Cannabis extracts for the treatment of pain, cancer, and epilepsy in animals

Abstract

The present disclosure relates to pharmaceutical compositions comprising a cannabis extract and a carrier. The disclosure also relates to dosage forms and methods of treatment using the pharmaceutical compositions.

Description

[Technical field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims the benefit of U.S. Provisional Application No. 63 / 262,457, filed October 13, 2021, and U.S. Provisional Application No. 63 / 269,308, filed March 14, 2022, the entire disclosures of each of which are incorporated herein by reference. [Background technology]

[0002] A recent survey by the American Holistic Veterinary Medicine Association found that approximately 60% of people who purchase cannabis products online use these products on their dogs. Industrial hemp products, which are low in THC (0.3%) and high in other cannabinoids, are reported to have health benefits including painkillers, anti-inflammatory agents, anti-anxiety agents, and anti-epileptic agents, and are legal according to the Industrial Hemp Act. Numerous online companies selling cannabis products containing CBD, CBG, and other oils claim that they are safe and effective for a variety of medical conditions in both pets and people. There is very little published data to support these claims, and no data exists showing the safety of using CBD, CBG, and other oils concurrently with chemotherapy in veterinary patients. In the absence of optimal treatments for these dogs for pain, epilepsy, or cancer, other potentially effective agents, including cannabinoids, are often sought. Summary of the Invention

[0003] The disclosure provides a pharmaceutical composition comprising a cannabis extract and a carrier, wherein the cannabis extract comprises cannabigerol and cannabigerol acid, and the ratio of cannabigerol to cannabigerol acid is from about 0.2:1 to about 1:0.2.

[0004] The present disclosure also provides a pharmaceutical composition comprising a cannabis extract and a carrier, wherein the cannabis extract comprises: Cannabigerolic acid, Cannabigerol, Cannabidiol, Cannabidiolic acid, Δ9-tetrahydrocannabinol, and Contains cannabichromene, A pharmaceutical composition is provided, wherein the ratio of cannabigerol to cannabigerolic acid is from about 0.6:1 to about 1:0.6.

[0005] In some embodiments, the pharmaceutical composition comprises: α-pinene, β-myrcene, β-pinene, δ-limonene, Linalool, β-caryophyllene, α-humulene, Nerolidol, Guaiol, Caryophyllene oxide, and Further contains α-bisabolol.

[0006] In some embodiments, the concentration of Δ9-tetrahydrocannabinol is insufficient to produce a psychotropic effect. In some embodiments, the ratio of Δ9-tetrahydrocannabinol to other cannabinoids is about 1:25. In some embodiments, the concentration of Δ9-tetrahydrocannabinol is less than about 10 mg / mL. In some embodiments, the concentration of Δ9-tetrahydrocannabinol is less than about 5 mg / mL. In some embodiments, the concentration of Δ9-tetrahydrocannabinol is less than about 3 mg / mL. In some embodiments, the concentration of Δ9-tetrahydrocannabinol is less than about 2 mg / mL. In some embodiments, the concentration of Δ9-tetrahydrocannabinol is less than about 1 mg / mL. In some embodiments, the concentration of Δ9-tetrahydrocannabinol is less than about 0.5 mg / mL. In some embodiments, the concentration of Δ9-tetrahydrocannabinol is less than about 0.3 mg / mL. In some embodiments, the concentration of Δ9-tetrahydrocannabinol is less than about 0.2 mg / mL. In some embodiments, the concentration of A9-tetrahydrocannabinol is less than about 0.1 mg / mL. In some embodiments, the concentration of A9-tetrahydrocannabinol is less than about 0.01 mg / mL. In some embodiments, the concentration of A9-tetrahydrocannabinol is about 0 mg / mL. In some embodiments, the concentration of A9-tetrahydrocannabinol is undetectable.

[0007] In some embodiments, the concentration of Δ9-tetrahydrocannabinol is less than about 1%. In some embodiments, the concentration of Δ9-tetrahydrocannabinol is less than about 0.5%. In some embodiments, the concentration of Δ9-tetrahydrocannabinol is less than about 0.3%. In some embodiments, the concentration of Δ9-tetrahydrocannabinol is less than about 0.2%. In some embodiments, the concentration of Δ9-tetrahydrocannabinol is less than about 0.1%. In some embodiments, the concentration of Δ9-tetrahydrocannabinol is less than about 0.01%.

[0008] In some embodiments the cannabis extract comprises: Approximately 1-10 mg / mL cannabigerol; Approximately 1-10 mg / mL cannabigerolic acid, Δ9-tetrahydrocannabinol less than 0.1 mg / mL, and Contains approximately 0.1-0.4 mg / mL of cannabichromene.

[0009] In some embodiments the cannabis extract comprises: Approximately 5mg / mL cannabigerol, Approximately 5 mg / mL cannabigerolic acid, Δ9-tetrahydrocannabinol less than 0.1 mg / mL, and Contains approximately 0.27 mg / mL of cannabichromene.

[0010] In some embodiments the cannabis extract comprises: Approximately 10-100mg / mL cannabigerol, Approximately 10-100 mg / mL cannabigerolic acid, Δ9-tetrahydrocannabinol less than 1 mg / mL, and Contains approximately 1-4 mg / mL of cannabichromene.

[0011] In some embodiments the cannabis extract comprises: Approximately 50mg / mL cannabigerol, Approximately 50 mg / mL cannabigerolic acid, Δ9-tetrahydrocannabinol less than 1 mg / mL, and Contains approximately 2.7 mg / mL of cannabichromene.

[0012] In some embodiments the cannabis extract comprises: Approximately 1-10% cannabigerol, Approximately 1-10% cannabigerolic acid, Less than 0.1% Δ9-tetrahydrocannabinol, and It contains approximately 0.1-0.4% cannabichromene.

[0013] In some embodiments the cannabis extract comprises: Approximately 5% cannabigerol, Approximately 5% cannabigerolic acid, Less than 0.1% Δ9-tetrahydrocannabinol, and Contains approximately 0.27% cannabichromene.

[0014] In some embodiments the cannabis extract comprises: Approximately 0.09-0.13% α-pinene, Approximately 0.23-0.44% β-myrcene, Approximately 0.04-0.09% β-pinene, Approximately 0.05-0.09% δ-limonene, Approximately 0.03-0.06% linalool, Approximately 0.04-0.07% β-caryophyllene, Approximately 0.02-0.04% α-humulene, Approximately 0.04-0.07% nerolidol, Approximately 0.02-0.04% guaiol, about 0.04-0.08% caryophyllene oxide, and Contains approximately 0.01-0.04% α-bisabolol.

[0015] In some embodiments the cannabis extract comprises: Camphene, β-ocimene, Eucalyptol, Isopulegol, and / or Contains nerolidol.

[0016] In some embodiments the cannabis extract comprises: Approximately 0.02% camphene, Approximately 0.02-0.03% β-ocimene, Approximately 0.02-0.05% eucalyptol, about 0.02% isopulegol, and / or Contains approximately 0.02-0.04% nerolidol.

[0017] In some embodiments, the composition is formulated in a carrier. 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.In some embodiments, the carrier comprises grapeseed oil.In some embodiments, the carrier comprises catnip oil.In some embodiments, the carrier comprises sesame oil.

[0018] In some embodiments, the composition comprises lecithin. In some embodiments, the lecithin is sunflower lecithin. In some embodiments, the sunflower lecithin is up to 40%.

[0019] In some embodiments, the composition further comprises NF-971P, in some embodiments, the NF-971P is at up to 2% weight / volume.

[0020] In some embodiments the cannabis extract comprises: Cannabigerolic acid, Cannabigerol, Cannabidiol, Cannabidiolic acid, Δ9-tetrahydrocannabinol, and Contains cannabichromene.

[0021] In some embodiments the cannabis extract comprises: Approximately 1-10 mg / mL cannabigerolic acid, Approximately 1-10 mg / mL cannabigerol; Approximately 0.1-0.5 mg / mL of cannabidiol, Approximately 0.1-0.5 mg / mL of cannabidiol acid, Δ9-tetrahydrocannabinol less than 0.1 mg / mL, and Contains approximately 0.1-0.4 mg / mL of cannabichromene.

[0022] In some embodiments the cannabis extract comprises: Approximately 10-100mg / mL cannabigerol, Approximately 10-100 mg / mL cannabigerolic acid, Approximately 1-5 mg / mL cannabidiol, Approximately 1-5 mg / mL cannabidiolic acid, Δ9-tetrahydrocannabinol less than 1 mg / mL, and Contains approximately 1-4 mg / mL of cannabichromene.

[0023] In some embodiments the cannabis extract comprises: Approximately 1-10% cannabigerol, Approximately 1-10% cannabigerolic acid, Approximately 0.1-0.5% cannabidiol, Approximately 0.1-0.5% cannabidiol acid, Less than 0.1% Δ9-tetrahydrocannabinol, and It contains approximately 0.1-0.4% cannabichromene.

[0024] In some embodiments, 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. In some embodiments, the ratio of cannabigerol to cannabigerolic acid is about 1:1.

[0025] In some embodiments, the concentration of Δ9-tetrahydrocannabinol is insufficient to produce a psychotropic effect. In some embodiments, the ratio of Δ9-tetrahydrocannabinol to other cannabinoids is about 1:25. In some embodiments, the concentration of Δ9-tetrahydrocannabinol is less than about 10 mg / mL. In some embodiments, the concentration of Δ9-tetrahydrocannabinol is less than about 5 mg / mL. In some embodiments, the concentration of Δ9-tetrahydrocannabinol is less than about 3 mg / mL. In some embodiments, the concentration of Δ9-tetrahydrocannabinol is less than about 2 mg / mL. In some embodiments, the concentration of Δ9-tetrahydrocannabinol is less than about 1 mg / mL. In some embodiments, the concentration of Δ9-tetrahydrocannabinol is less than about 0.5 mg / mL. In some embodiments, the concentration of Δ9-tetrahydrocannabinol is less than about 0.3 mg / mL. In some embodiments, the concentration of Δ9-tetrahydrocannabinol is less than about 0.2 mg / mL. In some embodiments, the concentration of A9-tetrahydrocannabinol is less than about 0.1 mg / mL. In some embodiments, the concentration of A9-tetrahydrocannabinol is about 0 mg / mL.

[0026] In some embodiments, the concentration of Δ9-tetrahydrocannabinol is less than about 1%. In some embodiments, the concentration of Δ9-tetrahydrocannabinol is less than about 0.5%. In some embodiments, the concentration of Δ9-tetrahydrocannabinol is less than about 0.3%. In some embodiments, the concentration of Δ9-tetrahydrocannabinol is less than about 0.2%. In some embodiments, the concentration of Δ9-tetrahydrocannabinol is less than about 0.1%. In some embodiments, the concentration of Δ9-tetrahydrocannabinol is less than about 0.01%.

[0027] In some embodiments the cannabis extract comprises: Approximately 1-10 mg / mL cannabigerol; Approximately 1-10 mg / mL cannabigerolic acid, Δ9-tetrahydrocannabinol less than 0.1 mg / mL, and Contains approximately 0.1-0.4 mg / mL of cannabichromene.

[0028] In some embodiments the cannabis extract comprises: Approximately 5mg / mL cannabigerol, Approximately 5 mg / mL cannabigerolic acid, Δ9-tetrahydrocannabinol less than 0.1 mg / mL, and Contains approximately 0.27 mg / mL of cannabichromene.

[0029] In some embodiments the cannabis extract comprises: Approximately 10-100mg / mL cannabigerol, Approximately 10-100 mg / mL cannabigerolic acid, Δ9-tetrahydrocannabinol less than 1 mg / mL, and Contains approximately 1-4 mg / mL of cannabichromene.

[0030] In some embodiments the cannabis extract comprises: Approximately 50mg / mL cannabigerol, Approximately 50 mg / mL cannabigerolic acid, Δ9-tetrahydrocannabinol less than 1 mg / mL, and Contains approximately 2.7 mg / mL of cannabichromene.

[0031] In some embodiments the cannabis extract comprises: Approximately 1-10% cannabigerol, Approximately 1-10% cannabigerolic acid, Less than 0.1% Δ9-tetrahydrocannabinol, and It contains approximately 0.1-0.4% cannabichromene.

[0032] In some embodiments the cannabis extract comprises: Approximately 5% cannabigerol, Approximately 5% cannabigerolic acid, Less than 0.1% Δ9-tetrahydrocannabinol, and Contains approximately 0.27% cannabichromene.

[0033] In some embodiments the cannabis extract comprises: α-pinene, β-myrcene, β-pinene, δ-limonene, Linalool, β-caryophyllene, α-humulene, Nerolidol, Guaiol, Caryophyllene oxide, and Contains alpha-bisabolol.

[0034] In some embodiments the cannabis extract comprises: Approximately 0.09-0.13% α-pinene, Approximately 0.23-0.44% β-myrcene, Approximately 0.04-0.09% β-pinene, Approximately 0.05-0.09% δ-limonene, Approximately 0.03-0.06% linalool, Approximately 0.04-0.07% β-caryophyllene, Approximately 0.02-0.04% α-humulene, Approximately 0.04-0.07% nerolidol, Approximately 0.02-0.04% guaiol, about 0.04-0.08% caryophyllene oxide, and Contains approximately 0.01-0.04% α-bisabolol.

[0035] In some embodiments the cannabis extract comprises: Camphene, β-ocimene, Eucalyptol, Isopulegol, and / or Contains nerolidol.

[0036] In some embodiments the cannabis extract comprises: Approximately 0.02% camphene, Approximately 0.02-0.03% β-ocimene, Approximately 0.02-0.05% eucalyptol, about 0.02% isopulegol, and / or Contains approximately 0.02-0.04% nerolidol.

[0037] The present disclosure also provides a dosage form comprising any of the pharmaceutical compositions described herein and one or more pharma- ceutically acceptable additives, flavoring agents, surfactants, and adjuvants. In some embodiments, the flavoring agent is selected from the group consisting of peppermint oil, mango extract, beef, chicken, and seafood. In some embodiments, the dosage form is formulated as a sublingual spray. In some embodiments, the dosage form is formulated as a water-soluble or alcohol-soluble solution, or a cream for transdermal application. In some embodiments, the dosage form is formulated as a gel for intrabuccal or intramucosal administration. In some embodiments, the dosage form is formulated as a powder. In some embodiments, the dosage form is formulated as a solution for subcutaneous injection. In some embodiments, the dosage form is formulated as a tablet. In some embodiments, the dosage form is formulated as a capsule. In some embodiments, the dosage form is formulated as a hard chewable. In some embodiments, the dosage form is formulated as a soft chewable. In some embodiments, the dosage form is formulated for administration using a nebulizer. In some embodiments, the dosage form is formulated for administration using a pet collar.

[0038] In some embodiments, the dosage form is formulated as a chew for oral administration. In some embodiments, the chew is produced using cold extrusion. In some embodiments, the chew weighs about 0.5-10 g. In some embodiments, the chew weighs about 4 g, about 6 g, about 9 g, or about 10 g. In some embodiments, the chew weighs about 4 g. In some embodiments, the chew is Approximately 7mg of cannabigerol, Approximately 6mg of cannabigerolic acid, approximately 0.32 mg of Δ9-tetrahydrocannabinol, and Contains approximately 0.36 mg of cannabichromene.

[0039] In some embodiments, the dosage form is formulated in a carrier for oral administration. In some embodiments, 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. In some embodiments, the carrier comprises grapeseed oil. In some embodiments, the carrier comprises catnip oil. In some embodiments, the carrier comprises sesame oil.

[0040] In some embodiments, the dosage form is formulated for inhalation.

[0041] The present disclosure also provides a method for treating or reducing pain in a subject in need thereof, comprising administering to the subject a therapeutically effective amount of any of the compositions or dosage forms disclosed herein, in some embodiments, the pain is associated with arthritis, post-operative pain, acute pain, joint pain, or polyarticular pain.

[0042] The present disclosure also provides a method for treating epilepsy in a subject in need thereof, comprising administering to the subject a therapeutically effective amount of any of the compositions or dosage forms disclosed herein. In some embodiments, the subject has previously experienced a generalized motor seizure or focal seizure episode. In some embodiments, the subject has a reduction in seizure frequency and / or duration.

[0043] The present disclosure also provides a method for improving quality of life in a subject with cancer, comprising administering to the subject a therapeutically effective amount of any of the compositions or dosage forms disclosed herein. In some embodiments, the subject is undergoing L-CHOP or CHOP chemotherapy. In some embodiments, the cannabis extract, composition, or dosage form is administered about every 12 hours starting from the 4th or 5th week of doxorubicin treatment. In some embodiments, the cancer is lymphoma. In some embodiments, the lymphoma is intermediate to high grade multicentric lymphoma. In some embodiments, after treatment, the subject experiences disappearance of lymphoma-related abnormalities or a decrease in lymph node size. In some embodiments, the subject weighs more than 15 kg. In some embodiments, the subject is at the end of the first cycle of L-CHOP chemotherapy.

[0044] The present disclosure also provides a method for treating post-operative pain in a subject in need thereof, comprising administering to the subject a therapeutically effective amount of any of the compositions or dosage forms disclosed herein. In some embodiments, the subject has undergone a tibial plateau leveling osteotomy. In some embodiments, the subject has been treated with fentanyl and / or a nerve block.

[0045] In some embodiments, any of the pharmaceutical compositions or dosage forms disclosed herein are administered at a dose of about 0.1-8.0 mg / kg. In some embodiments, any of the pharmaceutical compositions or dosage forms disclosed herein are administered at twice the therapeutically effective dose for one week, followed by administration at the therapeutically effective dose. In some embodiments, the therapeutically effective dose is about 0.1-0.5 mg / kg. In some embodiments, the therapeutically effective dose is about 2 mg / kg. In some embodiments, the therapeutically effective dose is about 8 mg / kg.

[0046] In some embodiments, any of the pharmaceutical compositions or dosage forms disclosed herein are administered at a dose of about 1 mg / kg for one week, followed by a dose of about 0.1-0.5 mg / kg. In some embodiments, any of the pharmaceutical compositions or dosage forms disclosed herein are administered at a dose of about 4 mg / kg for one week, followed by a dose of about 2 mg / kg. In some embodiments, any of the methods disclosed herein result in a therapeutically effective median maximum serum concentration of cannabigerol. In some embodiments, the median maximum serum concentration of cannabigerol is about 50 ng / mL. In some embodiments, the median maximum serum concentration of cannabigerol is about 2000 ng / mL.

[0047] In some embodiments, the subject is a veterinary subject. In some embodiments, the veterinary subject is a dog, a cat, a cow, a pig, or a horse. In some embodiments, the subject is a human.

[0048] The disclosure also provides a method of achieving an area under the curve for cannabigerol from 0 to 24 hours of 42.4 to 3048 ng hr / ml in a subject, comprising administering to the subject an effective amount of a cannabis extract. In some embodiments, the subject is a human, dog, or cat.

[0049] The disclosure also provides a method of treating or reducing pain in a subject in need thereof comprising administering a therapeutically effective amount of a pharmaceutical composition comprising a cannabis extract and a carrier, wherein the cannabis extract is Cannabigerol, and Contains cannabigerolic acid, Methods are provided wherein the ratio of cannabigerol to cannabigerolic acid is from about 0.6:1 to about 1:0.6.

