U.S. patent application number 16/729069 was filed with the patent office on 2020-06-18 for manufacturing methods, compositions, and medical applications of orally administered cannabis pharmaceuticals using representati.
The applicant listed for this patent is HARVEST DIRECT ENTERPRISES LLC. Invention is credited to Ahmed Gharib, Zeyead Gharib.
Application Number | 20200188461 16/729069 |
Document ID | / |
Family ID | 60203451 |
Filed Date | 2020-06-18 |
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United States Patent
Application |
20200188461 |
Kind Code |
A1 |
Gharib; Zeyead ; et
al. |
June 18, 2020 |
MANUFACTURING METHODS, COMPOSITIONS, AND MEDICAL APPLICATIONS OF
ORALLY ADMINISTERED CANNABIS PHARMACEUTICALS USING
REPRESENTATIVE/TOTAL/COMPLETE CANNABIS EXTRACTIONS (CANNABIS
INFUSED PILLS)
Abstract
Disclosed herein are embodiments of cannabis extraction methods,
apparatuses for extracting cannabis, and methods of using cannabis
extracts.
Inventors: |
Gharib; Zeyead; (Everett,
WA) ; Gharib; Ahmed; (Everett, WA) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
HARVEST DIRECT ENTERPRISES LLC |
Everett |
WA |
US |
|
|
Family ID: |
60203451 |
Appl. No.: |
16/729069 |
Filed: |
December 27, 2019 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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15588505 |
May 5, 2017 |
10517911 |
|
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16729069 |
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62332513 |
May 6, 2016 |
|
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62467060 |
Mar 3, 2017 |
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61K 31/05 20130101;
A61K 31/015 20130101; B01D 11/0257 20130101; A61K 31/01 20130101;
A61K 2236/17 20130101; A61K 31/192 20130101; A61K 2236/35 20130101;
A61K 2236/33 20130101; A23L 29/03 20160801; A23V 2002/00 20130101;
A61K 9/0053 20130101; A61K 36/185 20130101; A23L 33/105 20160801;
A61K 2236/53 20130101; C07D 311/80 20130101; A61K 9/48 20130101;
A61K 9/4875 20130101; A61K 2236/331 20130101; A61K 31/352 20130101;
A61K 2236/37 20130101; A61K 31/045 20130101; B01D 11/0288
20130101 |
International
Class: |
A61K 36/185 20060101
A61K036/185; A61K 9/48 20060101 A61K009/48; A23L 33/105 20060101
A23L033/105; B01D 11/02 20060101 B01D011/02; A61K 31/352 20060101
A61K031/352; A61K 31/192 20060101 A61K031/192; A61K 31/05 20060101
A61K031/05; A61K 31/045 20060101 A61K031/045; A61K 31/015 20060101
A61K031/015; A61K 31/01 20060101 A61K031/01; A61K 9/00 20060101
A61K009/00; A23L 29/00 20060101 A23L029/00 |
Claims
1.-42. (canceled)
43. A method of preparing a decarboxylated cannabis material,
comprising: adding a cannabis material to a reaction chamber;
treating the reaction chamber with an inert gas; initiating a
decarboxylation process on the cannabis material in the presence of
the inert gas to produce a decarboxylated cannabis material and
decarboxylation byproducts within the reaction chamber; condensing
the decarboxylated cannabis material within the reaction chamber;
removing the decarboxylation byproducts from the reaction chamber;
and removing the decarboxylated cannabis material from the reaction
chamber.
44. The method of claim 43, wherein the cannabis material is a
cannabis flower or a cannabis extract.
45. The method of claim 44, wherein the cannabis flower is selected
from the group consisting of Cannabis sativa, Cannabis indica,
Cannabis ruderalis, hybrids thereof, and combinations thereof.
46. The method of claim 43, wherein the method further comprises
applying an extraction process to a cannabis flower to yield the
cannabis material.
47. The method of claim 46, wherein the extraction process is a
solvent-based extraction.
48. The method of claim 47, wherein the solvent-based extraction
comprises a solvent selected from the group consisting of an
alcohol solvent, a lipid solvent, a hydrocarbon solvent, a CO.sub.2
solvent, a water-based solvent, and combinations thereof.
49. The method of claim 46, wherein the extraction process is a
solventless extraction process.
50. The method of claim 49, wherein the solventless extraction
process is selected from the group consisting of a heat extraction,
an unheated extraction, a rosin tech extraction, and combinations
thereof.
51. The method of claim 43, wherein the cannabis material is not
dried.
52. The method of claim 43, wherein the cannabis material is
dried.
53. The method of claim 43, wherein the reaction chamber during the
decarboxylation process is airtight.
54. The method of claim 53, wherein the reaction chamber during the
decarboxylation process is pressurized.
55. The method of claim 53, wherein the reaction chamber is purged
following the decarboxylation process.
56. The method of claim 43, wherein the decarboxylation byproducts
comprise CO.sub.2.
57. The method of claim 56, wherein the CO.sub.2 is removed through
a filter comprising pores that allow for removal of the CO.sub.2
from the reaction chamber and prevents removal or escape of the
decarboxylated cannabis material from the reaction chamber.
58. The method of claim 57, wherein the pores are from about 29
.ANG..sup.2 to about 31 .ANG..sup.2.
59. The method of claim 43, wherein the decarboxylation process
comprises using a targeted enzyme or cofactor.
60. The method of claim 43, wherein the decarboxylation process
further comprises application of H.sub.2O as a catalyst.
61. The method of claim 43, wherein the decarboxylation process
further comprises stirring the cannabis material.
62. The method of claim 43, wherein the decarboxylated cannabis
material comprises at least one cannabinoid and at least one
terpene.
63. The method of claim 43, wherein the decarboxylated cannabis
material comprises cannabinoids, terpenes/terpenoids, amino acids,
nitrogenous compounds, simple alcohols, aldehydes, ketones, esters,
lactones, and acids, fatty acids, steroids, non-cannabinoid
phenols, pigments, flavonoids, vitamins, proteins, enzymes,
glycoproteins, and hydrocarbons.
64. The method of claim 43, wherein the decarboxylated cannabis
material partially comprises non-decarboxylated cannabis
material.
65. A method of preparing a decarboxylated cannabis material,
comprising: adding a cannabis material to a reaction chamber;
initiating a decarboxylation process on the cannabis material in
the presence of vacuum to produce a decarboxylated cannabis
material and decarboxylation byproducts within the reaction
chamber; condensing the decarboxylated cannabis material within the
reaction chamber; removing the decarboxylation byproducts from the
reaction chamber; and removing the decarboxylated cannabis material
from the reaction chamber.
Description
RELATED APPLICATIONS
[0001] This application claims priority to U.S. application Ser.
No. 15/588,505, filed on May 5, 2017, which in turn is a
non-provisional application of U.S. Provisional Applications Ser.
No. 62/332,513 filed May 6, 2016; and Ser. No. 62/467,060 filed
Mar. 3, 2017, each of which is hereby incorporated by reference in
their entireties.
BACKGROUND
Field
[0002] Disclosed herein are embodiments of manufacturing methods
and apparatuses for producing cannabis extracts.
[0003] Description of the Related Art
[0004] Some cannabis extraction methods have been described in the
art. However, cannabis extraction methods that preserve all
compounds of cannabis while removing byproducts have proven
difficult to develop.
SUMMARY
[0005] In some embodiments, a method of extracting cannabis is
provided. The method comprises (i) adding any amount of at least
one species of cannabis plant or any amount of an extract of at
least one species of cannabis plant to a reaction chamber, (ii)
optionally producing cannabis extracts through extracting cannabis
from the amount of at least one species of cannabis plant in the
chamber, (iii) removing byproducts from the reaction chamber that
are produced from extracting cannabis, and (iv) retaining compounds
within the chamber derived from cannabis, wherein the reaction
chamber comprises a filter comprising pores that allow for removal
from the reaction chamber of the byproducts from the cannabis
extraction process and prevent removal from the chamber of the
compounds derived from cannabis.
[0006] In some embodiments, an apparatus for extracting cannabis is
provided comprising an airtight container comprising (i) an inner
surface, (ii) an outer surface, (iii) a reaction chamber, and (iv)
a size exclusion filter, wherein the size exclusion filter
comprises pores of sufficient size to allow byproducts of an
extraction process and a decarboxylation process to pass through
the filter but prevents compounds derived from cannabis from
passing through the filter.
[0007] In some embodiments, a cannabis extraction method is
provided that uses any of the cannabis extraction apparatuses
disclosed herein comprising the steps of (i) adding any amount of
at least one species of cannabis plant or any amount of an extract
of at least one species of cannabis plant to a reaction chamber,
(ii) optionally producing cannabis extracts through extracting
cannabis from the amount of at least one species of cannabis plant
in the chamber, (iii) removing byproducts from the reaction chamber
that are produced from extracting cannabis, and (iv) retaining
compounds within the chamber derived from cannabis, wherein the
reaction chamber comprises a filter comprising pores that allow for
removal from the reaction chamber of the byproducts from the
cannabis extraction process and prevent removal from the chamber of
compounds derived from cannabis.
[0008] In some embodiments, a mixture of compounds is provided
comprising at least one terpene compound derived from cannabis and
at least one cannabinoid compound derived from cannabis.
[0009] In some embodiments, a mixture of compounds derived from
cannabis is provided that comprises cannabinoids, nitrogenous
compounds, amino acids, proteins, enzymes, glycoproteins,
hydrocarbons, simple alcohols, aldehydes, ketones and acids, fatty
acids, simple esters and lactones, steroids, terpenes,
non-cannabinoid phenols, flavonoids, vitamins, and pigments.
[0010] In some embodiments, a method of treatment is provided
comprising administering a pharmaceutically acceptable amount of
any pharmaceutical composition disclosed herein to a patient in
need thereof.
[0011] In some embodiments, a method of treatment is provided
comprising administering any pharmaceutical composition disclosed
herein to treat any one or more of the following: nausea and
vomiting, wasting syndrome (AIDS), lack of appetite (exhibited in
cancer and AIDs patients as well as patients suffering from
anorexia nervosa), multiple sclerosis, spinal cord trauma,
epilepsy, pain, arthritis (and other musculoskeletal disorders),
movement disorders, glaucoma, asthma, hypertension, psychiatric
disorders, Alzheimer's and dementia, general inflammation,
gastrointestinal disorders.
BRIEF DESCRIPTION OF THE DRAWINGS
[0012] FIG. 1 depicts one embodiment of the entire process from
cannabis plant material to final product (cannabis
preparation).
[0013] FIG. 2A depicts a front view of an embodiment of a cannabis
extraction apparatus.
[0014] FIG. 2B depicts a side view of an embodiment of a cannabis
extraction apparatus.
[0015] FIG. 2C depicts a top view of an embodiment of a cannabis
extraction apparatus.
[0016] FIG. 3 depicts a schematic of an embodiment of an apparatus
utilizing a size exclusion filter.
[0017] FIG. 4 depicts the molecular structure of
tetrahydrocannabinol (the primary psychoactive component found in
cannabis).
[0018] FIG. 5 depicts the molecular structure of
tetrahydrocannabinolic acid.
[0019] FIG. 6 depicts the molecular structure of cannabidiol.
[0020] FIG. 7 depicts the molecular structure of cannabidiolic
acid.
[0021] FIG. 8 depicts the molecular structure of cannabinol
[0022] FIG. 9 depicts the molecular structure of
cannabichromene.
[0023] FIG. 10 depicts the molecular structure of
tetrahydrocannabivarin.
[0024] FIG. 11 depicts the molecular structure of
cannabidivarin.
[0025] FIG. 12 depicts the molecular structure of cannabigerol.
[0026] FIG. 13 depicts the molecular structure of alpha-pinene.
[0027] FIG. 14 depicts the molecular structure of linalool.
[0028] FIG. 15 depicts the molecular structure of myrcene.
[0029] FIG. 16 depicts the molecular structure of
beta-caryophyllene.
[0030] FIG. 17 depicts the molecular structure of limonene.
[0031] FIG. 18 depicts a visual representation of an embodiment of
the final product (cannabis edible and cannabis infused
pharmaceutical)
[0032] FIG. 19 Cannabinoid analysis of THCaps by NorthWest Cannabis
Solutions--a THC only formulation like Marinol.
[0033] FIG. 20 Terpene analysis of THCaps by NorthWest Cannabis
Solutions--a THC only formulation like Marinol.
[0034] FIG. 21 Cannabinoid analysis of Weed Pillz by Harvest Direct
Enterprises--an oral pharmaceutical preparation that is made from
complete/representative/total cannabis extractions.
[0035] FIG. 22 Terpene analysis of Weed Pillz by Harvest Direct
Enterprises--an oral pharmaceutical preparation that is made from
complete/representative/total cannabis extractions.
[0036] FIG. 23 Depicts one embodiment of producing a cannabis
extract using a size exclusion filter and a coil to condense
terpenes, compounds of pharmaceutical interest, and compounds of
organoleptic interest.
[0037] FIG. 24 depicts results from a cannabis extraction
experiment in which the extract was heated to 250.degree. F. for a
duration of 1.5 hours.
[0038] FIG. 25 depicts results from a cannabis extraction
experiment in which the extract was exposed to ambient temperatures
throughout the duration of the extraction process.
DETAILED DESCRIPTION
[0039] Disclosed herein are manufacturing methods, compositions,
and medical applications of representative/total/complete cannabis
preparations. These representative/total/complete cannabis
preparations allows for the "entourage effect"; wherein the myriad
of medically viable compounds found in cannabis, such as but not
limited to cannabinoids and terpenes, interact in the mammalian
endocannabinoid system to produce greater medical efficacy and
safety.
[0040] In some embodiments, retention of these medically viable
compounds during the cannabis extract purge process and the
decarboxylation process is achieved through isolating cannabis
extracts through using the apparatus as depicted in FIGS. 2A, 2B
and 2C. These preparations can optionally also make use of
surfactants and nutrients in order to increase the bioavailability
and subsequent absorption of these medically viable compounds in
the mammalian gastrointestinal tract. Extractions may originate
from all forms of cannabis plant material, including but not
limited to cannabis sativa, cannabis indica, cannabis
ruderalis--and any/all subspecies and any/all cross breeds
thereof--in both male and female varieties.
[0041] Disclosed herein is a representative/total/complete
extraction, using a variety of extraction mediums, including but
not limited to: cold water extraction and dry sift (hash), CO2,
hydrocarbons (including but not limited to: butane, propane,
hexane), alcohol (including but not limited to: ethanol,
iso-propyl, methanol), and rosin tech (heat extraction)) of
cannabis and any/all medically viable compounds found therein
(including but not limited to cannabinoids, nitrogenous compounds,
amino acids, proteins, enzymes, glycoproteins, hydrocarbons, simple
alcohols, aldehydes, ketones and acids, fatty acids, simple esters
and lactones, steroids, terpenes, non-cannabinoid phenols,
flavonoids, vitamins, and pigments) and its species (including but
not limited to cannabis sativa, cannabis indica, cannabis
ruderalis--and any/all subspecies and any/all cross breeds thereof
and any/all established strains--in both male and female
varieties--using both live and dried cannabis plant material) and
the subsequent conversion of these extracts into pill-able forms
for oral administration (immediate and extended release) is
described. In some embodiments, formulations disclosed herein will
utilize the use of surfactant(s)/emulsifier(s) and nutritional
compounds in order to increase the bioavailability and subsequent
absorption of these orally administered cannabis pills/capsules,
and the medically viable compounds found therein as a result of a
total cannabis extraction, within the mammalian gastrointestinal
tract (effectively bypassing the hepatic first pass effect).
