Pharmaceutical composition comprising rosuvastatin and acetylsalicylic acid, preparation process and uses thereof

Abstract

The present invention provides a pharmaceutical composition comprising a) a first phase comprising rosuvastatin, and b) a second phase comprising acetylsalicylic acid, wherein the first phase comprising rosuvastatin is a coated tablet and the second phase comprising acetylsalicylic acid is a granule; This pharmaceutical composition solves a set of important technological challenges due to the physicochemical properties and the difference in dosage of each drug. The pharmaceutical composition of the present invention is stable and, moreover, has comparable bioavailability to the single-drug combinations administered concomitantly, such that the composition is safe and effective in the treatment of hyperlipidemia and in the prevention of at least one cardiovascular disease. The invention also relates to a manufacturing process for the pharmaceutical composition.