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 pharmaceutical composition comprising:
(a) a compound of formula
(b) at least one compound selected from the group consisting of:
and
(c) at least one component selected from the group consisting of:
a stabilizer,
a surfactant/solubilizer,
a chelator,
a bulking agent/tonicity adjuster, and
a buffer.
2 . The pharmaceutical composition of claim 1 comprising a compound of formula
3 . The pharmaceutical composition of claim 1 comprising a compound of formula
4 . The pharmaceutical composition of claim 1 comprising a compound of formula
5 . The pharmaceutical composition of claim 1 comprising a compound of formula
6 . The pharmaceutical composition of claim 1 comprising at least two compounds selected from the group consisting of:
7 . The pharmaceutical composition of claim 1 comprising at least three compounds selected from the group consisting of:
8 . The pharmaceutical composition of claim 1 comprising:
9 . A use of the pharmaceutical composition according to claim 1 in a preparation of a medicament for treatment or prevention of a medical condition associated with total parenteral nutrition (TPN).
10 . The use of claim 9 wherein said medical condition is TPN-associated cholestatis.
11 . A use of the pharmaceutical composition according to claim 1 in combination with a hepatobiliary imaging agent for diagnostic imaging of a hepatobiliary system.
12 . The use of claim 11 , wherein the hepatobiliary imaging agent is a 99m Tc-IDA (Iminodiacetic acid) analog.
13 . The use of claim 11 , wherein the hepatobiliary imaging agent is 99m Tc-mebrofenin.
14 . The use of claim 11 for diagnosis of gallbladder diseases and related disorders.