Cannabinoid compositions

Abstract

The invention relates to cannabinoid compositions, uses of the cannabinoid compositions in the treatment or prophylaxis of pain, kits and inhalation devices comprising the cannabinoid compositions.

Description

[0001] Cannabinoid compositions

[0002] Field of the Invention

[0003] The invention relates to cannabinoid compositions, uses of the cannabinoid compositions in the treatment or prophylaxis of pain, kits and inhalation devices comprising the cannabinoid compositions.

[0004] Background of the Invention

[0005] Conventional methods to deliver cannabinoids include smoking dry cannabis cigarettes or inhaling cannabis plant extracts with vaping or heat-no-burn devices. The variability of (a) content of cannabinoids, both in types and amounts in the plant products or extracts; (b) contaminants in the plant extracts; (c) settings (e.g. temperature) of different heating element in existing devices; (d) different distribution of the major APIs in the inhalable product of the device; (e) consistency of such settings across the lifetime of the device; (f) person-to-person breathing and inhalation techniques, do not allow a trackable and predictable dosing of active pharmaceutical ingredients (APIs) in patients which is consistent with a defined pharmacological and toxicological profile. Because of these variables, conventional cannabinoid products cannot guarantee a constant efficacy profile, cannot be defined as delivering an accurate drug dose, cannot be approved by regulatory agencies, cannot be prescribed for a specific indication, and can pose a non- trackable health risk to users.

[0006] There remains a need to develop cannabinoid compositions having a trackable, measurable, constant and well-defined ratio of cannabinoids (e.g. CBD / THC) which is stable across manufacturing campaigns, devices, and through-life delivery of the composition.

[0007] Summary of the Invention

[0008] According to an aspect of the present invention, there is provided a composition, comprising: cannabidiol (CBD) and / or (-)-trans-A9-tetrahydrocannabinol (THC); and a pharmaceutically acceptable carrier. According to another aspect of the present invention, there is provided a composition for use in an inhalation device, comprising: cannabidiol (CBD) and / or (-)-trans-A9-tetrahydrocannabinol (THC); and a pharmaceutically acceptable carrier.

[0009] In an aspect, the composition comprises: cannabidiol (CBD);

[0010] (-)-trans-A9-tetrahydrocannabinol (THC); and a pharmaceutically acceptable carrier.

[0011] In an aspect, the pharmaceutically acceptable carrier comprises a solvent.

[0012] In an aspect, a content of the solvent is at least about 2 wt%, preferably at least about 3 wt%, more preferably at least about 4 wt%, even more preferably at least about 5 wt%, yet even more preferably at least about 6 wt%, or most preferably at least about 7 wt%, based on a total wt% content of the composition.

[0013] In an aspect, a content of the solvent is about 2 wt% to about 20 wt%, preferably about 3 wt% to about 15 wt%, more preferably about 4 wt% to about 12 wt%, even more preferably about 5 wt% to about 10 wt%, yet even more preferably about 6 wt% to about 9 wt%, or most preferably about 7 wt% to about 8 wt%, based on a total wt% content of the composition.

[0014] In an aspect, a content of the solvent is about 6 wt% to about 20 wt% based on a total wt% content of the composition

[0015] In an aspect, a wt% ratio of solvent:CBD is about 1 :1 to about 20:1 , preferably about 2:1 to about 15:1 , more preferably about 3:1 to about 10:1 , even more preferably about 4:1 to about 8:1 , yet even more preferably about 5:1 to about 7:1 , or most preferably about 5.5:1 to about 6:1.

[0016] In an aspect, a wt% ratio of solvent:THC is about 1 :1 to about 20:1 , preferably about 2:1 to about 15:1 , more preferably about 3:1 to about 10:1 , even more preferably about 4:1 to about 8:1 , yet even more preferably about 5:1 to about 7:1 , or most preferably about 5.5:1 to about 6:1.

