WO2016019353A1

WO2016019353A1 - Electronic cigarettes, cartridges, and inhalable formulations of medicinal cannabis compounds, and apparatuses and methods for making and using the same

Info

Publication number: WO2016019353A1
Application number: PCT/US2015/043320
Authority: WO
Inventors: Adam D. Cohen; James Lowe; John FRITZEL
Original assignee: MJAR Holdings, LLC
Priority date: 2014-07-31
Filing date: 2015-07-31
Publication date: 2016-02-04

Abstract

A pharmaceutical formulation of cannabis compounds is provided herein, which is suitable for pulmonary delivery. The formulation comprises a volatile liquid, which includes a mixture of: a cannabis oil extract having a known amount of a medicinal cannabis compound, and an aerosol precursor. The medicinal cannabis compound may include cannabinoids, terpenes, flavonoids, phytosterols, and/or other medicinally relevant compounds found in cannabis. Also provided is an apparatus for converting the volatile liquid into particles suitable for pulmonary delivery. The apparatus includes a reservoir holding the volatile liquid, and an atomizer adapted to atomize the volatile liquid. Activation of the atomizer causes at least a portion of the volatile liquid to atomize to form inhalable particles containing medicinal cannabis compounds. Using the electronic apparatus, the medicinal cannabis compounds may be administered to a patient in a controlled unit dose.

Description

ELECTRONIC CIGARETTES, CARTRIDGES, AND INHALABLE FORMULATIONS OF MEDICINAL CANNABIS COMPOUNDS, AND APPARATUSES AND METHODS

FOR MAKING AND USING THE SAME

BACKGROUND

CROSS-REFERENCE TO RELATED PATENT APPLICATIONS

[0001] This application claims priority to U.S. Provisional Application Serial Nos. 62/031,794, filed July 31, 2014; 62/031,787, filed July 31, 2014; and, 62/048,724, filed September 10, 2014, the disclosures of which are incorporated herein by reference in their entirety.

FIELD OF THE INVENTION

[0002] 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.

State of the Art

[0003] 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.

[0004] Cannabinoids are a group of chemicals that are known to activate cannabinoid receptors

(i.e., CB1 and CB2) in cells. Phytocannabinoids are produced by plants, including cannabis.

There are at least 85 different cannabinoids that can be isolated from Cannabis species, including

Cannabis sativa, Cannabis ruderalis, and Cannabis indica. Cannabinoids 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.

[0005] 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).

[0006] 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. Studies have shown that 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. For example, 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. Pat. No. 7,109,245 discloses cannabinoids useful as vasoconstrictors; 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; and U.S. Publ. No.

2010/0286098 discloses a method of treating tissue injury in a patient with colitis via administration of cannabinoids. [0007] 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. For example, THC is the main

psychoactive 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. Unlike THC, CBD does not produce psychoactive effects in humans. CBD is reported to exert analgesic, antioxidant, anti-inflammatory, and immunomodulatory effects.

[0008] Terpenes, including terpenoids, 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.

[0009] 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.

[0010] To date, however, medicinal marijuana has been mostly used as a generic product whereby the patient utilizes the entirety of the different compounds present in a marijuana plant product to achieve medicinal results. Efforts have been made to maximize the medicinal benefit of cannabis for a patient having a particular condition, but such efforts are invariably

complicated. For example, the currently available means of consuming cannabis lack consistency and control. Most commonly, patients roll dried marijuana leaves or buds into rolling paper to form a joint or they place it into a pipe or bong to smoke. Some patients additionally or alternatively bake the marijuana into edible treats. Such formats use substantially the entire marijuana leaf or bud indiscriminately, making it difficult to administer controlled concentrations of one or more desired medicinal cannabis compounds to the patient. Thus, current products and methods fail to provide maximum benefit to the patient.

[0011] In addition to failing to achieve optimum efficacy, consuming medical marijuana via smoking is less efficient. For example, with smoking, up to 40% of the available cannabinoids may be biologically unavailable due to combustion and sidestream smoke. Moreover, smoking medical marijuana carries increased risks of bronchitis and other respiratory irritation and damage.

[0012] When medical marijuana is consumed in foodstuffs, it is difficult to gauge the amount consumed and/or its effects. This is due, in part, to the delay in effect of the marijuana when it goes through the stomach. Following oral ingestion, maximum cannabinoid blood levels are not reached for approximately six hours post-consumption. Furthermore, digestion and processing by the liver may result in the formation of metabolites, including 11-hydroxy-THC, which can have undesirable effects. In addition, when ingested, the digestive process may break down the cannabis and medicinal cannabis compounds before they reach the bloodstream, causing a significant reduction in the therapeutic effectiveness or potency of the medicinal cannabis compounds.

