Nitrite formulations and their use as nitric oxide prodrugs

• US 8,962,038 B2
• Filed: 11/05/2012
• Issued: 02/24/2015
• Est. Priority Date: 06/13/2008
• Status: Active Grant

• Current Assignee: Human Power Of N Company, Board of Regents of the University of Texas System (University of Texas System)
• Original Assignee: Joseph M. Maraia, Board of Regents of the University of Texas System (University of Texas System)
• Inventors: Bryan, Nathan S., Zand, Janet
• Primary Examiner(s): ARNOLD, ERNST V
• Application Number:
  US13/668,776
• Publication Number:
  US 20130071494A1
• Time in Patent Office: 841 Days
• Field of Search: None
• US Class Current: 424/718
• CPC Class Codes: A23K 50/50 for rodents
• CPC Class Codes: A23L 33/105 Plant extracts, their artificial duplicates or their derivatives
• CPC Class Codes: A23L 33/15 Vitamins
• CPC Class Codes: A23L 33/16 Inorganic salts, minerals or trace elements
• CPC Class Codes: A23L 33/175 Amino acids
• CPC Class Codes: A23V 2002/00 Food compositions, function of food ingredients or processes for food or foodstuffs
• CPC Class Codes: A23V 2200/326 having effect on cardiovascular health
• CPC Class Codes: A23V 2250/0606 Arginine
• CPC Class Codes: A23V 2250/156 Mineral combination undefined extract A23V2250/1638
• CPC Class Codes: A23V 2250/21 Plant extracts
• CPC Class Codes: A23V 2250/708 Vitamin C
• 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 31/198 Alpha-amino acids, e.g. alanine or edetic acid [EDTA] betaine A61K31/205; proline A61K31/401; tryptophan A61K31/405; histidine A61K31/4172; peptides not degraded to individual amino acids A61K38/00
• CPC Class Codes: A61K 31/375 Ascorbic acid, i.e. vitamin C; Salts thereof
• CPC Class Codes: A61K 31/714 Cobalamins, e.g. cyanocobalamin, i.e. vitamin B12
• CPC Class Codes: A61K 33/00 Medicinal preparations containing inorganic active ingredients
• CPC Class Codes: A61K 36/00 Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines antigens from pollen A61K39/36
• CPC Class Codes: A61K 36/21 Amaranthaceae (Amaranth family), e.g. pigweed, rockwort or globe amaranth
• CPC Class Codes: A61K 36/734 Crataegus (hawthorn)
• CPC Class Codes: A61K 45/06 : Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
• CPC Class Codes: A61K 9/0056 : Mouth soluble or dispersible forms; Suckable, eatable, chewable coherent forms; Forms rapidly disintegrating in the mouth; Lozenges; Lollipops; Bite capsules; Baked products; Baits or other oral forms for animals
• CPC Class Codes: A61K 9/0095 : Drinks; Beverages; Syrups; Compositions for reconstitution thereof, e.g. powders or tablets to be dispersed in a glass of water; Veterinary drenches A61K9/0007 takes precedence; eatable gels or foams A61K9/0056; oral mucosa adhesive forms A61K9/006

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 the composition in methods of reducing triglycerides or reducing C-reactive protein levels are also provided.

Claims

1. A method of reducing a patient'"'"'s triglyceride 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 ingredients selected from the group consisting of mannitol, xylitol, sorbitol, sugar alcohols, cellulose, cellulose esters, cellulose ethers, starch, polysaccharides, oligosaccharides, disaccharides, saccharides, gelatin, polyvinylpyrrolidone, polyethylene glycol, binders, flavorants, colorants, magnesium stearate, antiadherent agents, stearate salts, sweeteners, silica, and lubricants.

3. The method of claim 2, wherein the lozenge weighs from about 600 mg to about 2000 mg.

4. The method of claim 2, wherein the administering is performed once or twice daily.