U.S. patent application number 16/058978 was filed with the patent office on 2018-12-06 for microencapsulated cannabinoid compositions.
The applicant listed for this patent is Ojai Energetics PBC. Invention is credited to Justin Kirkland, William Kleidon.
Application Number | 20180344686 16/058978 |
Document ID | / |
Family ID | 56108379 |
Filed Date | 2018-12-06 |
United States Patent
Application |
20180344686 |
Kind Code |
A1 |
Kleidon; William ; et
al. |
December 6, 2018 |
MICROENCAPSULATED CANNABINOID COMPOSITIONS
Abstract
The present invention relates to cannabinoid compositions. These
compositions can be encapsulated (e.g., microencapsulated). In
particular, these compositions can be administered to a subject,
such as through oral consumption or topical treatment.
Inventors: |
Kleidon; William; (Ojai,
CA) ; Kirkland; Justin; (Champaig, IL) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Ojai Energetics PBC |
Ojai |
CA |
US |
|
|
Family ID: |
56108379 |
Appl. No.: |
16/058978 |
Filed: |
August 8, 2018 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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15452530 |
Mar 7, 2017 |
10080736 |
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16058978 |
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PCT/US2015/065268 |
Dec 11, 2015 |
|
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15452530 |
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62091445 |
Dec 12, 2014 |
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62128761 |
Mar 5, 2015 |
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A23L 2/52 20130101; A23V
2002/00 20130101; A61P 19/02 20180101; A61K 31/57 20130101; A61P
25/14 20180101; A23L 29/256 20160801; A61P 25/00 20180101; A23L
33/105 20160801; A61P 25/18 20180101; A61K 31/352 20130101; A61P
7/06 20180101; A61P 25/04 20180101; A61P 37/08 20180101; A61K 8/733
20130101; A61P 31/04 20180101; A61P 35/00 20180101; A61K 36/185
20130101; A61P 3/10 20180101; A61P 25/28 20180101; A61K 9/5036
20130101; A61P 13/12 20180101; A61P 25/24 20180101; A23D 7/001
20130101; A23G 9/52 20130101; A61K 8/498 20130101; A61P 1/04
20180101; A61P 27/06 20180101; A61P 43/00 20180101; A61P 25/02
20180101; A61K 8/347 20130101; A61P 11/06 20180101; A61P 17/04
20180101; A61P 25/22 20180101; A61P 9/10 20180101; A61P 21/00
20180101; A61K 8/922 20130101; A61P 1/16 20180101; A61P 17/00
20180101; A61K 9/1075 20130101; A61K 8/068 20130101; A61K 31/045
20130101; A61P 3/06 20180101; A61P 9/00 20180101; A23L 33/115
20160801; A61K 45/06 20130101; A61P 19/10 20180101; A61P 29/00
20180101; A61P 31/10 20180101; A23D 9/00 20130101; A61K 31/015
20130101; A61K 31/192 20130101; A61P 1/12 20180101; A61Q 19/007
20130101; A61P 25/08 20180101; A61K 9/0095 20130101; A61K 31/05
20130101; A61P 1/08 20180101; A61P 25/20 20180101; A61P 3/04
20180101; A61P 17/06 20180101; A61K 31/57 20130101; A61K 2300/00
20130101; A61K 31/015 20130101; A61K 2300/00 20130101; A61K 31/045
20130101; A61K 2300/00 20130101; A61K 31/05 20130101; A61K 2300/00
20130101; A61K 31/192 20130101; A61K 2300/00 20130101; A61K 31/352
20130101; A61K 2300/00 20130101; A61K 36/185 20130101; A61K 2300/00
20130101 |
International
Class: |
A61K 31/352 20060101
A61K031/352; A23D 7/00 20060101 A23D007/00; A61K 9/107 20060101
A61K009/107; A61K 8/34 20060101 A61K008/34; A61K 8/49 20060101
A61K008/49; A61K 8/73 20060101 A61K008/73; A61K 8/92 20060101
A61K008/92; A61Q 19/00 20060101 A61Q019/00; A23G 9/52 20060101
A23G009/52; A61K 8/06 20060101 A61K008/06; A61K 9/50 20060101
A61K009/50; A61K 9/00 20060101 A61K009/00; A23L 33/115 20060101
A23L033/115; A23L 33/105 20060101 A23L033/105; A23L 29/256 20060101
A23L029/256; A23L 2/52 20060101 A23L002/52; A23D 9/00 20060101
A23D009/00; A61K 45/06 20060101 A61K045/06; A61K 31/015 20060101
A61K031/015; A61K 31/045 20060101 A61K031/045; A61K 31/05 20060101
A61K031/05; A61K 31/192 20060101 A61K031/192; A61K 31/57 20060101
A61K031/57; A61K 36/185 20060101 A61K036/185 |
Claims
1. A cannabinoid-containing composition comprising a plurality of
droplets in an emulsion, wherein an individual droplet of said
plurality comprises: (i) at least one cannabinoid compound; and
(ii) at least one terpene compound present in an amount of at least
about one microgram.
2. The cannabinoid-containing composition of claim 1, wherein said
droplet has a size less than or equal to about 0.5 micrometers.
3. The cannabinoid-containing composition of claim 1, wherein said
emulsion comprises a natural surfactant or a natural oil.
4. The cannabinoid-containing composition of claim 3, wherein said
natural surfactant is a saponin or rice bran.
5. The cannabinoid-containing composition of claim 1, wherein said
at least one cannabinoid compound comprises cannabidiol (CBD).
6. The cannabinoid-containing composition of claim 1, wherein said
individual droplet comprises less than 0.3% tetrahydrocannabinol
(THC).
7. The cannabinoid-containing composition of claim 1, wherein said
at least one cannabinoid compound has a bioavailability of at least
twice that of said at least one cannabinoid in
non-droplet-encapsulated form.
8. The cannabinoid-containing composition of claim 1, further
comprising a pharmaceutically acceptable excipient.
9. The cannabinoid-containing composition of claim 1, further
comprising a stabilizer.
10. The cannabinoid-containing composition of claim 9, wherein said
stabilizer is alginate.
11. The cannabinoid-containing composition of claim 1, further
comprising at least one agent selected from the group consisting of
an herb, an essential oil, a therapeutic compound, a food product,
a mushroom, pregnenolone, MSM, fulvic acid, L-Theanine, Fish Oil,
phenyl ethyl amine (PEA), tulsi, lemon balm, passion flower, blue
lotus, cacao, maca, schizandra, Siberian ginseng, kava, skullcap,
valerian, hops, California poppy, catuba, epidmedium, pao d'arco,
ashwaganda, ginko, albiza, reishi, lion's mane, maitake, chaga,
MSM, vitamin C, turmeric, CBD oil, bioperine, and xanthohumol.
12. The cannabinoid-containing composition of claim 1, wherein said
individual droplet of said plurality of droplets is characterized
by at least one of: i. a sigmoidal release profile of said at least
one cannabinoid compound; ii. a plasma half-life of said at least
one cannabinoid compound greater than twice that of said at least
one cannabinoid compound in non-encapsulated form; iii. a first
pass metabolism of said at least one cannabinoid compound reduced
by at least 50% compared to said at least one cannabinoid compound
in non-encapsulated form; iv. a rate of excretion of said at least
one cannabinoid compound from a subject's body reduced by at least
20% compared to said at least one cannabinoid compound in
non-encapsulated form; and v. a degradation rate at an ambient
temperature of at least 20.degree. C. of said at least one
cannabinoid compound of less than about 50% of a degradation rate
of said at least one cannabinoid compound in non-encapsulated
form.
13. The cannabinoid-containing composition of claim 12, wherein
said individual droplet has a size less than or equal to about 0.05
micrometers to 1 micrometer.
14. The cannabinoid-containing composition of claim 12, wherein
said emulsion comprises a stabilizer.
15. The cannabinoid-containing composition of claim 12, wherein
said at least one cannabinoid compound comprises cannabidiol
(CBD).
16. The cannabinoid-containing composition of claim 12, wherein
said individual droplet comprises less than 0.3%
tetrahydrocannabinol (THC).
17. The cannabinoid-containing composition of claim 12, wherein
said at least one cannabinoid compound has a bioavailability of at
least twice that of said at least one cannabinoid in
non-encapsulated form.
18. A method for preparing a cannabinoid-containing composition,
comprising: (a) providing a solution comprising cannabinoids; and
(b) using said solution to generate a plurality of droplets in an
emulsion, wherein a given droplet of said plurality of droplets
comprises (i) at least one cannabinoid compound and (ii) at least
one terpene compound present in an amount of at least about one
microgram.
19. The method of claim 18, wherein said given droplet has a size
less than or equal to about 0.5 micrometers.
20. The method of claim 18, wherein said emulsion comprises a
natural surfactant or a natural oil.
21. The method of claim 20, wherein said natural surfactant is a
saponin or rice bran.
22. The method of claim 18, wherein said at least one cannabinoid
compound comprises cannabidiol (CBD).
23. The method of claim 18, wherein said given droplet comprises
less than 0.3% tetrahydrocannabinol (THC).
24. The method of claim 18, wherein said at least one cannabinoid
compound has a bioavailability of at least twice that of said at
least one cannabinoid in non-droplet-encapsulated form.
25. The method of claim 18, wherein said emulsion comprises a
stabilizer.
26. The method of claim 25, wherein the stabilizer is alginate.
27. A system for administering a cannabinoid-containing composition
to a subject, comprising a container comprising said
cannabinoid-containing composition comprising a plurality of
droplets in an emulsion, wherein an individual droplet of said
plurality comprises (i) at least one cannabinoid compound, and (ii)
at least one terpene compound present in an amount of at least
about one microgram.
28. The system of claim 27, wherein said container is a float
tank.
29. The system of claim 27, wherein said emulsion comprises a
natural surfactant or a natural oil.
30. The system of claim 29, wherein said natural surfactant is a
saponin or rice bran.
Description
CROSS-REFERENCE
[0001] This application is a continuation of U.S. patent
application Ser. No. 15/452,530, filed on Mar. 7, 2017, which is a
continuation application of International Patent Application No.
PCT/US2015/065268, filed Dec. 11, 2015, which claims the benefit of
U.S. Provisional Application Ser. No. 62/091,445, filed Dec. 12,
2014, and U.S. Provisional Application Ser. No. 62/128,761, filed
Mar. 5, 2015, each of which is entirely incorporated herein by
reference.
BACKGROUND
[0002] Cannabinoids are a class of chemicals that can act on
cannabinoid receptors. Cannabinoid receptor ligands include
endocannabinoids, which can be found naturally occurring in humans
and other animals, phytocannabinoids, which can be found in
cannabis and other plants, other plants, and lichens, and synthetic
cannabinoids. Cannabinoids include tetrahydrocannabinol (THC), such
as delta-9-tetrahydrocannabinol, and cannabidiol (CBD). At least 85
different cannabinoids have been isolated from cannabis.
[0003] Cannabidiol (CBD) is a major phytocannabinoid considered to
have a wide scope of medical applications. Cannabis plants produce
CBD-carboxylic acid via the same metabolic pathway as THC, aside
from the last step of the pathway, which for CBD is performed by
CBDA synthase rather than THCA synthase.
[0004] Current cannabinoid compositions suffer from drawbacks
limiting their utility for administration to subjects. Many
cannabinoid compositions are destroyed, broken down, or cleared by
the liver, resulting in reduced delivery to the subject. Many
current cannabinoid compositions also have low bioavailability and
shelf life stability.
SUMMARY
[0005] There remains a substantial need for cannabinoid
compositions having increased bioavailability, increased shelf
stability, reduced first pass metabolism, and other beneficial
properties.
[0006] An aspect of the present disclosure provides a composition
comprising a plurality of microcapsules, wherein an individual
microcapsule of the plurality comprises (a) at least one
cannabinoid compound and (b) at least one terpene compound present
in an amount of at least about one microgram.
[0007] An aspect of the present disclosure provides a composition
comprising a plurality of microcapsules, wherein an individual
microcapsule of the plurality comprises at least one cannabinoid
compound, and wherein the microcapsules are not liposomes or
micelles.
[0008] An aspect of the present disclosure provides a composition
comprising a plurality of microcapsules, wherein an individual
microcapsule of the plurality of microcapsules comprises at least
one cannabinoid compound, and wherein the composition has a shelf
half-life of at least 30 days.
[0009] An aspect of the present disclosure provides a composition
comprising a plurality of microcapsules, wherein an individual
microcapsule of the plurality of microcapsules comprises at least
one cannabinoid compound and wherein the individual microcapsule of
the plurality of microcapsules is characterized by at least one of:
(a) a sigmoidal release profile of the at least one cannabinoid
compound; (b) a plasma half-life of the at least one cannabinoid
compound greater than twice that of the at least one cannabinoid
compound in non-encapsulated form; (c) a first pass metabolism of
the at least one cannabinoid compound reduced by at least 50%
compared to the at least one cannabinoid compound in
non-encapsulated form; (d) a rate of excretion of the at least one
cannabinoid compound from a subject's body reduced by at least 20%
compared to the at least one cannabinoid compound in
non-encapsulated form; or (e) a degradation rate at an ambient
temperature of at least 20.degree. C. of the at least one
cannabinoid compound of less than about 50% of a degradation rate
of the at least one cannabinoid compound in non-encapsulated
form.
[0010] In some embodiments of aspects provided herein, the at least
one cannabinoid compound comprises cannabidiol (CBD). In some
embodiments of aspects provided herein, the individual microcapsule
of the plurality of microcapsules comprises less than 0.3%
tetrahydrocannabinol (THC). In some embodiments of aspects provided
herein, the composition further comprises alginate. In some
embodiments of aspects provided herein, the at least one
cannabinoid compound has a bioavailability of at least twice that
of the at least one cannabinoid in non-encapsulated form. In some
embodiments of aspects provided herein, no more than 10% of the at
least one cannabinoid compound is released from the microcapsule
within 1 hour after administration of the composition to a subject.
In some embodiments of aspects provided herein, the at least one
cannabinoid compound exists in a liquid in the individual
microcapsule. In some embodiments of aspects provided herein, the
composition is a solid composition.