[0013] Thus, there is a need for an improved inhalable drug delivery device for administration of medicinal cannabis compounds; there is also a need for improved pharmaceutical formulations of medicinal cannabis compounds for use with the inhalable drug delivery device. SUMMARY

[0014] There is a need for a drug delivery device that can administer controlled amounts of selected medicinal cannabis compounds to a patient. For example, there is a need for 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. Further, there is a need for a drug delivery device that allows for convenient inhalation of medicinal cannabis compounds without the risk of respiratory problems associated with smoking marijuana. There is also a need for 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.

[0015] The systems and methods described herein each have several aspects, no single one of which is solely responsible for its desirable attributes. Without limiting the scope of this disclosure as expressed by the claims that follow, the more prominent features will now be discussed briefly. After considering this discussion, and particularly after reading the section entitled "Detailed Description," one will understand how the sample features described herein provide for improved systems, devices, compositions, and methods for delivering medicinal cannabis compounds to a patient.

[0016] One aspect of the disclosure relates to a pharmaceutical formulation of cannabis compounds suitable for pulmonary delivery to a patient. In various embodiments, 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. In some embodiments, 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.

[0017] In some embodiments, the volatile liquid is in an inhalable form. For example, the volatile liquid may be in an aerosol form or vapor form. In some embodiments, the volatile liquid comprises a plurality of droplets having a diameter of 10 μιη or smaller. In some embodiments, the medicinal cannabis compound of a known amount comprises one or more cannabinoids. In some such embodiments, the one or more cannabinoids have a ratio of CBD to THC of between about 1 : 1 and about 1 : 100. In other embodiments, the one or more

cannabinoids have a ratio of CBD to THC of between about 10: 1 and about 300: 1. Additionally or alternatively, in some embodiments, the medicinal cannabis compound of a known amount comprises one or more terpenes, one or more flavonoids, and/or one or more phytosterols.

[0018] In some embodiments, 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.

[0019] In some embodiments, the aerosol precursor comprises propylene glycol, glycerin, or a combination thereof. In some embodiments, 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. For example, 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.

[0020] Another aspect of the disclosure relates to an electronic apparatus for producing an inhalable pharmaceutical formulation having a known amount of medicinal cannabis compounds. In various embodiments, the electronic apparatus includes a reservoir holding 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.

[0021] In some embodiments, the atomizer comprises a resistive heating element configured to heat the volatile liquid. In some such embodiments, 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. In other embodiments, 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. In yet other embodiments, the atomizer comprises a pneumatic stimulator in the form of a pressurized canister with a nozzle.

[0022] One aspect of the disclosure relates to an electronic cartomizer. In various

embodiments, 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. In at least some embodiments, the electronic cartomizer is a medical product that is pharmaceutically prescribed.

[0023] 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).

[0024] In various embodiments, the electronic cigarette includes an electronic cigarette cartomizer, such as the cartomizer described above or elsewhere herein. Such 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.

[0025] The electronic cigarette may additionally include a visual use indicator, such as an LED light. In some embodiments, the power source is a battery, for example, a rechargeable battery. In some embodiments, the base component is reusable.

[0026] In various embodiments, the control circuit is or includes a microprocessor. In some such embodiments, 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. In some embodiments, 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.

[0027] Another aspect of the disclosure relates to a method of producing an inhalable pharmaceutical formulation of cannabis compounds suitable for pulmonary delivery. In various embodiments, 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. In various embodiments, 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

pharmaceutical formulation to form particles suitable for pulmonary delivery. In various embodiments, 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.

[0028] In some embodiments, the inhalable pharmaceutical formation of cannabis compounds is formed automatically. In such embodiments, the apparatus may be an electronic apparatus, which further includes a microprocessor coupled to a power source, a sensor, and the atomizer. In at least some such embodiments, 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.

[0029] 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. In various

embodiments, 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. In such embodiments, 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. In some such embodiments, the inhalable droplets of liquid have a diameter no greater than 10 μιη.

[0030] An additional aspect of the disclosure relates to a method of administering an inhalable formulation of medicinal cannabis compounds to a patient. In various embodiments, the method includes inhaling from an outlet of an electronic cigarette. In such embodiments, 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. In various embodiments, inhaling from the outlet causes a sensor coupled to the microprocessor to generate a signal indicative of a patient inhalation. In response to the signal, 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. [0031] Those skilled in the art will appreciate that the foregoing is a summary, and thus, contains, by necessity, simplifications and omissions of detail. Any particular device or method may have some or all these features or additional or alternative features. Other aspects, features, and advantages will become apparent in the description that follows.

