Sincalide Formulations

Abstract

The invention features sincalide formulations that include an effective amount of sincalide, a bulking agent/tonicity adjuster, a stabilizer, a surfactant, a chelator, and a buffer. The invention also features kits and methods for preparing improved sincalide formulations as well as methods for treating, preventing, and diagnosting gall bladder-related disorders using sincalide formulations.

We claim: 
     
         1 . A pharmaceutical composition comprising:
 (a) a compound of formula   
       
         
           
           
               
               
           
         
         (b) at least one compound selected from the group consisting of: 
       
       
         
           
           
               
               
           
         
       
       and
 (c) at least one component selected from the group consisting of:
 a stabilizer, 
 a surfactant/solubilizer, 
 a chelator, 
 a bulking agent/tonicity adjuster, and 
 a buffer. 
 
 
     
     
         2 . The pharmaceutical composition of  claim 1  comprising a compound of formula 
       
         
           
           
               
               
           
         
       
     
     
         3 . The pharmaceutical composition of  claim 1  comprising a compound of formula 
       
         
           
           
               
               
           
         
       
     
     
         4 . The pharmaceutical composition of  claim 1  comprising a compound of formula 
       
         
           
           
               
               
           
         
       
     
     
         5 . The pharmaceutical composition of  claim 1  comprising a compound of formula 
       
         
           
           
               
               
           
         
       
     
     
         6 . The pharmaceutical composition of  claim 1  comprising at least two compounds selected from the group consisting of: 
       
         
           
           
               
               
           
         
       
     
     
         7 . The pharmaceutical composition of  claim 1  comprising at least three compounds selected from the group consisting of: 
       
         
           
           
               
               
           
         
       
     
     
         8 . The pharmaceutical composition of  claim 1  comprising: 
       
         
           
           
               
               
           
         
       
     
     
         9 . A use of the pharmaceutical composition according to  claim 1  in a preparation of a medicament for treatment or prevention of a medical condition associated with total parenteral nutrition (TPN). 
     
     
         10 . The use of  claim 9  wherein said medical condition is TPN-associated cholestatis. 
     
     
         11 . A use of the pharmaceutical composition according to  claim 1  in combination with a hepatobiliary imaging agent for diagnostic imaging of a hepatobiliary system. 
     
     
         12 . The use of  claim 11 , wherein the hepatobiliary imaging agent is a  99m Tc-IDA (Iminodiacetic acid) analog. 
     
     
         13 . The use of  claim 11 , wherein the hepatobiliary imaging agent is  99m Tc-mebrofenin. 
     
     
         14 . The use of  claim 11  for diagnosis of gallbladder diseases and related disorders.