NOVEL PHARMACEUTICAL COMPOSITION

1 . A pharmaceutical tablet comprising:

a) an amount of a drug, which is N-{3-[3-cyclopropyl-5-(2-fluoro-4-iodo-phenylamino)-6,8-dimethyl-2,4,7-trioxo-3,4,6,7-tetrahydro-2H-pyrido[4,3-d]pyrimidin-1-yl]phenyl}acetamide dimethyl sulfoxide solvate, selected from: about 0.5635 mg, about 1.127 mq, and about 2.254 mg;

wherein,

b) the tablet contains from about 25% to about 89% by weight of one or more excipients, where the excipients are substantially free of water; and

c) the amount of unsolvated drug does not exceed about 20%.

2 . A pharmaceutical tablet according to claim 1 wherein the amount of unslovated drug does not exceed about 15%.

3 . A pharmaceutical tablet according to claim 1 wherein the amount of unsolvated drug does not exceed about 10%.

4 . A pharmaceutical tablet according to claim 1 wherein the amount of unsolvated drug does not exceed about 5%.

5 . A pharmaceutical tablet according to claim 1 wherein the amount of unsolvated drug does not exceed about 2%.

6 . A pharmaceutical tablet according to claim 1 wherein the drug particles are micronized.

7 . A pharmaceutical tablet according to claim 1 wherein at least 50% of the drug particles have a particle size of 30 micron or less.

8 . A pharmaceutical tablet according to claim 1 wherein at least 50% of the drug particles have a particle size of 5 micron or less.

9 . A pharmaceutical tablet according to claim 1 wherein the tablet contains from about 25% to about 89% by weight of one or more excipients selected from: microcrystalline cellulose, powdered cellulose, pregelatinized starch, starch, lactose, Di-calcium phosphate, lactitol, mannitol, sorbitol and maltodextrin, where the excipients are substantially free of water.

10 . A pharmaceutical tablet according to claim 1 wherein the tablet is produced on a scale suitable to prepare at least about 50,000 tablets.

11 . A pharmaceutical tablet according to claim 1 wherein the tablet is film coated.

12 . A pharmaceutical tablet according to claim 1 wherein the tablet is film coated and wherein the film coating contains a colorant.

13 . A pharmaceutical tablet according to claim 1 wherein the tablet is film coated and wherein the film coating contains a colorant that contains iron oxide.

14 . A method of treating cancer in a human in need thereof which comprises administering to such human a therapeutically effective amount of a pharmaceutical tablet according to claim 1 .

15 . A process for preparing pharmaceutical tablets containing an amount of a drug, which is N-{3-[3-cyclopropyl-5-(2-fluoro-4-iodo-phenylamino)-6,8-dimethyl-2,4,7-trioxo-3,4,6,7-tetrahydro-2H-pyrido[4,3-d]pyrimidin-1-yl]phenyl}acetamide dimethyl sulfoxide solvate, in an amount selected from: about 0.5635 mg, about 1.127 mq, and about 2.254 mg, which process comprises the steps of;

admixing:

N-{3-[3-cyclopropyl-5-(2-fluoro-4-iodo-phenylamino)-6,8-dimethyl-2,4,7-trioxo-3,4,6,7-tetrahydro-2H-pyrido[4,3-d]pyrimidin-1-yl]phenyl}acetamide dimethyl sulfoxide solvate,

one or more excipients, where the excipients are substantially free of water, and

further excipients,

to form a mixture; and

compressing the mixture into tablets;

provided:

each tablet contains N-{3-[3-cyclopropyl-5-(2-fluoro-4-iodo-phenylamino)-6,8-dimethyl-2,4,7-trioxo-3,4,6,7-tetrahydro-2H-pyrido[4,3-d]pyrimidin-1-yl]phenyl}acetamide dimethyl sulfoxidein solvate in an amount selected from: about 0.5635 mg, about 1.127 mq, and about 2.254 mg;

each tablet contains from about 25% to about 89% by weight of one or more excipients, where the excipients are substantially free of water; and

the amount of unsolvated drug does not exceed about 20%.