BRIEF DESCRIPTION OF THE DRAWINGS

[0032] The above-mentioned aspects, as well as other features, aspects, and advantages of the present technology are further described herein with reference to the accompanying drawings, which form part of the present disclosure. The illustrated embodiments are merely examples and are not intended to be limiting. Other embodiments may be utilized, and other changes may be made, without departing from the spirit or scope of the invention. The aspects of the present disclosure, as generally described herein and illustrated in the Figures, can be arranged, substituted, combined, and designed in a wide variety of different configurations, all of which are explicitly contemplated and form part of this disclosure. Unless specifically indicated, the features of the drawings are not drawn to scale.

[0033] 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.

[0034] 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. In the provided illustrations, the cover or housing of the device is transparent to reveal the internal components.

[0035] Figure 5 provides a schematic cross-sectional view of another non-limiting embodiment of an inhalable drug delivery device. [0036] 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.

DETAILED DESCRIPTION OF CERTAIN PREFERRED EMBODIMENTS

[0037] It is to be understood that this invention is not limited to the particular embodiments described and illustrated, as such may, of course, vary. The detailed description of the invention is divided into various sections only for the reader's convenience and disclosure found in any section may be combined with that in another section. It is also to be understood that the terminology used herein is for the purpose of describing particular embodiments only, and is not intended to be limiting, since the scope of this invention will be limited only by the appended claims.

Definitions

[0038] Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs. As used herein the following terms have the following meanings.

[0039] As used herein and in the appended claims, the singular forms "a", "an", and "the" include plural referents unless the context clearly dictates otherwise. Thus, for example, reference to "a cannabinoid" includes a plurality of cannabinoids. At times, the claims and/or disclosure may include terms such as "a plurality," "one or more," or "at least one;" however, the absence of such terms is not intended to mean, and should not be interpreted to mean, that a plurality is not conceived.

[0040] A "plurality" as used herein refers to more than one. For example, a plurality of compounds may be two, three, four, five, or more compounds. [0041] The term "about" when used before a numerical designation, e.g., temperature, time, amount, concentration, etc., including when used before a numerical range, indicates

approximations which may vary by ( + ) or ( - ) 10 %, 5 %, or 1 %.

[0042] "Comprising" or "comprises" is intended to mean that the devices, 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.

[0043] "Cannabis," "cannabis species," or "marijuana" refers to a flowering plant including the species (or sub-species): Cannabis sativa, Cannabis ruderalis, and Cannabis indica.

[0044] "Cannabinoids" 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.

[0045] Cannabis species express at least 85 different phytocannabinoids, which are

concentrated in resin produced in glandular trichomes. The phytocannabinoids are divided into subclasses, including cannabigerols, cannabichromenes, cannabidiols, tetrahydrocannabinols, cannabinols and cannabinodiols, and other cannabinoids.

[0046] 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). Phytocannabinoids and their structures are discussed in more detail in U.S. Patent Application Pub. No. 2013/0059018, which is incorporated herein by reference in its entirety.

[0047] 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. For example, THC is a CB1 receptor agonist, whereas the propyl variant THCV is a CB1 receptor antagonist meaning that it has almost opposite effects from THC.

[0048] "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). As used herein, the terpenes include terpenoids. Terpenes and terpenoids are often aromatic hydrocarbons and may have strong smells associated with them.

[0049] Terpenes known to be produced by cannabis include, without limitation,

aromadendrene, bergamottin, bergamotol, bisabolene, borneol, Δ-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.

[0050] Cannabis plants and products may also comprise other pharmaceutically relevant compounds, including flavonoids and phytosterols (e.g., apigenin, quercetin, cannflavin A, β- sitosterol and the like). [0051] "Medicinal cannabis compound," as used herein, 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. In the present invention, said compounds may be present in a natural or purified form; alternatively, said compounds may be synthetic.

[0052] As used herein, 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.

[0053] "Atomizing," as used herein, 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

embodiments provided herein, atomizing involves converting a liquid oil extract into a suspension or dispersion of fluid particles each having a diameter of no more than 10 μιη. 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.

[0054] "Inhalable drug delivery device," as used herein, refers to an apparatus used to administer one or more medicinal compounds to a patient via inhalation and absorption through the lungs. In particular, 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. In at least some embodiments, the liquid is atomized into particles or droplets having a diameter no greater than 10 μιη. In at least some embodiments of the inhalable drug delivery devices described herein, 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 μιη; in some such embodiments, the devices are configured to atomize the liquid into particles or droplets having a diameter between 1 and 3 μιη.

