WO2019083557A1

WO2019083557A1 - Nebulized cannabinoid administration system and method

Info

Publication number: WO2019083557A1
Application number: PCT/US2018/013924
Authority: WO
Inventors: David Crowe
Original assignee: Vuber Technologies, Llc
Priority date: 2017-10-28
Filing date: 2018-01-16
Publication date: 2019-05-02

Abstract

The present invention is a system and method of Cannabinoid administration via inhalation of a nebulized Cannabinoid-Water. The system and method provide a variety of significant advantages over other methods of administering Cannabinoids. The system and method provide rapid effect onset, similar to most inhalation methods, as Cannabinoids are introduced directly to the bloodstream. The present invention provides a method of administering inhalable cannabinoids that virtually eliminates throat and lung irritation. The invented system produces a fine inhalable mist or vapor without any significant heating. Discomfort is largely eliminated, as are negative health effects related to inhalation of carcinogens related to smoke. The system is simple to operate and the method is easy to perform. The invention provides substantially improved dosing controllability versus other prevalent administration methods. The system and method tend to generate minimal local emissions, odors, or residues. [00044] The present invention is a system and method of Cannabinoid administration via inhalation of a nebulized Cannabinoid-Water. The system and method provide a variety of significant advantages over other methods of administering Cannabinoids. The system and method provide rapid effect onset, similar to most inhalation methods, as Cannabinoids are introduced directly to the bloodstream. The present invention provides a method of administering inhalable cannabinoids that virtually eliminates throat and lung irritation. The invented system produces a fine inhalable mist or vapor without any significant heating. Discomfort is largely eliminated, as are negative health effects related to inhalation of carcinogens related to smoke. The system is simple to operate and the method is easy to perform. The invention provides substantially improved dosing controllability versus other prevalent administration methods. The system and method tend to generate minimal local emissions, odors, or residues.

Description

NEBULIZED CANNABINOID ADMINISTRATION SYSTEM AND METHOD

CROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims priority to U.S. Provisional Application No. 15/796,776 filed October 28, 2017. The content of the above application is incorporated by reference in its entirety. This disclosure, including written description and associated figures are identical in form and content to the referenced application.

FIELD OF THE DISCLOSURE

[0002] The overall field of invention is systems and methods related to administration of cannabinoid compounds.

BACKGROUND

[0003] Cannabis has long been used medicinally. Cannabis contains numerous compounds known as Cannabinoids. Cannabinoids are known to have medicinal effects. Dozens of Cannabinoids have been discovered, and the medicinal effects vary significantly within the class of compounds.

[0004] Traditionally, Cannabinoids were administered through smoking or ingesting the cannabis plant. Over time, various other methods of administering Cannabinoids have been developed. Many of these other methods have focused on extracting Cannabinoid compounds from the cannabis plant. [0005] Cannabinoids may be extracted from the cannabis plant through a wide variety of processes, and the Cannabinoid extract (Extract) takes many forms and consistencies.

Cannabinoids have long been extracted for ingestion by various cooking processes that generally exploited the lipid-solubility of Cannabinoid compounds. Other simple methods of Cannabinoid extraction generally focused on collecting portions of the raw plant that were known to have high Cannabinoid concentrations. Other modern methods of Cannabinoid extraction have been developed and become commercially prevalent. Chemically, Extracts may vary significantly in their proportions of individual Cannabinoids, along with varying levels of purity regarding non- medicinal compounds. Physically, Extracts vary significantly, including liquid oils of widely varying viscosity, solid waxes of widely varying plasticity, powders or particulates, and other semi-solid forms that exist as combinations of oil and wax. The chemical content and form or consistency of Extract depends on factors including the plant feedstock from which the

Cannabinoids are extracted, the specific process through which extraction occurs, and any post- extraction processing such as dilution, mixing, or physical processing. Extraction technology is advancing, and processes such as butane, C0₂, and other hydrocarbon extraction processes are common. Cannabinoids may also be synthesized. While Cannabinoids are highly soluble in a wide variety of solvents, including organic solvents such as alcohol or oil, Cannabinoids have very low aqueous solubility and high hydrophobicity. Consequently, primarily water-based Cannabinoid solutions or mixtures have not been available. Some semi-aqueous Cannabinoid solutions have been developed, but such solutions are comprised of relatively little water, wherein the solutions are not more than 50% water by volume.

