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WO2021127749A1 - Compositions comprenant des terpènes et leur utilisation dans le traitement ou le soulagement de la douleur ou de l'anxiété - Google Patents

Compositions comprenant des terpènes et leur utilisation dans le traitement ou le soulagement de la douleur ou de l'anxiété Download PDF

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Publication number
WO2021127749A1
WO2021127749A1 PCT/AU2020/051437 AU2020051437W WO2021127749A1 WO 2021127749 A1 WO2021127749 A1 WO 2021127749A1 AU 2020051437 W AU2020051437 W AU 2020051437W WO 2021127749 A1 WO2021127749 A1 WO 2021127749A1
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Prior art keywords
composition
oil
pain
anxiety
glyceryl
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Ceased
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PCT/AU2020/051437
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English (en)
Inventor
Philip Madden
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Cannadol Pharmaceuticals Ltd
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Cannadol Pharmaceuticals Ltd
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Priority claimed from AU2019904940A external-priority patent/AU2019904940A0/en
Application filed by Cannadol Pharmaceuticals Ltd filed Critical Cannadol Pharmaceuticals Ltd
Priority to AU2020412501A priority Critical patent/AU2020412501A1/en
Publication of WO2021127749A1 publication Critical patent/WO2021127749A1/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/01—Hydrocarbons
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/01—Hydrocarbons
    • A61K31/015—Hydrocarbons carbocyclic
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/045—Hydroxy compounds, e.g. alcohols; Salts thereof, e.g. alcoholates
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/045—Hydroxy compounds, e.g. alcohols; Salts thereof, e.g. alcoholates
    • A61K31/05—Phenols
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/185—Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
    • A61K31/19—Carboxylic acids, e.g. valproic acid
    • A61K31/192—Carboxylic acids, e.g. valproic acid having aromatic groups, e.g. sulindac, 2-aryl-propionic acids, ethacrynic acid 
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/33—Heterocyclic compounds
    • A61K31/335—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin
    • A61K31/35—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin having six-membered rings with one oxygen as the only ring hetero atom
    • A61K31/352—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin having six-membered rings with one oxygen as the only ring hetero atom condensed with carbocyclic rings, e.g. methantheline 
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/658—Medicinal preparations containing organic active ingredients o-phenolic cannabinoids, e.g. cannabidiol, cannabigerolic acid, cannabichromene or tetrahydrocannabinol
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/44—Oils, fats or waxes according to two or more groups of A61K47/02-A61K47/42; Natural or modified natural oils, fats or waxes, e.g. castor oil, polyethoxylated castor oil, montan wax, lignite, shellac, rosin, beeswax or lanolin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/4841—Filling excipients; Inactive ingredients
    • A61K9/4858—Organic compounds
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/4841—Filling excipients; Inactive ingredients
    • A61K9/4875—Compounds of unknown constitution, e.g. material from plants or animals
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00—Drugs for disorders of the nervous system
    • A61P25/22—Anxiolytics
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P29/00—Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
    • A61P29/02—Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID] without antiinflammatory effect
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2300/00—Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0014—Skin, i.e. galenical aspects of topical compositions
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
    • A61K9/0056—Mouth soluble or dispersible forms; Suckable, eatable, chewable coherent forms; Forms rapidly disintegrating in the mouth; Lozenges; Lollipops; Bite capsules; Baked products; Baits or other oral forms for animals
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/007—Pulmonary tract; Aromatherapy
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/06—Ointments; Bases therefor; Other semi-solid forms, e.g. creams, sticks, gels
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/08—Solutions
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/70—Web, sheet or filament bases ; Films; Fibres of the matrix type containing drug
    • A61K9/7023—Transdermal patches and similar drug-containing composite devices, e.g. cataplasms

Definitions

  • the present invention relates to the use of compositions comprising terpenes for the treatment or alleviation of pain in patients in need thereof.
  • the present invention also relates to the use of compositions comprising terpenes for the treatment or alleviation of anxiety in patients in need thereof.
  • the compositions may comprise mixtures of cannabinoids and appropriate terpenes.
  • Cannabis sativa L. produces more than 60 terpeno-phenols that are not found in any other plant. Many of these compounds are thought to be of medical importance.
  • a 9 -tetrahydrocannabinol (A 9 -THC) (Gaoni & Mechoulam, 1964) is an important member of this group and has been the subject of research for many years.
  • a 9 -THC is known as the major psychoactive component obtainable from cannabis products, and as such, is often less favoured as a compound of interest by medical researchers.
  • Other components of cannabis are not known to be psychoactive, and have been extensively researched for their medical properties.
  • cannabinoids are precursors of the neutral cannabinoids. These, such as THC acid and CBD acid, have been found by investigators to be antibiotic and have previously shown utility in veterinary medicine.
  • Terpenes are hydrocarbon compounds produced by many plants and insects.
  • terpenoids or isoprenoids
  • Terpenes and terpenoids are used to produce essential oils, which are the main constituents of many perfumes and traditional medicines. Those found in cannabis are thought to affect the functionality and bioavai!ability of the cannabinoids in cannabis products.