[0055] The inhalable drug delivery devices described herein may take many forms, but all notably have at least some common characteristics. For example, the inhalable drug delivery device may take the form of an electronic cigarette (i.e., e-cigarette). As used herein, an

"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.

[0056] Electronic cigarettes, as used herein, 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.

Moreover, in at least some embodiments of the present invention, the release of the vapor or aerosol from the device is well controlled. For example, the electronic cigarettes may be automatically activated when a patient takes a drag (i.e., draws a breath or inhales) from the electronic cigarette. In such embodiments, 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. Such existing vaporizers generate vapor having an uncontrolled and inconsistent composition.

[0057] 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.

2014/0096782 to Ampolini et al, US Publ. No. 2013/081642 to Safari, US Pat. No. 8,205,622 to Pan, and/or US Pat. No. 7,832,410 to Hon, the disclosures of which are herein incorporated by reference in their entireties; however, unlike existing e-cigarettes, the present embodiments are not intended to include tobacco, nicotine, or other tobacco-derived products. In other embodiments, 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.

7,845,359 to Montaser, or any other suitable atomizing device. Each of the above references is incorporated by reference in their entireties.

[0058] Inhalable drug delivery devices, as contemplated herein, include an atomizer and a liquid to be atomized. Importantly, in some aspects, 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.

Accordingly, regardless of the particular shape or arrangement of components, each of the inhalable drug delivery devices provided herein is configured to deliver controlled quantities or doses of one or more medicinal cannabis compounds to a patient.

[0059] As used herein, a "patient" refers to a user of any of the inhalable drug delivery devices described or contemplated herein. In some embodiments, the patient has received a prescription for medicinal marijuana use from a licensed medical practitioner.

Overview

[0060] As stated above, 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.

[0061] For example, with current cannabis products, the exact composition and concentration of medicinal cannabis compounds is often unknown. Accordingly, one aspect of the present invention is directed to pharmaceutical formulations having known amounts of medicinal cannabis compounds.

[0062] Additionally, with current delivery methods, a large, but difficult to quantify, amount of the cannabis compounds are released or degraded before they can be absorbed into a patient's bloodstream. For example, when ingested, the digestive process may break down much of the cannabis and medicinal cannabis compounds before they reach the bloodstream, causing a significant reduction in the therapeutic effectiveness or potency of the medicinal cannabis compounds. Similarly, when smoked, up to 40% of the available cannabinoids in the cannabis product may be biologically unavailable due to combustion and sidestream smoke. [0063] Accordingly, 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. Rather, the devices provided herein deliver cannabis compounds to the bloodstream via inhalation (i.e., through the lungs). Advantageously, such delivery occurs without any significant degradation of the medicinal compounds, and 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. Moreover, advantageously, 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.

[0064] Accordingly, 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

[0065] In various embodiments, the pharmaceutical formulation to be atomized is a liquid; in particular, it is a liquid comprising medicinal cannabis compounds. In various embodiments, 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. In some embodiments, propylene glycol, glycerin, or a combination thereof is used. Preferably, medical grade glycerin (i.e., glycerin USP) is used. Water may also be added to the mixture. In other embodiments, 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.

[0066] In various embodiments provided herein, 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. In one embodiment, the liquid comprises an extract (e.g. hash oil) from a cannabis plant. In one embodiment, one or more parts of a cannabis plant (e.g., stems, leaves, stalk and/or flowers) are extracted. In one embodiment, the extract is from a single strain of cannabis. In another embodiment, the extract is a blend from a plurality of strains of cannabis. In one embodiment, 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. In one embodiment, the cannabinoids and/or terpenes are purified and/or synthetic compounds.

[0067] In one embodiment, at least one component of the liquid is present in a known quantity. For example, an extract may be assayed to determine the concentration of at least one

cannabinoid and/or terpene. 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. In one embodiment, 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.

[0068] In one embodiment, 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. In one embodiment, 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.

[0069] In one embodiment, 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 : 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.

[0070] In various embodiments provided herein, percent refers to percent by weight. In one embodiment, 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. In one embodiment, 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

embodiments, 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.

[0071] In various embodiments, the liquid is sold to a patient within a reservoir. As described in more detail below, 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. In one embodiment, 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. For example, for a patient who needs or is prescribed a dose of 10 mg THC, 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.

[0072] In various embodiments, the oil composition within a reservoir can be selected to meet the medical needs of a patient. For example, 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. In some embodiments, 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. In some embodiments, each oil composition is formulated and selected to treat one or more health conditions.

