WO2019011664A1 - A composition comprising a scent for use as a substance dependency rehabilitation composition - Google Patents

A composition comprising a scent for use as a substance dependency rehabilitation composition Download PDF

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Publication number
WO2019011664A1
WO2019011664A1 PCT/EP2018/067486 EP2018067486W WO2019011664A1 WO 2019011664 A1 WO2019011664 A1 WO 2019011664A1 EP 2018067486 W EP2018067486 W EP 2018067486W WO 2019011664 A1 WO2019011664 A1 WO 2019011664A1
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cannabis
terpenes
percent
composition
solvent
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PCT/EP2018/067486
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French (fr)
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Jan Lund LARSEN
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Canna Therapeutic Aps
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Priority to EP18735555.7A priority Critical patent/EP3644975A1/en
Publication of WO2019011664A1 publication Critical patent/WO2019011664A1/en

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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/01Hydrocarbons
    • A61K31/015Hydrocarbons carbocyclic
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/01Hydrocarbons
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/185Magnoliopsida (dicotyledons)

Definitions

  • a composition comprising a scent for use as a substance dependency rehabilitation composition
  • the invention relates to a composition comprising a scent, characterized in that a cannabis smoker when exposed to the scent experience a response that in at least one parameter corresponds to a physiological response experienced in the same cannabis smoker upon smoking of cannabis, or a euphoric effect that in at least one parameter corresponds to an effect experienced in the same cannabis smoker upon smoking of cannabis.
  • Present invention also relates to a method by which recently harvested cannabis plant material is treated in order to recover a fraction of terpenes present in the plant material.
  • Substance dependency rehabilitation is the processes of medical or psychotherapeutic treatment, for dependency on psychoactive substances such as alcohol, prescription drugs, as well as cocaine, Cannabis, heroin, or amphetamines.
  • Cannabis withdrawal syndrome is a criterion of cannabis use disorders (CUDs) (Diagnostic and Statistical Manual of Mental Disorders - Fifth Edition) and cannabis dependence (International Classification of Diseases [ICD]-10).
  • CCDs Cannabis use disorders
  • ICD International Classification of Diseases
  • the intent of substance dependency rehabilitation treatment is to enable the subject in need thereof to confront substance dependence, and cease or reduce the substance dependency in order to avoid the psychological, legal, financial, social, or physical consequences.
  • Current treatment includes medication for depression or other psychiatric disorders, counseling by experts, and sharing of experience with other addicts in small closed groups (group therapy).
  • Some rehabilitation centers include meditation and spiritual wisdom in the treatment process.
  • Certain opioid medications such as methadone and buprenorphine are used to treat addiction and dependence on opioids such as heroin, morphine, or oxycodone.
  • Cannabis sativa has long been used for hemp fibre, for hemp oils, for medicinal purposes, and as a recreational drug.
  • the euphoric effect of Cannabis is obtained through the compound tetrahydrocannabinol (THC).
  • THC tetrahydrocannabinol
  • Cannabis contains more than one hundred different terpenes, with the relative concentrations of the individual terpenes varying greatly among the different strains currently in cultivation.
  • Terpenes are a large and diverse class of organic compounds, produced by a variety of plants.
  • the terpenes often have a strong odour and may protect the plants producing them by deterring herbivores and by attracting predators and parasites of herbivores.
  • Terpenes constitute the major components of resin, and of turpentine produced from resin. When terpenes are modified chemically e.g. by oxidation or rearrangement of the carbon skeleton, the resulting compounds are generally referred to as terpenoids. Terpenoids are also known as isoprenoids. The difference between terpenes and terpenoids is that terpenes are hydrocarbons, whereas terpenoids contain additional functional groups.
  • Terpenes and terpenoids are the primary constituents of the essential oils of many types of plants and flowers and in particular terpenes are an important constituent of cannabis plants, which plants normally contain at least 120 identified compounds. In general, the amount of terpenoids in cannabis plants is about 1 %. In cannabis terpenes are synthesized in secretory cells inside glandular trichomes, and production is increased with light exposure, i.e. the particular content of terpenes in a cannabis plant depend not only on the strain of cannabis, but also on where the cannabis grow and under which conditions it is grown i.e. the amount of sun, temperature etc.
  • terpenoids are - unlike cannabinoids - responsible for the aroma of cannabis.
  • Cannabis and extracts from cannabis are considered to be psychotropic or euphoriant substances.
  • the components causing the psychotropic affect are the cannabinoids, e.g. delta-9-tetrahydrocannabinol (THC) .
  • the main psychotropic cannabinoid, delta-9-tetrahydrocannabinol (THC) has been studied exhaustively.
  • Terpenes are generally recognized non-psychotropic, although the terpenes may act on receptors and neurotransmitters. In Denmark there is a zero-tolerance for driving with THC in the blood, which makes it impossible for persons to be subjected to a medical treatment with substances containing THC and maintain the possibility to legally drive a car.
  • essential oils are extracted from plant material by steam distillation or vaporization.
  • Myrcene (Boiling point 167 °C; water solubility: 5,6 mg/l at 25 °C)
  • Myrcene specifically ⁇ -myrcene, is a monoterpene and the most common terpene produced by cannabis (some varieties contain up to 60% of the essential oil). Its aroma has been described as musky, earthy, herbal - akin to cloves. A high myrcene level in cannabis (usually above 0.5%) is normally found in classic Indica strains. Myrcene is also found in oil of hops, citrus fruits, bay leaves, eucalyptus, wild thyme, lemon grass and many other plants. Myrcene has medicinal properties, including lowering the resistance across the blood to brain barrier, allowing itself and many other chemicals to cross the barrier easier and more quickly.
  • myrcene In the case of cannabinoids (like THC), myrcene allows the effects of the cannabinoid to take effect more quickly. More uniquely still, myrcene has been shown to increase the maximum saturation level of the CB1 receptor, allowing for a greater maximum psychoactive effect.
  • Pinene (opinene: Boiling point 155,9 °C, water solubility: 2,49 mg/l at 25 °C ⁇ -pinene: Boiling point 166,0 °C; water solubility: 4,890 mg/l at 25 °C)
  • Pinene is a bicyclic monoterpenoid. Pinene has distinctive aromas of pine and fir.
  • pinene There are two structural isomers of pinene found in nature: opinene and ⁇ -pinene.
  • pinene is the most widely encountered terpenoid in nature. Pinene is found in many other conifers, as well as in non-coniferous plants. It is found mostly in balsamic resin, pine woods and some citrus fruits. The two isomers of pinene constitute the main component of wood turpentine. It tends to react with other chemicals, forming a variety of other terpenes
  • Limonene (Boiling point 176 °C; water solubility: 13,8 mg/l at 25 °C)
  • Limonene is a monocyclic monoterpenoid and one of two major compounds formed from pinene. As the name suggests, varieties high in limonene have strong citrusy smells like oranges, lemons and limes. Strains high in limonene promote a general uplift in mood and attitude. This citrusy terpene is the major constituent in citrus fruit rinds, rosemary, juniper and peppermint, as well as in several pine needle oils.
  • Limonene is easily absorbed by inhalation and quickly appears in the bloodstream. It assists in the absorption of other terpenes through the skin and other body tissue. It is well documented that limonene suppresses the growth of many species of fungi and bacteria, making it an ideal antifungal agent for ailments such as toenail fungus. Plants use limonene as a natural insecticide to ward off predators. Limonene was primarily used in food and perfumes until a couple of decades ago, when it became better known as the main active ingredient in citrus cleaner. It has very low toxicity and adverse effects are rarely associated with it. Caryophyllene
  • Beta-caryophyllene is a sesquiterpene found in many plants such as Thai basils, cloves, cinnamon leaves and black pepper, and in minor quantities in lavender. Its aroma has been described as peppery, woody and/or spicy. Caryophyllene is the only terpene known to interact with the endocannabinoid system (CB2). Research shows show that ⁇ -caryophyllene selectively binds to the CB2 receptor and that it is a functional CB2 agonist. Further, ⁇ -caryophyllene was identified as a functional non-psychoactive CB2 receptor ligand in foodstuff and as a macrocyclic antiinflammatory cannabinoid in cannabis. Beta-caryophyllene is used in chewing gum when combined with other spicy mixtures or citrus flavourings.
  • Linalool (Boiling point 197 °C; water solubility: 1590 mg/l at 25 °C)
  • Linalool is a non-cyclic monoterpenoid and has been described as having floral and lavender undertones. Varieties high in linalool promote calming, relaxing effects. The Environmental Protection Agency has approved its use as a pesticide, flavour agent and scent. It is used in a wide variety of bath and body products and is commonly listed under ingredients for these products as beta linalool, linalyl alcohol, linaloyl oxide, p-linalool and alloocimenol. Terpinolene (Boiling point 186 °C; water solubility: 9,5 mg/l at 25 °C)
  • Terpinolene is a common component of sage and rosemary and is found in the oil derived from Monterey cypress. Its largest use in the United States is in soaps and perfumes. It is also a great insect repellent. Terpinolene is known to have a piney aroma with slight herbal and floral nuances. It tends to have a sweet flavour reminiscent of citrus fruits like oranges and lemons.
  • Camphene (Boiling point 160 °C; water solubility: 4,6 mg/l at 25 °C)
  • Camphene a plant-derived monoterpene, emits pungent odours of damp woodlands and fir needles. Camphene may play a critical role in cardiovascular disease. Camphene is a minor component of many essential oils such as turpentine, camphor oil, citronella oil and ginger oil and is used as a food additive for flavouring, and in the preparation of fragrances. It is produced industrially by catalytic isomerization of the more common opinene.
  • Terpineol ( ⁇ -Terpineol: Boiling point 220 °C; water solubility: 710 mg/l at 25 °C)
  • a-Terpineol, terpinen-4-ol and 4-terpineol (Boiling point 209 °C) are three closely related monoterpenoids.
  • the aroma of terpineol has been compared to lilacs and flower blossoms. Terpineol is often found in cannabis varieties that have high pinene levels, which unfortunately mask the fragrant aromas of terpineol.
  • Phellandrene (Boiling point 172 °C; water solubility: 2,860 mg/l at 25 °C)
  • Phellandrene is described as pepperminty with a slight scent of citrus. It is one of the main compounds in turmeric leaf oil, which is used to prevent and treat systemic fungal infections. Phellandrene from eucalyptus oil contain two isomeric phellandrene referred to as ophellandrene and ⁇ -phellandrene. Phellandrene can be found in a number of herbs and spices, including cinnamon, garlic, dill, ginger and parsley. A number of plants produce ⁇ -phellandrene as a constituent of their essential oils, including lavender and grand fir. The recognizable odour of some essential oils depends almost entirely upon the presence of phellandrene. Phellandrene, particularly ophellandrene, is absorbed through the skin, making it attractive for use in perfumes. It is also used as flavouring for food products.
  • Delta-3-carene is a bicyclic monoterpene with a sweet, pungent odour. It is found naturally in many essential oils, including cypress oil, juniper berry oil and fir needle essential oils. Humulene
  • Humulene is a sesquiterpene also known as ohumulene and a-caryophyllene; an isomer of ⁇ -caryophyllene. Humulene is found in hops, cannabis sativa strains, and Vietnamese coriander, among other naturally occurring substances. Humulene is what gives beer its distinct 'hoppy' aroma. Humulene has been used for generations in Chinese medicine and aids in weight loss by acting as an appetite suppressant.
  • Pulegone (Boiling point 224 °C)
  • Pulegone a monocyclic monoterpenoid
  • Pulegone is a minor component of cannabis. Higher concentrations of pulegone are found in rosemary. Rosemary breaks down acetylcholine in the brain, allowing nerve cells to communicate more effectively with one another. Pulegone has a pleasant peppermint aroma and is considered to be a strong insecticide. Sabinene
  • Sabinene is a bicyclic monoterpene whose aromas are reminiscent of the holidays (pines, oranges, spices). Sabinene occurs in many plants, including Norway spruce, black pepper and basil. Sabinene exists as (+)- and (-)-enantiomers.
  • Geraniol (Boiling point 230 °C; water solubility: 100 mg/l at 25 °C)
  • Geraniol produces a sweet, beloved smell similar to roses. This makes geraniol a popular choice for many bath and body products. It is also known to be an effective mosquito repellent. Medically, geraniol shows promise in the treatment of neuropathy. Summary of the invention
  • the object of the present invention is to provide new compositions comprising a scent, such as one or more terpenes and/or terpenoids for use as a substance dependency rehabilitation composition in substance dependency rehabilitation treatment of a subject in need thereof.
  • a scent such as one or more terpenes and/or terpenoids
  • the present invention provides new compositions. These new compositions are suitable for substance dependency rehabilitation treatment, which may be through e.g. the use of a simulated euphoric effect of the compositions.
  • a simulated euphoric effect is experienced when a person is experiencing euphoria but without being subjected to the actual euphoric compound (the psychoactive substance).
  • composition may be made having a similar smell and taste as e.g. Cannabis, but without containing THC, a simulated euphoric effect may be obtained when using such a composition.
  • a composition may be applicable in substance dependency rehabilitation treatment.
  • Another object of the present invention is the use of a new composition comprising one or more terpenes and/or terpenoids for the preparation of a medical product, said medical product having substance dependency rehabilitation properties.
  • the present invention provides a composition, and the use of such a composition for preparation of a medical product.
  • the composition of the invention exhibit a similar smell and/or taste as the substance the dependency of which is to be treated, ameliorated or alleviated.
  • the compositions of the invention simulate a euphoric or a physiologic effect similar to the effect experienced by the subject when using the drug or substance, the use of which the subject is dependent of.
  • the compositions of the invention is for use in treating or ameliorating or alleviating substance dependency.
  • the compositions of the invention are for use in reducing the level of use of a substance.
  • a composition comprising a scent
  • a cannabis smoker when exposed to the scent experience one or more of: a) a response in the cannabis smoker that in at least one parameter corresponds to a physiological response experienced in the same cannabis smoker upon smoking of cannabis or b) an euphoric effect that in at least one parameter corresponds to an effect experienced in the same cannabis smoker upon smoking of cannabis.
  • the compositions of the invention comprises a scent similar to the scent of Cannabis. In some embodiments, the compositions of the invention comprises a scent similar to the scent of Cannabis, wherein the scent does not comprise more than 2 % w/w of THC, such as no more than 1 % THC, such as no more than 0,5% THC, such as no more than 0,1 % THC, such as no more than 0,01 % THC.
  • a cannabis smoker experience a simulated euphoric effect when using the compositions of the invention.
  • the compositions of the invention triggers a physiological response similar to the response experienced by a cannabis smoker when smoking Cannabis.
  • compositions of the invention may therefore be applicable in substance dependency rehabilitation treatment of a Cannabis smoker, such as in treating, alleviating or ameliorating substance dependency.
  • the method according to the invention provides a liquid product comprising terpenes having a very low content of cannabinoids.
  • cannabinoids are normally present in amounts defined as trace elements, indicating that the amount of individual cannabinoids is below detection by the method used for detection and normally the total amount of cannabinoids will at least be below 2%.
  • the fraction of extracted terpenes may have a profile different from the total content of terpenes in the cannabis plant. That is, depending on the chosen solvent and the time of extraction it will be possible to vary the terpene-content profile of the final product.
  • the present invention relates to a method for isolating terpenes from cannabis plants.
  • Present invention also relates to a product obtained by the method according to the invention, wherein the product comprises a total content of cannabinoids of below 2%.
  • cent in the context of the present invention, is a composition capable of producing a vapor, characterized by a particular chemical composition which upon inhalation by a subject produces the perception in the subject of smelling a particular substance, such as in non limiting example of having smelled or smoked or used cannabis.
  • "An” or “a” applied before a substantive are in the present specification synonymous with the expression “one or more”.
  • Crobis plant and “hemp plant” when used in the specification and claims of this application both refer to a flowering plant including three species (and seven taxa) or subspecies, sativa, indica, and ruderalis and hybrids.
  • the terms include cannabis plants selected to produce an abundance of fibre having minimal levels of tetrahydrocannabinol a.o. THC or cannabinoids (often referred to as “hemp plants”) and cannabis plants having been selectively bred to produce a maximum of THC.
  • terpenes refer to from units of isoprene, which has the molecular formula C5H8.
  • the basic molecular formulae of terpenes are multiples of that, (C5H8)n where n is the number of linked isoprene units.
  • the isoprene units may be linked together "head to tail” to form linear chains or they may be arranged to form rings. If a terpene contains additional functional groups, it is normally referred to as a “terpenoid”. However, in the context of the present application “terpene” may also refer to units including functional groups e.g. an ether group or an alcohol group.
  • the term “cannabinoids” represents a group of C21 terpenophenolic compounds found in cannabis plants.
  • Terpenes are naturally occurring volatile hydrocarbons, emitted by many trees and plants, as well as some insects. They mostly have very strong smells and are responsible for the aromas of the vegetation in which they are found. Each plant strain has a unique composition of terpenes, which is responsible for e.g., the plants characteristic smell and distinctive flavor.
  • One aspect of the present invention is a composition comprising one or more terpenes and/or terpenoids for use as a substance dependency rehabilitation composition in substance dependency rehabilitation treatment, or for ameliorating or alleviating substance dependency of a subject in need thereof.
  • the present invention discloses that one of the advantages of using such a composition is that the smell and taste of a scent according to the invention, such as of the terpenes and/or terpenoids in the composition may associate the subject in need of rehabilitation with the psychoactive substances used in the current substance dependency.
  • a subject in need of substance dependency rehabilitation treatment is a subject addicted to or dependent on a psychoactive substance. Any substance dependency may progress to a habit that controls the person and his or her decisions. Substance dependency rehabilitation treatment is needed when a person has habits that control him or her. If substance dependency rehabilitation treatment is started as soon as these habits start to occur, an enormous damage may be prevented to the involved person and said persons family and social circle.
  • the substance dependency rehabilitation treatment is Cannabis dependency rehabilitation treatment.
  • the compositions according to the invention provides a scent, such as a scent comprising terpenes and/or terpenoids, such as a scent consisting of terpenes and/or terpenoids, wherein the scent cause an association to the situation of using cannabis.
  • a scent such as a scent comprising terpenes and/or terpenoids, such as a scent consisting of terpenes and/or terpenoids, wherein the scent cause an association to the situation of using cannabis.
  • the present invention provides compositions comprising terpenes and/or terpenoids.
  • the one or more terpenes and/or terpenoids comprised in the compositions may be selected from monoterpenes, monoterpenoids, sesquiterpenes, or sesquiterpenoids.
  • Terpenes and terpenoids consist of isoprene units.
  • Isoprene (2-methyl-1 ,3- butadiene, CsHe) is a common organic compound with the formula shown above. In its pure form it is a colorless volatile liquid. Isoprene is produced by many plants, and its polymers are the main component of terpenes, gibberellins, sterols, carotenoids etc.
  • Terpenes and terpenoids may be acyclic, monocyclic, or polycyclic hydrocarbons with substitution patterns including alcohols, ethers, aldehydes, ketones, and esters.
  • Monoterpenes and monoterpenoids consist of two isoprene units and typically have the molecular formula C10H16.
  • Examples of monoterpenes and monoterpenoids include Geraniol, Terpineol, Limonene, Myrcene, Linalool, or Pinene.
  • Sesquiterpenes and sesquiterpenoids consist of three isoprene units and typically have the molecular formula C15H24.
  • Examples of sesquiterpenes and sesquiterpenoids include Humulene, Farnesenes, Farnesol.
  • terpenes or terpenoids that are normally present in cannabis are comprised in the compositions of the present invention.
  • Myrcene (Boiling point 167 °C; water solubility: 5,6 mg/l at 25 °C)
  • Myrcene specifically ⁇ -myrcene, is a monoterpene and the most common terpene produced by cannabis (some varieties contain up to 60% of the essential oil). Its aroma has been described as musky, earthy, herbal - akin to cloves. A high myrcene level in cannabis (usually above 0.5%) is normally found in classic Indica strains. Myrcene is also found in oil of hops, citrus fruits, bay leaves, eucalyptus, wild thyme, lemon grass and many other plants.
