HEMP EXTRACT FOR TREATMENT OF PAIN, CANCER AND EPILEPSY IN ANIMALS
The present disclosure relates to pharmaceutical compositions comprising hemp extract and a carrier. The present disclosure also relates to dosage forms and methods of treatment using the pharmaceutical compositions.
1 . A pharmaceutical composition comprising hemp extract and a carrier, wherein the hemp extract comprises:
cannabigerol; and
cannbigerolic acid;
wherein the ratio of cannabigerol to cannabigerolic acid is about 0.2:1 to about 1:0.2.
2 . A pharmaceutical composition comprising hemp extract and a carrier, wherein the hemp extract comprises:
cannabigerolic acid;
cannabigerol;
cannabidiol;
cannabidiolic acid;
Δ9-tetrahydrocannabinol; and
cannabichromene;
wherein the ratio of cannabigerol to cannabigerolic acid is about 0.2:1 to about 1:0.2.
3 . The pharmaceutical composition of claim 1 or 2 , wherein the hemp extract further comprises:
α-pinene;
β-myrcene;
β-pinene;
δ-limonene;
linalool;
β-caryophyllene;
α-humulene;
nerolidol;
guaiol;
caryophyllene oxide; and
α-bisabolol.
4 . The pharmaceutical composition of claim 2 or 3 , wherein the concentration of Δ9-tetrahydrocannabinol is insufficient to produce a psychotropic effect.
5 . The pharmaceutical composition of any one of claims 2-4 , wherein the ratio of Δ9-tetrahydrocannabinol to the other cannabinoids is about 1:25.
6 . The pharmaceutical composition of any one of claims 2-5 , wherein the concentration of Δ9-tetrahydrocannabinol is less than about 10 mg/mL.
7 . The pharmaceutical composition of any one of claims 2-6 , wherein the concentration of Δ9-tetrahydrocannabinol is less than about 3 mg/mL.
8 . The pharmaceutical composition of any one of claims 2-7 , wherein the concentration of Δ9-tetrahydrocannabinol is less than about 1 mg/mL.
9 . The pharmaceutical composition of any one of claims 2-8 , wherein the concentration of Δ9-tetrahydrocannabinol is less than about 0.1 mg/mL.
10 . The pharmaceutical composition of any one of claims 2-9 , wherein the concentration of Δ9-tetrahydrocannabinol is undetectable.
11 . The pharmaceutical composition of any one of claims 2-10 , wherein the concentration of Δ9-tetrahydrocannabinol is about 0 mg/mL.
12 . The pharmaceutical composition of any one of claims 2-10 , wherein the hemp extract comprises:
about 10-100 mg/mL of cannabigerol;
about 10-100 mg/mL of cannabigerolic acid;
less than 1 mg/mL Δ9-tetrahydrocannabinol; and
about 1-4 mg/mL cannabichromene.
13 . The pharmaceutical composition of claim 12 , wherein the hemp extract comprises:
about 50 mg/mL of cannabigerol;
about 50 mg/mL of cannabigerolic acid;
less than 1 mg/mL Δ9-tetrahydrocannabinol; and
about 2.7 mg/mL cannabichromene.
14 . The pharmaceutical composition of any of one claims 1-13 , wherein the hemp extract comprises:
about 0.09-0.13% α-pinene;
about 0.23-0.44% β-myrcene;
about 0.04-0.09% β-pinene;
about 0.05-0.09% δ-limonene;
about 0.03-0.06% linalool;
about 0.04-0.07% β-caryophyllene;
about 0.02-0.04% α-humulene;
about 0.04-0.07% nerolidol;
about 0.02-0.04% guaiol;
about 0.04-0.08% caryophyllene oxide; and
about 0.01-0.04% α-bisabolol.
15 . The pharmaceutical composition of claim 14 , wherein the hemp extract further comprises:
camphene;
β-ocimene;
eucalyptol;
isopulegol; and/or
nerolidol.
