2019-11-22 17:49
(372 d 12:38 ago)

Posting: # 20861
Views: 2,294

 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

Edit: Category changed; see also this post #1[Helmut]
Vienna, Austria,
2019-11-24 10:51
(370 d 19:36 ago)

@ AB661
Posting: # 20864
Views: 1,431

 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

The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes

2019-12-03 17:06
(361 d 13:22 ago)

@ AB661
Posting: # 20909
Views: 1,258

 Bio-waiver of Sapropterin dihydrochloride powder for oral solution


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.


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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