  • Myrcene has medicinal properties, including lowering the resistance across the blood to brain barrier, allowing itself and many other chemicals to cross the barrier easier and more quickly.
  • myrcene allows the effects of the cannabinoid to take effect more quickly. More uniquely still, myrcene has been shown to increase the maximum saturation level of the CB1 receptor, allowing for a greater maximum psychoactive effect.
  • Pinene (opinene: Boiling point 155,9 °C, water solubility: 2,49 mg/l at 25 °C ⁇ -pinene: Boiling point 166,0 °C; water solubility: 4,890 mg/l at 25 °C)
  • Pinene is a bicyclic monoterpenoid. Pinene has distinctive aromas of pine and fir. There are two structural isomers of pinene found in nature: opinene and ⁇ -pinene. Both forms are important components of pine resin, opinene is the most widely encountered terpenoid in nature. Pinene is found in many other conifers, as well as in non-coniferous plants.
  • pinene constitute the main component of wood turpentine. It tends to react with other chemicals, forming a variety of other terpenes (like limonene) and other compounds.
  • Limonene (Boiling point 176 °C; water solubility: 13,8 mg/l at 25 °C)
  • Limonene is a monocyclic monoterpenoid and one of two major compounds formed from pinene. As the name suggests, varieties high in limonene have strong citrusy smells like oranges, lemons and limes. Strains high in limonene promote a general uplift in mood and attitude. This citrusy terpene is the major constituent in citrus fruit rinds, rosemary, juniper and peppermint, as well as in several pine needle oils. Limonene is easily absorbed by inhalation and quickly appears in the bloodstream. It assists in the absorption of other terpenes through the skin and other body tissue.
  • limonene suppresses the growth of many species of fungi and bacteria, making it an ideal antifungal agent for ailments such as toenail fungus. Plants use limonene as a natural insecticide to ward off predators. Limonene was primarily used in food and perfumes until a couple of decades ago, when it became better known as the main active ingredient in citrus cleaner. It has very low toxicity and adverse effects are rarely associated with it.
  • Beta-caryophyllene is a sesquiterpene found in many plants such as Thai basils, cloves, cinnamon leaves and black pepper, and in minor quantities in lavender. Its aroma has been described as peppery, woody and/or spicy. Caryophyllene is the only terpene known to interact with the endocannabinoid system (CB2). Research shows show that ⁇ -caryophyllene selectively binds to the CB2 receptor and that it is a functional CB2 agonist. Further, ⁇ -caryophyllene was identified as a functional non-psychoactive CB2 receptor ligand in foodstuff and as a macrocyclic antiinflammatory cannabinoid in cannabis. Beta-caryophyllene is used in chewing gum when combined with other spicy mixtures or citrus flavourings.
  • Linalool (Boiling point 197 °C; water solubility: 1590 mg/l at 25 °C)
  • Linalool is a non-cyclic monoterpenoid and has been described as having floral and lavender undertones. Varieties high in linalool promote calming, relaxing effects. The Environmental Protection Agency has approved its use as a pesticide, flavour agent and scent. It is used in a wide variety of bath and body products and is commonly listed under ingredients for these products as beta linalool, linalyl alcohol, linaloyl oxide, p-linalool and alloocimenol.
  • Terpinolene is a common component of sage and rosemary and is found in the oil derived from Monterey cypress. Its largest use in the United States is in soaps and perfumes. It is also a great insect repellent. Terpinolene is known to have a piney aroma with slight herbal and floral nuances. It tends to have a sweet flavour reminiscent of citrus fruits like oranges and lemons.
  • Camphene (Boiling point 160 °C; water solubility: 4,6 mg/l at 25 °C)
  • Camphene a plant-derived monoterpene, emits pungent odours of damp woodlands and fir needles. Camphene may play a critical role in cardiovascular disease.
  • Camphene is a minor component of many essential oils such as turpentine, camphor oil, citronella oil and ginger oil and is used as a food additive for flavouring, and in the preparation of fragrances. It is produced industrially by catalytic isomerization of the more common opinene.
  • Terpineol (a-Terpineol: Boiling point 220 °C; water solubility: 710 mg/l at 25 °C) oTerpineol, terpinen-4-ol and 4-terpineol (Boiling point 209 °C) are three closely related monoterpenoids.
  • the aroma of terpineol has been compared to lilacs and flower blossoms. Terpineol is often found in cannabis varieties that have high pinene levels, which unfortunately mask the fragrant aromas of terpineol.
  • Phellandrene (Boiling point 172 °C; water solubility: 2,860 mg/l at 25 °C)
  • Phellandrene is described as pepperminty with a slight scent of citrus. It is one of the main compounds in turmeric leaf oil, which is used to prevent and treat systemic fungal infections. Phellandrene from eucalyptus oil contain two isomeric
  • Phellandrene can be found in a number of herbs and spices, including cinnamon, garlic, dill, ginger and parsley. A number of plants produce ⁇ -phellandrene as a constituent of their essential oils, including lavender and grand fir. The recognizable odour of some essential oils depends almost entirely upon the presence of phellandrene.
  • Phellandrene particularly ophellandrene, is absorbed through the skin, making it attractive for use in perfumes. It is also used as flavouring for food products.
  • Delta-3-carene is a bicyclic monoterpene with a sweet, pungent odour. It is found naturally in many essential oils, including cypress oil, juniper berry oil and fir needle essential oils. Humulene
  • Humulene is a sesquiterpene also known as a-humulene and a-caryophyllene; an isomer of ⁇ -caryophyllene. Humulene is found in hops, cannabis sativa strains, and Vietnamese coriander, among other naturally occurring substances. Humulene is what gives beer its distinct 'hoppy' aroma. Humulene has been used for generations in Chinese medicine and aids in weight loss by acting as an appetite suppressant.
  • Pulegone (Boiling point 224 °C)
  • Pulegone a monocyclic monoterpenoid
  • Pulegone is a minor component of cannabis. Higher concentrations of pulegone are found in rosemary. Rosemary breaks down acetylcholine in the brain, allowing nerve cells to communicate more effectively with one another. Pulegone has a pleasant peppermint aroma and is considered to be a strong insecticide.
  • Sabinene is a bicyclic monoterpene whose aromas are reminiscent of the holidays (pines, oranges, spices). Sabinene occurs in many plants, including Norway spruce, black pepper and basil. Sabinene exists as (+)- and (-)-enantiomers.
  • Geraniol (Boiling point 230 °C; water solubility: 100 mg/l at 25 °C)
  • Geraniol produces a sweet, beloved smell similar to roses. This makes geraniol a popular choice for many bath and body products. It is also known to be an effective mosquito repellent. Medically, geraniol shows promise in the treatment of neuropathy.
  • Figure 1 illustrates an overview of the steps performed according to a method of the invention.
  • the compositions of the invention have a simulated euphoric effect on a subject exposed to the composition.
  • a simulated euphoric effect may be experienced from the subject in need of rehabilitation as the euphoric state known from the psychoactive substance but without being subjected to the actual psychoactive substance.
  • the composition has a simulated euphoric effect on a subject in need of substance dependency rehabilitation treatment.
  • the compositions of the present invention are for use in simulating a euphoric effect on a subject in need of treatment or alleviation or amelioration of substance dependency.
  • the compositions of the present invention are for use in simulating in a subject the use of a substance to which the subject is dependent, and thereby induce at least one physiologic effect that is normally experienced by the subject upon use of the substance, said simulation is for use in a method of treatment or alleviation or amelioration of substance dependency.
  • compositions simulate the euphoric or physiological effects of smoking cannabis, and are for use in treatment or alleviation or amelioration of cannabis dependency or for treatment or alleviation or amelioration of other substance dependency, such as in non-limiting example dependency of alcohol, nicotine, caffeine, cocaine or morfine derived substances.
  • the composition has a simulated euphoric effect on a subject in need of Cannabis dependency rehabilitation treatment.
  • compositions of the invention comprises one or more terpenes and/or terpenoids selected from terpenes and/or terpenoids naturally comprised in Cannabis.
  • the one or more terpenes and/or terpenoids are extracted from plant material.
  • the plant material is plant material obtained from Cannabis.
  • the extract from plant material is a whole extract.
  • whole extract as used in the present application, is meant a substance made by extracting all or most of the terpenes and/or terpenoids from a raw material e.g., leaves, seeds, or buds in a plant.
  • the whole extract will in some embodiments be made by extraction using a solvent.
  • the whole extract is not subsequently (after the solvent extraction step) to selectively remove specific terpenes or terpenoids from the extract.
  • the whole extract may be obtained using a solvent such as e.g., ethanol, octanol, polyethylene glycol or coconut oil.
  • the Cannabis is selected from the species Cannabis sativa, Cannabis indica, or Cannabis ruderalis.
  • the monoterpenes and/or monoterpenoids of the compositions of the invention are selected from one or more of Myrcene, Pinene, Limonene, Caryophyllene, Linalool, Terpinolene, Camphene, alpha-Terpineol, beta- Phellandrene, delta-3-carene, Humulene, Pulegone, cis-Sabinene hydrate, Geraniol, Ocimene, beta-Fenchol, Fenchone, Borneol, alpha-Thujene, or Ipsdienol.
  • the monoterpenes and/or monoterpenoids are selected from one or more of Myrcene, Pinene, Limonene, Caryophyllene, Linalool, Terpinolene, Camphene, Terpineol such as alpha-Terpineol, Phelandrene such as beta-Phellandrene, careen such as delta-3-carene, Humulene, Pulegone, Sabinene such as cis-Sabinene hydrate, or Geraniol.
  • the Ocimene is selected from one or more of irans-Ocimene or c/s-Ocimene.
  • the Pinene when present in the compositions of the invention, is selected from one or more of alpha-Pinene or beta-Pinene.
  • the monoterpenes and/or monoterpenoids are selected from one or more of Myrcene, alpha-Pinene, beta-Pinene, Limonene, Linalool, Terpinolene, Camphene, alpha-Terpineol, beta-Phellandrene, delta-3- carene, Pulegone, cis-Sabinene hydrate, or Geraniol.
  • the sesquiterpenes and/or sesquiterpenoids are selected from one or more of Caryophyllene, Farnesene, alpha-Humulene, Guajol, alpha-Guaiene, Eudesmol, Selinene, Bergamotene, gamma-Curcumene, epi-alpha- Bisabolol, alpha-Y GmbHe, beta-Elemene, gamma-Muurolene, alpha-Cadinene, alpha-Longipinene, or Bisabolene.
  • the Caryophyllene is selected from one or more of alpha-Caryophyllene, beta-Caryophyllene, or Caryophyllene oxide.
  • the Farnesene is selected from one or more of trans- alpha-Farnesene or c/s-beta-Farnesene.
  • the Eudesmol is selected from one or more of alpha- Eudesmol, beta-Eudesmol, or gamma-Eudesmol.
  • the Selinene is selected from one or more of alpha- Selinene or beta-Selinene.
  • the Bergamotene is selected from one or more of alpha-irans-Bergamotene or alpha-c/s-Bergamotene.
  • the Bisabolene is selected from one or more of c/ ' s- gamma-Bisabolene or irans-gamma-Bisabolene.
  • the sesquiterpenes and/or sesquiterpenoids are selected from one or more of alpha-Caryophyllene, beta-Caryophyllene, Caryophyllene oxide, alpha-Humulene.
  • the concentration of the one or more terpenes and/or terpenoids in the composition is in the range of from 0.01 % to 100 %.
  • a cannabinoid component is present in a percentage of less than 2 percent w/w.
  • a cannabinoid is a chemical compound that acts on cannabinoid receptors in cells that alter neurotransmitter release in the brain.
  • a class of cannabinoids is phytocannabinoids, which is found in cannabis. The most notable phytocannabinoids are tetrahydrocannabinol (THC) and Cannabidiol (CBD). There are over one hundred different cannabinoids in cannabis.
  • THC tetrahydrocannabinol
  • Tetrahydrocannabinol is the principal psychoactive cannabinoid of Cannabis.
  • THC is a clear, amber, or gold colored glassy solid when cold, which becomes viscous and sticky if warmed.
  • THC has a very low solubility in water, but good solubility in most organic solvents, specifically lipids and alcohols (Garrett ER et al., J. Pharm. Sci., 63 (7), 1056-64).
  • a cannabinoid component is present in a percentage of less than 5 percent w/w, such as less than 4 percent w/w, such as less than 3 percent w/w, such as less than 2 percent w/w, such as less than 1 percent w/w, such as less than 0.5 percent w/w, such as less than 0.1 percent w/w, such as less than 0.01 percent w/w.
  • a cannabinoid component is present in a percentage between 0 to 5 percent w/w, such as between 0 and 4 percent w/w, such as between 0 and 3 percent w/w, such as between 0 and 2 percent w/w, such as between 0 and 1 percent w/w, such as between 0 and 0.5 percent w/w.
  • a cannabinoid component is present in a percentage between 0 to 5 percent w/w, such as between 1 and 5 percent w/w, such as between 2 and 5 percent w/w, such as between 3 and 5 percent w/w, such as between 4 and 5 percent w/w.
  • a cannabinoid component is present in a percentage between 0 to 5 percent w/w, such as between 1 and 5 percent w/w, such as between 1 and 4 percent w/w, such as between 1 and 3 percent w/w, such as between 1 and 2 percent w/w, such as between 2 and 5 percent w/w, such as between 2 and 4 percent w/w, such as between 2 and 3 percent w/w, such as between 3 and 5 percent w/w, such as between 3 and 4 percent w/w, such as between 4 and 5 percent w/w.
  • a tetrahydrocannabinol (THC) component is present in a percentage of less than 0.1 percent w/w, such as less than 0.01 percent w/w.
  • a tetrahydrocannabinol (THC) component is present in a percentage of less than 0.75 percent w/w, such as less than 0.5 percent w/w, such as less than 0.25 percent w/w, such as less than 0.1 percent w/w.
  • a tetrahydrocannabinol (THC) component is present in a percentage of less than 5 percent w/w, such as less than 4 percent w/w, such as less than 3.5 percent w/w, such as less than 3 percent w/w, such as less than 2.5 percent w/w, such as less than 2 percent w/w, such as less than 1 .5 percent w/w, such as less than 1 percent w/w, such as less than 0.75 percent w/w, such as less than 0.5 percent w/w, such as less than 0.25 percent w/w or such as less than 0.1 percent w/w.
  • THC tetrahydrocannabinol
  • CBD cannabidiol
  • a cannabidiol (CBD) component is present in a percentage of less than 5 percent w/w, such as less than 4 percent w/w, such as less than 3.5 percent w/w, such as less than 3 percent w/w, such as less than 2.5 percent w/w, such as less than 2 percent w/w, such as less than 1 .5 percent w/w, such as less than 1 percent w/w, such as less than 0.75 percent w/w, such as less than 0.5 percent w/w, such as less than 0.25 percent w/w or such as less than 0.1 percent w/w.
  • the composition may be in a liquid form.
  • the composition may be in the form of a solution within an appropriate solvent.
  • Appropriate solvents are solvents that solubilize terpenes while not being harmful for the human body.
  • Non-limiting examples of such solvents may be, ethanol, octanol, polyethylene glycol, or coconut oil.
  • the one or more terpenes and/or terpenoids are dissolved in one or more of ethanol, octanol, polyethylene glycol, water or coconut oil with a dilution of between 5 percent and 99.99 percent w/w, such as between 10 and 99.99 percent w/w, such as between 20 and 99.99 percent w/w.
  • the composition is encapsulated in a shell/chamber.
  • the shell/chamber is in a delivery device, such as in an inhaler device.
  • the composition is adsorbed in an adsorbent such as in non limiting example anyone of cotton, tobacco, paper, dextrans, silica, diatomaceous earth, and porous synthetic polymers such as Tenax (Trademark) which is a porous polymer resin (2,6-diphenyl-p-phenylene oxide), and the like.
  • the composition is adsorbed in an adsorbent which is present in an inhaler device.
  • a shell is a structural element characterized by its three-dimensional geometry and a very small thickness when compared with other dimensions of said geometry. If the shell is closed all the way around, it creates a chamber inside the shell.
  • a chamber is a room/space/housing, which may contain a material/composition. Hereby, said material/composition is enclosed in said chamber and surrounded by said shell.
  • the composition is encapsulated in a shell or enclosed within a chamber.
  • the shell/chamber is made of glass, plastic, or water- soluble materials.
  • the shell/chamber may be in the form of small beads containing the composition.
  • the shell/chamber may be made of, but not limited to, glass, plastic, metal, or water-soluble materials. Retaining the composition of the invention in a shell/chamber may in some embodiments be used to keep the composition intact until use, such as keep the composition intact in a delivery device until use.
  • the composition is released by breaking the shell/chamber surrounding said composition. The breaking of said shell may be through e.g., mechanical means or chemical means.
  • compositions of the invention is formulated in a lozenge form for slow delivery in the oral cavity.
  • Methods for making lozenges are well known in the art.
  • the composition is used for treating or ameliorating substance dependency in a subject in need thereof.
  • the substance dependency is Cannabis dependency. In one or more embodiments, the substance dependency is Cannabis dependency mixed with other substance dependency. In one or more embodiments, the other substance dependency is opioid dependency.
  • the composition is comprised in an inhaler.
  • An inhaler is a device containing a composition, which is applied by suction through said device, whereby the composition (e.g., in the form of vaporized liquid) will distribute throughout the oral cavity and into the lungs.
  • the inhaler may comprise means for vaporizing, nebulizing, atomizing, spraying, inhaling, or steaming.
  • the inhaler may be a smoking device e.g., a cigarette.
  • an inhaler device is a device containing a composition, which is applied by suction through the inhaler, whereby the composition (e.g., in the form of vaporized liquid) will distribute throughout the oral cavity and into the lungs.
  • the inhaler may comprise means for vaporizing, nebulizing, atomizing, spraying, inhaling, or steaming.
  • the inhaler may be a smoking device e.g., a cigarette.
  • the inhaler device may in some embodiments be an electronic cigarette, where the composition of the invention is delivered in similar fashion as the nicotine compositions that are normally delivered by electronic cigarettes.
  • the inhaler device does not require means for heating, and in another embodiment, the inhaler/composition does not comprise a propellant.
  • compositions comprising one or more terpenes and/or terpenoids for the preparation of a medical product, said medical product having substance dependency rehabilitation properties.
  • the medical product is an inhaler device comprising the compositions of the invention.
  • An inhaler device is a device containing a composition, which is applied by suction through said device, whereby the composition (e.g., in the form of vaporized liquid) will distribute throughout the oral cavity and into the lungs.
  • the inhaler may comprise means for vaporizing, nebulizing, atomizing, spraying, inhaling, or steaming.
  • the inhaler may be a smoking device e.g., a cigarette.
  • the compositions of the invention may be used in the preparation of a medical product which will provide the user with the smell and taste of the terpenes and/or terpenoids in the composition. The smell and taste will associate the user with having used in example cannabis.
  • Such a simulated use will induce one or more of a euphoric effect or a physiological effect normally experienced by that user when using cannabis.
  • Such similated use of in example cannabis may be used in treatment, amelioration or alleviation of substance dependency in the subject and hereby help rehabilitating the subject.
  • the substance dependency rehabilitation properties is Cannabis dependency rehabilitation properties.
  • the medical product will have the smell and taste of the terpenes and/or terpenoids in the composition. This smell and taste will associate the user with Cannabis use without actually using cannabis, and hereby help in rehabilitating the user against Cannabis dependency.
  • the one or more terpenes and/or terpenoids are selected from monoterpenes, monoterpenoids, sesquiterpenes, or sesquiterpenoids.
