Claims for Patent: 11,304,961

Summary for Patent: 11,304,961

Title:	Compositions comprising dexamethasone
Abstract:	A pharmaceutical composition useful for the treatment of multiple myeloma in combination with an anti-cancer drug is provided. The pharmaceutical composition includes high-dose dexamethasone or a pharmaceutically acceptable salt or solvate thereof.
Inventor(s):	Kreyenborg; Caterina (Munster, DE), Meimberg; Elisabeth (Emsdetten, DE), Tissen; Corinna (Senden, DE), Bannefeld; Karl-Heinz (Munster, DE), Gold; Tomer (Herzliya, IL)
Assignee:	DEXCEL PHARMA TECHNOLOGIES LTD. (Or-Akiva, IL)
Application Number:	16/743,136
Patent Claims:	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.sub.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.sub.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.sub.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.sub.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.