Cannabis extract for pain management in animals

Abstract

The present disclosure relates to methods of treating pain in veterinary subjects using pharmaceutical compositions and dosage forms comprising Cannabis sativa extract. In one aspect, the present application provides a pharmaceutical composition comprising a Cannabis sativa extract and a carrier, wherein the Cannabis sativa extract comprises cannabidiol; and cannabidiolic acid, wherein the ratio of cannabidiol to cannabidiolic acid is from about 0.6:1 to about 1:0.6.

Description

Technical Field

[0001] Cross - Reference to Related Applications This application claims the benefit of U.S. Provisional Patent Application No. 62 / 655,170, filed Apr. 9, 2018, the entire disclosure of which is incorporated herein by reference.

Background Art

[0002] Although daily non - steroidal anti - inflammatory drug (NSAID) treatment is effective, it may not sufficiently relieve pain caused by osteoarthritis (OA), especially in patients with certain co - morbidities, who may have potential side effects that prevent the use of this NSAID treatment. In a systematic review of 35 dog models of OA and 29 clinical trials in dogs, NSAID treatment caused side effects in 35 of 64 studies (55%), with the most common being gastrointestinal symptoms. Although other drugs have been proposed, there is little evidence regarding their effectiveness in dogs with chronic pain or neuropathic pain associated with OA. When there is no optimal treatment for these dogs, other potentially effective drugs such as cannabinoids are often sought.

Summary of the Invention

Problems to be Solved by the Invention

[0003] This disclosure is directed to a composition comprising cannabidiol and the use of this composition for the treatment of pain in animals. In one aspect, provided herein is a pharmaceutical composition comprising an asafoetida extract and a carrier, wherein the asafoetida extract comprises cannabidiol; and cannabidiolic acid and the ratio of cannabidiol to cannabidiolic acid is from about 0.6:1 to about 1:0.6, which is a pharmaceutical composition.

Means for Solving the Problems

[0004] In one embodiment, this hemp extract is Cannabigerol acid; Δ9-tetrahydrocannabinol; and Cannabide chromium It also includes.

[0005] In one embodiment, this hemp extract is α-pinene; β-myrcene; β-pinene; δ-limonene; Linalool; β-caryophyllene; α-humulene; Nerolidol 2; Guaiol; Caryophyllene oxide; and α-Bisabolol It further includes four or more of the following.

[0006] In one embodiment, the concentration of Δ9-tetrahydrocannabinol in this hemp extract is insufficient to produce a psychoactive effect. In one embodiment, the ratio of Δ9-tetrahydrocannabinol to other cannabinoids is about 1:25. In another embodiment, the concentration of Δ9-tetrahydrocannabinol is less than about 1 mg / mL. In another embodiment, the concentration of Δ9-tetrahydrocannabinol is less than about 0.5 mg / mL. In another 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 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.

[0007] In certain embodiments, the ratio of cannabidiol to cannabidiolic acid is selected from the group consisting of about 1:100, about 1:50, about 1:10, and about 1:1. In another embodiment, the ratio of cannabidiol to cannabidiolic acid is about 1:1.

[0008] In certain embodiments, this hemp extract contains about 1 to 10 mg / mL of cannabidiol; contains about 1 to 10 mg / mL of cannabidiolic acid; contains about 0.05 to 0.2 mg / mL of cannabigerolic acid; contains about 0.1 to 0.3 mg / mL of Δ9-tetrahydrocannabinol; and contains about 0.1 to 0.4 mg / mL of cannabichromene .

[0009] In another embodiment, this hemp extract contains about 5 mg / mL of cannabidiol; contains about 5 mg / mL of cannabidiolic acid; contains about 0.11 mg / mL of cannabigerolic acid; contains about 0.25 mg / mL of Δ9-tetrahydrocannabinol; and contains about 0.27 mg / mL of cannabichromene .

[0010] In another embodiment, this hemp extract contains about 0.09 to 0.13% of α-pinene; contains about 0.23 to 0.44% of β-myrcene; contains about 0.04 to 0.09% of β-pinene; contains about 0.05 to 0.09% of δ-limonene; contains about 0.03 to 0.06% of linalool; contains about 0.04 to 0.07% of β-caryophyllene; contains about 0.02 to 0.04% of α-humulene; contains about 0.04 to 0.07% of nerolidol 2; contains about 0.02 to 0.04% of guaiol; About 0.04 to 0.08% of caryophyllene oxide; and about 0.01 to 0.04% of α-bisabolol and contains.

[0011] In another embodiment, this mugwort extract camphene; β-ocimene; eucalyptol; isopulegol; and / or nerolidol 1 further contains.

[0012] In another embodiment, this mugwort extract about 0.02% of camphene; about 0.02 to 0.03% of β-ocimene; about 0.02 to 0.05% of eucalyptol; about 0.02% of isopulegol; and / or about 0.02 to 0.04% of nerolidol 1 contains.

[0013] In certain embodiments, this mugwort extract contains 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 2, guaiol, caryophyllene oxide, α-bisabolol, camphene, β-ocimene, eucalyptol, isopulegol, and nerolidol 1.

[0014] In certain embodiments, this composition is formulated with a carrier. In another embodiment, the carrier is selected from the group consisting of linseed oil, olive oil, fish oil, salmon oil, coconut oil, mint oil, sesame oil, and grape seed oil. In another embodiment, the carrier is grape seed oil. In another embodiment, the carrier is mint oil. In another embodiment, this composition contains nepetalactone. In another embodiment, this composition contains taurine.

[0015] In one embodiment, this hemp extract is Cannabidiol; Cannabidiolic acid; Cannabigerol acid; Δ9-tetrahydrocannabinol; and Cannabide chromium Includes, This carrier is grape seed oil.

[0016] In one embodiment, the composition is formulated for administration using a nebulizer. In another embodiment, the composition is formulated for administration using a diffuser. In yet another embodiment, the composition is formulated for administration using a pet collar. In yet another embodiment, the composition is formulated as an oral pet food.

[0017] In one embodiment, the composition is formulated as an orally administered chewing agent. In another embodiment, the weight of the chewing agent is approximately 0.5 to 10 g. In yet another embodiment, the weight of the chewing agent is approximately 4 g, 6 g, 9 g, or 10 g. In yet another embodiment, the weight of the chewing agent is approximately 4 g.

[0018] In another embodiment, this chewing agent is Cannabidiol approximately 7 mg; Cannabidiolic acid, approximately 6 mg; Cannabigerol acid, approximately 0.12 mg; Δ9-tetrahydrocannabinol approximately 0.32 mg; and Cannabichromene approx. 0.36 mg Includes.

[0019] In another embodiment, the dosage form is: Cannabidiol; Cannabidiolic acid; Cannabigerol acid; Δ9-tetrahydrocannabinol; Cannabatic chromium; and One or more pharmaceutically acceptable additives, fragrances, surfactants, and adjuvants Includes.

[0020] In one embodiment, the concentration of Δ9-tetrahydrocannabinol in this dosage form is insufficient to produce a psychoactive effect. In one embodiment, the ratio of Δ9-tetrahydrocannabinol to other cannabinoids is about 1:25. In another embodiment, the concentration of Δ9-tetrahydrocannabinol is less than about 1 mg / mL. In another embodiment, the concentration of Δ9-tetrahydrocannabinol is less than about 0.5 mg / mL. In another 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 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.

[0021] In one embodiment, the ratio of cannabidiol to cannabidiolic acid is selected from the group consisting of about 1:100, about 1:50, about 1:10, and about 1:1. In another embodiment, the ratio of cannabidiol to cannabidiolic acid is about 1:1.

[0022] In another embodiment, this dosage form is Approximately 1-10 mg / mL of cannabidiol; Cannabidiolic acid at approximately 1-10 mg / mL; Cannabigerol acid at approximately 0.05-0.2 mg / mL; Approximately 0.1-0.3 mg / mL of Δ9-tetrahydrocannabinol; and Approximately 0.1-0.4 mg / mL of cannabichromene Includes.

[0023] In another embodiment, this dosage form is Approximately 5 mg / mL of cannabidiol; Approximately 5 mg / mL of cannabidiolic acid; Approximately 0.11 mg / mL of cannabigerol acid; Approximately 0.25 mg / mL of Δ9-tetrahydrocannabinol; and Approximately 0.27 mg / mL of cannabichromene Includes.

[0024] In one embodiment, this dosage form is α-pinene; β-myrcene; β-pinene; δ-limonene: Linalool; β-caryophyllene; α-humulene; Nerolidol 2; Guaiol; Caryophyllene oxide; and α-Bisabolol Includes four or more of the following.

[0025] In another embodiment, this dosage form is 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; Approximately 0.04-0.08% caryophyllene oxide; and Approximately 0.01-0.04% α-bisabolol Includes.

[0026] In another embodiment, this dosage form is Camphen; β-Ocimene; Eucalyptol; Isoplegol; and / or Nerolidol 1 It also includes.

[0027] In another embodiment, this dosage form is Approximately 0.02% camphene; Approximately 0.02-0.03% β-ocimene; Approximately 0.02-0.05% eucalyptol; Approximately 0.02% isopuregol; and / or Approximately 0.02-0.04% nerolidol Includes.

[0028] In another embodiment, the dosage form comprises 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15 or more of the following: α-pinene, β-myrcene, β-pinene, δ-limonene, linalool, β-caryophyllene, α-humulene, nerolidol 2, guaiol, caryophyllene oxide, α-bisabolol, camphene, β-ocimene, eucalyptol, isopulegol, and nerolidol 1.

[0029] In one embodiment, the dosage form includes a flavoring selected from the group consisting of catnip oil, peppermint oil, mango extract, beef, poultry meat, and seafood. In one embodiment, the flavoring is catnip oil. In one embodiment, the flavoring is selected from the group consisting of catnip oil, chicken liver powder, poultry meat extract, maltodextrin, butter, and bacon. In one embodiment, the flavoring is chicken liver powder.

[0030] In one embodiment, this dosage form contains nepetalactone. In another embodiment, this dosage form contains taurine.

[0031] In one embodiment, this dosage form is formulated as an orally administered chewable preparation. In another embodiment, this chewable preparation is manufactured using cold extrusion. In yet another embodiment, this dosage form is formulated as a sublingual spray. In yet another embodiment, this dosage form is formulated as a water or alcohol-soluble solution, gel, or cream for transdermal application. In yet another embodiment, this dosage form is formulated as a gel for buccal or mucosal administration. In yet another embodiment, this dosage form is formulated as a powder. In yet another embodiment, this dosage form is formulated as a solution for subcutaneous injection. In yet another embodiment, this dosage form is formulated as a tablet. In yet another embodiment, this dosage form is formulated as a capsule. In yet another embodiment, this dosage form is formulated as a hard chewable preparation. In yet another embodiment, this dosage form is formulated for inhalation. In yet another embodiment, this dosage form is formulated for administration using a nebulizer. In yet another embodiment, this dosage form is formulated for administration using a diffuser. In another embodiment, this dosage form is formulated for administration using a pet collar.

[0032] In one embodiment, this dosage form is formulated in a carrier for oral administration. In one embodiment, the carrier is selected from the group consisting of linseed oil, olive oil, fish oil, salmon oil, coconut oil, catnip oil, sesame oil, and grape seed oil. In another embodiment, the carrier is grape seed oil. In yet another embodiment, the carrier is catnip oil.

[0033] In one embodiment, the dosage form is Glucosamine HCl; Chondroitin sulfate (76%); Brewer's yeast; Gum arabic; Guar gum; flavoring agents; Verdilox; Previon; Hemp extract; Glycerin; Sunflower lecithin; and water Includes.

[0034] In another embodiment, this dosage form is 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% fragrance; Approximately 0.01-0.1% Verdilox; Approximately 0.5-1.5% Previon; Approximately 3-6% hemp extract; Approximately 13-17% glycerin; Approximately 3-7% sunflower lecithin; and Approximately 3-7% water Includes.

[0035] In another embodiment, this dosage form is 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% fragrance; Approximately 0.05% Verdilox; Approximately 0.9% Previon; Approximately 4.7% hemp extract; Approximately 15.1% glycerin; Approximately 5.7% sunflower lecithin; and Approximately 5.7% water Includes.

[0036] In one embodiment, the dosage form is Glucosamine HCl; Hyaluronic acid; Brewer's yeast; Gum arabic; Guar gum; flavoring agents; Verdilox; Previon; Hemp extract; Glycerin; Sunflower lecithin; and water Includes.

[0037] In another embodiment, this dosage form is Approximately 12-17% glucosamine HCl; Approximately 0.01-1% hyaluronic acid; Approximately 29-33% brewer's yeast; Approximately 3-6% gum arabic; Approximately 0.5-2% guar gum; Approximately 12-16% fragrance; Approximately 0.01-0.1% Verdilox; Approximately 0.5-1.5% Previon; Approximately 3-6% hemp extract; Approximately 13-17% glycerin; Approximately 3-7% sunflower lecithin; and Approximately 3-7% water Includes.

[0038] In another embodiment, this dosage form is 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% fragrance; Approximately 0.05% Verdilox; Approximately 0.97% Previon; Approximately 4.8% hemp extract; Approximately 15.5% glycerin; Approximately 5.8% sunflower lecithin; and Approximately 5.8% water Includes.

[0039] In another embodiment, the dosage form is: Hemp 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 Guar gum Includes.

[0040] In another embodiment, this dosage form is Approximately 5.0% hemp extract; Approximately 15.0% peanut butter; Approximately 12.5% ​​rice bran; Approximately 12.75% glucosamine HCl; Approximately 5.5% sweet potatoes; Approximately 8.0% dried molasses; Approximately 1% sorbic acid; Approximately 5.0% brewer's yeast; Approximately 6.0% sugar; Approximately 9.25% water; Approximately 13.0g of glycerin; Approximately 2.0% potato starch; Dehydrated peanut butter with approximately 1.0% moisture content; Approximately 2.0% rice starch; and Approximately 2.0% guar gum including

[0041] In another embodiment, this dosage form is Approximately 5.0% hemp extract; Approximately 15.0% peanut butter; Approximately 13.0% rice bran; Approximately 8.5% glucosamine HCl; Approximately 6.0% sweet potatoes; Approximately 9.0% dried molasses; Approximately 1% sorbic acid; Approximately 5.0% brewer's yeast; Approximately 6.0% sugar; Approximately 9.5% water; Approximately 13.0g of glycerin; Approximately 4.0% potato starch; Dehydrated peanut butter with approximately 1.0% moisture content; Approximately 2.0% rice starch; and 2.0% guar gum Includes.

[0042] In another embodiment, this dosage form is Approximately 3.0-10.0% hemp extract; Approximately 10.0-20.0% peanut butter; Approximately 10.0-15.0% rice bran; Approximately 5.0-15.0% glucosamine HCl; Approximately 4.0-10.0% sweet potatoes; Approximately 6.0-13.0% dried molasses; Approximately 0.5-5.0% sorbic acid; Approximately 2.0-8.0% brewer's yeast; Approximately 3.0-8.0% sugar; Approximately 5.0-15.0% water; Approximately 8.0-18.0% glycerin; Approximately 1.0-8.0% potato starch; Dehydrated peanut butter with a concentration of approximately 0.5-5.0%; Approximately 1.0-5.0% rice starch; and Approximately 1.0-5.0% guar gum Includes.

[0043] In some embodiments, the foregoing provides a method for treating or alleviating pain in a veterinary subject of need, comprising administering to the subject a therapeutically effective amount of any of the compositions or dosage forms described above. In some embodiments, the pain is arthritis, postoperative pain, acute pain, toothache, gingivitis pain, or polyarthralgia.

[0044] In one embodiment, the pharmaceutical composition or dosage form is administered twice a day at a dose of approximately 1.0 mg / kg. In another embodiment, the pharmaceutical composition or dosage form is administered three times a day at a dose of approximately 1.0 mg / kg. In yet another embodiment, the pharmaceutical composition or dosage form is administered twice a day at a dose of approximately 2.0 mg / kg. In yet another embodiment, the pharmaceutical composition or dosage form is administered three times a day at a dose of approximately 2.0 mg / kg. In yet another embodiment, the pharmaceutical composition or dosage form is administered at a dose of approximately 0.1 to 8.0 mg / kg.

[0045] In another embodiment, the pharmaceutical composition or dosage form is administered at twice the therapeutically effective dose over a week, followed by administration at the therapeutically effective dose. In another embodiment, the therapeutically effective dose is approximately 0.1 to 0.5 mg / kg. In another embodiment, the therapeutically effective dose is approximately 2 mg / kg. In another embodiment, the therapeutically effective dose is approximately 8 mg / kg. In another embodiment, the pharmaceutical composition or dosage form is administered at approximately 1 mg / kg over a week, followed by administration at approximately 0.1 to 0.5 mg / kg. In another embodiment, the pharmaceutical composition or dosage form is administered at approximately 4 mg / kg over a week, followed by administration at approximately 2 mg / kg.

[0046] In one embodiment, this method yields a therapeutically effective median maximal serum concentration (MSC) of cannabidiol. In one embodiment, this MSC is approximately 102 ng / mL. In another embodiment, this MSC is approximately 590 ng / mL.

[0047] In one embodiment, the foregoing provides a method for treating or alleviating arthritis pain, postoperative pain, acute pain, toothache, gingivitis pain, or polyarthralgia in a veterinary subject of need, comprising administering a therapeutically effective amount of hemp extract to the subject.

[0048] In one embodiment, the hemp extract is administered at a dose of approximately 0.1 to 8.0 mg / kg. In another embodiment, the hemp extract is administered at twice the therapeutically effective dose for one week, followed by administration at the therapeutically effective dose. In another embodiment, the therapeutically effective dose is approximately 0.1 to 0.5 mg / kg. In yet another embodiment, the therapeutically effective dose is approximately 1 mg / kg. In yet another embodiment, the therapeutically effective dose is approximately 2 mg / kg. In yet another embodiment, the therapeutically effective dose is approximately 8 mg / kg.

[0049] In one embodiment, the hemp extract is administered at a dose of approximately 1 mg / kg over one week, followed by a dose of approximately 0.1 to 0.5 mg / kg. In another embodiment, the hemp extract is administered at a dose of approximately 4 mg / kg over one week, followed by a dose of approximately 2 mg / kg.

[0050] In one embodiment, this method yields a therapeutically effective maximum serum median concentration of cannabidiol. In another embodiment, this maximum serum median concentration of cannabidiol is approximately 102 ng / mL. In yet another embodiment, this maximum serum median concentration of cannabidiol is approximately 590 ng / mL.

[0051] In one embodiment, the veterinary subject is a dog, cat, cow, pig, or horse. In another embodiment, the veterinary subject is a dog. In yet another embodiment, the veterinary subject is a cat.

[0052] In one embodiment, the foregoing provides a method for achieving a 0-24 hour area under the curve for cannabidiol of 42.4-3048 ng / hour / ml in a veterinary subject, comprising administering an effective amount of hemp extract to the subject. In one embodiment, the subject is a dog or a cat.