  • the composition has a simulated euphoric effect. In another embodiment, the composition has a simulated euphoric effect on a subject in need of substance dependency rehabilitation treatment. In yet another embodiment, the composition has a simulated euphoric effect on a subject in need of Cannabis dependency rehabilitation treatment. In some embodiments, the simulated euphoric effect is in a subject that is a cannabis user. In some embodiments, the exposure of a subject to the composition induce at least a euphoric effect or a physiological effect also seen in the same subject when using cannabis.
  • the one or more terpenes and/or terpenoids are naturally comprised in Cannabis sativa.
  • the one or more terpenes and/or terpenoids are extracted from plant material.
  • the plant material is plant material obtained from Cannabis.
  • the extract from plant material is a whole extract.
  • the monoterpenes and/or monoterpenoids are selected from one or more of Myrcene, Limonene, Linalool, Ocimene, Pinene, delta- 3-carene, beta-Fenchol, beta-Phellandrene, Terpinolene, alpha-Terpineol, Fenchone, Camphene, cis-Sabinene hydrate , Borneol, alpha-Thujene, Pulegone, Geraniol, or Ipsdienol.
  • the Pinene is selected from one or more of alpha-Pinene or beta-Pinene.
  • the monoterpenes and/or monoterpenoids are selected from one or more of Myrcene, alpha-Pinene, beta-Pinene, Limonene, Linalool, Terpinolene, Camphene, alpha-Terpineol, beta-Phellandrene, delta-3- carene, Pulegone, cis-Sabinene hydrate, or Geraniol.
  • the sesquiterpenes and/or sesquiterpenoids are selected from one or more of Caryophyllene, Farnesene, alpha-Humulene, Guajol, alpha-Guaiene, Eudesmol, Selinene, Bergamotene, gamma-Curcumene, epi-alpha- Bisabolol, alpha-Y GmbHe, beta-Elemene, gamma-Muurolene, alpha-Cadinene, alpha-Longipinene, or Bisabolene.
  • the Caryophyllene is selected from one or more of alpha-Caryophyllene, beta-Caryophyllene, or Caryophyllene oxide.
  • the Farnesene is selected from one or more of trans- alpha-Farnesene or c/s-beta-Farnesene.
  • the Eudesmol is selected from one or more of alpha- Eudesmol, beta-Eudesmol, or gamma-Eudesmol.
  • the Selinene is selected from one or more of alpha- Selinene or beta-Selinene.
  • the Bergamotene is selected from one or more of alpha-irans-Bergamotene or alpha-c/s-Bergamotene.
  • the Bisabolene is selected from one or more of c/ ' s- gamma-Bisabolene or irans-gamma-Bisabolene.
  • the sesquiterpenes and/or sesquiterpenoids are selected from one or more of alpha-Caryophyllene, beta-Caryophyllene, Caryophyllene oxide, alpha-Humulene.
  • the concentration of the one or more terpenes and/or terpenoids in the composition is in the range of from 0.001 % to 100%.
  • a cannabinoid component is present in a percentage of less than 2 percent w/w, such as less than 5%, such as less than 10%, such as less than 20%, such as less than 30%, such as less than 50 %, such as less than 60%, such as less than 75% w/w, such as less than 85%, such as less than 95% w/w.
  • An advantage of avoiding a composition containing cannabinoids may be to avoid all the negative effects these compounds exhibit when interacting with receptors in cells and hereby altering the neurotransmitter release in the brain.
  • a cannabinoid component is present in a percentage of less than 5 percent w/w, such as less than 4 percent w/w, such as less than 3 percent w/w, such as less than 2 percent w/w, such as less than 1 percent w/w, such as less than 0.5 percent w/w.
  • a cannabinoid component is present in a percentage between 0 to 5 percent w/w, such as between 0 and 4 percent w/w, such as between 0 and 3 percent w/w, such as between 0 and 2 percent w/w, such as between 0 and 1 percent w/w, such as between 0 and 0.5 percent w/w.
  • a cannabinoid component is present in a percentage between 0 to 5 percent w/w, such as between 1 and 5 percent w/w, such as between 2 and 5 percent w/w, such as between 3 and 5 percent w/w, such as between 4 and 5 percent w/w.
  • a cannabinoid component is present in a percentage between 0 to 5 percent w/w, such as between 1 and 5 percent w/w, such as between 1 and 4 percent w/w, such as between 1 and 3 percent w/w, such as between 1 and 2 percent w/w, such as between 2 and 5 percent w/w, such as between 2 and 4 percent w/w, such as between 2 and 3 percent w/w, such as between 3 and 5 percent w/w, such as between 3 and 4 percent w/w, such as between 4 and 5 percent w/w.
  • a tetrahydrocannabinol (THC) component from the plant extract is present in a percentage of less than 0.1 percent w/w.
  • THC tetrahydrocannabinol
  • a tetrahydrocannabinol (THC) component is present in a percentage of less than 5 percent w/w, such as less than 4 percent w/w, such as less than 3.5 percent w/w, such as less than 3 percent w/w, such as less than 2.5 percent w/w, such as less than 2 percent w/w, such as less than 1 .5 percent w/w, such as less than 1 percent w/w, such as less than 0.75 percent w/w, such as less than 0.5 percent w/w, such as less than 0.25 percent w/w or such as less than 0.1 percent w/w.
  • THC tetrahydrocannabinol
  • a cannabidiol (CBD) component from the plant extract is present in a percentage of less than 0.5 percent w/w. In one or more embodiments, a cannabidiol (CBD) component is present in a percentage of less than 5 percent w/w, such as less than 4 percent w/w, such as less than 3.5 percent w/w, such as less than 3 percent w/w, such as less than 2.5 percent w/w, such as less than 2 percent w/w, such as less than 1 .5 percent w/w, such as less than 1 percent w/w, such as less than 0.75 percent w/w, such as less than 0.5 percent w/w, such as less than 0.25 percent w/w or such as less than 0.1 percent w/w.
  • the composition may be in a liquid form.
  • the composition may be in the form of a solution within an appropriate solvent.
  • Appropriate solvents are solvents that solubilize terpenes while not being harmful for the human body. Examples of such solvents may be, but are not limited to, water, Octanol, polyethylene glycol, and coconut oil..
  • the one or more terpenes and/or terpenoids are dissolved in a solvent such as in non-limiting example Octanol, polyethylene glycol, and coconut oilwith a dilution of between 5 percent and 99.99 percent w/w, such as between 10 and 99.99 percent w/w, such as between 20 and 99.99 percent w/w.
  • a solvent such as in non-limiting example Octanol, polyethylene glycol, and coconut oilwith a dilution of between 5 percent and 99.99 percent w/w, such as between 10 and 99.99 percent w/w, such as between 20 and 99.99 percent w/w.
  • the medical product is for use in combination with different ways of known therapy, such as detoxification, behavioural counseling, group therapy, psychiatric therapy, or medication with e.g., opioids or tobacco.
  • the intent of substance dependency rehabilitation treatment is to enable the subject in need thereof to confront substance dependence, and cease the substance dependency in order to avoid negative consequences.
  • This combination therapy may give the subject in need of rehabilitation the advantages of the currently known treatments, while also benefiting with the advantages of the medical product comprising one or more terpenes and/or terpenoids in that the smell and taste of said medical product may be associated with the psychoactive substances used in the current substance dependency.
  • compositions comprising a scent, characterized in that a cannabis smoker when exposed to the scent experience one or more of: a) a response in the cannabis smoker that in at least one parameter corresponds to a physiological response experienced in the same cannabis smoker upon smoking of cannabis or b) an euphoric effect that in at least one parameter corresponds to an effect experienced in the same cannabis smoker upon smoking of cannabis.
  • One of the advantages of using such a composition is that the smell and/or taste of such a composition may associate the subject in need of rehabilitation with the psychoactive substances used in the current substance dependency.
  • the composition comprising a scent according to the invention comprises one or more terpenes and/or terpenoids.
  • the one or more terpenes and/or terpenoids are selected from monoterpenes, monoterpenoids, sesquiterpenes, or sesquiterpenoids.
  • the one or more terpenes and/or terpenoids are terpenes and/or terpenoids naturally found in Cannabis.
  • the one or more terpenes and/or terpenoids are extracted from plant material.
  • the plant material is obtained from Cannabis.
  • the Cannabis is selected from the species Cannabis sativa, Cannabis indica, or Cannabis ruderalis.
  • the extract from plant material is a whole extract.
  • whole extract is meant a substance made by extracting all or most of the terpenes and/or terpenoids from a raw material e.g., leaves, seeds, or buds in a plant.
  • the whole extract may be obtained using a solvent such as e.g., ethanol.
  • the extract is made from the leaf carrying parts of the plant.
  • the leaf carrying parts is the part of the plant located above the soil.
  • the extract is a cannabis extract made by alcohol extraction, such as by ethanol extraction.
  • the monoterpenes and/or monoterpenoids are selected from one or more of Myrcene, Pinene, Limonene, Caryophyllene, Linalool, Terpinolene, Camphene, Terpineol such as alpha-Terpineol, Phelandrene such as beta-Phellandrene, careen such as delta-3-carene, Humulene, Pulegone, Sabinene such as cis-Sabinene hydrate, or Geraniol.
  • the composition comprises one or more of Myrcene or Limonene.
  • the sesquiterpenes and/or sesquiterpenoids are selected from one or more of Caryophyllene, Farnesene, alpha-Humulene, Guajol, alpha-Guaiene, Eudesmol, Selinene, Bergamotene, gamma-Curcumene, epi-alpha- Bisabolol, alpha-Y GmbHe, beta-Elemene, gamma-Muurolene, alpha-Cadinene, alpha-Longipinene, or Bisabolene.
  • the monoterpenes and/or monoterpenoids are selected from one or more of Myrcene, Limonene, Linalool, Ocimene, Pinene, delta- 3-carene, beta-Fenchol, beta-Phellandrene, Terpinolene, alpha-Terpineol, Fenchone, Camphene, cis-Sabinene hydrate, Borneol, alpha-Thujene, Pulegone, Geraniol, or Ipsdienol.
  • the Ocimene is selected from one or more of trans- Ocimene or c/s-Ocimene.
  • the Pinene is selected from one or more of alpha- Pinene or beta-Pinene.
  • the monoterpenes and/or monoterpenoids are selected from one or more of Myrcene, alpha-Pinene, beta-Pinene, Limonene, Linalool, Terpinolene, Camphene, alpha-Terpineol, beta-Phellandrene, delta-3- carene, Pulegone, cis-Sabinene hydrate, or Geraniol.
  • the sesquiterpenes and/or sesquiterpenoids are selected from one or more of Caryophyllene, Farnesene, alpha-Humulene, Guajol, alpha-Guaiene, Eudesmol, Selinene, Bergamotene, gamma-Curcumene, epi-alpha- Bisabolol, alpha-Y GmbHe, beta-Elemene, gamma-Muurolene, alpha-Cadinene, alpha-Longipinene, or Bisabolene.
  • the Caryophyllene is selected from one or more of alpha-Caryophyllene, beta-Caryophyllene, or Caryophyllene oxide.
  • the Farnesene is selected from one or more of trans- alpha-Farnesene or c/s-beta-Farnesene.
  • the Eudesmol is selected from one or more of alpha- Eudesmol, beta-Eudesmol, or gamma-Eudesmol.
  • the Selinene is selected from one or more of alpha- Selinene or beta-Selinene.
  • the Bergamotene is selected from one or more of alpha-irans-Bergamotene or alpha-c/s-Bergamotene.
  • the Bisabolene is selected from one or more of c/ ' s- gamma-Bisabolene or irans-gamma-Bisabolene.
  • the sesquiterpenes and/or sesquiterpenoids are selected from one or more of alpha-Caryophyllene, beta-Caryophyllene, Caryophyllene oxide, alpha-Humulene.
  • the composition comprises caryophyllene.
  • the concentration of the one or more terpenes and/or terpenoids in the composition is in the range of 0.1 % - 100%.
  • a cannabinoid component is present in a percentage of less than 2 percent w/w.
  • An advantage of avoiding a composition containing cannabinoids may be to avoid all the negative effects these compounds exhibit when interacting with receptors in cells and hereby altering the neurotransmitter release in the brain.
  • a cannabinoid component is present in a percentage of less than 5 percent w/w, such as less than 4 percent w/w, such as less than 3 percent w/w, such as less than 2 percent w/w, such as less than 1 percent w/w, such as less than 0.5 percent w/w.
  • a cannabinoid component is present in a percentage between 0 to 5 percent w/w, such as between 0 and 4 percent w/w, such as between 0 and 3 percent w/w, such as between 0 and 2 percent w/w, such as between 0 and 1 percent w/w, such as between 0 and 0.5 percent w/w.
  • a cannabinoid component is present in a percentage between 0 to 5 percent w/w, such as between 1 and 5 percent w/w, such as between 2 and 5 percent w/w, such as between 3 and 5 percent w/w, such as between 4 and 5 percent w/w.
  • a cannabinoid component is present in a percentage between 0 to 5 percent w/w, such as between 1 and 5 percent w/w, such as between 1 and 4 percent w/w, such as between 1 and 3 percent w/w, such as between 1 and 2 percent w/w, such as between 2 and 5 percent w/w, such as between 2 and 4 percent w/w, such as between 2 and 3 percent w/w, such as between 3 and 5 percent w/w, such as between 3 and 4 percent w/w, such as between 4 and 5 percent w/w.
  • a tetrahydrocannabinol (THC) component is present in a percentage of less than 0.1 percent w/w, such as less than 0.001 % w/w.
  • THC tetrahydrocannabinol
  • a tetrahydrocannabinol (THC) component is present in a percentage of less than 5 percent w/w, such as less than 4 percent w/w, such as less than 3.5 percent w/w, such as less than 3 percent w/w, such as less than 2.5 percent w/w, such as less than 2 percent w/w, such as less than 1 .5 percent w/w, such as less than 1 percent w/w, such as less than 0.75 percent w/w, such as less than 0.5 percent w/w, such as less than 0.25 percent w/w or such as less than 0.1 percent w/w.
  • THC tetrahydrocannabinol
  • CBD cannabidiol
  • a cannabidiol (CBD) component is present in a percentage of less than 5 percent w/w, such as less than 4 percent w/w, such as less than 3.5 percent w/w, such as less than 3 percent w/w, such as less than 2.5 percent w/w, such as less than 2 percent w/w, such as less than 1 .5 percent w/w, such as less than 1 percent w/w, such as less than 0.75 percent w/w, such as less than 0.5 percent w/w, such as less than 0.25 percent w/w or such as less than 0.1 percent w/w.
  • CBD cannabidiol
  • the invention provides an inhaler device comprising the compositions of the invention.
  • One of the advantages of using an inhaler device is that the subject in need of rehabilitation will have a similar experience, as if the subject was smoking the substance.
  • the composition or inhaler device is for use as a medicament. In one or more embodiments, the composition or the inhaler device is for use in treating, alleviating or ameliorating substance dependency in a subject in need thereof. In one or more embodiments, the composition or the inhaler device is for use as a substance dependency rehabilitation composition in substance dependency rehabilitation treatment of a subject in need thereof.
  • the substance dependency is Cannabis dependency. In one or more embodiments, the substance dependency is Cannabis dependency mixed with other substance dependency. In one or more embodiments, the other substance dependency is opioid dependency. In some embodiments, the other substance is one or more of nicotine, caffeine, cocaine, alcohol or opiates.
  • compositions of the invention will provide an entourage effect that will enhance or balance the effects of the use of other substances, allowing the user to reduce the amount of other substance used.
  • other substances may in non-limiting example be selected from the list of: alcohol, cannabis, opiates or opiate related drugs, cocaine, nicotine.
  • compositions comprising a scent, characterized in that a cannabis smoker when exposed to the scent experience one or more of: a) a response in the cannabis smoker that in at least one parameter corresponds to a physiological response experienced in the same cannabis smoker upon smoking of cannabis or b) an euphoric effect that in at least one parameter corresponds to an effect experienced in the same cannabis smoker upon smoking of cannabis as disclosed herein, for the preparation of a medical product, said medical product having substance dependency rehabilitation properties.
  • the medical product is an inhaler device comprising the compositions of the invention.
  • An inhaler device is a device containing a composition, which is applied by suction through said device, whereby the composition (e.g., in the form of vaporized liquid) will distribute throughout the oral cavity and into the lungs.
  • the inhaler may comprise means for vaporizing, nebulizing, atomizing, spraying, inhaling, or steaming.
  • the inhaler may be a smoking device e.g., a cigarette.
  • the terpenes and/or terpenoids may be extracted using the following method:
  • the top of the cannabis plants such as the top 30 cm, such as the top 40 cm, such as the top 50 cm, are harvested to obtain a plant extract or a whole extract containing terpenes from the surface of the leaves and flowers.
  • the cannabis material is contacted with an amount of alcohol (e.g., a liquid containing at least 99% ethanol and no more than 1 % water or a liquid containing at least 96% ethanol and no more than 4% water).
  • the plant material is immersed into the alcohol and moved around in the alcohol.
  • the alcohol is separated from the plant material by filtering.
  • the alcohol including extract is collected in a container.
  • the alcohol Before pouring the alcohol over the plant material, the alcohol is cooled to a temperature between minus 20 and minus 10 °C, and during the contacting step the temperature of the alcohol increases to a temperature between minus 18 and minus 8 °C.
  • the alcohol is then separated from the plant material and collected in a container.
  • a new portion of absolute alcohol, cooled to a temperature between minus 20 and minus 10 °C, is poured over the plant material, where after the plant material is moved gently around.
  • the step of contacting the plant material with cooled, alcohol is repeated several times, such as between 2 and 10 times, providing a total alcohol solution including extracted components.
  • the liquid, containing alcohol and plant extract, is subjected to a filtration where small particles of remaining plant material are removed from the liquid.
  • the liquid is then subjected to a distillation process where the alcohol is separated from the terpenes. After the distillation process an oily liquid constituting a fraction of terpenes and or terpenoids originally present in the complete Cannabis plant is obtained.
  • the composition according to the present invention may be administered to a human subject up to 20 times per day, such as up to 15 times per day, such as up to 10 times per day, such as up to 5 times per day or less.
  • the human subject should use the composition formulated e.g. as an inhaler, whenever needed to alleviate the Cannabis craving.
  • the composition is administered when needed.
  • the composition may be administered for up to 2 times every hour.
  • compositions of the invention may in some embodiments be used when needed by a subject, such as at times when the subject feel a need for using a drug by which the subject is dependent.
  • the duration of treatment may be as long as needed, such as for as long as the subject feels a need.
  • a composition, according to the present invention may be administered to a human subject several times per day for a duration of a specified time, such as between 1 and 5 days, such as between 5 and 8 days, such as between 8 and 14 days.
  • a new terpene and/or terpenoid composition may be administered to the human subject several times per day for a duration of a specified time, such as between 1 and 5 days, such as between 5 and 8 days, such as between 8 and 14 days.
  • the composition may then again be switched to a new terpene and/or terpenoid composition to be administered to the human subject several times per day for a duration of a specified time such as between 1 and 5 days, such as between 5 and 8 days, such as between 8 and 14 days.
  • a duration of a specified time such as between 1 and 5 days, such as between 5 and 8 days, such as between 8 and 14 days.
  • a composition may be used in combination with Cannabis by mixing the composition with Cannabis and then smoking said Cannabis-composition mixture.
  • the subject in need of rehabilitation will experience the composition in combination with Cannabis, which still contains the euphoric compound THC.
  • the subject in need of rehabilitation may then gradually add more composition and less Cannabis to reduce the substance dependency slowly.
  • composition or the inhaler device as disclosed herein can be used in combination with different ways of known therapy, such as detoxification, behavioural counseling, group therapy, psychiatric therapy, cognitive behavioural therapy, comorbid cognitive behavioural therapy, the Minnesota Model of addiction therapy, or medication with e.g., opioids or tobacco.
  • the intent of substance dependency rehabilitation treatment is to enable the subject in need thereof to confront substance dependence, and cease the substance dependency in order to avoid negative consequences.
