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US 2016.000O843A1 (19) United States (12) Patent Application Publication (10) Pub. No.: US 2016/0000843 A1 LOWe et al. (43) Pub. Date: Jan. 7, 2016

(54) HIGH CANNABIDIOL STRAINS Publication Classification (71) Applicant: MJAR Holdings, LLC, Miami, FL (US) (51) Int. Cl. A61E36/85 (2006.01) (72) Inventors: James Lowe, Denver, CO (US); A63L/92 (2006.01) Matthew Curran, Denver (CO); A63L/047 (2006.01) Benjamin Franz, Denver (CO) (52) U.S. Cl. CPC ...... A61K 36/185 (2013.01); A61 K3I/047 (73) Assignee: MUAR Holdings, LLC, Miami, FL (US) (2013.01); A6 IK3I/92 (2013.01) (21) Appl. No.: 14/755,275 (57) ABSTRACT (22) Filed: Jun. 30, 2015 The invention described herein relates to a cannabis cultivar O O that produces high concentrations of cannabidiol. The inven Related U.S. Application Data tion further relates to preparations and products derived from (60) Provisional application No. 62/019,810, filed on Jul. 1, the cannabis cultivar. Also provided are methods of treating 2014, provisional application No. 62/031.538, filed on conditions that are treatable by cannabidiol. by administering Jul. 31, 2014. a preparation or product derived from the cannabis cultivar. US 2016/0000843 A1 Jan. 7, 2016

HIGH CANNABDOL CANNABSSTRANS the glioma tumor, PCT Publication WO/2007/148094 dis closes use of composition for the treatment of CROSS-REFERENCE TO OTHER neuropathic ; and U.S. Pat. Publication US2010/0286098 APPLICATIONS discloses a method of treating tissue injury in a patient with colitis administering the cannabinoids. 0001. This application claims priority to U.S. Provisional 0009 While a wide range of medical uses has been iden Application Ser. No. 62/019,810, filed Jul. 1, 2014, and tified, the benefits achieved by cannabinoids for a particular 62/031.538, filed Jul. 31, 2014, each of which is incorporated disease or condition are believed to be attributable to a sub herein by reference in its entirety. group of cannabinoids or to individual cannabinoids. That is BACKGROUND OF THE INVENTION to say that different Subgroups or single cannabinoids have beneficial effects on certain conditions, while other sub 0002 1. Field of the Invention groups or individual cannabinoids have beneficial effects on 0003. This invention is directed in part to cannabis culti other conditions. For example, THC is the main psychoactive vars with high concentrations of cannabidiol and/or canna produced by Cannabis and is well-characterized bidiolic acid and low concentrations of A9-tetrahydrocannab for its biological activity and potential therapeutic application inol and/or tetrahydrocannabinolic acid. in a broad spectrum of diseases. CBD, another major cannab 0004 2. State of the Art inoid constituent of Cannabis, acts as an inverse of the 0005 Cannabis has long been considered to have medici CB1 and CB2 cannabinoid receptors. Unlike THC, CBD does nal properties. Many states, such as Colorado, Washington, not produce psychoactive effects in humans. CBD is reported Oregon, California, Alaska, Maine, Hawaii, Nevada, Ver to exert , antioxidant, anti-inflammatory, and immu mont, Montana, Rhode Island, New Mexico, Michigan, New nomodulatory effects. Jersey, allow the use of medicinal cannabis by persons with 0010 , including terpenoids, are another class of debilitating medical conditions as certified by physicians. compounds that are produced by cannabis. Reportedly, as 0006 Cannabinoids, which are compounds derived from many as 200 or more terpenes can be produced by cannabis cannabis, are a group of chemicals from Cannabis species, plants, although the types and ratios ofterpenes produced by including , , and Can a are dependent on genetics and growth con nabis indica plant that are known to activate cannabinoid ditions (e.g., lighting, fertilization, Soil, watering frequency/ receptors (i.e., CB1 and CB2) in cells. There are at least 85 amount, humidity, carbon dioxide concentration, and the different cannabinoids that can be isolated from cannabis. like), as well as age, maturation, and time of day. Terpenes Plant cannabinoids are termed “phytocannabinoids.” Can have been shown to have medicinal properties, and may be nabinoids are also produced endogenously in humans and responsible for at least a portion of the medicinal value of other animals and are termed “endocannabinoids.” “Syn cannabis. thetic cannabinoids' are manmade chemicals with the same/ 0011. Some of the medical benefits attributable to one or similar structures as phytocannabinoids or endocannab more of the terpenes isolated from cannabis include treatment inoids. of sleep disorders, , , and seizures, pain, microbial infections (fungal, bacterial, etc.), , 0007 Cannabinoids are cyclic molecules exhibiting par inflammation, spasms, gastric reflux, depression, and asthma. ticular properties, such as the ability to easily cross the blood Some terpenes have been shown to: lower the resistance brain barrier, weak toxicity and few side effects. The most across the blood-brain barrier, act on cannabinoid receptors notable cannabinoids produced by cannabis are A9-tetrahy and other neuronal receptors, stimulate the immune system, drocannabinol (i.e., THC) and cannabidiol (i.e., CBD). and/or Suppress appetite. 0008. Some of the medical benefits attributable to one or 0012 To date, however, medicinal is used as a more of the cannabinoids isolated from cannabis include generic product whereby the patient utilizes the entirety of the treatment of pain, nausea, AIDS-related weight loss and wast different cannabinoids to achieve medicinal results. Efforts ing, , allergies, infection, depression, have been made to maximize the medicinal benefit of can migraine, bipolar disorders, hypertension, post-stroke neuro nabis for a patient having a particular condition, but Such protection, epilepsy, and fibromyalgia, as well as inhibition of efforts are invariably complicated. For example, because tumor growth, angiogenesis and metastasis. Studies have THC is psychoactive, Some patients and regulatory authori shown that cannabinoids may also be useful for treating con ties view cannabis with high CBD (and low THC) as being an ditions such as glaucoma, Parkinson's disease, Huntington's alternative to traditional marijuana that is acceptable, legally, disease, migraines, inflammation, Crohn's disease, dystonia, medically, and/or culturally. Additionally, cannabis rheumatoid arthritis, emesis due to chemotherapy, inflamma tory bowel disease, atherosclerosis, posttraumatic stress dis employed by a patient lacks consistent cannabinoid compo order, cardiac , prostate carcinoma, and nents and concentrations, and thereby fails to provide the Alzheimer's disease. For example, U.S. Pat. No. 6,630,507 maximum benefit to the patient. discloses cannabinoids for use as antioxidants and neuropro 0013 Cannabis expresses a large number of cannabinoids tectants; U.S. Pat. No. 7,105,685 discloses cannabinoids for which are useful in the treatment of a variety of diseases. the treatment of diseases associated with immune dysfunc However, the usefulness of a cannabis cultivar for a particular tion, particularly HIV disease and neoplastic disorders; U.S. disease is dependent upon the concentration of one or more Pat. No. 7,109,245 discloses cannabinoids useful as vasocon specific cannabinoids, and/or the ratio between amounts of strictors; U.S. Pat. Publication US2011/0257256 discloses cannabinoids, produced by the cultivar. THC-CBD composition for use in treating or preventing Cog nitive Impairment and Dementia; PCT Publication WO/2009/ SUMMARY OF THE INVENTION 147439 discloses use of cannabinoids in the manufacture of a 0014 Cannabis and products or preparations thereof can medicament for use in the treatment of cancer, in particular be used to treat a variety of medical conditions in patients. US 2016/0000843 A1 Jan. 7, 2016

