# US 10,374,036 B2 · Food and beverage compositions infused with lipophilic active agents and methods of use thereof

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- Number: US 10,374,036 B2
- Document ID: US10374036B2
- Status: Granted
- Kind: B2
- Application number: 16/148,473
- Filed: 2018-10-01
- Published: 2019-01-31
- Granted: 2019-08-06
- Earliest claimed: 2014-06-11
- Applicants: PoViva Tea, LLC
- Inventors: Michelle Reillo; Marian E. Washington
- Web page: https://patentgrep.com/patent/US10374036B2

## CPC

- A23L 33/10: using additives (addition of substantially indigestible substances A23L33/21)
- A23B 2/92: Freeze drying
- A23C 9/156: Flavoured milk preparations {; Addition of fruits, vegetables, sugars, sugar alcohols or sweeteners}
- A23C 9/16: Agglomerating or granulating milk powder; Making instant milk powder; Products obtained thereby (A23C9/18 takes precedence)
- A23F 3/405: {Flavouring with flavours other than natural tea flavour or tea oil}
- A23F 5/28: Drying or concentrating coffee extract {(A23F5/246 takes precedence)}
- A23F 5/465: {Flavouring with flavours other than natural coffee flavour or coffee oil}
- A23L 2/52: Adding ingredients (adding preservatives A23B70/10)
- A23L 27/84: {Flavour masking or reducing agents}
- A23L 29/035: {containing oxygen as heteroatom (gums A23L29/25; sugar or sugar alcohols A23L29/30)}
- A23L 29/25: Exudates, e.g. gum arabic, gum acacia, gum karaya or tragacanth
- A23L 33/105: Plant extracts, their artificial duplicates or their derivatives
- A23L 33/115: Fatty acids or derivatives thereof; Fats or oils
- A23L 33/15: Vitamins
- 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 9/0095: {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)}
- A61K 9/148: {with compounds of unknown constitution, e.g. material from plants or animals (with oils, fats, waxes, shellac A61K9/145)}
- A61K 31/167: having the nitrogen of a carboxamide group directly attached to the aromatic ring, e.g. lidocaine, paracetamol
- A61K 31/196: the amino group being directly attached to a ring, e.g. anthranilic acid, mefenamic acid, diclofenac, chlorambucil
- A61K 31/355: Tocopherols, e.g. vitamin E
- A61K 31/405: Indole-alkanecarboxylic acids; Derivatives thereof, e.g. tryptophan, indomethacin
- A61K 31/455: Nicotinic acids, e.g. niacin; Derivatives thereof, e.g. esters, amides
- A61K 31/465: Nicotine; Derivatives thereof
- A61K 31/5415: ortho- or peri-condensed with carbocyclic ring systems, e.g. phenothiazine, chlorpromazine, piroxicam
- A61K 31/616: by carboxylic acids, e.g. acetylsalicylic acid
- A61K 31/621: having the hydroxy group in position 2 esterified, e.g. benorylate
- A61K 31/658: {o-phenolic cannabinoids, e.g. cannabidiol, cannabigerolic acid, cannabichromene or tetrahydrocannabinol}
- A61K 36/3482: {Cannabis}
- A61K 36/5777: {Theobroma, e.g. cocao or cocoa}
- A61K 36/742: {Coffea, e.g. coffee}
- A61K 36/82: Theaceae (Tea family), e.g. camellia
- A61K 47/44: Oils, fats or waxes according to two or more groups of A61K47/02-A61K47/42; Natural or modified natural oils, fats or waxes, e.g. castor oil, polyethoxylated castor oil, montan wax, lignite, shellac, rosin, beeswax or lanolin (synthetic glycerides, e.g. medium-chain triglycerides, A61K47/14)
- A61K 47/46: Ingredients of undetermined constitution or reaction products thereof, e.g. skin, bone, milk, cotton fibre, eggshell, oxgall or plant extracts
- A61P 1/00: Drugs for disorders of the alimentary tract or the digestive system
- A61P 1/02: Stomatological preparations, e.g. drugs for caries, aphtae, periodontitis
- A61P 1/04: for ulcers, gastritis or reflux esophagitis, e.g. antacids, inhibitors of acid secretion, mucosal protectants
- A61P 1/14: Prodigestives, e.g. acids, enzymes, appetite stimulants, antidyspeptics, tonics, antiflatulents
- A61P 1/16: for liver or gallbladder disorders, e.g. hepatoprotective agents, cholagogues, litholytics
- A61P 1/18: for pancreatic disorders, e.g. pancreatic enzymes
- A61P 3/02: Nutrients, e.g. vitamins, minerals
- A61P 3/04: Anorexiants; Antiobesity agents
- A61P 3/10: for hyperglycaemia, e.g. antidiabetics
- A61P 5/00: Drugs for disorders of the endocrine system
- A61P 5/24: of the sex hormones
- A61P 9/00: Drugs for disorders of the cardiovascular system
