Claims for Patent: 12,053,463
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Summary for Patent: 12,053,463
| Title: | Solid forms of ((s)-5-((1-(6-chloro-2-oxo-1,2-dihydroquinolin-3-yl)ethyl)amino)-1-methyl-6-oxo-1,6-dihydropyridine-2-carbonitrile |
| Abstract: | The present disclosure reports solid forms of ((S)-5-((1-(6-chloro-2-oxo-1,2-dihydroquinolin-3-yl)ethyl)amino)-1-methyl-6-oxo-1,6-dihydropyridine-2-carbonitrile. |
| Inventor(s): | George P. Luke, Pratik SHETH |
| Assignee: | Forma Therapeutics Inc |
| Application Number: | US18/215,727 |
| Patent Claims: |
1. A solid form of Compound 1: characterized by an X-ray Powder Diffraction (XRPD) pattern with a peak at angle (2 theta±0.2) of 6.3. 2. The solid form of claim 1, wherein the XRPD pattern further comprises a peak at angle (2 theta±0.2) of 5.7. 3. The solid form of claim 1 characterized by a differential scanning calorimetry (DSC) thermogram with an endothermic event observed at about 256.6° C. 4. An oral unit dosage form comprising, a solid form of (S)-5-((1-(6-chloro-2-oxo-1,2-dihydroquinolin-3-yl)ethyl)amino)-1-methyl-6-oxo-1,6-dihydropyridine-2-carbonitrile, wherein the solid form is characterized by an X-ray Powder Diffraction (XRPD) pattern with a peak at angle (2 theta±0.2) of 6.3, and one or more excipients selected from the group consisting of a filler, a disintegrant, a lubricant, and a glidant. 5. The oral unit dosage form of claim 4, comprising a total of about 50-150 mg of the ((S)-5-((1-(6-chloro-2-oxo-1,2-dihydroquinolin-3-yl)ethyl)amino)-1-methyl-6-oxo-1,6-dihydropyridine-2-carbonitrile. 6. The oral unit dosage form of claim 4, comprising a total of about 150 mg of the ((S)-5-((1-(6-chloro-2-oxo-1,2-dihydroquinolin-3-yl)ethyl)amino)-1-methyl-6-oxo-1,6-dihydropyridine-2-carbonitrile. 7. The oral unit dosage form of claim 4, comprising a filler wherein the filler comprises microcrystalline cellulose. 8. The oral unit dosage form of claim 4, comprising a disintegrant, wherein the disintegrant comprises croscarmellose sodium. 9. The oral dosage unit of claim 4, comprising a glidant, wherein the glidant comprises colloidal silicon dioxide. 10. The oral dosage unit of claim 4, further comprising a lubricant. 11. The oral dosage unit of claim 10, wherein the lubricant comprises magnesium stearate. 12. The oral dosage unit of claim 4, wherein the (S)-5-((1-(6-chloro-2-oxo-1,2-dihydroquinolin-3-yl)ethyl)amino)-1-methyl-6-oxo-1,6-dihydropyridine-2-carbonitrile is about 33 percent by weight of the oral dosage unit. 13. The oral dosage unit of claim 10, wherein the (S)-5-((1-(6-chloro-2-oxo-1,2-dihydroquinolin-3-yl)ethyl)amino)-1-methyl-6-oxo-1,6-dihydropyridine-2-carbonitrile, the filler, the disintegrant and the lubricant are present in a relative weight ratio of about 33:61:5:1. |
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