Hemp extract and methods of use thereof

Abstract

To provide hemp extract and its use methods for veterinary subjects.SOLUTION: The present invention relates to a composition comprising hemp extract used for treating atopic conditions in veterinary subjects, the method comprising administering to a subject in need thereof a therapeutically effective amount of hemp extract.SELECTED DRAWING: None

Description

Technical Field

[0001] Cross - Reference to Related Applications This application claims the benefit of U.S. Provisional Patent Application No. 62 / 933,340, filed on November 8, 2019, the entire disclosure of which is incorporated herein by reference.

Background Art

[0002] Industrial hemp products with low THC (0.3%) and higher amounts of other cannabinoids have been reported to have health benefits including analgesia, anti - anxiety, anti - inflammatory, anti - anxiolytic, and anti - seizure effects and are legal under industrial hemp laws. There are numerous online companies selling cannabis products, including CBD oils, which claim to be safe and effective for various medical conditions in humans as well as their pets. A recent survey by the American Holistic Veterinary Medical Association revealed that approximately 60% of people who purchase cannabis products online are using these products on their dogs. However, little data has been published to support the claims of safety and efficacy in human and veterinary patients. When optimal treatments do not exist for both people and their pets, other potentially effective agents, including cannabinoids, are often sought.

Prior Art Documents

Patent Documents

[0003]

Patent Document 1

Summary of the Invention

Means for Solving the Problems

[0004] The present disclosure is directed to compositions comprising cannabidiol for the treatment of periuria, diabetes, lung cancer, inflammatory bowel disease, skin conditions, seizures, obsessive - compulsive behavior, migraine, and insect bites in a subject and their use.

[0005] In one aspect, provided herein is a method for treating it in a veterinary subject in need of treatment of urinary house soiling, the method comprising administering to the subject a therapeutically effective amount of a cannabis extract. In one embodiment, the veterinary subject is a dog, cat, cow, pig, or horse. In another embodiment, the veterinary subject is a dog. In another embodiment, the veterinary subject is a cat. In one embodiment, the cat is suffering from chronic pain, urological conditions, anxiety, and / or frustration. In another embodiment, the condition is cystitis. In another embodiment, the condition is feline lower urinary tract disease.

[0006] In one aspect, provided herein is a method for treating it in a veterinary subject in need of treatment of diabetes, lung cancer, inflammatory bowel disease, skin conditions, seizures, or obsessive-compulsive behavior, the method comprising administering to the subject a therapeutically effective amount of a cannabis extract. In one embodiment, the veterinary subject is a mammal. In one embodiment, the mammal is a dog, cat, cow, pig, or horse. In one embodiment, the cannabis extract is administered twice a day. In another embodiment, the cannabis extract is administered at a dosage of about 2 mg / kg.

[0007] In one aspect, provided herein is a method for treating it in a subject in need of treatment of migraine, the method comprising administering to the subject a therapeutically effective amount of a cannabis extract. In another embodiment, the subject is a human. In one embodiment, about 1 mL of the cannabis extract is administered. In one embodiment, about 70 mg of cannabinoid is administered. In another embodiment, the cannabis extract is administered sublingually.

[0008] In one embodiment, the cannabis extract is cannabidiol, and contains cannabidiolic acid, and the ratio of cannabidiol to cannabidiolic acid is from about 0.6:1 to about 1:0.6.

[0009] In another embodiment, the cannabis extract is Cannabigerolic acid, Δ9 - tetrahydrocannabinol, and further comprises cannabichromene.

[0010] In one embodiment, the cannabis extract cannabidiol, cannabidiolic acid, cannabigerolic acid, Δ9 - tetrahydrocannabinol, and comprises cannabichromene, and the ratio of cannabidiol to cannabidiolic acid is from about 0.6:1 to about 1:0.6.

[0011] In another embodiment, the cannabis extract α - pinene, β - myrcene, β - pinene, △ - limonene, linalool, β - caryophyllene, α - humulene, nerolidol 2, guaiol, caryophyllene oxide, and further comprises α - bisabolol.

[0012] In one embodiment, the concentration of Δ9-tetrahydrocannabinol is insufficient to cause psychoactive effects. In another 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 one embodiment, the concentration of Δ9-tetrahydrocannabinol is less than about 0.3 mg / mL. In one embodiment, the concentration of Δ9-tetrahydrocannabinol is less than about 0.2 mg / mL. In one embodiment, the concentration of Δ9-tetrahydrocannabinol is less than about 0.1 mg / mL. In one embodiment, the concentration of Δ9-tetrahydrocannabinol is less than about 0.05 mg / mL. In one embodiment, the concentration of Δ9-tetrahydrocannabinol is less than about 0 mg / mL.

[0013] In one embodiment, the cannabis extract contains about 1-10 mg / mL of cannabidiol, about 1-10 mg / mL of cannabidiolic acid, about 0.05-0.2 mg / mL of cannabigerolic acid, about 0.1-0.3 mg / mL of Δ9-tetrahydrocannabinol, and about 0.1-0.4 mg / mL of cannabinol.

[0014] In one embodiment, the cannabis extract contains 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 cannabinol.

[0015] In another embodiment, the cannabis extract contains about 0.09-0.13% of α-pinene, about 0.23-0.44% 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, About 0.04 to 0.07% of nerolidol 2, About 0.04 to 0.08% of caryophyllene oxide, and About 0.01 to 0.04% of α-bisabolol.

[0016] In one embodiment, the cannabis extract is, camphene, β-ocimene, eucalyptol, isopulegol, and / or nerolidol 1.

[0017] In another embodiment, the cannabis extract is, 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.

[0018] In one embodiment, the composition is formulated with a carrier. In one embodiment, the carrier is selected from the group consisting of cannabis seed oil, flaxseed oil, olive oil, fish oil, salmon oil, coconut oil, catnip oil, sesame oil, MCT oil, and grape seed oil. In one embodiment, the carrier is grape seed oil. In another embodiment, the carrier is catnip oil. In one embodiment, the carrier is sesame seed oil.

[0019] In one embodiment, the composition contains lecithin. In another embodiment, the lecithin is sunflower lecithin. In another embodiment, the sunflower lecithin is up to 40%. In one embodiment, the composition further contains NF-971P. In another embodiment, NF-971P has a weight / volume ratio of up to 2%.

[0020] In one embodiment, the cannabis extract contains nepetalactone. In one embodiment, the cannabis extract contains taurine.

[0021] In one embodiment, the cannabis extract contains cannabidiol, cannabidiolic acid, cannabigerolic acid, Δ9-tetrahydrocannabinol, and cannabichromene, The carrier is grape seed oil.

[0022] 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.

[0023] In one embodiment, the cannabis extract is administered in a dosage form containing one or more pharmaceutically acceptable additives, flavoring agents, surfactants, and adjuvants. In one embodiment, the flavoring agent is selected from the group consisting of peppermint oil, mango extract, beef, chicken, and seafood. In one embodiment, the flavoring agent is selected from the group consisting of peanut butter, catnip oil, chicken liver powder, chicken extract, maltodextrin, butter, and bacon. In another embodiment, the flavoring agent is chicken liver powder. In another embodiment, the flavoring agent is catnip oil. In another embodiment, the flavoring agent is peanut butter.

[0024] In one embodiment, the dosage form contains nepetalactone. In another embodiment, the dosage form contains taurine.

[0025] In one embodiment, the dosage form is formulated as a sublingual spray. In another embodiment, the dosage form is formulated as an aqueous or alcohol-soluble solution, or a cream, for topical or transdermal application. In another embodiment, the dosage form is formulated as a gel for oral or intra-mucosal administration. In another embodiment, the dosage form is formulated as a powder. In another embodiment, the dosage form is formulated as a solution for subcutaneous injection. In another embodiment, the dosage form is formulated as a tablet. In another embodiment, the dosage form is formulated as a capsule. In another embodiment, the dosage form is formulated as a hard chewable. In another embodiment, the dosage form is formulated as a soft chewable. In another embodiment, the dosage form is formulated for administration using a nebulizer. In another embodiment, the dosage form is formulated for inhalation. In another embodiment, the dosage form is formulated for administration using a pet collar. In another embodiment, the dosage form is formulated as pet food for oral administration.

[0026] In one embodiment, the dosage form is formulated as a chew for oral administration. In one embodiment, the chew is produced using cold extrusion. In one embodiment, the weight of the chew is from about 0.5 to 10 g. In another embodiment, the weight of the chew is about 4 g, about 6 g, about 9 g, or about 10 g. In another embodiment, the weight of the chew is about 4 g.

[0027] In one embodiment, the chew comprises about 7 mg of cannabidiol, about 6 mg of cannabidiolic acid, about 0.12 mg of cannabigerolic acid, about 0.32 mg of Δ9-tetrahydrocannabinol, and about 0.36 mg of cannabichromene.

[0028] In one embodiment, the dosage form is formulated with a carrier for oral administration. In one embodiment, the carrier is selected from the group consisting of hemp seed oil, flaxseed oil, olive oil, fish oil, salmon oil, coconut oil, catnip oil, sesame oil, MCT oil, and grape seed oil. In one embodiment, the carrier is grape seed oil. In one embodiment, the carrier is catnip oil. In one embodiment, the carrier is sesame seed oil.

[0029] In one embodiment, the dosage form is glucosamine HCl, chondroitin sulfate (76%), brewer's yeast, gum arabic, guar gum, flavoring agent, Verdilox, Previon, hemp extract, glycerin, sunflower lecithin, and water.

[0030] In another embodiment, the dosage form is about 12 - 17% glucosamine HCl, about 1 - 4% chondroitin sulfate (76%), about 29 - 33% brewer's yeast, about 3 - 6% gum arabic, about 0.5 - 2% guar gum, about 12 - 16% flavoring agent, about 0.01 - 0.1% Verdilox, about 0.5 - 1.5% Previon, about 3 - 6% hemp extract, about 13 - 17% glycerin, about 3 - 7% sunflower lecithin, and about 3 - 7% water.

[0031] In another embodiment, the dosage form is about 15.6% glucosamine HCl, about 2.6% chondroitin sulfate (76%), Approximately 30% brewing yeast, Approximately 4.7% gum arabic, Approximately 0.9% guar gum, Approximately 14.2% flavoring agent, Approximately 0.05% Verdilox, Approximately 0.9% Previon, Approximately 4.7% cannabis extract, Approximately 15.1% glycerin, Approximately 5.7% sunflower lecithin, and Approximately 5.7% water.

[0032] In one embodiment, the dosage form is Glucosamine HCl, Hyaluronic acid, Brewing yeast, Gum arabic, Guar gum, Flavoring agent, Verdilox, Previon, Cannabis extract, Glycerin, Sunflower lecithin, and Water.

[0033] In another embodiment, the dosage form is Approximately 12 - 17% Glucosamine HCl, Approximately 0.01 - 1% Hyaluronic acid, Approximately 29 - 33% brewing yeast, Approximately 3 - 6% gum arabic, Approximately 0.5 - 2% guar gum, Approximately 12 - 16% flavoring agent, Approximately 0.01 - 0.1% Verdilox, Approximately 0.5 - 1.5% Previon, Approximately 3 - 6% cannabis extract, Approximately 13 - 17% glycerin, Approximately 3 - 7% sunflower lecithin, and Approximately 3 - 7% water.

[0034] In another embodiment, the dosage form is Approximately 16% glucosamine HCl, Approximately 0.1% hyaluronic acid, Approximately 30.6% brewing yeast, Approximately 4.8% gum arabic, Approximately 0.97% guar gum, Approximately 14.5% flavoring agent, Approximately 0.05% Verdilox, Approximately 0.97% Previon, Approximately 4.8% cannabis extract, Approximately 15.5% glycerin, Approximately 5.8% sunflower lecithin, and Contains approximately 5.8% water.

[0035] In one embodiment, the dosage form is Cannabis extract, Peanut butter, Rice bran, Glucosamine HCl, Sweet potato, Dried molasses, Sorbic acid Brewing yeast, Sugar, Water, Glycerin, Potato starch, Dried peanut butter, Rice starch, and Contains guar gum.

[0036] In another embodiment, the dosage form is Approximately 3.0 - 10.0% cannabis extract, Approximately 10.0 - 20.0% peanut butter, Approximately 10.0 - 15.0% rice bran, Approximately 5.0 - 15.0% glucosamine HCl, Approximately 4.0 - 10.0% sweet potato, Approximately 6.0 - 13.0% dried molasses, Approximately 0.5 - 5.0% sorbic acid, Approximately 2.0 - 8.0% brewing yeast, Approximately 3.0 - 8.0% sugar, Approximately 5.0 - 15.0% water, About 8.0 to 18.0% glycerin, about 1.0 to 8.0% potato starch, about 0.5 to 5.0% dry peanut butter, about 1.0 to 5.0% rice starch, and about 1.0 to 5.0% guar gum.

[0037] In another embodiment, the dosage form is about 5.0% cannabis extract, about 15.0% peanut butter, about 12.5% rice bran, about 12.75% glucosamine HCl, about 5.5% sweet potato, about 8.0% dry molasses, about 1% sorbic acid, about 5.0% brewing yeast, about 6.0% sugar, about 9.25% water, about 13.0% glycerin, about 2.0% potato starch, about 1.0% dry peanut butter, about 2.0% rice starch, and about 2.0% guar gum.

[0038] In another embodiment, the dosage form is about 5.0% cannabis extract, about 15.0% peanut butter, about 13.0% rice bran, about 8.5% glucosamine HCl, about 6.0% sweet potato, about 9.0% dry molasses, about 1% sorbic acid, about 5.0% brewing yeast, about 6.0% sugar, about 9.5% water, about 13.0% glycerin, about 4.0% potato starch, about 1.0% dry peanut butter, Contains about 2.0% rice starch and about 2.0% guar gum.

[0039] In one embodiment, the dosage form is cannabis extract, peanut butter, rice bran, glucosamine HCl, sweet potato, dried molasses, sorbic acid brewer's yeast, sugar, water, glycerin, potato starch, dried peanut butter, DigestaWell PET, rice starch, and guar gum.

[0040] In another embodiment, the dosage form is about 3.0 - 10.0% cannabis extract, about 5.0 - 20.0% peanut butter, about 10.0 - 15.0% rice bran, about 5.0 - 15.0% glucosamine HCl, about 4.0 - 10.0% sweet potato, about 6.0 - 13.0% dried molasses, about 0.5 - 5.0% sorbic acid, about 2.0 - 8.0% brewer's yeast, about 3.0 - 8.0% sugar, about 5.0 - 15.0% water, about 8.0 - 18.0% glycerin, about 1.0 - 8.0% potato starch, about 0.5 - 5.0% dried peanut butter, about 0.1 - 3.0% DigestaWell PET, about 1.0 - 8.0% rice starch, and about 1.0 - 5.0% guar gum.

[0041] In another embodiment, the dosage form is about 5.0% cannabis extract, about 10.0% peanut butter, about 12.0% rice bran, about 12.75% glucosamine HCl, about 5.5% sweet potato, about 8.0% dried molasses, about 1% sorbic acid, about 5.0% brewer's yeast, about 6.0% sugar, about 7.25% water, about 10.0% glycerin, about 5.0% potato starch, about 4.0% dried peanut butter, about 0.5% DigestaWell PET, about 6.0% rice starch, and about 2.0% guar gum.

[0042] In yet another embodiment, the dosage form is about 5.0% cannabis extract, about 10.0% peanut butter, about 12.5% rice bran, about 8.5% glucosamine HCl, about 8.0% sweet potato, about 9.0% dried molasses, about 1% sorbic acid, about 5.0% brewer's yeast, about 6.0% sugar, about 6.0% water, about 10.0% glycerin, about 6.0% potato starch, about 4.0% dried peanut butter, about 0.5% DigestaWell PET, about 6.5% rice starch, and about 2.0% guar gum.

[0043] In one embodiment, the dosage form is cannabis extract, Peanut butter, rice bran, glucosamine HCl, sweet potato, dried molasses, sorbic acid brewer's yeast, sugar, water, glycerin, potato starch, dried peanut butter, chondroitin, DigestaWell PET, rice starch, and contains guar gum.

[0044] In another embodiment, the dosage form is about 3.0 - 10.0% cannabis extract, about 5.0 - 20.0% peanut butter, about 10.0 - 15.0% rice bran, about 5.0 - 15.0% glucosamine HCl, about 4.0 - 10.0% sweet potato, about 6.0 - 13.0% dried molasses, about 0.5 - 5.0% sorbic acid, about 2.0 - 8.0% brewer's yeast, about 3.0 - 8.0% sugar, about 5.0 - 15.0% water, about 8.0 - 18.0% glycerin, about 1.0 - 8.0% potato starch, about 0.5 - 5.0% dried peanut butter, about 0.5 - 5.0% chondroitin, about 0.1 - 3.0% DigestaWell PET, about 1.0 - 8.0% rice starch, and about 1.0 - 5.0% contains guar gum

[0045] In another embodiment, the dosage form is about 5.0% cannabis extract, about 10.0% peanut butter, Approximately 12.0% rice bran, approximately 12.75% glucosamine HCl, approximately 5.5% sweet potato, approximately 8.0% dried molasses, approximately 1% sorbic acid, approximately 5.0% brewing yeast, approximately 6.0% sugar, approximately 7.25% water, approximately 10.0% glycerin, approximately 4.0% potato starch, approximately 4.0% dried peanut butter, approximately 2.5% chondroitin, approximately 0.5% DigestaWell PET, approximately 4.5% rice starch, and approximately 2.0% guar gum.

[0046] In another embodiment, the dosage form is approximately 5.0% cannabis extract, approximately 10.0% peanut butter, approximately 12.5% rice bran, approximately 8.5% glucosamine HCl, approximately 8.0% sweet potato, approximately 9.0% dried molasses, approximately 1% sorbic acid, approximately 5.0% brewing yeast, approximately 6.0% sugar, approximately 6.0% water, approximately 10.0% glycerin, approximately 5.0% potato starch, approximately 4.0% dried peanut butter, approximately 2.5% chondroitin, approximately 0.5% DigestaWell PET, approximately 5.0% rice starch, and approximately 2.0% guar gum.

[0047] In one embodiment, the cannabis extract, dosage form, or pharmaceutical composition is packaged to provide one or more dosages of the cannabis extract per package. In one embodiment, the package is resealable. In one embodiment, one dosage of the cannabis extract is a therapeutically effective amount.

[0048] In one aspect, provided herein is a method for treating a subject in need of treatment for an insect bite, the method comprising administering to the subject a therapeutically effective amount of a cannabis extract. In one embodiment, the cannabis extract is formulated for topical administration. In one embodiment, the cannabis extract comprises about 70 mg / mL of cannabinoids. In one embodiment, the cannabinoids are cannabidiol and cannabidiolic acid. BRIEF DESCRIPTION OF THE DRAWINGS

[0049]

Figure 1

Figure 2

Figure 3A

Figure 3B

Figure 4

Figure 5A

Figure 5B

Figure 5C

Figure 5D

Figure 5E

Figure 5F

Mode for Carrying Out the Invention

[0050] The endocannabinoid system is known to be involved in pain regulation and attenuation of inflammation. Cannabinoid receptors (CB1 and CB2) are widely distributed throughout the central and peripheral nervous systems and are also present in synovium. However, the psychotropic effects of certain cannabinoids have hindered extensive research on their use as single agents for pain relief. Cannabinoids are a group of over 60 different compounds that may or may not act on CB receptors. Cannabidiol (CBD), a class of cannabinoids, may actually be an antagonist of CB receptors. In lower vertebrates, CBD also has immunomodulatory, antinociceptive, anti-nociceptive, anxiolytic, and anti-inflammatory effects and may be an attractive therapeutic option for animals.

[0051] The problem of urine soiling in cats (urine house soiling) can be divided into those related to toileting behavior and those related to marking. Chronic pain and anxiety / frustration may be shown in both of these conditions. Marking is generally regarded as a response to threats to important resources within the cat's behavioral center, and toileting-related problems generally arise from issues related to access to what the cat recognizes as an appropriate toilet (Barcelos et al., (2018) Front. Vet. Sci. 5:108). These can all be regarded as limitations of the cat's autonomy and, therefore, are likely to cause frustration. This can be combined with anxiety as the cat may either perceive a physical threat from other individuals (in the case of marking) or may potentially be suffering from a lack of access to a desirable toilet. In addition, if the cat has some painful condition of the urinary system, discomfort may occur during urination and anxiety may arise. A recent review has shown that cats suffering from urine house soiling may be about four times more likely to have a history of urinary tract disease. (Barcelos et al., 2018). In recent years, it has been reported that when soiling becomes unpleasant, the cat's posture may change from a crouched posture to a spraying posture or vice versa (Ramos et al., (2018) J Feline Med Surg. doi:10.1177 / 1098612X18801034). It is also worth noting that approximately 40% of apparently healthy subjects suffering from urine house soiling may have a medical problem detectable on initial clinical examination, and with more detailed medical evaluation, this figure rises to 66.7% in the case of spraying cats and 56.5% in the case of toileting cats (Ramos et al., 2018).

[0052] Migraine is a common neurovascular disorder that occurs during migraine attacks, which can reach severe pain levels in many patients and lead to substantial functional impairment. The recent Global Burden of Disease Study 2010 (GBD2010) conducted by the World Health Organization estimated the global prevalence of migraine to be 14.7%, ranking 3rd among the most common diseases, 7th among specific causes of physical disabilities, and 1st among neurological disorders as a cause of total years lived with disability. Therefore, migraine affects millions of people. So far, the pathophysiology of migraine has not been fully understood.

[0053] The present disclosure is directed to compositions comprising cannabis extracts for the treatment of pain, anxiety, aggression, behavioral problems, urinary house soiling, diabetes, lung cancer, inflammatory bowel disease, skin conditions, seizures, obsessive behaviors, migraine, or insect bites in a subject and their use. Methods for treating pain in a human subject are also provided herein. The effectiveness of these compositions and therapies has not been previously demonstrated. Clinical trial and pharmacokinetic data regarding administration are also provided herein.

[0054] Definitions Definitions of various terms used herein are listed below. These definitions apply to the terms used throughout this specification and the claims, individually or as part of a larger group, unless otherwise limited in a particular instance.

[0055] Unless otherwise defined, all technical and scientific terms used herein generally have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs. Generally, the nomenclature used herein, and the experimental procedures in cell culture, molecular genetics, organic chemistry, and peptide chemistry are well known and commonly used in the art.

[0056] As used herein, the articles "a" and "an" refer to one or more of the grammatical objects of the article (i.e., at least one). By way of example, "an element" means one element or more than one element. Further, the use of the term "including" is not limiting, as are other forms such as "include", "includes", and "included".