[0006] Traditionally, Cannabinoids were introduced into the human body for medicinal purposes by ingestion of the cannabis plant or Extract, by smoking cannabis plant or Extract, or by inhalation vaporized cannabis plant or Extract. Other medical treatments have included intranasal and intravenous administration, but such methods have never gained prevalence. Each of these methods presents advantages and disadvantages, which generally tend to relate to rate of onset of effect, difficulty in performing the given method, efficiency of action, bioavailability, and flavor or aroma preferences, among others.

[0007] Cannabinoid administration by smoking is highly prevalent. Smoking is a relatively simple method that provides rapid onset of effects, which is frequently desirable.

However, smoking tends to result in significant pulmonary irritation due to elements such as high smoke or vapor temperature and presence of carcinogenic compounds, air-born particulates, or other throat and lung irritants. This is undesirable due to both health consequences and discomfort. Dosing of Cannabinoids when administered by this method is extremely inexact and can be difficult to predict.

[0008] Cannabinoid administration by Extract vaporization has become prevalent. Like smoking, onset is rapid. The difficulty of performing the method will range from very simple to more complex than smoking. Throat and lung irritation tends to be less than smoking. Dosing predictability varies depending on specific vaporization method and system, and while dosability tends to be more predictable than smoking, it is still inexact. Both smoking and vaporization tend to emit odor into the local environment.

[0009] Cannabinoids may be eaten as the raw cannabis plant or in food by adding

Cannabinoids to edible products. Bioavailability of Cannabinoids administered through eating is highly dependent on the specific preparation techniques used. Onset tends to be slow through this method, and dosing can range from highly predictable to highly unpredictable. [00010] Recently a method of dissolving Cannabinoids in an entirely aqueous solution has been developed. The method is believed to involve entrapping Cannabinoid compounds within a molecular shell such that the entrapped Cannabinoid is water-soluble. The method is currently kept as a trade secret, and details are unavailable regarding its precise formulation or structure. The product produced by this method is a liquid solution, colloid, or suspension of Cannabinoids in water, hereafter referred to as Cannabinoid-Water.

[00011] Cannabinoid-Water may be administered by methods including drinking or intranasal spray, for example, but the bioavailability of the contained Cannabinoids is low. This is believed to be a result of the fact that the entrapped Cannabinoid compounds are not readily released from the encasement after administration. The result is that these administration methods have low bioavailability and relatively little medicinal effect.

[00012] A need exists for a system and method of administering Cannabinoids that is simple to perform or operate, provides rapid effect onset, dosing predictability, low throat and lung irritation, high bioavailability, and low odor.

SUMMARY

[00013] The disclosure presented herein relates to a system and method for administering Cannabinoids via nebulized aqueous solution. In some embodiments, the preceding and following embodiments and descriptions are for illustrative purposes only and are not intended to limit the scope of this disclosure. Other aspects and advantages of this disclosure will become apparent from the following detailed description.

[00014] Certain terminology and derivations thereof may be used in the following description for convenience in reference only, and will not be limiting. For example, words such as "upward," "downward," "left," and "right" would refer to directions in the drawings to which reference is made unless otherwise stated. Similarly, words such as "inward" and "outward" would refer to directions toward and away from, respectively, the geometric center of a device or area and designated parts thereof. References in the singular tense include the plural, and vice versa, unless otherwise noted.

[00015] The present invention is a system and method of Cannabinoid administration via inhalation of nebulized Cannabinoid-Water. The system and method provide a variety of significant advantages over other methods of administering Cannabinoids. The system and method provide rapid effect onset, similar to most inhalation methods, as Cannabinoids are introduced directly to the bloodstream. The present invention provides a method of administering inhalable cannabinoids that virtually eliminates throat and lung irritation. The invented system produces a fine inhalable mist or vapor without any significant heating. Discomfort is largely eliminated, as are negative health effects related to inhalation of carcinogens related to smoke. The system is simple to operate and the method is easy to perform. The invention provides substantially improved dosing controllability versus other prevalent administration methods. The system and method tend to generate minimal local emissions, odors, or residues.

