WO2016019353A1 - Cigarettes électroniques, cartouches et préparations inhalables à base de composés de cannabis à usage thérapeutique et appareils et procédés permettant de les fabriquer et de les utiliser - Google Patents

Cigarettes électroniques, cartouches et préparations inhalables à base de composés de cannabis à usage thérapeutique et appareils et procédés permettant de les fabriquer et de les utiliser Download PDF

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Publication number
WO2016019353A1
WO2016019353A1 PCT/US2015/043320 US2015043320W WO2016019353A1 WO 2016019353 A1 WO2016019353 A1 WO 2016019353A1 US 2015043320 W US2015043320 W US 2015043320W WO 2016019353 A1 WO2016019353 A1 WO 2016019353A1
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WIPO (PCT)
Prior art keywords
liquid
cannabis
electronic
pharmaceutical formulation
cartomizer
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PCT/US2015/043320
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English (en)
Inventor
Adam D. Cohen
James Lowe
John FRITZEL
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MJAR Holdings, LLC
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Publication of WO2016019353A1 publication Critical patent/WO2016019353A1/fr

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    • 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
    • A24—TOBACCO; CIGARS; CIGARETTES; SIMULATED SMOKING DEVICES; SMOKERS' REQUISITES
    • A24F—SMOKERS' REQUISITES; MATCH BOXES; SIMULATED SMOKING DEVICES
    • A24F40/00—Electrically operated smoking devices; Component parts thereof; Manufacture thereof; Maintenance or testing thereof; Charging means specially adapted therefor
    • A24F40/05—Devices without heating means
    • A—HUMAN NECESSITIES
    • A24—TOBACCO; CIGARS; CIGARETTES; SIMULATED SMOKING DEVICES; SMOKERS' REQUISITES
    • A24F—SMOKERS' REQUISITES; MATCH BOXES; SIMULATED SMOKING DEVICES
    • A24F40/00—Electrically operated smoking devices; Component parts thereof; Manufacture thereof; Maintenance or testing thereof; Charging means specially adapted therefor
    • A24F40/50—Control or monitoring
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/185—Magnoliopsida (dicotyledons)
    • 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
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M11/00—Sprayers or atomisers specially adapted for therapeutic purposes
    • A61M11/04—Sprayers or atomisers specially adapted for therapeutic purposes operated by the vapour pressure of the liquid to be sprayed or atomised
    • A61M11/041—Sprayers or atomisers specially adapted for therapeutic purposes operated by the vapour pressure of the liquid to be sprayed or atomised using heaters
    • A61M11/042—Sprayers or atomisers specially adapted for therapeutic purposes operated by the vapour pressure of the liquid to be sprayed or atomised using heaters electrical
    • A—HUMAN NECESSITIES
    • A24—TOBACCO; CIGARS; CIGARETTES; SIMULATED SMOKING DEVICES; SMOKERS' REQUISITES
    • A24F—SMOKERS' REQUISITES; MATCH BOXES; SIMULATED SMOKING DEVICES
    • A24F40/00—Electrically operated smoking devices; Component parts thereof; Manufacture thereof; Maintenance or testing thereof; Charging means specially adapted therefor
    • A24F40/10—Devices using liquid inhalable precursors
    • 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
    • A61K9/0073—Sprays or powders for inhalation; Aerolised or nebulised preparations generated by other means than thermal energy
    • A61K9/0078—Sprays or powders for inhalation; Aerolised or nebulised preparations generated by other means than thermal energy for inhalation via a nebulizer such as a jet nebulizer, ultrasonic nebulizer, e.g. in the form of aqueous drug solutions or dispersions
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M11/00—Sprayers or atomisers specially adapted for therapeutic purposes
    • A61M11/005—Sprayers or atomisers specially adapted for therapeutic purposes using ultrasonics
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M15/00—Inhalators
    • A61M15/06—Inhaling appliances shaped like cigars, cigarettes or pipes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes
    • A61M16/0003—Accessories therefor, e.g. sensors, vibrators, negative pressure
    • A61M2016/0015—Accessories therefor, e.g. sensors, vibrators, negative pressure inhalation detectors
    • A61M2016/0018—Accessories therefor, e.g. sensors, vibrators, negative pressure inhalation detectors electrical
    • A61M2016/0021—Accessories therefor, e.g. sensors, vibrators, negative pressure inhalation detectors electrical with a proportional output signal, e.g. from a thermistor
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes
    • A61M16/0003—Accessories therefor, e.g. sensors, vibrators, negative pressure
    • A61M2016/0027—Accessories therefor, e.g. sensors, vibrators, negative pressure pressure meter
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes
    • A61M16/0003—Accessories therefor, e.g. sensors, vibrators, negative pressure
    • A61M2016/003—Accessories therefor, e.g. sensors, vibrators, negative pressure with a flowmeter
    • A61M2016/0033—Accessories therefor, e.g. sensors, vibrators, negative pressure with a flowmeter electrical
    • A61M2016/0039—Accessories therefor, e.g. sensors, vibrators, negative pressure with a flowmeter electrical in the inspiratory circuit
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/36—General characteristics of the apparatus related to heating or cooling
    • A61M2205/3653—General characteristics of the apparatus related to heating or cooling by Joule effect, i.e. electric resistance
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/58—Means for facilitating use, e.g. by people with impaired vision
    • A61M2205/583—Means for facilitating use, e.g. by people with impaired vision by visual feedback
    • A61M2205/584—Means for facilitating use, e.g. by people with impaired vision by visual feedback having a color code
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/82—Internal energy supply devices
    • A61M2205/8206—Internal energy supply devices battery-operated

Definitions

  • the present disclosure relates to an inhalable pharmaceutical formulation having a known amount of a medicinal cannabis compound.
  • Apparatuses and methods for forming the inhalable pharmaceutical formulation are also provided.
  • Apparatuses include electronic inhalation devices, sometimes generically called electronic cigarettes, and components thereof, which atomize fluid containing medicinal cannabis compounds in order to deliver said compounds to patients in inhalable form.
  • Related methods are also provided.
  • Cannabis has long been considered to have medicinal properties. Many states, such as Colorado, Washington, Oregon, California, Alaska, Maine, Hawaii, Nevada, Vermont, Montana, Rhode Island, New Mexico, Michigan, and New Jersey, allow the use of medicinal cannabis by persons with debilitating medical conditions, as certified by physicians.
  • Cannabinoids are a group of chemicals that are known to activate cannabinoid receptors
  • Phytocannabinoids are produced by plants, including cannabis.
  • cannabinoids that can be isolated from Cannabis species, including
  • Cannabis sativa, Cannabis ruderalis, and Cannabis indica are also produced endogenously in humans and other animals and are termed endocannabinoids.
  • Synthetic cannabinoids are manmade chemicals with the same structure as plant cannabinoids or endocannabinoids.
  • Cannabinoids are cyclic molecules exhibiting particular properties such as the ability to easily cross the blood-brain barrier, weak toxicity, and few side effects.
  • the most notable cannabinoids are A9-Tetrahydrocannabinol (i.e., THC) and cannabidiol (i.e., CBD).
  • Some of the medical benefits attributable to one or more of the cannabinoids isolated from cannabis include treatment of pain, nausea, AIDS-related weight loss and wasting, multiple sclerosis, allergies, infection, depression, migraine, bipolar disorders, hypertension, post-stroke neuroprotection, epilepsy, fibromyalgia, as well as inhibition of tumor growth, angiogenesis, and metastasis.
  • cannabinoids may also be useful for treating conditions, such as glaucoma, Parkinson's disease, Huntington's disease, migraines, inflammation, Crohn's disease, dystonia, rheumatoid arthritis, emesis due to chemotherapy, inflammatory bowel disease, atherosclerosis, posttraumatic stress disorder, cardiac reperfusion injury, prostate carcinoma, and Alzheimer's disease.
  • U.S. Pat. No. 6,630,507 discloses cannabinoids for use as antioxidants and neuroprotectants
  • U.S. Pat. No. 7,105,685 discloses cannabinoids for the treatment of diseases associated with immune dysfunction, particularly HIV disease and neoplastic disorders
  • U.S. Publ. No. 2011/0257256 discloses THC-CBD composition for use in treating or preventing Cognitive Impairment and Dementia
  • PCT Publication WO/2009/147439 discloses use of cannabinoids in the manufacture of a medicament for use in the treatment of cancer, in particular the glioma tumor
  • PCT Publication WO/2007/148094 discloses use of cannabinoids composition for the treatment of neuropathic pain
  • 2010/0286098 discloses a method of treating tissue injury in a patient with colitis via administration of cannabinoids.