16 . The pharmaceutical composition of claim 15 , wherein the hemp extract comprises:
about 0.02% camphene;
about 0.02-0.03% β-ocimene;
about 0.02-0.05% eucalyptol;
about 0.02% isopulegol; and/or
about 0.02-0.04% nerolidol.
17 . The pharmaceutical composition of any one of claims 1-16 , wherein the composition is formulated in a carrier.
18 . The pharmaceutical composition of claim 17 , wherein the carrier is selected from the group consisting of linseed oil, olive oil, fish oil, salmon oil, coconut oil, catnip oil, sesame oil, MCT oil, and grapeseed oil.
19 . The pharmaceutical composition of claim 18 , wherein the carrier comprises grapeseed oil.
20 . The pharmaceutical composition of claim 18 , wherein the carrier comprises catnip oil.
21 . The pharmaceutical composition of claim 18 , wherein the carrier comprises sesame oil.
22 . The pharmaceutical composition of any one of claims 1-21 , wherein the carrier comprises lecithin.
23 . The pharmaceutical composition of claim 22 , wherein the lecithin is sunflower lecithin.
24 . The pharmaceutical composition of claim 23 , wherein the sunflower lecithin is up to 40%.
25 . The pharmaceutical composition of any one of claims 1-24 , wherein the composition further comprises NF-971P.
26 . The pharmaceutical composition of claim 25 , wherein the NF-971P is up to 2% weight/volume ratio.
27 . A pharmaceutical composition comprising hemp extract and a carrier, wherein the hemp extract comprises:
cannabigerolic acid;
cannabigerol;
cannabidiol;
cannabidiolic acid;
Δ9-tetrahydrocannabinol; and
cannabichromene.
28 . The pharmaceutical composition of claim 27 , wherein the ratio of cannabigerol to cannabigerolic acid is selected from the group consisting of about 1:100, about 1:50, about 1:10, and about 1:1.
29 . The pharmaceutical composition of claim 27 or 28 , wherein the ratio of cannabigerol to cannabigerolic acid is about 1:1.
30 . The pharmaceutical composition of any one of claims 27-29 , wherein the concentration of Δ9-tetrahydrocannabinol is insufficient to produce a psychotropic effect.
31 . The pharmaceutical composition of any one of claims 27-30 , wherein the ratio of Δ9-tetrahydrocannabinol to the other cannabinoids is about 1:25.
32 . The pharmaceutical composition of any one of claims 27-31 , wherein the concentration of Δ9-tetrahydrocannabinol is less than about 10 mg/mL.
33 . The pharmaceutical composition of any one of claims 27-32 , wherein the concentration of Δ9-tetrahydrocannabinol is less than about 5 mg/mL.
34 . The pharmaceutical composition of any one of claims 27-33 , wherein the concentration of Δ9-tetrahydrocannabinol is less than about 3 mg/mL.
35 . The pharmaceutical composition of any one of claims 27-34 , wherein the concentration of Δ9-tetrahydrocannabinol is less than about 2 mg/mL.
36 . The pharmaceutical composition of any one of claims 27-34 , wherein the concentration of Δ9-tetrahydrocannabinol is less than about 1 mg/mL.
37 . The pharmaceutical composition of any one of claims 27-35 , wherein the concentration of Δ9-tetrahydrocannabinol is about 0 mg/mL.
38 . The pharmaceutical composition of any one of claims 27-35 , wherein the hemp extract comprises:
about 10-100 mg/mL of cannabigerol;
about 10-100 mg/mL of cannabigerolic acid;
less than 1 mg/mL Δ9-tetrahydrocannabinol; and
about 1-4 mg/mL cannabichromene.
39 . The pharmaceutical composition of claim 38 , wherein the hemp extract comprises:
about 10-100 mg/mL of cannabigerolic acid;
about 10-100 mg/mL of cannabigerol;
about 1-5 mg/mL cannabidiol;
about 1-5 mg/mL cannabidiolic acid;
less than 1 mg/mL Δ9-tetrahydrocannabinol; and
about 1-4 mg/mL cannabichromene.