[0057] As used herein, the term "about" is understood by those skilled in the art and varies somewhat depending on the context in which it is used. As used herein, when referring to measurable values such as amounts, durations, etc., the term "about" means including a variation of ±5% from the specified value as a variation appropriate to carry out the disclosed method.

[0058] As used in this specification and the claims, the term "comprising" may include "consisting of" and "consisting essentially of" embodiments. The terms "comprise(s)", "include(s)", "having", "has", "may", "contain(s)", and their variations as used herein are intended to be transitional phrases, terms, or words that do not require the presence of the specified component / step and allow the presence of other components / steps without limitation. However, such descriptions should be construed as describing the composition or process as "consisting of" and "consisting essentially of" the recited compounds, which allow only the presence of the specified compounds together with any pharmaceutically acceptable carriers and exclude other compounds.

[0059] All ranges disclosed herein include the recited endpoints and can be combined independently (e.g., the range of "50 mg to 500 mg" includes the endpoints, 50 mg and 500 mg, as well as all intermediate values). The endpoints and any values disclosed herein are not limited to the exact ranges or values, but are sufficiently imprecise to include values approximating these ranges and / or values.

[0060] As used herein, the term "treat" or "treating" means applying or administering a therapeutic agent, i.e., a compound provided herein, to a patient or subject (alone or in combination with another pharmaceutical agent) for the purpose of treating, curing, alleviating, reducing, modifying, salvaging, improving, or affecting the symptoms of a disease, disorder, syndrome, or condition, or applying or administering the therapeutic agent to a tissue or cell line isolated from a patient (e.g., for diagnostic or ex vivo use). Such treatment can be specifically adjusted or modified based on knowledge obtained from the field of pharmacogenomics.

[0061] In certain embodiments, the compositions described herein reduce pain in a subject. Pain can be measured using any measurement criteria known in the art. For example, pain can be measured using the Canine Brief Pain Inventory (CBPI), the Hudson Activity Scale, flexion and extension measurements, and gait analysis. A decrease in any of these metrics indicates treatment or alleviation of pain.

[0062] As used herein, the term "prevent" or "preventing" means, when nothing has occurred, the absence of the onset of a disorder or disease, or, when the onset of a disorder or disease has already occurred, the absence of the onset of a further disorder or disease. Also considered is the ability to prevent some or all of the symptoms associated with a disorder or disease.

[0063] As used herein, the term "use" includes each of one or more of the following embodiments of the present invention: use in the treatment of pain, use for the manufacture of a pharmaceutical composition for use in the treatment of these diseases, for example, use in the manufacture of a medicament, the method of using the compound of the present invention in the treatment of these diseases, a medicament having the compound of the present invention for the treatment of these diseases, and the compound of the present invention for use in the treatment of these diseases, unless otherwise specified, these uses appropriately and conveniently.

[0064] As used herein, the terms "patient", "individual", or "subject" are intended to include organisms, such as prokaryotes and eukaryotes, that can suffer from or be afflicted with a disease, disorder, or condition associated with the activity of a protein kinase. Examples of subjects include mammals such as humans, dogs, cows, horses, pigs, sheep, goats, cats, mice, rabbits, rats, and transgenic non-human animals. In certain embodiments, the subject is, for example, a human suffering from schizophrenia, a human at risk of developing the condition, or a human who may be at risk of developing the condition. In another embodiment, the subject is a cell.

[0065] With respect to the methods of treatment / prevention and the use of the compounds and pharmaceutical compositions described herein, an "individual in need thereof" can be an individual diagnosed with or previously treated for the condition to be treated. With respect to prevention, an individual in need thereof can also be an individual at risk of the condition (e.g., family history of the condition, lifestyle factors indicative of the risk of the condition, etc.). Typically, when the step of administering a compound of the present invention is disclosed herein, the present invention further contemplates the step of identifying an individual or subject in need of a particular treatment to be administered or having a particular condition to be treated.

[0066] In some embodiments, the individual is a mammal including, but not limited to, cows, horses, cats, rabbits, dogs, rodents, or primates. In some embodiments, the mammal is a primate. In some embodiments, the primate is a human. In some embodiments, the individual is a human including adults, children, and infants. In some embodiments, the individual is a non-mammal. In some variations, the primate is a non-human primate such as a chimpanzee and other apes and monkey species. The term "individual" does not denote a particular age or sex.

[0067] As used herein, the term "pharmaceutically acceptable" refers to materials such as carriers or diluents that do not impair the biological activity or properties of a compound and are relatively non-toxic, i.e., materials that can be administered to an individual without causing undesirable biological effects or interacting in a harmful manner with any of the components contained in the composition.

[0068] As used herein, the term "pharmaceutically acceptable salt" refers to derivatives of the disclosed compounds in which the parent compound is modified by converting an existing acidic or basic moiety into its salt form. Examples of pharmaceutically acceptable salts include, but are not limited to, mineral or organic acid salts of basic residues such as amines, and alkali or organic salts of acidic residues such as carboxylic acids. Pharmaceutically acceptable salts of the present invention include, for example, conventional non-toxic salts of the parent compounds formed from non-toxic inorganic or organic acids. Pharmaceutically acceptable salts of the present invention can be synthesized from parent compounds containing basic or acidic moieties by conventional chemical methods. Generally, such salts can be prepared by reacting the free acid or base forms of these compounds with a stoichiometric amount of the appropriate base or acid, in water or an organic solvent, or in a mixture of the two, and generally, non-aqueous media such as ether, ethyl acetate, ethanol, isopropanol, or acetonitrile are preferred. Lists of suitable salts can be found in Remington’s Pharmaceutical Sciences, 17th ed., Mack Publishing Company, Easton, Pa., 1985, p. 1418, and Journal of Pharmaceutical Science, 66, 2 (1977), each of which is incorporated herein by reference in its entirety.

[0069] As used herein, the term "composition" or "pharmaceutical composition" refers to a mixture of a pharmaceutically acceptable carrier and at least one compound useful within the present invention. Pharmaceutical compositions facilitate the administration of the compounds to a patient or subject. A number of techniques for administering compounds exist in the art and include, but are not limited to, intravenous, oral, aerosol, parenteral, ocular, pulmonary, and topical administration.

[0070] As used herein, the term "pharmaceutically acceptable carrier" or "carrier" means a pharmaceutically acceptable material, composition, or carrier such as a liquid or solid filler, stabilizer, dispersing agent, suspending agent, diluent, excipient, thickening agent, solvent, or encapsulating material, and is involved in transporting or delivering a compound useful within the present invention or to a patient so as to be capable of performing its 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 of being compatible with the other ingredients of the formulation and not injurious to the patient or subject, including a compound useful within the present invention. Some examples of materials that can serve as pharmaceutically acceptable carriers include sugars such as lactose, glucose, and sucrose, starches such as corn starch and potato starch, cellulose and its derivatives such as carboxymethylcellulose sodium, ethylcellulose, and cellulose acetate, excipients such as powdered tragacanth, malt, gelatin, talc, cocoa butter, and suppository waxes, oils such as peanut oil, cottonseed oil, safflower oil, sesame oil, olive oil, corn oil, and soybean oil, glycols such as propylene glycol, polyols such as glycerin, sorbitol, mannitol, and polyethylene glycol, esters such as ethyl oleate and ethyl laurate, agar, buffering agents such as magnesium hydroxide and aluminum hydroxide, surface active agents, alginic acid, pyrogen-free water, isotonic saline, Ringer's solution, ethyl alcohol, phosphate buffer solutions, and other non-toxic compatible substances used in pharmaceutical formulations. As used herein, "pharmaceutically acceptable carrier" also includes any and all coatings, antibacterial and antifungal agents, and absorption delaying agents that are compatible with the activity of the compounds useful within the present invention and physiologically acceptable to the patient or subject. Supplementary active compounds can also be incorporated into the compositions. The "pharmaceutically acceptable carrier" or "carrier" can further include pharmaceutically acceptable salts of the compounds useful within the present invention.Other additional components that may be included in the pharmaceutical composition used in the practice of the present invention are known in the art and are described, for example, in Remington’s Pharmaceutical Sciences (Genaro, Ed., Mack Publishing Co., 1985, Easton, PA), which is hereby incorporated by reference.

[0071] As used herein, the term “stabilizer” refers to a polymer that can inhibit or prevent chemical degradation. A stabilizer is added to the formulation of a compound to improve the chemical and physical stability of the compound.

[0072] As used herein, the term “adjuvant” can include, for example, preservatives, wetting agents, suspending agents, sweetening agents, flavoring agents, fragrances, emulsifying agents, and dispensing agents. Prevention of the action of microorganisms is generally provided by various antibacterial and antifungal agents such as parabens, chlorobutanol, phenol, sorbic acid, etc. Isotonic agents such as sugars and sodium chloride may also be included. Prolonged absorption of injectable pharmaceutical forms can be brought about by the use of agents that retard absorption, such as aluminum monostearate and gelatin. Excipients can also include wetting agents, emulsifying agents, pH buffers, and antioxidants such as citric acid, sorbitan monolaurate, triethanolamine oleate, butylated hydroxytoluene, etc.

[0073] As used herein, the terms “effective amount,” “pharmaceutically effective amount,” and “therapeutically effective amount” refer to a non-toxic but sufficient amount of an agent to provide the desired biological result. This result can be the alleviation or mitigation of the symptoms, signs, or causes of a disease, or any other desirable change in a biological system. The appropriate therapeutic amount in any individual case can be determined by one of ordinary skill in the art using routine experimentation.

[0074] As used herein, the term "weight percent" means the amount by weight of a compound and / or component in a composition as a percentage of the weight of the component by weight of the entire composition. Weight percent can also be calculated by multiplying the mass fraction by 100. "Mass fraction" is such that weight percent = (m 1 / m T ) × 100, where m T is the mass of the entire composition and m 1 is the mass of one substance, which is the ratio of the mass of one substance to the mass of the entire composition.

[0075] "Aqueous buffer" refers to an aqueous solution that resists changes in hydronium ion and hydroxide ion concentrations (and the resulting pH) upon addition of small amounts of acid or base or upon dilution. A buffer consists of a weak acid and its conjugate base (more common), or a weak base and its conjugate acid (less common). Buffers can be prepared by methods well known in the art using appropriate buffering agents to obtain the desired pH value. Examples of suitable buffering agents include hydrochloric acid, lactic acid, acetic acid, citric acid, malic acid, maleic acid, pyruvic acid, succinic acid, tris-hydroxymethylaminomethane, sodium hydroxide, sodium bicarbonate, phosphoric acid, sodium phosphate, and other biologically acceptable buffering agents. Aqueous buffers are commercially available and can be used in the preparation of the compositions of the present invention without further treatment.

[0076] As used herein, the term "cannabis extract" refers to a composition of cannabinoids and terpenes isolated from the cannabis plant. The terms "cannabis extract" and "CBD oil" have the same meaning and are used interchangeably herein. Cannabis extracts can be obtained by any method known in the art. For example, cannabis extracts can be obtained by supercritical (or subcritical) CO2 extraction, which uses carbon dioxide under high pressure and low temperature to isolate, preserve, and maintain the purity of the cannabis extract. In one embodiment, the cannabis extract is obtained from supercritical CO2 extraction. For example, supercritical CO2 extraction may be performed as described in U.S. Patent No. 8,895,078, which is hereby incorporated by reference in its entirety. Alternatively, solvents such as petroleum ether, ethanol, methanol, butanol, acetone, dry ice, or olive oil can be used for passive extraction by stirring at room temperature (ambient temperature), heating to a temperature above room temperature, or using under reflux as known in the art to provide a cannabis extract. In another embodiment, the cannabis extract from butanol extraction is used as a starting material for the methods disclosed herein.

[0077] Suitable methods for measuring the cannabinoid and terpene content in cannabis extracts are known in the art. In one embodiment, the cannabinoid content is determined using liquid chromatography with mass spectrometry detection (LC-MS). In another embodiment, the terpene content is determined using gas chromatography with headspace flame ionization detector analysis (GC-FID).

[0078] As used herein, the term "flavorant" refers to a component added to a composition to impart a particular flavor, aroma, or other sensory receptive characteristics.

[0079] As used herein, the term "oil" refers to a nonpolar viscous liquid that is both hydrophobic and lipophilic. Oils may be separated from animal, plant, or petrochemical products.

[0080] As used herein, the term "chew" refers to a product or a portion thereof having rheological and other texture and sensory receptive properties that tend to promote chewing of the article by the target animal. Generally, a chewable matrix exhibits sufficient ductility such that it is at least slightly malleable when chewed by the target animal, and sufficient palatability such that it is not deterred by the target animal's taste when chewed multiple times. In contrast, "chewable" does not simply mean that the article can be chewed by an animal (i.e., does not simply mean that a portion of the article fits sufficiently within the animal's mouth to permit engagement of the animal's teeth with that portion).

[0081] As used herein, the "maximum serum concentration value" of a substance refers to the maximum value of the substance present in a plasma sample after a single administration.

[0082] As used herein, the term "cold extrusion" refers to a process for producing edible food products that includes several unit operations including mixing, kneading, shearing, shaping, and forming, all of which are carried out at or near ambient temperature.

[0083] As used herein, the term "psychoactive" refers to a modification of brain function that results in a change in perception, mood, consciousness, or behavior.

[0084] Pharmaceutical composition In one aspect, a pharmaceutical composition is provided herein that includes a cannabis extract and a carrier, the cannabis extract comprising cannabidiol, and cannabidiolic acid.

[0085] In another embodiment, the cannabis extract further comprises cannabidiol, cannabidiolic acid, cannabigerolic acid, Δ9-tetrahydrocannabinol, and cannabichromene.

[0086] In another embodiment, the ratio of Δ9-tetrahydrocannabinol to other cannabinoids is from about 1:50 to about 1:20. In one embodiment, the ratio of cannabidiol to cannabidiolic acid is from 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 from about 0.6:1 to about 1:0.6. In still another embodiment, the ratio of cannabidiol to cannabidiolic acid is about 1:1.

[0087] 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 from about 1:50 to about 1:20. In yet another embodiment, the ratio of Δ9-tetrahydrocannabinol to other cannabinoids is about 1:50. In still 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 still another embodiment, the ratio of Δ9-tetrahydrocannabinol to other cannabinoids is about 1:25. In one embodiment, the ratio of Δ9-tetrahydrocannabinol to other cannabinoids is about 1:20.

[0088] In one embodiment, the concentration of Δ9-tetrahydrocannabinol is less than about 2 mg / mL. In another embodiment, the concentration of Δ9-tetrahydrocannabinol is less than about 1.5 mg / mL. In yet another embodiment, the concentration of Δ9-tetrahydrocannabinol is less than about 1 mg / mL. In still another embodiment, the concentration of Δ9-tetrahydrocannabinol is less than about 0.9 mg / mL. In yet another embodiment, the concentration of Δ9-tetrahydrocannabinol is less than about 0.8 mg / mL. In one embodiment, the concentration of Δ9-tetrahydrocannabinol is less than about 0.7 mg / mL. In another embodiment, the concentration of Δ9-tetrahydrocannabinol is less than about 0.6 mg / mL. In yet another embodiment, the concentration of Δ9-tetrahydrocannabinol is less than about 0.5 mg / mL. In still another embodiment, the concentration of Δ9-tetrahydrocannabinol is less than about 0.4 mg / mL. In one embodiment, the concentration of Δ9-tetrahydrocannabinol is less than about 0.3 mg / mL. In another embodiment, the concentration of Δ9-tetrahydrocannabinol is less than about 0.2 mg / mL. In yet another embodiment, the concentration of Δ9-tetrahydrocannabinol is less than about 0.1 mg / mL. In another embodiment, the concentration of Δ9-tetrahydrocannabinol is less than about 0.05 mg / mL. In another embodiment, the concentration of Δ9-tetrahydrocannabinol is about 0 mg / mL.

[0089] In one embodiment, the cannabis extract is about 0.1 to 20 mg / mL of cannabidiol, about 0.1 to 20 mg / mL of cannabidiolic acid, about 0.01 to 0.5 mg / mL of cannabigerolic acid, about 0.01 to 0.5 mg / mL of Δ9-tetrahydrocannabinol, and about 0.01 to 0.5 mg / mL of cannabinol.

[0090] In another embodiment, the cannabis extract is about 1 to 10 mg / mL of cannabidiol, About 1 to 10 mg / mL of cannabidiolic acid, 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.

[0091] In yet another embodiment, the cannabis extract contains 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.

[0092] In one embodiment, the cannabis extract contains about 5 mg / mL of cannabinoids. In one embodiment, the cannabis extract contains about 10 mg / mL of cannabinoids. In one embodiment, the cannabis extract contains about 20 mg / mL of cannabinoids. In one embodiment, the cannabis extract contains about 30 mg / mL of cannabinoids. In one embodiment, the cannabis extract contains about 40 mg / mL of cannabinoids. In one embodiment, the cannabis extract contains about 50 mg / mL of cannabinoids. In one embodiment, the cannabis extract contains about 60 mg / mL of cannabinoids. In one embodiment, the cannabis extract contains about 70 mg / mL of cannabinoids. In one embodiment, the cannabis extract contains about 80 mg / mL of cannabinoids. In one embodiment, the cannabis extract contains about 90 mg / mL of cannabinoids. In one embodiment, the cannabis extract contains about 100 mg / mL of cannabinoids. In one embodiment, the cannabinoids are cannabidiol and cannabidiolic acid. According to some embodiments, about 0.05 to 0.5 mL of the extract is administered topically.

[0093] In one embodiment, a pharmaceutical composition comprising a cannabis extract and a carrier is provided herein, the cannabis extract contains α-pinene, β-Myrcene, β-Pinene, Δ-Limonene, Linalool, β-Caryophyllene, α-Humulene, Nerolidol 2, Guaiol, Caryophyllene oxide, and α-Bisabolol.

[0094] In another embodiment, the cannabis extract is about 0.09 - 0.13% α-Pinene, about 0.23 - 0.44% β-Myrcene, about 0.04 - 0.09% β-Pinene, about 0.05 - 0.09% Δ-Limonene, about 0.03 - 0.06% Linalool, about 0.04 - 0.07% β-Caryophyllene, about 0.02 - 0.04% α-Humulene, 0.04 - 0.07% Nerolidol 2, about 0.02 - 0.04% Guaiol, about 0.04 - 0.08% Caryophyllene oxide, and about 0.01 - 0.04% α-Bisabolol.

[0095] In another embodiment, the cannabis extract is about 0.07 - 0.30% α-Pinene, about 0.10 - 0.60% β-Myrcene, about 0.02 - 0.20% β-Pinene, about 0.03 - 0.20% Δ-Limonene, about 0.01 - 0.08% Linalool, about 0.03 - 0.09% β-Caryophyllene, about 0.01 - 0.06% α-Humulene, about 0.02 - 0.09% Nerolidol 2, and about 0.01 - 0.06% Guaiol.

[0096] In another embodiment, the cannabis extract is about 0.01 - 0.50% α-pinene, about 0.01 - 0.90% β-myrcene, about 0.01 - 0.50% β-pinene, about 0.01 - 0.50% Δ-limonene, about 0.01 - 0.50% linalool, about 0.01 - 0.50% β-caryophyllene, about 0.01 - 0.50% α-humulene, about 0.01 - 0.50% nerolidol 2, about 0.01 - 0.50% guaiol, about 0.01 - 0.50% caryophyllene oxide, and about 0.01 - 0.50% α-bisabolol.

[0097] In another embodiment, the cannabis extract is camphene, β-ocimene, eucalyptol, isopulegol, and / or nerolidol 1.

[0098] In another embodiment, the cannabis extract is about 0.02% camphene, about 0.02 - 0.03% β-ocimene, about 0.02 - 0.05% eucalyptol, about 0.02% isopulegol, and / or about 0.02 - 0.04% nerolidol 1.

[0099] In another embodiment, the cannabis extract is about 0.01 - 0.04% camphene, about 0.01 - 0.05% β-ocimene, about 0.01 - 0.07% eucalyptol, about 0.01 - 0.04% isopulegol, and / or It contains about 0.01 - 0.05% of nerolidol 1.

[0100] In another embodiment, the cannabis extract contains about 0.01 - 0.50% of camphene, about 0.01 - 0.50% of β-ocimene, about 0.01 - 0.50% of eucalyptol, about 0.01 - 0.50% of isopulegol, and / or about 0.01 - 0.50% of nerolidol 1.

[0101] In one embodiment, the cannabis extract does not contain terpenes.

[0102] In one embodiment, the cannabis 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.

[0103] In one embodiment, the cannabis 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.

[0104] In one embodiment, the cannabis 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.

[0105] In one embodiment, the cannabis 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.

[0106] In one embodiment, the cannabis 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.

[0107] In one embodiment, the cannabis 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.

[0108] In one embodiment, the cannabis 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.

[0109] In one embodiment, the cannabis 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.

[0110] In one embodiment, the cannabis extract comprises 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.

[0111] In one embodiment, the cannabis extract comprises ten 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 cannabis extract comprises eleven 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 cannabis extract comprises twelve 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 cannabis extract comprises thirteen 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 cannabis extract comprises 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.

[0116] In one embodiment, the cannabis extract comprises 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.

[0117] In one embodiment, the cannabis extract comprises 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 composition is formulated as an oil. In another embodiment, the carrier is selected from the group consisting of cannabis seed oil, flaxseed oil, olive oil, fish oil, salmon oil, coconut oil, catnip oil, sesame oil, MCT oil, and grape seed oil. In yet another embodiment, the carrier is grape seed oil. In one embodiment, the carrier is sesame seed oil.

[0119] In one embodiment, the dosage form comprises nepatalactone.

[0120] In one embodiment, the dosage form comprises taurine.

[0121] In one embodiment, the pharmaceutical composition comprises lecithin. In another embodiment, the lecithin is sunflower lecithin. In another embodiment, the sunflower lecithin is about 5%, about 10%, about 15%, about 20%, about 25%, about 30%, about 35%, about 40%, about 45%, or 50%.

[0122] In one embodiment, the pharmaceutical composition comprises NF-971P. In one embodiment, NF-971P is at a weight / volume ratio of about 0.5%, about 1.0%, about 1.5%, about 2.0%, about 2.5%, or about 3.0%.