Varieties will include but will not be limited to: Vegan, kosher,
halal, gluten free, extremely potent, CBD rich, low potency,
non-decarboxylated (non-psychoactive), live plant material,
allergen-free, extended release, very low or sodium free,
established cannabis strains, and more.
[0042] In Marinol, only cannabis sativa is utilized. This oversight
completely disregards the variety and distinct variations found in
the Cannabis genus. Current research shows that the cannabis genus
has seven sub species, including but not limited to cannabis
sativa, cannabis indica, and cannabis ruderalis--any/all subspecies
and any/all crossbreeds thereof and any/all established
strains.
[0043] Furthermore, the prior art (Marinol) only makes use of
female varieties. Current research also shows that hemp (male form
of cannabis) may be particularly medicinally beneficial due to its
low THC and high CBD chemotypes. This ratio is particularly
interesting to medical applications due to its low psychoactivity
and increased medical viability.
[0044] Furthermore, Marinol is formulated using a THC--only
extract. This completely ignores the entourage effect exhibited by
cannabis and other herbal remedies/formulations wherein secondary
compounds increase the medical efficacy and safety of primary
constituents while at the same time helping to mitigate their
negative/undesirable side effects. In some embodiments, methods and
compositions are disclosed herein that take advantage of the
entourage effect by including as many of these medically viable
compounds as possible, primarily cannabinoids and terpenes, as a
result of representative/total/complete cannabis extractions. It
should be noted that cannabis is comprised of at least 545 distinct
compounds that span 20 chemical classes including cannabinoids,
terpenes/terpenoids, amino acids, nitrogenous compounds, simple
alcohols, aldehydes, ketones, esters, lactones, and acids, fatty
acids, steroids, non-cannabinoid phenols, pigments, flavonoids,
vitamins, proteins, enzymes, glycoproteins, and hydrocarbons.
Cannabinoids and terpenes, in particular, have shown great
potential in terms of medicinal value.
[0045] Also, the prior art only mentions cannabis sativa. The
Cannabis genus: including cannabis sativa, cannabis indica, and
cannabis ruderalis species (and the seven sub-species) and their
cross breeds (including established strains) in both female and
male varieties, have been shown to contain chemical compounds that
have both psychotropic and medicinal effects.
Cannabis
[0046] The cannabis genus (marijuana, weed) is a wind-pollinated
dioecious flowering plant that belongs to the Cannabaceae family.
Current research shows that the cannabis genus has seven sub
species, including but not limited to cannabis sativa, cannabis
indica, and cannabis ruderalis--any/all subspecies and any/all
crossbreeds thereof and any/all established strains. The
therapeutic use of cannabis stretches back to ancient times; it was
cultivated in China around 4000BC and is included in the world's
oldest pharmacopoeia written by Pen Ts'ao Ching. There are three
common subspecies of cannabis: cannabis sativa (biannual), cannabis
indica (annual) and cannabis ruderalis (varies), but there are
seven subspecies total. Current research shows that there are over
3,000 established cannabis strains. Growing conditions and genetics
influence the characteristics of developing plants and the
subsequent chemical characteristics of finished cannabis
products.
[0047] Mature male plants, known as hemp, have minute cannabinoid
contents and are typically used to manufacture goods and as an
alternative energy source. Hemp may be medicinally beneficial due
to its low THC and high CBD chemotypes, which results in low
psychoactivity and increased medical viability.
[0048] The harvested flowers originating from mature female
cannabis plants are characteristically higher in phytocannabinoid
content and typically possess significant concentrations of other
phytochemicals, such as terpenes, that are also of pharmaceutical
interest. Cannabinoids and terpenes are secreted by glandular
trichomes that occur most abundantly on the floral calyxes and
bracts of the female marijuana plant. Dried cannabis flowers are
the most basic form of cannabis. Other, more potent, preparations
of cannabis include hashish (typically ranging from 20-65%
tetrahydrocannabinol (THC)) and hash oil (typically ranging from
50-90% THC).
[0049] Cannabis has at least 545 distinct compounds that span 20
chemical classes including cannabinoids, terpenes/terpenoids, amino
acids, nitrogenous compounds, simple alcohols, aldehydes, ketones,
esters, lactones, and acids, fatty acids, steroids, non-cannabinoid
phenols, pigments, flavonoids, vitamins, proteins, enzymes,
glycoproteins, and hydrocarbons. Cannabinoids and terpenes, in
particular, have shown great potential in terms of medicinal
value.
The Endocannabinoid System
[0050] The endocannabinoid system (ECS) consists of the two known
cannabinoid receptors, CB1 and CB2, the CB receptor ligands, 2-AG
and AEA, as well as the endocannabinoid synthesizing and degrading
enzymes FAAH and MAGL. Other receptors, such as TRPV1, are closely
related to the CB receptors and may explain the
allosteric/synergistic effects exhibited. These
allosteric/synergistic effects are a direct result of the various
cannabinoids and terpenes found within the cannabis plant. The ECS
has been implicated in a wide variety of physiological and
pathophysiological processes including neural development, immune
function, inflammation, appetite, metabolism and energy
homeostasis, cardiovascular function, digestion, bone development
and bone density, synaptic plasticity and learning, pain,
reproduction, psychiatric disease, psychomotor behavior, memory,
wake/sleep cycles, and the regulation of stress and emotional
state. Therefore, cannabinoids (and other allosteric compounds such
as terpenes) can theoretically be used as novel therapeutics in any
disease in which any of the previously mentioned processes are
affected. Such diseases and ailments include but are not limited
to: nausea and vomiting, wasting syndrome (AIDS), lack of appetite
(exhibited in cancer and AIDs patients as well as patients
suffering from anorexia nervosa), multiple sclerosis, spinal cord
trauma, epilepsy, pain, arthritis (and other musculoskeletal
disorders), movement disorders, glaucoma, asthma, hypertension,
psychiatric disorders, Alzheimer's and dementia, general
inflammation, gastrointestinal disorders, and very likely, many,
many more.
[0051] Phytocannabinoids, such as THC and CBD, are molecules that
target cannabinoid receptors found throughout the body, providing
relief to an array of symptoms including pain, nausea, and
inflammation. The most common cannabinoids found in cannabis are
tetrahydrocannabinol (THC), cannabidiol (CBD), and cannabinol
(CBN).The network of cannabinoid receptors found throughout the
body is known as the endocannabinoid system. Phytocannabinoids,
cannabinoids that originate from plant sources, mimic the actions
of endocannabinoids, cannabinoids synthesized naturally in the
body. For example, anandamide, is an endocannabinoid that is
released post-workout and found to be responsible for the "runner's
high" exhibited. Anandamide does so through interactions with
endocannabinoid system, just like THC and CBD.
Tetrahydrocannabinol (THC), Cannabidiol (CBD), and Cannabinol
(CBN)
[0052] Tetrahydrocannabinol (THC) is the primary psychoactive
compound found in cannabis. This molecule is by far the most well
studied and understood component of cannabis. It is extremely safe
from a toxicological perspective; not a single case of overdose has
been attributed to THC (or to cannabis as a whole) despite its
widespread use. Effects include analgesic, muscle relaxant,
antispasmodic, bronchodilator, neuroprotective antioxidant,
antiemetic, antipruritic agent in cholestatic jaundice,
anti-inflammatory (20 times as effective as aspirin and 2 times as
effective as hydrocortisone, added benefit: no COX-1 or COX-2
inhibition).THC induces euphoria and appetite stimulation.
Extremely high doses can cause adverse effects such as paranoia,
auditory and visual hallucinations, and temporary psychosis. It
should be noted that these adverse effects are often negated
through the entourage/synergistic effects of the phytochemicals in
cannabis such as terpenes and other less prevalent cannabinoids.
THC has also been shown to help reduce tic severity in Tourette's
syndrome and has shown potential in treating glaucoma (reduce
intraocular pressure).
[0053] Cannabidiol (CBD) is one of the principal cannabinoids found
in cannabis and is largely considered to the most medically
significant. CBD is non-psychoactive, meaning that unlike THC, CBD
does not produce a high. CBD indirectly stimulates the
endocannabinoid system, causing broad and complicated effects that
have been shown to mitigate some of the negative effects of THC and
other cannabinoids, contributing to the entourage/synergistic
effect. Effects: modulates THC-associated adverse effects (ie.
anxiety, tachycardia, hunger, and sedation), analgesic,
neuroprotective antioxidant, anticonvulsant (effects on par with
Dilantin--standard antiepileptic drug), antiemetic, sedative,
anti-anxiety, anti-psychotic, antidepressant, anti-inflammatory,
anti-tumor (prevents spread of breast cancer and many other cell
lines while preserving healthy cells), shown to help rheumatoid
arthritis, improves mood, displays powerful activity against
methicillin-resistant Staphylococcus aureus (MRSA), reduces risk of
stroke, ability to affect improvement in cognition, reduces acne,
and acts as an immunomodulator. CBD also shows potential in the
treatment of multiple sclerosis, Parkinson's disease, Alzheimer' s,
sleep disorders, psychotic symptoms of schizophrenia, and in fear
reduction. It should also be noted that a lot of these ailments and
conditions have very poor prognoses. At the very least, cannabis
can be used to improve the quality of life in these patients.
[0054] Phytocannabinoids, such as THC and CBD, are molecules that
target cannabinoid receptors found throughout the body providing
relief to an array of symptoms including pain, nausea, and
inflammation. Extremely high doses of THC can cause adverse effects
such as paranoia, auditory and visual hallucinations, and temporary
psychosis. It should be noted that these adverse effects are often
negated through the entourage/synergistic effects of the
phytochemicals in cannabis such as terpenes and other less
prevalent cannabinoids. For example, CBD has been shown to modulate
THC-associated adverse effects such anxiety, tachycardia, hunger,
and sedation. Other phytochemicals found within cannabis may have
similar effects that will not only result in a marked potency
increase but will also increase the safety of these formulations as
well as reducing any of the negative/undesirable effects that
result from primary constituents.
[0055] Cannabinol (CBN) is another principal cannabinoid; it is
shown to have very mild psychoactive effects. Research shows that
THC can naturally degrade into CBN over a long period of time and
as a result of improper storage. Effects: immunomodulator,
analgesic, anticonvulsant, anti-inflammatory, and also displayed
powerful activity against methicillin-resistant Staphylococcus
aureus (MRSA), shown to help treat burns, promotes bone
formation/growth, inhibits cancer resistance protein (making
chemotherapy more effective). CBN has been shown to increase the
sedation effects of THC. Research also shows that CBN can
effectively reduce intraocular pressure (similar to THC), making it
an ideal therapeutic in the case of ocular diseases, such as
glaucoma.
[0056] Each one of the various cannabinoids found in cannabis has
its own medical benefits. Research shows that when they work in
unison, and with other compounds in cannabis such as terpenes, they
achieve the entourage effects--wherein cannabis's medical efficacy
and safety is increased many times over.
Terpenes
[0057] Terpenes are a classification of organic molecules that are
found in a wide variety of plants and animals. These molecules are
known for their characteristic scents and flavors. The varying
terpene concentrations found in cannabis directly influence the
resulting taste and smell, as well as the observed effects. Even a
small variation in terpene concentration can cause noticeable
differences in the entourage/synergistic effects of cannabis.
[0058] Terpenes are an important component to the overall cannabis
experience, not only influencing a strain's taste and smell but
also influencing its effects on the mind and body. The total effect
of all of the components in cannabis is referred to as the
"entourage effect." This documented phenomenon is what
distinguishes one strain from another, and research shows it relies
heavily on the physiological effects produced by terpenes. Over 100
different terpenes have been identified in cannabis; and despite
not being quite as popular or as well-studied as cannabinoids,
these diverse molecules are instrumental in delivering the
physiological and psychoactive effects of cannabis.
Products of Cannabis and Methods of Administering Cannabis
[0059] Cannabis edibles or cannabis infused pharmaceuticals for
oral administration are often associated with the following
problems: undesirable cannabis taste, high in calorie content,
contain gluten, contain animal byproducts, they do not account for
the entourage effect, and they do not effectively circumvent the
hepatic first pass effect.
[0060] Orally administered cannabis-based pharmaceuticals such as
Marinol, which contains a single cannabinoid:
delta-9-tetrahydrocannabinol, do not effectively utilize all of the
medically viable compounds found within the cannabis plant. This
neglects to take into account the entourage effect, a
scientifically proven phenomenon wherein several compounds found in
natural herbal remedies, such as cannabis, work in a synergistic
capacity with primary compounds, such as THC in the case of
cannabis. This effect is a product of the combined physiological
and psychoactive properties of the components of natural herbal
remedies, such as cannabis, in order to maximize medical efficacy
and safety. Research shows that these synergistic effects lead to a
three to four time increase in medical efficacy; meaning a
representative/total/complete cannabis extract will be three to
four times as effective as a THC--only extract. Studies also show
that these synergistic compounds help mitigate some of the negative
side effects of primary constituents, such as THC in the case of
cannabis. This poly-pharmacological effect is a recognized and
accepted theory in peer-review scientific literature. It is
important to note that an underlying tenant of herbal remedies,
such as cannabis, is that they often contain secondary compounds,
such as terpenes, flavonoids, and other cannabinoids, that work
synergistically with primary compounds, such as THC.
[0061] Furthermore, Marinol is composed of sesame seed oil, THC
extract, and gel capsules. This significantly limits the absorbance
of the THC and other medically viable compounds found in cannabis.
By failing to factor in the hepatic first pass effect the current
state of the art fails to capitalize on known methods of increasing
orally administered pharmaceutical potency and efficacy. This
oversight leads to a reduced efficacy and absorbance of the
medically viable compounds found in cannabis. The hepatic first
pass effect can be explained as a loss of drug potency and
concentration before it reaches systemic circulation. After
entering the digestive system and the hepatic portal system, the
drug in question is carried through the portal vein and into the
liver before it is distributed throughout the body. The liver
notices that this is a drug and not the nutrients it is used to and
places the drug on a metabolization path that greatly reduces the
drug's absorption in the body. This effect is mediated by four
primary systems: enzymes of the gastrointestinal lumen, gut wall
enzymes, bacterial enzymes, and hepatic enzymes.
[0062] The Cannabis genus: including cannabis sativa, cannabis
indica, and cannabis ruderalis species (and the seven sub-species)
and their cross breeds (including established strains) in both
female and male varieties, have been shown to contain chemical
compounds that have both psychotropic and medicinal effects.
[0063] For centuries, the primary method of cannabis consumption
has been smoking. Research shows us that smoking anything has a
marked detrimental effect on the respiratory system. Furthermore,
as cannabis becomes a widely accepted medicine, patients and
doctors alike are seeking drug delivery methods that can optimize
efficacy, potency, and duration without exerting any adverse
effects on the patient. Other forms of ingestion include: oral,
suppositories, inhalers, vaporization, topical, sublingual, and
many more.
