SINCALIDE FORMULATIONS AND METHODS OF USE
The present invention relates to improved Sincalide ready-to-use formulations. The presently disclosed formulations eliminate the need for freeze drying and reconstitution with water for injection at the time of use. The present invention also relates to Sincalide formulations characterized by improved stability and ease of commercial manufacturing.
1 . (canceled)
2 . A stable, ready-to-use composition comprising a physiologically effective amount of Sincalide, and at least one pharmaceutically acceptable excipient.
3 . The stable, ready-to-use composition according to claim 1 , wherein the composition comprises an aqueous solution of Sincalide, and the composition is suitable for administration by injection.
4 . The stable, ready-to-use composition according to claim 2 , wherein the at least one pharmaceutically acceptable excipient is selected from a stabilizer, a chelator, a tonicity adjuster, and a buffer.
5 . The stable, ready-to-use composition according to claim 3 , wherein the stabilizer is an antioxidant or a reducing agent.
6 . The stable, ready-to-use composition according to claim 3 , wherein the chelator is EDTA or a derivative thereof. (New) The stable, ready-to-use composition according to claim 3 , wherein the tonicity adjuster is sodium chloride.
8 . The stable, ready-to-use composition according to claim 3 , wherein the buffer is selected from phosphoric acid, monobasic or dibasic sodium phosphate, monobasic or dibasic potassium phosphate, citric acid, sodium citrate, sulfosalicylate, acetic acid, potassium acetate, sodium acetate, methyl boronic acid, disodium succinate hexahydrate, amino acids, amino acid salts, lactic acid, sodium lactate, maleic acid, maleate, potassium chloride, benzoic acid, sodium benzoate, carbonic acid, sodium carbonate, sodium bicarbonate, boric acid, sodium borate, sodium chloride, succinic acid, sodium succinate, tartaric acid, sodium tartrate, tris-(hydroxy methyl amino methane, and biological buffers.
9 . The stable, ready-to-use composition of claim 2 , wherein the composition is contained in a vial or syringe.
10 . The stable, ready-to-use composition of claim 2 , wherein the composition has a pH from 5.5 to 9.1.
11 . The stable, ready-to-use composition of claim 3 , wherein the stabilizer is disodium EDTA dihydrate.
12 . A method for treating, preventing, or diagnosing gall bladder-related disorders, comprising administering to a subject in need thereof; the injectable composition as claimed in claim 1 in an amount effective to treat, prevent, or diagnose gall-bladder-related disorders.