  • Myrcene is also present in mangoes, and is the most abundant terpene found in cannabis, constituting up to 65% of the terpene profile of some strains. Myrcene provides much of the aroma of cannabis, and may have anti-inflammatory and sedative properties. Limonene
  • Limonene is found in citrus fruits and provides them with their distinctive aroma. It is also the second most abundant terpene found in cannabis. Limonene is known as an anti-fungal and antibacterial compound and to provide mood enhancement.
  • Pinene is found in pine and provides its distinctive scent. Pinene has been used in traditional medicine as a bronchodilator, anti-inflammatory and an antiseptic.
  • Linalool is found in lavender and is known for its relaxant, anti-anxiety and anti-depressant effects.
  • Endocannabinoids are cannabinoids naturally occurring in the human body. These compounds include the well-known anandamide and 2-arachidonoyl glycerol, and have been found to be involved in the regulation of the immune, cardiovascular, reproductive, respiratory, skeletal and central nervous systems of the human body. They appear to target the CB1/CB2 receptors amongst others (Howlett et ai, 2002), and it is thought that the plant cannabinoids may be able to bind and influence the same receptors.
  • CBD cannabinoids
  • CBD administered alone has been found to have antipsychotic effects as efficacious as standard anti-psychotic drugs but with fewer side effects. It also has shown impressive efficacy in treating intractable childhood epilepsy that cannot be treated with conventional anti-convulsants.
  • Panamax Panamax
  • Non-steroidal anti-inflammatory (NSAIDs) drugs such as ibuprofen
  • NSAIDs are another such non-prescription medication, which are effective against mild to moderate pain.
  • NSAIDs have the potential of serious side-effects and may not be suitable for people with stomach troubles, heart problems, kidney impairment, high blood pressure or asthma.
  • Oral NSAIDs are not recommended for older people. Again, with NSAIDS, overdosing can be dangerous.
  • Cannabinoids have shown significant promise in basic experiments on pain. Cannabinoids appear to block peripheral nerve pain in experimental animals due to directly targeting cannabinoid receptors on peripheral nerves. Research also appears to suggest that opiates and cannabinoids use different pathways to treat pain, which could lead to the addition of cannabis-based medicines to opiates to increase their efficacy while limiting their side effects. The present inventors have surprisingly found that certain terpenes and combinations thereof are also extremely beneficial in the treatment of pain.
  • Antidepressants can improve mood, but they do not provide a long-term solution. Side effects are often experienced, and the risks and benefits must be considered. Common side effects of antidepressant medication can include nausea, headaches, anxiety, sweating, dizziness, agitation, weight gain, dry mouth and sexual difficulties.
  • cannabis-based medicaments can alter mood, perception and motivation. Unregulated or high doses of cannabis have reportedly led to undesirable reactions, such as anxiety, panic or hallucinations, and may lead to impairment of cognitive functions, perception, reaction time, learning and memory.
  • the present inventors have surprisingly found that certain terpenes and combinations thereof are also extremely beneficial in the treatment of anxiety.
  • compositions of the invention have been found to effectively treat pain and anxiety whilst at the same time do not lead to psychoactive effects, impairment of cognitive functions, perception, reaction time, learning or memory.
  • the compositions of the invention are therefore useful alternatives to the traditionally utilised medications currently available in the art for such indications.
  • compositions for use in the treatment of pain or anxiety comprising one or more terpene.
  • the composition may comprise a pharmaceutically acceptable carrier or excipient.
  • the composition further comprises one or more cannabinoid.
  • the composition may further comprise one or more additional cannabinoid.
  • additional cannabinoid optionally selected from the group consisting of THCA (tetrahydrocannabinolic acid), CBD (cannabidiol), CBDA (cannabidiolic acid), CBN (cannabinol), CBG (cannabigerol), CBC (cannabichromene), CBCA (cannabichromenic acid), CBL (cannabicyclol), CBV (cannabivarin), THCV (tetrahydrocannabivarin), CBDV (cannabidivarin), CBCV (cannabichromevarin), CBGV (cannabigerovarin), CBGM (cannabigerol monomethyl ether), CBE (cannabielsoin) and CBT (cannabicitran).
  • said one or more further cannabinoid is selected from the group consisting of CBD and CBG, most preferably CBD.
  • A9-THC may be present in trace amounts, or may be not present in the composition.
  • the composition may be completely free of THC.
  • the A 9 -THC is present in the composition at least 0.01, 0.015, 0.02, 0.025, 0.03, 0.035, 0.04, 0.045, 0.05, 0.055, 0.06, 0.065, 0.07, 0.075, 0.08, 0.085, 0.09, 0.095, 0.100, 0.105, 0.110, 0.115, 0.120, 0.130, 0.135, 0.140, 0.145, 0.150, 0.155, 0.160, 0.165, 0.170, 0.175, 0.180, 0.185, 0.190, 0.195, 0.200, 0.205, 0.210, 0.215, 0.220, 0.225, 0.230, 0.235, 0.240, 0.245, 0.250, 0.255, 0.260, 0.265, 0.270, 0.275, 0.280, 0.285, 0.290 or 0.300 percent by volume.
  • the A9-THC is present in the composition at about 0.120- 0.150 percent by volume.
