Compositions comprising dexamethasone

1. A pharmaceutical composition comprising:

i) about 15 to about 25 wt.-% dexamethasone or a pharmaceutically acceptable salt or solvate thereof;

ii) about 45 to about 60 wt.-% filler;

iii) about 10 to about 30 wt.-% binder;

iv) about 2 to about 10 wt.-% disintegrant; and

v) about 0.01 to about 5 wt.-% lubricant;

wherein presence of all components add to 100 wt.-%, and wherein the pharmaceutical composition is prepared by wet granulation.

2. The pharmaceutical composition of claim 1 , wherein the filler comprises lactose.

3. The pharmaceutical composition of claim 1 , wherein the binder comprises starch, polyvinylpyrrolidone or a combination thereof.

4. The pharmaceutical composition of claim 1 , wherein the disintegrant comprises sodium carboxymethyl starch.

5. The pharmaceutical composition of claim 1 , wherein the lubricant comprises magnesium stearate.

6. The pharmaceutical composition of claim 1 in the form of a tablet.

7. The pharmaceutical composition of claim 6 in the form of an uncoated tablet.

8. The pharmaceutical composition of claim 1 formulated into a unit dosage form suitable for oral administration.

9. The pharmaceutical composition of claim 8 , wherein the unit dosage form comprises 20 mg of dexamethasone.

10. A process for preparing the pharmaceutical composition of claim 1 , the process comprising:

i) wet granulating dexamethasone or a pharmaceutically acceptable salt or solvate thereof, a binder, a filler, and a disintegrant to obtain a wet granulate;

ii) drying the wet granulate of step (i) to obtain a dry granulate having a Loss on Drying (LOD) % of about 1.5% to about 5%; and

iii) admixing the dry granulate of step (ii) with a lubricant to obtain a pharmaceutical composition.

11. The process of claim 10 , wherein step (i) comprises:

i a ) dry mixing dexamethasone or a pharmaceutically acceptable salt or solvate thereof, a binder, a filler, and a disintegrant to obtain a dry mixture; and

i b ) spraying the thus obtained dry mixture with a granulation solution or suspension to obtain a wet granulate.

12. The process of claim 10 , further comprising the step of:

iv) compressing the pharmaceutical composition of step iii) to obtain a tablet or a caplet.

13. A pharmaceutical composition prepared by the process of claim 10 .

14. A method of treating multiple myeloma in a subject in need thereof comprising administering to the subject the pharmaceutical composition of claim 1 in combination with an anti-cancer drug.

15. The method of claim 14 , wherein the anti-cancer drug is thalidomide.

16. An uncoated tablet comprising:

i) about 15 to about 25 wt.-% dexamethasone or a pharmaceutically acceptable salt or solvate thereof;

ii) about 45 to about 60 wt.-% filler;

iii) about 10 to about 30 wt.-% binder;

iv) about 2 to about 10 wt.-% disintegrant; and

v) about 0.01 to about 5 wt.-% lubricant;

wherein presence of all components add to 100 wt.-%, and wherein the uncoated tablet is prepared by wet granulation.

17. The uncoated tablet of claim 16 , wherein the filler comprises lactose.

18. The uncoated tablet of claim 16 , wherein the binder comprises starch, polyvinylpyrrolidone or a combination thereof.

19. The uncoated tablet of claim 16 , wherein the disintegrant comprises sodium carboxymethyl starch.

20. The uncoated tablet of claim 16 , wherein the lubricant comprises magnesium stearate.

21. The uncoated tablet of claim 16 comprising 20 mg of dexamethasone.

22. A process for preparing the uncoated tablet of claim 16 , the process comprising:

i) wet granulating dexamethasone or a pharmaceutically acceptable salt or solvate thereof, a binder, a filler, and a disintegrant to obtain a wet granulate;

ii) drying the wet granulate of step (i) to obtain a dry granulate having a Loss on Drying (LOD) % of about 1.5% to about 5%;

iii) admixing the dry granulate of step (ii) with a lubricant to obtain a pharmaceutical composition; and

iv) compressing the pharmaceutical composition of step iii) to obtain an uncoated tablet.

23. The process of claim 22 , wherein step (i) comprises:

i a ) dry mixing dexamethasone or a pharmaceutically acceptable salt or solvate thereof, a binder, a filler, and a disintegrant to obtain a dry mixture; and

i b ) spraying the thus obtained dry mixture with a granulation solution or suspension to obtain a wet granulate.

24. An uncoated tablet prepared by the process of claim 22 .

25. A method of treating multiple myeloma in a subject in need thereof comprising administering to the subject the uncoated tablet of claim 16 in combination with an anti-cancer drug.

26. The method of claim 25 , wherein the anti-cancer drug is thalidomide.

27. The pharmaceutical composition of claim 2 , wherein the filler comprises lactose monohydrate.

28. The uncoated tablet of claim 17 , wherein the filler comprises lactose monohydrate.