[0011] Compositions of the present disclosure can comprise one or
more herbal ingredients. Herbal ingredients can include but are not
limited to: maca, he shou wu, iporuru (Alchornea castaneifolia),
kanna (Sceletium Tortosum), honokiol (Magnolia grandiflora), Sour
Jujube Seed Semen (Ziziphi Spinosae), Cnidium Fruit (Fructus
Cnidii), Corydalis Rhizome (Corydalis yanhusuo), Albizia Bark or
Flower (Cortex albiziae), Ginseng (Panax ginseng), Polygonum
(Polygoni Multiflori), Fu ling (Poria cocos), Cornus Fruit (Fructus
corni), Chinese Yam (Rhizoma dioscoreae), Muira puama, Dendrobium
sp., Licorice Root Radix (Glycyrrhizae Preparata), Cordyceps
(Cordyceps sinensis), Chinese Angelica Root (Angelicae Sinensis),
Kratom (Mitragyna speciosa), Bacopa monnieri, Catuaba, Ashwaghanda,
Peganum harmala, Wheat Grass, Alfalfa Grass, Oat Grass, Kamut
Grass, Echinacea, Chlorella, Amla Fruit, Stinging Nettles, Carob,
Mesquite, Chuchuhuasai, Clavo Huasca, Chanca Piedra, Guayusa
Powder, Rhodiola rosea, Shilajit, Higenamine, Moringa (Moringa
oleifera), Horny Goat Weed (Epidmedium), Astragalus, Aloe Vera,
Turmeric, Pine Pollen, Cucurmine (tumeric compound), Hops,
Xanthohumol (hops compound), Passion Flower, Mucuna Puriens, Tusli,
Black Pepper, Bioperine (black pepper compound), Siberian Ginseng,
American Ginseng, Yerba Mate, Lemon Balm, Astragulus, Kava Kava,
Schizandra, Skullcap, Valerian, California Poppy, Epidmedium, Pau
D'Arco, Gingko, Blue Lotus, White Lilly, and Cacao. Herbal
ingredients can comprise essential oils.
[0012] Exemplary essential oils include but are not limited to:
Linalool; B-Caryophyllene; B-Myrcene; D-Limonene; Humulene;
a-Pinene; Ylang Ylang (Cananga odorata); Yarrow (Achillea
millefolium); Violet (Viola odorata); Vetiver (Vetiveria
zizanoides); Vanilla (Vanilla plantifolia); Tuberose (Polianthes
tuberosa); Thyme (Thymus vulgaris L.); Tea Tree (Melaleuca
alternifolia); Tangerine (Citrus reticulata); Spruce, Black (Picea
mariana); Spruce (Tsuga Canadensis); Spikenard (Nardostachys
jatamansi); Spearmint (Mentha spicata); Sandalwood (Santalum
spicatum); Rosewood (Aniba rosaeodora); Rosemary Verbenone
(Rosmarinus officinalis); Rosemary (Rosmarinus officinalis); Rose
(Rosa damascena); Rose Geranium (Pelargonium roseum); Ravensara
(Ravensara aromatica); Plai (Zingiber cassumunar) Pine Needle
(Pinus sylvestris L.) Petitgrain (Citrus aurantium); Peppermint
(Mentha piperita); Pepper, Black (Piper nigrum L.); Patchouli
(Pogostemon cablin); Palo Santo (Bursera graveolens); Palmarosa
(Cymbopogon martini); Osmanthus (Osmanthus fragrans); Oregano
(Origanum vulgare); Orange, Sweet (Citrus sinensis); Oak Moss
(Evernia prunastri); Nutmeg (Myristica fragrans) Niaouli (Melaleuca
viridifloria); Neroli (aka Orange Blossom) (Citrus aurantium);
Myrtle (Myrtus communis); Myrrh (Commiphora myrrha); Mimosa (Acacia
decurrens); Melissa (Melissa officinalis L.); Marjoram, Sweet
(Origanum majorana); Manuka (Leptospermum scoparium); Mandarin, Red
(Citrus deliciosa); Mandarin (Citrus deliciosa); Lotus, White
(Nelumbo nucifera); Lotus, Pink (Nelumbo nucifera); Lotus, Blue
(Nelumbo nucifera); Lime (Citrus aurantifolia); Lily (Lilum
aurantum); Lemongrass (Cymbopogon citratus); Lemon (Citrus
limonum); Lavender (Lavandula angustifolium); Lavandin (Lavandula
hybrida grosso); Kanuka (Kunzea ericoides); Juniper Berry
(Juniperus cummunis); Jasmine (Jasminum officinale); Jasmine Abs
(Jasminum sambac); Helichrysum (Helichrysum italicum); Grapefruit,
White (Citrus.times.paradisi); Grapefruit, Pink (Citrus paradisi);
Ginger (Zingiber officinalis); Geranium (Pelargonium graveolens);
Geranium, Bourbon (Pelargonium graveolens, 'Herit); Gardenia
(Gardenia jasminoides); Galbanum (Ferula galbaniflua); Frankincense
(Boswellia carterii); Frangipani (Plumeria alba); Fir Needle White
(Abies alba); Fir Needle Siberia (Abies siberica); Fir Needle
Canada (Abies balsamea); Fennel, Sweet (Foeniculum vulgare);
Eucalyptus Smithii. Eucalyptus Radiata, Eucalyptus Globulus,
Eucalyptus Citriodora, Eucalyptus Blue Mallee (Eucalyptus
polybractea); Elemi (Canarium luzonicum); Dill (Anethum
graveolens); Cypress (Cupressus sempervirens); Cumin (Cuminum
cyminum); Coriander (Coriandum sativum); Cocoa (Theobroma cacao);
Clove (Eugenia caryophylatta); Clary Sage (Salvia sclarea); Cistus
(aka Labdanum) (Cistus ladaniferus L.); Cinnamon (Cinnamomum
zeylanicum); Chamomile, Roman (Anthemis nobilis); Chamomile, Blue
(Matricaria chamomilla); Celery Seed (Apium graveolins); Cedarwood,
Western Red (Thuja plicata); Cedarwood, Blood (Juniperus
virginiana); Cedarwood Atlas (Cedrus atlantica); Carrot Seed
(Daucus carota); Cardamon (Elettaria cardamomum); Caraway Seed
(Carum carvi); Cajeput (Melaleuca cajuputi); Cade (Juniperus
oxycedrus); Birch, White (Betula alba); Birch, Sweet (Betula
lenta); Bergamot (Citrus bergamia); Bay Laurel (Laurus nobilis);
Basil (Ocimum basilicum); Basil, Holy (Ocimum sanctum); Basil
(Ocimum basilicum); Balsam Poplar (Populus balsamifera); Balsam
Peru (Myroxylon balsamum); Angelica (Angelica archangelica L.); and
combinations thereof.
[0013] Compositions of the present disclosure can comprise one or
more additional compounds or derivatives thereof, including but not
limited to pregnenolone, MSM, fulvic acid, L-Theanine, Fish Oil,
and phenylethylamine (PEA).
[0014] In some examples, a composition of the present disclosure
comprises ingredients including tulsi, lemon balm, passion flower,
and blue lotus. In some examples, a composition of the present
disclosure comprises ingredients including cacao, maca, schizandra,
and Siberian ginseng. In some examples, a composition of the
present disclosure comprises ingredients including kava, skullcap,
valerian, hops, and California poppy. In some examples, a
composition of the present disclosure comprises ingredients
including maca, catuba, epidmedium, and pao d'arco. In some
examples, a composition of the present disclosure comprises
ingredients including ashwaganda, ginko, and albiza. In some
examples, a composition of the present disclosure comprises
ingredients including reishi, lion's mane, maitake, and chaga. In
some examples, a composition of the present disclosure comprises
ingredients including MSM, vitamin C, turmeric, CBD oil, bioperine,
and xanthohumol.
[0015] In some embodiments of aspects provided herein, the
composition is formulated for oral administration to a subject. In
some embodiments of aspects provided herein, the composition is a
pharmaceutical composition, further comprising a pharmaceutically
acceptable excipient. In some embodiments of aspects provided
herein, the pharmaceutically acceptable excipient comprises at
least one inorganic salt of alginate.
[0016] An aspect of the present disclosure provides a food
composition comprising: (a) a food carrier; and (b) a composition
of the present disclosure.
[0017] In some embodiments of aspects provided herein, said food
composition is packaged as a beverage. In some embodiments of
aspects provided herein, said food composition is packaged as a
solid food. In some embodiments of aspects provided herein, said
food composition is packaged as semi-solid food. In some
embodiments of aspects provided herein, said food composition is
packaged as a food product selected from the group consisting of a
snack bar, cereal product, bakery product, and dairy product.
[0018] An aspect of the present disclosure provides a method of
providing cannabinoid supplementation to a subject, comprising
administering to the subject a composition of the present
disclosure.
[0019] An aspect of the present disclosure provides a method of
preparing a cannabinoid-containing composition comprising: (a)
providing a solution comprising cannabinoids; and (b)
micro-encapsulating said solution to form a plurality of
microcapsules of a composition of the present disclosure.
[0020] An aspect of the present disclosure provides a composition
suitable for oral consumption, food preparation, or topical
application, comprising: (a) at least 0.04% by weight of a
cannabinoid compound; and (b) a coconut product.
[0021] An aspect of the present disclosure provides a composition
suitable for oral consumption, food preparation, or topical
application, comprising: (a) at least 50 milligrams (mg) of a
cannabinoid compound; and (b) a coconut product.
[0022] In some embodiments of aspects provided herein, said
cannabinoid compound is a cannabidiol (CBD) compound. In some
embodiments of aspects provided herein, said cannabidiol compound
is cannabidiolic acid (CBDA). In some embodiments of aspects
provided herein, said coconut product is coconut oil. In some
embodiments of aspects provided herein, said cannabinoid compound
is encapsulated within microcapsules. In some embodiments of
aspects provided herein, said composition is suitable for oral
consumption, food preparation, or topical application. In some
embodiments of aspects provided herein, said composition is solid,
semi-solid, gel, or liquid. In some embodiments of aspects provided
herein, said composition further comprises at least 75 mg of a
cannabinoid compound. In some embodiments of aspects provided
herein, said composition further comprises at least 100 mg of a
cannabinoid compound. In some embodiments of aspects provided
herein, said composition further comprises at least 150 mg of a
cannabinoid compound. In some embodiments of aspects provided
herein, said composition further comprises at least 200 mg of a
cannabinoid compound.
[0023] An aspect of the present disclosure provides a unit dosage
comprising: (a) a food product; and (b) at least 0.04% by weight of
a cannabinoid compound.
[0024] An aspect of the present disclosure provides a unit dosage
comprising: (a) a food product; and (b) a cannabinoid compound,
wherein said unit dosage substantially lacks a psychoactive amount
of THC.
[0025] In some embodiments of aspects provided herein, said
composition is suitable for consumption or use in food preparation.
In some embodiments of aspects provided herein, said food product
is a beverage or beverage mix. In some embodiments of aspects
provided herein, said beverage mix is a chocolate beverage mix. In
some embodiments of aspects provided herein, said beverage is
selected from the group consisting of coconut water, tea, coffee,
soft drink, alcoholic beverage, water, milk, yogurt, and
combinations thereof. In some embodiments of aspects provided
herein, said water in electrolyte-enriched. In some embodiments of
aspects provided herein, said food product is a dairy product. In
some embodiments of aspects provided herein, said dairy product is
selected from the group consisting of milk, butter, cream, cheese,
and ice cream. In some embodiments of aspects provided herein, said
food product is a grain product. In some embodiments of aspects
provided herein, said grain product is selected from the group
consisting of bread, cake, pastry, pie, cereal, granola, bagel,
donut, and cracker. In some embodiments of aspects provided herein,
said food product is a spread. In some embodiments of aspects
provided herein, said spread is nut butter or seed butter. In some
embodiments of aspects provided herein, said food product is
cooking oil. In some embodiments of aspects provided herein, said
food product is an energy-dense or electrolyte-enriched product and
wherein said food product is selected from the group consisting of
energy gels, sports drinks, energy powders, energy bars, energy
shots, protein powders, and protein drinks. In some embodiments of
aspects provided herein, said unit dosage further comprises a
fungus ingredient selected from the group consisting of reishi
mushroom, chaga mushroom, maitake mushroom, oyster mushroom, and
cordyceps. In some embodiments of aspects provided herein, said
unit dosage further comprises an herbal ingredient including those
disclosed herein. In some embodiments of aspects provided herein,
at least a portion of said cannabinoid compound is in a
microencapsulated form. In some embodiments of aspects provided
herein, said unit dosage further comprises between about 1
milligram (mg) and about 50 mg of pregnenolone. In some embodiments
of aspects provided herein, at least a portion of said pregnenolone
is in a microencapsulated form. The unit dosage of claim 35 or 36,
further comprising terpinolene, terpineol, and linalool. In some
embodiments of aspects provided herein, the plurality of
microcapsules has a polydispersity index of less than about 10. In
some embodiments of aspects provided herein, the plurality of
microcapsules has a polydispersity index of less than about 5. In
some embodiments of aspects provided herein, the plurality of
microcapsules has a polydispersity index of less than about 2. In
some embodiments of aspects provided herein, the plurality of
microcapsules has a polydispersity index of less than about
1.2.
[0026] An aspect of the present disclosure provides a method of
providing cannabinoid supplementation to a subject, comprising
administering to the subject said unit dosage.
[0027] Other goals and advantages of the invention will be further
appreciated and understood when considered in conjunction with the
following description and accompanying drawings. While the
following description may contain specific details describing
particular embodiments of the invention, this should not be
construed as limitations to the scope of the invention but rather
as an exemplification of preferable embodiments. For each aspect of
the invention, many variations are possible as suggested herein
that are known to those of ordinary skill in the art. A variety of
changes and modifications can be made within the scope of the
invention without departing from the spirit thereof.
INCORPORATION BY REFERENCE
[0028] All publications, patents, and patent applications mentioned
in this specification are herein incorporated by reference to the
same extent as if each individual publication, patent, or patent
application was specifically and individually indicated to be
incorporated by reference.
BRIEF DESCRIPTION OF THE DRAWINGS
[0029] The novel features of the invention are set forth with
particularity in the appended claims. A better understanding of the
features and advantages of the present invention will be obtained
by reference to the following detailed description that sets forth
illustrative embodiments, in which the principles of the invention
are utilized, and the accompanying drawings or figures (also "FIG."
and "FIGs." herein), of which:
[0030] FIG. 1A shows an exemplary microscope image of an
unprocessed composition of quillaja extract, hemp oil, and water at
400.times. magnification;
[0031] FIG. 1B shows an exemplary microscope image of an
unprocessed composition of quillaja extract, hemp oil, and water at
1000.times. magnification;
[0032] FIG. 2A shows an exemplary microscope image of a
microfluidic processed composition of quillaja extract, hemp oil,
and water at 400.times. magnification;
[0033] FIG. 2B shows an exemplary microscope image of a
microfluidic processed composition of quillaja extract, hemp oil,
and water at 400.times. magnification;
[0034] FIG. 2C shows an exemplary microscope image of a
microfluidic processed composition of quillaja extract, hemp oil,
and water at 1000.times. magnification;
[0035] FIG. 2D shows an exemplary microscope image of a
microfluidic processed composition of quillaja extract, hemp oil,
and water at 1000.times. magnification;
[0036] FIG. 3A shows an exemplary microscope image of a
microfluidic processed composition of quillaja extract, hemp oil,
water, and sodium alginate at 1000.times. magnification;
[0037] FIG. 3B shows an exemplary microscope image of a
microfluidic processed composition of quillaja extract, hemp oil,
water, and sodium alginate at 1000.times. magnification; and
[0038] FIG. 3C shows an exemplary microscope image of a
microfluidic processed composition of quillaja extract, hemp oil,
water, and sodium alginate at 1000.times. magnification.