However, the effectiveness of a given cannabis strain or cul drocannabinolic acid concentration of less than about 1% by tivar in the treatment of a certain medical condition or symp weight. In a preferred embodiment, the cannabis cultivar tom is dependent on the type(s) of cannabinoids present in the produces an assayable combined A9- cultivar, strain, or preparation, both with respect to the and tetrahydrocannabinolic acid concentration of less than amount of given cannabinoids and the ratios thereof. Cannab about 0.1% by weight. inoid types and concentrations are dependent on a number of 0021. In one embodiment, the cannabis cultivar produces factors, including cultivar or strain type (e.g., genetic back an estimated active cannabidiol concentration is at least about ground), growth conditions, harvest conditions, and methods 18% by weight. In one embodiment, the cannabis cultivar of preparation. produces an estimated active cannabidiol concentration is at 0015 Cannabidiol (CBD) has been implicated in the treat least about 20% by weight. ment of a wide variety of diseases and symptoms, including 0022. In one embodiment, the cannabis cultivar produces cancer, nausea, chronic pain, spasms, seizures/epilepsy, anxi an active A9-tetrahydrocannabinol concentration of less than ety, psoriasis, Crohn's disease, rheumatoid arthritis, diabetes, about 3% by weight. In one embodiment, the cannabis culti schizophrenia, post-traumatic stress disorder (PTSD), alco var produces an active A9-tetrahydrocannabinol concentra holism, strokes, Multiple Sclerosis, and cardiovascular dis tion of less than about 2% by weight. In one embodiment, the ease. CBD also has been reported to act as a , cannabis cultivar produces an active A9-tetrahydrocannab antibiotic, anti-inflammatory, and bone stimulant, as well as inol concentration of less than about 1% by weight. In a to improve blood circulation, cause drowsiness, and protect preferred embodiment, the cannabis cultivar produces an the nervous system. active A9-tetrahydrocannabinol concentration of less than 0016 A9-Tetrahydrocannabinol (THC) is also implicated about 0.1% by weight. in the treatment of disease. However, the psychotropic activ 0023. In one aspect, this invention is directed to a prepa ity of THC makes it undesirable for some patients and/or ration of the cannabis cultivar, wherein the preparation is a indications. flower, an , an oil, an edible, a , an infusion, a 0017. This invention relates to a cannabis cultivar with a , or a . high CBD concentration but low THC concentration. This 0024. In one aspect, this invention is directed to a method achieves the desire of patients to be treated with CBD without of treating a cannabidiol-treatable condition and/or symptom the side-effects (e.g., psychoactivity) of THC. thereof in a patient in need thereof by administering a high 0018. This invention is further predicated on the discovery cannabidiol cannabis cultivar or preparation or product that uniform cultivation parameters between batches of the thereof to the patient. same cannabis cultivar allows for Substantially the same can nabinoid composition to be obtained from the same cultivar, DETAILED DESCRIPTION OF THE PREFERRED regardless of batch. Cultivation parameters include, for EMBODIMENTS example and without limitation, light intensity, light duration, fertilizer timing, fertilizer composition, watering schedules, 0025. It is to be understood that this invention is not lim watering quantity, amount of media, container size used, ited to particular embodiments described, as Such may, of propagation methods, harvesting protocols, carbon dioxide course, vary. It is also to be understood that the terminology concentrations, etc. Other considerations include water qual used herein is for the purpose of describing particular ity, pruning, plant Support (e.g., trellising), pesticides and pest embodiments only, and is not intended to be limiting, since management, repotting, drying/curing, product storage, and the scope of this invention will be limited only by the the like. Implementation of the standardized processes appended claims. described herein leads to improvement of the quality, unifor 0026. The detailed description of the invention is divided mity, yield predictability and potential of the cultivars. In into various sections only for the reader's convenience and Some embodiments, the cannabinoid composition of the har disclosure found in any section may be combined with that in Vested cannabis is substantially the same in each batch. another section. Unless defined otherwise, all technical and 0019. In one aspect, this invention is directed to a cannabis Scientific terms used herein have the same meaning as com cultivar that produces an assayable combined cannabidiolic monly understood by one of ordinary skill in the art to which acid and cannabidiol concentration of at least about 18% by this invention belongs. weight. In one embodiment, the cannabis cultivar produces an assayable combined and cannabidiol con Definitions centration of at least about 20% by weight. In one embodi ment, the cannabis cultivar produces an assayable combined 0027. It must be noted that as used herein and in the cannabidiolic acid and cannabidiol concentration of between appended claims, the singular forms “a”, “an', and “the about 18% to about 60% by weight. In one embodiment, the include plural referents unless the context clearly dictates cannabis cultivar produces an assayable combined cannabid otherwise. Thus, for example, reference to “a compound iolic acid and cannabidiol concentration of between about includes a plurality of compounds. 20% to about 60% by weight. 0028. Unless defined otherwise, all technical and scien 0020. In one embodiment, the cannabis cultivar produces tific terms used herein have the same meaning as commonly anassayable combined A9-tetrahydrocannabinol and tetrahy understood by one of ordinary skill in the art to which this drocannabinolic acid concentration of less than about 3% by invention belongs. As used herein the following terms have weight. In one embodiment, the cannabis cultivar produces an the following meanings assayable combined A9-tetrahydrocannabinol and tetrahy 0029. The term “about when used before a numerical drocannabinolic acid concentration of less than about 2% by designation, e.g., temperature, time, amount, concentration, weight. In one embodiment, the cannabis cultivar produces an and Such other, including a range, indicates approximations assayable combined A9-tetrahydrocannabinol and tetrahy which may vary by (+) or (-) 10%, 5% or 1%. US 2016/0000843 A1 Jan. 7, 2016

0030 "Comprising” or “comprises” is intended to mean their structures are discussed in more detail in U.S. Patent that the compositions and methods include the recited ele Application Pub. No. 2013/0059018, which is incorporated ments, but not excluding others. "Consisting essentially of herein by reference in its entirety. when used to define compositions and methods, shall mean 0038 Phytocannabinoids can occur as either the pentyl(5 excluding other elements of any essential significance to the carbon atoms) or propyl(3 carbon atoms) variant. The propyl combination for the stated purpose. Thus, a composition con and pentyl variants may have distinct properties from one sisting essentially of the elements as defined herein would not another. For example, THC is a CB1 agonist, exclude other materials or steps that do not materially affect whereas the propyl variant THCV is a CB1 receptor antago the basic and novel characteristic(s) of the claimed invention. nist meaning that it has almost opposite effects from THC. “Consisting of shall mean excluding more than trace ele 0039. “Terpenes” or “terpenoids” refers to a class of ments of other ingredients and Substantial method steps. chemicals produced by plants, including cannabis. The term Embodiments defined by each of these transition terms are “terpenoid generally refers to a chemically modified within the scope of this invention. (e.g., by oxidation). As used herein, the terpenes include 0031 “Administration” refers to introducing an agent into terpenoids. Terpenes and terpenoids are often aromatic a patient. Typically, an effective amount is administered, and may have strong Smells associated with which amount can be determined by the treating physician or them. the like. Any , such as oral, topical, 0040 Terpenes known to be produced by cannabis , nasal, buccal, Sublingual, intranasal, or intrapul include, without limitation, aromadendrene, bergamottin, monary can be used. bergamotol, bisabolene, borneol, 