# US 12,337,064 B2 · Formulations and compositions for ortho- and/or retro-nasal delivery and associated systems, methods and articles

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- Number: US 12,337,064 B2
- Document ID: US12337064B2
- Status: Granted
- Kind: B2
- Application number: 17/273,689
- Filed: 2019-09-04
- Published: 2021-10-14
- Granted: 2025-06-24
- Earliest claimed: 2018-09-05
- Assignees: Sensory Cloud, Inc.
- Applicants: Sensory Cloud, LLC
- Inventors: David A. Edwards; Tom Devlin
- Web page: https://patentgrep.com/patent/US12337064B2

## CPC

- A61K 9/0078: {for inhalation via a nebulizer such as a jet nebulizer, ultrasonic nebulizer, e.g. in the form of aqueous drug solutions or dispersions}
- A61K 33/14: Alkali metal chlorides; Alkaline earth metal chlorides
- A23L 33/10: using additives (addition of substantially indigestible substances A23L33/21)
- A23L 33/105: Plant extracts, their artificial duplicates or their derivatives
- A61K 9/0043: {Nose}
- A61K 31/045: Hydroxy compounds, e.g. alcohols; Salts thereof, e.g. alcoholates
- A61K 31/202: having three or more double bonds, e.g. linolenic (eicosanoids, e.g. leukotrienes A61K31/557)
- A61K 31/4525: containing a five-membered ring with oxygen as a ring hetero atom
- A61K 31/465: Nicotine; Derivatives thereof
- A61K 33/00: Medicinal preparations containing inorganic active ingredients
- A61K 33/18: Iodine; Compounds thereof
- A61K 35/00: Medicinal preparations containing materials or reaction products thereof with undetermined constitution
- A61K 36/22: Anacardiaceae (Sumac family), e.g. smoketree, sumac or poison oak
- A61K 36/42: Cucurbitaceae (Cucumber family)
- A61K 36/53: Lamiaceae or Labiatae (Mint family), e.g. thyme, rosemary or lavender
- A61K 36/54: Lauraceae (Laurel family), e.g. cinnamon or sassafras
- A61K 36/73: Rosaceae (Rose family), e.g. strawberry, chokeberry, blackberry, pear or firethorn
- A61K 36/752: Citrus, e.g. lime, orange or lemon
- A61K 36/81: Solanaceae (Potato family), e.g. tobacco, nightshade, tomato, belladonna, capsicum or jimsonweed
- A61K 36/8962: Allium, e.g. garden onion, leek, garlic or chives
- A61K 36/899: Poaceae or Gramineae (Grass family), e.g. bamboo, corn or sugar cane
- A61K 36/9068: Zingiber, e.g. garden ginger
- A61K 45/06: Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
- A61M 11/003: {by passing the aerosol trough sieves or filters}
- A61M 11/005: {using ultrasonics (spraying or atomising liquids using ultrasonic vibrations in general B05B17/06)}
- A61M 15/0003: {with means for dispensing more than one drug}
- A61M 15/0028: {using prepacked dosages, one for each application, e.g. capsules to be perforated or broken-up}
- A61M 15/0085: {using ultrasonics (spraying or atomising liquids using ultrasonic vibrations in general B05B17/06)}
- A61M 15/009: {using medicine packages with incorporated spraying means, e.g. aerosol cans (pocket atomiser of the injector type A61M11/08)}
- A61M 15/08: Inhaling devices inserted into the nose
- A61P 3/02: Nutrients, e.g. vitamins, minerals
- A61P 25/36: Opioid-abuse
- A23V 2002/00: Food compositions, function of food ingredients or processes for food or foodstuffs
- A61J 1/062: {Carpules}
- A61J 1/065: {Rigid ampoules, e.g. glass ampoules}
- A61J 1/1487: {with friction fit, e.g. connecting tubes directly to a protruding port}
- 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)}
- A61M 2202/0468: non-physiological
- A61M 2202/064: Powder
- A61M 2205/0294: Piezoelectric materials
- A61M 2205/103: rotating
- A61M 2205/106: reciprocating
- A61M 2205/14: Detection of the presence or absence of a tube, a connector or a container in an apparatus
- A61M 2205/215: Tilt detection, e.g. for warning or shut-off
- A61M 2205/3306: Optical measuring means
- A61M 2205/3317: Electromagnetic, inductive or dielectric measuring means
- A61M 2205/332: Force measuring means
- A61M 2205/3592: using telemetric means, e.g. radio or optical transmission
- A61M 2205/50: with microprocessors or computers
- A61M 2205/584: having a color code
- A61M 2205/587: Lighting arrangements
- A61M 2205/8206: battery-operated
- A61M 2205/8268: Fuel storage cells
- A61M 2205/8293: Solar
- A61M 2209/01: Remote controllers for specific apparatus
- A61M 2209/045: for filling, e.g. for filling reservoirs
- A61M 2209/086: Docking stations
- A61M 2210/065: Throat; Pharynx
- G16H 20/13: delivered from dispensers
- 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)
- A23L: FOODS, FOODSTUFFS OR NON-ALCOHOLIC BEVERAGES, NOT OTHERWISE PROVIDED FOR; PREPARATION OR TREATMENT THEREOF (preservation thereof A23B)
- A61M: DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY (introducing media into or onto the bodies of animals A61D7/00; means for inserting tampons A61F13/26; devices for administering food or medicines orally A61J; containers for collecting, storing or administering blood or medical fluids A61J1/05); DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY (surgery A61B; chemical aspects of surgical articles A61L); DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR {(Electrotherapy, e.g. producing anaesthesia by the use of alternating or intermittent currents A61N1/36021)}
- A61P: SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A23V: INDEXING SCHEME RELATING TO FOODS, FOODSTUFFS OR NON-ALCOHOLIC BEVERAGES AND LACTIC OR PROPIONIC ACID BACTERIA USED IN FOODSTUFFS OR FOOD PREPARATION
- A61J: CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
- G16H: HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA

