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Last Updated: May 20, 2024

Claims for Patent: 10,590,087


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Summary for Patent: 10,590,087
Title:Solid state forms of (S)-2-(((S)-6,8-difluoro-1,2,3,4-tetrahydronaphthalen-2-yl)amino)-N-(1-(2-methyl-1-(neopentylamino)propan-2-yl)-1H-imidazol-4-yl)pentanamide and uses thereof
Abstract:The present disclosure relates to: a) solid state forms of hydrobromide salts of Compound 1; b) pharmaceutical compositions comprising one or more solid state forms of hydrobromide salts of Compound 1, and, optionally, a pharmaceutically acceptable carrier; c) methods of treating tumors or cancers by administering one or more solid state forms of hydrobromide salts of Compound 1 to a subject in need thereof; and d) methods for the preparation of solid state forms of Compound 1.
Inventor(s):Greer Elaine, Anderson Stephen, Maloney Mark, Yu Shu, Albert Ekaterina, Rigsbee Emily
Assignee:Pfizer Inc.
Application Number:US16537394
Patent Claims: 2. The crystalline form of claim 1 , wherein the crystalline Form A is anhydrous.3. The crystalline form of claim 1 , wherein the melting point of crystalline Form A is about 254° C.4. The crystalline form of claim 1 , wherein Form A is characterized by an XRPD pattern having peaks at 8.8±0.2 claim 1 , 9.8±0.2 claim 1 , 23.3±0.2 claim 1 , 25.4±0.2 claim 1 , 28.0±0.2 claim 1 , and 29.3±0.2 degrees two theta.5. The crystalline form of claim 1 , wherein Form A is characterized by an XRPD pattern having peaks at 8.8±0.2 claim 1 , 9.8±0.2 claim 1 , 20.0±0.2 claim 1 , 23.3±0.2 claim 1 , 25.4±0.2 claim 1 , 28.0±0.2 claim 1 , 29.3±0.2 claim 1 , and 32.5±0.2 degrees two theta.6. The crystalline form of claim 1 , wherein Form A is characterized by an XRPD pattern substantially as shown in .7. The crystalline form of claim 1 , wherein Form A is characterized by a TGA profile substantially as shown in .8. The crystalline form of claim 1 , wherein Form A is characterized by a DSC profile substantially as shown in .9. The crystalline form of claim 1 , wherein Form A has a unit cell that indexes as primitive monoclinic.10. The crystalline form of claim 1 , wherein Form A has a unit cell with an a value of 10.035 Å claim 1 , a b value of 7.532 Å claim 1 , and a c value of 20.092 Å.11. The crystalline form of claim 1 , wherein Form A has a unit A cell with a volume of 1518.1 Å.12. The crystalline form of claim 1 , wherein the Form A has one or more of a D[V claim 1 ,0.10] particle size between 0.5 μm and about 15 μm claim 1 , a D[V claim 1 ,0.50] particle size between 2 μm and 30 μm claim 1 , a D[V claim 1 ,0.90] particle size between 8 μam and 600 μm claim 1 , or a D[4 claim 1 ,3] particle size of 5 μm to 200 μm.13. A pharmaceutical composition comprising the crystalline form of and a pharmaceutically acceptable carrier.14. The pharmaceutical composition of claim 13 , wherein the pharmaceutical composition is a tablet.15. The pharmaceutical composition of claim 1 , wherein the A pharmaceutical composition comprises 25 mg to 400 mg of the hydrobromide salt of (S)-2-(((S)-6 claim 1 ,8-difluoro-1 claim 1 ,2 claim 1 ,3 claim 1 ,4-tetrahydronaphthalen-2-yl)amino)-N-(1-(2-methyl-1-(neopentylamino) propan-2-yl)-1H-imidazol-4-yl)pentanamide.16. The pharmaceutical composition of claim 13 , wherein the A pharmaceutical composition comprises 50 mg of the hydrobromide salt of (S)-2-(((S)-6 claim 13 ,8-difluoro-1 claim 13 ,2 claim 13 ,3 claim 13 ,4-tetrahydronaphthalen-2-yl)amino)-N-(1-(2-methyl-1-(neopentylamino) propan-2-yl)-1H-imidazol-4-yl)pentanamide.17. The pharmaceutical composition of claim 13 , wherein the A pharmaceutical composition comprises 100 mg of the hydrobromide salt of (S)-2-(((S)-6 claim 13 ,8-difluoro-1 claim 13 ,2 claim 13 ,3 claim 13 ,4-tetrahydronaphthalen-2-yl)amino)-N-(1-(2-methyl-1-(neopentylamino) propan-2-yl)-1H-imidazol-4-yl)pentanamide.18. The pharmaceutical composition of claim 13 , wherein the A pharmaceutical composition comprises 150 mg of the hydrobromide salt of (S)-2-(((S)-6 claim 13 ,8-difluoro-1 claim 13 ,2 claim 13 ,3 claim 13 ,4-tetrahydronaphthalen-2-yl)amino)-N-(1-(2-methyl-1-(neopentylamino) propan-2-yl)-1H-imidazol-4-yl)pentanamide.

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