4-3-carene, , 0032. The related terms and phrases “administering and cineolefeucalyptol, p-cymene, dihydroj asmone, elemene, “administration of, when used in connection with a com farnesene, fenchol, geranylacetate, guaiol, humulene, isop pound or pharmaceutical composition (and grammatical ulegol, limonene, , menthone, , menthofuran, equivalents) refer both to direct administration, which may be myrcene, nerylacetate, neomenthylacetate, ocimene, perilly administration to a patient by a medical professional or by lalcohol, phellandrene, pinene, pulegone, Sabinene, ter self-administration by the patient, and/or to indirect admin pinene, terpineol, terpineol-4-ol, terpinolene, and derivatives, istration, which may be the act of prescribing a drug. For isomers, enantiomers, etc. of each thereof. example, a physician who instructs a patient to self-adminis 0041 Cannabis plants and products may also comprise ter a drug and/or provides a patient with a prescription for a other pharmaceutically relevant compounds, including fla drug is administering the drug to the patient. Vonoids and phytosterols (e.g., , quercetin, cannfla 0033 “Atomizing,” as used herein, means forming a spray. vin A, B-sitosterol and the like). The term refers to the act of converting a liquid into fine 0042 “Products of cannabis” as used herein refers to any particles Suspended within the air. Atomizing is a general products derived from the cannabis plant, including but not term which encompasses both vaporizing and aerosolizing. In limited to the flower, resin (hashish), and oil (), as well at least some embodiments provided herein, atomizing as any preparations thereof. Preparations include, by way of involves converting a liquid oil into a Suspension or disper non-limiting example, dried flower, kief, hashish, tincture, sion of fluid particles each having a diameter of no more than 10gm. hash oil, infusions, pipe resins, edibles, and the like. 0043. As used herein, the term “flower,” “bud, or “dried 0034). “Cannabis.” “cannabis species, or “marijuana' flower” refers to dried cannabis flowers, as well as the leaves refers to a flowering plant including the species (or Sub (e.g., bracts) and stems associated therewith. This is the most species) Cannabis sativa, Cannabis ruderalis, and Cannabis widely consumed form of cannabis, and is often referred to as indica. marijuana. 0035 “Cannabinoids’ refers to a class of chemical com pounds that act on the cannabinoid receptors. "Endocannab 0044) The term "kief refers to a trichome-rich powder. It inoids' are produced naturally in animals, including humans. can be sifted from cannabis leaves and flowers. Trichomes are "Phytocannabinoids are naturally-occurring cannabinoids structures present on cannabis leaves, stems, and flowers that produced in plants. “ are artificially produce cannabinoids. manufactured cannabinoids. 0045. The term “hashish' or “hash refers to a concen 0036 Cannabis species express at least 85 different phy trated cake made from pressed kief. tocannabinoids, which are concentrated in resin produced in 0046. The term “tincture” refers to cannabis made glandular trichomes. The phytocannabinoids are divided into using high-proof . Subclasses based on structure, including cannabigerols, can 0047. The term “hash oil refers to oil extracted from nabichromenes, cannabidiols, , can cannabis flower and leaves. nabinols and cannabinodiols, and other cannabinoids. 0048. The term “infusion” refers to infusion of cannabis in 0037 Cannabinoids found in cannabis include, without a variety of products. Non-limiting examples include tea, limitation: (CBG), (CBC), cocoa butter, dairy butter, cooking oil, glycerine, and other cannabidiol (CBD), tetrahydrocannabinol (THC), cannab oils (e.g., skin moisturizers). Infusions include edibles like inol (CBN) and (CBDL), beer, Soda, peanut butter, and the like. (CBL), (CBV), 0049. The term "edible” refers to any cannabis product (THCV), (CBDV), that can be consumed as food. In some cases, edibles are made (CBCV), cannabigerovarin (CBGV), cannabigerol monom by infusion of the cannabis into a foodstuff. In some cases, ethyl ether (CBGM), cannabinerolic acid, cannabidiolic acid edibles are made by combining a cannabis product (e.g., dried (CBDA), propyl variant (CBNV), cannabitriol flower, kief, hashish, tincture, hash oil, or infusion) with other (CBO), tetrahydrocannabinolic acid (THCA), and tetrahy ingredients to make an edible (e.g., a cookie, chocolate, lol drocannabivarinic acid (THCVA). Phytocannabinoids and lipop, beer, popcorn, etc.). US 2016/0000843 A1 Jan. 7, 2016

0050) “Yield potential as used herein refers to the grams condition and prior medical history of the patient being of product per square foot of cultivation space expected to be treated. However, it is within the skill of the art to start doses generated by a given cannabis Strain or cultivar over a period of the compound at levels lower than required to achieve the of time. In a preferred embodiment, the period of time is the desired therapeutic effect and to gradually increase the dos time from propagation to harvest of a cannabis plant or batch. age until the desired effect is achieved. 0051 Cannabis plants go through a vegetative stage of 0058. The term “modulate' or “modulating” means any growth, followed by a flowering cycle. The period of growth treatment of a disease or disorder in a subject, Such as a between germination or cutting rooting and flowering is mammal, including: known as the vegetative phase of plant development. Vegeta 0059 preventing or protecting against the disease or tion is the sporophytic state of the Cannabis plant. Plants do disorder, that is, causing the abnormal biological reac not produce flowers during the vegetative stage and are bulk tion or symptoms not to develop; ing up to a desired production size for flowering. During the 0060 inhibiting the disease or disorder, that is, arresting Vegetative phase, plants are busy carrying out photosynthesis or Suppressing the development of abnormal biological and accumulating resources that will be needed for flowering reactions and/or clinical symptoms; and/or and reproduction. 0061 relieving the disease or disorder that is, causing 0052 “Flowering cycle' or “flowering stage' (also called the regression of abnormal biological reactions and/or “bud cycle') refers to the period during which the plant pro clinical symptoms. duces buds and flowers. This is the reproductive phase of 0062. As used herein, the term “preventing refers to the plant growth, cannabis is dioecious having female and male prophylactic treatment of a patient in need thereof. The pro reproduction parts on separate plants. Flowering is the game phylactic treatment can be accomplished by providing an tophytic or reproductive state of Cannabis. For production, appropriate of a therapeutic agent to a subject at risk of only females are selected for cultivation. For some cultivars, Suffering from an ailment, thereby Substantially averting the Switch from the vegetative stage to the flowering stage is onset of the ailment. light-dependent. Some cultivars are autoflowering, meaning 0063. As used herein, the term “condition” refers to a they switch to the flowering stage automatically (e.g., with disease state for which the compounds, compositions and age). methods provided herein are being used. 0053 “Cannabis cultivar” refers to cannabis plants that 0064. As used herein, the term “patient’ or “subject’ have been selected for one or more desirable characteristics refers to mammals and includes humans and non-human and propagated. Where the term cultivar is used, it is to be mammals. In particular embodiments herein, the patient or understood that the cultivar may be a result of breeding and/or Subject is a human. the result of genetic manipulation. A cannabis cultivar as described herein is not naturally-occurring. Propagation may High Cannabidiol Cannabis occur in any manner, including, without limitation, sexual 0065. In one aspect, described herein is a cannabis cultivar reproduction (e.g., seed), cloning (e.g., cuttings, Vegetative that produces high levels of CBD (and/or CBDA) and low propagation), self-pollinization, and the like. levels of THC (and/or THCA). In one embodiment, the can 0054 A“plurality” as used herein refers to more than one. nabis cultivar produces an assayable combined cannabidiolic For example, a plurality of cannabinoids may be two, three, acid and cannabidiol concentration of about 18% to about four, five, or more cannabinoids. 