Sincalide Formulations
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.