IP Library Granted Patent US 10,927,124
Granted Patent B2
US 10,927,124 · App. 16/214,985 · Granted Feb 23, 2021

Compounds and compositions and uses thereof

Inventors: Linghong Xie (Southborough, MA); Michele L. R. Heffernan (Holliston, MA); Philip Glyn Jones (Marlborough, MA); Taleen G. Hanania (Valhalla, NY)
Assignees: Sunovion Pharmaceuticals Inc.; PGI Drug Discovery LLC
C07D493/04C07D307/87C07D311/76C07D313/08
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Quick Facts
Patent No.
US 10,927,124
App. No.
16/214,985
Granted
Feb 23, 2021
Kind
B2
Abstract

Disclosed are compounds of formula (I): and pharmaceutical compositions containing such compounds. Methods of treating neurological or psychiatric disease and disorders in a subject in need are also disclosed.

Claims (38)

1. A process for preparing (R)-1-(8-fluoroisochroman-1-yl)-N-methylmethanamine, having the structure:

or a pharmaceutically acceptable salt thereof, comprising deprotecting tert-butyl ((8-fluoroisochroman-1-yl)methyl)(methyl)carbamate, having the structure:

2. The process of claim 1 , wherein the deprotecting comprises treating tert-butyl ((8-fluoroisochroman-1-yl)methyl)(methyl)carbamate with hydrochloric acid.

3. The process of claim 2 , wherein the treating tert-butyl ((8-fluoroisochroman-1-yl)methyl)(methyl)carbamate with hydrochloric acid is carried out in the presence of ethyl acetate.

4. The process of claim 2 , wherein the treating tert-butyl ((8-fluoroisochroman-1-yl)methyl)(methyl)carbamate with hydrochloric acid is carried out at ambient temperature.

5. The process of claim 2 , wherein the treating tert-butyl ((8-fluoroisochroman-1-yl)methyl)(methyl)carbamate with hydrochloric acid is carried out for about 16 h.

6. The process of claim 1 , further comprising separating (S)-1-(8-fluoroisochroman-1-yl)-N-methylmethanamine and (R)-1-(8-fluoroisochroman-1-yl)-N-methylmethanamine.

7. The process of claim 6 , wherein the separating is performed by chiral HPLC.

8. The process of claim 1 , wherein tert-butyl ((8-fluoroisochroman-1-yl)methyl)(methyl)carbamate is prepared by a process comprising converting tert-butyl ((5-bromo-8-fluoroisochroman-1-yl)methyl)(methyl)carbamate, having the structure:

to tert-butyl ((8-fluoroisochroman-1-yl)methyl)(methyl)carbamate.

9. The process of claim 8 , wherein the converting tert-butyl ((5-bromo-8-fluoroisochroman-1-yl)methyl)(methyl)carbamate to tert-butyl ((8-fluoroisochroman-1-yl)methyl)(methyl)carbamate comprises treating tert-butyl ((5-bromo-8-fluoroisochroman-1-yl)methyl)(methyl)carbamate with Pd/C under an H 2 atmosphere.

10. The process of claim 9 , wherein the treating tert-butyl ((5-bromo-8-fluoroisochroman-1-yl)methyl)(methyl)carbamate with Pd/C under an H 2 atmosphere is carried out in the presence of methanol.

11. The process of claim 9 , wherein the treating tert-butyl ((5-bromo-8-fluoroisochroman-1-yl)methyl)(methyl)carbamate with Pd/C under H 2 atmosphere is carried out at ambient temperature.

12. The process of claim 9 , wherein the treating tert-butyl ((5-bromo-8-fluoroisochroman-1-yl)methyl)(methyl)carbamate with Pd/C under H 2 atmosphere is carried out for about 4 h.

13. The process of claim 8 , wherein tert-butyl ((5-bromo-8-fluoroisochroman-1-yl)methyl)(methyl)carbamate is prepared by a process comprising protecting 1-(5-bromo-8-fluoroisochroman-1-yl)-N-methylmethanamine, having the structure:

14. The process of claim 13 , wherein the protecting 1-(5-bromo-8-fluoroisochroman-1-yl)-N-methylmethanamine comprises treating 1-(5-bromo-8-fluoroisochroman-1-yl)-N-methylmethanamine with di-tert-butyl dicarbonate.