[0050] The disclosure also provides a method of treating epilepsy in a subject in need thereof comprising administering a therapeutically effective amount of a pharmaceutical composition comprising a cannabis extract and a carrier, wherein the cannabis extract: Cannabigerol, and Contains cannabigerolic acid, Methods are provided wherein the ratio of cannabigerol to cannabigerolic acid is from about 0.6:1 to about 1:0.6.

[0051] The disclosure also provides a method of treating cancer in a subject in need thereof comprising administering a therapeutically effective amount of a pharmaceutical composition comprising a cannabis extract and a carrier, wherein the cannabis extract: Cannabigerol, and Contains cannabigerolic acid, Methods are provided wherein the ratio of cannabigerol to cannabigerolic acid is from about 0.6:1 to about 1:0.6.

[0052] The disclosure also provides a method of improving quality of life in a subject with cancer comprising administering a therapeutically effective amount of a pharmaceutical composition comprising a cannabis extract and a carrier, wherein the cannabis extract comprises: Cannabigerol, and Contains cannabigerolic acid, Methods are provided wherein the ratio of cannabigerol to cannabigerolic acid is from about 0.6:1 to about 1:0.6.

[0053] In some embodiments the cannabis extract comprises: Cannabigerolic acid, Δ9-tetrahydrocannabinol, and Further comprising cannabichromene, In some embodiments the cannabis extract comprises: α-pinene, β-myrcene, β-pinene, δ-limonene, Linalool, β-caryophyllene, α-humulene, Nerolidol, Guaiol, Caryophyllene oxide, and It further contains four or more of α-bisabolol.

[0054] In some embodiments, the concentration of Δ9-tetrahydrocannabinol is insufficient to produce a psychotropic effect. In some embodiments, the ratio of Δ9-tetrahydrocannabinol to other cannabinoids is about 1:25. In some embodiments, the concentration of Δ9-tetrahydrocannabinol is less than about 10 mg / mL. In some embodiments, the concentration of Δ9-tetrahydrocannabinol is less than about 5 mg / mL. In some embodiments, the concentration of Δ9-tetrahydrocannabinol is less than about 3 mg / mL. In some embodiments, the concentration of Δ9-tetrahydrocannabinol is less than about 2 mg / mL. In some embodiments, the concentration of Δ9-tetrahydrocannabinol is less than about 1 mg / mL. In some embodiments, the concentration of Δ9-tetrahydrocannabinol is less than about 0.5 mg / mL. In some embodiments, the concentration of Δ9-tetrahydrocannabinol is less than about 0.3 mg / mL. In some embodiments, the concentration of Δ9-tetrahydrocannabinol is less than about 0.2 mg / mL. In some embodiments, the concentration of A9-tetrahydrocannabinol is less than about 0.1 mg / mL. In some embodiments, the concentration of A9-tetrahydrocannabinol is about 0 mg / mL.

[0055] In some embodiments, the concentration of Δ9-tetrahydrocannabinol is less than about 1%. In some embodiments, the concentration of Δ9-tetrahydrocannabinol is less than about 0.5%. In some embodiments, the concentration of Δ9-tetrahydrocannabinol is less than about 0.3%. In some embodiments, the concentration of Δ9-tetrahydrocannabinol is less than about 0.2%. In some embodiments, the concentration of Δ9-tetrahydrocannabinol is less than about 0.1%. In some embodiments, the concentration of Δ9-tetrahydrocannabinol is less than about 0.01%.

[0056] In some embodiments the cannabis extract comprises: Approximately 1-10 mg / mL cannabigerol; Approximately 1-10 mg / mL cannabigerolic acid, Δ9-tetrahydrocannabinol less than 0.1 mg / mL, and Contains approximately 0.1-0.4 mg / mL of cannabichromene.

[0057] In some embodiments the cannabis extract comprises: Approximately 5mg / mL cannabigerol, Approximately 5 mg / mL cannabigerolic acid, Δ9-tetrahydrocannabinol less than 0.1 mg / mL, and Contains approximately 0.27 mg / mL of cannabichromene.

[0058] In some embodiments the cannabis extract comprises: Approximately 10-100mg / mL cannabigerol, Approximately 10-100 mg / mL cannabigerolic acid, Δ9-tetrahydrocannabinol less than 1 mg / mL, and Contains approximately 1-4 mg / mL of cannabichromene.

[0059] In some embodiments the cannabis extract comprises: Approximately 50mg / mL cannabigerol, Approximately 50 mg / mL cannabigerolic acid, Δ9-tetrahydrocannabinol less than 1 mg / mL, and Contains approximately 2.7 mg / mL of cannabichromene.

[0060] In some embodiments the cannabis extract comprises: Approximately 1-10% cannabigerol, Approximately 1-10% cannabigerolic acid, Less than 0.1% Δ9-tetrahydrocannabinol, and It contains approximately 0.1-0.4% cannabichromene.

[0061] In some embodiments the cannabis extract comprises: Approximately 5% cannabigerol, Approximately 5% cannabigerolic acid, Less than 0.1% Δ9-tetrahydrocannabinol, and Contains approximately 0.27% cannabichromene.

[0062] In some embodiments the cannabis extract comprises: Approximately 0.09-0.13% α-pinene, Approximately 0.23-0.44% β-myrcene, Approximately 0.04-0.09% β-pinene, Approximately 0.05-0.09% δ-limonene, Approximately 0.03-0.06% linalool, Approximately 0.04-0.07% β-caryophyllene, Approximately 0.02-0.04% α-humulene, Approximately 0.04-0.07% nerolidol, Approximately 0.02-0.04% guaiol, about 0.04-0.08% caryophyllene oxide, and Contains approximately 0.01-0.04% α-bisabolol.

[0063] In some embodiments the cannabis extract comprises: Camphene, β-ocimene, Eucalyptol, Isopulegol, and / or Further contains nerolidol.

[0064] In some embodiments the cannabis extract comprises: Approximately 0.02% camphene, Approximately 0.02-0.03% β-ocimene, Approximately 0.02-0.05% eucalyptol, about 0.02% isopulegol, and / or Contains approximately 0.02-0.04% nerolidol.

[0065] In some embodiments, the cannabis extract comprises 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15 or more of 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.

[0066] In some embodiments, any of the compositions disclosed herein can be formulated in a carrier.In some embodiments, 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.In some embodiments, the carrier comprises grapeseed oil.In some embodiments, the carrier comprises catnip oil.In some embodiments, the carrier comprises sesame oil.

[0067] In some embodiments, any of the compositions disclosed herein may include nepetalactone. In some embodiments, any of the compositions disclosed herein may include taurine.

[0068] In some embodiments, any of the compositions disclosed herein may be formulated for administration using a nebulizer. In some embodiments, any of the compositions disclosed herein may be formulated for administration using a diffuser. In some embodiments, any of the compositions disclosed herein may be formulated for administration using a pet collar. In some embodiments, any of the compositions disclosed herein may be formulated as a pet food for oral administration.

[0069] In some embodiments, any of the compositions disclosed herein may be formulated as a chew for oral administration. In some embodiments, the chew weighs about 0.5-10 g. In some embodiments, the chew weighs about 4 g, about 6 g, about 9 g, or about 10 g. In some embodiments, the chew weighs about 4 g. In some embodiments, the chew weighs about Approximately 7mg of cannabigerol, Approximately 6mg of cannabigerolic acid, approximately 0.32 mg of Δ9-tetrahydrocannabinol, and Contains approximately 0.36 mg of cannabichromene.

[0070] In some embodiments, the chew comprises: Approximately 70mg of cannabigerol, Approximately 60mg of cannabigerolic acid, Approximately 3.2 mg of Δ9-tetrahydrocannabinol, and Contains approximately 3.6 mg of cannabichromene. [Brief description of the drawings]

[0071] Aspects, features, benefits, and advantages of the embodiments described herein will become apparent with regard to the following description, the appended claims, and the accompanying drawings.

[0072] [Figure 1] Figure 2 shows serum levels of CBG at the indicated time points for fed and fasted dogs treated with cannabis extract compositions. [Diagram 2] FIG. 1 shows serum levels of CBGA at the indicated time points for fed and fasted dogs treated with cannabis extract compositions. [Diagram 3] Figure 14 shows serum levels of CBG after 1 week and 2 weeks of twice daily dosing with a cannabis extract composition in dogs. [Figure 4] Figure 14 shows serum levels of CBGA after 1 and 2 weeks of twice daily dosing with a cannabis extract composition in dogs. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0073] The endocannabinoid receptor system is known to play a role in pain regulation and attenuation of inflammation. Cannabinoid receptors (CB1 and CB2) are widely distributed throughout the central and peripheral nervous systems and are also present in the synovial membrane. However, the psychotropic effects of certain cannabinoids have prevented extensive research into their use as single agents for pain relief. Cannabinoids are a group of as many as 60 different compounds that may or may not act on CB receptors.

[0074] Epilepsy The use of cannabinoid derivatives in the treatment of various neurological disorders in humans has been explored recently, particularly in the treatment of chronic pain and epilepsy. Full-spectrum cannabinoid-rich industrial hemp products containing less than 0.3% THC have been shown to have no psychotropic effects and moderate activity through non-cannabinoid receptor pathways affecting serotonergic, glycinergic, and GABAergic neurotransmitter pathways. Recent studies using full-spectrum cannabinoid-rich HBN have revealed the efficacy of these products in dogs with chronic pain (Wakshlag et al., Front Vet Sci, 2018). Furthermore, human epilepsy studies, and the launch of Epidiolex as a viable treatment, show the benefits of cannabidiol in the treatment of epilepsy, but there are no published studies evaluating the efficacy of HBN in canine epilepsy models. It remains to be evaluated whether treatment of refractory canine epilepsy with HBN reduces seizure number or duration, and whether it alters the metabolism of other drugs commonly used for seizure control in dogs.

[0075] Postoperative pain relief The use of cannabinoid derivatives in the treatment of various neurological disorders in humans has been recently explored, especially in the treatment of chronic pain and epilepsy. Industrial hemp-based dietary supplements (HBN), rich in full-spectrum cannabinoids with less than 0.3% THC, have been shown to have no psychoactive effects and moderate activity through non-cannabinoid receptor pathways affecting serotonergic, glycinergic, and GABA neurotransmitter pathways, potentially reducing pain and inflammation. Recent studies in chronic pain have demonstrated their efficacy. HBN has been shown to reduce chronic osteoarthritic pain based on objective client-based validated surveys, but has not yet been explored for postoperative pain relief. The use of HBN should help reduce postoperative pain and improve outcomes for dogs undergoing tibial plateau leveling osteotomy for cranial cruciate fractures.

[0076] Additionally, cannabinoids may be useful in reducing postoperative pain after spinal cord injury and hemilaminectomy. Postoperative pain after spinal cord injury and hemilaminectomy is complex and involves inflammatory nociceptive and neuropathic pain mechanisms. This complexity of postoperative hemilaminectomy pain necessitates a multimodal analgesic protocol. The current standard of care in patients after hemilaminectomy is parenteral opioids, with adjunctive analgesic protocols varying from institution to institution. While opioid use is effective in controlling postoperative pain, it may be associated with undesirable adverse effects such as vomiting, anorexia, dysphoria, central nervous system and respiratory depression, constipation, and sedation. The goal of adjunctive analgesia in patients after hemilaminectomy is twofold: to reduce the amount of opioids required for pain control and to target multiple pain mechanisms. Typical adjunctive analgesics include gabapentin, diazepam, and nonsteroidal anti-inflammatory or steroidal agents. Gabapentin, the gold standard for neuropathic pain, is generally well tolerated by patients and is commonly used in post-neurosurgical patients.

[0077] The present disclosure is directed to compositions comprising cannabis extracts and their use for the treatment of pain in animals. Also provided herein are methods for treating pain in veterinary subjects. The efficacy of these compositions and treatments has not been demonstrated to date. Clinical trials and pharmacokinetic data regarding administration are also provided herein.

[0078] definition Listed below are definitions of various terms used in this specification. These definitions apply to the terms as they are used throughout this specification and claims, unless otherwise limited in specific instances, either individually or as part of a larger group.

[0079] Unless otherwise defined, all technical and scientific terms used herein generally have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs. Generally, the nomenclature used herein and the laboratory procedures in cell culture, molecular genetics, organic chemistry, and peptide chemistry are those well known and commonly employed in the art.

[0080] As used herein, the articles "a" and "an" refer to one or to more than one (i.e., to at least one) of the grammatical object of the article. By way of example, "an element" means one element or more than one element. Furthermore, use of the term "including" is not limiting, as are other forms such as "include," "includes," and "included."

[0081] As used herein, the term "about" is understood by those of ordinary skill in the art and varies to some extent depending on the context in which it is used. As used herein, when referring to a measurable value such as an amount, duration over time, etc., the term "about" is meant to encompass a ±5% variation from the specified value as a variation appropriate for carrying out the disclosed method.

[0082] As used herein and in the claims, the term "comprising" can include "consisting of" and "consisting essentially of" embodiments. As used herein, the terms "comprise(s)", "include(s)", "having", "has", "may", "contain(s)", and variations thereof are intended to be open-ended transitional phrases, terms, or words that require the presence of the specified components / steps and permit the presence of other components / steps. However, such descriptions should be construed to describe compositions or processes as "consisting of" and "consisting essentially of" the recited compounds, which permit the presence of only the specified compounds, along with any pharma- ceutically acceptable carriers, and exclude other compounds.

[0083] All ranges disclosed herein are inclusive of the recited endpoints and are independently combinable (e.g., the range "50 mg to 500 mg" includes the endpoints 50 mg and 500 mg, and all intermediate values). The endpoints and any values ​​of the ranges disclosed herein are not intended to be limited to the exact ranges or values, but are sufficiently imprecise to include values ​​that are close to those ranges and / or values.

[0084] As used herein, the term "treatment" or "treating" is defined as the application or administration of a therapeutic agent, i.e., a compound provided herein (alone or in combination with another pharmaceutical agent), to a patient, or the application or administration of a therapeutic agent to a tissue or cell line isolated from a patient (e.g., for diagnostic or ex vivo uses), with the intent to cure, remedy, alleviate, relieve, alter, relieve, ameliorate, or affect the symptoms of a disease, disorder, syndrome, or condition. Such treatments may be specifically tailored or modified based on knowledge gained from the field of pharmacogenomics.

[0085] In certain embodiments, the compositions described herein reduce pain in subjects.Pain can be measured using any indicator known in the art.For example, pain can be measured using the Canine Brief Pain Inventory (CBPI), Hudson Activity Scale, flexion and extension measurement, and gait analysis.The reduction of any of these indicators indicates the treatment or reduction of pain.

[0086] As used herein, the term "prevent" or "prevention" refers to the absence of onset of a disorder or disease, if none has occurred, or the absence of further onset of a disorder or disease, if onset of a disorder or disease has already occurred. Also considered is the ability to prevent some or all of the symptoms associated with a disorder or disease.

[0087] As used herein, the term "use" includes any one or more of the following embodiments of the invention, respectively: use in the treatment of pain, use for the manufacture of a pharmaceutical composition for use in the treatment of these diseases, e.g. use in the manufacture of a medicament; methods of using a compound of the invention in the treatment of these diseases; medicaments having a compound of the invention for the treatment of these diseases; and a compound of the invention for use in the treatment of these diseases; where appropriate and convenient, unless otherwise specified.

[0088] As used herein, the terms "patient," "individual," or "subject" are intended to include organisms, e.g., prokaryotes and eukaryotes, that suffer from or can be afflicted with a disease, disorder, or condition associated with protein kinase activity. Examples of subjects include mammals, e.g., humans, dogs, cows, horses, pigs, sheep, goats, cats, mice, rabbits, rats, and transgenic non-human animals. In certain embodiments, the subject is a human, e.g., a human suffering from, at risk of, or potentially suffering from schizophrenia. In another embodiment, the subject is a cell.

[0089] When used in relation to the methods of treatment / prophylaxis and the use of the compounds and pharmaceutical compositions thereof described herein, an individual "in need thereof" may be an individual who has been diagnosed with or previously treated for the condition to be treated. With respect to prevention, an individual in need thereof may also be an individual at risk for the condition (e.g., family history of the condition, lifestyle factors indicative of risk for the condition, etc.). Typically, when a step of administering a compound of the invention is disclosed herein, the invention further contemplates a step of identifying an individual or subject in need of the particular treatment to be administered or having the particular condition to be treated.

[0090] In some embodiments, the individual is a mammal, including but not limited to a cow, horse, cat, rabbit, dog, rodent, or primate. In some embodiments, the mammal is a primate. In some embodiments, the primate is a human. In some embodiments, the individual is a human, including adults, children, and premature infants. In some embodiments, the individual is a non-mammal. In some variations, the primate is a non-human primate, such as a chimpanzee and other ape and monkey species. The term "individual" does not denote a particular age or sex.

[0091] As used herein, the term "pharmaceutical acceptable" refers to a material, such as a carrier or diluent, that does not destroy the biological activity or properties of the compound and is relatively non-toxic, i.e., the material may be administered to an individual without causing undesired biological effects or interacting in a deleterious manner with any of the components contained in the composition.

[0092] As used herein, the term "pharmaceutically acceptable salts" refers to derivatives of the disclosed compounds, where the parent compound is modified by converting an existing acid or base moiety into its salt form. Examples of pharmaceutically acceptable salts include, but are not limited to, mineral or organic acid salts of basic residues such as amines, alkali or organic salts of acidic residues such as carboxylic acids, and the like. The pharmaceutically acceptable salts of the present invention include conventional non-toxic salts of the parent compound formed, for example, from non-toxic inorganic or organic acids. The pharmaceutically acceptable salts of the present invention can be synthesized from the parent compound containing a basic or acidic moiety by conventional chemical methods. In general, such salts can be prepared by reacting the free acid or base forms of these compounds with a stoichiometric amount of the appropriate base or acid in water or an organic solvent, or in a mixture of the two, generally in non-aqueous media such as ether, ethyl acetate, ethanol, isopropanol, or acetonitrile. Lists of suitable salts can be found in Remington's Pharmaceutical Sciences, 17th ed., Mack Publishing Company, Easton, Pa., 1985, p. 1418, and Journal of Pharmaceutical Science, 66, 2 (1977), each of which is incorporated herein by reference in its entirety.

[0093] As used herein, the term "composition" or "pharmaceutical composition" refers to a mixture of a pharmaceutically acceptable carrier and at least one compound useful within the present invention. A pharmaceutical composition facilitates administration of a compound to a patient or subject. Multiple techniques for administering a compound exist in the art, including, but not limited to, intravenous, oral, aerosol, parenteral, ocular, pulmonary, and topical administration.

