Compositions and methods to inhibit kidney stone growth

Abstract

An oral dosage form or plurality of oral dosage forms comprising as active ingredients citric acid, magnesium citrate, phytin, pyridoxine, and musa is disclosed. The oral dosage form(s) is useful for inhibiting calcium oxalate crystal growth and for treating or inhibiting growth of kidney stones. Methods of inhibiting calcium oxalate crystal growth and of treating or preventing kidney stones are also disclosed.

1 . An oral dosage form or a plurality of dosage forms comprising as active ingredients citric acid, magnesium citrate, phytin, pyridoxine, and musa. 
     
     
         2 . The oral dosage form or plurality of dosage forms of  claim 1 , wherein citric acid is present in an amount selected from about 101 mg to about 352 mg, about 101 mg to about 176 mg, about 176 mg to about 700 mg, and about 352 mg to about 700 mg. 
     
     
         3 . The oral dosage form or plurality of dosage forms of  claim 1 , wherein magnesium citrate is present in an amount selected from about 76 mg to about 201 mg, about 76 mg to about 150 mg, about 150 to about 226 mg, and about 201 mg to about 225 mg. 
     
     
         4 . The oral dosage form or plurality of dosage forms of  claim 1 , wherein phytin is present in an amount selected from about 3 mg to about 400 mg, about 3 mg to about 202 mg, about 3 mg to about 100 mg, about 100 mg to about 600 mg, about 200 mg to about 600 mg, and about 400 mg to about 600 mg. 
     
     
         5 . The oral dosage form or plurality of dosage forms of  claim 1 , wherein pyridoxine is present in an amount selected from about 0.2 mg to about 10 mg, about 0.2 mg to about 6 mg, about 0.2 mg to about 2.7 mg, about 2.7 mg to about 15 mg, about 6.0 mg to about 15 mg, and about 10 mg to about 15 mg. 
     
     
         6 . The oral dosage form or plurality of dosage forms of  claim 1 , wherein musa is present in amount selected from about 1 mg to about 167 mg, about 1 mg to about 85 mg, about 1 mg to about 41 mg, about 41 mg to about 251 mg, about 85 mg to about 251 mg, and about 167 mg to about 251 mg. 
     
     
         7 . The oral dosage form or plurality of dosage forms of  claim 1 , wherein the amount of one of the active ingredients is selected from:
 citric acid is present in an amount of about 101 mg to about 700 mg;   magnesium citrate is present in an amount of about 76 mg to about 226 mg;   phytin is present in an amount of about 3 mg to about 600 mg;   pyridoxine is present in an amount of about 0.1 mg to about 15 mg; and   musa is present in amount of about 1 mg to about 251 mg.   
     
     
         8 . The oral dosage form or plurality of dosage forms of  claim 1 , wherein the amounts of two of the active ingredients are selected from:
 citric acid is present in an amount of about 101 mg to about 700 mg;   magnesium citrate is present in an amount of about 76 mg to about 226 mg;   phytin is present in an amount of about 3 mg to about 600 mg;   pyridoxine is present in an amount of about 0.1 mg to about 15 mg; and   musa is present in amount of about 1 mg to about 251 mg.   
     
     
         9 . The oral dosage form or plurality of dosage forms of  claim 1 , wherein the amounts of 3 of the ingredients are selected from:
 citric acid is present in an amount of about 101 mg to about 700 mg;   magnesium citrate is present in an amount of about 76 mg to about 226 mg;   phytin is present in an amount of about 3 mg to about 600 mg;   pyridoxine is present in an amount of about 0.1 mg to about 15 mg; and   musa is present in amount of about 1 mg to about 251 mg.   
     
     
         10 . The oral dosage form or plurality of dosage forms of  claim 1 , wherein the amounts of 4 of the ingredients are selected from:
 citric acid is present in an amount of about 101 mg to about 700 mg;   magnesium citrate is present in an amount of about 76 mg to about 226 mg;   phytin is present in an amount of about 3 mg to about 600 mg;   pyridoxine is present in an amount of about 0.1 mg to about 15 mg; and   musa is present in amount of about 1 mg to about 251 mg.   
     
     
         11 . The oral dosage form or plurality of dosage forms of  claim 1 , wherein
 citric acid is present in an amount of about 350 mg;   magnesium citrate is present in an amount of about 150 mg;   phytin is present in an amount of about 200 mg;   pyridoxine is present in an amount of about 5 mg; and   musa is present in amount of about 250 mg.   
     
     
         12 . The oral dosage form or a plurality of dosage forms according to  claim 1 , wherein the percent inhibition of calcium oxalate crystal formation by the combination of active ingredients is greater than about 92%. 
     
     
         13 . The oral dosage form or plurality of dosage forms according to  claim 12 , where the percent inhibition is greater than about 96%. 
     
     
         14 . The oral dosage form or plurality of dosage forms according to  claim 12  where the percent inhibition is greater than about 99%. 
     
     
         15 . The oral dosage form or plurality of dosage forms according to  claim 1 , comprising an oral dosage form in the form of a capsule. 
     
     
         16 . A method of treating or inhibiting formation of kidney stones comprising administering to a patient in need thereof the oral dosage form or plurality of dosage forms according to  claim 1 . 
     
     
         17 . The method of  claim 16 , wherein the oral dosage form or plurality of dosage forms comprises
 about 101 mg to about 700 mg citric acid;   about 76 mg to about 226 mg magnesium citrate;   about 3 mg to about 600 mg phytin;   about 0.1 mg to about 15 mg pyridoxine; and   about 1 mg to about 251 mg musa.   
     
     
         18 . A method of inhibiting growth of calcium oxalate crystals comprising
 contacting an aqueous solution comprising calcium oxalate with the oral dosage form or plurality of dosage forms according to  claim 1 .   
     
     
         19 . The method of  claim 18 , wherein the oral dosage form or plurality of dosage forms comprises
 about 101 mg to about 700 mg citric acid;   about 76 mg to about 226 mg magnesium citrate;   about 3 mg to about 600 mg phytin;   about 0.1 mg to about 15 mg pyridoxine; and   about 1 mg to about 251 mg musa.   
     
     
         20 . The method of  claim 19 , wherein
 citric acid is present in an amount selected from: about 51 101 mg to about 352 mg, about 101 mg to about 176 mg, about 176 mg to about 700 mg, and about 352 mg to about 700 mg;   magnesium citrate is present in an amount selected from: about 76 mg to about 201 mg, about 76 mg to about 150 mg, about 150 to about 226 mg, and about 201 mg to about 225 mg;   phytin is present in an amount selected from: about 3 mg to about 400 mg, about 3 mg to about 202 mg, about 3 mg to about 100 mg, about 100 mg to about 600 mg, about 200 mg to about 600 mg, and about 400 mg to about 600 mg;   pyridoxine is present in an amount selected from: about 0.2 mg to about 10 mg, about 0.2 mg to about 6 mg, about 0.2 mg to about 2.7 mg, about 2.7 mg to about 15 mg, about 6.0 mg to about 15 mg, and about 10 mg to about 15 mg; and   musa is present in an amount selected from: about 1 mg to about 167 mg, about 1 mg to about 85 mg, about 1 mg to about 41 mg, about 41 mg to about 251 mg, about 85 mg to about 251 mg, and about 167 mg to about 251 mg.