## Abstract

A composition of food or therapeutic and other substances for administration as a cloud of droplets, the cloud comprising readily-soluble droplets having a median size range of approximately 3 microns to approximately 20 microns, or 5 microns to 10 microns, or 6 microns to 10 microns, for introduction to an animal via an ortho-nasal or retro-nasal route. Agonists or antagonists may include one or more of the following: sodium iodide, sodium chloride, magnesium chloride, capsaicin, piperine, linalool, ground cinnamon, a cannabinoid, pimento, onion, clove, thyme, ginger, menthol, or TRPV antagonists, and chocolate, Irish cream, caramel, lemon, lime, mango, raspberry, watermelon, blueberry, strawberry, mint, popcorn, meat, Resolvin D2 or nicotine. Devices for delivering compositions as an aerosol are described.

## Claims

### Claim 1

A composition for ortho-nasal or retro-nasal food or therapeutic applications, the composition comprising:
an aerosol of droplets dispensed from a nebulizer, the aerosol of droplets having a mass median droplet size of from 3 μm to 20 μm, the droplets of the aerosol of droplets comprising an amount of water or a mixture of water and alcohol and which carry agonists or antagonists of all of: transient receptor potential vanilloid (TRPV) receptors, olfactory receptors, and taste receptors, and wherein a concentration of all agonists or antagonists in the composition is in a range of 50 μg/mL to 2 mg/mL, the composition delivered ortho-nasally and/or retro-nasally as the aerosol of droplets from the nebulizer.

### Claim 2 (depends on 1)

The composition of claim 1 wherein the agonists or antagonists of TRPV receptors are agonists or antagonists at least one of TRPV1 receptors, TRPV3 receptors, TRPV4 receptors, or TRPV8 receptors.

### Claim 3 (depends on 1)

The composition of claim 1 wherein the composition comprises two or more types of TRPV antagonists.

### Claim 4 (depends on 1)

The composition of claim 1 wherein the composition comprises one or more of: ground cinnamon, a cannabinoid, pimento, onion, clove, thyme, ginger, menthol, Irish cream, lemon, lime, mango, raspberry, watermelon, blueberry, strawberry, popcorn, meat, resolvin D2 or nicotine.

### Claim 5 (depends on 1)

The composition of claim 1 wherein the droplets of the aerosol of droplets have a mass median droplet size of 5 μm to 10 μm.

### Claim 6 (depends on 1)

The composition of claim 1 wherein the droplets of the aerosol of droplets have a mass median droplet size of between 6 μm and 10 μm.

### Claim 7 (depends on 1)

The composition of claim 1 wherein a mass of the composition as delivered to a nose as the aerosol of droplets is less than 1 mg total mass, and a total quantity of the agonists or antagonists of TRPV receptors acting on TRPV, olfactory, or taste receptors is less than approximately 100 μg.

### Claim 8 (depends on 1)

The composition of claim 1 wherein the concentration of all agonists or antagonists of taste, olfactory and TRPV receptors is in a range of 50 μg/mL to 1 mg/mL.

### Claim 9 (depends on 1)

The composition of claim 1 wherein the composition further comprises one or more of: sodium iodide, sodium chloride, and magnesium chloride.

### Claim 10 (depends on 1)

The composition of claim 1 wherein the composition further comprises linalool.

### Claim 11 (depends on 10)

The composition of claim 10 wherein, at least a majority of the droplets in the aerosol of droplets are between 5 μm and 10 μm in size.

### Claim 12 (depends on 1)

The composition of claim 1 wherein the concentration of all agonists or antagonists of TRPV, olfactory, or taste receptors is in a range of 50 μg/mL to 500 μg/mL.