  • group therapy e.g. opioids
  • the composition or the inhaler device is for use in ameliorating the symptoms of withdrawal from substance dependency rehabilitation treatment.
  • the Cannabis dependency is characterized by the subject abusing Cannabis or Cannabis derived products at least once per week, such as at least twice per week, such as at least any one of 3, 4, 5, 6, or 7 days per week.
  • the cannabis dependency is characterized by the subject using Cannabis or Cannabis derived products daily.
  • the cannabis dependency is characterized by the subject in need thereof is a subject that seeks treatment for the dependency.
  • the effect of the use of the composition or the inhaler device as disclosed herein is determined by observing one or more of increased heart rate, red eyes, thirst, or sugar craving, or one or more of decreased working memory or processing speed, as measured by the Wechsler Adult Intelligence Scale test.
  • WAIS Wechsler Adult Intelligence Scale
  • an effect of the use of the composition or the inhaler device as disclosed herein is determined by observing one or more of increased heart rate, decreased working memory, decreased processing speed, or increased systolic blood pressure.
  • the effect of the use of the composition or the inhaler device as disclosed herein is determined by observing an increased heart rate.
  • the Heart rate is the speed of the heartbeat measured by the number of contractions of the heart per minute (bpm).
  • the effect of the use of the composition or the inhaler device as disclosed herein is determined by observing an increased heart rate of at least 5%, such as at least 10%, such as at least 15%, such as at least 20%, such as at least 25%. In one or more embodiments, the effect of the use of the composition or the inhaler device as disclosed herein is determined by observing at least a 20% increase in heart rate for at least one minute within the first 30 minutes of the use. In one or more embodiments, the effect of the use of the composition or the inhaler device as disclosed herein is determined by observing an increased systolic blood pressure.
  • the systolic blood pressure is the maximum blood pressure during one heartbeat, whereas the diastolic blood pressure is the minimum pressure in between two heartbeats.
  • the blood pressure is normally described as the systolic blood pressure over the diastolic blood pressure. It is usually measured in millimeters of mercury (mmHg).
  • the blood pressure is one of the vital signs. Other vital signs are respiratory rate, heart rate, oxygen saturation, and body temperature.
  • the effect of the use is determined by observing an increased systolic blood pressure by at least 5%, such as at least 10%, such as at least 15%.
  • the effect of the use of the composition or the inhaler device as disclosed herein is determined by observing one or more of decreased working memory or processing speed, as measured by the Wechsler Adult Intelligence Scale test.
  • present invention relates to a method for extracting terpenes.
  • the method according to the invention may comprise one or more steps for extracting terpenes.
  • the method may comprises the following steps:
  • feed material is provided by harvesting the top of cannabis plants. Normally, the upper 35-40 cm of the cannabis plants is harvested and used. However, the length of the harvested material may vary with the strain and the conditions of the plants. In order to obtain an extract with the required terpene composition and without cannabinoids harvested plant material is not subjected to cutting or crushing operations before entering the extraction process.
  • an amount of harvested cannabis material is transported to an extraction unit containing one or more vessels.
  • the contacting step b) is performed and the extraction step b) is conducted by either placing the cannabis plant material in a vessel and pouring a solvent over the cannabis plant material or alternatively by immersing the cannabis plant material into a pool of solvent. While the cannabis plant material is immersed at least partly or wholly in the solvent the cannabis plant material may be gently agitated in the solvent thereby increasing the contact between solvent and solid material.
  • the solvent must be liquid during the time of contact and the solvent must therefore have a melting point below the contact temperature and a boiling point higher than the temperature at which contact takes place.
  • the terpenes are non-polar molecules or at least has a larger non-polar part, the solvent should also be non- polar or have a non-polar part.
  • solvent there are numerous types of solvent that may be used in the extraction procedure such as alkanes or alkenes, various aromatic compounds, alcohols, ethers and halogenated hydrocarbons.
  • Aromatic compounds used as solvents may be e.g. benzene or toluene.
  • ethanol is considered to be a useful solvent as ethanol is liquid around -20°C, and as it has a relatively low boiling point, i.e. the boiling point of ethanol is considerably lower than the boiling point of the terpenes, which boiling point is around 165°C for the terpenes having the lowest boiling point. The difference in boiling temperatures allows a very gently removal of the solvent.
  • ethanol has a non-polar part i.e. the d- -CI- -group allowing ethanol to act as a solvent for non-polar components.
  • Another example is methanol.
  • ethers of various kinds and notably diethylether and/or tetrahydrofuran.
  • halogenated hydrocarbons may be envisaged.
  • Halogenated hydrocarbons may be e.g. dichloromethane or chloroform, or may be mixed chloro-fluoro hydrocarbons such as e.g. CC F, CCI2F2, CCIF3, or mixtures hereof, and usually referred to as Freons having a boiling point around -30°C. This implies that the contact temperature should be below -30°C, possibly around -40°C.
  • the solvent may be any mix of the above mentioned solvent.
  • it is important that the solvent is cold during the complete contacting step b.
  • cold is meant below normal standard temperature of 20- 25°C.
  • the temperature should be below 10°C, and preferably as low as possible. This will be dependent upon the solvent or solvent mixtures used in the extraction process. How low a temperature it is possible to obtain is merely a financial matter, but it may also depend on the physical circumstances at which the extraction takes place. If energy is expensive and the climate at the position of extraction is very warm, it could be very expensive to the lower the temperature below -20- -18°C, although it might be desired.
  • a low temperature prevents cannabinoids from being extracted, or at least reduces the amount of cannabinoids being extracted and entering the solvent phase, in favour of having the terpenes extracted into the solvent/organic phase.
  • the time of contact between solvent and cannabis plant material is kept relatively short.
  • the time of contact of step b) should therefore not exceed 30 minutes, and normally the time of contact of step b) will not exceed 15 minutes.
  • the "time of contact” is considered to be from the moment where the cannabis plant material is immersed in solvent to the moment where the solvent is separated from the cannabis plant material.
  • the cannabis plant material is subjected to yet a contacting step b.
  • the contacting step b will normally be repeated from 2 to 10 times, the time of contact may vary for each step, but the duration i.e. the time of contact for each contacting step will not exceed 30 minutes.
  • the solvent including extracted components may be transferred (6) to a filtration unit and subjected to one or more steps of filtration. This procedure can remove any remaining parts of plant material from the liquid.
  • the solvent including the extracted components is subjected to a separation process providing a fraction (7) containing terpenes and a fraction (8) containing solvent.
  • the terpenes included in cannabis plants have boiling points from 165°C and above, it will normally be possible to evaporate the solvent from the terpene mixture. However, if a solvent with a high boiling point is chosen, other separation methods may be chosen.
  • the invention is further illustrated in the below seen non-limiting example.
  • the top 40 cm of four cannabis plants where harvested in order to extract terpenes from the surface of the leaves and flowers. Approximately one kg of Cannabis plant material was obtained.
  • One hour after harvesting the Cannabis material it is contacted with 5 litres of absolute alcohol.
  • the plant material is immersed into the alcohol and moved gently around in the alcohol for about 5 minutes, and then the alcohol is separated from the plant material by filtering.
  • the alcohol including extract is collected in a container.
  • the alcohol is cooled to minus 18 °C, and during the contacting step the temperature of the alcohol increases, however during the complete contacting step the temperature remains below minus 14 °C.
  • the alcohol is separated from the plant material and collected in the container, and a new portion of 5 litres of absolute alcohol, cooled to a temperature of minus 18 °C, is poured over the plant material, where after the plant material is immersed into the alcohol and moved gently around for about 5 minutes.
  • the step of contacting the plant material with cooled, absolute alcohol is repeated 7 times, providing a total of 35 litres of alcohol including extracted components.
  • the approximately 35 litres of liquid containing alcohol and extract is subjected to a filtration where small particles of remaining plant material are removed from the liquid.
  • the liquid is then subjected to an evaporation process where the alcohol is separated from the terpenes.
  • the evaporation process is performed in a rotary evaporator at a temperature of 90 °C.
  • an oily liquid constituting a fraction of terpenes originally present in the complete Cannabis plant is obtained.
  • the content of terpenes in the oily liquid is examined by Gas chromatography-mass spectrometry (GC-MS) and shown I table 1 below.
  • Table 1 Composition of terpene fraction obtained by separation from
  • the remaining part of the terpene fraction (i.e. 23.7%) contains a mixture of terpenes and/or terpenoids each represented by a content below 1 %.
  • the total amount of cannabinoids present in the mixture is characterized as trace elements i.e. the total amount of cannabinoids is well below 1 %.
  • small amounts of other types of extracts such as e.g., hydrocarbons, lipids, or proteins may be present.
  • the top 40 cm of 4 cannabis plants were harvested in order to extract terpenes from the collected plant material. Approximately 5 kg of cannabis plant material was obtained. The material was dried for approximately 20 hours or less.
  • the cannabis material is contacted with 20-30 litres of absolute ethyl alcohol i.e. a liquid containing at least 99% ethanol and no more than 1 % water.
  • the plant material is immersed into the alcohol and moved gently around in the alcohol for about 5 minutes, and then the alcohol is separated from the plant material by filtering.
  • the alcohol including extract is collected in a container.
  • the alcohol is cooled to -18°C, and during the contacting step the temperature of the alcohol increases, however during the complete contacting step the temperature remains below -14°C.
  • the alcohol is separated from the plant material and collected in the container, and a new portion of 20-30 litres of absolute alcohol cooled to a temperature of -18°C is poured over the plant material where after the plant material is immersed into the alcohol and moved gently around for about 5 minutes.
  • the step of contacting the plant material with cooled, absolute alcohol is repeated 7 to 10 times, providing a total of about 200-300 litres of alcohol including extracted components.
  • the approximately 200-300 litres of liquid containing alcohol and extract is subjected to a filtration where small particles of remaining plant material are removed from the liquid.
  • the liquid is then subjected to an evaporation process where the alcohol is separated from the terpenes.
  • the evaporation process is performed on a rotary evaporator at a temperature of about 35-40°C, or alternatively the solvent is allowed to evaporate spontaneously.
  • the remaining part of the terpene fraction i.e. 23.7% contains a mixture of terpenes and/or terpenoids each represented by a content below 1 %.
  • the total amount of cannabinoids present in the mixture is characterized as trace elements i.e. the total amount of cannabinoids is well below 1 %.
  • small amounts of other types of extracts such as e.g. hydrocarbons, lipids or proteins may be present.
  • present invention also relates to the following items:
  • a composition comprising a scent, characterized in that a cannabis smoker when exposed to the scent experience one or more of:
  • composition according to item 1 characterized in that the composition comprises one or more terpenes and/or terpenoids.
  • a composition according to item 2 wherein the one or more terpenes and/or terpenoids are selected from monoterpenes, monoterpenoids, sesquiterpenes, or sesquiterpenoids.
  • a composition according to anyone of items 1 -3 for use in alleviation of substance dependency in a subject in need thereof.
  • a composition according to item 4 wherein the one or more terpenes and/or terpenoids are selected from monoterpenes, monoterpenoids, sesquiterpenes, or sesquiterpenoids.
  • composition comprising one or more terpenes and/or terpenoids for the preparation of a medical product, said medical product having substance dependency rehabilitation properties.
  • present invention also relates to the following articles: 1. Method for isolating terpenes from cannabis plants comprising the following steps:
  • the harvested fraction of cannabis plant material is brought into contact with a liquid solvent having a temperature below 10°C, the contact is maintained until at least part of the terpenes contained in the cannabis plant material is extracted and enters the solvent phase,
  • the solvent is separated from the plant material providing a terpene-enriched fraction of solvent, and the plant material is returned to step b) if the terpene-content of the cannabis plant material is considered high enough
  • step c) the terpene-enriched solvent fractions obtained in step c) are subjected to a separation procedure by which procedure the solvent is separated from the extracted terpenes.
  • step c) is initiated less than 12 hours after harvesting the cannabis plants i.e. after step a), alternatively less than 8 hours, less than 4 hours or less than 1 hour after harvesting the cannabis plant material.
  • step c) is initiated less than 12 hours after harvesting the cannabis plants i.e. after step a), alternatively less than 8 hours, less than 4 hours or less than 1 hour after harvesting the cannabis plant material.
  • step b) has a temperature below 5°C during complete contact step b), alternatively below 0°C, below -10°C, or below -20°C during complete contact step b).
  • a product obtained according to article 1 1 wherein the combination of terpenes comprises a group of at least 3 different terpenes, alternatively at least 5 different terpenes, present in amounts above 3% of the total amount, and at least two of caryophyllene, myrcene and opinene are in this group.

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Abstract

The invention relates to a composition comprising a scent, characterized in that a cannabis smoker when exposed to the scent experience one or more of:a response in the cannabis smoker that in at least one parameter corresponds to a physiological response experienced in the same cannabis smoker upon smoking of cannabis, or a euphoric effect that in at least one parameter corresponds to an effect experienced in the same cannabis smoker upon smoking of cannabis. Present invention also relates to novel methods of extraction and apparatus for use in such extractions, in particular using ehtanol at t < 5°C.

Description

A composition comprising a scent for use as a substance dependency rehabilitation composition
Technical Field
The invention relates to a composition comprising a scent, characterized in that a cannabis smoker when exposed to the scent experience a response that in at least one parameter corresponds to a physiological response experienced in the same cannabis smoker upon smoking of cannabis, or a euphoric effect that in at least one parameter corresponds to an effect experienced in the same cannabis smoker upon smoking of cannabis. Present invention also relates to a method by which recently harvested cannabis plant material is treated in order to recover a fraction of terpenes present in the plant material.
Background art
Substance dependency rehabilitation is the processes of medical or psychotherapeutic treatment, for dependency on psychoactive substances such as alcohol, prescription drugs, as well as cocaine, Cannabis, heroin, or amphetamines.
Epidemiological studies have shown that Cannabis is the most commonly used illegal drug in the United States. Individuals suffering from Cannabis dependency, exhibit a high incidence of comorbid substance use disorders and depression (AM J Drug Alcohol Abuse. 2004;30(1 ):121 -7). The cannabis withdrawal syndrome (CWS) is a criterion of cannabis use disorders (CUDs) (Diagnostic and Statistical Manual of Mental Disorders - Fifth Edition) and cannabis dependence (International Classification of Diseases [ICD]-10). Several lines of evidence from animal and human studies indicate that cessation from long-term and regular cannabis use precipitates a specific withdrawal syndrome with mainly mood and behavioral symptoms of light to moderate intensity (Bonnet and Preuss, subst abuse rehabil. 2017 Apr 27;8;9-37).
The intent of substance dependency rehabilitation treatment is to enable the subject in need thereof to confront substance dependence, and cease or reduce the substance dependency in order to avoid the psychological, legal, financial, social, or physical consequences. Current treatment includes medication for depression or other psychiatric disorders, counseling by experts, and sharing of experience with other addicts in small closed groups (group therapy). Some rehabilitation centers include meditation and spiritual wisdom in the treatment process. Certain opioid medications such as methadone and buprenorphine are used to treat addiction and dependence on opioids such as heroin, morphine, or oxycodone.
World Drug Report estimated that in 2014, the number of cannabis users world wide were about 182.5 million in the age group from 15-64 years of age (World Drug Report 2016, Vienna, Austria, May 2016). Cannabis sativa has long been used for hemp fibre, for hemp oils, for medicinal purposes, and as a recreational drug. The euphoric effect of Cannabis is obtained through the compound tetrahydrocannabinol (THC). In addition to THC Cannabis contains more than one hundred different terpenes, with the relative concentrations of the individual terpenes varying greatly among the different strains currently in cultivation.
There is a need for novel treatments and methods for alleviating and ameliorating substance dependency.
Terpenes are a large and diverse class of organic compounds, produced by a variety of plants. The terpenes often have a strong odour and may protect the plants producing them by deterring herbivores and by attracting predators and parasites of herbivores.
Terpenes constitute the major components of resin, and of turpentine produced from resin. When terpenes are modified chemically e.g. by oxidation or rearrangement of the carbon skeleton, the resulting compounds are generally referred to as terpenoids. Terpenoids are also known as isoprenoids. The difference between terpenes and terpenoids is that terpenes are hydrocarbons, whereas terpenoids contain additional functional groups.
Terpenes and terpenoids are the primary constituents of the essential oils of many types of plants and flowers and in particular terpenes are an important constituent of cannabis plants, which plants normally contain at least 120 identified compounds. In general, the amount of terpenoids in cannabis plants is about 1 %. In cannabis terpenes are synthesized in secretory cells inside glandular trichomes, and production is increased with light exposure, i.e. the particular content of terpenes in a cannabis plant depend not only on the strain of cannabis, but also on where the cannabis grow and under which conditions it is grown i.e. the amount of sun, temperature etc.
Terpenes, terpenoids are - unlike cannabinoids - responsible for the aroma of cannabis. Cannabis and extracts from cannabis are considered to be psychotropic or euphoriant substances. The components causing the psychotropic affect are the cannabinoids, e.g. delta-9-tetrahydrocannabinol (THC) . The main psychotropic cannabinoid, delta-9-tetrahydrocannabinol (THC), has been studied exhaustively. Terpenes are generally recognized non-psychotropic, although the terpenes may act on receptors and neurotransmitters. In Denmark there is a zero-tolerance for driving with THC in the blood, which makes it impossible for persons to be subjected to a medical treatment with substances containing THC and maintain the possibility to legally drive a car.
Traditionally, essential oils are extracted from plant material by steam distillation or vaporization.
It is known to make extracts of cannabis plants with alcohol, however, with present invention the composition of various terpenes will be different in the extract compared to traditional methods and the amount of cannabinoids will be higher compared to traditional methods.
The following terpenes are common in cannabis:
Myrcene (Boiling point 167 °C; water solubility: 5,6 mg/l at 25 °C)
Myrcene, specifically β-myrcene, is a monoterpene and the most common terpene produced by cannabis (some varieties contain up to 60% of the essential oil). Its aroma has been described as musky, earthy, herbal - akin to cloves. A high myrcene level in cannabis (usually above 0.5%) is normally found in classic Indica strains. Myrcene is also found in oil of hops, citrus fruits, bay leaves, eucalyptus, wild thyme, lemon grass and many other plants. Myrcene has medicinal properties, including lowering the resistance across the blood to brain barrier, allowing itself and many other chemicals to cross the barrier easier and more quickly. In the case of cannabinoids (like THC), myrcene allows the effects of the cannabinoid to take effect more quickly. More uniquely still, myrcene has been shown to increase the maximum saturation level of the CB1 receptor, allowing for a greater maximum psychoactive effect.
Pinene (opinene: Boiling point 155,9 °C, water solubility: 2,49 mg/l at 25 °C β-pinene: Boiling point 166,0 °C; water solubility: 4,890 mg/l at 25 °C)
Pinene is a bicyclic monoterpenoid. Pinene has distinctive aromas of pine and fir.
There are two structural isomers of pinene found in nature: opinene and β-pinene.
Both forms are important components of pine resin, opinene is the most widely encountered terpenoid in nature. Pinene is found in many other conifers, as well as in non-coniferous plants. It is found mostly in balsamic resin, pine woods and some citrus fruits. The two isomers of pinene constitute the main component of wood turpentine. It tends to react with other chemicals, forming a variety of other terpenes
(like limonene) and other compounds. Limonene (Boiling point 176 °C; water solubility: 13,8 mg/l at 25 °C)
Limonene is a monocyclic monoterpenoid and one of two major compounds formed from pinene. As the name suggests, varieties high in limonene have strong citrusy smells like oranges, lemons and limes. Strains high in limonene promote a general uplift in mood and attitude. This citrusy terpene is the major constituent in citrus fruit rinds, rosemary, juniper and peppermint, as well as in several pine needle oils.
