Process for preparing a creatine heterocyclic acid salt and method of use

Abstract

This invention relates to a process for the synthesis and method of use of an effective amount of a creatine heterocyclic acid salt for the regulation athletic function in humans.

1. A process for the synthesis of a creatine orotic acid, thioorotic acid, and dihydroorotic heterocyclic acid salt comprising the steps of:
 a) mixing creatine with a water appetent organic alcohol solvents, other water appetent organic solvents, solvent or water at a temperature of 1 to 100 degree Celsius, 
 b) reacting the product mixture of step a) with orotic acid, thioorotic acid, or dihydroorotic acid at a temperature of 1 to 100 degree Celsius to produce a residue including the creatine heterocyclic acid salt; 
 C) filtering to remove the solvent andc) washing the residue with a water appetent organic alcohol solvents, other water appetent organic solvents,solvent or water; and  
 for the recovery ofd) recovering the creatine heterocyclic acid salt from the residue, 
 wherein the creatine heterocyclic acid salt is a mono, di, or tricreatine orotic acid, thioorotic acid, and or dihydroorotic acid salt. 
 
     
     
       2. The process according to  claim 1  step a), wherein the reaction mixing in step a) is carried out at a temperature under 22 degree Celsius. 
     
     
       3. The process according to  claim 1  step a), wherein said creatine is creatine monohydrate and said water appetent organic alcohol solvent of step a) is selected from the group consisting of methanol, ethanol, or and propanol. 
     
     
       4. The process according to  claim 1  step b), wherein the reaction of step b) is carried out at a temperature under 22 degree Celsius. 
     
     
       5. The process according to  claim 1  step c), wherein the said residue of step c) is washed with a water appetent organic alcohol solvent is selected from the group consisting of methanol, ethanol, and propanol. 
     
     
       6. A method for providing creatine to a human to enhance physical performance, comprising:
 receivingadministering to a human in need thereof an effective amount of a creatine heterocyclic acid salt selected from the group consisting of mono, di, or tricreatine orotic acid, thioorotic acid, and dihydroorotic acid salt by the human, wherein the creatine orotic acid, thioorotic acid, and dihydroorotic acid salt is suitable for being modified by the human to form creatinesalts. 
 
     
     
       7. The method as described in  claim 6 , wherein the creatine orotic acid, thioorotic acid, and dihydroorotic heterocyclic acid salt is suitable for peroral, transdermal, sublingual, and or intranasal administration. 
     
     
       8. The method as described in  claim 6 , wherein the creatine orotic acid, thioorotic acid, and dihydroorotic heterocyclic acid salt is suitable orally administered in a daily dose of 1 to 40,000 mg/day. 
     
     
       9. The method as described in  claim 6 , wherein the creatine orotic acid, thioorotic acid, and dihydroorotic heterocyclic acid salt is received by the human, the creatine orotic acid, thioorotic acid, and dihydroorotic acid salt is modified by the human into creatine and orotic acid, thioorotic acid, and dihydroorotic acid enters the blood stream intact.