this article, https://www.ncbi.nlm.nih.gov/pubmed/29382433

Best regards,
Osama
Mauricio Sampaio
★    

Brazil,
2018-11-26 18:17

@ wienui
Posting: # 19652
Views: 1,060
 

 BCS Biowaiver for oral suspension

Dear Osama

» No for USA & some other countries »

Why not? The article ( https://www.ncbi.nlm.nih.gov/pubmed/29382433) does't explain the reason! Do you know?

Best regards
wienui
★    

Germany, Oman,
2018-11-27 03:50
(edited by wienui on 2018-11-28 03:01)

@ Mauricio Sampaio
Posting: # 19653
Views: 1,053
 

 BCS Biowaiver for oral suspension

Dear Mauricio,

» Why not? The article ( https://www.ncbi.nlm.nih.gov/pubmed/29382433) does't explain the reason! Do you know?

There are a lot of differences between the global jurisdictions, some of them referred to different scientific opinions ( which I can accept it) on the other hand a lot of them you can't find any scientific reasons behind at all. Guidelines ( Guidances) are made from Human, who are different and harmoni(s)zation will still be not achievable dream.
Plz. s. this post from Helmut, https://forum.bebac.at/mix_entry.php?id=12529#p12535.

I'm myself inclined to the Pro- waiving of semisolid dosage form.

Best regards,
Osama
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