[0094] As used herein, the term "pharmaceutically acceptable carrier" or "carrier" refers to a pharma- ceutically acceptable material, composition, or carrier, such as a liquid or solid filler, stabilizer, dispersant, suspending agent, diluent, excipient, thickener, solvent, or encapsulating material, involved in carrying or transporting a compound useful in the present invention or to a patient so that it can perform its intended function. Typically, such constructs are carried or transported from one organ or part of the body to another organ or part of the body. Each carrier must be "acceptable" in the sense of being compatible with the other ingredients of the formulation, including the compound useful in the present invention, and not harmful to the patient. Some examples of materials which may serve as pharma- ceutically acceptable carriers include sugars such as lactose, glucose, and sucrose; starches such as corn starch and potato starch; cellulose and its derivatives such as sodium carboxymethylcellulose, ethylcellulose, and cellulose acetate; powdered tragacanth; malt; gelatin; talc; excipients such as cocoa butter and suppository waxes; oils such as peanut oil, cottonseed oil, safflower oil, sesame oil, olive oil, corn oil, and soybean oil; glycols such as propylene glycol; polyols such as glycerin, sorbitol, mannitol, and polyethylene glycol; esters such as ethyl oleate and ethyl laurate; agar; buffers such as magnesium hydroxide and aluminum hydroxide; surface-active agents; alginic acid; pyrogen-free water; isotonic saline; Ringer's solution; ethyl alcohol; phosphate buffers; and other non-toxic compatible substances used in pharmaceutical formulations. As used herein, "pharmacologically acceptable carrier" also includes any and all coatings, antibacterial and antifungal agents, absorption delaying agents, and the like, that are compatible with the activity of the compounds useful within the invention and are physiologically acceptable to the patient. Supplementary active compounds can also be incorporated into the compositions. A "pharmacologically acceptable carrier" or "carrier" can further include pharma- ceutically acceptable salts of the compounds useful within the invention.Other additional ingredients that may be included in pharmaceutical compositions used to practice the invention are known in the art and are described, for example, in Remington's Pharmaceutical Sciences (Genaro, Ed., Mack Publishing Co., 1985, Easton, Pa.), which is incorporated herein by reference.

[0095] As used herein, the term "stabilizer" refers to a polymer that can chemically inhibit or prevent degradation. Stabilizers are added to formulations of compounds to improve the chemical and physical stability of the compounds.

[0096] As used herein, the term "adjuvants" may include, for example, preservatives, wetting agents, suspending agents, sweeteners, flavoring agents, perfuming agents, emulsifying agents, and dispensing agents. Prevention of microbial action is generally provided by various antibacterial and antifungal agents, such as parabens, chlorobutanol, phenol, sorbic acid, and the like. Isotonic agents, such as sugars, sodium chloride, and the like, may also be included. Prolonged absorption of injectable pharmaceutical forms may be brought about by the use of agents that delay absorption, such as aluminum monostearate and gelatin. Auxiliaries may also include wetting agents, emulsifying agents, pH buffers, and antioxidants, such as, for example, citric acid, sorbitan monolaurate, triethanolamine oleate, butylated hydroxytoluene, and the like.

[0097] As used herein, the terms "effective amount," "pharmacologically effective amount," and "therapeutically effective amount" refer to a non-toxic but sufficient amount of an agent to provide a desired biological result. This result may be reduction or alleviation of the signs, symptoms, or causes of a disease, or any other desired alteration of a biological system. The appropriate therapeutic amount in any individual case may be determined by one of ordinary skill in the art using routine experimentation.

[0098] As used herein, the term "weight percent" is meant to refer to the amount by weight of a compound and / or ingredient in a composition as the amount by weight of the component of the composition as a percentage of the weight of the entire composition. Weight percent can also be calculated by multiplying the mass fraction by 100. "Mass fraction" is calculated as follows: weight percent = (ml / m T )*100, the mass m of the entire composition T mass m of one substance l When "%" is used herein, unless otherwise indicated, it is assumed to be percent by weight.

[0099] "Aqueous buffer" refers to an aqueous solution that resists changes in hydronium ion and hydroxide ion concentration (and resulting pH) upon addition of small amounts of acid or base or upon dilution. Buffers consist of a weak acid and its conjugated base (more common) or a weak base and its conjugated acid (less common). Buffers are prepared by methods well known in the art with an appropriate buffering agent to obtain the desired pH value. Examples of suitable buffering agents include hydrochloric acid, lactic acid, acetic acid, citric acid, malic acid, maleic acid, pyruvic acid, succinic acid, tris-hydroxymethylaminomethane, sodium hydroxide, sodium bicarbonate, phosphoric acid, sodium phosphate, and other biologically acceptable buffering agents. Aqueous buffers are readily available commercially and can be used in the preparation of the compositions of the present invention without further processing.

[0100] As used herein, the term "cannabis extract" refers to a composition of cannabinoids and terpenes isolated from a cannabis plant. The terms "cannabis extract" and "CBG / CBGA oil" have the same meaning and are used interchangeably herein. Cannabis extracts can be obtained by any method known in the art. For example, cannabis extracts can be obtained by supercritical (or subcritical) CO2 extraction, which uses carbon dioxide under high pressure and low temperature to isolate, preserve, and maintain the purity of the cannabis extract. In one embodiment, cannabis extracts are obtained from supercritical CO2 extraction. For example, supercritical CO2 extraction may be performed as described in U.S. Patent No. 8,895,078, which is incorporated herein by reference in its entirety. Alternatively, solvents such as petroleum ether, ethanol, methanol, butanol, acetone, dry ice, or olive oil can be used to provide a cannabis extract by passive extraction, heating to a temperature above room temperature or under reflux, as known in the art, with stirring at room temperature (ambient temperature). In another embodiment, the cannabis extract from butanol extraction is used as starting material for the methods disclosed herein. In some embodiments, the cannabis extract undergoes an additional step to enrich one or more components of the cannabis extract. In some embodiments, the cannabis extract is enriched for the presence of CBG and / or CBGA.

[0101] Suitable methods for measuring the cannabinoid and terpene content in cannabis extracts are known in the art. In one embodiment, the cannabinoid content is determined using liquid chromatography with mass spectrometry detection (LC-MS). In another embodiment, the terpene content is determined using gas chromatography with flame ionization detection of headspace (GC-FID).

[0102] As used herein, the term "flavoring agent" refers to an ingredient added to a composition to impart a particular flavor, aroma, or other sensory characteristic.

[0103] As used herein, the term "oil" refers to a non-polar viscous liquid that is both hydrophobic and lipophilic. Oils may be isolated from animals, plants, or petrochemicals.

[0104] As used herein, the term "chew" refers to a product or portion thereof that has rheological and other textural and sensory properties that tend to promote chewing of the article by a target animal. Generally, a chewable matrix exhibits sufficient ductility to be at least slightly malleable when chewed by a target animal, and sufficient palatability that the target animal is not deterred by its taste when chewed multiple times. In contrast, "chewable" does not simply mean that the article can be chewed by an animal (i.e., does not simply mean that a portion of the article fits sufficiently within an animal's mouth to permit engagement of the animal's teeth therewith).

[0105] As used herein, the "maximum serum concentration level" of a substance refers to the maximum level of the substance found in a plasma sample following a single administration.

[0106] As used herein, the term "cold extrusion" refers to a process for producing edible food products that involves several unit operations, including mixing, kneading, shearing, shaping, and forming, all of which are carried out at or near ambient temperature.

[0107] As used herein, the term "psychotropic effect" refers to alterations in brain function that result in changes in perception, mood, consciousness, or behavior.

[0108] As used herein, a "chemotherapeutic agent" is any compound used to treat a proliferative disorder. Examples of chemotherapeutic agents include, but are not limited to, the following classes of agents: Nitrogen mustards, such as cyclophosphamide, trophosphamide, ifosfamide, and chlorambucil; Nitrosoureas such as Carmustine (BCNU), Lomustine (CCNU), Semustine (methyl-CCNU), and Nimustine (ACNU); Ethylenimines and methyl-melamines such as Thiotepa; Folic acid analogues, e.g., methotrexate; Pyrimidine analogues, such as 5-fluorouracil and cytarabine; Purine analogues such as mercaptopurine and azathioprine; Vinca alkaloids such as Vinblastine, Vincristine, and Vindesine; Epipodophyllotoxins such as Etoposide and Teniposide; Antibiotics such as dactinomycin, daunorubicin, doxorubicin, epirubicin, bleomycin a2, mitomycin c, and mitoxantrone; Estrogens, such as ethylstilbestrol; Gonadotropin-releasing hormone analogues such as leuprolide, buserelin, and goserelin; Antiestrogens such as Tamoxifen and Aminoglutethimide; Androgens such as Testolactone and Drostanolone Proprionate; Platinates, such as cisplatin and carboplatin; and Interferon - Interferons including alpha, beta and gamma.

[0109] As used herein, the term "quality of life" or "QoL" is generally considered a multidimensional concept that is a subjective assessment of factors that contribute to overall health, with recent publications suggesting fatigue, anxiety, and digestive function. The Likert scale system appears to be an appropriate assessment of QoL (Giuffrida et al. (2018) J Amer Vet Med Assoc. 252:1073-1083.) and will be used in this study.

[0110] Pharmaceutical Compositions In one aspect, there is provided herein a pharmaceutical composition comprising a cannabis extract and a carrier, the cannabis extract comprising: Cannabigerol, and Contains cannabigerolic acid.

[0111] In another embodiment, the cannabis extract comprises: Cannabigerol, Cannabigerolic acid, Cannabidiol, Cannabidiolic acid, Δ9-tetrahydrocannabinol, and Contains cannabichromene.

[0112] In another embodiment, the ratio of Δ9-tetrahydrocannabinol to other cannabinoids is about 1:50 to about 1:20. In one embodiment, the ratio of cannabigerol to cannabigerolic acid is about 0.1:1 to about 1:0.1. In another embodiment, the ratio of cannabigerol to cannabigerolic acid is about 0.1:1, about 0.2:1, about 0.3:1, about 0.4:1, about 0.5:1, about 0.6:1, about 0.7:1, about 0.8:1, about 0.9:1, about 1:1, about 1:0.9, about 1:0.8, about 1:0.7, about 1:0.6, about 1:0.5, about 1:0.4, about 1:0.3, about 1:0.2, or about 1:0.1. In yet another embodiment, the ratio of cannabigerol to cannabigerolic acid is about 0.2:1 to about 1:0.2. In yet another embodiment, the ratio of cannabigerol to cannabigerolic acid is about 0.4:1 to about 1:0.4. In yet another embodiment, the ratio of cannabigerol to cannabigerolic acid is about 0.6:1 to about 1:0.6. In yet another embodiment, the ratio of cannabigerol to cannabigerolic acid is about 1:1.

[0113] In one embodiment, the concentration of Δ9-tetrahydrocannabinol is insufficient to produce a psychotropic effect. In another embodiment, the ratio of Δ9-tetrahydrocannabinol to other cannabinoids is about 1:50 to about 1:20. In yet another embodiment, the ratio of Δ9-tetrahydrocannabinol to other cannabinoids is about 1:50. In yet another embodiment, the ratio of Δ9-tetrahydrocannabinol to other cannabinoids is about 1:45. In one embodiment, the ratio of Δ9-tetrahydrocannabinol to other cannabinoids is about 1:40. In another embodiment, the ratio of Δ9-tetrahydrocannabinol to other cannabinoids is about 1:35. In yet another embodiment, the ratio of Δ9-tetrahydrocannabinol to other cannabinoids is about 1:30. In yet another embodiment, the ratio of Δ9-tetrahydrocannabinol to other cannabinoids is about 1:25. In one embodiment, the ratio of A9-tetrahydrocannabinol to other cannabinoids is about 1:20.

[0114] In one embodiment, the concentration of Δ9-tetrahydrocannabinol is less than about 20 mg / mL. In another embodiment, the concentration of Δ9-tetrahydrocannabinol is less than about 10 mg / mL. In another embodiment, the concentration of Δ9-tetrahydrocannabinol is less than about 5 mg / mL. In another embodiment, the concentration of Δ9-tetrahydrocannabinol is less than about 3 mg / mL. In another embodiment, the concentration of Δ9-tetrahydrocannabinol is less than about 2 mg / mL. In another embodiment, the concentration of Δ9-tetrahydrocannabinol is less than about 1.5 mg / mL. In yet another embodiment, the concentration of Δ9-tetrahydrocannabinol is less than about 1 mg / mL. In yet another embodiment, the concentration of Δ9-tetrahydrocannabinol is less than about 0.9 mg / mL. In yet another embodiment, the concentration of Δ9-tetrahydrocannabinol is less than about 0.8 mg / mL. In one embodiment, the concentration of Δ9-tetrahydrocannabinol is less than about 0.7 mg / mL. In another embodiment, the concentration of Δ9-tetrahydrocannabinol is less than about 0.6 mg / mL. In yet another embodiment, the concentration of Δ9-tetrahydrocannabinol is less than about 0.5 mg / mL. In yet another embodiment, the concentration of Δ9-tetrahydrocannabinol is less than about 0.4 mg / mL. In one embodiment, the concentration of Δ9-tetrahydrocannabinol is less than about 0.3 mg / mL. In another embodiment, the concentration of Δ9-tetrahydrocannabinol is less than about 0.2 mg / mL. In yet another embodiment, the concentration of Δ9-tetrahydrocannabinol is less than about 0.1 mg / mL. In another embodiment, the concentration of Δ9-tetrahydrocannabinol is about 0 mg / mL.

[0115] In some embodiments, the concentration of Δ9-tetrahydrocannabinol is less than about 2%. In some embodiments, the concentration of Δ9-tetrahydrocannabinol is less than about 1%. In some embodiments, the concentration of Δ9-tetrahydrocannabinol is less than about 0.5%. In some embodiments, the concentration of Δ9-tetrahydrocannabinol is less than about 0.3%. In some embodiments, the concentration of Δ9-tetrahydrocannabinol is less than about 0.2%. In some embodiments, the concentration of Δ9-tetrahydrocannabinol is less than about 0.1%. In some embodiments, the concentration of Δ9-tetrahydrocannabinol is less than about 0.01%.

[0116] In one embodiment the cannabis extract comprises: Approximately 0.1 to 20 mg / mL of cannabigerol; Approximately 0.1 to 20 mg / mL of cannabigerolic acid; about 0.01-0.5 mg / mL Δ9-tetrahydrocannabinol, and Contains approximately 0.01-0.5 mg / mL of cannabichromene.

[0117] In another embodiment, the cannabis extract comprises: Approximately 1-10 mg / mL cannabigerol; Approximately 1-10 mg / mL cannabigerolic acid, Δ9-tetrahydrocannabinol less than 0.1 mg / mL, and Contains approximately 0.1-0.4 mg / mL of cannabichromene.

[0118] In yet another embodiment, the cannabis extract comprises: Approximately 5mg / mL cannabigerol, Approximately 5 mg / mL cannabigerolic acid, Δ9-tetrahydrocannabinol less than 0.1 mg / mL, and Contains approximately 0.27 mg / mL of cannabichromene.

[0119] In another embodiment, the cannabis extract comprises: Approximately 1-10 mg / mL cannabigerolic acid, Approximately 1-10 mg / mL cannabigerol; Approximately 0.1-0.5 mg / mL of cannabidiol, Approximately 0.1-0.5 mg / mL of cannabidiol acid, Δ9-tetrahydrocannabinol less than 0.1 mg / mL, and Contains approximately 0.1-0.4 mg / mL of cannabichromene.

[0120] In another embodiment, the cannabis extract comprises: Approximately 1-200 mg / mL cannabigerol, Approximately 1-200 mg / mL cannabigerolic acid, Δ9-tetrahydrocannabinol between 0.1 and 5 mg / mL, and Contains approximately 0.1-5 mg / mL of cannabichromene.

[0121] In another embodiment, the cannabis extract comprises: Approximately 10-100mg / mL cannabigerol, Approximately 10-100 mg / mL cannabigerolic acid, Δ9-tetrahydrocannabinol less than 1 mg / mL, and Contains approximately 1-4 mg / mL of cannabichromene.

[0122] In another embodiment, the cannabis extract comprises: Approximately 50mg / mL cannabigerol, Approximately 50 mg / mL cannabigerolic acid, Δ9-tetrahydrocannabinol less than 1 mg / mL, and Contains approximately 2.7 mg / mL of cannabichromene.

[0123] In another embodiment, the cannabis extract comprises: Approximately 10-100mg / mL cannabigerol, Approximately 10-100 mg / mL cannabigerolic acid, Approximately 1-5 mg / mL cannabidiol, Approximately 1-5 mg / mL cannabidiolic acid, Δ9-tetrahydrocannabinol less than 1 mg / mL, and Contains approximately 1-4 mg / mL of cannabichromene.

[0124] In another embodiment, the cannabis extract comprises: Approximately 1-10% cannabigerol, Approximately 1-10% cannabigerolic acid, Less than 0.1% Δ9-tetrahydrocannabinol, and It contains approximately 0.1-0.4% cannabichromene.

[0125] In another embodiment, the cannabis extract comprises: Approximately 5% cannabigerol, Approximately 5% cannabigerolic acid, Less than 0.1% Δ9-tetrahydrocannabinol, and Contains approximately 0.27% cannabichromene.

[0126] In another embodiment, the cannabis extract comprises: Approximately 0.1 to 20% cannabigerol, Approximately 0.1-20% cannabigerolic acid, about 0.01 to 0.5% Δ9-tetrahydrocannabinol, and It contains approximately 0.01-0.5% cannabichromene.

[0127] In another embodiment, the cannabis extract comprises: Approximately 1-10% cannabigerol, Approximately 1-10% cannabigerolic acid, Less than 0.1% Δ9-tetrahydrocannabinol, and It contains approximately 0.1-0.4% cannabichromene.

[0128] In yet another embodiment, the cannabis extract comprises: Approximately 5% cannabigerol, Approximately 5% cannabigerolic acid, Less than 0.1% Δ9-tetrahydrocannabinol, and Contains approximately 0.27% cannabichromene.

[0129] In another embodiment, the cannabis extract comprises: Approximately 1-10% cannabigerolic acid, Approximately 1-10% cannabigerol, Approximately 0.1-0.5% cannabidiol, Approximately 0.1-0.5% cannabidiol acid, Less than 0.1% Δ9-tetrahydrocannabinol, and It contains approximately 0.1-0.4% cannabichromene.

[0130] In one embodiment there is provided herein a pharmaceutical composition comprising a cannabis extract and a carrier, the cannabis extract comprising: α-pinene, β-myrcene, β-pinene, δ-limonene, Linalool, β-caryophyllene, α-humulene, Nerolidol, Guaiol, Caryophyllene oxide, and Contains alpha-bisabolol.

[0131] In another embodiment, the cannabis extract comprises: Approximately 0.09-0.13% α-pinene, Approximately 0.23-0.44% β-myrcene, Approximately 0.04-0.09% β-pinene, Approximately 0.05-0.09% δ-limonene, Approximately 0.03-0.06% linalool, Approximately 0.04-0.07% β-caryophyllene, Approximately 0.02-0.04% α-humulene, Approximately 0.04-0.07% nerolidol, Approximately 0.02-0.04% guaiol, about 0.04-0.08% caryophyllene oxide, and Contains approximately 0.01-0.04% α-bisabolol.

[0132] In another embodiment, the cannabis extract comprises: Approximately 0.07-0.30% α-pinene, Approximately 0.10 to 0.60% β-myrcene, Approximately 0.02-0.20% β-pinene, Approximately 0.03 to 0.20% δ-limonene, Approximately 0.01 to 0.08% linalool, Approximately 0.03-0.09% β-caryophyllene, Approximately 0.01 to 0.06% α-humulene, Approximately 0.02 to 0.09% nerolidol, and It contains approximately 0.01-0.06% guaiol.

