Modified release fixed dose combination product with two poorly soluble drug substances

A sponsor company contracted Recipharm to develop a modified release fixed dose combination (FDC) product of existing molecules for treatment of a neurodegenerative disorder. There are two poorly soluble molecules in this combination product: one is a BCS class II molecule (A); and the other is a BCS class IV molecule (B). The concentration of both molecules is in a ratio of 1:10 in the existing formulation and the sponsor wished to develop a formulation with a similar rate of dissolution of both molecules.

Register below to download the full Case study.
/sites/default/files/media/Modified%20release%20FDC%20product%20with%20two%20poorly%20soluble%20drug%20substances.pdf
False
True