  • cannabinoids While a wide range of medical uses has been identified, the benefits achieved by cannabinoids for a particular disease or condition are believed to be attributable to a subgroup of cannabinoids or to individual cannabinoids. That is to say that different subgroups or single cannabinoids have beneficial effects to certain conditions, while other subgroups or individual cannabinoids have benefit effect to other conditions.
  • THC is the main
  • CBD cannabinoid produced by Cannabis and is well-characterized for its biological activity and potential therapeutic application in a broad spectrum of diseases.
  • CBD another major cannabinoid constituent of Cannabis, acts as an inverse agonist of the CB1 and CB2 cannabinoid receptors.
  • CBD does not produce psychoactive effects in humans.
  • CBD is reported to exert analgesic, antioxidant, anti-inflammatory, and immunomodulatory effects.
  • Terpenes are another class of compounds that are produced by cannabis. Reportedly, as many as 200 or more terpenes can be produced by cannabis plants, although the types and ratios of terpenes produced by a cannabis strain are dependent on genetics and growth conditions (e.g., lighting, fertilization, soil, watering frequency/amount, humidity, carbon dioxide concentration, and the like), as well as age, maturation, and time of day. Terpenes have been shown to have medicinal properties, and may be responsible for at least a portion of the medicinal value of cannabis.
  • genetics and growth conditions e.g., lighting, fertilization, soil, watering frequency/amount, humidity, carbon dioxide concentration, and the like
  • Some of the medical benefits attributable to one or more of the terpenes isolated from cannabis include treatment of sleep disorders, psychosis, anxiety, epilepsy and seizures, pain, microbial infections (fungal, bacterial, etc.), cancer, inflammation, spasms, gastric reflux, depression, and asthma.
  • Some terpenes have been shown to: lower the resistance across the blood-brain barrier, act on cannabinoid receptors and other neuronal receptors, stimulate the immune system, and/or suppress appetite.
  • a drug delivery device that can administer controlled amounts of selected medicinal cannabis compounds to a patient.
  • a device that can deliver a prescribed unit dose and/or other known quantity of one or more medicinal cannabis compounds.
  • Such a device can be designed to deliver the compounds to a patient quickly and easily in a portable format that can be used in public without drawing attention to the patient's usage of medicinal marijuana.
  • a drug delivery device that allows for convenient inhalation of medicinal cannabis compounds without the risk of respiratory problems associated with smoking marijuana.
  • pharmaceutical formulations comprising known concentrations, or known relative concentrations, of medicinal cannabis compounds for use with said delivery devices.
  • Various aspects disclosed herein may fulfill one or more of these needs.
  • the pharmaceutical formulation includes a volatile liquid, which comprises a mixture of: a cannabis oil extract having a known amount of a medicinal cannabis compound, and an aerosol precursor.
  • a cannabis oil extract having a known amount refers to a cannabis oil extract having a known concentration of one or more medicinal cannabis compounds; in other embodiments, a cannabis oil extract having a known amount refers to a cannabis oil extract having a known relative concentration (i.e., a known ratio) of two or more medicinal cannabis compounds.
  • the volatile liquid is in an inhalable form.
  • the volatile liquid may be in an aerosol form or vapor form.
  • the volatile liquid comprises a plurality of droplets having a diameter of 10 ⁇ or smaller.
  • the medicinal cannabis compound of a known amount comprises one or more cannabinoids.
  • the one or more cannabinoids have a ratio of CBD to THC of between about 1 : 1 and about 1 : 100.
  • the one or more cannabinoids have a ratio of CBD to THC of between about 1 : 1 and about 1 : 100.
  • cannabinoids have a ratio of CBD to THC of between about 10: 1 and about 300: 1.
  • the medicinal cannabis compound of a known amount comprises one or more terpenes, one or more flavonoids, and/or one or more phytosterols.
  • the known amount of the medicinal cannabis compound has a concentration and volume equal to a single dose unit of the medicinal cannabis compound. In other embodiments, the known amount of the medicinal cannabis compound has a concentration and volume equal to a plurality of dose units, for example, two, three, four, five, six, seven, or more dose units, of the medicinal cannabis compound.
  • the aerosol precursor comprises propylene glycol, glycerin, or a combination thereof.
  • the volatile liquid atomizes or vaporizes at a temperature in the range of approximately 125 degrees Celsius and 425 degrees Celsius.
  • the particular vaporization temperature or atomization temperature may vary based on the particular composition (i.e., the particular compounds and concentrations of the compounds) present in the volatile liquid.
  • the atomization/vaporization temperature of the volatile liquid may vary based on the composition of the cannabis oil extract and/or the composition of aerosol precursors.
  • an electronic apparatus for producing an inhalable pharmaceutical formulation having a known amount of medicinal cannabis compounds.
  • the electronic apparatus includes a reservoir holding a pharmaceutical formulation, such as the pharmaceutical formulation described above or elsewhere herein.
  • a pharmaceutical formulation such as the pharmaceutical formulation described above or elsewhere herein.
  • Such an electronic drug delivery apparatus additionally includes an atomizer adapted to atomize or aerosolize the pharmaceutical formulation to form particles suitable for pulmonary delivery.
  • the atomizer comprises a resistive heating element configured to heat the volatile liquid.
  • the electronic apparatus further includes a heating chamber in which the heating element is disposed, and a wick which transports the volatile liquid gradually from the reservoir to the heating chamber.
  • the atomizer comprises an oscillating stimulator configured to disturb the volatile liquid and cause liquid particles to break away from a surface of the volatile liquid.
  • the atomizer comprises a pneumatic stimulator in the form of a pressurized canister with a nozzle.
  • One aspect of the disclosure relates to an electronic cartomizer.
  • the electronic cartomizer includes a heating chamber having an inlet and an outlet, a heating element disposed within the heating chamber, a reservoir of liquid comprising medicinal cannabis compounds, and a wick extending from the reservoir of liquid to the heating chamber.
  • the wick formed of a material adaptable to facilitate transport of the liquid from the reservoir to the heating chamber via capillary action.
  • the electronic cartomizer is a medical product that is pharmaceutically prescribed.
  • One embodiment of the disclosure relates to an electronic inhalation device, which is an "e-cigarette” (except unlike currently available e-cigarettes, the various e-cigarette embodiments contemplated herein lack nicotine, tobacco products, and tobacco-derived products; rather, the "e-cigarette” inhalation devices of the current invention include a composition comprising cannabis oil extract intended for inhalation).
  • the electronic cigarette includes an electronic cigarette cartomizer, such as the cartomizer described above or elsewhere herein.
  • an electronic cigarette additionally includes a base component, which includes a power source and a control circuit. The power source and the control circuit are electrically coupled to the cartomizer.
  • the electronic cigarette may additionally include a visual use indicator, such as an LED light.
  • the power source is a battery, for example, a rechargeable battery.
  • the base component is reusable.
  • control circuit is or includes a microprocessor.
  • the microprocessor selects and controls a heating protocol of the heating element, and the heating protocol is selected based on the contents of the liquid within the reservoir.
  • the microprocessor is programmable to control the heating element such that the heating element is deactivated following controlled release of a single dose of the liquid.
  • the method includes providing an apparatus configured to form a pharmaceutical formulation of cannabis compounds in a form suitable for pulmonary delivery, and inhaling from an outlet of the apparatus.
  • the apparatus includes: a reservoir holding a mixture of a cannabis oil extract having a known amount of a medicinal cannabis compound and an aerosol precursor, and an atomizer adapted to atomize, aerosolize, or vaporize the
  • the atomizer upon activation of the atomizer, at least a portion of the volatile liquid is atomized, aerosolized, or vaporized to form inhalable droplets of liquid containing medicinal cannabis compounds.
  • the inhalable pharmaceutical formation of cannabis compounds is formed automatically.
  • the apparatus may be an electronic apparatus, which further includes a microprocessor coupled to a power source, a sensor, and the atomizer.
  • inhaling from the outlet causes the sensor to generate a signal indicative of a patient inhalation, and in response to the signal, the microprocessor automatically activates the atomizer.
  • Another aspect of the disclosure relates to a method of delivering an inhalable form of medicinal cannabis compounds from an electronic cigarette to a patient.
  • said electronic cigarette comprises: a heating chamber having a heating element disposed therein, a reservoir of liquid comprising medicinal cannabis compounds, and a power source and microprocessor electrically coupled to the heating element.
