Compositions of tolperisone

Abstract

The present disclosure relates to tolperisone, or a pharmaceutically acceptable salt or hydrate thereof, with 10 ppm 2-methyl-1-(4-methylphenyl)-propenone (4-MMPPO) or less, methods of producing the same, as well as compositions related thereto. The disclosure further relates to methods of treating a subject with tolperisone under conditions that limit exposure of the subject to tolerable levels of 4-MMPPO.

What is claimed is: 
     
         1 . A pharmaceutical formulation, comprising:
 a) tolperisone, or a pharmaceutically acceptable salt or hydrate thereof, with 10 ppm 2-methyl-1-(4-methylphenyl)-propenone (4-MMPPO) or less; and   b) one or more pharmaceutically acceptable carriers.   
     
     
         2 . The pharmaceutical formulation of  claim 1  with 9 ppm 4-MMPPO or less. 
     
     
         3 . The pharmaceutical formulation of  claim 1  with 8 ppm 4-MMPPO or less. 
     
     
         4 . The pharmaceutical formulation of  claim 1  with 7 ppm 4-MMPPO or less. 
     
     
         5 . The pharmaceutical formulation of  claim 1  with 6 ppm 4-MMPPO or less. 
     
     
         6 . The pharmaceutical formulation of  claim 1  with 5 ppm 4-MMPPO or less. 
     
     
         7 . The pharmaceutical formulation of  claim 1  with 4 ppm 4-MMPPO or less. 
     
     
         8 . The pharmaceutical formulation of  claim 1  with 3 ppm 4-MMPPO or less. 
     
     
         9 . The pharmaceutical formulation of  claim 1  with 2 ppm 4-MMPPO or less. 
     
     
         10 . The pharmaceutical formulation of  claim 1  with 1 ppm 4-MMPPO or less. 
     
     
         11 . The pharmaceutical formulation of  claim 1 , wherein the pharmaceutically acceptable salt of tolperisone comprises tolperisone hydrochloride. 
     
     
         12 . A pharmaceutical composition formulated for treating muscle spasms or spasticity, comprising:
 a) tolperisone, or a pharmaceutically acceptable salt or hydrate thereof, with 10 ppm 2-methyl-1-(4-methylphenyl)-propenone (4-MMPPO) or less; and   b) one or more pharmaceutically acceptable carriers.   
     
     
         13 . The pharmaceutical composition of  claim 12  with 9 ppm 4-MMPPO or less. 
     
     
         14 . The pharmaceutical composition of  claim 12  with 8 ppm 4-MMPPO or less. 
     
     
         15 . The pharmaceutical composition of  claim 12  with 7 ppm 4-MMPPO or less. 
     
     
         16 . The pharmaceutical composition of  claim 12  with 6 ppm 4-MMPPO or less. 
     
     
         17 . The pharmaceutical composition of  claim 12  with 5 ppm 4-MMPPO or less. 
     
     
         18 . The pharmaceutical composition of  claim 12  with 4 ppm 4-MMPPO or less. 
     
     
         19 . The pharmaceutical composition of  claim 12  with 3 ppm 4-MMPPO or less. 
     
     
         20 . The pharmaceutical composition of  claim 12  with 2 ppm 4-MMPPO or less. 
     
     
         21 . The pharmaceutical composition of  claim 12  with 1 ppm 4-MMPPO or less. 
     
     
         22 . The pharmaceutical composition of  claim 12 , wherein the pharmaceutically acceptable salt of tolperisone comprises tolperisone hydrochloride.