DETAILED DESCRIPTION
[0039] While preferred embodiments of the present invention have
been shown and described herein, it will be obvious to those
skilled in the art that such embodiments are provided by way of
example only. Numerous variations, changes, and substitutions will
now occur to those skilled in the art without departing from the
invention. It should be understood that various alternatives to the
embodiments of the invention described herein may be employed in
practicing the invention. It is intended that the following claims
define the scope of the invention and that methods and structures
within the scope of these claims and their equivalents be covered
thereby.
[0040] The term "about" or "nearly" as used herein refers to within
+/-10%, 9%, 8%, 7%, 6%, 5%, 4%, 3%, 2%, or 1% of the designated
amount.
[0041] This disclosure provides cannabinoid compositions, and
methods for the manufacture, delivery, and use of such
compositions. The compositions of the present disclosure can
comprise cannabinoids, terpenes, and other desirable compounds.
Cannabinoid compositions can be encapsulated, including in
microcapsules. Microencapsulation can provide benefits such as
shelf stability, improved bioavailability, reduced first-pass
metabolism, and extended or modified release profiles.
[0042] In one embodiment, the present invention provides a
composition comprising a plurality of microcapsules, wherein an
individual microcapsule of the plurality comprises at least one
cannabinoid compound and at least one terpene compound present in
an amount of at least about one microgram. In another embodiment,
the present invention provides a composition comprising a plurality
of microcapsules, wherein an individual microcapsule of the
plurality comprises at least one cannabinoid compound, and wherein
the microcapsules are not liposomes or micelles. In another
embodiment, the present invention provides a composition comprising
a plurality of microcapsules, wherein an individual microcapsule of
the plurality of microcapsules comprises at least one cannabinoid
compound, and wherein the composition has a shelf half-life of at
least 30 days. In other embodiments, the present invention provides
food products that are rich in cannabinoids, including food
products with hemp oil or hemp seed oil.
Compositions
[0043] Cannabinoids utilized in the compositions disclosed herein
include but are not limited to cannabigerol-type (CBG),
cannabigerolic acid (CBGA), cannabigerolic acid monomethylether
(CBGAM), cannabigerol monomethyl ether (CBGM), cannabichromene-type
(CBC), cannabichromanon (CBCN), cannabichromenic acid (CBCA),
cannabichromevarin-type (CBCV), cannabichromevarinic acid (CBCVA),
cannabidiol-type (CBD), tetrahydrocannabinol-type (THC),
iso-tetrahydrocannabinol-type (iso-THC), cannabinol-type (CBN),
cannabinolic acid (CBNA), cannabinol methylether (CBNM),
cannabinol-C.sub.4 (CBN-C.sub.4), cannabinol-C.sub.2 (CBN-C.sub.2),
cannabiorcol (CBN-C.sub.1), cannabinodiol (CBND),
cannabielsoin-type (CBE), cannabielsoic acid A (CBEA-A),
cannabielsoic acid B (CBEA-B), cannabicyclol-type (CBL),
cannabicyclolic acid (CBLA), cannabicyclovarin (CBLV),
cannabicitran-type (CBT), cannabitriol, cannabitriolvarin (CBTV),
ethoxy-cannabitiolvarin (CBTVE), cannabivarin-type (CBV),
cannabinodivarin (CBVD), tetrahydrocannabivarin-type (THCV),
cannabidivarin-type (CBDV), cannabigerovarin-type (CBGV),
cannabigerovarinic acid (CBGVA), cannabifuran (CBF),
dehydrocannabifuran (DCBF), and cannabiripsol (CBR)
cannabinoids.
[0044] Cannabinoids used in compositions of the present disclosure
can be derived from various sources, including but not limited to
hemp (e.g. hemp stalk, hemp stem, hemp seed), cannabis (e.g.,
cannabis flower, cannabis leaf, cannabis stalk, cannabis stem,
cannabis seed), Echinacea purpurea, Echinacea angustifolia,
Echinacea pallida, Acmella oleracea, Helichrysum umbraculigerum,
Radula marginata, kava, black truffle, Syzygium aromaticum
(cloves), Rosmarinus oficinalis, basil, oregano, black pepper,
lavender, true cinnamon, malabathrum, cananga odorata, copaifera
spp., and hops.
[0045] Encapsulated cannabinoids can be present in a quantity of at
least about 0.1, 0.2, 0.3, 0.4, 0.5, 0.6, 0.7, 0.8, 0.9, 1, 2, 3,
4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 25,
30, 35, 40, 45, or 50 micrograms per microcapsule. Encapsulated
cannabinoids can be present in a quantity of at most about 0.1,
0.2, 0.3, 0.4, 0.5, 0.6, 0.7, 0.8, 0.9, 1, 2, 3, 4, 5, 6, 7, 8, 9,
10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 25, 30, 35, 40, 45, or
50 micrograms per microcapsule. Encapsulated cannabinoids can be
present in a quantity of about 0.1, 0.2, 0.3, 0.4, 0.5, 0.6, 0.7,
0.8, 0.9, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16,
17, 18, 19, 20, 25, 30, 35, 40, 45, or 50 micrograms per
microcapsule. Encapsulated cannabinoids can be present in a
quantity of from about 1 to about 10 micrograms per microcapsule.
Encapsulated cannabinoids can be present in a quantity of at least
about 0.1%, 0.2%, 0.3%, 0.4%, 0.5%, 0.6%, 0.7%, 0.8%, 0.9%, 1%, 2%,
3%, 4%, 5%, 6%, 7%, 8%, 9%, 10%, 11%, 12%, 13%, 14%, 15%, 16%, 17%,
18%, 19%, 20%, 25%, 30%, 35%, 40%, 45%, or 50% by weight of a
microcapsule. Encapsulated cannabinoids can be present in a
quantity of at most about 0.1%, 0.2%, 0.3%, 0.4%, 0.5%, 0.6%, 0.7%,
0.8%, 0.9%, 1%, 2%, 3%, 4%, 5%, 6%, 7%, 8%, 9%, 10%, 11%, 12%, 13%,
14%, 15%, 16%, 17%, 18%, 19%, 20%, 25%, 30%, 35%, 40%, 45%, or 50%
by weight of a microcapsule. Encapsulated cannabinoids can be
present in a quantity of about 0.1%, 0.2%, 0.3%, 0.4%, 0.5%, 0.6%,
0.7%, 0.8%, 0.9%, 1%, 2%, 3%, 4%, 5%, 6%, 7%, 8%, 9%, 10%, 11%,
12%, 13%, 14%, 15%, 16%, 17%, 18%, 19%, 20%, 25%, 30%, 35%, 40%,
45%, or 50% by weight of a microcapsule.
[0046] Cannabinoids can be present in a product, such as a food
product, in a quantity of at least about 0.1, 0.2, 0.3, 0.4, 0.5,
0.6, 0.7, 0.8, 0.9, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14,
15, 16, 17, 18, 19, 20, 25, 30, 35, 40, 45, 50, 60, 70, 80, 90,
100, 150, 200, 250, 300, 350, 400, 450, or 500 milligrams (mg).
Cannabinoids can be present in a product, such as a food product,
in a quantity of at most about 0.1, 0.2, 0.3, 0.4, 0.5, 0.6, 0.7,
0.8, 0.9, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16,
17, 18, 19, 20, 25, 30, 35, 40, 45, 50, 60, 70, 80, 90, 100, 150,
200, 250, 300, 350, 400, 450, or 500 milligrams (mg). Cannabinoids
can be present in a product, such as a food product, in a quantity
of about 0.1, 0.2, 0.3, 0.4, 0.5, 0.6, 0.7, 0.8, 0.9, 1, 2, 3, 4,
5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 25, 30,
35, 40, 45, 50, 60, 70, 80, 90, 100, 150, 200, 250, 300, 350, 400,
450, or 500 milligrams (mg). Cannabinoids can be present in a
product, such as a food product, in a quantity of from about 50 to
about 150 milligrams. Cannabinoids can be present in a product,
such as a food product, in a quantity of at least about 0.01%,
0.02%, 0.03%, 0.04%, 0.05%, 0.06%, 0.07%, 0.08%, 0.09%, 0.1%, 0.2%,
0.3%, 0.4%, 0.5%, 0.6%, 0.7%, 0.8%, 0.9%, 1%, 2%, 3%, 4%, 5%, 6%,
7%, 8%, 9%, 10%, 11%, 12%, 13%, 14%, 15%, 16%, 17%, 18%, 19%, 20%,
25%, 30%, 35%, 40%, 45%, or 50% by weight of the product.
Cannabinoids can be present in a product, such as a food product,
in a quantity of at most about 0.01%, 0.02%, 0.03%, 0.04%, 0.05%,
0.06%, 0.07%, 0.08%, 0.09%, 0.1%, 0.2%, 0.3%, 0.4%, 0.5%, 0.6%,
0.7%, 0.8%, 0.9%, 1%, 2%, 3%, 4%, 5%, 6%, 7%, 8%, 9%, 10%, 11%,
12%, 13%, 14%, 15%, 16%, 17%, 18%, 19%, 20%, 25%, 30%, 35%, 40%,
45%, or 50% by weight of the product. Cannabinoids can be present
in a product, such as a food product, in a quantity of about 0.01%,
0.02%, 0.03%, 0.04%, 0.05%, 0.06%, 0.07%, 0.08%, 0.09%, 0.1%, 0.2%,
0.3%, 0.4%, 0.5%, 0.6%, 0.7%, 0.8%, 0.9%, 1%, 2%, 3%, 4%, 5%, 6%,
7%, 8%, 9%, 10%, 11%, 12%, 13%, 14%, 15%, 16%, 17%, 18%, 19%, 20%,
25%, 30%, 35%, 40%, 45%, or 50% by weight of the product.
[0047] The cannabinoids of the compositions disclosed herein can
comprise cannabidiol-class compounds, including but not limited to
cannabidiol (CBD), cannabidiolic acid (CBDA), cannabidiol
monomethylether (CBDM), cannabidiol-C.sub.4 (CBD-C.sub.4),
cannabidivarin (CBDV), cannabidivarinic acid (CBDVA),
cannabidiorcol (CBD-C.sub.1), and combinations thereof. CBD can
comprise delta-1-cannabidiol, delta-2-cannabidiol,
delta-3-cannabidiol, delta-3,7-cannabidiol, delta-4-cannabidiol,
delta-5-cannabidiol, delta-6-cannabidiol, and combinations
thereof.
[0048] Encapsulated cannabidiol compounds can be present in a
quantity of at least about 0.1, 0.2, 0.3, 0.4, 0.5, 0.6, 0.7, 0.8,
0.9, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18,
19, 20, 25, 30, 35, 40, 45, or 50 micrograms per microcapsule.
Encapsulated cannabidiol compounds can be present in a quantity of
at most about 0.1, 0.2, 0.3, 0.4, 0.5, 0.6, 0.7, 0.8, 0.9, 1, 2, 3,
4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 25,
30, 35, 40, 45, or 50 micrograms per microcapsule. Encapsulated
cannabidiol compounds can be present in a quantity of about 0.1,
0.2, 0.3, 0.4, 0.5, 0.6, 0.7, 0.8, 0.9, 1, 2, 3, 4, 5, 6, 7, 8, 9,
10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 25, 30, 35, 40, 45, or
50 micrograms per microcapsule. Encapsulated cannabidiol compounds
can be present in a quantity of from about 1 to about 10 micrograms
per microcapsule. Encapsulated cannabidiol compounds can be present
in a quantity of at least about 0.1%, 0.2%, 0.3%, 0.4%, 0.5%, 0.6%,
0.7%, 0.8%, 0.9%, 1%, 2%, 3%, 4%, 5%, 6%, 7%, 8%, 9%, 10%, 11%,
12%, 13%, 14%, 15%, 16%, 17%, 18%, 19%, 20%, 25%, 30%, 35%, 40%,
45%, or 50% by weight of a microcapsule. Encapsulated cannabidiol
compounds can be present in a quantity of at most about 0.1%, 0.2%,
0.3%, 0.4%, 0.5%, 0.6%, 0.7%, 0.8%, 0.9%, 1%, 2%, 3%, 4%, 5%, 6%,
7%, 8%, 9%, 10%, 11%, 12%, 13%, 14%, 15%, 16%, 17%, 18%, 19%, 20%,
25%, 30%, 35%, 40%, 45%, or 50% by weight of a microcapsule.
Encapsulated cannabidiol compounds can be present in a quantity of
about 0.1%, 0.2%, 0.3%, 0.4%, 0.5%, 0.6%, 0.7%, 0.8%, 0.9%, 1%, 2%,
3%, 4%, 5%, 6%, 7%, 8%, 9%, 10%, 11%, 12%, 13%, 14%, 15%, 16%, 17%,
18%, 19%, 20%, 25%, 30%, 35%, 40%, 45%, or 50% by weight of a
microcapsule.
[0049] Cannabidiol compounds can be present in a product, such as a
food product, in a quantity of at least about 0.1, 0.2, 0.3, 0.4,
0.5, 0.6, 0.7, 0.8, 0.9, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13,
14, 15, 16, 17, 18, 19, 20, 25, 30, 35, 40, 45, 50, 60, 70, 80, 90,
100, 150, 200, 250, 300, 350, 400, 450, or 500 milligrams (mg).
Cannabidiol compounds can be present in a product, such as a food
product, in a quantity of at most about 0.1, 0.2, 0.3, 0.4, 0.5,
0.6, 0.7, 0.8, 0.9, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14,
15, 16, 17, 18, 19, 20, 25, 30, 35, 40, 45, 50, 60, 70, 80, 90,
100, 150, 200, 250, 300, 350, 400, 450, or 500 milligrams (mg).