[0073] In some embodiments, 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. As non-limiting examples, in some embodiments, the liquid within each reservoir comprises about 0.1 mg to about 100 mg THC; in some

embodiments, the liquid within each reservoir comprises about 0.1 mg to about 100 mg CBD.

[0074] In one embodiment, the amount of liquid in the reservoir and the amount of

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. 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.

[0075] In some embodiments, 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. As non-limiting examples, in some embodiments, 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.

[0076] Together, 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

[0077] 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. In various embodiments, 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.

Advantageously, in contrast to both ingestible pharmaceutical preparations of cannabis compounds and means for smoking medicinal marijuana, in various embodiments of the present invention, the release of the vapor or aerosol from the device is well controlled.

[0078] Advantageously, 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. With conventional smoking methods and apparatuses, such chemicals may be inhaled by patients smoking marijuana and nearby individuals. Additionally, a lit joint or marijuana cigarette poses a fire hazard if not properly extinguished. Moreover, with 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.

[0079] Additionally, advantageously, with the atomizing devices described 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.

[0080] In at least some embodiments, the disclosed inhalable drug delivery devices are handheld and portable. In some embodiments, 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. Advantageously, 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.

[0081] While some embodiments illustrated and described herein have the form factor of an electronic cigarette, it will be appreciated by those skilled in the art that the present disclosure is applicable and directed to any electronic device designed to deliver a controlled quantity of medicinal cannabis compounds to a patient in the form of an inhalable vapor or aerosol.

[0082] While the form factor of the devices contemplated herein may vary significantly, each device has several common features and components. For example, 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.

[0083] The internal components stored within the interior space of the housing include: a reservoir holding the liquid comprising medicinal cannabis compounds, and an atomizer. In some embodiments, the walls of the housing form the reservoir in which the liquid is stored. In other embodiments, 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. As described in detail below with reference to several example drug delivery devices, 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. In such embodiments, 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.

[0084] In at least some embodiments, the internal components further include a power source electrically coupled to: a sensor, a control circuit, and the atomizer. In such embodiments, the atomizing process is initiated and operated automatically.

[0085] In various automatic embodiments, the power source is a battery. The power source may be any suitable battery. As non-limiting examples, the power source may be a rechargeable lithium-ion battery, a long-lasting lithium battery or nickel cadmium battery, or an inexpensive alkaline battery. In a preferred embodiment, the battery is rechargeable. In some embodiments, the base unit includes a port in electrical communication with the battery, allowing for convenient recharging of the battery inside the base unit. For example, in some embodiments, 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

embodiments, 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. In other embodiments, the battery is removable, for example, to replace the battery or to recharge the battery. In still other embodiments, the power source is a cord and plug configured to connect to an AC or DC outlet.

[0086] 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. In various embodiments, 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. In various embodiments, the functionality described herein may be performed by hardware, software, or a combination thereof.

[0087] In at least some embodiments, the control circuit is electrically coupled to an inhalation sensor, which detects when a patient inhales through the outlet of the drug delivery device.

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. In some such embodiments, 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. In other embodiments, the sensor is an electric air flow sensor. In some embodiments, the inhalation sensor is a digital sensor configured to turn the atomizer on or off. In other embodiments, the inhalation sensor is an analog sensor designed to detect a relative change in pressure or flow corresponding to a relative strength of inhalation. In such embodiments, 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. In various automatic

embodiments, 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.

[0088] In some embodiments, 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. [0089] In some embodiments, the drug delivery device is a single, integral unit. In some such embodiments, 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. In other such embodiments, the reservoir is refillable, for example, by a patient or a licensed dispensary, when the liquid runs low within the reservoir. In still other embodiments, the drug delivery device is formed of at least two, separable components: a base unit and a cartridge or cartomizer unit. In such embodiments, the base unit houses the power source and all or a portion of the control circuit. When a cartridge is present in the embodiment, the base unit also houses the atomizer. The cartridge comprises the reservoir of liquid. In other embodiments, a cartomizer unit is present in the embodiment instead of a cartridge. The cartomizer unit houses the liquid-filled reservoir and the atomizer. In some embodiments, 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. In some cartridge and cartomizer embodiments, the liquid-filled reservoir may be replaceable or refillable.

[0090] In embodiments formed of separably engageable base units and cartridge or cartomizer units, 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

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 cartridge/cartomizer unit. In other embodiments, 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. Additionally, when a cartomizer unit is used, 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. [0091] In some embodiments, the control circuit may include an identification component configured to detect the identity of the cartridge or cartomizer. In such embodiments, 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. In some embodiments, 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.

