Claims for Patent: 11,723,905
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Summary for Patent: 11,723,905
| 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: | US17/183,606 |
| Patent Claims: |
1. An olutasidenib oral unit dosage form comprising olutasidenib in a crystalline form, and having a total of 150 mg olutasidenib in the unit dosage form. 2. The unit dosage form of claim 1, further comprising a 50-100 micrometer particle size filler blended with the olutasidenib. 3. The unit dosage form of claim 2, wherein the filler comprises microcrystalline cellulose. 4. The unit dosage form of claim 2, wherein the filler is microcrystalline cellulose. 5. The unit dosage form of claim 4, wherein the unit dosage form further comprises the filler and the olutasidenib in a relative weight ratio of about 61:33. 6. The unit dosage form of claim 1, further comprising a disintegrant blended with the olutasidenib. 7. The unit dosage form of claim 6, wherein the disintegrant is croscarmellose sodium. 8. The unit dosage form of claim 7, wherein the unit dosage form further comprises the disintegrant and the olutasidenib in a relative weight ratio of about 5:33. 9. The unit dosage form of claim 1, further comprising a filler and a disintegrant blended with the olutasidenib. 10. The unit dosage form of claim 9, wherein the filler is microcrystalline cellulose NF/EP, and the disintegrant is croscarmellose sodium NF/EP. 11. The unit dosage form of claim 10, wherein the unit dosage form comprises the olutasidenib, filler and disintegrant in a relative weight ratio of about 33:61:5. 12. The unit dosage form of claim 11, wherein the unit dosage form is a capsule. 13. The unit dosage form of claim 1, wherein the unit dosage form is a capsule. 14. A 150 mg dosage strength olutasidenib oral capsule unit dosage form comprising a total of 150 mg of micronized olutasidenib active pharmaceutical ingredient in a crystalline form enclosed in the oral capsule unit dosage form. 15. The capsule unit dosage form of claim 14, further comprising a microcrystalline cellulose filler and a croscarmellose sodium disintegrant blended with the olutasidenib. 16. The capsule unit dosage form of claim 15, wherein the unit dosage form comprises the olutasidenib, filler and disintegrant in a relative weight ratio of about 33:61:5. 17. The capsule unit dosage form of claim 16, wherein the unit dosage form is a size 00 capsule. 18. The capsule unit dosage form of claim 14, wherein the unit dosage form is a size 00 capsule. 19. A 150 mg dosage strength olutasidenib oral capsule unit dosage form comprising a total of 150 mg of micronized olutasidenib active pharmaceutical ingredient in a crystalline form blended with one or more excipients in a relative weight ratio of about 33:67. 20. The olutasidenib oral capsule unit dosage form of claim 19, wherein the excipients are selected from the group consisting of: a microcrystalline cellulose filler and a croscarmellose sodium disintegrant blended with the olutasidenib. 21. A pharmaceutical composition comprising a capsule containing about 150 mg of olutasidenib in crystalline form. 22. The pharmaceutical composition of claim 21, wherein the olutasidenib is micronized. 23. The pharmaceutical composition of claim 22, further comprising one or more excipients selected from the group consisting of a filler, a disintegrant, a lubricant, and a glidant. 24. The pharmaceutical composition of claim 23, wherein the filler is microcrystalline cellulose. 25. The pharmaceutical composition of claim 23, wherein the disintegrant is croscarmellose sodium. 26. The pharmaceutical composition of claim 23, wherein the lubricant is magnesium stearate. 27. The pharmaceutical composition of claim 23, wherein the glidant is colloidal silicon dioxide. |
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