# US 2019/0314404 A1 · Method of producing physiological and therapeutic levels of nitric oxide through an oral delivery system > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 2019/0314404 A1 - Document ID: US20190314404A1 - Status: Published application - Kind: A1 - Application number: 16/425,681 - Filed: 2019-05-29 - Published: 2019-10-17 - Earliest claimed: 2009-06-15 - Assignees: Board of Regents, The University of Texas System; Neogenis Labs, Inc. - Applicants: Board of Regents of the University of Texas System; Neogenis Labs, Inc. - Inventors: Nathan S. Bryan; Jose G. Rocca - Web page: https://patentgrep.com/patent/US20190314404A1 ## CPC - A61K 33/00: Medicinal preparations containing inorganic active ingredients - A61K 9/0053: {Mouth and digestive tract, i.e. intraoral and peroral administration} - 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} - A61K 9/20: Pills, tablets, {discs, rods (A61K9/0004, A61K9/0007, A61K9/0056, A61K9/0065 take precedence; for reconstitution of a drink A61K9/0095)} - A61K 9/2009: {Inorganic compounds} - A61K 9/2013: {Organic compounds, e.g. phospholipids, fats} - A61K 9/2018: {Sugars, or sugar alcohols, e.g. lactose, mannitol; Derivatives thereof, e.g. polysorbates} - A61K 9/2054: {Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose} - A61K 31/195: having an amino group - 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) - A61K 31/375: Ascorbic acid, i.e. vitamin C; Salts thereof - A61K 31/714: Cobalamins, e.g. cyanocobalamin, i.e. vitamin B12 - A61K 36/21: Amaranthaceae (Amaranth family), e.g. pigweed, rockwort or globe amaranth - A61K 36/734: Crataegus (hawthorn) - A61K 38/44: Oxidoreductases (1) - A61K 45/06: Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca - C12Y 107/02001: Nitrite reductase (NO-forming) (1.7.2.1) - A61K: PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES (devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms A61J3/00; chemical aspects of, or use of materials for deodorisation of air, for disinfection or sterilisation, or for bandages, dressings, absorbent pads or surgical articles A61L; soap compositions C11D) - C12Y: ENZYMES ## 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 ### Claim 1 A delivery system comprising: at least one nitric oxide-producing component; and a dispersable 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 dispersable medium. ### Claim 2 (depends on 1) The delivery system of claim 1, wherein the dispersable medium is dissolvable in the oral cavity. ### Claim 3 (depends on 1) The delivery system of claim 1, wherein the dispersable medium is dissolvable in about five minutes or less. ### Claim 4 (depends on 1) The delivery system of claim 1, wherein the delivery system is adapted to generate nitric oxide in the oral cavity. ### Claim 5 (depends on 1) The delivery system of claim 1, where the nitric oxide-producing component is adapted to generate nitric oxide in-vivo in response to dissolution of the delivery system in the gastro intestinal tract. ### Claim 6 (depends on 1) The delivery system of claim 1, wherein the delivery system is formed of a lozenge, liquid, powder, solid, semi-solid, cream, gel, emulsion, suspension, heterogenic liquid, film, or topical. ### Claim 7 (depends on 1) The delivery system of claim 1, wherein the dispersable medium comprises one or more of a sugar, dispersing agent, flavor, sweetener, color, alcohol, maltodextren, or filler. ### Claim 8 (depends on 1) The delivery system of claim 1, wherein the nitric oxide-producing component is comprised of a nitrite, nitrate, or reductase or a combination of nitrite, nitrate and reductase. ### Claim 9 (depends on 1) The delivery system of claim 1 further comprising a barrier for preventing contact of two or more species of the nitric oxide-producing component. ### Claim 10 (depends on 9) The delivery system of claim 9, wherein the two or more species are nitrite and nitrite reductase. ### Claim 11 (depends on 9) The delivery system of claim 9, wherein the barrier comprises sugar, dispersing agent, flavors, sweetener, color, alcohol, maltodextren, or filler. ### Claim 12 (depends on 1) The delivery system of claim 1 further comprising a disintegrating agent, a compactible excipient, or both. ### Claim 13 (depends on 12) The delivery system of claim 12, wherein the disintegrating agent absorbs fluid upon contact with fluid. ### Claim 14 (depends on 12) The delivery system of claim 12, wherein the compactable excipient is adapted to maintain the delivery system in a compressed form. ### Claim 15 (depends on 12) The delivery system of claim 12, wherein the compactable excipient is chemically inert, does not absorb fluid, is non-hydroscopic, protects water-sensitive nitric oxide-producing components, does not react with nitric oxide-producing components and/or has a narrow particle size distribution. ### Claim 16 (depends on 12) The delivery system of claim 12 wherein the disintegrating agent causes the compactable excipient to break apart upon expansion.