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 diagnosing gall bladder-related disorders using sincalide formulations.

1 - 9 . (canceled) 
     
     
         10 . A pharmaceutically acceptable formulation comprising an effective amount of Sincalide and a multi-functional excipient, wherein the multi-functional excipient can serve as a bulking agent, a stabilizer, and a buffer. 
     
     
         11 . The pharmaceutically acceptable formulation of  claim 10 , wherein the multi-functional excipient can serve as a chelator. 
     
     
         12 . The pharmaceutically acceptable formulation of  claim 10  further comprising a surfactant/solubilizer. 
     
     
         13 . The pharmaceutically acceptable formulation of  claim 10  further comprising a bulking agent/tonicity adjuster. 
     
     
         14 . The pharmaceutically acceptable formulation of  claim 10 , wherein the multi-functional excipient comprising an amino acid. 
     
     
         15 . A kit comprising a power mixture of Sincalide and a multi-functional excipient, wherein the multi-functional excipient can serve as a bulking agent, a stabilizer, and a buffer; and a container to hold the powder mixture of Sincalide. 
     
     
         16 . The kit of  claim 15 , further comprising a pharmaceutically acceptable fluid. 
     
     
         17 . A method for imaging a hepatobiliary system of a subject comprising:
 administering the pharmaceutically acceptable formulation of  claim 10  to the subject,   administering a hepatobiliary imaging agent to the subject, and detecting the hepatobiliary imaging agent in the subject with a detection device.   
     
     
         18 . The method for imaging the hepatobiliary system of  claim 17 , wherein the detection device is a cholescintigraphy device. 
     
     
         19 . The method for imaging the hepatobiliary system of  claim 17 , wherein the detection device is a hepatobiliary scintigraphy device. 
     
     
         20 . The method for imaging the hepatobiliary system of  claim 17 , wherein the detection device is a ultrasonography device.