[0092] In some embodiments, the identification key is used to distinguish the cartridge or cartomizer as belonging to a particular brand. For example, in some embodiments, the base unit may be configured to operate only when coupled to a cartridge or cartomizer unit of the same manufacturer or brand. Additionally or alternatively, the identification key may identify the model (or the particular drug dosage) of the cartridge/cartomizer unit. For example, a plurality of cartridge or cartomizer models may exist; the models may each: have a different

concentration, ratio, or dosage of THC, CBD, or other active ingredient; have a different added flavor; or be derived from a different cannabis species or strain. Different cannabinoids have different vaporization points; thus, 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. Accordingly, in such embodiments, 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.

[0093] In some embodiments, the base unit's microprocessor compares the unique

identification key signals to a database of identification keys stored in memory. Within the database of some embodiments, 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.

[0094] In some embodiments, 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. In other embodiments, the control unit with the microprocessor may include a transmitter and a receiver for wireless bidirectional communication. In some such embodiments, the base unit can receive updates wirelessly. For example, in some embodiments, 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.

[0095] In a similar manner, a user may be able to control other operations of the drug delivery device. For example, in some embodiments, 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. In some such embodiments, 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. Additionally or alternatively, 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. Using the front end application, 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. For example, 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. In various embodiments, 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.

[0096] In one aspect, the present disclosure relates to a e-cigarette as described herein. 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. In some embodiments, the cartridge and atomizer are integrated into a single unit, referred to as a "cartomizer." In general, a cartomizer includes separate sections for the liquid reservoir and the atomizer, but the sections together form a single device. In some designs, 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.

[0097] In the various embodiments provided herein, 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. In some embodiments, the outlet is positioned on or in a mouthpiece.

[0098] The housing may be formed of any suitable material or materials configured to retain the shape of the device during storage and use. In various embodiments, the housing is formed of a single wall, such as, for example, a single tubular wall. The housing of various

embodiments 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. In some embodiments, the housing is formed of one or more polymers or ceramics. In other embodiments, 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. In some embodiments, 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.

[0099] Within the interior space of the housing, 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. In various embodiments, the control circuit and power source are physically isolated from the liquid and from any resulting vapor or aerosol formed within the device.

[0100] In some embodiments, the housing is a single, integral unit. In such embodiments, the entire e-cigarette is disposable and generally configured to be disposed of once the liquid has been depleted from the liquid- filled reservoir. In other embodiments, the housing is formed of two, separable components: a base unit and a cartomizer unit. In such embodiments, 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. In some such embodiments, the housing of the base unit and the cartomizer unit are formed of the same material. In other embodiments, the housing of the reusable base unit is formed of a sturdier and more durable material than the disposable cartomizer unit. In some embodiments, the liquid- filled reservoir may be replaceable or refillable.

[0101] In embodiments formed of separably engageable base units and cartomizer units, 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. In other embodiments, 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.

[0102] 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. In various embodiments, 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. In various embodiments, the functionality described herein may be performed by hardware, software, or a combination thereof. [0103] In at least some embodiments, the 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. Such activation results in the heating of a liquid and formation of a vapor or aerosol, which is released into the patient's mouth during the inhalation. In some such embodiments, 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. In other embodiments, the sensor is an electric air flow sensor. In some embodiments, the inhalation sensor is a digital sensor configured to turn the heating element on or off. In other embodiments, the inhalation sensor is an analog sensor designed to detect a relative change in pressure or flow corresponding to a relative strength of inhalation. In such embodiments, 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.

[0104] In some embodiments, 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.

[0105] In some embodiments, the 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. In use, as a user inhales from an outlet on the proximal end, the use indicator on the distal end glows, thus simulating the appearance of a conventional cigarette or joint.

[0106] 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. In preferred embodiments, 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.

[0107] The wick may be formed of any suitable wicking material that facilitates movement of liquid along the wick via capillary action. In some embodiments, a fibrous material is used. For example, 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. In some embodiments, a non-combustible material is used. In other embodiments, the wick is formed of a material known to emit few, if any, toxins when combusted. For example, in some embodiments, the wick is formed of polylactic acid (PLA). In still other embodiments, a non- fibrous material is selected for the wick, such as, for example, porous ceramic materials.

[0108] In various embodiments, the heating element is a resistive heating element. In a preferred embodiment, 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

embodiments, 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.

[0109] As shown and described in more detail below, the materials and configuration of the heating chamber and the liquid-filled reservoir can vary significantly. In preferred embodiments, 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.

[0110] Several non-limiting examples of inhalable drug delivery devices, in the form of electronic cigarettes, are provided in Figures 1-4. A schematic representation of the outer housing of one embodiment of an electronic cigarette is illustrated in Figure 1. As shown, 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.