  • the method is executed by the microprocessor and includes receiving a signal from a sensor coupled to the microprocessor, the signal indicative of a patient inhaling from the electronic cigarette, and activating the heating element, wherein activating the heating element causes the liquid within the heating chamber to atomize and form inhalable droplets of liquid containing cannabis compounds.
  • the inhalable droplets of liquid have a diameter no greater than 10 ⁇ .
  • An additional aspect of the disclosure relates to a method of administering an inhalable formulation of medicinal cannabis compounds to a patient.
  • the method includes inhaling from an outlet of an electronic cigarette.
  • the electronic cigarette includes: a heating chamber having a heating element disposed therein, an inlet, and the outlet; a reservoir of liquid comprising medicinal cannabis compounds; a wick extending from the reservoir of liquid to the heating chamber; and a power source and microprocessor electrically coupled to the heating element.
  • inhaling from the outlet causes a sensor coupled to the microprocessor to generate a signal indicative of a patient inhalation.
  • the microprocessor activates the heating element, causing liquid on the wick in the heating chamber to atomize to form inhalable droplets of liquid containing medicinal cannabis compounds. Upon inhalation, the inhalable droplets of liquid exit the outlet into a patient's mouth.
  • Figure 1 is a schematic perspective view of one embodiment of an inhalable drug delivery device configured to deliver a known amount of medicinal cannabis compounds to a patient in inhalable form.
  • Figures 2-4 each provide schematic side plan views of various embodiments of an inhalable drug delivery device configured to deliver a known amount of medicinal cannabis compounds to a patient in inhalable form.
  • the cover or housing of the device is transparent to reveal the internal components.
  • Figure 5 provides a schematic cross-sectional view of another non-limiting embodiment of an inhalable drug delivery device.
  • Figure 6 is a schematic exploded perspective view of one embodiment of a medicinal cannabis compound-delivering electronic cigarette comprising a base unit and a cartomizer component.
  • a "plurality” as used herein refers to more than one.
  • a plurality of compounds may be two, three, four, five, or more compounds.
  • compositions, and methods include the recited elements, and may additionally include any other elements.
  • Consisting essentially of shall mean that the devices, compositions, and methods include the recited elements and exclude other elements of any essential significance to the combination for the stated purpose. Thus, a device, composition, or method consisting essentially of the elements as defined herein would not exclude other materials or steps that do not materially affect the basic and novel characteristic(s) of the claimed invention. "Consisting of shall mean that the devices, compositions, and methods include the recited elements and exclude anything more than trivial or inconsequential elements or steps. Embodiments defined by each of these transitional terms are within the scope of this disclosure.
  • Crobis refers to a flowering plant including the species (or sub-species): Cannabis sativa, Cannabis ruderalis, and Cannabis indica.
  • Crobinoids refers to a class of chemical compounds that act on the cannabinoid receptors. “Endocannabinoids” are produced naturally in animals, including humans.
  • “Phytocannabinoids” are naturally-occurring cannabinoids produced in plants. “Synthetic cannabinoids” are artificially manufactured cannabinoids.
  • Cannabis species express at least 85 different phytocannabinoids, which are
  • phytocannabinoids are divided into subclasses, including cannabigerols, cannabichromenes, cannabidiols, tetrahydrocannabinols, cannabinols and cannabinodiols, and other cannabinoids.
  • Cannabinoids found in cannabis include, without limitation: cannabigerol (CBG), cannabichromene (CBC), cannabidiol (CBD), tetrahydrocannabinol (THC), cannabinol (CBN) and cannabinodiol (CBDL), cannabicyclol (CBL), cannabivarin (CBV), tetrahydrocannabivarin (THCV), cannabidivarin (CBDV), cannabichromevarin (CBCV), cannabigerovarin (CBGV), cannabigerol monomethyl ether (CBGM), cannabinerolic acid, cannabidiolic acid (CBDA), Cannabinol propyl variant (CBNV), cannabitriol (CBO), tetrahydrocannabmolic acid (THCA), and tetrahydrocannabivarinic acid (THCV A).
  • CBD cannabigerol
  • Phytocannabinoids can occur as either the pentyl (5 carbon atoms) or propyl (3 carbon atoms) variant.
  • the propyl and pentyl variants may have distinct properties from one another.
  • THC is a CB1 receptor agonist
  • the propyl variant THCV is a CB1 receptor antagonist meaning that it has almost opposite effects from THC.
  • Terpenes or “terpenoids” refers to a class of chemicals produced by plants, including cannabis.
  • the term “terpenoid” generally refers to a chemically modified terpene (e.g., by oxidation).
  • the terpenes include terpenoids.
  • Terpenes and terpenoids are often aromatic hydrocarbons and may have strong smells associated with them.
  • Terpenes known to be produced by cannabis include, without limitation,
  • aromadendrene bergamottin, bergamotol, bisabolene, borneol, ⁇ -3-carene, caryophyllene, cineole/eucalyptol, p-cymene, dihydrojasmone, elemene, farnesene, fenchol, geranylacetate, guaiol, humulene, isopulegol, limonene, linalool, menthone, menthol, menthofuran, myrcene, nerylacetate, neomenthylacetate, ocimene, perillylalcohol, phellandrene, pinene, pulegone, sabinene, terpinene, terpineol, terpineol-4-ol, terpinolene, and derivatives, isomers, enantiomers, etc. of each thereof.
  • Cannabis plants and products may also comprise other pharmaceutically relevant compounds, including flavonoids and phytosterols (e.g., apigenin, quercetin, cannflavin A, ⁇ - sitosterol and the like).
  • Medicinal cannabis compound refers to any compound present in marijuana, which has a therapeutic, analgesic, anti-nausea, or other medically relevant effect on a patient, including, for example, cannabinoids, terpenes, flavonoids, and phytosterols.
  • said compounds may be present in a natural or purified form; alternatively, said compounds may be synthetic.
  • a "unit dose” corresponds to a specific amount (e.g., by weight, ratio, or concentration) of medicinal cannabis compounds, which from administration to administration will not vary by more than 20%, and preferably, by no more than 10%, preferably, no more than 5% or 1%.
  • the amount that constitutes a unit dose will vary by patient and by condition.
  • the specific amount constituting a unit dose for a particular patient is based on the prescribing clinician's judgment based on a patient's age, gender, weight, height, illness, severity of illness, and/or any other factors relevant to medication dosing.
  • An example unit dose is a product comprising 0.01-99.99%) THC; another example unit dose is a product comprising 0.01-99.99%) CBD.
  • Atomizing means forming a spray. The term refers to the act of converting a liquid into fine particles suspended within the air. Atomizing shall be treated as a general term which encompasses both vaporizing and aerosolizing. In at least some
  • atomizing involves converting a liquid oil extract into a suspension or dispersion of fluid particles each having a diameter of no more than 10 ⁇ . In at least some embodiments, atomizing involves converting a liquid oil extract into droplets sized for inhalation and absorption through the lungs of a patient.
  • Inhalable drug delivery device refers to an apparatus used to administer one or more medicinal compounds to a patient via inhalation and absorption through the lungs.
  • the inhalable drug delivery devices described herein convert a liquid containing medicinal cannabis compounds into particles or droplets sufficiently small enough to be inhaled and absorbed into the lungs.
  • the liquid is atomized into particles or droplets having a diameter no greater than 10 ⁇ .
  • the devices are configured to optimize absorption through the lungs; in at least some preferred embodiments, the devices are configured to atomize the liquid into particles or droplets having a diameter between 0.05 and 5 ⁇ ; in some such embodiments, the devices are configured to atomize the liquid into particles or droplets having a diameter between 1 and 3 ⁇ .
  • the inhalable drug delivery devices described herein may take many forms, but all notably have at least some common characteristics.
  • the inhalable drug delivery device may take the form of an electronic cigarette (i.e., e-cigarette).
  • an electronic cigarette i.e., e-cigarette.
  • an electronic cigarette i.e., e-cigarette.
  • Electronic cigarette or “e-cigarette” refers to an elongated, hand-held device configured to atomize a liquid stored therein. It is a general term referring to electronic cigarettes, electronic cigars, electronic joints, and the like. Electronic cigarettes of the present invention may be shaped to resemble a conventional cigarette, joint, cigar, pipe, or other elongated hand-held smoking device.
  • the electronic cigarettes described herein are distinguishable from existing electronic cigarettes, which are used to simulate the act of tobacco smoking, preferably by producing an aerosol or vapor having a flavor, sensation, and nicotine content similar to that of conventional cigarette smoking.
