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.

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