[0111] 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. Along 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.

[0112] Figures 2-4 provide non-limiting examples of the internal components of an inhalable drug delivery device taking the form of an e-cigarette. In these figures, 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. Alternatively, the internal components of Figure 1 may be arranged in any alternative configuration that allows the components to function in the manner described herein.

[0113] In Figure 2, 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. In the depicted embodiment, 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. In such an embodiment, 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.

[0114] When a patient inhales from an outlet on the proximal end 201, 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. As 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.

[0115] 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. In Figure 3, 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.

[0116] In the embodiment of Figure 3, 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. As illustrated, 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. Liquid is steadily drawn into the heating chamber 326 and into close proximity to the heating element 324 via a wick 330, which extends from the reservoir 328 into the heating chamber 326. As shown, in at least some embodiments, the heating element 324 is a coiled wire wound around a portion of the wick 330.

[0117] 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. As shown in Figure 4, in some embodiments, 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. In some embodiments, 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.

[0118] In use, the electronic cigarettes of Figures 3 and 4 function in substantially the same manner as the electronic cigarette of Figure 2 described above.

[0119] Another non- limiting embodiment of a drug delivery device is provided in Figure 5. The drug delivery device of the present embodiment is a nebulizer 500. As in embodiments described above, 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. For example, 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.

[0120] Additionally, as in embodiments described above, 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. In the nebulizer 500 embodiment provided here, 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. Specifically, the atomizer comprises a piezoelectric material 524, such as a slice of lead zirconate titanate (PZT), sandwiched between two electrodes 525. In some embodiments, 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. In some embodiments, 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. As shown, in at least some embodiments, the cover is formed of at least two layers, for example, a first layer 526 and a second layer 527. In one embodiment, the first layer 526 is formed of aluminum and the second layer 527 is formed of stainless steel.

[0121] 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.

[0122] In use, 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. In one non-limiting example, the piezoelectric material 524 vibrates with a frequency of 1.4-1.5 MHz. In other embodiments, the vibrational frequency may be varied as needed to atomize the particular composition of the liquid stored within the device 500. In some embodiments, the droplets formed are less than 10 μιη in diameter. In some embodiments, 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.

[0123] 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. As shown, 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. [0124] It is to be understood that while the invention has been described in conjunction with the above embodiments, the foregoing description and examples are intended to illustrate and not limit the scope of the invention. Other aspects, advantages, omissions, substitutions and modifications may be made without departing from said scope. Therefore, the scope of the invention is defined by the claims that follow rather than by the foregoing description. All variations coming within the meaning and range of equivalency of the claims are embraced within their scope.

Claims

WHAT IS CLAIMED IS:

1. A pharmaceutical formulation of cannabis compounds suitable for pulmonary delivery to a patient, comprising:

a volatile liquid, wherein the volatile liquid comprises a mixture of:

a cannabis oil extract having a known amount of a medicinal cannabis compound; and

an aerosol precursor.

2. The pharmaceutical formulation of Claim 1, wherein the volatile liquid is in an inhalable form.

3. The pharmaceutical formulation of Claim 1, wherein the volatile liquid is in an aerosol form.

4. The pharmaceutical formulation of Claim 1, wherein the volatile liquid is in vapor form.

5. The pharmaceutical formulation of Claim 1, wherein the volatile liquid comprises a plurality of droplets having a diameter of 10 μιη or smaller.

6. The pharmaceutical formulation of Claim 1, wherein the medicinal cannabis compound of known amount comprises one or more cannabinoids.

7. The pharmaceutical formulation of Claim 6, wherein the one or more

cannabinoids have a ratio of CBD to THC of between about 1 : 1 and about 1 : 100.

8. The pharmaceutical formulation of Claim 6, wherein the one or more

cannabinoids have a ratio of CBD to THC of between about 10: 1 and about 300: 1.

9. The pharmaceutical formulation of Claim 1, wherein the medicinal cannabis compound of known amount comprises one or more terpenes.

10. The pharmaceutical formulation of Claim 1, wherein the medicinal cannabis compound of known amount comprises one or more flavonoids and/or phytosterols.

11. The pharmaceutical formulation of Claim 1 , wherein the known amount of the medicinal cannabis compound comprises a single dose unit of the medicinal cannabis compound.

12. The pharmaceutical formulation of Claim 1, wherein the aerosol precursor comprises propylene glycol, glycerin, or a combination thereof.

13. The pharmaceutical formulation of Claim 1, wherein the volatile liquid atomizes at a temperature in the range of approximately 125 degrees Celsius and 425 degrees Celsius.

