IP Library Granted Patent US 11,723,905
Granted Patent B2
US 11,723,905 · App. 17/183,606 · Granted Aug 15, 2023

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

Inventors: George P. Luke (Clinton, CT); Pratik Sheth (Watertown, MA)
Assignee: FORMA Therapeutics, Inc.
A61K31/4709A61K9/0053A61K47/12A61K47/38
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Quick Facts
Patent No.
US 11,723,905
App. No.
17/183,606
Granted
Aug 15, 2023
Kind
B2
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.

Claims (27)

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.

Assignments (2)
SECURITY INTEREST Recorded May 8, 2026
From: RIGEL PHARMACEUTICALS, INC.
To: MIDCAP FUNDING IV TRUST
Reel/Frame 075576/0880 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Mar 1, 2021
From: LUKE, GEORGE P.; SHETH, PRATIK
To: FORMA THERAPEUTICS, INC.
Reel/Frame 055444/0095 →
Continuity (6)
Continuation 16693642 · Nov 25, 2019
Continuation 16414716 · May 16, 2019
Provisional Application 62692591 · Jun 29, 2018
Provisional Application 62672461 · May 16, 2018
Provisional Application 62672462 · May 16, 2018
Related Publication 20210177829A1 · Jun 17, 2021