[00016] Importantly and unexpectedly, the invention creates high bioavailability of administered cannabinoids and is efficient to perform or operate. Although Cannabinoid-Water administered through other methods has low bioavailability due to the molecular encasement of the Cannabinoid compounds that is required to create the Cannabinoid-Water, the nebulization process affects and partially or fully destroys the molecular encasement. The result is that the contained Cannabinoids become significantly more bioavailable through the process of nebulization. Ultrasonic nebulization has been found to be particularly effective in generating high bioavailability. BRIEF DESCRIPTION OF THE DRAWINGS

[00017] Embodiments of the present disclosure are described in detail below with reference to the following drawings. These and other features, aspects, and advantages of the present disclosure will become better understood with regard to the following description, appended claims, and accompanying drawings. The drawings described herein are for illustrative purposes only of selected embodiments and not all possible implementations and are not intended to limit the scope of the present disclosure. Also, the drawings included herein are considered by the applicant to be informal.

[00018] Fig. 1 is view of a preferred embodiment of the system with a single reservoir

[00019] Fig. 2 is a view of an alternative embodiment of the system with a plurality of reservoirs

[00020] Fig. 3 is an view of an alternative embodiment with an enlarged accumulation chamber

[00021] Fig 4. is view of an alternative embodiment with alternative fluid control mechanism.

[00022] Figs 5. is a view of an alternative embodiment with a submerged transducer.

[00023] Figs 6. is a flow diagram of the preferred method.

DEFINITIONS

[00024] Cannabinoid-Water: a liquid solution, colloid, or suspension of Cannabinoids in water, comprised of at least 90% water by volume. [00025] Nebulizer: A device used to administer a medicament in the form of a micron mist inhaled into the lungs.

[00026] Nebula: a micron mist

[00027] Micron mist: a mist of mean droplet size of 1-10 μιη

DETAILED DESCRIPTION

[00028] In the Summary above and in this Detailed Description, and the claims below, and in the accompanying drawings, reference is made to particular features (including method steps) of the invention. It is to be understood that the disclosure of the invention in this specification includes all possible combinations of such particular features. For example, where a particular feature is disclosed in the context of a particular aspect or embodiment of the invention, or a particular claim, that feature can also be used, to the extent possible, in combination with and/or in the context of other particular aspects and embodiments of the invention, and in the invention generally.

[00029] The term "comprises" and grammatical equivalents thereof are used herein to mean that other components, ingredients, steps, among others, are optionally present. For example, an article "comprising" (or "which comprises") components A, B and C can consist of (i.e., contain only) components A, B and C, or can contain not only components A, B, and C but also contain one or more other components.

[00030] Where reference is made herein to a method comprising two or more defined steps, the defined steps can be carried out in any order or simultaneously (except where the context excludes that possibility), and the method can include one or more other steps which are carried out before any of the defined steps, between two of the defined steps, or after all the defined steps (except where the context excludes that possibility).

[00031] The term "at least" followed by a number is used herein to denote the start of a range beginning with that number (which may be a range having an upper limit or no upper limit, depending on the variable being defined). For example, "at least 1" means 1 or more than 1. The term "at most" followed by a number (which may be a range having 1 or 0 as its lower limit, or a range having no lower limit, depending upon the variable being defined). For example, "at most 4" means 4 or less than 4, and "at most 40%" means 40%or less than 40%. When, in this specification, a range is given as "(a first number) to (a second number)" or "(a first number) - (a second number)," this means a range whose limit is the second number. For example, 25 to 100 mm means a range whose lower limit is 25 mm and upper limit is 100 mm.

[00032] Fig. 1 shows an embodiment of the Cannabinoid administration system. The system is comprised of an ultrasonic misting transducer 102, a reservoir 104 containing

Cannabinoid-Water 106, a mist accumulation chamber 108, and an inhalation port 110. The transducer 102 generates a micron mist 120 of Cannabinoid-Water 106 in the accumulation chamber 108, which a user 118 may inhale through an inhalation port 110. The transducers 102 are controlled by a transducer control unit 112. The transducer control unit 112 includes a user interface 114 that allows a user 118 to control an electrical power output signal sent from the control unit 112 through wiring 116 to the to the transducer 102. A user 118 may operate the system through the user interface 114 to send the power output signal to the transducer 102.