[0123] In one embodiment, the pharmaceutical composition is formulated as a sublingual spray. In yet another embodiment, the pharmaceutical composition is formulated as an aqueous or alcohol-soluble solution, or a cream for topical or transdermal application. In one embodiment, the pharmaceutical composition is applied to the back of the neck. In another embodiment, the pharmaceutical composition is administered at a dose of about 4 mg / kg. In another embodiment, the pharmaceutical composition is administered twice daily for 4 weeks. In one embodiment, the pharmaceutical composition is formulated as a gel for oral or intramucosal administration. In one embodiment, the pharmaceutical composition is formulated as a powder. In another embodiment, the pharmaceutical composition is formulated as a subcutaneous injection solution. 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. In one embodiment, the pharmaceutical composition is formulated as a soft chewable.

[0124] In one embodiment, the composition is formulated as a chew for oral administration. In another embodiment, the chew is produced using cold extrusion. In another embodiment, the weight of the chew is from about 0.5 to 10 g. In yet another embodiment, the weight of the chew is about 4 g, about 6 g, about 9 g, or about 10 g. In still another embodiment, the weight of the chew is about 0.5 g. In one embodiment, the weight of the chew is about 1 g. In another embodiment, the weight of the chew is about 1.5 g. In yet another embodiment, the weight of the chew is about 2 g. In still another embodiment, the weight of the chew is about 3 g. In one embodiment, the weight of the chew is about 4 g. In another embodiment, the weight of the chew is about 5 g. In yet another embodiment, the weight of the chew is about 6 g. In still another embodiment, the weight of the chew is about 7 g. In one embodiment, the weight of the chew is about 8 g. In another embodiment, the weight of the chew is about 9 g. In yet another embodiment, the weight of the chew is about 10 g.

[0125] In one embodiment, a 4 g chew contains about 7 mg of cannabidiol, about 6 mg of cannabidiolic acid, about 0.12 mg of cannabigerolic acid, about 0.32 mg of Δ9-tetrahydrocannabinol, and about 0.36 mg of cannabichromene.

[0126] The pharmaceutical compositions of the present disclosure can be manufactured by processes well known in the art, such as conventional mixing, dissolving, granulating, milling, pulverizing, sugar coating, gelling, emulsifying, encapsulating, entrapping, or lyophilization processes.

[0127] Accordingly, the compositions for use according to the present disclosure can be formulated in a conventional manner using one or more pharmaceutically acceptable carriers including excipients and auxiliaries that facilitate processing the active compounds into a preparation that can be pharmaceutically used. Appropriate formulation depends on the route of administration selected.

[0128] Dosage form In one aspect, cannabidiol, and cannabidiolic acid, and one or more pharmaceutically acceptable additives, flavoring agents, surfactants, and adjuvants are provided herein in a dosage form.

[0129] In another embodiment, the dosage form comprises cannabidiol, and cannabidiolic acid, and cannabigerolic acid, and Δ9-tetrahydrocannabinol, and cannabichromene, and one or more pharmaceutically acceptable additives, flavoring agents, surfactants, and adjuvants.

[0130] 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 still another embodiment, the ratio of cannabidiol to cannabidiolic acid is about 1:1.

[0131] In one embodiment, the concentration of Δ9-tetrahydrocannabinol is insufficient to cause psychoactive effects. In another embodiment, the ratio of Δ9-tetrahydrocannabinol to other cannabinoids is from about 1:50 to about 1:20. In yet another embodiment, the ratio of Δ9-tetrahydrocannabinol to other cannabinoids is about 1:50. In still 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 still another embodiment, the ratio of Δ9-tetrahydrocannabinol to other cannabinoids is about 1:25. In one embodiment, the ratio of Δ9-tetrahydrocannabinol to other cannabinoids is about 1:20.

[0132] In one embodiment, the concentration of Δ9-tetrahydrocannabinol is less than about 2 mg / mL. In another embodiment, the concentration of Δ9-tetrahydrocannabinol is less than about 1.5 mg / mL. In yet another embodiment, the concentration of Δ9-tetrahydrocannabinol is less than about 1 mg / mL. In still another embodiment, the concentration of Δ9-tetrahydrocannabinol is less than about 0.9 mg / mL. In yet another embodiment, the concentration of Δ9-tetrahydrocannabinol is less than about 0.8 mg / mL. In one embodiment, the concentration of Δ9-tetrahydrocannabinol is less than about 0.7 mg / mL. In another embodiment, the concentration of Δ9-tetrahydrocannabinol is less than about 0.6 mg / mL. In yet another embodiment, the concentration of Δ9-tetrahydrocannabinol is less than about 0.5 mg / mL. In still another embodiment, the concentration of Δ9-tetrahydrocannabinol is less than about 0.4 mg / mL. In one embodiment, the concentration of Δ9-tetrahydrocannabinol is less than about 0.3 mg / mL. In another embodiment, the concentration of Δ9-tetrahydrocannabinol is less than about 0.2 mg / mL. In yet another embodiment, the concentration of Δ9-tetrahydrocannabinol is less than about 0.1 mg / mL. In another embodiment, the concentration of Δ9-tetrahydrocannabinol is less than about 0.05 mg / mL. In another embodiment, the concentration of Δ9-tetrahydrocannabinol is about 0 mg / mL.

[0133] In one embodiment, the dosage form is about 0.1 to 20 mg / mL of cannabidiol, about 0.1 to 20 mg / mL of cannabidiolic acid, about 0.01 to 0.5 mg / mL of cannabigerolic acid, about 0.01 to 0.5 mg / mL of Δ9-tetrahydrocannabinol, and about 0.01 to 0.5 mg / mL of cannabinol.

[0134] In another embodiment, the dosage form is about 1 to 10 mg / mL of cannabidiol, About 1 to 10 mg / mL of cannabidiolic acid, 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.

[0135] In yet another embodiment, the 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.

[0136] In some embodiments, the dosage form is α - pinene, β - myrcene, β - pinene, Δ - limonene, linalool, β - caryophyllene, α - humulene, nerolidol 2, guaiol, caryophyllene oxide, and α - bisabolol.

[0137] In another embodiment, the 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, about 0.04 to 0.07% of nerolidol 2, About 0.02 to 0.04% guaiol, about 0.04 to 0.08% caryophyllene oxide, and about 0.01 to 0.04% α-bisabolol.

[0138] In another embodiment, the dosage form is about 0.07 to 0.30% α-pinene, about 0.10 to 0.60% β-myrcene, about 0.02 to 0.20% β-pinene, about 0.03 to 0.20% Δ-limonene, about 0.01 to 0.08% linalool, about 0.03 to 0.09% β-caryophyllene, about 0.01 to 0.06% α-humulene, about 0.02 to 0.09% nerolidol 2, and about 0.01 to 0.06% guaiol.

[0139] In another embodiment, the dosage form is about 0.01 to 0.50% α-pinene, about 0.01 to 0.90% β-myrcene, about 0.01 to 0.50% β-pinene, about 0.01 to 0.50% Δ-limonene, about 0.01 to 0.50% linalool, about 0.01 to 0.50% β-caryophyllene, about 0.01 to 0.50% α-humulene, about 0.01 to 0.50% nerolidol 2, about 0.01 to 0.50% guaiol, about 0.01 to 0.50% caryophyllene oxide, and about 0.01 to 0.50% α-bisabolol.

[0140] In another embodiment, the dosage form is camphene, β-ocimene, eucalyptol, Isopulegol, and / or further contains nerolidol 1.

[0141] In another embodiment, the dosage form is about 0.02% camphene, about 0.02 - 0.03% β-ocimene, about 0.02 - 0.05% eucalyptol, about 0.02% isopulegol, and / or about 0.02 - 0.04% nerolidol 1.

[0142] In another embodiment, the dosage form is about 0.01 - 0.04% camphene, about 0.01 - 0.05% β-ocimene, about 0.01 - 0.07% eucalyptol, about 0.01 - 0.04% isopulegol, and / or about 0.01 - 0.05% nerolidol 1.

[0143] In another embodiment, the dosage form is about 0.01 - 0.50% camphene, about 0.01 - 0.50% β-ocimene, about 0.01 - 0.50% eucalyptol, about 0.01 - 0.50% isopulegol, and / or about 0.01 - 0.50% nerolidol 1.

[0144] In one embodiment, the cannabis extract does not contain terpenes.

[0145] In one embodiment, the cannabis 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.

[0146] In one embodiment, the cannabis extract comprises 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.

[0147] In one embodiment, the cannabis extract comprises 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.

[0148] In one embodiment, the cannabis extract comprises 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.

[0149] In one embodiment, the dosage form comprises 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.

[0150] In one embodiment, the dosage form comprises 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.

[0151] In one embodiment, the dosage form comprises 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.

[0152] In one embodiment, the dosage form comprises 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.

[0153] In one embodiment, the dosage form comprises 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.

[0154] In one embodiment, the dosage form comprises ten 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, the dosage form comprises eleven 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, the 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.

[0157] In one embodiment, the 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.

[0158] In one embodiment, the 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.

[0159] In one embodiment, the 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.

[0160] In one embodiment, the dosage form contains 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.

[0161] In one embodiment, the flavoring agent is selected from the group consisting of peanut butter, catnip oil, peppermint oil, mango extract, beef, chicken, and seafood. In another embodiment, the flavoring agent is peanut butter.

[0162] In one embodiment, the dosage form is formulated as a sublingual spray. In yet another embodiment, the dosage form is formulated as an aqueous or alcohol-soluble solution, gel, or cream for topical or transdermal application. In one embodiment, the pharmaceutical composition is applied to the back of the neck. In another embodiment, the pharmaceutical composition is administered at a dose of about 4 mg / kg. In another embodiment, the pharmaceutical composition is administered twice daily for 4 weeks. In one embodiment, the dosage form is formulated as a gel for oral or intramucosal administration. In one embodiment, the dosage form is formulated as a powder. In another embodiment, the dosage form is formulated as a subcutaneous injection solution. In yet another embodiment, the dosage form is formulated as a tablet. In yet another embodiment, the dosage form is formulated as a capsule. In one embodiment, the dosage form is formulated as a soft chewable.

[0163] In some embodiments, the present invention includes infusing a cannabis extract into an edible product. In another embodiment, the edible product is an extruded food, a baked food, peanut butter, a spread, a pellet feed, or a processed food. In another embodiment, the edible product is pet food. In another embodiment, the pet food is in a dried, room-temperature-storable form such as dry meal, dried fish, dried dairy products, fish meal, fish flour, cereal, wheat flour, carbohydrates, dried fruit. In another embodiment, the pet food is wet or semi-wet. In another embodiment, the pet food contains food additives or supplements such as vitamins, minerals, chemicals, enzymes, etc., for example, substances that can remove dental plaque or tartar from an animal's teeth. In one embodiment, the cannabis extract is administered with catnip oil. In another embodiment, any of the described dosage forms can also include catnip.

[0164] In another embodiment, the cannabis extract is administered using a nebulizer. In another embodiment, the nebulizer delivery device and system can effectively and efficiently administer one or more atomized agents to an animal. In another embodiment, the nebulizer system can be easily used by an animal without moving the animal from its natural environment. In another embodiment, the nebulizer delivery device and system enable an animal to be easily treated once or multiple times a day without excessive stress or requiring extensive resources. In another embodiment, the nebulizer delivery device and system can be used with animals having various training levels.

[0165] In one embodiment, the cannabis extract is administered using a diffuser. The diffuser can be any device that disperses the cannabis extract into the air. The cannabis extract can be dispersed by any method such as natural convection, forced convection, heating of a core or pad (e.g., holding the cannabis extract), use of a pump, or use of a fan.

[0166] In one embodiment, the cannabis extract is administered by a pet collar. The pet collar can include a belt with attachment means such as a buckle on one side, a free end on the opposite side, and an opening disposed longitudinally within the central portion of the belt, or a quick-release clasp mechanism for securing the collar in a closed-loop configuration. The pet collar may be made of various materials including nylon, polyester leather, or other suitable materials. The belt material may be treated with a water-resistant compound. Nylon or polyester belts may be woven with reflective fibers to enhance the visibility of the pet collar at night. In one embodiment, the cannabis extract is infused into the collar.

[0167] Chew In one embodiment, the dosage form is formulated as a chew for oral administration. In another embodiment, the chew is produced using cold extrusion. In another embodiment, the weight of the chew is about 0.5 to 10 g. In yet another embodiment, the weight of the chew is about 4 g, about 6 g, about 9 g, or about 10 g. In still another embodiment, the weight of the chew is about 0.5 g. In one embodiment, the weight of the chew is about 1 g. In another embodiment, the weight of the chew is about 1.5 g. In yet another embodiment, the weight of the chew is about 2 g. In still another embodiment, the weight of the chew is about 3 g. In one embodiment, the weight of the chew is about 4 g. In another embodiment, the weight of the chew is about 5 g. In yet another embodiment, the weight of the chew is about 6 g. In still another embodiment, the weight of the chew is about 7 g. In one embodiment, the weight of the chew is about 8 g. In another embodiment, the weight of the chew is about 9 g. In yet another embodiment, the weight of the chew is about 10 g.

[0168] In one embodiment, the dosage form is brewer's yeast, gum arabic, guar gum, flavoring agent, Verdilox, Previon, cannabis extract, glycerin, sunflower lecithin, and water.

[0169] In another embodiment, the dosage form is about 25 - 35% brewer's yeast, about 1 - 10% gum arabic, about 0.1 - 4% guar gum, about 10 - 20% flavoring agent, about 0.01 - 1% Verdilox, about 0.1 - 2% Previon, about 1 - 10% cannabis extract, about 10 - 20% glycerin, about 1 - 10% sunflower lecithin, and It contains about 1 - 10% water.

[0170] In another embodiment, the dosage form is about 29 - 33% brewing yeast, about 3 - 6% gum arabic, about 0.5 - 2% guar gum, about 12 - 16% flavoring agent, about 0.01 - 0.1% Verdilox, about 0.5 - 1.5% Previon, about 3 - 6% cannabis extract, about 13 - 17% glycerin, about 3 - 7% sunflower lecithin, and about 3 - 7% water.

[0171] In yet another embodiment, the dosage form is about 30% brewing yeast, about 4.7% gum arabic, about 0.9% guar gum, about 14.2% flavoring agent, about 0.05% Verdilox, about 0.9% Previon, about 4.7% cannabis extract, about 15.1% glycerin, about 5.7% sunflower lecithin, and about 5.7% water.

[0172] In one embodiment, the dosage form is glucosamine HCl, brewing yeast, gum arabic, guar gum, flavoring agent, Verdilox, Previon, cannabis extract, glycerin, sunflower lecithin, and water.

[0173] In another embodiment, the dosage form is About 10 - 20% glucosamine HCl, about 25 - 35% brewer's yeast, about 1 - 10% gum arabic, about 0.1 - 4% guar gum, about 10 - 20% flavoring agent, about 0.01 - 1% Verdilox, about 0.1 - 2% Previon, about 1 - 10% cannabis extract, about 10 - 20% glycerin, about 1 - 10% sunflower lecithin, and about 1 - 10% water.

[0174] In another embodiment, the dosage form is about 12 - 17% glucosamine HCl, about 29 - 33% brewer's yeast, about 3 - 6% gum arabic, about 0.5 - 2% guar gum, about 12 - 16% flavoring agent, about 0.01 - 0.1% Verdilox, about 0.5 - 1.5% Previon, about 3 - 6% cannabis extract, about 13 - 17% glycerin, about 3 - 7% sunflower lecithin, and about 3 - 7% water.

[0175] In yet another embodiment, the dosage form is about 15.6% glucosamine HCl, about 30% brewer's yeast, about 4.7% gum arabic, about 0.9% guar gum, about 14.2% flavoring agent, about 0.05% Verdilox, about 0.9% Previon, about 4.7% cannabis extract, about 15.1% glycerin, about 5.7% sunflower lecithin, and It contains about 5.7% water.

[0176] In one embodiment, the dosage form is glucosamine HCl, chondroitin sulfate (76%), brewer's yeast, gum arabic, guar gum, flavoring agent, Verdilox, Previon, cannabis extract, glycerin, sunflower lecithin, and water.

[0177] In another embodiment, the dosage form is about 10 - 20% glucosamine HCl, about 0.1 - 7% chondroitin sulfate (76%), about 25 - 35% brewer's yeast, about 1 - 10% gum arabic, about 0.1 - 4% guar gum, about 10 - 20% flavoring agent, about 0.01 - 1% Verdilox, about 0.1 - 2% Previon, about 1 - 10% cannabis extract, about 10 - 20% glycerin, about 1 - 10% sunflower lecithin, and about 1 - 10% water.

[0178] In another embodiment, the dosage form is about 12 - 17% glucosamine HCl, about 1 - 4% chondroitin sulfate (76%), about 29 - 33% brewer's yeast, about 3 - 6% gum arabic, about 0.5 - 2% guar gum, about 12 - 16% flavoring agent, about 0.01 - 0.1% Verdilox, about 0.5 - 1.5% Previon, About 3 to 6% of cannabis extract, About 13 to 17% of glycerin, About 3 to 7% of sunflower lecithin, and Contains about 3 to 7% of water.

[0179] In yet another embodiment, the dosage form is, About 15.6% of glucosamine HCl, About 2.6% of chondroitin sulfate (76%), About 30% of brewer's yeast, About 4.7% of gum arabic, About 0.9% of guar gum, About 14.2% of flavoring agent, About 0.05% of Verdilox, About 0.9% of Previon, About 4.7% of cannabis extract, About 15.1% of glycerin, About 5.7% of sunflower lecithin, and Contains about 5.7% of water.

[0180] In another embodiment, the dosage form is, Hyaluronic acid, Brewer's yeast, Gum arabic, Guar gum, Flavoring agent, Verdilox, Previon, Cannabis extract, Glycerin, Sunflower lecithin, and Contains water.

[0181] In another embodiment, the dosage form is, About 0.01 to 3% of hyaluronic acid, About 25 to 35% of brewer's yeast, About 1 to 10% of gum arabic, About 0.1 to 5% of guar gum, About 10 to 20% of flavoring agent, About 0.01 to 1% of Verdilox, About 0.1 to 3% of Previon, about 1 to 10% of cannabis extract, about 10 to 20% of glycerin, about 1 to 10% of sunflower lecithin, and about 1 to 10% of water.

[0182] In another embodiment, the dosage form is about 0.01 to 1% of hyaluronic acid, about 29 to 33% of brewing yeast, about 3 to 6% of gum arabic, about 0.5 to 2% of guar gum, about 12 to 16% of flavoring agent, about 0.01 to 0.1% of Verdilox, about 0.5 to 1.5% Previon, about 3 to 6% of cannabis extract, about 13 to 17% of glycerin, about 3 to 7% of sunflower lecithin, and about 3 to 7% of water.

[0183] In yet another embodiment, the dosage form is about 0.1% of hyaluronic acid, about 30.6% of brewing yeast, about 4.8% of gum arabic, about 0.97% of guar gum, about 14.5% of flavoring agent, about 0.05% of Verdilox, about 0.97% of Previon, about 4.8% of cannabis extract, about 15.5% of glycerin, about 5.8% of sunflower lecithin, and about 5.8% of water.

[0184] In another embodiment, the dosage form is Glucosamine HCl, hyaluronic acid, brewing yeast, gum arabic, guar gum, flavoring agent, Verdilox, Previon, cannabis extract, glycerin, sunflower lecithin, and water.

[0185] In another embodiment, the dosage form is about 10 - 20% glucosamine HCl, about 0.01 - 3% hyaluronic acid, about 25 - 35% brewer's yeast, about 1 - 10% gum arabic, about 0.1 - 5% guar gum, about 10 - 20% flavoring agent, about 0.01 - 1% Verdilox, about 0.1 - 3% Previon, about 1 - 10% cannabis extract, about 10 - 20% glycerin, about 1 - 10% sunflower lecithin, and about 1 - 10% water.

[0186] In another embodiment, the dosage form is about 12 - 17% glucosamine HCl, about 0.01 - 1% hyaluronic acid, about 29 - 33% brewer's yeast, about 3 - 6% gum arabic, about 0.5 - 2% guar gum, about 12 - 16% flavoring agent, about 0.01 - 0.1% Verdilox, about 0.5 - 1.5% Previon, about 3 - 6% cannabis extract, about 13 - 17% glycerin, about 3 - 7% sunflower lecithin, and about 3 - 7% water.

[0187] In yet another embodiment, the dosage form is about 16% glucosamine HCl, About 0.1% hyaluronic acid, about 30.6% brewing yeast, about 4.8% gum arabic, about 0.97% guar gum, about 14.5% flavoring agent, about 0.05% Verdilox, about 0.97% Previon, about 4.8% cannabis extract, about 15.5% glycerin, about 5.8% sunflower lecithin, and about 5.8% water.

[0188] In yet another embodiment, the dosage form is cannabis extract, peanut butter, rice bran, sweet potato, dried molasses, sorbic acid brewing yeast, sugar, water, glycerin, potato starch, dried peanut butter, rice starch, and guar gum.

[0189] In another embodiment, the dosage form is about 3.0 - 10.0% cannabis extract, about 10.0 - 20.0% peanut butter, about 10.0 - 15.0% rice bran, about 4.0 - 10.0% sweet potato, about 6.0 - 13.0% dried molasses, about 0.5 - 5.0% sorbic acid, about 2.0 - 8.0% brewing yeast, about 3.0 - 8.0% sugar, about 5.0 - 15.0% water, about 8.0 - 18.0% glycerin, about 1.0 - 8.0% potato starch, About 0.5 to 5.0% of dry peanut butter, about 1.0 to 5.0% of rice starch, and about 1.0 to 5.0% of guar gum.

[0190] In another embodiment, the dosage form is about 5.0% of cannabis extract, about 15.0% of peanut butter, about 12.5% of rice bran, about 5.5% of sweet potato, about 8.0% of dry molasses, about 1% of sorbic acid, about 5.0% of brewing yeast, about 6.0% of sugar, about 9.25% of water, about 13.0% of glycerin, about 2.0% of potato starch, about 1.0% of dry peanut butter, about 2.0% of rice starch, and about 2.0% of guar gum.

[0191] In yet another embodiment, the dosage form is about 5.0% of cannabis extract, about 15.0% of peanut butter, about 13.0% of rice bran, about 6.0% of sweet potato, about 9.0% of dry molasses, about 1% of sorbic acid, about 5.0% of brewing yeast, about 6.0% of sugar, about 9.5% of water, about 13.0% of glycerin, about 4.0% of potato starch, about 1.0% of dry peanut butter, about 2.0% of rice starch, and about 2.0% of guar gum.

[0192] In one embodiment, the dosage form is cannabis extract, peanut butter, Rice bran, Glucosamine HCl, Sweet potato, Dried molasses, Sorbic acid Brewing yeast, Sugar, Water, Glycerin, Potato starch, Dried peanut butter, Rice starch, and Contains guar gum.

