Therapeutic combination

Abstract

This invention relates to pharmaceutical combinations of amlodipine or a pharmaceutically acceptable acid addition salt thereof and atorvastatin or a pharmaceutically acceptable salt thereof, kits containing such combinations and methods of using such combinations to treat subjects suffering from angina pectoris, atherosclerosis, combined hypertension and hyperlipidemia and to treat subjects presenting with symptoms of cardiac risk, including humans. This invention also relates to additive and synergistic combinations of amlodipine and atorvastatin whereby those synergistic combinations are useful in treating subjects suffering from angina pectoris, atherosclerosis, combined hypertension and hyperlipidemia and those subjects presenting with symptoms of cardiac risk, including humans.

1 . A single pharmaceutical composition comprising:
 an amount of amlodipine or a pharmaceutically acceptable acid addition salt thereof;   an amount of atorvastatin or a pharmaceutically acceptable salt thereof; and   a pharmaceutically acceptable carrier or diluent.   
   
   
       2 . A pharmaceutical composition of  claim 1  comprising amlodipine besylate. 
   
   
       3 . A pharmaceutical composition of  claim 2  comprising the hemicalcium salt of atorvastatin. 
   
   
       4 - 117 . (canceled) 
   
   
       118 . The pharmaceutical composition of  claim 1  comprising the hemicalcium salt of atorvastatin. 
   
   
       119 . The pharmaceutical composition of  claim 1  wherein said atorvastatin is present in an amount from about 2.5 mg to about 160 mg. 
   
   
       120 . The pharmaceutical composition of  claim 1  wherein said atorvastatin is present in an amount from about 10 mg to about 80 mg. 
   
   
       121 . The pharmaceutical composition of  claim 2  wherein said amlodipine besylate is present in an amount from about 2.5 mg to about 20 mg. 
   
   
       122 . The pharmaceutical composition of  claim 2  wherein said amlodipine besylate is present in an amount from about 5 mg to about 10 mg. 
   
   
       123 . The pharmaceutical composition of  claim 2  wherein said atorvastatin is present in an amount from about 2.5 mg to about 160 mg and said amlodipine besylate is present in an amount from about 2.5 mg to about 20 mg. 
   
   
       124 . The pharmaceutical composition of  claim 3  wherein said hemicalcium salt of atorvastatin is present in an amount from about 2.5 mg to about 160 mg. 
   
   
       125 . The pharmaceutical composition of  claim 3  wherein said hemicalcium salt of atorvastatin is present in an amount from about 10 mg to about 80 mg. 
   
   
       126 . The pharmaceutical composition of  claim 3  wherein said hemicalcium salt of atorvastatin is present in an amount from about 2.5 mg to about 160 mg and said amlodipine besylate is present in an amount from about 2.5 mg to about 20 mg. 
   
   
       127 . The pharmaceutical composition of  claim 3  wherein said hemicalcium salt of atorvastatin is present in an amount from about 10 mg to about 80 mg and said amlodipine besylate is present in an amount from about 5 mg to about 10 mg. 
   
   
       128 . The pharmaceutical composition of  claim 1  wherein said amlodipine or said pharmaceutically acceptable acid addition salt thereof occurs as a hydrate or a solvate. 
   
   
       129 . The pharmaceutical composition of  claim 1  wherein said atorvastatin or said pharmaceutically acceptable acid addition salt thereof occurs as a hydrate or a solvate. 
   
   
       130 . The pharmaceutical composition of  claim 1  wherein said pharmaceutical composition is in the form of a tablet and comprises at least one excipient, at least one disintegrant, and at least one binding agent. 
   
   
       131 . The pharmaceutical composition of  claim 130  wherein said excipient is selected from the group consisting of sodium citrate, calcium carbonate, and calcium phosphate. 
   
   
       132 . The pharmaceutical composition of  claim 130  wherein said disintegrant is potato starch or tapioca starch. 
   
   
       133 . A pharmaceutical composition of  claim 130  wherein said binding agent is selected from the group consisting of polyvinylpyrrolidone, sucrose, gelatin, and acacia. 
   
   
       134 . A pharmaceutical composition of  claim 130  wherein said tablet comprises at least one lubricating agent. 
   
   
       135 . The pharmaceutical composition of  claim 1  further comprising an excipient. 
   
   
       136 . The pharmaceutical composition of  claim 135  wherein the excipient is calcium carbonate. 
   
   
       137 . The pharmaceutical composition of  claim 1  further comprising a disintegrant. 
   
   
       138 . The pharmaceutical composition of  claim 137  wherein the disintegrant is starch. 
   
   
       139 . A pharmaceutical composition of  claim 1  wherein said pharmaceutical composition is in the form of an aqueous suspension and comprises at least one sweetening agent, at least one flavoring agent, at least one coloring agent, at least one emulsifying agent, and at least one suspending agent. 
   
   
       140 . A pharmaceutical composition of  claim 135  wherein said diluent is selected from the group consisting of water, ethanol, propylene glycol, and glycerin. 
   
   
       141 . A pharmaceutical composition of  claim 1  in a form suitable for oral administration comprising a solution, suspension, tablet, pill, capsule or powder containing atorvastatin or a pharmaceutically acceptable salt thereof in an amount from about 2.5 mg to about 160 mg and amlodipine or a pharmaceutically acceptable acid addition salt thereof in an amount from about 2.5 mg to about 20 mg. 
   
   
       142 . A pharmaceutical composition of  claim 137  containing from about 5 mg to about 10 mg amlodipine besylate and from about 10 mg to about 80 mg of the hemicalcium salt of atorvastatin. 
   
   
       143 . A pharmaceutical composition of  claim 1  in the form of a tablet containing from about 5 mg to about 10 mg amlodipine besylate, from about 10 mg to about 80 mg of the hemicalcium salt of atorvastatin, at least one excipient, at least one disintegrant, at least one lubricating agent and at least one binding agent. 
   
   
       144 . A pharmaceutical composition of  claim 139  in the form of a controlled release formulation. 
   
   
       145 . The pharmaceutical composition of  claim 1  comprising amlodipine mesylate. 
   
   
       146 . The pharmaceutical composition of  claim 1  comprising amlodipine maleate. 
   
   
       147 . The pharmaceutical composition of  claim 1  comprising amlodipine tosylate.