Purification of olmesartan medoxomil

• US 20100076200A1
• Filed: 09/17/2009
• Published: 03/25/2010
• Est. Priority Date: 09/02/2004
• Status: Abandoned Application

• Current Assignee: Esti Esty Marom, Gideon Pilarsky, Lilach Hedvati, Yuriy Raizi
• Original Assignee: Esti Esty Marom, Gideon Pilarsky, Lilach Hedvati, Yuriy Raizi
• Inventors: Marom, Esti Esty, Pilarsky, Gideon, Hedvati, Lilach, Raizi, Yuriy
• Application Number:
  US12/586,186
• Publication Number:
  US 20100076200A1
• Time in Patent Office: Days
• US Class Current: 548/253
• CPC Class Codes: A61P 43/00 Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
• CPC Class Codes: A61P 9/12 Antihypertensives
• CPC Class Codes: C07D 405/14 containing three or more hetero rings

Abstract

The present invention provides a process for purifying olmesartan medoxomil.

Claims

1. A process for purifying olmesartan medoxomil comprising:

a) providing a solution of olmesartan medoxomil in a C_3-6 ketone;

b) adding water to the solution; and

c) recovering purified olmesartan medoxomil.

2. The process of claim 1, wherein the C_3-6 ketone is selected from the group consisting of acetone, methyl ethyl ketone, diethyl ketone, and t-butyl methyl ketone.

3. The process of claim 2, wherein the C_3-6 ketone is acetone.

4. The process of claim 1, wherein the amount of the C_3-6 ketone is at least about 7 volumes to about 1 gram of solid olmesartan medoxomil.

5. The process of claim 4, wherein the amount of the C_3-6 ketone is at least about 10 volumes to about 1 gram of solid olmesartan medoxomil.

6. The process of claim 1, wherein the solution of olmesartan medoxomil in the C_3-6 ketone further comprises about 4% to about 14% water by volume.

7. The process of claim 6, wherein the solution of olmesartan medoxomil in the C_3-6 ketone further comprises about 4% water by volume.

8. The process of claim 1, further comprising heating the solution of olmesartan medoxomil in acetone to about 30°

C. to about reflux temperature.

9. The process of claim 8, wherein the solution of olmesartan medoxomil in acetone is heated to about 40°

C. to about reflux temperature.

10. The process of claim 1, wherein the amount of water added is about 0.5 to about 2 volumes water to about 1 volume of the C_3-6 ketone.

11. The process of claim 10, wherein the amount of water added is at least about 1 volume water to about 1 volume of the C_3-6 ketone.

12. The process of claim 1, further comprising cooling the solution after step b) to a temperature below about 30°

C.

13. The process of claim 12, wherein the solution is cooled to about room temperature.

14. The process of claim 1, further comprising drying the purified olmesartan medoxomil.

15. The process of claim 1, wherein the purified olmesartan medoxomil contains less than about 0.3% OLM-acid.

16. The process of claim 15, wherein the purified olmesartan medoxomil contains less than about 0.05% OLM-acid.

17. The process of claim 16, wherein the purified olmesartan medoxomil contains less than about 0.03% OLM-acid.

18-29. -29. (canceled)