IP Library Granted Patent US 12,053,463
Granted Patent B2
US 12,053,463 · App. 18/215,727 · Granted Aug 6, 2024

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 12,053,463
App. No.
18/215,727
Granted
Aug 6, 2024
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 (15)

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.

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 Jun 17, 2024
From: LUKE, GEORGE P.; SHETH, PRATIK
To: FORMA THERAPEUTICS, INC.
Reel/Frame 067749/0606 →
Continuity (7)
Continuation 17183606 · Feb 24, 2021
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 20240033261A1 · Feb 1, 2024