US2012208854A1PendingUtilityA1

Therapeutic combination

57
Assignee: SCOTT ROBERT ANDREW DONALDPriority: Aug 29, 1997Filed: Apr 12, 2012Published: Aug 16, 2012
Est. expiryAug 29, 2017(expired)· nominal 20-yr term from priority
Inventors:Robert Andrew Donald Scott
A61P 7/02A61P 9/10A61P 9/12A61P 37/04A61P 9/00A61P 43/00A61P 3/06A61K 31/4422A61P 11/06A61K 39/39A61K 31/40A61K 2039/55577A61K 47/40A61K 31/44A61K 31/435A61K 47/26A61K 9/0019Y02A50/30
57
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References
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Claims

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.

Claims

exact text as granted — not AI-modified
1 - 117 . (canceled) 
     
     
         118 . A method for treating a mammal suffering from angina comprising administering to said mammal
 (a) an amount of a first therapeutic agent, said first agent being amlodipine or a pharmaceutically acceptable acid addition salt thereof; and   (b) an amount of a second therapeutic agent, said second agent being atorvastatin or a pharmaceutically acceptable salt thereof;   wherein said first agent and second agent are administered together in a single pharmaceutical composition containing a pharmaceutically acceptable carrier or diluent.   
     
     
         119 . The method of  claim 118  wherein said first agent comprises amlodipine besylate. 
     
     
         120 . The method of  claim 118  wherein said second agent comprises hemicalcium salt of atorvastatin. 
     
     
         121 . The method of  claim 119  wherein said second agent comprises hemicalcium salt of atorvastatin. 
     
     
         122 . The method of  claim 118  wherein said first agent is present in an amount of from about 2.5 mg to about 20 mg and said second agent is present in an amount of from about 2.5 mg to about 160 mg. 
     
     
         123 . The method of  claim 121 , wherein said hemicalcium salt of atorvastatin is present in an amount of from about 2.5 mg to about 160 mg and said amlodipine besylate is present in an amount of from about 2.5 mg to about 20 mg. 
     
     
         124 . The method of  claim 121 , wherein said hemicalcium salt of atorvastatin is present in an amount of from about 10 mg to about 80 mg and said amlodipine besylate is present in an amount of from about 5 mg to about 10 mg. 
     
     
         125 . The method of  claim 118  wherein said mammal is a human who also suffers from hypertension. 
     
     
         126 . The method of  claim 118  wherein said mammal is a human who also suffers from hyperlipidemia. 
     
     
         127 . The method of  claim 118  wherein said mammal is a human who also suffers from combined hypertension and hyperlipidemia. 
     
     
         128 . The method of  claim 118  wherein said mammal is a human who also suffers from atherosclerosis. 
     
     
         129 . The method of  claim 123  wherein said mammal is a human who also suffers from hypertension. 
     
     
         130 . The method of  claim 123  wherein said mammal is a human who also suffers from hyperlipidemia. 
     
     
         131 . The method of  claim 123  wherein said mammal is a human who also suffers from combined hypertension and hyperlipidemia. 
     
     
         132 . The method of  claim 123  wherein said mammal is a human who also suffers from atherosclerosis. 
     
     
         133 . The method of  claim 131  wherein said hemicalcium salt of atorvastatin is present in an amount of from about 10 mg to about 80 mg and said amlodipine besylate is present in an amount of from about 5 mg to about 10 mg. 
     
     
         134 . The method of  claim 118  wherein the pharmaceutically acceptable acid addition salt of amlodipine is not amlodipine besylate, and is present in an amount equivalent to from 2.5 mg to 20 mg of amlodipine besylate. 
     
     
         135 . The method of  claim 134  wherein said first agent comprises amlodipine mesylate. 
     
     
         136 . The method of  claim 134  wherein said first agent comprises amlodipine maleate. 
     
     
         137 . The method of  claim 134  wherein said first agent comprises amlodipine tosylate. 
     
     
         138 . The method of  claim 118  wherein said pharmaceutical composition is administered orally in the form of a solution, suspension, tablet, pill, capsule or powder. 
     
     
         139 . The method of  claim 121  comprising 5 mg of amlodipine besylate and 10 mg of atorvastatin hemicalcium. 
     
     
         140 . The method of  claim 121  comprising 5 mg of amlodipine besylate and 80 mg of atorvastatin hemicalcium. 
     
     
         141 . The method of  claim 121  comprising 10 mg of amlodipine besylate and 10 mg of atorvastatin hemicalcium. 
     
     
         142 . The method of  claim 121  comprising 10 mg of amlodipine besylate and 80 mg of atorvastatin hemicalcium. 
     
