US2012178813A1PendingUtilityA1

Lipid-lowering antidiabetic agent

53
Individually held — no corporate assignee on recordPriority: Jan 12, 2011Filed: Jan 11, 2012Published: Jul 12, 2012
Est. expiryJan 12, 2031(~4.5 yrs left)· nominal 20-yr term from priority
Inventors:Banavara L. MylariFrank C. Sciavolino
A61P 7/00A61P 9/00A61P 3/06A61P 9/06A61P 3/10A61P 9/10A61P 3/04C07C 279/26A61K 31/155A61K 31/202C07C 279/04C07C 57/03C07C 251/08A01N 37/52
53
PatentIndex Score
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Claims

Abstract

A composition which includes a salt of metformin and the use of the composition for treatment of or use in prediabetes, diabetes, lowering triglycerides and/or other conditions in mammals.

Claims

exact text as granted — not AI-modified
1 . A composition of structure I, which is a salt of metformin 
       
         
           
           
               
               
           
         
       
       with at least one polyunsaturated fatty acid represented by RH or a mixture of metformin and at least one acid RH or a pharmaceutically acceptable solvate or hydrate thereof. 
     
     
         2 . The composition of  claim 1  in which the polyunsaturated fatty acid RH is an omega-3 fatty acid. 
     
     
         3 . A composition of  claim 1  wherein RH is an omega-3 polyunsaturated C 16-24  fatty acid optionally substituted with from 1-3 hydroxy groups 
     
     
         4 . A composition as claimed in  claim 2  wherein RH is a fatty acid of 20 or 22 carbon atoms with a total of 4- or 5 unsaturated linkages in the fatty acid chain in addition to the omega-3 unsaturated bond. 
     
     
         5 . A composition of  claim 1 , wherein RH is selected from the group consisting of resolvins D1, D2, D3, D4, E1, and E2. 
     
     
         6 . The composition of  claim 1  in which the polyunsaturated fatty acid RH is eicosapentaenoic acid. 
     
     
         7 . The composition of  claim 1  in which the polyunsaturated fatty acid RH is docosahexaenoic acid. 
     
     
         8 . A composition according to  claim 1 , wherein R is a mixture of polyunsaturated fatty acids. 
     
     
         9 . The mixture of  claim 8  in which the polyunsaturated fatty acid comprises a mixture of eicosapentaenoic acid and docosahexaenoic acid. 
     
     
         10 . A pharmaceutical composition comprising a compound according to  claim 6  and a pharmaceutically acceptable carrier, vehicle or diluent. 
     
     
         11 . A pharmaceutical composition comprising a compound according to  claim 7  and a pharmaceutically acceptable carrier, vehicle or diluent. 
     
     
         12 . A pharmaceutical composition comprising a mixture according to  claim 8  and a pharmaceutically acceptable carrier, vehicle or diluent. 
     
     
         13 . A kit comprising a) a unit dosage form comprising the compound of  claim 6 ; b) instructions on how to use the kit; and c) at least one container for holding the unit dosage forms. 
     
     
         14 . A kit comprising a) a unit dosage form comprising the compound of  claim 7 ; b) instructions on how to use the kit; and c) at least one container for holding the unit dosage forms. 
     
     
         15 . A kit comprising a) a unit dosage form comprising the salts of  claim 8  b) instructions on how to use the kit; and c) at least one container for holding the unit dosage forms. 
     
     
         16 . A method for treating diabetes in a mammal, comprising administering a therapeutically effective amount of a compound according to  claim 6 . 
     
     
         17 . A method for treating diabetes in a mammal, comprising administering to said mammal a therapeutically effective amount of a composition according to  claim 7 . 
     
     
         18 . A method for treating diabetes in a mammal, comprising administering to said mammal a therapeutically effective amount of a composition according to  claim 8 . 
     
     
         19 . A method for treating diabetes in a mammal, comprising administering to said mammal a therapeutically effective amount of a composition according to  claim 9 . 
     