  • Existing e-cigarettes were largely created to provide consumers with a "smoking" experience while avoiding the odor and health risks associated with the combustion process of conventional tobacco cigarettes.
  • Electronic cigarettes are distinguishable from other vaporizers, at least in part, by their portable, hand-held configuration.
  • the e-cigarettes provided herein are lightweight and compact, and they do not require the user to add any water to the device.
  • the release of the vapor or aerosol from the device is well controlled.
  • the electronic cigarettes may be automatically activated when a patient takes a drag (i.e., draws a breath or inhales) from the electronic cigarette.
  • the e-cigarette is configured such that a patient can take multiple drags from the e-cigarette, with the vapor or aerosol only released from the device in any significant amount when the patient draws a breath from it.
  • Such controlled release allows the e-cigarettes to function as effective drug delivery systems, administering a controlled dosage to a patient.
  • the provided e-cigarettes may further control drug dosage by employing a known formulation of cannabis oil extract as a vapor precursor.
  • Such e-cigarettes are distinguishable from existing marijuana vaporizers such as bongs and hookahs which are combustion-based and use dried buds and/or leaves of the marijuana plant as the vapor precursor.
  • existing vaporizers generate vapor having an uncontrolled and inconsistent composition.
  • Electronic cigarette embodiments contemplated herein may have components resembling those of existing nicotine-based electronic cigarettes, for example, the electronic cigarette components disclosed in US Publ. No. 2013/0192617 to Thompson, US Publ. No. 2014/0123989 to LaMothe, US Publ. No. 2012/0318882 to Abehasera, US Publ. No.
  • the inhalable drug delivery device may take the form of an electronic hookah, for example, as described in US Pat. No. 8,757,170 to Kaplani, an electronic bong, an electronic water pipe, for example, as described in US Publ. No. 2010/0126516 to Yomtov et al, a nebulizer, for example, as described in US Pat. No. 5,429,302 to Abbott or in US Pat. No.
  • Inhalable drug delivery devices include an atomizer and a liquid to be atomized.
  • the inhalable drug delivery devices of the present are not combustion-based systems. Rather, the disclosed devices rely on the atomizer to form a vapor or aerosol for inhalation.
  • the devices are adapted for use with pharmaceutical formulations having known amounts of one or more medicinal cannabis compounds.
  • each of the inhalable drug delivery devices is configured to deliver controlled quantities or doses of one or more medicinal cannabis compounds to a patient.
  • a "patient” refers to a user of any of the inhalable drug delivery devices described or contemplated herein.
  • the patient has received a prescription for medicinal marijuana use from a licensed medical practitioner.
  • medicinal marijuana is prescribed by physicians in a growing number of states and jurisdictions to persons with debilitating medical conditions. Typically, under current practices, a physician will certify that a qualifying patient is eligible to use medical marijuana, and the patient is then given a card or other documentation, which can be presented at dispensaries to buy the allotted amount of marijuana permitted under state or local law. Unlike most prescription drugs, with medicinal marijuana, physicians do not typically prescribe an exact dosage, in part because with current cannabis products, it is nearly impossible to monitor and quantify the amount of medicinal cannabis compounds a patient actually consumes.
  • one aspect of the present invention is directed to pharmaceutical formulations having known amounts of medicinal cannabis compounds.
  • another aspect of the invention is directed to devices capable of controlled release of cannabis compounds. Specifically, in order to achieve controlled release, the devices provided herein deliver cannabis compounds to patients without ingestion and with no or minimal smoking/combustion.
  • the devices provided herein deliver cannabis compounds to the bloodstream via inhalation (i.e., through the lungs).
  • inhalation i.e., through the lungs.
  • pulmonary administration results in nearly immediate absorption into the bloodstream with the peak effect of the inhalable cannabis compounds felt within 30 minutes or less from the time of inhalation.
  • each device provided herein keeps the medicinal cannabis compounds substantially or entirely contained within the device until a patient inhales directly therefrom; thus, medicinal cannabis compounds are not lost to sidestream smoke, off-gassing, or other unintentional release.
  • the use of the devices provided herein with a known quantity of liquid having a known amount of medicinal cannabis compounds results in the delivery of a controlled amount of cannabis compounds and enables one to administer a controlled unit dose.
  • the pharmaceutical formulation to be atomized is a liquid; in particular, it is a liquid comprising medicinal cannabis compounds.
  • the liquid is a cannabis oil extract.
  • the liquid is formulated to be volatile so as to readily aerosolize or vaporize.
  • Cannabis oil is light and fairly volatile by nature, but in at least some embodiments, the cannabis oil extract is mixed with a polyhydric alcohol to increase volatility.
  • the oil may be mixed with an alcohol and a glycerol.
  • propylene glycol, glycerin, or a combination thereof is used.
  • medical grade glycerin i.e., glycerin USP
  • Water may also be added to the mixture.
  • any other suitable aerosol precursors may be used.
  • Exemplary compositions of aerosol precursors as well as other casing materials and flavoring agents that may be added are disclosed in US Publ. No. 2014/0096782, the disclosure of which is herein incorporated by reference in its entirety.
  • the liquid is specially formulated to provide therapeutic, analgesic, or other medicinal value.
  • Said liquid may be formulated, for example, to provide a medically prescribed dosage of cannabinoid(s), terpene(s), and/or other medically relevant cannabis compounds.
  • the liquid comprises an extract (e.g. hash oil) from a cannabis plant.
  • one or more parts of a cannabis plant e.g., stems, leaves, stalk and/or flowers
  • the extract is from a single strain of cannabis.
  • the extract is a blend from a plurality of strains of cannabis.
  • the strain or strains of cannabis is selected to achieve a desired cannabinoid and/or terpene content. That is, one or more strains with a desired concentration of a given cannabinoid and/or terpene is used, based on the medical condition to be treated.
  • the cannabinoids and/or terpenes are purified and/or synthetic compounds.
  • At least one component of the liquid is present in a known quantity.
  • an extract may be assayed to determine the concentration of at least one
  • a liquid comprising an extract may be recommended for one or more medical conditions based on the components (and/or ratios of components) present therein.
  • the concentrations of CBD and THC in the liquid are known.
  • Various extracts may be blended together to achieve a desired concentration or combination of concentrations of one or more medically relevant cannabis compounds.
  • the liquid contains a high ratio of CBD:THC. In one embodiment, the liquid contains a CBD:THC ratio of at least about 10: 1. In one embodiment, the liquid contains a CBD:THC ratio of about 10: 1 to about 300: 1. In one embodiment, the liquid is from a cannabis strain as described in U.S. Provisional Patent Application No. 62/019,810, which is incorporated herein by reference in its entirety. In one embodiment, the ratio of estimated active cannabidiol to estimated active THC is between about 300: 1 and about 15: 1. In one embodiment, the ratio of active cannabidiol to active THC is between about 300: 1 and about 20: 1.
  • the ratio of active cannabidiol to active THC is between about 300: 1 and about 30: 1. In one embodiment, the ratio of active cannabidiol to active THC is between about 300: 1 and about 50: 1. In one embodiment, the ratio of active cannabidiol to active THC is between about 300: 1 and about 70: 1. In one embodiment, the ratio of active cannabidiol to active THC is between about 300: 1 and about 80:1. In one embodiment, the ratio of active cannabidiol to active THC is between about 300: 1 and about 100: 1. In one embodiment, the ratio of active cannabidiol to active THC is between about 300: 1 and about 200: 1. The ratio may be any ratio or range within the stated ranges, including endpoints.
  • the CBD :THC ratio is between about 1 : 1 and about 1 : 100. In one embodiment, the CBD:THC ratio is between about 1 : 1 and about 1 :80. In one embodiment, the CBD:THC ratio is between about 1 : 1 and about 1 :60. In one embodiment, the CBD:THC ratio is between about 1 : 1 and about 1 :40. In one embodiment, the CBD:THC ratio is between about 1 : 1 and about 1 :20. In one embodiment, the CBD:THC ratio is between about 1 : 1 and about 1 : 10. In one embodiment, the CBD:THC ratio is between about 1 : 10 and about 1 : 100. In one embodiment, the CBD:THC ratio is between about 1 : 1 and about 1 :80. In one embodiment, the CBD:THC ratio is between about 1 : 1 and about 1 :60. In one embodiment, the CBD:THC ratio is between about 1 : 1 and about 1 :40. In one embodiment, the CBD:THC ratio is between about 1 : 1 and
  • the CBD:THC ratio is between about 1 : 10 and about 1 :80. In one embodiment, the CBD:THC ratio is between about 1 : 10 and about 1 :60. In one embodiment, the CBD:THC ratio is between about 1 : 10 and about 1 :40. In one embodiment, the CBD:THC ratio is between about 1 : 10 and about 1 :20. In one embodiment, the CBD:THC ratio is between about 1 : 1 and about 10: 1. The ratio may be any ratio or range within the stated ranges, including endpoints.
