Method of Making a Magnesium Salt of an Alpha Keto Acid of Leucine, Isoleucine, and Valine

Abstract

A method of making a magnesium salt of an alpha keto acid of the amino acid comprising valine, leucine, and/or isoleucine: 1) combining ingredients comprising: a calcium salt of an amino acid valine, leucine, or isoleucine; water; hydrochloric acid; and methyl tert-butyl ether; 2) stirring for about thirty minutes; 3) allowing the composition to settle into two layers, and collecting the top organic layer, and adding water and magnesium carbonate to the top organic layer; 4) heating the composition for one hour to 60-65° Celsius; 5) removing the solvent, cooling, and adding methyl-tert-butyl ether; 6) stirring the composition for one hour at 25-30° Celsius; 7) filtering, washing, drying under vacuum, and storing the composition as a powder; and 8) wherein the powder is a safe consumable low nitrogen product orally administered within a food, a beverage, or a tablet to treat kidney disease.

What is claimed is: 
     
         1 . A method of making a magnesium salt of an alpha keto acid of the amino acid comprising leucine, isoleucine, and valine the steps comprising:
 1) combining ingredients to make a composition comprising: a calcium salt of an amino acid valine, or leucine, or isoleucine; a water; a hydrochloric acid; and a methyl tert-butyl ether;   2) stirring the composition for about thirty minutes;   3) (a) allowing the composition to settle into two layers and collecting the top organic layer;
 (b) adding water and stirring for 15 minutes; 
 (c) repeating step 3(a); and 
 (d) adding water and magnesium carbonate to the top organic layer; 
   4) heating the composition for about one hour to about 60-65 degrees Celsius;   5) removing the solvent, cooling, and adding methyl-tert-butyl ether to the composition;   6) stirring the composition for about one hour at about 25-30 degrees Celsius;   7) filtering, washing, drying under vacuum, and storing the composition as a powder; and   8) wherein the powder is a safe consumable low nitrogen product orally administered within a food, a beverage, or a tablet or pill.   
     
     
         2 . The method of making of  claim 1 , wherein the method does not involve the use of ICH class -1 solvents comprising one or more of: a Benzene; a carbon tetrachloride; a 1,2-Dichloroethane;
 and a 1,1,1-trichloroethane.   
     
     
         3 . The method of making of  claim 1 , wherein the method further comprises the user of ICH-class class-2 and/or class-3 solvents that are used in the manufacturing process are within the acceptable criteria of ICH requirements. 
     
     
         4 . The method of making of  claim 1 , wherein the composition and/or ingredients are tested for one or more microbial levels comprising: a total microbial count; a yeast and mold count; a level or absence of one or more bacterial strains comprising  Escherichia coli, Salmonella,  and  Pseudomonas aeruginosa.    
     
     
         5 . The method of making the magnesium salt of leucine of  claim 1 , wherein the composition ingredients comprises in step 1:
 a) about 570 milliliters of water;   b) about 100 grams of the calcium salt of leucine;   c) about 480 milliliters of methyl-tert-butyl ether;   d) about 60 milliliters of hydrochloric acid.   
     
     
         6 . The method of making the magnesium salt of leucine of  claim 5 , wherein step 3 of  claim 1  further comprises:
 1) allowing the composition to settle into two layers and collecting the top organic layer; 
 2) adding about 300 milliliters of water and stirring for 15 minutes; 
 3) repeating step 6(a); and 
 4) adding about 800 milliliters water and about 25.2 grams of magnesium carbonate to the top organic layer. 
 
     
     
         7 . The method of making the magnesium salt of leucine of  claim 5 , wherein step 5 of  claim 1  further comprises adding 300 milliliters of methyl-tert-butyl ether. 
     
     
         8 . The method of making the magnesium salt of leucine of  claim 5 , wherein step 7 of  claim 1  further comprises adding 200 milliliters of methyl-tert-butyl ether. 
     
     
         9 . The method of making the magnesium salt of isoleucine of  claim 1 , wherein the composition ingredients in step 1 comprise:
 a) about 2.39 liters of water;   b) about 418 milliliters of the calcium salt of isoleucine;   c) about 2.04 liters of methyl-tert-butyl ether; and   d) about 0.32 liters of hydrochloric acid.   
     
     
         10 . The method of making the magnesium salt of isoleucine of  claim 9 , wherein step 3 of  claim 1  further comprises:
 1) allowing the composition to settle into two layers and collecting the top organic layer; 
 2) adding about 1.25 liters of water and stirring for 15 minutes; 
 3) repeating step 6(a); and 
 4) adding about 3.34 liters of water and about 84.2 grams of magnesium carbonate to the top organic layer. 
 
     
     
         11 . The method of making the magnesium salt of isoleucine of  claim 9 , wherein step 5 of  claim 1  further comprises adding about 1.25 liters milliliters of methyl-tert-butyl ether. 
     
     
         12 . The method of making the magnesium salt of isoleucine of  claim 9 , wherein step 7 of  claim 1  further comprises adding about 0.836 liters of methyl-tert-butyl ether. 
     
     
         13 . The method of making the magnesium salt of valine of  claim 1 , wherein the composition ingredients of step 1 comprise:
 a) about 280 milliliters of water;   b) about 50 grams of the calcium salt of valine;   c) about 240 milliliters of methyl-tert-butyl ether; and   d) about 30 milliliters of hydrochloric acid.   
     
     
         14 . The method of making the magnesium salt of valine of  claim 13 , wherein step 3 of  claim 1  further comprises:
 1) allowing the composition to settle into two layers and collecting the top organic layer; 
 2) adding about 150 milliliters of water and stirring for 15 minutes; 
 3) repeating step 6(a); and 
 4) adding about 400 milliliters of water and about 12.6 grams of magnesium carbonate to the top organic layer. 
 
     
     
         15 . The method of making the magnesium salt of valine of  claim 9 , wherein step 5 of  claim 1  further comprises adding about 150 milliliters of methyl-tert-butyl ether. 
     
     
         16 . The method of making the magnesium salt of valine of  claim 9 , wherein step 7 of  claim 1  further comprises adding about 100 milliliters of methyl-tert-butyl ether.