[0064] Smoking cannabis is a terrible delivery system for the
medically viable components found in cannabis because it is
inefficient, harmful to the patient, and because it does not
provide accurately dosed cannabis. In practice, only 25-27% of the
medically viable compounds found in cannabis are absorbed and
delivered to systemic circulation making this method largely
inefficient. Smoking anything introduces tar and carcinogens into
the respiratory tract and is therefore harmful to the patient or
user. The tar, carbon monoxide, ammonia, oxides of nitrogen, and
hydrogen cyanide involved with smoking any plant material make it
an extremely poor choice for drug delivery. Lastly, smoking does
not provide the patient nor the doctor with any reasonable
information as to the dosage consumed. The bioavailability of
smoked cannabis can vary greatly and depends on depth of
inhalation, puff duration, and breathhold. There are too many
variables involved for this to be a reliable drug delivery
system.
[0065] A common alternative to smoking cannabis is oral
administration, or eating it. There are three main drawbacks to
this method of ingestion and the present invention addresses all of
these issues.
[0066] Firstly, edibles and orally administered cannabis-infused
pharmaceuticals are notoriously inefficient. This is largely due to
the hepatic first pass effect discussed at length in the Background
of the Invention section. Embodied herein are at least three
methods of overcoming these issues: (1) the inclusion of
surfactants (such as soy lecithin) helps emulsify the mixture
causing a more uniform distribution of the active ingredients and
causing the lipids utilized to bind to the medically viable
compounds of interest at a greater rate--causing a marked increase
in potency, efficacy, and onset, (2) nutrients (such as alcohols,
fats, proteins, and carbohydrates) help "trick" the liver into
recognizing the incoming substance as food or nutrients and
therefore decreases the prevalence of the hepatic first pass
effect, and (3) multiple iterations of heating and cooling that
have been shown to break cannabinoid clusters and lead to a more
potent and effective end product.
[0067] The second drawback when it comes to edibles and cannabis
infused pharmaceuticals is the slow onset. The present invention's
use of nutrients and surfactants does shorten the onset time but
not to a significant degree.
[0068] The third drawback, and the most common complaint from users
and patients who consume cannabis edibles or cannabis infused
pharmaceuticals, is the taste. The present invention completely
nullifies this complaint as the present invention is presented in
the form of a gelatin capsule and is therefore tasteless as the
user administers it.
[0069] Other drawbacks associated with most cannabis edibles and
cannabis infused pharmaceuticals: high in calorie content, contain
animal byproducts, contain gluten, high in sodium, religious
dietary restrictions, contain food allergens, and they often ignore
the entourage effect. In regards to the high calorie content,
embodied herein are low calorie and no calorie compositions (due to
their size vs. drug content ratio). In regards to containing
gluten, embodied herein are gluten free compositions to ensure that
patients with gluten intolerance can still use cannabis infused
pharmaceuticals and cannabis edibles. In regards to containing high
sodium contents, embodied herein are compositions that are sodium
free. In regards to containing animal byproducts, embodied herein
are compositions that are vegan, which ensures no animal byproducts
are used in the production of this cannabis edible or cannabis
infused pharmaceutical. In regards to religious dietary
restrictions, embodied herein are compositions that are of the
kosher and halal varieties, which ensure that patients and users of
all religious backgrounds can, in good faith, consume the proposed
cannabis edible or cannabis infused pharmaceutical. In regards to
the food allergens, embodied herein are compositions that are
allergen-free version that are completely void of the most common
allergens such as, but not limited to, peanuts, soy, milk, egg,
etc., thus ensuring that people with food allergies can safely
consume cannabis edibles and cannabis based pharmaceuticals.
Lastly, regarding the disregard of the entourage effect, as
detailed earlier in this section, embodied herein are compositions
that are the complete/full/representative cannabis extraction,
which therefore makes full use of the entourage effect.
[0070] In the state of art, orally administered cannabis-based
pharmaceuticals such as Marinol, which contains a single
cannabinoid: delta-9-tetrahydrocannabinol, do not effectively
utilize all of the medically viable compounds found within the
cannabis plant. This neglects to take into account the entourage
effect, a scientifically proven phenomenon wherein several
compounds found in natural herbal remedies, such as cannabis, work
in a synergistic capacity with primary compounds, such as THC in
the case of cannabis. This effect is a product of the combined
physiological and psychoactive properties of the components of
natural herbal remedies, such as cannabis, in order to maximize
medical efficacy and safety. Research shows that these synergistic
effects lead to a three to four time increase in medical efficacy;
meaning a representative/complete cannabis extract will be three to
four times as effective as a THC--only extract. Studies also show
that these synergistic compounds help mitigate some of the negative
side effects of primary constituents, such as THC in the case of
cannabis. This poly-pharmacological effect is a recognized and
accepted theory in peer-review scientific literature. It is
important to note that an underlying tenant of herbal remedies,
such as cannabis, is that they often contain secondary compounds,
such as terpenes, flavonoids, and other cannabinoids, that work
synergistically with primary compounds, such as THC.
[0071] Also, the prior art only mentions cannabis sativa. The
Cannabis genus: including cannabis sativa, cannabis indica, and
cannabis ruderalis species (and the seven sub-species) and their
cross breeds (including established strains) in both female and
male varieties, have been shown to contain chemical compounds that
have both psychotropic and medicinal effects.
[0072] For oral administration, the instant composition can be also
formulated readily by combining the active compounds with
pharmaceutically acceptable carriers well known in the art. Such
pharmaceutically acceptable carriers enable the compounds of the
present embodiments to be formulated as tablets, pills, dragees,
capsules, liquids, gels, syrups, slurries, suspensions and the
like, for oral ingestion by a patient to be treated. Pharmaceutical
formulations for oral use can be obtained by combining the active
compounds with solid excipient, optionally grinding a resulting
mixture, and processing the mixture of granules, after adding
suitable auxiliaries, if desired, to obtain tablets or dragee
cores. Suitable excipients are, in particular, fillers such as
sugars, including lactose, sucrose, mannitol, or sorbitol;
cellulose preparations such as, for example, maize starch, wheat
starch, rice starch, potato starch, gelatin, gum tragacanth, methyl
cellulose, hydroxypropylmethyl-cellulose, sodium
carboxymethylcellulose, and/or polyvinylpyrrolidone (PVP). If
desired, disintegrating agents may be added, such as the
cross-linked polyvinyl pyrrolidone, agar, or alginic acid or a salt
thereof such as sodium alginate. Dragee cores are provided with
suitable coatings. For this purpose, concentrated sugar solutions
may be used, which may optionally contain gum arabic, talc,
polyvinyl pyrrolidone, carbopol gel, polyethylene glycol, and/or
titanium dioxide, lacquer solutions, and suitable organic solvents
or solvent mixtures. Dyestuffs or pigments may be added to the
tablets or dragee coatings for identification or to characterize
different combinations of active compound doses. For this purpose,
concentrated sugar solutions may be used, which may optionally
contain gum arabic, talc, polyvinyl pyrrolidone, carbopol gel,
polyethylene glycol, and/or titanium dioxide, lacquer solutions,
and suitable organic solvents or solvent mixtures. Dyestuffs or
pigments may be added to the tablets or dragee coatings for
identification or to characterize different combinations of active
compound doses.
[0073] Alternatively, the formulations may be presented in a form
suitable for once-daily, once-weekly or once-monthly
administration; for example, an insoluble salt of the active
compound may be adapted to provide a preparation for intramuscular
injection. The pharmaceutical formulations described herein can be
administered to a patient per se, or in pharmaceutical formulations
where they are mixed with other active ingredients, as in
combination therapy, or suitable pharmaceutically acceptable
carriers or excipient(s). Techniques for formulation and
administration of the compounds of the instant application may be
found in "Remington's Pharmaceutical Sciences," Mack Publishing
Co., Easton, Pa., 18th edition, 1990.
[0074] The daily dosage of the products may be varied over a wide
range; e.g., from about 10 to about 10,000 mg per adult human per
day. For oral administration, the formulations are preferably
provided in the form of tablets containing about 0.1, 0.25, 0.5,
1.00, 5.00, 10.0, 15.0, 25.0, 50.0, 100, 200, 300, 400, 500, 600,
700, 800, 900 1000, 2000, 3000, 4000, 5000, 6000, 7000, 8000, 9000
or 10,000 milligrams of the active ingredient for the symptomatic
adjustment of the dosage to the patient to be treated. The instant
pharmaceutical formulations typically contain from 10 mg to about
2000 mg of the instant compounds, preferably, from about 50 mg to
about 1000 mg of active ingredient. An effective amount of the
instant compounds is ordinarily supplied at a dosage level of from
about 0.002 mg/kg to about 150 mg/kg of body weight per day.
Preferably, the range is from about 0.02 to about 80 mg/kg of body
weight per day, and especially from about 0.2 mg/kg to about 40
mg/kg of body weight per day. The compounds may be administered on
a regimen of about 1 to about 10 times per day. It is understood
that the dosage may vary widely from person to person based on
numerous factors.
Entourage Effect
[0075] The entourage effect, or the combinatory effects of the
phytochemicals (at varying ratios) found in cannabis, is generally
a more supported notion for therapeutic uses rather than isolated
cannabinoids. Isolated cannabinoids, such as CBD, do exhibit
efficacy on their own (in the case of schizophrenia, for example)
but the interactions among all of the various phytochemicals in
cannabis produce a much more effective and safe drug for patients.
Isolated THC (Marinol) is known to produce extremely adverse
effects in patients, so much so that some patients stop taking the
drug (anorexia study). The entourage effect mitigates the negatives
and highlights the positives. In order to truly treat a disease or
ailment, the entourage effect can be fine-tuned to meet the needs
of the patient.
[0076] Terpenes and cannabinoids have been shown to be largely
responsible for the beneficial effects of cannabis. In fact, it is
the varying concentrations medically viable compounds that result
in different strains (genotypes) and their resulting chemotypes
(which can vary with grow conditions). Even a small variation in
terpene or cannabinoid concentration can cause noticeable
differences in the entourage/synergistic effects of cannabis. This
documented phenomenon is what distinguishes one strain from
another, and research shows it relies heavily on the physiological
effects produced by terpenes. Over 100 different terpenes have been
identified in cannabis; and despite not being as well-studied as
cannabinoids, these diverse molecules are instrumental in
delivering the physiological and psychoactive effects of
cannabis.
[0077] In the solvent based extractions detailed above, the
residual solvents are purged from the extract. The primary method
of purging the residual solvents utilized in the cannabis extract
industry is through use of a purge/vacuum oven/chamber. A
purge/vacuum oven is generally operated in the following manner:
the oven contains racks where trays of unpurged cannabis extracts
are placed. The purge/vacuum oven can then be set to a variety of
temperature and pressure programs aimed at accelerating the purge
process to bring the amounts of residual solvents in these extract
to below action limits set by the state in which the
processor/extractor operates. The main and obvious drawback that
comes with using purge/vacuum ovens/chambers is that they do not
exclusively purge solvents; they also purge other volatile
compounds such as terpenes (and other compounds of
pharmaceutical/organoleptic interest) as demonstrated in FIGS. 19
and 20. This process can strip the cannabis extract of many
volatile pharmaceutical components, thereby lowering the overall
pharmaceutical efficacy and potency of the cannabis extract.
Embodiments of Methods and Apparatuses
[0078] Disclosed herein are methods of cannabis extraction in which
these compounds (including but not limited to cannabinoids,
terpenes, etc.) that contribute to the entourage effect are
retained. In some embodiments, the apparatus disclosed in FIGS. 2A,
2B, and 2C is used to retain these compounds through the use of a
size exclusion filter wherein compounds of a certain size are
retained in the chamber/reaction vessel and compounds smaller than
a certain size will pass through the size exclusion filter and exit
the chamber/reaction vessel. Leveraging the physical differences
between compounds allow for the formulation of cannabis products
with unprecedented quality as there will be virtually no loss of
the compounds in cannabis and cannabis extracts that contribute to
its pharmaceutical efficacy (compounds that contribute to the
entourage effect).
[0079] The use of any/all medically viable compounds found within
the cannabis plant leads to the effective utilization of the
entourage effect, ensuring a safer and more effective
pharmaceutical formulation. These compounds activate and regulate
the endocannabinoid system resulting in a wide variety of effects
and possible therapeutic applications. The ECS has been implicated
in a wide variety of physiological and pathophysiological processes
including but not limited to neural development, immune function,
inflammation, appetite, metabolism and energy homeostasis,
cardiovascular function, digestion, bone development and bone
density, synaptic plasticity and learning, pain, reproduction,
psychiatric disease, psychomotor behavior, memory, wake/sleep
cycles, and the regulation of stress and emotional state.
Therefore, cannabinoids (and other allosteric compounds such as
terpenes) can theoretically be used as novel therapeutics in any
disease in which any of the previously mentioned processes is
affected. Such diseases and ailments include but are not limited
to: nausea and vomiting, wasting syndrome (AIDS), lack of appetite
(exhibited in cancer and AIDS patients as well as patients
suffering from anorexia nervosa), multiple sclerosis, spinal cord
trauma, epilepsy, pain, arthritis (and other musculoskeletal
disorders), movement disorders, glaucoma, asthma, hypertension,
psychiatric disorders, dementia, general inflammation,
gastrointestinal disorders, acute stress disorder; affective
disorders, including depressive disorders (major depressive
disorder, dysthymia, childhood depression, atypical depression,
bipolar disorder, mania and hypomania) and anxiety disorders
(generalized anxiety disorder, social anxiety disorder, phobias,
obsessive compulsive disorder, panic disorder, post-traumatic
stress disorder); premenstrual dysphoric disorder (also known as
pre-menstrual syndrome); psychotic disorders, such as brief
psychotic disorder, schizophrenia, psychotic mood disorder
(depression and/or mania); attention deficit disorder (with and
without hyperactivity); obesity, eating disorders such as anorexia
nervosa and bulimia nervosa; vasomotor flushing; cocaine and
alcohol addiction; sexual dysfunction and related illnesses; acute
and chronic pain syndromes, as exemplified by fibromyalgia, chronic
low back pain, trigeminal neuralgia; visceral pain syndromes, such
as irritable bowel syndrome, noncardiac chest pain, functional
dyspepsia, interstitial cystitis, essential vulvodynia, urethral
syndrome, orchialgia, temperomandibular disorder, atypical face
pain, migraine headache, and tension headache; functional somatic
disorders, for example, chronic fatigue syndrome; neurologic
disorders including seizure disorder, Tourette Syndrome,
Parkinson's Disease, Huntington's Chorea, Alzheimer's Disease,
subcortical and other dementias, Tardive Dyskinesia, Rett Syndrome,
amyotrophic lateral sclerosis and others. It should also be noted
that a lot of these ailments and conditions have very poor
prognoses. At the very least cannabis can be used to improve the
quality of life in these patients.
[0080] Embodiments of the cannabis extraction process disclosed
herein include the use methods and apparatuses that preserve
important pharmaceutical components of the cannabis extraction
process. (See, for example, FIGS. 2A, 2B, 2C, and 3).
[0081] In some embodiments, all species or any combination of
various species of cannabis are used in the extraction process
including cannabis sativa, cannabis indica, and cannabis ruderalis
species (and the seven sub-species) and their cross breeds
(including established strains) in both female and male varieties.