[0053] In one embodiment, the herein provides a pharmaceutical composition comprising a hemp extract and a carrier, wherein the hemp extract is Cannabidiol; and Cannabidiolic acid Includes, The ratio of cannabidiol to cannabidiolic acid is approximately 0.6:1 to approximately 1:0.6. This hemp extract does not contain terpenes. It is a pharmaceutical composition. [Brief explanation of the drawing]

[0054] [Figure 1] This is a box plot of serum alkaline phosphatase (ALP) activity at each time point for the treated oil and placebo oil. The boxes represent the mean, 25th percentile, and 75th percentile values, while the whiskers represent the 99th percentile and 1st percentile values. [Figure 2] This shows the serum concentrations (ng / mL) of CBD oil administered orally at doses of 2 mg / kg and 8 mg / kg over time (minutes). [Figure 3A] This is a box plot of the total CBPI scores at each time point for the treatment oil and placebo oil. The boxes represent the mean, 25th percentile, and 75th percentile values, while the whiskers represent the 99th percentile and 1st percentile values. [Figure 3B]This is a box plot of the total Hudson scores at each time point for the treatment oil and placebo oil. The boxes represent the mean, 25th percentile, and 75th percentile values, while the whiskers represent the 99th percentile and 1st percentile values. [Figure 4] This is a box plot of total veterinary pain assessment at each time point for treatment oil and placebo oil. [Figure 5A] This graph shows the trot stance % gait cycle symmetry for five dogs treated with CBD oil. [Figure 5B] This graph shows the trot stance % gait cycle for five dogs treated with CBD oil. [Figure 5C] This graph shows the trot step / stide ratio for five dogs treated with CBD oil. [Figure 5D] This graph shows the walk stance % gait cycle symmetry for five dogs treated with CBD oil. [Figure 5E] This graph shows the walk stance % gait cycle for five dogs treated with CBD oil. [Figure 5F] This graph shows the walk step / stide ratio for five dogs treated with CBD oil. [Modes for carrying out the invention]

[0055] The endogenous cannabinoid receptor system is known to play a role in pain regulation and inflammation reduction. Cannabinoid receptors (CB1 and CB2) are widely distributed throughout the central and peripheral nervous systems and are also present in the synovial membrane. However, due to the psychoactive effects of certain cannabinoids, extensive research has not been conducted on the use of cannabinoids as monotherapy for pain relief. Cannabinoids are a group of as many as 60 different compounds that may or may not act on CB receptors. Cannabidiol (CBD), one class of cannabinoids, can actually be an antagonist of CB receptors. In lower vertebrates, CBD may also have immunomodulatory, anti-algesic, anti-nociceptive, and anti-inflammatory effects, making it an attractive treatment option in dogs with osteoarthritis (OA).

[0056] This disclosure is directed toward compositions comprising hemp extracts and the use of these compositions for the treatment of pain in animals. Similarly, methods for the treatment of pain in veterinary subjects are provided herein. The efficacy of these compositions and treatment methods has not been demonstrated to date. Clinical trial and pharmacokinetic data relating to administration are also provided herein.

[0057] definition The following are definitions of various terms used herein. These definitions apply to terms used throughout this specification and the claims, unless otherwise limited in specific examples, individually or as part of a larger group.

[0058] Unless otherwise defined, all technical and scientific terms used herein have the same meanings as commonly understood by those skilled in the art to which this invention pertains. Generally, the nomenclature and experimental procedures used herein in cell culture, molecular genetics, organic chemistry, and peptide chemistry are known and commonly practiced in the art.

[0059] As used herein, the articles “a” and “an” refer to one or more (i.e., at least one) grammatical objects of these articles. For example, “an element” means one or more elements. Furthermore, the use of the term “include” is not limited to the other forms (e.g., “include,” “includes,” and “included”).

[0060] As used herein, the term “about” will be understood by those skilled in the art and will vary to some extent depending on the context in which it is used. As used herein, when referring to measurable values ​​such as quantities, durations over time, and similar items, the term “about” means to include a variation of ±5% from the specified value, because such variation is appropriate for carrying out the disclosed method.

[0061] As used herein and in the claims, the term “comprising” may include embodiments of “consisting of” and “consisting essentially of.” The terms “comprise(s),” “include(s),” “having,” “has,” “may,” and “contain(s),” and their variations, as used herein, are intended to be open-ended transitional phrases, terms, or words that require the presence of the listed components / steps but also permit the presence of other components / steps. However, such descriptions should be interpreted as also describing compositions or processes as “being” and “essentially being” of the listed compounds, thereby permitting the presence of only the specified compounds, along with any pharmaceutically acceptable carrier, and excluding other compounds.

[0062] All ranges disclosed herein include the listed endpoints and can be combined independently (for example, the range "approximately 50 mg to 500 mg" includes the endpoints 50 mg and 500 mg and all intermediate values). The endpoints and any values ​​in the ranges disclosed herein are not limited to exact ranges or values ​​and are sufficiently imprecise to include values ​​that approximate these ranges and / or values.

[0063] As used herein, the terms “treatment” or “to treat” are defined as the application or administration of a therapeutic agent (i.e., the compounds provided herein) to a patient (alone or in combination with other therapeutic agents) for the purpose of curing, healing, alleviating, relieving, modifying, treating, relieving, improving, or affecting the symptoms of a disease, disorder, syndrome, or condition, or the application or administration of a therapeutic agent to tissue or cell lineage isolated from a patient (for example, for diagnostic or ex vivo application). Such treatments may be specifically adapted or modified based on knowledge derived from the field of pharmacogenomics.

[0064] In certain embodiments, the compositions described herein reduce pain in the subject. Pain can be measured using any metric known in the art. For example, pain can be measured using the Canine Brief Pain Questionnaire (CBPI), the Hudson Activity Scale, flexion and extension measurements, and gait analysis. A decrease in any of these metrics indicates treatment or reduction of pain.

[0065] As used herein, the terms “prevent” or “prevent” mean, if the disability or disease had not occurred, that the disability or disease would not occur, and if the disability or disease had already occurred, that further disability or disease would not occur. The ability to prevent some or all of the symptoms associated with the disability or disease is also considered similarly.

[0066] As used herein, the term “use” includes, as appropriate and as appropriate, one or more of the following embodiments of the Invention: use in the treatment of pain, use for the manufacture of pharmaceutical compositions for use in the treatment of these diseases (e.g., in the manufacture of drugs), unless otherwise specified; methods of use of the compounds of the Invention in the treatment of these diseases; pharmaceuticals having the compounds of the Invention for the treatment of these diseases; and compounds of the Invention for use in the treatment of these diseases.

[0067] As used herein, the terms “patient,” “individual,” or “subject” are intended to include organisms (e.g., prokaryotes and eukaryotes) that are susceptible to or suffering from a disease, disorder, or condition associated with protein kinase activity. Examples of subjects include mammals (e.g., humans, dogs, cattle, horses, pigs, sheep, goats, cats, mice, rabbits, rats) and transgenic non-human animals. In certain embodiments, the subject is a human, for example, a human who has, is at risk of, or is potentially susceptible to schizophrenia. In other embodiments, the subject is a cell.

[0068] When used in relation to methods of treatment / prevention, and the use of the compounds and their pharmaceutical compositions described herein, the “needed” individuals may be individuals diagnosed with the condition being treated or who have already been treated for the condition. In relation to prevention, the needed individuals may also be individuals at risk for the condition (e.g., a family history of the condition, lifestyle factors indicating risk for the condition, etc.). Typically, where the step of administering the compounds of the present invention is disclosed herein, the present invention further intends to include a step of identifying individuals or subjects who require the specific treatment to be administered or who have the specific condition to be treated.

[0069] In some embodiments, the individual is a mammal (e.g., cattle, horses, cats, rabbits, dogs, rodents, or primates). In some embodiments, this mammal is a primate. In some embodiments, this primate is a human. In some embodiments, this individual is a human (e.g., an adult, a child, and a premature infant). In some embodiments, this individual is a non-mammal. In some variations, the primate is a non-human primate (e.g., chimpanzees and other apes, as well as monkey species). The term “individual” does not indicate a specific age or sex.

[0070] As used herein, the term “pharmaceutically acceptable” means a substance (e.g., a carrier or diluent) that does not impair the biological activity or properties of a compound and is relatively non-toxic, i.e., the substance can be administered to an individual without causing undesirable biological effects or interacting in a harmful manner with any of the components of a composition containing the substance.

[0071] As used herein, the term “pharmaceutically acceptable salt” refers to a derivative of a compound of the disclosed compound, wherein the parent compound is modified by converting an existing acidic or basic moiety to its salt form. Examples of pharmaceutically acceptable salts include, but are not limited to, mineral salts or organic acid salts of basic residues such as amines; alkali salts or organic salts of acidic residues such as carboxylic acids; and the like. Examples of pharmaceutically acceptable salts of the present invention include conventional non-toxic salts of the parent compound formed from non-toxic inorganic or organic acids. Pharmaceutically acceptable salts of the present invention can be synthesized from a parent compound containing a chlorinated or acidic moiety by conventional chemical methods. Generally, such salts can be prepared by reacting the free acid or free base form of the compound with a stoichiometric amount of a suitable base or acid in water, an organic solvent, or a mixture thereof, generally preferred in non-aqueous media such as ether, ethyl acetate, ethanol, isopropanol, or acetonitrile. A list 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.

[0072] As used herein, the terms “composition” or “pharmaceutical composition” refer to a mixture of at least one compound useful in the present invention and a pharmaceutically acceptable carrier. Pharmaceutical compositions facilitate the administration of compounds to a patient or subject. In the art, there are several techniques for administering compounds, including, but not limited to, intravenous administration, oral administration, aerosol administration, parenteral administration, ophthalmic administration, pulmonary administration, and topical administration.

[0073] As used herein, the terms “pharmaceutically acceptable carrier” or “carrier” mean a pharmaceutically acceptable substance, composition, and carrier (e.g., liquid or solid fillers, stabilizers, dispersants, suspending agents, diluents, additives, thickeners, solvents, or encapsulating materials) that are involved in the transport or delivery of compounds useful in the present invention to or within a patient in such a manner that they can perform their intended function. Typically, such constructs are transported or delivered from one organ or part of the body to another organ or part of the body. Each carrier must be “acceptable” in the sense that it is compatible with other components of the formulation, such as compounds useful in the present invention, and is not harmful to the patient. Some examples of substances that can function as pharmaceutically acceptable carriers include: sugars, e.g., lactose, glucose, and sucrose; starches, e.g., corn starch and potato starch; cellulose and its derivatives, e.g., sodium carboxymethylcellulose, ethylcellulose, and cellulose acetate; powdered tragacanth; malt; gelatin; talc; additives, e.g., cocoa butter and suppository wax; oils, e.g., peanut oil, cottonseed oil, safflower oil, sesame oil, olive oil, corn oil, and soybean oil; glycols, e.g., propylene glycol; polyols, e.g., glycerin, sorbitol, mannitol, and polyethylene glycol; esters, e.g., ethyl oleate and ethyl laurate; agar; buffers, e.g., magnesium hydroxide and aluminum hydroxide; surfactants; alginic acid; pyrogen-free water; isotonic saline; Ringer's solution; ethyl alcohol; phosphate buffer solution; and other non-toxic, suitable substances used in pharmaceutical formulations. As used herein, “pharmaceutically acceptable carrier” also includes any coatings, antimicrobial and antifungal agents, as well as absorption retarders, and the like, that are compatible with the activity of compounds useful in the present invention and are physiologically acceptable to patients. Supplementary active compounds may also be incorporated into this composition. “pharmaceutically acceptable carrier” or “carrier” may further include pharmaceutically acceptable salts of compounds useful in the present invention.In the art, other additional components that may be included in pharmaceutical compositions used in practice of the present invention are known and are described, for example, in Remington's Pharmaceutical Sciences (Genaro, Ed., Mack Publishing Co., 1985, Easton, PA), which is incorporated herein by reference.

[0074] As used herein, the term "stabilizer" refers to a polymer that can chemically inhibit or prevent degradation. Stabilizers are added to formulations of the compound to improve the chemical and physical stability of the compound.

[0075] As used herein, the term “adjuvant” may include, for example, preservatives, humectants, suspending agents, sweeteners, flavorings, fragrances, emulsifiers, and dispensing agents. Prevention of microbial action is generally achieved by various antimicrobial and antifungal agents (e.g., parabens, chlorobutanol, phenol, sorbic acid, and the like). Isotonic agents (e.g., sugars, sodium chloride, and the like) may also be included. Sustained absorption of injectable pharmaceutical formulations may be achieved by the use of absorption-delaying agents (e.g., aluminum monostearate and gelatin). Other adjuvants may include humectants, emulsifiers, pH buffers, and antioxidants (e.g., citric acid, sorbitan monolaurate, triethanolamine oleate, butylated hydroxytoluene, and the like).

[0076] As used herein, the terms “effective dose,” “pharmaceutically effective dose,” and “therapeutically effective dose” refer to a dose of a drug that is harmless but sufficient to produce a desired biological effect. This effect may be a reduction or mitigation of signs, symptoms, or causes of a disease, or any other desired alteration of a biological system. The appropriate therapeutic dose in any individual case may be determined by those skilled in the art using routine experimentation.

[0077] As used herein, the term “weight percentage” means the amount by weight of the compounds and / or components in this composition as a percentage of the total weight of the composition, as the amount by weight of the components of this composition. A weight percentage may also be calculated by multiplying the mass fraction by 100. “Mass fraction” is given by weight percentage = (m1 / m T ) * The total mass m of the composition that equals 100 T This is the ratio of the mass m1 of one substance to the mass m1 of the substance.

[0078] An aqueous buffer solution refers to an aqueous solution that resists changes in hydronium ion concentration and hydroxide ion concentration (and consequently pH) upon the addition of small amounts of acid or base, or upon dilution. Buffer solutions consist (more commonly) of a weak acid and its conjugate base, or (less commonly) of a weak base and its conjugate acid. Buffer solutions can be prepared by methods known in the art, using appropriate buffers to impart the desired pH value. Examples of suitable buffers 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 bioacidic buffers. Aqueous buffer solutions are commercially readily available and can be used in the preparation of the compositions of the present invention without further processing.

[0079] As used herein, the term “hemp extract” refers to a composition of cannabinoids and terpenes isolated from the hemp plant. The terms “hemp extract” and “CBD oil” are synonymous and are used interchangeably herein. Hemp extract can be obtained by any method known in the art. For example, hemp extract can be obtained by supercritical (or subcritical) CO2 extraction using carbon dioxide under high pressure and low temperature to isolate, preserve, and maintain the purity of the hemp extract. In some embodiments, hemp extract is obtained from supercritical CO2 extraction. For example, supercritical CO2 extraction can be carried out as described in U.S. Patent No. 8,895,078, which is incorporated herein by reference in whole. Alternatively, solvents such as petroleum ether, ethanol, methanol, butanol, acetone, dry ice, or olive oil can be used to obtain hemp extract by passive extraction with stirring at room temperature (ambient temperature), heated to a temperature above room temperature, or used under reflux, as is known in the art. In another embodiment, a hemp extract derived from butanol extract is used as a starting material for the method disclosed herein.

[0080] Suitable methods for measuring the cannabinoid and terpene content in hemp extracts are known in the art. In one embodiment, the cannabinoid content is determined using liquid chromatography (LC-MS) with mass spectrometry detection. In another embodiment, the terpene content is determined using gas chromatography-focal-ionization (GC-FID) analysis with headspace flame ionization detection.

[0081] As used herein, the term “flavoring” refers to an ingredient added to a composition to impart a particular flavor, aroma, or other sensory stimulating properties.

[0082] As used herein, the term “oil” refers to a nonpolar, viscous liquid that is both hydrophobic and lipophilic. Oils may be isolated from animals, plants, or petrochemical products.

[0083] As used herein, the term “chewable” refers to a product or part thereof that possesses rheological properties, other texture properties, and sensory stimulation properties that tend to encourage a target animal to chew the article. Generally speaking, a chewable matrix would exhibit sufficient ductility to be at least slightly malleable when bitten by a target animal, and sufficient palatability that would deter the target animal from chewing the matrix multiple times due to its taste. In contrast, “chewable” does not simply mean that an article can be chewed by an animal (i.e., it does not simply mean that a portion of the article fits sufficiently into the animal’s mouth and that the animal’s teeth can bite into this portion).

[0084] When used herein, the "maximum serum concentration level" of a substance refers to the highest level of the substance found in a plasma sample after a single dose.

[0085] As used herein, the term “cold extrusion” refers to a process of producing edible food products that includes several unit operations such as mixing, kneading, shearing, shaping, and forming (all of which are performed at or near ambient temperature).

[0086] As used herein, the term “psychotropic effect” refers to an alteration of brain function that results in an alteration of perception, mood, consciousness, or behavior.

[0087] Pharmaceutical composition In one embodiment, the herein provides a pharmaceutical composition comprising a hemp extract and a carrier, wherein the hemp extract is Cannabidiol; Cannabidiolic acid; Cannabigerol acid; Δ9-tetrahydrocannabinol; and Cannabide chromium It is a pharmaceutical composition containing [the specified ingredient].

[0088] 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 cannabidiol to cannabidiolic acid is about 0.1:1 to about 1:0.1. In another embodiment, the ratio of cannabidiol to cannabidiolic 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 cannabidiol to cannabidiolic acid is about 0.6:1 to about 1:0.6. In yet another embodiment, the ratio of cannabidiol to cannabidiolic acid is about 1:1.

[0089] In one embodiment, the concentration of Δ9-tetrahydrocannabinol is insufficient to produce a psychoactive 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 Δ9-tetrahydrocannabinol to other cannabinoids is approximately 1:20.

[0090] In one embodiment, the concentration of Δ9-tetrahydrocannabinol is less than approximately 2 mg / mL. In another embodiment, the concentration of Δ9-tetrahydrocannabinol is less than approximately 1.5 mg / mL. In yet another embodiment, the concentration of Δ9-tetrahydrocannabinol is less than approximately 1 mg / mL. In yet another embodiment, the concentration of Δ9-tetrahydrocannabinol is less than approximately 0.9 mg / mL. In yet another embodiment, the concentration of Δ9-tetrahydrocannabinol is less than approximately 0.8 mg / mL. In one embodiment, the concentration of Δ9-tetrahydrocannabinol is less than approximately 0.7 mg / mL. In another embodiment, the concentration of Δ9-tetrahydrocannabinol is less than approximately 0.6 mg / mL. In yet another embodiment, the concentration of Δ9-tetrahydrocannabinol is less than approximately 0.5 mg / mL. In yet another embodiment, the concentration of Δ9-tetrahydrocannabinol is less than approximately 0.4 mg / mL. In one embodiment, the concentration of Δ9-tetrahydrocannabinol is less than approximately 0.3 mg / mL. In another embodiment, the concentration of Δ9-tetrahydrocannabinol is less than approximately 0.2 mg / mL. In yet another embodiment, the concentration of Δ9-tetrahydrocannabinol is less than approximately 0.1 mg / mL. In yet another embodiment, the concentration of Δ9-tetrahydrocannabinol is about 0 mg / mL.

[0091] In one embodiment, this hemp extract is Approximately 0.1-20 mg / mL of cannabidiol; Cannabidiolic acid at approximately 0.1-20 mg / mL; Cannabigerol acid at approximately 0.01-0.5 mg / mL; Approximately 0.01-0.5 mg / mL of Δ9-tetrahydrocannabinol; and Approximately 0.01-0.5 mg / mL of cannabichromene Includes.

[0092] In another embodiment, this hemp extract is Approximately 1-10 mg / mL of cannabidiol; Cannabidiolic acid at approximately 1-10 mg / mL; Cannabigerol acid at approximately 0.05-0.2 mg / mL; Approximately 0.1-0.3 mg / mL of Δ9-tetrahydrocannabinol; and Approximately 0.1-0.4 mg / mL of cannabichromene Includes.