[0133] In another embodiment, the cannabis extract comprises: Approximately 0.01 to 0.50% α-pinene, Approximately 0.01 to 0.90% β-myrcene, Approximately 0.01 to 0.50% β-pinene, Approximately 0.01 to 0.50% δ-limonene, Approximately 0.01 to 0.50% linalool, Approximately 0.01 to 0.50% β-caryophyllene, Approximately 0.01 to 0.50% α-humulene, Approximately 0.01 to 0.50% nerolidol, Approximately 0.01-0.50% guaiol, about 0.01 to 0.50% caryophyllene oxide, and Contains approximately 0.01-0.50% α-bisabolol.

[0134] In another embodiment, the cannabis extract comprises: Camphene, β-ocimene, Eucalyptol, Isopulegol, and / or Further contains nerolidol.

[0135] In another embodiment, the cannabis extract comprises: Approximately 0.02% camphene, Approximately 0.02-0.03% β-ocimene, Approximately 0.02-0.05% eucalyptol, about 0.02% isopulegol, and / or Contains approximately 0.02-0.04% nerolidol.

[0136] In another embodiment, the cannabis extract comprises: Approximately 0.01-0.04% camphene, Approximately 0.01-0.05% β-ocimene, Approximately 0.01 to 0.07% eucalyptol, About 0.01 to 0.04% isopulegol, and / or Contains approximately 0.01-0.05% nerolidol.

[0137] In another embodiment, the cannabis extract comprises: Approximately 0.01 to 0.50% camphene, Approximately 0.01-0.50% β-ocimene, Approximately 0.01 to 0.50% eucalyptol, About 0.01 to 0.50% isopulegol, and / or Contains approximately 0.01-0.50% nerolidol1.

[0138] In one embodiment the cannabis extract is terpene-free.

[0139] In one embodiment, the cannabis extract comprises one or more of 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.

[0140] In one embodiment, the cannabis extract comprises two or more of 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.

[0141] In one embodiment, the cannabis extract comprises three or more of 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.

[0142] In one embodiment, the cannabis extract comprises four or more of 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.

[0143] In one embodiment, the cannabis extract comprises five or more of 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.

[0144] In one embodiment, the cannabis extract comprises six or more of 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.

[0145] In one embodiment, the cannabis extract comprises seven or more of 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.

[0146] In one embodiment, the cannabis extract comprises eight or more of 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.

[0147] In one embodiment, the cannabis extract comprises nine or more of 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.

[0148] In one embodiment, the cannabis extract comprises ten or more of 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.

[0149] In one embodiment, the cannabis extract comprises eleven or more of 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.

[0150] In one embodiment, the cannabis extract comprises twelve or more of 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.

[0151] In one embodiment, the cannabis extract comprises thirteen or more of 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.

[0152] In one embodiment, the cannabis extract comprises 14 or more of 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.

[0153] In one embodiment, the cannabis extract comprises 15 or more of 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.

[0154] In one embodiment, the cannabis extract comprises 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.

[0155] In one embodiment, the composition is formulated in a carrier, for example, an oil. In some embodiments, the oil functions as a carrier). In another embodiment, 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. In yet another embodiment, the carrier comprises grapeseed oil. In yet another embodiment, the carrier comprises sesame oil.

[0156] In one embodiment, the pharmaceutical composition comprises nepetalactone.

[0157] In one embodiment, the pharmaceutical composition comprises taurine.

[0158] In one embodiment, the pharmaceutical composition comprises lecithin. In another embodiment, the lecithin is sunflower lecithin. In another embodiment, the lecithin is about 5 w / v%, about 10 w / v%, about 15 w / v%, about 20 w / v%, about 25 w / v%, about 30 w / v%, about 35 w / v%, about 40 w / v%, about 45 w / v%, or 50 w / v% of the pharmaceutical composition. In other embodiments, the pharmaceutical composition comprises lecithin mixed with another oil. In some embodiments, the other oil is sesame oil. In some embodiments, the lecithin and the other oil are mixed in a ratio of about 1:4, 1:2, 1:1, 2:1, or 4:1. In some embodiments, the pharmaceutical composition comprises a cannabis extract and a carrier oil. In some embodiments, the carrier oil is substantially all lecithin. In other embodiments, the carrier oil is 100% lecithin.

[0159] In one embodiment, the pharmaceutical composition comprises NF-971P, hi one embodiment, the NF-971P is in a weight / volume ratio of about 0.5%, about 1.0%, about 1.5%, about 2.0%, about 2.5%, or about 3.0% of the pharmaceutical composition.

[0160] In one embodiment, the pharmaceutical composition is formulated as a sublingual spray. In yet another embodiment, the pharmaceutical composition is formulated as an aqueous or alcoholic solution, a gel, or a cream for transdermal application. In one embodiment, the pharmaceutical composition is formulated as a gel for buccal or intramucosal administration. In one embodiment, the pharmaceutical composition is formulated as a powder. In another embodiment, the pharmaceutical composition is formulated as a solution for subcutaneous injection. In yet another embodiment, the pharmaceutical composition is formulated as a tablet. In yet another embodiment, the pharmaceutical composition is formulated as a capsule. In one embodiment, the pharmaceutical composition is formulated as a hard chew. In one embodiment, the pharmaceutical composition is formulated as a soft chew.

[0161] In one embodiment, the composition is formulated as a chew for oral administration. In another embodiment, the chew is produced using cold extrusion. In another embodiment, the chew weighs about 0.5-10 g. In yet another embodiment, the chew weighs about 4 g, about 6 g, about 9 g, or about 10 g. In yet another embodiment, the chew weighs about 0.5 g. In one embodiment, the chew weighs about 1 g. In another embodiment, the chew weighs about 1.5 g. In yet another embodiment, the chew weighs about 2 g. In yet another embodiment, the chew weighs about 3 g. In one embodiment, the chew weighs about 4 g. In another embodiment, the chew weighs about 5 g. In yet another embodiment, the chew weighs about 6 g. In yet another embodiment, the chew weighs about 7 g. In one embodiment, the chew weighs about 8 g. In another embodiment, the chew weighs about 9 g. In yet another embodiment, the chew weighs about 10 g.

[0162] In one embodiment, a 4g chew comprises: Approximately 7mg of cannabigerol, Approximately 6mg of cannabigerolic acid, approximately 0.32 mg of Δ9-tetrahydrocannabinol, and Contains approximately 0.36 mg of cannabichromene.

[0163] In one embodiment, a 4g chew comprises: Approximately 70mg of cannabigerol, Approximately 60mg of cannabigerolic acid, Approximately 3.2 mg of Δ9-tetrahydrocannabinol, and Contains approximately 3.6 mg of cannabichromene.

[0164] The pharmaceutical compositions of the present disclosure may be manufactured by processes well known in the art, e.g., by conventional mixing, dissolving, granulating, milling, comminuted, dragee-making, suspending, emulsifying, encapsulating, entrapping, or lyophilizing processes.

[0165] Thus, the compositions for use according to the present disclosure may be formulated in a conventional manner using one or more pharma- ceutically acceptable carriers, including excipients and adjuvants, that facilitate the processing of the active compounds into pharma- ceutically usable preparations. Appropriate formulations vary depending on the selected route of administration.

[0166] Dosage form In one aspect, the present specification provides a method for producing a pharmaceutical composition comprising the steps of: Cannabigerol, and Cannabigerolic acid, and Dosage forms are provided that include one or more pharma- ceutically acceptable excipients, flavoring agents, surfactants, and adjuvants.

[0167] In another embodiment, the dosage form comprises: Cannabigerol, Cannabigerolic acid, Cannabidiol, Cannabidiolic acid, Δ9-tetrahydrocannabinol, Cannabichromene, and It may include one or more pharma- ceutically acceptable excipients, flavoring agents, surfactants, and adjuvants.

[0168] In one embodiment, 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. In one embodiment, the ratio of cannabigerol to cannabigerolic acid is about 0.1:1 to about 1:0.1. In another embodiment, the ratio of cannabigerol to cannabigerolic acid is about 0.1:1, about 0.2:1, about 0.3:1, about 0.4:1, about 0.5:1, about 0.6:1, about 0.7:1, about 0.8:1, about 0.9:1, about 1:1, about 1:0.9, about 1:0.8, about 1:0.7, about 1:0.6, about 1:0.5, about 1:0.4, about 1:0.3, about 1:0.2, or about 1:0.1. In yet another embodiment, the ratio of cannabigerol to cannabigerolic acid is about 0.6:1 to about 1:0.6. In another embodiment, the ratio of cannabigerol to cannabigerolic acid is about 0.2:1 to about 1:0.2. In yet another embodiment, the ratio of cannabigerol to cannabigerolic acid is about 0.4:1 to about 1:0.4. In yet another embodiment, the ratio of cannabigerol to cannabigerolic acid is about 1:1.

[0169] In one embodiment, the concentration of Δ9-tetrahydrocannabinol is insufficient to produce a psychotropic effect. In another embodiment, the ratio of Δ9-tetrahydrocannabinol to other cannabinoids is about 1:50 to about 1:20. In yet another embodiment, 、 The ratio of A9-tetrahydrocannabinol to other cannabinoids is about 1:50. In yet another embodiment, the ratio of A9-tetrahydrocannabinol to other cannabinoids is about 1:45. In one embodiment 、 The ratio of Δ9-tetrahydrocannabinol to other cannabinoids is about 1:40. In another embodiment, the ratio of Δ9-tetrahydrocannabinol to other cannabinoids is about 1:35. In yet another embodiment, the ratio of Δ9-tetrahydrocannabinol to other cannabinoids is about 1:30. In yet another embodiment, the ratio of Δ9-tetrahydrocannabinol to other cannabinoids is about 1:25. In one embodiment, the ratio of Δ9-tetrahydrocannabinol to other cannabinoids is about 1:20.

[0170] In one embodiment, the concentration of Δ9-tetrahydrocannabinol is less than about 20 mg / mL. In another embodiment, the concentration of Δ9-tetrahydrocannabinol is less than about 10 mg / mL. In another embodiment, the concentration of Δ9-tetrahydrocannabinol is less than about 5 mg / mL. In another embodiment, the concentration of Δ9-tetrahydrocannabinol is less than about 3 mg / mL. In another embodiment, the concentration of Δ9-tetrahydrocannabinol is less than about 2 mg / mL. In another embodiment, the concentration of Δ9-tetrahydrocannabinol is less than about 1.5 mg / mL. In yet another embodiment, the concentration of Δ9-tetrahydrocannabinol is less than about 1 mg / mL. In yet another embodiment, the concentration of Δ9-tetrahydrocannabinol is less than about 1 mg / mL. 、 The concentration of Δ9-tetrahydrocannabinol is less than about 0.9 mg / mL. In yet another embodiment, the concentration of Δ9-tetrahydrocannabinol is less than about 0.8 mg / mL. In one embodiment, the concentration of Δ9-tetrahydrocannabinol is less than about 0.7 mg / mL. In another embodiment, the concentration of Δ9-tetrahydrocannabinol is less than about 0.6 mg / mL. In yet another embodiment, the concentration of Δ9-tetrahydrocannabinol is less than about 0.5 mg / mL. In yet another embodiment, the concentration of Δ9-tetrahydrocannabinol is less than about 0.4 mg / mL. In one embodiment, the concentration of Δ9-tetrahydrocannabinol is less than about 0.3 mg / mL. In another embodiment, the concentration of Δ9-tetrahydrocannabinol is less than about 0.2 mg / mL. In yet another embodiment, the concentration of Δ9-tetrahydrocannabinol is less than about 0.1 mg / mL. In another embodiment, the concentration of Δ9-tetrahydrocannabinol is about 0 mg / mL.

[0171] In some embodiments, the concentration of Δ9-tetrahydrocannabinol is less than about 2%. In some embodiments, the concentration of Δ9-tetrahydrocannabinol is less than about 1%. In some embodiments, the concentration of Δ9-tetrahydrocannabinol is less than about 0.5%. In some embodiments, the concentration of Δ9-tetrahydrocannabinol is less than about 0.3%. In some embodiments, the concentration of Δ9-tetrahydrocannabinol is less than about 0.2%. In some embodiments, the concentration of Δ9-tetrahydrocannabinol is less than about 0.1%. In some embodiments, the concentration of Δ9-tetrahydrocannabinol is less than about 0.01%.

[0172] In one embodiment, the dosage form comprises: Approximately 0.1 to 20 mg / mL of cannabigerol; Approximately 0.1 to 20 mg / mL of cannabigerolic acid; about 0.01-0.5 mg / mL Δ9-tetrahydrocannabinol, and Contains approximately 0.01-0.5 mg / mL of cannabichromene.

[0173] In another embodiment, the dosage form comprises: Approximately 1-10 mg / mL cannabigerol; Approximately 1-10 mg / mL cannabigerolic acid, Δ9-tetrahydrocannabinol less than 0.1 mg / mL, and Contains approximately 0.1-0.4 mg / mL of cannabichromene.

[0174] In yet another embodiment, the dosage form comprises: Approximately 5mg / mL cannabigerol, Approximately 5 mg / mL cannabigerolic acid, Δ9-tetrahydrocannabinol less than 0.1 mg / mL, and Contains approximately 0.27 mg / mL of cannabichromene.

[0175] In another embodiment, the cannabis extract comprises: Approximately 1-200 mg / mL cannabigerol, Approximately 1-200 mg / mL cannabigerolic acid, Δ9-tetrahydrocannabinol between 0.1 and 5 mg / mL, and Contains approximately 0.1-5 mg / mL of cannabichromene.

[0176] In another embodiment, the cannabis extract comprises: Approximately 10-100mg / mL cannabigerol, Approximately 10-100 mg / mL cannabigerolic acid, Δ9-tetrahydrocannabinol less than 1 mg / mL, and Contains approximately 1-4 mg / mL of cannabichromene.

[0177] In another embodiment, the cannabis extract comprises: Approximately 50mg / mL cannabigerol, Approximately 50 mg / mL cannabigerolic acid, Δ9-tetrahydrocannabinol less than 1 mg / mL, and Contains approximately 2.7 mg / mL of cannabichromene.

[0178] In another embodiment, the cannabis extract comprises: Approximately 1-10% cannabigerol, Approximately 1-10% cannabigerolic acid, Less than 0.1% Δ9-tetrahydrocannabinol, and It contains approximately 0.1-0.4% cannabichromene.

[0179] In another embodiment, the cannabis extract comprises: Approximately 5% cannabigerol, Approximately 5% cannabigerolic acid, Less than 0.1% Δ9-tetrahydrocannabinol, and Contains approximately 0.27% cannabichromene.

[0180] In one embodiment the cannabis extract comprises: Approximately 0.1 to 20% cannabigerol, Approximately 0.1-20% cannabigerolic acid, about 0.01 to 0.5% Δ9-tetrahydrocannabinol, and It contains approximately 0.01-0.5% cannabichromene.

[0181] In another embodiment, the cannabis extract comprises: Approximately 1-10% cannabigerol, Approximately 1-10% cannabigerolic acid, Less than 0.1% Δ9-tetrahydrocannabinol, and It contains approximately 0.1-0.4% cannabichromene.

[0182] In yet another embodiment, the cannabis extract comprises: Approximately 5% cannabigerol, Approximately 5% cannabigerolic acid, Less than 0.1% Δ9-tetrahydrocannabinol, and Contains approximately 0.27% cannabichromene.

[0183] In some embodiments, the dosage form comprises: α-pinene, β-myrcene, β-pinene, δ-limonene, Linalool, β-caryophyllene, α-humulene, Nerolidol, Guaiol, Caryophyllene oxide, and Contains a-bisabolol.

[0184] In another embodiment, the dosage form comprises: Approximately 0.09-0.13% α-pinene, Approximately 0.23-0.44% β-myrcene, Approximately 0.04-0.09% β-pinene, Approximately 0.05-0.09% δ-limonene, Approximately 0.03-0.06% linalool, Approximately 0.04-0.07% β-caryophyllene, Approximately 0.02-0.04% α-humulene, Approximately 0.04-0.07% nerolidol, Approximately 0.02-0.04% guaiol, about 0.04-0.08% caryophyllene oxide, and Contains approximately 0.01-0.04% α-bisabolol.

[0185] In another embodiment, the dosage form comprises: Approximately 0.07-0.30% α-pinene, Approximately 0.10 to 0.60% β-myrcene, Approximately 0.02-0.20% β-pinene, Approximately 0.03 to 0.20% δ-limonene, Approximately 0.01 to 0.08% linalool, Approximately 0.03-0.09% β-caryophyllene, Approximately 0.01 to 0.06% α-humulene, Approximately 0.02 to 0.09% nerolidol, and It contains approximately 0.01-0.06% guaiol.

[0186] In another embodiment, the dosage form comprises: Approximately 0.01 to 0.50% α-pinene, Approximately 0.01 to 0.90% β-myrcene, Approximately 0.01 to 0.50% β-pinene, Approximately 0.01 to 0.50% δ-limonene, Approximately 0.01 to 0.50% linalool, Approximately 0.01 to 0.50% β-caryophyllene, Approximately 0.01 to 0.50% α-humulene, Approximately 0.01 to 0.50% nerolidol, Approximately 0.01-0.50% guaiol, about 0.01 to 0.50% caryophyllene oxide, and Contains approximately 0.01-0.50% α-bisabolol.

[0187] In another embodiment, the dosage form comprises: Camphene, β-ocimene, Eucalyptol, Isopulegol, and / or Further contains nerolidol.

[0188] In another embodiment, the dosage form comprises: Approximately 0.02% camphene, Approximately 0.02-0.03% β-ocimene, Approximately 0.02-0.05% eucalyptol, about 0.02% isopulegol, and / or Contains approximately 0.02-0.04% nerolidol.

[0189] In another embodiment, the dosage form comprises: Approximately 0.01-0.04% camphene, Approximately 0.01-0.05% β-ocimene, Approximately 0.01 to 0.07% eucalyptol, About 0.01 to 0.04% isopulegol, and / or Contains approximately 0.01-0.05% nerolidol.

[0190] In another embodiment, the dosage form comprises: Approximately 0.01 to 0.50% camphene, Approximately 0.01-0.50% β-ocimene, Approximately 0.01 to 0.50% eucalyptol, About 0.01 to 0.50% isopulegol, and / or Contains approximately 0.01-0.50% nerolidol.

[0191] In one embodiment, the dosage form is terpene-free.

[0192] In one embodiment, the dosage form contains α-pinene, β-myrcene, β-pinene, δ-limonene, linalool, β-caryophyllene. α-humulene, nerolidol, guaiol, caryophyllene oxide, α-bisabolol. 、Includes one or more of camphene, β-ocimene, eucalyptol, isopulegol, and nerolidol.

[0193] In one embodiment, the dosage form comprises two or more of 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.

[0194] In one embodiment, the dosage form comprises three or more of 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.

[0195] In one embodiment, the dosage form comprises four or more of 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.

[0196] In one embodiment, the dosage form comprises five or more of 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.

[0197] In one embodiment, the dosage form includes six or more of 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.

[0198] In one embodiment, the dosage form includes seven or more of 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.

[0199] In one embodiment, the dosage form includes eight or more of 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.

[0200] In one embodiment, the dosage form includes nine or more of 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.

[0201] In one embodiment, the dosage form comprises ten or more of 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.

[0202] In one embodiment, the dosage form comprises 11 or more of 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.

[0203] In one embodiment, the dosage form includes 12 or more of 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.