Limonene is easily absorbed by inhalation and quickly appears in the bloodstream. It assists in the absorption of other terpenes through the skin and other body tissue. It is well documented that limonene suppresses the growth of many species of fungi and bacteria, making it an ideal antifungal agent for ailments such as toenail fungus. Plants use limonene as a natural insecticide to ward off predators. Limonene was primarily used in food and perfumes until a couple of decades ago, when it became better known as the main active ingredient in citrus cleaner. It has very low toxicity and adverse effects are rarely associated with it. Caryophyllene
Beta-caryophyllene is a sesquiterpene found in many plants such as Thai basils, cloves, cinnamon leaves and black pepper, and in minor quantities in lavender. Its aroma has been described as peppery, woody and/or spicy. Caryophyllene is the only terpene known to interact with the endocannabinoid system (CB2). Research shows show that β-caryophyllene selectively binds to the CB2 receptor and that it is a functional CB2 agonist. Further, β-caryophyllene was identified as a functional non-psychoactive CB2 receptor ligand in foodstuff and as a macrocyclic antiinflammatory cannabinoid in cannabis. Beta-caryophyllene is used in chewing gum when combined with other spicy mixtures or citrus flavourings.
Linalool (Boiling point 197 °C; water solubility: 1590 mg/l at 25 °C)
Linalool is a non-cyclic monoterpenoid and has been described as having floral and lavender undertones. Varieties high in linalool promote calming, relaxing effects. The Environmental Protection Agency has approved its use as a pesticide, flavour agent and scent. It is used in a wide variety of bath and body products and is commonly listed under ingredients for these products as beta linalool, linalyl alcohol, linaloyl oxide, p-linalool and alloocimenol. Terpinolene (Boiling point 186 °C; water solubility: 9,5 mg/l at 25 °C)
Terpinolene is a common component of sage and rosemary and is found in the oil derived from Monterey cypress. Its largest use in the United States is in soaps and perfumes. It is also a great insect repellent. Terpinolene is known to have a piney aroma with slight herbal and floral nuances. It tends to have a sweet flavour reminiscent of citrus fruits like oranges and lemons.
Camphene (Boiling point 160 °C; water solubility: 4,6 mg/l at 25 °C)
Camphene, a plant-derived monoterpene, emits pungent odours of damp woodlands and fir needles. Camphene may play a critical role in cardiovascular disease. Camphene is a minor component of many essential oils such as turpentine, camphor oil, citronella oil and ginger oil and is used as a food additive for flavouring, and in the preparation of fragrances. It is produced industrially by catalytic isomerization of the more common opinene. Terpineol (α-Terpineol: Boiling point 220 °C; water solubility: 710 mg/l at 25 °C) a-Terpineol, terpinen-4-ol and 4-terpineol (Boiling point 209 °C) are three closely related monoterpenoids. The aroma of terpineol has been compared to lilacs and flower blossoms. Terpineol is often found in cannabis varieties that have high pinene levels, which unfortunately mask the fragrant aromas of terpineol.
Phellandrene (Boiling point 172 °C; water solubility: 2,860 mg/l at 25 °C)
Phellandrene is described as pepperminty with a slight scent of citrus. It is one of the main compounds in turmeric leaf oil, which is used to prevent and treat systemic fungal infections. Phellandrene from eucalyptus oil contain two isomeric phellandrene referred to as ophellandrene and β-phellandrene. Phellandrene can be found in a number of herbs and spices, including cinnamon, garlic, dill, ginger and parsley. A number of plants produce β-phellandrene as a constituent of their essential oils, including lavender and grand fir. The recognizable odour of some essential oils depends almost entirely upon the presence of phellandrene. Phellandrene, particularly ophellandrene, is absorbed through the skin, making it attractive for use in perfumes. It is also used as flavouring for food products.
Carene
Delta-3-carene is a bicyclic monoterpene with a sweet, pungent odour. It is found naturally in many essential oils, including cypress oil, juniper berry oil and fir needle essential oils. Humulene
Humulene is a sesquiterpene also known as ohumulene and a-caryophyllene; an isomer of β-caryophyllene. Humulene is found in hops, cannabis sativa strains, and Vietnamese coriander, among other naturally occurring substances. Humulene is what gives beer its distinct 'hoppy' aroma. Humulene has been used for generations in Chinese medicine and aids in weight loss by acting as an appetite suppressant.
Pulegone (Boiling point 224 °C)
Pulegone, a monocyclic monoterpenoid, is a minor component of cannabis. Higher concentrations of pulegone are found in rosemary. Rosemary breaks down acetylcholine in the brain, allowing nerve cells to communicate more effectively with one another. Pulegone has a pleasant peppermint aroma and is considered to be a strong insecticide. Sabinene
Sabinene is a bicyclic monoterpene whose aromas are reminiscent of the holidays (pines, oranges, spices). Sabinene occurs in many plants, including Norway spruce, black pepper and basil. Sabinene exists as (+)- and (-)-enantiomers.
Geraniol (Boiling point 230 °C; water solubility: 100 mg/l at 25 °C)
Geraniol produces a sweet, delightful smell similar to roses. This makes geraniol a popular choice for many bath and body products. It is also known to be an effective mosquito repellent. Medically, geraniol shows promise in the treatment of neuropathy. Summary of the invention
The object of the present invention is to provide new compositions comprising a scent, such as one or more terpenes and/or terpenoids for use as a substance dependency rehabilitation composition in substance dependency rehabilitation treatment of a subject in need thereof.
The present invention provides new compositions. These new compositions are suitable for substance dependency rehabilitation treatment, which may be through e.g. the use of a simulated euphoric effect of the compositions. A simulated euphoric effect is experienced when a person is experiencing euphoria but without being subjected to the actual euphoric compound (the psychoactive substance).
If a composition is made having a similar smell and taste as e.g. Cannabis, but without containing THC, a simulated euphoric effect may be obtained when using such a composition. Hence, such composition may be applicable in substance dependency rehabilitation treatment.
Another object of the present invention is the use of a new composition comprising one or more terpenes and/or terpenoids for the preparation of a medical product, said medical product having substance dependency rehabilitation properties. To solve the problem with current substance dependency rehabilitation treatment, the present invention provides a composition, and the use of such a composition for preparation of a medical product. In some embodiments, the composition of the invention exhibit a similar smell and/or taste as the substance the dependency of which is to be treated, ameliorated or alleviated. In some embodiments, the compositions of the invention simulate a euphoric or a physiologic effect similar to the effect experienced by the subject when using the drug or substance, the use of which the subject is dependent of. In some embodiments, the compositions of the invention is for use in treating or ameliorating or alleviating substance dependency. In some embodiments, the compositions of the invention are for use in reducing the level of use of a substance.
Thus, in one aspect of the present invention a composition comprising a scent is provided, characterized in that a cannabis smoker when exposed to the scent experience one or more of: a) a response in the cannabis smoker that in at least one parameter corresponds to a physiological response experienced in the same cannabis smoker upon smoking of cannabis or b) an euphoric effect that in at least one parameter corresponds to an effect experienced in the same cannabis smoker upon smoking of cannabis.
In some embodiments, the compositions of the invention comprises a scent similar to the scent of Cannabis. In some embodiments, the compositions of the invention comprises a scent similar to the scent of Cannabis, wherein the scent does not comprise more than 2 % w/w of THC, such as no more than 1 % THC, such as no more than 0,5% THC, such as no more than 0,1 % THC, such as no more than 0,01 % THC. In some embodiments, a cannabis smoker experience a simulated euphoric effect when using the compositions of the invention. In some embodiments, the compositions of the invention triggers a physiological response similar to the response experienced by a cannabis smoker when smoking Cannabis. The compositions of the invention may therefore be applicable in substance dependency rehabilitation treatment of a Cannabis smoker, such as in treating, alleviating or ameliorating substance dependency. With respect to the methods as disclosed herein, the method according to the invention provides a liquid product comprising terpenes having a very low content of cannabinoids. In fact cannabinoids are normally present in amounts defined as trace elements, indicating that the amount of individual cannabinoids is below detection by the method used for detection and normally the total amount of cannabinoids will at least be below 2%.
The fraction of extracted terpenes may have a profile different from the total content of terpenes in the cannabis plant. That is, depending on the chosen solvent and the time of extraction it will be possible to vary the terpene-content profile of the final product.
However, when considering which solvent to use, their toxicity and safety are also important.
Thus, in one aspect, the present invention relates to a method for isolating terpenes from cannabis plants.
Present invention also relates to a product obtained by the method according to the invention, wherein the product comprises a total content of cannabinoids of below 2%.
Detailed description of the invention
In describing the aspects of the invention specific terminology will be resorted to for the sake of clarity. However, the invention is not intended to be limited to the specific terms so selected, and it is understood that each specific term includes all technical equivalents, which operate in a similar manner to accomplish a similar purpose.
The term "scent" in the context of the present invention, is a composition capable of producing a vapor, characterized by a particular chemical composition which upon inhalation by a subject produces the perception in the subject of smelling a particular substance, such as in non limiting example of having smelled or smoked or used cannabis. "An" or "a" applied before a substantive are in the present specification synonymous with the expression "one or more".
The terms "Cannabis plant" and "hemp plant" when used in the specification and claims of this application both refer to a flowering plant including three species (and seven taxa) or subspecies, sativa, indica, and ruderalis and hybrids. The terms include cannabis plants selected to produce an abundance of fibre having minimal levels of tetrahydrocannabinol a.o. THC or cannabinoids (often referred to as "hemp plants") and cannabis plants having been selectively bred to produce a maximum of THC.
The word "terpenes" refer to from units of isoprene, which has the molecular formula C5H8. The basic molecular formulae of terpenes are multiples of that, (C5H8)n where n is the number of linked isoprene units. The isoprene units may be linked together "head to tail" to form linear chains or they may be arranged to form rings. If a terpene contains additional functional groups, it is normally referred to as a "terpenoid". However, in the context of the present application "terpene" may also refer to units including functional groups e.g. an ether group or an alcohol group. The term "cannabinoids" represents a group of C21 terpenophenolic compounds found in cannabis plants.
Moreover, "Terpenes" are naturally occurring volatile hydrocarbons, emitted by many trees and plants, as well as some insects. They mostly have very strong smells and are responsible for the aromas of the vegetation in which they are found. Each plant strain has a unique composition of terpenes, which is responsible for e.g., the plants characteristic smell and distinctive flavor.
One aspect of the present invention, is a composition comprising one or more terpenes and/or terpenoids for use as a substance dependency rehabilitation composition in substance dependency rehabilitation treatment, or for ameliorating or alleviating substance dependency of a subject in need thereof. The present invention discloses that one of the advantages of using such a composition is that the smell and taste of a scent according to the invention, such as of the terpenes and/or terpenoids in the composition may associate the subject in need of rehabilitation with the psychoactive substances used in the current substance dependency.
A subject in need of substance dependency rehabilitation treatment is a subject addicted to or dependent on a psychoactive substance. Any substance dependency may progress to a habit that controls the person and his or her decisions. Substance dependency rehabilitation treatment is needed when a person has habits that control him or her. If substance dependency rehabilitation treatment is started as soon as these habits start to occur, an enormous damage may be prevented to the involved person and said persons family and social circle. In one or more embodiments, the substance dependency rehabilitation treatment is Cannabis dependency rehabilitation treatment.
In some embodiments, the compositions according to the invention provides a scent, such as a scent comprising terpenes and/or terpenoids, such as a scent consisting of terpenes and/or terpenoids, wherein the scent cause an association to the situation of using cannabis. In some embodiments, the present invention provides compositions comprising terpenes and/or terpenoids.
In one or more embodiments of the present invention, the one or more terpenes and/or terpenoids comprised in the compositions may be selected from monoterpenes, monoterpenoids, sesquiterpenes, or sesquiterpenoids.
Figure imgf000012_0001
Structure of Isoprene
Terpenes and terpenoids consist of isoprene units. Isoprene (2-methyl-1 ,3- butadiene, CsHe) is a common organic compound with the formula shown above. In its pure form it is a colorless volatile liquid. Isoprene is produced by many plants, and its polymers are the main component of terpenes, gibberellins, sterols, carotenoids etc.
Terpenes and terpenoids may be acyclic, monocyclic, or polycyclic hydrocarbons with substitution patterns including alcohols, ethers, aldehydes, ketones, and esters.
Monoterpenes and monoterpenoids (C10 skeleton) consist of two isoprene units and typically have the molecular formula C10H16. Examples of monoterpenes and monoterpenoids include Geraniol, Terpineol, Limonene, Myrcene, Linalool, or Pinene.
Sesquiterpenes and sesquiterpenoids (C15 skeleton) consist of three isoprene units and typically have the molecular formula C15H24. Examples of sesquiterpenes and sesquiterpenoids include Humulene, Farnesenes, Farnesol.
In some embodiments, terpenes or terpenoids that are normally present in cannabis are comprised in the compositions of the present invention.
The following terpenes are common in cannabis:
Myrcene (Boiling point 167 °C; water solubility: 5,6 mg/l at 25 °C)
Myrcene, specifically β-myrcene, is a monoterpene and the most common terpene produced by cannabis (some varieties contain up to 60% of the essential oil). Its aroma has been described as musky, earthy, herbal - akin to cloves. A high myrcene level in cannabis (usually above 0.5%) is normally found in classic Indica strains. Myrcene is also found in oil of hops, citrus fruits, bay leaves, eucalyptus, wild thyme, lemon grass and many other plants.
Myrcene has medicinal properties, including lowering the resistance across the blood to brain barrier, allowing itself and many other chemicals to cross the barrier easier and more quickly. In the case of cannabinoids (like THC), myrcene allows the effects of the cannabinoid to take effect more quickly. More uniquely still, myrcene has been shown to increase the maximum saturation level of the CB1 receptor, allowing for a greater maximum psychoactive effect.
Pinene (opinene: Boiling point 155,9 °C, water solubility: 2,49 mg/l at 25 °C β-pinene: Boiling point 166,0 °C; water solubility: 4,890 mg/l at 25 °C) Pinene is a bicyclic monoterpenoid. Pinene has distinctive aromas of pine and fir. There are two structural isomers of pinene found in nature: opinene and β-pinene. Both forms are important components of pine resin, opinene is the most widely encountered terpenoid in nature. Pinene is found in many other conifers, as well as in non-coniferous plants. It is found mostly in balsamic resin, pine woods and some citrus fruits. The two isomers of pinene constitute the main component of wood turpentine. It tends to react with other chemicals, forming a variety of other terpenes (like limonene) and other compounds.
Limonene (Boiling point 176 °C; water solubility: 13,8 mg/l at 25 °C)
Limonene is a monocyclic monoterpenoid and one of two major compounds formed from pinene. As the name suggests, varieties high in limonene have strong citrusy smells like oranges, lemons and limes. Strains high in limonene promote a general uplift in mood and attitude. This citrusy terpene is the major constituent in citrus fruit rinds, rosemary, juniper and peppermint, as well as in several pine needle oils. Limonene is easily absorbed by inhalation and quickly appears in the bloodstream. It assists in the absorption of other terpenes through the skin and other body tissue. It is well documented that limonene suppresses the growth of many species of fungi and bacteria, making it an ideal antifungal agent for ailments such as toenail fungus. Plants use limonene as a natural insecticide to ward off predators. Limonene was primarily used in food and perfumes until a couple of decades ago, when it became better known as the main active ingredient in citrus cleaner. It has very low toxicity and adverse effects are rarely associated with it.
Caryophyllene
Beta-caryophyllene is a sesquiterpene found in many plants such as Thai basils, cloves, cinnamon leaves and black pepper, and in minor quantities in lavender. Its aroma has been described as peppery, woody and/or spicy. Caryophyllene is the only terpene known to interact with the endocannabinoid system (CB2). Research shows show that β-caryophyllene selectively binds to the CB2 receptor and that it is a functional CB2 agonist. Further, β-caryophyllene was identified as a functional non-psychoactive CB2 receptor ligand in foodstuff and as a macrocyclic antiinflammatory cannabinoid in cannabis. Beta-caryophyllene is used in chewing gum when combined with other spicy mixtures or citrus flavourings.
Linalool (Boiling point 197 °C; water solubility: 1590 mg/l at 25 °C)
Linalool is a non-cyclic monoterpenoid and has been described as having floral and lavender undertones. Varieties high in linalool promote calming, relaxing effects. The Environmental Protection Agency has approved its use as a pesticide, flavour agent and scent. It is used in a wide variety of bath and body products and is commonly listed under ingredients for these products as beta linalool, linalyl alcohol, linaloyl oxide, p-linalool and alloocimenol.
Terpinolene (Boiling point 186 °C; water solubility: 9,5 mg/l at 25 °C)
Terpinolene is a common component of sage and rosemary and is found in the oil derived from Monterey cypress. Its largest use in the United States is in soaps and perfumes. It is also a great insect repellent. Terpinolene is known to have a piney aroma with slight herbal and floral nuances. It tends to have a sweet flavour reminiscent of citrus fruits like oranges and lemons.
Camphene (Boiling point 160 °C; water solubility: 4,6 mg/l at 25 °C)
Camphene, a plant-derived monoterpene, emits pungent odours of damp woodlands and fir needles. Camphene may play a critical role in cardiovascular disease.
Camphene is a minor component of many essential oils such as turpentine, camphor oil, citronella oil and ginger oil and is used as a food additive for flavouring, and in the preparation of fragrances. It is produced industrially by catalytic isomerization of the more common opinene.
Terpineol (a-Terpineol: Boiling point 220 °C; water solubility: 710 mg/l at 25 °C) oTerpineol, terpinen-4-ol and 4-terpineol (Boiling point 209 °C) are three closely related monoterpenoids. The aroma of terpineol has been compared to lilacs and flower blossoms. Terpineol is often found in cannabis varieties that have high pinene levels, which unfortunately mask the fragrant aromas of terpineol.
Phellandrene (Boiling point 172 °C; water solubility: 2,860 mg/l at 25 °C)
Phellandrene is described as pepperminty with a slight scent of citrus. It is one of the main compounds in turmeric leaf oil, which is used to prevent and treat systemic fungal infections. Phellandrene from eucalyptus oil contain two isomeric
phellandrene referred to as ophellandrene and β-phellandrene. Phellandrene can be found in a number of herbs and spices, including cinnamon, garlic, dill, ginger and parsley. A number of plants produce β-phellandrene as a constituent of their essential oils, including lavender and grand fir. The recognizable odour of some essential oils depends almost entirely upon the presence of phellandrene.
Phellandrene, particularly ophellandrene, is absorbed through the skin, making it attractive for use in perfumes. It is also used as flavouring for food products.
Carene
Delta-3-carene is a bicyclic monoterpene with a sweet, pungent odour. It is found naturally in many essential oils, including cypress oil, juniper berry oil and fir needle essential oils. Humulene
Humulene is a sesquiterpene also known as a-humulene and a-caryophyllene; an isomer of β-caryophyllene. Humulene is found in hops, cannabis sativa strains, and Vietnamese coriander, among other naturally occurring substances. Humulene is what gives beer its distinct 'hoppy' aroma. Humulene has been used for generations in Chinese medicine and aids in weight loss by acting as an appetite suppressant.
Pulegone (Boiling point 224 °C)
Pulegone, a monocyclic monoterpenoid, is a minor component of cannabis. Higher concentrations of pulegone are found in rosemary. Rosemary breaks down acetylcholine in the brain, allowing nerve cells to communicate more effectively with one another. Pulegone has a pleasant peppermint aroma and is considered to be a strong insecticide.
Sabinene
Sabinene is a bicyclic monoterpene whose aromas are reminiscent of the holidays (pines, oranges, spices). Sabinene occurs in many plants, including Norway spruce, black pepper and basil. Sabinene exists as (+)- and (-)-enantiomers.
Geraniol (Boiling point 230 °C; water solubility: 100 mg/l at 25 °C)
Geraniol produces a sweet, delightful smell similar to roses. This makes geraniol a popular choice for many bath and body products. It is also known to be an effective mosquito repellent. Medically, geraniol shows promise in the treatment of neuropathy.
Brief description of the drawings Figure 1 illustrates an overview of the steps performed according to a method of the invention.
