PHARMACEUTICAL COMPOSITION 271

1 . 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 consists essentially of one or more pharmaceutically acceptable carriers selected from the following groups:

(a) d-alpha-tocopheryl polyethylene glycol 1000 succinate;

(b) polyglycolised glycerides;

(c) polyethylene glycols (PEGs); and

(d) hard fats;

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.

2 . A pharmaceutical composition according to claim 1 , wherein the carrier matrix consists essentially of one or more groups selected from the following groups:

a. d-alpha-tocopheryl polyethylene glycol 1000 succinate;

b. polyglycolised glycerides; and

c. polyethylene glycols.

3 . A pharmaceutical composition according to claim 2 , wherein the carrier matrix consists essentially of one or both of the following:

a. d-alpha-tocopheryl polyethylene glycol 1000 succinate; and

b. polyglycolised glycerides.

4 . A pharmaceutical composition according to claim 1 , wherein the carrier matrix is d-alpha-tocopheryl polyethylene glycol 1000 succinate or Lauroyl Macrogol-32 Glycerides.

5 . A pharmaceutical composition according to claim 1 , wherein the carrier matrix is a mixture of d-alpha-tocopheryl polyethylene glycol 1000 succinate and Lauroyl Macrogol-32 Glycerides and wherein the Lauroyl Macrogol-32 Glycerides is present in an amount to make up approximately 30-55% by weight of the carrier matrix component of the composition.

6 . A pharmaceutical composition according to claim 1 , wherein the carrier matrix is d-alpha-tocopheryl polyethylene glycol 1000 succinate.

7 . A pharmaceutical composition according to claim 6 , wherein the d-alpha-tocopheryl polyethylene glycol 1000 succinate is present in an amount to make up approximately 65 to 95% by weight of the composition.

8 . A pharmaceutical composition according to claim 1 , wherein greater than 90% by weight of the total amount 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 present in the composition is dispersed within the carrier matrix.

9 . A pharmaceutical composition according to claim 1 , wherein the composition contains between 5 to 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.

10 . A pharmaceutical composition according to claim 1 , wherein the composition is semi-solid or solid at ambient temperature.

11 . A pharmaceutical composition according to claim 1 , 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 in the form of finely divided particles that are distributed throughout the phase comprising the carrier matrix.

12 . A pharmaceutical composition according to claim 1 , comprising:

(i) from 15 to 25 parts of 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

(ii) from 75 to 85 parts of Vitamin E TPGS;

wherein both parts are by weight and the sum of the parts (i)+(ii)=100;

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 Vitamin E TPGS and the composition is semi-solid or solid at ambient temperature.

13 . A pharmaceutical composition according to claim 1 , comprising:

(i) from 18 to 22 parts of 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

(ii) from 78 to 82 parts of Vitamin E TPGS;

wherein both parts are by weight and the sum of the parts (i)+(ii)=100;

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 Vitamin E TPGS and the composition is semi-solid or solid at ambient temperature.

14 . A pharmaceutical composition according to claim 1 , comprising:

(i) 19-21 parts of hydrogen sulphate salt of 6-(4-bromo-2-chloro-phenylamino)-7-fluoro-3-methyl-3H-benzoimidazole-5-carboxylic acid (2-hydroxy-ethoxy)-amide; and

(ii) 79-81 parts of Vitamin E TPGS;

wherein both parts are by weight and the sum of the parts (i)+(ii)=100; 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 Vitamin E TPGS and the composition is semi-solid or solid at ambient temperature.

15 . A pharmaceutical composition according to claim 1 , wherein the composition is an oral capsule composition.

16 . A process for the preparation of a pharmaceutical composition according to claim 1 comprising the steps of:

a. Mixing and melting the components of the carrier matrix;

b. Mixing the Agent into the carrier matrix in order to obtain a homogenous mixture; and

c. Filling the product of step (b) into a capsule and allowing the mixture to cool to form a viscous liquid, semi-solid or solid mass within the capsule.

17 . A method for treating a warm blooded animal (preferably a human) suffering from a condition treatable by the hydrogen sulphate salt of 6-(4-bromo-2-chloro-phenylamino)-7-fluoro-3-methyl-3H-benzoimidazole-5-carboxylic acid (2-hydroxy-ethoxy)-amide comprising administering thereto a pharmaceutical composition according to claim 1 .

18 . A method for treating cancer in a warm blooded animal (preferably a human) comprising administering thereto a pharmaceutical composition according to claim 1 .

19 . (canceled)

20 . (canceled)