- A61P 9/10: for treating ischaemic or atherosclerotic diseases, e.g. antianginal drugs, coronary vasodilators, drugs for myocardial infarction, retinopathy, cerebrovascula insufficiency, renal arteriosclerosis
- A61P 11/00: Drugs for disorders of the respiratory system
- A61P 11/02: Nasal agents, e.g. decongestants
- A61P 11/06: Antiasthmatics
- A61P 13/08: of the prostate
- A61P 13/12: of the kidneys
- A61P 15/00: Drugs for genital or sexual disorders (for disorders of sex hormones A61P5/24); Contraceptives
- A61P 15/08: for gonadal disorders or for enhancing fertility, e.g. inducers of ovulation or of spermatogenesis
- A61P 17/00: Drugs for dermatological disorders
- A61P 17/02: for treating wounds, ulcers, burns, scars, keloids, or the like
- A61P 17/06: Antipsoriatics
- A61P 19/02: for joint disorders, e.g. arthritis, arthrosis
- A61P 19/06: Antigout agents, e.g. antihyperuricemic or uricosuric agents
- A61P 25/00: Drugs for disorders of the nervous system
- A61P 25/02: for peripheral neuropathies
- A61P 25/04: Centrally acting analgesics, e.g. opioids
- A61P 25/06: Antimigraine agents
- A61P 25/16: Anti-Parkinson drugs
- A61P 25/18: Antipsychotics, i.e. neuroleptics; Drugs for mania or schizophrenia
- A61P 25/28: for treating neurodegenerative disorders of the central nervous system, e.g. nootropic agents, cognition enhancers, drugs for treating Alzheimer's disease or other forms of dementia
- A61P 25/32: Alcohol-abuse
- A61P 25/34: Tobacco-abuse
- A61P 25/36: Opioid-abuse
- A61P 27/02: Ophthalmic agents
- A61P 29/00: Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
- A61P 31/04: Antibacterial agents
- A61P 31/10: Antimycotics
- A61P 31/16: for influenza or rhinoviruses
- A61P 31/18: for HIV
- A61P 31/22: for herpes viruses
- A61P 35/00: Antineoplastic agents
- A61P 37/02: Immunomodulators
- A61P 37/08: Antiallergic agents (antiasthmatic agents A61P11/06; ophthalmic antiallergics A61P27/14)
- A61P 39/02: Antidotes
- A61P 43/00: Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
- B82Y 10/00: Nanotechnology for information processing, storage or transmission, e.g. quantum computing or single electron logic
- H10D 30/014: {of FETs having zero-dimensional [0D] or one-dimensional [1D] channels, e.g. quantum wire FETs, single-electron transistors [SET] or Coulomb blockade transistors}
- H10D 30/024: {of fin field-effect transistors [FinFET]}
- H10D 30/43: having one-dimensional [1D] charge carrier gas channels, e.g. quantum wire FETs or transistors having 1D quantum-confined channels
- H10D 30/62: Fin field-effect transistors [FinFET]
- H10D 30/6735: {having gates fully surrounding the channels, e.g. gate-all-around}
- H10D 62/121: {oriented parallel to substrates}
- H10D 64/017: {using dummy gates in processes wherein at least parts of the final gates are self-aligned to the dummy gates, i.e. replacement gate processes}
- H10D 64/518: {characterised by their lengths or sectional shapes}
- H10D 84/0167: {Manufacturing their channels}
- H10D 84/038: {using silicon technology, e.g. SiGe}
- H10P 14/2905: {Silicon, silicon germanium or germanium}
- H10P 14/3218: {Phosphides}
- H10P 14/3411: {Silicon, silicon germanium or germanium}
- H10P 14/3462: {Nanowires}
- A23V 2002/00: Food compositions, function of food ingredients or processes for food or foodstuffs
- H10D 84/85: Complementary IGFETs, e.g. CMOS
- A23L: FOODS, FOODSTUFFS OR NON-ALCOHOLIC BEVERAGES, NOT OTHERWISE PROVIDED FOR; PREPARATION OR TREATMENT THEREOF (preservation thereof A23B)
- A23B: PRESERVATION OF FOODS, FOODSTUFFS OR NON-ALCOHOLIC BEVERAGES; CHEMICAL RIPENING OF FRUIT OR VEGETABLES
- A23C: DAIRY PRODUCTS, e.g. MILK, BUTTER OR CHEESE; MILK OR CHEESE SUBSTITUTES; PREPARATION THEREOF (preservation thereof A23B11/00)
- A23F: COFFEE; TEA; THEIR SUBSTITUTES; MANUFACTURE, PREPARATION, OR INFUSION THEREOF
- 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)
- A61P: SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- B82Y: SPECIFIC USES OR APPLICATIONS OF NANOSTRUCTURES; MEASUREMENT OR ANALYSIS OF NANOSTRUCTURES; MANUFACTURE OR TREATMENT OF NANOSTRUCTURES
- H10D: INORGANIC ELECTRIC SEMICONDUCTOR DEVICES
- H10P: GENERIC PROCESSES OR APPARATUS FOR THE MANUFACTURE OR TREATMENT OF DEVICES COVERED BY CLASS H10
- A23V: INDEXING SCHEME RELATING TO FOODS, FOODSTUFFS OR NON-ALCOHOLIC BEVERAGES AND LACTIC OR PROPIONIC ACID BACTERIA USED IN FOODSTUFFS OR FOOD PREPARATION