In some embodiments, a representative/total/complete preparation
made using the apparatus depicted in FIGS. 2A, 2B, and 2C is
provided. A variety of extraction mediums may be used, including
but not limited to: cold water extraction and dry sift (hash), CO2,
hydrocarbons (including but not limited to: butane, propane,
hexane), alcohol (including but not limited to: ethanol,
iso-propyl, methanol), and rosin tech (heat extraction)) of
cannabis and any/all medically viable compounds found therein
(including but not limited to cannabinoids, nitrogenous compounds,
amino acids, proteins, enzymes, glycoproteins, hydrocarbons, simple
alcohols, aldehydes, ketones and acids, fatty acids, simple esters
and lactones, steroids, terpenes, non-cannabinoid phenols,
flavonoids, vitamins, and pigments) and its species (including but
not limited to cannabis sativa, cannabis indica, cannabis
ruderalis--and any/all subspecies and any/all cross breeds thereof
and any/all established strains--in both male and female
varieties--using both live and dried cannabis plant material) and
the subsequent conversion of these extracts into pill-able forms
for oral administration (immediate and extended release).
[0082] In some embodiments, surfactant(s)/emulsifier(s) and
nutritional compounds are used in order to increase the
bioavailability and subsequent absorption of these orally
administered cannabis pills/capsules, and the medically viable
compounds found therein as a result of a total cannabis extraction,
within the mammalian gastrointestinal tract (effectively bypassing
the hepatic first pass effect). Varieties will include but will not
be limited to: Vegan, kosher, halal, gluten free, extremely potent,
CBD rich, low potency, non-decarboxylated (non-psychoactive), live
plant material, allergen-free, extended release, very low or sodium
free, established cannabis strains, and more. The Apparatus
depicted in FIGS. 2A, 2B, and 2C may be used to retain compounds of
pharmaceutical interest (during the cannabis extract purge process
and the cannabis/cannabis extract decarboxylation process) by
utilizing a size exclusion filter. Thus, the apparatus leverages
the physical differences between compounds the seeking to be
retained and the compounds that should be purged
[0083] The following sections provide description of further
embodiments. Following this, descriptions of non-limiting examples
are provided.
Embodiments of Methods of Extracting Cannabis
[0084] In some embodiments, a method of cannabis extraction is
provided. The method comprises (i) adding any amount of at least
one species of cannabis plant or any amount of an extract of at
least one species of cannabis plant to a reaction chamber, (ii)
optionally producing cannabis extracts through extracting cannabis
from the amount of at least one species of cannabis plant in the
chamber, (iii) removing byproducts from the reaction chamber that
are produced from extracting cannabis, (iv) retaining compounds
within the chamber derived from cannabis. The chamber comprises a
filter in which the pores of the filter allow for removal from the
reaction chamber of byproducts of the extraction process but
prevent removal of compounds derived from cannabis.
[0085] Any species of cannabis, whether it is a currently known
species or a species to be discovered in the future, can be added
to the reaction chamber in step (i). Any number of species can be
added to the reaction chamber in a given reaction, up to and
including adding all of the species of cannabis. In some
embodiments, the species of cannabis added to the reaction chamber
comprise Cannabis sativa, Cannabis indica, and Cannabis ruderalis.
In some embodiments, any one of these species is added to the
reaction chamber. In some embodiments, any two of these species are
added to the reaction chamber. In some embodiments, all three of
these species are added to the reaction chamber.
[0086] In some embodiments, the cannabis used in the extraction
process is a live extract. In some embodiments, the cannabis used
in the extraction process is a dried and/or cured extract.
[0087] In some embodiments, the reaction chamber used in the method
is an airtight reaction chamber.
[0088] In some embodiments, the extraction step (ii) comprises a
solvent based extraction method. Any solvent known in the art that
is used to extract cannabis may be used to in the extraction step.
In some embodiments, the solvent used is, for example, iso-propyl,
methanol, n-propyl alcohol, propane, butane, iso-butane, methanol,
and ethanol.
[0089] In some embodiments, the extraction step (ii) does not use a
solvent. In some embodiments, the extraction is a heat extraction,
an unheated extraction, a cold water extraction, a CO2 extraction,
and a rosin tech extraction.
[0090] In some embodiments a method is provided that comprises a
optional cannabis extraction step and a decarboxylation step. Any
temperature/time period known in the art sufficient to
decarboxylate cannabis can be used in the decarboxylation step. In
some embodiments, the decarboxylation step comprises using an
enzyme or cofactor that catalyzes the decarboxylation step, for
example, a decarboxylase. In some embodiments, H.sub.2O is used as
a catalyst of the decarboxylation reaction. In some embodiments,
the decarboxylation step occurs in the presence of an inert gas.
The inert gas may be any of the noble gas including helium, neon,
argon, krypton, xenon, and radon.
[0091] In some embodiments, the cannabis extraction method further
comprises the step of treating the reaction chamber with an inert
gas prior to the decarboxylation reaction.
[0092] The decarboxylation step will result in the release of
CO.sub.2. In some embodiments, the CO.sub.2 is released from the
reaction chamber by passing the CO.sub.2 through the filter.
[0093] In some embodiments a non-solvent based extraction process
is used in step (ii). In some embodiments, a cold water extraction
is used. In some embodiments, a heat extraction is used.
[0094] In some embodiments, a method of cannabis extraction is
provided wherein the compounds retained within the chamber in step
(iv) that are derived from cannabis comprise cannabinoids. In some
embodiments, a method of cannabis extraction is provided wherein
the compounds retained within the chamber in step (iv) that are
derived from cannabis comprise terpenes. In some embodiments, the
compounds retained within the chamber comprise cannabinoids and
terpenes.
[0095] In some embodiments, a method of cannabis extraction is
provided wherein the compounds retained within the chamber in step
(iv) that are derived from cannabis comprise cannabinoids,
terpenes/terpenoids, amino acids, nitrogenous compounds, simple
alcohols, aldehydes, ketones, esters, lactones, and acids, fatty
acids, steroids, non-cannabinoid phenols, pigments, flavonoids,
vitamins, proteins, enzymes, glycoproteins, and hydrocarbons. The
compounds retained within the chamber may comprise any one or more
of these compounds, in any combination.
[0096] In some embodiments, a method of cannabis extraction is
provided wherein the compounds retained within the chamber in step
(iv) that are derived from cannabis comprise the at least 545
distinct compounds in cannabis. The compounds retained within the
chamber may comprise any one or more of the at least 545 distinct
compounds, in any combination. In some embodiments, the compounds
derived from cannabis in step (iv) comprise cannabinoids,
nitrogenous compounds, amino acids, proteins, enzymes,
glycoproteins, hydrocarbons, simple alcohols, aldehydes, ketones
and acids, fatty acids, simple esters and lactones, steroids,
terpenes, non-cannabinoid phenols, flavonoids, vitamins, and
pigments, in any combination. In some embodiments, the compounds
derived from cannabis in step (iv) comprise any one more of
cannabinoids, nitrogenous compounds, amino acids, proteins,
enzymes, glycoproteins, hydrocarbons, simple alcohols, aldehydes,
ketones and acids, fatty acids, simple esters and lactones,
steroids, terpenes, non-cannabinoid phenols, flavonoids, vitamins,
and pigments, in any combination.
[0097] In some embodiments, a method is provided which comprises
extracting cannabis from plant material (live or dried) using a
variety of extraction protocols (including but not limited to: cold
water extraction and dry sift (hash), CO2, hydrocarbons (including
but not limited to: butane, propane, hexane), alcohol (including
but not limited to: ethanol, iso-propyl, methanol, n-propyl
alcohol), and rosin tech (heated or unheated pressed extraction))
from any/all cannabis species (including but not limited to
cannabis sativa, cannabis indica, cannabis ruderalis--and any/all
subspecies and any/all cross breeds thereof and any/all established
strains--in both male and female varieties--using both live and
dried cannabis plant material).
[0098] The resulting extract is composed of one or more of the
following compounds, in any combination: cannabinoids, terpenes,
and any/all medically viable compounds found therein (including but
not limited to cannabinoids, nitrogenous compounds, amino acids,
proteins, enzymes, glycoproteins, hydrocarbons, simple alcohols,
aldehydes, ketones and acids, fatty acids, simple esters and
lactones, steroids, terpenes, non-cannabinoid phenols, flavonoids,
vitamins, and pigments).
[0099] In some embodiments, a method of preserving terpenes (and
other compounds of pharmaceutical and organoleptic interest) in the
decarboxylation process and extraction purge process is provided.
In some embodiments the method utilizes a chamber/reaction vessel
that makes use of a size-exclusion filter (filtration based on
molecular dimensions) as a means of retaining terpenes (and other
compounds of pharmaceutical/organoleptic interest) while allowing
CO.sub.2 (the primary byproduct of cannabinoid
decarboxylation--i.e. activation of the cannabinoids) and residual
solvents (including but not limited to: alcohols--such as ethanol
and alkanes--such as butane) to exit the chamber/reaction
vessel.
[0100] In some embodiments a method is provided comprising
condensing compounds of interest within a coil. In some embodiments
the compounds condensed in the chamber comprise any one or more of
terpenes, compounds of pharmaceutical interest, and compounds of
organoleptic interest. In some embodiments, the coil is temperature
regulated. In some embodiments, the terpenes and/or compounds are
condensed within the coil immediately before the compounds contact
a filter.
[0101] Any of the methods described herein for extracting cannabis
may further comprise the use of a surfactant. Any of the methods
described herein for extracting cannabis may further comprise the
use of an emulsifier. Any emulsifier known in the art can be used.
Examples of emulsifiers include but are not limited to soy
lecithin, egg yolk, sodium phosphates, and sodium stearoyl
lactylate, amongst others.
Embodiments of Apparatuses for Extracting Cannabis and Methods of
Using the Apparatuses
[0102] In some embodiments, an apparatus for extracting cannabis is
provided. In some embodiments an apparatus for extracting cannabis
is provided that is depicted in FIGS. 2A, 2B, and 2C. The apparatus
comprises an airtight container (1) with a reaction chamber (20)
and a size exclusion filter (10). The size exclusion filter
comprises pores (30) that are of sufficient size to allow
byproducts of a cannabis extraction process and of the
decarboxylation process to pass through the filter. The size
exclusion filter prevents the passage of compounds derived from
cannabis.
[0103] In some embodiments the size exclusion filter with a filter
size between 0.01 .ANG..sup.2 and 100 .ANG..sup.2, for example
between 20 and 40 .ANG..sup.2, between 22 .ANG..sup.2 and 38
.ANG..sup.2, between 24 .ANG..sup.2 and 36 .ANG..sup.2, between 26
.ANG..sup.2 and 34 .ANG..sup.2, between 28 .ANG..sup.2 and 32
.ANG..sup.2. In some embodiments the size exclusion filter is
between 29 .ANG..sup.2-31 .ANG..sup.2. Varying the size of the
filters will allow users to retain desired products within the
reaction chamber while allowing unwanted byproducts to escape.
[0104] One embodiment of this use of different filter sizes is to
leverage the difference in size between CO.sub.2 (the most common
byproduct of a decarboxylation process) and Myrcene (one of the
smallest known terpenes found in cannabis) from passing through the
filter. CO.sub.2 has a minimum projecting area of 9.08 .ANG..sup.2
and Myrcene has a minimum projection area of 30.96 .ANG..sup.2. A
filter embodied in the ranges above could be used that prevents the
passage of Myrcene through the filter, thus retaining Myrcene in
the reaction chamber, while allowing CO.sub.2 to pass through the
filter, thus purging CO.sub.2. Further embodiments of this idea are
illustrated in Table 1. As shown on Table 1, the minimum projection
area of the terpenes and cannabinoids (which are non-limiting
examples of compounds derived from cannabis that a user may want to
retain) are larger than the maximum projection area of inert gases,
residuals solvents, and product of decarboxylation (which are
non-limiting examples of byproducts that a user may want to purge
from the reaction chamber).
TABLE-US-00001 TABLE 1 Minimum Maximum Compound/Element Projection
Area Projection Area Compound Type Name (.ANG..sup.2) (.ANG..sup.2)
Inert Gas Helium 6.16 6.16 Neon 7.45 7.45 Argon 11.1 11.1 Residual
Solvents Propane 18.11 23.67 Butane 18.85 29.47 Iso-Butane 22.11
29.22 Methanol 11.18 15.32 Ethanol 15.61 21.19 Product of Carbon
Dioxide 9.08 14.11 Decarboxylation Terpenes Myrcene 30.96 51.62
Alpha-Pinene 34.54 43.89 Linalool 31.27 57.99 Caryophyllene 44.48
62.5 Eucalyptol 38.81 45.67 Alpha-Bisabolol 45.45 72.85
Cannabinoids Tetrahydro- 48.89 100.62 cannabinol I Cannabidiol
54.88 94.23 Cannabinol 47.35 99.6
[0105] In some embodiments, the apparatus comprises a coil that
precedes the filter. In some embodiments, the coil is temperature
regulated. In some embodiments, the coil functions to condense the
terpenes and other molecules of pharmaceutical and organoleptic
interest before they reach the size exclusion filter.
[0106] Turning again to FIGS. 2A, 2B, and 2C, in some embodiments,
the apparatus comprises a stir bar (60), for example, a magnetic
stir bar. In some embodiments, a base is provided that rotates the
stir bar. In some embodiments, the inner surface of the apparatus
is lined with a non-stick coating Any non-stick coating known in
the art can be used. Examples of a non-stick coating include but
are not limited to Teflon and silicone.
[0107] An embodiment of an apparatus that combines a stir bar with
a non-stick surface, can aid in facilitating the removal of
cannabis extracts after any byproducts of the extraction process
and/or the decarboxylation process have been removed through the
size exclusion filter.
[0108] In some embodiments, the apparatus is temperature
controlled. In some embodiments, the apparatus is pressure
controlled. In some embodiments, the apparatus is both temperature
and pressure controlled. An apparatus that is both temperature and
pressure controlled can allow for multiple combinations of
temperature and pressure during the cannabis extraction process
and/or the decarboxylation process. For example, less heat can be
utilized during a longer purge/decarboxylation duration in order to
prevent any unwanted side reactions.
[0109] In some embodiments, the apparatus comprises a loading door
(40) that is used for the introduction of cannabis or cannabis
extracts, which can be latched shut to preserve the airtight seal
of the apparatus. The dimensions of the loading door can be
adjusted as needed to allow for the introduction of different
amounts and different types of cannabis material into the
apparatus.
[0110] In some embodiments, the apparatus comprises a steel rod
(50) that is attached to the size exclusion filter and that is
within the reaction chamber. In some embodiments, the steel rod
passes through the center of the reaction chamber. In some
embodiments, the size exclusion filter is able to move up and down
on the steel rod. Moving the size exclusion filter up and down the
steel rod, allows the size exclusion filter to be placed at an
optimal distance from the material that is undergoing the
extraction process and/or decarboxylation process.
[0111] In some embodiments, the apparatus comprises one or more
valves (70) that function to introduce the inert gas into the
reaction chamber. In some embodiments, the apparatus comprises two
valves.
[0112] In some embodiments, methods of extracting cannabis are
provided in which any of the apparatuses described herein are used.