In one or more embodiments, the compositions of the invention have a simulated euphoric effect on a subject exposed to the composition. A simulated euphoric effect may be experienced from the subject in need of rehabilitation as the euphoric state known from the psychoactive substance but without being subjected to the actual psychoactive substance.
In one or more embodiments, the composition has a simulated euphoric effect on a subject in need of substance dependency rehabilitation treatment. Thus in some embodiments the compositions of the present invention are for use in simulating a euphoric effect on a subject in need of treatment or alleviation or amelioration of substance dependency. In some embodiments, the compositions of the present invention are for use in simulating in a subject the use of a substance to which the subject is dependent, and thereby induce at least one physiologic effect that is normally experienced by the subject upon use of the substance, said simulation is for use in a method of treatment or alleviation or amelioration of substance dependency. In some embodiments, the compositions simulate the euphoric or physiological effects of smoking cannabis, and are for use in treatment or alleviation or amelioration of cannabis dependency or for treatment or alleviation or amelioration of other substance dependency, such as in non-limiting example dependency of alcohol, nicotine, caffeine, cocaine or morfine derived substances.
In one or more embodiments, the composition has a simulated euphoric effect on a subject in need of Cannabis dependency rehabilitation treatment.
In one or more embodiments, the compositions of the invention comprises one or more terpenes and/or terpenoids selected from terpenes and/or terpenoids naturally comprised in Cannabis.
In one or more embodiments, the one or more terpenes and/or terpenoids are extracted from plant material. In another embodiment, the plant material is plant material obtained from Cannabis. In yet another embodiment, the extract from plant material is a whole extract.
By whole extract as used in the present application, is meant a substance made by extracting all or most of the terpenes and/or terpenoids from a raw material e.g., leaves, seeds, or buds in a plant. The whole extract will in some embodiments be made by extraction using a solvent. In some embodiments, the whole extract is not subsequently (after the solvent extraction step) to selectively remove specific terpenes or terpenoids from the extract. The whole extract may be obtained using a solvent such as e.g., ethanol, octanol, polyethylene glycol or coconut oil. In one or more embodiments, the Cannabis is selected from the species Cannabis sativa, Cannabis indica, or Cannabis ruderalis.
In one or more embodiments, the monoterpenes and/or monoterpenoids of the compositions of the invention are selected from one or more of Myrcene, Pinene, Limonene, Caryophyllene, Linalool, Terpinolene, Camphene, alpha-Terpineol, beta- Phellandrene, delta-3-carene, Humulene, Pulegone, cis-Sabinene hydrate, Geraniol, Ocimene, beta-Fenchol, Fenchone, Borneol, alpha-Thujene, or Ipsdienol.
In one or more embodiments, the monoterpenes and/or monoterpenoids are selected from one or more of Myrcene, Pinene, Limonene, Caryophyllene, Linalool, Terpinolene, Camphene, Terpineol such as alpha-Terpineol, Phelandrene such as beta-Phellandrene, careen such as delta-3-carene, Humulene, Pulegone, Sabinene such as cis-Sabinene hydrate, or Geraniol. In one or more embodiments, when present in the compositions of the invention, the Ocimene is selected from one or more of irans-Ocimene or c/s-Ocimene.
In one or more embodiments, when present in the compositions of the invention, the Pinene is selected from one or more of alpha-Pinene or beta-Pinene.
In one or more embodiments, the monoterpenes and/or monoterpenoids are selected from one or more of Myrcene, alpha-Pinene, beta-Pinene, Limonene, Linalool, Terpinolene, Camphene, alpha-Terpineol, beta-Phellandrene, delta-3- carene, Pulegone, cis-Sabinene hydrate, or Geraniol.
In one or more embodiments, the sesquiterpenes and/or sesquiterpenoids are selected from one or more of Caryophyllene, Farnesene, alpha-Humulene, Guajol, alpha-Guaiene, Eudesmol, Selinene, Bergamotene, gamma-Curcumene, epi-alpha- Bisabolol, alpha-Ylangene, beta-Elemene, gamma-Muurolene, alpha-Cadinene, alpha-Longipinene, or Bisabolene.
In one or more embodiments, the Caryophyllene is selected from one or more of alpha-Caryophyllene, beta-Caryophyllene, or Caryophyllene oxide. In one or more embodiments, the Farnesene is selected from one or more of trans- alpha-Farnesene or c/s-beta-Farnesene.
In one or more embodiments, the Eudesmol is selected from one or more of alpha- Eudesmol, beta-Eudesmol, or gamma-Eudesmol.
In one or more embodiments, the Selinene is selected from one or more of alpha- Selinene or beta-Selinene. In one or more embodiments, the Bergamotene is selected from one or more of alpha-irans-Bergamotene or alpha-c/s-Bergamotene.
In one or more embodiments, the Bisabolene is selected from one or more of c/'s- gamma-Bisabolene or irans-gamma-Bisabolene.
In one or more embodiments, the sesquiterpenes and/or sesquiterpenoids are selected from one or more of alpha-Caryophyllene, beta-Caryophyllene, Caryophyllene oxide, alpha-Humulene. In one or more embodiments, the concentration of the one or more terpenes and/or terpenoids in the composition is in the range of from 0.01 % to 100 %.
In one or more embodiments, a cannabinoid component is present in a percentage of less than 2 percent w/w.
A cannabinoid is a chemical compound that acts on cannabinoid receptors in cells that alter neurotransmitter release in the brain. A class of cannabinoids is phytocannabinoids, which is found in cannabis. The most notable phytocannabinoids are tetrahydrocannabinol (THC) and Cannabidiol (CBD). There are over one hundred different cannabinoids in cannabis.
Figure imgf000020_0001
Structure of tetrahydrocannabinol (THC)
Tetrahydrocannabinol (THC) is the principal psychoactive cannabinoid of Cannabis. THC is a clear, amber, or gold colored glassy solid when cold, which becomes viscous and sticky if warmed. THC has a very low solubility in water, but good solubility in most organic solvents, specifically lipids and alcohols (Garrett ER et al., J. Pharm. Sci., 63 (7), 1056-64).
In one or more embodiments, a cannabinoid component is present in a percentage of less than 5 percent w/w, such as less than 4 percent w/w, such as less than 3 percent w/w, such as less than 2 percent w/w, such as less than 1 percent w/w, such as less than 0.5 percent w/w, such as less than 0.1 percent w/w, such as less than 0.01 percent w/w.
In another embodiment, a cannabinoid component is present in a percentage between 0 to 5 percent w/w, such as between 0 and 4 percent w/w, such as between 0 and 3 percent w/w, such as between 0 and 2 percent w/w, such as between 0 and 1 percent w/w, such as between 0 and 0.5 percent w/w.
In another embodiment, a cannabinoid component is present in a percentage between 0 to 5 percent w/w, such as between 1 and 5 percent w/w, such as between 2 and 5 percent w/w, such as between 3 and 5 percent w/w, such as between 4 and 5 percent w/w.
In yet another embodiment, a cannabinoid component is present in a percentage between 0 to 5 percent w/w, such as between 1 and 5 percent w/w, such as between 1 and 4 percent w/w, such as between 1 and 3 percent w/w, such as between 1 and 2 percent w/w, such as between 2 and 5 percent w/w, such as between 2 and 4 percent w/w, such as between 2 and 3 percent w/w, such as between 3 and 5 percent w/w, such as between 3 and 4 percent w/w, such as between 4 and 5 percent w/w.
In one or more embodiments, a tetrahydrocannabinol (THC) component is present in a percentage of less than 0.1 percent w/w, such as less than 0.01 percent w/w.
In one or more embodiments, a tetrahydrocannabinol (THC) component is present in a percentage of less than 0.75 percent w/w, such as less than 0.5 percent w/w, such as less than 0.25 percent w/w, such as less than 0.1 percent w/w.
In one or more embodiments, a tetrahydrocannabinol (THC) component is present in a percentage of less than 5 percent w/w, such as less than 4 percent w/w, such as less than 3.5 percent w/w, such as less than 3 percent w/w, such as less than 2.5 percent w/w, such as less than 2 percent w/w, such as less than 1 .5 percent w/w, such as less than 1 percent w/w, such as less than 0.75 percent w/w, such as less than 0.5 percent w/w, such as less than 0.25 percent w/w or such as less than 0.1 percent w/w.
In another embodiment, a cannabidiol (CBD) component is present in a percentage of less than 0.5 percent w/w.
In one or more embodiments, a cannabidiol (CBD) component is present in a percentage of less than 5 percent w/w, such as less than 4 percent w/w, such as less than 3.5 percent w/w, such as less than 3 percent w/w, such as less than 2.5 percent w/w, such as less than 2 percent w/w, such as less than 1 .5 percent w/w, such as less than 1 percent w/w, such as less than 0.75 percent w/w, such as less than 0.5 percent w/w, such as less than 0.25 percent w/w or such as less than 0.1 percent w/w. In one or more embodiments, the composition may be in a liquid form.
In another embodiment, the composition may be in the form of a solution within an appropriate solvent. Appropriate solvents are solvents that solubilize terpenes while not being harmful for the human body. Non-limiting examples of such solvents may be, ethanol, octanol, polyethylene glycol, or coconut oil.
In one or more embodiments, the one or more terpenes and/or terpenoids are dissolved in one or more of ethanol, octanol, polyethylene glycol, water or coconut oil with a dilution of between 5 percent and 99.99 percent w/w, such as between 10 and 99.99 percent w/w, such as between 20 and 99.99 percent w/w.
In one or more embodiments, the composition is encapsulated in a shell/chamber. In some embodiments, the shell/chamber is in a delivery device, such as in an inhaler device. In some embodiments, the composition is adsorbed in an adsorbent such as in non limiting example anyone of cotton, tobacco, paper, dextrans, silica, diatomaceous earth, and porous synthetic polymers such as Tenax (Trademark) which is a porous polymer resin (2,6-diphenyl-p-phenylene oxide), and the like. In some embodiments, the composition is adsorbed in an adsorbent which is present in an inhaler device.
A shell is a structural element characterized by its three-dimensional geometry and a very small thickness when compared with other dimensions of said geometry. If the shell is closed all the way around, it creates a chamber inside the shell. A chamber is a room/space/housing, which may contain a material/composition. Hereby, said material/composition is enclosed in said chamber and surrounded by said shell. In one or more embodiments, the composition is encapsulated in a shell or enclosed within a chamber.
In one or more embodiments, the shell/chamber is made of glass, plastic, or water- soluble materials.
In one or more embodiments, the shell/chamber may be in the form of small beads containing the composition. The shell/chamber may be made of, but not limited to, glass, plastic, metal, or water-soluble materials. Retaining the composition of the invention in a shell/chamber may in some embodiments be used to keep the composition intact until use, such as keep the composition intact in a delivery device until use. In one or more embodiments, the composition is released by breaking the shell/chamber surrounding said composition. The breaking of said shell may be through e.g., mechanical means or chemical means.
In one embodiment, the compositions of the invention is formulated in a lozenge form for slow delivery in the oral cavity. Methods for making lozenges are well known in the art.
In one or more embodiments, the composition is used for treating or ameliorating substance dependency in a subject in need thereof.
In one or more embodiments, the substance dependency is Cannabis dependency. In one or more embodiments, the substance dependency is Cannabis dependency mixed with other substance dependency. In one or more embodiments, the other substance dependency is opioid dependency.
In one or more embodiments, the composition is comprised in an inhaler. An inhaler is a device containing a composition, which is applied by suction through said device, whereby the composition (e.g., in the form of vaporized liquid) will distribute throughout the oral cavity and into the lungs. The inhaler may comprise means for vaporizing, nebulizing, atomizing, spraying, inhaling, or steaming. The inhaler may be a smoking device e.g., a cigarette.
In one or more embodiments, is also provided the composition according to the invention for use in the manufacture of an inhaler device. An inhaler device, is a device containing a composition, which is applied by suction through the inhaler, whereby the composition (e.g., in the form of vaporized liquid) will distribute throughout the oral cavity and into the lungs. The inhaler may comprise means for vaporizing, nebulizing, atomizing, spraying, inhaling, or steaming. The inhaler may be a smoking device e.g., a cigarette. The inhaler device may in some embodiments be an electronic cigarette, where the composition of the invention is delivered in similar fashion as the nicotine compositions that are normally delivered by electronic cigarettes. In one or more embodiments, the inhaler device does not require means for heating, and in another embodiment, the inhaler/composition does not comprise a propellant.
Another aspect of the present invention is use of a composition comprising one or more terpenes and/or terpenoids for the preparation of a medical product, said medical product having substance dependency rehabilitation properties.
In one embodiment, the medical product is an inhaler device comprising the compositions of the invention. An inhaler device is a device containing a composition, which is applied by suction through said device, whereby the composition (e.g., in the form of vaporized liquid) will distribute throughout the oral cavity and into the lungs. The inhaler may comprise means for vaporizing, nebulizing, atomizing, spraying, inhaling, or steaming. The inhaler may be a smoking device e.g., a cigarette. The compositions of the invention may be used in the preparation of a medical product which will provide the user with the smell and taste of the terpenes and/or terpenoids in the composition. The smell and taste will associate the user with having used in example cannabis. Experiencing such a simulated use will induce one or more of a euphoric effect or a physiological effect normally experienced by that user when using cannabis. Such similated use of in example cannabis may be used in treatment, amelioration or alleviation of substance dependency in the subject and hereby help rehabilitating the subject.
In one or more embodiments, the substance dependency rehabilitation properties is Cannabis dependency rehabilitation properties.
One of the advantages of a usage of such a composition in preparation of a medical product for treatment, amelioration or alleviation of cannabis dependency, is that the medical product will have the smell and taste of the terpenes and/or terpenoids in the composition. This smell and taste will associate the user with Cannabis use without actually using cannabis, and hereby help in rehabilitating the user against Cannabis dependency. In one or more embodiments, the one or more terpenes and/or terpenoids are selected from monoterpenes, monoterpenoids, sesquiterpenes, or sesquiterpenoids.
In one or more embodiments, the composition has a simulated euphoric effect. In another embodiment, the composition has a simulated euphoric effect on a subject in need of substance dependency rehabilitation treatment. In yet another embodiment, the composition has a simulated euphoric effect on a subject in need of Cannabis dependency rehabilitation treatment. In some embodiments, the simulated euphoric effect is in a subject that is a cannabis user. In some embodiments, the exposure of a subject to the composition induce at least a euphoric effect or a physiological effect also seen in the same subject when using cannabis.
In one or more embodiments, the one or more terpenes and/or terpenoids are naturally comprised in Cannabis sativa.
In one or more embodiments, the one or more terpenes and/or terpenoids are extracted from plant material. In another embodiment, the plant material is plant material obtained from Cannabis. In yet another embodiment, the extract from plant material is a whole extract.
In one or more embodiments, the monoterpenes and/or monoterpenoids are selected from one or more of Myrcene, Limonene, Linalool, Ocimene, Pinene, delta- 3-carene, beta-Fenchol, beta-Phellandrene, Terpinolene, alpha-Terpineol, Fenchone, Camphene, cis-Sabinene hydrate , Borneol, alpha-Thujene, Pulegone, Geraniol, or Ipsdienol.
In one embodiment, the Pinene is selected from one or more of alpha-Pinene or beta-Pinene. In one or more embodiments, the monoterpenes and/or monoterpenoids are selected from one or more of Myrcene, alpha-Pinene, beta-Pinene, Limonene, Linalool, Terpinolene, Camphene, alpha-Terpineol, beta-Phellandrene, delta-3- carene, Pulegone, cis-Sabinene hydrate, or Geraniol.
In one or more embodiments, the sesquiterpenes and/or sesquiterpenoids are selected from one or more of Caryophyllene, Farnesene, alpha-Humulene, Guajol, alpha-Guaiene, Eudesmol, Selinene, Bergamotene, gamma-Curcumene, epi-alpha- Bisabolol, alpha-Ylangene, beta-Elemene, gamma-Muurolene, alpha-Cadinene, alpha-Longipinene, or Bisabolene.
In one or more embodiments, the Caryophyllene is selected from one or more of alpha-Caryophyllene, beta-Caryophyllene, or Caryophyllene oxide. In one or more embodiments, the Farnesene is selected from one or more of trans- alpha-Farnesene or c/s-beta-Farnesene.
In one or more embodiments, the Eudesmol is selected from one or more of alpha- Eudesmol, beta-Eudesmol, or gamma-Eudesmol.
In one or more embodiments, the Selinene is selected from one or more of alpha- Selinene or beta-Selinene.
In one or more embodiments, the Bergamotene is selected from one or more of alpha-irans-Bergamotene or alpha-c/s-Bergamotene.
In one or more embodiments, the Bisabolene is selected from one or more of c/'s- gamma-Bisabolene or irans-gamma-Bisabolene. In one or more embodiments, the sesquiterpenes and/or sesquiterpenoids are selected from one or more of alpha-Caryophyllene, beta-Caryophyllene, Caryophyllene oxide, alpha-Humulene. In one or more embodiments, the concentration of the one or more terpenes and/or terpenoids in the composition is in the range of from 0.001 % to 100%.
In one or more embodiments, a cannabinoid component is present in a percentage of less than 2 percent w/w, such as less than 5%, such as less than 10%, such as less than 20%, such as less than 30%, such as less than 50 %, such as less than 60%, such as less than 75% w/w, such as less than 85%, such as less than 95% w/w. An advantage of avoiding a composition containing cannabinoids may be to avoid all the negative effects these compounds exhibit when interacting with receptors in cells and hereby altering the neurotransmitter release in the brain.
In one or more embodiments, a cannabinoid component is present in a percentage of less than 5 percent w/w, such as less than 4 percent w/w, such as less than 3 percent w/w, such as less than 2 percent w/w, such as less than 1 percent w/w, such as less than 0.5 percent w/w.
In another embodiment, a cannabinoid component is present in a percentage between 0 to 5 percent w/w, such as between 0 and 4 percent w/w, such as between 0 and 3 percent w/w, such as between 0 and 2 percent w/w, such as between 0 and 1 percent w/w, such as between 0 and 0.5 percent w/w.
In another embodiment, a cannabinoid component is present in a percentage between 0 to 5 percent w/w, such as between 1 and 5 percent w/w, such as between 2 and 5 percent w/w, such as between 3 and 5 percent w/w, such as between 4 and 5 percent w/w.
In yet another embodiment, a cannabinoid component is present in a percentage between 0 to 5 percent w/w, such as between 1 and 5 percent w/w, such as between 1 and 4 percent w/w, such as between 1 and 3 percent w/w, such as between 1 and 2 percent w/w, such as between 2 and 5 percent w/w, such as between 2 and 4 percent w/w, such as between 2 and 3 percent w/w, such as between 3 and 5 percent w/w, such as between 3 and 4 percent w/w, such as between 4 and 5 percent w/w.
In one or more embodiments, a tetrahydrocannabinol (THC) component from the plant extract is present in a percentage of less than 0.1 percent w/w.
An advantage of avoiding THC may be that the subject utilizing the compound avoids the psychoactive activity of said compound. In one or more embodiments, a tetrahydrocannabinol (THC) component is present in a percentage of less than 0.75 percent w/w, such as less than 0.5 percent w/w, such as less than 0.25 percent w/w.
In one or more embodiments, a tetrahydrocannabinol (THC) component is present in a percentage of less than 5 percent w/w, such as less than 4 percent w/w, such as less than 3.5 percent w/w, such as less than 3 percent w/w, such as less than 2.5 percent w/w, such as less than 2 percent w/w, such as less than 1 .5 percent w/w, such as less than 1 percent w/w, such as less than 0.75 percent w/w, such as less than 0.5 percent w/w, such as less than 0.25 percent w/w or such as less than 0.1 percent w/w.