[0017] In an aspect, a wt% ratio of solvent:(CBD+THC) is about 0.5:1 to about 10:1 , preferably about 1 : 1 to about 7.5:1 , more preferably about 1 .5: 1 to about 15:1 , even more preferably about 2:1 to about 4:1 , yet even more preferably about 2.5:1 to about 3.5:1 , or most preferably about 2.75:1 to about 3:1.

[0018] In an aspect, the solvent is an organic solvent.

[0019] In an aspect, the solvent is an alcohol.

[0020] In an aspect, the solvent is a C1-C12 alkyl alcohol (e.g. a C2-C12 alkyl alcohol), preferably a C1-C6 alkyl alcohol (e.g. a C2-C6 alkyl alcohol), more preferably a C1-C4 alkyl alcohol (e.g. a C2-C4 alkyl alcohol).

[0021] In an aspect, the solvent is ethanol.

[0022] In an aspect, the solvent is anhydrous.

[0023] In an aspect, the solvent comprises less than 0.1 wt% water, preferably less than 0.05 wt% water, more preferably less than 0.02 wt% water, or even more preferably less than 0.01 wt% water, based on a total wt% content of the solvent.

[0024] In an aspect, the pharmaceutically acceptable carrier comprises a propellant.

[0025] In an aspect, a content of the propellant is at least about 50 wt%, preferably at least about 60 wt%, more preferably at least about 70 wt%, even more preferably at least about 80 wt%, yet even more preferably at least about 82 wt%, or most preferably at least about 85 wt%, based on a total wt% content of the composition.

[0026] In an aspect, a content of the propellant is about 50 wt% to about 99.5 wt%, preferably about 60 wt% to about 99 wt%, more preferably about 70 wt% to about 98 wt%, even more preferably about 80 wt% to about 97 wt%, yet even more preferably about 82 wt% to about 96 wt%, or most preferably about 85 wt% to about 95 wt%, based on a total wt% content of the composition.

[0027] In an aspect, a wt% ratio of propellant:CBD is about 10:1 to about 100:1 , preferably about 20: 1 to about 90: 1 , more preferably about 30: 1 to about 85: 1 , even more preferably about 40: 1 to about 80: 1 , yet even more preferably about 50: 1 to about 75: 1 , or most preferably about 60: 1 to about 70: 1 .

[0028] In an aspect, a wt% ratio of propellant:THC is about 10:1 to about 100:1 , preferably about 20: 1 to about 90: 1 , more preferably about 30: 1 to about 85: 1 , even more preferably about 40: 1 to about 80: 1 , yet even more preferably about 50: 1 to about 75: 1 , or most preferably about 60:1 to about 70:1.

[0029] In an aspect, a wt% ratio of propellant:(CBD+THC) is about 5:1 to about 50:1 , preferably about 10:1 to about 45:1 , more preferably about 15:1 to about 42.5:1 , even more preferably about 20: 1 to about 40: 1 , yet even more preferably about 25: 1 to about 37.5: 1 , or most preferably about 30:1 to about 35:1.

[0030] In an aspect, the propellant is selected from a hydrofluorocarbon, a hydrochlorofluorocarbon, chlorofluorocarbon, a hydrocarbon, an ether, or a combination thereof.

[0031] In an aspect, the propellant is a hydrofluorocarbon.

[0032] In an aspect, the propellant is 1 ,1 ,1 ,2-tetrafluoroethane.

[0033] In an aspect, wherein the pharmaceutically acceptable carrier comprises a solvent and a propellant, and a wt% ratio of solvent: propellant is about 5:1 to about 25:1 , preferably about 7:1 to about 20:1 , more preferably about 8:1 to about 18:1 , even more preferably about 9:1 to about 16:1 , yet even more preferably about 10:1 to about 15:1 , or most preferably about 11 :1 to about 14:1.

[0034] In an aspect, wherein a content of the CBD is at least about 0.1 wt%, preferably at least about 0.25 wt%, more preferably at least about 0.5 wt%, even more preferably at least about 0.75 wt%, yet even more preferably at least about 1 .0 wt%, or most preferably at least about 1.3 wt%, based on a total wt% content of the composition.