In some embodiments a method is provided comprising using any of
the apparatuses described herein, comprising the steps of (i)
adding any amount of at least one species of cannabis plant or any
amount of an extract of at least one species of cannabis plant to a
reaction chamber, (ii) optionally producing cannabis extracts
through extracting cannabis from the amount of at least one species
of cannabis plant in the chamber, (iii) removing byproducts from
the reaction chamber that are produced from extracting cannabis,
and (iv) retaining compounds within the chamber derived from
cannabis, wherein the reaction chamber comprises a filter in which
the pores allow for removal from the reaction chamber of the
byproducts from the cannabis extraction process and prevent removal
from the chamber of the compounds derived from cannabis.
Embodiments of Mixtures of Compounds Derived from Cannabis
[0113] In some embodiments, a mixture of compounds derived from
cannabis is provided. In some embodiments, the mixture comprises
any of the compounds depicted in FIGS. 4-17, in any
combination.
[0114] In some embodiments, a mixture of compounds is provided that
comprises at least one terpene compound derived from cannabis and
at least one cannabinoid compound derived from cannabis.
[0115] In some embodiments, any of the mixtures of compounds
described herein comprise at least 5 terpene compounds derived from
cannabis, for example, at least 10 terpene compounds derived from
cannabis, at least 15 terpene compounds derived from cannabis, or
at least 20 terpene compounds derived from cannabis.
[0116] In some embodiments, the mixture of compounds comprises 24
terpene compounds derived from cannabis. In some embodiments the 24
terpene compounds comprise, .alpha.-Pinene, Camphene,
.beta.-Pinene, .beta.-Myrcene, 3-Carene, .alpha.-Terphinene,
D-Limonene, p-Cymene, Eucalyptol, cis-.beta.-Ocimene,
.gamma.-Terpinen, Terpinolene, Linalool, trans-.beta.-Ocimene,
Fenchol, Isopulegol, Geraniol, .beta.-Caryophyllene,
.alpha.-Humulene, cis-Nerolidol, trans-Nerolidol, Guaiol,
Caryophyllene Oxide, and .alpha.-Bisabolol.
[0117] In any of the embodiments of mixtures of compounds described
herein, the percent mass of each terpene compound is between
0.0001% and 10%, for example between 0.0001% and 0.1%, between
0.0005% and 0.07% or between 0.001% and 0.05%.
[0118] In some embodiments, the terpene profile is similar to the
profile depicted in FIG. 22.
[0119] In some embodiments, any of the mixtures of compounds
described herein comprise at least 3 cannabinoid compounds derived
from cannabis, for example, 7 compounds derived from cannabis. In
some embodiments, the 7 cannabinoid compounds comprise: THC-A,
CBL-A, .DELTA.9-THC, CBN, CBC, CBG, and THCV.
[0120] In any of the embodiments of mixtures of compounds described
herein, the mg/ml of each cannabinoid is between 0.0001 mg/ml and
1000 mg/ml, for example, 0.01 mg/1 and 25 mg/ml or between 0.1
mg/ml and 22 mg/ml.
[0121] In some embodiments, the cannabinoid profile is similar to
the profile depicted in FIG. 21.
[0122] In some embodiments, a mixture of compounds derived from
cannabis is provided that comprises cannabinoids, nitrogenous
compounds, amino acids, proteins, enzymes, glycoproteins,
hydrocarbons, simple alcohols, aldehydes, ketones and acids, fatty
acids, simple esters and lactones, steroids, terpenes,
non-cannabinoid phenols, flavonoids, vitamins, and pigments. In
some embodiments, a mixture of compounds derived from cannabis is
provided that comprises any one or more of cannabinoids,
nitrogenous compounds, amino acids, proteins, enzymes,
glycoproteins, hydrocarbons, simple alcohols, aldehydes, ketones
and acids, fatty acids, simple esters and lactones, steroids,
terpenes, non-cannabinoid phenols, flavonoids, vitamins, and
pigments, in any combination.
[0123] In any of the embodiments of mixtures of compounds described
herein, the compounds may be contained within a capsule. In some
embodiments, the capsule is a gelatin capsule that is depicted in
FIG. 18.
[0124] In some embodiments, any of the capsules described herein
comprises a pharmaceutical formulation. In some embodiments, any of
the cannabis formulations described herein comprise a
pharmaceutical formulation.
Methods of Treatment
[0125] In some embodiments, a method of treatment is provided that
comprises administering a pharmaceutically acceptable amount of any
of the pharmaceutical formulations described herein to a patient in
need thereof. In some embodiments administering the mixture to the
patient results in the patient experiencing the entourage
effect.
[0126] Any of the pharmaceutical formulations described herein may
be administered for the purpose of treating any one or more of the
following: nausea and vomiting, wasting syndrome (AIDS), lack of
appetite (exhibited in cancer and AIDs patients as well as patients
suffering from anorexia nervosa), multiple sclerosis, spinal cord
trauma, epilepsy, pain, arthritis (and other musculoskeletal
disorders), movement disorders, glaucoma, asthma, hypertension,
psychiatric disorders, Alzheimer's and dementia, general
inflammation, gastrointestinal disorders.
[0127] As used herein, the term "patient" refers to the recipient
of a therapeutic treatment and includes all organisms within the
kingdom animalia. In preferred embodiments, the animal is within
the family of mammals, such as humans, bovine, ovine, porcine,
feline, buffalo, canine, goat, equine, donkey, deer and primates.
In some embodiments, the animal is human.
[0128] As used herein, the terms "treat" "treating" and "treatment"
include "prevent" "preventing" and "prevention" respectively.
[0129] Language of degree used herein, such as the terms
"approximately," "about," "generally," and "substantially" as used
herein represent a value, amount or characteristic close to the
stated value, amount or characteristic that still performs a
desired function or achieves a desired result. For example, the
terms "approximately," "about," "generally," and "substantially"
may refer to an amount that is within less than 10% of, within less
than 5% of, within less than 1% of, within less than 0.1% of, and
within less than 0.01% of the stated amount. As another example, in
certain embodiments, the terms "generally parallel" and
"substantially parallel" refer to a value, amount, or
characteristic that departs from exactly parallel by less than or
equal to 15.degree., 10.degree., 5.degree., 3.degree., 1.degree.,
0.1.degree., or otherwise.
[0130] Similarly, in certain embodiments, the terms "generally
perpendicular" and "substantially perpendicular" refer to a value,
amount, or characteristic that departs from exactly perpendicular
by less than or equal to 15.degree., 10.degree., 5.degree.,
3.degree., 1.degree., 0.1.degree. , or otherwise.
EXAMPLES
[0131] Some aspects of the embodiments discussed above are
disclosed in further detail in the following examples, which are
not in any way intended to limit the scope of the present
disclosure.
Example 1
[0132] Cannabis Extraction Using Hybrid Strains
[0133] Starting with cannabis plant material that originates from
any and all hybrid cannabis strain (mixed breed of cannabis,
including but not limited to cannabis sativa, cannabis indica,
and/or cannabis ruderalis--and any/all sub species--in both male
and female varieties), the sample was dried and cured (proper
drying and storage protocol ensures maximal terpene content), then
the medically viable compounds (primarily cannabinoids and
terpenes) were extracted from the plant material using a variety of
extraction methods (including but not limited to: cold water
extraction and dry sift (hash), CO2, hydrocarbons (including but
not limited to: butane, propane, hexane), alcohol (including but
not limited to: ethanol, iso-propyl, methanol), and rosin tech
(heat extraction)) or alternatively, no extraction is
performed.
[0134] For solvent based cannabis extracts, the residual solvents
were purged from the extract while retaining compounds of
pharmaceutical and organoleptic interest. Next, the sample was
decarboxylated (at a variety of temperatures (.about.90-180.degree.
C.). This decarboxylation was performed in an airtight container in
order to prevent and limit the escape and degradation of vaporized
medically viable compounds including but not limited to terpenes
and cannabinoids. Next, an organic medium (including but not
limited to: lipids, alcohols, etc.) and surfactant(s) (including
but not limited to: soy lecithin, egg yolk, yucca extract) were
added to the decarboxylated extract (or decarboxylated plant
material). The mixture was then subjected to an optional heating
step temperatures (.about.90-180.degree. C.). The duration of the
heating step varied depending on batch size, desired
characteristics of final product, and other factors. Varying the
temperatures, pressures, methods, and durations of heat exposure
greatly influenced the medical characteristics of the final
product.
[0135] In an optional step, nutritional compounds (including but
not limited to: alcohols, fats, carbohydrates, and proteins) and
food coloring were added to the mixture after which the mixture was
frozen. In some of the extractions, the mixture was subjected to
further iterations of heating and freezing cycles. The mixture,
which was a yellow/light brown/golden in color, was filtered and
used to fill gelatin capsules (FIG. 18). The capsules were then
stored. FIGS. 21 and 22 show the amounts and percentages of
terpenes and cannabinoids that resulted from this decarboxylation
method.
[0136] All ingredients may vary in ratio in final product, from
0-100% by weight. Not all ingredients or steps listed above must be
performed. For example, (1) omission of nutrients does not
constitute a new product and (2) omission of the freezing step does
not constitute a new manufacturing process.
Example 2
[0137] Cannabis Extraction Using the Cannabis Indicia Strain
[0138] Starting with cannabis plant material that originates from
any and all cannabis indica strains (and any/all subspecies--in
both male and female varieties), the sample is dried and cured
(proper drying and storage protocol ensures maximal terpene
content), then the medically viable compounds (primarily
cannabinoids and terpenes) are extracted from the plant material
using a variety of extraction methods (including but not limited
to: cold water extraction and dry sift (hash), CO2, hydrocarbons
(including but not limited to: butane, propane, hexane), alcohol
(including but not limited to: ethanol, iso-propyl, methanol), and
rosin tech (heat extraction)) or alternatively, no extraction is
performed.
[0139] If the cannabis extract was solvent based then the residual
solvents can be purged from the extract while retaining compounds
of pharmaceutical and organoleptic interest (described in FIG. 3).
Next, the sample is fully (or partially) decarboxylated (at a
variety of temperatures (.about.90-180.degree. C.), pressures,
methods, and durations can vary depending on batch size, desired
characteristics of final product, and other factors). This
decarboxylation step can be performed in an airtight container in
order to prevent and limit the escape and degradation of vaporized
medically viable compounds including but not limited to terpenes
and cannabinoids. Next, an organic medium (including but not
limited to: lipids, alcohols, etc.) and surfactant(s) (including
but not limited to: soy lecithin, egg yolk, yucca extract) are
added to the decarboxylated extract (or decarboxylated plant
material) the mixture is then optionally heated (temperatures
(.about.90-180.degree. C.) and durations can vary depending on
batch size, desired characteristics of final product, and other
factors). Varying the temperatures, pressures, methods, and
durations of heat exposure can greatly influence the medical
characteristics of the final product. Nutritional compounds
(including but not limited to: alcohols, fats, carbohydrates, and
proteins) are optionally added to the mixture. Food coloring may
also be added at this point. The mixture is then optionally frozen.
Further iterations of heating and freezing may be utilized. The
mixture should be yellow/light brown/golden in color. It is then
filtered and used to fill gelatin capsules. The capsules are then
stored.
[0140] All ingredients may vary in ratio in final product, from
0-100% by weight. Not all ingredients or steps listed above must be
performed. For example, (1) omission of nutrients, surfactants, or
food coloring does not constitute a new product and (2) omission of
the freezing step does not constitute a new manufacturing
process.
Example 3
[0141] Cannabis Extraction Using the Cannabis Sativa Strain
[0142] Starting with cannabis plant material that originates from
any and all cannabis sativa strains (and any/all subspecies--in
both male and female varieties), the sample is dried and cured
(proper drying and storage protocol ensures maximal terpene
content), then the medically viable compounds (primarily
cannabinoids and terpenes) are extracted from the plant material
using a variety of extraction methods (including but not limited
to: cold water extraction and dry sift (hash), CO2, hydrocarbons
(including but not limited to: butane, propane, hexane), alcohol
(including but not limited to: ethanol, iso-propyl, methanol), and
rosin tech (heat extraction)) or alternatively, no extraction is
performed.
[0143] If the cannabis extract was solvent based then the residual
solvents can be purged from the extract while retaining compounds
of pharmaceutical and organoleptic interest (described in FIG. 3).
Next, the sample is fully (or partially) decarboxylated (at a
variety of temperatures (.about.90-180.degree. C.), pressures,
methods, and durations can vary depending on batch size, desired
characteristics of final product, and other factors). This
decarboxylation can be performed in an airtight container in order
to prevent and limit the escape and degradation of vaporized
medically viable compounds including but not limited to terpenes
and cannabinoids. Next, an organic medium (including but not
limited to: lipids, alcohols, etc.) and surfactant(s) (including
but not limited to: soy lecithin, egg yolk, yucca extract) are
added to the decarboxylated extract (or decarboxylated plant
material) the mixture is then optionally heated (temperatures
(.about.90-180.degree. C.) and durations can vary depending on
batch size, desired characteristics of final product, and other
factors). Varying the temperatures, pressures, methods, and
durations of heat exposure can greatly influence the medical
characteristics of the final product. Nutritional compounds
(including but not limited to: alcohols, fats, carbohydrates, and
proteins) are optionally added to the mixture. Food coloring may
also be added at this point. The mixture is then optionally frozen.
Further iterations of heating and freezing may be utilized. The
mixture should be yellow/light brown/golden in color. It is then
filtered and used to fill gelatin capsules. The capsules are then
stored.
[0144] All ingredients may vary in ratio in final product, from
0-100% by weight. Not all ingredients or steps listed above must be
performed. For example, (1) omission of nutrients, surfactants, or
food coloring does not constitute a new product and (2) omission of
the freezing step does not constitute a new manufacturing
process.
Example 4
[0145] Cannabis Extraction Using an Established Strain
[0146] Starting with cannabis plant material that originates from
any and all established strains, for example Sour Diesel strain and
any/all sub strains (in both male and female varieties), the sample
is dried and cured (proper drying and storage protocol ensures
maximal terpene content), then the medically viable compounds
(primarily cannabinoids and terpenes) are extracted from the plant
material using a variety of extraction methods (including but not
limited to: cold water extraction and dry sift (hash), CO2,
hydrocarbons (including but not limited to: butane, propane,
hexane), alcohol (including but not limited to: ethanol,
iso-propyl, methanol), and rosin tech (heat extraction)) or
alternatively, no extraction is performed.
[0147] If the cannabis extract was solvent based then the residual
solvents from be purged from the extract while retaining compounds
of pharmaceutical and organoleptic interest (described in FIG. 3).
Next, the sample is fully (or partially) decarboxylated (at a
variety of temperatures (.about.90-180.degree. C.), pressures,
methods, and durations can vary depending on batch size, desired
characteristics of final product, and other factors). This
decarboxylation step can be performed in an airtight container in
order to prevent and limit the escape and degradation of vaporized
medically viable compounds including but not limited to terpenes
and cannabinoids. Next, an organic medium (including but not
limited to: lipids, alcohols, etc.) and surfactant(s) (including
but not limited to: soy lecithin, egg yolk, yucca extract) are
added to the decarboxylated extract (or decarboxylated plant
material) the mixture is then optionally heated (temperatures
(.about.90-180.degree. C.) and durations can vary depending on
batch size, desired characteristics of final product, and other
factors). Varying the temperatures, pressures, methods, and
durations of heat exposure can greatly influence the medical
characteristics of the final product. Nutritional compounds
(including but not limited to: alcohols, fats, carbohydrates, and
proteins) are optionally added to the mixture. Food coloring may
also be added at this point. The mixture is then optionally frozen.