  • the A9-THC-acid is present in the composition at about 0.010, 0.015, 0.020, 0.025, 0.030, 0.035, 0.040, 0.045, 0.050, 0.055, 0.060, 0.065, 0.070, 0.075, 0.080, 0.085, 0.090, 0.095, 0.100, 0.105, 0.110, 0.115, 0.120, 0.125, 0.130, 0.135, 0.140, 0.145, or 0.150 percent by volume.
  • the A 9 -THC acid if present, is present in the composition at about 0.050-0.100 percent by volume.
  • the terpene of the composition is selected from the group consisting of a pinene, limonene, linalool, caryophyllene, caryophyllene oxide, myrcene, humulene, borneol, eucalyptol, terpineol, nerolidol, phytol, geraniol, bisabolol, camphene, beta- amyrin, thujone, citronellol, pulegone, 1,8-cineole and cycloartenol.
  • Terpenes suitable for use in the invention may be selected from the group consisting of a-Pinene and b-Pinene.
  • a-Pinene is present in the compositions at about 0.100, 0.105, 0.110, 0.115, 0.120, 0.130, 0.135, 0.140, 0.145, 0.150, 0.155, 0.160, 0.165,
  • a-Pinene may be present at about 0.20-0.30 percent by volume.
  • b-Pinene is present in the compositions at about
  • b-Pinene may be present in the compositions at about 0.050-0.100 percent by volume.
  • b-myrcene is present in the compositions at about
  • limonene is present at about 1% to ⁇ 5% w/v.
  • limonene is present in the compositions at about 1,
  • linalool is present at about 1% to ⁇ 5% w/v.
  • linalool is present in the compositions at about 1,
  • b-caryophyllene is present at about 1% to ⁇ 5% w/v.
  • b-caryophyllene is present in the compositions at about 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5 or 4.9% w/v.
  • the present invention relates to a composition for treating a disorder selected from the group consisting of pain and anxiety, said composition comprising: a) b-myrcene at about 1 % to ⁇ 5 % w/v; b) limonene at about 1 to ⁇ 5 % w/v; c) linalool, at about 1 to ⁇ 5 % w/v; d) b-caryophyllene at about 1 to ⁇ 5 % w/v; and e) a pharmaceutically acceptable carrier or excipient.
  • the present invention relates to a composition for treating a disorder selected from the group consisting of pain and anxiety, said composition comprising:
  • compositions of the invention may be formulated for sublingual or buccal delivery.
  • compositions may be formulated for parenteral delivery.
  • compositions are formulated for oral delivery.
  • compositions are formulated as a spray.
  • the compositions are formulated as a solid dosage form, such as a gel capsule or a tablet.
  • the compositions may also be formulated as a cream, an ointment, a gel, a paste, a powder, a medical patch, a cigarette, a vaporizer liquid or are prepared as a liquid suitable for parenteral administration.
  • the excipient may comprise a solvent.
  • the solvent is an oil.
  • the solvent comprises an alcohol.
  • the composition is formulated as a solution comprising a pharmaceutically effective amount of a terpene of the invention dispersed in a pharmaceutically acceptable oil-based carrier; and a hard gelatin capsule encapsulating the mixture of the terpene and the oil-based carrier.
  • the oil-based carrier is hemp oil.
  • the hemp oil may comprise about 20% to about 90% w/v of the composition, preferably about 70% to about 90% w/v of the composition.
  • the hemp oil is pure hemp oil at 75, 76, 77, 78, 79, 80, 81, 82, 83, 84 or 85% w/v of the composition.
  • the composition may be formulated as a solution comprising a pharmaceutically effective amount of a terpene of the invention and optionally a cannabinoid of the invention, dispersed in a pharmaceutically acceptable oil-based carrier; and a hard gelatin capsule encapsulating the mixture of the terpene, cannabinoid (if present) and the oil-based carrier.
  • the composition is formulated as a solution comprising a pharmaceutically effective amount of a terpene of the invention, a filler active ingredient and pure hemp oil.
  • the composition is formulated as a solution comprising a pharmaceutically effective amount of a terpene of the invention, rosa indica and pure hemp oil.
  • the composition is formulated as a solution comprising a pharmaceutically effective amount of a terpene of the invention at about 1% to ⁇ 5% w/v, rosa indica at 1% to 5% w/v and pure hemp oil at 79% w/v.
  • the composition is formulated as a solution comprising a pharmaceutically effective amount of a terpene of the invention at about 1% to ⁇ 5% w/v, rosa indica at 1% w/v and pure hemp oil at 79% w/v.
  • the composition is formulated to comprise a pharmaceutically effective amount of a terpene of the invention at about 1% to ⁇ 5% w/v, rosa indica at 1% to 5% w/v and pure hemp oil at 79% w/v.
  • the rosa indica is at 1% w/v.
  • the composition is formulated to comprise a pharmaceutically effective amount of a terpene of the invention at about 1% to ⁇ 5% w/v, rosa indica at 1% w/v and pure hemp oil at 79% w/v.