14. The pharmaceutical formulation of Claim 13, wherein the atomization temperature of the volatile liquid varies based on a composition of the cannabis oil extract.

15. An electronic apparatus for producing an inhalable pharmaceutical formulation having a known amount of medicinal cannabis compounds, the apparatus comprising:

a reservoir holding the pharmaceutical formulation of Claim 1; and an atomizer adapted to atomize the pharmaceutical formulation to form particles suitable for pulmonary delivery.

16. The electronic apparatus of Claim 15, wherein the atomizer comprises a resistive heating element configured to heat the volatile liquid.

17. The electronic apparatus of Claim 16, further comprising: 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.

18. The electronic apparatus of Claim 15, wherein 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.

19. The electronic apparatus of Claim 15, wherein the atomizer comprises a pneumatic stimulator in the form of a pressurized canister with a nozzle.

20. A method of automatically producing a pharmaceutical formulation of cannabis compounds in a form suitable for pulmonary delivery, the method comprising:

providing an electronic apparatus configured to form a pharmaceutical formulation of cannabis compounds in a form suitable for pulmonary delivery, the apparatus comprising:

a reservoir holding: a mixture of a cannabis oil extract having a known amount of a medicinal cannabis compound, and an aerosol precursor, an atomizer adapted to atomize the pharmaceutical formulation to form particles suitable for pulmonary delivery, and

a microprocessor coupled to a power source and the atomizer; and inhaling from an outlet of the electronic apparatus,

wherein inhaling from the outlet causes a sensor coupled to the microprocessor to generate a signal indicative of a patient inhalation, and

wherein, in response to the signal, the microprocessor activates the atomizer, causing at least a portion of the volatile liquid to atomize to form inhalable droplets of liquid containing medicinal cannabis compounds.

21. An electronic cartomizer, comprising:

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.

22. The electronic cartomizer of Claim 21, wherein the liquid comprises a marijuana oil extract.

23. The electronic cartomizer of Claim 21 or 22, wherein the medicinal cannabis compounds comprise one or more cannabinoids.

24. The electronic cartomizer of any one of Claims 21-23, wherein the medicinal cannabis compounds comprise one or more terpenes.

25. The electronic cartomizer of any one of Claims 21-24, wherein the medicinal cannabis compounds comprise one or more flavonoids and/or phytosterols.

26. The electronic cartomizer of any one of Claims 21-25, wherein the reservoir of liquid stores at least one unit dose of a particular medicinal cannabis compound.

27. The electronic cartomizer of any one of Claims 21-26, wherein the liquid has a ratio of CBD to THC of between about 1 : 1 and about 1 : 100.

28. The electronic cartomizer of any one of Claims 21-27, wherein the liquid has a ratio of CBD to THC of between about 10: 1 and about 300: 1.

29. The electronic cartomizer of any one of Claims 21-28, wherein the electronic cartomizer is pharmaceutically prescribed.

30. An electronic cigarette, comprising:

the cartomizer of any preceding claim; and a base component comprising a power source and a control circuit, wherein the power source and the control circuit are electrically coupled to the cartomizer.

31. The electronic cigarette of Claim 30, further comprising a visual use indicator.

32. The electronic cigarette of Claim 31 , wherein the visual indicator is an LED light.

33. The electronic cigarette of Claim 30, wherein the power source is a battery.

34. The electronic cigarette of Claim 33, wherein the battery is rechargeable.

35. The electronic cigarette of Claim 30, wherein the base component is reusable.

36. The electronic cigarette of Claim 30, wherein the control circuit comprises a microprocessor.

37. The electronic cigarette of Claim 36, wherein the microprocessor selects and controls a heating protocol of the heating element, and wherein the heating protocol is selected based on the contents of the liquid within the reservoir.

38. The electronic cigarette of Claim 36, wherein 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.

39. A method of delivering a medicinal cannabis compound from an electronic cigarette to a patient, the electronic cigarette comprising: 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, wherein the method is executed by the microprocessor and comprises: 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 forming inhalable droplets of liquid containing cannabis compounds.

40. The method of Claim 39, wherein the inhalable droplets of liquid have a diameter no greater than 10 μιη.

41. A method of administering an inhalable formulation of medicinal cannabis compounds to a patient, the method comprising:

inhaling from an outlet of an electronic cigarette, wherein the electronic cigarette comprises:

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;

wherein inhaling from the outlet causes a sensor coupled to the microprocessor to generate a signal indicative of a patient inhalation,

wherein, in response to the signal, 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, and

wherein the inhalable droplets of liquid exit the outlet into a patient's mouth upon inhalation.