AB661
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India,
2019-11-22 17:49

Posting: # 20861
Views: 1,672
 

 Bio-waiver of Sapro­pterin dihydrochloride powder for oral solution [Dissolution / BCS / IVIVC]

Dear All,

We are developing Sapropterin dihydrochloride powder for oral solution,

We are going to file BCS based Bio-waiver approach using solubility, dissolution & composition similarity.

But for permeability study there is no literature support for human absolute bioavailability study or in-vitro permeability study of Sapropterin dihydrochloride. Whether USFDA accept our proposal without permeability study data ?

With regards
AB


Edit: Category changed; see also this post #1[Helmut]
Helmut
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Vienna, Austria,
2019-11-24 10:51

@ AB661
Posting: # 20864
Views: 908
 

 Please do your homework first

Hi AB,

» Whether USFDA accept our proposal without permeability study data ?

No way – and for good reasons. Though the drug is highly soluble, you don’t know whether it is in class 1 or 3 (Guidance Sections III.B. and VII.B.). Biowaivers for class 3 drugs are acceptable only if fulfilling certain conditions.

Dif-tor heh smusma 🖖
Helmut Schütz
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Achievwin
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US,
2019-12-03 17:06

@ AB661
Posting: # 20909
Views: 730
 

 Bio-waiver of Sapropterin dihydrochloride powder for oral solution

Hi:

Innovator Biomarian was given Biowaiver based on the position that excipients (Mannitol) is same as oral tablets, additionally the powder for solution has a sucralose. See if this argument applies for you. Ref: SBA, Australian review points out that this is a a BCS III compound.

Best of luck and please post outcome of your experience in this forum.

Achievwin


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]
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