[0204] In one embodiment, the dosage form includes 13 or more of 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.

[0205] In one embodiment, the dosage form includes 14 or more of 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.

[0206] In one embodiment, the dosage form includes 15 or more of 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.

[0207] In one embodiment, the dosage form comprises 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. In one embodiment, the flavoring agent is selected from the group consisting of catnip oil, peppermint oil, mango extract, beef, chicken, and seafood.

[0208] In one embodiment, the dosage form is formulated as a sublingual spray. In yet another embodiment, the dosage form is formulated as an aqueous or alcoholic solution, a gel, or a cream for transdermal application. In one embodiment, the dosage form is formulated as a powder. In one embodiment, the dosage form is formulated as a gel for buccal or intramucosal administration. In another embodiment, the dosage form is formulated as a solution for subcutaneous injection. In yet another embodiment, the dosage form is formulated as a tablet. In yet another embodiment, the dosage form is formulated as a capsule. In one embodiment, the dosage form is formulated as a hard chewable. In one embodiment, the dosage form is formulated as a soft chewable.

[0209] In some embodiments, the invention includes infusing an edible product with cannabis extract. In another embodiment, the edible product is an extruded food product, a baked food product, a nut butter, a spread, a pelleted feed, or a processed food product. In another embodiment, the edible product is a pet food product. In another embodiment, the pet food is in a dry shelf-stable form, such as dry meal, dried fish, dried dairy, fish meal, fish meal, cereals, flour, carbohydrates, dried fruit, etc. In another embodiment, the pet food is moist or semi-moist. In another embodiment, the pet food includes food additives or supplements, such as vitamins, minerals, drugs, such as chemicals, enzymes, etc., that can remove plaque or tartar from the animal's teeth.

[0210] In one embodiment, the cannabis extract is administered with catnip oil. In another embodiment, any of the dosage forms described may also include catnip.

[0211] In another embodiment, the cannabis extract is administered using a nebulizer. In another embodiment, the nebulizer delivery device and system can effectively and efficiently administer one or more nebulized drugs to animals. In another embodiment, the nebulizer system can be easily used on animals without removing the animals from their natural environment. In another embodiment, the nebulizer delivery device and system allows animals to be easily treated once a day or multiple times a day without undue stress or requiring extensive resources. In another embodiment, the nebulizer delivery device and system can be used on animals with various training levels.

[0212] In one embodiment, the cannabis extract is administered using a diffuser. A diffuser can be any device that disperses the cannabis extract into the air. The cannabis extract can be dispersed by any method, such as natural convection, forced convection, heating a wick or pad that holds the cannabis extract, using a pump, or by a fan.

[0213] In one embodiment, the cannabis extract is administered by a pet collar. The pet collar may include a belt with a buckle on one side, a free end on the other side, and an attachment means such as an opening located longitudinally within a central portion of the belt, or a quick release clasp mechanism for securing the collar in a closed loop configuration. The pet collar may be made from a variety of materials including nylon, polyester leather, or other suitable materials. The belt material may be treated with a water-resistant compound. The nylon or polyester belt may be interwoven with reflective fibers to increase the visibility of the pet collar at night. In one embodiment, the collar is infused with the cannabis extract.

[0214] Kiss In one embodiment, the dosage form is formulated as a chew for oral administration. In another embodiment, the chew is produced using cold extrusion. In another embodiment, the chew weighs about 0.5-10 g. In yet another embodiment, the chew weighs about 4 g, about 6 g, about 9 g, or about 10 g. In yet another embodiment, the chew weighs about 0.5 g. In one embodiment, the chew weighs about 1 g. In another embodiment, the chew weighs about 1.5 g. In yet another embodiment, the chew weighs about 2 g. In yet another embodiment, the chew weighs about 3 g. In one embodiment, the chew weighs about 4 g. In another embodiment, the chew weighs about 5 g. In yet another embodiment, the chew weighs about 6 g. In yet another embodiment, the chew weighs about 7 g. In one embodiment, the chew weighs about 8 g. In another embodiment, the chew weighs about 9 g. In yet another embodiment, the chew weighs about 10 g.

[0215] In one embodiment, the dosage form comprises: Brewer's yeast, Gum arabic, Guar gum, Flavoring agents, Verdilox, Previon, cannabis extract, Glycerin, Sunflower lecithin, and Contains water.

[0216] In another embodiment, the dosage form comprises: Approximately 25-35% brewer's yeast, Approximately 1-10% gum arabic, Approximately 0.1-4% guar gum, Approximately 10-20% flavoring agent, Approximately 0.01-1% Verdilox, Previon of about 0.1 to 2% Approximately 1-10% cannabis extract, Approximately 10-20% glycerin, Approximately 1-10% sunflower lecithin, and Contains approximately 1-10% water.

[0217] In another embodiment, the dosage form comprises: Approximately 29-33% brewer's yeast, Approximately 3-6% gum arabic, Approximately 0.5-2% guar gum, Approximately 12-16% flavorings, Approximately 0.01-0.1% Verdilox, Approximately 0.5 to 1.5% Previon, Approximately 3-6% cannabis extract, Approximately 13-17% glycerin, Approximately 3-7% sunflower lecithin, and Contains approximately 3-7% water.

[0218] In yet another embodiment, the dosage form comprises: Approximately 30% brewer's yeast, Approximately 4.7% gum arabic, Approximately 0.9% guar gum, Approximately 14.2% flavorings; Approximately 0.05% Verdilox, Previon, about 0.9% Approximately 4.7% cannabis extract, Approximately 15.1% glycerin, Approximately 5.7% sunflower lecithin, and Contains approximately 5.7% water.

[0219] In one embodiment, the dosage form comprises: Glucosamine HCl, Brewer's yeast, Gum arabic, Guar gum, Flavoring agents, Verdilox, Previon, cannabis extract, Glycerin, Sunflower lecithin, and Contains water.

[0220] In another embodiment, the dosage form comprises: Approximately 10-20% Glucosamine HCl, Approximately 25-35% brewer's yeast, Approximately 1-10% gum arabic, Approximately 0.1-4% guar gum, Approximately 10-20% flavoring agent, Approximately 0.01-1% Verdilox, Previon of about 0.1 to 2% Approximately 1-10% cannabis extract, Approximately 10-20% glycerin, Approximately 1-10% sunflower lecithin, and Contains approximately 1-10% water.

[0221] In another embodiment, the dosage form comprises: Approximately 12-17% Glucosamine HCl, Approximately 29-33% brewer's yeast, Approximately 3-6% gum arabic, Approximately 0.5-2% guar gum, Approximately 12-16% flavorings, Approximately 0.01-0.1% Verdilox, Approximately 0.5 to 1.5% Previon, Approximately 3-6% cannabis extract, Approximately 13-17% glycerin, Approximately 3-7% sunflower lecithin, and Contains approximately 3-7% water.

[0222] In yet another embodiment, the dosage form comprises: Approximately 15.6% Glucosamine HCl, Approximately 30% brewer's yeast, Approximately 4.7% gum arabic, Approximately 0.9% guar gum, Approximately 14.2% flavorings; Approximately 0.05% Verdilox, Previon, about 0.9% Approximately 4.7% cannabis extract, Approximately 15.1% glycerin, Approximately 5.7% sunflower lecithin, and Contains approximately 5.7% water.

[0223] In one embodiment, the dosage form comprises: Glucosamine HCl, Chondroitin sulfate (76%), Brewer's yeast, Gum arabic, Guar gum, Flavoring agents, Verdilox, Previon, cannabis extract, Glycerin, Sunflower lecithin, and Contains water.

[0224] In another embodiment, the dosage form comprises: Approximately 10-20% Glucosamine HCl, Approximately 0.1-7% chondroitin sulfate (76%), Approximately 25-35% brewer's yeast, Approximately 1-10% gum arabic, Approximately 0.1-4% guar gum, Approximately 10-20% flavoring agent, Approximately 0.01-1% Verdilox, Previon of about 0.1 to 2% Approximately 1-10% cannabis extract, Approximately 10-20% glycerin, Approximately 1-10% sunflower lecithin, and Contains approximately 1-10% water.

[0225] In another embodiment, the dosage form comprises: Approximately 12-17% Glucosamine HCl, Approximately 1-4% chondroitin sulfate (76%), Approximately 29-33% brewer's yeast, Approximately 3-6% gum arabic, Approximately 0.5-2% guar gum, Approximately 12-16% flavorings, Approximately 0.01-0.1% Verdilox, Approximately 0.5 to 1.5% Previon, Approximately 3-6% cannabis extract, Approximately 13-17% glycerin, Approximately 3-7% sunflower lecithin, and Contains approximately 3-7% water.

[0226] In yet another embodiment, the dosage form comprises: Approximately 15.6% Glucosamine HCl, Approximately 2.6% chondroitin sulfate (76%), Approximately 30% brewer's yeast, Approximately 4.7% gum arabic, Approximately 0.9% guar gum, Approximately 14.2% flavorings; Approximately 0.05% Verdilox, Previon, about 0.9% Approximately 4.7% cannabis extract, Approximately 15.1% glycerin, Approximately 5.7% sunflower lecithin, and Contains approximately 5.7% water.

[0227] In another embodiment, the dosage form comprises: Hyaluronic acid, Brewer's yeast, Gum arabic, Guar gum, Flavoring agents, Verdilox, Previon, cannabis extract, Glycerin, Sunflower lecithin, and Contains water.

[0228] In another embodiment, the dosage form comprises: Approximately 0.01 to 3% hyaluronic acid, Approximately 25-35% brewer's yeast, Approximately 1-10% gum arabic, Approximately 0.1-5% guar gum, Approximately 10-20% flavoring agent, Approximately 0.01-1% Verdilox, Previon of about 0.1 to 3% Approximately 1-10% cannabis extract, Approximately 10-20% glycerin, Approximately 1-10% sunflower lecithin, and Contains approximately 1-10% water.

[0229] In another embodiment, the dosage form comprises: Approximately 0.01 to 1% hyaluronic acid, Approximately 29-33% brewer's yeast, Approximately 3-6% gum arabic, Approximately 0.5-2% guar gum, Approximately 12-16% flavorings, Approximately 0.01-0.1% Verdilox, Approximately 0.5 to 1.5% Previon, Approximately 3-6% cannabis extract, Approximately 13-17% glycerin, Approximately 3-7% sunflower lecithin, and Contains approximately 3-7% water.

[0230] In yet another embodiment, the dosage form comprises: Approximately 0.1% hyaluronic acid, Approximately 30.6% brewer's yeast, Approximately 4.8% gum arabic, Approximately 0.97% guar gum, Approximately 14.5% flavorings; Approximately 0.05% Verdilox, Previon at approximately 0.97% Approximately 4.8% cannabis extract, Approximately 15.5% glycerin, Approximately 5.8% sunflower lecithin, and Contains approximately 5.8% water.

[0231] In another embodiment, the dosage form comprises: Glucosamine HCl, Hyaluronic acid, Brewer's yeast, Gum arabic, Guar gum, Flavoring agents, Verdilox, Previon, cannabis extract, Glycerin, Sunflower lecithin, and Contains water.

[0232] In another embodiment, the dosage form comprises: Approximately 10-20% Glucosamine HCl, Approximately 0.01 to 3% hyaluronic acid, Approximately 25-35% brewer's yeast, Approximately 1-10% gum arabic, Approximately 0.1-5% guar gum, Approximately 10-20% flavoring agent, Approximately 0.01-1% Verdilox, Previon of about 0.1 to 3% Approximately 1-10% cannabis extract, Approximately 10-20% glycerin, Approximately 1-10% sunflower lecithin, and Contains approximately 1-10% water.

[0233] In another embodiment, the dosage form comprises: Approximately 12-17% Glucosamine HCl, Approximately 0.01 to 1% hyaluronic acid, Approximately 29-33% brewer's yeast, Approximately 3-6% gum arabic, Approximately 0.5-2% guar gum, Approximately 12-16% flavorings, Approximately 0.01-0.1% Verdilox, Approximately 0.5 to 1.5% Previon, Approximately 3-6% cannabis extract, Approximately 13-17% glycerin, Approximately 3-7% sunflower lecithin, and Contains approximately 3-7% water.

[0234] In yet another embodiment, the dosage form comprises: Approximately 16% Glucosamine HCl, Approximately 0.1% hyaluronic acid, Approximately 30.6% brewer's yeast, Approximately 4.8% gum arabic, Approximately 0.97% guar gum, Approximately 14.5% flavorings; Approximately 0.05% Verdilox, Previon at approximately 0.97% Approximately 4.8% cannabis extract, Approximately 15.5% glycerin, Approximately 5.8% sunflower lecithin, and Contains approximately 5.8% water.

[0235] In yet another embodiment, the dosage form comprises: cannabis extract, Peanut butter, Rice bran, Glucosamine HCl, Sweet potato, dried molasses, Sorbic acid Brewer's yeast, sugar, water, Glycerin, Potato starch, dehydrated peanut butter, Rice starch, and Contains guar gum.

[0236] In yet another embodiment, the dosage form comprises: Approximately 5.0% cannabis extract, Approximately 15.0% peanut butter, Approximately 12.5% ​​rice bran, About 5.5% of sweet potatoes, Approximately 8.0% dry molasses; Approximately 1% sorbic acid, Approximately 5.0% brewer's yeast, Approximately 6.0% sugar, Approximately 9.25% water, Approximately 13.0% glycerin, Approximately 2.0% potato starch, Approximately 1.0% dehydrated peanut butter, Approximately 2.0% rice starch, and Contains approximately 2.0% guar gum.

[0237] In yet another embodiment, the dosage form comprises: Approximately 5.0% cannabis extract, Approximately 15.0% peanut butter, Approximately 13.0% rice bran, Sweet potatoes account for approximately 6.0%; dry molasses, about 9.0%; Approximately 1% sorbic acid, Approximately 5.0% brewer's yeast, Approximately 6.0% sugar, Approximately 9.5% water, Approximately 13.0% glycerin, Approximately 4.0% potato starch, Approximately 1.0% dehydrated peanut butter, Approximately 2.0% rice starch, and Contains approximately 2.0% guar gum.

[0238] In yet another embodiment, the dosage form comprises: Approximately 3.0-10.0% cannabis extract, Approximately 10.0-20.0% peanut butter, Approximately 10.0-15.0% rice bran, Approximately 4.0 to 10.0% of sweet potatoes, Approximately 6.0-13.0% dry molasses; Approximately 0.5 to 5.0% sorbic acid, Approximately 2.0-8.0% brewer's yeast, Approximately 3.0-8.0% sugar, Approximately 5.0 to 15.0% water, Approximately 8.0 to 18.0% glycerin, Approximately 1.0-8.0% potato starch, Approximately 0.5 to 5.0% dehydrated peanut butter, Approximately 1.0 to 5.0% rice starch, and Contains approximately 1.0-5.0% guar gum.

[0239] In yet another embodiment, the dosage form comprises: Approximately 5.0% cannabis extract, Approximately 15.0% peanut butter, Approximately 12.5% ​​rice bran, Approximately 12.75% Glucosamine HCl, About 5.5% of sweet potatoes, Approximately 8.0% dry molasses; Approximately 1% sorbic acid, Approximately 5.0% brewer's yeast, Approximately 6.0% sugar, Approximately 9.25% water, Approximately 13.0% glycerin, Approximately 2.0% potato starch, Approximately 1.0% dehydrated peanut butter, Approximately 2.0% rice starch, and Contains approximately 2.0% guar gum.

[0240] In yet another embodiment, the dosage form comprises: Approximately 5.0% cannabis extract, Approximately 15.0% peanut butter, Approximately 13.0% rice bran, Approximately 8.5% Glucosamine HCl, Sweet potatoes account for approximately 6.0%; Approximately 9.0% dry molasses; Approximately 1% sorbic acid, Approximately 5.0% brewer's yeast, Approximately 6.0% sugar, Approximately 9.5% water, Approximately 13.0% glycerin, Approximately 4.0% potato starch, Approximately 1.0% dehydrated peanut butter, Approximately 2.0% rice starch, and Contains approximately 2.0% guar gum.

[0241] In yet another embodiment, the dosage form comprises: Approximately 3.0-10.0% cannabis extract, Approximately 10.0-20.0% peanut butter, Approximately 10.0-15.0% rice bran, Approximately 5.0-15.0% Glucosamine HCl, Approximately 4.0 to 10.0% of sweet potatoes, Approximately 6.0-13.0% dry molasses; Approximately 0.5 to 5.0% sorbic acid, Approximately 2.0-8.0% brewer's yeast, Approximately 3.0-8.0% sugar, Approximately 5.0 to 15.0% water, Approximately 8.0 to 18.0% glycerin, Approximately 1.0-8.0% potato starch, Approximately 0.5 to 5.0% dehydrated peanut butter, Approximately 1.0 to 5.0% rice starch, and Contains approximately 1.0-5.0% guar gum.

[0242] In another embodiment, the dosage form further comprises chondroitin sulfate.

[0243] In another embodiment, the dosage form comprises 2.0% cannabis extract. In another embodiment, the dosage form comprises 3.0% cannabis extract. In another embodiment, the dosage form comprises 4.0% cannabis extract. In another embodiment, the dosage form comprises 5.0% cannabis extract. In another embodiment, the dosage form comprises 6.0% cannabis extract. In another embodiment, the dosage form comprises 7.0% cannabis extract. In another embodiment, the dosage form comprises 8.0% cannabis extract. In another embodiment, the dosage form comprises 9.0% cannabis extract. In another embodiment, the dosage form comprises 10.0% cannabis extract.

[0244] In one embodiment the cannabis extract comprises: Cannabigerolic acid, Cannabigerol, Cannabidiol, Cannabidiolic acid, Δ9-tetrahydrocannabinol, and Contains cannabichromene.

[0245] In one embodiment, 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. In one embodiment, the ratio of cannabigerol to cannabigerolic acid is about 0.1:1 to about 1:0.1. In another embodiment, the ratio of cannabigerol to cannabigerolic acid is about 0.1:1, about 0.2:1, about 0.3:1, about 0.4:1, about 0.5:1, about 0.6:1, about 0.7:1, about 0.8:1, about 0.9:1, about 1:1, about 1:0.9, about 1:0.8, about 1:0.7, about 1:0.6, about 1:0.5, about 1:0.4, about 1:0.3, about 1:0.2, or about 1:0.1. In yet another embodiment, the ratio of cannabigerol to cannabigerolic acid is about 0.6:1 to about 1:0.6. In yet another embodiment, the ratio of cannabigerol to cannabigerolic acid is about 0.2:1 to about 1:0.2. In yet another embodiment, the ratio of cannabigerol to cannabigerolic acid is about 0.4:1 to about 1:0.4. In yet another embodiment, the ratio of cannabigerol to cannabigerolic acid is about 1:1.

[0246] In one embodiment, the concentration of Δ9-tetrahydrocannabinol is insufficient to produce a psychotropic effect. In another embodiment, the ratio of Δ9-tetrahydrocannabinol to other cannabinoids is about 1:50 to about 1:20. In yet another embodiment, the ratio of Δ9-tetrahydrocannabinol to other cannabinoids is about 1:50. In yet another embodiment, the ratio of Δ9-tetrahydrocannabinol to other cannabinoids is about 1:45. In one embodiment, the ratio of Δ9-tetrahydrocannabinol to other cannabinoids is about 1:40. In another embodiment, the ratio of Δ9-tetrahydrocannabinol to other cannabinoids is about 1:35. In yet another embodiment, the ratio of Δ9-tetrahydrocannabinol to other cannabinoids is about 1:30. In yet another embodiment, the ratio of Δ9-tetrahydrocannabinol to other cannabinoids is about 1:25. In one embodiment, the ratio of A9-tetrahydrocannabinol to other cannabinoids is about 1:20.