  • percent refers to percent by weight.
  • the liquid comprises about 95% or more of at least one desired cannabinoid and/or terpene. In one embodiment, the liquid comprises about 90% or more of at least one desired cannabinoid and/or terpene. In one embodiment, the liquid comprises about 80% or more of at least one desired cannabinoid and/or terpene. In one embodiment, the liquid comprises about 70% or more of at least one desired cannabinoid and/or terpene. In one embodiment, the liquid comprises about 60% or more of at least one desired cannabinoid and/or terpene.
  • the liquid comprises about 50% or more of at least one desired cannabinoid and/or terpene. In one embodiment, the liquid comprises about 40% or more of at least one desired cannabinoid and/or terpene. In one embodiment, the liquid comprises about 30% or more of at least one desired cannabinoid and/or terpene. In one embodiment, the liquid comprises about 20% or more of at least one desired cannabinoid and/or terpene. In one embodiment, the liquid comprises about 10% or more of at least one desired cannabinoid and/or terpene. In one aspect, the liquid is diluted to a desired cannabinoid and/or terpene concentration. In some embodiment, the liquid comprises about 50% or more of at least one desired cannabinoid and/or terpene concentration. In some embodiment, the liquid comprises about 40% or more of at least one desired cannabinoid and/or terpene. In one embodiment, the liquid comprises about 30% or more of at least one desired cannabinoid and/or terpen
  • the liquid or oil extract comprises 75-95 wt% CBD and 0-15 wt% THC. In one embodiment, the liquid or oil extract comprises 83 wt% CBD and 5 wt% THC.
  • the liquid is sold to a patient within a reservoir.
  • the reservoir may form a portion of a cartridge or cartomizer.
  • the cartridge or cartomizer may be sold separately or as an integrated part of an inhalable drug delivery device, such as an e-cigarette.
  • the amount of liquid in the reservoir, and the concentration of one or more specific cannabinoids and/or terpenes in the liquid is selected such that a patient can administer a pre-determined dose of the one or more
  • cannabinoids and/or terpenes in a single inhalation or a series of inhalations.
  • the liquid is diluted to provide about 10 mg THC in a single inhalation or in a single use session or over a certain number of inhalations or period of time.
  • the dose may be any amount of one or more cannabinoids, terpenes, and/or other medically relevant cannabis compounds, as determined by a clinician or the patient.
  • the oil composition within a reservoir can be selected to meet the medical needs of a patient.
  • a plurality of reservoirs may be available for sale (each sold, for example, as part of a cartridge, cartomizer, or e-cigarette), the plurality of reservoirs containing varying oil compositions formulated to comprise varying amounts of active compounds.
  • a reservoir is available with an oil composition comprising, for example, 75-100 wt% CBD and 0-25 wt% THC; another reservoir may be available with an oil composition comprising, for example, 75-100 wt% THC and 0-25 wt% CBD; and another product may be available with an oil composition comprising, for example, 25-75% CBD and 25-75% THC.
  • each oil composition is formulated and selected to treat one or more health conditions.
  • each reservoir comes filled with a liquid equal to a single prescribed dose. In other embodiments, each reservoir comes filled with more than one dose, but as described below, the drug delivery device is programmed to shut off or deactivate upon the administration of a prescribed single dose.
  • the liquid within each reservoir comprises about 0.1 mg to about 100 mg THC; in some
  • the liquid within each reservoir comprises about 0.1 mg to about 100 mg CBD.
  • cannabinoid and/or terpene in the liquid is selected such that a patient using the electronic cigarette is administered a pre-determined dose of cannabinoid and/or terpene in a single inhalation or a series of inhalations.
  • a pre-determined dose of cannabinoid and/or terpene in a single inhalation or a series of inhalations For example, for a patient who needs or is prescribed a dose of 50 mg THC, the liquid is diluted to provide about 50 mg THC in a single inhalation or in a single session or over a certain number of inhalations or period of time.
  • the dose may be any amount of one or more cannabinoids and/or terpenes, as determined by a clinician or the patient.
  • each disposable cartomizer is configured to contain liquid equal to a single prescribed dose. In other embodiments, each disposable cartomizer is configured to contain more than one dose and the e-cigarette is programmed to shut off or deactivate the heating element, as described above, upon the administration of a prescribed single dose.
  • the liquid within each cartomizer comprises about 0.1 mg to about 100 mg THC; in some embodiments, the liquid within each cartomizer comprises about 0.1 mg to about 100 mg CBD.
  • the cannabis compound-containing liquid embodiments and the electronic cigarette embodiments described herein function to provide a means of delivering a pharmaceutical formulation of medicinal marijuana compounds to a patient via pulmonary delivery, which is a safe, convenient, and effective means of delivering said compounds.
  • the Drug Delivery Device The Drug Delivery Device
  • Embodiments provided herein are directed to improved drug delivery devices, and in particular, to devices for delivering controlled volumes of liquid having known amounts of medicinal cannabis compounds to a patient in an inhalable form.
  • the drug delivery devices disclosed herein convert a liquid comprising medicinal cannabis compounds, for example, an oil extract from cannabis, into a vapor or aerosol.
  • the disclosed inhalable drug delivery devices atomize the liquid while causing little or no combustion.
  • the release of the vapor or aerosol from the device is well controlled.
  • a device that generates an inhalable form of cannabis compounds with little-to-no combustion is safer for patients and their environments than a device dependent on combustion.
  • Conventional, incomplete combustion of marijuana may result in the release of smoke, toxins, and/or other chemicals that can irritate the respiratory system.
  • smoke, toxins, and/or other chemicals may be inhaled by patients smoking marijuana and nearby individuals.
  • a lit joint or marijuana cigarette poses a fire hazard if not properly extinguished.
  • smoking as much as 40% or more of the biologically available cannabis compounds may be lost due to combustion and sidestream smoke.
  • Such risks and drawbacks may be reduced or eliminated with use of one or more of the device embodiments provided herein.
  • the inhalable cannabis compounds can be absorbed into the bloodstream almost immediately.
  • the peak effect may be felt, for example, within 30 minutes or less from the time of inhalation. Such absorption times are a particular improvement over ingested cannabis delivery where the peak effect may not be felt for six or more hours.
  • the disclosed inhalable drug delivery devices are handheld and portable.
  • the inhalable drug delivery device is an electronic cigarette, a device that is growing in popularity and acceptable to use in many public and social settings.
  • such a design may allow patients to administer, via pulmonary delivery, a therapeutic amount of medicinal cannabis compounds whenever needed, for example, at the onset of severe pain, nausea, or other debilitating symptoms.
  • each inhalable drug delivery device includes a housing.
  • the housing forms the outer surface of the device and defines an interior space in which various internal components are stored.
  • the housing includes an inlet and an outlet. The inlet and outlet are in fluid communication such that air can pass through the interior space of the device from the inlet to the outlet when a patient draws on, or inhales through, the outlet.
  • the internal components stored within the interior space of the housing include: a reservoir holding the liquid comprising medicinal cannabis compounds, and an atomizer.
  • the walls of the housing form the reservoir in which the liquid is stored.
  • the reservoir is a separate component and may include, for example, a sponge or other absorbent material operating to hold the liquid or a substantially closed container disposed within the interior space of the housing.
  • the atomizer may include a resistive heating element, an oscillating stimulator, or a pneumatic stimulator.
  • the resistive heating element may be, for example, a conductive coil, which heats a portion of the liquid, causing it to vaporize.
  • the oscillating stimulator may be a piezoelectric element, an ultrasonic element, or other element that creates vibrations or oscillations in the reservoir of liquid, causing disturbances to the liquid, which results in liquid particles breaking away from the surface of the liquid.
  • the pneumatic stimulator may be a pressurized canister with a spray nozzle.
  • the liquid is stored in the reservoir under such pressure that, when released through the spray nozzle, the liquid is expelled with such speed and force that it causes the expelling liquid to aerosolize.
  • the internal components further include a power source electrically coupled to: a sensor, a control circuit, and the atomizer.
  • the atomizing process is initiated and operated automatically.
  • the power source is a battery.
  • the power source may be any suitable battery.
