L-tartrate salt of pridopidine

Patent metadata

Field	Value
Publication number	US-9796673-B2
Application number	US-201514975248-A
Country	US
Kind code	B2
Filing date	Dec 18, 2015
Priority date	Dec 22, 2014
Publication date	Oct 24, 2017
Grant date	Oct 24, 2017

Abstract

The subject invention provides pridopidine L-tartrate, compositions and a process for manufacture thereof.

First claim

The invention claimed is:

1. Pridopidine L-tartrate, characterized by a XRPD pattern with reflections corresponding to the d-spacing values 8.5±0.1, 4.8±0.1, 4.3±0.1, and 3.7±0.1, wherein the pridopidine L-tartrate is in crystalline form A1.

2. The pridopidine L-tartrate of claim 1 , which is pridopidine mono L-tartrate.

3. The pridopidine L-tartrate of claim 1 characterized by a XRPD pattern with reflections corresponding to the d-spacing values 8.5±0.1, 6.2±0.1, 5.7±0.1, 4.8±0.1, 4.5±0.1, 4.3±0.1, 4.1±0.1, 3.9±0.1, 3.8±0.1, 3.7±0.1, and 3.2±0.1, wherein the pridopidine L-tartrate is in crystalline form A1.

4. The pridopidine L-tartrate of claim 1 which is isolated.

5. A composition comprising the pridopidine L-tartrate of claim 1 , and a carrier.

6. A composition comprising the pridopidine L-tartrate of claim 1 , wherein the composition is free of L-tartaric acid.

7. A composition comprising the pridopidine L-tartrate of claim 1 , wherein the composition has less than 5% L-tartaric acid by weight.

8. The composition of claim 5 , further comprising pridopidine base.

9. The composition of claim 8 , wherein the pridopidine base is present in an amount of less than 5% based on total pridopidine content of the composition.

10. The composition of claim 5 , which is free of pridopidine base.

11. The composition of claim 5 , wherein the composition has less than 5% pridopidine base by weight.

12. The composition of claim 5 , wherein the composition is a pharmaceutical composition and the carrier is a pharmaceutically acceptable carrier.

13. The pharmaceutical composition of claim 12 , which is in tablet form.

14. The pharmaceutical composition of claim 13 , wherein the tablet unit form comprises between 22.5-315 mg pridopidine or between 90-315 mg pridopidine.

15. The pharmaceutical composition of claim 13 , wherein the tablet unit form comprises about 22.5 mg, about 45 mg, about 67.5 mg, about 90 mg, about 100 mg, about 112.5 mg, about 125 mg, about 135 mg, about 150 mg, about 180 mg, about 200 mg, about 250 mg, or about 315 mg pridopidine.

16. The pharmaceutical composition of claim 13 , wherein the tablet unit form is prepared for once daily administration.

17. The pharmaceutical composition of claim 13 , wherein the tablet unit form is prepared for more than once daily administration.

18. A process for manufacture of the pridopidine L-tartrate of claim 1 comprising:
a) combining L-tartaric acid with pridopidine free base to form a mixture
b) obtaining pridopidine L-tartrate from the mixture.

19. A method of treating a human subject afflicted with Huntington's disease comprising administering to the human subject an amount of the pridopidine L-tartrate of claim 1 effective to treat the human subject.

Assignees

• Wu Raeann
• Haltiwanger Ralph Curtis
• Bierlmaier Stephen
• Yazdanian Mehran
• Teva Pharmaceuticals Int Gmbh

Inventors

• Wu Raeann
• Haltiwanger Ralph Curtis
• Bierlmaier Stephen
• Yazdanian Mehran

Classifications

• C07D211/24 Primary

  by sulfur atoms to which a second hetero atom is attached · CPC title

• C07C59/255

  Tartaric acid · CPC title

• C07C51/412

  by conversion of the acids, their salts, esters or anhydrides with the same carboxylic acid part · CPC title

• A61P25/14

  for treating abnormal movements, e.g. chorea, dyskinesia · CPC title