[0247] In one embodiment, the concentration of Δ9-tetrahydrocannabinol is less than about 20 mg / mL. In another embodiment, the concentration of Δ9-tetrahydrocannabinol is less than about 10 mg / mL. In another embodiment, the concentration of Δ9-tetrahydrocannabinol is less than about 5 mg / mL. In another embodiment, the concentration of Δ9-tetrahydrocannabinol is less than about 3 mg / mL. In another embodiment, the concentration of Δ9-tetrahydrocannabinol is less than about 2 mg / mL. In another embodiment, the concentration of Δ9-tetrahydrocannabinol is less than about 1.5 mg / mL. In yet another embodiment, the concentration of Δ9-tetrahydrocannabinol is less than about 1 mg / mL. In yet another embodiment, the concentration of Δ9-tetrahydrocannabinol is less than about 0.9 mg / mL. In yet another embodiment, the concentration of Δ9-tetrahydrocannabinol is less than about 0.8 mg / mL. In one embodiment, the concentration of Δ9-tetrahydrocannabinol is less than about 0.7 mg / mL. In another embodiment, the concentration of Δ9-tetrahydrocannabinol is less than about 0.6 mg / mL. In yet another embodiment, the concentration of Δ9-tetrahydrocannabinol is less than about 0.5 mg / mL. In yet another embodiment, the concentration of Δ9-tetrahydrocannabinol is less than about 0.4 mg / mL. In one embodiment, the concentration of Δ9-tetrahydrocannabinol is less than about 0.3 mg / mL. In another embodiment, the concentration of Δ9-tetrahydrocannabinol is less than about 0.2 mg / mL. In yet another embodiment, the concentration of Δ9-tetrahydrocannabinol is less than about 0.1 mg / mL. In yet another embodiment, the concentration of Δ9-tetrahydrocannabinol is about 0 mg / mL.

[0248] In some embodiments, the concentration of Δ9-tetrahydrocannabinol is less than about 2%. In some embodiments, the concentration of Δ9-tetrahydrocannabinol is less than about 1%. In some embodiments, the concentration of Δ9-tetrahydrocannabinol is less than about 0.5%. In some embodiments, the concentration of Δ9-tetrahydrocannabinol is less than about 0.3%. In some embodiments, the concentration of Δ9-tetrahydrocannabinol is less than about 0.2%. In some embodiments, the concentration of Δ9-tetrahydrocannabinol is less than about 0.1%. In some embodiments, the concentration of Δ9-tetrahydrocannabinol is less than about 0.01%.

[0249] In one embodiment the cannabis extract comprises: Approximately 0.1 to 20 mg / mL of cannabigerol; Approximately 0.1 to 20 mg / mL of cannabigerolic acid; about 0.01-0.5 mg / mL Δ9-tetrahydrocannabinol, and Contains approximately 0.01-0.5 mg / mL of cannabichromene.

[0250] In another embodiment, the cannabis extract comprises: Approximately 1-10 mg / mL cannabigerol; Approximately 1-10 mg / mL cannabigerolic acid, Δ9-tetrahydrocannabinol less than 0.1 mg / mL, and Contains approximately 0.1-0.4 mg / mL of cannabichromene.

[0251] In yet another embodiment, the cannabis extract comprises: Approximately 5mg / mL cannabigerol, Approximately 5 mg / mL cannabigerolic acid, Δ9-tetrahydrocannabinol less than 0.1 mg / mL, and Contains approximately 0.27 mg / mL of cannabichromene.

[0252] In another embodiment, the cannabis extract comprises: Approximately 1-200 mg / mL cannabigerol, Approximately 1-200 mg / mL cannabigerolic acid, Δ9-tetrahydrocannabinol between 0.1 and 5 mg / mL, and Contains approximately 0.1-5 mg / mL of cannabichromene.

[0253] In another embodiment, the cannabis extract comprises: Approximately 10-100mg / mL cannabigerol, Approximately 10-100 mg / mL cannabigerolic acid, Δ9-tetrahydrocannabinol less than 1 mg / mL, and Contains approximately 1-4 mg / mL of cannabichromene.

[0254] In another embodiment, the cannabis extract comprises: Approximately 50mg / mL cannabigerol, Approximately 50 mg / mL cannabigerolic acid, Δ9-tetrahydrocannabinol less than 1 mg / mL, and Contains approximately 2.7 mg / mL of cannabichromene.

[0255] In another embodiment, the cannabis extract comprises: Approximately 1-10% cannabigerol, Approximately 1-10% cannabigerolic acid, Less than 0.1% Δ9-tetrahydrocannabinol, and It contains approximately 0.1-0.4% cannabichromene.

[0256] In another embodiment, the cannabis extract comprises: Approximately 5% cannabigerol, Approximately 5% cannabigerolic acid, Less than 0.1% Δ9-tetrahydrocannabinol, and Contains approximately 0.27% cannabichromene.

[0257] In one embodiment the cannabis extract comprises: Approximately 0.1 to 20% cannabigerol, Approximately 0.1-20% cannabigerolic acid, about 0.01 to 0.5% Δ9-tetrahydrocannabinol, and It contains approximately 0.01-0.5% cannabichromene.

[0258] In another embodiment, the cannabis extract comprises: Approximately 1-10% cannabigerol, Approximately 1-10% cannabigerolic acid, Less than 0.1% Δ9-tetrahydrocannabinol, and It contains approximately 0.1-0.4% cannabichromene.

[0259] In yet another embodiment, the cannabis extract comprises: Approximately 5% cannabigerol, Approximately 5% cannabigerolic acid, Less than 0.1% Δ9-tetrahydrocannabinol, and Contains approximately 0.27% cannabichromene.

[0260] In one embodiment the cannabis extract comprises: α-pinene, β-myrcene, β-pinene, δ-limonene, Linalool, β-caryophyllene, α-humulene, Nerolidol, Guaiol, Caryophyllene oxide, and Contains alpha-bisabolol.

[0261] In another embodiment, the cannabis extract comprises: Approximately 0.09-0.13% α-pinene, Approximately 0.23-0.44% β-myrcene, Approximately 0.04-0.09% β-pinene, Approximately 0.05-0.09% δ-limonene, Approximately 0.03-0.06% linalool, Approximately 0.04-0.07% β-caryophyllene, Approximately 0.02-0.04% α-humulene, Approximately 0.04-0.07% nerolidol 2, Approximately 0.02-0.04% guaiol, about 0.04-0.08% caryophyllene oxide, and Contains approximately 0.01-0.04% α-bisabolol.

[0262] In another embodiment, the cannabis extract comprises: Approximately 0.07-0.30% α-pinene, Approximately 0.10 to 0.60% β-myrcene, Approximately 0.02-0.20% β-pinene, Approximately 0.03 to 0.20% δ-limonene, Approximately 0.01 to 0.08% linalool, Approximately 0.03-0.09% β-caryophyllene, Approximately 0.01 to 0.06% α-humulene, Approximately 0.02 to 0.09% nerolidol, and It contains approximately 0.01-0.06% guaiol.

[0263] In another embodiment, the cannabis extract comprises: Approximately 0.01 to 0.50% α-pinene, Approximately 0.01 to 0.90% β-myrcene, Approximately 0.01 to 0.50% β-pinene, Approximately 0.01 to 0.50% δ-limonene, Approximately 0.01 to 0.50% linalool, Approximately 0.01 to 0.50% β-caryophyllene, Approximately 0.01 to 0.50% α-humulene, Approximately 0.01 to 0.50% nerolidol, Approximately 0.01-0.50% guaiol, about 0.01 to 0.50% caryophyllene oxide, and Contains approximately 0.01-0.50% α-bisabolol.

[0264] In another embodiment, the cannabis extract comprises: Camphene, β-ocimene, Eucalyptol, Isopulegol, and / or Further contains nerolidol.

[0265] In another embodiment, the cannabis extract comprises: Approximately 0.02% camphene, Approximately 0.02-0.03% β-ocimene, Approximately 0.02-0.05% eucalyptol, about 0.02% isopulegol, and / or Contains approximately 0.02-0.04% nerolidol.

[0266] In another embodiment, the cannabis extract comprises: Approximately 0.01-0.04% camphene, Approximately 0.01-0.05% β-ocimene, Approximately 0.01 to 0.07% eucalyptol, About 0.01 to 0.04% isopulegol, and / or Contains approximately 0.01-0.05% nerolidol.

[0267] In another embodiment, the cannabis extract comprises: Approximately 0.01 to 0.50% camphene, Approximately 0.01-0.50% β-ocimene, Approximately 0.01 to 0.50% eucalyptol, About 0.01 to 0.50% isopulegol, and / or Contains approximately 0.01-0.50% nerolidol.

[0268] In one embodiment, the composition is formulated as oil.In another embodiment, 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.In yet another embodiment, the carrier comprises grapeseed oil.In yet another embodiment, the carrier comprises sesame oil.

[0269] In one embodiment, the flavoring agent is selected from the group consisting of catnip oil, chicken liver powder, chicken extract, maltodextrin, butter, and bacon, hi another embodiment, the flavoring agent is chicken liver powder.

[0270] In one embodiment, the composition is formulated as a chew for oral administration. In another embodiment, the chew is produced using cold extrusion. In another embodiment, the chew weighs about 0.5-10 g. In yet another embodiment, the chew weighs about 4 g, about 6 g, about 9 g, or about 10 g. In yet another embodiment, the chew weighs about 0.5 g. In one embodiment, the chew weighs about 1 g. In another embodiment, the chew weighs about 1.5 g. In yet another embodiment, the chew weighs about 2 g. In yet another embodiment, the chew weighs about 3 g. In one embodiment, the chew weighs about 4 g. In another embodiment, the chew weighs about 5 g. In yet another embodiment, the chew weighs about 6 g. In yet another embodiment, the chew weighs about 7 g. In one embodiment, the chew weighs about 8 g. In another embodiment, the chew weighs about 9 g. In yet another embodiment, the chew weighs about 10 g.

[0271] In one embodiment, a 4g chew comprises: Approximately 7mg of cannabigerol, Approximately 6mg of cannabigerolic acid, approximately 0.32 mg of Δ9-tetrahydrocannabinol, and Contains approximately 0.36 mg of cannabichromene.

[0272] In some embodiments, the chew comprises: Approximately 70mg of cannabigerol, Approximately 60mg of cannabigerolic acid, Approximately 3.2 mg of Δ9-tetrahydrocannabinol, and Contains approximately 3.6 mg of cannabichromene.

[0273] Treatment method In one aspect, the disclosure provides a method for treating or reducing pain in a veterinary subject in need thereof, comprising administering to the subject a therapeutically effective amount of any of the compositions or dosage forms described above.

[0274] In one embodiment, the pain is associated with arthritis, post-operative pain, acute pain, dental pain, pain associated with gingivitis, arthralgia, or polyarticular pain.

[0275] In one embodiment, the veterinary subject has cancer. In one embodiment, the cancer is a solid tumor, such as lung cancer, prostate cancer, colorectal cancer, thyroid cancer, renal cancer, adrenal cancer, liver cancer, pancreatic cancer, breast cancer, and central and peripheral nervous system cancer. In another embodiment, the cancer is a hematopoietic tumor, such as lymphoma and leukemia.

[0276] In one embodiment, the veterinary subject is undergoing chemotherapy, hi one embodiment, the chemotherapy is L-asparaginase, cyclophosphamide, doxorubicin, vincristine, and prednisolone (L-CHOP) or cyclophosphamide, doxorubicin, vincristine, and prednisolone (CHOP).

[0277] In one embodiment, the method results in a reduction in tumor burden. In another embodiment, the method results in apoptosis of tumor cells. In another embodiment, the method results in a reduction in proliferation of tumor cells.

[0278] In one embodiment, the pharmaceutical composition or dosage form is administered at a dose of about 0.1-15.0 mg / kg. In another embodiment, the pharmaceutical composition or dosage form is administered at a dose of about 0.1-10.0 mg / kg. In yet another embodiment, the pharmaceutical composition or dosage form is administered at a dose of about 0.1 mg / kg. In yet another embodiment, the pharmaceutical composition or dosage form is administered at a dose of about 0.2 mg / kg. In yet another embodiment, the pharmaceutical composition or dosage form is administered at a dose of about 0.3 mg / kg. In one embodiment, the pharmaceutical composition or dosage form is administered at a dose of about 0.4 mg / kg. In another embodiment, the pharmaceutical composition or dosage form is administered at a dose of about 0.5 mg / kg. In yet another embodiment, the pharmaceutical composition or dosage form is administered at a dose of about 0.6 mg / kg. In yet another embodiment, the pharmaceutical composition or dosage form is administered at a dose of about 0.7 mg / kg. In yet another embodiment, the pharmaceutical composition or dosage form is administered at a dose of about 0.8 mg / kg. In one embodiment, the pharmaceutical composition or dosage form is administered at a dose of about 0.9 mg / kg. In another embodiment, the pharmaceutical composition or dosage form is administered at a dose of about 1 mg / kg. In yet another embodiment, the pharmaceutical composition or dosage form is administered at a dose of about 1.5 mg / kg. In yet another embodiment, the pharmaceutical composition or dosage form is administered at a dose of about 2 mg / kg. In one embodiment, the pharmaceutical composition or dosage form is administered at a dose of about 3 mg / kg. In another embodiment, the pharmaceutical composition or dosage form is administered at a dose of about 4 mg / kg. In yet another embodiment, the pharmaceutical composition or dosage form is administered at a dose of about 5 mg / kg. In yet another embodiment, the pharmaceutical composition or dosage form is administered at a dose of about 6 mg / kg. In one embodiment, the pharmaceutical composition or dosage form is administered at a dose of about 7 mg / kg. In another embodiment, the pharmaceutical composition or dosage form is administered at a dose of about 8 mg / kg. In yet another embodiment, the pharmaceutical composition or dosage form is administered at a dose of about 9 mg / kg. In yet another embodiment, the pharmaceutical composition or dosage form is administered at a dose of about 10 mg / kg. In one embodiment, the pharmaceutical composition or dosage form is administered at a dose of about 11 mg / kg. In another embodiment, the pharmaceutical composition or dosage form is administered at a dose of about 12 mg / kg. In yet another embodiment, the pharmaceutical composition or dosage form is administered at a dose of about 13 mg / kg.In yet another embodiment, the pharmaceutical composition or dosage form is administered at a dose of about 14 mg / kg. In one embodiment, the pharmaceutical composition or dosage form is administered at a dose of about 15 mg / kg.

[0279] In another embodiment, the pharmaceutical composition or dosage form is administered at twice the therapeutically effective dose for one week, followed by administration at a subsequent therapeutically effective dose. In yet another embodiment, the therapeutically effective dose is about 0.1-0.5 mg / kg. In yet another embodiment, the therapeutically effective dose is about 2 mg / kg. In one embodiment, the therapeutically effective dose is about 8 mg / kg.

[0280] In one embodiment, the pharmaceutical composition or dosage form is administered at a dose of about 1 mg / kg for one week, followed by a subsequent dose of about 0.1-0.5 mg / kg thereafter.In another embodiment, the pharmaceutical composition or dosage form is administered at a dose of about 4 mg / kg for one week, followed by a subsequent dose of about 2 mg / kg thereafter.

[0281] In one embodiment, the pharmaceutical composition or dosage form is administered at a dose of about 2 mg / kg every 12 hours for two weeks, followed by a dose of about 1 mg / kg every 12 hours for two weeks, followed by a dose of about 2 mg / kg every 12 hours for four weeks.

[0282] In one embodiment, the pharmaceutical composition or dosage form is administered once daily at a dose of about 1.0 mg / kg. In one embodiment, the pharmaceutical composition or dosage form is administered twice daily at a dose of about 1.0 mg / kg. In one embodiment, the pharmaceutical composition or dosage form is administered three times daily at a dose of about 1.0 mg / kg. In one embodiment, the pharmaceutical composition or dosage form is administered four times daily at a dose of about 1.0 mg / kg.

[0283] In one embodiment, the pharmaceutical composition or dosage form is administered once daily at a dose of about 2.0 mg / kg. In one embodiment, the pharmaceutical composition or dosage form is administered twice daily at a dose of about 2.0 mg / kg. In one embodiment, the pharmaceutical composition or dosage form is administered three times daily at a dose of about 2.0 mg / kg. In one embodiment, the pharmaceutical composition or dosage form is administered four times daily at a dose of about 2.0 mg / kg.

[0284] In one embodiment, the pharmaceutical composition or dosage form is administered once daily at a dose of about 3.0 mg / kg. In one embodiment, the pharmaceutical composition or dosage form is administered twice daily at a dose of about 3.0 mg / kg. In one embodiment, the pharmaceutical composition or dosage form is administered three times daily at a dose of about 3.0 mg / kg. In one embodiment, the pharmaceutical composition or dosage form is administered four times daily at a dose of about 3.0 mg / kg.

[0285] In one embodiment, the pharmaceutical composition or dosage form is administered once daily at a dose of about 4.0 mg / kg. In one embodiment, the pharmaceutical composition or dosage form is administered twice daily at a dose of about 4.0 mg / kg. In one embodiment, the pharmaceutical composition or dosage form is administered three times daily at a dose of about 4.0 mg / kg. In one embodiment, the pharmaceutical composition or dosage form is administered four times daily at a dose of about 4.0 mg / kg. In one embodiment, the pharmaceutical composition or dosage form is administered once daily at a dose of about 5.0 mg / kg. In one embodiment, the pharmaceutical composition or dosage form is administered twice daily at a dose of about 5.0 mg / kg. In one embodiment, the pharmaceutical composition or dosage form is administered three times daily at a dose of about 5.0 mg / kg. In one embodiment, the pharmaceutical composition or dosage form is administered four times daily at a dose of about 5.0 mg / kg.

[0286] In one embodiment, the pharmaceutical composition or dosage form is administered once daily at a dose of about 6.0 mg / kg. In one embodiment, the pharmaceutical composition or dosage form is administered twice daily at a dose of about 6.0 mg / kg. In one embodiment, the pharmaceutical composition or dosage form is administered three times daily at a dose of about 6.0 mg / kg. In one embodiment, the pharmaceutical composition or dosage form is administered four times daily at a dose of about 6.0 mg / kg.

[0287] In one embodiment, the pharmaceutical composition or dosage form is administered once daily at a dose of about 7.0 mg / kg. In one embodiment, the pharmaceutical composition or dosage form is administered twice daily at a dose of about 7.0 mg / kg. In one embodiment, the pharmaceutical composition or dosage form is administered three times daily at a dose of about 7.0 mg / kg. In one embodiment, the pharmaceutical composition or dosage form is administered four times daily at a dose of about 7.0 mg / kg.

