3′-[(2Z)-[1-(3,4-dimethylphenyl)-1,5-dihydro-3-methyl-5-oxo-4H-pyrazol-4-ylidene]hydrazino]-2′-hydroxy-[1,1′-biphenyl]-3-carboxylic acid bis-(monoethanolamine)

1. A pharmaceutical tablet consisting essentially of:

a) about 15.95 mg of the compound 3′-[(2Z)-[1-(3,4-dimethylphenyl)-1,5-dihydro-3-methyl -5-oxo-4H-pyrazol-4-ylidene]hydrazino]-2′-hydroxy-[1,1′-biphenyl]-3-carboxylic acid bis-(monoethanolamine);

wherein,

b) about 90% of the compound particles have a particle size of greater than 10 micron but less than 90 micron;

c) the tablet is produced on a scale suitable to prepare at least about 50,000 tablets;

d) the tablet contains from about 25% to about 89% by weight of one or more excipients selected from the group consisting of microcrystalline cellulose, powdered cellulose, pregelatinized starch, starch, lactitol, mannitol, sorbitol and maltodextrin;

e) the tablet is film coated;

f) the tablet contains a disintegrant in an amount from 4% to about 12% by weight;

g) the tablet optionally contains a binder in an amount up to about 8% by weight; and

h) the tablet optionally contains a lubricant in an amount up to about 2% by weight.

2. 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 the group consisting of microcrystalline cellulose and mannitol.

3. A process for preparing pharmaceutical tablets containing about 15.95 mg of 3′-[(2Z)-[1-(3,4-dimethylphenyl)-1,5-dihydro-3-methyl-5-oxo-4H-pyrazol -4-ylidene]hydrazino]-2′-hydroxy-[1,1′-biphenyl]-3-carboxylic acid bis-(monoethanolamine), which process comprises the steps of;

a) admixing:

the compound 3′-[(2Z)-[1-(3,4-dimethylphenyl)-1,5-dihydro-3-methyl-5-oxo-4H-pyrazol-4-ylidene]hydrazino]-2′-hydroxy-[1,1′-biphenyl]-3-carboxylic acid bis -(monoethanolamine), wherein about 90% of the compound particles have a particle size of greater than 10 micron but less than 90 micron; one or more excipients selected from the group consisting of

microcrystalline cellulose, powdered cellulose, pregelatinized starch, starch, lactitol, mannitol, sorbitol and maltodextrin; and

further excipients;

to form a mixture;

b) compressing the mixture into tablets; and

c) applying a film coating to the tablets;

provided:

the process is carried out on a scale suitable to prepare at least about 50,000 tablets;

each tablet contains about 15.95 mg of 3′-[(2Z)-[1(3,4-dimethylphenyl)-1,5-dihydro -3-methyl-5-oxo-4H-pyrazol-4-ylidene]hydrazino]-2′-hydroxy -[1,1′-biphenyl]-3-carboxylic acid bis-(monoethanolamine); and

each tablet contains from about 25% to about 89% by weight of one or more excipients selected from the group consisting of microcrystalline cellulose, powdered cellulose, pregelatinized starch, starch, lactitol, mannitol, sorbitol and maltodextrin;

each tablet contains a disintegrant in an amount from 4% to about 12% by weight;

each tablet optionally contains a binder in an amount up to about 8% by weight; and

each tablet optionally contains a lubricant in an amount up to about 2% by weight.

4. A process according to claim 3 wherein:

each tablet contains from about 25% to about 89% by weight of one or more excipients selected from the group consisting of microcrystalline cellulose and mannitol.

5. A pharmaceutical tablet consisting essentially of:

a) about 15.95 mg of the compound 3′-[(2Z)-[1-(3,4-dimethylphenyl)-1,5-dihydro-3-methyl -5-oxo-4H-pyrazol-4-ylidene]hydrazino]-2′-hydroxy-[1,1′-biphenyl]-3-carboxylic acid bis-(monoethanolamine);

wherein,

b) about 90% of the compound particles have a particle size of greater than 10 micron but less than 90 micron;

c) the tablet contains from about 25% to about 89% by weight of one or more excipients selected from the group consisting of microcrystalline cellulose, powdered cellulose, pregelatinized starch, starch, lactitol, mannitol, sorbitol and maltodextrin;

d) the tablet is film coated;

e) the tablet contains a disintegrant in an amount from 4% to about 12% by weight;

f) the tablet optionally contains a binder in an amount up to about 8% by weight; and

g) the tablet optionally contains a lubricant in an amount up to about 2% by weight.

6. A pharmaceutical tablet according to claim 5 wherein:

the tablet contains from about 25% to about 89% by weight of one or more excipients selected from the group consisting of microcrystalline cellulose and mannitol.

7. A process for preparing pharmaceutical tablets containing about 15.95 mg of 3′-[(2Z)-[1-(3,4-dimethylphenyl)-1,5-dihydro-3-methyl-5-oxo-4H-pyrazol -4-ylidene]hydrazino]-2′-hydroxy-[1,1′-biphenyl]-3-carboxylic acid bis-(monoethanolamine), which process comprises the steps of;

a) admixing:

the compound 3′-[(2Z)-[1-(3,4-dimethylphenyl)-1,5-dihydro-3-methyl-5-oxo-4H-pyrazol-4-ylidene]hydrazino]-2′-hydroxy-[1,1′-biphenyl]-3-carboxylic acid bis-(monoethanolamine), wherein about 90% of the compound particles have a particle size of greater than 10 micron but less than 90 micron; one or more excipients selected from the group consisting of

microcrystalline cellulose, powdered cellulose, pregelatinized starch, starch, lactitol, mannitol, sorbitol and maltodextrin; and

further excipients;

to form a mixture;

b) compressing the mixture into tablets; and

c) applying a film coating to the tablets;

provided:

each tablet contains about 15.95 mg of 3′-[(2Z)-[1-(3,4-dimethylphenyl)-1,5-dihydro -3-methyl-5-oxo-4H-pyrazol-4-ylidene]hydrazino]-2′-hydroxy -[1,1′-biphenyl]-3-carboxylic acid bis-(monoethanolamine); and

each tablet contains from about 25% to about 89% by weight of one or more excipients selected from the group consisting of microcrystalline cellulose, powdered cellulose, pregelatinized starch, starch, lactitol, mannitol, sorbitol and maltodextrin;

each tablet contains a disintegrant in an amount from 4% to about 12% by weight;

each tablet optionally contains a binder in an amount up to about 8% by weight; and

each tablet optionally contains a lubricant in an amount up to about 2% by weight.

8. A process according to claim 7 wherein:

each tablet contains from about 25% to about 89% by weight of one or more excipients selected from the group consisting of microcrystalline cellulose and mannitol.

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

10. A method of treating thrombocytopenia in a human in need thereof which comprises administering to such human a therapeutically effective amount of a pharmaceutical tablet according to claim 2 .

11. A method of treating thrombocytopenia in a human in need thereof which comprises administering to such human a therapeutically effective amount of a pharmaceutical tablet according to claim 5 .

12. A method of treating thrombocytopenia in a human in need thereof which comprises administering to such human a therapeutically effective amount of a pharmaceutical tablet according to claim 6 .