  • said oil-based carrier may be a triglyceride selected from the group consisting of almond oil; babassu oil; borage oil; blackcurrant seed oil; canola oil; castor oil; coconut oil; corn oil; cottonseed oil; evening primrose oil; grapeseed oil; groundnut oil; mustard seed oil; olive oil; palm oil; palm kernel oil; peanut oil; rapeseed oil; safflower oil; sesame oil; shark liver oil; soybean oil; sunflower oil; hydrogenated castor oil; hydrogenated coconut oil; hydrogenated palm oil; hydrogenated soybean oil; hydrogenated vegetable oil; hydrogenated cottonseed and castor oil; partially hydrogenated soybean oil; soy oil; glyceryl tricaproate; glyceryl tricaprylate; glyceryl tricaprate; glyceryl triundecanoate; glyceryl trilaurate; glyceryl trioleate; glyceryl trilinoleate
  • the composition additionally contains an additive selected from the group consisting of antioxidants, emulsifiers and texturizers vegetable oils, plant extracts, honey, sucrose, glucose and fructose, pharmaceutical excipients and combinations thereof.
  • an additive selected from the group consisting of antioxidants, emulsifiers and texturizers vegetable oils, plant extracts, honey, sucrose, glucose and fructose, pharmaceutical excipients and combinations thereof.
  • the present invention provides a method of treating pain in a subject, comprising administering to a subject in need thereof a therapeutically effective amount of a composition according to the invention.
  • extracting comprises contacting said cannabis plant material with an extractant to form an extract, and said extractant comprises at least selected from the group consisting of b- myrcene, limonene, linalool, and b-caryophyllene.
  • the method comprises administering a dose of the composition of 5 mg/kg/day and increased by 2 to 5 mg/kg increments to a maximum dose of 20 mg/kg/d ay.
  • the anxiety treated by the compositions of the invention is related to a patient having a terminal disease, or having a chronic disease.
  • the anxiety may be generalised anxiety disorder.
  • the anxiety may be selected from the group consisting of social anxiety, one or more specific phobias, panic disorder, obsessive compulsive disorder, and post-traumatic stress disorder.
  • the composition is administered at a dose of 5 mg/kg/day and increased by 2 to 5 mg/kg increments to a maximum dose of 20 mg/kg/day.
  • the treatment involves administering a plurality of compositions comprising one or more terpenes and optionally cannabinoids of the invention, wherein said plurality of compositions are administered separately, sequentially or simultaneously to one another, and wherein at least one of the compositions comprises a terpene selected from the group consisting of b-myrcene, limonene, linalool, and b- caryophyllene.
  • the present invention provides a product comprising tablets, gel capsules, medical patches, cigarettes and vaporizer liquids containing the composition of the invention.
  • the invention provides a use of a therapeutically effective amount of a composition according to the invention for the manufacture of a medicament for treating pain in a subject.
  • the invention provides a use of a therapeutically effective amount of a composition according to the invention for the manufacture of a medicament for treating anxiety in a subject.
  • the invention also provides a composition according to the invention for use as a medicament.
  • the invention also provides a composition according to the invention for treating pain in a subject.
  • the invention provides a composition according to the invention for treating anxiety in a subject.
  • weight ratio means the ratio between weight content, e.g. in an aqueous solution containing 20% solute and 80% water, the solute to water weight ratio is 20:80 or 1:4.
  • % w/v is also used herein to describe the concentration of certain components in the compositions of the invention.
  • w/v as used herein means weight by volume. It is calculated by dividing the mass of solute dissolved in 100ml of solution, and multiplying by 100 to obtain a percentage.
  • said composition comprises at least two cannabinoids, at least three, at least four or at least five.
  • Cannabinoids have an acid form as known in the art, and a non-acid form (which is also referred to as decarboxylated form, since it can be generated by decarboxylating the acid form).
  • the acid form may be indicated herein by the letter (a) at the end of the cannabinoid acronym, e.g. tetrahydrocannabiniolic acid is indicated as THCa, while the decarboxylated form is THC.
  • the acid form may also be indicated herein by the use of the word “acid”, such as THC acid.
  • said cannabinoids are selected from the group consisting of THCa or THC, CBCa or CBC, CBDa or CBD, CBGa or CBG, THCVa or THCV, CBDVa or CBDV and CBNa or CBN.
  • At least one of said cannabinoids may be in acid form. In one embodiment, at least one of said cannabinoids is at least partially in decarboxylated form.
  • the composition of the invention may comprise a carrier at least at 5%, 10%, 15%, 20%, 25%, 30%, 35% or 40% by volume.
  • the carrier in some embodiments is selected from the group consisting of hemp oil, vegetable oils, such as olive oil, coconut oil or sesame oil, honey, bees wax, cellulose or pharmaceutical excipients, and combinations thereof.
  • cellulose refers to cellulose, hemicellulose and their combinations.
  • the composition is used in treatment against pain and or anxiety, especially resulting from motor neurone disease, rheumatoid arthritis or Crohn's Disease, sarcoidosis, asthma, Alzheimers disease, multiple sclerosis, psoriasis, ulcerative colitis, osteoarthritis or spondyloarthropathy (erg. ankylosing spondylitis), and pain and or anxiety resulting from terminal disease.
