Novel polymorphs and salts

Abstract

Novel polymorphic forms and salts of 1-(3′,4′-dichloro-2-fluorobiphenyl-4-yl)cyclopropanecarboxylic acid are useful for the prevention or treatment of Alzheimer's Disease.

1 - 12 . (canceled) 
     
     
         13 . A method of treating Alzheimer's Disease in a patient having hypertension associated with Alzheimer's Disease, the method comprising administering an effective amount of a salt of 1-(3′,4′-dichloro-2-fluorobiphenyl-4-yl)cyclopropanecarboxylic acid to the patient, the salt of 1-(3′,4′-dichloro-2-fluorobiphenyl-4-yl)cyclopropanecarboxylic acid being selected from the group consisting of:
 L-Arginine salt of 1-(3′,4′-dichloro-2-fluorobiphenyl-4-yl)cyclopropanecarboxylic acid; 
 D-Arginine salt of 1-(3′,4′-dichloro-2-fluorobiphenyl-4-yl)cyclopropanecarboxylic acid; and 
 L-Lysine salt of 1-(3′,4′-dichloro-2-fluorobiphenyl-4-yl)cyclopropanecarboxylic acid. 
 
     
     
         14 . The method of  claim 13 , comprising administering the L-Arginine salt of 1-(3′,4′-dichloro-2-fluorobiphenyl-4-yl)cyclopropanecarboxylic acid. 
     
     
         15 . The method of  claim 13 , comprising administering the D-Arginine salt of 1-(3′,4′-dichloro-2-fluorobiphenyl-4-yl)cyclopropanecarboxylic acid. 
     
     
         16 . The method of  claim 13 , comprising administering the L-Lysine salt of 1-(3′,4′-dichloro-2-fluorobiphenyl-4-yl)cyclopropanecarboxylic acid. 
     
     
         17 . A method of treating Alzheimer's Disease in a patient having hypertension associated with Alzheimer's Disease, the method comprising administering a pharmaceutical composition to the patient, wherein:
 the pharmaceutical composition comprises an effective amount of a substantially pure salt of 1-(3′,4′-dichloro-2-fluorobiphenyl-4-yl)cyclopropanecarboxylic acid and a pharmaceutically acceptable carrier; and   the salt of 1-(3′,4′-dichloro-2-fluorobiphenyl-4-yl)cyclopropanecarboxylic acid is selected from the group consisting of:
 L-Arginine salt of 1-(3′,4′-dichloro-2-fluorobiphenyl-4-yl)cyclopropanecarboxylic acid; 
 D-Arginine salt of 1-(3′,4′-dichloro-2-fluorobiphenyl-4-yl)cyclopropanecarboxylic acid; and 
 L-Lysine salt of 1-(3′,4′-dichloro-2-fluorobiphenyl-4-yl)cyclopropanecarboxylic acid. 
   
     
     
         18 . The method of  claim 17 , wherein the pharmaceutical composition comprises the L-Arginine salt of 1-(3′,4′-dichloro-2-fluorobiphenyl-4-yl)cyclopropanecarboxylic acid. 
     
     
         19 . The method of  claim 18 , wherein the pharmaceutical composition is formulated for oral administration. 
     
     
         20 . The method of  claim 19 , wherein the pharmaceutical composition is in a dosage form comprising a single dose of 100 to 800 mg of the salt. 
     
     
         21 . The method of  claim 17 , wherein the pharmaceutical composition comprises the D-Arginine salt of 1-(3′,4′-dichloro-2-fluorobiphenyl-4-yl)cyclopropanecarboxylic acid. 
     
     
         22 . The method of  claim 21 , wherein the pharmaceutical composition is formulated for oral administration. 
     
     
         23 . The method of  claim 22 , wherein the pharmaceutical composition is in a dosage form comprising a single dose of 100 to 800 mg of the salt. 
     
     
         24 . The method of  claim 17 , wherein the pharmaceutical composition comprises the L-Lysine salt of 1-(3′,4′-dichloro-2-fluorobiphenyl-4-yl)cyclopropanecarboxylic acid. 
     
     
         25 . The method of  claim 24 , wherein the pharmaceutical composition is formulated for oral administration. 
     
     
         26 . The method of  claim 25 , wherein the pharmaceutical composition is in a dosage form comprising a single dose of 100 to 800 mg of the salt.