In one or more embodiments, a cannabidiol (CBD) component from the plant extract is present in a percentage of less than 0.5 percent w/w. In one or more embodiments, a cannabidiol (CBD) component is present in a percentage of less than 5 percent w/w, such as less than 4 percent w/w, such as less than 3.5 percent w/w, such as less than 3 percent w/w, such as less than 2.5 percent w/w, such as less than 2 percent w/w, such as less than 1 .5 percent w/w, such as less than 1 percent w/w, such as less than 0.75 percent w/w, such as less than 0.5 percent w/w, such as less than 0.25 percent w/w or such as less than 0.1 percent w/w.
In one or more embodiments, the composition may be in a liquid form. In another embodiment, the composition may be in the form of a solution within an appropriate solvent. Appropriate solvents are solvents that solubilize terpenes while not being harmful for the human body. Examples of such solvents may be, but are not limited to, water, Octanol, polyethylene glycol, and coconut oil..
In some embodiments, the one or more terpenes and/or terpenoids are dissolved in a solvent such as in non-limiting example Octanol, polyethylene glycol, and coconut oilwith a dilution of between 5 percent and 99.99 percent w/w, such as between 10 and 99.99 percent w/w, such as between 20 and 99.99 percent w/w.
In one or more embodiments, the medical product is for use in combination with different ways of known therapy, such as detoxification, behavioural counselling, group therapy, psychiatric therapy, or medication with e.g., opioids or tobacco. The intent of substance dependency rehabilitation treatment is to enable the subject in need thereof to confront substance dependence, and cease the substance dependency in order to avoid negative consequences. There are many different ways of known therapy. These current treatments includes detoxification, medication for depression or other psychiatric disorders, medication with e.g. opioids, counseling by experts, and sharing of experience with other addicts in small closed groups (group therapy). It may be advantageous to combine a medical product comprising one or more terpenes and/or terpenoids with currently used treatments. This combination therapy may give the subject in need of rehabilitation the advantages of the currently known treatments, while also benefiting with the advantages of the medical product comprising one or more terpenes and/or terpenoids in that the smell and taste of said medical product may be associated with the psychoactive substances used in the current substance dependency.
Another aspect of the present invention is a composition comprising a scent, characterized in that a cannabis smoker when exposed to the scent experience one or more of: a) a response in the cannabis smoker that in at least one parameter corresponds to a physiological response experienced in the same cannabis smoker upon smoking of cannabis or b) an euphoric effect that in at least one parameter corresponds to an effect experienced in the same cannabis smoker upon smoking of cannabis.
One of the advantages of using such a composition is that the smell and/or taste of such a composition may associate the subject in need of rehabilitation with the psychoactive substances used in the current substance dependency.
In one or more embodiments, the composition comprising a scent according to the invention, comprises one or more terpenes and/or terpenoids.
In one or more embodiments, the one or more terpenes and/or terpenoids are selected from monoterpenes, monoterpenoids, sesquiterpenes, or sesquiterpenoids.
In one or more embodiments, the one or more terpenes and/or terpenoids are terpenes and/or terpenoids naturally found in Cannabis.
In one or more embodiments, the one or more terpenes and/or terpenoids are extracted from plant material. In one or more embodiments, the plant material is obtained from Cannabis. In one or more embodiments, the Cannabis is selected from the species Cannabis sativa, Cannabis indica, or Cannabis ruderalis.
In one or more embodiments, the extract from plant material is a whole extract. By whole extract is meant a substance made by extracting all or most of the terpenes and/or terpenoids from a raw material e.g., leaves, seeds, or buds in a plant. The whole extract may be obtained using a solvent such as e.g., ethanol.
In one or more embodiments, the extract is made from the leaf carrying parts of the plant. The leaf carrying parts is the part of the plant located above the soil. In one or more embodiments, the extract is a cannabis extract made by alcohol extraction, such as by ethanol extraction.
In one or more embodiments, the monoterpenes and/or monoterpenoids are selected from one or more of Myrcene, Pinene, Limonene, Caryophyllene, Linalool, Terpinolene, Camphene, Terpineol such as alpha-Terpineol, Phelandrene such as beta-Phellandrene, careen such as delta-3-carene, Humulene, Pulegone, Sabinene such as cis-Sabinene hydrate, or Geraniol. In one or more embodiments, the composition comprises one or more of Myrcene or Limonene.
In one or more embodiments, the sesquiterpenes and/or sesquiterpenoids are selected from one or more of Caryophyllene, Farnesene, alpha-Humulene, Guajol, alpha-Guaiene, Eudesmol, Selinene, Bergamotene, gamma-Curcumene, epi-alpha- Bisabolol, alpha-Ylangene, beta-Elemene, gamma-Muurolene, alpha-Cadinene, alpha-Longipinene, or Bisabolene.
In one or more embodiments, the monoterpenes and/or monoterpenoids are selected from one or more of Myrcene, Limonene, Linalool, Ocimene, Pinene, delta- 3-carene, beta-Fenchol, beta-Phellandrene, Terpinolene, alpha-Terpineol, Fenchone, Camphene, cis-Sabinene hydrate, Borneol, alpha-Thujene, Pulegone, Geraniol, or Ipsdienol. In one or more embodiments, the Ocimene is selected from one or more of trans- Ocimene or c/s-Ocimene.
In one or more embodiments, the Pinene is selected from one or more of alpha- Pinene or beta-Pinene.
In one or more embodiments, the monoterpenes and/or monoterpenoids are selected from one or more of Myrcene, alpha-Pinene, beta-Pinene, Limonene, Linalool, Terpinolene, Camphene, alpha-Terpineol, beta-Phellandrene, delta-3- carene, Pulegone, cis-Sabinene hydrate, or Geraniol.
In one or more embodiments, the sesquiterpenes and/or sesquiterpenoids are selected from one or more of Caryophyllene, Farnesene, alpha-Humulene, Guajol, alpha-Guaiene, Eudesmol, Selinene, Bergamotene, gamma-Curcumene, epi-alpha- Bisabolol, alpha-Ylangene, beta-Elemene, gamma-Muurolene, alpha-Cadinene, alpha-Longipinene, or Bisabolene.
In one or more embodiments, the Caryophyllene is selected from one or more of alpha-Caryophyllene, beta-Caryophyllene, or Caryophyllene oxide.
In one or more embodiments, the Farnesene is selected from one or more of trans- alpha-Farnesene or c/s-beta-Farnesene. In one or more embodiments, the Eudesmol is selected from one or more of alpha- Eudesmol, beta-Eudesmol, or gamma-Eudesmol.
In one or more embodiments, the Selinene is selected from one or more of alpha- Selinene or beta-Selinene.
In one or more embodiments, the Bergamotene is selected from one or more of alpha-irans-Bergamotene or alpha-c/s-Bergamotene.
In one or more embodiments, the Bisabolene is selected from one or more of c/'s- gamma-Bisabolene or irans-gamma-Bisabolene.
In one or more embodiments, the sesquiterpenes and/or sesquiterpenoids are selected from one or more of alpha-Caryophyllene, beta-Caryophyllene, Caryophyllene oxide, alpha-Humulene.
In one or more embodiments, the composition comprises caryophyllene.
In one or more embodiments, the concentration of the one or more terpenes and/or terpenoids in the composition is in the range of 0.1 % - 100%.
In one or more embodiment, a cannabinoid component is present in a percentage of less than 2 percent w/w. An advantage of avoiding a composition containing cannabinoids may be to avoid all the negative effects these compounds exhibit when interacting with receptors in cells and hereby altering the neurotransmitter release in the brain. In one or more embodiments, a cannabinoid component is present in a percentage of less than 5 percent w/w, such as less than 4 percent w/w, such as less than 3 percent w/w, such as less than 2 percent w/w, such as less than 1 percent w/w, such as less than 0.5 percent w/w. In another embodiment, a cannabinoid component is present in a percentage between 0 to 5 percent w/w, such as between 0 and 4 percent w/w, such as between 0 and 3 percent w/w, such as between 0 and 2 percent w/w, such as between 0 and 1 percent w/w, such as between 0 and 0.5 percent w/w. In another embodiment, a cannabinoid component is present in a percentage between 0 to 5 percent w/w, such as between 1 and 5 percent w/w, such as between 2 and 5 percent w/w, such as between 3 and 5 percent w/w, such as between 4 and 5 percent w/w. In yet another embodiment, a cannabinoid component is present in a percentage between 0 to 5 percent w/w, such as between 1 and 5 percent w/w, such as between 1 and 4 percent w/w, such as between 1 and 3 percent w/w, such as between 1 and 2 percent w/w, such as between 2 and 5 percent w/w, such as between 2 and 4 percent w/w, such as between 2 and 3 percent w/w, such as between 3 and 5 percent w/w, such as between 3 and 4 percent w/w, such as between 4 and 5 percent w/w.
In one or more embodiments, a tetrahydrocannabinol (THC) component is present in a percentage of less than 0.1 percent w/w, such as less than 0.001 % w/w.
An advantage of avoiding THC may be that the subject utilizing the compound avoids the psychoactive activity of said compound. In one or more embodiments, a tetrahydrocannabinol (THC) component is present in a percentage of less than 0.75 percent w/w, such as less than 0.5 percent w/w, such as less than 0.25 percent w/w. In one or more embodiments, a tetrahydrocannabinol (THC) component is present in a percentage of less than 5 percent w/w, such as less than 4 percent w/w, such as less than 3.5 percent w/w, such as less than 3 percent w/w, such as less than 2.5 percent w/w, such as less than 2 percent w/w, such as less than 1 .5 percent w/w, such as less than 1 percent w/w, such as less than 0.75 percent w/w, such as less than 0.5 percent w/w, such as less than 0.25 percent w/w or such as less than 0.1 percent w/w.
In one or more embodiments, a cannabidiol (CBD) component is present in a percentage of less than 0.5 percent w/w.
In one or more embodiments, a cannabidiol (CBD) component is present in a percentage of less than 5 percent w/w, such as less than 4 percent w/w, such as less than 3.5 percent w/w, such as less than 3 percent w/w, such as less than 2.5 percent w/w, such as less than 2 percent w/w, such as less than 1 .5 percent w/w, such as less than 1 percent w/w, such as less than 0.75 percent w/w, such as less than 0.5 percent w/w, such as less than 0.25 percent w/w or such as less than 0.1 percent w/w.
In one or more embodiments, the invention provides an inhaler device comprising the compositions of the invention.
One of the advantages of using an inhaler device is that the subject in need of rehabilitation will have a similar experience, as if the subject was smoking the substance.
In one or more embodiments, the composition or inhaler device is for use as a medicament. In one or more embodiments, the composition or the inhaler device is for use in treating, alleviating or ameliorating substance dependency in a subject in need thereof. In one or more embodiments, the composition or the inhaler device is for use as a substance dependency rehabilitation composition in substance dependency rehabilitation treatment of a subject in need thereof.
In one or more embodiments, the substance dependency is Cannabis dependency. In one or more embodiments, the substance dependency is Cannabis dependency mixed with other substance dependency. In one or more embodiments, the other substance dependency is opioid dependency. In some embodiments, the other substance is one or more of nicotine, caffeine, cocaine, alcohol or opiates.
In some embodiments, use of the compositions of the invention will provide an entourage effect that will enhance or balance the effects of the use of other substances, allowing the user to reduce the amount of other substance used. Such other substances may in non-limiting example be selected from the list of: alcohol, cannabis, opiates or opiate related drugs, cocaine, nicotine. Another aspect of the present invention is use of a composition comprising a scent, characterized in that a cannabis smoker when exposed to the scent experience one or more of: a) a response in the cannabis smoker that in at least one parameter corresponds to a physiological response experienced in the same cannabis smoker upon smoking of cannabis or b) an euphoric effect that in at least one parameter corresponds to an effect experienced in the same cannabis smoker upon smoking of cannabis as disclosed herein, for the preparation of a medical product, said medical product having substance dependency rehabilitation properties.
In one embodiment, the medical product is an inhaler device comprising the compositions of the invention. An inhaler device is a device containing a composition, which is applied by suction through said device, whereby the composition (e.g., in the form of vaporized liquid) will distribute throughout the oral cavity and into the lungs. The inhaler may comprise means for vaporizing, nebulizing, atomizing, spraying, inhaling, or steaming. The inhaler may be a smoking device e.g., a cigarette.
In one or more embodiments, where the terpenes and/or terpenoids comes from Cannabis, the terpenes and/or terpenoids may be extracted using the following method: The top of the cannabis plants, such as the top 30 cm, such as the top 40 cm, such as the top 50 cm, are harvested to obtain a plant extract or a whole extract containing terpenes from the surface of the leaves and flowers. Within e.g. one hour after harvesting, the cannabis material is contacted with an amount of alcohol (e.g., a liquid containing at least 99% ethanol and no more than 1 % water or a liquid containing at least 96% ethanol and no more than 4% water). The plant material is immersed into the alcohol and moved around in the alcohol. The alcohol is separated from the plant material by filtering. The alcohol including extract is collected in a container. Before pouring the alcohol over the plant material, the alcohol is cooled to a temperature between minus 20 and minus 10 °C, and during the contacting step the temperature of the alcohol increases to a temperature between minus 18 and minus 8 °C. The alcohol is then separated from the plant material and collected in a container. A new portion of absolute alcohol, cooled to a temperature between minus 20 and minus 10 °C, is poured over the plant material, where after the plant material is moved gently around. The step of contacting the plant material with cooled, alcohol is repeated several times, such as between 2 and 10 times, providing a total alcohol solution including extracted components. The liquid, containing alcohol and plant extract, is subjected to a filtration where small particles of remaining plant material are removed from the liquid. The liquid is then subjected to a distillation process where the alcohol is separated from the terpenes. After the distillation process an oily liquid constituting a fraction of terpenes and or terpenoids originally present in the complete Cannabis plant is obtained.
In one or more embodiments of the invention the composition according to the present invention (that is both the composition comprising a scent as disclosed in claim 1 and the composition comprising one or more terpenes and/or terpenoids as disclosed in claim 4) may be administered to a human subject up to 20 times per day, such as up to 15 times per day, such as up to 10 times per day, such as up to 5 times per day or less. The human subject should use the composition formulated e.g. as an inhaler, whenever needed to alleviate the Cannabis craving. Thus in some embodiments, the composition is administered when needed. In one embodiment the composition may be administered for up to 2 times every hour. The compositions of the invention may in some embodiments be used when needed by a subject, such as at times when the subject feel a need for using a drug by which the subject is dependent. The duration of treatment may be as long as needed, such as for as long as the subject feels a need. In one or more embodiments of the invention, a composition, according to the present invention, may be administered to a human subject several times per day for a duration of a specified time, such as between 1 and 5 days, such as between 5 and 8 days, such as between 8 and 14 days. Then a new terpene and/or terpenoid composition may be administered to the human subject several times per day for a duration of a specified time, such as between 1 and 5 days, such as between 5 and 8 days, such as between 8 and 14 days. The composition may then again be switched to a new terpene and/or terpenoid composition to be administered to the human subject several times per day for a duration of a specified time such as between 1 and 5 days, such as between 5 and 8 days, such as between 8 and 14 days. Through this method of treatment, the subject in need of rehabilitation will be tricked to experience the composition as if it was actually containing the euphoric compound.
In one or more embodiments of the invention, a composition, according to the present invention, may be used in combination with Cannabis by mixing the composition with Cannabis and then smoking said Cannabis-composition mixture. Through this method of treatment, the subject in need of rehabilitation will experience the composition in combination with Cannabis, which still contains the euphoric compound THC. The subject in need of rehabilitation may then gradually add more composition and less Cannabis to reduce the substance dependency slowly.
The composition or the inhaler device as disclosed herein (this encompass both the composition comprising a scent as disclosed in claim 1 and the composition comprising one or more terpenes and/or terpenoids as disclosed in claim 4) can be used in combination with different ways of known therapy, such as detoxification, behavioural counselling, group therapy, psychiatric therapy, cognitive behavioural therapy, comorbid cognitive behavioural therapy, the Minnesota Model of addiction therapy, or medication with e.g., opioids or tobacco.
The intent of substance dependency rehabilitation treatment is to enable the subject in need thereof to confront substance dependence, and cease the substance dependency in order to avoid negative consequences. There are many different ways of known therapy. These current treatments includes detoxification, medication for depression or other psychiatric disorders, medication with e.g. opioids, counseling by experts, and sharing of experience with other addicts in small closed groups (group therapy). It may be advantageous to combine a medical product according to the present disclosure in a combination with currently used treatments. This combination therapy may give the subject in need of rehabilitation the advantages of the currently known treatments, while also benefiting with the advantages of the medical product in that the smell and taste of said medical product may be associated with the psychoactive substances used in the current substance dependency.
In one or more embodiments, the composition or the inhaler device is for use in ameliorating the symptoms of withdrawal from substance dependency rehabilitation treatment. In one or more embodiments, the Cannabis dependency is characterized by the subject abusing Cannabis or Cannabis derived products at least once per week, such as at least twice per week, such as at least any one of 3, 4, 5, 6, or 7 days per week. In one or more embodiments, the cannabis dependency is characterized by the subject using Cannabis or Cannabis derived products daily.
In one or more embodiments, the cannabis dependency is characterized by the subject in need thereof is a subject that seeks treatment for the dependency. In one or more embodiments, the effect of the use of the composition or the inhaler device as disclosed herein is determined by observing one or more of increased heart rate, red eyes, thirst, or sugar craving, or one or more of decreased working memory or processing speed, as measured by the Wechsler Adult Intelligence Scale test.
The Wechsler Adult Intelligence Scale (WAIS) is an IQ test designed to measure intelligence and cognitive ability in adults and older adolescents. The original WAIS (Form I) was published in February 1955 by David Wechsler, as a revision of the Wechsler-Bellevue Intelligence Scale, released in 1939. It is currently in its fourth edition (WAIS-IV) released in 2008 by Pearson. It is a well-known and used psychological test and is the most widely used IQ test, for both adults and older adolescents, in the world.
In one or more embodiments, an effect of the use of the composition or the inhaler device as disclosed herein is determined by observing one or more of increased heart rate, decreased working memory, decreased processing speed, or increased systolic blood pressure.
In one or more embodiments, the effect of the use of the composition or the inhaler device as disclosed herein is determined by observing an increased heart rate. The Heart rate is the speed of the heartbeat measured by the number of contractions of the heart per minute (bpm).
In one or more embodiments, the effect of the use of the composition or the inhaler device as disclosed herein is determined by observing an increased heart rate of at least 5%, such as at least 10%, such as at least 15%, such as at least 20%, such as at least 25%. In one or more embodiments, the effect of the use of the composition or the inhaler device as disclosed herein is determined by observing at least a 20% increase in heart rate for at least one minute within the first 30 minutes of the use. In one or more embodiments, the effect of the use of the composition or the inhaler device as disclosed herein is determined by observing an increased systolic blood pressure. The systolic blood pressure is the maximum blood pressure during one heartbeat, whereas the diastolic blood pressure is the minimum pressure in between two heartbeats. The blood pressure is normally described as the systolic blood pressure over the diastolic blood pressure. It is usually measured in millimeters of mercury (mmHg). The blood pressure is one of the vital signs. Other vital signs are respiratory rate, heart rate, oxygen saturation, and body temperature.
In one or more embodiments, the effect of the use is determined by observing an increased systolic blood pressure by at least 5%, such as at least 10%, such as at least 15%.
In one or more embodiments, the effect of the use of the composition or the inhaler device as disclosed herein is determined by observing one or more of decreased working memory or processing speed, as measured by the Wechsler Adult Intelligence Scale test.
In one aspect, present invention relates to a method for extracting terpenes.
The method according to the invention may comprise one or more steps for extracting terpenes. The method may comprises the following steps:
In the first step a) feed material is provided by harvesting the top of cannabis plants. Normally, the upper 35-40 cm of the cannabis plants is harvested and used. However, the length of the harvested material may vary with the strain and the conditions of the plants. In order to obtain an extract with the required terpene composition and without cannabinoids harvested plant material is not subjected to cutting or crushing operations before entering the extraction process.