60% by weight. In one embodiment, the cannabis cultivar 0055. The term “active cannabinoid as used herein refers produces an assayable combined cannabidiolic acid and can to the non-acid form of the cannabinoid plus the amount of nabidiol concentration of about 20% to about 40% by weight. non-acid form estimated to be formed upon decarboxylation In one embodiment, the cannabis cultivar produces an assay of the acid form. able combined cannabidiolic acid and cannabidiol concentra 0056 Cannabinoids in their acid forms (e.g., CBDA or tion of about 20% to about 30% by weight. In one embodi THCA) can be converted to their non-acid forms (e.g., THC ment, the cannabis cultivar produces an assayable combined or CBD) by decarboxylation. Decarboxylation occurs when cannabidiolic acid and cannabidiol concentration of about the cannabinoid is heated. In addition, cannabinoid acid 25% to about 35% by weight. It should be understood that any forms have been shown to have therapeutic activity. Cannab subvalue or subrange from within the values described above inoids lose mass when they are converted from the acid to are contemplated for use with the embodiments described non-acid (“active') form. In order to determine the estimated herein. amount of active cannabinoid that will be present after decar 0066. In one embodiment, the cannabis cultivar produces boxylation, the amount of the acid form can be multiplied by an assayable combined cannabidiolic acid and cannabidiol 87.7%. This is a rough estimate, and the actual amount of concentration of at least about 18% by weight. In one embodi active cannabinoid that will be produced may be dependent ment, the cannabis cultivar produces an assayable combined upon the cannabinoid, method of decarboxylation, further cannabidiolic acid and cannabidiol concentration of at least breakdown of the cannabinoid during the decarboxylation about 19% by weight. In a preferred embodiment, the can process (e.g., due to heat), etc. nabis cultivar produces an assayable combined cannabidiolic 0057. In one embodiment, “therapeutically effective acid and cannabidiol concentration of at least about 20% by amount refers to that amount of a compound that results in weight. In one embodiment, the cannabis cultivar produces an prevention or amelioration of symptoms in a patient or a assayable combined cannabidiolic acid and cannabidiol con desired biological outcome, e.g., improved clinical signs, centration of at least about 21% by weight. In one embodi delayed onset of disease, etc. The effective amount can be ment, the cannabis cultivar produces an assayable combined determined by one of ordinary skill in the art. The selected cannabidiolic acid and cannabidiol concentration of at least dosage level can depend upon factors including, but not lim about 22% by weight. In one embodiment, the cannabis cul ited to, the severity of the condition being treated, and the tivar produces an assayable combined cannabidiolic acid and US 2016/0000843 A1 Jan. 7, 2016

cannabidiol concentration of at least about 23% by weight. In assayable combined A9-tetrahydrocannabinol and tetrahy one embodiment, the cannabis cultivar produces an assayable drocannabinolic acid concentration of between about 0% to combined cannabidiolic acid and cannabidiol concentration about 0.01% by weight. In one embodiment, the cannabis of at least about 24% by weight. In one embodiment, the cultivar produces an assayable combined A9-tetrahydrocan cannabis cultivar produces an assayable combined cannabid nabinol and tetrahydrocannabinolic acid concentration of iolic acid and cannabidiol concentration of at least about 25% between about 0.02% to about 3% by weight. In a preferred by weight. In one embodiment, the cannabis cultivar pro embodiment, the cannabis cultivar produces an assayable duces an assayable combined cannabidiolic acid and canna combined A9-tetrahydrocannabinol and tetrahydrocannabin bidiol concentration of at least about 26% by weight. In one olic acid concentration of between about 0.02% to about 2% embodiment, the cannabis cultivar produces an assayable by weight. In one embodiment, the cannabis cultivar pro combined cannabidiolic acid and cannabidiol concentration duces an assayable combined A9-tetrahydrocannabinol and of at least about 27% by weight. In one embodiment, the tetrahydrocannabinolic acid concentration of between about cannabis cultivar produces an assayable combined cannabid 0.03% to about 2% by weight. In one embodiment, the can iolic acid and cannabidiol concentration of at least about 28% nabis cultivar produces an assayable combined A9-tetrahy by weight. In one embodiment, the cannabis cultivar pro drocannabinol and tetrahydrocannabinolic acid concentra duces an assayable combined cannabidiolic acid and canna tion of between about 0.05% to about 2% by weight. In one bidiol concentration of at least about 29% by weight. In one embodiment, the cannabis cultivar produces an assayable embodiment, the cannabis cultivar produces an assayable combined A9-tetrahydrocannabinol and tetrahydrocannabin combined cannabidiolic acid and cannabidiol concentration olic acid concentration of between about 0.07% to about 2% of at least about 30% by weight. by weight. It should be understood that any subvalue or sub 0067. In one embodiment, the cannabis cultivar produces range from within the values described above are contem anassayable combined A9-tetrahydrocannabinol and tetrahy plated for use with the embodiments described herein. drocannabinolic acid concentration of between about 0% to 0068. In one embodiment, the cannabis cultivar produces about 3% by weight. In one embodiment, the cannabis culti anassayable combined A9-tetrahydrocannabinol and tetrahy var produces an assayable combined A9-tetrahydrocannab drocannabinolic acid concentration of less than about 3% by inol and tetrahydrocannabinolic acid concentration of weight. In one embodiment, the cannabis cultivar produces an between about 0% to about 2% by weight. In one embodi assayable combined A9-tetrahydrocannabinol and tetrahy ment, the cannabis cultivar produces an assayable combined drocannabinolic acid concentration of less than about 2% by A9-tetrahydrocannabinol and tetrahydrocannabinolic acid weight. In one embodiment, the cannabis cultivar produces an concentration of between about 0% to about 1% by weight. In assayable combined A9-tetrahydrocannabinol and tetrahy one embodiment, the cannabis cultivar produces an assayable drocannabinolic acid concentration of less than about 1.9% combined A9-tetrahydrocannabinol and tetrahydrocannabin by weight. In one embodiment, the cannabis cultivar pro olic acid concentration of between about 0% to about 0.3% by duces an assayable combined A9-tetrahydrocannabinol and weight. In one embodiment, the cannabis cultivar produces an tetrahydrocannabinolic acid concentration of less than about assayable combined A9-tetrahydrocannabinol and tetrahy 1.8% by weight. In one embodiment, the cannabis cultivar drocannabinolic acid concentration of between about 0% to produces an assayable combined A9-tetrahydrocannabinol about 0.1% by weight. In one embodiment, the cannabis and tetrahydrocannabinolic acid concentration of less than cultivar produces an assayable combined A9-tetrahydrocan about 1.7% by weight. In one embodiment, the cannabis nabinol and tetrahydrocannabinolic acid concentration of cultivar produces an assayable combined A9-tetrahydrocan between about 0% to about 0.09% by weight. In one embodi nabinol and tetrahydrocannabinolic acid concentration of less ment, the cannabis cultivar produces an assayable combined than about 1.6% by weight. In one embodiment, the cannabis A9-tetrahydrocannabinol and tetrahydrocannabinolic acid cultivar produces an assayable combined A9-tetrahydrocan concentration of between about 0% to about 0.08% by nabinol and tetrahydrocannabinolic acid concentration of less weight. In one embodiment, the cannabis