[0035] In an aspect, wherein a content of the CBD is about 0.1 wt% to about 5.0 wt %, preferably about 0.25 wt% to about 3.0 wt%, more preferably about 0.5 wt% to about 2.0 wt%, even more preferably about 0.75 wt% to about 1 .75 wt%, yet even more preferably about 1 .0 wt% to about 1.5 wt%, or most preferably about 1.3 wt% to about 1.4 wt%, based on a total wt% content of the composition.

[0036] In an aspect, the purity of CBD is at least about 90%, preferably at least about 95%, more preferably at least about 96%, even more preferably at least about 97%, yet even more preferably at least about 98%, most preferably at least about 99%.

[0037] In an aspect, a content of the THC is at least about 0.1 wt%, preferably at least about 0.25 wt%, more preferably at least about 0.5 wt%, even more preferably at least about 0.75 wt%, yet even more preferably at least about 1.0 wt%, or most preferably at least about 1 .3 wt%, based on a total wt% content of the composition.

[0038] In an aspect, a content of the THC is about 0.1 wt% to about 5.0 wt %, preferably about 0.25 wt% to about 3.0 wt%, more preferably about 0.5 wt% to about 2.0 wt%, even more preferably about 0.75 wt% to about 1.75 wt%, yet even more preferably about 1.0 wt% to about 1.5 wt%, or most preferably about 1.3 wt% to about 1.4 wt%, based on a total wt% content of the composition.

[0039] In an aspect, the purity of THC is at least about 90%, preferably at least about 95%, more preferably at least about 96%, even more preferably at least about 97%, yet even more preferably at least about 98%, most preferably at least about 99%.

[0040] In an aspect, a wt% ratio of CBD:THC is about 6:1 to about 1 :6, preferably about 3:1 to about 1 :3, more preferably about 2:1 to about 1 :2, even more preferably about 1.5:1 to about 1 :1.5, yet even more preferably about 1.2:1 to about 1 :1.2, or most preferably about 1 :1.

[0041] In an aspect, a combined content of the CBD and THC is at least about 0.2 wt%, preferably at least about 0.5 wt%, more preferably at least about 1.0 wt%, even more preferably at least about 1.5 wt%, yet even more preferably at least about 2.0 wt%, or most preferably at least about 2.6 wt%, based on a total wt% content of the composition.

[0042] In an aspect, a combined content of the CBD and THC is about 0.2 wt% to about 10 wt%, preferably about 0.5 wt% to about 6.0 wt%, more preferably about 1.0 wt% to about 4.0 wt%, even more preferably about 1 .5 wt% to about 3.5 wt%, yet even more preferably about 2.0 wt% to about 3.0 wt%, or most preferably about 2.6 wt% to about 2.8 wt%, based on a total wt% content of the composition.

[0043] In an aspect, a content of the pharmaceutically acceptable carrier is at least about 50 wt%, preferably at least about 60 wt%, more preferably at least about 70 wt%, even more preferably at least about 80 wt%, yet even more preferably at least about 90 wt%, or most preferably at least about 95 wt%, based on a total wt% content of the composition.

[0044] In an aspect, a content of the pharmaceutically acceptable carrier is about 50 wt% to about 99.5 wt%, preferably about 60 wt% to about 99 wt%, more preferably about 70 wt% to about 98.5 wt%, even more preferably about 80 wt% to about 98 wt%, yet even more preferably about 90 wt% to about 97.8 wt%, or most preferably about 95 wt% to about 97.5 wt%, based on a total wt% content of the composition.

[0045] In an aspect, a wt% ratio of pharmaceutically acceptable carrierCBD is about 20:1 to about 500:1 , preferably about 30:1 to about 250:1 , more preferably about 50:1 to about 150:1 , even more preferably about 55:1 to about 100:1 , yet even more preferably about 65: 1 to about 90: 1 , or most preferably about 70: 1 to about 75: 1.

