Octreotide injection

Abstract

The present invention relates to a sterile solution comprising: octreotide in the form of a pharmaceutically acceptable salt, present at a concentration equivalent to 2.0 mg/ml to 2.5 mg/ml of octreotide base, and at least one preservative in a pharmaceutically acceptable vehicle, wherein the sterile solution is present in an injection device.

1 . A sterile solution comprising: octreotide in the form of a pharmaceutically acceptable salt, present at a concentration equivalent to 2.0 mg/ml to 2.5 mg/ml of octreotide base, and at least one preservative in a pharmaceutically acceptable vehicle, wherein the sterile solution is present in an injection device. 
     
     
         2 . The sterile solution according to  claim 1 , wherein the concentration of octreotide base is 2.1, 2.15, 2.2, 2.25, 2.3, 2.35, 2.4, 2.45 or 2.5 mg/ml. 
     
     
         3 . The sterile solution according to  claim 1 , wherein the concentration of octreotide base is 2.5 mg/ml. 
     
     
         4 . The sterile solution according to  claim 1 , wherein the volume of solution contained in the injection device is in the range of 2.8 ml to 3.2 ml. 
     
     
         5 . The sterile solution according to  claim 1 , wherein the preservative is selected from phenol, benzyl alcohol, m-cresol, methyl parabens, propylparabens, butylparabens, chlorbutanol, thimerosal, phenylmercuric salts or mixtures thereof. 
     
     
         6 . The sterile solution according to  claim 1 , wherein the solution further comprises mannitol in an amount ranging from about 20 mg/ml to about 25 mg/ml. 
     
     
         7 . The sterile solution according to  claim 1 , further comprising: 
       
         
           
                 
                 
                 
               
                     
                     
                 
                     
                     
                   Concentration 
                 
                     
                   Ingredients 
                   in mg/ml 
                 
                     
                     
                 
                     
                 
                 
                 
                 
               
                     
                   octreotide base in the form of its salt 
                   2.5 
                 
                     
                   lactic acid 
                   3.4 
                 
                     
                   mannitol 
                   22.5 
                 
                     
                     
                 
             
                
                
                
                
               
               
                
               
            
             
                
                
                
                
               
            
           
         
         wherein the pH of the sterile solution is in the range from 3.9 to 4.5. 
       
     
     
         8 . The sterile solution according to  claim 1 , further comprising: 
       
         
           
                 
                 
                 
               
                     
                     
                 
                     
                     
                   Concentration 
                 
                     
                   Ingredients 
                   in mg/ml 
                 
                     
                     
                 
                     
                 
                 
                 
                 
               
                     
                   octreotide base in the form of its salt 
                   2.0 
                 
                     
                   lactic acid 
                   3.4 
                 
                     
                   mannitol 
                   22.5 
                 
                     
                     
                 
             
                
                
                
                
               
               
                
               
            
             
                
                
                
                
               
            
           
         
         wherein the pH of the sterile solution is in the range from 3.9 to 4.5. 
       
     
     
         9 . The sterile solution according to  claim 1 , wherein the injection device is configured to inject 20 μl to 250 μl of the sterile solution per injection. 
     
     
         10 . The sterile solution according to  claim 9 , wherein the injection device is configured to inject 20 μl to 80 μl of the sterile solution per injection. 
     
     
         11 . The sterile solution according to  claim 1 , wherein the injection device is a pen injection device.