  • the power source may be a rechargeable lithium-ion battery, a long-lasting lithium battery or nickel cadmium battery, or an inexpensive alkaline battery.
  • the battery is rechargeable.
  • the base unit includes a port in electrical communication with the battery, allowing for convenient recharging of the battery inside the base unit.
  • the base unit-side of the connector includes a USB, micro-USB, or other port configured to plug into a personal computer, a mobile computing device, or a charging station; in other
  • the base unit-side connector includes a USB, micro-USB, or other receptacle designed to receive charge from a power cord connected to a computer, charging station, or wall outlet.
  • the battery is removable, for example, to replace the battery or to recharge the battery.
  • the power source is a cord and plug configured to connect to an AC or DC outlet.
  • the control circuit of the drug delivery device is in electrical communication with the power source and the heating element.
  • the control circuit may be formed of one or a plurality of circuits.
  • the control circuit includes a microprocessor or microcontroller with programmed instructions stored on memory (e.g., a non-transient computer- readable storage medium), said instructions causing the microprocessor, circuitry, and electronically connected components to perform some or all of the functions and operations described herein.
  • the functionality described herein may be performed by hardware, software, or a combination thereof.
  • control circuit is electrically coupled to an inhalation sensor, which detects when a patient inhales through the outlet of the drug delivery device.
  • the control circuit When inhalation is detected by the sensor, the control circuit sends a signal to the atomizer to activate the atomizer. Such activation results in the excitation of a liquid (e.g., via heating or oscillations) and formation of a vapor or aerosol, which is released into the patient's mouth during the inhalation.
  • the inhalation sensor is a differential pressure sensor configured to sense when the pressure within the housing changes, said pressure change indicative of a patient's inhalation from the device.
  • the sensor is an electric air flow sensor.
  • the inhalation sensor is a digital sensor configured to turn the atomizer on or off.
  • the inhalation sensor is an analog sensor designed to detect a relative change in pressure or flow corresponding to a relative strength of inhalation.
  • the device may be configured to produce an amount of vapor corresponding to the strength of inhalation such that, the harder a patient drags on the e-cigarette, the more vapor the patient receives per drag.
  • vapor is only produced and released from the drug delivery device while a patient inhales from the device. Such a feature helps prevent unintended release of cannabis compounds from the device, enabling controlled administration of said compounds.
  • the control circuit is electrically coupled to a charge indicator, such as a light or line of lights, configured to display a particular color or illuminate a particular length, respectively, to indicate a relative amount of charge remaining in the device.
  • a charge indicator such as a light or line of lights
  • the drug delivery device is a single, integral unit.
  • the entire drug delivery device is disposable and generally configured to be disposed of once the liquid has been depleted from the liquid-filled reservoir.
  • the reservoir is refillable, for example, by a patient or a licensed dispensary, when the liquid runs low within the reservoir.
  • the drug delivery device is formed of at least two, separable components: a base unit and a cartridge or cartomizer unit.
  • the base unit houses the power source and all or a portion of the control circuit.
  • the base unit also houses the atomizer.
  • the cartridge comprises the reservoir of liquid.
  • a cartomizer unit is present in the embodiment instead of a cartridge.
  • the cartomizer unit houses the liquid-filled reservoir and the atomizer.
  • the base unit is reusable while the separable cartridge or cartomizer unit is generally configured to be thrown away once the liquid has been depleted from the liquid-filled reservoir.
  • the liquid-filled reservoir may be replaceable or refillable.
  • a connector is provided to connect the two units physically and electrically.
  • the connector includes means for securably yet releasably connect the base unit and the cartridge or cartomizer unit.
  • Such means may include, for example, a male fitting and a female fitting having
  • the means for securably yet releasably connecting the base unit and the cartridge/cartomizer unit may include a snap fit or friction fit.
  • At least one air flow opening exists within the connector, allowing air entering through an inlet in the base unit to flow through the device from the inlet to an outlet at or near a proximal end of the cartridge/cartomizer unit.
  • at least a portion of the connector is electrically conducting and configured to delivery current and/or voltage from the power source to the atomizer.
  • the control circuit may include an identification component configured to detect the identity of the cartridge or cartomizer.
  • the cartridge/cartomizer unit includes an identification key, which generates identification signals.
  • the identification key may be a resistive element, for example, a surface mount resistor or a resistive ink-based element having a unique size or shape, or it may be another unique electrical signal generator.
  • the identification component is integrated into, or coupled to, the base unit side of the connector, and the identification key is integrated into, or coupled to, the cartridge or cartomizer unit side of the connector.
  • the identification key is used to distinguish the cartridge or cartomizer as belonging to a particular brand.
  • the base unit may be configured to operate only when coupled to a cartridge or cartomizer unit of the same manufacturer or brand.
  • the identification key may identify the model (or the particular drug dosage) of the cartridge/cartomizer unit.
  • a plurality of cartridge or cartomizer models may exist; the models may each: have a different
  • the various cartridge/cartomizer models may each require the atomizer to reach a different level of stimulation (e.g., a different unique temperature, unique heating protocol, or a different frequency of oscillation) in order to atomize the liquid of the cartridge or cartomizer unit.
  • the identification component of the base unit is configured to receive and detect the signal generated by the identification key of the cartridge/cartomizer unit, and the control circuit with the microprocessor is configured to identify a proper stimulation protocol based on the identification key signals.
  • the base unit's microprocessor compares the unique
  • identification key signals to a database of identification keys stored in memory.
  • each identification key is associated with a particular cartridge or cartomizer model and stimulation protocol. If the identification key signals match a key in the database, the corresponding stimulation protocol will be selected and executed by the control circuit.
  • the base unit receives updates periodically in order to stay up to date on the various available cartridge or cartomizer units and their corresponding identification keys and stimulation protocols.
  • Such updates are stored in a server and may be accessed by an internet-enabled computer and delivered to the base unit while the base unit is plugged into the internet-enabled computer, for example, while charging.
  • the control unit with the microprocessor may include a transmitter and a receiver for wireless bidirectional communication.
  • the base unit can receive updates wirelessly.
  • the base unit is configured to receive and transmit radio- frequency signals, such as Bluetooth® signals.
  • An internet-enabled device may access and download updates from the server periodically or as they become available, and the updates may be transmitted from the internet-enabled device to the base unit when in close proximity to one another.
  • a user may be able to control other operations of the drug delivery device.
  • a patient or health care provider can program certain controls into the drug delivery device using a personal computer, mobile computing device, or other external controller.
  • the patient or provider can download a front-end application from a server onto their external controller.
  • This application may allow the patient or provider to specify the number of inhalations a patient can consume per session.
  • the application may allow the patient or provider to specify a maximum frequency of use or a minimum interval of time required between each session. For example, a provider may want to prescribe cannabinoids to a patient while putting limits on its usage.
  • the provider may be able to limit the number of inhalations per use (such as, for example, to 20 inhalations per use session), limit the number of uses per day (such as, for example, to twice daily), or require a certain interval of time to pass between use (such as, for example, at least 6 hours between sessions). Additionally or alternatively, a patient may be able to select one of multiple settings for the device.
  • a patient may be able to select a low setting, which heats the atomizer to a low temperature to atomize the most volatile compounds, generating primarily flavor and smell, and a patient may be able to select one or more higher settings, which heats the atomizer to one or more higher temperatures and atomizes one or more of the active medicinal ingredients.
  • these controls are transmitted from the external controller to the drug delivery device wirelessly, for example, via Bluetooth, or via a wired connection such as a removable cable.
  • the drug delivery device may store these instructions in memory and execute these instructions via the device's microprocessor.
  • a drug delivery device programmed in this manner may be inoperable (i.e., it may not activate upon inhalation) if a patient tries to use the device more than prescribed (i.e., beyond the programmed limits). In this manner, the inhalable drug delivery device can be used to administer a controlled unit dose to a patient.
  • E- cigarettes are formed of three necessary components: a cartridge, which is or includes a reservoir configured to hold the liquid intended for consumption; an atomizer, which is or includes a heating element configured to heat a portion of the liquid until it atomizes; and a base unit, which includes a power source and a control circuit.
  • the cartridge and atomizer are integrated into a single unit, referred to as a "cartomizer.”
  • a cartomizer includes separate sections for the liquid reservoir and the atomizer, but the sections together form a single device.
  • the base unit and cartomizer unit are configured to removably couple to each other. In at least some such designs, the base unit is reusable, while the cartomizer unit is disposable and designed to be replaced when all liquid is depleted from the reservoir. More details about the structure of e-cigarettes are provided below.