[0093] In yet another embodiment, this hemp extract is, Approximately 5 mg / mL of cannabidiol; Approximately 5 mg / mL of cannabidiolic acid; Approximately 0.11 mg / mL of cannabigerol acid; Approximately 0.25 mg / mL of Δ9-tetrahydrocannabinol; and Approximately 0.27 mg / mL of cannabichromene Includes.

[0094] In one embodiment, provided herein is a pharmaceutical composition comprising a hemp extract and a carrier, wherein the hemp extract is α-pinene; β-myrcene; β-pinene; δ-limonene; Linalool; β-caryophyllene; α-humulene; Nerolidol 2; Guaiol; Caryophyllene oxide; and α-Bisabolol It is a pharmaceutical composition containing [the specified ingredient].

[0095] In another embodiment, this hemp extract is 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; Approximately 0.04-0.08% caryophyllene oxide; and Approximately 0.01-0.04% α-bisabolol Includes.

[0096] In another embodiment, this hemp extract is Approximately 0.07-0.30% α-pinene; Approximately 0.10-0.60% β-myrcene; Approximately 0.02-0.20% β-pinene; Approximately 0.03-0.20% δ-limonene: Approximately 0.01-0.08% linalool; Approximately 0.03-0.09% β-caryophyllene; Approximately 0.01-0.06% α-humulene; Approximately 0.02-0.09% nerolidol 2; and Approximately 0.01-0.06% guaiol Includes.

[0097] In another embodiment, this hemp extract is Approximately 0.01-0.50% α-pinene; Approximately 0.01-0.90% β-myrcene; Approximately 0.01-0.50% β-pinene; Approximately 0.01-0.50% δ-limonene: Approximately 0.01-0.50% linalool; Approximately 0.01-0.50% β-caryophyllene; Approximately 0.01-0.50% α-humulene; Approximately 0.01-0.50% nerolidol 2; Approximately 0.01-0.50% guaiol; Approximately 0.01-0.50% caryophyllene oxide; and Approximately 0.01-0.50% α-bisabolol Includes.

[0098] In another embodiment, this hemp extract is Camphen; β-Ocimene; Eucalyptol; Isoplegol; and / or Nerolidol 1 It also includes.

[0099] In another embodiment, this hemp extract is Approximately 0.02% camphene; Approximately 0.02-0.03% β-ocimene; Approximately 0.02-0.05% eucalyptol; Approximately 0.02% isopuregol; and / or Approximately 0.02-0.04% nerolidol Includes.

[0100] In another embodiment, this hemp extract is Approximately 0.01-0.04% camphene; Approximately 0.01-0.05% β-ocimene; Approximately 0.01-0.07% eucalyptol; Approximately 0.01-0.04% isopuregol; and / or Approximately 0.01-0.05% nerolidol Includes.

[0101] In another embodiment, this hemp extract is Approximately 0.01-0.50% camphene; Approximately 0.01-0.50% β-ocimene; Approximately 0.01-0.50% eucalyptol; Approximately 0.01-0.50% isopuregol; and / or Approximately 0.01-0.50% nerolidol Includes.

[0102] In one embodiment, this hemp extract does not contain terpenes.

[0103] In one embodiment, the hemp extract contains one or more of the following: α-pinene, β-myrcene, β-pinene, δ-limonene, linalool, β-caryophyllene, α-humulene, nerolidol 2, guaiol, caryophyllene oxide, α-bisabolol, camphene, β-ocimene, eucalyptol, isopulegol, and nerolidol 1.

[0104] In one embodiment, the hemp extract contains two or more of the following: α-pinene, β-myrcene, β-pinene, δ-limonene, linalool, β-caryophyllene, α-humulene, nerolidol 2, guaiol, caryophyllene oxide, α-bisabolol, camphene, β-ocimene, eucalyptol, isopulegol, and nerolidol 1.

[0105] In one embodiment, the hemp extract contains three or more of the following: α-pinene, β-myrcene, β-pinene, δ-limonene, linalool, β-caryophyllene, α-humulene, nerolidol 2, guaiol, caryophyllene oxide, α-bisabolol, camphene, β-ocimene, eucalyptol, isopulegol, and nerolidol 1.

[0106] In one embodiment, the hemp extract contains four or more of the following: α-pinene, β-myrcene, β-pinene, δ-limonene, linalool, β-caryophyllene, α-humulene, nerolidol 2, guaiol, caryophyllene oxide, α-bisabolol, camphene, β-ocimene, eucalyptol, isopulegol, and nerolidol 1.

[0107] In one embodiment, the hemp extract contains five or more of the following: α-pinene, β-myrcene, β-pinene, δ-limonene, linalool, β-caryophyllene, α-humulene, nerolidol 2, guaiol, caryophyllene oxide, α-bisabolol, camphene, β-ocimene, eucalyptol, isopulegol, and nerolidol 1.

[0108] In one embodiment, the hemp extract contains six or more of the following: α-pinene, β-myrcene, β-pinene, δ-limonene, linalool, β-caryophyllene, α-humulene, nerolidol 2, guaiol, caryophyllene oxide, α-bisabolol, camphene, β-ocimene, eucalyptol, isopulegol, and nerolidol 1.

[0109] In one embodiment, the hemp extract contains seven or more of the following: α-pinene, β-myrcene, β-pinene, δ-limonene, linalool, β-caryophyllene, α-humulene, nerolidol 2, guaiol, caryophyllene oxide, α-bisabolol, camphene, β-ocimene, eucalyptol, isopulegol, and nerolidol 1.

[0110] In one embodiment, the hemp extract contains eight or more of the following: α-pinene, β-myrcene, β-pinene, δ-limonene, linalool, β-caryophyllene, α-humulene, nerolidol 2, guaiol, caryophyllene oxide, α-bisabolol, camphene, β-ocimene, eucalyptol, isopulegol, and nerolidol 1.

[0111] In one embodiment, the hemp extract contains nine or more of the following: α-pinene, β-myrcene, β-pinene, δ-limonene, linalool, β-caryophyllene, α-humulene, nerolidol 2, guaiol, caryophyllene oxide, α-bisabolol, camphene, β-ocimene, eucalyptol, isopulegol, and nerolidol 1.

[0112] In one embodiment, the hemp extract contains 10 or more of the following: α-pinene, β-myrcene, β-pinene, δ-limonene, linalool, β-caryophyllene, α-humulene, nerolidol 2, guaiol, caryophyllene oxide, α-bisabolol, camphene, β-ocimene, eucalyptol, isopulegol, and nerolidol 1.

[0113] In one embodiment, the hemp extract contains 11 or more of the following: α-pinene, β-myrcene, β-pinene, δ-limonene, linalool, β-caryophyllene, α-humulene, nerolidol 2, guaiol, caryophyllene oxide, α-bisabolol, camphene, β-ocimene, eucalyptol, isopulegol, and nerolidol 1.

[0114] In one embodiment, the hemp extract contains 12 or more of the following: α-pinene, β-myrcene, β-pinene, δ-limonene, linalool, β-caryophyllene, α-humulene, nerolidol 2, guaiol, caryophyllene oxide, α-bisabolol, camphene, β-ocimene, eucalyptol, isopulegol, and nerolidol 1.

[0115] In one embodiment, the hemp extract contains 13 or more of the following: α-pinene, β-myrcene, β-pinene, δ-limonene, linalool, β-caryophyllene, α-humulene, nerolidol 2, guaiol, caryophyllene oxide, α-bisabolol, camphene, β-ocimene, eucalyptol, isopulegol, and nerolidol 1.

[0116] In one embodiment, the hemp extract contains 14 or more of the following: α-pinene, β-myrcene, β-pinene, δ-limonene, linalool, β-caryophyllene, α-humulene, nerolidol 2, guaiol, caryophyllene oxide, α-bisabolol, camphene, β-ocimene, eucalyptol, isopulegol, and nerolidol 1.

[0117] In one embodiment, the hemp extract contains 15 or more of the following: α-pinene, β-myrcene, β-pinene, δ-limonene, linalool, β-caryophyllene, α-humulene, nerolidol 2, guaiol, caryophyllene oxide, α-bisabolol, camphene, β-ocimene, eucalyptol, isopulegol, and nerolidol 1.

[0118] In one embodiment, the hemp extract contains α-pinene, β-myrcene, β-pinene, δ-limonene, linalool, β-caryophyllene, α-humulene, nerolidol 2, guaiol, caryophyllene oxide, α-bisabolol, camphene, β-ocimene, eucalyptol, isopulegol, and nerolidol 1.

[0119] In one embodiment, the composition is formulated as an 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, and grape seed oil. In yet another embodiment, the carrier is grape seed oil.

[0120] In one embodiment, this dosage form contains nepetalactone.

[0121] In one embodiment, this dosage form contains taurine.

[0122] In one embodiment, the pharmaceutical composition is formulated as a sublingual spray. In yet another embodiment, the pharmaceutical composition is formulated as a water or alcohol-soluble solution, gel, or cream for transdermal application. In one embodiment, the dosage form is formulated as a gel for buccal or mucosal 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 chewable tablet.

[0123] In one embodiment, the composition is formulated as an orally administered chewing agent. In another embodiment, the chewing agent is manufactured using cold extrusion. In another embodiment, the weight of the chewing agent is about 0.5 to 10 g. In yet another embodiment, the weight of the chewing agent is about 4 g, about 6 g, about 9 g, or 10 g. In yet another embodiment, the weight of the chewing agent is about 0.5 g. In one embodiment, the weight of the chewing agent is about 1 g. In another embodiment, the weight of the chewing agent is about 1.5 g. In yet another embodiment, the weight of the chewing agent is about 2 g. In yet another embodiment, the weight of the chewing agent is about 3 g. In one embodiment, the weight of the chewing agent is about 4 g. In another embodiment, the weight of the chewing agent is about 5 g. In yet another embodiment, the weight of this chewing agent is approximately 6 g. In yet another embodiment, the weight of this chewing agent is approximately 7 g. In one embodiment, the weight of this chewing agent is approximately 8 g. In another embodiment, the weight of this chewing agent is approximately 9 g. In yet another embodiment, the weight of this chewing agent is approximately 10 g.

[0124] In one embodiment, 4g of chewing agent is Cannabidiol approximately 7 mg; Cannabidiolic acid, approximately 6 mg; Cannabigerol acid, approximately 0.12 mg; Δ9-tetrahydrocannabinol approximately 0.32 mg; and Cannabichromene approx. 0.36 mg Includes.

[0125] The pharmaceutical compositions of this disclosure may be manufactured by processes known in the art, for example, by conventional mixing, dissolving, granulation, grinding, pulverization, sugar-coated tablet manufacturing, wet grinding, emulsification, encapsulation, encapsulation, or freeze-drying processes.

[0126] Therefore, compositions for use according to this disclosure may be formulated in a conventional manner using one or more pharmaceutically acceptable carriers, including additives and auxiliaries, thereby facilitating the processing of the active compound into pharmaceutically usable preparations. The appropriate formulation depends on the selected route of administration.

[0127] Dosage form In some embodiments, what is provided herein is Cannabidiol; Cannabidiolic acid; Cannabigerol acid; Δ9-tetrahydrocannabinol; Cannabatic chromium; and One or more pharmaceutically acceptable additives, fragrances, surfactants, and adjuvants It is a dosage form that contains [ingredient].

[0128] In one embodiment, the ratio of cannabidiol to cannabidiolic 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 cannabidiol to cannabidiolic acid is about 0.1:1 to about 1:0.1. In another embodiment, the ratio of cannabidiol to cannabidiolic 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 cannabidiol to cannabidiolic acid is about 0.6:1 to about 1:0.6. In yet another embodiment, the ratio of cannabidiol to cannabidiolic acid is about 1:1.

[0129] In one embodiment, the concentration of Δ9-tetrahydrocannabinol is insufficient to produce a psychoactive 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 Δ9-tetrahydrocannabinol to other cannabinoids is approximately 1:20.

[0130] In one embodiment, the concentration of Δ9-tetrahydrocannabinol is less than approximately 2 mg / mL. In another embodiment, the concentration of Δ9-tetrahydrocannabinol is less than approximately 1.5 mg / mL. In yet another embodiment, the concentration of Δ9-tetrahydrocannabinol is less than approximately 1 mg / mL. In yet another embodiment, the concentration of Δ9-tetrahydrocannabinol is less than approximately 0.9 mg / mL. In yet another embodiment, the concentration of Δ9-tetrahydrocannabinol is less than approximately 0.8 mg / mL. In one embodiment, the concentration of Δ9-tetrahydrocannabinol is less than approximately 0.7 mg / mL. In another embodiment, the concentration of Δ9-tetrahydrocannabinol is less than approximately 0.6 mg / mL. In yet another embodiment, the concentration of Δ9-tetrahydrocannabinol is less than approximately 0.5 mg / mL. In yet another embodiment, the concentration of Δ9-tetrahydrocannabinol is less than approximately 0.4 mg / mL. In one embodiment, the concentration of Δ9-tetrahydrocannabinol is less than approximately 0.3 mg / mL. In another embodiment, the concentration of Δ9-tetrahydrocannabinol is less than approximately 0.2 mg / mL. In yet another embodiment, the concentration of Δ9-tetrahydrocannabinol is less than approximately 0.1 mg / mL. In yet another embodiment, the concentration of Δ9-tetrahydrocannabinol is about 0 mg / mL.

[0131] In one embodiment, this dosage form is Approximately 0.1-20 mg / mL of cannabidiol; Cannabidiolic acid at approximately 0.1-20 mg / mL; Cannabigerol acid at approximately 0.01-0.5 mg / mL; Approximately 0.01-0.5 mg / mL of Δ9-tetrahydrocannabinol; and Approximately 0.01-0.5 mg / mL of cannabichromene Includes.

[0132] In another embodiment, this dosage form is Approximately 1-10 mg / mL of cannabidiol; Cannabidiolic acid at approximately 1-10 mg / mL; About 0.05 to 0.2 mg / mL of cannabigerolic acid; About 0.1 to 0.3 mg / mL of Δ9-tetrahydrocannabinol; and about 0.1 to 0.4 mg / mL of cannabichromene contained.

[0133] In yet another embodiment, this dosage form is about 5 mg / mL of cannabidiol; about 5 mg / mL of cannabidiolic acid; about 0.11 mg / mL of cannabigerolic acid; about 0.25 mg / mL of Δ9-tetrahydrocannabinol; and about 0.27 mg / mL of cannabichromene contained.

[0134] In some embodiments, this dosage form is α-pinene; β-myrcene; β-pinene; δ-limonene; linalool; β-caryophyllene; α-humulene; nerolidol 2; guaiol; A caryophyllene oxide; and α-bisabolol contained.

[0135] In another embodiment, this dosage form is about 0.09 to 0.13% of α-pinene; about 0.23 to 0.44% of β-myrcene; about 0.04 to 0.09% of β-pinene; about 0.05 to 0.09% of δ-limonene: about 0.03 to 0.06% of linalool; about 0.04 to 0.07% of β-caryophyllene; about 0.02 to 0.04% of α-humulene; Approximately 0.04-0.07% nerolidol 2; Approximately 0.02-0.04% guaiol; Approximately 0.04-0.08% caryophyllene oxide; and Approximately 0.01-0.04% α-bisabolol Includes.

[0136] In another embodiment, this dosage form is Approximately 0.07-0.30% α-pinene; Approximately 0.10-0.60% β-myrcene; Approximately 0.02-0.20% β-pinene; Approximately 0.03-0.20% δ-limonene: Approximately 0.01-0.08% linalool; Approximately 0.03-0.09% β-caryophyllene; Approximately 0.01-0.06% α-humulene; Approximately 0.02-0.09% nerolidol 2; and Approximately 0.01-0.06% guaiol Includes.

[0137] In another embodiment, this dosage form is Approximately 0.01-0.50% α-pinene; Approximately 0.01-0.90% β-myrcene; Approximately 0.01-0.50% β-pinene; Approximately 0.01-0.50% δ-limonene: Approximately 0.01-0.50% linalool; Approximately 0.01-0.50% β-caryophyllene; Approximately 0.01-0.50% α-humulene; Approximately 0.01-0.50% nerolidol 2; Approximately 0.01-0.50% guaiol; Approximately 0.01-0.50% caryophyllene oxide; and Approximately 0.01-0.50% α-bisabolol Includes.

[0138] In another embodiment, this dosage form contains camphor; β-ocimene; eucalyptol; isopulegol; and / or nerolidol 1 and further contains.

[0139] In another embodiment, this dosage form contains about 0.02% camphor; contains about 0.02 - 0.03% β-ocimene; contains about 0.02 - 0.05% eucalyptol; [[ID= / / ]] contains about 0.02% isopulegol; and / or contains about 0.02 - 0.04% nerolidol 1 and contains.

[0140] In another embodiment, this dosage form contains about 0.01 - 0.04% camphor; contains about 0.01 - 0.05% β-ocimene; contains about 0.01 - 0.07% eucalyptol; contains about 0.01 - 0.04% isopulegol; and / or contains about 0.01 - 0.05% nerolidol 1 and contains.

[0141] In another embodiment, this dosage form contains about 0.01 - 0.50% camphor; contains about 0.01 - 0.50% β-ocimene; contains about 0.01 - 0.50% eucalyptol; contains about 0.01 - 0.50% isopulegol; and / or contains about 0.01 - 0.50% nerolidol 1 and contains.

[0142] In one embodiment, this asafoetida extract does not contain terpenes.

[0143] In one embodiment, the hemp extract contains one or more of the following: α-pinene, β-myrcene, β-pinene, δ-limonene, linalool, β-caryophyllene, α-humulene, nerolidol 2, guaiol, caryophyllene oxide, α-bisabolol, camphene, β-ocimene, eucalyptol, isopulegol, and nerolidol 1.

[0144] In one embodiment, the hemp extract contains two or more of the following: α-pinene, β-myrcene, β-pinene, δ-limonene, linalool, β-caryophyllene, α-humulene, nerolidol 2, guaiol, caryophyllene oxide, α-bisabolol, camphene, β-ocimene, eucalyptol, isopulegol, and nerolidol 1.

[0145] In one embodiment, the hemp extract contains three or more of the following: α-pinene, β-myrcene, β-pinene, δ-limonene, linalool, β-caryophyllene, α-humulene, nerolidol 2, guaiol, caryophyllene oxide, α-bisabolol, camphene, β-ocimene, eucalyptol, isopulegol, and nerolidol 1.

[0146] In one embodiment, the hemp extract contains four or more of the following: α-pinene, β-myrcene, β-pinene, δ-limonene, linalool, β-caryophyllene, α-humulene, nerolidol 2, guaiol, caryophyllene oxide, α-bisabolol, camphene, β-ocimene, eucalyptol, isopulegol, and nerolidol 1.

[0147] In one embodiment, this dosage form contains five or more of the following: α-pinene, β-myrcene, β-pinene, δ-limonene, linalool, β-caryophyllene, α-humulene, nerolidol 2, guaiol, caryophyllene oxide, α-bisabolol, camphene, β-ocimene, eucalyptol, isopulegol, and nerolidol 1.

[0148] In one embodiment, this dosage form contains six or more of the following: α-pinene, β-myrcene, β-pinene, δ-limonene, linalool, β-caryophyllene, α-humulene, nerolidol 2, guaiol, caryophyllene oxide, α-bisabolol, camphene, β-ocimene, eucalyptol, isopulegol, and nerolidol 1.