     
         143 . A method of treating a human diagnosed as suffering from angina, and who would benefit from the administration of prescribed therapeutic agents, the method comprising administering to said human
 (a) an amount of a first therapeutic agent, said first agent being amlodipine or a pharmaceutically acceptable acid addition salt thereof; and   (b) an amount of a second therapeutic agent, said second agent being atorvastatin or a pharmaceutically acceptable salt thereof;   wherein said first agent and second agent are administered together in a single pharmaceutical composition containing a pharmaceutically acceptable carrier or diluent.   
     
     
         144 . The method of  claim 143  wherein said first agent comprises amlodipine besylate. 
     
     
         145 . The method of  claim 143  wherein said second agent comprises hemicalcium salt of atorvastatin. 
     
     
         146 . The method of  claim 144  wherein said second agent comprises hemicalcium salt of atorvastatin. 
     
     
         147 . The method of  claim 146 , wherein said hemicalcium salt of atorvastatin is present in an amount of from about 2.5 mg to about 160 mg and said amlodipine besylate is present in an amount of from about 2.5 mg to about 20 mg. 
     
     
         148 . The method of  claim 146 , wherein said hemicalcium salt of atorvastatin is present in an amount of from about 10 mg to about 80 mg and said amlodipine besylate is present in an amount of from about 5 mg to about 10 mg. 
     
     
         149 . The method of  claim 143  wherein the pharmaceutically acceptable acid addition salt of amlodipine is not amlodipine besylate, and is present in an amount equivalent to from 2.5 mg to 20 mg of amlodipine besylate. 
     
     
         150 . The method of  claim 143  wherein said mammal is a human who also suffers from hypertension. 
     
     
         151 . The method of  claim 143  wherein said mammal is a human who also suffers from hyperlipidemia. 
     
     
         152 . The method of  claim 143  wherein said mammal is a human who also suffers from combined hypertension and hyperlipidemia. 
     
     
         153 . The method of  claim 143  wherein said mammal is a human who also suffers from atherosclerosis. 
     
     
         154 . A method for treating angina in a human who has been examined for angina by a medical practitioner and diagnosed in need of therapy for said angina treatment by the joint administration of a first therapeutic agent and a second therapeutic agent, which comprises administering to said human
 (a) an amount of said first therapeutic agent, said first agent being amlodipine or a pharmaceutically acceptable acid addition salt thereof; and   (b) an amount of said second therapeutic agent, said second agent being atorvastatin or a pharmaceutically acceptable salt thereof;   wherein said first agent and second agent are administered together in a single pharmaceutical composition containing a pharmaceutically acceptable carrier or diluent.   
     
     
         155 . The method of  claim 154  wherein said first agent comprises amlodipine besylate. 
     
     
         156 . The method of  claim 154  wherein said second agent comprises hemicalcium salt of atorvastatin. 
     
     
         157 . The method of  claim 155  wherein said second agent comprises hemicalcium salt of atorvastatin. 
     
     
         158 . The method of  claim 154  wherein said first agent is present in an amount of from about 2.5 mg to about 20 mg and said second agent is present in an amount of from about 2.5 mg to about 160 mg. 
     
     
         159 . The method of  claim 154  wherein said pharmaceutical composition is administered orally in the form of a solution, suspension, tablet, pill, capsule or powder. 
     
     
         160 . The method of  claim 154  wherein said first agent comprises amlodipine mesylate. 
     
     
         161 . The method of  claim 154  wherein said first agent comprises amlodipine maleate. 
     
     
         162 . The method of  claim 154  wherein said first agent comprises amlodipine tosylate. 
     
     
         163 . The method of  claim 157  comprising 5 mg of amlodipine besylate and 10 mg of atorvastatin hemicalcium. 
     
     
         164 . The method of  claim 157  comprising 5 mg of amlodipine besylate and 80 mg of atorvastatin hemicalcium. 
     
     
         165 . The method of  claim 157  comprising 10 mg of amlodipine besylate and 10 mg of atorvastatin hemicalcium. 
     
     
         166 . The method of  claim 157  comprising 10 mg of amlodipine besylate and 80 mg of atorvastatin hemicalcium. 
     
     
         167 . The method of  claim 154  wherein said human also suffers from hypertension. 
     
     
         168 . The method of  claim 154  wherein said human also suffers from hyperlipidemia. 
     
     
         169 . The method of  claim 154  wherein said human also suffers from combined hypertension and hyperlipidemia. 
     
     
         170 . The method of  claim 154  wherein said human also suffers from atherosclerosis.

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