  • each inhalable drug delivery device includes a housing.
  • the housing forms the outer surface of the device and defines an interior space in which various internal components are stored.
  • the housing includes an inlet and an outlet.
  • the inlet and the outlet are holes or apertures within the housing extending through the outer surface of the housing to the interior space.
  • the inlet and outlet are in fluid communication such that air can pass through the device from the inlet to the outlet when a patient draws on, or inhales through, the outlet.
  • the outlet is positioned on or in a mouthpiece.
  • the housing may be formed of any suitable material or materials configured to retain the shape of the device during storage and use.
  • the housing is formed of a single wall, such as, for example, a single tubular wall.
  • the housing is formed of a heat resistant material configured to retain its structural integrity when subjected to temperatures at least as hot as those generated by an internal heating element.
  • the housing is formed of one or more polymers or ceramics.
  • a paper or other natural fiber is used; in such embodiments, the paper or fiber may be lined on an interior wall with a polymer, ceramic, aluminum foil, or other heat resistant material.
  • the housing material is selected, at least in part, based on weight, with the housing configured to be lightweight so as to resemble the feel of a regular cigarette or joint.
  • the internal components include: a power source; a control circuit; a heating chamber; a heating element within the heating chamber; a reservoir holding a volatile liquid comprising medicinal cannabis compounds; and a wick extending into both the liquid-filled reservoir and the heating chamber.
  • the control circuit and power source are physically isolated from the liquid and from any resulting vapor or aerosol formed within the device.
  • the housing is a single, integral unit.
  • the entire e-cigarette is disposable and generally configured to be disposed of once the liquid has been depleted from the liquid- filled reservoir.
  • the housing is formed of two, separable components: a base unit and a cartomizer unit.
  • the base unit houses the power source and all or a portion of the control circuit.
  • the cartomizer unit houses the heating element, the heating chamber, the wick, and the liquid- filled reservoir.
  • the base unit is reusable while the separable cartomizer unit is generally configured to be thrown away once the liquid has been depleted from the liquid- filled reservoir.
  • the housing of the base unit and the cartomizer unit are formed of the same material.
  • the housing of the reusable base unit is formed of a sturdier and more durable material than the disposable cartomizer unit.
  • the liquid- filled reservoir may be replaceable or refillable.
  • a connector is provided to connect the two units physically and electrically.
  • the connector includes means for securably yet releasably connect the base unit and the cartomizer unit.
  • Such means may include, for example, a male fitting and a female fitting having complementary threading disposed thereon, wherein one of the fittings forms a portion of the base unit and the other fitting forms a portion of the cartomizer unit.
  • the means for securably yet releasably connecting the base unit and the cartomizer unit may include a snap fit or friction fit.
  • At least one air flow opening exists within the connector, allowing air entering through an inlet in the base unit to flow through the device from the inlet to an outlet at or near a proximal end of the cartomizer unit. Additionally, at least a portion of the connector is electrically conducting and configured to delivery current and/or voltage from the power source to the heating element.
  • the control circuit of the electronic cigarette is in electrical communication with the power source (e.g., the battery) and the heating element.
  • the control circuit may be formed of one or a plurality of circuits.
  • the control circuit includes a
  • control circuit is electrically coupled to an inhalation sensor, which detects when a patient inhales through the outlet of the e-cigarette. When inhalation is detected by the sensor, the control circuit sends a signal to the heating element to activate the heating element.
  • the inhalation sensor is a differential pressure sensor configured to sense when the pressure within the e-cigarette changes, said pressure change indicative of a patient's inhalation from the device.
  • the sensor is an electric air flow sensor.
  • the inhalation sensor is a digital sensor configured to turn the heating element on or off.
  • the inhalation sensor is an analog sensor designed to detect a relative change in pressure or flow corresponding to a relative strength of inhalation.
  • the device may be configured to produce an amount of vapor corresponding to the strength of inhalation such that, the harder a patient drags on the e-cigarette, the more vapor the patient receives per drag.
  • control circuit is electrically coupled to a charge indicator, such as a light or line of lights, configured to display a particular color or illuminate a particular length, respectively, to indicate a relative amount of charge remaining in the device.
  • a charge indicator such as a light or line of lights
  • control circuit is electrically coupled to a use indicator, such as an LED light, disposed at a distal end of the e-cigarette.
  • the use indicator is configured to activate with activation of the heating element such that the use indicator illuminates each time a user inhales vapor from the e-cigarette.
  • the use indicator on the distal end glows, thus simulating the appearance of a conventional cigarette or joint.
  • the cartomizer unit When successfully activated, the cartomizer unit operates in the following manner. Capillary action draws liquid along a wick from the liquid- filled reservoir to the heating chamber.
  • the heating element is disposed around or near the wick within the heating chamber. Upon activation, heat from the heating element causes the liquid within the heating chamber to vaporize or aerosolize such that the air within the heating chamber contains inhalable medicinal cannabis compounds or inhalable droplets of liquid comprising medicinal cannabis compounds, and the cannabis compound-rich air travels through the heating chamber to the outlet, exiting the e-cigarette and entering a patient's mouth when the patient inhales.
  • the wick may be formed of any suitable wicking material that facilitates movement of liquid along the wick via capillary action.
  • a fibrous material is used.
  • the wick may be formed of cotton, hemp, polyester, rayon, a metallic mesh, metal oxide based fibers, silicon oxide based fibers, woven ceramic fibers, or combinations thereof.
  • a non-combustible material is used.
  • the wick is formed of a material known to emit few, if any, toxins when combusted.
  • the wick is formed of polylactic acid (PLA).
  • PVA polylactic acid
  • a non- fibrous material is selected for the wick, such as, for example, porous ceramic materials.
  • the heating element is a resistive heating element.
  • the heating element includes a conductive wire having a positive terminal lead, a negative terminal lead, and a plurality of coils therebetween. In at least some
  • the coils of the heating element are wound around a portion of the wick.
  • the positive and negative terminal leads are electrically connected to the control circuit, for example, via the connector, and the operation of the heating element is controlled by the control circuit.
  • the materials and configuration of the heating chamber and the liquid-filled reservoir can vary significantly.
  • the heating chamber and liquid-filled reservoir are substantially isolated from each other such that liquid does not leak into the heating chamber, but rather, only enters slowly and steadily via capillary action along the wick. While a few examples of heating chambers and liquid- filled reservoirs are described in detail below, it will be appreciated by those skilled in the art that the specific positional arrangement and structural form of the reservoir and the heating chamber can vary as long as the described functions are achieved.
  • FIG. 1 A schematic representation of the outer housing of one embodiment of an electronic cigarette is illustrated in Figure 1.
  • the electronic cigarette 100 includes a protective body casing, i.e., a housing 110.
  • the housing 110 is elongated and cylindrical to resemble the look and feel of a conventional cigarette.
  • the housing 110 has a proximal end 101 with an outlet 112 extending through a proximal wall of the housing 110.
  • the proximal end 101 is adapted for insertion into a patient's mouth.
  • the opposite end of the device which is the portion of the device located furthest from the patient's mouth during inhalation, is referred to as the distal end 102.
  • a use indicator 150 in the form of an LED light, is provided on the distal end 102.
  • the housing preferably on or near the distal end 102 or on a distal half of the device 100, lies one or more inlets 114 extending through the housing wall. The inlets 114 allow air to pass between the interior and exterior of the e-cigarette 100.
  • Figures 2-4 provide non-limiting examples of the internal components of an inhalable drug delivery device taking the form of an e-cigarette.
  • all provided components are shown from a side view, as though the outer housing (e.g., housing 110) is transparent.
  • the e-cigarette 100 of Figure 1 may have internal components arranged to match the configuration of any one of Figures 2-4.
  • the internal components of Figure 1 may be arranged in any alternative configuration that allows the components to function in the manner described herein.
  • the provided electronic cigarette 200 includes a circuit on a printed circuit board 220, a power source 222, an atomizer in the form of a heating element 224, a heating chamber 226, a reservoir 228 holding a liquid comprising medicinal cannabis compounds, a wick 230 configured to move small quantities of liquid from the reservoir 228 to the heating chamber 226, and a connector 232 to electrically couple the heating element 224 to the power source 222.
  • the connector 232 includes one or more passageways 233 extending therethrough, allowing air to flow between the distal and proximal sides of the connector 232.
  • the reservoir 228 of liquid is a discrete storage vessel having walls separating the liquid in the reservoir 228 from the surrounding heating chamber 226.