[0149] In one embodiment, this dosage form contains seven or more of the following: α-pinene, β-myrcene, β-pinene, δ-limonene, linalool, β-caryophyllene, α-humulene, nerolidol 2, guaiol, caryophyllene oxide, α-bisabolol, camphene, β-ocimene, eucalyptol, isopulegol, and nerolidol 1.

[0150] In one embodiment, this dosage form contains eight or more of the following: α-pinene, β-myrcene, β-pinene, δ-limonene, linalool, β-caryophyllene, α-humulene, nerolidol 2, guaiol, caryophyllene oxide, α-bisabolol, camphene, β-ocimene, eucalyptol, isopulegol, and nerolidol 1.

[0151] In one embodiment, this dosage form contains nine or more of the following: α-pinene, β-myrcene, β-pinene, δ-limonene, linalool, β-caryophyllene, α-humulene, nerolidol 2, guaiol, caryophyllene oxide, α-bisabolol, camphene, β-ocimene, eucalyptol, isopulegol, and nerolidol 1.

[0152] In one embodiment, this dosage form contains 10 or more of the following: α-pinene, β-myrcene, β-pinene, δ-limonene, linalool, β-caryophyllene, α-humulene, nerolidol 2, guaiol, caryophyllene oxide, α-bisabolol, camphene, β-ocimene, eucalyptol, isopulegol, and nerolidol 1.

[0153] In one embodiment, this dosage form contains 11 or more of the following: α-pinene, β-myrcene, β-pinene, δ-limonene, linalool, β-caryophyllene, α-humulene, nerolidol 2, guaiol, caryophyllene oxide, α-bisabolol, camphene, β-ocimene, eucalyptol, isopulegol, and nerolidol 1.

[0154] In one embodiment, this dosage form contains 12 or more of the following: α-pinene, β-myrcene, β-pinene, δ-limonene, linalool, β-caryophyllene, α-humulene, nerolidol 2, guaiol, caryophyllene oxide, α-bisabolol, camphene, β-ocimene, eucalyptol, isopulegol, and nerolidol 1.

[0155] In one embodiment, this dosage form contains 13 or more of the following: α-pinene, β-myrcene, β-pinene, δ-limonene, linalool, β-caryophyllene, α-humulene, nerolidol 2, guaiol, caryophyllene oxide, α-bisabolol, camphene, β-ocimene, eucalyptol, isopulegol, and nerolidol 1.

[0156] In one embodiment, this dosage form contains 14 or more of the following: α-pinene, β-myrcene, β-pinene, δ-limonene, linalool, β-caryophyllene, α-humulene, nerolidol 2, guaiol, caryophyllene oxide, α-bisabolol, camphene, β-ocimene, eucalyptol, isopulegol, and nerolidol 1.

[0157] In one embodiment, this dosage form contains 15 or more of the following: α-pinene, β-myrcene, β-pinene, δ-limonene, linalool, β-caryophyllene, α-humulene, nerolidol 2, guaiol, caryophyllene oxide, α-bisabolol, camphene, β-ocimene, eucalyptol, isopulegol, and nerolidol 1.

[0158] In one embodiment, this dosage form comprises α-pinene, β-myrcene, β-pinene, δ-limonene, linalool, β-caryophyllene, α-humulene, nerolidol 2, guaiol, caryophyllene oxide, α-bisabolol, camphene, β-ocimene, eucalyptol, isopulegol, and nerolidol 1.

[0159] In one embodiment, the flavoring agent is selected from the group consisting of catnip oil, peppermint oil, mango extract, beef, poultry meat, and seafood.

[0160] In one embodiment, this dosage form is formulated as a sublingual spray. In yet another embodiment, this dosage form is formulated as a water or alcohol-soluble solution, gel, or cream for transdermal application. In one embodiment, this dosage form is formulated as a powder. In one embodiment, this dosage form is formulated as a gel for buccal or mucosal administration. In another embodiment, this dosage form is formulated as a solution for subcutaneous injection. In yet another embodiment, this dosage form is formulated as a tablet. In yet another embodiment, this dosage form is formulated as a capsule. In one embodiment, this dosage form is formulated as a hard chewable tablet.

[0161] In some embodiments, the present invention involves infusing a hemp extract into an edible product. In another embodiment, the edible product is an extruded food, a baked food, a nut butter, a spread, a pelletized feed, or a processed food. In yet another embodiment, the edible product is pet food. In yet another embodiment, the pet food is in a dry, well-storable form (e.g., dried meal, dried fish, dried dairy products, fish meal, fish flour, grains, wheat flour, carbohydrates, dried fruit, etc.). In yet another embodiment, the pet food is moist or slightly moist. In yet another embodiment, the pet food contains food additives or nutritional supplements such as vitamins, minerals, pharmaceuticals, etc., including, for example, chemicals, enzymes, etc., that can remove plaque or tartar from the teeth of animals.

[0162] In one embodiment, the hemp extract is administered together with catnip oil. In another embodiment, any of the dosage forms described may also contain catnip.

[0163] In another embodiment, hemp extract is administered using a nebulizer. In another embodiment, the nebulizer delivery device and system can efficiently and effectively administer one or more sprayed drugs to an animal. In another embodiment, the nebulizer system can be easily used on an animal without moving it from its natural environment. In another embodiment, the nebulizer delivery device and system allows for easy treatment of an animal daily or multiple times a day without causing excessive stress or requiring large resources. In another embodiment, the nebulizer delivery device and system can be used on animals with varying levels of training.

[0164] In one embodiment, the hemp extract is administered using a diffuser. This diffuser can be any device that disperses the hemp extract into the air. The hemp extract can be dispersed by any means, for example, by natural convection, by forced convection, by heating a wick or pad that holds the hemp extract, by using a pump, or by a fan.

[0165] In one embodiment, hemp extract is administered via a pet collar. This pet collar may include a belt having a buckle on one side and a free end on the other, and having attachment means for securing the collar in a closed loop configuration (e.g., an opening positioned longitudinally within the central portion of the belt, or a quick-release clasp mechanism). This pet collar may be manufactured from a variety of materials, such as nylon, polyester leather, or other suitable materials. The belt material may be treated with a waterproofing compound. Reflective fibers may be woven into a nylon or polyester belt to enhance the visibility of the pet collar at night. In one embodiment, the collar is infused with hemp extract.

[0166] Chewing agent In one embodiment, this dosage form is formulated as an orally administered chewing agent. In another embodiment, this chewing agent is manufactured using cold extrusion. In another embodiment, the weight of this chewing agent is about 0.5 to 10 g. In yet another embodiment, the weight of this chewing agent is about 4 g, about 6 g, about 9 g, or about 10 g. In yet another embodiment, the weight of this chewing agent is about 0.5 g. In one embodiment, the weight of this chewing agent is about 1 g. In another embodiment, the weight of this chewing agent is about 1.5 g. In yet another embodiment, the weight of this chewing agent is about 2 g. In yet another embodiment, the weight of this chewing agent is about 3 g. In one embodiment, the weight of this chewing agent is about 4 g. In another embodiment, the weight of this chewing agent is approximately 5 g. In yet another embodiment, the weight of this chewing agent is approximately 6 g. In yet another embodiment, the weight of this chewing agent is approximately 7 g. In one embodiment, the weight of this chewing agent is approximately 8 g. In another embodiment, the weight of this chewing agent is approximately 9 g. In yet another embodiment, the weight of this chewing agent is approximately 10 g.

[0167] In one embodiment, this dosage form is Brewer's yeast; Gum arabic; Guar gum; flavoring agents; Verdilox; Previon; Hemp extract; Glycerin; Sunflower lecithin; and water Includes.

[0168] In another embodiment, this dosage form is Approximately 25-35% brewer's yeast; Approximately 1-10% gum arabic; Approximately 0.1-4% guar gum; Approximately 10-20% fragrance; Approximately 0.01-1% Verdilox; Previon of approximately 0.1-2%; Approximately 1-10% hemp extract; Approximately 10-20% glycerin; Approximately 1-10% sunflower lecithin; and Approximately 1-10% water Includes.

[0169] In another embodiment, this dosage form is Approximately 29-33% brewer's yeast; Approximately 3-6% gum arabic; Approximately 0.5-2% guar gum; Approximately 12-16% fragrance; Approximately 0.01-0.1% Verdilox; Approximately 0.5-1.5% Previon; Approximately 3-6% hemp extract; Approximately 13-17% glycerin; Approximately 3-7% sunflower lecithin; and Approximately 3-7% water Includes.

[0170] In yet another embodiment, this dosage form is Approximately 30% brewer's yeast; Approximately 4.7% gum arabic; Approximately 0.9% guar gum; Approximately 14.2% fragrance; Approximately 0.05% Verdilox; Approximately 0.9% Previon; Approximately 4.7% hemp extract; Approximately 15.1% glycerin; Approximately 5.7% sunflower lecithin; and Approximately 5.7% water Includes.

[0171] In one embodiment, this dosage form is Glucosamine HCl; Brewer's yeast; Gum arabic; Guar gum; flavoring agents; Verdilox; Previon; Hemp extract; Glycerin; Sunflower lecithin; and water Includes.

[0172] In another embodiment, this dosage form is 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% fragrance; Approximately 0.01-1% Verdilox; Previon of approximately 0.1-2%; Approximately 1-10% hemp extract; Approximately 10-20% glycerin; Approximately 1-10% sunflower lecithin; and Approximately 1-10% water Includes.

[0173] In another embodiment, this dosage form is 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% fragrance; Approximately 0.01-0.1% Verdilox; Approximately 0.5-1.5% Previon; Approximately 3-6% hemp extract; Approximately 13-17% glycerin; Approximately 3-7% sunflower lecithin; and Approximately 3-7% water Includes.

[0174] In yet another embodiment, this dosage form is Approximately 15.6% glucosamine HCl; Approximately 30% brewer's yeast; Approximately 4.7% gum arabic; Approximately 0.9% guar gum; Approximately 14.2% fragrance; Approximately 0.05% Verdilox; Approximately 0.9% Previon; Approximately 4.7% hemp extract; Approximately 15.1% glycerin; Approximately 5.7% sunflower lecithin; and Approximately 5.7% water Includes.

[0175] In one embodiment, this dosage form is Glucosamine HCl; Chondroitin sulfate (76%); Brewer's yeast; Gum arabic; Guar gum; flavoring agents; Verdilox; Previon; Hemp extract; Glycerin; Sunflower lecithin; and water Includes.

[0176] In another embodiment, this dosage form is 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% fragrance; Approximately 0.01-1% Verdilox; Previon of approximately 0.1-2%; Approximately 1-10% hemp extract; Approximately 10-20% glycerin; Approximately 1-10% sunflower lecithin; and Approximately 1-10% water Includes.

[0177] In another embodiment, this dosage form is 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% fragrance; Approximately 0.01-0.1% Verdilox; Approximately 0.5-1.5% Previon; Approximately 3-6% hemp extract; Approximately 13-17% glycerin; Approximately 3-7% sunflower lecithin; and Approximately 3-7% water Includes.

[0178] In yet another embodiment, this dosage form is 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% fragrance; Approximately 0.05% Verdilox; Approximately 0.9% Previon; Approximately 4.7% hemp extract; Approximately 15.1% glycerin; Approximately 5.7% sunflower lecithin; and Approximately 5.7% water Includes.

[0179] In another embodiment, this dosage form is Hyaluronic acid; Brewer's yeast; Gum arabic; Guar gum; flavoring agents; Verdilox; Previon; Hemp extract; Glycerin; Sunflower lecithin; and water Includes.

[0180] In another embodiment, this dosage form is Approximately 0.01-3% hyaluronic acid; Approximately 25-35% brewer's yeast; Approximately 1-10% gum arabic; Approximately 0.1-5% guar gum; Approximately 10-20% fragrance; Approximately 0.01-1% Verdilox; Prevation of approximately 0.1-3%; Approximately 1-10% hemp extract; Approximately 10-20% glycerin; Approximately 1-10% sunflower lecithin; and Approximately 1-10% water Includes.

[0181] In another embodiment, this dosage form is Approximately 0.01-0.1% hyaluronic acid; Approximately 29-33% brewer's yeast; Approximately 3-6% gum arabic; Approximately 0.5-2% guar gum; Approximately 12-16% fragrance; Approximately 0.01-1% Verdilox; Approximately 0.5-1.5% Previon; Approximately 3-6% hemp extract; Approximately 13-17% glycerin; Approximately 3-7% sunflower lecithin; and Approximately 3-7% water Includes.

[0182] In yet another embodiment, this dosage form is Approximately 0.1% hyaluronic acid; Approximately 30.6% brewer's yeast; Approximately 4.8% gum arabic; Approximately 0.97% guar gum; Approximately 14.5% fragrance; Approximately 0.05% Verdilox; Approximately 0.97% Previon; Approximately 4.8% hemp extract; Approximately 15.5% glycerin; Approximately 5.8% sunflower lecithin; and Approximately 5.8% water Includes.

[0183] In another embodiment, this dosage form is Glucosamine HCl; Hyaluronic acid; Brewer's yeast; Gum arabic; Guar gum; flavoring agents; Verdilox; Previon; Hemp extract; Glycerin; Sunflower lecithin; and water Includes.

[0184] In another embodiment, this dosage form is Approximately 10-20% glucosamine HCl; Approximately 0.01-3% hyaluronic acid; Approximately 25-35% brewer's yeast; Approximately 1-10% gum arabic; Approximately 0.1-5% guar gum; Approximately 10-20% fragrance; Approximately 0.01-1% Verdilox; Prevation of approximately 0.1-3%; Approximately 1-10% hemp extract; Approximately 10-20% glycerin; Approximately 1-10% sunflower lecithin; and Approximately 1-10% water Includes.

[0185] In another embodiment, this dosage form is Approximately 12-17% glucosamine HCl; Approximately 0.01-1% hyaluronic acid; Approximately 29-33% brewer's yeast; Approximately 3-6% gum arabic; Approximately 0.5-2% guar gum; Approximately 12-16% fragrance; Approximately 0.01-0.1% Verdilox; Approximately 0.5-1.5% Previon; Approximately 3-6% hemp extract; Approximately 13-17% glycerin; Approximately 3-7% sunflower lecithin; and Approximately 3-7% water Includes.

[0186] In yet another embodiment, this dosage form is 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% fragrance; Approximately 0.05% Verdilox; Approximately 0.97% Previon; Approximately 4.8% hemp extract; Approximately 15.5% glycerin; Approximately 5.8% sunflower lecithin; and Approximately 5.8% water Includes.

[0187] In yet another embodiment, this dosage form is Hemp 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 Guar gum Includes.

[0188] In yet another embodiment, this dosage form is Approximately 5.0% hemp extract; Approximately 15.0% peanut butter; Approximately 12.5% ​​rice bran; Approximately 5.5% sweet potatoes; Approximately 8.0% dried molasses; Approximately 1% sorbic acid; Approximately 5.0% brewer's yeast; Approximately 6.0% sugar; Approximately 9.25% water; Approximately 13.0g of glycerin; Approximately 2.0% potato starch; Dehydrated peanut butter with approximately 1.0% moisture content; Approximately 2.0% rice starch; and Approximately 2.0% guar gum Includes.

[0189] In yet another embodiment, this dosage form is Approximately 5.0% hemp extract; Approximately 15.0% peanut butter; Approximately 13.0% rice bran; Approximately 6.0% sweet potatoes; Approximately 9.0% dried molasses; Approximately 1% sorbic acid; Approximately 5.0% brewer's yeast; Approximately 6.0% sugar; Approximately 9.5% water; Approximately 13.0g of glycerin; Approximately 4.0% potato starch; Dehydrated peanut butter with approximately 1.0% moisture content; Approximately 2.0% rice starch; and Approximately 2.0% guar gum Includes.

[0190] In yet another embodiment, this dosage form is Approximately 3.0-10.0% hemp extract; Approximately 10.0-20.0% peanut butter; Approximately 10.0-15.0% rice bran; Approximately 4.0-10.0% sweet potatoes; Approximately 6.0-13.0% dried molasses; Approximately 0.5-5.0% sorbic acid; Approximately 2.0-8.0% brewer's yeast; Approximately 3.0-8.0% sugar; Approximately 5.0-15.0% water; Approximately 8.0-18.0% glycerin; Approximately 1.0-8.0% potato starch; Dehydrated peanut butter with a concentration of approximately 0.5-5.0%; Approximately 1.0-5.0% rice starch; and Approximately 1.0-5.0% guar gum Includes.

[0191] In yet another embodiment, this dosage form is Approximately 5.0% hemp extract; Approximately 15.0% peanut butter; Approximately 12.5% ​​rice bran; Approximately 12.75% glucosamine HCl; Approximately 5.5% sweet potatoes; Approximately 8.0% dried molasses; Approximately 1% sorbic acid; Approximately 5.0% brewer's yeast; Approximately 6.0% sugar; Approximately 9.25% water; Approximately 13.0g of glycerin; Approximately 2.0% potato starch; Dehydrated peanut butter with approximately 1.0% moisture content; Approximately 2.0% rice starch; and Approximately 2.0% guar gum Includes.

[0192] In yet another embodiment, this dosage form is Approximately 5.0% hemp extract; Approximately 15.0% peanut butter; Approximately 13.0% rice bran; Approximately 8.5% glucosamine HCl; Approximately 6.0% sweet potatoes; Approximately 9.0% dried molasses; Approximately 1% sorbic acid; Approximately 5.0% brewer's yeast; Approximately 6.0% sugar; Approximately 9.5% water; Approximately 13.0g of glycerin; Approximately 4.0% potato starch; Dehydrated peanut butter with approximately 1.0% moisture content; Approximately 2.0% rice starch; and Approximately 2.0% guar gum Includes.

[0193] In yet another embodiment, this dosage form is Approximately 3.0-10.0% hemp extract; Approximately 10.0-20.0% peanut butter; Approximately 10.0-15.0% rice bran; Approximately 5.0-15.0% glucosamine HCl; Approximately 4.0-10.0% sweet potatoes; Approximately 6.0-13.0% dried molasses; Approximately 0.5-5.0% sorbic acid; Approximately 2.0-8.0% brewer's yeast; Approximately 3.0-8.0% sugar; Approximately 5.0-15.0% water; Approximately 8.0-18.0% glycerin; Approximately 1.0-8.0% potato starch; Dehydrated peanut butter with a concentration of approximately 0.5-5.0%; Approximately 1.0-5.0% rice starch; and Approximately 1.0-5.0% guar gum Includes.

[0194] In another embodiment, this dosage form further comprises chondroitin sulfate.

[0195] In another embodiment, this dosage form contains 2.0% hemp extract. In another embodiment, this dosage form contains 3.0% hemp extract. In another embodiment, this dosage form contains 4.0% hemp extract. In another embodiment, this dosage form contains 5.0% hemp extract. In another embodiment, this dosage form contains 6.0% hemp extract. In another embodiment, this dosage form contains 7.0% hemp extract. In another embodiment, this dosage form contains 8.0% hemp extract. In another embodiment, this dosage form contains 9.0% hemp extract. In another embodiment, this dosage form contains 10.0% hemp extract.

[0196] In one embodiment, this hemp extract is Cannabidiol; Cannabidiolic acid; Cannabigerol acid; Δ9-tetrahydrocannabinol; and Cannabide chromium Includes.