Further iterations of heating and freezing may be utilized. The
mixture should be yellow/light brown/golden in color. It is then
filtered and used to fill gelatin capsules. The capsules are then
stored.
[0148] All ingredients may vary in ratio in final product, from
0-100% by weight. Not all ingredients or steps listed above must be
performed. For example, (1) omission of nutrients, surfactants, or
food coloring does not constitute a new product and (2) omission of
the freezing step does not constitute a new manufacturing
process.
Example 5
[0149] Cannabis Extraction Using Live Plant Material that is Not
Dried or Cured
[0150] Starting with live/not dried cannabis plant material that
originates from any and all cannabis species (including but not
limited to cannabis sativa, cannabis indica, cannabis
ruderalis--and any/all subspecies and any/all cross breeds
thereof--in both male and female varieties) the medically viable
compounds (primarily cannabinoids and terpenes) are extracted from
the plant material using a variety of extraction methods (including
but not limited to: cold water extraction and dry sift (hash), CO2,
hydrocarbons (including but not limited to: butane, propane,
hexane), alcohol (including but not limited to: ethanol,
iso-propyl, methanol), and rosin tech (heat extraction)) or
alternatively, no extraction is performed.
[0151] If the cannabis extract was solvent based then the residual
solvents can be purged from the extract while retaining compounds
of pharmaceutical and organoleptic interest (described in FIG. 3).
Next, the sample is fully (or partially) decarboxylated (at a
variety of temperatures (.about.90-180.degree. C.), pressures,
methods, and durations can vary depending on batch size, desired
characteristics of final product, and other factors). This
decarboxylation can be performed in an airtight container in order
to prevent and limit the escape and degradation of vaporized
medically viable compounds including but not limited to terpenes
and cannabinoids. Next, an organic medium (including but not
limited to: lipids, alcohols, etc.) and surfactant(s) (including
but not limited to: soy lecithin, egg yolk, yucca extract) are
added to the decarboxylated extract (or decarboxylated plant
material) the mixture is then optionally heated (temperatures
(.about.90-180.degree. C.) and durations can vary depending on
batch size, desired characteristics of final product, and other
factors). Varying the temperatures, pressures, methods, and
durations of heat exposure can greatly influence the medical
characteristics of the final product. Nutritional compounds
(including but not limited to: alcohols, fats, carbohydrates, and
proteins) are optionally added to the mixture. Food coloring may
also be added at this point. The mixture is then optionally frozen.
Further iterations of heating and freezing may be utilized. The
mixture should be yellow/light brown/golden in color. It is then
filtered and used to fill gelatin capsules. The capsules are then
stored.
[0152] All ingredients may vary in ratio in final product, from
0-100% by weight. Not all ingredients or steps listed above must be
performed. For example, (1) omission of nutrients, surfactants, or
food coloring does not constitute a new product and (2) omission of
the freezing step does not constitute a new manufacturing
process.
Example 6
[0153] Cannabis Extraction to Produce Kosher Extracts
[0154] Starting with cannabis plant material that originates from
any and all cannabis species (including but not limited to cannabis
sativa, cannabis indica, cannabis ruderalis--and any/all subspecies
and any/all cross breeds thereof--in both male and female
varieties), the sample is dried and cured (proper drying and
storage protocol ensures maximal terpene content), then the
medically viable compounds (primarily cannabinoids and terpenes)
are extracted from the plant material using a variety of extraction
methods (including but not limited to: cold water extraction and
dry sift (hash), CO2, hydrocarbons (including but not limited to:
butane, propane, hexane), alcohol (including but not limited to:
ethanol, iso-propyl, methanol), and rosin tech (heat extraction))
or alternatively, no extraction is performed.
[0155] If the cannabis extract was solvent based then the residual
solvents can be purged from the extract while retaining compounds
of pharmaceutical and organoleptic interest (described in FIG. 3).
Next, the sample is fully (or partially) decarboxylated (at a
variety of temperatures (.about.90-180.degree. C.), pressures,
methods, and durations can vary depending on batch size, desired
characteristics of final product, and other factors). This
decarboxylation step can be performed in an airtight container in
order to prevent and limit the escape and degradation of vaporized
medically viable compounds including but not limited to terpenes
and cannabinoids. Next, an organic medium (including but not
limited to: lipids, alcohols, etc.) and surfactant(s) (including
but not limited to: soy lecithin, egg yolk, yucca extract) are
added to the decarboxylated extract (or decarboxylated plant
material) the mixture is then optionally heated (temperatures
(.about.90-180.degree. C.) and durations can vary depending on
batch size, desired characteristics of final product, and other
factors). Varying the temperatures, pressures, methods, and
durations of heat exposure can greatly influence the medical
characteristics of the final product. Nutritional compounds
(including but not limited to: alcohols, fats, carbohydrates, and
proteins) are optionally added to the mixture. Food coloring may
also be added at this point. The mixture is then optionally frozen.
Further iterations of heating and freezing may be utilized. The
mixture should be yellow/light brown/golden in color. It is then
filtered and used to fill gelatin capsules. The capsules are then
stored.
[0156] All ingredients may vary in ratio in final product, from
0-100% by weight. Not all ingredients or steps listed above must be
performed. For example, (1) omission of nutrients, surfactants, or
food coloring does not constitute a new product and (2) omission of
the freezing step does not constitute a new manufacturing
process.
Example 7
[0157] Cannabis Extraction to Produce Halal Extracts
[0158] Under Islamic Law, as it pertains to dietary restrictions,
anything that is considered "kosher" is also considered halal.
Therefore the composition of this formulation will be exactly the
same as that of Example 6.
Example 8
[0159] Cannabis Extraction to Produce Vegan Extracts
[0160] Starting with cannabis plant material that originates from
any and all cannabis species (including but not limited to cannabis
sativa, cannabis indica, cannabis ruderalis--and any/all subspecies
and any/all cross breeds thereof--in both male and female
varieties), the sample is dried and cured (proper drying and
storage protocol ensures maximal terpene content), then the
medically viable compounds (primarily cannabinoids and terpenes)
are extracted from the plant material using a variety of extraction
methods (including but not limited to: cold water extraction and
dry sift (hash), CO2, hydrocarbons (including but not limited to:
butane, propane, hexane), alcohol (including but not limited to:
ethanol, iso-propyl, methanol), and rosin tech (heat extraction))
or alternatively, no extraction is performed.
[0161] If the cannabis extract was solvent based then the residual
solvents can be purged from the extract while retaining compounds
of pharmaceutical and organoleptic interest (described in FIG. 3).
Next, the sample is fully (or partially) decarboxylated (at a
variety of temperatures (.about.90-180.degree. C.), pressures,
methods, and durations can vary depending on batch size, desired
characteristics of final product, and other factors). This
decarboxylation step can be performed in an airtight container in
order to prevent and limit the escape and degradation of vaporized
medically viable compounds including but not limited to terpenes
and cannabinoids. Next, an organic medium (including but not
limited to: lipids, alcohols, etc.) and surfactant(s) (including
but not limited to: soy lecithin, egg yolk, yucca extract) are
added to the decarboxylated extract (or decarboxylated plant
material) the mixture is then optionally heated (temperatures
(.about.90-180.degree. C.) and durations can vary depending on
batch size, desired characteristics of final product, and other
factors). Varying the temperatures, pressures, methods, and
durations of heat exposure can greatly influence the medical
characteristics of the final product. Nutritional compounds
(including but not limited to: alcohols, fats, carbohydrates, and
proteins) are optionally added to the mixture. Food coloring may
also be added at this point. The mixture is then optionally frozen.
Further iterations of heating and freezing may be utilized. The
mixture should be yellow/light brown/golden in color. It is then
filtered and used to fill gelatin capsules. The capsules are then
stored.
[0162] All ingredients used in this vegan variety will be sourced
from non-animal sources. All ingredients may vary in ratio in final
product, from 0-100% by weight. Not all ingredients or steps listed
above must be performed. For example, (1) omission of nutrients,
surfactants, or food coloring does not constitute a new product and
(2) omission of the freezing step does not constitute a new
manufacturing process.
Example 9
[0163] Cannabis Extraction to Produce Gluten-Free Extracts
[0164] Starting with cannabis plant material that originates from
any and all cannabis species (including but not limited to cannabis
sativa, cannabis indica, cannabis ruderalis--and any/all subspecies
and any/all cross breeds thereof--in both male and female
varieties), the sample is dried and cured (proper drying and
storage protocol ensures maximal terpene content), then the
medically viable compounds (primarily cannabinoids and terpenes)
are extracted from the plant material using a variety of extraction
methods (including but not limited to: cold water extraction and
dry sift (hash), CO2, hydrocarbons (including but not limited to:
butane, propane, hexane), alcohol (including but not limited to:
ethanol, iso-propyl, methanol), and rosin tech (heat extraction))
or alternatively, no extraction is performed.
[0165] If the cannabis extract was solvent based the residual
solvents can be purged from the extract while retaining compounds
of pharmaceutical and organoleptic interest (described in FIG. 3).
Next, the sample is fully (or partially) decarboxylated (at a
variety of temperatures (.about.90-180.degree. C.), pressures,
methods, and durations can vary depending on batch size, desired
characteristics of final product, and other factors). This
decarboxylation step can be performed in an airtight container in
order to prevent and limit the escape and degradation of vaporized
medically viable compounds including but not limited to terpenes
and cannabinoids. Next, an organic medium (including but not
limited to: lipids, alcohols, etc.) and surfactant(s) (including
but not limited to: soy lecithin, egg yolk, yucca extract) are
added to the decarboxylated extract (or decarboxylated plant
material) the mixture is then optionally heated (temperatures
(.about.90-180.degree. C.) and durations can vary depending on
batch size, desired characteristics of final product, and other
factors). Varying the temperatures, pressures, methods, and
durations of heat exposure can greatly influence the medical
characteristics of the final product. Nutritional compounds
(including but not limited to: alcohols, fats, carbohydrates, and
proteins) are optionally added to the mixture. Food coloring may
also be added at this point. The mixture is then optionally frozen.
Further iterations of heating and freezing may be utilized. The
mixture should be yellow/light brown/golden in color. It is then
filtered and used to fill gelatin capsules. The capsules are then
stored.
[0166] All ingredients may vary in ratio in final product, from
0-100% by weight. All ingredients used in this variety will be
gluten-free. Not all ingredients or steps listed above must be
performed. For example, (1) omission of nutrients, surfactants, or
food coloring does not constitute a new product and (2) omission of
the freezing step does not constitute a new manufacturing
process.
Example 10
[0167] Cannabis Extraction that Does Not Utilize a Decarboxylation
Step
[0168] Starting with cannabis plant material that originates from
any and all cannabis species (including but not limited to cannabis
sativa, cannabis indica, cannabis ruderalis--and any/all subspecies
and any/all cross breeds thereof--in both male and female
varieties), the sample is dried and cured (proper drying and
storage protocol ensures maximal terpene content), then the
medically viable compounds (primarily cannabinoids and terpenes)
are extracted from the plant material using a variety of extraction
methods (including but not limited to: cold water extraction and
dry sift (hash), CO2, hydrocarbons (including but not limited to:
butane, propane, hexane), alcohol (including but not limited to:
ethanol, iso-propyl, methanol), and rosin tech (heat extraction))
or alternatively, no extraction is performed.
[0169] If the cannabis extract was solvent based then the residual
solvents can be purged from the extract while retaining compounds
of pharmaceutical and organoleptic interest (described in FIG. 3).
Next, the sample is fully (or partially) decarboxylated (at a
variety of temperatures (.about.90-180.degree. C.), pressures,
methods, and durations can vary depending on batch size, desired
characteristics of final product, and other factors). This
decarboxylation can be performed in an airtight container in order
to prevent and limit the escape and degradation of vaporized
medically viable compounds including but not limited to terpenes
and cannabinoids. Next, an organic medium (including but not
limited to: lipids, alcohols, etc.) and surfactant(s) (including
but not limited to: soy lecithin, egg yolk, yucca extract) are
added to the decarboxylated extract (or decarboxylated plant
material) the mixture is then optionally heated (temperatures
(.about.90-180.degree. C.) and durations can vary depending on
batch size, desired characteristics of final product, and other
factors). Varying the temperatures, pressures, methods, and
durations of heat exposure can greatly influence the medical
characteristics of the final product. In this embodiment, the
cannabis/cannabis extract will not be decarboxylated. Nutritional
compounds (including but not limited to: alcohols, fats,
carbohydrates, and proteins) are optionally added to the mixture.
Food coloring may also be added at this point. The mixture is then
optionally frozen. Further iterations of heating and freezing may
be utilized. The mixture should be yellow/light brown/golden in
color. It is then filtered and used to fill gelatin capsules. The
capsules are then stored.
[0170] All ingredients may vary in ratio in final product, from
0-100% by weight. Not all ingredients or steps listed above must be
performed. For example, (1) omission of nutrients, surfactants, or
food coloring does not constitute a new product and (2) omission of
the freezing step does not constitute a new manufacturing
process.
Example 11
[0171] Producing a Highly Potent Cannabis Extract
[0172] Starting with cannabis plant material that originates from
any and all cannabis species (including but not limited to cannabis
sativa, cannabis indica, cannabis ruderalis--and any/all subspecies
and any/all cross breeds thereof--in both male and female
varieties), the sample is dried and cured (proper drying and
storage protocol ensures maximal terpene content), then the
medically viable compounds (primarily cannabinoids and terpenes)
are extracted from the plant material using a variety of extraction
methods (including but not limited to: cold water extraction and
dry sift (hash), CO2, hydrocarbons (including but not limited to:
butane, propane, hexane), alcohol (including but not limited to:
ethanol, iso-propyl, methanol), and rosin tech (heat extraction))
or alternatively, no extraction is performed.
[0173] If the cannabis extract was solvent based then the residual
solvents can be purged from the extract while retaining compounds
of pharmaceutical and organoleptic interest (described in FIG. 3).
Next, the sample is fully (or partially) decarboxylated (at a
variety of temperatures (.about.90-180.degree. C.), pressures,
methods, and durations can vary depending on batch size, desired
characteristics of final product, and other factors). This
decarboxylation can be performed in an airtight container in order
to prevent and limit the escape and degradation of vaporized
medically viable compounds including but not limited to terpenes
and cannabinoids. Next, an organic medium (including but not
limited to: lipids, alcohols, etc.) and surfactant(s) (including
but not limited to: soy lecithin, egg yolk, yucca extract) are
added to the decarboxylated extract (or decarboxylated plant
material) the mixture is then optionally heated (temperatures
(.about.90-180.degree. C.) and durations can vary depending on
batch size, desired characteristics of final product, and other
factors). Varying the temperatures, pressures, methods, and
durations of heat exposure can greatly influence the medical
characteristics of the final product. For a high potency version a
greater ratio of cannabis extract to the organic medium and other
ingredients is used. For example, in this embodiment the ratio of
cannabis extract to lipids and other ingredients may be 10:1.