Cannabidiol compounds can be present in a product, such as a food
product, in a quantity of about 0.1, 0.2, 0.3, 0.4, 0.5, 0.6, 0.7,
0.8, 0.9, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16,
17, 18, 19, 20, 25, 30, 35, 40, 45, 50, 60, 70, 80, 90, 100, 150,
200, 250, 300, 350, 400, 450, or 500 milligrams (mg). Cannabidiol
compounds can be present in a product, such as a food product, in a
quantity of from about 50 to about 150 milligrams. Cannabidiol
compounds can be present in a product, such as a food product, in a
quantity of at least about 0.01%, 0.02%, 0.03%, 0.04%, 0.05%,
0.06%, 0.07%, 0.08%, 0.09%, 0.1%, 0.2%, 0.3%, 0.4%, 0.5%, 0.6%,
0.7%, 0.8%, 0.9%, 1%, 2%, 3%, 4%, 5%, 6%, 7%, 8%, 9%, 10%, 11%,
12%, 13%, 14%, 15%, 16%, 17%, 18%, 19%, 20%, 25%, 30%, 35%, 40%,
45%, or 50% by weight of the product. Cannabidiol compounds can be
present in a product, such as a food product, in a quantity of at
most about 0.01%, 0.02%, 0.03%, 0.04%, 0.05%, 0.06%, 0.07%, 0.08%,
0.09%, 0.1%, 0.2%, 0.3%, 0.4%, 0.5%, 0.6%, 0.7%, 0.8%, 0.9%, 1%,
2%, 3%, 4%, 5%, 6%, 7%, 8%, 9%, 10%, 11%, 12%, 13%, 14%, 15%, 16%,
17%, 18%, 19%, 20%, 25%, 30%, 35%, 40%, 45%, or 50% by weight of
the product. Cannabidiol compounds can be present in a product,
such as a food product, in a quantity of about 0.01%, 0.02%, 0.03%,
0.04%, 0.05%, 0.06%, 0.07%, 0.08%, 0.09%, 0.1%, 0.2%, 0.3%, 0.4%,
0.5%, 0.6%, 0.7%, 0.8%, 0.9%, 1%, 2%, 3%, 4%, 5%, 6%, 7%, 8%, 9%,
10%, 11%, 12%, 13%, 14%, 15%, 16%, 17%, 18%, 19%, 20%, 25%, 30%,
35%, 40%, 45%, or 50% by weight of the product.
[0050] The compositions of the present disclosure can comprise
tetrahydrocannabinol (THC) as a type of cannabinoids. THC can
comprise delta-9-THC, delta-8-THC, and combinations thereof. THC
can comprise delta-6a,7-tetrahydrocannabinol,
delta-7-tetrahydrocannabinol, delta-8-tetrahydrocannabinol,
delta-9,11-tetrahydrocannabinol, delta-9-tetrahydrocannabinol,
delta-10-tetrahydrocannabinol, delta-6a,10a-tetrahydrocannabinol,
and combinations thereof. Delta-9-tetrahydrocannabinol can comprise
stereoisomers including (6aR,10aR)-delta-9-tetrahydrocannabinol,
(6aS,10aR)-delta-9-tetrahydrocannabinol,
(6aS,10aS)-delta-9-tetrahydrocannabinol,
(6aR,10aS)-delta-9-tetrahydrocannabinol, and combinations
thereof.
[0051] In cases where the compositions comprise microcapsules, THC
compounds can be present in a quantity of at least about 0.1, 0.2,
0.3, 0.4, 0.5, 0.6, 0.7, 0.8, 0.9, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10,
11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 25, 30, 35, 40, 45, or 50
micrograms per microcapsule. Encapsulated THC compounds can be
present in a quantity of at most about 0.1, 0.2, 0.3, 0.4, 0.5,
0.6, 0.7, 0.8, 0.9, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14,
15, 16, 17, 18, 19, 20, 25, 30, 35, 40, 45, or 50 micrograms per
microcapsule. Encapsulated THC compounds can be present in a
quantity of from about 1 to about 10 micrograms per microcapsule.
Encapsulated THC compounds can be present in a quantity of about
0.1, 0.2, 0.3, 0.4, 0.5, 0.6, 0.7, 0.8, 0.9, 1, 2, 3, 4, 5, 6, 7,
8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 25, 30, 35, 40,
45, or 50 micrograms per microcapsule. Encapsulated THC compounds
can be present in a quantity of at least about 0.1%, 0.2%, 0.3%,
0.4%, 0.5%, 0.6%, 0.7%, 0.8%, 0.9%, 1%, 2%, 3%, 4%, 5%, 6%, 7%, 8%,
9%, 10%, 11%, 12%, 13%, 14%, 15%, 16%, 17%, 18%, 19%, 20%, 25%,
30%, 35%, 40%, 45%, or 50% by weight of a microcapsule.
Encapsulated THC compounds can be present in a quantity of at most
about 0.1%, 0.2%, 0.3%, 0.4%, 0.5%, 0.6%, 0.7%, 0.8%, 0.9%, 1%, 2%,
3%, 4%, 5%, 6%, 7%, 8%, 9%, 10%, 11%, 12%, 13%, 14%, 15%, 16%, 17%,
18%, 19%, 20%, 25%, 30%, 35%, 40%, 45%, or 50% by weight of a
microcapsule. Encapsulated THC compounds can be present in a
quantity of about 0.1%, 0.2%, 0.3%, 0.4%, 0.5%, 0.6%, 0.7%, 0.8%,
0.9%, 1%, 2%, 3%, 4%, 5%, 6%, 7%, 8%, 9%, 10%, 11%, 12%, 13%, 14%,
15%, 16%, 17%, 18%, 19%, 20%, 25%, 30%, 35%, 40%, 45%, or 50% by
weight of a microcapsule.
[0052] THC compounds can be present in a product, such as a food
product, in a quantity of at least about 0.1, 0.2, 0.3, 0.4, 0.5,
0.6, 0.7, 0.8, 0.9, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14,
15, 16, 17, 18, 19, 20, 25, 30, 35, 40, 45, 50, 60, 70, 80, 90,
100, 150, 200, 250, 300, 350, 400, 450, or 500 milligrams (mg). THC
compounds can be present in a product, such as a food product, in a
quantity of at most about 0.1, 0.2, 0.3, 0.4, 0.5, 0.6, 0.7, 0.8,
0.9, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18,
19, 20, 25, 30, 35, 40, 45, 50, 60, 70, 80, 90, 100, 150, 200, 250,
300, 350, 400, 450, or 500 milligrams (mg). THC compounds can be
present in a product, such as a food product, in a quantity of
about 0.1, 0.2, 0.3, 0.4, 0.5, 0.6, 0.7, 0.8, 0.9, 1, 2, 3, 4, 5,
6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 25, 30, 35,
40, 45, 50, 60, 70, 80, 90, 100, 150, 200, 250, 300, 350, 400, 450,
or 500 milligrams (mg). THC compounds can be present in a product,
such as a food product, in a quantity of from about 50 to about 150
milligrams. THC compounds can be present in a product, such as a
food product, in a quantity of at least about 0.01%, 0.02%, 0.03%,
0.04%, 0.05%, 0.06%, 0.07%, 0.08%, 0.09%, 0.1%, 0.2%, 0.3%, 0.4%,
0.5%, 0.6%, 0.7%, 0.8%, 0.9%, 1%, 2%, 3%, 4%, 5%, 6%, 7%, 8%, 9%,
10%, 11%, 12%, 13%, 14%, 15%, 16%, 17%, 18%, 19%, 20%, 25%, 30%,
35%, 40%, 45%, or 50% by weight of the product. THC compounds can
be present in a product, such as a food product, in a quantity of
at most about 0.01%, 0.02%, 0.03%, 0.04%, 0.05%, 0.06%, 0.07%,
0.08%, 0.09%, 0.1%, 0.2%, 0.3%, 0.4%, 0.5%, 0.6%, 0.7%, 0.8%, 0.9%,
1%, 2%, 3%, 4%, 5%, 6%, 7%, 8%, 9%, 10%, 11%, 12%, 13%, 14%, 15%,
16%, 17%, 18%, 19%, 20%, 25%, 30%, 35%, 40%, 45%, or 50% by weight
of the product. THC compounds can be present in a product, such as
a food product, in a quantity of about 0.01%, 0.02%, 0.03%, 0.04%,
0.05%, 0.06%, 0.07%, 0.08%, 0.09%, 0.1%, 0.2%, 0.3%, 0.4%, 0.5%,
0.6%, 0.7%, 0.8%, 0.9%, 1%, 2%, 3%, 4%, 5%, 6%, 7%, 8%, 9%, 10%,
11%, 12%, 13%, 14%, 15%, 16%, 17%, 18%, 19%, 20%, 25%, 30%, 35%,
40%, 45%, or 50% by weight of the product.
[0053] In some cases, a composition of the present disclosure does
not contain a psychoactive amount of THC. For example, cannabinoids
in compositions of the present disclosure can contain less than
100%, 90%, 80%, 70%, 60%, 50%, 40%, 30%, 20%, 10%, 5%, 1%, 0.7%,
0.5%, 0.3%, or 0.1% THC relative to the total quantity of
cannabinoid compounds. In some cases, the ratio of a non-THC
cannabinoid (e.g., cannabidiol) to THC in a composition of the
present disclosure is greater than or equal to about 1:1, 2:1, 3:1,
4:1, 5:1, 6:1, 7:1, 8:1, 9:1, 10:1, 11:1, 12:1, 13:1, 14:1, 15:1,
16:1, 17:1, 18:1, 19:1, 20:1, 25:1, 30:1, 35:1, 40:1, 45:1, 50:1,
or 100:1. In some cases, compositions of the present disclosure
contain less than 0.3% THC.
[0054] The compositions of the present disclosure can comprise one
or more terpene compounds, including but not limited to terpenoids
such as monoterpenoids, sesquiterpenoids, diterpenoids, and
triterpenoids. Terpenes can be acyclic, monocyclic, or polycyclic.
Terpenes can include but are not limited to myrcene, limonene,
linalool, trans-ocimene, cis-ocimene, alpha-pinene, beta-pinene,
alpha-humulene (alpha-caryophyllene), beta-caryophyllene,
delta-3-carene, trans-gamma-bisabolene, cis-gamma-bisabolene,
trans-alpha-famesene, cis-beta-farnesene, beta-fenchol,
beta-phellandrene, guajol, alpha-gualene, alpha-eudesmol,
beta-eudesmol, gamma-eudesmol, terpinolene, alpha-selinene,
beta-selinene, alpha-terpineol, fenchone, camphene, cis-sabinene
hydrate, alpha-trans-bergamotene, alpha-cis-bergamotene, borneol,
gamma-curcumene, alpha-thujene, epi-alpha-bisabolol, ipsdienol,
alpha-ylangene, beta-elemene, gamma-muurolene, alpha-cadinene,
alpha-longipinene, caryophyllene oxide, and combinations
thereof.
[0055] Encapsulated terpenes can be present in a quantity of at
least about 0.1, 0.2, 0.3, 0.4, 0.5, 0.6, 0.7, 0.8, 0.9, 1, 2, 3,
4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 25,
30, 35, 40, 45, or 50 micrograms per microcapsule. Encapsulated
terpenes can be present in a quantity of at most about 0.1, 0.2,
0.3, 0.4, 0.5, 0.6, 0.7, 0.8, 0.9, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10,
11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 25, 30, 35, 40, 45, or 50
micrograms per microcapsule. Encapsulated terpenes can be present
in a quantity of about 0.1, 0.2, 0.3, 0.4, 0.5, 0.6, 0.7, 0.8, 0.9,
1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19,
20, 25, 30, 35, 40, 45, or 50 micrograms per microcapsule.
Encapsulated terpene compounds can be present in a quantity of from
about 1 to about 10 micrograms per microcapsule. Encapsulated
terpenes can be present in a quantity of at least about 0.1%, 0.2%,
0.3%, 0.4%, 0.5%, 0.6%, 0.7%, 0.8%, 0.9%, 1%, 2%, 3%, 4%, 5%, 6%,
7%, 8%, 9%, 10%, 11%, 12%, 13%, 14%, 15%, 16%, 17%, 18%, 19%, 20%,
25%, 30%, 35%, 40%, 45%, or 50% by weight of a microcapsule.
Encapsulated terpenes can be present in a quantity of at most about
0.1%, 0.2%, 0.3%, 0.4%, 0.5%, 0.6%, 0.7%, 0.8%, 0.9%, 1%, 2%, 3%,
4%, 5%, 6%, 7%, 8%, 9%, 10%, 11%, 12%, 13%, 14%, 15%, 16%, 17%,
18%, 19%, 20%, 25%, 30%, 35%, 40%, 45%, or 50% by weight of a
microcapsule. Encapsulated terpenes can be present in a quantity of
about 0.1%, 0.2%, 0.3%, 0.4%, 0.5%, 0.6%, 0.7%, 0.8%, 0.9%, 1%, 2%,
3%, 4%, 5%, 6%, 7%, 8%, 9%, 10%, 11%, 12%, 13%, 14%, 15%, 16%, 17%,
18%, 19%, 20%, 25%, 30%, 35%, 40%, 45%, or 50% by weight of a
microcapsule.
[0056] Terpene compounds can be present in a product, such as a
food product, in a quantity of at least about 0.1, 0.2, 0.3, 0.4,
0.5, 0.6, 0.7, 0.8, 0.9, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13,
14, 15, 16, 17, 18, 19, 20, 25, 30, 35, 40, 45, 50, 60, 70, 80, 90,
100, 150, 200, 250, 300, 350, 400, 450, or 500 milligrams (mg).
Terpene compounds can be present in a product, such as a food
product, in a quantity of at most about 0.1, 0.2, 0.3, 0.4, 0.5,
0.6, 0.7, 0.8, 0.9, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14,
15, 16, 17, 18, 19, 20, 25, 30, 35, 40, 45, 50, 60, 70, 80, 90,
100, 150, 200, 250, 300, 350, 400, 450, or 500 milligrams (mg).