40 . The pharmaceutical composition of claim 38 or 39 , wherein the hemp extract comprises:
about 50 mg/mL of cannabigerol;
about 50 mg/mL of cannabigerolic acid;
less than 1 mg/mL Δ9-tetrahydrocannabinol; and
about 2.7 mg/mL cannabichromene.
41 . The pharmaceutical composition of any one of claims 38-40 , wherein the hemp extract comprises:
about 50 mg/mL of cannabigerolic acid;
about 50 mg/mL of cannabigerol;
about 3 mg/mL cannabidiol;
about 3 mg/mL cannabidiolic acid;
less than 1 mg/mL Δ9-tetrahydrocannabinol; and
about 2.7 mg/mL cannabichromene.
42 . The pharmaceutical composition of any one of claims 27-41 , wherein the hemp extract comprises:
α-pinene;
β-myrcene;
β-pinene;
δ-limonene;
linalool;
β-caryophyllene;
α-humulene;
nerolidol;
guaiol;
caryophyllene oxide; and
α-bisabolol.
43 . The pharmaceutical composition of claim 42 , wherein the hemp extract comprises:
about 0.09-0.13% α-pinene;
about 0.23-0.44% β-myrcene;
about 0.04-0.09% β-pinene;
about 0.05-0.09% δ-limonene;
about 0.03-0.06% linalool;
about 0.04-0.07% β-caryophyllene;
about 0.02-0.04% α-humulene;
about 0.04-0.07% nerolidol;
about 0.02-0.04% guaiol;
about 0.04-0.08% caryophyllene oxide; and
about 0.01-0.04% α-bisabolol.
44 . The pharmaceutical composition of claim 42 or 43 , wherein the hemp extract further comprises:
camphene;
β-ocimene;
eucalyptol;
isopulegol; and/or
nerolidol.
45 . The pharmaceutical composition of claim 44 , wherein the hemp extract comprises:
about 0.02% camphene;
about 0.02-0.03% β-ocimene;
about 0.02-0.05% eucalyptol;
about 0.02% isopulegol; and/or
about 0.02-0.04% nerolidol.
46 . A dosage form comprising any of the pharmaceutical compositions of any one of claims 1-45 and one or more pharmaceutically acceptable additives, flavoring agents, surfactants, and adjuvants.
47 . The dosage form of claim 46 , wherein the flavoring agent is selected from the group consisting of peppermint oil, mango extract, beef, poultry, and seafood.
48 . The dosage form of claim 46 , formulated as a sublingual spray.
49 . The dosage form of claim 46 , formulated as a water or alcohol soluble solution, or a cream for transdermal application.
50 . The dosage form of claim 46 , formulated as a gel for buccal or mucosal administration.
51 . The dosage form of claim 46 , formulated as a powder.
52 . The dosage form of claim 46 , formulated as a solution for subcutaneous injection.
53 . The dosage form of claim 46 , formulated as a tablet.
54 . The dosage form of claim 46 , formulated as a capsule.
55 . The dosage form of claim 46 , formulated as a hard chewable.
56 . The dosage form of claim 46 , formulated as a soft chewable.
57 . The dosage form of claim 46 , wherein the composition is formulated for administration using a nebulizer.
58 . The dosage form of claim 46 , wherein the composition is formulated for administration using a pet collar.
59 . The dosage of claim 46 , wherein the composition is formulated as a chew for oral administration.
60 . The dosage form of claim 59 , where the chew is produced using cold extrusion.
61 . The dosage form of claim 60 , wherein the weight of the chew is about 0.5-10 g.
62 . The dosage form of claim 60 , wherein the weight of the chew is about 4 g, about 6 g, about 9 g, or about 10 g.