  • Such a design may be configured to thermally separate the stored liquid from the heating chamber 226.
  • the reservoir 228 is substantially sealed liquid-tight with room only for the wick 230 to penetrate and protrude from the reservoir 228.
  • the electronic cigarette 200 of Figure 2 may be formed of a single integrated unit or it may be formed of a separable base unit and cartomizer unit.
  • a change in pressure or airflow within the electronic cigarette 200 causes a sensor positioned on, or electrically coupled to, the printed circuit board 220 to generate a signal, which is processed by components of the control circuit (e.g., the microprocessor) and activates the heating element 224.
  • the change in pressure also causes air to be drawn into one or more inlets 214 and through one or more passageways 233 into the heating chamber 226.
  • Liquid stored on the wick 230 is heated by the heating element, thereby causing the liquid on the wick to vaporize or aerosolize such that the air within the heating chamber 226 contains inhalable medicinal cannabis compounds or inhalable droplets of liquid containing cannabis compounds.
  • the heat excites and atomizes the liquid, removing it from the wick, more liquid flows along the wick from the reservoir 228 to the heating chamber 226 via capillary action.
  • the cannabis compound-rich air travels through the heating chamber 226 to the outlet on the proximal end 201 as the patient continues to inhale.
  • the electronic cigarette 300 of Figure 3 has a control circuit on a printed circuit board 320, a power source 322 and use indicator 350 constructed substantially similar to the e-cigarette of Figure 2.
  • the circuit board 320 and power source 322 are disposed within the base unit 310.
  • An atomizer in the form of a heating element 324, heating chamber 326, and reservoir of liquid 328 are disposed within a cartomizer unit 315.
  • the connector 332 is shown as comprising two portions, a base unit portion and a cartomizer unit portion. The two portions of the connector 332 engage together to securely couple the base unit 310 to the cartomizer unit 315.
  • Air inlets 314 extend through the housing of the base unit 310, an outlet (not visible) extends through the housing at the proximal end 301 of the cartomizer unit 315, and one or more passageways 333 extend through the connector 332, fluidly connecting the outlet and heating chamber 326 directly or indirectly to the inlets 314.
  • the cartomizer unit 315 is double-walled, forming an inner cylinder and an outer cylinder.
  • the inner cylinder forms the heating chamber 326 and is in fluid communication with the passageways 333 and the outlet at the proximal end 301.
  • the outer cylinder surrounding the inner cylinder, forms the reservoir 328 of cannabis compound- containing liquid.
  • the reservoir 328 of liquid coaxially surrounds the heating chamber 326.
  • the wall separating the reservoir 328 from the heating chamber 326 may be impervious to liquid, preventing the liquid from leaking into the heating chamber 326.
  • the heating element 324 is a coiled wire wound around a portion of the wick 330.
  • the electronic cigarette 400 of Figure 4 is substantially similar to the electronic cigarette 300 of Figure 3.
  • Electronic cigarette 400 is formed of a base unit 410 having a control circuit, including a microprocessor, arranged on a printed circuit board 420 and a power source 422, use indicator 450, and connector 432 connected thereto.
  • the e-cigarette 400 is further formed of a cartomizer unit 415 having a heating element 424 disposed within a heating chamber 426, which is surrounded by a reservoir storing liquid containing medicinal cannabis compounds 428.
  • a wick 430 facilitates the transport of liquid from the reservoir 428 to the heating chamber 426, where it is atomized due to heat from the heating element 424.
  • the reservoir 428 is not a separate container, but instead is a sponge or other absorbent material adapted to retain the liquid.
  • the reservoir 428 may be substantially separated from the heating chamber 426 by a cloth tube, for example, a tube formed of DACRON® (polyethylene terephthalate) or other natural or synthetic material.
  • the sponge or other absorbent material of the reservoir 428 is sufficiently absorbent so as to limit or prevent liquid from leaking from the reservoir 428 to the heating chamber 426. Accordingly, in such embodiments, a wick 430 is still provided to draw liquid from the reservoir 428 into the heating chamber 426 portion of the cartomizer unit 415.
  • the drug delivery device of the present embodiment is a nebulizer 500.
  • the nebulizer is formed, in part, by a housing 510, which comprises walls of the device and defines one or more interior spaces of the device.
  • interior walls of the housing 510 define a reservoir 528 in which a liquid 529 is held, the liquid comprising a known quantity (e.g., a unit dose) of one or more medicinal cannabis compounds.
  • the reservoir 528 is in fluid communication with an inlet 514 and an outlet 512.
  • a barrier 518 may be present within an airway 516 extending between the inlet 514 and the outlet 512, the barrier 518 configured to cause air flowing through the device from the inlet 514 to the outlet 512 to interact with the fluid within the reservoir 528.
  • the nebulizer 500 has an atomizer configured to vaporize and/or aerosolize the liquid to form inhalable particles.
  • the inhalable particles are small liquid droplets containing medicinal cannabis compounds.
  • the atomizer is an oscillating or vibrating stimulator, such as an ultrasonic oscillator, which causes high frequency vibrations to be applied to the bottom of the reservoir 528 of liquid 529.
  • the atomizer comprises a piezoelectric material 524, such as a slice of lead zirconate titanate (PZT), sandwiched between two electrodes 525.
  • the two electrodes 525 are formed of silver or other metal.
  • the electrodes 525 are attached to a source of alternating current 522 located within or external to the device 500.
  • the upper electrode is bonded to a cover, which transmits the vibrational energy from the piezoelectric material 524 to the liquid 529 in the reservoir 528.
  • the cover is formed of at least two layers, for example, a first layer 526 and a second layer 527.
  • the first layer 526 is formed of aluminum and the second layer 527 is formed of stainless steel.
  • Activation of the atomizer may be automatic, for example, the atomizer may activate upon inhalation due to signals received from a sensor and microprocessor coupled to the atomizer and power source, as described in embodiments above. In other embodiments, the atomizer is activated whenever a user turns on the power source 522 or connects the nebulizer 500 to the power source 522.
  • the piezoelectric material 524 vibrates, and these vibrations disturb the liquid 529, causing a mist of fine droplets to break away from the liquid 529 surface. These droplets can then be inhaled readily by a patient.
  • the piezoelectric material 524 vibrates with a frequency of 1.4-1.5 MHz.
  • the vibrational frequency may be varied as needed to atomize the particular composition of the liquid stored within the device 500.
  • the droplets formed are less than 10 ⁇ in diameter.
  • the nebulizer 500 holds a single unit dose of liquid 529 and atomizes the dose in a single session of use for inhalation by a patient.
  • the nebulizer 500 of various embodiments enables controlled pulmonary delivery of one or more medicinal cannabis compounds stored within the liquid 529.
  • Figure 6 provides a non-limiting example of an electronic cigarette 600 formed of a base unit 610 and a cartomizer unit 615, depicting the components as they appear on the outer surface.
  • the e-cigarette 600 includes one or more inlets 614 and an outlet 612.
  • a connector 632 having a male portion on the base unit 610 and a complementary female portion on the cartomizer unit 615 is also visible in the exploded view.

Abstract

La présente invention concerne une préparation pharmaceutique à base de composés de cannabis, qui est adaptée à l'administration par voie pulmonaire. Cette préparation comprend un liquide volatil, qui contient un mélange d'un extrait d'huile de cannabis comportant une quantité connue d'un composé de cannabis à usage thérapeutique, et un précurseur d'aérosol. Le composé de cannabis à usage thérapeutique peut correspondre à un cannabinoïde, un terpène, un flavonoïde, un phytostérol et/ou un autre composé à usage thérapeutique présents dans le cannabis. L'invention concerne également un appareil permettant de convertir le liquide volatil en particules adaptées à une administration par voie pulmonaire. L'appareil comprend un réservoir contenant le liquide volatil, et un atomiseur conçu pour atomiser le liquide volatil. L'activation de l'atomiseur entraîne l'atomisation d'au moins une partie du liquide volatil, avec pour résultat, la formation de particules inhalables contenant des composés de cannabis à usage thérapeutique. Les composés de cannabis à usage thérapeutique peuvent être administrés à un patient à l'aide de cet appareil électronique et sous la forme d'une dose unitaire contrôlée.
PCT/US2015/043320 2014-07-31 2015-07-31 Cigarettes électroniques, cartouches et préparations inhalables à base de composés de cannabis à usage thérapeutique et appareils et procédés permettant de les fabriquer et de les utiliser WO2016019353A1 (fr)

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US62/031,787 2014-07-31
US201462048724P 2014-09-10 2014-09-10
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