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 - 108 . (cancelled)  
     
     
         109 . A stabilized, physiologically acceptable formulation of sincalide comprising: 
 (a) an effective amount of sincalide, and    (b) at least one multi-functional excipient.    
     
     
         110 . The formulation of  claim 109 , 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.  
     
     
         111 . The formulation of  claim 109 , wherein said at least one multi-functional excipient is an amino acid.  
     
     
         112 . 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.    
     
     
         113 . 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.    
     
     
         114 . A kit, comprising: 
 (i) a powder mixture 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, and  
   (ii) a container to hold said powder mixture; and    (iii) optionally, a physiologically acceptable fluid.    
     
     
         115 . 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.    
     
     
         116 . 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.    
     
     
         117 . 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.