[0193] In another embodiment, the dosage form is About 5.0% cannabis extract, About 15.0% peanut butter, About 12.5% rice bran, About 12.75% glucosamine HCl, About 5.5% sweet potato, About 8.0% dried molasses, About 1% sorbic acid, About 5.0% brewing yeast, About 6.0% sugar, About 9.25% water, About 13.0% glycerin, About 2.0% potato starch, About 1.0% dried peanut butter, About 2.0% rice starch, and About 2.0% guar gum.

[0194] In yet another embodiment, the dosage form is About 5.0% cannabis extract, About 15.0% peanut butter, About 13.0% rice bran, About 8.5% glucosamine HCl, About 6.0% sweet potato, About 9.0% dried molasses, About 1% sorbic acid, About 5.0% brewing yeast, About 6.0% sugar, About 9.5% water, About 13.0% glycerin, about 4.0% potato starch, about 1.0% dry peanut butter, about 2.0% rice starch, and about 2.0% guar gum.

[0195] In yet another embodiment, the dosage form is about 3.0 - 10.0% cannabis extract, about 10.0 - 20.0% peanut butter, about 10.0 - 15.0% rice bran, about 5.0 - 15.0% glucosamine HCl, about 4.0 - 10.0% sweet potato, about 6.0 - 13.0% dry molasses, about 0.5 - 5.0% sorbic acid, about 2.0 - 8.0% brewing yeast, about 3.0 - 8.0% sugar, about 5.0 - 15.0% water, about 8.0 - 18.0% glycerin, about 1.0 - 8.0% potato starch, about 0.5 - 5.0% dry peanut butter, about 1.0 - 5.0% rice starch, and about 1.0 - 5.0% guar gum.

[0196] In another embodiment, the dosage form further comprises chondroitin sulfate.

[0197] In one embodiment, the dosage form is cannabis extract, peanut butter, rice bran, glucosamine HCl, sweet potato, dry molasses, sorbic acid brewing yeast, sugar, water, glycerin, potato starch, Dry peanut butter, DigestaWell PET, rice starch, and guar gum.

[0198] In another embodiment, the dosage form is, about 3.0 - 10.0% cannabis extract, about 5.0 - 20.0% peanut butter, about 10.0 - 15.0% rice bran, about 5.0 - 15.0% glucosamine HCl, about 4.0 - 10.0% sweet potato, about 6.0 - 13.0% dried molasses, about 0.5 - 5.0% sorbic acid, about 2.0 - 8.0% brewing yeast, about 3.0 - 8.0% sugar, about 5.0 - 15.0% water, about 8.0 - 18.0% glycerin, about 1.0 - 8.0% potato starch, about 0.5 - 5.0% dry peanut butter, about 0.1 - 3.0% DigestaWell PET, about 1.0 - 8.0% rice starch, and about 1.0 - 5.0% guar gum.

[0199] In another embodiment, the dosage form is, about 5.0% cannabis extract, about 10.0% peanut butter, about 12.0% rice bran, about 12.75% glucosamine HCl, about 5.5% sweet potato, about 8.0% dried molasses, about 1% sorbic acid, about 5.0% brewing yeast, about 6.0% sugar, about 7.25% water, about 10.0% glycerin, about 5.0% potato starch, Approximately 4.0% dry peanut butter, Approximately 0.5% DigestaWell PET, Approximately 6.0% rice starch, and Approximately 2.0% guar gum.

[0200] In yet another embodiment, the dosage form is Approximately 5.0% cannabis extract, Approximately 10.0% peanut butter, Approximately 12.5% rice bran, Approximately 8.5% glucosamine HCl, Approximately 8.0% sweet potato, Approximately 9.0% dried molasses, Approximately 1% sorbic acid, Approximately 5.0% brewing yeast, Approximately 6.0% sugar, Approximately 6.0% water, Approximately 10.0% glycerin, Approximately 6.0% potato starch, Approximately 4.0% dry peanut butter, Approximately 0.5% DigestaWell PET, Approximately 6.5% rice starch, and Approximately 2.0% guar gum.

[0201] In one embodiment, the dosage form is Cannabis extract, Peanut butter, Rice bran, Glucosamine HCl, Sweet potato, Dried molasses, Sorbic acid Brewing yeast, Sugar, Water, Glycerin, Potato starch, Dry peanut butter, Chondroitin, DigestaWell PET, Rice starch, and Guar gum.

[0202] In another embodiment, the dosage form is about 3.0 to 10.0% cannabis extract, about 5.0 to 20.0% peanut butter, about 10.0 to 15.0% rice bran, about 5.0 to 15.0% glucosamine HCl, about 4.0 to 10.0% sweet potato, about 6.0 to 13.0% dried molasses, about 0.5 to 5.0% sorbic acid, about 2.0 to 8.0% brewing yeast, about 3.0 to 8.0% sugar, about 5.0 to 15.0% water, about 8.0 to 18.0% glycerin, about 1.0 to 8.0% potato starch, about 0.5 to 5.0% dried peanut butter, about 0.5 to 5.0% chondroitin, about 0.1 to 3.0% DigestaWell PET, about 1.0 to 8.0% rice starch, and about 1.0 to 5.0% guar gum.

[0203] In another embodiment, the dosage form is about 5.0% cannabis extract, about 10.0% peanut butter, about 12.0% rice bran, about 12.75% glucosamine HCl, about 5.5% sweet potato, about 8.0% dried molasses, about 1% sorbic acid, about 5.0% brewing yeast, about 6.0% sugar, about 7.25% water, about 10.0% glycerin, about 4.0% potato starch, about 4.0% dried peanut butter, about 2.5% chondroitin, Approximately 0.5% DigestaWell PET, approximately 4.5% rice starch, and approximately 2.0% guar gum.

[0204] In yet another embodiment, the dosage form further comprises approximately 5.0% cannabis extract, approximately 10.0% peanut butter, approximately 12.5% rice bran, approximately 8.5% glucosamine HCl, approximately 8.0% sweet potato, approximately 9.0% dried molasses, approximately 1% sorbic acid, approximately 5.0% brewing yeast, approximately 6.0% sugar, approximately 6.0% water, approximately 10.0% glycerin, approximately 5.0% potato starch, approximately 4.0% dried peanut butter, approximately 2.5% chondroitin, approximately 0.5% DigestaWell PET, approximately 5.0% rice starch, and approximately 2.0% guar gum.

[0205] In one embodiment, the dosage form further comprises dry yeast, fructooligosaccharide, fumaric acid, lactic acid, citric acid, malic acid, thyme oil, anethole, cinnamaldehyde, vegetable oil, dehydrated alfalfa meal, mineral oil, and / or sodium aluminosilicate.

[0206] In another embodiment, the dosage form contains 2.0% cannabis extract. In another embodiment, the dosage form contains 3.0% cannabis extract. In another embodiment, the dosage form contains 4.0% cannabis extract. In another embodiment, the dosage form contains 5.0% cannabis extract. In another embodiment, the dosage form contains 6.0% cannabis extract. In another embodiment, the dosage form contains 7.0% cannabis extract. In another embodiment, the dosage form contains 8.0% cannabis extract. In another embodiment, the dosage form contains 9.0% cannabis extract. In another embodiment, the dosage form contains 10.0% cannabis extract.

[0207] In one embodiment, the cannabis extract is cannabidiol, cannabidiolic acid, cannabigerolic acid, Δ9 - tetrahydrocannabinol, and cannabichromene.

[0208] 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 from 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 from about 0.6:1 to about 1:0.6. In still another embodiment, the ratio of cannabidiol to cannabidiolic acid is about 1:1.

[0209] In one embodiment, the concentration of Δ9-tetrahydrocannabinol is insufficient to cause psychoactive effects. In another embodiment, the ratio of Δ9-tetrahydrocannabinol to other cannabinoids is from about 1:50 to about 1:20. In yet another embodiment, the ratio of Δ9-tetrahydrocannabinol to other cannabinoids is about 1:50. In still 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 still another embodiment, the ratio of Δ9-tetrahydrocannabinol to other cannabinoids is about 1:25. In one embodiment, the ratio of Δ9-tetrahydrocannabinol to other cannabinoids is about 1:20.

[0210] In one embodiment, the concentration of Δ9-tetrahydrocannabinol is less than about 2 mg / mL. In another embodiment, the concentration of Δ9-tetrahydrocannabinol is less than about 1.5 mg / mL. In yet another embodiment, the concentration of Δ9-tetrahydrocannabinol is less than about 1 mg / mL. In still another embodiment, the concentration of Δ9-tetrahydrocannabinol is less than about 0.9 mg / mL. In yet another embodiment, the concentration of Δ9-tetrahydrocannabinol is less than about 0.8 mg / mL. In one embodiment, the concentration of Δ9-tetrahydrocannabinol is less than about 0.7 mg / mL. In another embodiment, the concentration of Δ9-tetrahydrocannabinol is less than about 0.6 mg / mL. In yet another embodiment, the concentration of Δ9-tetrahydrocannabinol is less than about 0.5 mg / mL. In still another embodiment, the concentration of Δ9-tetrahydrocannabinol is less than about 0.4 mg / mL. In one embodiment, the concentration of Δ9-tetrahydrocannabinol is less than about 0.3 mg / mL. In another embodiment, the concentration of Δ9-tetrahydrocannabinol is less than about 0.2 mg / mL. In yet another embodiment, the concentration of Δ9-tetrahydrocannabinol is less than about 0.1 mg / mL. In another embodiment, the concentration of Δ9-tetrahydrocannabinol is less than about 0.05 mg / mL. In yet another embodiment, the concentration of Δ9-tetrahydrocannabinol is about 0 mg / mL.

[0211] In one embodiment, the cannabis extract is about 0.1 to 20 mg / mL of cannabidiol, about 0.1 to 20 mg / mL of cannabidiolic acid, about 0.01 to 0.5 mg / mL of cannabigerolic acid, about 0.01 to 0.5 mg / mL of Δ9-tetrahydrocannabinol, and about 0.01 to 0.5 mg / mL of cannabinol.

[0212] In another embodiment, the cannabis extract is about 1 to 10 mg / mL of cannabidiol, About 1 to 10 mg / mL of cannabidiolic acid, 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.

[0213] In yet another embodiment, the cannabis extract contains 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.

[0214] In one embodiment, the cannabis extract contains α-pinene, β-myrcene, β-pinene, Δ-limonene, linalool, β-caryophyllene, α-humulene, nerolidol 2, guaiol, caryophyllene oxide, and α-bisabolol.

[0215] In another embodiment, the cannabis extract contains 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, about 0.04 to 0.07% of nerolidol 2, About 0.02 to 0.04% guaiol, about 0.04 to 0.08% caryophyllene oxide, and about 0.01 to 0.04% α-bisabolol.

[0216] In another embodiment, the cannabis extract is about 0.07 to 0.30% α-pinene, about 0.10 to 0.60% β-myrcene, about 0.02 to 0.20% β-pinene, about 0.03 to 0.20% Δ-limonene, about 0.01 to 0.08% linalool, about 0.03 to 0.09% β-caryophyllene, about 0.01 to 0.06% α-humulene, about 0.02 to 0.09% nerolidol 2, and about 0.01 to 0.06% guaiol.

[0217] In another embodiment, the cannabis extract is about 0.01 to 0.50% α-pinene, about 0.01 to 0.90% β-myrcene, about 0.01 to 0.50% β-pinene, about 0.01 to 0.50% Δ-limonene, about 0.01 to 0.50% linalool, about 0.01 to 0.50% β-caryophyllene, about 0.01 to 0.50% α-humulene, about 0.01 to 0.50% nerolidol 2, about 0.01 to 0.50% guaiol, about 0.01 to 0.50% caryophyllene oxide, and about 0.01 to 0.50% α-bisabolol.

[0218] In another embodiment, the cannabis extract is camphene, β-ocimene, eucalyptol, Isopulegol, and / or further comprises nerolidol 1.

[0219] In another embodiment, the cannabis extract comprises about 0.02% camphene, about 0.02 - 0.03% β-ocimene, about 0.02 - 0.05% eucalyptol, about 0.02% isopulegol, and / or about 0.02 - 0.04% nerolidol 1.

[0220] In another embodiment, the cannabis extract comprises about 0.01 - 0.04% camphene, about 0.01 - 0.05% β-ocimene, about 0.01 - 0.07% eucalyptol, about 0.01 - 0.04% isopulegol, and / or about 0.01 - 0.05% nerolidol 1.

[0221] In another embodiment, the cannabis extract comprises about 0.01 - 0.50% camphene, about 0.01 - 0.50% β-ocimene, about 0.01 - 0.50% eucalyptol, about 0.01 - 0.50% isopulegol, and / or about 0.01 - 0.50% nerolidol 1.

[0222] In one embodiment, the composition is formulated as an oil. In another embodiment, the carrier is selected from the group consisting of cannabis seed oil, flaxseed oil, olive oil, fish oil, salmon oil, coconut oil, catnip oil, sesame oil, MCT oil, and grape seed oil. In yet another embodiment, the carrier is grape seed oil. In one embodiment, the carrier is sesame seed oil.

[0223] In one embodiment, the flavoring agent is selected from the group consisting of peanut butter, catnip oil, chicken liver powder, chicken extract, maltodextrin, butter, and bacon. In another embodiment, the flavoring agent is chicken liver powder. In another embodiment, the flavoring agent is peanut butter.

[0224] In one embodiment, the composition is formulated as a chew for oral administration. In another embodiment, the chew is produced using cold extrusion. In another embodiment, the weight of the chew is about 0.5 - 10 g. In yet another embodiment, the weight of the chew is about 4 g, about 6 g, about 9 g, or about 10 g. In still another embodiment, the weight of the chew is about 0.5 g. In one embodiment, the weight of the chew is about 1 g. In another embodiment, the weight of the chew is about 1.5 g. In yet another embodiment, the weight of the chew is about 2 g. In still another embodiment, the weight of the chew is about 3 g. In one embodiment, the weight of the chew is about 4 g. In another embodiment, the weight of the chew is about 5 g. In yet another embodiment, the weight of the chew is about 6 g. In still another embodiment, the weight of the chew is about 7 g. In one embodiment, the weight of the chew is about 8 g. In another embodiment, the weight of the chew is about 9 g. In yet another embodiment, the weight of the chew is about 10 g.

[0225] In one embodiment, a 4 g chew contains about 7 mg of cannabidiol, about 6 mg of cannabidiolic acid, about 0.12 mg of cannabigerolic acid, about 0.32 mg of Δ9 - tetrahydrocannabinol, and about 0.36 mg of cannabichromene.

[0226] Therapy In one aspect, provided herein is a method for treating or reducing pain in a subject in need thereof, the method comprising administering to the subject a therapeutically effective amount of any of the above - described compositions or dosage forms.

[0227] In one embodiment, the pain is associated with migraine.

[0228] In one aspect, provided herein is a method for treating it in a veterinary subject in need of treatment for urinary house soiling, the method comprising administering to the subject a therapeutically effective amount of any of the above-described compositions or dosage forms. In one embodiment, the veterinary subject suffers from chronic pain, urological conditions, anxiety, and / or dissatisfaction.

[0229] In one embodiment, the veterinary subject is a cat. In one embodiment, the cat is over 6 months old and under 12 years old. In one embodiment, the cat is under 6 months old. In one embodiment, the cat is about 6 - 12 months old. In one embodiment, the cat is about 1 - 3 years old. In one embodiment, the cat is about 3 - 6 years old. In one embodiment, the cat is about 6 - 9 years old. In one embodiment, the cat is about 9 - 12 years old. In one embodiment, the cat is about 12 - 15 years old. In one embodiment, the cat is over about 15 years old.

[0230] In one embodiment, the veterinary subject has diabetes, lung cancer, inflammatory bowel disease, skin conditions, seizures, or obsessive behaviors.

[0231] In one embodiment, the pharmaceutical composition or dosage form is administered at a dosage of about 0.1 to 15.0 mg / kg. In another embodiment, the pharmaceutical composition or dosage form is administered at a dosage of about 0.1 to 10.0 mg / kg. In yet another embodiment, the pharmaceutical composition or dosage form is administered at a dosage of about 0.1 mg / kg. In still another embodiment, the pharmaceutical composition or dosage form is administered at a dosage of about 0.2 mg / kg. In yet another embodiment, the pharmaceutical composition or dosage form is administered at a dosage of about 0.3 mg / kg. In one embodiment, the pharmaceutical composition or dosage form is administered at a dosage of about 0.4 mg / kg. In another embodiment, the pharmaceutical composition or dosage form is administered at a dosage of about 0.5 mg / kg. In yet another embodiment, the pharmaceutical composition or dosage form is administered at a dosage of about 0.6 mg / kg. In still another embodiment, the pharmaceutical composition or dosage form is administered at a dosage of about 0.7 mg / kg. In yet another embodiment, the pharmaceutical composition or dosage form is administered at a dosage of about 0.8 mg / kg. In one embodiment, the pharmaceutical composition or dosage form is administered at a dosage of about 0.9 mg / kg. In another embodiment, the pharmaceutical composition or dosage form is administered at a dosage of about 1 mg / kg. In yet another embodiment, the pharmaceutical composition or dosage form is administered at a dosage of about 1.5 mg / kg. In still another embodiment, the pharmaceutical composition or dosage form is administered at a dosage of about 2 mg / kg. In one embodiment, the pharmaceutical composition or dosage form is administered at a dosage of about 3 mg / kg. In another embodiment, the pharmaceutical composition or dosage form is administered at a dosage of about 4 mg / kg. In yet another embodiment, the pharmaceutical composition or dosage form is administered at a dosage of about 5 mg / kg. In still another embodiment, the pharmaceutical composition or dosage form is administered at a dosage of about 6 mg / kg. In one embodiment, the pharmaceutical composition or dosage form is administered at a dosage of about 7 mg / kg. In another embodiment, the pharmaceutical composition or dosage form is administered at a dosage of about 8 mg / kg. In yet another embodiment, the pharmaceutical composition or dosage form is administered at a dosage of about 9 mg / kg. In still another embodiment, the pharmaceutical composition or dosage form is administered at a dosage of about 10 mg / kg. In one embodiment, the pharmaceutical composition or dosage form is administered at a dosage of about 11 mg / kg. In another embodiment, the pharmaceutical composition or dosage form is administered at a dosage of about 12 mg / kg.In yet another embodiment, the pharmaceutical composition or dosage form is administered at a dosage of about 13 mg / kg. In still another embodiment, the pharmaceutical composition or dosage form is administered at a dosage of about 14 mg / kg. In one embodiment, the pharmaceutical composition or dosage form is administered at a dosage of about 15 mg / kg.

[0232] In another embodiment, the pharmaceutical composition or dosage form is administered for one week at twice the therapeutically effective dosage and then at the therapeutically effective dosage. In yet another embodiment, the therapeutically effective dosage is about 0.1 - 0.5 mg / kg. In still another embodiment, the therapeutically effective dosage is about 2 mg / kg. In one embodiment, the therapeutically effective dosage is about 8 mg / kg.

[0233] In one embodiment, the pharmaceutical composition or dosage form is administered for one week at a dosage of about 1 mg / kg and then at a dosage of about 0.1 - 0.5 mg / kg. In another embodiment, the pharmaceutical composition or dosage form is administered for one week at a dosage of about 4 mg / kg and then at a dosage of about 2 mg / kg.

[0234] In one embodiment, the pharmaceutical composition or dosage form is administered once a day at a dosage of about 1.0 mg / kg. In one embodiment, the pharmaceutical composition or dosage form is administered twice a day at a dosage of about 1.0 mg / kg. In one embodiment, the pharmaceutical composition or dosage form is administered three times a day at a dosage of about 1.0 mg / kg. In one embodiment, the pharmaceutical composition or dosage form is administered four times a day at a dosage of about 1.0 mg / kg.

[0235] In one embodiment, the pharmaceutical composition or dosage form is administered once a day at a dosage of about 2.0 mg / kg. In one embodiment, the pharmaceutical composition or dosage form is administered twice a day at a dosage of about 2.0 mg / kg. In one embodiment, the pharmaceutical composition or dosage form is administered three times a day at a dosage of about 2.0 mg / kg. In one embodiment, the pharmaceutical composition or dosage form is administered four times a day at a dosage of about 2.0 mg / kg.

[0236] In one embodiment, the pharmaceutical composition or dosage form is administered once daily at a dosage of about 3.0 mg / kg. In one embodiment, the pharmaceutical composition or dosage form is administered twice daily at a dosage of about 3.0 mg / kg. In one embodiment, the pharmaceutical composition or dosage form is administered three times daily at a dosage of about 3.0 mg / kg. In one embodiment, the pharmaceutical composition or dosage form is administered four times daily at a dosage of about 3.0 mg / kg.

[0237] In one embodiment, the pharmaceutical composition or dosage form is administered once daily at a dosage of about 4.0 mg / kg. In one embodiment, the pharmaceutical composition or dosage form is administered twice daily at a dosage of about 4.0 mg / kg. In one embodiment, the pharmaceutical composition or dosage form is administered three times daily at a dosage of about 4.0 mg / kg. In one embodiment, the pharmaceutical composition or dosage form is administered four times daily at a dosage of about 4.0 mg / kg. In one embodiment, the pharmaceutical composition or dosage form is administered once daily at a dosage of about 5.0 mg / kg. In one embodiment, the pharmaceutical composition or dosage form is administered twice daily at a dosage of about 5.0 mg / kg. In one embodiment, the pharmaceutical composition or dosage form is administered three times daily at a dosage of about 5.0 mg / kg. In one embodiment, the pharmaceutical composition or dosage form is administered four times daily at a dosage of about 5.0 mg / kg.

[0238] In one embodiment, the pharmaceutical composition or dosage form is administered once daily at a dosage of about 6.0 mg / kg. In one embodiment, the pharmaceutical composition or dosage form is administered twice daily at a dosage of about 6.0 mg / kg. In one embodiment, the pharmaceutical composition or dosage form is administered three times daily at a dosage of about 6.0 mg / kg. In one embodiment, the pharmaceutical composition or dosage form is administered four times daily at a dosage of about 6.0 mg / kg.

[0239] In one embodiment, the pharmaceutical composition or dosage form is administered once daily at a dosage of about 7.0 mg / kg. In one embodiment, the pharmaceutical composition or dosage form is administered twice daily at a dosage of about 7.0 mg / kg. In one embodiment, the pharmaceutical composition or dosage form is administered three times daily at a dosage of about 7.0 mg / kg. In one embodiment, the pharmaceutical composition or dosage form is administered four times daily at a dosage of about 7.0 mg / kg.

