Pharmaceutical composition containing a combination of a statin and aspirin and method

Abstract

A pharmaceutical composition is provided which is useful for cholesterol lowering and reducing the risk of a myocardial infarction, which includes a statin, such as pravastatin, lovastatin, simvastatin, atorvastatin, cerivastatin or fluvastatin, in combination with aspirin, in a manner to minimize interaction of aspirin with the statin and minimize side effects of aspirin. A method for lowering cholesterol and reducing risk of a myocardial infarction employing such composition is also provided.

What is claimed is:  
     
         1 . A pharmaceutical composition comprising a statin cholesterol lowering agent and aspirin in a formulation designed to minimize statin:aspirin interaction.  
     
     
         2 . The pharmaceutical composition as defined in  claim 1  wherein the statin and aspirin are formulated together in the same dosage formulation.  
     
     
         3 . The pharmaceutical composition as defined in  claim 2  wherein the statin and aspirin are formulated together in a single tablet.  
     
     
         4 . The pharmaceutical composition as defined in  claim 3  wherein the tablet is a bilayered tablet wherein the aspirin is present in a first layer, and the statin is present in a second layer.  
     
     
         5 . The pharmaceutical composition as defined in  claim 4  wherein the layer containing the statin also includes one or more buffering agents.  
     
     
         6 . The pharmaceutical composition as defined in  claim 3  wherein the tablet includes a core and a coating layer surrounding said core and wherein one of the statin and aspirin is present in the core and the other is present in the coating layer surrounding the core.  
     
     
         7 . The pharmaceutical composition as defined in  claim 6  wherein the aspirin is present in the core and the statin is present in the coating layer.  
     
     
         8 . The pharmaceutical composition as defined in  claim 7  wherein the coating layer also includes one or more buffering agents.  
     
     
         9 . The pharmaceutical composition as defined in  claim 1  wherein the statin is pravastatin, lovastatin, simvastatin, fluvastatin, atorvastatin or cerivastatin.  
     
     
         10 . The pharmaceutical composition as defined in  claim 1  further including one or more buffering agents in combination with the statin.  
     
     
         11 . The pharmaceutical composition as defined in  claim 3  further including an outer protective coating or finishing layer surrounding said tablet.  
     
     
         12 . The pharmaceutical composition as defined in  claim 1  wherein the aspirin is in the form of enteric coated aspirin granules.  
     
     
         13 . The pharmaceutical composition as defined in  claim 12  in the form of tablets or granules contained in a capsule.  
     
     
         14 . The pharmaceutical composition as defined in  claim 12  wherein the enteric coated aspirin granules include a finishing overcoat, and the coated aspirin and statin are in the form of a tablet or capsule.  
     
     
         15 . The pharmaceutical composition as defined in  claim 14  wherein the coated aspirin granules and statin granules are encapsulated separately into the same capsule shells.  
     
     
         16 . The pharmaceutical composition as defined in  claim 2  wherein the aspirin is in the form of enteric coated granules of aspirin and the statin is in the form of enteric coated granules of statin, in the form of compressed tablets or capsules.  
     
     
         17 . The pharmaceutical composition as defined in  claim 1  in the form of a tablet or capsule containing both aspirin granules and statin granules.  
     
     
         18 . The pharmaceutical composition as defined in  claim 17  wherein the statin is in the form of enteric coated statin granules.  
     
     
         19 . The pharmaceutical composition as defined in  claim 17  wherein the statin granules include an outer protective coating to minimize interaction with aspirin.  
     
     
         20 . The pharmaceutical composition as defined in  claim 1  in the form of a bilayered tablet which comprises a first layer comprising aspirin granules and one or more excipients, and a second layer comprising a statin and one or more buffering compounds and one or more excipients.  
     
     
         21 . The pharmaceutical composition as defined in  claim 20  wherein the first layer comprises aspirin granules, one or more bulking agents and optionally a lubricant, and the second layer comprises a statin, optionally a wet granulating agent, one or more buffering compounds selected from the group consisting of calcium carbonate, magnesium oxide, magnesium carbonate and mixtures thereof, and optionally magnesium stearate.  
     
     
         22 . The pharmaceutical composition as defined in  claim 20  further including an outer protective coating surrounding said bilayered tablet.  
     
     
         23 . The pharmaceutical composition as defined in  claim 1  further including an antioxidant.  
     
     
         24 . The pharmaceutical composition as defined in  claim 23  wherein the antioxidant is vitamin C and/or vitamin E.  
     
     
         25 . A method for lowering serum cholesterol or preventing or inhibiting or treating atherosclerosis or reducing risk of or treating a cardiovascular event or desease, coronary artery disease or cerebrovascular disease, which comprises administering to a patient in need of treatment a therapeutically effective amount of a pharmaceutical composition comprising a combination of a statin cholesterol lowering agent and aspirin in a single dosage form, which dosage form minimizes interaction between the statin and aspirin, and reduces the side effects of aspirin.  
     
     
         26 . The method as defined in  claim 25  wherein the statin employed is pravastatin, lovastatin, simvastatin, atorvastatin, fluvastatin or cerivastatin.