IP Library Granted Patent US 9,119,823
Granted Patent B2
US 9,119,823 · App. 14/610,492 · Granted Sep 1, 2015

Nitrite formulations and their use as nitric oxide prodrugs

Inventors: Nathan S. Bryan (Rockdale, TX); Janet Zand (Austin, TX)
Assignees: Board of Regents, The University of Texas System; Neogenis Labs, Inc.
A61K31/198A61K31/375A61K31/714A61K33/00A61K36/21A61K36/734
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Quick Facts
Patent No.
US 9,119,823
App. No.
14/610,492
Granted
Sep 1, 2015
Kind
B2
Abstract

Compositions comprising from about 40 weight parts to about 1000 weight parts of a botanical nitrate source; from about 20 weight parts to about 500 weight parts of a botanical source of nitrite reduction activity; and from about 4 weight parts to about 100 weight parts of a nitrite salt. Use of said composition in methods of reducing triglycerides or reducing C-reactive protein levels are also provided.

Claims (23)

1. A method of reducing a patient's C-reactive protein level, comprising:

administering to the patient a composition in a form of a lozenge dissolvable in the mouth, the composition comprising:

from about 40 weight parts to about 1000 weight parts of a botanical nitrate source;

from about 20 weight parts to about 500 weight parts of a botanical source of nitrite reduction activity;

from about 20 weight parts to about 500 weight parts L-citrulline; and

from about 4 weight parts to about 100 weight parts of a nitrite salt.

2. The method of claim 1 , wherein the botanical nitrate source is selected from the group consisting of beet root, artichoke, holy basil, gingko, and mixtures thereof and is present at about 200 weight parts;

the botanical source of nitrite reduction activity is selected from the group consisting of hawthorn berry, Schisandra , green tea, beet root, pine bark, and mixtures thereof and is present at about 100 weight parts;

the L-citrulline is present at about 100 weight parts; and

the nitrite salt is selected from the group consisting of sodium nitrite, potassium nitrite, and mixtures thereof and is present at about 20 weight parts;

and the composition further comprises:

about 1 weight part vitamin B12 in a form selected from the group consisting of methylcobalamin, cyanocobalamin, and mixtures thereof;

about 100 weight parts vitamin C in a form selected from the group consisting of magnesium ascorbate, ascorbic acid, and mixtures thereof; and

from about 50 weight parts to about 1500 weight parts of one or more other ingredients selected from the group consisting of mannitol, xylitol, sorbitol, other sugar alcohols, cellulose, cellulose esters, cellulose ethers, starch, other polysaccharides, oligosaccharides, disaccharides, saccharides, gelatin, polyvinylpyrrolidone, polyethylene glycol, other binders, flavorants, colorants, magnesium stearate, other antiadherent agents, other stearate salts, sweeteners, silica, and other lubricants.

3. The method of claim 1 , wherein the nitrite salt is selected from the group consisting of sodium nitrite, potassium nitrite, magnesium nitrite, calcium nitrite, and mixtures thereof.

4. The method of claim 1 , wherein the botanical source of nitrite reduction activity is selected from the group consisting of hawthorn berry, Schisandra , green tea, beet root, pine bark, holy basil, gymnema sylvestre, ashwagandha root, salvia, St. John wort, broccoli, stevia, spinach, gingko, kelp, tribulus, eleuthero, epimedium, eucommia, rhodiola, green tea, codonopsys, panax ginseng, astragalus, dodder seed, cordyceps, berries, tea, beer, grapes, wine, olive oil, chocolate, cocoa, coffee, walnuts, peanuts, borojo, pomegranates, popcorn, yerba mate, and mixtures thereof.

5. The method of claim 1 , wherein: the botanical nitrate source is selected from the group consisting of beet root, artichoke, holy basil, gingko, and mixtures thereof and is present at about 200 weight parts; the botanical source of nitrite reduction activity is selected from the group consisting of hawthorn berry, Schisandra , green tea, beet root, pine bark, and mixtures thereof and is present at about 100 weight parts; and the nitrite salt is selected from the group consisting of sodium nitrite, potassium nitrite, and mixtures thereof and is present at about 20 weight parts; and the composition further comprises: about 100 weight parts L-citrulline; about 1 weight part vitamin B12 in a form selected from the group consisting of methylcobalamin, cyanocobalamin, and mixtures thereof; and about 100 weight parts vitamin C in a form selected from the group consisting of magnesium ascorbate, ascorbic acid, and mixtures thereof.

6. The method of claim 2 , wherein the vitamin B12 is in a form selected from the group consisting of methylcobalamin, cyanocobalamin, and mixtures thereof.

7. The method of claim 2 , wherein the vitamin C is in a form selected from the group consisting of magnesium ascorbate, sodium ascorbate, potassium ascorbate, ascorbic acid, and mixtures thereof.

8. The method of claim 1 , further comprising from about 20 weight parts to about 1000 weight parts L-arginine.

9. The method of claim 1 , further comprising from about from about 20 weight parts to about 500 weight parts of a nitrate salt selected from the group consisting of sodium nitrate, potassium nitrate, and mixtures thereof.

10. The method of claim 1 , wherein the lozenge weighs from about 600 mg to about 2000 mg.

11. The method of claim 1 , wherein the administering is performed once or twice daily.

Assignments (4)
CORRECTIVE ASSIGNMENT TO CORRECT THE ASSIGNEE NAME PREVIOUSLY RECORDED AT REEL: 034857 FRAME: 0192. ASSIGNOR(S) HEREBY CONFIRMS THE ASSIGNMENT. Recorded Jun 9, 2022
From: ZAND, JANET
To: NEOGENIS LABORATORIES, INC.
Reel/Frame 060328/0317 →
CHANGE OF NAME Recorded Jun 9, 2022
From: NEOGENIS LABORATORIES, INC.
To: HUMAN POWER OF N COMPANY
Reel/Frame 060329/0196 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jan 30, 2015
From: BRYAN, NATHAN SCOTT
To: BOARD OF REGENTS, THE UNIVERSITY OF TEXAS SYSTEM
Reel/Frame 034856/0954 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jan 30, 2015
From: ZAND, JANET
To: NEOGENIS LABS, INC.
Reel/Frame 034857/0192 →
Continuity (5)
Continuation 13668776 · Nov 5, 2012
Continuation 12856957 · Aug 16, 2010
Continuation In Part 12484364 · Jun 15, 2009
Provisional Application 61061251 · Jun 13, 2008
Related Publication 20150164839A1 · Jun 18, 2015