Biowaiver with Dissolution for Oxolamine Citrate [Dissolution / BCS / IVIVC]
Dear All,
Oxolamine citrate is a very common known used antitussif active pharmaceutical ingredient, in a great number of fixed dose combinations as immidiate release tablets, for years.
My question is, a biowaiver can be acceptable with dissolution for Oxolamine citrate from immidiate release tablet formulation.
If you could share any scientific data or article, I will be glad.
Regards
Mehtap Saydam (M Sc Pharm)
Edit: Category changed. Welcome o the BABE-Forum. BTW, your post is # 1,000 this year. [Helmut]
Oxolamine citrate is a very common known used antitussif active pharmaceutical ingredient, in a great number of fixed dose combinations as immidiate release tablets, for years.
My question is, a biowaiver can be acceptable with dissolution for Oxolamine citrate from immidiate release tablet formulation.
If you could share any scientific data or article, I will be glad.
Regards
Mehtap Saydam (M Sc Pharm)
Edit: Category changed. Welcome o the BABE-Forum. BTW, your post is # 1,000 this year. [Helmut]