cultivar produces an than about 1.5% by weight. In one embodiment, the cannabis assayable combined A9-tetrahydrocannabinol and tetrahy cultivar produces an assayable combined A9-tetrahydrocan drocannabinolic acid concentration of between about 0% to nabinol and tetrahydrocannabinolic acid concentration of less about 0.07% by weight. In one embodiment, the cannabis than about 1.4% by weight. In one embodiment, the cannabis cultivar produces an assayable combined A9-tetrahydrocan cultivar produces an assayable combined A9-tetrahydrocan nabinol and tetrahydrocannabinolic acid concentration of nabinol and tetrahydrocannabinolic acid concentration of less between about 0% to about 0.06% by weight. In one embodi than about 1.3% by weight. In one embodiment, the cannabis ment, the cannabis cultivar produces an assayable combined cultivar produces an assayable combined A9-tetrahydrocan A9-tetrahydrocannabinol and tetrahydrocannabinolic acid nabinol and tetrahydrocannabinolic acid concentration of less concentration of between about 0% to about 0.05% by than about 1.2% by weight. In one embodiment, the cannabis weight. In one embodiment, the cannabis cultivar produces an cultivar produces an assayable combined A9-tetrahydrocan assayable combined A9-tetrahydrocannabinol and tetrahy nabinol and tetrahydrocannabinolic acid concentration of less drocannabinolic acid concentration of between about 0% to than about 1% by weight. In one embodiment, the cannabis about 0.04% by weight. In one embodiment, the cannabis cultivar produces an assayable combined A9-tetrahydrocan cultivar produces an assayable combined A9-tetrahydrocan nabinol and tetrahydrocannabinolic acid concentration of less nabinol and tetrahydrocannabinolic acid concentration of than about 0.5% by weight. In one embodiment, the cannabis between about 0% to about 0.03% by weight. In one embodi cultivar produces an assayable combined A9-tetrahydrocan ment, the cannabis cultivar produces an assayable combined nabinol and tetrahydrocannabinolic acid concentration of less A9-tetrahydrocannabinol and tetrahydrocannabinolic acid than about 0.3% by weight. In one embodiment, the cannabis concentration of between about 0% to about 0.02% by cultivar produces an assayable combined A9-tetrahydrocan weight. In one embodiment, the cannabis cultivar produces an nabinol and tetrahydrocannabinolic acid concentration of less US 2016/0000843 A1 Jan. 7, 2016

than about 0.2% by weight. In one embodiment, the cannabis 23% by weight. In one embodiment, the estimated active cultivar produces an assayable combined A9-tetraydrocanab cannabidiol concentration is at least about 24% by weight. In inol and tetrahydrocannabinolic acid concentration of less one embodiment, the estimated active cannabidiol concentra than about 0.1% by weight...In one embodiment, the cannabis tion is at least about 25% by weight. In one embodiment, the cultivar produces an assayable combined A9-tetrahydrocan estimated active cannabidiol concentration is at least about nabinol and tetrahydrocannabinolic acid concentration of less 26% by weight. In one embodiment, the estimated active than about 0.09% by weight. . In one embodiment, the can cannabidiol concentration is at least about 27% by weight. In nabis cultivar produces an assayable combined A9-tetrahy one embodiment, the estimated active cannabidiol concentra drocannabinol and tetrahydrocannabinolic acid concentra tion is at least about 28% by weight. In one embodiment, the tion of less than about 0.08% by weight... In one embodiment, estimated active cannabidiol concentration is at least about the cannabis cultivar produces an assayable combined A9-tet 29% by weight. In one embodiment, the estimated active rahydrocannabinol and tetrahydrocannabinolic acid concen cannabidiol concentration is at least about 30% by weight. tration of less than about 0.07% by weight... In one embodi 0071. In one aspect, this invention is directed to a cannabis ment, the cannabis cultivar produces an assayable combined strain or product thereof, wherein the ratio of estimated active A9-tetrahydrocannabinol and tetrahydrocannabinolic acid cannabidiol to estimated active THC is between about 400:1 concentration of less than about 0.06% by weight. In one and about 15:1. In one embodiment, the ratio of active can embodiment, the cannabis cultivar produces an assayable nabidiol to active THC is between about 300:1 and about combined A9-tetrahydrocannabinol and tetrahydrocannabin 20:1. In one embodiment, the ratio of active cannabidiol to olic acid concentration of less than about 0.05% by weight.. active THC is between about 300:1 and about 25:1. In one In one embodiment, the cannabis cultivar produces an assay embodiment, the ratio of active cannabidiol to active THC is able combined A9-tetrahydrocannabinol and tetrahydrocan between about 300:1 and about 30:1. In one embodiment, the nabinolic acid concentration of less than about 0.04% by ratio of active cannabidiol to active THC is between about weight... In one embodiment, the cannabis cultivar produces 300:1 and about 50:1. In one embodiment, the ratio of active anassayable combined A9-tetrahydrocannabinol and tetrahy cannabidiol to active THC is between about 300:1 and about drocannabinolic acid concentration of less than about 0.03% 70:1. In one embodiment, the ratio of active cannabidiol to by weight. . In one embodiment, the cannabis cultivar pro active THC is between about 300:1 and about 8.0:1. In one duces an assayable combined A9-tetrahydrocannabinol and embodiment, the ratio of active cannabidiol to active THC is tetrahydrocannabinolic acid concentration of less than about between about 300:1 and about 100:1. In one embodiment, 0.02% by weight... In one embodiment, the cannabis cultivar the ratio of active cannabidiol to active THC is between about produces an assayable combined A9-tetrahydrocannabinol 300:1 and about 200:1. and tetrahydrocannabinolic acid concentration of less than 0072 The concentration of cannabinoids can be deter about 0.01% by weight. In one embodiment, the cannabis mined based on a sample taken from any portion of the cultivar produces an assayable combined A9-tetrahydrocan cannabis plant. The concentration of cannabinoids can be nabinol and tetrahydrocannabinolic acid concentration of determined based on a sample taken at any point in the life about 0.07% by weight. cycle of the plant. In a preferred embodiment, the sample is 0069. In one embodiment, the estimated active canna taken from a flower (or inflorescence) of a cannabis plant. In bidiol concentration is between about 18% and about 60% by one embodiment, the sample is taken from one or more flow weight. In one embodiment, the estimated active cannabidiol ers, leaves, stems, or a combination thereof. In one embodi concentration is between about 20% and about 60% by ment, the sample is taken during a vegetative stage of the weight. In one embodiment, the estimated active cannabidiol cannabis life cycle. In one embodiment, the sample is taken concentration is between about 20% and about 50% by during the flowering stage of the cannabis life cycle. weight. In one embodiment, the estimated active cannabidiol 0073. In one aspect of the invention, the cannabis cultivar concentration is between about 20% and about 40% by is cultivated by a method as described in U.S. patent applica weight. In one embodiment, the estimated active cannabidiol tion Ser. No. 14/745,358, which is incorporated herein by concentration is between about 20% and about 30% by reference in its entirety. weight. In one embodiment, the estimated active cannabidiol concentration is between about 20% and about 25% by Products and Preparations weight. In one embodiment, the estimated active cannabidiol 0074 The cannabis cultivar provided herein can be pro concentration is between about 25% and about 40% by cessed into a variety of products or preparations. Generally, at weight. In one embodiment, the estimated active cannabidiol least a portion of a cannabis plant is processed, for example a concentration is between about 25% and about 30% by flower, inflorescence, leaf, and/or stem. In one embodiment, weight. It should be understood that any subvalue or Subrange the portion of the plant is harvested and dried prior to further from within the values described above are contemplated for processing. use with the embodiments described herein. 