IMMEDIATE RELEASE FORMULATION OF A TRIPLE COMBINATION OF ACTIVE PHARMACEUTICAL INGREDIENTS USEFUL IN THE TREATMENT OF POLYCYSTIC OVARY SYNDROME

摘要

Immediate release formulation of a triple combination of active pharmaceutical ingredients useful in the treatment of polycystic ovarysyndrome It relates to an immediate release formulation for oral administration, comprising; a) a combination of three active pharmaceutical ingredients which are spironolactone; pioglitazone or a salt thereof; and metformin or a salt thereof; and b) solid polyethylene glycol having an average molecular weight from 3350 to 8000 g/mol; wherein: each of the active pharmaceutical ingredients are present in a therapeutically effective amount; and the polyethylene glycol is present in an amount such that decreases the dissolution profiles in vitro of each one of the active pharmaceutical ingredients without modifying the disintegration time of the formulation compared with the dissolution profiles of each one of the active pharmaceutical ingredients of a formulation having the same composition but without the solid polyethylene glycol, as well as, to its preparation process.