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 - 108 . (cancelled)
109 . A stabilized, physiologically acceptable formulation of sincalide comprising:
(a) an effective amount of sincalide, and
(b) at least one multi-functional excipient.
110 . The formulation of claim 109 , 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.
111 . The formulation of claim 109 , wherein said at least one multi-functional excipient is an amino acid.
112 . 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.
113 . 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.
114 . A kit, comprising:
(i) a powder mixture 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, and
(ii) a container to hold said powder mixture; and
(iii) optionally, a physiologically acceptable fluid.
115 . 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.
116 . 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.
117 . 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.