63 . The dosage form of claim 62 , wherein the weight of the chew is about 4 g.
64 . The dosage form of any one of claims 55-63 , wherein the chew comprises:
about 70 mg of cannabigerol;
about 60 mg of cannabigerolic acid;
about 3.2 mg Δ9-tetrahydrocannabinol; and
about 3.6 mg cannabichromene.
65 . The dosage form of claim 64 , formulated in a carrier for oral administration.
66 . The dosage form of claim 65 , wherein the carrier is selected from the group consisting of linseed oil, olive oil, fish oil, salmon oil, coconut oil, catnip oil, sesame oil, MCT oil, and grapeseed oil.
67 . The dosage form of claim 66 , wherein the carrier comprises grapeseed oil.
68 . The dosage form of claim 66 , wherein the carrier comprises catnip oil.
69 . The dosage form of claim 66 , wherein the carrier comprises sesame oil.
70 . The dosage form of claim 46 , formulated for inhalation.
71 . A method for treating or reducing pain in a subject in need thereof, comprising administering to the subject a therapeutically effective amount of the composition of any of claims 1-43 , or a dosage form of any of claims 46-70 .
72 . The method of claim 71 , wherein the pain is associated with arthritis, post-operative pain, acute pain, joint pain, or multi-joint pain.
73 . A method for treating epilepsy in a subject in need thereof, comprising administering to the subject a therapeutically effective amount of the composition of any of claims 1-45 , or a dosage form of any of claims 46-70 .
74 . The method of claim 73 , wherein the subject has previously experienced generalized motor seizures or focal seizure episodes.
75 . The method of claim 73 , wherein the subject has a decrease in the frequency and/or duration of seizures.
76 . A method for improving quality of life in a subject with cancer, comprising administering to the subject a therapeutically effective amount of the composition of any of claims 1-45 , or a dosage form of any of claims 46-70 .
77 . The method of claim 76 , wherein the subject is receiving L-CHOP or CHOP chemotherapy.
78 . The method of claim 76 or 77 , wherein the hemp extract, composition or dosage form is administered about every 12 hours starting at week 4 or 5 of doxorubicin treatment.
79 . The method of any one of claims 76-78 , wherein the cancer is lymphoma.
80 . The method of claim 79 , wherein the lymphoma is intermediate to high-grade multicentric lymphoma.
81 . The method of claim 80 , wherein following treatment the subject experiences an absence of lymphoma-associated abnormalities or a decrease in lymph node diameter.
82 . The method of any one of claims 76-80 , wherein the subject has a body weight >15 kg.
83 . The method of any one of claims 76-82 , wherein the subject is entering the end of the first cycle of L-CHOP chemotherapy.
84 . A method for treating post-operative pain in a subject in need thereof, comprising administering to the subject a therapeutically effective amount of the composition of any of claims 1-45 , or a dosage form of any of claims 46-70 .
85 . The method of claim 84 , wherein the subject has undergone tibial plateau leveling osteotomy surgery.
86 . The method of claim 85 , wherein the subject has been treated with fentanyl and/or a nerve block.
87 . The method of any one of claims 76-86 , wherein the pharmaceutical composition or dosage form is administered at a dosage of about 0.1-8.0 mg/kg.
88 . The method of any one of claims 76-86 , wherein the pharmaceutical composition or dosage form is administered at twice the therapeutically effective dosage for one week, and then subsequently administered at a therapeutically effective dosage.
89 . The method of claim 88 , wherein the therapeutically effective dosage is about 0.1-0.5 mg/kg.
90 . The method of claim 88 , wherein the therapeutically effective dosage is about 2 mg/kg.
91 . The method of claim 88 , wherein the therapeutically effective dosage is about 8 mg/kg.
92 . The method of any one of claims 76-85 , wherein the pharmaceutical composition or dosage form is administered at a dosage of about 1 mg/kg for one week, and then subsequently administered at a dosage of about 0.1-0.5 mg/kg.