  • motor neurone disease especially resulting from motor neurone disease, rheumatoid arthritis or Crohn's Disease, sarcoidosis, asthma, Alzheimers disease, multiple sclerosis, psoriasis, ulcerative colitis, osteoarthritis or spondyloarthropathy (erg. ankylosing spondylitis), and pain and or anxiety resulting from terminal disease.
  • the patient is preferably a mammal such as a human.
  • cannabinoid as used herein means chemical compounds of a class able to act on cannabinoid receptors in cells that alter neurotransmitter release in the brain.
  • Cannabinoids may be endocannabinoids (produced in the body of animals), phytocannabinoids (produced in cannabis and some other plants), and synthetically manufactured cannabinoids.
  • Cannabinoids useful in the compositions of the invention comprise one or more cannabinoid selected from the following group consisting of:
  • THC tetrahydrocannabinol
  • THCA tetrahydrocannabinolic acid
  • CBD canannabidiol
  • CBDA canannabidiolic acid
  • CBN canannabinol
  • CBG canannabigerol
  • CBC cannabichromene
  • CBL cannabicyclol
  • CBV cannabivarin
  • THCV tetrahydrocannabivarin
  • CBDV canbidivarin
  • CBCV canbichromevarin
  • CBGV canbigerovarin
  • CBGM canannabigerol monomethyl ether
  • CBE cannabielsoin
  • CBT canannabicitran
  • Tetrahydrocannabinol is the primary psychoactive component of the Cannabis plant. Forms include Delta-9-tetrahydrocannabinol (A9-THC, THC) and delta-8- tetrahydrocannabinol (Dd-THC). These cannabinoids bind to the CB1 cannabinoid receptors in the brain.
  • Cannabidiol is a non-psychotropic cannabinoid. Cannabidiol does not bind strongly to CB1 and CB2 receptors but appears to act as an indirect antagonist of cannabinoid agonists. CBD is though to be an antagonist of the GPR55 receptor, expressed in the caudate nucleus and putamen. Cannabidiol is however an agonist of the 5-HT1 A receptor. CBD may inhibit with the uptake of adenosine, and may play a role in promoting sleep and suppressing arousal. CBD may prevent the short-term memory loss associated with THC.
  • CBD has shown promise as a treatment for chronic pain, and is currently used as a topical oil treatment.
  • Cannabinol (CBN) is produced by THC degradation, but is only mildly psychoactive. It has higher affinity to the CB2 receptor than the CB1 receptor.
  • Cannabigerol (CBG) is thought to be non-psychoactive. CBG binds to the CB2 receptor and has been shown in animal studies to promote apoptosis in cancer cells and lead to inhibition of tumour growth.
  • CBG is an agonist of a2-adrenergic receptor, and is a 5-HT1A and CB1 receptor antagonist.
  • THC Tetrahydrocannabivarin
  • Cannabidivarin is found in small quantities in cannabis, although little is known at the present date of its properties..
  • Cannabichromene is a non-psychoactive agonist of TRPV1 and TRPA1 receptors, and appears to inhibit with their ability to break down endocannabinoids. CBC has shown promising antitumor effects in animal breast cancer models.
  • Synthetic cannabinoids are compounds that have a cannabinoid or cannabinoid- like structure and are artificially manufactured using chemical means rather than produced naturally by an animal or by a plant.
  • terpene refers to a class of hydrocarbon organic compounds, produced for chemical protection by many plants and insects. Terpenes may have a strong odour and when modified to have additional functional groups are known as “terpenoids (or isoprenoids)”.
  • isolated is intended to include a naturally occurring substance that has been purified from its natural source or has been chemically synthesised.
  • compositions of the invention can be used alone or in combination with other pharmaceutically active agents.
  • other pharmaceutically active agents include, but are not limited to, anti-inflammatory agents (e.g., NSAIDS, bradykinin receptor antagonists, hormones and autacoids such as corticosteroids), anti-depressant agents, anti viral agents, antiseptic agents (e.g., antibacterials), local anaesthetics, anti-migraine agents, opioids, and other pain relieving medication.
  • the invention provides pharmaceutical compositions of any of the foregoing cannabinoids and/or terpenes.
  • Exemplary pharmaceutical compositions are formulated in a pharmaceutically acceptable carrier.
  • the compositions of the invention may optionally be used alone or as part of a therapeutic regimen together with other treatments, therapies, or interventions prescribed for the particular disease, condition, injury or disorder being treated.
  • the compositions may be used together with a treatment modalities selected from the group consisting of administration of cannabinoid pharmaceuticals, chemotherapy, radiotherapy, homeopathic therapy, diet, stress management, and surgery.
  • compositions of the invention are administered to treat a particular primary disease, injury, disorder, or condition. Additionally or alternatively, the compositions of the invention may be administered to treat pain associated with a disease, injury, disorder, or condition. In other embodiments, compositions of the invention may be administered to treat symptoms secondary to the primary disease, injury, disorder, or conditions.
  • preventing is art-recognized to include administration of a composition which reduces the frequency of, or delays the onset of, symptoms of a medical condition in a subject relative to a subject which does not receive the composition.
