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Last Updated: September 21, 2021

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Claims for Patent: 8,790,708


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Summary for Patent: 8,790,708
Title:Coated tablet formulations and uses thereof
Abstract: The present invention provides coated tablet formulations comprising neratinib maleate, and improved methods for making such coated tablets.
Inventor(s): Ashraf; Muhammad (Elmwood Park, NJ), Mahmud; Mainuddin (Oak Ridge, NJ), Goolcharran; Chimanlall (East Lyme, CT), Ghosh; Krishnendu (Sparkill, NY), Nagi; Arwinder Singh (Moorpark, CA)
Assignee: Wyeth LLC (New York, NY)
Application Number:13/972,764
Patent Claims: 1. A pharmaceutical composition comprising: (A) intragranular components: (a) about 35 weight percent of neratinib maleate measured in the amount of neratinib free base; (b) mannitol; (c) about 10.6 weight percent of microcrystalline cellulose; (d) about 3 weight percent of crospovidone; (e) about 2 weight percent of colloidal silicon dioxide; and (f) about 5 weight percent of povidone; and (B) extragranular components: (g) about 1.5 weight percent of microcrystalline cellulose; (h) about 2 weight percent of crospovidone; and (i) about 2 weight percent of magnesium stearate; and (C) a film-coating.

2. The pharmaceutical composition of claim 1, comprising about 40 mg of neratinib maleate as measured in the amount of neratinib free base.

3. The pharmaceutical composition of claim 1, comprising about 12 mg of microcrystalline cellulose as an intragranular component.

4. The pharmaceutical composition of claim 1, comprising about 240 mg of neratinib maleate as measured in the amount of neratinib free base.

5. The pharmaceutical composition of claim 1, comprising about 72 mg of microcrystalline cellulose as an intragranular component.

6. The pharmaceutical composition of claim 1, wherein the composition is formulated as a tablet.

7. The pharmaceutical composition of claim 1, wherein the composition is formulated as a capsule.

8. The pharmaceutical composition of claim 1, wherein the composition is formulated as a dry-filled capsule.

9. The pharmaceutical composition of claim 1, comprising about 3 weight percent of the film-coating.

10. The pharmaceutical composition of claim 1, wherein the film-coating is a polyvinyl alcohol.

11. The pharmaceutical composition of claim 1, wherein the film-coating is red, yellow, or pink.

12. The pharmaceutical composition of claim 10, wherein the film-coating is red, yellow, or pink.

13. A pharmaceutical composition comprising: (A) intragranular components: (a) about 42.3 weight percent of neratinib maleate; (b) mannitol; (c) about 10.6 weight percent of microcrystalline cellulose; (d) about 3 weight percent of crospovidone; (e) about 2 weight percent of colloidal silicon dioxide; and (f) about 5 weight percent of povidone; (B) extragranular components: (g) about 1.5 weight percent of microcrystalline cellulose; (h) about 2 weight percent of crospovidone; and (i) about 2 weight percent of magnesium stearate; and (C) a film-coating.

14. The pharmaceutical composition of claim 13, comprising about 48.3 mg of neratinib maleate.

15. The pharmaceutical composition of claim 13, comprising about 289.9 mg of neratinib maleate.

16. The pharmaceutical composition of claim 13, wherein the composition is formulated as a tablet.

17. The pharmaceutical composition of claim 13, wherein the composition is formulated as a capsule.

18. The pharmaceutical composition of claim 13, wherein the composition is formulated as a dry-filled capsule.

19. The pharmaceutical composition of claim 13, comprising about 3 weight percent of the film-coating.

20. The pharmaceutical composition of claim 13, wherein the film-coating is a polyvinyl alcohol.

21. The pharmaceutical composition of claim 13, wherein the film-coating is red, yellow, or pink.

22. The pharmaceutical composition of claim 20, wherein the film-coating is red, yellow, or pink.

23. A method for treating cancer in a subject, comprising administering to the subject the composition of claim 1.

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