Terpene compounds can be present in a product, such as a food
product, in a quantity of about 0.1, 0.2, 0.3, 0.4, 0.5, 0.6, 0.7,
0.8, 0.9, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16,
17, 18, 19, 20, 25, 30, 35, 40, 45, 50, 60, 70, 80, 90, 100, 150,
200, 250, 300, 350, 400, 450, or 500 milligrams (mg). Terpene
compounds can be present in a product, such as a food product, in a
quantity of from about 50 to about 150 milligrams. Terpene
compounds can be present in a product, such as a food product, in a
quantity of at least about 0.01%, 0.02%, 0.03%, 0.04%, 0.05%,
0.06%, 0.07%, 0.08%, 0.09%, 0.1%, 0.2%, 0.3%, 0.4%, 0.5%, 0.6%,
0.7%, 0.8%, 0.9%, 1%, 2%, 3%, 4%, 5%, 6%, 7%, 8%, 9%, 10%, 11%,
12%, 13%, 14%, 15%, 16%, 17%, 18%, 19%, 20%, 25%, 30%, 35%, 40%,
45%, or 50% by weight of the product. Terpene compounds can be
present in a product, such as a food product, in a quantity of at
most about 0.01%, 0.02%, 0.03%, 0.04%, 0.05%, 0.06%, 0.07%, 0.08%,
0.09%, 0.1%, 0.2%, 0.3%, 0.4%, 0.5%, 0.6%, 0.7%, 0.8%, 0.9%, 1%,
2%, 3%, 4%, 5%, 6%, 7%, 8%, 9%, 10%, 11%, 12%, 13%, 14%, 15%, 16%,
17%, 18%, 19%, 20%, 25%, 30%, 35%, 40%, 45%, or 50% by weight of
the product. Terpene compounds can be present in a product, such as
a food product, in a quantity of about 0.01%, 0.02%, 0.03%, 0.04%,
0.05%, 0.06%, 0.07%, 0.08%, 0.09%, 0.1%, 0.2%, 0.3%, 0.4%, 0.5%,
0.6%, 0.7%, 0.8%, 0.9%, 1%, 2%, 3%, 4%, 5%, 6%, 7%, 8%, 9%, 10%,
11%, 12%, 13%, 14%, 15%, 16%, 17%, 18%, 19%, 20%, 25%, 30%, 35%,
40%, 45%, or 50% by weight of the product.
[0057] The compositions of the present disclosure can be enriched
in cannabinoids compared to hemp oil. For example, a composition
can comprise hemp oil and cannabinoids from plant sources such as
extracts (e.g., hemp extract) and essential oils. A composition can
comprise about 0%, 10%, 20%, 30%, 40%, 50%, 60%, 70%, 80%, 90%,
100%, 200%, 300%, 400%, 500%, 600%, 700%, 800%, 900%, or 1000%
greater concentration of cannabinoids compared to hemp oil.
[0058] The compositions of the present disclosure can be enriched
in cannabidiol compounds compared to hemp oil. For example, a
composition can comprise hemp oil and cannabidiol compounds from
plant sources such as extracts (e.g., hemp extract) and essential
oils. A composition can comprise about 0%, 10%, 20%, 30%, 40%, 50%,
60%, 70%, 80%, 90%, 100%, 200%, 300%, 400%, 500%, 600%, 700%, 800%,
900%, or 1000% greater concentration of cannabidiol compounds
compared to hemp oil.
[0059] The compositions of the present disclosure can be enriched
in THC compounds compared to hemp oil. For example, a composition
can comprise hemp oil and THC compounds from plant sources such as
extracts (e.g., hemp extract) and essential oils. A composition can
comprise about 0%, 10%, 20%, 30%, 40%, 50%, 60%, 70%, 80%, 90%,
100%, 200%, 300%, 400%, 500%, 600%, 700%, 800%, 900%, or 1000%
greater concentration of THC compounds compared to hemp oil.
[0060] The compositions of the present disclosure can be enriched
in terpenes compared to hemp oil. For example, a composition can
comprise hemp oil and terpenes from plant sources such as extracts
(e.g., hemp extract) and essential oils. A composition can comprise
about 0%, 10%, 20%, 30%, 40%, 50%, 60%, 70%, 80%, 90%, 100%, 200%,
300%, 400%, 500%, 600%, 700%, 800%, 900%, or 1000% greater
concentration of terpenes compared to hemp oil.
[0061] Compounds included in the compositions of the present
disclosure can be derived from various sources. Compound sources
can be natural, such as plant extracts or essential oils. Compounds
in the compositions of the present disclosure can be derived from
hemp oil, including cannabinoid compounds, THC compounds, and
terpene compounds. Compounds in the compositions of the present
disclosure can be derived from essential oils, including but not
limited to those essential oils discussed further in this
disclosure. These compounds can include cannabinoid compounds and
terpene compounds. In some cases, all the compounds or ingredients
in a composition are natural or naturally-derived. In some cases,
all the compounds or ingredients in a composition are vegetarian.
In some cases, all the compounds or ingredients in a composition
are vegan.
[0062] Terpenes and/or essential oils in compositions of the
present disclosure can be selected to provide benefits for
particular conditions or subjects. Terpenes and/or essential oils
can be employed in combination with each other, as well as in
combination with cannabinoids, for example to target treatment of
particular conditions. For example, terpinolene, terpineol and
linalool or lavender, valerian and jasmine essential oils can be
combined with cannabinoids or cannabis extract to act as a sleep
aid or treat sleep disorders.
[0063] Alpha-pinene can be used as an anti-inflammatory, an
antiangiogenic, an anti-ulcer agent, and a bronchodilator.
[0064] Linalool can be used for reducing anxiety, reducing
inflammation (e.g., lung inflammation), to improve Alzheimer's
disease or symptoms thereof, as a sedative, an analgesic, an
anti-microbial, an antibacterial, and an anti-epileptic.
[0065] Myrcene can be used as an antibacterial, a neuroprotective
agent, an antinociceptive, an analgesic, and to alleviate
neuropathic pain, peptic ulcer disease, and inflammation. Depending
on concentration, myrcene can be used as a sedative (e.g., over
0.5% myrcene) or to provide energizing effects (e.g., less than
0.5% myrcene).
[0066] Limonene can be used to reduce anxiety and depression, to
dissolve cholesterol-containing gallstones, to neutralize gastric
acid, support normal peristalsis, relieve heartburn and
gastroesophageal reflux, to improve immune function, and as a
chemopreventative against cancer.
[0067] Ocimene can be used as an antifungal agent, an antitumor
agent, and a cytotoxic agent.
[0068] Terpinolene can be used for antioxidant, mood regulation,
central nervous system (CNS) regulation, anti-inflammatory,
anti-diarrheal, anti-filarial, anti-fungal, antimalarial,
anti-amoebic, anti-bacterial, cytotoxic, and anticancer
effects.
[0069] Terpineol can be used to relax a subject, to aid digestion
and improve gastrointestinal disorders, and to relieve influenza,
bronchitis, cough, nasal congestion, and sinusitis.
[0070] Beta-caryophyllene can be used as an anti-inflammatory
agent, an anti-tumor agent, and an analgesic.
[0071] Geraniol can be used to reduce or protect against
neuropathy, as an antidepressant, to suppress angiogenesis, to
improve anti-cancer agent efficacy, to suppress growth of cancer
cells (e.g., lung cancer), as a chemopreventive against cancer, to
reduce inflammation and apoptosis (e.g., in liver cells), to reduce
oxidative stress, as an antioxidant, and as an antimicrobial.
[0072] Alpha-humulene can be used as an appetite suppressant, an
anti-inflammatory agent, an insect repellant, an antibacterial, an
antioxidant, and an allelopathic agent.
[0073] Phellandrene can be used as an antidepressant and an
antihyperalgesic.
[0074] Carene can be used as an antioxidant, an antiproliferative,
an antimicrobial, and to reduce excess body fluid production, such
as of tears, mucous, or sweat.
[0075] Terpinene can be used as an antioxidant, an
anti-inflammatory, an antimicrobial, an antiproliferative, to
reduce oxidative stress, and to manage diabetes.
[0076] Fenchol can be used as an antibacterial agent, an
antimycobacterial, an antimicrobial, and an antioxidant.
[0077] Borneol can be used to alleviate hyperalgesia, as a TRPA1
inhibitor, an anti-inflammatory agent, and an anti-nociceptive
agent.
[0078] Bisabolol can be used as an anti-cancer agent, such as to
induce apoptosis in leukemia, an anti-tumor agent (e.g., pancreatic
cancer), and an antigenotoxicity agent.
[0079] Phytol can be used to relax a subject, such as by inhibiting
degradation of GABA, as an anxiolytic, to resist menadione-induced
oxidative stress, and as an antimicrobial.
[0080] Camphene can be used for pain relief, as an antioxidant, to
induce apoptosis in cancer cells (e.g., melanoma), an antitumor
agent, and an antibacterial.
[0081] Sabinene can be used as an antioxidant, an antimicrobial, an
anticancer agent (e.g., oral, liver, lung, colon, melanoma, and
leukemic cancer), to aid liver function, aid digestion, relieve
arthritis, and relieve skin conditions.
[0082] Camphor can be used to improve skin healing (e.g.,
reconstructed human epidermis), as a local anesthetic, a muscle
relaxant, an antipathogenic, and an antimicrobial agent.
[0083] Isoborneol can be used as an antioxidant, a cytotoxic, a
DNA-protective, to inhibit herpes simplex virus type 1, and to
inhibit HIV.
[0084] Menthol can be used as an analgesic, to desensitize
.alpha.3.beta.4 nicotinic acetylcholine receptors, as an
antinociceptive, and as an anti-inflammatory agent.
[0085] Nerolidol can be used as an antifungal agent, an
antimicrobial agent, an antioxidant, and an antimalarial agent.
[0086] Guaiol can be used as an antimicrobial agent, an antifungal
agent, and an antibiotic.
[0087] Isopulegol can be used as a gastroprotective agent, an
anti-inflammatory agent, to enhance permeability for transdermal
administration of compounds, and to reduce the severity of
seizures.
[0088] Geranyl acetate can be used as an antimicrobial agent, an
antibacterial, and an antioxidant.
[0089] Cymene can be used as an anti-inflammatory agent, an
anti-hyperalgesic, an antioxidant, an anti-diabetic, to aid in
weight loss, to aid immune disorders, and to protect against acute
lung injury.
[0090] Eucalyptol can be used as an antifungal agent, to alleviate
inflammation (e.g., lung inflammation), an antioxidant, and an
anticancer agent.
[0091] Pulegone can be used to enhance skin permeability, as an
insecticide, and an antioxidant.
[0092] The compositions of the present disclosure can comprise one
or more essential oils or essential oil compounds. Essential oils
can include, but are not limited to: Linalool; B-Caryophyllene;
B-Myrcene; D-Limonene; Humulene; a-Pinene; Ylang Ylang (Cananga
odorata); Yarrow (Achillea millefolium); Violet (Viola odorata);
Vetiver (Vetiveria zizanoides); Vanilla (Vanilla plantifolia);
Tuberose (Polianthes tuberosa); Thyme (Thymus vulgaris L.); Tea
Tree (Melaleuca alternifolia); Tangerine (Citrus reticulata);
Spruce, Black (Picea mariana); Spruce (Tsuga Canadensis); Spikenard
(Nardostachys jatamansi); Spearmint (Mentha spicata); Sandalwood
(Santalum spicatum); Rosewood (Aniba rosaeodora); Rosemary
Verbenone (Rosmarinus officinalis); Rosemary (Rosmarinus
officinalis); Rose (Rosa damascena); Rose Geranium (Pelargonium
roseum); Ravensara (Ravensara aromatica); Plai (Zingiber
cassumunar) Pine Needle (Pinus sylvestris L.); Petitgrain (Citrus
aurantium); Peppermint (Mentha piperita); Pepper, Black (Piper
nigrum L.); Patchouli (Pogostemon cablin); Palo Santo (Bursera
graveolens); Palmarosa (Cymbopogon martini); Osmanthus (Osmanthus
fragrans); Oregano (Origanum vulgare); Orange, Sweet (Citrus
sinensis); Oak Moss (Evernia prunastri); Nutmeg (Myristica
fragrans) Niaouli (Melaleuca viridifloria); Neroli (aka Orange
Blossom) (Citrus aurantium); Myrtle (Myrtus communis); Myrrh
(Commiphora myrrha); Mimosa (Acacia decurrens); Melissa (Melissa
officinalis L.); Marjoram, Sweet (Origanum majorana); Manuka
(Leptospermum scoparium); Mandarin, Red (Citrus deliciosa);
Mandarin (Citrus deliciosa); Lotus, White (Nelumbo nucifera);
Lotus, Pink (Nelumbo nucifera); Lotus, Blue (Nelumbo nucifera);
Lime (Citrus aurantifolia); Lily (Lilum aurantum); Lemongrass
(Cymbopogon citratus); Lemon (Citrus limonum); Lavender (Lavandula
angustifolium); Lavandin (Lavandula hybrida grosso); Kanuka (Kunzea
ericoides); Juniper Berry (Juniperus cummunis); Jasmine (Jasminum
officinale); Jasmine Abs (Jasminum sambac); Helichrysum
(Helichrysum italicum); Grapefruit, White (Citrus.times.paradisi);
Grapefruit, Pink (Citrus paradisi); Ginger (Zingiber officinalis);
Geranium (Pelargonium graveolens); Geranium, Bourbon (Pelargonium
graveolens, 'Herit); Gardenia (Gardenia jasminoides); Galbanum
(Ferula galbaniflua); Frankincense (Boswellia carterii); Frangipani
(Plumeria alba); Fir Needle White (Abies alba); Fir Needle Siberia
(Abies siberica); Fir Needle Canada (Abies balsamea); Fennel, Sweet
(Foeniculum vulgare); Eucalyptus Smithii. Eucalyptus Radiata,
Eucalyptus Globulus, Eucalyptus Citriodora, Eucalyptus Blue Mallee
(Eucalyptus polybractea); Elemi (Canarium luzonicum); Dill (Anethum
graveolens); Cypress (Cupressus sempervirens); Cumin (Cuminum
cyminum); Coriander (Coriandum sativum); Cocoa (Theobroma cacao);
Clove (Eugenia caryophylatta); Clary Sage (Salvia sclarea); Cistus
(aka Labdanum) (Cistus ladaniferus L.); Cinnamon (Cinnamomum
zeylanicum); Chamomile, Roman (Anthemis nobilis); Chamomile, Blue
(Matricaria chamomilla); Celery Seed (Apium graveolins); Cedarwood,
Western Red (Thuja plicata); Cedarwood, Blood (Juniperus
virginiana); Cedarwood Atlas (Cedrus atlantica); Carrot Seed
(Daucus carota); Cardamon (Elettaria cardamomum); Caraway Seed
(Carum carvi); Cajeput (Melaleuca cajuputi); Cade (Juniperus
oxycedrus); Birch, White (Betula alba); Birch, Sweet (Betula
lenta); Bergamot (Citrus bergamia); Bay Laurel (Laurus nobilis);
Basil (Ocimum basilicum); Basil, Holy (Ocimum sanctum); Basil
(Ocimum basilicum); Balsam Poplar (Populus balsamifera); Balsam
Peru (Myroxylon balsamum); Angelica (Angelica archangelica L.); and
combinations thereof.
