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 . A stabilized, physiologically acceptable formulation of sincalide comprising:
 a) an effective amount of sincalide, and   b) at least one multi-functional excipient.   
     
     
         2 . The formulation of  claim 1 , wherein said at least one multi-functional excipient performs the function of a stabilizer, a chelator, a bulking agent/tonicity adjuster, a surfactant/solubilizer, and a buffer. 
     
     
         3 . The formulation of  claim 1 , wherein said at least one multi-functional excipient is an amino acid. 
     
     
         4 . A stabilized, physiologically acceptable formulation of sincalide comprising:
 a) an effective amount of sincalide, and   b) one or more excipients which perform the function of a stabilizer, a chelator, a bulking agent/tonicity adjuster, a surfactant/solubilizer, and a buffer.   
     
     
         5 . A method of making a stabilized formulation of sincalide, said method comprising the step of mixing:
 a) sincalide, and   b) one or more excipients which perform the function of a stabilizer, a chelator, a bulking agent/tonicity adjuster, a surfactant/solubilizer, and a buffer.   
     
     
         6 . A kit, comprising:
 a) a powder mixture comprising:
 (i) sincalide, and 
 (ii) one or more excipients which perform the function of a stabilizer, a chelator, a bulking agent/tonicity adjuster, a surfactant/solubilizer, and a buffer, and 
   b) a container to hold said powder mixture; and   c) optionally, a physiologically acceptable fluid.   
     
     
         7 . A method for treating or preventing a medical condition associated with total parental nutrition (TPN), said method comprising administering to a patient receiving TPN an effective amount of a sincalide formulation, said formulation comprising:
 a) sincalide, and   b) one or more excipients which perform the function of a stabilizer, a chelator, a bulking agent/tonicity adjuster, a surfactant/solubilizer, and a buffer.   
     
     
         8 . A method for imaging the hepatobiliary system of a subject, said method comprising:
 a) administering a hepatobiliary imaging agent to said subject;   b) before or after step (a), administering to a subject a sincalide formulation comprising:
 (i) sincalide, and 
 (ii) one or more excipients which perform the function of a stabilizer, a chelator, a bulking agent/tonicity adjuster, a surfactant/solubilizer, and a buffer, and 
   c) detecting said imaging agent in said subject with a detection device.   
     
     
         9 . A method for imaging the hepatobiliary system of a subject, said method comprising:
 a) administering to a subject a sincalide formulation comprising:
 (i) sincalide, and 
 (ii) one or more excipients which perform the function of a stabilizer, a chelator, a bulking agent/tonicity adjuster, a surfactant/solubilizer, and a buffer, and 
   b) scanning the subject using a diagnostic imaging modality.