0075. Oil, cannabinoids, and/or other compounds can be 0070. In one embodiment, the estimated active canna extracted from portions of the cannabis plant using known bidiol concentration is at least about 18% by weight. In one extraction methods. By way of non-limiting example, a por embodiment, the estimated active cannabidiol concentration tion of the cannabis plant can be contacted with one or more is at least about 19% by weight. In one embodiment, the Solvents (including, but not limited to, butane, propane, car estimated active cannabidiol concentration is at least about bon dioxide, and/or alcohol, e.g., ethanol). In a preferred 20% by weight. In one embodiment, the estimated active embodiment, the solvent is an alcohol. In an especially pre cannabidiol concentration is at least about 21% by weight. In ferred embodiment, the alcohol is ethanol. one embodiment, the estimated active cannabidiol concentra 0076 Portions of the cannabis plant that can be used to tion is at least about 22% by weight. In one embodiment, the extract cannabinoids include the flowers, inflorescences, estimated active cannabidiol concentration is at least about leaves, and/or stems. The plant or portion thereof to be US 2016/0000843 A1 Jan. 7, 2016

extracted is optionally dried prior to extraction. In one (CBCV), cannabigerovarin (CBGV), cannabigerol monom embodiment, a portion of the cannabis plant is mechanically ethyl ether (CBGM), cannabinerolic acid, cannabidiolic acid processed (e.g., cut, sifted, or ground). Where the portion of (CBDA), Cannabinol propyl variant (CBNV), cannabitriol the cannabis plant is mechanically processed, the resulting (CBO), tetrahydrocannabinolic acid (THCA), or tetrahydro material may be used directly (e.g., to administer to a patient, cannabivarinic acid (THCVA). as an ingredient in an edible, etc.) or may be extracted or I0081. In one aspect, the cannabinoid and/or terpene com otherwise further processed prior to use. position of the strain is determined by assaying the concen 0077. After the desired portion(s) of the cannabis plant are tration of at least one cannabinoid in a Subset (e.g., sample) of processed, the resulting material may be used to make can the harvested product. In one embodiment, THC concentra nabis preparations. In one aspect, this invention relates to a tion is assayed. In one embodiment, CBD concentration is preparation of a cannabis plant as described herein. In one assayed. In one embodiment, the cannabinoid is CBN. In one embodiment, the preparation is a flower or a dried flower. In embodiment, the cannabinoid is at least one of cannabigerol one embodiment, the preparation is an extract. In one embodi (CBG), cannabichromene (CBC), cannabidiol (CBD), tet ment, the preparation is a kief. In one embodiment, the prepa rahydrocannabinol (THC), cannabinol (CBN) and cannab ration is an infusion. In one embodiment, the preparation is a inodiol (CBDL), cannabicyclol (CBL), cannabivarin (CBV), tincture. In one embodiment, the preparation is a hashish. In tetrahydrocannabivarin (THCV), cannabidivarin (CBDV), one embodiment, the preparation is a topical formulation. In cannabichromevarin (CBCV), cannabigerovarin (CBGV), one embodiment, the preparation is a spray. In one embodi cannabigerol monomethyl ether (CBGM), cannabinerolic ment, the preparation is a salve. acid, cannabidiolic acid (CBDA), Cannabinol propyl variant 0078. In a preferred embodiment, the preparation is an oil. (CBNV), cannabitriol (CBO), tetrahydrocannabinolic acid In one embodiment, the oil comprises less than about 3% by (THCA), or tetrahydrocannabivarinic acid (THCVA). In one weight of the solvent used for extraction of the cannabinoids. embodiment, the concentration of one or more terpenes is In one embodiment, the oil comprises less than about 2% by assayed. weight of the solvent used for extraction of the cannabinoids. I0082 Assays used heretofore to determine cannabinoid In one embodiment, the oil comprises less than about 1% by concentrations have shown significant deviation for the same weight of the solvent used for extraction of the cannabinoids. plant. Such deviation is a problem for the cannabis industry as In one embodiment, the oil comprises less than about 0.5% by a whole, and particularly the medical marijuana industry, weight of the solvent used for extraction of the cannabinoids. which requires reproducibility. After careful examination, it In one embodiment, the oil comprises less than about 0.1% by is contemplated that the moisture content of the assayed com weight of the solvent used for extraction of the cannabinoids. position is a critical parameter in the variability of the assayed In one embodiment, the oil comprises less than about 0.01% concentrations. Surprisingly, such variability can be mini by weight of the solvent used for extraction of the cannab mized by rendering the moisture content consistent from inoids. In one embodiment, the oil comprises less than about assay to assay. In one aspect, this invention relates to a method 0.001% by weight of the solvent used for extraction of the of assaying cannabinoid concentration of a cannabis sample cannabinoids. such that the assay provides reproducible results between 0079. In one embodiment, the preparation is an edible. different samples, e.g., batches and/or strains. The edible can be any foodstuff comprising cannabinoids 0083. In one embodiment, the moisture content of a derived from a cannabis plant as described herein. In one sample to be tested (e.g., for cannabinoid content) is adjusted embodiment, the edible is a chocolate, popcorn, butter, cook to a consistent level prior to performing the assay. In one ing oil, cookie, pastry, bread, beer, tea, Soda, mint, candy, embodiment, a sample to be tested is adjusted to 40% mois lollipop, peanut butter, brownie, shake, concentrate, punch, ture or less. In one embodiment, a sample to be tested is cocoa, gummy candy, protein bar, candy bar, etc. adjusted to about 40% moisture. In one embodiment, a sample to be tested is adjusted to about 30% moisture. In one Cannabinoid Composition embodiment, a sample to be tested is adjusted to about 20% 0080. In one aspect, the cannabinoid and/or terpene com moisture. In one embodiment, a sample to be tested is position of a strain of cannabis is consistent between batches. adjusted to about 15% moisture. In one embodiment, a In one embodiment, the cannabinoid and/or terpene compo sample to be tested is adjusted to about 14% moisture. In one sition of a particular strain is consistent between batches embodiment, a sample to be tested is adjusted to about 13% grown and harvested at different times. In one embodiment, moisture. In one embodiment, a sample to be tested is the cannabinoid and/or terpene composition of a particular adjusted to about 12% moisture. In one embodiment, a strain is consistent between batches grown and/or harvested sample to be tested is adjusted to about 11% moisture. In one at different locations (e.g., different cultivation facilities). embodiment, a sample to be tested is adjusted to about 10% The term "consistent means that the concentration of a given moisture. In one embodiment, a sample to be tested is cannabinoid and/or terpene present in a particular strain does adjusted to about 9% moisture. In one embodiment, a sample not vary by more than 20%, preferably 15%, 10%, or 5%. In to be tested is adjusted to about 8% moisture. In one embodi one embodiment, the cannabinoid is a phytocannabinoid. In ment, a sample to be tested is adjusted to about 7% moisture. one embodiment, the cannabinoid is CBD. In one embodi In one embodiment, a sample to be tested is adjusted to about ment, the cannabinoid is THC. In one embodiment, the can 6% moisture. In one embodiment, a sample to be tested is nabinoid is CBN. In one embodiment, the cannabinoid is at adjusted to about 5% moisture. In yet another approach, the least one of cannabigerol (CBG), cannabichromene (CBC), composition is lyophilized prior to assay. Methods for deter cannabidiol (CBD), tetrahydrocannabinol (THC), cannab mining moisture content are well-known in the art. inol (CBN) and cannabinodiol (CBDL), cannabicyclol I0084. The moisture content of a sample to be tested can be (CBL), cannabivarin (CBV), tetrahydrocannabivarin adjusted using any method for adjusting moisture content. In (THCV), cannabidivarin (CBDV), cannabichromevarin one embodiment, the moisture content is adjusted by placing US 2016/0000843 A1 Jan. 7, 2016