[0093] The compositions of the present disclosure can comprise one
or more additional ingredients, including but not limited to
mushrooms or mushroom derivative products (e.g., reishi mushroom,
chaga mushroom, maitake mushroom, oyster mushroom, cordyceps), maca
(Lepidium meyenii), he sho wu (also he show wu or shou wu chih),
superfoods or superfood derivative products (e.g., blueberries,
acai berries, inca berries, goji berries, camucamu, coconut,
lucuma, kale, cacao (e.g., cacao powder, cacao butter), sacha
inchi, chia, flax, hemp, amaranth, quinoa, moringa oleifera), and
combinations thereof.
[0094] Compounds used in compositions of the present disclosure can
be extracted by a variety of methods. For example, extraction can
be performed by maceration, infusion, decoction, percolation,
Soxhlet extraction, pressurized solvent extraction, counter current
extraction, ultrasonication, or supercritical fluid (e.g., carbon
dioxide) extraction.
[0095] In some cases, compounds used in compositions of the present
disclosure are extracted via supercritical fluid (e.g., carbon
dioxide) extraction. For example, cannabinoid compounds can be
extracted from hemp (e.g., hemp stalk and hemp stems) using
supercritical carbon dioxide extraction.
[0096] The compositions of the present disclosure can comprise
pregnenolone, including derivatives thereof. Pregnenolone can help
protect a subject from cannabis intoxication, for example from THC.
Pregnenolone or derivatives thereof can be formulated to be water
soluble. A composition of the present disclosure can comprise
between about 1 and 50 milligrams (mg) of pregnenolone or
derivatives thereof. For example, a unit dosage of the present
disclosure can comprise between about 1 and 50 milligrams (mg) of
pregnenolone. Compositions of the present disclosure (e.g., unit
dosages) can comprise about 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 15, 20,
25, 30, 35, 40, 45, or 50 mg of pregnenolone. Compositions of the
present disclosure (e.g., unit dosages) can comprise at least about
1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 15, 20, 25, 30, 35, 40, 45, or 50 mg
of pregnenolone. Compositions of the present disclosure (e.g., unit
dosages) can comprise at most about 1, 2, 3, 4, 5, 6, 7, 8, 9, 10,
15, 20, 25, 30, 35, 40, 45, or 50 mg of pregnenolone. Compositions
comprising pregnenolone can be used in combination with any other
compounds, ingredients, or formulations described herein, including
esters, cyclodextrin complexes, microcapsules (e.g., sodium
alginate microcapsules), immediate release formulations, delayed or
extended release formulations, transbuccal formulations, and
sublingual formulations.
[0097] Compositions of the present disclosure can be used to treat
various diseases or conditions in subjects (e.g., humans, mammals,
vertebrates), including but not limited to ALS, Alzheimer's,
antibacterial resistant infections, anxiety, atherosclerosis,
arthritis, asthma, cancer, colitis, Crohn's, diabetes, depression,
endocrine disorders, epilepsy, seizures, fibromyalgia, glaucoma,
heart disease, Huntington's, inflammation, irritable bowel syndrome
(IBS), kidney disease, liver disease, motion sickness, nausea,
neurodegeneration, neuropathic pain, neuropathy, obesity, obsessive
compulsive disorder (OCD), osteoporosis, Parkinson's, prion
diseases, Mad Cow disease, post-traumatic stress disorder (PTSD),
rheumatism, schizophrenia, sickle cell anemia, skin conditions
(e.g., psoriasis, dermatitis, allergic inflammation, chronic
pruritus), sleep disorders (e.g., sleep-wake disorders, apnea),
spinal cord injury, stress, stroke, and traumatic brain injury
(TBI).
Encapsulation and Delivery
[0098] The compositions of the present disclosure can comprise
microcapsules. Microcapsules can comprise components discussed in
this disclosure, such as cannabinoid compounds, terpene compounds,
cannabidiol, THC, and others, in microencapsulated form. In some
cases, compositions can be encapsulated without the use of
liposomes. In some cases, compositions can be encapsulated without
the use of micelles. In some cases, compositions can be
encapsulated without the use of liposomes or micelles. Compounds of
the composition can exist within a microcapsule in forms including
but not limited to liquid, gel, semi-solid, and solid.
Microcapsules of compositions disclosed herein can further be
processed into forms including but not limited to solids, powders,
liquids, suspensions, gels, tablets, foods, lotions, cosmetics, and
other forms discussed in this disclosure.
[0099] Microencapsulation can be performed with a
microencapsulation device, including microfluidic droplet
generation or encapsulation devices. An exemplary
microencapsulation device is described, for example, in U.S. Pat.
No. 7,482,152, incorporated here by reference in its entirety.
Microfluidic droplets or emulsions can be generated by flow of a
fluid to be encapsulated with an immiscible carrier fluid. For
example, an oil fluid to be encapsulated can be flowed with an
aqueous carrier fluid, or an aqueous fluid to be encapsulated can
be flowed with an oil carrier fluid. Air can also be used as a
fluid. Microfluidic droplet generators useful for
microencapsulation include those employing co-flowing streams,
cross-flowing streams (e.g., flow of streams at a T-junction), flow
focusing, flow through perforated plates, and flow through nozzles.
Droplet size can be controlled by parameters including device
geometry, relative flow rates of the fluid streams, and operating
pressure.
[0100] Microencapsulation can be performed at a range of operating
parameters, such as different flow rates or pressures.
Microencapsulation can be conducted at a pressure of at least about
10 pounds per square inch (psi), 20 psi, 30 psi, 40 psi, 50 psi, 60
psi, 70 psi, 80 psi, 90 psi, 100 psi, 200 psi, 300 psi, 400 psi,
500 psi, 600 psi, 700 psi, 800 psi, 900 psi, 1000 psi, 2000 psi,
3000 psi, 4000 psi, 5000 psi, 6000 psi, 7000 psi, 8000 psi, 9000
psi, 10000 psi, 15000 psi, 20000 psi, 25000 psi, 30000 psi, 35000
psi, 40000 psi, 45000 psi, 50000 psi, or more. Microencapsulation
can be conducted at a pressure of at most about 10 pounds per
square inch (psi), 20 psi, 30 psi, 40 psi, 50 psi, 60 psi, 70 psi,
80 psi, 90 psi, 100 psi, 200 psi, 300 psi, 400 psi, 500 psi, 600
psi, 700 psi, 800 psi, 900 psi, 1000 psi, 2000 psi, 3000 psi, 4000
psi, 5000 psi, 6000 psi, 7000 psi, 8000 psi, 9000 psi, 10000 psi,
15000 psi, 20000 psi, 25000 psi, 30000 psi, 35000 psi, 40000 psi,
45000 psi, or 50000 psi. Microencapsulation can be conducted at a
pressure of about 10 pounds per square inch (psi), 20 psi, 30 psi,
40 psi, 50 psi, 60 psi, 70 psi, 80 psi, 90 psi, 100 psi, 200 psi,
300 psi, 400 psi, 500 psi, 600 psi, 700 psi, 800 psi, 900 psi, 1000
psi, 2000 psi, 3000 psi, 4000 psi, 5000 psi, 6000 psi, 7000 psi,
8000 psi, 9000 psi, 10000 psi, 15000 psi, 20000 psi, 25000 psi,
30000 psi, 35000 psi, 40000 psi, 45000 psi, 50000 psi, or more.
Microencapsulation can be conducted at a flow rate of at least
about 1 milliliter per minute (mL/min), 2 mL/min 3 mL/min, 4
mL/min, 5 mL/min, 6 mL/min, 7 mL/min, 8 mL/min, 9 mL/min, 10
mL/min, 20 mL/min, 30 mL/min, 40 mL/min, 50 mL/min, 60 mL/min, 70
mL/min, 80 mL/min, 90 mL/min, 100 mL/min, 110 mL/min, 120 mL/min,
130 mL/min, 140 mL/min, 150 mL/min, 160 mL/min, 170 mL/min, 180
mL/min, 190 mL/min, 200 mL/min, 210 mL/min, 220 mL/min, 230 mL/min,
240 mL/min, 250 mL/min, 260 mL/min, 270 mL/min, 280 mL/min, 290
mL/min, 300 mL/min, 310 mL/min, 320 mL/min, 330 mL/min, 340 mL/min,
350 mL/min, 360 mL/min, 370 mL/min, 380 mL/min, 390 mL/min, 400
mL/min, 410 mL/min, 420 mL/min, 430 mL/min, 440 mL/min, 450 mL/min,
460 mL/min, 470 mL/min, 480 mL/min, 490 mL/min, 500 mL/min, or
more. Microencapsulation can be conducted at a flow rate of at most
about 1 milliliter per minute (mL/min), 2 mL/min 3 mL/min, 4
mL/min, 5 mL/min, 6 mL/min, 7 mL/min, 8 mL/min, 9 mL/min, 10
mL/min, 20 mL/min, 30 mL/min, 40 mL/min, 50 mL/min, 60 mL/min, 70
mL/min, 80 mL/min, 90 mL/min, 100 mL/min, 110 mL/min, 120 mL/min,
130 mL/min, 140 mL/min, 150 mL/min, 160 mL/min, 170 mL/min, 180
mL/min, 190 mL/min, 200 mL/min, 210 mL/min, 220 mL/min, 230 mL/min,
240 mL/min, 250 mL/min, 260 mL/min, 270 mL/min, 280 mL/min, 290
mL/min, 300 mL/min, 310 mL/min, 320 mL/min, 330 mL/min, 340 mL/min,
350 mL/min, 360 mL/min, 370 mL/min, 380 mL/min, 390 mL/min, 400
mL/min, 410 mL/min, 420 mL/min, 430 mL/min, 440 mL/min, 450 mL/min,
460 mL/min, 470 mL/min, 480 mL/min, 490 mL/min, or 500 mL/min.
Microencapsulation can be conducted at a flow rate of about 1
milliliter per minute (mL/min), 2 mL/min 3 mL/min, 4 mL/min, 5
mL/min, 6 mL/min, 7 mL/min, 8 mL/min, 9 mL/min, 10 mL/min, 20
mL/min, 30 mL/min, 40 mL/min, 50 mL/min, 60 mL/min, 70 mL/min, 80
mL/min, 90 mL/min, 100 mL/min, 110 mL/min, 120 mL/min, 130 mL/min,
140 mL/min, 150 mL/min, 160 mL/min, 170 mL/min, 180 mL/min, 190
mL/min, 200 mL/min, 210 mL/min, 220 mL/min, 230 mL/min, 240 mL/min,
250 mL/min, 260 mL/min, 270 mL/min, 280 mL/min, 290 mL/min, 300
mL/min, 310 mL/min, 320 mL/min, 330 mL/min, 340 mL/min, 350 mL/min,
360 mL/min, 370 mL/min, 380 mL/min, 390 mL/min, 400 mL/min, 410
mL/min, 420 mL/min, 430 mL/min, 440 mL/min, 450 mL/min, 460 mL/min,
470 mL/min, 480 mL/min, 490 mL/min, 500 mL/min, or more.
[0101] Droplet generators can employ multiple parallel droplet
generation operations in parallel. For example, a droplet generator
(e.g., a plate, a device with channels) can employ at least 1, 2,
3, 4, 5, 6, 7, 8, 9, 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, 60,
65, 70, 75, 80, 85, 90, 95, 100, or more droplet generating
features (e.g., holes, channels, nozzles). A droplet generator can
employ at most 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 15, 20, 25, 30, 35,
40, 45, 50, 55, 60, 65, 70, 75, 80, 85, 90, 95, or 100 droplet
generating features. A droplet generator can employ about 1, 2, 3,
4, 5, 6, 7, 8, 9, 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, 65,
70, 75, 80, 85, 90, 95, 100, or more droplet generating
features.
[0102] Microencapsulation can be performed via an emulsification
process. For example, compositions can be emulsified in a mixer,
such as an agitator, impeller, centrifugal mixer, or high-shear
mixer. High-shear mixers can include batch high-shear mixers and
inline high-shear mixers (e.g., rotor-stator mixers).
Emulsification can also be conducted without a mixer, by combining
fluids thermodynamically favored to form an emulsion, optionally
with the aid of one or more emulsifiers or surfactants.
[0103] Microencapsulation processes can be conducted with the aid
of one or more emulsifiers or surfactants. Emulsifiers and
surfactants can include but are not limited to saponins (e.g.,
quillaja tree extract such as Q-NATURALE.RTM., yucca extract),
lecithin, soy lecithin, mustard seed hull extract, sodium stearoyl
lactylate, polysorbate 20, and combinations thereof.
[0104] Microcapsules can comprise one or more stabilizers or
gelling agents, which can be used to stabilize a microcapsule or
emulsion. Stabilizers or gelling agents can include but are not
limited to alginate (also algin or alginic acid) and agar. Alginate
can be used in a variety of forms, including but not limited to
inorganic salts such as sodium alginate, potassium alginate,
calcium alginate, and combinations thereof. Alginate can be derived
from sources such as seaweed (e.g., Macrocystis pyrifera,
Ascophyllum nodosum, Laminaria spp.) or bacteria (e.g., Pseudomonas
spp., Azotobacter spp.). Cross-linking agents or solutions, such as
calcium chloride, can be used to stabilize or gel
microcapsules.
[0105] Microcapsules can be characterized by a size (e.g., a
diameter). The microcapsule size can be about 0.154 micrometers.
The microcapsule size can be less than or equal to about 0.154
micrometers. The microcapsule size can be greater than or equal to
about 0.154 micrometers. The microcapsule size can be about 0.001,
0.002, 0.003, 0.004, 0.005, 0.006, 0.007, 0.008, 0.009, 0.01, 0.02,
0.03, 0.04, 0.05, 0.06, 0.07, 0.08, 0.09, 0.1, 0.15, 0.2, 0.25,
0.3, 0.35, 0.4, 0.45, 0.5, 0.55, 0.6, 0.65, 0.7, 0.75, 0.8, 0.85,
0.9, 0.95, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5,
8, 8.5, 9, 9.5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, 65, 70,
75, 80, 85, 90, 95, 100, 150, 200, 250, 300, 350, 400, 450, or 500
micrometers. The microcapsule size can be less than or equal to
about 0.001, 0.002, 0.003, 0.004, 0.005, 0.006, 0.007, 0.008,
0.009, 0.01, 0.02, 0.03, 0.04, 0.05, 0.06, 0.07, 0.08, 0.09, 0.1,
0.15, 0.2, 0.25, 0.3, 0.35, 0.4, 0.45, 0.5, 0.55, 0.6, 0.65, 0.7,
0.75, 0.8, 0.85, 0.9, 0.95, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5,
6, 6.5, 7, 7.5, 8, 8.5, 9, 9.5, 10, 15, 20, 25, 30, 35, 40, 45, 50,
55, 60, 65, 70, 75, 80, 85, 90, 95, 100, 150, 200, 250, 300, 350,
400, 450, or 500 micrometers. The microcapsule size can be greater
than or equal to about 0.001, 0.002, 0.003, 0.004, 0.005, 0.006,
0.007, 0.008, 0.009, 0.01, 0.02, 0.03, 0.04, 0.05, 0.06, 0.07,
0.08, 0.09, 0.1, 0.15, 0.2, 0.25, 0.3, 0.35, 0.4, 0.45, 0.5, 0.55,
0.6, 0.65, 0.7, 0.75, 0.8, 0.85, 0.9, 0.95, 1, 1.5, 2, 2.5, 3, 3.5,
4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5, 9, 9.5, 10, 15, 20, 25, 30,
35, 40, 45, 50, 55, 60, 65, 70, 75, 80, 85, 90, 95, 100, 150, 200,
250, 300, 350, 400, 450, or 500 micrometers. The microcapsule size
can be from about 0.1 to about 0.2 micrometers. The microcapsule
size can be from about 0.05 to about 0.25 micrometers. The
microcapsule size can be from about 0.05 to about 0.55 micrometers.