93 . The method of any one of claims 76-86 , wherein the pharmaceutical composition or dosage form is administered at a dosage of about 4 mg/kg for one week, and then subsequently administered at a dosage of about 2 mg/kg.
94 . The method of any of claims 74-91 , wherein the method results in a therapeutically effective median maximal serum concentration of cannabigerol.
95 . The method of claim 94 , wherein the median maximal serum concentration of cannabigerol is about 102 ng/mL.
96 . The method of claim 94 , wherein the median maximal serum concentration of cannabigerol is about 590 ng/mL.
97 . The method of any one of claims 76-96 , wherein the subject is veterinary.
98 . The method of claim 97 , wherein the veterinary subject is canine, feline, bovine, porcine, or equine.
99 . The method of any one of claims 76-96 , wherein the subject is human.
100 . A method of achieving an area under the curve from 0 time to 24 hours of between 42.4 and 3048 ng hr/ml for cannabigerol in a subject comprising administering to the subject an effective amount of hemp extract.
101 . The method of claim 100 , wherein the subject is human, canine or feline.
102 . A method of treating or reducing pain in a subject in need thereof, comprising administering a therapeutically effective amount of a pharmaceutical composition comprising hemp extract and a carrier, wherein the hemp extract comprises:
cannabigerol; and
cannabigerolic acid;
wherein the ratio of cannabigerol to cannabigerolic acid is about 0.2:1 to about 1:0.2.
103 . A method of treating epilepsy in a subject in need thereof, comprising administering a therapeutically effective amount of a pharmaceutical composition comprising hemp extract and a carrier, wherein the hemp extract comprises:
cannabigerol; and
cannabigerolic acid;
wherein the ratio of cannabigerol to cannabigerolic acid is about 0.2:1 to about 1:0.2.
104 . A method of treating cancer in a subject in need thereof, comprising administering a therapeutically effective amount of a pharmaceutical composition comprising hemp extract and a carrier, wherein the hemp extract comprises:
cannabigerol; and
cannabigerolic acid;
wherein the ratio of cannabigerol to cannabigerolic acid is about 0.2:1 to about 1:0.2.
105 . A method of improving quality of life in a subject with cancer, comprising administering a therapeutically effective amount of a pharmaceutical composition comprising hemp extract and a carrier, wherein the hemp extract comprises:
cannabigerol; and
cannabigerolic acid;
wherein the ratio of cannabigerol to cannabigerolic acid is about 0.2:1 to about 1:0.2.
106 . The method of any one of claims 102-105 , wherein the hemp extract further comprises:
cannabigerolic acid;
Δ9-tetrahydrocannabinol; and
cannabichromene.
107 . The method of any one of claims 102-105 , wherein the hemp extract further comprises four or more of the following:
α-pinene;
β-myrcene;
β-pinene;
δ-limonene;
linalool;
β-caryophyllene;
α-humulene;
nerolidol;
guaiol;
caryophyllene oxide; and
α-bisabolol.
108 . The method of claim 106 or 107 , wherein the concentration of Δ9-tetrahydrocannabinol is insufficient to produce a psychotropic effect.
109 . The method of any one of claims 106-108 , wherein the ratio of Δ9-tetrahydrocannabinol to the other cannabinoids is about 1:25.
110 . The method of any one of claims 106-109 , wherein the concentration of Δ9-tetrahydrocannabinol is less than about 10 mg/mL.
111 . The method of any one of claims 106-110 , wherein the concentration of Δ9-tetrahydrocannabinol is less than about 5 mg/mL.
112 . The method of any one of claims 106-111 , wherein the concentration of Δ9-tetrahydrocannabinol is less than about 3 mg/mL.
113 . The method of any one of claims 106-112 , wherein the concentration of Δ9-tetrahydrocannabinol is less than about 2 mg/mL.
