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.

1 . A container holding a stabilized, physiologically acceptable formulation of sincalide, wherein the formulation comprises:
 0.005 mg of sincalide,   at least one stabilizer,   at least one chelator, and   at least one bulking agent/tonicity adjuster.   
     
     
         2 - 3 . (canceled) 
     
     
         4 . The container of  claim 1 , wherein the stabilizer is selected from the group consisting of antioxidants and amino acids. 
     
     
         5 . The container of  claim 4 , wherein the stabilizer is an antioxidant. 
     
     
         6 . The container of  claim 4 , wherein the stabilizer is sodium metabisulfite. 
     
     
         7 . The container of  claim 1 , wherein the formulation comprises a plurality of stabilizers. 
     
     
         8 . (canceled) 
     
     
         9 . The container of  claim 7 , wherein the stabilizers comprise L-arginine monohydrochloride and L-methionine. 
     
     
         10 . The container of  claim 7 , wherein the stabilizers comprise L-lysine monohydrochloride and sodium metabisulfite. 
     
     
         11 . The container of  claim 7 , wherein the stabilizers comprise L-arginine monohydrochloride and L-lysine monohydrochloride. 
     
     
         12 . The container of  claim 7 , wherein the stabilizers comprise L-methionine and sodium metabisulfite. 
     
     
         13 . The container of  claim 7 , wherein the stabilizers comprise L-arginine monohydrochloride, L-methionine, L-lysine monohydrochloride, and sodium metabisulfite. 
     
     
         14 - 15 . (canceled) 
     
     
         16 . The container of  claim 1 , wherein the formulation further comprises a buffer. 
     
     
         17 . The container of  claim 1 , wherein the bulking agent/tonicity adjuster is selected from the group consisting of mannitol, amino acids, lactose, potassium chloride, maltose, sucrose, PEG's, trehalose, raffinose, dextrose, cyclodextrins, dextran, galacturonic acid, Ficoll, and polyvinylpyrrolidone (PVP). 
     
     
         18 . The container of  claim 17 , wherein the bulking agent/tonicity adjuster is D-mannitol. 
     
     
         19 . A container holding a stabilized, physiologically acceptable formulation of sincalide, wherein the formulation comprises:
 0.005 mg of sincalide;   at least one stabilizer selected from the group consisting of antioxidants and amino acids;   at least one chelator; and   at least one bulking agent/tonicity adjuster selected from the group consisting of mannitol, amino acids, lactose, potassium chloride, maltose, sucrose, PEG's, trehalose, raffinose, dextrose, cyclodextrins, dextran, galacturonic acid, Ficoll, and polyvinylpyrrolidone (PVP).   
     
     
         20 . A container holding a stabilized, physiologically acceptable formulation of sincalide, wherein the formulation comprises:
 0.005 mg of sincalide;   at least one stabilizer;   at least one chelator; and   at least one bulking agent/tonicity adjuster selected from the group consisting of mannitol, amino acids, lactose, potassium chloride, maltose, sucrose, PEG's, trehalose, raffinose, dextrose, cyclodextrins, dextran, galacturonic acid, Ficoll, and polyvinylpyrrolidone (PVP).   
     
     
         21 . The container of  claim 19 , wherein the formulation further comprises a buffer. 
     
     
         22 . The container of  claim 20 , wherein the formulation further comprises a buffer.