Claims for Patent: 10,278,974

Summary for Patent: 10,278,974

Title:	Salts and polymorphs of 8-fluoro-2-{4-[(methylamino)methyl]phenyl}-1,3,4,5-tetrahydro-6H-azepino[- 5,4,3-cd]indol-6-one
Abstract:	The present invention relates to novel polymorphic forms of 8-fluoro-2-{4-[(methylamino)methyl]phenyl}-1,3,4,5-tetrahydro-6H-azepino[- 5,4,3-cd]indol-6-one, and to processes for their preparation. Such polymorphic forms may be a component of a pharmaceutical composition and may be used to treat a mammalian disease condition mediated by poly(ADP-ribose) polymerase activity including the disease condition such as cancer.
Inventor(s):	Basford; Patricia Ann (Sandwich, GB), Campeta; Anthony Michael (Ledyard, CT), Gillmore; Adam (Sandwich, GB), Jones; Matthew Cameron (Sandwich, GB), Kougoulos; Eleftherios (Morrisville, NC), Luthra; Suman (Groton, CT), Walton; Robert (Sandwich, GB)
Assignee:	Pfizer Inc. (New York, NY)
Application Number:	15/833,073
Patent Claims:	1. A pharmaceutical composition comprising a crystalline camsylate salt of 8-fluoro-2-{4-[(methylamino)methyl]phenyl}-1,3,4,5-tetrahydro-6H-azepi- no[5,4,3-cd]indol-6-one, wherein the salt has a powder X-ray diffraction pattern comprising peaks at diffraction angles (2.theta.) 12.2.+-.0.2, 14.8.+-.0.2, and 22.4.+-.0.2, wherein said powder x-ray diffraction pattern is obtained using copper k-alpha.sub.1 x-rays at a wave length of 1.5406 .ANG.ngstroms, wherein the pharmaceutical composition comprises one or more of a pharmaceutically acceptable carrier, a pharmaceutically acceptable diluent, a pharmaceutically acceptable vehicle, or a pharmaceutically acceptable excipient. 2. The pharmaceutical composition of claim 1, wherein the salt has a solid state NMR spectrum comprising .sup.19F chemical shifts at -118.9.+-.0.2 and -119.7.+-.0.2 ppm. 3. The pharmaceutical composition of claim 1 comprising a pharmaceutically acceptable excipient. 4. The pharmaceutical composition of claim 1, wherein the salt has a powder X-ray diffraction pattern comprising peaks at diffraction angles (2.theta.) 12.2.+-.0.2, 13.8.+-.0.2, 14.8.+-.0.2, 18.3.+-.0.2, and 22.4.+-.0.2. 5. A pharmaceutical composition comprising a crystalline camsylate salt of 8-fluoro-2-{4-[(methylamino)methyl]phenyl}-1,3,4,5 -tetrahydro-6H-azepino[5,4,3-cd]indol-6-one, wherein the salt has a powder X-ray diffraction pattern comprising peaks at diffraction angles (2.theta.) 14.8.+-.0.2 and 22.4.+-.0.2, wherein said powder x-ray diffraction pattern is obtained using copper k-alpha.sub.1x-rays at a wave length of 1.5406 .ANG.ngstroms, and wherein the DSC thermogram of the salt comprises an endotherm onset at 303.2.+-.5.degree. C., wherein the pharmaceutical composition comprises one or more of a pharmaceutically acceptable carrier, a pharmaceutically acceptable diluent, a pharmaceutically acceptable vehicle, or a pharmaceutically acceptable excipient. 6. The pharmaceutical composition of claim 5, wherein the salt has a solid state NMR spectrum comprising .sup.19F chemical shifts at -118.9.+-.0.2 and -119.7.+-.0.2 ppm. 7. The pharmaceutical composition of claim 5 comprising a pharmaceutically acceptable excipient. 8. A pharmaceutical composition comprising a crystalline camsylate salt of 8-fluoro-2-{4-[(methylamino)methyl]phenyl}-1,3,4,5-tetrahydro-6H-azepi- no[5,4,3-cd]indol-6-one Form A, wherein the salt has a powder X-ray diffraction pattern comprising peaks at diffraction angles (2.theta.) 12.2.+-.0.2 and 22.4.+-.0.2 , wherein said powder x-ray diffraction pattern is obtained using copper k-alpha .sub.1 x-rays at a wave length of 1.5406 .ANG.ngstroms, wherein the pharmaceutical composition comprises one or more of a pharmaceutically acceptable carrier, a pharmaceutically acceptable diluent, a pharmaceutically acceptable vehicle, or a pharmaceutically acceptable excipient. 9. The pharmaceutical composition of claim 8, wherein the salt has a solid state NMR spectrum comprising .sup.19F chemical shifts at -118.9.+-.0.2 and -119.7.+-.0.2 ppm. 10. The pharmaceutical composition of claim 8 comprising a pharmaceutically acceptable excipient. 11. The pharmaceutical composition of claim 1, wherein the salt has a solid state NMR spectrum comprising a .sup.19F chemical shift at -119.7.+-.0.2 ppm.