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 diagnosing gall bladder-related disorders using sincalide formulations.
1 - 9 . (canceled)
10 . A pharmaceutically acceptable formulation comprising an effective amount of Sincalide and a multi-functional excipient, wherein the multi-functional excipient can serve as a bulking agent, a stabilizer, and a buffer.
11 . The pharmaceutically acceptable formulation of claim 10 , wherein the multi-functional excipient can serve as a chelator.
12 . The pharmaceutically acceptable formulation of claim 10 further comprising a surfactant/solubilizer.
13 . The pharmaceutically acceptable formulation of claim 10 further comprising a bulking agent/tonicity adjuster.
14 . The pharmaceutically acceptable formulation of claim 10 , wherein the multi-functional excipient comprising an amino acid.
15 . A kit comprising a power mixture of Sincalide and a multi-functional excipient, wherein the multi-functional excipient can serve as a bulking agent, a stabilizer, and a buffer; and a container to hold the powder mixture of Sincalide.
16 . The kit of claim 15 , further comprising a pharmaceutically acceptable fluid.
17 . A method for imaging a hepatobiliary system of a subject comprising:
administering the pharmaceutically acceptable formulation of claim 10 to the subject,
administering a hepatobiliary imaging agent to the subject, and detecting the hepatobiliary imaging agent in the subject with a detection device.
18 . The method for imaging the hepatobiliary system of claim 17 , wherein the detection device is a cholescintigraphy device.
19 . The method for imaging the hepatobiliary system of claim 17 , wherein the detection device is a hepatobiliary scintigraphy device.
20 . The method for imaging the hepatobiliary system of claim 17 , wherein the detection device is a ultrasonography device.