After harvest, an amount of harvested cannabis material is transported to an extraction unit containing one or more vessels. In these one or more vessels the contacting step b) is performed and the extraction step b) is conducted by either placing the cannabis plant material in a vessel and pouring a solvent over the cannabis plant material or alternatively by immersing the cannabis plant material into a pool of solvent. While the cannabis plant material is immersed at least partly or wholly in the solvent the cannabis plant material may be gently agitated in the solvent thereby increasing the contact between solvent and solid material.
The solvent must be liquid during the time of contact and the solvent must therefore have a melting point below the contact temperature and a boiling point higher than the temperature at which contact takes place. As the terpenes are non-polar molecules or at least has a larger non-polar part, the solvent should also be non- polar or have a non-polar part.
There are numerous types of solvent that may be used in the extraction procedure such as alkanes or alkenes, various aromatic compounds, alcohols, ethers and halogenated hydrocarbons.
Aromatic compounds used as solvents may be e.g. benzene or toluene. With respect to alcohols, ethanol is considered to be a useful solvent as ethanol is liquid around -20°C, and as it has a relatively low boiling point, i.e. the boiling point of ethanol is considerably lower than the boiling point of the terpenes, which boiling point is around 165°C for the terpenes having the lowest boiling point. The difference in boiling temperatures allows a very gently removal of the solvent. Also, ethanol has a non-polar part i.e. the d- -CI- -group allowing ethanol to act as a solvent for non-polar components. Another example is methanol.
Yet a further example is ethers of various kinds and notably diethylether and/or tetrahydrofuran.
With respect to other solvent, halogenated hydrocarbons may be envisaged. Halogenated hydrocarbons may be e.g. dichloromethane or chloroform, or may be mixed chloro-fluoro hydrocarbons such as e.g. CC F, CCI2F2, CCIF3, or mixtures hereof, and usually referred to as Freons having a boiling point around -30°C. This implies that the contact temperature should be below -30°C, possibly around -40°C. It should be noted that the solvent may be any mix of the above mentioned solvent. As mentioned above, it is important that the solvent is cold during the complete contacting step b. By "cold" is meant below normal standard temperature of 20- 25°C. Normally, the temperature should be below 10°C, and preferably as low as possible. This will be dependent upon the solvent or solvent mixtures used in the extraction process. How low a temperature it is possible to obtain is merely a financial matter, but it may also depend on the physical circumstances at which the extraction takes place. If energy is expensive and the climate at the position of extraction is very warm, it could be very expensive to the lower the temperature below -20- -18°C, although it might be desired. A low temperature prevents cannabinoids from being extracted, or at least reduces the amount of cannabinoids being extracted and entering the solvent phase, in favour of having the terpenes extracted into the solvent/organic phase.
In order to further impede the extraction of cannabinoids, the time of contact between solvent and cannabis plant material is kept relatively short. The time of contact of step b) should therefore not exceed 30 minutes, and normally the time of contact of step b) will not exceed 15 minutes. The "time of contact" is considered to be from the moment where the cannabis plant material is immersed in solvent to the moment where the solvent is separated from the cannabis plant material. After a contacting step b), the mixture of cannabis plant material and solvent is separated in a step c), and the cannabis plant material is either subjected to a further contacting step b (3) or the cannabis plant material is being disposed of (4). If the cannabis plant material is believed to still contain an available amount of terpenes, the cannabis plant material is subjected to yet a contacting step b. The contacting step b will normally be repeated from 2 to 10 times, the time of contact may vary for each step, but the duration i.e. the time of contact for each contacting step will not exceed 30 minutes. After the last contacting step the solvent including extracted components may be transferred (6) to a filtration unit and subjected to one or more steps of filtration. This procedure can remove any remaining parts of plant material from the liquid. When a satisfyingly clear liquid is obtained, the solvent including the extracted components is subjected to a separation process providing a fraction (7) containing terpenes and a fraction (8) containing solvent. As the terpenes included in cannabis plants have boiling points from 165°C and above, it will normally be possible to evaporate the solvent from the terpene mixture. However, if a solvent with a high boiling point is chosen, other separation methods may be chosen.
The invention is further illustrated in the below seen non-limiting example.
When describing the embodiments of the present invention, the combinations and permutations of all possible embodiments have not been explicitly described. Nevertheless, the mere fact that certain measures are recited in mutually different dependent claims or described in different embodiments does not indicate that a combination of these measures cannot be used to advantage. The present invention envisages all possible combinations and permutations of the described embodiments.
Examples
Example 1
Terpene or scent extraction
The top 40 cm of four cannabis plants where harvested in order to extract terpenes from the surface of the leaves and flowers. Approximately one kg of Cannabis plant material was obtained.
One hour after harvesting the Cannabis material it is contacted with 5 litres of absolute alcohol. The plant material is immersed into the alcohol and moved gently around in the alcohol for about 5 minutes, and then the alcohol is separated from the plant material by filtering. The alcohol including extract is collected in a container. Before pouring the alcohol over the plant material, the alcohol is cooled to minus 18 °C, and during the contacting step the temperature of the alcohol increases, however during the complete contacting step the temperature remains below minus 14 °C.
The alcohol is separated from the plant material and collected in the container, and a new portion of 5 litres of absolute alcohol, cooled to a temperature of minus 18 °C, is poured over the plant material, where after the plant material is immersed into the alcohol and moved gently around for about 5 minutes. The step of contacting the plant material with cooled, absolute alcohol is repeated 7 times, providing a total of 35 litres of alcohol including extracted components. The approximately 35 litres of liquid containing alcohol and extract is subjected to a filtration where small particles of remaining plant material are removed from the liquid.
The liquid is then subjected to an evaporation process where the alcohol is separated from the terpenes. The evaporation process is performed in a rotary evaporator at a temperature of 90 °C.
After the evaporation process, an oily liquid constituting a fraction of terpenes originally present in the complete Cannabis plant is obtained. The content of terpenes in the oily liquid is examined by Gas chromatography-mass spectrometry (GC-MS) and shown I table 1 below.
Component
22,0 Caryophyllene; MW: 204 g/mol; MF: C15H24; bicyclic sesquiterpene
%
15,0 Myrcene; MW: 136 g/mol; MF: C10H16; acyclic monoterpene
%
9,7 % alpha-Pinene; MW: 136; MF: C10H16; bicyclic monoterpene
7,8 % Humulene; MW: 204 g/mol; MF: C15H24; monocyclic sesquiterpene
6,6 % Limonene; MW: 136; MF: C10H16; monocyclic monoterpene
4,3 % alpha-Gurjunene or Guaiene; MW: 204 g/mol; MF:CisH24; tricyclic or
bicyclic sesquiterpenes
4,0 % beta-Pinene; MW: 136; MF: C10H16; bicyclic monoterpene
3,7 % Caryophyllene oxide; MW: 220 g/mol; MF: C15H24O; sesquiterpenoid
3,2 % Carene or terpinolene; MW: 136 g/mol; MF: C10H16; bicyclic or monocyclic monoterpene
Table 1 : Composition of terpene fraction obtained by separation from
alcohol (Example 1 )
The remaining part of the terpene fraction (i.e. 23.7%) contains a mixture of terpenes and/or terpenoids each represented by a content below 1 %. The total amount of cannabinoids present in the mixture is characterized as trace elements i.e. the total amount of cannabinoids is well below 1 %. Also, small amounts of other types of extracts such as e.g., hydrocarbons, lipids, or proteins may be present.
Example 2
The top 40 cm of 4 cannabis plants were harvested in order to extract terpenes from the collected plant material. Approximately 5 kg of cannabis plant material was obtained. The material was dried for approximately 20 hours or less.
Within 1 hour after harvesting the cannabis material is contacted with 20-30 litres of absolute ethyl alcohol i.e. a liquid containing at least 99% ethanol and no more than 1 % water. The plant material is immersed into the alcohol and moved gently around in the alcohol for about 5 minutes, and then the alcohol is separated from the plant material by filtering. The alcohol including extract is collected in a container. Before pouring the alcohol over the plant material, the alcohol is cooled to -18°C, and during the contacting step the temperature of the alcohol increases, however during the complete contacting step the temperature remains below -14°C.
The alcohol is separated from the plant material and collected in the container, and a new portion of 20-30 litres of absolute alcohol cooled to a temperature of -18°C is poured over the plant material where after the plant material is immersed into the alcohol and moved gently around for about 5 minutes. The step of contacting the plant material with cooled, absolute alcohol is repeated 7 to 10 times, providing a total of about 200-300 litres of alcohol including extracted components. The approximately 200-300 litres of liquid containing alcohol and extract is subjected to a filtration where small particles of remaining plant material are removed from the liquid.
The liquid is then subjected to an evaporation process where the alcohol is separated from the terpenes. The evaporation process is performed on a rotary evaporator at a temperature of about 35-40°C, or alternatively the solvent is allowed to evaporate spontaneously.
After the distillation process an oily liquid constituting a fraction of terpenes originally present in the complete cannabis plant is obtained. The content of terpenes in the oily liquid is examined by Gas chromatography-mass spectrometry (GC-MS).
Content Component
22,0 % Caryophyllene
MW: 204 g/mol; MF: C15H24;
bicyclic sesquiterpene
Figure imgf000046_0001
Figure imgf000046_0003
15,0 % Myrcene
MW: 136 g/mol, MF: C10-H16;
Figure imgf000046_0002
acyclic monoterpene
Figure imgf000047_0002
Figure imgf000047_0001
Figure imgf000047_0003
Figure imgf000048_0002
Figure imgf000048_0001
Figure imgf000049_0002
Figure imgf000049_0001
3,2 % Carene or terpinolene
MW: 136 g/mol; MF: C10-H16
Bicyclic monoterpene and monocyclic
monoterpene
Figure imgf000050_0001
76,3 % Total amount of terpenes
Table 2: Composition of terpene fraction obtained by separation from alcohol
The remaining part of the terpene fraction i.e. 23.7% contains a mixture of terpenes and/or terpenoids each represented by a content below 1 %. The total amount of cannabinoids present in the mixture is characterized as trace elements i.e. the total amount of cannabinoids is well below 1 %. Also, small amounts of other types of extracts such as e.g. hydrocarbons, lipids or proteins may be present. In one aspect, present invention also relates to the following items:
1. A composition comprising a scent, characterized in that a cannabis smoker when exposed to the scent experience one or more of:
a. a response in the cannabis smoker that in at least one parameter corresponds to a physiological response experienced in the same cannabis smoker upon smoking of cannabis, or
b. an euphoric effect that in at least one parameter corresponds to an effect experienced in the same cannabis smoker upon smoking of cannabis.
2. A composition according to item 1 , characterized in that the composition comprises one or more terpenes and/or terpenoids. A composition according to item 2, wherein the one or more terpenes and/or terpenoids are selected from monoterpenes, monoterpenoids, sesquiterpenes, or sesquiterpenoids. A composition according to anyone of items 1 -3, for use in alleviation of substance dependency in a subject in need thereof. A composition according to item 4, wherein the one or more terpenes and/or terpenoids are selected from monoterpenes, monoterpenoids, sesquiterpenes, or sesquiterpenoids. A composition according to anyone of items 1 -3 or items 4 or 5, wherein a cannabinoid component is present in a percentage of less than 2 percent w/w. A composition according to anyone of items 1 -3 or items 4-6, for use in treating or ameliorating substance dependency in a subject in need thereof. A composition according to anyone of items 1 -3, for use as a substance dependency rehabilitation composition in substance dependency rehabilitation treatment of a subject in need thereof. A composition according to item 7 or 8, wherein an effect of the use is determined by observing one or more of increased heart rate, decreased working memory, decreased processing speed, or increased systolic blood pressure. Use of a composition comprising one or more terpenes and/or terpenoids for the preparation of a medical product, said medical product having substance dependency rehabilitation properties. further aspect, present invention also relates to the following articles: 1. Method for isolating terpenes from cannabis plants comprising the following steps:
a) harvesting cannabis plant material by cutting the stems at preferred height determined according to the grown cannabis,
b) the harvested fraction of cannabis plant material is brought into contact with a liquid solvent having a temperature below 10°C, the contact is maintained until at least part of the terpenes contained in the cannabis plant material is extracted and enters the solvent phase,
c) the solvent is separated from the plant material providing a terpene-enriched fraction of solvent, and the plant material is returned to step b) if the terpene-content of the cannabis plant material is considered high enough,
e) the terpene-enriched solvent fractions obtained in step c) are subjected to a separation procedure by which procedure the solvent is separated from the extracted terpenes.
2. Method according to article 1 , wherein step c) is initiated less than 12 hours after harvesting the cannabis plants i.e. after step a), alternatively less than 8 hours, less than 4 hours or less than 1 hour after harvesting the cannabis plant material. 3. Method according to article 1 or 2, wherein the one or more terpene-enriched solvent fractions obtained after step c) are subjected to filtration in a step d) before entering step e).
4. Method according to any of previous articles, wherein the solvent of step b) has a temperature below 5°C during complete contact step b), alternatively below 0°C, below -10°C, or below -20°C during complete contact step b).
5. Method according to any of previous articles, wherein the solvent is liquid at the contact temperature of step b) i.e. the solvent has a melting point below the contact temperature of step b) and the solvent is non-polar or comprises a non-polar part.
6. Method according to any of previous articles, wherein the solvent is ethanol having a water content between 0.001 and 10%, between 0.001 and 5 %, between 0.001 and 1 % or below 1 %. 7. Method according to any of previous articles wherein the contact between solvent and cannabis plant material lasts or is maintained between 5 seconds to 15 minutes, between 5 seconds and 10 minutes, between 1 minute and 10 minutes or between 1 minute and 5 minutes.
8. Method according to any of previous articles, wherein the cannabis plant material in contact step b) is soaked in solvent while stirring. 9. Method according to any of previous articles, wherein the terpene-enriched fractions of step e) is either collected to a batch portion which is then subjected to separation or the terpene-enriched fractions are continuously subjected to a separation. 10. Method according to any of previous articles, wherein the terpene-enriched fractions of step d) is subjected to fractional distillation in order to separate solvent from terpenes.
11. A product obtained by the method according to any of the articles 1 -10, wherein the product is liquid and comprises or is constituted of a combination of terpenes originating from and extracted from cannabis plants and the total content of cannabinoids in the product is below 2%, below 1 % or below 0.1 %.
12. A product obtained according to article 1 1 , wherein the combination of terpenes comprises a group of at least 3 different terpenes, alternatively at least 5 different terpenes, present in amounts above 3% of the total amount, and at least two of caryophyllene, myrcene and opinene are in this group.
13. A product obtained according to any of articles 1 1 -12, wherein the combination of terpenes comprises a group of at least 5 different terpenes, alternatively at least 7 different terpenes, present in amounts above 1 %, and at least two of caryophyllene, myrcene and opinene are in this group and at least one of limonene and humulene is in this group. 14. A product obtained according to any of the articles 1 1 -13, wherein the product does not comprise a terpene comprising an OH-group such as linalool, fenchol, terpineol guaiol and eudesmol in an amount of more than 1 %.

Claims

Claims
A composition comprising a scent, characterized in that a cannabis smoker when exposed to the scent experience one or more of:
a. a response in the cannabis smoker that in at least one parameter corresponds to a physiological response experienced in the same cannabis smoker upon smoking of cannabis, or
b. an euphoric effect that in at least one parameter corresponds to an effect experienced in the same cannabis smoker upon smoking of cannabis.
A composition according to claim 1 , characterized in that the composition comprises one or more terpenes and/or terpenoids.
A composition according to claim 2, wherein the one or more terpenes and/or terpenoids are selected from monoterpenes, monoterpenoids, sesquiterpenes, or sesquiterpenoids.
A composition according to anyone of claims 1 -3, for use in alleviation of substance dependency in a subject in need thereof.
A composition according to claim 4, wherein the one or more terpenes and/or terpenoids are selected from monoterpenes, monoterpenoids, sesquiterpenes, or sesquiterpenoids.
A composition according to anyone of claims 1 -3 or claims 4 or 5, wherein a cannabinoid component is present in a percentage of less than 2 percent w/w.
A composition according to anyone of claims 1 -3 or claims 4-6, for use in treating or ameliorating substance dependency in a subject in need thereof.
A composition according to anyone of claims 1 -3, for use as a substance dependency rehabilitation composition in substance dependency rehabilitation treatment of a subject in need thereof.
9. A composition according to claim 7 or 8, wherein an effect of the use is determined by observing one or more of increased heart rate, decreased working memory, decreased processing speed, or increased systolic blood pressure.
10. Use of a composition comprising one or more terpenes and/or terpenoids for the preparation of a medical product, said medical product having substance dependency rehabilitation properties.
11. Method for isolating onr or more terpenes from cannabis plants comprising the following steps:
a) harvesting cannabis plant material by cutting the stems at preferred height determined according to the grown cannabis,
b) the harvested fraction of cannabis plant material is brought into contact with a liquid solvent having a temperature below 10°C, the contact is maintained until at least part of the terpenes contained in the cannabis plant material is extracted and enters the solvent phase,
c) the solvent is separated from the plant material providing a terpene- enriched fraction of solvent, and the plant material is returned to step b) if the terpene-content of the cannabis plant material is considered high enough, e) the terpene-enriched solvent fractions obtained in step c) are subjected to a separation procedure by which procedure the solvent is separated from the extracted terpenes.
12. Method according to claim 1 1 , wherein step c) is initiated less than 12 hours after harvesting the cannabis plants i.e. after step a), alternatively less than 8 hours, less than 4 hours or less than 1 hour after harvesting the cannabis plant material.
13. Method according to claim 1 1 or 12, wherein the one or more terpene-enriched solvent fractions obtained after step c) are subjected to filtration in a step d) before entering step e).
14. Method according to any previous claims 1 1 -13, wherein the solvent of step b) has a temperature below 5°C during complete contact step b), alternatively below 0°C, below -10°C, or below -20°C during complete contact step b).
15. Method according to any previous claims 1 1 -14, wherein the solvent is liquid at the contact temperature of step b) i.e. the solvent has a melting point below the contact temperature of step b) and the solvent is non-polar or comprises a non-polar part.
16. Method according to any previous claims 1 1 -15, wherein the solvent is ethanol having a water content between 0.001 and 10%, between 0.001 and 5 %, between 0.001 and 1 % or below 1 %.
17. Method according to any previous claims 1 1 -16, wherein the contact between solvent and cannabis plant material lasts or is maintained between 5 seconds to 15 minutes, between 5 seconds and 10 minutes, between 1 minute and 10 minutes or between 1 minute and 5 minutes.
18. Method according to any previous claims 1 1 -17, wherein the cannabis plant material in contact step b) is soaked in solvent while stirring.
19. Method according to any previous claims 1 1 -18, wherein the terpene-enriched fractions of step e) is either collected to a batch portion which is then subjected to separation or the terpene-enriched fractions are continuously subjected to a separation.
20. Method according to any previous claims 1 1 -19, wherein the terpene-enriched fractions of step d) is subjected to fractional distillation in order to separate solvent from terpenes.
21. A product obtained by the method according to any of the claims 1 1 -20, wherein the product is liquid and comprises or is constituted of a combination of terpenes originating from and extracted from cannabis plants and the total content of cannabinoids in the product is below 2%, below 1 % or below 0.1 %.
22. A product obtained according to claim 21 , wherein the combination of terpenes comprises a group of at least 3 different terpenes, alternatively at least 5 different terpenes, present in amounts above 3% of the total amount, and at least two of caryophyllene, myrcene and opinene are in this group.
23. A product obtained according to any of claims 21 -22, wherein the combination of terpenes comprises a group of at least 5 different terpenes, alternatively at least 7 different terpenes, present in amounts above 1 %, and at least two of caryophyllene, myrcene and opinene are in this group and at least one of limonene and humulene is in this group.
24. A product obtained according to any of the claims 21 -23, wherein the product does not comprise a terpene comprising an OH-group such as linalool, fenchol, terpineol guaiol and eudesmol in an amount of more than 1 %.
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