High dosage strength tablets of rucaparib

1. A tablet comprising 45-90% w/w of an active pharmaceutical ingredient compound 8-fluoro-2-{4-[(methylamino)methyl]phenyl}-1,3,4,5-tetrahydro-6H-azepino[5,4,3-cd]indol-6-one camsylate.

2. The tablet according to claim 1 , wherein the active pharmaceutical ingredient is included in the range of 50-90%.

3. The tablet according to claim 1 , wherein the active pharmaceutical ingredient is included in the range of 55-90%.

4. The tablet according to claim 1 , wherein the active pharmaceutical ingredient is included in the range of 60-90%.

5. The tablet according to claim 1 , wherein the active pharmaceutical ingredient is included in the range of 65-85%.

6. The tablet according to claim 1 , wherein the active pharmaceutical ingredient is included in the range of 70-80%.

7. The tablet according to claim 1 further comprises

5-50% w/w of a filler;

1-20% w/w of a disintegrant;

0.20-2.5% w/w of a lubricant.

8. The tablet according to claim 7 , wherein the active pharmaceutical ingredient is included in the range of 50-90% w/w, the filler is included in the range of 5-45% w/w, the disintegrant is included in the range of 2-10% w/w, the lubricant is included in the range of 0.25-2.5% w/w.

9. The tablet according to claim 8 , wherein the active pharmaceutical ingredient is included in the range of 70-80% w/w.

10. The tablet according to claim 1 , wherein the tablet includes 200 mg or more of 8-fluoro-2-{4-[(methylamino)methyl]phenyl}-1,3,4,5-tetrahydro-6H-azepino[5,4,3-cd]indol-6-one.

11. The tablet according to claim 10 , wherein the tablet includes 300 mg or more of 8-fluoro-2-{4-[(methylamino)methyl]phenyl}-1,3,4,5-tetrahydro-6H-azepino[5,4,3-cd]indol-6-one.

12. The tablet according to claim 9 , wherein the filler is microcrystalline cellulose.

13. The tablet according to claim 9 , wherein the lubricant is magnesium stearate.

14. The tablet according to claim 9 , wherein the disintegrant is sodium starch glycolate.

15. The tablet according to claim 9 , wherein the filler is microcrystalline cellulose, the disintegrant is sodium starch glycolate, and the lubricant is magnesium stearate.

16. The tablet according to claim 9 , wherein at least 95% w/w of the active pharmaceutical ingredient is released within 30 min, when tested in 0.01N HCl according to USP II Paddles and at 75 rpm.

17. The tablet according to claim 16 , wherein at least 95% w/w of the active pharmaceutical ingredient is released within 15 min, when tested in 0.01N HCl according to USP II Paddles and at 75 rpm.

18. The tablet according to claim 16 , wherein at least 95% w/w of the active pharmaceutical ingredient is released within 10 min, when tested in 0.01N HCl according to USP II Paddles and at 75 rpm.

19. A dry granulated tablet comprising 45-90% w/w of an active pharmaceutical ingredient compound 8-fluoro-2-{4-[(methylamino)methyl]phenyl}-1,3,4,5-tetrahydro-6H-azepino[5,4,3-cd]indol-6-one camsylate, wherein the tablet includes 200 mg or more of 8-fluoro-2-{4-[(methylamino)methyl]phenyl}-1,3,4,5-tetrahydro-6H-azepino[5,4,3-cd]indol-6-one.

20. The dry granulated tablet according to claim 19 wherein the tablet includes 300 mg or more of 8-fluoro-2-{4-[(methylamino)methyl]phenyl}-1,3,4,5-tetrahydro-6H-azepino[5,4,3-cd]indol-6-one.

21. The dry granulated tablet according to claim 19 further comprises 5-50% w/w of a filler; 1-20% w/w of a disintegrant; 0.20-2.5% w/w of a lubricant.

22. The dry granulated tablet according to claim 20 further comprises 5-50% w/w of a filler; 1-20% w/w of a disintegrant; 0.20-2.5% w/w of a lubricant.

23. The dry granulated tablet according to claim 21 , wherein the active pharmaceutical ingredient is included in the range of 50-80% w/w, the filler is included in the range of 15-45% w/w, the disintegrant is included in the range of 2-10% w/w, the lubricant is included in the range of 0.25-2.5% w/w.

24. The dry granulated tablet according to claim 23 , wherein the filler is microcrystalline cellulose, the disintegrant is sodium starch glycolate, and the lubricant is magnesium stearate.

25. A dry granulated composition comprising 45-90% w/w of an active pharmaceutical ingredient compound 8-fluoro-2-{4-[(methylamino)methyl]phenyl}-1,3,4,5-tetrahydro-6H-azepino[5,4,3-cd]indol-6-one camsylate, wherein the composition includes 200 mg or more of 8-fluoro-2-{4-[(methylamino)methyl]phenyl}-1,3,4,5-tetrahydro-6H-azepino[5,4,3-cd]indol-6-one.

26. The dry granulated composition according to claim 25 wherein the composition includes 300 mg or more of 8-fluoro-2-{4-[(methylamino)methyl]phenyl}-1,3,4,5-tetrahydro-6H-azepino[5,4,3-cd]indol-6-one.

27. A capsule comprising 45-90% w/w of an active pharmaceutical ingredient compound 8-fluoro-2-{4-[(methylamino)methyl]phenyl}-1,3,4,5-tetrahydro-6H-azepino[5,4,3-cd]indol-6-one camsylate.

28. The tablet according to claim 1 , wherein the tablet includes 250 mg or more of 8-fluoro-2-{4-[(methylamino)methyl]phenyl}-1,3,4,5-tetrahydro-6H-azepino[5,4,3-cd]indol-6-one.