Method of producing physiological and therapeutic levels of nitric oxide through an oral delivery system

• US 9,821,006 B2
• Filed: 01/06/2016
• Issued: 11/21/2017
• Est. Priority Date: 06/15/2009
• 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., Rocca, Jose G.
• Primary Examiner(s): Arnold, Ernst V
• Application Number:
  US14/989,714
• Publication Number:
  US 20160287628A1
• Time in Patent Office: 685 Days
• Field of Search: None
• 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 36/21 Amaranthaceae (Amaranth family), e.g. pigweed, rockwort or globe amaranth
• CPC Class Codes: A61K 36/734 Crataegus (hawthorn)
• CPC Class Codes: A61K 38/44 Oxidoreductases (1)
• CPC Class Codes: A61K 45/06 Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
• CPC Class Codes: A61K 9/0053 Mouth and digestive tract, i.e. intraoral and peroral administration rectal administration A61K9/0031
• 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 9/20 Pills, tablets, discs, rods A61K9/0004, A61K9/0007, A61K9/0056, A61K9/0065 take precedence; for reconstitution of a drink A61K9/0095
• CPC Class Codes: A61K 9/2009 Inorganic compounds
• CPC Class Codes: A61K 9/2013 Organic compounds, e.g. phospholipids, fats
• CPC Class Codes: A61P 3/00 Drugs for disorders of the metabolism of the blood or the extracellular fluid A61P7/00
• CPC Class Codes: A61P 3/06 Antihyperlipidemics
• CPC Class Codes: A61P 9/00 Drugs for disorders of the cardiovascular system
• CPC Class Codes: C12Y 107/02001 Nitrite reductase (NO-forming) (1.7.2.1)

Abstract

A composition and method of providing nitric oxide and nitrite therapy to patients whereby a therapeutic amount is bioavailable within approximately 30 minutes of administration. In embodiments of the invention, nitric oxide is produced in the oral cavity.

Claims

1. A method of increasing levels of nitric oxide in an individual, comprising the step of orally delivering a therapeutically effective amount of a composition to the individual, wherein the composition comprises:

at least one nitric oxide-producing component; and

a dispersible medium adapted to be consumed in the oral cavity;

wherein the nitric oxide-producing component is adapted to generate nitric oxide in vivo upon consumption of the dispersible medium, and wherein the composition comprises about 1 mg to about 150 mg of a nitrite salt and about 10 mg to about 10,000 mg of nitrite reductase and wherein the composition comprises about 1,000 mg to about 10,000 mg of beet root in powder form.

2. The method of claim 1, wherein the composition comprises about 10 mg to 500 mg of nitrate.

3. A method of enhancing cardiovascular performance in an individual, comprising the step of orally administering a composition to the individual, wherein the composition comprises:

at least one nitric oxide-producing component; and

a dispersible medium adapted to be consumed in the oral cavity;

wherein the nitric oxide-producing component is adapted to generate nitric oxide in vivo upon consumption of the dispersible medium, and wherein the composition comprises about 1 mg to about 150 mg of a nitrite salt and about 10 mg to about 10,000 mg of nitrite reductase and wherein the composition comprises about 1,000 mg to about 10,000 mg of beet root in powder form.

4. The method of claim 3, wherein the composition comprises about 10 mg to 500 mg of nitrate.