| CPC A61K 31/513 (2013.01) [A61K 9/2009 (2013.01); A61K 9/2018 (2013.01); A61K 9/2027 (2013.01); A61K 9/2059 (2013.01); A61P 5/30 (2018.01); A61P 15/00 (2018.01)] | 16 Claims |
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1. A pharmaceutical composition comprising:
from about 20 to about 60% by weight of sodium 4-((R)-2-[5-(2-fluoro-3-methoxy-phenyl)-3-(2-fluoro-6-trifluoromethyl-benzyl)-4-methyl-2,6-dioxo-3,6-dihydro-2H-pyrimidin-1-yl]-1-phenyl-ethylamino)butanoate (“elagolix sodium”);
from about 10 to about 30% by weight of sodium carbonate; and
a first filler in an amount from about 20% to about 50% by weight and a second filler in an amount from about 1% to about 20% by weight,
wherein the first filler is mannitol and the second filler is pregelatinized starch,
wherein each weight percentage is on the basis of the total weight of the pharmaceutical composition, and
wherein said composition is in the form of a stable immediate release tablet.
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