[0197] In one embodiment, the ratio of cannabidiol to cannabidiolic 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 cannabidiol to cannabidiolic acid is about 0.1:1 to about 1:0.1. In another embodiment, the ratio of cannabidiol to cannabidiolic 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 cannabidiol to cannabidiolic acid is about 0.6:1 to about 1:0.6. In yet another embodiment, the ratio of cannabidiol to cannabidiolic acid is about 1:1.

[0198] In one embodiment, the concentration of Δ9-tetrahydrocannabinol is insufficient to produce a psychoactive 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 Δ9-tetrahydrocannabinol to other cannabinoids is approximately 1:20.

[0199] In one embodiment, the concentration of Δ9-tetrahydrocannabinol is less than approximately 2 mg / mL. In another embodiment, the concentration of Δ9-tetrahydrocannabinol is less than approximately 1.5 mg / mL. In yet another embodiment, the concentration of Δ9-tetrahydrocannabinol is less than approximately 1 mg / mL. In yet another embodiment, the concentration of Δ9-tetrahydrocannabinol is less than approximately 0.9 mg / mL. In yet another embodiment, the concentration of Δ9-tetrahydrocannabinol is less than approximately 0.8 mg / mL. In one embodiment, the concentration of Δ9-tetrahydrocannabinol is less than approximately 0.7 mg / mL. In another embodiment, the concentration of Δ9-tetrahydrocannabinol is less than approximately 0.6 mg / mL. In yet another embodiment, the concentration of Δ9-tetrahydrocannabinol is less than approximately 0.5 mg / mL. In yet another embodiment, the concentration of Δ9-tetrahydrocannabinol is less than approximately 0.4 mg / mL. In one embodiment, the concentration of Δ9-tetrahydrocannabinol is less than approximately 0.3 mg / mL. In another embodiment, the concentration of Δ9-tetrahydrocannabinol is less than approximately 0.2 mg / mL. In yet another embodiment, the concentration of Δ9-tetrahydrocannabinol is less than approximately 0.1 mg / mL. In yet another embodiment, the concentration of Δ9-tetrahydrocannabinol is about 0 mg / mL.

[0200] In one embodiment, this hemp extract is Approximately 0.1-20 mg / mL of cannabidiol; Cannabidiolic acid at approximately 0.1-20 mg / mL; Cannabigerol acid at approximately 0.01-0.5 mg / mL; Approximately 0.01-0.5 mg / mL of Δ9-tetrahydrocannabinol; and Approximately 0.01-0.5 mg / mL of cannabichromene Includes.

[0201] In another embodiment, this hemp extract is Approximately 1-10 mg / mL of cannabidiol; Cannabidiolic acid at approximately 1-10 mg / mL; Cannabigerol acid at approximately 0.05-0.2 mg / mL; Approximately 0.1-0.3 mg / mL of Δ9-tetrahydrocannabinol; and Approximately 0.1-0.4 mg / mL of cannabichromene Includes.

[0202] In yet another embodiment, this hemp extract is, Approximately 5 mg / mL of cannabidiol; Approximately 5 mg / mL of cannabidiolic acid; Approximately 0.11 mg / mL of cannabigerol acid; Approximately 0.25 mg / mL of Δ9-tetrahydrocannabinol; and Approximately 0.27 mg / mL of cannabichromene Includes.

[0203] In one embodiment, this hemp extract is α-pinene; β-myrcene; β-pinene; δ-limonene; Linalool; β-caryophyllene; α-humulene; Nerolidol 2; Guaiol; Caryophyllene oxide; and α-Bisabolol Includes.

[0204] In another embodiment, this hemp extract is 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; Approximately 0.04-0.08% caryophyllene oxide; and Approximately 0.01-0.04% α-bisabolol Includes.

[0205] In another embodiment, this hemp extract is Approximately 0.07-0.30% α-pinene; Approximately 0.10-0.60% β-myrcene; Approximately 0.02-0.20% β-pinene; Approximately 0.03-0.20% δ-limonene: Approximately 0.01-0.08% linalool; Approximately 0.03-0.09% β-caryophyllene; Approximately 0.01-0.06% α-humulene; Approximately 0.02-0.09% nerolidol 2; and Approximately 0.01-0.06% guaiol Includes.

[0206] In another embodiment, this hemp extract is Approximately 0.01-0.50% α-pinene; Approximately 0.01-0.90% β-myrcene; Approximately 0.01-0.50% β-pinene; Approximately 0.01-0.50% δ-limonene: Approximately 0.01-0.50% linalool; Approximately 0.01-0.50% β-caryophyllene; Approximately 0.01-0.50% α-humulene; Approximately 0.01-0.50% nerolidol 2; Approximately 0.01-0.50% guaiol; Approximately 0.01-0.50% caryophyllene oxide; and Approximately 0.01-0.50% α-bisabolol Includes.

[0207] In another embodiment, this hemp extract is Camphen; β-Ocimene; Eucalyptol; Isoplegol; and / or Nerolidol 1 It also includes.

[0208] In another embodiment, this hemp extract is Approximately 0.02% camphene; Approximately 0.02-0.03% β-ocimene; Approximately 0.02-0.05% eucalyptol; Approximately 0.02% isopuregol; and / or Approximately 0.02-0.04% nerolidol Includes.

[0209] In another embodiment, this hemp extract is Approximately 0.01-0.04% camphene; Approximately 0.01-0.05% β-ocimene; Approximately 0.01-0.07% eucalyptol; Approximately 0.01-0.04% isopuregol; and / or Approximately 0.01-0.05% nerolidol Includes.

[0210] In another embodiment, this hemp extract is Approximately 0.01-0.50% camphene; Approximately 0.01-0.50% β-ocimene; Approximately 0.01-0.50% eucalyptol; Approximately 0.01-0.50% isopuregol; and / or Approximately 0.01-0.50% nerolidol Includes.

[0211] In one embodiment, the composition is formulated as an 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, and grape seed oil. In yet another embodiment, the carrier is grape seed oil.

[0212] In one embodiment, the flavoring agent is selected from the group consisting of catnip oil, chicken liver powder, poultry meat extract, maltodextrin, butter, and bacon. In another embodiment, the flavoring agent is chicken liver powder.

[0213] In one embodiment, the composition is formulated as an orally administered chewing agent. In another embodiment, the chewing agent is manufactured using cold extrusion. In another embodiment, the weight of the chewing agent is about 0.5 to 10 g. In yet another embodiment, the weight of the chewing agent is about 4 g, about 6 g, about 9 g, or 10 g. In yet another embodiment, the weight of the chewing agent is about 0.5 g. In one embodiment, the weight of the chewing agent is about 1 g. In another embodiment, the weight of the chewing agent is about 1.5 g. In yet another embodiment, the weight of the chewing agent is about 2 g. In yet another embodiment, the weight of the chewing agent is about 3 g. In one embodiment, the weight of the chewing agent is about 4 g. In another embodiment, the weight of the chewing agent is about 5 g. In yet another embodiment, the weight of this chewing agent is approximately 6 g. In yet another embodiment, the weight of this chewing agent is approximately 7 g. In one embodiment, the weight of this chewing agent is approximately 8 g. In another embodiment, the weight of this chewing agent is approximately 9 g. In yet another embodiment, the weight of this chewing agent is approximately 10 g.

[0214] In one embodiment, 4g of chewing agent is Cannabidiol approximately 7 mg; Cannabidiolic acid, approximately 6 mg; Cannabigerol acid, approximately 0.12 mg; Δ9-tetrahydrocannabinol approximately 0.32 mg; and Cannabichromene approx. 0.36 mg Includes.

[0215] Treatment method In one embodiment, the foregoing provides a method for treating or reducing pain in a veterinary subject of need, comprising administering to the subject a therapeutically effective amount of any of the compositions or dosage forms described above.

[0216] In some embodiments, this pain may be associated with arthritis, postoperative pain, acute pain, toothache, gingivitis, or polyarthralgia.

[0217] In one embodiment, the pharmaceutical composition or dosage form is administered at a dose of approximately 0.1 to 15.0 mg / kg. In another embodiment, the pharmaceutical composition or dosage form is administered at a dose of approximately 0.1 to 10.0 mg / kg. In yet another embodiment, the pharmaceutical composition or dosage form is administered at a dose of approximately 0.1 mg / kg. In yet another embodiment, the pharmaceutical composition or dosage form is administered at a dose of approximately 0.2 mg / kg. In yet another embodiment, the pharmaceutical composition or dosage form is administered at a dose of approximately 0.3 mg / kg. In one embodiment, the pharmaceutical composition or dosage form is administered at a dose of approximately 0.4 mg / kg. In another embodiment, the pharmaceutical composition or dosage form is administered at a dose of approximately 0.5 mg / kg. In yet another embodiment, the pharmaceutical composition or dosage form is administered at a dose of approximately 0.6 mg / kg. In yet another embodiment, the pharmaceutical composition or dosage form is administered at a dose of approximately 0.7 mg / kg. In yet another embodiment, the pharmaceutical composition or dosage form is administered at a dose of approximately 0.8 mg / kg. In one embodiment, the pharmaceutical composition or dosage form is administered at a dose of approximately 0.9 mg / kg. In another embodiment, the pharmaceutical composition or dosage form is administered at a dose of approximately 1 mg / kg. In yet another embodiment, the pharmaceutical composition or dosage form is administered at a dose of approximately 1.5 mg / kg. In yet another embodiment, the pharmaceutical composition or dosage form is administered at a dose of approximately 2 mg / kg. In one embodiment, the pharmaceutical composition or dosage form is administered at a dose of approximately 3 mg / kg. In another embodiment, the pharmaceutical composition or dosage form is administered at a dose of approximately 4 mg / kg. In yet another embodiment, the pharmaceutical composition or dosage form is administered at a dose of approximately 5 mg / kg. In yet another embodiment, the pharmaceutical composition or dosage form is administered at a dose of approximately 6 mg / kg. In one embodiment, the pharmaceutical composition or dosage form is administered at a dose of approximately 7 mg / kg. In another embodiment, the pharmaceutical composition or dosage form is administered at a dose of approximately 8 mg / kg. In yet another embodiment, the pharmaceutical composition or dosage form is administered at a dose of approximately 9 mg / kg. In yet another embodiment, the pharmaceutical composition or dosage form is administered at a dose of approximately 10 mg / kg. In one embodiment, the pharmaceutical composition or dosage form is administered at a dose of approximately 11 mg / kg.In another embodiment, the pharmaceutical composition or dosage form is administered at a dose of approximately 12 mg / kg. In yet another embodiment, the pharmaceutical composition or dosage form is administered at a dose of approximately 13 mg / kg. In yet another embodiment, the pharmaceutical composition or dosage form is administered at a dose of approximately 14 mg / kg. In one embodiment, the pharmaceutical composition or dosage form is administered at a dose of approximately 15 mg / kg.

[0218] In another embodiment, the pharmaceutical composition or dosage form is administered at twice the therapeutically effective dose over a week, followed by administration at the therapeutically effective dose. In yet another embodiment, the therapeutically effective dose is approximately 0.1 to 0.5 mg / kg. In yet another embodiment, the therapeutically effective dose is approximately 2 mg / kg. In one embodiment, the therapeutically effective dose is approximately 8 mg / kg.

[0219] In one embodiment, the pharmaceutical composition or dosage form is administered at a dose of approximately 1 mg / kg over one week, followed by a dose of approximately 0.1 to 0.5 mg / kg. In another embodiment, the pharmaceutical composition or dosage form is administered at a dose of approximately 4 mg / kg over one week, followed by a dose of approximately 2 mg / kg.

[0220] In one embodiment, the pharmaceutical composition or dosage form is administered at a dose of approximately 2 mg / kg every 12 hours for two weeks, then at a dose of approximately 1 mg / kg every 12 hours for two weeks, and then at a dose of approximately 2 mg / kg every 12 hours for four weeks.

[0221] In one embodiment, the pharmaceutical composition or dosage form is administered once a day at a dose of approximately 1.0 mg / kg. In another embodiment, the pharmaceutical composition or dosage form is administered twice a day at a dose of approximately 1.0 mg / kg. In yet another embodiment, the pharmaceutical composition or dosage form is administered three times a day at a dose of approximately 1.0 mg / kg. In yet another embodiment, the pharmaceutical composition or dosage form is administered four times a day at a dose of approximately 1.0 mg / kg.

[0222] In one embodiment, the pharmaceutical composition or dosage form is administered once a day at a dose of approximately 2.0 mg / kg. In another embodiment, the pharmaceutical composition or dosage form is administered twice a day at a dose of approximately 2.0 mg / kg. In yet another embodiment, the pharmaceutical composition or dosage form is administered three times a day at a dose of approximately 2.0 mg / kg. In yet another embodiment, the pharmaceutical composition or dosage form is administered four times a day at a dose of approximately 2.0 mg / kg.

[0223] In one embodiment, the pharmaceutical composition or dosage form is administered once a day at a dose of approximately 3.0 mg / kg. In another embodiment, the pharmaceutical composition or dosage form is administered twice a day at a dose of approximately 3.0 mg / kg. In yet another embodiment, the pharmaceutical composition or dosage form is administered three times a day at a dose of approximately 3.0 mg / kg. In yet another embodiment, the pharmaceutical composition or dosage form is administered four times a day at a dose of approximately 3.0 mg / kg.

[0224] In one embodiment, the pharmaceutical composition or dosage form is administered once a day at a dose of approximately 4.0 mg / kg. In another embodiment, the pharmaceutical composition or dosage form is administered twice a day at a dose of approximately 4.0 mg / kg. In another embodiment, the pharmaceutical composition or dosage form is administered three times a day at a dose of approximately 4.0 mg / kg. In yet another embodiment, the pharmaceutical composition or dosage form is administered four times a day at a dose of approximately 4.0 mg / kg. In yet another embodiment, the pharmaceutical composition or dosage form is administered once a day at a dose of approximately 5.0 mg / kg. In yet another embodiment, the pharmaceutical composition or dosage form is administered twice a day at a dose of approximately 5.0 mg / kg. In yet another embodiment, the pharmaceutical composition or dosage form is administered three times a day at a dose of approximately 5.0 mg / kg. In yet another embodiment, the pharmaceutical composition or dosage form is administered four times a day at a dose of approximately 5.0 mg / kg.

[0225] In one embodiment, the pharmaceutical composition or dosage form is administered once a day at a dose of approximately 6.0 mg / kg. In another embodiment, the pharmaceutical composition or dosage form is administered twice a day at a dose of approximately 6.0 mg / kg. In yet another embodiment, the pharmaceutical composition or dosage form is administered three times a day at a dose of approximately 6.0 mg / kg. In yet another embodiment, the pharmaceutical composition or dosage form is administered four times a day at a dose of approximately 6.0 mg / kg.

[0226] In one embodiment, the pharmaceutical composition or dosage form is administered once a day at a dose of approximately 7.0 mg / kg. In another embodiment, the pharmaceutical composition or dosage form is administered twice a day at a dose of approximately 7.0 mg / kg. In yet another embodiment, the pharmaceutical composition or dosage form is administered three times a day at a dose of approximately 7.0 mg / kg. In yet another embodiment, the pharmaceutical composition or dosage form is administered four times a day at a dose of approximately 7.0 mg / kg.

[0227] In one embodiment, the pharmaceutical composition or dosage form is administered once a day at a dose of approximately 8.0 mg / kg. In another embodiment, the pharmaceutical composition or dosage form is administered twice a day at a dose of approximately 8.0 mg / kg. In yet another embodiment, the pharmaceutical composition or dosage form is administered three times a day at a dose of approximately 8.0 mg / kg. In yet another embodiment, the pharmaceutical composition or dosage form is administered four times a day at a dose of approximately 8.0 mg / kg.

[0228] In one embodiment, the pharmaceutical composition or dosage form is administered once a day at a dose of approximately 9.0 mg / kg. In another embodiment, the pharmaceutical composition or dosage form is administered twice a day at a dose of approximately 9.0 mg / kg. In yet another embodiment, the pharmaceutical composition or dosage form is administered three times a day at a dose of approximately 9.0 mg / kg. In yet another embodiment, the pharmaceutical composition or dosage form is administered four times a day at a dose of approximately 9.0 mg / kg.

[0229] In one embodiment, the pharmaceutical composition or dosage form is administered once a day at a dose of approximately 10.0 mg / kg. In another embodiment, the pharmaceutical composition or dosage form is administered twice a day at a dose of approximately 10.0 mg / kg. In yet another embodiment, the pharmaceutical composition or dosage form is administered three times a day at a dose of approximately 10.0 mg / kg. In yet another embodiment, the pharmaceutical composition or dosage form is administered four times a day at a dose of approximately 10.0 mg / kg.

[0230] In one embodiment, this method yields a therapeutically effective maximum serum median concentration of cannabidiol. In another embodiment, this maximum serum median concentration of cannabidiol is approximately 90–310 ng / mL. In yet another embodiment, this maximum serum median concentration of cannabidiol is approximately 90 ng / mL. In yet another embodiment, this maximum serum median concentration of cannabidiol is approximately 100 ng / mL. In yet another embodiment, this maximum serum median concentration of cannabidiol is approximately 102 ng / mL. In one embodiment, this maximum serum median concentration of cannabidiol is approximately 200 ng / mL. In another embodiment, this maximum serum median concentration of cannabidiol is approximately 300 ng / mL. In yet another embodiment, this maximum serum median concentration of cannabidiol is approximately 400 ng / mL. In yet another embodiment, this maximum serum median concentration of cannabidiol is approximately 500 ng / mL. In one embodiment, this maximum serum median concentration of cannabidiol is approximately 590 ng / mL. In another embodiment, the median maximum serum concentration of this cannabidiol is approximately 600 ng / mL.

[0231] In one embodiment, the veterinary subject is a dog, cat, cow, pig, or horse. In another embodiment, the veterinary subject is a dog. In yet another embodiment, the veterinary subject is a cat.

[0232] In one embodiment, the foregoing provides a method for treating or alleviating arthritis pain, postoperative pain, acute pain, toothache, gingivitis pain, or polyarthralgia in a veterinary subject of need, comprising administering a therapeutically effective amount of hemp extract to the subject.

[0233] In one embodiment, the hemp extract is administered at a dose of approximately 0.1 to 15.0 mg / kg. In another embodiment, the hemp extract is administered at a dose of approximately 0.1 to 10.0 mg / kg. In yet another embodiment, the hemp extract is administered at a dose of approximately 0.1 mg / kg. In yet another embodiment, the hemp extract is administered at a dose of approximately 0.2 mg / kg. In yet another embodiment, the hemp extract is administered at a dose of approximately 0.3 mg / kg. In one embodiment, the hemp extract is administered at a dose of approximately 0.4 mg / kg. In another embodiment, the hemp extract is administered at a dose of approximately 0.5 mg / kg. In yet another embodiment, the hemp extract is administered at a dose of approximately 0.6 mg / kg. In yet another embodiment, the hemp extract is administered at a dose of approximately 0.7 mg / kg. In yet another embodiment, the hemp extract is administered at a dose of approximately 0.8 mg / kg. In one embodiment, the hemp extract is administered at a dose of approximately 0.9 mg / kg. In another embodiment, the hemp extract is administered at a dose of approximately 1 mg / kg. In yet another embodiment, the hemp extract is administered at a dose of approximately 1.5 mg / kg. In yet another embodiment, the hemp extract is administered at a dose of approximately 2 mg / kg. In one embodiment, the hemp extract is administered at a dose of approximately 3 mg / kg. In another embodiment, the hemp extract is administered at a dose of approximately 4 mg / kg. In yet another embodiment, the hemp extract is administered at a dose of approximately 5 mg / kg. In yet another embodiment, the hemp extract is administered at a dose of approximately 6 mg / kg. In one embodiment, the hemp extract is administered at a dose of approximately 7 mg / kg. In another embodiment, the hemp extract is administered at a dose of approximately 8 mg / kg. In yet another embodiment, the hemp extract is administered at a dose of approximately 9 mg / kg. In yet another embodiment, the hemp extract is administered at a dose of approximately 10 mg / kg. In one embodiment, the hemp extract is administered at a dose of approximately 11 mg / kg. In another embodiment, the hemp extract is administered at a dose of approximately 12 mg / kg. In yet another embodiment, the hemp extract is administered at a dose of approximately 13 mg / kg. In yet another embodiment, the hemp extract is administered at a dose of approximately 14 mg / kg.In one embodiment, this hemp extract is administered at a dose of approximately 15 mg / kg.

