Compositions comprising nebivolol

• US 7,803,838 B2
• Filed: 05/31/2005
• Issued: 09/28/2010
• Est. Priority Date: 06/04/2004
• Status: Active Grant

• Current Assignee: Mylan Laboratories Incorporated (Pfizer Inc.)
• Original Assignee: Forest Laboratories Holdings Limited (Abbvie Incorporated)
• Inventors: Bottini, Peter, O'Donnell, John, Davis, Eric
• Primary Examiner(s): Krass; Frederick
• Assistant Examiner(s): Webb; Walter E
• Application Number:
  US11/141,235
• Publication Number:
  US 20050272810A1
• Time in Patent Office: 1,946 Days
• Field of Search: 514/1, 514/183, 514/451, 514/456
• US Class Current: 514/456
• CPC Class Codes: A61K 2300/00 Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00
• CPC Class Codes: A61K 31/35 having six-membered rings with one oxygen as the only ring hetero atom
• CPC Class Codes: A61K 31/353 3,4-Dihydrobenzopyrans, e.g. chroman, catechin
• CPC Class Codes: A61K 31/401 Proline; Derivatives thereof, e.g. captopril
• CPC Class Codes: A61K 31/403 condensed with carbocyclic rings, e.g. carbazole
• CPC Class Codes: A61K 45/06 Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca

Abstract

Nebivolol has been shown to be beneficial in the treatment of cardiovascular diseases such hypertension, congestive heart failure, arterial stiffness and endothelial dysfunction. The present invention features a pharmaceutical composition comprising nebivolol and at least one other active agent, wherein the at least one other active agent is a cardiovascular agent.

Claims

1. A composition comprising between about 0.125 mg to about 40 mg nebivolol or a pharmaceutically acceptable salt thereof and between about 1 mg to about 1200 mg of an angiotensin II receptor antagonist (ARB) selected from the group consisting of olmesartan, losartan, valsartan and pharmaceutically acceptable salts thereof wherein the composition provides a higher therapeutic index when administered to a patient having hypertension than either the corresponding amount of nebivolol or the ARB administered alone.

2. The composition of claim 1 wherein the ARB is olmesartan or a pharmaceutically acceptable salt thereof.

3. The composition of claim 1 wherein the ARB is losartan or a pharmaceutically acceptable salt thereof.

4. The composition of claim 1 wherein the ARB is valsartan or a pharmaceutically acceptable salt thereof.

5. A composition comprising between about 0.125 mg to about 40 mg nebivolol or a pharmaceutically acceptable salt thereof and between about 1 mg to about 1200 mg of an angiotensin II receptor antagonist (ARB) selected from the group consisting of olmesartan, losartan, valsartan and pharmaceutically acceptable salts thereof wherein the effectiveness of the composition when administered to a patient having hypertension is greater than the sum of the nebivolol or the ARB used alone.

6. The composition of claim 5 wherein the ARB is olmesartan or a pharmaceutically acceptable salt thereof.

7. The composition of claim 5 wherein the ARB is losartan or a pharmaceutically acceptable salt thereof.

8. The composition of claim 5 wherein the ARB is valsartan or a pharmaceutically acceptable salt thereof.

9. A composition comprising between about 0.125 mg to about 40 mg nebivolol or a pharmaceutically acceptable salt thereof and between about 1 mg to about 1200 mg of an angiotensin II receptor antagonist (ARB) selected from the group consisting of olmesartan, losartan, valsartan and pharmaceutically acceptable salts thereof wherein the composition is at least 100% more effective than treatment with nebivolol or the ARB administered alone.

10. The composition of claim 9 wherein the ARB is olmesartan or a pharmaceutically acceptable salt thereof.

11. The composition of claim 9 wherein the ARB is losartan or a pharmaceutically acceptable salt thereof.

12. The composition of claim 9 wherein the ARB is valsartan or a pharmaceutically acceptable salt thereof.