[00033] In some embodiments, the user interface 114 may provide a user 118 simple on/off control such that a user can control the on/off state of the power output signal to the transducer 102. In alternative embodiments, the user interface 114 may include controls that allow the user 118 to modulate the power output signal. Power may be modulated by pulse width modulation or other power modulation technique. Mist 120 output rate will depend on the character of the power output signal that is supplied by the control unit 112. By modulating the power output signal, a user 118 is able to control the mist output rate. In some embodiments, the interface may include switches, buttons, sliders, knobs, or other physical controls. In alternative embodiment, the user interface may be a digital or touch sensitive interface. In some

embodiments, the user interface is integral to the control unit 112. In alternative embodiments, the user interface 114 exists on remote device such as a remote control or a wirelessly connected phone or tablet.

[00034] Mist 120 generation rate can be highly predictable and controllable. A user 118 may control Cannabinoid dose size by controlling the rate and/or time of mist 118 generation.

[00035] Fig. 2 shows an embodiment of the system that incorporates a plurality of transducers, reservoirs, and volumes of Cannabinoid-Water. In an embodiment, a first transducer 200 is coupled to first reservoir 202 containing a first volume of Cannabinoid-Water 204, and a second transducer 212 is coupled to a second reservoir 206 containing a second volume of Cannabinoid-Water 208. In this embodiment, the first 204 and second 208 volumes of

Cannabinoid-Water may contain differing Cannabinoid formulations with differing medicinal effect. A user may operate the user interface 114 to supply power output signals to the first 200 and second 212 transducers. By controlling or modulating the power output signal to the transducers 200 and 212 independently, the user can vary constitution and medicinal effect of the produced mist. In this manner, the user is able to adjust the medicinal effect of the mist 120 through the user interface 114. In an embodiment, the system further comprises additional transducers, reservoirs, and volumes of Cannabinoid-Water, such that a user 118 may generate a wider variety of mist 120 formulations by independently varying the rate or state of mist generation of each individual transducer.

[00036] Fig. 3 shows an alternative embodiment of the system. Because the nebulized Cannabinoid-Water 120 can have micron-sized droplet mist, the mist 120 can remain suspended in air for an extended period. In an embodiment, the mist accumulation chamber 108 may be adapted to be large enough to allow users to physically enter the chamber as in a Turkish bath or steam shower. In other embodiments, the accumulation chamber 108 may be eliminated and the mist may be expelled freely into the environment or directly into an inhalation port.

[00037] Fig. 4 shows an alternative embodiment of the system in which the Cannabinoid-

Water reservoir 104 is remote from the transducer 102. Cannabinoid-Water is supplied to the transducer by a port or tube 402. In this embodiment, flow of Cannabinoid-Water to the transducer 102 may be directly regulated. The Cannabinoid-Water may be supplied passively, as in a gravity-feed that and would be controllable by valving 404. Alternatively, Cannabinoid- Water may be supplied actively by a pump 406. In an embodiment, a remote reservoir may be desirable for packaging or other purposes, and one of or both the valving 404 and pump 406 could be eliminated.

[00038] Fig. 5 shows an alternative embodiment in which the reservoir 104 doubles as the accumulation chamber 108. The ultrasonic transducer 102 is submerged within the volume of Cannabinoid-Water 106. When a power output signal is supplied by the transducer control unit 112 through the wiring 116 to the transducer 102, the transducer will produce the micron mist 120 that will then be expelled through the surface of the volume of Cannabinoid-Water 106.

[00039] Fig. 6 shows a flow diagram of the method of administration of Cannabinoids via nebulized aqueous solution. In this method, Cannabinoid-Water micron mist is generated 602. The Cannabinoid-Water micron mist is then inhaled 604 by the user. The benefits of this method of administration of Cannabinoid-Water by ultrasonic nebulization over other methods of administering Cannabinoids and Cannabinoid-Water are discussed in the Summary above.