[0234] In another embodiment, the hemp extract is administered at twice the therapeutically effective dose for one week, followed by administration at the therapeutically effective dose. In yet another embodiment, this therapeutically effective dose is approximately 0.1–0.5 mg / kg. In yet another embodiment, this therapeutically effective dose is approximately 2 mg / kg. In one embodiment, this therapeutically effective dose is approximately 8 mg / kg.

[0235] In one embodiment, the hemp extract is administered at a dose of approximately 1 mg / kg over one week, followed by a dose of approximately 0.1 to 0.5 mg / kg. In another embodiment, the hemp extract is administered at a dose of approximately 4 mg / kg over one week, followed by a dose of approximately 2 mg / kg.

[0236] In one embodiment, this method yields a therapeutically effective maximum serum median concentration of cannabidiol. In another embodiment, this maximum serum median concentration of cannabidiol is approximately 90–310 ng / mL. In yet another embodiment, this maximum serum median concentration of cannabidiol is approximately 90 ng / mL. In yet another embodiment, this maximum serum median concentration of cannabidiol is approximately 100 ng / mL. In yet another embodiment, this maximum serum median concentration of cannabidiol is approximately 102 ng / mL. In one embodiment, this maximum serum median concentration of cannabidiol is approximately 200 ng / mL. In another embodiment, this maximum serum median concentration of cannabidiol is approximately 300 ng / mL. In yet another embodiment, this maximum serum median concentration of cannabidiol is approximately 400 ng / mL. In yet another embodiment, this maximum serum median concentration of cannabidiol is approximately 500 ng / mL. In one embodiment, this maximum serum median concentration of cannabidiol is approximately 590 ng / mL. In another embodiment, the median maximum serum concentration of this cannabidiol is approximately 600 ng / mL.

[0237] In one embodiment, the veterinary subject is a dog, cat, cow, pig, or horse. In another embodiment, the veterinary subject is a dog. In yet another embodiment, the veterinary subject is a cat.

[0238] The pharmaceutical compositions and dosage forms of this disclosure may be administered by any convenient route, for example, by infusion or bolus injection, by absorption through the epithelium or inner layers of the skin mucosa (e.g., oral mucosa, rectal mucosa, and intestinal mucosa), and may be administered together with any other therapeutic agent. Administration may be systemic or topical.

[0239] The therapeutic compositions of the present invention are administered together with appropriate carriers, excipients, and other agents incorporated into the formulation to provide improvements in transfer, delivery, tolerance, and the like. Many suitable formulations can be found in the following prescription collection known to all pharmacists: Remington's Pharmaceutical Sciences, Mack Publishing Company, Easton, PA. Examples of such formulations include powders, pastes, ointments, gels, waxes, oils, lipids, lipid (cationic or anionic)-containing vesicles (e.g., LIPOFECTIN®), DNA conjugates, anhydrous absorbent pastes, oil-in-water and water-in-oil emulsions, emulsion carbowaxes (polyethylene glycol of various molecular weights), semi-solid gels, and semi-solid mixtures containing carbowaxes. See also Powell et al. “Compendium of excipients for parenteral formulations” PDA (1998) J Pharm Sci Technol 52:238-311.

[0240] The dosage may vary depending on the age and weight of the recipient, the target disease, condition, route of administration, and similar factors. Various delivery systems are known and can be used to administer the pharmaceutical composition of the present invention (e.g., encapsulation in liposomes, microparticles, microcapsules, receptor-mediated endocytosis) (see, for example, Wu et al. (1987) J. Biol. Chem. 262:4429-4432). Methods of delivery include, but are not limited to, intradermal, intramuscular, intraperitoneal, intravenous, transdermal, buccal, sublingual, subcutaneous, nasal, epidural, and oral routes. The composition may be administered by any convenient route, for example, by infusion or bolus injection, by absorption via the epithelium or inner layers of the skin mucosa (e.g., oral mucosa, rectal and intestinal mucosa), and may be administered together with other bioactive agents. Administration may be systemic or topical.

[0241] Pharmaceutical preparations for oral use may be manufactured by using solid additives, optionally grinding the resulting mixture, adding appropriate auxiliary agents as needed, and then processing the granular mixture to obtain a tablet or sugar-coated tablet core. Suitable additives include, in particular, fillers such as sugars, e.g., lactose, sucrose, mannitol, or sorbitol; cellulose preparations, e.g., corn starch, wheat starch, rice starch, potato starch, gelatin, gum, methylcellulose, hydroxypropyl methylcellulose, sodium carboxymethylcellulose, and / or physiologically acceptable polymers, e.g., polyvinylpyrrolidone (PVP). Disintegrants such as cross-linked polyvinylpyrrolidone, agar, or alginic acid or its salts (e.g., sodium alginate) may be added as needed.

[0242] The core of the sugar-coated tablet is appropriately coated. For this purpose, a concentrated sugar solution may optionally be used, which may contain gum arabic, talc, polyvinylpyrrolidone, Carbopol gel, polyethylene glycol, titanium dioxide, lacquer solution, and a suitable organic solvent or solvent mixture.

[0243] Injectable formulations may include dosage forms for intravenous injection, subcutaneous injection, intradermal injection, intramuscular injection, local injection, and intravenous infusion. These injectable formulations can be prepared by known methods. For example, they can be prepared by dissolving, suspending, or emulsifying the pharmaceutical composition or dosage form in a sterile aqueous or oily medium conventionally used for injection. Examples of aqueous media for injection include physiological saline, isotonic solutions containing glucose and other adjuvants, which can be used in combination with appropriate solubilizers such as alcohol (e.g., ethanol), polyhydric alcohols (e.g., propylene glycol, polyethylene glycol), and nonionic surfactants [e.g., polysorbate 80, HCO-50 (polyoxyethylene (50 mol) adduct of hydrogenated castor oil)]. Examples of oily media include sesame oil and soybean oil, which can be used in combination with solubilizers such as benzyl benzoate and benzyl alcohol. The injectable formulations thus prepared can be filled into appropriate ampoules.

[0244] Examples of pharmaceutical compositions that can be used orally include push-in capsules made of gelatin, and soft, sealed capsules made of gelatin and a plasticizer (e.g., glycerol or sorbitol). Push-in capsules may contain an active ingredient in a mixture of a filler such as lactose, a binder such as starch, a lubricant such as talc or magnesium stearate, and an optional stabilizer. In soft capsules, the active ingredient can be dissolved or suspended in a suitable liquid such as fatty oil, liquid paraffin, or liquid polyethylene glycol.

[0245] Alternatively, the composition may be in powder form for preparation before use with a suitable vehicle (e.g., sterile, pyrogen-free water). The exact formulation, route of administration, and dosage may be selected by a physician familiar with the patient's condition. (See, for example, Fingl, et al., 1975, “The Pharmacological Basis of Therapeutics,” Chapter I, page 1). Depending on the severity and responsiveness of the condition being treated, administration may also be a single dose of the sustained-release composition, and the course of treatment may last for several days to several weeks, or until a cure is achieved or a reduction in the condition is achieved.

[0246] Advantageously, the pharmaceutical compositions for oral or parenteral use described above are prepared into unit dose dosage forms suitable for the dose of the active ingredient. Examples of such unit dose dosage forms include tablets, pills, capsules, injections (ampoules), suppositories, chewable preparations, and pet food. In certain embodiments, with respect to the doses described above, this dose is administered in a single feeding of pet food, for example, with 1 mg / kg of hemp extract provided in a single feeding of pet food.

[0247] Pharmaceutical formulations may be administered to a patient using any acceptable device or mechanism according to the methods disclosed herein. For example, this administration may be achieved using a syringe and needle, or with a reusable pen and / or auto-injector delivery device. The methods of the present invention include the use of a number of reusable pens and / or auto-injector delivery devices for administering pharmaceutical formulations.

[0248] In some embodiments of non-human animal administration, the term "pharmaceuticals" may be replaced with "veterinary medicine" as used herein. [Examples]

[0249] Example 1: Approval of CBD oil and protocol The industrial hemp strain used in this study is a specialized strain utilizing ethanol and heat extraction. The final dried product was reconstituted in an olive oil base containing approximately 10 mg / ml of CBD as an equal mixture of CBD and CBD carboxylic acid (CBDa), 0.24 mg / ml of tetrahydrocannabinol (THC), 0.27 mg / ml of cannabichromene (CBC), and 0.11 mg / ml of dehydrated cannabigerol (CBG), with all other cannabinoids present at less than 0.01 mg / ml. Analysis of five different production runs using a commercial analytical laboratory (MCR Laboratories, Framingham, MA) showed less than 9% variation between batches for each of the detected cannabinoids listed above. This study was conducted after approval by the Cornell University Institutional Animal Care and Use Committee (IACUC) for this study in accordance with IACUC guidelines for animal use. Client-owned dogs were registered after informed consent in accordance with the Declaration of Helsinki.

[0250] Example 2: Terpene Profile Terpene profiles were determined using gas chromatography-FID (GC-FID) analysis with headspace flame ionization detection for four separate oil extractions. All oils contained 0.09–0.13% α-pinene, 0.23–0.44% β-myrcene, 0.04–0.09% β-pinene, 0.05–0.09% δ-limonene, 0.03–0.06% linalool, 0.04–0.07% β-caryophyllene, 0.02–0.04% α-humulene, 0.04–0.07% nerolidol-2, 0.02–0.04% guaiol, 0.04–0.08% caryophyllene oxide, and 0.01–0.04% α-bisabolol. In addition, some of the tested oils contained 0.02% camphene, 0.02–0.03% β-ocimene, 0.02–0.05% eucalyptol, 0.02% isopulegol, and / or 0.02–0.04% nerolidol-1. The total terpene content ranged from 0.73–1.10%.

[0251] Example 3: Pharmacokinetics Initial oral pharmacokinetic studies of a single dose were conducted in four beagles (3.5–7 years old, neutered males, 10.7–11.9 kg). Each dog was administered an oral dose of 2 mg / kg of CBD oil and an oral dose of 8 mg / kg of CBD oil, with a two-week washout period between each experiment. The dogs were fed two hours after administration. Physical examinations were performed at 0, 4, 8, and 24 hours post-administration. Posture, behavior, proprioception, and gait were subjectively assessed at each time point during free running / walking and navigation around standard traffic cones (weaving). 5 ml of blood was collected at 0, 0.5, 1, 2, 4, 8, 12, and 24 hours post-oil administration. Blood samples were obtained by jugular vein puncture and transferred to a coagulation tube over 20 minutes. The samples were centrifuged at 3,600 × g for 10 minutes (VWR, Clinical Centrifuge) to remove serum, and stored at -80°C until analysis using liquid chromatography-mass spectrometry (LC-MS) at the Colorado State University Core Mass Spectrometry facility.

[0252] Example 4: Extraction and mass spectrometry of CBD from dog serum CBD was extracted from canine serum using a combination of protein precipitation and liquid-liquid extraction with n-hexane, with some modifications for microflow ultra-high pressure liquid chromatography (UHPLC). Briefly, 0.05 ml of canine serum was subjected to protein precipitation in the presence of ice-cold acetonitrile (80% final concentration), with deuterated CBD added as an internal standard (0.06 mg / ml, CDB-d3 Cerealant, Round Rock, TX, USA). After adding 0.2 ml of water to each sample, 1.0 ml of hexane was added to enhance liquid-liquid phase separation. The hexane extract was removed, and the samples were concentrated to dryness under laboratory nitrogen. Before LC-MS analysis, the samples were resuspended in 0.06 mL of 100% acetonitrile. A standard curve using CBD analysis standards was prepared using canine serum extracted as described above, without exposure to CBD. Cannabidiol concentrations in serum were quantified using a chromatographically coupled triple-quadropole mass spectrometer (UHPLC-QQQ-MS).

[0253] Example 5: Analysis of CBD serum concentration data Peak areas for CBD detected in biological samples were extracted from UHPLC-QQQ-MS data and normalized to the peak area of ​​the internal standard CBD-d3 in each sample using Skyline and in-house R Script (www.r-project.org). CBD concentration to nanograms per mL of serum was calculated, determined by the regression line of the standard curve (r² = 0.9994, 0–1000 ng / mL). For this assay, the limit of detection (LOD) and limit of quantification (LOQ) represent the lower limits of detection and quantification for each compound in the matrix of this study. Pharmacokinetic variables were estimated by non-compartmental analysis using the pharmacokinetic software package (PK Solution, version 2.0, Montrose, CO, USA).

[0254] Example 6: Inclusion and Exclusion Criteria for Clinical Trials The study population consisted of client-owned dogs that visited Cornell University Hospital for Animals for evaluation and treatment of lameness due to osteoarthritis (OA). Dogs were considered for inclusion in this study if they had radiographic evidence of OA, signs of pain as assessed by their owners, lameness detectable by visual gait assessment, and joint pain on palpation. Each dog underwent an initial complete blood count ([CBC] Bayer Advia 120, Siemens Corp., New York, NY, USA) and serological analysis (Hitachi 911, Roche Diagnostics, Indianapolis, IN, USA) to rule out any underlying conditions that might preclude enrollment. Elevated levels of alkaline phosphatase (ALP), alanine aminotransferase (ALT), and aspartate aminotransferase (AST) were tolerated if they were judged to be within the normal limits based on prior hepatic ultrasound examination, excluding potential non-progressive nodules (possible nodular hyperplasia of the liver).

[0255] All owners completed a short questionnaire to define the affected limb, the duration of lameness, and the duration of administration of analgesics or other medications.

[0256] All dogs underwent X-ray examinations of the affected joints, and radiologists checked for the presence of osteoarthritis (OA) and ruled out the presence of complications that could interfere with registration (i.e., soluble lesions).

[0257] During this study, dogs were permitted to receive NSAIDs, fish oil, and / or glucosamine / chondroitin sulfate as standard treatment for the course of the disease, either four weeks prior to or during the 10-week study period, without any changes to these medications. Any other analgesics being used (e.g., gabapentin and tramadol) were discontinued at least two weeks prior to enrollment. Dogs with evidence of renal disease, uncontrolled endocrine disorders, neurological disorders, or neoplastic diseases, or those with a temperament unsuitable for walking on a leash or receiving physiotherapy, were excluded. All dogs were fed their normal diet without any changes permitted during this study.

[0258] Example 7: Clinical Trial This study was a placebo-controlled, double-blind, crossover clinical trial. Dogs were administered either of the following two treatments in a random order (using the Randomizer iPhone® Application): CBD (2 mg / kg every 12 hours) or a placebo every 12 hours (equal amounts of olive oil containing 10 / 1000 parts anise oil and 5 / 1000 parts peppermint oil to provide a similar herbal aroma). Each treatment was administered for 4 weeks, with a 2-week washout period between treatments. For each treatment, blood samples were collected at weeks 2 and 4 for repeated complete hematological counts and chemical analyses.

[0259] At each visit, each dog was evaluated by a veterinarian based on a scoring system, and also evaluated by the dog's owner before the start of treatment and at 2 and 4 weeks after the start of treatment (Canine Brief Pain Inventory [CBPI], Hudson Activity Scale).

[0260] Example 8: Statistical Analysis An initial power analysis was performed using prior data suggesting a baseline CBPI with a standard deviation of 20 or a Hudson score change of approximately 15 points (two-sided), and the number of dogs needed for this study was assessed as a crossover design with alphas of 0.80 and 0.05. It was calculated and assumed that 14 dogs would be needed to find significance.

[0261] Statistical analysis was performed using a commercially available software package (JMP 12.0, Cary, NC, USA). All data were evaluated for normality using the Shapiro-Wilks test. Given that the majority of the inventors' blood, serum, and scoring data were normally distributed, a mixed model analysis of variances was used. The crossover study variables included in this model were: treatment, time, oil order, sex, age, NSAID use, fixed effect of treatment time x; and random effects of observation period, nested period within dogs, and nested time point within the nested period within dogs. To control for differences and relative changes in CBPI pain and activity impairment assessments and Hudson scoring among dogs, a fixed effect of the initial CPBI or Hudson score was also included in this analysis. Dunnett's test was performed retrospectively on any significant effect of treatment at time x to evaluate the difference from week 0 of CBD oil or placebo oil as a baseline time point for comparison. For all analyses, p-values ​​less than 0.05 were determined to be significant.

[0262] Example 9: Pharmacokinetic results Pharmacokinetics showed that the median half-life of CBD elimination was 4.2 hours (3.8–6.8 hours) at a dose of 2 mg / kg and 4.2 hours (3.8–4.8 hours) at a dose of 8 mg / kg (Table 1). The median maximum concentration of CBD oil (Figure 2) was 102.3 mg / ml (60.7–132.0 ng / mL; 180 nM) and 590.8 ng / mL (389.5–904.5 ng / mL; 1.2 μM) for doses of 2 and 8 mg / kg, reached after 1.5 hours and 2 hours, respectively. No significant psychoactive effects were observed at any point in time between the 2 and 8 mg / kg doses over a 24-hour period. These results led to the practical administration of 2 mg / kg body weight every 12 hours during clinical trials.

[0263] [Table 1]

[0264] Example 10: Dogs included in the clinical trial Twenty-two client-owned dogs with clinically and radiographically confirmed evidence of osteoarthritis were included. Sixteen of these dogs completed the study and were included in the analysis. Their breed, weight, age, sex, weaker limb, radiographic findings, NSAID use, and treatment sequence are summarized in Table 2. Dogs were removed due to osteosarcoma at enrollment, gastric torsion (placebo), history of aggression issues (CBD oil), pyelonephritis / renal failure (CBD oil), recurrent pododermatitis (placebo oil), and diarrhea (placebo oil).

[0265] [Table 2]

[0266] Example 11: Results of the clinical trial CBPI and Hudson scores (Figures 3A and 3B) showed a significant reduction in pain and an increase in activity at weeks 2 and 4 during CBD treatment compared to baseline week 0 (p<0.01), while placebo treatment showed no difference in CBPI and Hudson scores from pre-treatment scores (Table 3). Lameness as assessed by veterinarians (Figure 4) showed an increase in lameness with age (p<0.01), but lameness was significantly less with NSAID use (p=0.03). Veterinary pain scores showed that pain was significantly lower in dogs with NSAIDs (p<0.01). CBD oil resulted in significantly lower pain compared to baseline at both week 2 and week 4 assessments (p<0.03), while placebo treatment showed no significant difference. When evaluated using a veterinary lameness and pain scoring system, no changes in weight-bearing capacity were observed (Table 3).

