Nitrite formulations and their use as nitric oxide prodrugs

• US 8,298,589 B1
• Filed: 06/15/2009
• Issued: 10/30/2012
• Est. Priority Date: 06/13/2008
• Status: Active Grant

• Current Assignee: Board of Regents of the University of Texas System (University of Texas System)
• Original Assignee: Board of Regents of the University of Texas System (University of Texas System)
• Inventors: Bryan, Nathan Scott
• Primary Examiner(s): ARNOLD, ERNST V
• Application Number:
  US12/484,364
• Time in Patent Office: 1,233 Days
• Field of Search: None
• US Class Current: 424/718
• 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 31/195 having an amino group
• CPC Class Codes: A61K 31/375 Ascorbic acid, i.e. vitamin C; Salts thereof
• CPC Class Codes: A61K 33/00 Medicinal preparations containing inorganic active ingredients

Abstract

Compositions comprising a nitrite salt, a nitrate salt, and ascorbic acid are provided in several embodiments. Use of said composition in a method of enhancing cardiovascular performance or treating adverse cardiovascular event in a mammal is also provided.

Claims

1. A composition, comprising:

a nitrite salt wherein said nitrite salt is provided in an amount ranging from about 10 mg to about 100 mg;

a nitrate salt, wherein said nitrate salt is provided in an amount ranging from about 50 mg to about 500 mg; and

ascorbic acid, wherein said ascorbic acid is provided in an amount ranging from about 100 mg to about 2000 mg;

wherein said composition is provided in a single oral dose.

2. The composition of claim 1, wherein the nitrite salt is selected from the group consisting of at least one of the following:

sodium nitrite and potassium nitrite.

3. The composition of claim 1, wherein the nitrate salt is selected from the group consisting of at least one of the following:

sodium nitrate and potassium nitrate.

4. The composition of claim 1, comprising from about 1 weight part to about 8 weight parts nitrite, from about 5 weight parts to about 50 weight parts nitrate, and from about 20 weight parts to about 200 weight parts ascorbic acid.

5. The composition of claim 1, further comprising L-arginine.

6. The composition of claim 5, comprising from about 20 weight parts to about 200 weight parts L-arginine.

7. The composition of claim 1, further comprising water.

8. A composition, comprising:

a nitrite salt wherein said nitrite salt is provided in an amount ranging from about 10 mg to about 100 mg;

a nitrate salt, wherein said nitrate salt is provided in an amount ranging from about 50 mg to about 500 mg; and

ascorbic acid, wherein said ascorbic acid is provided in an amount ranging from about 100 mg to about 2000 mg;

wherein said composition is provided in a single oral dose and is formulated to be exposed to commensal bacteria in the mouth.

9. A composition, comprising:

a nitrite salt wherein said nitrite salt is provided in an amount ranging from about 10 mg to about 100 mg;

a nitrate salt, wherein said nitrate salt is provided in an amount ranging from about 50 mg to about 500 mg; and

ascorbic acid, wherein said ascorbic acid is provided in an amount ranging from about 100 mg to about 2000 mg;

wherein said composition is solid and is provided in a single oral dose.

10. A composition, comprising:

a nitrite salt wherein said nitrite salt is provided in an amount ranging from about 10 mg to about 100 mg;

a nitrate salt, wherein said nitrate salt is provided in an amount ranging from about 50 mg to about 500 mg; and

ascorbic acid, wherein said ascorbic acid is provided in an amount ranging from about 100 mg to about 2000 mg;

wherein said composition is solid and is provided in a single dose and is formulated to be exposed to commensal bacteria in the mouth.