Claims for Patent: 11,884,635
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Summary for Patent: 11,884,635
| 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): | Elaine Greer, Stephen Anderson, Mark Maloney, Shu Yu, Ekaterina Albert, Emily Rigsbee |
| Assignee: | Pfizer Inc |
| Application Number: | US18/361,545 |
| Patent Claims: |
1. A pharmaceutical composition comprising a solid form 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 or a salt thereof, wherein the solid form exhibits a loss of at least 8 wt % between about 60 and about 190° C. according to thermogravimetric analysis. 2. The pharmaceutical composition of claim 1, wherein the composition comprises about 50 mg of the solid form 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 or a salt thereof. 3. The pharmaceutical composition of claim 1, wherein the solid form has a D[V,0.90] particle size of about 8 to about 100 μm. 4. The pharmaceutical composition of claim 3, wherein the solid form has a D[V,0.90] particle size of from about 8 to about 75 μm. 5. A pharmaceutical composition comprising a solid form of (S)-2-4(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 or a salt thereof, wherein the solid form is characterized by a thermogravimetric analysis profile substantially as shown in FIG. 2 . 6. The pharmaceutical composition of claim 5, wherein the composition comprises about 50 mg of the solid form 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 or a salt thereof. 7. The pharmaceutical composition of claim 5, wherein the solid form has a D[V,0.90] particle size of about 8 to about 100 μm. 8. The pharmaceutical composition of claim 7, wherein the solid form has a D[V,0.90] particle size of about 8 to about 75 μm. 9. A pharmaceutical composition comprising a solid form 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 or a salt thereof, wherein the solid form exhibits a loss of about 1.2 to about 2.5 wt % between about 24 and about 109° C. according to thermogravimetric analysis. |
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