  • prevention of pain or anxiety includes, for example, reducing the degree of, or delaying, pain or anxiety sensations experienced by subjects in a treated population versus an untreated control population.
  • treating includes prophylactic and/or therapeutic treatments.
  • prophylactic or therapeutic treatment is recognized in the art and comprises administration to a subject one or more of the compositions of the invention.
  • the treatment is prophylactic if it is administered prior to clinical manifestation of the unwanted condition (e.g., disease or other unwanted state of the host animal) as it protects the host against developing the unwanted condition.
  • the treatment is therapeutic if it is administered after manifestation of the unwanted condition, as it is intended to diminish, ameliorate, or stabilize the existing unwanted condition or side effects thereof.
  • Pain may be chronic pain or acute pain. Chronic pain or acute pain differ in duration, and underlying mechanism. Chronic pain is persistent and often does not respond well to treatment with currently available analgesics, non-steroidal anti-inflammatory drugs, and opioids.
  • Neuropathic pain and cancer pain are subcategories of chronic pain known in the art (Wang and Wang (2003) Advanced Drug Delivery Reviews 55: 949-965). Neuropathic pain results from damage (e.g., from disease, injury, age) to the nervous system (e.g., nerves, spinal cord, CNS, PNS). Cancer-related pain can be related to the particular treatment regimen (e.g., radiation, chemotherapeutics, surgery) undertaken or to tumour infiltration, compression of nerves and substances secreted by tumours.
  • the particular treatment regimen e.g., radiation, chemotherapeutics, surgery
  • Pain treated by the compositions of the invention may be nociceptive, inflammatory, or neuropathic.
  • Nociceptive pain is pain experienced following, for example, changes or extremes in temperature, exposure to acids, exposure to chemical agents, exposure to force, and exposure to pressure.
  • Inflammation results from the immune system's response to injury or disease and the recruitment of macrophages, mast cells, neutrophils, and other cells of the immune system.
  • cytokines and other factors e.g., histamine, serotonin, bradykinin, prostaglandins, ATP, H+, nerve growth factor, TNFa, endothelins, interleukins
  • Standard therapy for the pain of inflammation include Cox2 inhibitors and opioids.
  • Neuropathic pain results from damage (e.g., from disease, injury, age) to the nervous system- (e.g., nerves, spinal cord, CNS, PNS).
  • Tricyclic antidepressants, anticonvulsants, Na+ channel blockers, NMDA receptor antagonists, and opioids are useful in the treatment of neuropathic pain.
  • Pain is typically studied in one of many animal models understood by those with skill in the present art. Such models use a variety of agents or procedures to simulate pain resulting from injuries, diseases, or other conditions (Blackburn-Munro (2004) Trends in Pharmacological Sciences 25: 299-305). Compounds or procedures that are found to reduce pain in the animals can be advance for further research in humans using procedures understood by those with skill in the present art.
  • terapéuticaally effective amount means that amount of an active ingredient, or composition of the present invention that is effective for producing some desired therapeutic effect in an animal, at a reasonable benefit/risk ratio applicable to any medical treatment.
  • the term describes an amount of an active ingredient or a composition of the present invention effective in inhibiting the above-noted diseases and thus producing the desired therapeutic, ameliorative, inhibitory or preventative effect desired.
  • pharmaceutically acceptable carrier means a pharmaceutically acceptable material, composition or vehicle, such as a liquid or solid filler, diluent, excipient, solvent or encapsulating material, suitable for carrying the active ingredients of the invention.
  • “Acceptable” means being compatible with the other ingredients of the formulation and not harmful to the patient.
  • Potentially useful pharmaceutically acceptable carriers include: (1) sugars, such as lactose, glucose and sucrose; (2) starches, such as corn starch and potato starch; (3) cellulose, and its derivatives, such as sodium carboxymethyl cellulose, ethyl cellulose and cellulose acetate; (4) powdered tragacanth; (5) malt; (6) gelatin; (7) talc; (8) excipients, such as cocoa butter and suppository waxes; (9) oils, such as peanut oil, cottonseed oil, safflower oil, sesame oil, olive oil, corn oil and soybean oil; (10) glycols, such as propylene glycol; (11) polyols, such as glycerin, sorbitol, mannitol and polyethylene glycol; (12) esters, such as ethyl oleate and ethyl laurate; (13) agar; (14) buffering agents, such as magnesium hydroxide and aluminum hydroxide; (15) alg
  • Lubricants including sodium lauryl sulfate and magnesium stearate, as well as coating agents, colouring agents, release agents, sweetening, flavouring and perfuming agents, preservatives and antioxidants can also be present in the compositions.
  • Antioxidants that are considered pharmaceutically acceptable in the present invention include: (1) water soluble antioxidants, such as ascorbic acid, cysteine hydrochloride, sodium bisulfate, sodium metabisulfite, sodium sulfite and the like; (2) oil-soluble antioxidants, such as ascorbyl palmitate, butylated hydroxyanisole (BHA), butylated hydroxytoluene (BHT), lecithin, propyl gallate, alpha-tocopherol, and the like; and (3) metal chelating agents, such as citric acid, ethylenediamine tetraacetic acid (EDTA), sorbitol, tartaric acid, phosphoric acid, and similar antioxidents which would be understood as useful by one having skill in the present art.