## Abstract

Aspects described herein relate to food and beverage compositions infused with lipophilic active agents and methods of use for the treatment of a variety of disorders. More particularly, aspects described herein relate to food and beverage compositions infused with lipophilic active agents such as cannabinoids, nicotine, nonsteroidal anti-inflammatories (NSAIDs), and vitamins, that provide enhanced bioavailability of the lipophilic active agents in a subject, and that mask unpleasant tastes of lipophilic active agents.

## Claims

### Claim 1

A process for making lipophilic active agent infused tea leaves, coffee beans, or cocoa powder comprising the steps of:
(i) contacting the tea leaves, coffee beans, or cocoa powder with an oil comprising the cannabinoid, the at least one additional lipophilic active agent, and the bioavailability enhancing agent; and
(ii) dehydrating the tea leaves, coffee beans, or cocoa powder; thereby producing the lipophilic active agent infused tea leaves, coffee beans, or cocoa powder;
wherein the lipophilic active agent infused tea leaves, coffee beans, or cocoa powder comprise a therapeutically effective amount of a cannabinoid and at least one additional lipophilic active agent, wherein the bioavailability enhancing agent comprises an edible oil comprising long chain fatty acids, wherein the bioavailability of the cannabinoid in a subject is at least 1.5 times greater than the bioavailability of the cannabinoid in the subject in the absence of the bioavailability enhancing agent, and further wherein the additional lipophilic active agent is selected from the group consisting of nicotine, a non-steroidal anti-inflammatory drug (NSAID), and a vitamin.

### Claim 2 (depends on 1)

A process for making the lipophilic active agent infused tea leaves, coffee beans, or cocoa powder of claim 1, wherein the bioavailability of the cannabinoid in a subject is at least 3 times greater than the bioavailability of the cannabinoid in the subject in the absence of the bioavailability enhancing agent.

### Claim 3 (depends on 1)

A process for making the lipophilic active agent infused tea leaves, coffee beans, or cocoa powder of claim 1, wherein the bioavailability of the cannabinoid in a subject is at least 4.5 times greater than the bioavailability of the cannabinoid in the subject in the absence of the bioavailability enhancing agent.

