Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Serving hundreds of leading biopharmaceutical companies globally:

US Army
Accenture
McKesson
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Covington

Generated: August 18, 2019

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Claims for Patent: 9,987,285

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Summary for Patent: 9,987,285
Title:High dosage strength tablets of rucaparib
Abstract: A tablet including high dosage of 8-fluoro-2-{4-[(methylamino)methyl]phenyl}-1,3,4,5-tetrahydro-6H-azepino[- 5,4,3-cd]indol-6-one camsylate salt has been disclosed.
Inventor(s): Etter; Jeffrey (Boulder, CO)
Assignee: CLOVIS ONCOLOGY, INC. (Boulder, CO)
Application Number:14/828,065
Patent Claims: 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-azepi- no[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.

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Serving hundreds of leading biopharmaceutical companies globally:

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US Army

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