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 stabilized, physiologically acceptable formulation of sincalide comprising:
 an effective amount of sincalide,   at least one stabilizer,   at least one chelator, and   at least one bulking agent/tonicity adjuster.   
     
     
         2 . The formulation of  claim 1 , comprising about 0.0008-0.0012 mg/mL sincalide. 
     
     
         3 . The formulation of  claim 1 , comprising about 0.005 mg/vial sincalide. 
     
     
         4 . The formulation of  claim 1 , wherein the stabilizer is selected from the group consisting of antioxidants and amino acids. 
     
     
         5 . The formulation of  claim 4 , wherein the stabilizer is an antioxidant. 
     
     
         6 . The formulation of  claim 4 , wherein the stabilizer is sodium metabisulfite. 
     
     
         7 . The formulation of  claim 1 , wherein the formulation comprises a plurality of stabilizers. 
     
     
         8 . The formulation of  claim 7 , wherein the stabilizers comprise L-arginine monohydrochloride, L-methionine, L-lysine monohydrochloride, or sodium metabisulfite. 
     
     
         9 . The formulation of  claim 7 , wherein the stabilizers comprise L-arginine monohydrochloride and L-methionine. 
     
     
         10 . The formulation of  claim 7 , wherein the stabilizers comprise L-lysine monohydrochloride and sodium metabisulfite. 
     
     
         11 . The formulation of  claim 7 , wherein the stabilizers comprise L-arginine monohydrochloride and L-lysine monohydrochloride. 
     
     
         12 . The formulation of  claim 7 , wherein the stabilizers comprise L-methionine and sodium metabisulfite. 
     
     
         13 . The formulation of  claim 7 , wherein the stabilizers comprise L-arginine monohydrochloride, L-methionine, L-lysine monohydrochloride, and sodium metabisulfite. 
     
     
         14 . The formulation of  claim 8 , comprising about 0.0008-0.0012 mg/mL sincalide. 
     
     
         15 . The formulation of  claim 8 , comprising about 0.005 mg/vial sincalide. 
     
     
         16 . The formulation of  claim 1 , further comprising a buffer. 
     
     
         17 . The formulation of  claim 1 , wherein the bulking agent/tonicity adjuster is selected from the group consisting of mannitol, amino acids, lactose, potassium chloride, sodium chloride, maltose, sucrose, PEG's, trehalose, raffinose, dextrose, cyclodextrins, dextran, galacturonic acid, Ficoll, and polyvinylpyrrolidone (PVP). 
     
     
         18 . The formulation of  claim 17 , wherein the bulking agent/tonicity adjuster is D-mannitol. 
     
     
         19 . A stabilized, physiologically acceptable formulation of sincalide comprising: about 0.005 mg/vial sincalide;
 at least one stabilizer wherein the stabilizers comprise L-arginine monohydrochloride, L-methionine, L-lysine monohydrochloride, or sodium metabisulfite;   at least one chelator; and   at least one bulking agent/tonicity adjuster selected from the group consisting of mannitol, amino acids, lactose, potassium chloride, sodium chloride, maltose, sucrose, PEG's, trehalose, raffinose, dextrose, cyclodextrins, dextran, galacturonic acid, Ficoll, and polyvinylpyrrolidone (PVP).   
     
     
         20 . A stabilized, physiologically acceptable formulation of sincalide comprising:
 about 0.005 mg/vial 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, sodium chloride, maltose, sucrose, PEG's, trehalose, raffinose, dextrose, cyclodextrins, dextran, galacturonic acid, Ficoll, and polyvinylpyrrolidone (PVP).