[0288] In one embodiment, the pharmaceutical composition or dosage form is administered once daily at a dose of about 8.0 mg / kg. In one embodiment, the pharmaceutical composition or dosage form is administered twice daily at a dose of about 8.0 mg / kg. In one embodiment, the pharmaceutical composition or dosage form is administered three times daily at a dose of about 8.0 mg / kg. In one embodiment, the pharmaceutical composition or dosage form is administered four times daily at a dose of about 8.0 mg / kg.

[0289] In one embodiment, the pharmaceutical composition or dosage form is administered once daily at a dose of about 9.0 mg / kg. In one embodiment, the pharmaceutical composition or dosage form is administered twice daily at a dose of about 9.0 mg / kg. In one embodiment, the pharmaceutical composition or dosage form is administered three times daily at a dose of about 9.0 mg / kg. In one embodiment, the pharmaceutical composition or dosage form is administered four times daily at a dose of about 9.0 mg / kg.

[0290] In one embodiment, the pharmaceutical composition or dosage form is administered once daily at a dose of about 10.0 mg / kg. In one embodiment, the pharmaceutical composition or dosage form is administered twice daily at a dose of about 10.0 mg / kg. In one embodiment, the pharmaceutical composition or dosage form is administered three times daily at a dose of about 10.0 mg / kg. In one embodiment, the pharmaceutical composition or dosage form is administered four times daily at a dose of about 10.0 mg / kg.

[0291] In one embodiment, the method results in a therapeutically effective median maximum serum concentration of cannabigerol. In another embodiment, the median maximum serum concentration of cannabigerol is about 20-200 ng / mL. In another embodiment, the median maximum serum concentration of cannabigerol is about 30-80 ng / mL. In another embodiment, the median maximum serum concentration of cannabigerol is about 30-60 ng / mL. In another embodiment, the median maximum serum concentration of cannabigerol is about 40-50 ng / mL. In another embodiment, the median maximum serum concentration of cannabigerol is about 50-200 ng / mL. In another embodiment, the median maximum serum concentration of cannabigerol is about 75-200 ng / mL. In another embodiment, the median maximum serum concentration of cannabigerol is about 100-200 ng / mL.

[0292] In one embodiment, the method results in a therapeutically effective median maximum serum concentration of cannabigerolic acid. In another embodiment, the median maximum serum concentration of cannabigerolic acid is about 1000-4000 ng / mL. In another embodiment, the median maximum serum concentration of cannabigerolic acid is about 1000-3000 ng / mL. In another embodiment, the median maximum serum concentration of cannabigerolic acid is about 1500-3000 ng / mL. In another embodiment, the median maximum serum concentration of cannabigerolic acid is about 1200-2200 ng / mL. In another embodiment, the median maximum serum concentration of cannabigerolic acid is about 2000-3000 ng / mL. In another embodiment, the median maximum serum concentration of cannabigerolic acid is about 3000-4000 ng / mL.

[0293] In one embodiment, the veterinary subject is a dog, a cat, a cow, a pig, or a horse. In another embodiment, the veterinary subject is a dog. In yet another embodiment, the veterinary subject is a cat.

[0294] In one aspect, provided herein is a method for treating or reducing arthritis associated pain, post-operative pain, acute pain, dental pain, pain associated with gingivitis, joint pain, or polyarticular pain in a veterinary subject in need thereof, comprising administering to the subject a therapeutically effective amount of a cannabis extract.

[0295] In one embodiment, the cannabis extract is administered at a dose of about 0.1-15.0 mg / kg. In another embodiment, the cannabis extract is administered at a dose of about 0.1-10.0 mg / kg. In yet another embodiment, the cannabis extract is administered at a dose of about 0.1 mg / kg. In yet another embodiment, the cannabis extract is administered at a dose of about 0.2 mg / kg. In yet another embodiment, the cannabis extract is administered at a dose of about 0.3 mg / kg. In one embodiment, the cannabis extract is administered at a dose of about 0.4 mg / kg. In another embodiment, the cannabis extract is administered at a dose of about 0.5 mg / kg. In yet another embodiment, the cannabis extract is administered at a dose of about 0.6 mg / kg. In yet another embodiment, the cannabis extract is administered at a dose of about 0.7 mg / kg. In yet another embodiment, the cannabis extract is administered at a dose of about 0.8 mg / kg. In one embodiment, the cannabis extract is administered at a dose of about 0.9 mg / kg. In another embodiment, the cannabis extract is administered at a dose of about 1 mg / kg. In yet another embodiment, the cannabis extract is administered at a dose of about 1.5 mg / kg. In yet another embodiment, the cannabis extract is administered at a dose of about 2 mg / kg. In one embodiment, the cannabis extract is administered at a dose of about 3 mg / kg. In another embodiment, the cannabis extract is administered at a dose of about 4 mg / kg. In yet another embodiment, the cannabis extract is administered at a dose of about 5 mg / kg. In yet another embodiment, the cannabis extract is administered at a dose of about 6 mg / kg. In one embodiment, the cannabis extract is administered at a dose of about 7 mg / kg. In another embodiment, the cannabis extract is administered at a dose of about 8 mg / kg. In yet another embodiment, the cannabis extract is administered at a dose of about 9 mg / kg. In yet another embodiment, the cannabis extract is administered at a dose of about 10 mg / kg. In one embodiment, the cannabis extract is administered at a dose of about 11 mg / kg. In another embodiment, the cannabis extract is administered at a dose of about 12 mg / kg. In yet another embodiment, the cannabis extract is administered at a dose of about 13mg / kg. In yet another embodiment, the cannabis extract is administered at a dose of about 14mg / kg. In one embodiment, the cannabis extract is administered at a dose of about 15mg / kg.

[0296] In another embodiment, the cannabis extract is administered at twice the therapeutically effective dose for one week, followed by subsequent administration of the therapeutically effective dose. In yet another embodiment, the therapeutically effective dose is about 0.1-0.5 mg / kg. In yet another embodiment, the therapeutically effective dose is about 2 mg / kg. In one embodiment, the therapeutically effective dose is about 8 mg / kg.

[0297] In one embodiment, the cannabis extract is administered at a dose of about 1 mg / kg for one week, followed by a subsequent dose of about 0.1-0.5 mg / kg thereafter. In another embodiment, the cannabis extract is administered at a dose of about 4 mg / kg for one week, followed by a subsequent dose of about 2 mg / kg thereafter.

[0298] In one embodiment, the veterinary subject is administered gabapentin in combination with a dose of the cannabis extract provided herein. In another embodiment, the veterinary subject is administered about 1, 10, 15, 20, 25, 30, 35, 40, 45 or 50 mg / kg of gabapentin in combination with a dose of the cannabis extract provided herein. In another embodiment, the veterinary subject is administered about 10 mg / kg of gabapentin in combination with a dose of the cannabis extract provided herein.

[0299] In another embodiment, the veterinary subject is administered a dose of gabapentin between 1 mg / kg and 50 mg / kg together with a dose of a cannabis extract provided herein. In another embodiment, the veterinary subject is administered a dose of gabapentin between 10 mg / kg and 40 mg / kg together with a dose of a cannabis extract provided herein. In another embodiment, the veterinary subject is administered a dose of gabapentin between 1 mg / kg and 20 mg / kg together with a dose of a cannabis extract provided herein. In another embodiment, the veterinary subject is administered a dose of gabapentin between 5 mg / kg and 15 mg / kg together with a dose of a cannabis extract provided herein. In another embodiment, the veterinary subject is administered a dose of gabapentin between 12 mg / kg and 14 mg / kg together with a dose of a cannabis extract provided herein.

[0300] In some embodiments, the veterinary subject is administered gabapentin along with a dose of a cannabis extract provided herein about every 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, or 12 hours. In one embodiment, the veterinary subject is administered gabapentin along with a dose of a cannabis extract provided herein about every 8 hours. In one embodiment, the veterinary subject is administered gabapentin along with a dose of a cannabis extract provided herein about every 8-12 hours. The cannabis extract can be administered at a different time and / or schedule with the gabapentin.

[0301] In another embodiment, the veterinary subject is administered gabapentin 1, 2, 3, 4, 5 or 6 times per day along with a dose of cannabis extract provided herein. The cannabis extract can be administered with the gabapentin or at a different time and / or on a different schedule.

[0302] In one embodiment, the veterinary subject is administered about 10 mg / kg of gabapentin about every 8 hours along with a dose of cannabis extract provided herein. The cannabis extract can be administered with the gabapentin or at a different time and / or on a different schedule. In another embodiment, the veterinary subject is administered 10 mg / kg of gabapentin and 8 mg / kg of cannabis extract every 8 hours. The cannabis extract can be administered with the gabapentin or at a different time.

[0303] In one embodiment, the veterinary subject is a dog, a cat, a cow, a pig, or a horse. In another embodiment, the veterinary subject is a dog. In yet another embodiment, the veterinary subject is a cat.

[0304] The pharmaceutical compositions and dosage forms of the present disclosure can be administered to the epithelium or mucocutaneous linings (e.g., oral mucosa) by any convenient route, for example, by infusion or bolus injection. 、The agent may be administered by absorption through the rectum and intestinal mucosa, etc., and may be administered together with any other therapeutic agent. Administration may be systemic or local. In one embodiment, administration is local. In another embodiment, local administration is used to treat local pain. In another embodiment, the local pain is joint pain. In one embodiment, the veterinary subject is an animal over 100 kg (e.g., a horse, cow, or pig).

[0305] The therapeutic compositions of the present invention are administered with suitable carriers, excipients, and other agents that are incorporated into the formulation to provide improved transport, delivery, tolerance, and the like. Many suitable formulations can be found in formularies known to any pharmacist: Remington's Pharmaceutical Sciences, Mack Publishing Company, Easton, PA. These formulations include, for example, powders, pastes, ointments, jellies, waxes, oils, lipids, lipid (cationic or anionic)-containing vesicles (such as LIPOFECTIN™), DNA conjugates, anhydrous absorption pastes, water-in-oil and oil-in-water emulsions, emulsions carbowax (polyethylene glycols of various molecular weights), semi-solid gels, and semi-solid mixtures containing carbowax. See also Powell et al. "Compendium of excipients for parenteral formulations" PDA (1998) J Pharm Sci Technol 52:238-311.

[0306] The dosage may vary depending on the age and weight of the subject to be administered, the target disease, condition, route of administration, etc. Various delivery systems are known and can be used to administer the pharmaceutical composition of the present invention, such as encapsulation in liposomes, microparticles, microcapsules, receptor-mediated endocytosis, etc. (see, for example, Wu et al. (1987) J.Biol.Chem.262:4429-4432). Methods of introduction include, but are not limited to, intradermal, intramuscular, intraperitoneal, intravenous, transdermal, buccal, sublingual, subcutaneous, intranasal, epidural, and oral routes. The composition may be administered by any convenient route, for example, by infusion or bolus injection, by absorption through epithelial or mucocutaneous linings (e.g., oral mucosa, rectal and intestinal mucosa, etc.), and may be administered together with other biologically active agents. Administration may be systemic or local.

[0307] The pharmaceutical preparation for oral use can be prepared using solid excipients, and the mixture obtained can be milled as necessary, and after adding suitable auxiliary agents as required, the mixture of granules can be processed to obtain tablets or dragee cores.Suitable excipients are in particular fillers such as sugars, including lactose, sucrose, mannitol, or sorbitol; for example, corn starch, wheat starch, rice starch, potato starch, gelatin, gums, cellulose preparations such as methylcellulose, hydroxypropylmethylcellulose, sodium carbomethylcellulose, and / or physiologically acceptable polymers such as polyvinylpyrrolidone (PVP).If desired, disintegrants such as cross-linked polyvinylpyrrolidone, agar, or alginic acid or its salts, such as sodium alginate, can be added.

[0308] Dragee cores are provided with suitable coatings. For this purpose, concentrated sugar solutions may be used which may optionally contain gum arabic, talc, polyvinylpyrrolidone, carbopol gel, polyethylene glycol, titanium dioxide, lacquer solutions and suitable organic solvents or solvent mixtures.

[0309] The injectable preparations may include dosage forms for intravenous, subcutaneous, intradermal, and intramuscular injections, local injections, infusions, and the like. These injectable preparations may be prepared by known methods. For example, the injectable preparations may be prepared, for example, by dissolving, suspending, or emulsifying the pharmaceutical composition or dosage form in a sterile aqueous or oily medium conventionally used for injections. Aqueous media for injection include, for example, saline, isotonic solutions containing glucose and other auxiliary agents, and these may be used in combination with suitable solubilizers such as alcohol (e.g., ethanol), polyalcohols (e.g., propylene glycol, polyethylene glycol), nonionic surfactants [e.g., polysorbate 80, HCO-50 (polyoxyethylene (50 mol) adduct of hydrogenated castor oil)]. As oily media, for example, sesame oil, soybean oil, and the like may be used in combination with solubilizers such as benzyl benzoate, benzyl alcohol, and the like. The injectable preparations thus prepared may be filled into suitable ampoules.

[0310] Pharmaceutical compositions that can be used orally include push-fit capsules made of gelatin, and soft sealed capsules made of gelatin and plasticizers such as glycerol or sorbitol.Push-fit capsules may contain active ingredients mixed with fillers such as lactose, binders such as starch, lubricants such as talc or magnesium stearate, and optionally stabilizers.In soft capsules, active ingredients may be dissolved or suspended in suitable liquids such as fatty oils, liquid paraffin, or liquid polyethylene glycols.

[0311] Alternatively, the composition may be in powder form for constitution before use with a suitable vehicle, e.g., sterile pyrogen-free water. The exact formulation, route of administration, and dosage can be chosen by a physician familiar with the patient's condition. (See, e.g., Fingl, et al., 1975, in "The Pharmacological Basis of Therapeutics", Chapter I, p.1). Depending on the severity and responsiveness of the condition to be treated, administration may also be a single dose of a sustained release composition, with the course of treatment lasting from several days to several weeks, or until a cure is effected or the condition is abated.

[0312] Advantageously, the pharmaceutical composition for oral or parenteral use described above is prepared in dosage form with a unit dose suitable for the dosage of active ingredient.Such dosage forms in unit dose include, for example, tablets, pills, capsules, injections (ampoules), suppositories, chews, pet food, etc.In a particular embodiment, the dosage provided above is administered in one serving of pet food, such as 1 mg / kg of cannabis extract provided in one serving of pet food.

[0313] According to the methods disclosed herein, the pharmaceutical formulation can be administered to the patient using any acceptable device or mechanism. For example, administration can be accomplished using a syringe and needle, or with a reusable pen and / or autoinjector delivery device. The methods of the present invention include the use of a number of reusable pen and / or autoinjector delivery devices to administer the pharmaceutical formulation.

[0314] In non-human animal administration embodiments, the term "pharmaceutical" as used herein may be substituted for "veterinary." EXAMPLES

[0315] Example 1 Pharmacokinetic and safety studies in dogs A study was conducted to evaluate the pharmacokinetics of CBGA and CBG using 24-hour pharmacokinetic analysis and determination of steady-state levels after two weeks of treatment under both fed and fasted conditions. Secondly, the study assessed the safety of these compounds in dogs over the course of a two-week study using physical examinations (e.g., heart rate), complete blood counts, and serum chemistry evaluations.

[0316] Animals and protocols Six intact male beagles, all 2 years old and weighing 18.6-22.2 kilograms, were housed at the Baker Institute for Animal Health, and all procedures were approved by the Cornell University Institutional Animal Care and Use Committee (Protocol 2019-0001). All dogs underwent a 2-week fasting treatment trial, followed by a 2-week washout before beginning the feeding phase of the study, which included ¼ of a 13-ounce can of wet food (PURINA® Pro Plan Savory Chicken and Rice Formula, Nestle Purina, St. Louis, MO) at the time of administration. Twenty-four-hour pharmacokinetic analysis of serum cannabinoid levels was performed 1 day after a single dose in the fed or fasted state. Serum cannabinoids were then measured the following day after twice-daily administration of the treatment oil at both 7 am and 7 pm for 2 weeks. All dogs were bled prior to the study for complete blood counts and serum chemistries and again at the end of each phase of the 2-week study. Complete blood counts (white blood cells [WBC], hematocrit, hemoglobin, red blood cells [RBC], neutrophils, lymphocytes, platelets, monocytes, eosinophils, basophils) and serum biochemistry analyses (sodium, potassium, chloride, magnesium, calcium, phosphorus, albumin, total protein, globulin, urea nitrogen, creatinine, alkaline phosphatase [ALP], alanine aminotransferase [ALT], aspartate aminotransferase [AST], cholesterol, total bilirubin, glucose, and gamma glutamyltransferase [GGT]) were performed at the Cornell University Diagnostic Laboratory. For the fasted and fed portions of the 24-hour pharmacokinetic analysis study, dogs were administered 2 mg / kg body weight of an equal mixture of 30 mg / mL CBG and 30 mg / mL CBGA from cannabis extract in a sesame oil base and tested again at the end of the study, showing virtually identical analytical profiles. Two milliliters of blood were collected via jugular vein puncture for all six dogs prior to the first dose (0 hours), and then again at 0.5, 1, 2, 4, 8, 12, and 24 hours.Prior to enrollment, all dogs involved in the study were deemed healthy based on physical examination. Behavioral observations were performed 2 hours after the morning dose for each phase of the study. Behavioral observations were performed on days 1, 3, 7, and 14. Physical and behavioral examinations were performed to evaluate for adverse events including diarrhea, vomiting, lethargy, somnolence, ataxia, or abnormal behavior within the colony. Due to the potential effect of CBG / CBGA on heart rate, dogs were manually assessed for resting heart rate for 30 seconds and extrapolated to relative beats per minute after the first dose at 0, 1, 2, 4, 12, 24, and 48 hours for both fed and fasted arms of the study, and again after the morning dose on days 7 and 14. For further serum cannabinoid measurements, serum was also obtained 6 hours after the morning dose on days 7 and 14 to establish relative steady-state serum concentrations.

[0317] Serum cannabinoid analysis Analyses were performed at the Toxicology Research Laboratory, University of Illinois at Chicago using exploratory methods for the rapid measurement of 13 cannabinoids and their metabolites. Reference standards for CBD and CBDA were obtained from Restek Corporation (Bellefonte, PA), and all other reference and internal standards, including CBG and CBGA, were obtained from Cerilliant Corporation (Round Rock, TX). Concentrations of cannabinoids (CBD, CBDA, 7-COOH cannabidiol (7-COOH-CBD), THC, THCA, cannabinol (CBN), cannabichromene (CBC), CBG, and CBGA) and their metabolites (7-OH-CBD, 7-COOH-CBD, COOH-THC, and COOH-THC-Glu) in dog serum were determined using high-performance liquid chromatography with tandem mass spectrometry (LC-MS / MS) (Nexera X2 and LCMS 8050, Shimadzu Corp., Kyoto, Japan).