[0267] [Table 3]

[0268] Chemical analysis and CBC were performed at each visit. No significant changes were observed in measured CBC values ​​in dogs treated with CBD oil or placebo (data not shown). Serum chemistry levels were similar between CBD oil and the comparison placebo, with the exception of alkaline phosphatase (ALP), which increased significantly over time from baseline by week 4 of CBD oil treatment (p=0.005) (Table 4). Nine out of 16 dogs showed increases over time (Figure 1). All values ​​remained within the normal range, but glucose increased in dogs administered placebo oil at each time point (p=0.04), and creatinine levels increased over time in both dogs administered CBD oil and placebo oil (p<0.01). Other significant differences in serum chemistry levels were mainly associated with age or NSAID use. Increased age was associated with significantly higher blood urea nitrogen (BUN; p<0.001), calcium (p=0.014), phosphorus (p=0.001), alanine aminotransferase (ALT; p=0.028), ALP (p=0.012), gamma glutamyl transferase (GGT; p=0.018), globulin (p=0.021), and cholesterol (p=0.002). NSAID use was associated with significantly higher BUN (p=0.003) and creatinine (p=0.017), as well as significant increases in total protein (p<0.001) and serum globulin (p<0.001).

[0269] [Table 4]

[0270] Example 12: Safety study in dogs A 12-week safety study was conducted in dogs to evaluate the safety of a soft chewing agent containing CBD.

[0271] Animal and research design As shown in Table 5, eight purebred Beagle dogs, aged 11 months to 5 years and weighing between 7.39 and 11.95 kg at the start of the study, were selected for this research.

[0272] [Table 5]

[0273] Dogs were housed individually in cages of a size compliant with the Animal Welfare Act, under target conditions of 50°–85°F and a 12-hour light / 12-hour dark cycle. Cages and food bowls were cleaned and disinfected daily in accordance with the Animal Welfare Act. Fresh tap water suitable for human consumption was freely available via an automated watering system. No known contaminants that could reasonably be expected to be present in the feed materials were found to be potentially hindering the purpose or conduct of this study.

[0274] During this study, the only source of food supplied to each animal once daily for approximately one hour was the control diet Purina Dog Chow. Dogs were fed according to their ideal physical condition and fasted for at least 12 hours prior to blood collection. CBD was administered twice daily at a dose of approximately 2 mg / kg using a soft chewing agent. The administration is shown in Table 6.

[0275] [Table 6]

[0276] CBC and Serum Chemistry Before the start of the study, 5 ml of blood was collected from each dog and used to determine its eligibility for the study. During the study, 5 ml of blood was collected weekly (±2 days). Blood was collected by jugular vein puncture using a sterile syringe. The samples were divided into two tubes: a serum separator tube with a red stopper and an EDTA tube with a lavender stopper. The tube with the red stopper was centrifuged in a refrigerated centrifuge at 3000 RPM for 15 minutes after coagulation. The tube with the lavender stopper was placed on a locker to allow the blood and anticoagulant to mix thoroughly. The blood samples were packaged and sent to Antech Diagnostics for analysis on a priority overnight basis.

[0277] Pharmacokinetic (PK) blood sampling On the first day of administration, blood samples were collected from 6 of the 8 dogs for PK analysis. The most cooperative dog was selected for PK analysis. Approximately 6 ml of blood was collected by jugular vein puncture with a sterile syringe at 0, 30, 60, 2, 4, 8, 12, and 24 hours post-procedure. The samples were placed in coagulation tubes with red stoppers that did not have serum separators. Serum was recovered by centrifugation at 3000 RPM for 15 minutes. The recovered serum was placed in cryovials and stored at -70°C. Each tube was labeled with dog ID, collection date, and collection time. The samples were transported overnight on dry ice to the Proteomics & Metabolomics Facility at Colorado State University.

[0278] Clinical observation Veterinarians performed a complete physical examination of all dogs before and at the end of this study. Each dog was evaluated for overall health, physical condition, and coat condition. Qualified personnel performed clinical observations twice daily in accordance with Summit Ridge Farms' Program of Veterinary Care and SOP VC-003 (Rounds Observations). All animals were evaluated twice daily with reference to SOP VC-016 (Recognizing Pain, Stress, and / or Distress). Clinical laboratory diagnostic procedures were performed as needed. Veterinary care was provided appropriately to each individual animal in accordance with the Program of Veterinary Care.

[0279] blood analysis Blood was analyzed for white blood cell count, red blood cell count, hemoglobin, hematocrit, MCV, MCHC, MCH, and platelet count, along with complete differentiation. In addition, a 22-test chemistry screen was performed, consisting of glucose, urea nitrogen, creatinine, total protein, albumin, total bilirubin, alkaline phosphatase, ALT, AST, CPK, cholesterol, calcium, phosphorus, sodium, potassium, chloride, A / G ratio, BUN / creatinine ratio, globulin, triglycerides, GGTP, and magnesium. Measurements were performed before the start of this study and then weekly throughout the course of the study.

[0280] PK analysis The blood levels and pharmacokinetics of the test substance were analyzed as described in Gamble et al. (2018) Front Vet Sci. 165:1-9.

[0281] result body weight The average weight change in dogs during the 12-week period of this study was -0.04 kg (-0.43%). Weight data are shown in Tables 7 and 8.

[0282] [Table 7]

[0283] [Table 8]

[0284] Feeding amount The average daily food intake per week for dogs during this study was 204 g. Food intake data is shown in Tables 9 and 10.

[0285] [Table 9]

[0286] [Table 10]

[0287] Test substance consumption Five out of eight dogs accepted the chewing agent 100% of the time. During this study, the following three dogs had to be administered the agent occasionally: Dog ID #13644 (administered with a 6.5% probability), Dog ID #13513 (administered with a 2.4% probability), and Dog ID #2784123 (administered with a 17.3% probability).

[0288] Hematology and Serum Chemistry From week 1 onward, the mean alkaline phosphatase (ALP) levels in the group increased slightly. This value remained stable until week 7, when the mean ALP levels in the group gradually increased. The highest mean group level was observed during the final week of this study, but did not exceed the normal reference range shown in Table 11. The increase in the mean group level was thought to be due to three dogs (13536, 2753822, and 2808987). By the end of this study, 13536 and 2753822 had levels above 100 U / L, but not above the high-normal value of 131 U / L. Therefore, these levels remained within the normal reference range. The elevation observed in only a few animals in the group may indicate individual sensitivity to this product. All other blood parameters remained within the normal limits, and no clear trends were observed. The hematological and serological results are shown in Tables 12-19.

[0289] [Table 11]

[0290] [Table 12]

[0291] [Table 13]

[0292] [Table 14]

[0293] [Table 15]

[0294] [Table 16]

[0295] [Table 17]

[0296] [Table 18]

[0297] [Table 19]

[0298] Clinical observation During this study, occasional instances of loose stools and vomiting were recorded. Dog ID # 13536 was observed to have 5 cases of vomiting of food or bile and 6 cases of loose stools. Dog ID # 13513 was observed to have 2 cases of loose stools. Dog ID # 27583822 was observed to have 2 cases of vomiting of food and 8 cases of loose stools. Dog ID # 13644 was observed to have 12 cases of loose stools. Dog ID # 13490 was observed to have 2 cases of loose stools. Dog ID # 2808987 was observed to have 4 cases of loose stools. Dog ID # 2963028 was observed to have 6 cases of loose stools. Dog ID # 2784123 was observed to have 6 cases of loose stools. Occasional episodes of loose stools and bile vomiting were not uncommon in the canine colony and were not considered to be related to the test substance. Clinical observations are listed in Table 20.

[0299] [Table 20]

[0300] conclusion There were no adverse effects on body weight or food intake. Group mean alkaline phosphatase levels showed a slight increase during the study without exceeding the normal reference range. Remaining hematological and serological results remained within the normal limits throughout the study, and no significant trends were observed over the long term. No clinical observations considered to be related to the administration of the test substance were observed in any of the dogs during the course of this study. The overall tolerability of this treatment was 96.7%, with 5 out of 8 dogs consuming the treatment with 100% probability over the duration of this study.

[0301] Example 13: Pilot study in dogs A pilot study was conducted to evaluate the efficacy of ElleVet Mobility Oil in the treatment of osteoarthritis in dogs.

[0302] method As shown in Tables 21 and 22, five dogs suffering from end-stage osteoarthritis, arthralgia, and senile pain were selected for this study.

[0303] Following the manufacturer's instructions, dogs were administered a loading dose of 2 mg / kg every 12 hours for the first two weeks, then reduced to 1 mg / kg every 12 hours for two weeks. The dogs were then returned to a dose of 2 mg / kg every 12 hours for the final four weeks of this study.

[0304] On days 0, 14, 30, and 60, dogs were evaluated by flexion and extension measurements, muscle tissue measurements, a simplified canine pain questionnaire, and gait analysis using a pressure-sensing passage.

[0305] [Table 21]

[0306] [Table 22]

[0307] result Three out of five owners (60%) reported significant improvements in pain severity scores and pain interference scores. Gait analysis, as shown in Tables 23-24 and Figures 5A-5F, revealed that total pressure index (TPI%), stride-to-step ratio, and stance phase ratio did not significantly improve or decrease throughout the study. Flexion improved in three out of five dogs and decreased by more than 5 degrees in two of them. Extension improved in two out of five dogs and decreased in one of them. After completion of the study, three out of four owners who responded to the questionnaire indicated they would like to continue using this supplement. Improvements observed by owners included improvements in function and comfort (lying down, standing, resting, walking, energy, playing, and overall health).

[0308] [Table 23]

[0309] [Table 24]

[0310] [Table 25]

[0311] [Table 26]

[0312] [Table 27]

[0313] [Table 28]

[0314] [Table 29]

[0315] [Table 30]

[0316] [Table 31]

[0317] [Table 32]

[0318] [Table 33]

[0319] [Table 34]

[0320] Example 14: Safety study of cats A 12-week safety study was conducted in cats to evaluate the safety of oil containing CBD.

[0321] Animal and research design As shown in Table 35, eight cats aged 2 to 6 years with a weight of 3.33 to 5.17 kg at the start of the study were selected for this research.

[0322] [Table 35]

[0323] Cats were housed individually in cages of a size compliant with the Animal Welfare Act, under target conditions of 50°–85°F and a 12-hour light / 12-hour dark cycle. Cages, food bowls, water bowls, and litter boxes were cleaned and disinfected daily in accordance with the Animal Welfare Act. Fresh tap water suitable for human consumption was freely available in stainless steel bowls. No known contaminants, reasonably expected to be present in the feed materials, were found to be potentially hindering the purpose or conduct of this study.

[0324] During this study, the sole source of food supplied to each animal once daily for approximately 4 hours was the control diet Purina Cat Chow. Cats were fed according to their ideal physical condition and fasted for at least 12 hours prior to blood collection. CBD oil was administered orally twice daily using a 1 ml syringe at a dose of 2 mg / kg. The total dose per 24 hours was 4 mg / kg. The administration is shown in Tables 36 and 37.

[0325] [Table 36]

[0326] [Table 37]

[0327] CBC and Serum Chemistry Before the start of the study, 5 ml of blood was collected from each cat and used to determine its eligibility for the study. During the study, 5 ml of blood was collected weekly (±2 days). Blood was collected by jugular vein puncture using a sterile syringe. The samples were divided into two tubes: a serum separator tube with a red stopper and an EDTA tube with a lavender stopper. The tube with the red stopper was centrifuged in a refrigerated centrifuge at 3000 RPM for 15 minutes after coagulation. The tube with the lavender stopper was placed on a locker to allow the blood and anticoagulant to mix thoroughly. The blood samples were packaged and sent to Antech Diagnostics for analysis on a priority overnight basis.

[0328] Pharmacokinetic (PK) blood sampling On the first day of administration, blood samples were collected from 6 of the 8 cats for PK analysis. The most cooperative cat was selected for PK analysis. Approximately 4 ml of blood was collected by jugular vein puncture with a sterile syringe one day before the procedure (time 0), and then at 1, 4, 8, and 24 hours after the procedure. The samples were placed in coagulation tubes with red stoppers that did not have serum separators. Serum was recovered by centrifugation at 3000 RPM for 15 minutes. The recovered serum was placed in cryovials and stored at -70°C. Each tube was labeled with the cat ID, collection date, and collection time. The samples were transported overnight on dry ice to the Proteomics & Metabolomics Facility at Colorado State University.

[0329] Clinical observation Veterinarians performed a complete physical examination of all cats before and after the start of this study. Each cat was evaluated for overall health, physical condition, and coat condition. Qualified personnel performed clinical observations twice daily in accordance with Summit Ridge Farms' Program of Veterinary Care and SOP VC-003 (Rounds Observations). All animals were evaluated twice daily with reference to SOP VC-016 (Recognizing Pain, Stress, and / or Distress). Clinical laboratory diagnostic procedures were performed as needed. Veterinary care was provided appropriately to each individual animal in accordance with the Program of Veterinary Care.

[0330] blood analysis Blood was analyzed for white blood cell count, red blood cell count, hemoglobin, hematocrit, MCV, MCHC, MCH, and platelet count, along with complete differentiation. In addition, a 22-test chemistry screen was performed, consisting of glucose, urea nitrogen, creatinine, total protein, albumin, total bilirubin, alkaline phosphatase, ALT, AST, CPK, cholesterol, calcium, phosphorus, sodium, potassium, chloride, A / G ratio, BUN / creatinine ratio, globulin, triglycerides, GGTP, and magnesium. Measurements were performed before the start of this study and then weekly throughout the course of the study.

[0331] PK analysis Extraction of cannabidiol from cat serum for LC-MS. Aliquots of cat serum were delivered to the facility on dry ice and stored at -80°C upon receipt. For cannabidiol (CBD) extraction, the serum was thawed on ice, and 50 μL of each sample was placed in a 2.0 ml glass extraction vial (VWR ROBO Unassembled Autosampler Vial) and kept cool on ice. 200 μL of cold (-20°C) 100% acetonitrile (with 60 ng / mL of d3-CBD added) was added to each sample and vortexed at room temperature for 5 minutes. 200 μL of water was added and vortexed for another 5 minutes. Then, 1 ml of 100% hexane was added to each sample and vortexed for the last 5 minutes. Phase separation was enhanced by centrifugation at 3000 rpm for 15 minutes at 4°C. The upper hexane layer was transferred to newly labeled glass vials (approximately 900 μL per sample), carefully avoiding the intermediate and lower layers. The sample was concentrated to dryness under N2 and resuspended in 60 μL of 100% acetonitrile (Zgair et al. (2015) J Pharm Biomed Anal. 114:145-51).

[0332] standard curve Using blank serum, an 8-point standard curve for CBD was constructed against a matrix background. The concentrations ranged from 0 ng / mL to 1000 ng / mL (3.2-fold dilution series). 50 μL of each added serum sample was extracted as described above.

[0333] LC-MS / MS analysis LC-MS / MS was performed using a Waters Acquity M-Class UPLC connected to a Waters Xevo TQ-S triple quadrupole mass spectrometer. Chromatographic separation was performed using a Waters BEH C18 iKey Separation Device (150 μm × 50 mm, 1.7 μM). The mobile phases were 99.9% acetonitrile, 0.1% formic acid (B), and water containing 0.1% formic acid (A). The analytical gradients were as follows: time = 0 min, 70% B; time = 1.0 min, 70% B; time = 6 min, 100% B; time = 7.0 min, 100% B; time = 7.5 min, 70% B. The total run time was 10 minutes. The flow rate was 3.0 μL / min, and the injection volume was 2.0 μL. The samples were held in an autosampler at 6°C, and the column was operated at 70°C. The MS was operated in Selective Reaction Monitoring (SRM) mode. The parent ion was selected by the first quadrupole and fragmented in the collision cell, and then the fragment ion was selected by the third quadrupole. The product ion, collision energy, and cone voltage were optimized for each analyte by direct injection of individual synthetic standards. The inter-channel delay was set to 3 ms. The MS was operated in cationization mode with the capillary voltage set to 3.6 kV. The source temperature was 120°C, and the desolvation temperature was 992°C. The desolvation gas flow rate was 1 L / hour, the cone gas flow rate was 150 L / hour, and the collision gas flow rate was 0.2 mL / min. The nebulizer pressure (nitrogen) was set to 7 Bar. Argon was used as the collision gas.

[0334] Data analysis and statistics All raw data files were imported into the Skyline open-source software package (MacLean et al. (2010) Bioinformatics. 26(7):966-8). Each target analyte was visually inspected for retention time and peak area integration. Peak areas for the target compounds detected in the biological samples were extracted and normalized to the peak areas of appropriate internal standards in each sample using an in-house R script (TQS-tool). CBD concentration was calculated in nanograms per milliliter of extract (0.06 mL) and then converted back to nanograms per milliliter of serum (0.05 mL).

[0335] Calculating variance using QC pool All serum samples (cat and dog) were pooled in 50 μL portions into a single Quality Control sample, and 50 μL was extracted as described above. This QC pool was injected every 10 samples, and the technical variance over the data acquisition process was measured using CBD concentration.

[0336] Limit of Detection (LOD) and Limit of Quantification (LOQ) LOD and LOQ represent the detection limit and quantification limit of each compound in the matrix of this study. LOD is given by the formula: LOD = 3 * The standard deviation (Sy) of the response to the zero-point calibration criterion (i.e., CBD of 0 ng / mL as an estimate of noise) and the slope (S) of the calibration curve at a level approximating the LOD are calculated according to (Sy / S). LOQ = 10 * (Sy / S). Sy in y is the standard deviation used to calculate LOD and LOQ (Shrivastava (2011) Chronicles of Young Scientists. 2:21-5; Broccardo et al. (2013) Chromatogr B Analyt Technol Biomed Life Sci. 934:16-21).

[0337] result body weight The average weight change in cats during the 12-week period of this study was 0.06 kg (1.04%). Weight data are shown in Tables 38 and 39.

[0338] [Table 38]

[0339] [Table 39]

[0340] Feeding amount The average daily food intake per week for cats during this study was 62g. Food intake data is shown in Tables 40 and 41.

[0341] [Table 40]

[0342] [Table 41]

[0343] Acceptability of the test substance Overall, all cats exhibited behaviors such as aversion to the test substance, licking, spitting, walking slowly, shaking their heads, chewing noisily, and anger towards the dose (uncooperative behavior) at various intervals throughout the study. The results are shown in Tables 42-69.

[0344] [Table 42]

[0345] [Table 43]

[0346] [Table 44]

[0347] Table 45

[0348] Table 46

[0349] Table 47

[0350] Table 48

[0351] Table 49

[0352] Table 50

[0353] Table 51

[0354] Table 52

[0355] Table 53

[0356] Table 54

[0357] Table 55

[0358] Table 56

[0359] Table 57

[0360] Table 58

[0361] Table 59

[0362] Table 60

[0363] Table 61

[0364] Table 62

[0365] Table 63

[0366] Table 64

[0367] [Table 65]

[0368] [Table 66]

[0369] [Table 67]

[0370] [Table 68]

[0371] [Table 69]

[0372] Hematology and Serum Chemistry From week 2 onward, the mean alanine aminotransferase (ALT) levels in the group increased. This level remained elevated from baseline until the end of the study. Throughout the study, mild elevations in individual ALT levels were observed in the majority of cats. Cat 13CNL3 had the highest ALT (above the normal reference range of 100 U / L) and simultaneously high aspartate aminotransferase (AST). From week 4 onward, this cat's ALT and AST levels began to decrease but remained elevated from baseline. The ALT level remained above the normal reference range shown in Table 70 throughout the duration of the study. Similarly, during week 2, the ALT levels of cats 13IRD3 and 13CPJ7 increased by 23–31 U / L from baseline, respectively. The ALT level of cat 13CPJ7 returned to baseline by week 10. At week 4, the ALT of cat 13CCL1 increased by 32 U / L from baseline. Levels returned to baseline by week 10. The test substance appeared to cause mild ALT changes in most cats, and one cat remained elevated above the normal limit throughout the study. Group mean values ​​for all other blood parameters remained within the normal limits, and no clear trends were observed. Hematological and serological results are shown in Tables 71-74.