  • water soluble antioxidants such as ascorbic acid, cysteine hydrochloride, sodium bisulfate, sodium metabisulfite, sodium sulfite and the like
  • oil-soluble antioxidants such as ascorbyl palmitate, but
  • compositions of the present invention may be formulated for oral, nasal, topical (including buccal and sublingual), rectal, vaginal and/or parenteral administration.
  • the formulations may be provided in unit dosage form by any methods well known to those skilled in the art of pharmacy.
  • the amount of active ingredient which can be combined with a carrier material to produce a single dosage form will change.
  • the quantity of active ingredient that can be combined with a carrier material to produce a single dosage form for the invention will usually be an amount of the active ingredient sufficient to produce a therapeutic effect.
  • compositions of the invention may be prepared by bringing into association an active ingredient of the present invention with the carrier and, optionally, one or more accessory ingredients.
  • an active ingredient of the present invention is brought into intimate association with a liquid carrier, and/or a finely divided solid carrier, and then, if necessary, the product is shaped.
  • compositions of the invention may be prepared for oral administration as capsules, pills, tablets, cachets, granules, lozenges, powders, or may be formulated as a solution or a suspension in an aqueous or non-aqueous liquid, or as an oil-in-water or water-in-oil liquid emulsion, or as a syrup, bolus, electuary or paste, or a mouth wash, or an elixir, or as pastilles (using an inert base, such as gelatin and glycerin, or sucrose and acacia) and/or as mouth washes or other useful form known to the art, each containing a predetermined amount of an active ingredient of the present invention.
  • an inert base such as gelatin and glycerin, or sucrose and acacia
  • Pharmaceutically acceptable carriers for solid dose forms include sodium citrate or dicalcium phosphate, and/or any of the following: (1) fillers or extenders, such as starches, lactose, sucrose, glucose, mannitol, and/or silicic acid; (2) binders, such as, for example, carboxymethylcellulose, alginates, gelatin, polyvinyl pyrrolidone, sucrose and/or acacia; (3) humectants, such as glycerol; (4) disintegrating agents, such as agar-agar, calcium carbonate, potato, or tapioca starch, alginic acid, certain silicates, and sodium carbonate; (5) solution retarding agents, such as paraffin; (6) absorption accelerators, such as quaternary ammonium compounds; (7) wetting agents, such as, for example, cetyl alcohol and glycerol monostearate; (8) absorbents, such as kaolin and bentonite clay; (9) lubricants,
  • Compositions of the invention may also be formulated as fillers in soft and hard-filled gelatin capsules using such excipients as lactose or milk sugars, as well as high molecular weight polyethylene glycols and the like.
  • compositions for use in the invention include active ingredients including, but not limited to, rosa indica.
  • Compressed or moulded tablets can be prepared with additional binder (such as, gelatin or hydroxypropyl methyl cellulose), lubricant, inert diluent, preservative, disintegrant (for example, sodium starch glycolate or cross-linked sodium carboxymethyl cellulose), surface- active or dispersing agent.
  • binder such as, gelatin or hydroxypropyl methyl cellulose
  • lubricant such as, gelatin or hydroxypropyl methyl cellulose
  • inert diluent such as, lubricant, inert diluent, preservative, disintegrant (for example, sodium starch glycolate or cross-linked sodium carboxymethyl cellulose), surface- active or dispersing agent.
  • preservative for example, sodium starch glycolate or cross-linked sodium carboxymethyl cellulose
  • disintegrant for example, sodium starch glycolate or cross-linked sodium carboxymethyl cellulose
  • the solid dosage forms of the invention may optionally be provided with coatings and shells, such as enteric coatings and other coatings well known in the pharmaceutical- formulating art so as to provide slow or controlled release of the active ingredient therein.
  • coatings and shells such as enteric coatings and other coatings well known in the pharmaceutical- formulating art so as to provide slow or controlled release of the active ingredient therein. Examples include using hydroxypropylmethyl cellulose in varying proportions to provide the desired release profile, other polymer matrices, liposomes and/or microspheres.
  • adjuvants can be included, such as wetting agents, emulsifying and suspending agents, sweetening, flavouring, colouring, perfuming and preservative agents.
  • Suspending agents suitable for use with suspensions of the present invention include aluminum metahydroxide, bentonite, ethoxylated isostearyl alcohols, polyoxyethylene sorbitol and sorbitan esters, microcrystalline cellulose, tragacanth and agar-agar and mixtures thereof.
  • the invention also contemplates the administration of the compositions via catheter, stent, wire, or other intraluminal device. Administration of such devices may include administering to the bladder, urethra, ureter, rectum, or intestine.
  • compositions of the present invention can be prepared as a powder, a spray, an ointment, a paste, a cream, a lotion, a gel, a solution, a patch and an inhalant.
  • a powder, a spray, an ointment, a paste, a cream, a lotion, a gel, a solution, a patch and an inhalant The formulation of such products would be well within the skill of a skilled person in the art.