the sample in a hydrator or humidity chamber at a desired 0092 Cannabis as described herein can also be used in humidity level for a period of time before it is assayed. In one conjunction with any of the vehicles and excipients com embodiment, the moisture content is adjusted by dehydrating monly employed in pharmaceutical preparations, e.g., talc, the sample to a desired moisture content. The sample can be gum Arabic, lactose, starch, magnesium Stearate, cocoa but dehydrated using any dehydration method. In one embodi ter, aqueous or non-aqueous solvents, oils, paraffin deriva ment, the moisture content is adjusted by lyophilizing the tives, glycols, etc. Coloring and flavoring agents may also be sample. In one embodiment, the moisture content of more added to preparations, particularly to those for oral adminis than one sample is adjusted at the same time. In one embodi tration. can be prepared using water or physiologi ment, the moisture content of the sample is determined before cally compatible organic solvents such as ethanol, 1,2-propy the adjusting step. In one embodiment, the moisture content lene glycol, polyglycols, dimethylsulfoxide, fatty , of the sample is not determined before the adjusting step. triglycerides, partial esters of glycerine and the like. 0085. In one embodiment, the concentration of cannab Parenteral compositions containing may be pre inoids is determined irrespective of the moisture content. For pared using conventional techniques that may include sterile example, the dry weight of the sample can be determined, and isotonic saline, water, 1,3-butanediol, ethanol. 1,2-propylene the cannabinoid content is determined relative to the dry glycol, polyglycols mixed with water, Ringer's , etc. weight. 0093. The compositions utilized herein may be formu 0.086. After the desired moisture content has been lated for aerosol administration, particularly to the respira achieved, the cannabinoid content can be determined using tory tract and including intrapulmonary or intranasal admin any method. Methods include, without limitation, radioim istration. The compound will generally have a small particle munoassay, gas chromatography/mass spectrometry, gas size, for example of the order of 5 microns or less. Such a chromatography, liquid chromatography, liquid chromatog particle size may be obtained by means known in the art, for raphy/mass spectrometry, and immunoassay. example by micronization. The active ingredient may be pro vided in a pressurized pack with a suitable propellant Such as Methods of Treatment a chlorofluorocarbon (CFC), (for example, dichlorodifluo 0087. In one aspect, this invention relates to a method of romethane, trichlorofluoromethane, or dichlorotetrafluoroet treating a cannabidiol-treatable condition and/or symptom hane), carbon dioxide or other suitable gases. The aerosol thereof in a patient in need thereof. In one embodiment, the may conveniently also contain a surfactant such as lecithin. method comprises administering to the patient an effective The dose of drug may be controlled by a metered valve. amount of the cannabis cultivar, cannabis product, or prepa Alternatively, the active ingredients may be provided in the ration as described above, wherein the condition and/or form of a dry powder, for example a powder mix of the symptom is treated. compound in a suitable powder base Such as lactose, starch, 0088. In one embodiment, the condition is a cancer, nau starch derivatives such as hydroxypropylmethylcellulose and sea, chronic pain, spasms, seizures, epilepsy, anxiety, psoria polyvinylpyrrolidine. In some embodiments, the powder car sis, Crohn's disease, rheumatoid arthritis, diabetes, Schizo rier will form a gel in the nasal cavity. The powder composi phrenia, post-traumatic stress disorder, alcoholism, strokes, tion may be presented in unit dose form, for example in Multiple Sclerosis, or cardiovascular disease. In a preferred capsules or cartridges, gelatin or blisterpacks, from which the embodiment, spasms and/or seizures are treated. In another powder may be administered by means of an inhaler. preferred embodiment, anxiety is treated. In one embodi 0094. In one aspect, the compositions utilized herein may ment, a symptom of the condition is treated. beformulated for Sublingual administration, for example as a 0089. In one embodiment, the effective amount of the tincture or Sublingual tablets. Sublingual tablets are designed cannabis cultivar, cannabis product, or preparation acts as a to dissolve very rapidly. The formulations of these tablets muscle relaxant, antibiotic, anti-inflammatory, bone stimu contain, in addition to the drug, a limited number of soluble lant, improves blood circulation, causes drowsiness, and/or excipients, usually lactose and powdered , but some protects the nervous system. times dextrose and mannitol. 0090. In one embodiment, the administration of cannabis 0095. In one aspect, cannabis as described herein may be as described herein attenuates a symptom of a cannabidiol inhaled. In one embodiment, cannabis as described herein treatable condition. In one embodiment, the administration of may be administered in an atomized or nebulized form, for cannabis as described herein prevents a symptom of a canna example by the use of an , vaporizer, atom bidiol-treatable condition. In one embodiment, the adminis izer, or nebulizer. In one embodiment, the cannabis is Smoked tration of cannabis as described herein modulates a symptom (i.e., burned and inhaled). In various embodiments, a drug of a cannabidiol-treatable condition. delivery device converts a liquid comprising medicinal can 0091. The compositions, provided herein or known, suit nabis compounds, for example, an oil extract from cannabis able for administration in accordance with the methods pro strains as described herein, into a vapor or aerosol. In at least vided herein, can be suitable for a variety of delivery modes some embodiments, the inhalable drug delivery devices including, without limitation, transdermal. Sublingual, intra atomize the liquid while causing little or no combustion. pulmonary, or intranasal delivery. Compositions Suitable for Advantageously, inhalable cannabis compounds can be internal, pulmonary, and lingual routes may also be used. absorbed into the bloodstream almost immediately. The peak Other dosage forms include tablets, capsules, pills, powders, effect may be felt, for example, within 30 minutes or less from aerosols, Suppositories, parenterals, and oral liquids, includ the time of inhalation. Such absorption times are a particular ing Suspensions, Solutions and emulsions. Sustained release improvement overingested cannabis delivery where the peak dosage forms may also be used. All dosage forms may be effect may not be felt for six or more hours. prepared using methods that are standard in the art (see e.g., 0096. In one embodiment, described herein is a composi Remington’s Pharmaceutical Sciences, 16th ed., A. Oslo edi tion comprising atomized cannabidiol and/or cannabidiolic tor, Easton Pa. 1980). acid. In one embodiment, the composition comprises one or US 2016/0000843 A1 Jan. 7, 2016