[0240] In one embodiment, the pharmaceutical composition or dosage form is administered once daily at a dosage of about 8.0 mg / kg. In one embodiment, the pharmaceutical composition or dosage form is administered twice daily at a dosage of about 8.0 mg / kg. In one embodiment, the pharmaceutical composition or dosage form is administered three times daily at a dosage of about 8.0 mg / kg. In one embodiment, the pharmaceutical composition or dosage form is administered four times daily at a dosage of about 8.0 mg / kg.

[0241] In one embodiment, the pharmaceutical composition or dosage form is administered once daily at a dosage of about 9.0 mg / kg. In one embodiment, the pharmaceutical composition or dosage form is administered twice daily at a dosage of about 9.0 mg / kg. In one embodiment, the pharmaceutical composition or dosage form is administered three times daily at a dosage of about 9.0 mg / kg. In one embodiment, the pharmaceutical composition or dosage form is administered four times daily at a dosage of about 9.0 mg / kg.

[0242] In one embodiment, the pharmaceutical composition or dosage form is administered once daily at a dosage of about 10.0 mg / kg. In one embodiment, the pharmaceutical composition or dosage form is administered twice daily at a dosage of about 10.0 mg / kg. In one embodiment, the pharmaceutical composition or dosage form is administered three times daily at a dosage of about 10.0 mg / kg. In one embodiment, the pharmaceutical composition or dosage form is administered four times daily at a dosage of about 10.0 mg / kg.

[0243] In one embodiment, the pharmaceutical composition or dosage form is administered twice daily at a dosage of about 2 mg / kg.

[0244] In one embodiment, a dropperful of the pharmaceutical composition or dosage form is administered to the subject. In another embodiment, 0.5 mL of the pharmaceutical composition or dosage form is administered to the subject. In another embodiment, 1 mL of the pharmaceutical composition or dosage form is administered to the subject. In another embodiment, 2 mL of the pharmaceutical composition or dosage form is administered to the subject. In another embodiment, 3 mL of the pharmaceutical composition or dosage form is administered to the subject. In another embodiment, 4 mL of the pharmaceutical composition or dosage form is administered to the subject. In another embodiment, 5 mL of the pharmaceutical composition or dosage form is administered to the subject. In another embodiment, 6 mL of the pharmaceutical composition or dosage form is administered to the subject. In another embodiment, 7 mL of the pharmaceutical composition or dosage form is administered to the subject. In another embodiment, 8 mL of the pharmaceutical composition or dosage form is administered to the subject. In another embodiment, 9 mL of the pharmaceutical composition or dosage form is administered to the subject. In another embodiment, 10 mL of the pharmaceutical composition or dosage form is administered to the subject.

[0245] In one embodiment, the method provides a median maximum serum concentration of cannabidiol that is therapeutically effective. In another embodiment, the median maximum serum concentration of cannabidiol is from about 90 to 310 ng / mL. In yet another embodiment, the median maximum serum concentration of cannabidiol is about 90 ng / mL. In still another embodiment, the median maximum serum concentration of cannabidiol is about 100 ng / mL. In still another embodiment, the median maximum serum concentration of cannabidiol is about 102 ng / mL. In one embodiment, the median maximum serum concentration of cannabidiol is about 200 ng / mL. In another embodiment, the median maximum serum concentration of cannabidiol is about 300 ng / mL. In yet another embodiment, the median maximum serum concentration of cannabidiol is about 400 ng / mL. In still another embodiment, the median maximum serum concentration of cannabidiol is about 500 ng / mL. In one embodiment, the median maximum serum concentration of cannabidiol is about 590 ng / mL. In another embodiment, the median maximum serum concentration of cannabidiol is about 600 ng / mL.

[0246] 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.

[0247] In one aspect, provided herein is a method for treating urinary house soiling, diabetes, lung cancer, inflammatory bowel disease, skin conditions, seizures, obsessive-compulsive behavior, migraine, or insect bites in a subject, the method comprising administering to the subject a therapeutically effective amount of a cannabis extract.

[0248] In one embodiment, the cannabis extract is administered at a dosage of about 0.1 to 15.0 mg / kg. In another embodiment, the cannabis extract is administered at a dosage of about 0.1 to 10.0 mg / kg. In yet another embodiment, the cannabis extract is administered at a dosage of about 0.1 mg / kg. In still another embodiment, the cannabis extract is administered at a dosage of about 0.2 mg / kg. In yet another embodiment, the cannabis extract is administered at a dosage of about 0.3 mg / kg. In one embodiment, the cannabis extract is administered at a dosage of about 0.4 mg / kg. In another embodiment, the cannabis extract is administered at a dosage of about 0.5 mg / kg. In yet another embodiment, the cannabis extract is administered at a dosage of about 0.6 mg / kg. In still another embodiment, the cannabis extract is administered at a dosage of about 0.7 mg / kg. In yet another embodiment, the cannabis extract is administered at a dosage of about 0.8 mg / kg. In one embodiment, the cannabis extract is administered at a dosage of about 0.9 mg / kg. In another embodiment, the cannabis extract is administered at a dosage of about 1 mg / kg. In yet another embodiment, the cannabis extract is administered at a dosage of about 1.5 mg / kg. In still another embodiment, the cannabis extract is administered at a dosage of about 2 mg / kg. In one embodiment, the cannabis extract is administered at a dosage of about 3 mg / kg. In another embodiment, the cannabis extract is administered at a dosage of about 4 mg / kg. In yet another embodiment, the cannabis extract is administered at a dosage of about 5 mg / kg. In still another embodiment, the cannabis extract is administered at a dosage of about 6 mg / kg. In one embodiment, the cannabis extract is administered at a dosage of about 7 mg / kg. In another embodiment, the cannabis extract is administered at a dosage of about 8 mg / kg. In yet another embodiment, the cannabis extract is administered at a dosage of about 9 mg / kg. In still another embodiment, the cannabis extract is administered at a dosage of about 10 mg / kg. In one embodiment, the cannabis extract is administered at a dosage of about 11 mg / kg. In another embodiment, the cannabis extract is administered at a dosage of about 12 mg / kg. In yet another embodiment, the cannabis extract is administered at a dosage of about 13 mg / kg. In still another embodiment, the cannabis extract is administered at a dosage of about 14 mg / kg. In one embodiment, the cannabis extract is administered at a dosage of about 15 mg / kg.

[0249] In another embodiment, the cannabis extract is administered for one week at twice the therapeutically effective dosage, and then at the therapeutically effective dosage. In yet another embodiment, the therapeutically effective dosage is about 0.1 - 0.5 mg / kg. In still another embodiment, the therapeutically effective dosage is about 2 mg / kg. In one embodiment, the therapeutically effective dosage is about 8 mg / kg.

[0250] In one embodiment, the cannabis extract is administered for one week at a dosage of about 1 mg / kg, and then at a dosage of about 0.1 - 0.5 mg / kg. In another embodiment, the cannabis extract is administered for one week at a dosage of about 4 mg / kg, and then at a dosage of about 2 mg / kg.

[0251] In one embodiment, the method provides a median maximum serum concentration of cannabidiol that is therapeutically effective. In another embodiment, the median maximum serum concentration of cannabidiol is about 90 - 310 ng / mL. In yet another embodiment, the median maximum serum concentration of cannabidiol is about 90 ng / mL. In still another embodiment, the median maximum serum concentration of cannabidiol is about 100 ng / mL. In still another embodiment, the median maximum serum concentration of cannabidiol is about 102 ng / mL. In one embodiment, the median maximum serum concentration of cannabidiol is about 200 ng / mL. In another embodiment, the median maximum serum concentration of cannabidiol is about 300 ng / mL. In yet another embodiment, the median maximum serum concentration of cannabidiol is about 400 ng / mL. In still another embodiment, the median maximum serum concentration of cannabidiol is about 500 ng / mL. In one embodiment, the median maximum serum concentration of cannabidiol is about 590 ng / mL. In another embodiment, the median maximum serum concentration of cannabidiol is about 600 ng / mL.

[0252] 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.

[0253] The pharmaceutical compositions and dosage forms of the present disclosure may be administered by any convenient route, for example, by infusion or bolus injection, by absorption through epithelial or cutaneous mucosa (such as oral mucosa, rectal and intestinal mucosa, etc.), and may be administered together with any other therapeutic agent. Administration may be systemic or local. In one embodiment, the administration is local. In another embodiment, local administration is used to treat local pain. In another embodiment, the local pain is joint pain. In one embodiment, the veterinary subject is an animal weighing more than 100 kg (such as a horse, cow, or pig).

[0254] The therapeutic compositions of the present invention are administered together with suitable carriers, excipients, and other agents incorporated into the formulation to provide improved transport, delivery, resistance, etc. Numerous suitable formulations can be found in formularies known to all pharmacists: Remington’s Pharmaceutical Sciences, Mack Publishing Company, Easton, PA. These formulations include, for example, powders, pastes, ointments, jellies, waxes, oils, lipids, lipid (cationic or anionic) - containing vesicles (such as LIPOFECTIN™), DNA conjugates, anhydrous absorption pastes, oil - in - water and water - in - oil emulsions, emulsion carbowaxes (polyethylene glycols of various molecular weights), semi - solid gels, and carbowax - containing semi - solid mixtures. See also Powell et al. “Compendium of excipients for parenteral formulations” PDA (1998) J Pharm Sci Technol 52:238 - 311.

[0255] The dosage may vary depending on the age and weight of the subject to be administered, the target disease, condition, route of administration, etc. Various delivery systems are known and can be used to administer the pharmaceutical composition of the present invention, for example, encapsulation in liposomes, microparticles, microcapsules, receptor-mediated endocytosis, etc. (see, for example, Wu et al. (1987) J. Biol. Chem. 262:4429-4432). Introduction methods include, but are not limited to, intradermal, intramuscular, intraperitoneal, intravenous, transdermal, oral, sublingual, subcutaneous, intranasal, epidural, and oral routes. The composition may be administered by any convenient route, for example, by injection or bolus injection, by absorption through epithelial or skin mucosa (such as oral mucosa, rectal and intestinal mucosa, etc.), and may also be administered together with other biologically active agents. Administration may be systemic or local.

[0256] For pharmacological preparations for oral use, solid excipients are used, and optionally, the resulting mixture is pulverized, and if desired, after adding suitable adjuvants, the mixture of granules is processed to obtain tablets or dragee cores. Suitable excipients include, in particular, fillers such as sugars including lactose, sucrose, mannitol, or sorbitol; cellulose preparations such as corn starch, wheat starch, rice starch, potato starch, gelatin, gum, methylcellulose, hydroxypropylmethylcellulose, sodium carboxymethylcellulose, etc., and / or physiologically acceptable polymers such as polyvinylpyrrolidone (PVP). If desired, disintegrants such as crosslinked polyvinylpyrrolidone, agar, or salts thereof such as alginic acid or sodium alginate may be added.

[0257] The dragee cores are provided with suitable coatings. For this purpose, a concentrated sugar solution that may optionally contain gum arabic, talc, polyvinylpyrrolidone, carbopol gel, polyethylene glycol, titanium dioxide, shellac solution, and suitable organic solvents or solvent mixtures may be used.

[0258] Injectable preparations may include dosage forms for intravenous, subcutaneous, intradermal, and intramuscular injections, topical injections, infusions, etc. These injectable preparations can be prepared by known methods. For example, injectable preparations can be prepared by dissolving, suspending, or emulsifying a pharmaceutical composition or dosage form in a sterile aqueous medium or an oily medium conventionally used for injection. Examples of aqueous media for injection include physiological saline, isotonic solutions containing glucose and other adjuvants, and these can be used in combination with appropriate solubilizers such as alcohol (e.g., ethanol), polyalcohols (e.g., propylene glycol, polyethylene glycol), nonionic surfactants [e.g., polysorbate 80, HCO-50 (polyoxyethylene (50 mol) adduct of hydrogenated castor oil)]. As the oily medium, for example, sesame oil, soybean oil, etc. are used, and these can be used in combination with solubilizers such as benzyl benzoate, benzyl alcohol. The injectable prepared in this way can be filled into appropriate ampoules.

[0259] Pharmaceutical compositions that can be used orally include push-fit capsules made of gelatin, as well as soft sealed capsules made of gelatin and plasticizers such as glycerol or sorbitol. Push-fit capsules may contain an active ingredient mixed with a filler such as lactose, a binder such as starch, a lubricant such as talc or magnesium stearate, and optionally a stabilizer. In soft capsules, the active ingredient can be dissolved or suspended in an appropriate liquid such as fatty oil, liquid paraffin, or liquid polyethylene glycol.

[0260] Alternatively, the composition may be in powder form for constitution before use with a suitable vehicle, such as sterile pyrogen-free water. The exact formulation, route of administration, and dosage will be selected by a physician who is knowledgeable about the patient's condition. (See, for example, Fingl, et al., 1975, “The Pharmacological Basis of Therapeutics”, Chapter I, p. 1). Depending on the severity and responsiveness of the condition being treated, administration may be by a single dose of a sustained release composition, and the treatment course may last from several days to several weeks, or until healing is brought about or a diminution of the pathological state is achieved.

[0261] Advantageously, the pharmaceutical compositions for the above oral or parenteral use are prepared in dosage forms in unit doses suitable for accommodating the dosage of the active ingredient. Such dosage forms in unit doses include, for example, tablets, pills, capsules, injections (ampoules), suppositories, chewables, pet foods, etc. In certain embodiments, for the dosages provided above, administration is in a single pet food meal, for example, with 1 mg / kg of cannabis extract provided in a single pet food meal.

[0262] The cannabis extracts, dosage forms, and pharmaceutical compositions described herein can be packaged to provide one or more doses of the cannabis extract per package. Any suitable type of packaging can be used, including wrappers, pouches, boxes, tabs, cans, blister packs, and bags. Such packaging is convenient and accessible for consumers, improves consumer ease of use, reduces the presence of pathogens, extends shelf life, and reduces spoilage. In one embodiment, the cannabis extract, dosage form, or pharmaceutical composition is packaged to provide one or more doses of the cannabis extract per package. In one embodiment, the package is resealable. In some embodiments, the dosage form is edible. In some embodiments, the edible dosage form is formed in a flat shape that can be more easily divided. In some embodiments, this flat shape is a disk or cookie shape. In some embodiments, the edible dosage form includes score marks to indicate where the edible dosage form should be divided to provide a specific dosage. In some embodiments, the edible dosage form is provided in multiple pieces. In some embodiments, each of the multiple pieces provides a specific dosage. In some embodiments, the package includes 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, or 20 pieces. In some embodiments, the package is resealable. In one embodiment, one dose of the cannabis extract is a therapeutically effective amount. According to the methods disclosed herein, the pharmaceutical formulation can be administered to a patient or subject using any acceptable device or mechanism. For example, administration can be accomplished using a syringe and needle, or a reusable pen and / or self-injecting injector. The methods of the invention include the use of a number of reusable pens and / or self-injecting injectors for administering the pharmaceutical formulation.

[0263] In one embodiment of non-human animal administration, the term "pharmaceutical" as used herein may be replaced with "veterinary".

Examples

[0264] Example 1: CBD Oil and Protocol Approval The industrial hemp strain used in this trial was a proprietary hemp strain utilizing ethanol and heat extraction, and the final dried product was reconstituted into an olive oil base containing approximately 10 mg / ml CBD, 0.24 mg / ml tetrahydrocannabinol (THC), 0.27 mg / ml cannabichromene (CBC), and 0.11 mg / ml dehydrated cannabigerol (CBG) as an equivalent mixture of CBD and its carboxylic acid (CBDa), with all other cannabinoids being 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% difference between batches for each of the detected cannabinoids noted above. This trial was conducted after approval by the Cornell University Institutional Animal Care and Use Committee (IACUC) for a study conducted in accordance with the IACUC's Guide for the Care and Use of Animals. Client-owned dogs were enrolled after informed consent in accordance with the Helsinki Declaration.

[0265] Example 2: Terpene Profile The terpene profile was determined using gas chromatography by headspace flame ionization detection (GC-FID) analysis of four separate oil extracts. 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 oils tested 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. Total terpenes ranged from 0.73 - 1.10%.

[0266] Example 3: Pharmacokinetics An initial investigation on single-dose oral pharmacokinetics was conducted using four beagle dogs (3.5 - 7 years old, castrated male, 10.7 - 11.9 kg). Each dog was orally administered 2 mg / kg and 8 mg / kg of CBD oil, and the washout period was 2 weeks between each experiment. The dogs were fed 2 hours after administration. Physical examinations were performed at 0, 4, 8, and 24 hours after administration. The free running / walking around a standard traffic cone (weaving) and the attitude, behavior, proprioceptive sensation, and walking during navigation were subjectively evaluated at each time point. Five milliliters of blood were collected at 0, 0.5, 1, 2, 4, 8, 12, and 24 hours after oil administration. Blood samples were obtained by jugular venipuncture and transferred to clotting tubes for 20 minutes. The samples were centrifuged at 3,600×g for 10 minutes (VWR, clinical centrifuge), the serum was removed, and they were stored at -80°C until analyzed using liquid chromatography-mass spectrometry (LC-MS) at the Colorado State University Core Mass Spectrometry Facility.

[0267] Example 4: Extraction and Mass Spectrometry of CBD from Dog Serum CBD was extracted from dog serum using a combination of protein precipitation and liquid-liquid extraction with n-hexane, with slight modification to microflow ultra-high pressure liquid chromatography (UHPLC). Briefly, 0.05 ml of dog serum was subjected to protein precipitation in the presence of ice-cold acetonitrile (final concentration 80%), and deuterated CBD was added as an internal standard (0.06 mg / ml, CDB-d 3 Cerilliant, 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 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 a CBD analysis standard was created with dog serum that had not been exposed to CBD and was extracted as described above. The cannabidiol concentration in the serum was quantified using a triple quadrupole mass spectrometer coupled to chromatography (UHPLC-QQQ-MS).

[0268] Example 5: CBD Serum Concentration Data Analysis From the UHPLC-QQQ-MS data, the peak area of CBD detected in the biological samples was extracted and normalized to the peak area of the internal standard CBD-d in each sample using Skyline and in-house R scripts (www.r-project.org). The CBD concentration was calculated to nanograms per milliliter of serum as determined by the regression line of the standard curve (r2 = 0.9994, 0 - 1000 ng / mL). In this assay, the limit of detection (LOD) and limit of quantification (LOQ) represent the lower limits of detection and quantification of each compound in the matrix of this study. Pharmacokinetic variables were estimated by non-compartmental analysis using a pharmacokinetic software package (PK Solution, version 2.0, Montrose, CO, USA). 3 The peak area of CBD detected in the biological samples was extracted from the UHPLC-QQQ-MS data and normalized to the peak area of the internal standard CBD-d in each sample using Skyline and in-house R scripts (www.r-project.org). The CBD concentration was calculated to nanograms per milliliter of serum as determined by the regression line of the standard curve (r2 = 0.9994, 0 - 1000 ng / mL). In this assay, the limit of detection (LOD) and limit of quantification (LOQ) represent the lower limits of detection and quantification of each compound in the matrix of this study. Pharmacokinetic variables were estimated by non-compartmental analysis using a pharmacokinetic software package (PK Solution, version 2.0, Montrose, CO, USA).

[0269] Example 6: Inclusion and Exclusion Criteria for Clinical Trials The study population consisted of dogs owned by clients who visited the Cornell University Animal Hospital for the evaluation and treatment of lameness due to OA. Dogs were considered for inclusion in this study if they had X-ray images indicative of OA, had signs of pain as evaluated by the dog owner, had detectable lameness on visual gait evaluation, and had joints with pain on palpation. To exclude underlying diseases that could interfere with enrollment, a complete blood count ([CBC] Bayer Advia 120, Siemens Corp., New York, NY, USA) and serum chemistry analysis (Hitachi 911, Roche Diagnostics, Indianapolis, IN, USA) were initially performed on each dog. Elevations in alkaline phosphatase (ALP), alanine aminotransferase (ALT), and aspartate aminotransferase (AST) were tolerated if previous liver ultrasounds were considered within normal limits, except for potential non-progressive nodules (possibility of hepatic nodular hyperplasia).

[0270] All owners answered a simple questionnaire to define the affected limb, duration of lameness, and duration of analgesic or other medication use.

[0271] All dogs underwent X-ray examination of the affected joints, and a radiologist confirmed the presence or absence of OA, excluding dogs with complications (i.e., lytic lesions) that could interfere with registration.

[0272] During the trial, dogs were only permitted to receive NSAIDs, fish oil, and / or glucosamine / chondroitin sulfate as standard treatment for the disease process for 4 weeks prior to the 10-week trial period or during the trial period without changing these medications. The use of other analgesics such as gabapentin and tramadol was also discontinued at least 2 weeks before registration. Dogs with evidence of renal disease, uncontrolled endocrine disease, neurological disease, or neoplastic disease, or with a temperament unsuitable for walking on a leash, or those receiving physical therapy were excluded. All dogs were given a normal diet and no changes were permitted during the test.

[0273] Example 7: Clinical Trial This trial was a placebo-controlled, double-blind, crossover clinical trial. Dogs were given two treatments: CBD at 2 mg / kg every 12 hours or placebo (10 / 1000 anise oil and 5 / 1000 peppermint oil added to an equal volume of olive oil to provide a similar herbal scent) every 12 hours, each in a random order (using a randomizer iPhone (registered trademark) application). Each treatment was administered for 4 weeks, and the washout period was 2 weeks between treatments. Blood was collected and complete blood count tests and chemical analyses were repeated at the 2-week and 4-week time points of each treatment.

[0274] At each examination, each dog was evaluated by a veterinarian based on a scoring system and also by the dog's owner at the time points before treatment initiation and 2 weeks and 4 weeks later (Canine Brief Pain Inventory [CBPI], Hudson Activity Scale).

[0275] Example 8: Statistical Analysis Initial output analysis was performed, and the number of dogs required for this study was evaluated as a crossover design with a power of 0.80 and an alpha of 0.05, using prior data suggesting a baseline CBPI or Hudson score change of approximately 15 points (bilateral) with a standard deviation of 20. In the calculations, it was assumed that 14 dogs were required to find significance.