Nutritional compounds (including but not limited to: alcohols,
fats, carbohydrates, and proteins) are optionally added to the
mixture. Food coloring may also be added at this point. The mixture
is then optionally frozen. Further iterations of heating and
freezing may be utilized. The mixture should be yellow/light
brown/golden in color. It is then filtered and used to fill gelatin
capsules. The capsules are then stored.
[0174] All ingredients may vary in ratio in final product, from
0-100% by weight. Not all ingredients or steps listed above must be
performed. For example, (1) omission of nutrients, surfactants, or
food coloring does not constitute a new product and (2) omission of
the freezing step does not constitute a new manufacturing
process.
Example 12
[0175] Producing a Low Potency Cannabis Extract
[0176] Starting with cannabis plant material that originates from
any and all cannabis species (including but not limited to cannabis
sativa, cannabis indica, cannabis ruderalis--and any/all subspecies
and any/all cross breeds thereof--in both male and female
varieties), the sample is dried and cured (proper drying and
storage protocol ensures maximal terpene content), then the
medically viable compounds (primarily cannabinoids and terpenes)
are extracted from the plant material using a variety of extraction
methods (including but not limited to: cold water extraction and
dry sift (hash), CO2, hydrocarbons (including but not limited to:
butane, propane, hexane), alcohol (including but not limited to:
ethanol, iso-propyl, methanol), and rosin tech (heat extraction))
or alternatively, no extraction is performed.
[0177] If the cannabis extract was solvent based then the residual
solvents can be purged from the extract while retaining compounds
of pharmaceutical and organoleptic interest (described in FIG. 3).
Next, the sample is fully (or partially) decarboxylated (at a
variety of temperatures (.about.90-180.degree. C.), pressures,
methods, and durations can vary depending on batch size, desired
characteristics of final product, and other factors). This
decarboxylation step can be performed in an airtight container in
order to prevent and limit the escape and degradation of vaporized
medically viable compounds including but not limited to terpenes
and cannabinoids. Next, an organic medium (including but not
limited to: lipids, alcohols, etc.) and surfactant(s) (including
but not limited to: soy lecithin, egg yolk, yucca extract) are
added to the decarboxylated extract (or decarboxylated plant
material) the mixture is then optionally heated (temperatures
(.about.90-180.degree. C.) and durations can vary depending on
batch size, desired characteristics of final product, and other
factors). Varying the temperatures, pressures, methods, and
durations of heat exposure can greatly influence the medical
characteristics of the final product. For a low potency version a
smaller ratio of cannabis extract to the organic medium and other
ingredients is used. For example, in this embodiment the ratio of
cannabis extract to lipids and other ingredients may be 1:10.
Nutritional compounds (including but not limited to: alcohols,
fats, carbohydrates, and proteins) are optionally added to the
mixture. Food coloring may also be added at this point. The mixture
is then optionally frozen. Further iterations of heating and
freezing may be utilized. The mixture should be yellow/light
brown/golden in color. It is then filtered and used to fill gelatin
capsules. The capsules are then stored.
[0178] All ingredients may vary in ratio in final product, from
0-100% by weight. Not all ingredients or steps listed above must be
performed. For example, (1) omission of nutrients, surfactants, or
food coloring does not constitute a new product and (2) omission of
the freezing step does not constitute a new manufacturing
process.
Example 13
[0179] Producing a CBD Cannabis Extract
[0180] Starting with cannabis plant material that originates from
any and all cannabis species that have determined and high
concentrations of CBD, like "Charlotte's Web" for example
(including but not limited to cannabis sativa, cannabis indica,
cannabis ruderalis--and any/all subspecies and any/all cross breeds
thereof--in both male and female varieties), the sample is dried
and cured (proper drying and storage protocol ensures maximal
terpene content), then the medically viable compounds (primarily
cannabinoids and terpenes) are extracted from the plant material
using a variety of extraction methods (including but not limited
to: cold water extraction and dry sift (hash), CO2, hydrocarbons
(including but not limited to: butane, propane, hexane), alcohol
(including but not limited to: ethanol, iso-propyl, methanol), and
rosin tech (heat extraction)) or alternatively, no extraction is
performed.
[0181] If the cannabis extract was solvent based then the residual
solvents can be from the extract while retaining compounds of
pharmaceutical and organoleptic interest. Next, the sample is fully
(or partially) decarboxylated (at a variety of temperatures
(.about.90-180.degree. C.), pressures, methods, and durations can
vary depending on batch size, desired characteristics of final
product, and other factors). This decarboxylation step may be
performed in an airtight container in order to prevent and limit
the escape and degradation of vaporized medically viable compounds
including but not limited to terpenes and cannabinoids. Next, an
organic medium (including but not limited to: lipids, alcohols,
etc.) and surfactant(s) (including but not limited to: soy
lecithin, egg yolk, yucca extract) are added to the decarboxylated
extract (or decarboxylated plant material) the mixture is then
optionally heated (temperatures (.about.90-180.degree. C.) and
durations can vary depending on batch size, desired characteristics
of final product, and other factors). Varying the temperatures,
pressures, methods, and durations of heat exposure can greatly
influence the medical characteristics of the final product.
Nutritional compounds (including but not limited to: alcohols,
fats, carbohydrates, and proteins) are optionally added to the
mixture. Food coloring may also be added at this point. The mixture
is then optionally frozen. Further iterations of heating and
freezing may be utilized. The mixture should be yellow/light
brown/golden in color. It is then filtered and used to fill gelatin
capsules. The capsules are then stored.
[0182] All ingredients may vary in ratio in final product, from
0-100% by weight. Not all ingredients or steps listed above must be
performed. For example, (1) omission of nutrients, surfactants, or
food coloring does not constitute a new product and (2) omission of
the freezing step does not constitute a new manufacturing
process.
Example 14
[0183] Producing an Extended Release Cannabis Extract
[0184] Starting with cannabis plant material that originates from
any and all cannabis species (including but not limited to cannabis
sativa, cannabis indica, cannabis ruderalis--and any/all subspecies
and any/all cross breeds thereof--in both male and female
varieties), the sample is dried and cured (proper drying and
storage protocol ensures maximal terpene content), then the
medically viable compounds (primarily cannabinoids and terpenes)
are extracted from the plant material using a variety of extraction
methods (including but not limited to: cold water extraction and
dry sift (hash), CO2, hydrocarbons (including but not limited to:
butane, propane, hexane), alcohol (including but not limited to:
ethanol, iso-propyl, methanol), and rosin tech (heat extraction))
or alternatively, no extraction is performed.
[0185] If the cannabis extract was solvent based then the residual
solvents cam be purged from the extract while retaining compounds
of pharmaceutical and organoleptic interest (described in FIG. 3).
Next, the sample is fully (or partially) decarboxylated (at a
variety of temperatures (.about.90-180.degree. C.), pressures,
methods, and durations can vary depending on batch size, desired
characteristics of final product, and other factors). This
decarboxylation step can be performed in an airtight container in
order to prevent and limit the escape and degradation of vaporized
medically viable compounds including but not limited to terpenes
and cannabinoids. Next, an organic medium (including but not
limited to: lipids, alcohols, etc.) and surfactant(s) (including
but not limited to: soy lecithin, egg yolk, yucca extract) are
added to the decarboxylated extract (or decarboxylated plant
material) the mixture is then optionally heated (temperatures
(.about.90-180.degree. C.) and durations can vary depending on
batch size, desired characteristics of final product, and other
factors). Varying the temperatures, pressures, methods, and
durations of heat exposure can greatly influence the medical
characteristics of the final product. Nutritional compounds
(including but not limited to: alcohols, fats, carbohydrates, and
proteins) are optionally added to the mixture. Food coloring may
also be added at this point. Optionally, a FAAH inhibitor can be
added to the mixture--drastically limiting the degradation of
cannabinoids in the mammalian endocannabinoid system and resulting
in prolonged psychoactive and medicinal effects. The mixture is
then optionally frozen. Further iterations of heating and freezing
may be utilized. The mixture should be yellow/light brown/golden in
color. It is then filtered and used to fill gelatin capsules. The
capsules are then stored.
[0186] All ingredients may vary in ratio in final product, from
0-100% by weight. Not all ingredients or steps listed above must be
performed. For example, (1) omission of nutrients, surfactants, or
food coloring does not constitute a new product and (2) omission of
the freezing step does not constitute a new manufacturing
process.
Example 15
[0187] Producing an Allergen Free Cannabis Extract
[0188] Starting with cannabis plant material that originates from
any and all cannabis species (including but not limited to cannabis
sativa, cannabis indica, cannabis ruderalis--and any/all subspecies
and any/all cross breeds thereof--in both male and female
varieties), the sample is dried and cured (proper drying and
storage protocol ensures maximal terpene content), then the
medically viable compounds (primarily cannabinoids and terpenes)
are extracted from the plant material using a variety of extraction
methods (including but not limited to: cold water extraction and
dry sift (hash), CO2, hydrocarbons (including but not limited to:
butane, propane, hexane), alcohol (including but not limited to:
ethanol, iso-propyl, methanol), and rosin tech (heat extraction))
or alternatively, no extraction is performed.
[0189] If the cannabis extract was solvent based then the residual
solvents can be purged from the extract while retaining compounds
of pharmaceutical and organoleptic interest (described in FIG. 3).
Next, the sample is fully (or partially) decarboxylated (at a
variety of temperatures (.about.90-180.degree. C.), pressures,
methods, and durations can vary depending on batch size, desired
characteristics of final product, and other factors). This
decarboxylation step can be performed in an airtight container in
order to prevent and limit the escape and degradation of vaporized
medically viable compounds including but not limited to terpenes
and cannabinoids. Next, an allergen-free organic medium (including
but not limited to: lipids, alcohols, etc.) and allergen-free
surfactant(s) (including but not limited to: soy lecithin, egg
yolk, yucca extract) are added to the decarboxylated extract (or
decarboxylated plant material) the mixture is then optionally
heated (temperatures (.about.90-180.degree. C.) and durations can
vary depending on batch size, desired characteristics of final
product, and other factors). Varying the temperatures, pressures,
methods, and durations of heat exposure can greatly influence the
medical characteristics of the final product. Optionally,
allergen-free nutritional compounds (including but not limited to:
alcohols, fats, carbohydrates, and proteins) are added to the
mixture. Food coloring may also be added at this point. The mixture
is then optionally frozen. Further iterations of heating and
freezing may be utilized. The mixture is then filtered and used to
fill gelatin capsules. The capsules are then stored.
[0190] All ingredients may vary in ratio in final product, from
0-100% by weight. All ingredients will be sourced from
allergen-free sources. Not all ingredients or steps listed above
must be performed. For example, (1) omission of nutrients,
surfactants, or food coloring does not constitute a new product and
(2) omission of the freezing step does not constitute a new
manufacturing process.
Example 16
[0191] Producing a Low Sodium or Sodium Free Cannabis Extract
[0192] Starting with cannabis plant material that originates from
any and all cannabis species (including but not limited to cannabis
sativa, cannabis indica, cannabis ruderalis--and any/all subspecies
and any/all cross breeds thereof--in both male and female
varieties), the sample is dried and cured (proper drying and
storage protocol ensures maximal terpene content), then the
medically viable compounds (primarily cannabinoids and terpenes)
are extracted from the plant material using a variety of extraction
methods (including but not limited to: cold water extraction and
dry sift (hash), CO2, hydrocarbons (including but not limited to:
butane, propane, hexane), alcohol (including but not limited to:
ethanol, iso-propyl, methanol), and rosin tech (heat extraction))
or alternatively, no extraction is performed.
[0193] If the cannabis extract was solvent based then the residual
solvents can be purged from the extract while retaining compounds
of pharmaceutical and organoleptic interest (described in FIG. 3).
Next, the sample is fully (or partially) decarboxylated (at a
variety of temperatures (.about.90-180.degree. C.), pressures,
methods, and durations can vary depending on batch size, desired
characteristics of final product, and other factors). This
decarboxylation step can be performed in an airtight container to
prevent and limit the escape and degradation of vaporized medically
viable compounds including but not limited to terpenes and
cannabinoids. Next, an organic medium (including but not limited
to: lipids, alcohols, etc.) and surfactant(s) (including but not
limited to: soy lecithin, egg yolk, yucca extract) are added to the
decarboxylated extract (or decarboxylated plant material) the
mixture is then optionally heated (temperatures
(.about.90-180.degree. C.) and durations can vary depending on
batch size, desired characteristics of final product, and other
factors). Varying the temperatures, pressures, methods, and
durations of heat exposure can greatly influence the medical
characteristics of the final product. Nutritional compounds
(including but not limited to: alcohols, fats, carbohydrates, and
proteins) are optionally added to the mixture. Food coloring may
also be added at this point. The mixture is then optionally frozen.
Further iterations of heating and freezing may be utilized. The
mixture should be yellow/light brown/golden in color. It is then
filtered and used to fill gelatin capsules. The capsules are then
stored.
[0194] All ingredients may vary in ratio in final product, from
0-100% by weight. All ingredients will contain very little to no
sodium. Not all ingredients or steps listed above must be
performed. For example, (1) omission of nutrients, surfactants, or
food coloring does not constitute a new product and (2) omission of
the freezing step does not constitute a new manufacturing
process.
Example 17
[0195] Examples of Other Cannabis Extracts
[0196] Starting with cannabis plant material that originates from
any and all cannabis species (including but not limited to cannabis
sativa, cannabis indica, cannabis ruderalis--and any/all subspecies
and any/all cross breeds thereof--in both male and female
varieties), the sample is dried and cured (proper drying and
storage protocol ensures maximal terpene content), then the
medically viable compounds (primarily cannabinoids and terpenes)
are extracted from the plant material using a variety of extraction
methods (including but not limited to: cold water extraction and
dry sift (hash), CO2, hydrocarbons (including but not limited to:
butane, propane, hexane), alcohol (including but not limited to:
ethanol, iso-propyl, methanol), and rosin tech (heat extraction))
or alternatively, no extraction is performed.
[0197] If the cannabis extract was solvent based then the residual
solvents can be purged from the extract while retaining compounds
of pharmaceutical and organoleptic interest (described in FIG. 3).
Next, the sample is fully (or partially) decarboxylated (at a
variety of temperatures (.about.90-180.degree. C.), pressures,
methods, and durations can vary depending on batch size, desired
characteristics of final product, and other factors). This
decarboxylation step can be performed in an airtight container in
order to prevent and limit the escape and degradation of vaporized
medically viable compounds including but not limited to terpenes
and cannabinoids. Next, an organic medium (including but not
limited to: lipids, alcohols, etc.) and surfactant(s) (including
but not limited to: soy lecithin, egg yolk, yucca extract) are
added to the decarboxylated extract (or decarboxylated plant
material) the mixture is then optionally heated (temperatures
(.about.90-180.degree. C.) and durations can vary depending on
batch size, desired characteristics of final product, and other
factors). Varying the temperatures, pressures, methods, and
durations of heat exposure can greatly influence the medical
characteristics of the final product. Nutritional compounds
(including but not limited to: alcohols, fats, carbohydrates, and
proteins) are optionally added to the mixture. Food coloring may
also be added at this point. The mixture is then optionally frozen.