The microcapsule size can be from about 0.05 to about 1
micrometers. The size distribution in a population of microcapsules
can be homogeneous or substantially homogeneous. For example, a
population of microcapsules can be characterized by dispersity, or
polydispersity index (PDI), of less than or equal to about 20, 19,
18, 17, 16, 16, 15, 14, 13, 12, 11, 10, 9, 8, 7, 6, 5, 4.9, 4.8,
4.7, 4.6, 4.5, 4.4, 4.3, 4.2, 4.1, 4.0, 3.9, 3.8, 3.7, 3.6, 3.5,
3.4, 3.3, 3.2, 3.1, 3.0, 2.9, 2.8, 2.7, 2.6, 2.5, 2.4, 2.3, 2.2,
2.1, 2.0, 1.9, 1.8, 1.7, 1.6, 1.5, 1.45, 1.40, 1.35, 1.30, 1.25,
1.20, 1.15, 1.14, 1.13, 1.12, 1.11, 1.10, 1.09, 1.08, 1.07, 1.06,
1.05, 1.04, 1.03, 1.02, 1.01, or 1.00.
[0106] The compositions of the present disclosure can be provided
as a dry powder. For example, an oil-based composition (e.g., hemp
oil) can be combined with a drying or powdering agent, such as
cyclodextrin. In some cases, a powder composition can be provided
on its own. In other cases, a powder composition can be provided in
another product, such as a food product, cosmetic product, or other
products and compositions such as those disclosed herein.
[0107] The compositions of the present disclosure can be provided
in any suitable form, including but not limited to a liquid form, a
gel form, a semi-liquid (e.g., a liquid, such as a viscous liquid,
containing some solid) form, a semi-solid (a solid containing some
liquid) form, or a solid form. Compositions can be provided in, for
example, a tablet form, a capsule form, a food form a chewable
form, a non-chewable form, a transbuccal form, a sublingual form, a
slow-release form, a non-slow-release form, a sustained release
form, or a non-sustained-release form.
[0108] The compositions of the present disclosure can be
administered in any oral dosage form, including liquid dosage forms
(e.g., a suspension or slurry), and oral solid dosage forms (e.g.,
a tablet or bulk powder). Tablets can include tablets, caplets,
capsules, including soft gelatin capsules, and lozenges. Tablets
can further comprise suitable binders, lubricants, diluents,
disintegrating agents, colorants, flavoring agents, flow-inducing
agents, and melting agents.
[0109] The compositions of the present disclosure can be
administered transdermally, such as via a patch. The compositions
of the present disclosure can be administered intravenously. The
compositions of the present disclosure can be administered
topically. The compositions of the present disclosure can be
administered via exposure to an aqueous solution, such as a subject
immersing in a float tank. The compositions of the present
disclosure can be formulated as a bath salt or liquid bath product,
which can be dissolved or dispersed in water (e.g., a bath) for
skin exposure, for example by immersion of the subject.
[0110] The compositions of the present disclosure can be provided
as cosmetics or personal care products, such as soaps (e.g., solid,
bar, liquid, or foaming), hand sanitizer, lotions, massage oils
masks, makeup, moisturizers, sunscreen, toothpaste, mouth wash, or
throat spray. Use of cannabinoids in such applications can provide
benefits including reduction of inflammation in a subject.
[0111] The compositions of the present disclosure can be provided
as a food composition in combination with a food carrier, including
but not limited to food bars (e.g., granola bars, protein bars,
candy bars), cereal products (e.g., oatmeal, breakfast cereals,
granola), bakery products (e.g., bread, donuts, crackers, bagels,
pastries, cakes), dairy products (e.g., milk, yogurt, cheese),
beverages (e.g., milk-based beverages, sports drinks, fruit juices,
teas, soft drinks, alcoholic beverages, bottled waters), beverage
mixes, pastas, grains (e.g., rice, corn, oats, rye, wheat, flour),
egg products, snacks (e.g., candy, chips, gum, gummies, lozenges,
mints, chocolate), meats, fruits, vegetables or combinations
thereof. Food compositions can comprise solid foods. Food
compositions can comprise semi-solid foods. Food compositions can
comprise liquid foods. A composition in a liquid form may be
formulated from a dry mix, such as a dry beverage mix or a powder.
A dry mix may be suitable in terms of transportation, storage, or
shelf life. The composition can be formulated from the dry mix in
any suitable manner, such as by adding a suitable liquid (e.g.,
water, milk, fruit juice, tea, or alcohol).
[0112] A food composition or food product can comprise a food bar,
including but not limited to granola bars, protein bars, candy
bars, and energy bars. A food composition or food product can
comprise a cereal product, including but not limited to oatmeal,
flour (e.g., wheat flour, rice flour, corn flour, barley flour),
breakfast cereal, granola, bread, pasta, rice cakes, and popcorn. A
food composition or food product can comprise a bakery product,
including but not limited to bread, pastries, brownies, cakes,
pies, donuts, crackers, and muffins. A food composition or food
product can comprise a dairy product, including but not limited to
milk, fermented milk, curd, whey, yogurt, cream, cheese, butter,
clarified butter, ghee, and ice cream. A food composition or food
product can comprise a nut butter or seed butter, including but not
limited to peanut butter, almond butter, cashew butter, hazelnut
butter, macadamia nut butter, pecan butter, pistachio butter,
walnut butter, pumpkin seed butter, sesame seed butter, soybean
butter, and sunflower seed butter. A food composition or food
product can comprise an oil (e.g., a cooking oil), including but
not limited to olive oil, coconut oil, vegetable oil, canola oil,
corn oil, peanut oil, sunflower seed oil, almond oil, avocado oil,
rice bran oil, cottonseed oil, flaxseed oil, linseed oil, grape
seed oil, hemp oil, mustard oil, macadamia oil, palm oil, tea seed
oil, walnut oil, margarine, lard, butter, clarified butter, ghee,
or tallow. A food composition or food product can comprise sports
food products such as energy gels, sports drinks, energy powders,
energy bars, energy shots, protein powders, and protein drinks
(e.g., protein shakes). A food composition or food product can
comprise a beverage, including but not limited to water,
electrolyte drinks, soda, coconut water, tea (e.g., Jun tea, black
tea, green tea, white tea, herbal tea), coffee, a soft drink, an
alcoholic beverage (e.g., cocktail, liquor, spirits, beer, wine,
malt beverage), water, juice (e.g., apple juice, orange juice,
tomato juice, vegetable juice, cranberry juice), a sports drink,
electrolyte-enriched water, vitamin-enhanced water, a
hangover-recovery drink, milk (e.g., dairy-based milk, coconut
milk, almond milk, soy milk, hemp milk, rice milk, oat milk, cashew
milk, hazelnut milk), and yogurt. A food composition or food
product can comprise a fungus or fermented food or drink, including
but not limited to kifir (kefir), jun, amasi, amazake, appam,
ayran, doogh, bagoong, brem, cheonggukj ang, chicha, kombucha,
fermented bean curd, kimchi, lassi, miso, poi, yakult, and
yogurt.
[0113] Compositions of the present disclosure can comprise pet or
other animal products, such as animal food (e.g., dog food, cat
food), treats, and nutritional supplements (e.g., liquids, sprays,
or powders for application to food or water). These compositions
can be formulated for or administered to domestic or pet animals
(e.g., dogs, cats, small mammals, birds), livestock and other farm
animals (e.g., cows, pigs, horses, sheep, goats), zoo animals, or
any other vertebrates. Compositions for administration to animals
can be formulated with microencapsulated cannabinoid-rich oil or
non-encapsulated cannabinoid-rich oil, alone or in combination with
essential oils, terpenes, and other components described herein.
Compositions for administration to animals can be mixed into feed
or water, prepared for spraying application (e.g., mixed in
glycerin), for intravenous administration (e.g., in a syringe or an
IV bag), in salves, vitamins, liquid vitamin pumps, treats, or
other forms.
[0114] The compositions of the present disclosure can comprise an
additional agent or agents, whether active or passive. Examples of
such an agent include a sweetening agent, a flavoring agent, a
coloring agent, a filling agent, a binding agent, a lubricating
agent, an excipient, a preservative, or a manufacturing agent.
Additional pharmaceutically acceptable excipients (in the case of
pharmaceuticals) or other additives (for non-pharmaceutical
applications) can be added to the composition. For example, if
desired, any generally accepted soluble or insoluble inert
pharmaceutical filler (diluent) material can be included in the
final product (e.g., a solid dosage form). Such inert
pharmaceutical filler can comprise a monosaccharide, a
disaccharide, a polyhydric alcohol, inorganic phosphates, sulfates
or carbonates, and combinations thereof. Examples of suitable inert
pharmaceutical fillers include sucrose, dextrose, lactose, xylitol,
fructose, sorbitol, calcium phosphate, calcium sulfate, calcium
carbonate, microcrystalline cellulose, and combinations thereof. An
effective amount of any generally accepted pharmaceutical
lubricant, such as calcium or magnesium soaps, can be added.
[0115] The compositions of the present disclosure can be
administered to a subject. Compositions can be administered in a
variety of ways, including but not limited to oral and topical
administration.
[0116] Administering the compositions of the present disclosure to
a subject can provide one or more beneficial effects. Beneficial
effects can include but are not limited to pain relief, reduced
bacterial growth, reduced blood sugar levels, improved blood lipid
and cholesterol profiles, increased fat burning, reduced appetite,
stimulated appetite, reduced vomiting or nausea, reduced seizures
or convulsions, antifungal effects, reduced inflammation, reduced
arthritis (e.g., rheumatoid arthritis), reduced insomnia or aided
sleep, reduced arterial blockage, inhibited cancer cell growth,
improved psoriasis, tranquilizing effects, antispasmodic effects,
reduced anxiety, bone growth promotion, reduced intestinal
contractions, and nervous system protection.
[0117] Any of the subject compositions can be provided in a unit
dosage form. A unit dosage is an amount of a compound, such as a
cannabinoid compound delivered alone or in combination with other
components, which is to be administered to a subject at or about
one time point. Other components which can be included with a unit
dosage include but are not limited to cosmetics, food carriers,
food bars, baked goods, dairy products, oils, beverages, solid
dosages (e.g., tablets), or liquid dosages. A unit dosage of a
cannabinoid compound can be about 10, 20, 30, 40, 50, 60, 70, 80,
90, 100, 125, 150, 175, 200, 250, 300, 350, 400, 450, 500, 600,
700, 800, 900, 1000 or more milligrams (mg). A unit dosage of a
cannabinoid compound can be at least about 10, 20, 30, 40, 50, 60,
70, 80, 90, 100, 125, 150, 175, 200, 250, 300, 350, 400, 450, 500,
600, 700, 800, 900, 1000 or more milligrams (mg). A unit dosage of
a cannabinoid compound can be at most about 10, 20, 30, 40, 50, 60,
70, 80, 90, 100, 125, 150, 175, 200, 250, 300, 350, 400, 450, 500,
600, 700, 800, 900, 1000 or more milligrams (mg). A unit dosage can
be an hourly dosage. A unit dosage can be a daily dosage. A unit
dosage can provide about 1/24, 1/12, 1/8, 1/6, 1/4, 1/3, 1/2, or
all of a daily dosage of one or more cannabinoids for a subject. A
unit dosage can take the form of a tablet, gel, liquid, food
product, food bar, container of liquid of defined volume, or other
forms described herein, packaged for one-time consumption or
administration.
[0118] The compositions described herein can provide several
advantages, including but not limited to increased shelf stability,
increased bioavailability, increased bioactivity, and delayed
release. The compositions described herein, when administered to a
subject, can have various release profiles, half-lives, and
metabolic characteristics. The subject compositions can comprise a
plurality of microcapsules, wherein an individual microcapsule in
the plurality is characterized by exhibiting at least one of: (a) a
sigmoidal release profile of the at least one cannabinoid compound;
(b) a plasma half-life of the at least one cannabinoid compound
greater than twice that of the at least one cannabinoid compound in
non-encapsulated form; (c) a first pass metabolism of the at least
one cannabinoid compound reduced by at least 50% compared to the at
least one cannabinoid compound in non-encapsulated form; d) a rate
of excretion of the at least one cannabinoid compound from a
subject's body reduced by at least 20% compared to the at least one
cannabinoid compound in non-encapsulated form; or (e) a degradation
rate at an ambient temperature of at least 20.degree. C. of the at
least one cannabinoid compound of less than about 50% of a
degradation rate of the at least one cannabinoid compound in
non-encapsulated form.
[0119] The compositions described herein can have a shelf half-life
of at least about 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14,
15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 35,
40, 45, 50, 55, 60, 65, 70, 75, 80, 85, 90, 95, 100, 110, 120, 130,
140, 150, 160, 170, 180, 190, 200, 210, 240, 270, 300, 330, or 360
days. In some cases, the compositions described herein can have a
shelf half-life of at least about 1, 2, 3, 4, or 5 years.
Compositions in microencapsulated form can be characterized by a
cannabinoid degradation rate at an ambient temperature of at least
20.degree. C. of at least 5%, 10%, 15%, 20%, 25%, 30%, 35%, 40%,
45%, 50%, 55%, 60%, 65%, 70%, 75%, 80%, 85%, 90%, 95%, 96%, 97%,
98%, or 99% less than the degradation rate of a non-encapsulated
cannabinoid composition.