[0276] 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. Considering that most of our blood, serum, and scoring data were normally distributed, a mixed model analysis of variance was used. The crossover study variables included in the model were the fixed effects of treatment, time, order of oils, sex, age, NSAID use, number of treatments, as well as the variable effects of the observation period, period nested within dogs, and time points nested within the period nested within dogs. To control for differences and relative changes in CBPI pain and activity interference assessments and Hudson scores between dogs, the fixed effect of the initial CPBI or Hudson score was also included in these analyses. Dunnett's test was performed post hoc for any significant effects of the number of treatments, and the differences from week 0 of CBD oil or placebo oil were evaluated as the baseline time point for comparison. A p-value of less than 0.05 was determined to be significant for all analyses.

[0277] Example 9: Results of Pharmacokinetics Pharmacokinetics showed that the median CBD elimination half-life 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 ng / mL (60.7 - 132.0 ng / mL, 180 nM) and 590.8 ng / mL (389.5 - 904.5 ng / mL, 1.2 μM) at doses of 2 mg / kg and 8 mg / kg, respectively, and was reached at 1.5 hours and 2 hours, respectively. No obvious psychoactive properties were observed at any time point during 24-hour administration at 2 mg / kg and 8 mg / kg. These results led to a practical dose of 2 mg / kg body weight every 12 hours during the clinical trial.

Table 1

[0278] Example 10: Dogs Incorporated into the Clinical Trial Twenty-two client-owned dogs with clinically and radiographically confirmed evidence of osteoarthritis were recruited. Sixteen of these dogs completed the study and were included in this analysis. Their breed, weight, age, gender, affected limb, radiographic findings, NSAID use, and treatment sequence are summarized in Table 2. Dogs were excluded for osteosarcoma at enrollment, gastric dilation-volvulus (placebo), past aggression problems (CBD oil), pyelonephritis / renal insufficiency (CBD oil), recurrent foot dermatitis (placebo oil), and diarrhea (placebo oil).

Table 2

[0279] Example 11: Clinical Trial Results CBPI and the Hudson score (Figs. 3A and 3B) showed a significant reduction in pain and an increase in activity (p<0.01) at weeks 2 and 4 during CBD treatment compared to week 0 at baseline, while no difference was seen between the score before treatment initiation and the CBPI and Hudson scores in the placebo treatment (Table 3). Lameness evaluated by a veterinarian (Fig. 4) showed an increase in lameness with age (p<0.01), while the use of NSAIDs (p=0.03) significantly reduced lameness. The veterinary pain score showed a significant reduction in pain in dogs administered NSAIDs (p<0.01). CBD oil resulted in a significant reduction in pain compared to baseline at both the 2-week and 4-week evaluations (p<0.03), while no significant difference was shown in the 24 placebo treatments. No change in weight-bearing capacity was observed when evaluated using the veterinary lameness and pain scoring system (Table 3).

Table 3

[0280] Chemical analysis and CBC were performed at each examination. No significant changes were observed in the measured CBC values in either the dogs treated with CBD oil or the dogs treated with placebo (data not shown). Serum chemistry values showed no difference between placebo and CBD oil, except for alkaline phosphatase (ALP), which significantly increased over time from baseline until the fourth week of CBD oil treatment (Table 4) (p = 0.005), and nine out of 16 dogs showed an increase over time (Figure 1). Glucose increased at each time point in the dogs administered placebo oil (p = 0.04), and creatinine values increased over time in both the dogs administered CBD oil and the dogs administered placebo oil (p < 0.01), but all values remained within the reference range. Other significant associations in serum chemistry values were mainly related to age or NSAID use. Increasing 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) values. NSAID use was associated with significantly higher BUN (p = 0.003) and creatinine (p = 0.017), as well as significant decreases in total protein (p < 0.001) and serum globulin (p < 0.001).

Table 4

[0281] Example 12: Safety Test in Dogs To evaluate the safety of the soft chews containing CBD, a 12-week safety test was conducted in dogs.

[0282] Animals and Study Design As shown in Table 5, eight purebred beagles aged 11 months to 5 years with a body weight of 7.39 - 11.95 kg at the start of the study were selected for this study.

Table 5

[0283] Dogs were individually housed in cages sized in accordance with the Animal Welfare Act, and the target conditions were a 12-hour light / 12-hour dark cycle and 50°–85°F. The 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 automatic water supply system. There were no known contaminants reasonably expected to be present in the diet ingredients that were known to potentially interfere with the purpose or conduct of this study.

[0284] During the study, the control diet, Purina Dog Chow, was the only food source provided once daily to each animal for approximately 1 hour. Dogs were fed according to their ideal body condition and fasted for at least 12 hours prior to blood sampling. CBD was administered via soft chews provided twice daily at a dosage of approximately 2 mg / kg. The administration is shown in Table 6.

Table 6

[0285] CBC and Serum Chemistry Prior to the start of the study, 5 milliliters of blood was collected from each dog and used to determine eligibility for the study. During the study, 5 milliliters of blood was collected weekly (±2 days). Blood was collected by jugular venipuncture using a sterile syringe. The samples were divided into two tubes, a red-top serum separator tube and a lavender-top EDTA tube. The red-top tube was allowed to clot and then centrifuged in a refrigerated centrifuge at 3000 RPM for 15 minutes. The lavender-top tube was placed in a rocker to ensure proper mixing of the blood with the anticoagulant. The blood samples were packaged and sent to Antech Diagnostics on a priority basis (overnight) for analysis.

[0286] Pharmacokinetics (PK) Blood Sampling On the first day of administration, blood for PK analysis was collected from 6 out of 8 dogs. The most cooperative dogs were selected for PK analysis. Approximately 6 milliliters of blood was collected by jugular vein puncture using a sterile syringe at 0 minutes, 30 minutes, 60 minutes, 2 hours, 4 hours, 8 hours, 12 hours, and 24 hours after treatment. The samples were placed in red-top clotting tubes without serum separator. Serum was collected by centrifuging the tubes at 3000 RPM for 15 minutes. The collected serum was placed in cryovials and stored at -70°C. Each tube was labeled with the dog ID, collection date, and collection time point. The samples were transported overnight to the Proteomics & Metabolomics Facility at Colorado State University while placed on dry ice.

[0287] Clinical Findings Veterinarians performed a complete physical examination of all dogs before the start of the clinical trial and at the end of the clinical trial. Each dog was evaluated for general health status, physical condition, and coat condition. Qualified staff conducted clinical observations twice a day according to the veterinary care program at Summit Ridge Farms and SOP VC-003 (round observation). All animals were evaluated twice a day with reference to SOP VC-016 (recognition of pain, stress, and / or distress). Clinical diagnostic procedures were performed as necessary. Appropriate veterinary care was provided for each individual according to the veterinary care program.

[0288] Blood Analysis Blood was analyzed for white blood cell count, red blood cell count, hemoglobin, hematocrit, MCV, MCHC, MCH, and platelet count with complete differentials. In addition, a 22-test chemical screening 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, triglyceride, GGTP, and magnesium was performed. Measurements were taken before the start of the clinical trial and then weekly during the clinical trial.

[0289] PK Analysis The blood concentration values of the test substance and the pharmacokinetic analysis were performed as described in Gamble et al. (2018) Front Vet Sci. 165:1-9.

[0290] Results Body weight During the 12-week trial, the mean body weight change in dogs was -0.04 kg (-0.43%).

[0291] Food consumption The mean weekly food consumption of dogs during the trial was 204 g.

[0292] Test substance consumption Five out of eight dogs had a 100% chew acceptance rate. During the trial, three dogs needed to be dosed intermittently: dog ID number 13644 (dosed with a 6.5% probability), dog ID number 13513 (dosed with a 2.4% probability), and dog ID number 2784123 (dosed with a 17.3% probability).

[0293] Hematology and serum chemistry From week 1, the mean alkaline phosphatase (ALP) value of the group increased slightly. This value remained stable until week 7 when the group mean ALP value gradually increased. The highest group mean value was observed in the final week of the trial but did not exceed the normal reference range. The cause of the increase in the group mean value seemed to be due to three dogs (dog ID numbers 13536, 2753822, and 2808987). By the end of the trial, dog ID numbers 13536 and 2753822 exceeded 100 U / L but did not exceed the normal maximum value of 131 U / L. Therefore, those values remained within the normal reference range. The increase observed in only a few dogs in the group may indicate individual sensitivity to the product. All other blood parameters remained within the normal range and no obvious trend was observed.

[0294] Clinical findings During the trial, cases of loose stools and vomiting were occasionally recorded. In dog ID number 13536, 5 cases of food or bile vomiting and 6 cases of loose stools were observed. In dog ID number 13513, 2 cases of loose stools were observed. In dog ID number 27583822, 2 cases of food vomiting and 8 cases of loose stools were observed. In dog ID number 13644, 12 cases of loose stools were observed. In dog ID number 13490, 2 cases of loose stools were observed. In dog ID number 2808987, 4 cases of loose stools were observed. In dog ID number 2963028, 6 cases of loose stools were observed. In dog ID number 2784123, 6 cases of loose stools were observed. Loose stools and bile vomiting occurring occasionally in the dog colony were not considered unusual and were not considered related to the test substance. The clinical findings are listed in Table 7.

Table 7

[0295] Conclusion There was no harmful effect on body weight or food consumption. The group mean alkaline phosphatase value showed a slight increase during the trial without exceeding the normal reference range. The remaining hematological and serum chemistry results remained within the normal range throughout the trial, and no obvious trend was observed over time. No clinical findings considered related to the administration of the test substance were observed in any of the dogs. The overall acceptance rate of snacks was 96.7%, and 5 out of 8 dogs consumed snacks with a 100% probability during the trial period.

[0296] Example 13: Pilot Test in Dogs A pilot test was conducted to evaluate the effectiveness of cannabis extract in the treatment of osteoarthritis in dogs.

[0297] Method As shown in Tables 8 and 9, 5 dogs suffering from end-stage osteoarthritis, joint pain, and senile pain were selected for this test.

[0298] In accordance with the manufacturer's instructions, dogs were administered a loading dose of 2 mg / kg every 12 hours for the first two weeks, and then the dose was reduced to 1 mg / kg every 12 hours for the next two weeks. Subsequently, the dose administered to the dogs was returned to 2 mg / kg every 12 hours for the last four weeks of the study.

[0299] On days 0, 14, 30, and 60, the dogs were evaluated by flexion and extension measurements, muscle tissue measurements, a canine simple pain questionnaire, and gait analysis using a pressure-sensing pathway.

Table 8

Table 9

[0300] Results Three out of five (60%) owners reported a significant improvement in pain severity scores and pain interference scores. Gait analysis revealed that, as shown in Figures 5A - 5F, throughout the study, the total pressure index (TPI%), step / stride ratio, and stance rate did not show significant improvement or decrease. Flexion improved in three out of five dogs and decreased by more than 5 degrees in two out of five dogs. Extension improved in two out of five dogs and decreased in one out of five dogs. After the end of the trial, three out of four owners who responded to the questionnaire wished to continue using the supplement. Improvements observed by the owners included rolling over, getting up, resting, walking, energy, playing, and overall improvement in health function and comfort.

[0301] Example 14: Safety Test in Cats To evaluate the safety of an oil containing CBD, a 12-week safety study was conducted in cats.

[0302] Animals and Study Design As shown in Table 10, eight cats aged 2 - 6 years with a body weight of 3.33 - 5.17 kg at the start of the study were selected for this study.

Table 10

[0303] Cats were individually housed in cages sized according to the Animal Welfare Act, and maintained under target conditions of a 12-hour light / 12-hour dark cycle and 50°–85°F. 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. There were no known contaminants reasonably expected to be present in the diet ingredients that were known to potentially interfere with the purpose or conduct of this study.

[0304] During the study, the control diet, Purina Cat Chow, was the only food source provided once daily to each animal for approximately 4 hours. Cats were fed according to their ideal body condition and fasted for at least 12 hours prior to blood collection. CBD oil was orally administered twice daily at a dosage of 2 mg / kg using a 1-ml syringe. The total daily dose was 4 mg / kg. Administration is shown in Tables 11 and 12.

Table 11

Table 12

[0305] CBC and Serum Chemistry Prior to the start of the study, 5 milliliters of blood was collected from each cat and used to determine eligibility for the study. During the study, 5 milliliters of blood was collected weekly (±2 days). Blood was collected by jugular venipuncture using a sterile syringe. Samples were divided into two tubes, a red-top serum separator tube and a lavender-top EDTA tube. The red-top tube was centrifuged at 3000 RPM for 15 minutes in a refrigerated centrifuge after clotting. The lavender-top tube was placed in a rocker to ensure proper mixing of the blood with the anticoagulant. Blood samples were packaged and sent to Antech Diagnostics on a priority basis (overnight) for analysis.

[0306] Pharmacokinetic (PK) Blood Collection On the first day of administration, blood for PK analysis was collected from 6 out of 8 cats. The most cooperative cats were selected for PK analysis. Approximately 4 milliliters of blood was collected by jugular vein puncture with a sterile syringe one day before treatment (time point 0), and then at 1, 4, 8, and 24 hours after treatment. The samples were placed in red-top clotting tubes without serum separator. Serum was collected by centrifuging the tubes at 3000 RPM for 15 minutes. The collected serum was placed in cryovials and stored at -70°C. Each tube was labeled with the cat ID, collection date, and collection time point. The samples were transported overnight to the Proteomics & Metabolomics Facility at Colorado State University while placed on dry ice.

[0307] Clinical Findings Veterinarians performed a complete physical examination of all cats before the start of the clinical trial and at the end of the clinical trial. Each cat was evaluated regarding general health, body, and coat condition. Qualified staff conducted clinical observations twice a day according to the veterinary care program at Summit Ridge Farms and SOP VC-003 (round observation). All animals were evaluated twice a day with reference to SOP VC-016 (recognition of pain, stress, and / or distress). Clinical examination diagnostic procedures were performed as necessary. Appropriate veterinary care was provided for each individual according to the veterinary care program.

[0308] Blood Analysis Blood was analyzed for white blood cell count, red blood cell count, hemoglobin, hematocrit, MCV, MCHC, MCH, and platelet count with complete differentials. In addition, a 22-test chemical screening 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, triglyceride, GGTP, and magnesium was performed. The measurements were taken before the start of the clinical trial and then weekly during the course of the clinical trial.

[0309] PK Analysis Extraction of Cannabidiol from Feline Serum for LC-MS Aliquots of feline serum were delivered to the facility on dry ice and stored at -80 °C immediately upon receipt. For cannabidiol (CBD) extraction, the serum was thawed on ice and 50 μL of each sample was placed into 2.0 mL glass extraction vials (VWR ROBO Unassembled Autosampler Vial) cooled 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 for 5 minutes at room temperature. 200 μL of water was added and vortexed for an additional 5 minutes. Then, 1 mL of 100% hexane was added to each sample and finally vortexed for 5 minutes. Phase separation was enhanced by centrifuging at 3000 rpm for 15 minutes at 4 °C. The upper hexane layer was transferred to a newly labeled glass vial (approximately 900 uL per sample), being careful to avoid the middle and lower layers. The samples were 2 concentrated to dryness under N and resuspended in 60 μL of 100% acetonitrile (Zgair et al. (2015) J Pharm Biomed Anal. 114:145 - 51).

[0310] Standard Curve An 8-point standard curve for CBD was generated in matrix background using blank serum. The concentrations ranged from 0 ng / mL to 1000 ng / mL (a 3.2-fold dilution series). 50 μL of each spiked serum sample was extracted as described above.

[0311] LC-MS / MS Analysis LC-MS / MS was performed on a Waters Acquity M-Class UPLC coupled to a Waters Xevo TQ-S triple quadrupole mass spectrometer. Chromatographic separation was carried out on a Waters BEH C18 iKey Separation Device (150 μm × 50 mm, 1.7 μM). The mobile phases were acetonitrile 99.9%, formic acid 0.1% (B), and water containing 0.1% formic acid (A). The analytical gradient was 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 min. The flow rate was 3.0 μL / min and the injection volume was 2.0 μL. Samples were held at 6 °C in the autosampler and the column was operated at 70 °C. MS was operated in selected reaction monitoring (SRM) mode, where the parent ion was selected by the first quadrupole, fragmented in the collision cell, and then the fragment ions were selected by the third quadrupole. Product ions, collision energies, and cone voltages were optimized for each analyte by directly injecting individual synthetic standards. The interchannel delay was set to 3 milliseconds. MS was operated in positive ionization 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 / h, the cone gas flow rate was 150 L / h, 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.

[0312] 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. The peak areas of the target compounds detected in the biological samples were extracted and normalized to the peak areas of the appropriate internal standards in each sample using an in-house R script (TQS tool). The CBD concentration was calculated in nanograms per milliliter of extract (0.06 mL) and then back-calculated to nanograms per milliliter of serum (0.05 mL of serum).

[0313] Dispersion calculation using QC pools All 50 uL of serum samples (cats and dogs) were pooled into a single quality control sample and 50 uL was extracted as described above. The QC pool was injected every 10 samples and the CBD concentration was used to measure technical variations during the data acquisition process.

[0314] Limit of detection (LOD) and limit of quantification (LOQ) The LOD and LOQ represent the lower limits of detection and quantification of each compound in the matrix of this study. The LOD was calculated according to the following formula based on the standard deviation (Sy) of the response of the zero-point calibration standard (i.e., 0 ng / mL CBD as an estimate of noise) and the slope (S) of the calibration curve for a value approximating the LOD: LOD = 3×(Sy / S). LOQ = 10×(Sy / S). The Sy of y is the standard deviation used for the calculation of 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).

[0315] Results Body weight During the 12-week trial, the mean body weight change in cats was 0.06 kg (1.04%).

[0316] Food consumption The average weekly food consumption of the cats in the trial was 62 g.

[0317] Acceptance of the test substance Overall, all cats presented licking behavior, salivation, side-to-side pacing, head flipping, gobbling behavior, aversion to the dose (non-cooperative behavior), etc., indicating aversion to the test substance at various intervals throughout the trial.

[0318] Hematology and serum chemistry From the second week, the mean alanine aminotransferase (ALT) value of this group increased. This value continued to increase from the baseline until the end of the trial. Throughout the trial, a mild increase in individual ALT values was observed in the majority of cats. The cat with the largest increase in ALT (exceeding 100 U / L, which is the normal reference range) and a simultaneous increase in aspartate aminotransferase (AST) was cat ID number 13CNL3. From the fourth week, the ALT and AST values of this cat began to decrease but remained higher than the baseline. During the trial period, the ALT value remained above the normal reference range shown in Table 70. Also, in the second week, the ALT values of cat ID numbers 13IRD3 and 13CPJ7 increased by 23 - 31 U / L from their baseline values, respectively. The ALT value of cat ID number 13CPJ7 returned to the baseline by the tenth week. In the fourth week, the ALT of cat ID number 13CCL1 increased by 32 U / L from the baseline. The value returned to the baseline by the tenth week. The test substance appeared to cause mild ALT changes in the majority of cats, and one cat maintained an increase in ALT values above the normal range throughout the trial. The group mean values of all other blood parameters remained within the normal range, and no obvious trend was observed.

[0319] Clinical findings During the trial, as shown in Table 13, occasional cases of loose stools and vomiting were recorded. In cat ID number 13CCL1, 5 cases of food vomiting were observed. In cat ID number 13CNL3, 1 case of hairball vomiting and 1 case of hair and bile vomiting were observed. In cat ID number 13IRD3, 1 case of food vomiting was observed. In cat ID number 15EGA5, 3 cases of food vomiting and 1 case of hair and bile vomiting were observed. In cat ID number GJY3, 2 cases of hairball vomiting and 1 case of food vomiting were observed. It is not uncommon for hairballs and food vomiting to occur occasionally in the cat colony and was not considered related to the test substance.

Table 13

[0320] PK data Table 14 shows the quantification of cannabidiol in cat serum, and Table 15 shows the pharmacokinetics of cannabidiol in cats.

Table 14-1

Table 14-2

Table 14-3

Table 15

[0321] 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).

[0322] Conclusion There was no harmful effect on body weight or food consumption. The group mean alanine aminotransferase value increased during the study and reached a peak at week 2. The value decreased after the following week but did not return to the baseline value. The ALT value of one cat (cat ID number 13CNL3) remained significantly elevated throughout the study and exceeded the normal reference range during the treatment period. The hematological and serum chemical mean values of the remaining groups were within the normal reference range throughout the study, and no clear trend was observed over time. No adverse clinical findings considered related to the administration of the test substance were observed in any of the cats. However, the acceptance of the test substance was considered insufficient.

[0323] Example 15: Cat Litter Box Soiling Test A test is conducted to determine the effectiveness of cannabis extract in treating litter box soiling in cats.

[0324] Animals and Study Design This study includes 10 cats with litter box problems and 10 cats with marking problems. The cats enrolled in this study have litter box soiling but no defecation outside the cat litter box. There is clear evidence that the cat is involved in cats with suspected problem behavior (e.g., only cat or video evidence). The cats have no known ongoing medical problems and are over 6 months and under 12 years old. The cats enrolled in this study have not experienced major changes in their home environment in the past 4 weeks (e.g., moving to a new home, introduction of a new cat, children leaving home, etc.) and no changes are expected in the next 3 months. The client has not changed the management of litter box soiling and is not currently using any treatment. If the above criteria have not been verified or the cat has a medical problem requiring urgent intervention, those cats are not enrolled in this study. In addition, if the client is seeking urgent treatment, wishes to introduce changes on their own in addition to the changes required in this study, or does not submit an informed consent, the cat is not enrolled in this study.

[0325] Cats enrolled in this trial undergo an initial assessment that includes a complete behavioral history and preliminary clinical examinations. Additional medical evaluations, including a CBC, biochemical tests, and abdominal ultrasound, are also performed.

[0326] Baseline data are collected as the number of urine patches checked daily on a rough floor plan of the home. A log is submitted for at least 7 days, ideally 14 days.

[0327] Cats that experience a medical problem requiring emergency intervention, or for whom a contraindication to cannabidiol treatment is identified, or whose client withdraws informed consent, are withdrawn from this trial.

[0328] Cats enrolled in this trial are classified into treatment groups. Treatments consist of administration of cannabis extract, a urine cleaning regimen using a biological cleaner found at home, and routine litter box management for cats. Progress is reviewed weekly, and treatments are reviewed after 2 weeks and 4 weeks. Ask the client whether they wish to continue the current treatment, continue with further management advice, or withdraw. This trial is completed after 4 weeks of treatment. After completion of this trial, outcome measures are evaluated, including the average number of urine patches at week 4 of treatment as a percentage of baseline values, the owner satisfaction score, and the number of clients who withdrew before completion of treatment.