Further iterations of heating and freezing may be utilized. The
mixture should be yellow/light brown/golden in color. It is then
filtered and used to fill gelatin capsules. The capsules are then
stored.
[0198] All ingredients may vary in ratio in final product, from
0-100% by weight. ALL ingredients will contain very little to no
sodium. Not all ingredients or steps listed above must be
performed. For example, (1) omission of nutrients, surfactants, or
food coloring does not constitute a new product and (2) omission of
the freezing step does not constitute a new manufacturing
process.
Example 18
[0199] Cooks were Performed Using the Following Naming Convention:
"Cook 1" and "Cook 3"
[0200] "Cook 1" used 3.00 grams of cannabis extract with the strain
name Afghan Skunk (Washington Liquor and Cannabis Control Board Lot
# 6034347010022992). This cannabis extract was made using a
hydrocarbon extraction of cannabis plant material. The Device
chamber was flushed with nitrogen prior to the cook. The Device
chamber and cannabis extract were then heated to 250.degree. F. for
a duration of 1.5 hours. The valve leading from The Device chamber
to the size exclusion filter was left open throughout the cook. The
coil proceeding the size exclusion filter was cooled for the
duration of the cook using an ice bath. After allowing The Device
chamber to cool to room temperature (approximately 45 minutes), 60
mL of iso-propyl alcohol was then used to flush the coil to
recapture any condensed terpenes, this same aliquot of isopropyl
alcohol was then used to dissolve the extract after the cook had
completed.
[0201] "Cook 3" used 3.00 grams of cannabis extract with the strain
name Afghan Skunk (Washington Liquor and Cannabis Control Board Lot
# 6034347010022992). This cannabis extract was made using a
hydrocarbon extraction of cannabis plant material. For the duration
of this cook the vessel was exposed to ambient conditions (matching
prior art preparations). The vessel and cannabis extract were then
heated to 250 F for a duration of 1.5 hours. After allowing the
vessel to cool to room temperature (approximately 45 minutes), 60
mL of iso-propyl alcohol was then used to dissolve the extract
after the cook had completed.
[0202] Included is the data corresponding to these two cooks. The
data for "Cook 1" is shown in FIG. 24. The data for "Cook 3" is
shown in FIG. 25. As shown by this data, "Cook 1" contained
2.74.times. the terpene content found in "Cook 3" while containing
relatively the same cannabinoid content. Furthermore "Cook 1"
contained virtually no THC-A while "Cook 3" contained 0.27 mg/g of
THC-A. This shows that the decarboxylation process occurred to
completion in "Cook 1", the same could not be said for Cook 3 "Cook
1" had a greater terpene diversity than "Cook 3". In "Cook 1", 6%
of the terpenes quantified were monoterpenes, 3% were
monoterpenoids, and 89% sesquiterpenes. In "Cook 3", 0% of the
terpenes quantified were monoterpenes, 2% were monoterpenoids, 96%
were sesquiterpenes. It should be noted that when ranked by
volatility, monoterpenes are the most volatile followed by
monoterpenoids, then sesquiterpenes, and lastly
sesquiterpenoids.
[0203] The data indicates that using an N2 flush, a cooling coil,
and a size exclusion filter, is more effective at retaining
terpenes and progressing the decarboxylation process. "Cook 1"
progressed the decarboxylation of other cannabinoids in addition to
THC-A, such as CBG-A. Increasing the diversity of active
cannabinoids and terpenes further enforces the entourage effect
discussed at length in this disclosure.
[0204] The examples can be combined. For example: (1) a gluten free
preparation that originates from a cannabis indica strain that is
kosher and extremely potent (2) allergen-free preparation that
originates from a cannabis sativa strain that is halal and sodium
free and low potency (3) a CBD rich preparation that originates
from live plant material and is extended release, vegan, and
non-decarboxylated--using an established strain.
[0205] A method of cannabis extraction, comprising the steps of:
(i) adding an amount of at least one species of cannabis plant or
an amount of an extract of at least one species of cannabis plant
to a reaction chamber; (ii) removing byproducts from the reaction
chamber that are produced from extracting cannabis; and (iii)
retaining compounds within the chamber derived from cannabis,
[0206] wherein the reaction chamber comprises a filter comprising
pores that allow for removal from the reaction chamber of the
byproducts from the cannabis extraction process and prevent removal
or escape from the chamber of the compounds derived from the at
least one cannabis plant or extract of at least one species of
cannabis plant.
[0207] In some embodiments the at least one cannabis plant is at
least one from the group consisting of Cannabis sativa, Cannabis
indica, and Cannabis ruderalis. In some embodiments, the reaction
chamber is an airtight chamber. In some embodiments, extracting
cannabis comprises a solvent based extraction. In some embodiments,
the solvent is at least one from the group consisting of
iso-propyl, methanol, n-propyl alcohol, propane, butane,
iso-butane, methanol, and ethanol. In some embodiments, extracting
cannabis does not use a solvent. In some embodiments, the
non-solvent extraction is at least one from the group consisting of
a heat extraction, an unheated extraction, a cold water extraction,
a CO.sub.2 extraction, and a rosin tech extraction. In some
embodiments, the method further comprises a decarboxylation step
wherein the extracts or the cannabis plant material are
decarboxylated. In some embodiments, the method further comprises
removing CO.sub.2 from the reaction chamber after decarboxylating
the extracts or cannabis plant material. In some embodiments, the
CO.sub.2 is removed through the filter. In some embodiments, the
decarboxylation reaction occurs in the presence of an inert gas. In
some embodiments the reaction chamber will be treated with an inert
gas before prior to the decarboxylation step. In some embodiments,
the inert gas is at least one from the group consisting of helium,
neon, argon krypton, xenon, and radon. In some embodiments, the
decarboxylation step further comprises using a targeted enzyme or
cofactor.
[0208] In some embodiments, the decarboxylation step further
comprises H.sub.2O as a catalyst. In some embodiments, the reaction
chamber further comprises a magnetic stir bar. In some embodiments,
the cannabis extract that originates from live cannabis material.
In some embodiments, the cannabis extract originates from
dried/cured cannabis plant material. In some embodiments, the
compounds within the chamber derived from cannabis comprise at
least one cannabinoid and at least one terpene. In some
embodiments, the compounds within the chamber derived from cannabis
comprise cannabinoids, terpenes/terpenoids, amino acids,
nitrogenous compounds, simple alcohols, aldehydes, ketones, esters,
lactones, and acids, fatty acids, steroids, non-cannabinoid
phenols, pigments, flavonoids, vitamins, proteins, enzymes,
glycoproteins, and hydrocarbons. In some embodiments, the compounds
within the chamber derived from cannabis in step (iv) comprise the
at least about 545 distinct compounds in cannabis.
[0209] In some embodiments, the method of cannabis extraction
comprises using a surfactant. In some embodiments the method of
cannabis extraction comprises using an emulsifier. In some
embodiments, the method of cannabis extraction uses any one or more
species of cannabis. In some embodiments, the method of cannabis
extraction comprises using any one or more subspecies of cannabis
plant. In some embodiments, the method of cannabis extraction
comprises using any one or more strains of cannabis plant. In some
embodiments, the method of cannabis extraction comprises using a
cannabis plant derived from a female source. In some embodiments,
the method of cannabis extraction comprises using a cannabis plant
derived from a male source.
[0210] In some embodiments, an apparatus for the extraction of
cannabis is provided comprising: (i) an airtight container
comprising: (ii) an inner surface; (iii) an outer surface; (iv) a
reaction chamber; and (iv) a size exclusion filter, wherein the
size exclusion filter comprises pores of sufficient size to allow
byproducts of an extraction process and a decarboxylation process
to pass through the filter but prevents compounds derived from
cannabis from passing through the filter. In some embodiments, the
pores are from about 0.01 .ANG..sup.2 to 100 .ANG..sup.2.
[0211] In some embodiments, the reaction chamber comprises a stir
bar. In some embodiments, the reaction chamber is temperature
controlled and pressure controlled. In some embodiments, the stir
bar is a magnetic stir bar. In some embodiments, the apparatus
further comprises a stirring base that rotates the stir bar. In
some embodiments, the magnetic stir bar is coated with a non-stick
coating. In some embodiments, the inner surface of the apparatus
comprises a non-stick coating. In some embodiments, the non-stick
coating is silicone. In some embodiments, the apparatus further
comprises a loading door. In some embodiments, the apparatus
further comprises a steel rod wherein the steel rod is within the
reaction chamber, and wherein the steel rod is attached to the size
exclusion filter. In some embodiments, the steel rod passes through
the center of the reaction chamber. In some embodiments, the size
exclusion filter is configured to move up and down on the steel rod
within the reaction chamber. In some embodiments, the reaction
chamber further comprises at least one valve. In some embodiments
the at least one valve comprises two valves.
[0212] In some embodiments a cannabis extraction method is provided
comprising using any of the apparatuses disclosed herein comprising
the steps of: (i) adding at least one species of cannabis plant or
extract of at least one species of cannabis plant to a reaction
chamber; (ii) producing cannabis extracts through extracting
cannabis from the at least one plant or extract of at least one
species of cannabis plant in the reaction chamber; (iii) removing
byproducts from the reaction chamber that are produced from
extracting cannabis; and (iv) retaining compounds within the
chamber derived from cannabis, wherein the reaction chamber
comprises a filter, and wherein pores in the filter allow for
removal from the reaction chamber of the byproducts from the
cannabis extraction process and prevent removal or escape from the
chamber of the compounds derived from cannabis.
[0213] In some embodiments, an isolated mixture of compounds is
provided, comprising at least one terpene compound derived from
cannabis and at least one cannabinoid compound derived from
cannabis. In some embodiments the mixture of compounds comprises at
least 5 terpene compounds derived from cannabis. In some
embodiments the mixture of compounds comprises at least 10 terpene
compounds derived from cannabis. In some embodiments the mixture of
compounds comprises at least 15 terpene compounds derived from
cannabis. In some embodiments the mixture of compounds comprises at
least 20 terpene compounds derived from cannabis. In some
embodiments, the mixture of compounds is 24 terpene compounds
derived from cannabis. In some embodiments, the 24 terpene
compounds derived from cannabis comprise: .alpha.-Pinene, Camphene,
.beta.-Pinene, .beta.-Myrcene, 3-Carene, .alpha.-Terphinene,
D-Limonene, p-Cymene, Eucalyptol, cis-.beta.-Ocimene,
.gamma.-Terpinen, Terpinolene, Linalool, trans-.beta.-Ocimene,
Fenchol, Isopulegol, Geraniol, .beta.-Caryophyllene,
.alpha.-Humulene, cis-Nerolidol, trans-Nerolidol, Guaiol,
Caryophyllene Oxide, and .alpha.-Bisabolol.
[0214] In some embodiments the percent mass of each terpene
compound is between 0.0001% and 010%. In some embodiments, the
percent mass of each terpene compound is between 0.0005% and 0.07%.
In some embodiments, the percent mass of each compound is between
0.001% and 0.05%.
[0215] In some embodiments the mixture of compounds comprises at
least 3 cannabinoid compounds derived from cannabis. In some
embodiments, the mixture of compounds comprises 7 cannabinoid
compounds derived from cannabis. In some embodiments, the 7
cannabinoid compounds derived from cannabis comprise: THC-A, CBL-A,
.DELTA..sup.9-THC, CBN, CBC, CBG, and THCV. In some embodiments,
the mg/ml of each cannabinoid is between 0.01 mg/ml and 1,000
mg/ml. In some embodiments, the mg/ml of each cannabinoid is
between 0.1 mg/ml and 25 mg/ml.
[0216] In some embodiments, the mixture of compounds is in a
capsule. In some embodiments, the capsule is a gelatin capsule. In
some embodiments the capsule comprises a pharmaceutical
formulation.
[0217] In some embodiments a method of cannabis extraction is
provided wherein the cannabis plant that is added is Cannabis
sativa. In some embodiments, the cannabis plant that is added
Cannabis indica. In some embodiments, the cannabis plant that is
added is Cannabis ruderalis.
[0218] In some embodiments, a method of treatment is provided
comprising: administering a pharmaceutically acceptable amount of
the mixture to a patient in need thereof.
[0219] In some embodiments, administering the mixture to the
patient results in the patient experiencing the entourage effect.
In some embodiments, the treatment is for any one or more of the
following: nausea and vomiting, wasting syndrome (AIDS), lack of
appetite (exhibited in cancer and AIDs patients as well as patients
suffering from anorexia nervosa), multiple sclerosis, spinal cord
trauma, epilepsy, pain, arthritis (and other musculoskeletal
disorders), movement disorders, glaucoma, asthma, hypertension,
psychiatric disorders, Alzheimer's and dementia, general
inflammation, gastrointestinal disorders.
[0220] In some embodiments, the compounds within the chamber
derived from cannabis comprise cannabinoids, nitrogenous compounds,
amino acids, proteins, enzymes, glycoproteins, hydrocarbons, simple
alcohols, aldehydes, ketones and acids, fatty acids, simple esters
and lactones, steroids, terpenes, non-cannabinoid phenols,
flavonoids, vitamins, and pigments.
[0221] In some embodiments, an isolated mixture of compounds
derived from cannabis is provided comprising cannabinoids,
nitrogenous compounds, amino acids, proteins, enzymes,
glycoproteins, hydrocarbons, simple alcohols, aldehydes, ketones
and acids, fatty acids, simple esters and lactones, steroids,
terpenes, non-cannabinoid phenols, flavonoids, vitamins, and
pigments. In some embodiments, the mixture of compounds is
contained within a capsule. In some embodiments, the capsule is a
gelatin capsule. In some embodiments, the capsule comprises a
pharmaceutical formulation.
[0222] In some embodiments, a method of treatment is provided
comprising: administering a pharmaceutically acceptable amount of
the mixture to a patient in need thereof. In some embodiments, the
treatment is for the purpose of treating any one or more of the
following: nausea and vomiting, wasting syndrome (AIDS), lack of
appetite (exhibited in cancer and AIDs patients as well as patients
suffering from anorexia nervosa), multiple sclerosis, spinal cord
trauma, epilepsy, pain, arthritis (and other musculoskeletal
disorders), movement disorders, glaucoma, asthma, hypertension,
psychiatric disorders, Alzheimer's and dementia, general
inflammation and gastrointestinal disorders.
[0223] In some embodiments, a method is provided comprising the
steps of: (i) adding cannabis or cannabis extract to a reaction
chamber; (ii) removing byproducts from the reaction chamber
produced from processing cannabis; and (iii) retaining compounds
within the chamber derived from cannabis, wherein the reaction
chamber comprises a filter comprising pores that allow for removal
from the reaction chamber of the byproducts produced from
processing cannabis and prevent removal or escape from the chamber
of the compounds derived from the cannabis or cannabis extract.
[0224] The foregoing written specification is considered to be
sufficient to enable one skilled in the art to practice the present
embodiments. The foregoing description details certain preferred
embodiments and describes the best mode contemplated by the
inventors. It will be appreciated, however, that no matter how
detailed the foregoing may appear in text, the present embodiments
may be practiced in many ways and the present embodiments should be
construed in accordance with the appended claims and any
equivalents thereof.
* * * * *