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 . A stabilized, physiologically acceptable formulation of sincalide comprising:
a) an effective amount of sincalide, and
b) at least one multi-functional excipient.
2 . The formulation of claim 1 , wherein said at least one multi-functional excipient performs the function of a stabilizer, a chelator, a bulking agent/tonicity adjuster, a surfactant/solubilizer, and a buffer.
3 . The formulation of claim 1 , wherein said at least one multi-functional excipient is an amino acid.
4 . A stabilized, physiologically acceptable formulation of sincalide comprising:
a) an effective amount of sincalide, and
b) one or more excipients which perform the function of a stabilizer, a chelator, a bulking agent/tonicity adjuster, a surfactant/solubilizer, and a buffer.
5 . A method of making a stabilized formulation of sincalide, said method comprising the step of mixing:
a) sincalide, and
b) one or more excipients which perform the function of a stabilizer, a chelator, a bulking agent/tonicity adjuster, a surfactant/solubilizer, and a buffer.
6 . A kit, comprising:
a) a powder mixture comprising:
(i) sincalide, and
(ii) one or more excipients which perform the function of a stabilizer, a chelator, a bulking agent/tonicity adjuster, a surfactant/solubilizer, and a buffer, and
b) a container to hold said powder mixture; and
c) optionally, a physiologically acceptable fluid.
7 . A method for treating or preventing a medical condition associated with total parental nutrition (TPN), said method comprising administering to a patient receiving TPN an effective amount of a sincalide formulation, said formulation comprising:
a) sincalide, and
b) one or more excipients which perform the function of a stabilizer, a chelator, a bulking agent/tonicity adjuster, a surfactant/solubilizer, and a buffer.
8 . A method for imaging the hepatobiliary system of a subject, said method comprising:
a) administering a hepatobiliary imaging agent to said subject;
b) before or after step (a), administering to a subject a sincalide formulation comprising:
(i) sincalide, and
(ii) one or more excipients which perform the function of a stabilizer, a chelator, a bulking agent/tonicity adjuster, a surfactant/solubilizer, and a buffer, and
c) detecting said imaging agent in said subject with a detection device.
9 . A method for imaging the hepatobiliary system of a subject, said method comprising:
a) administering to a subject a sincalide formulation comprising:
(i) sincalide, and
(ii) one or more excipients which perform the function of a stabilizer, a chelator, a bulking agent/tonicity adjuster, a surfactant/solubilizer, and a buffer, and
b) scanning the subject using a diagnostic imaging modality.