[0318] Dog serum (40 μL) was mixed with 20 μL of internal standards [CBD-d3, THC-d3, THCA-d3, 7-COOH-CBD-d3, COOH-THC-d9, and COOH-THC-Glu-d3 at 100 ng / mL in water:methanol (50:50)] in a 96-well plate. Proteins were precipitated and compounds were extracted by adding 100 μL of ice-cold acetonitrile to the samples, followed by vortexing for 1-2 min and centrifugation at 4,000 rpm for 10 min at 4 °C. The supernatant (70 μL) was mixed with 70 μL of water in a different 96-well plate and centrifuged again. 10 μL of the treated sample was injected onto a WATERS™ ATLANTIS® T3 HPLC column (3 μm 2.1×50 mm) with a guard cartridge (WATERS™ VanGuard ATLANTIS® T3) connected to an LC-MS / MS (Waters Corporation, Milford, Massachusetts, United States). The column was equilibrated to 50% B with mobile phase A (0.1% formic acid in water) and mobile phase B (acetonitrile). Compounds were eluted with a linear gradient from 50% B to 95% B over 6 min, then held at 95% B for 1 min. The column was then re-equilibrated at the initial composition for 1 min at a flow rate of 0.3 mL / min. The autosampler and column temperatures were set at 4 and 30° C., respectively. Compounds were detected in electrospray ionization positive and / or negative modes. The interface voltage and temperature were 4 kV and 300° C., respectively. The desolvation line and heat block temperatures were 250 and 400° C., respectively. The atomization, heating, and drying gas flows were 2.7, 5, and 5 L / min, respectively.

[0319] The concentration of cannabinoids was calculated based on the relative response (peak area of ​​cannabinoid / peak area of ​​internal standard) as 1 / c 2 The results were calculated by LabSolutions software (Shimadzu Corp., Kyoto, Japan) using a quadratic calibration curve with weights of 0.01 to 0.01.

[0320] Pharmacokinetic and statistical analysis A 24-hour noncompartmental pharmacokinetic analysis of CBG and CBGA was performed using a commercially available software system (PK solutions 2.0, Summit PK, Montrose, CO). A semi-logarithmic plot was used to determine the linearity of the elimination profiles. Results were calculated as time to maximum concentration (Tmax), maximum serum concentration (Cmax), elimination half-life (T1 / 2), area under the curve to the final time point (AUC 0-24 ), and mean residence time (MRT). The program predicts steady-state mean, minimum and maximum as well as average concentrations upon chronic dosing (Css Ave) based on the assumption that steady-state is achieved after 5 half-lives of dosing.

[0321] Statistical analysis of the pharmacokinetic results was performed using Student's T-test for fed and fasted 24-hour pharmacokinetics to determine if there were significant differences. Similarly, complete blood count data and selected serum chemistry data (hepatic and renal parameters) from dogs at each stage were compared at baseline and 2 weeks for both the fed and fasted portions of the study using Student's T-test. For each stage of the study (fed and fasted), one-way ANOVA was performed on the heart rate assessments over time. Two-way ANOVA was performed on the fed and fasted data at weeks 1 and 2 to assess differences between the two groups over time. For all statistical tests, p-values ​​were set at <0.05 for significance. All statistical tests were performed using GraphPad Prism 6.0 (Graphpad, LaJolla, CA) and figures were generated by the same software. Any results that were below the quantifiable limit of the respective cannabinoid were considered as 0 for all graphs and representations of the data (CBG lower limit 0.5 ng / mL, CBGA lower limit 1 ng / mL).

[0322] result 24-hour, 1-week, and 2-week pharmacokinetics The 24-hour PK analysis provided calculable Cmax (ng / mL), Tmax (hours), elimination T1 / 2 lifetime (hours), AUC 0-24 (ng-h / mL), MRT (hours), and predicted steady-state means for CBG and CBGA. No other cannabinoids were found in the detectable range. All data, means, and standard deviations for CBG and CBGA in fed and fasted states are found in Tables 1 and 2, respectively. When comparing fed and fasted results, no statistically significant differences were observed across all pharmacokinetic parameters (Table 1). CBGA serum concentrations were much higher than those found for CBG overall across all dogs, and both CBG and CBGA concentrations were higher in the fasted state, although not statistically significant (Figures 1 and 2). No significant differences in CBG serum concentrations were observed at week 1 in the fed (12.7+12.3ng / mL) or fasted (5.0+3.5ng / mL) states. Similarly, CBG serum concentrations were not significantly different between fed (9.6+8.4ng / mL) and fasted (6.1+6.0ng / mL) states at week 2, respectively (Figure 3). No significant differences in CBG were found between weeks or fed and fasted states (Time p=0.65, Fed / Fast p=0.10, Time*Fed / Fast p=0.46). Weeks 1 and 2, 6 hours after morning administration of oil, showed CBGA serum concentrations of 564+574ng / mL and 223+197ng / mL, respectively, in the fed state, and 437+414ng / mL and 260+300ng / mL, respectively, in the fasted state (Figure 4). No significant differences in CBGA were found between weeks or between fed and fasted states (Time p=0.11, Fed / Fasted p=0.69, Time*Fed / Fasted p=0.48). All of these results are in a similar order to the predicted steady state concentrations observed from the pharmacokinetic analysis. [Table 1] Cmax, maximum serum concentration Tmax, time to maximum concentration T1 / 2, elimination half-life AUC(0-24), area under the serum concentration curve up to 24 hours MRT, mean residence time Css Ave, predicted mean steady-state serum concentration No significant differences were found between fed and fasted conditions. [Table 2] Cmax, maximum serum concentration Tmax, time to maximum concentration T1 / 2, elimination half-life AUC(0-24), area under the serum concentration curve up to 24 hours MRT, mean residence time Css Ave, predicted mean steady-state serum concentration No significant differences were found between fed and fasted conditions.

[0323] Serum chemistry and complete blood count Mean and standard deviation serum chemistry tests and complete blood counts at baseline and week 2 are shown in Tables 3 and 4, respectively. Serum chemistry changes associated with treatment with cannabinoid and oil-based products suggest that for serum creatinine there was a very modest increase in the fed and fasted state (fasting p<0.01, fed p<0.01), with no values ​​falling outside the reference range. Serum albumin (p=0.03), cholesterol (p=0.03), and AST (p=0.01) levels also showed a significant increase during the feeding phase at week 2, while serum ALP (fasting p=0.02, fed p=0.05) showed a decrease during the feeding and fasting phases at week 2. None of these increases or decreases fell outside the reference range for each parameter. No other significance was observed between the remaining renal and hepatic parameters. Serum electrolytes showed no significant differences over time with treatment (data not shown).

[0324] Complete blood count data noted higher white blood cell counts at week 2 during both fed and fasted states (fasting p=0.02, fed p=0.01). Similarly, when examining specific cell types, neutrophils were found to increase at week 2 after each phase of treatment (fasting p=0.02, fed p=0.01). Platelets and monocytes were significantly increased at week 2 during the fasting phase of the study (p<0.01). Hematocrit concentrations were found to be significantly increased in the fed state after two weeks of treatment (p=0.01). No parameters were above or below the reference interval.

[0325] Physical examinations performed throughout revealed no observable abnormalities in activity, neurological disorders, or behavior during any phase of the study. One dog experienced vomiting on the second day after the morning dose during the fasting phase, but there were no other changes in appetite, vomiting, or diarrhea. Heart rates observed during the two-week period across both phases of the study are seen in Table 5. No significant differences were observed across the fed and fasting phases of the study.

[0326] Conclusion and Discussion This is the first pharmacokinetic serum evaluation of CBG and CBGA using infused sesame oil containing a mixture of 30 mg / ml CBG and 30 mg / ml CBGA administered orally to dogs. Cultivars that specifically synthesize primarily CBG or its acid derivatives are likely to be developed for sale as dietary supplements. Evaluating CBG and CBGA in companion animals such as dogs is important to better understand the pharmacokinetics and usefulness of these products, especially in light of NSAID intolerance and the need for safe alternatives for pain control.

[0327] Our 24-hour pharmacokinetic study of CBG and CBGA shows a significant increase in CBGA concentrations when compared to CBG in dog serum. CBGA levels in serum show approximately 40-fold higher Cmax compared to CBG in both fed and fasted states, with similar Tmax and T1 / 2 lifetimes for both compounds. With limited human literature, little focus on the acidic form, via oral ingestion, this study is novel in a higher mammalian species, examining the pharmacokinetics of CBG and CBGA and showing a definitive superiority in absorption and retention of CBGA.

[0328] The pharmacokinetics of CBG and CBGA over a two-week period show absorption and retention after oral administration in both fasted and fed states. However, CBGA is absorbed at much higher concentrations and maintains much higher serum concentrations compared to CBG. In comparison, the absorption and retention of CBGA appears to be nearly 10-fold higher than can be achieved with CBG, making it a better pharmacological molecule. In our small study, there were no significant differences between weeks or fed / fasted states for either CBG or CBGA, but the p-value over time for CBGA was 0.11, pointing to potential differences over time that may or may not be clinically relevant. Interestingly, concentrations at week 2 were lower than week 1, regardless of fed or fasted state, suggesting that there may be changes in hepatic metabolism occurring at the onset of dosing that could lead to elimination of CBG in the urine or bile, necessitating further investigation into enzymatic induction or inhibition of cytochrome p450. CBG and CBGA administered orally at 2 mg / kg twice daily for 2 weeks appear to be very safe for dogs. Physical examination revealed no changes in behavior, neurological status, or activity levels. Serum biochemistry evaluation in the fed state over a 2-week period revealed mild but significant elevations in albumin, creatinine, AST, and cholesterol. In the fasted state, there was also a mild but significant elevation in creatinine. However, none of these variations were outside the reference range. More importantly, there was no elevation of liver enzymes in our population. In particular, ALP was observed to decrease in both the fasted and fed states. Table 3 shows the serum biochemistry results.

[0329] When evaluating complete blood counts, there was a modest but significant increase in white blood cell counts and neutrophils in both the fasted and fed states at 2 weeks compared to baseline. Platelets and monocytes were significantly increased only in the fasted state. Hematocrit was elevated only in the fed state. Although statistically significant changes occurred, none fell outside the reference range and therefore were clinically relevant. It is unclear whether the elevation in white blood cell counts and neutrophils could be secondary to immune stimulation of CBG or CBGA or to the oils used as a vehicle for administration. Due to a major limitation of our study in that there was no placebo treatment during the study, these findings are weak and therefore the effects on serum chemistry changes and complete blood counts may be attributable to the small amount of sesame oil as the base of the cannabis supplement provided. Furthermore, the dogs used in this study were a small homogenous population that may not be reflective of companion dogs with comorbidities. Complete blood count data are shown in Table 4.

[0330] Dogs were followed for bradycardia during the first dose and over the 2-week treatment period, with no significant changes in heart rate. The low dose and poor absorption of CBG may have led to an overall lack of alpha-2 adrenergic stimulation, and it can be safely assumed that the CBGA molecule does not induce bradycardia upon oral absorption in our small cohort. Heart rate data is shown in Table 5.

[0331] In conclusion, this study is the first to show that CBG and CBGA cannabis extracts administered orally in sesame oil at 2 mg / kg twice daily for 2 weeks are absorbed and retained in dogs. Although further studies are needed to understand the elimination kinetics and long-term therapeutic concerns, CBGA is much more absorbable and retained at higher serum concentrations for longer periods of time, likely having pharmacological benefits. In short-term evaluations of serum biochemistry, blood counts, physical examination, and heart rate monitoring in a healthy canine population, both CBG and CBGA appear to be safe. This particular cannabis extract appears to be safe for short-term consumption, and caution should be used when making direct comparisons with other products due to differences in cannabis ingredients, carrier oils utilized, or other emulsions. Clinical trials are needed to evaluate the pharmacological benefits of CBG and CBGA in pain, neurological, and inflammatory conditions, and a focus on the acidic forms may be worthwhile due to the absorption kinetics observed. [Table 3] ALT, alanine aminotransferase; AST, aspartate aminotransferase; ALP, alkaline phosphatase; GGT, gamma-glutamyltransferase [Table 4] [Table 5]

Claims

1. 1. A pharmaceutical composition comprising a cannabis extract and a carrier, said cannabis extract comprising: cannabigerol, and Cambigerol acid Including, A pharmaceutical composition, wherein the ratio of cannabigerol to cannabigerolic acid is from about 0.2:1 to about 1:0.

2.

2. 1. A pharmaceutical composition comprising a cannabis extract and a carrier, said cannabis extract comprising: cannabigerolic acid, cannabigerol, cannabidiol, cannabidiolic acid, Δ9-tetrahydrocannabinol, and Cannabichromene Including, Preferably, 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; or A pharmaceutical composition, wherein the ratio of cannabigerol to cannabigerolic acid is from about 0.2:1 to about 1:0.

2.

3. the cannabis extract α-pinene, β-myrcene, β-pinene, δ-limonene, Linalool, β-caryophyllene, α-humulene, Nerolidol, Guaiol, caryophyllene oxide, and α-bisabolol The pharmaceutical composition of claim 1 or 2, further comprising:

4. the concentration of Δ9-tetrahydrocannabinol is insufficient to produce psychotropic effects, and / or the ratio of Δ9-tetrahydrocannabinol to other cannabinoids is about 1:25; and / or The concentration of Δ9-tetrahydrocannabinol is less than about 10 mg / mL, preferably The concentration of Δ9-tetrahydrocannabinol is less than about 3 mg / mL, more preferably The concentration of Δ9-tetrahydrocannabinol is less than about 1 mg / mL, and even more preferably The concentration of Δ9-tetrahydrocannabinol is less than about 0.1 mg / mL, most preferably Δ9-tetrahydrocannabinol concentrations are undetectable, typically the concentration of Δ9-tetrahydrocannabinol is about 0 mg / mL; The pharmaceutical composition of claim 2.

5. the cannabis extract about 10-100 mg / mL cannabigerol; about 10-100 mg / mL cannabigerolic acid; less than 1 mg / mL Δ9-tetrahydrocannabinol, and Approximately 1-4 mg / mL of cannabichromene and preferably the cannabis extract about 50 mg / mL cannabigerol, about 50 mg / mL cannabigerolic acid, less than 1 mg / mL Δ9-tetrahydrocannabinol, and Approximately 2.7 mg / mL of cannabichromene Including, The pharmaceutical composition of claim 2.

6. the cannabis extract about 0.09 to 0.13% α-pinene; about 0.23 to 0.44% β-myrcene; about 0.04 to 0.09% β-pinene; about 0.05 to 0.09% δ-limonene; Approximately 0.03-0.06% linalool, about 0.04 to 0.07% β-caryophyllene; about 0.02 to 0.04% α-humulene; about 0.04-0.07% nerolidol, approximately 0.02-0.04% guaiol, about 0.04-0.08% caryophyllene oxide, and about 0.01 to 0.04% α-bisabolol and preferably the cannabis extract Camphene, β-ocimene, eucalyptol, isopulegol, and / or Nerolidol and more preferably the cannabis extract about 0.02% camphene, about 0.02-0.03% β-ocimene; about 0.02-0.05% eucalyptol; about 0.02% isopulegol, and / or Approximately 0.02-0.04% nerolidol Including, The pharmaceutical composition according to claim 1 or 2.

7. The composition is formulated in a carrier, preferably 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, and more preferably the carrier comprises grape seed oil, or the carrier comprises catnip oil, or The carrier comprises sesame oil. The pharmaceutical composition according to claim 1 or 2.

8. The carrier comprises lecithin, preferably The lecithin is sunflower lecithin, more preferably The sunflower lecithin is up to 40%. The pharmaceutical composition according to claim 1 or 2.

9. The composition further comprises NF-971P, preferably The NF-971P is present in a weight / volume ratio of up to 2%. The pharmaceutical composition according to claim 1 or 2.

10. A dosage form comprising any of the pharmaceutical compositions according to claim 1 or 2 and one or more pharmaceutically acceptable additives, flavourings, surfactants and adjuvants, preferably the flavoring agent is selected from the group consisting of peppermint oil, mango extract, beef, chicken, and seafood; or the dosage form is formulated as a sublingual spray; or the dosage form is formulated as an aqueous or alcoholic solution, or as a cream for transdermal application; or the dosage form is formulated as a gel for buccal or intramucosal administration; or the dosage form is formulated as a powder, or the dosage form is formulated as a solution for subcutaneous injection; or the dosage form is formulated as a tablet; or the dosage form is formulated as a capsule; or the dosage form is formulated as a hard chewable; or the dosage form is formulated as a soft chewable; or the composition is formulated for administration using a nebulizer; or The composition is formulated for administration using a pet collar. Dosage form.

11. The composition is formulated as a chew for oral administration, preferably The chew is produced using cold extrusion, more preferably The chew weighs about 0.5 to 10 g, and even more preferably The chew weighs about 4 g, about 6 g, about 9 g, or about 10 g, typically The chew weighs about 4 g. The dosage form of claim 10.

12. The chew Approximately 70 mg of cannabigerol, Approximately 60 mg of cannabigerolic acid, approximately 3.2 mg of Δ9-tetrahydrocannabinol, and Approximately 3.6 mg of cannabichromene and preferably The dosage form is formulated in a carrier for oral administration, more preferably 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, and is typically The carrier comprises grapeseed oil, catnip oil, or sesame oil. The dosage form of claim 11.

13. 11. The dosage form of claim 10, formulated for inhalation.

14. 3. A composition according to claim 1 or 2 for use in a method for treating or reducing pain in a subject in need thereof, preferably comprising The pain is associated with arthritis, post-operative pain, acute pain, arthralgia, or polyarticular pain, more preferably The pain is postoperative pain, typically The subject has undergone a tibial plateau leveling osteotomy, and more preferably the subject is being treated with fentanyl and / or a nerve block; composition.

15. 3. A composition according to claim 1 or 2 for use in a method for treating epilepsy in a subject in need thereof, preferably comprising the subject has previously experienced a generalized motor or focal seizure episode; or the subject has a reduction in frequency and / or duration of seizures. composition.

16. 3. A composition according to claim 1 or 2 for use in a method for improving the quality of life in a subject with cancer, preferably comprising the subject is receiving L-CHOP or CHOP chemotherapy, and / or the cannabis extract or composition is administered about every 12 hours starting on week 4 or 5 of doxorubicin treatment, and / or The cancer is lymphoma, typically The lymphoma is an intermediate to high grade multicentric lymphoma, preferably After treatment, the subject experiences a disappearance of lymphoma-related abnormalities or a decrease in lymph node size. composition.

17. the subject has a body weight of more than 15 kg, and / or the subject is at the end of the first cycle of L-CHOP chemotherapy; 17. A composition for use according to claim 16.

18. the pharmaceutical composition is administered at a dose of about 0.1 to 8.0 mg / kg; or The pharmaceutical composition is administered at twice the therapeutically effective dose for one week, followed by subsequent administration of the therapeutically effective dose, preferably the therapeutically effective dose is about 0.1 to 0.5 mg / kg; or the therapeutically effective dose is about 2 mg / kg; or the therapeutically effective dose is about 8 mg / kg; 17. A composition for use according to claim 16.

19. the pharmaceutical composition is administered at a dose of about 1 mg / kg for one week, followed by subsequent doses of about 0.1 to 0.5 mg / kg thereafter; or the pharmaceutical composition is administered at a dose of about 4 mg / kg for one week, followed by a subsequent dose of about 2 mg / kg thereafter; 17. A composition for use according to claim 16.

20. said method results in a median maximum therapeutically effective serum concentration of cannabigerol, preferably the median maximum serum concentration of cannabigerol is about 102 ng / mL; or the median maximum serum concentration of cannabigerol is about 590 ng / mL; 16. A composition for use according to claim 15.

21. The subject is a veterinary subject, preferably the veterinary subject is a dog, cat, cow, pig, or horse; or the subject is a human; 17. A composition for use according to claim 16.

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