FORMULATIONS FOR CGRP RECEPTOR ANTAGONISTS
The instant invention relates to liquid pharmaceutical compositions containing CGRP receptor antagonists. The CGRP receptor antagonist liquid pharmaceutical compositions of the instant invention are alcohol-free, low volume liquid pharmaceutical compositions that can be taken without water for the treatment of migraine headache.
1 . A liquid pharmaceutical composition comprising (S)-N-((3S, 5S, 6R)-6-methyl-2-oxo-5-phenyl-1-(2,2,2-trifluoroethyl)piperidine-3-yl)-2′-oxo-1′,2′,5,7-tetrahydrospiro[cyclopenta[b]pyridine-6,3′-pyrrolo[2,3-b]pyridine]-3-carboxamide trihydrate present in an amount of 0.25% to 2% by weight of the composition, and a pharmaceutically acceptable carrier comprising VitE-TPGS, polyvinylpyrrolidone, PEG 400, and propylene glycol.
2 . (canceled)
3 . (canceled)
4 . The liquid pharmaceutical composition according to claim 1 , wherein the carrier further comprises water.
5 - 9 . (canceled)
10 . The liquid pharmaceutical composition according to claim 1 , wherein the VitE-TPGS is present in an amount of 0.1% to 15.0% by weight of the composition.
11 . The liquid pharmaceutical composition according to claim 10 , wherein the VitE-TPGS is present in an amount of 2.5% to 10% by weight of the composition
12 - 14 . (canceled)
15 . The liquid pharmaceutical composition according to claim 1 , wherein the volume of carrier is less than 5 mL.
16 . The liquid pharmaceutical composition according to claim 1 , further comprising one or more pharmaceutically acceptable excipients selected from the group consisting of anti-nucleating polymers, antioxidants, chelating agents, souring agents, sodium chloride, colors, sweeteners and flavors.
17 . The liquid pharmaceutical composition according to claim 1 further comprising, Water, Sucralose, Menthol, and a mint or peppermint flavor.
18 . The liquid pharmaceutical composition according to claim 17 , which further comprises a souring agent.
19 . A method of treating migraine headache by administering a liquid pharmaceutical composition according to claim 1 .
20 . A method of treating migraine headache by administering a liquid pharmaceutical composition according to claim 17 .
21 . The liquid pharmaceutical composition according to claim 1 , wherein the VitE-TPGS is present in an amount of about 10.00% by weight of the composition.
22 . The liquid pharmaceutical composition according to claim 1 , wherein the polyvinylpyrrolidone is present in an amount of about 1.00% by weight of the composition.
23 . The liquid pharmaceutical composition according to claim 1 , wherein the PEG 400 is present in an amount of about 33.61% by weight of the composition.
24 . The liquid pharmaceutical composition according to claim 1 , wherein the propylene glycol is present in an amount of about 33.61% by weight of the composition.
25 . The liquid pharmaceutical composition according to claim 1 , wherein the CGRP receptor antagonist is present in an amount of about 1.38% by weight of the composition.