[0329] Example 16: Diabetes The pet owner has a dog that routinely suffers from diabetes with hyperglycemia. After consulting with a veterinarian, the dog was treated with a cannabis extract at a dose of 1 mg / kg twice a day for 2 months. The pet owner kept a log of blood glucose measurements taken twice a day during the treatment period. Over 6 weeks, the dog's blood glucose measurements significantly decreased from 700 - 800 to 200 - 300. In some cases, the measurements were below 200. No changes were made to the dog's diet or medications other than adding the cannabis extract.

[0330] Example 17: Lung Cancer Darla is a mixed-breed dog that presented with coughing and lethargy. An X-ray was performed by Darla's veterinarian, and a tumor was found in the lungs, clearly visible in the X-ray images. In October 2018, Darla was diagnosed with lung cancer. The pet owner decided to treat Darla with 2 mg / kg of cannabis oil twice a day and with curcumin only. In January 2019, the veterinarian performed additional X-rays. At that time, the mass was gone and not visible in any of the X-ray images. Curcumin is known to have an absorption of approximately 5%. The conclusion was drawn by the veterinarian and the pet owner that the cannabis extract had shrunk the tumor and ultimately made it disappear.

[0331] Example 18: Inflammatory Bowel Disease (IBD) Multiple pet owners have reported improvement in their pet's IBD symptoms, such as chronic diarrhea and intolerance to many foods, after treatment with cannabis extracts. One veterinarian in California reported that a dog with IBD who had been on a prescription diet for life showed improvement after taking cannabis extracts for one month and was able to discontinue the prescription diet.

[0332] Example 19: Skin Conditions A pet owner in Florida reported that her small dog was constantly suffering from itchy and inflamed skin and needed to be bathed daily to relieve the skin pain and discomfort. Following the advice of her small dog's dermatologist, she tried cannabis extracts and reported a significant reduction in redness, inflammation, and itching.

[0333] Example 20: Seizures Multiple pet owners and veterinarians treating dogs with seizures have reported a positive response to treatment with cannabis extracts. One dog, Mac, was receiving phenobarbital and Keppra treatment and still having breakthrough seizures multiple times a week. When treatment with cannabis extracts was started, the seizures decreased to once every three months. The cannabis extract treatment is being continued with continued success.

[0334] Example 21: Compulsive Behaviors At a zoo in Pennsylvania, cannabis extracts are being used to treat a jaguar's compulsive behaviors, such as tail biting and pacing side to side. Jaguars that received the treatment twice a day have experienced a significant reduction in compulsive behaviors.

[0335] Example 22: Migraine in Humans Three subjects suffering from migraines took cannabis extracts sublingually at the onset of a migraine, and in each case, the migraine disappeared within 15 minutes. These subjects had been taking migraine medications with no improvement in the degree of pain, and reported that only the cannabis extracts were effective. Furthermore, the subjects mentioned that the migraine did not recur on that day.

[0336] Example 23: Insect Bites in Humans Two subjects experienced inflammation and itching due to insect bites. After topical application of a cannabis extract (70 mg / mL cannabidiol / cannabidiolic acid), both subjects experienced symptom relief.

[0337] Example 24: Dog Atopy Test A test is conducted to determine the effectiveness of cannabis extracts in the treatment of atopy in dogs.

[0338] Animals and Study Design This study is a double-blind, forward-looking, placebo-controlled, randomized trial. It includes dogs owned by clients with atopic dermatitis. Eligible dogs are diagnosed with cAD based on published guidelines. Informed consent from the owner is obtained for each case prior to the study. Parasitic and infectious sources of itching are excluded by negative combing, skin scraping, and cytological examination. The dogs have not shown improvement on a hydrolyzed diet or a novel protein elimination diet for the previous two months. For each case, a dermatological examination is performed, and lesions and itching are evaluated using a valid scoring system. Only cases of localized and mild to moderate cAD are included. Mild to moderate cAD is defined as patients with a pVAS score of 3 - 7 and a CADESI-4 score of 10 - 35.

[0339] Do not permit the co - administration of ciclosporin (either under the trade name Atopica or a generic micro - emulsion), and exclude patients who have received this drug within the past two months. Permit the co - administration of allergen - specific immunotherapy by injection or sublingually to patients who have received this treatment for at least one year prior to the initial trial. Permit the co - administration of oclacitinib, oral glucocorticoids, ketoconazole, and other imidazoles to patients who have received these drugs for at least two months prior to the initial trial. Exclude patients who have received Cytopoint injection within three months of the initial trial. During the trial, do not permit other treatments, concomitant medications, or changes in medications. During the trial, do not permit changes to the patient's typical bathing routine. During the trial, do not permit changes in diet.

[0340] The principal investigator of the trial is blinded to the group assignment. Group A consists of patients who receive oral oily CBD at a dose of 2 mg / kg once a day in capsule form. Group B consists of patients who receive a matching placebo oil in capsule form. Exclude dogs with co - morbidities such as renal insufficiency, liver disease, endocrine disease, or other immunological dysfunctions (ITP, IMHA). This trial is designed to enroll at least 36 dogs with cAD. The dosing regimen with systemic CBD is approximately 2 mg / kg, twice a day, for 28 days. Request that the owner administer the drug with food.

[0341] During the trial period, the dose of the permitted drug that the patient was receiving prior to the trial remains unchanged. In addition, the dosing has not been changed within 21 days before the start of the trial.

[0342] Procedure Request the client to sign the consent form. On day 0, each dog undergoes a first consultation by the principal investigator of the clinical trial, including a detailed medical history and physical examination. Start the treatment as described above and conduct follow-up visits at weeks 2 and 4. Evaluate the change in the owner's perception of the extent and severity of atopic dermatitis using the pVAS. Evaluate the change in the extent and severity of atopic dermatitis using the veterinarian-based CADESI-4. The benchmarks for distinguishing normal / remission from mild, moderate, and severe cAD using CADESI-4 are 10, 35, and 60, respectively, as suggested by the validation trial. Before the start of the investigation, train all participating principal investigators in the evaluation method and interpretation method of CADESI-4, including the evaluation of clinical cases. Store 1 cc of serum at 0 and 4 visits at -20 degrees for future cytokine analysis and serum CBD testing.

[0343] Analysis Current power analysis reveals that with a standard deviation of 2.5 and a change of 2.0 in the vAS score by the owner, the population required to find statistical significance is approximately 13 patients. To ensure proper enrollment and completion of the trial, 18 dogs are enrolled based on a random number generator that assigns up to 36 patients to group A or group B. After data collection and cleaning, all scores and blood parameters are evaluated using a mixed model analysis of variance that includes time, treatment, the effect of concomitant medications, and the random effect of dogs with an alpha set of 0.05 or less considered significant. If a difference is found, Tukey's post hoc analysis is performed to evaluate the difference between time points.

[0344] The scope of the disclosed subject matter should not be limited by the specific embodiments and examples described herein. Indeed, various modifications of the present 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 fall within the scope of the appended claims.

[0345] All references cited in this specification (e.g., publications or patents or patent applications) are hereby incorporated by reference in their entirety for all purposes to the same extent as if each individual reference (e.g., publication or patent or patent application) had been specifically and individually indicated to be incorporated by reference in its entirety for all purposes. Other embodiments are within the scope of the following claims.

[0346] A further aspect of the invention is provided by the subject matter of the following clauses. [Clause 1] A method for treating a veterinary subject in need of treatment for urinary house soiling, the method comprising administering to the subject a therapeutically effective amount of a cannabis extract. [Clause 2] The method according to clause 1, wherein the veterinary subject is a dog, cat, cow, pig, or horse. [Clause 3] The method according to clause 2, wherein the veterinary subject is a dog. [Clause 4] The method according to clause 2, wherein the veterinary subject is a cat. [Clause 5] The method according to clause 4, wherein the cat is suffering from chronic pain, urinary conditions, anxiety, and / or dissatisfaction. [Clause 6] The method according to clause 5, wherein the urinary condition is cystitis. [Clause 7] The method according to clause 5, wherein the urinary condition is feline lower urinary tract disease. [Clause 8] A method for treating a veterinary subject in need of treatment for diabetes, lung cancer, inflammatory bowel disease, skin conditions, seizures, or obsessive-compulsive behavior, the method comprising administering to the subject a therapeutically effective amount of a cannabis extract. [Clause 9] The method according to clause 8, wherein the veterinary subject is a mammal. [Clause 10] The method according to clause 9, wherein the mammal is a dog, cat, cow, pig, or horse. [Clause 11] The method according to item 8, wherein the cannabis extract is administered twice a day. [Item 12] The method according to item 8, wherein the cannabis extract is administered at a dose of 2 mg / kg. [Item 13] A method for treating it in a subject in need of treating migraine, comprising administering a therapeutically effective amount of a cannabis extract to the subject. [Item 14] The method according to item 13, wherein the subject is a human. [Item 15] The method according to item 13, wherein about 1 mL of the cannabis extract is administered. [Item 16] The method according to item 13, wherein about 70 mg of cannabinoid is administered. [Item 17] The method according to item 13, wherein the cannabis extract is administered sublingually. [Item 18] The cannabis extract is cannabidiol, and cannabidiolic acid, and The method according to any one of the preceding items, wherein the ratio of cannabidiol to cannabidiolic acid is from about 0.6:1 to about 1:0.6. [Item 19] The cannabis extract is cannabigerolic acid, Δ9-tetrahydrocannabinol, and The method according to item 18, further comprising cannabichromene. [Item 20] The cannabis extract is cannabidiol, cannabidiolic acid, cannabigerolic acid, Δ9-tetrahydrocannabinol, and cannabichromene, and The method according to any one of the preceding items, wherein the ratio of cannabidiol to cannabidiolic acid is from about 0.6:1 to about 1:0.6. [Item 21] The cannabis extract is α-Pinene, β-Myrcene, β-Pinene, Δ-Limonene, Linalool, β-Caryophyllene, α-Humulene, Nerolidol 2, Guaiol, Caryophyllene oxide, and α-Bisabolol, and the method according to any one of items 18 to 20. [Item 22] The method according to any one of items 18 to 21, wherein the concentration of Δ9-tetrahydrocannabinol is insufficient to cause a psychoactive effect. [Item 23] The method according to any one of items 18 to 22, wherein the ratio of Δ9-tetrahydrocannabinol to the other cannabinoids is about 1:25. [Item 24] The method according to any one of items 18 to 23, wherein the concentration of Δ9-tetrahydrocannabinol is less than about 1 mg / mL. [Item 25] The method according to any one of items 18 to 24, wherein the concentration of Δ9-tetrahydrocannabinol is less than about 0.5 mg / mL. [Item 26] The method according to any one of items 18 to 25, wherein the concentration of Δ9-tetrahydrocannabinol is less than about 0.3 mg / mL. [Item 27] The method according to any one of items 18 to 26, wherein the concentration of Δ9-tetrahydrocannabinol is less than about 0.2 mg / mL. [Item 28] The method according to any one of items 18 to 27, wherein the concentration of Δ9-tetrahydrocannabinol is less than about 0.1 mg / mL. [Item 29] The method according to any one of items 18 to 28, wherein the concentration of Δ9-tetrahydrocannabinol is about 0 mg / mL. [Item 30] The cannabis extract Cannabidiol at about 1 to 10 mg / mL, Cannabidiolic acid at about 1 to 10 mg / mL, Cannabigerolic acid at about 0.05 to 0.2 mg / mL, Δ9 - Tetrahydrocannabinol at about 0.1 to 0.3 mg / mL, and Cannabichromene at about 0.1 to 0.4 mg / mL, the method according to any one of items 18 to 26. [Item 31] wherein the cannabis extract contains cannabidiol at about 5 mg / mL, cannabidiolic acid at about 5 mg / mL, cannabigerolic acid at about 0.11 mg / mL, Δ9 - Tetrahydrocannabinol at about 0.25 mg / mL, and cannabichromene at about 0.27 mg / mL, the method according to item 30. [Item 32] wherein the cannabis extract contains 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, about 0.04 to 0.07% of nerolidol 2, about 0.04 to 0.08% of caryophyllene oxide, and about 0.01 to 0.04% of α - bisabolol, the method according to any one of items 18 to 31. [Item 33] wherein the cannabis extract further contains camphene, β - ocimene, eucalyptol, isopulegol, and / or nerolidol 1, the method according to item 32. [Item 34] The cannabis extract is about 0.02% camphene, about 0.02 - 0.03% β-ocimene, about 0.02 - 0.05% eucalyptol, about 0.02% isopulegol, and / or about 0.02 - 0.04% nerolidol 1, and the method according to item 33. [Item 35] The method according to any one of items 18 - 34, wherein the cannabis extract is formulated in a carrier. [Item 36] The method according to item 35, wherein the carrier is selected from the group consisting of cannabis seed oil, linseed oil, olive oil, fish oil, salmon oil, coconut oil, catnip oil, sesame oil, MCT oil, and grape seed oil. [Item 37] The method according to item 36, wherein the carrier is grape seed oil. [Item 38] The method according to item 36, wherein the carrier is catnip oil. [Item 39] The method according to item 36, wherein the carrier is sesame oil. [Item 40] The method according to any one of items 18 - 39, wherein the cannabis extract contains lecithin. [Item 41] The method according to item 40, wherein the lecithin is sunflower lecithin. [Item 42] The method according to item 41, wherein the sunflower lecithin is at most 40%. [Item 43] The method according to any one of items 18 - 42, wherein the cannabis extract further contains NF - 971P. [Item 44] The method according to item 43, wherein the NF - 971P is at a maximum weight / volume ratio of 2%. [Item 45] The method according to any one of items 18 - 44, wherein the cannabis extract contains nepetalactone. [Item 46] The method according to any one of items 18 to 45, wherein the cannabis extract contains taurine. [Item 47] The cannabis extract is cannabidiol, cannabidiolic acid, cannabigerolic acid, Δ9 - tetrahydrocannabinol, and cannabichromene, and The method according to any one of items 1 to 17, wherein the carrier is grape seed oil. [Item 48] The method according to item 47, wherein 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. [Item 49] The method according to item 47 or 48, wherein the ratio of cannabidiol to cannabidiolic acid is about 1:1. [Item 50] The method according to any one of items 47 to 49, wherein the concentration of Δ9 - tetrahydrocannabinol is insufficient to cause a psychoactive effect. [Item 51] The method according to any one of items 47 to 50, wherein the ratio of Δ9 - tetrahydrocannabinol to the other cannabinoids is about 1:25. [Item 52] The method according to any one of items 47 to 51, wherein the concentration of Δ9 - tetrahydrocannabinol is less than about 1 mg / mL. [Item 53] The method according to any one of items 47 to 52, wherein the concentration of Δ9 - tetrahydrocannabinol is less than about 0.5 mg / mL. [Item 54] The method according to any one of items 47 to 53, wherein the concentration of Δ9 - tetrahydrocannabinol is less than about 0.3 mg / mL. [Item 55] The cannabis extract is about 1 to 10 mg / mL of cannabidiol, about 1 to 10 mg / mL of cannabidiolic acid, 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, the method according to any one of items 47 to 54. [Item 56] wherein the cannabis extract contains 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, the method according to item 55. [Item 57] wherein the cannabis extract contains α-pinene, β-myrcene, β-pinene, Δ-limonene, linalool, β-caryophyllene, α-humulene, nerolidol 2, guaiol, caryophyllene oxide, and α-bisabolol, the method according to any one of items 47 to 56. [Item 58] wherein the cannabis extract contains 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, about 0.04 to 0.07% of nerolidol 2, about 0.02 to 0.04% of guaiol, About 0.04 to 0.08% of caryophyllene oxide, and The method according to item 57, comprising about 0.01 to 0.04% of α-bisabolol. [Item 59] Wherein the cannabis extract Camphene, β-ocimene, Eucalyptol, Isopulegol, and / or The method according to item 57 or 58, further comprising nerolidol 1. [Item 60] Wherein the cannabis extract Contains 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 The method according to item 59, comprising about 0.02 to 0.04% of nerolidol 1. [Item 61] The method according to any one of the preceding items, wherein the cannabis extract is administered in a dosage form containing one or more pharmaceutically acceptable additives, flavoring agents, surfactants, and adjuvants. [Item 62] The method according to item 61, wherein the flavoring agent is selected from the group consisting of peppermint oil, mango extract, beef, chicken, and seafood. [Item 63] The method according to item 61, wherein the flavoring agent is selected from the group consisting of peanut butter, catnip oil, chicken liver powder, chicken extract, maltodextrin, butter, and bacon. [Item 64] The method according to item 63, wherein the flavoring agent is chicken liver powder. [Item 65] The method according to item 63, wherein the flavoring agent is catnip oil. [Item 66] The method according to item 63, wherein the flavoring agent is peanut butter. [Item 67] The method according to item 61, wherein the dosage form contains nepatalactone. [Item 68] The method according to item 61, wherein the dosage form contains taurine. [Item 69] The method according to item 61, wherein the dosage form is formulated as a sublingual spray. [Item 70] The method according to item 61, wherein the dosage form is formulated as an aqueous or alcohol-soluble solution, or a cream for topical or transdermal application. [Item 71] The method according to item 61, wherein the dosage form is formulated as a gel for oral or intramucosal administration. [Item 72] The method according to item 61, wherein the dosage form is formulated as a powder. [Item 73] The method according to item 61, wherein the dosage form is formulated as a subcutaneous injection solution. [Item 74] The method according to item 61, wherein the dosage form is formulated as a tablet. [Item 75] The method according to item 61, wherein the dosage form is formulated as a capsule. [Item 76] The method according to item 61, wherein the dosage form is formulated as a hard chewable. [Item 77] The method according to item 61, wherein the dosage form is formulated as a soft chewable. [Item 78] The method according to item 61, wherein the dosage form is formulated for administration using a nebulizer. [Item 79] The method according to item 61, wherein the dosage form is formulated for inhalation. [Item 80] The method according to item 61, wherein the dosage form is formulated for administration using a pet collar. [Item 81] The method according to item 61, wherein the composition is formulated as a pet food for oral administration. [Item 82] The method according to item 61, wherein the dosage form is formulated as a chew for oral administration. [Item 83] The method according to item 82, wherein the chew is produced using cold extrusion. [Item 84] The method according to item 83, wherein the weight of the chew is about 0.5 to 10 g. [Item 85] The method according to item 84, wherein the weight of the chew is about 4 g, about 6 g, about 9 g, or about 10 g. [Item 86] The method according to item 84, wherein the weight of the chew is about 4 g. [Item 87] The chew is about 7 mg of cannabidiol, about 6 mg of cannabidiolic acid, about 0.12 mg of cannabigerolic acid, about 0.32 mg of Δ9-tetrahydrocannabinol, and about 0.36 mg of cannabichromene, and the method according to item 86. [Item 88] The method according to item 61, wherein the dosage form is formulated with a carrier for oral administration. [Item 89] The method according to item 88, wherein the carrier is selected from the group consisting of cannabis seed oil, flaxseed oil, olive oil, fish oil, salmon oil, coconut oil, catnip oil, sesame oil, MCT oil, and grape seed oil. [Item 90] The method according to item 89, wherein the carrier is grape seed oil. [Item 91] The method according to item 89, wherein the carrier is catnip oil. [Item 92] The method according to item 89, wherein the carrier is sesame oil. [Item 93] The dosage form is glucosamine HCl, chondroitin sulfate (76%), brewer's yeast, gum arabic, guar gum, flavoring agent, Verdilox, Previon, Cannabis extract, glycerin, sunflower lecithin, and water, the method according to item 61. [Item 94] The dosage form is about 12 - 17% glucosamine HCl, about 1 - 4% chondroitin sulfate (76%), about 29 - 33% brewing yeast, about 3 - 6% gum arabic, about 0.5 - 2% guar gum, about 12 - 16% flavoring agent, about 0.01 - 0.1% Verdilox, about 0.5 - 1.5% Previon, about 3 - 6% cannabis extract, about 13 - 17% glycerin, about 3 - 7% sunflower lecithin, and about 3 - 7% water, the method according to item 93. [Item 95] The dosage form is about 15.6% glucosamine HCl, about 2.6% chondroitin sulfate (76%), about 30% brewing yeast, about 4.7% gum arabic, about 0.9% guar gum, about 14.2% flavoring agent, about 0.05% Verdilox, about 0.9% Previon, about 4.7% cannabis extract, about 15.1% glycerin, about 5.7% sunflower lecithin, and about 5.7% water, the method according to item 93 or 94. [Item 96] The dosage form is glucosamine HCl, hyaluronic acid, brewing yeast, gum arabic, guar gum, flavoring agent, Verdilox, Previon, cannabis extract, glycerin, sunflower lecithin, and water, the method according to claim 61. [Claim 97] wherein the dosage form is about 12 - 17% glucosamine HCl, about 0.01 - 1% hyaluronic acid, about 29 - 33% brewing yeast, about 3 - 6% gum arabic, about 0.5 - 2% guar gum, about 12 - 16% flavoring agent, about 0.01 - 0.1% Verdilox, about 0.5 - 1.5% Previon, about 3 - 6% cannabis extract, about 13 - 17% glycerin, about 3 - 7% sunflower lecithin, and about 3 - 7% water, the method according to claim 96. [Claim 98] wherein the dosage form is about 16% glucosamine HCl, about 0.1% hyaluronic acid, about 30.6% brewing yeast, about 4.8% gum arabic, about 0.97% guar gum, about 14.5% flavoring agent, about 0.05% Verdilox, about 0.97% Previon, about 4.8% cannabis extract, about 15.5% glycerin, about 5.8% sunflower lecithin, and about 5.8% water, the method according to claim 96 or 97. [Claim 99] wherein the dosage form is cannabis extract, peanut butter, rice bran, Glucosamine HCl, sweet potato, dried molasses, sorbic acid brewer's yeast, sugar, water, glycerin, potato starch, dried peanut butter, rice starch, and the method according to claim 61, comprising guar gum. [Claim 100] wherein the dosage form is about 3.0 to 10.0% cannabis extract, about 10.0 to 20.0% peanut butter, about 10.0 to 15.0% rice bran, about 5.0 to 15.0% glucosamine HCl, about 4.0 to 10.0% sweet potato, about 6.0 to 13.0% dried molasses, about 0.5 to 5.0% sorbic acid, about 2.0 to 8.0% brewer's yeast, about 3.0 to 8.0% sugar, about 5.0 to 15.0% water, about 8.0 to 18.0% glycerin, about 1.0 to 8.0% potato starch, about 0.5 to 5.0% dried peanut butter, about 1.0 to 5.0% rice starch, and about 1.0 to 5.0% guar gum, the method according to claim 99. [Claim 101] wherein the dosage form is about 5.0% cannabis extract, about 15.0% peanut butter, about 12.5% rice bran, about 12.75% glucosamine HCl, about 5.5% sweet potato, about 8.0% dried molasses, about 1% sorbic acid, about 5.0% brewer's yeast, About 6.0% sugar, about 9.25% water, about 13.0% glycerin, about 2.0% potato starch, about 1.0% dry peanut butter, about 2.0% rice starch, and about 2.0% guar gum, the method according to item 99 or 100. [Item 102] wherein the dosage form is about 5.0% cannabis extract, about 15.0% peanut butter, about 13.0% rice bran, about 8.5% glucosamine HCl, about 6.0% sweet potato, about 9.0% dry molasses, about 1% sorbic acid, about 5.0% brewing yeast, about 6.0% sugar, about 9.5% water, about 13.0% glycerin, about 4.0% potato starch, about 1.0% dry peanut butter, about 2.0% rice starch, and about 2.0% guar gum, the method according to item 99 or 100. [Item 103] wherein the dosage form is cannabis extract, peanut butter, rice bran, glucosamine HCl, sweet potato, dry molasses, sorbic acid brewing yeast, sugar, water, glycerin, potato starch, dry peanut butter, DigestaWell PET, rice starch, and guar gum, the method according to item 61. [Item 104] The dosage form is about 3.0 to 10.0% cannabis extract, about 5.0 to 20.0% peanut butter, about 10.0 to 15.0% rice bran, about 5.0 to 15.0% glucosamine HCl, about 4.0 to 10.0% sweet potato, about 6.0 to 13.0% dried molasses, about 0.5 to 5.0% sorbic acid, about 2.0 to 8.0% brewing yeast, about 3.0 to 8.0% sugar, about 5.0 to 15.0% water, about 8.0 to 18.0% glycerin, about 1.0 to 8.0% potato starch, about 0.5 to 5.0% dried peanut butter, about 0.1 to 3.0% DigestaWell PET, about 1.0 to 8.0% rice starch, and about 1.0 to 5.0% guar gum, the method according to item 103. [Item 105] The dosage form is about 5.0% cannabis extract, about 10.0% peanut butter, about 12.0% rice bran, about 12.75% glucosamine HCl, about 5.5% sweet potato, about 8.0% dried molasses, about 1% sorbic acid, about 5.0% brewing yeast, about 6.0% sugar, about 7.25% water, about 10.0% glycerin, about 5.0% potato starch, about 4.0% dried peanut butter, about 0.5% DigestaWell PET, about 6.0% rice starch, and The method according to item 103 or 104, containing about 2.0% of guar gum. [Item 106] The dosage form is about 5.0% of cannabis extract, about 10.0% of peanut butter, about 12.5% of rice bran, about 8.5% of glucosamine HCl, about 8.0% of sweet potato, about 9.0% of dried molasses, about 1% of sorbic acid, about 5.0% of brewing yeast, about 6.0% of sugar, about 6.0% of water, about 10.0% of glycerin, about 6.0% of potato starch, about 4.0% of dried peanut butter, about 0.5% of DigestaWell PET, about 6.5% of rice starch, and about 2.0% of guar gum, the method according to item 103 or 104. [Item 107] The dosage form is cannabis extract, peanut butter, rice bran, glucosamine HCl, sweet potato, dried molasses, sorbic acid brewing yeast, sugar, water, glycerin, potato starch, dried peanut butter, chondroitin, DigestaWell PET, rice starch, and guar gum, the method according to item 61. [Item 108] The dosage form is about 3.0 - 10.0% of cannabis extract, About 5.0 to 20.0% peanut butter, About 10.0 to 15.0% rice bran, About 5.0 to 15.0% glucosamine HCl, About 4.0 to 10.0% sweet potato, About 6.0 to 13.0% dried molasses, About 0.5 to 5.0% sorbic acid, About 2.0 to 8.0% brewing yeast, About 3.0 to 8.0% sugar, About 5.0 to 15.0% water, About 8.0 to 18.0% glycerin, About 1.0 to 8.0% potato starch, About 0.5 to 5.0% dried peanut butter, About 0.5 to 5.0% chondroitin, About 0.1 to 3.0% DigestaWell PET, About 1.0 to 8.0% rice starch, and About 1.0 to 5.0% guar gum, the method according to claim 107. [Claim 109] The dosage form is About 5.0% cannabis extract, About 10.0% peanut butter, About 12.0% rice bran, About 12.75% glucosamine HCl, About 5.5% sweet potato, About 8.0% dried molasses, About 1% sorbic acid, About 5.0% brewing yeast, About 6.0% sugar, About 7.25% water, About 10.0% glycerin, About 4.0% potato starch, About 4.0% dried peanut butter, About 2.5% chondroitin, About 0.5% DigestaWell PET, About 4.5% rice starch, and About 2.0% guar gum, the method according to claim 107 or 108. [Item 110] wherein the dosage form is about 5.0% cannabis extract, about 10.0% peanut butter, about 12.5% rice bran, about 8.5% glucosamine HCl, about 8.0% sweet potato, about 9.0% dried molasses, about 1% sorbic acid, about 5.0% brewing yeast, about 6.0% sugar, about 6.0% water, about 10.0% glycerin, about 5.0% potato starch, about 4.0% dried peanut butter, about 2.5% chondroitin, about 0.5% DigestaWell PET, about 5.0% rice starch, and about 2.0% guar gum, the method according to item 107 or 108. [Item 111] The method according to any one of the preceding items, wherein the cannabis extract, dosage form, or pharmaceutical composition is packaged to provide one or more doses of cannabis extract per package. [Item 112] The method according to item 111, wherein the package is resealable. [Item 113] The method according to item 111, wherein one dose of cannabis extract is a therapeutically effective amount. [Item 114] A method of treating a subject in need of treatment for an insect bite, the method comprising administering to the subject a therapeutically effective amount of a cannabis extract. [Item 115] The method according to item 114, wherein the cannabis extract is formulated for topical administration. [Item 116] The method according to item 115, wherein the cannabis extract contains about 70 mg / mL of cannabinoids. [Item 117] The method according to item 116, wherein the cannabinoid is cannabidiol and cannabidiolic acid. [Item 118] A method for treating a veterinary subject in need of treatment for an atopic condition, the method comprising administering to the subject a therapeutically effective amount of a cannabis extract. [Item 119] The method according to item 118, wherein the mammal is a dog, a cat, a cow, a pig, or a horse. [Item 120] The method according to item 119, wherein the veterinary subject is a dog. [Item 121] The method according to item 118, wherein the atopic condition is atopic dermatitis. [Item 122] The method according to item 118, wherein the cannabis extract is administered at a dosage of 2 mg / kg. [Item 123] The method according to item 120, wherein the cannabis extract is administered approximately every 12 hours for 4 weeks.