[0046] In an aspect, a wt% ratio of pharmaceutically acceptable carrierTHC is about 20:1 to about 500:1 , preferably about 30:1 to about 250:1 , more preferably about 50:1 to about 150:1 , even more preferably about 55:1 to about 100:1 , yet even more preferably about 65: 1 to about 90: 1 , or most preferably about 70: 1 to about 75: 1.

[0047] In an aspect, a wt% ratio of pharmaceutically acceptable carrier: (CBD+THC) is about 10:1 to about 250:1 , preferably about 15:1 to about 125:1 , more preferably about 25:1 to about 75:1 , even more preferably about 27.5:1 to about 50:1 , yet even more preferably about 32.5:1 to about 45:1 , or most preferably about 35:1 to about 37.5:1. In an aspect, the composition comprises less than 0.1 wt% water, preferably less than 0.05 wt% water, more preferably less than 0.02 wt% water, or even more preferably less than 0.01 wt% water, based on a total wt% content of the composition.

[0048] According to another aspect of the present invention, there is provided a composition as described herein, for use as a medicament.

[0049] According to another aspect of the present invention, there is provided a composition as described herein, for use in the treatment or prophylaxis of pain.

[0050] According to another aspect of the present invention, there is provided a use of a composition as described herein in the manufacture of a medicament.

[0051] According to another aspect of the present invention, there is provided a use of a composition as described herein in the manufacture of a medicament for the treatment or prophylaxis of pain.

[0052] According to another aspect of the present invention, there is provided a method for the treatment or prophylaxis of pain comprising administering an effective amount of a composition as described herein to a subject in need thereof.

[0053] According to another aspect of the present invention, there is provided a kit comprising a composition as described herein and instructions for use in the composition in the treatment or prophylaxis of pain.

[0054] According to another aspect of the present invention, there is provided a pressurised canister comprising a composition as described herein.

[0055] According to another aspect of the present invention, there is provided a kit comprising a pressurised canister as described herein and an inhalation device configured to receive the pressurised canister.

[0056] According to another aspect of the present invention, there is provided an inhalation device comprising a composition as described herein or a pressurised canister as described herein. In one aspect, the inhalation device is an inhaler.

[0057] In one aspect, the inhaler is a metered-dose inhaler (e.g. a pressurised metered-dose inhaler).

[0058] Brief Description of the Figures

[0059] The present invention is further described in the following non-limiting figures.

[0060] Figure 1 shows solubility of CBD at different temperatures in Example 1 based on % w / w.

[0061] Figure 2 shows solubility of CBD at different temperatures in Example 1 based on CBD per 50 pL dose (mg).

[0062] Figure 3 shows the effects of changing CBD / THC amounts and ethanol on particle size and drug loading in Example 2. Figure 3A shows effects of changing CBD / THC amounts on the upper aerodynamic diameter (CBD and THC curves at 2 mg are overlapping; CBD and THC curves at 0.5 mg are overlapping) at 15 % w / w ethanol in HFA 134a. Figure 3B shows effects of changing ethanol amounts on the fine particle fraction at 2 mg CBD and 2 mg THC. Figure 3C shows effects of changing ethanol amounts on the drug loading.

[0063] Figure 4 shows the results of optimising solvent content for fine particle dose and fraction in Example 2. Figure 4A shows effects of changing ethanol amounts on the upper aerodynamic diameter for CBD at 1 mg CBD. Figure 4B shows effects of changing ethanol amounts on the upper aerodynamic diameter for THC at 1 mg THC.

[0064] Figure 5 shows lifetime testing of the composition in Example 3. Figure 5A shows variance in upper aerodynamic particle diameter at BOL (beginning of life) and EOL (end of life) for CBD. Figure 5B shows variance in upper aerodynamic particle diameter at BOL (beginning of life) and EOL (end of life) for THC (labelled as DBN).