114 . The method of any one of claims 106-113 , wherein the concentration of Δ9-tetrahydrocannabinol is less than about 1 mg/mL.
115 . The method of any one of claims 106-114 , wherein the concentration of Δ9-tetrahydrocannabinol is about 0 mg/mL.
116 . The method of any one of claims 102-105 , wherein the hemp extract comprises:
about 10-100 mg/mL of cannabigerol;
about 10-100 mg/mL of cannabigerolic acid;
less than 1 mg/mL Δ9-tetrahydrocannabinol; and
about 1-4 mg/mL cannabichromene.
117 . The method of claim 116 , wherein the hemp extract comprises:
about 50 mg/mL of cannabigerol;
about 50 mg/mL of cannabigerolic acid;
less than 1 mg/mL Δ9-tetrahydrocannabinol; and
about 2.7 mg/mL cannabichromene.
118 . The method of any of one claims 102-117 , wherein the hemp extract comprises:
about 0.09-0.13% α-pinene;
about 0.23-0.44% β-myrcene;
about 0.04-0.09% β-pinene;
about 0.05-0.09% δ-limonene;
about 0.03-0.06% linalool;
about 0.04-0.07% β-caryophyllene;
about 0.02-0.04% α-humulene;
about 0.04-0.07% nerolidol;
about 0.02-0.04% guaiol;
about 0.04-0.08% caryophyllene oxide; and
about 0.01-0.04% α-bisabolol.
119 . The method of claim 118 , wherein the hemp extract further comprises:
camphene;
β-ocimene;
eucalyptol;
isopulegol; and/or
nerolidol.
120 . The method of claim 119 , wherein the hemp extract comprises:
about 0.02% camphene;
about 0.02-0.03% β-ocimene;
about 0.02-0.05% eucalyptol;
about 0.02% isopulegol; and/or
about 0.02-0.04% nerolidol.
121 . The method of claim any one of claims 102-120 , wherein the hemp extract comprises 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15 or more of the following: α-pinene, β-myrcene, β-pinene, δ-limonene, linalool, β-caryophyllene, α-humulene, nerolidol, guaiol, caryophyllene oxide, α-bisabolol, camphene, β-ocimene, eucalyptol, isopulegol, and nerolidol.
122 . The method of any one of claims 102-121 , wherein the composition is formulated in a carrier.
123 . The method of claim 122 , wherein the carrier is selected from the group consisting of linseed oil, olive oil, fish oil, salmon oil, coconut oil, catnip oil, sesame oil, MCT oil, and grapeseed oil.
124 . The method of claim 123 , wherein the carrier comprises grapeseed oil.
125 . The method of claim 123 , wherein the carrier comprises catnip oil.
126 . The method of claim 123 , wherein the carrier comprises sesame oil.
127 . The method of any one of claims 102-126 , wherein the composition comprises nepetalactone.
128 . The method of any one of claims 102-127 , wherein the composition comprises taurine.
129 . The method of any one of claims 102-128 , wherein the composition is formulated for administration using a nebulizer.
130 . The method of any one of claims 102-128 , wherein the composition is formulated for administration using a diffuser.
131 . The method of any one of claims 102-128 , wherein the composition is formulated for administration using a pet collar.
132 . The method of any one of claims 102-128 , wherein the composition is formulated as a pet food for oral administration.
133 . The method of any one of claims 102-128 , wherein the composition is formulated as a chew for oral administration.
134 . The method of claim 133 , wherein the weight of the chew is about 0.5-10 g.
135 . The method of claim 134 , wherein the weight of the chew is about 4 g, about 6 g, about 9 g, or about 10 g.
136 . The method of claim 135 , wherein the weight of the chew is about 4 g.
137 . The method of any one of claims 133-136 , wherein the chew comprises:
about 70 mg of cannabigerol;
about 60 mg of cannabigerolic acid;
about 3.2 mg Δ9-tetrahydrocannabinol; and
about 3.6 mg cannabichromene.