  • compositions of this invention may be formulated to comprise one or more pharmaceutically acceptable sterile isotonic aqueous or nonaqueous solutions, dispersions, suspensions or emulsions, or sterile powders which are reconstitutable into sterile injectable solutions or dispersions before using as understood by those skilled in the art.
  • Aqueous and nonaqueous carriers useful in formulations of the compositions of the invention include water, ethanol, polyols (such as glycerol, propylene glycol, polyethylene glycol, and the like), and suitable mixtures thereof, vegetable oils, such as olive oil, hemp oil and injectable organic esters, such as ethyl oleate.
  • polyols such as glycerol, propylene glycol, polyethylene glycol, and the like
  • vegetable oils such as olive oil, hemp oil
  • injectable organic esters such as ethyl oleate.
  • the required dose can be readily determined by a physician or veterinarian of skill in the art based on the factors above.
  • the physician or veterinarian may determine the correct dose by administering a very low dose of the active ingredients followed by gradually increasing the dosage until the desired effect is achieved.
  • the lowest dose effective to produce a therapeutic effect is given on a recurring basis, and this can be readily determined by one skilled in the relevant art.
  • the dose of the active ingredient of the invention may optionally be separated into two, three, four, five, six or more sub-doses for separate administration throughout the day.
  • compositions of the present invention may be useful to treat mammals such as pets or livestock, and primates, in particular humans.
  • a “subject” is a mammal, preferably a human, but can also be an animal in need of veterinary treatment, e.g., companion animals (e.g., dogs, cats, and the like), farm animals (e.g., cows, sheep, pigs, horses, and the like) and laboratory animals (e.g., rats, mice, guinea pigs, and the like).
  • companion animals e.g., dogs, cats, and the like
  • farm animals e.g., cows, sheep, pigs, horses, and the like
  • laboratory animals e.g., rats, mice, guinea pigs, and the like.
  • the term “substantially free of” means that a particular substance is not purposefully added to a composition and only is present in trace amounts or as an impurity. As used herein, the term “completely free of” means that a composition does not comprise a particular material. That is, the composition comprises 0 weight percent of such material.
  • Figure 1 shows GCMS analysis indicating Total Ion Chromatogram for a sample of myrcene.
  • Figure 3 shows GCMS analysis indicating Total Ion Chromatogram analysis of the abundance of myrcene, limonene, linalool and caryophyllene in a mixed sample.
  • Figure 4 and 5 shows GCMS analysis indicating an overlay of total ion chromatogram and extracted ion chromatogram of several terpenes in a sample composition.
  • Figure 6 shows GCMS analysis indicating the mass to charge (mz) calculation for myrcene in a sample.
  • Figure 7 shows GCMS analysis indicating the mass to charge (mz) calculation for limonene, linalool and caryophyllene in a sample.
  • a single-centre, 5-week (1-week run-in, 4-week treatment), randomized, double-blind, placebo-controlled, parallel-group trial is held for 20 patients having MND and central pain states (including dysesthetic and/or painful spasms) of a composition of the invention (CCC), containing a mixture of terpenes as shown in Table 2, delivered via an oil in clear gel-capsule of 1 ml, as adjunctive analgesic treatment.
  • Each capsule delivers b-myrcene at about 12% w/v, limonene at about 7% w/v, linalool at about 9% w/v, and b-caryophyllene at about 27% w/v.
  • Patients can gradually self-titrate to a maximum of 12 tablets in 24 hours.
  • CCC Pain and sleep disturbance are recorded daily on an 11 -point numerical rating scale.
  • the CCC is superior to placebo in reducing the mean intensity of pain at a 95% Cl and sleep disturbance at a 95% Cl: CCC is generally well tolerated, with no or negligible reported side effects.
  • CCC is effective in reducing pain and sleep disturbance in patients with motor neurone disease related central neuropathic pain and is well tolerated.
  • a single-centre, 5-week (1-week run-in, 4-week treatment), randomized, double-blind, placebo-controlled, parallel-group trial is held for 20 patients having chronic anxiety of a composition of the invention (CCC), containing a mixture of terpenes as shown in Table 2, delivered via an oil in clear gel-capsule of 1 ml, as adjunctive analgesic treatment.
  • CCC composition of the invention
  • Each capsule delivers b-myrcene at about 12% w/v, limonene at about 7% w/v, linalool at about 9% w/v, and b-caryophyllene at about 27% w/v.
  • Patients can gradually self-titrate to a maximum of 12 tablets in 24 hours.
  • CCC is effective in reducing anxiety and sleep disturbance in patients with chronic anxiety central neuropathic pain and is well tolerated.

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Abstract

La présente invention concerne des compositions comprenant un ou plusieurs terpènes, par exemple le β-myrcène, le limonène, le linalol et le β-caryophyllène destinés à être utilisés dans le traitement de la douleur ou de l'anxiété. La composition peut en outre comprendre un support ou excipient pharmaceutiquement acceptable et/ou un ou plusieurs cannabinoïdes.
PCT/AU2020/051437 2019-12-24 2020-12-24 Compositions comprenant des terpènes et leur utilisation dans le traitement ou le soulagement de la douleur ou de l'anxiété Ceased WO2021127749A1 (fr)

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