IP Library › Patent Application 16597237
Patent Application
App. No. 16/597,237

PHARMACEUTICAL COMPOSITION

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Quick Facts
Patent No.
US None
App. No.
16/597,237
Abstract

The invention concerns pharmaceutical compositions containing a hydrogen sulphate salt of 6-(4-bromo-2-chloro-phenylamino)-7-fluoro-3-methyl-3H-benzoimidazole-5-carboxylic acid (2-hydroxy-ethoxy)-amide and solvates, crystalline forms and amorphous forms thereof, to the use of said compositions as a medicament; and to processes for the preparation of said compositions.

Claims (7)

1 - 20 . (canceled)

21 . A pharmaceutical composition comprising a hydrogen sulphate salt of 6-(4-bromo-2-chloro-phenylamino)-7-fluoro-3-methyl-3H-benzoimidazole-5-carboxylic acid (2-hydroxy-ethoxy)-amide, and a carrier matrix, wherein the carrier matrix comprises a polyglycolised glyceride; and wherein the hydrogen sulphate salt of 6-(4-bromo-2-chloro-phenylamino)-7-fluoro-3-methyl-3H-benzoimidazole-5-carboxylic acid (2-hydroxy-ethoxy)-amide is dispersed within the carrier matrix.

22 . The pharmaceutical composition of claim 21 , wherein the polyglycolised glyceride comprises stearoyl macrogolglycerides.

23 . The pharmaceutical composition of claim 22 , wherein the composition comprises approximately 5% to approximately 30% by weight of the hydrogen sulphate salt of 6-(4-bromo-2-chloro-phenylamino)-7-fluoro-3-methyl-3H-benzoimidazole-5-carboxylic acid (2-hydroxy-ethoxy)-amide.

24 . A pharmaceutical composition comprising a hydrogen sulphate salt of 6-(4-bromo-2-chloro-phenylamino)-7-fluoro-3-methyl-3H-benzoimidazole-5-carboxylic acid (2-hydroxy-ethoxy)-amide, and a carrier matrix, wherein the carrier matrix comprises d-alpha-tocopheryl polyethylene glycol 1000 succinate; and wherein the hydrogen sulphate salt of 6-(4-bromo-2-chloro-phenylamino)-7-fluoro-3-methyl-3H-benzoimidazole-5-carboxylic acid (2-hydroxy-ethoxy)-amide is dispersed within the carrier matrix.

25 . The pharmaceutical composition according to claim 24 , wherein the d-alpha-tocopheryl polyethylene glycol 1000 succinate is present in an amount of approximately 65% to approximately 95% by weight of the composition.

26 . The pharmaceutical composition of claim 25 , wherein the composition comprises approximately 5% to approximately 30% by weight of the hydrogen sulphate salt of 6-(4-bromo-2-chloro-phenylamino)-7-fluoro-3-methyl-3H-benzoimidazole-5-carboxylic acid (2-hydroxy-ethoxy)-amide.