Stable liquid formulations of melphalan

Abstract

The present invention relates to stable, liquid parenteral formulations of Melphalan or pharmaceutically acceptable salts thereof. Further this invention also describes process of preparing such formulations.

1 . (canceled) 
     
     
         2 : The formulation of  claim 3 , wherein the pH of the formulation is between 2 to 5. 
     
     
         3 : A stable, liquid parenteral formulation consisting essentially of:
 (i) Melphalan   (ii) one or more solvents and   (iii) one or more anti-oxidants.   
     
     
         4 : A stable, liquid parenteral formulation consisting essentially of:
 (i) Melphalan hydrochloride   (ii) one or more solvents selected from dimethyl acetamide, polyethylene glycol, ethanol, propylene glycol and glycerine.   (iii) anti-oxidants selected from monothioglycerol, L-cysteine and chelating agents.   
     
     
         5 . (canceled) 
     
     
         6 : The stable, liquid parenteral formulation of  claim 4  consisting of: 
       
         
           
                 
                 
                 
               
                     
                 
                   (i) 
                   Melphalan hydrochloride 
                   1 to 30% 
                 
                   (ii) 
                   dimethylacetamide 
                   20 to 85% 
                 
                   (iii) 
                   ethanol 
                   0 to 50% 
                 
                   (iv) 
                   propylene glycol 
                   5 to 50% 
                 
                   (v) 
                   at least one of monothioglycerol, chelating agent, 
                   0.05 to 5% 
                 
                     
                   and both in combination by weight of the composi- 
                 
                     
                   tion. 
                 
                     
                 
             
                
               
               
                
                
                
                
                
                
                
                
               
            
           
         
       
     
     
         7 : The stable, liquid parenteral formulation of  claim 4  consisting of: 
       
         
           
                 
                 
                 
               
                     
                 
                   (i) 
                   Melphalan hydrochloride 
                   1 to 30% 
                 
                   (ii) 
                   polyethylene glycol 
                   20 to 85% 
                 
                   (iii) 
                   ethanol 
                   0 to 50% 
                 
                   (iv) 
                   propylene glycol 
                   5 to 50% 
                 
                   (v) 
                   at least one of monothioglycerol, chelating agent, 
                   0.05 to 5% 
                 
                     
                   and both in combination by weight of the composi- 
                 
                     
                   tion. 
                 
                     
                 
             
                
               
               
                
                
                
                
                
                
                
                
               
            
           
         
       
     
     
         8 : A stable, liquid parenteral formulation of Melphalan consisting essentially of: 
       
         
           
                 
                 
                 
               
                     
                 
                   (i) 
                   Melphalan hydrochloride 
                   1 to 30% 
                 
                   (ii) 
                   polyethylene glycol 
                   20 to 85% 
                 
                   (iii) 
                   propylene glycol 
                   5 to 50% 
                 
                   (iv) 
                   monothioglycerol 
                   0.05 to 5% 
                 
                   (v) 
                   chelating agent by weight of the composition. 
                   0.01 to 5%