### Claim 4 (depends on 1)

A process for making the lipophilic active agent infused tea leaves, coffee beans, or cocoa powder of claim 1, wherein the bioavailability enhancing agent is free of omega-6 fatty acids.

### Claim 5 (depends on 1)

A process for making the lipophilic active agent infused tea leaves, coffee beans, or cocoa powder of claim 1, wherein the cannabinoid is a psychoactive cannabinoid.

### Claim 6 (depends on 1)

A process for making the lipophilic active agent infused tea leaves, coffee beans, or cocoa powder of claim 1, wherein the cannabinoid is a nonpsychoactive cannabinoid.

### Claim 7 (depends on 1)

A process for making the lipophilic active agent infused tea leaves, coffee beans, or cocoa powder of claim 1, wherein the bioavailability enhancing agent is a protective colloid, an edible oil or fat, and a cannabinoid taste masking agent.

### Claim 8 (depends on 1)

A process for making the lipophilic active agent infused tea leaves, coffee beans, or cocoa powder of claim 1, wherein the bioavailability enhancing agent is nonfat dry milk.

### Claim 9 (depends on 8)

A process for making the lipophilic active agent infused tea leaves, coffee beans, or cocoa powder of claim 8, further wherein the lipophilic active agent infused tea leaves, coffee beans, or cocoa powder are lyophilized.

### Claim 10

A process for making a lipophilic active agent infused beverage product comprising the steps of:
(i) contacting tea leaves, coffee beans, or cocoa powder with an oil comprising a cannabinoid, an additional lipophilic active agent, and a bioavailability enhancing agent;
(ii) dehydrating the coffee beans or cocoa powder, thereby producing lipophilic active agent infused coffee beans or cocoa powder; and
(iii) steeping the lipophilic active agent infused tea leaves, coffee beans, or cocoa powder in a liquid, thereby producing the lipophilic active agent infused beverage product;
wherein the lipophilic active agent infused tea leaves, coffee beans, or cocoa powder comprise a therapeutically effective amount of the cannabinoid and the additional lipophilic active agent, wherein the bioavailability enhancing agent comprises an edible oil comprising long chain fatty acids, wherein the bioavailability of the cannabinoid in a subject is at least 1.5 times greater than the bioavailability of the cannabinoid in the subject in the absence of the bioavailability enhancing agent, and further wherein the additional lipophilic active agent is selected from the group consisting of nicotine, a non-steroidal anti-inflammatory drug (NSAID), and a vitamin.

### Claim 11 (depends on 10)

A process for making the lipophilic active agent infused beverage product of claim 10, wherein the bioavailability of the cannabinoid in a subject is at least 3 times greater than the bioavailability of the cannabinoid in the subject in the absence of the bioavailability enhancing agent.

### Claim 12 (depends on 10)

A process for making the lipophilic active agent infused beverage product of claim 10, wherein the bioavailability of the cannabinoid in a subject is at least 4.5 times greater than the bioavailability of the cannabinoid in the subject in the absence of the bioavailability enhancing agent.

### Claim 13 (depends on 10)

A process for making the lipophilic active agent infused beverage product of claim 10, wherein the bioavailability enhancing agent is free of omega-6 fatty acids.

### Claim 14 (depends on 10)

A process for making the lipophilic active agent infused beverage product of claim 10, wherein the cannabinoid is a psychoactive cannabinoid.

### Claim 15 (depends on 10)

A process for making the lipophilic active agent infused beverage product of claim 10, wherein the cannabinoid is a nonpsychoactive cannabinoid.

### Claim 16 (depends on 10)

A process for making the lipophilic active agent infused beverage product of claim 10, wherein the bioavailability enhancing agent is a protective colloid, an edible oil or fat, and a cannabinoid taste masking agent.

### Claim 17 (depends on 10)

A process for making the lipophilic active agent infused beverage product of claim 10, wherein the bioavailability enhancing agent is nonfat dry milk.

### Claim 18 (depends on 10)

A process for making the lipophilic active agent infused beverage product of claim 10, further wherein the lipophilic active agent infused tea leaves, coffee beans, or cocoa powder are lyophilized.