[0373] [Table 70]

[0374] [Table 71]

[0375] [Table 72]

[0376] [Table 73]

[0377] [Table 74]

[0378] Clinical observation During this study, occasional episodes of loose stools and vomiting were recorded, as shown in Table 75. Five cases of food vomiting were observed in cat ID# 13CCL1. One case of hairball vomiting and one case of hair and bile vomiting were observed in cat ID# 13CNL3. One case of food vomiting was observed in cat ID# 13IRD3. Three cases of food vomiting and one case of hair and bile vomiting were observed in cat ID# 15EGA5. Two cases of hairball vomiting and one case of food vomiting were observed in cat ID# GJY3. Occasional episodes of hairball and food vomiting are not uncommon in the cat colony and were not considered to be associated with the test substance.

[0379] [Table 75]

[0380] PK data Table 76 shows the quantitative analysis of cannabidiol in feline serum, and Table 77 shows the pharmacokinetics of feline cannabidiol.

[0381] [Table 76]

[0382] [Table 77]

[0383] [Table 78]

[0384] The LOD of CBD in cat serum was calculated to be 1.9 ng / mL (ppb in serum). The LOQ of CBD in cat serum was calculated to be 6.2 ng / mL (ppb in serum).

[0385] conclusion There were no adverse effects on body weight or food intake. Group mean alanine aminotransferase levels increased throughout this study, peaking at week 2. Levels decreased over the following weeks but did not return to baseline levels. One cat (13CNL3) had significantly elevated ALT levels throughout the study, remaining above the normal reference range for the duration of treatment. The remaining group mean hematological and serological values ​​remained within the normal reference limits throughout the study, and no clear trends were observed over the long term. No adverse clinical observations considered to be associated with the administration of the test substance were observed in any of the cats during the course of this study. However, the test substance was considered to have low tolerability.

[0386] The subject matter disclosed is not limited in scope by the specific embodiments and examples described herein. In practice, various modifications of this disclosure, in addition to those described, will be apparent to those skilled in the art from the foregoing description and the accompanying drawings. Such modifications are intended to be included within the scope of the accompanying claims.

[0387] All references cited herein (e.g., publications, patents, or patent applications) are incorporated herein by reference in the same manner as each individual reference (e.g., publications, patents, or patent applications) was specifically and individually indicated so as to be incorporated by reference in whole for all purposes. Other embodiments are included in the following claims.

Claims

1. An orally delivered pharmaceutical composition characterized by comprising a hemp extract and a carrier, wherein the hemp extract is Cannabidiol; Cannabidiolic acid Cannabigerol acid; and Δ9-tetrahydrocannabinol Includes, The ratio of cannabidiol to cannabidiolic acid is approximately 0.6:1 to approximately 1:0.6; The ratio of Δ9-tetrahydrocannabinol to other cannabinoids is 1:50 to 1:

20. Pharmaceutical composition.

2. The aforementioned hemp extract is Cannabide chromium The pharmaceutical composition according to claim 1, further comprising:

3. The pharmaceutical composition according to claim 1 or 2, characterized in that the ratio of cannabidiol to cannabidiolic acid is approximately 1:

1.

4. A pharmaceutical composition for oral delivery comprising hemp extract, The aforementioned hemp extract is Cannabidiol; Cannabidiolic acid; Cannabigerol acid; Δ9-tetrahydrocannabinol; and Cannabide chromium Includes, The ratio of cannabidiol to cannabidiolic acid is approximately 0.6:1 to approximately 1:0.6; An orally delivered pharmaceutical composition characterized by a ratio of Δ9-tetrahydrocannabinol to other cannabinoids of 1:50 to 1:

20.

5. The pharmaceutical composition according to claim 4, characterized in that cannabidiol; cannabidiolic acid; cannabigerolic acid; Δ9-tetrahydrocannabinol; and cannabichromene are contained in the hemp extract.

6. The aforementioned hemp extract is α-pinene; β-myrcene; β-pinene; δ-limonene; Linalool; β-caryophyllene; α-humulene; Nerolidol 2; Guaiol; Caryophyllene oxide; and α-Bisabolol A pharmaceutical composition according to any one of claims 1 to 5, further comprising four or more of the above.

7. The pharmaceutical composition according to any one of claims 1 to 6, characterized in that the concentration of Δ9-tetrahydrocannabinol is insufficient to produce a psychotropic effect.

8. The pharmaceutical composition according to any one of claims 1 to 7, characterized in that the ratio of Δ9-tetrahydrocannabinol to other cannabinoids is about 1:

25.

9. The concentration of Δ9-tetrahydrocannabinol is less than approximately 1 mg / mL, or The concentration of Δ9-tetrahydrocannabinol is less than approximately 0.5 mg / mL, or The concentration of Δ9-tetrahydrocannabinol is less than approximately 0.3 mg / mL, or The concentration of Δ9-tetrahydrocannabinol is less than approximately 0.2 mg / mL, or The concentration of Δ9-tetrahydrocannabinol is less than approximately 0.1 mg / mL. A pharmaceutical composition according to any one of claims 1 to 8, characterized in that

10. The aforementioned hemp extract is Cannabidiol at approximately 1-10 mg / mL; Cannabidiolic acid at approximately 1-10 mg / mL; Cannabigerol acid at approximately 0.05–0.2 mg / mL; Approximately 0.1–0.3 mg / mL of Δ9-tetrahydrocannabinol; and Approximately 0.1–0.4 mg / mL of cannabichromene including, or Depending on the circumstances, the hemp extract may be Approximately 5 mg / mL of cannabidiol; Approximately 5 mg / mL of cannabidiolic acid; Approximately 0.11 mg / mL of cannabigerol acid; Approximately 0.25 mg / mL of Δ9-tetrahydrocannabinol; and Approximately 0.27 mg / mL of cannabichromene A pharmaceutical composition according to any one of claims 1 to 9, characterized by containing the following:

11. The aforementioned hemp extract is 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; Approximately 0.04–0.08% caryophyllene oxide; and Approximately 0.01-0.04% α-bisabolol A pharmaceutical composition according to any one of claims 1 to 10, characterized by containing the following:

12. The aforementioned hemp extract is Camphen; β-Ocimene; Eucalyptol; Isoplegol; and / or Nerolidol 1 Further including, and Depending on the circumstances, the hemp extract may be Approximately 0.02% camphene; Approximately 0.02–0.03% β-ocimene; Approximately 0.02–0.05% eucalyptol; Approximately 0.02% isopuregol; and / or Approximately 0.02-0.04% nerolidol 1 A pharmaceutical composition according to any one of claims 1 to 11, characterized by containing the following:

13. The pharmaceutical composition according to any one of claims 1 to 12, characterized in that the hemp extract contains 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15 or more of the following: α-pinene, β-myrcene, β-pinene, δ-limonene, linalool, β-caryophyllene, α-humulene, nerolidol 2, guaiol, caryophyllene oxide, α-bisabolol, camphene, β-ocimene, eucalyptol, isopulegol, and nerolidol 1.

14. The pharmaceutical composition according to any one of claims 1 to 13, characterized in that the composition is incorporated into 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, and grape seed oil. Depending on the circumstances, The carrier is grape seed oil. or The carrier is catnip oil, in this pharmaceutical composition.

15. The pharmaceutical composition according to any one of claims 1 to 14, characterized in that the composition comprises nepetalactone and / or taurine.

16. The pharmaceutical composition according to any one of claims 1 to 15, wherein the composition is formulated as pet food or an orally administered chewing agent.

17. The weight of the chewing agent is approximately 0.5 to 10 g. Depending on the circumstances, The weight of the chewing agent is approximately 4g, 6g, 9g, or 10g. And / or The weight of the aforementioned chewing agent is approximately 4g. The pharmaceutical composition according to claim 16, characterized in that...

18. The aforementioned chewing agent is Cannabidiol approximately 7 mg; Cannabidiolic acid, approximately 6 mg; Cannabigerol acid, approximately 0.12 mg; Δ9-tetrahydrocannabinol approximately 0.32 mg; and Cannabichromene approx. 0.36 mg The pharmaceutical composition according to claim 17, characterized by containing the following:

19. A pharmaceutical composition according to any one of claims 1 to 18, and One or more pharmaceutically acceptable additives, fragrances, surfactants, and adjuvants A dosage form characterized by containing [the specified ingredient].

20. The dosage form according to claim 19, characterized in that it is formulated as an orally administered chewable preparation, as a sublingual spray, as a powder, as a tablet, as a capsule, as a hard chewable preparation, or incorporated into an orally administered carrier.

21. The dosage form according to claim 20, characterized in that the chewing agent is manufactured using cold extrusion.

22. The carrier is selected from the group consisting of linseed oil, olive oil, fish oil, salmon oil, coconut oil, catnip oil, sesame oil, and grape seed oil. Depending on the circumstances, The carrier is grape seed oil; The carrier is catnip oil. The dosage form according to claim 20, characterized in that it is the same as the one described in claim 20.

23. Glucosamine HCl; Chondroitin sulfate (76%); Brewer's yeast; Gum arabic; Guar gum; Flavoring agent; Verdilox; Previon; Hemp extract; Glycerin; Sunflower lecithin; and water A dosage form according to any one of claims 19 to 22, characterized by containing the following:

24. 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% fragrance; Approximately 0.01–0.1% Verdilox; Previon of approximately 0.5-1.5%; Approximately 3-6% hemp extract; Approximately 13-17% glycerin; Approximately 3-7% sunflower lecithin; and Approximately 3-7% water including, Depending on the circumstances, 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% fragrance; Approximately 0.05% Verdilox; Approximately 0.9% Previon; Approximately 4.7% hemp extract; Approximately 15.1% glycerin; Approximately 5.7% sunflower lecithin; and Approximately 5.7% water The dosage form according to claim 23, characterized by containing the following:

25. Glucosamine HCl; Hyaluronic acid; Brewer's yeast; Gum arabic; Guar gum; Flavoring agent; Verdilox; Previon; Hemp extract; Glycerin; Sunflower lecithin; and water A dosage form according to any one of claims 19 to 22, characterized by containing the following:

26. Approximately 12-17% glucosamine HCl; Approximately 0.01-1% hyaluronic acid; Approximately 29-33% brewer's yeast; Approximately 3-6% gum arabic; Approximately 0.5-2% guar gum; Approximately 12-16% fragrance; Approximately 0.01–0.1% Verdilox; Previon of approximately 0.5-1.5%; Approximately 3-6% hemp extract; Approximately 13-17% glycerin; Approximately 3-7% sunflower lecithin; and Approximately 3-7% water including, Depending on the circumstances, 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% fragrance; Approximately 0.05% Verdilox; Approximately 0.97% Previon; Approximately 4.8% hemp extract; Approximately 15.5% glycerin; Approximately 5.8% sunflower lecithin; and Approximately 5.8% water The dosage form according to claim 25, characterized by containing the following:

27. Hemp 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 Guar gum A dosage form according to any one of claims 19 to 22, characterized by containing the following:

28. Approximately 5.0% hemp extract; Approximately 15.0% peanut butter; Approximately 12.5% ​​rice bran; Approximately 12.75% glucosamine HCl; Approximately 5.5% sweet potatoes; Approximately 8.0% dried molasses; Approximately 1% sorbic acid; Approximately 5.0% brewer's yeast; Approximately 6.0% sugar; Approximately 9.25% water; Approximately 13.0g of glycerin; Approximately 2.0% potato starch; Dehydrated peanut butter with approximately 1.0% moisture content; Approximately 2.0% rice starch; and Approximately 2.0% guar gum including, Depending on the circumstances, Approximately 5.0% hemp extract; Approximately 15.0% peanut butter; Approximately 13.0% rice bran; Approximately 8.5% glucosamine HCl; Approximately 6.0% sweet potatoes; Approximately 9.0% dried molasses; Approximately 1% sorbic acid; Approximately 5.0% brewer's yeast; Approximately 6.0% sugar; Approximately 9.5% water; Approximately 13.0g of glycerin; Approximately 4.0% potato starch; Dehydrated peanut butter with approximately 1.0% moisture content; Approximately 2.0% rice starch; and Approximately 2.0% guar gum including, Furthermore, in some cases, Approximately 3.0-10.0% hemp extract; Approximately 10.0-20.0% peanut butter; Approximately 10.0-15.0% rice bran; Approximately 5.0-15.0% glucosamine HCl; Approximately 4.0-10.0% sweet potatoes; Approximately 6.0-13.0% dried molasses; Approximately 0.5-5.0% sorbic acid; Approximately 2.0-8.0% brewer's yeast; Approximately 3.0-8.0% sugar; Approximately 5.0-15.0% water; Approximately 8.0-18.0% glycerin; Approximately 1.0-8.0% potato starch; Dehydrated peanut butter with a concentration of approximately 0.5-5.0%; Approximately 1.0-5.0% rice starch; and Approximately 1.0-5.0% guar gum The dosage form according to claim 27, characterized by containing the following:

29. The dosage form according to claim 27 or 28, characterized in that it contains about 5.0% hemp extract.

30. The aforementioned flavoring is selected from the group consisting of catnip oil, chicken liver powder, poultry meat extract, maltodextrin, butter, and bacon. The aforementioned flavoring is chicken liver powder, or The aforementioned fragrance is catnip oil. A dosage form according to any one of claims 23 to 26, characterized in that

31. The dosage form according to any one of claims 23 to 30, characterized in that it contains nepetalactone and taurine.

32. The use of the composition according to any one of claims 1 to 18, or the dosage form according to any one of claims 19 to 31, in the manufacture of a medicament for treating or alleviating pain in a veterinary subject in need.

33. The use according to claim 32, characterized in that the pain is accompanied by arthritis, postoperative pain, acute pain, toothache, pain accompanied by gingivitis, or polyarthritis.

34. The pharmaceutical composition or dosage form is formulated to be administered twice a day at a dose of approximately 1.0 mg / kg. The pharmaceutical composition or dosage form is formulated to be administered three times a day at a dose of approximately 1.0 mg / kg. The pharmaceutical composition or dosage form is formulated to be administered twice a day at a dose of approximately 2.0 mg / kg. A pharmaceutical composition or dosage form is formulated to be administered three times a day at a dose of approximately 2.0 mg / kg, or The use according to claim 32 or 33, characterized in that the pharmaceutical composition or dosage form is formulated to be administered in a dose of about 0.1 to 8.0 mg / kg.

35. The pharmaceutical composition or dosage form is formulated to be administered at twice the therapeutically effective dose over one week, and thereafter at a therapeutically effective dose. The therapeutically effective dose is approximately 0.1 to 0.5 mg / kg. The therapeutically effective dose is approximately 2 mg / kg, or The therapeutically effective dose is approximately 8 mg / kg. The use according to any one of claims 32 to 34, characterized in that

36. The use according to any one of claims 32 to 35, characterized in that the pharmaceutical composition or dosage form is formulated to be administered at a dose of approximately 1 mg / kg over one week, and thereafter at a dose of approximately 0.1 to 0.5 mg / kg.

37. The use according to any one of claims 32 to 35, characterized in that the pharmaceutical composition or dosage form is formulated to be administered at a dose of approximately 4 mg / kg over one week, and then at a dose of approximately 2 mg / kg thereafter.

38. Through the aforementioned use, the median maximum serum concentration of cannabidiol that is therapeutically effective can be obtained. The median maximum serum concentration of the aforementioned cannabidiol is approximately 102 ng / mL. or The median maximum serum concentration of the aforementioned cannabidiol is approximately 590 ng / mL. The use according to any one of claims 32 to 37, characterized in that

39. The aforementioned veterinary subjects are dogs, cats, cattle, pigs, or horses. Depending on the circumstances, The aforementioned veterinary subject is a dog, or The aforementioned veterinary subject is a cat. The use according to any one of claims 32 to 38, characterized in that

40. The use of hemp extract in the manufacture of a pharmaceutical product for treating or alleviating arthritis pain, postoperative pain, acute pain, toothache, gingivitis pain, or polyarthralgia in a veterinary subject in need, wherein the hemp extract is Cannabidiol; Cannabidiolic acid; Cannabigerol acid; Δ9-tetrahydrocannabinol; and Cannabide chromium Includes, The ratio of cannabidiol to cannabidiolic acid is approximately 0.6:1 to approximately 1:0.6; The ratio of Δ9-tetrahydrocannabinol to other cannabinoids is 1:50 to 1:20, according to usage guidelines.

41. The use according to claim 40, wherein the hemp extract is formulated to be administered in a dose of approximately 0.1 to 8.0 mg / kg.

42. The hemp extract is formulated to be administered at twice the therapeutically effective dose for one week, and thereafter at a therapeutically effective dose. The therapeutically effective dose is approximately 0.1 to 0.5 mg / kg. The therapeutically effective dose is approximately 1 mg / kg. The therapeutically effective dose is approximately 2 mg / kg. or The therapeutically effective dose is approximately 8 mg / kg. The use according to claim 40 or 41, characterized in that it is the same as the use according to claim 40 or 41.

43. The aforementioned hemp extract is formulated to be administered at a dose of approximately 1 mg / kg over one week, and then at a dose of approximately 0.1 to 0.5 mg / kg thereafter. Depending on the circumstances, The aforementioned hemp extract is formulated to be administered at a dose of approximately 4 mg / kg over one week, and then at a dose of approximately 2 mg / kg thereafter. The use according to any one of claims 40 to 42, characterized in that

44. Through the aforementioned use, the median maximum serum concentration of cannabidiol that is therapeutically effective can be obtained. The median maximum serum concentration of the aforementioned cannabidiol is approximately 102 ng / mL. Or, The median maximum serum concentration of the aforementioned cannabidiol is approximately 590 ng / mL. The use according to any one of claims 40 to 43, characterized in that

45. The aforementioned veterinary subjects are dogs, cats, cattle, pigs, or horses. Depending on the circumstances, The aforementioned veterinary subject is a dog. Or, The aforementioned veterinary subject is a cat. The use according to any one of claims 40 to 44, characterized in that

46. The use of hemp extract in the manufacture of a pharmaceutical product for achieving a 0-24 hour area under the cannabidiol curve of 42.4-3048 ng / hour / ml in veterinary subjects, wherein the hemp extract is Cannabidiol; Cannabidiolic acid; Cannabigerol acid; Δ9-tetrahydrocannabinol; and Cannabide chromium Includes, The ratio of cannabidiol to cannabidiolic acid is approximately 0.6:1 to approximately 1:0.6; The ratio of Δ9-tetrahydrocannabinol to other cannabinoids is 1:50 to 1:20, according to usage guidelines.

47. The use according to claim 46, characterized in that the subject is a dog or a cat.

48. The pharmaceutical composition according to claim 1 or 4, wherein the hemp extract does not contain terpenes.

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