15. The process of claim 14 , wherein the treating 1-(5-bromo-8-fluoroisochroman-1-y1)-N-methylmethanamine with di-tert-butyl dicarbonate is carried out in the presence of water.

16. The process of claim 14 , wherein the treating 1-(5-bromo-8-fluoroisochroman-1-y1)-N-methylmethanamine with di-tert-butyl dicarbonate is carried out at ambient temperature.

17. The process of claim 14 , wherein the treating 1-(5-bromo-8-fluoroisochroman-1-y1)-N-methylmethanamine with di-tert-butyl dicarbonate is carried out for about 3 h.

18. The process of claim 13 , wherein 1-(5-bromo-8-fluoroisochroman-1-yl)-N-methylmethanamine is prepared by a process comprising reacting 2-(2-bromo-5-fluorophenyl) ethanol, having the structure:

with 2,2-dimethoxy-N-methylethanamine, having the structure:

in the presence of an acid.

19. The process of claim 18 , wherein the acid is trifluoromethanesulfonic acid.

20. The process of claim 18 , wherein the acid is trimethylsilyl trifluoromethanesulfonate.

21. The process of claim 18 , wherein the reacting of 2-(2-bromo-5-fluorophenyl) ethanol with 2,2-dimethoxy-N-methylethanamine is carried out in the presence of dichloromethane.

22. The process of claim 18 , wherein the reacting of 2-(2-bromo-5-fluorophenyl) ethanol with 2,2-dimethoxy-N-methylethanamine is carried out at about 0° C.

23. The process of claim 18 , wherein the reacting of 2-(2-bromo-5-fluorophenyl) ethanol with 2,2-dimethoxy-N-methylethanamine is carried out for about 16 h.

24. A process for preparing (R)-1-(8-fluoroisochroman-1-yl)-N-methylmethanamine, having the structure:

or a pharmaceutically acceptable salt thereof, comprising:

a) reacting 2-(2-bromo-5-fluorophenyl) ethanol, having the structure:

with 2,2-dimethoxy-N-methylethanamine, having the structure:

in the presence of an acid to provide 1-(5-bromo-8-fluoroisochroman-1-yl)-N-methylmethanamine, having the structure:

b) protecting 1-(5-bromo-8-fluoroisochroman-1-yl)-N-methylmethanamine to provide tert-butyl ((5-bromo-8-fluoroisochroman-1-yl)methyl)(methyl)carbamate, having the structure:

c) converting tent-butyl ((5-bromo-8-fluoroisochroman-1-yl)methyl)(methyl)carbamate to tent-butyl ((8-fluoroisochroman-1-yl)methyl)(methyl)carbamate having the structure:

and

d) deprotecting tent-butyl ((8-fluoroisochroman-1-yl)methyl)(methyl)carbamate to provide (R)-1-(8-fluoroisochroman-1-yl)-N-methylmethanamine, or a pharmaceutically acceptable salt thereof.

25. A compound, which is (R)-1-(8-fluoroisochroman-1-yl)-N-methylmethanamine, or a pharmaceutically acceptable salt thereof, prepared by the process of claim 1 .

26. A compound, which is (R)-1-(8-fluoroisochroman-1-yl)-N-methylmethanamine, or a pharmaceutically acceptable salt thereof, prepared by the process of claim 24 .

Assignments (3)
MERGER AND CHANGE OF NAME Recorded Nov 8, 2023
From: SUNOVION PHARMACEUTICALS INC.; SUMITOMO PHARMA AMERICA, INC.
To: SUMITOMO PHARMA AMERICA, INC.
Reel/Frame 065519/0101 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded May 15, 2019
From: HEFFERNAN, MICHELE L.R.; JONES, PHILIP GLYN; XIE, LINGHONG
To: SUNOVION PHARMACEUTICALS INC.
Reel/Frame 049180/0988 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded May 15, 2019
From: HANANIA, TALEEN G.
To: PGI DRUG DISCOVERY LLC
Reel/Frame 049181/0050 →
Continuity (3)
Continuation 15663688 · Jul 28, 2017
Provisional Application 62368526 · Jul 29, 2016
Related Publication 20190308990A1 · Oct 10, 2019