more additional cannabinoids. In one embodiment, the com CBD and/or CBD-A. In one embodiment, a unit dose com position comprises A9-tetrahydrocannabinol and/or tetrahy prises up to about 25 mg CBD and/or CBD-A. In one embodi drocannabinolic acid. In one embodiment, the composition ment, a unit dose comprises up to about 20 mg CBD and/or comprises at least one terpene. In one embodiment, the com CBD-A. In one embodiment, a unit dose comprises up to position comprises one or more additional compounds made about 15 mg CBD and/or CBD-A. In one embodiment, a unit by cannabis. dose comprises up to about 10 mg CBD and/or CBD-A. 0097. In one embodiment, the composition comprises a 0102. In one aspect, a unit dose comprises less than about ratio of cannabidiol and/or cannabidiolic acid (or active 12 mg THC and/or THC-A. In one embodiment, a unit dose CBD) to A9-tetrahydrocannabinol and/or tetrahydrocannab comprises less than about 10 mg THC and/or THC-A. In one inolic acid (or active THC) of about 25:1 to about 300:1. In embodiment, a unit dose comprises less than about 8 mg THC one embodiment, the ratio of active cannabidiol to active and/or THC-A. In one embodiment, a unit dose comprises THC is between about 300:1 and about 30:1. In one embodi less than about 6 mg THC and/or THC-A. In one embodi ment, the ratio of active cannabidiol to active THC is between ment, a unit dose comprises less than about 4 mg. THC and/or about 300:1 and about 50:1. In one embodiment, the ratio of THC-A. In one embodiment, a unit dose comprises less than active cannabidiol to active THC is between about 300:1 and about 2 mg THC and/or THC-A. In one embodiment, a unit about 70:1. In one embodiment, the ratio of active canna dose comprises less than about 1 mg THC and/or THC-A. In bidiol to active THC is between about 300:1 and about 8.0:1. one embodiment, a unit dose comprises less than about 0.8 In one embodiment, the ratio of active cannabidiol to active mg THC and/or THC-A. In one embodiment, a unit dose THC is between about 300:1 and about 100:1. In one embodi comprises less than about 0.6 mg THC and/or THC-A. In one ment, the ratio of active cannabidiol to active THC is between embodiment, a unit dose comprises less than about 0.4 mg about 300:1 and about 200:1. THC and/or THC-A. In one embodiment, a unit dose com 0098. In one aspect, the atomized composition is provided prises less than about 0.2 mg THC and/or THC-A. In one by any device capable of atomizing a cannabinoid-containing embodiment, a unit dose comprises less than about 0.1 mg composition. In one embodiment, the atomized composition THC and/or THC-A. In one embodiment, a unit dose com is provided by a nebulizer. In one embodiment, the atomized prises about 0 mg THC and/or THC-A. composition is provided by an electronic cigarette. In one embodiment, the atomized composition is provided by a EXAMPLES vaporizer. In one embodiment, the atomized composition is provided by an atomizer. In one aspect, the atomized compo (0103) Additional embodiments are disclosed in further sition is administered to a patient. In one aspect, the atomized detail in the following examples, which are not in any way composition is Suitable for pulmonary delivery to a patient. intended to limit the scope of the claims. 0099. In one aspect, cannabis is administered orally, for example incorporated into a food or beverage. In one embodi Example 1 ment, the edible is a chocolate, popcorn, butter, cooking oil, cookie, pastry, bread, beer, tea, Soda, mint, candy, lollipop, Cannabis Cultivar A peanut butter, brownie, shake, concentrate, punch, cocoa, gummy candy, proteinbar, candy bar, etc. 0104. The cannabis cultivar was harvested and dried, and 0100. In one aspect, cannabis is administered as a unit an inflorescence was taken as a sample for analysis. dose form. The term “unit dose” refers to a dose of cannabis 0105. The sample was tested for cannabinoid content. The that is given to the patient to provide therapeutic results, values are shown in Table 1. Total assayable cannabinoid independent of the weight of the patient. In such an instance, concentration was determined to be approximately 22.79%. the unit dose is sold in a standard form (e.g., 20 mg tablet). Moisture content was approximately 9.23%. The unit dose may be administered as a single dose or a series of Subdoses. In some embodiments, the unit dose provides a TABLE 1 standardized level of drug to the patient, independent of ASSayable Cannabinoids Active Cannabinoids weight of patient. In one embodiment, the unit dose is a single (% by weight) (estimated;% by weight) serving of a cannabis-infused food. In one embodiment, the CBD-A 21.77 Max CBD 20.03 unit dose is provided in transdermal form. In one embodi CBD O.94 ment, the unit dose is a tablet, caplet, or pill. In one embodi THC-A O.08 Max THC 0.071 ment, the unit dose is provided in an electronic cigarette THC <0.001 cartridge. In one embodiment, the unit dose is provided by CBN <0.001 programming an electronic cigarette or vaporizer to admin An initial reading provided a max THC value of 0.29%. However, the assay was repeated ister the unit dose within a given period of time, number of and the initial reading was found to be in error. The current reading is believed to be correct, uses, etc. In one embodiment, the unit dose is provided by a metered dose of a flower, an extract, an oil, an edible, a kief, 0106 The sample contained less than 0.001% each of an infusion, a tincture, or a hashish. CBD-V, CBG, THC-V, and CBC. 0101. In one aspect, a unit dose comprises up to about 300 mg CBD and/or CBD-A. In one embodiment, a unit dose 1. A cannabis cultivar that produces an assayable combined comprises up to about 250 mg CBD and/or CBD-A. In one cannabidiolic acid and cannabidiol concentration of at least embodiment, a unit dose comprises up to about 200 mg CBD about 20% by weight. and/or CBD-A. In one embodiment, a unit dose comprises up 2. The cannabis cultivar of claim 1 that produces an assay to about 150 mg CBD and/or CBD-A. In one embodiment, a able combined A9-tetrahydrocannabinol and tetrahydrocan unit dose comprises up to about 100 mg CBD and/or CBD-A. nabinolic acid concentration of less than about 0.1% by In one embodiment, a unit dose comprises up to about 50 mg weight. US 2016/0000843 A1 Jan. 7, 2016

3. The cannabis cultivar of claim 1, wherein the estimated 15. A method of treating a cannabidiol-treatable condition active cannabidiol concentration is at least about 20% by and/or symptom thereof in a patient in need thereof, the weight. method comprising administering to the patient an effective 4. The cannabis cultivar of claim 1, wherein the active amount of a composition comprising the cannabis cultivar of A9-tetrahydrocannabinol concentration is less than about claim 1, wherein the condition and/or symptom is treated. 0.1% by weight. 16. The method of claim 15, wherein the condition is 5. The cannabis cultivar of claim 1, wherein the cannab selected from the group consisting of cancer, nausea, chronic inoid concentration is determined based on a moisture con pain, spasms, seizures, epilepsy, anxiety, psoriasis, Crohn's tent of between about 5% and about 10%. disease, rheumatoid arthritis, diabetes, schizophrenia, post 6. The cannabis cultivar of claim 5, wherein the cannab traumatic stress disorder, alcoholism, strokes, Multiple Scle inoid concentration is determined based on a moisture con rosis, and cardiovascular disease. tent of between about 8% and about 10%. 7. A seed of the cannabis cultivar of claim 1. 17. A unit dose of the cannabis cultivar of claim 1. 8. A clone of the cannabis cultivar of claim 1. 18. The unit dose of claim 17 comprising up to about 300 9. A cannabis product that is a dehydrated portion of the mg of cannabidiol and/or cannabidiolic acid. cannabis cultivar of claim 1. 19. The unit dose of claim 17 comprising less than about 12 10. The cannabis product of claim 9, wherein the dehy mg A9-tetrahydrocannabinol and/or tetrahydrocannabinolic drated portion is one or more of an inflorescence, a flower, a acid. leaf, or a stem. 20. A composition comprising atomized cannabidiol and/ 11. A preparation of the cannabis cultivar of claim 1, or cannabidiolic acid, wherein the ratio of atomized canna wherein the preparation is a flower, an extract, an oil, an bidiol and/or cannabidiolic acid to atomized A9-tetrahydro edible, a kief, an infusion, a tincture, or a hashish. cannabinol and/or tetrahydrocannabinolic acid is between 12. The preparation of claim 11, wherein the preparation is about 300:1 and about 25:1. an oil. 13. The preparation of claim 12, comprisingless than about 21. The composition of claim 20, wherein the atomized 1% by weight of a solvent used for extraction. cannabidiol and/or cannabidiolic acid is provided by an elec 14. The preparation of claim 1 in a container that is imper tronic cigarette, a nebulizer, or a vaporizer. vious to visible light. k k k k k