     
         20 . A method of lowering triglycerides in a mammal, comprising administering to said mammal a therapeutically effective amount of the composition according to  claim 6 . 
     
     
         21 . A method of lowering triglycerides in a mammal, comprising administering to said mammal a therapeutically effective amount of the composition according to  claim 7 . 
     
     
         22 . A method of lowering triglycerides in a mammal, comprising administering to said mammal a therapeutically effective amount of the composition according to  claim 8 . 
     
     
         23 . A method of lowering triglycerides in a mammal, comprising administering to said mammal a therapeutically effective amount of the composition according to  claim 9 . 
     
     
         24 . A method of treating prediabetes in a mammal, comprising administering to said mammal a therapeutically effective amount of the composition according to  claim 6 . 
     
     
         25 . A method of treating prediabetes in a mammal, comprising administering to said mammal a therapeutically effective amount of the composition according to  claim 7 . 
     
     
         26 . A method of treating prediabetes in a mammal, comprising administering to said mammal a therapeutically effective amount of the composition according to  claim 8 . 
     
     
         27 . A method of treating prediabetes in a mammal, comprising administering to said mammal a therapeutically effective amount of the composition according to  claim 9 . 
     
     
         28 . A method of treating obesity in a mammal, comprising administering to said mammal a therapeutically effective amount of the composition according to  claim 6 . 
     
     
         29 . A method of treating obesity in a mammal, comprising administering to said mammal a therapeutically effective amount of the composition according to  claim 7 . 
     
     
         30 . A method of treating obesity in a mammal, comprising administering to said mammal a therapeutically effective amount of the composition according to  claim 8 . 
     
     
         31 . A method of treating obesity in a mammal, comprising administering to said mammal a therapeutically effective amount of the composition according to  claim 9 . 
     
     
         32 . A method of treating cardiac arrhythmia in a mammal, comprising administering to said mammal a therapeutically effective amount of the composition according to  claim 6 . 
     
     
         33 . A method of treating cardiac arrhythmia in a mammal, comprising administering to said mammal a therapeutically effective amount of the composition according to  claim 7 . 
     
     
         34 . A method of treating cardiac arrhythmia in a mammal, comprising administering to said mammal a therapeutically effective amount of the composition according to  claim 8 . 
     
     
         35 . A method of treating cardiac arrhythmia in a mammal, comprising administering to said mammal a therapeutically effective amount of the composition according to  claim 9 . 
     
     
         36 . A method of treating cardiomyopathy in a mammal, comprising administering to said mammal a therapeutically effective amount of the composition according to  claim 6 . 
     
     
         37 . A method of treating cardiomyopathy in a mammal, comprising administering to said mammal a therapeutically effective amount of the composition according to  claim 7 . 
     
     
         38 . A method of treating cardiomyopathy in a mammal, comprising administering to said mammal a therapeutically effective amount of the composition according to  claim 8 . 
     
     
         39 . A method of treating cardiomyopathy in a mammal, comprising administering to said mammal a therapeutically effective amount of the composition according to  claim 9 . 
     
     
         40 . A method of treating myocardial infarction in a mammal, comprising administering to said mammal a therapeutically effective amount of the composition according to  claim 6 . 
     
     
         41 . A method of treating myocardial infarction in a mammal, comprising administering to said mammal a therapeutically effective amount of the composition according to  claim 7 . 
     
     
         42 . A method of treating myocardial infarction in a mammal, comprising administering to said mammal a therapeutically effective amount of the composition according to  claim 8 . 
     
     
         43 . A method of treating myocardial infarction in a mammal, comprising administering to said mammal a therapeutically effective amount of the composition according to  claim 9 . 
     
     
         44 . A method for the manufacture of the composition of  claim 1  comprising: a) freshly preparing the free base of metformin from a suitable metformin salt; and b) reacting the freshly prepared free base of metformin with eicosapentaenoic acid, docosahexaenoic acid or a mixture thereof at a temperature between about 1 degree C. and about 60 degree C.

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