Ultrasonic nebulization is a highly controllable process capable of generating droplets of controllable size. Droplet size has significant effect in bioavailability. Droplet alveolar deposition is maximized with droplet size 2-5 μπι, while total deposition percentage within the respiratory tract decreases directly with droplet size. For example, an 8 μπι nebula is 93% absorbed within the human body when inhaled, though only 5% is absorbed by the alveoli and the rest is deposited in the upper respiratory tract, while a 2 μπι nebula is only 42% absorbed, but fully 40% absorbed by the alveoli in the lower respiratory tract. Research indicates that the method produces greatest bioavailability in the 2-5 μπι droplet diameter range. The preferred method is therefore to generate a Cannabinoid-Water mist with a mean droplet size of approximately 4 μπι, and to inhale said mist.

[00040] While preferred and alternate embodiments have been illustrated and described, as noted above, many changes can be made without departing from the spirit and scope of the invention. Accordingly, the scope of the invention is not limited by the disclosure of these preferred and alternate embodiments. Instead, the scope of the invention shoujd_.be determined entirely by reference to the claims. Insofar as the description above and the accompanying drawings disclose any additional subject matter that is not within the scope of the claims below, the inventions are not dedicated to the public and Applicant hereby reserves the right to file one or more applications to claim such additional inventions.

[00041] The reader's attention is directed to all papers and documents which are filed concurrently with this specification and which are open to public inspection with this specification, and the contents of all such papers and documents are incorporated herein by reference.

[00042] All the features disclosed in this specification (including any accompanying claims, abstract, and drawings) may be replaced by alternative features serving the same, equivalent or similar purpose, unless expressly stated otherwise. Thus, unless expressly stated otherwise, each feature disclosed is one example of a generic series of equivalent or similar features.

[00043] Any element in a claim that does not explicitly state "means for" performing a specified function, or "step for" performing a specific function is not to be interpreted as a "means" or "step" clause as specified in 35. U.S.C. §112 ]f 6. In particular, the use of "step of in the claims herein is not intended to invoke the provisions of U.S.C. §112 ]f 6.

Claims

CLAIMS We Claim:

1. A system comprising:

A reservoir containing a volume Cannabinoid-Water

coupled to an ultrasonic transducer capable of generating a micron mist, such that said volume of Cannabinoid-Water is in conference with said ultrasonic transducer,

with said ultrasonic transducer controlled by a transducer control unit

that supplies a power output signal from said transducer control unit through wiring to said ultrasonic transducer to generate a micron mist.

2. The system of claim 1, wherein the micron mist has a mean droplet size of 2-5 μιη.

3. The system of claim 2, wherein the generated micron mist is expelled into a mist

accumulation chamber.

4. The system of claim 3, wherein said power output signal is controllable by a user

interface.

5. The system of claim 4, wherein said user interface incorporates a control to modulate said power output signal such that the rate of generation is controllable by said user interface.

6. The system of claim 5, wherein the system comprises a plurality of reservoirs containing Cannabinoid-Water, a plurality of ultrasonic transducers, each of said reservoirs being coupled to an ultrasonic transducer, each of said ultrasonic transducers having an independent micron mist generation rate, and each of said ultrasonic transducers being independently modulable by said user interface, such that the individual micron mist generation rate of each of said ultrasonic transducers is independently modulable.

7. The system of claim 6, wherein

said ultrasonic transducer is integrated such that it forms a permeable barrier between said reservoir and said accumulation chamber, and

said ultrasonic transducer is operable to pump said volume of Cannabinoid-Water from said reservoir and expel said volume of Cannabinoid-Water as a micron mist into said accumulation chamber.

8. The system of claim 6, wherein

said ultrasonic transducer is submerged within said volume of Cannabinoid- Water, and

said micron mist is expelled upward such that it emerges through said volume of Cannabinoid-Water.

9. A system comprising:

A volume of Cannabinoid-Water,

a means for generating a micron mist of said Cannabinoid Water,

a means for collecting said micron mist,

and a means for conducting said micron mist from said collection means to an outlet port.

10. A method for administering Cannabinoids comprising,

placing a volume of Cannabinoid-Water in conference with an ultrasonic transducer,

supplying a power output signal to said ultrasonic transducer

to generate a micron mist

at a rate generation rate,

capturing said micron mist,

and inhaling said micron mist.

11. The method of claim 9, wherein

said power output signal to said ultrasonic transducer may be modulated such that said rate of micron mist generation is modulated according to the power output signal.

12. The method of claim 9, wherein

said micron mist has a mean droplet size of 2-5 μιη.