High Dosage Strength Tablets of Rucaparib
AssigneeClovis Oncology, Inc.
InventorJeffrey Etter
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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.
Claims37
1-14. (canceled)
A tablet comprising the 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 said compound is present in an amount that the tablet contains at least about 200 mg of 8-fluoro-2-{4-[(methylamino) methyl] phenyl}-1, 3, 4, 5-tetrahydro-6H-azepino [5,4,3-cd] indol-6-one, wherein at least 95% w/w of the active pharmaceutical ingredient is released within 60 min, when tested in 0.01N HCl according to USP II Paddles and at 75 rpm.
A tablet comprising the active pharmaceutical ingredient 8-fluoro-2-{4-[(methylamino) methyl] phenyl}-1, 3, 4, 5-tetrahydro-6H-azepino [5,4,3-cd] indol-6-one camsylate, wherein said compound is present in an amount that the tablet contains at least about 200 mg of 8-fluoro-2-{4-[(methylamino) methyl] phenyl}-1, 3, 4, 5-tetrahydro-6H-azepino [5,4,3-cd] indol-6-one, wherein the tablet can be compressed to a tensile strength of at least 2 MPa at a compression stress less than 250 MPa.
Dependencies are inferred from the claim text.