[0120] Cannabinoid compositions in microencapsulated form can be
characterized by a plasma half-life in a subject of at least 1.1,
1.2, 1.3, 1.4, 1.5, 1.6, 1.7, 1.8, 1.9, 2.0, 2.1, 2.2, 2.3, 2.4,
2.5, 2.6, 2.7, 2.8, 2.9, 3.0, 3.5, 4.0, 4.5, or 5.0 times that of a
non-encapsulated cannabinoid composition. Plasma half-life of a
composition can be determined experimentally by administering the
composition to a subject, taking plasma samples from a subject at
multiple time points, and measuring the concentration of the
compound or compounds of interest in those plasma samples. The
concentration of the compound or compounds of interest will reach a
peak value in the plasma, then fall as the compound or compounds
are metabolized, degraded, or cleared from the blood stream. The
plasma half-life is the time for the plasma concentration value to
be halved.
[0121] The cannabinoid release profile can be sigmoidal (e.g.,
having an `S` shape curve, such as a logistic function). The
cannabinoid release profile can be non-sigmoidal. The cannabinoid
release profile can be linear. The cannabinoid release profile can
be non-linear. The cannabinoid release profile can be instant
release. The cannabinoid release profile can be non-instant
release. The cannabinoid release profile can be delayed release.
The cannabinoid release profile can be constant or sustained
release. The cannabinoid release profile can be non-constant or
non-sustained release.
[0122] Tablets can be formulated in sustained release format.
Methods of making sustained release tablets are known in the art;
see, for example, U.S. Patent Publication No. 2006/0051416 and U.S.
Patent Publication No. 2007/0065512. Gradual-release tablets are
known in the art; examples of such tablets are set forth in U.S.
Pat. No. 3,456,049, for example. A slow- or sustained-release form
may delay disintegration or absorption of the composition or one or
more components thereof.
[0123] In some cases, no more than 5%, 10%, 15%, 20%, 25%, 30%,
35%, 40%, 45%, 50%, 55%, 60%, 65%, 70%, 75%, 80%, 85%, 90%, 95%,
96%, 97%, 98%, or 99% of a cannabinoid compound is released from a
microcapsule within 1 hour of administration to a subject. In some
cases, no more than 5%, 10%, 15%, 20%, 25%, 30%, 35%, 40%, 45%,
50%, 55%, 60%, 65%, 70%, 75%, 80%, 85%, 90%, 95%, 96%, 97%, 98%, or
99% of a cannabinoid compound is released from a microcapsule
within 2 hours of administration to a subject. In some cases, no
more than 5%, 10%, 15%, 20%, 25%, 30%, 35%, 40%, 45%, 50%, 55%,
60%, 65%, 70%, 75%, 80%, 85%, 90%, 95%, 96%, 97%, 98%, or 99% of a
cannabinoid compound is released from a microcapsule within 3 hours
of administration to a subject. In some cases, no more than 5%,
10%, 15%, 20%, 25%, 30%, 35%, 40%, 45%, 50%, 55%, 60%, 65%, 70%,
75%, 80%, 85%, 90%, 95%, 96%, 97%, 98%, or 99% of a cannabinoid
compound is released from a microcapsule within 4 hours of
administration to a subject. In some cases, no more than 5%, 10%,
15%, 20%, 25%, 30%, 35%, 40%, 45%, 50%, 55%, 60%, 65%, 70%, 75%,
80%, 85%, 90%, 95%, 96%, 97%, 98%, or 99% of a cannabinoid compound
is released from a microcapsule within 5 hours of administration to
a subject. In some cases, no more than 5%, 10%, 15%, 20%, 25%, 30%,
35%, 40%, 45%, 50%, 55%, 60%, 65%, 70%, 75%, 80%, 85%, 90%, 95%,
96%, 97%, 98%, or 99% of a cannabinoid compound is released from a
microcapsule within 6 hours of administration to a subject. In some
cases, no more than 5%, 10%, 15%, 20%, 25%, 30%, 35%, 40%, 45%,
50%, 55%, 60%, 65%, 70%, 75%, 80%, 85%, 90%, 95%, 96%, 97%, 98%, or
99% of a cannabinoid compound is released from a microcapsule
within 7 hours of administration to a subject. In some cases, no
more than 5%, 10%, 15%, 20%, 25%, 30%, 35%, 40%, 45%, 50%, 55%,
60%, 65%, 70%, 75%, 80%, 85%, 90%, 95%, 96%, 97%, 98%, or 99% of a
cannabinoid compound is released from a microcapsule within 8 hours
of administration to a subject.
[0124] A release profile is the relationship between time and the
amount of a compound released into a subject or the concentration
of the compound within the subject (e.g., within the plasma).
Release profiles can be measured in a similar manner to plasma
half-life. A composition can be administered to a subject, and
samples (e.g., plasma samples or blood samples) can be taken from
the subject at multiple time points. The concentration of the
compound or compounds of interest can be measured in those samples,
and a release profile can be plotted.
[0125] Compounds taken up into a subject via the gastrointestinal
system can be transported to the liver before entering general
circulation. Compounds susceptible to metabolic degradation in the
liver can have their activities substantially reduced by the
first-pass metabolism through the liver. Encapsulation (e.g.,
microencapsulation) of compounds can reduce first-pass metabolism
of the compounds in the liver. Compositions in microencapsulated
form can be characterized by a first pass cannabinoid metabolism in
a subject of at least 5%, 10%, 15%, 20%, 25%, 30%, 35%, 40%, 45%,
50%, 55%, 60%, 65%, 70%, 75%, 80%, 85%, 90%, 95%, 96%, 97%, 98%, or
99% less than that of a non-encapsulated cannabinoid composition.
Compositions in microencapsulated form can be characterized by a
cannabinoid excretion rate from a subject of at least 5%, 10%, 15%,
20%, 25%, 30%, 35%, 40%, 45%, 50%, 55%, 60%, 65%, 70%, 75%, 80%,
85%, 90%, 95%, 96%, 97%, 98%, or 99% less than that of a
non-encapsulated cannabinoid composition.
[0126] The compositions described herein, when administered to a
subject, can have improved bioavailability, bioactivity, or both.
Bioavailability is the fraction of an administered dosage of
unchanged compound that reaches systemic circulation. Cannabinoid
compositions in microencapsulated form can be characterized by a
bioavailability in a subject of at least 1.1, 1.2, 1.3, 1.4, 1.5,
1.6, 1.7, 1.8, 1.9, 2.0, 2.1, 2.2, 2.3, 2.4, 2.5, 2.6, 2.7, 2.8,
2.9, 3.0, 3.5, 4.0, 4.5, 5.0, 5.5, 6.0, 6.5, 7.0, 7.5, 8.0, 8.5,
9.0, 9.5, or 10.0 times that of a non-encapsulated cannabinoid
composition. Cannabinoid compositions in microencapsulated form can
be characterized by a bioavailability in a subject of at least 5%,
10%, 15%, 20%, 25%, 30%, 35%, 40%, 45%, 50%, 55%, 60%, 65%, 70%,
75%, 80%, 85%, 90%, 95%, 96%, 97%,%, 98%, 99%, or 100%.
Bioactivity, or biological activity, is the activity exerted by the
active ingredient or ingredients in a composition. Cannabinoid
compositions in microencapsulated form can be characterized by a
bioactivity in a subject of at least 1.1, 1.2, 1.3, 1.4, 1.5, 1.6,
1.7, 1.8, 1.9, 2.0, 2.1, 2.2, 2.3, 2.4, 2.5, 2.6, 2.7, 2.8, 2.9,
3.0, 3.5, 4.0, 4.5, 5.0, 5.5, 6.0, 6.5, 7.0, 7.5, 8.0, 8.5, 9.0,
9.5, or 10.0 times that of a non-encapsulated cannabinoid
composition.
[0127] Subjects of the present disclosure can include humans and
other animals, such as pets (e.g., dogs, cats, birds, small
mammals, snakes) and livestock or farm animals (e.g., cows, pigs,
horses, sheep, chickens). Compositions of the present disclosure
can be useful for veterinary applications.
EXAMPLES
Example 1--Microencapsulation of Cannabinoids
[0128] A hemp oil composition is produced, comprising cannabinoids
including cannabidiol. Additional essential oils are added to the
composition. Alginate (e.g., sodium alginate) and quillaja tree
extract are added to the composition. The composition is
microencapsulated via a microfluidic nozzle device. Calcium
chloride is used to cross-link the microcapsules. The microcapsules
are packaged in a suspension, transported, and sold.
Example 2--Administration of Cannabinoid Composition to a
Subject
[0129] A cannabinoid composition, such as the microencapsulated
cannabinoid composition described in Example 1, is administered to
a subject suffering from a cannabinoid deficiency related
condition. The level of cannabinoids in the subject increases, and
the condition is improved.
Example 3--Cannabidiol-Rich Hemp and Coconut Oil Product
[0130] Hempseed oil is enriched in cannabidiol compounds by
addition of hemp stalk and stem extract containing 10% to 40%
cannabidiol compounds by weight. The enriched hempseed oil is
blended into coconut oil to produce a final composition of about
100 milligrams of cannabidiol compounds in 8 fluid ounces of
coconut oil. The coconut oil product is then used to produce
consumer products such as moisturizers, lotions, cooking oils,
smoothies, spreads, and other food products.
Example 4--Cannabidiolic Acid-Rich Hemp and Coconut Oil Product
[0131] Hempseed oil is enriched in cannabidiolic acid by addition
of hemp stalk and stem extract containing 10% to 40% cannabidiolic
acid by weight. The enriched hempseed oil is blended into coconut
oil to produce a final composition of about 100 milligrams of
cannabidiolic acid in 8 fluid ounces of coconut oil. The coconut
oil product is then used to produce consumer products such as
moisturizers, lotions, cooking oils, smoothies, spreads, and other
food products.
Example 5--Cannabidiol-Rich Hot Chocolate Mix
[0132] Hempseed oil is enriched in cannabidiol compounds by
addition of hemp stalk and stem extract containing 10% to 40%
cannabidiol compounds. Hempseed oil rich in cannabidiol compounds
is then combined with cyclodextrin (e.g., certified organic
cyclodextrin) to form a dry powder. The hemp oil powder is mixed
with powdered cacao, cacao butter mix, sweeteners, and optionally
superfood products such as reishi mushroom powder, chaga mushroom
powder, maca, or he shou wu. The mixture is packaged and sold as a
chocolate beverage mix (e.g., hot chocolate mix).
Example 6--Production and Packaging of Cannabinoid-Rich Product
[0133] A standardized supercritical carbon dioxide extract of hemp
stalk and stem is extracted. The extract (e.g., a paste) is blended
into hemp seed oil. The blend of hemp extract and hemp oil is
prepared with a THC content below 0.3%, and with CBD content of
about 10-40% by weight. The hemp extract and hemp oil blend is
further blended into coconut oil to provide about 100 mg of CBD per
8 ounce of coconut oil (about 423 milligrams per liter). The
coconut oil blend with CBD is packaged (e.g., in a jar) and sold to
a consumer.
Example 7--Administration of Pregnenolone Composition to a
Subject
[0134] A cannabinoid and pregnenolone composition, such as the
microencapsulated cannabinoid composition described in Example 1
further comprising pregnenolone (e.g., 1-50 mg of pregnenolone), is
administered to a subject suffering from cannabinoid intoxication
or addiction. The subject is protected from CB1 receptor
overactivation, and the condition is improved.
Example 8--Preparation of Microencapsulated Composition
[0135] Formulations comprising quillaja extract (e.g., Q Natural),
hemp oil, water, and optionally sodium alginate were prepared using
a microfluidic fluid processor (e.g., Microfluidizer from
Microfluidics/IDEX Corporation). Formulations were prepared as
described in Table 1. Test 1 was prepared with 60 g of quillaja
extract (e.g., Q Natural), 80 g of hemp oil, and 100 g of water, at
an operating pressure of 30,000 psi in the microfluidic fluid
processor. Test 2 was prepared with 10 g of quillaja extract (e.g.,
Q Natural), 15 g of hemp oil, 198 g of water, and 2 g of sodium
alginate, at an operating pressure of 30,000 psi in the
microfluidic fluid processor.
[0136] After processing in the microfluidic fluid processor,
particle size distribution was analyzed using a laser diffraction
particle size analyzer (e.g., Horiba LA950). Optical microscope
images were also taken.
[0137] Three passes each of Test 1 and Test 2 were conducted, and
the tenth percentile (D10), fiftieth percentile (D50), and
ninetieth percentile (D90) particle sizes are reported in Table 1.
Particle sizes were also analyzed for an unprocessed solution (Test
1, Pass 0).
TABLE-US-00001 TABLE 1 Formulation and size distribution
information for microencapsulated compositions. Q Hemp Sodium D10
D50 D90 Test Pass # Pressure Natural Oil Water alginate (.mu.m)
(.mu.m) (.mu.m) 1 0 30,000 60 g 80 g 100 g -- 1.9737 7.117 35.703 1
psi -- 0.0768 0.1296 0.2881 2 -- 0.0697 0.1096 0.1791 3 -- 0.0929
0.1405 0.2202 2 1 30,000 10 g 15 g 198 g 2 g 0.1171 0.1965 2.0719 2
psi 0.0688 0.1097 0.2209 3 0.099 0.1583 1.3443
[0138] FIG. 1A shows a 400.times. magnification micrograph image of
an unprocessed quillaja extract, hemp oil, and water composition
(Test 1, Pass 0), with a 50 .mu.m scale bar. FIG. 1B shows a
1000.times. magnification micrograph image of an unprocessed
quillaja extract, hemp oil, and water composition (Test 1, Pass 0),
with a 50 .mu.m scale bar.
[0139] FIG. 2A shows a 400.times. magnification micrograph image of
a quillaja extract, hemp oil, and water composition (Test 1, Pass
1), with a 50 .mu.m scale bar. FIG. 2B shows a 400.times.
magnification micrograph image of a quillaja extract, hemp oil, and
water composition (Test 1, Pass 2), with a 50 .mu.m scale bar. FIG.
2C shows a 1000.times. magnification micrograph image of a quillaja
extract, hemp oil, and water composition (Test 1, Pass 2), with a
10 .mu.m scale bar. FIG. 2D shows a 1000.times. magnification
micrograph image of a quillaja extract, hemp oil, and water
composition (Test 1, Pass 3), with a 10 .mu.m scale bar.
[0140] FIG. 3A shows a 1000.times. magnification micrograph image
of a quillaja extract, hemp oil, water, and sodium alginate
composition (Test 2, Pass 1), with a 10 .mu.m scale bar. FIG. 3B
shows a 1000.times. magnification micrograph image of a quillaja
extract, hemp oil, water, and sodium alginate composition (Test 2,
Pass 2), with a 10 .mu.m scale bar. FIG. 3C shows a 1000.times.
magnification micrograph image of a quillaja extract, hemp oil,
water, and sodium alginate composition (Test 2, Pass 3), with a 10
.mu.m scale bar.
* * * * *