Posting: # 20861
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 ?
Edit: Category changed; see also this post #1. [Helmut]
Posting: # 20864
» 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.
The quality of responses received is directly proportional to the quality of the question asked. 🚮
Posting: # 20909
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]