Claims

1. 1. A composition comprising a cannabis extract for use in a method of treating an atopic condition in a veterinary subject in need thereof, the method comprising administering to the subject a therapeutically effective amount of the cannabis extract.

2. the veterinary subject is a dog, a cat, a cow, a pig, or a horse; 10. The composition of claim 1, optionally wherein the veterinary subject is a dog, and further optionally, wherein the cannabis extract is administered every 12 hours for four weeks.

3. the atopic condition is atopic dermatitis; or 2. The composition of claim 1, wherein the cannabis extract is administered in a dosage of about 2 mg / kg.

4. The cannabis extract Cannabidiol, and Contains cannabidiol acid, a ratio of cannabidiol to cannabidiol acid of about 0.6:1 to about 1:0.6; Optionally, the cannabis extract comprises: Cannabigerophosphate, Δ9-tetrahydrocannabinol, and Further containing cannabichromene, Further optionally, said cannabis extract comprises: Cannabidiol, Cannabidiolic acid, Cannabigerophosphate, Δ9-tetrahydrocannabinol, and Contains cannabichromene, 4. The composition of any one of claims 1 to 3, wherein the ratio of cannabidiol to cannabidiolic acid is from about 0.6:1 to about 1:0.

6.

5. The cannabis extract α-pinene, β-myrcene, β-pinene, δ-limonene, Linalool, β-caryophyllene, α-humulene, Nerolidol 2, Guaiol, Caryophyllene oxide, and and / or further comprising α-bisabolol Optionally, and / or the ratio of cannabidiol to cannabidiolic acid is about 1:1; and / or The concentration of Δ9-tetrahydrocannabinol is insufficient to produce a psychotropic effect, and / or and / or the ratio of Δ9-tetrahydrocannabinol to other cannabinoids is about 1:25; and / or and / or the concentration of Δ9-tetrahydrocannabinol is less than about 1 mg / mL; and / or and / or the concentration of Δ9-tetrahydrocannabinol is less than about 0.5 mg / mL; and / or and / or the concentration of Δ9-tetrahydrocannabinol is less than about 0.3 mg / mL; and / or and / or the concentration of Δ9-tetrahydrocannabinol is less than about 0.2 mg / mL; and / or and / or the concentration of Δ9-tetrahydrocannabinol is less than about 0.1 mg / mL; and / or the concentration of Δ9-tetrahydrocannabinol is about 0 mg / mL; or The cannabis extract about 1-10 mg / mL cannabidiol; about 1-10 mg / mL cannabidiolic acid; about 0.05-0.2 mg / mL cannabigerophosphate; about 0.1-0.3 mg / mL Δ9-tetrahydrocannabinol, and about 0.1-0.4 mg / mL of cannabichromene; Optionally, the cannabis extract comprises: About 5 mg / mL cannabidiol, About 5 mg / mL cannabidiolic acid, about 0.11 mg / mL cannabigerophosphate; about 0.25 mg / mL Δ9-tetrahydrocannabinol, and 5. The composition of claim 4 comprising about 0.27 mg / mL of cannabichromene.

6. The cannabis extract about 0.09 to 0.13% α-pinene; about 0.23 to 0.44% β-myrcene; about 0.04 to 0.09% β-pinene; about 0.05 to 0.09% δ-limonene, Approximately 0.03-0.06% linalool, about 0.04 to 0.07% β-caryophyllene; about 0.02 to 0.04% α-humulene; about 0.04-0.07% nerolidol 2, about 0.04-0.08% caryophyllene oxide, and about 0.01-0.04% α-bisabolol; Optionally, the cannabis extract comprises: Camphene, β-ocimene, Eucalyptol, Isopulegol, and / or Further comprising nerolidol 1, Further optionally, said cannabis extract comprises: about 0.02% camphene, about 0.02-0.03% β-ocimene, about 0.02-0.05% eucalyptol, about 0.02% isopulegol, and / or The composition according to claim 4 or 5, comprising about 0.02 to 0.04% of nerolidol 1.

7. The cannabis extract is formulated in a carrier; Optionally, the carrier is selected from the group consisting of hemp seed oil, flaxseed oil, olive oil, fish oil, salmon oil, coconut oil, catnip oil, sesame oil, MCT oil, and grape seed oil; Further optionally, the carrier is grape seed oil or catnip oil or sesame oil.

8. The cannabis extract contains lecithin Optionally, the lecithin is sunflower lecithin; Further optionally, the sunflower lecithin is up to 40%.

9. the cannabis extract further comprises NF-971P; 9. The composition of any one of claims 4 to 8, optionally wherein the NF-971P is at most 2% weight / volume.

10. wherein the cannabis extract comprises nepetalactone; 10. The composition of any one of claims 4 to 9, further optionally, the cannabis extract comprises taurine.

11. 11. The composition of any of claims 1 to 10, wherein the cannabis extract is administered in a dosage form comprising one or more pharma- ceutically acceptable additives, flavoring agents, surfactants, and adjuvants.

12. the flavoring agent is selected from the group consisting of peppermint oil, mango extract, beef, chicken, and seafood; or the flavoring agent is selected from the group consisting of peanut butter, catnip oil, chicken liver powder, chicken extract, maltodextrin, butter, and bacon; 12. The composition of claim 11, optionally wherein the flavoring agent is chicken liver powder or catnip oil or peanut butter.

13. the dosage form comprises nepetalactone, or the dosage form comprises taurine, or the dosage form is formulated as a sublingual spray; or The dosage form is formulated as a water- or alcohol-soluble solution, or a cream for topical or transdermal application; or the dosage form is formulated as a gel for buccal or intramucosal administration; or the dosage form is formulated as a powder, or The dosage form is formulated as a solution for subcutaneous injection; or the dosage form is formulated as a tablet; or the dosage form is formulated as a capsule; or the dosage form is formulated as a hard chew; or the dosage form is formulated as a soft chew; or the dosage form is formulated for administration using a nebulizer; or the dosage form is formulated for inhalation; or the dosage form is formulated for administration using a pet collar; or The composition of claim 11 , wherein the composition is formulated as a pet food for oral administration.

14. the dosage form is formulated as a chew for oral administration; Optionally, the chew is produced using cold extrusion; Further optionally, the chew weighs about 0.5-10 g; Further optionally, the chew weighs about 4 g, about 6 g, about 9 g, or about 10 g; Optionally, the chew weighs about 4 g; Further optionally, the chew comprises: Approximately 7 mg of cannabidiol, Approximately 6 mg of cannabidiolic acid, Approximately 0.12 mg of cannabigerophosphate, about 0.32 mg of Δ9-tetrahydrocannabinol, and 12. The composition of claim 11 comprising about 0.36 mg of cannabichromene.

15. The dosage form is formulated in a carrier for oral administration; Optionally, the carrier is selected from the group consisting of hemp seed oil, flaxseed oil, olive oil, fish oil, salmon oil, coconut oil, catnip oil, sesame oil, MCT oil, and grape seed oil; Optionally, the carrier is grape seed oil, catnip oil, or sesame oil.

16. The dosage form comprises: Glucosamine HCl, Chondroitin sulfate (76%), Brewer's yeast, Gum arabic, Guar gum, Flavoring agents, Verdilox, Previon, cannabis extract, Glycerin, Sunflower lecithin, and Contains water, Optionally, the dosage form comprises: About 12-17% Glucosamine HCl; Approximately 1-4% chondroitin sulfate (76%), Approximately 29-33% brewer's yeast, Approximately 3-6% gum arabic, about 0.5-2% guar gum, about 12-16% flavoring agent; about 0.01-0.1% Verdilox, Approximately 0.5 to 1.5% Previon, Approximately 3-6% cannabis extract, Approximately 13-17% glycerin, about 3-7% sunflower lecithin, and contains about 3-7% water; and / or The dosage form comprises: About 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, about 14.2% flavoring agents, Approximately 0.05% Verdilox, Previon at about 0.9% Approximately 4.7% cannabis extract, Approximately 15.1% glycerin, about 5.7% sunflower lecithin, and 12. The composition of claim 11 comprising about 5.7% water.

17. The dosage form comprises: Glucosamine HCl, Hyaluronic acid, Brewer's yeast, Gum arabic, Guar gum, Flavoring agents, Verdilox, Previon, cannabis extract, Glycerin, Sunflower lecithin, and Contains water, Optionally, the dosage form comprises: About 12-17% Glucosamine HCl; Approximately 0.01 to 1% hyaluronic acid, Approximately 29-33% brewer's yeast, Approximately 3-6% gum arabic, about 0.5-2% guar gum, about 12-16% flavoring agent; about 0.01-0.1% Verdilox, Approximately 0.5 to 1.5% Previon, Approximately 3-6% cannabis extract, Approximately 13-17% glycerin, about 3-7% sunflower lecithin, and contains about 3-7% water; and / or The dosage form comprises: About 16% Glucosamine HCl, Approximately 0.1% hyaluronic acid, Approximately 30.6% brewer's yeast, Approximately 4.8% gum arabic, approximately 0.97% guar gum, about 14.5% flavoring agents, Approximately 0.05% Verdilox, Previon at about 0.97% Approximately 4.8% cannabis extract, Approximately 15.5% glycerin, about 5.8% sunflower lecithin, and 12. The composition of claim 11 comprising about 5.8% water.

18. The dosage form comprises: cannabis extract, Peanut butter, Rice bran, Glucosamine HCl, Sweet potato, dried molasses, Sorbic acid Brewer's yeast, sugar, water, Glycerin, Potato starch, dry peanut butter, Rice starch, and Contains guar gum, Optionally, the dosage form comprises: about 3.0-10.0% cannabis extract, about 10.0 to 20.0% peanut butter, Approximately 10.0 to 15.0% rice bran, About 5.0-15.0% Glucosamine HCl; Approximately 4.0 to 10.0% of sweet potatoes, about 6.0-13.0% dry molasses; about 0.5 to 5.0% sorbic acid, about 2.0 to 8.0% brewer's yeast, about 3.0-8.0% sugar, about 5.0-15.0% water, about 8.0 to 18.0% glycerin, about 1.0-8.0% potato starch, about 0.5 to 5.0% dry peanut butter; about 1.0-5.0% rice starch, and and / or about 1.0-5.0% guar gum; and / or The dosage form comprises: Approximately 5.0% cannabis extract, Approximately 15.0% peanut butter, Approximately 12.5% ​​rice bran, About 12.75% Glucosamine HCl, About 5.5% of sweet potatoes, about 8.0% dry molasses; Approximately 1% sorbic acid, Approximately 5.0% brewer's yeast, Approximately 6.0% sugar, Approximately 9.25% water, about 13.0% glycerin, about 2.0% potato starch, about 1.0% dry peanut butter, about 2.0% rice starch, and about 2.0% guar gum; or The dosage form comprises: Approximately 5.0% cannabis extract, Approximately 15.0% peanut butter, Approximately 13.0% rice bran, About 8.5% Glucosamine HCl, About 6.0% of sweet potatoes, about 9.0% dry molasses; Approximately 1% sorbic acid, Approximately 5.0% brewer's yeast, Approximately 6.0% sugar, Approximately 9.5% water, about 13.0% glycerin, about 4.0% potato starch, about 1.0% dry peanut butter, about 2.0% rice starch, and 12. The composition of claim 11 comprising about 2.0% guar gum.

19. The dosage form comprises: cannabis extract, Peanut butter, Rice bran, Glucosamine HCl, Sweet potato, dried molasses, Sorbic acid Brewer's yeast, sugar, water, Glycerin, Potato starch, dry peanut butter, DigestaWell PET, Rice starch, and Contains guar gum, Optionally, the dosage form comprises: about 3.0-10.0% cannabis extract, about 5.0 to 20.0% peanut butter, Approximately 10.0 to 15.0% rice bran, About 5.0-15.0% Glucosamine HCl; Approximately 4.0 to 10.0% of sweet potatoes, about 6.0-13.0% dry molasses; about 0.5 to 5.0% sorbic acid, about 2.0 to 8.0% brewer's yeast, about 3.0-8.0% sugar, about 5.0-15.0% water, about 8.0 to 18.0% glycerin, about 1.0-8.0% potato starch, about 0.5 to 5.0% dry peanut butter; about 0.1-3.0% DigestaWell PET; about 1.0-8.0% rice starch, and and / or about 1.0-5.0% guar gum; and / or The dosage form comprises: Approximately 5.0% cannabis extract, Approximately 10.0% peanut butter, Approximately 12.0% rice bran, About 12.75% Glucosamine HCl, About 5.5% of sweet potatoes, about 8.0% dry molasses; Approximately 1% sorbic acid, Approximately 5.0% brewer's yeast, Approximately 6.0% sugar, Approximately 7.25% water, about 10.0% glycerin, about 5.0% potato starch, about 4.0% dry peanut butter, Approximately 0.5% DigestaWell PET, about 6.0% rice starch, and about 2.0% guar gum; or The dosage form comprises: Approximately 5.0% cannabis extract, Approximately 10.0% peanut butter, Approximately 12.5% ​​rice bran, About 8.5% Glucosamine HCl, Approximately 8.0% of sweet potatoes, about 9.0% dry molasses; Approximately 1% sorbic acid, Approximately 5.0% brewer's yeast, Approximately 6.0% sugar, Approximately 6.0% water, about 10.0% glycerin, about 6.0% potato starch, about 4.0% dry peanut butter, Approximately 0.5% DigestaWell PET, about 6.5% rice starch, and 12. The composition of claim 11 comprising about 2.0% guar gum.

20. The dosage form comprises: cannabis extract, Peanut butter, Rice bran, Glucosamine HCl, Sweet potato, dried molasses, Sorbic acid Brewer's yeast, sugar, water, Glycerin, Potato starch, dry peanut butter, Chondroitin, DigestaWell PET, Rice starch, and Contains guar gum, Optionally, the dosage form comprises: about 3.0-10.0% cannabis extract, about 5.0 to 20.0% peanut butter, Approximately 10.0 to 15.0% rice bran, About 5.0-15.0% Glucosamine HCl; Approximately 4.0 to 10.0% of sweet potatoes, about 6.0-13.0% dry molasses; about 0.5 to 5.0% sorbic acid, about 2.0 to 8.0% brewer's yeast, about 3.0-8.0% sugar, about 5.0-15.0% water, about 8.0 to 18.0% glycerin, about 1.0-8.0% potato starch, about 0.5 to 5.0% dry peanut butter; about 0.5 to 5.0% chondroitin, about 0.1-3.0% DigestaWell PET; about 1.0-8.0% rice starch, and and / or about 1.0-5.0% guar gum; and / or The dosage form comprises: Approximately 5.0% cannabis extract, Approximately 10.0% peanut butter, Approximately 12.0% rice bran, About 12.75% Glucosamine HCl, About 5.5% of sweet potatoes, about 8.0% dry molasses; Approximately 1% sorbic acid, Approximately 5.0% brewer's yeast, Approximately 6.0% sugar, Approximately 7.25% water, about 10.0% glycerin, about 4.0% potato starch, about 4.0% dry peanut butter, Approximately 2.5% DigestaWell PET, about 4.5% rice starch, and about 2.0% guar gum; or The dosage form comprises: Approximately 5.0% cannabis extract, Approximately 10.0% peanut butter, Approximately 12.5% ​​rice bran, About 8.5% Glucosamine HCl, Approximately 8.0% of sweet potatoes, about 9.0% dry molasses; Approximately 1% sorbic acid, Approximately 5.0% brewer's yeast, Approximately 6.0% sugar, Approximately 6.0% water, about 10.0% glycerin, about 5.0% potato starch, about 4.0% dry peanut butter, Approximately 2.5% chondroitin, Approximately 0.5% DigestaWell PET, about 5.0% rice starch, and 12. The composition of claim 11 comprising about 2.0% guar gum.

21. wherein the cannabis extract or dosage form is packaged to provide one or more doses of cannabis extract per package; Optionally, the package is resealable; or 21. A composition according to any one of claims 1 to 20, wherein the dose of cannabis extract is a therapeutically effective amount.

Images