[0065] Figure 6 shows batch testing of the composition in Example 3. Figure 6A shows variance in delivered dose across different batches and actuations for CBD. Figure 6B shows variance in delivered across different batches and actuations for THC (labelled as dronabinol).

[0066] Figure 7 shows batch testing of the composition in Example 3. The shot weights of different shot numbers at BOB (beginning of batch), MOB (middle of batch) and EOB (end of batch) are shown.

[0067] Figure 8 shows the results of the rat tail-flick study in Example 4.

[0068] Detailed Description of the Invention

[0069] It is envisaged that any of the features described herein can be combined with any one or more of the other features described herein.

[0070] General definitions

[0071] As used herein, the term “cannabidiol” (or CBD) refers to a compound of the following structure:

[0072] As used herein, the term (-)-trans-A9-tetrahydrocannabinol (or THC), also referred to herein as dronabinol (or DBN), refers to a compound of the following structure:

[0073] As used herein, the term “pharmaceutically acceptable carrier” may refer to a carrier that does not cause any untoward effects to a patient at the concentrations and / or doses utilised. Pharmaceutically acceptable carriers are also typically compatible with the other components of the composition.

[0074] As used herein, the term “alkyl” as used herein refers to both straight and branched chain radicals of up to twelve carbons. For example, an alkyl group may contain 1 , 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 or 12 carbon atoms. Non-limiting examples of C1-C12 alkyl groups include methyl, ethyl, propyl, isopropyl, butyl, sec-butyl, tert-butyl, 3-pentyl, hexyl and octyl groups. Preferably, the term “alkyl” as used herein may refer to a straight or branched chain radical comprising from one to eight carbon atoms, more preferably one to six carbon atoms and even more preferably one to four carbon atoms.

[0075] As used herein, the term “solvent” may refer to a liquid (e.g. a liquid at room temperature (such as at 20 °C) and at atmospheric pressure (such as 1 atm)) which is able to solubilise other components of a composition. For example, a “solvent” may dissolve solid components making up the composition.

[0076] As used herein, the term “propellant” may refer to a substance that is able to force a composition out of a container. A propellant as described herein is typically a gas or a pressurised liquid (e.g. at pressures of greater than 1 atm to about 10 atm, about 2 atm to about 8 atm, or about 3 atm to about 5 atm).

[0077] As used herein, the term “hydrofluorocarbon” may refer to compounds containing only carbon, fluorine and hydrogen atoms. A “hydrofluorocarbon” may be saturated (i.e. lacking carbon-carbon double / triple bonds) or unsaturated (i.e. including carbon-carbon double / triple bonds). A hydrofluoroalkane is a type of saturated “hydrofluorocarbon”, whilst a hydrofluoroolefin is a type of unsaturated “hydrofluorocarbon”.

[0078] As used herein, the term “hydrochlorofluorocarbon” may refer to compounds containing only carbon, chlorine, fluorine and hydrogen atoms. A “hydrochlorofluorocarbon” may be saturated (i.e. lacking carbon-carbon double / triple bonds) or unsaturated (i.e. including carbon-carbon double / triple bonds).

[0079] As used herein, the term “chlorofluorocarbon” may refer to compounds containing only carbon, chlorine and fluorine atoms. A “chlorofluorocarbon” may be saturated (i.e. lacking carbon-carbon double / triple bonds) or unsaturated (i.e. including carbon-carbon double / triple bonds).

[0080] As used herein, the term “hydrocarbon” may refer to compounds including only carbon and hydrogen atoms. A “hydrocarbon” may be saturated (i.e. lacking carbon-carbon double / triple bonds) or unsaturated (i.e. including carbon-carbon double / triple bonds).

[0081] The disclosure also embraces isotopically-labelled compounds of the present disclosure which are identical to those recited herein, but for the fact that one or more atoms are replaced by an atom having an atomic mass or mass number different from the atomic mass or mass number usually found in nature. Examples of isotopes that may be incorporated into compounds of the disclosure include isotopes of hydrogen, carbon, and oxygen, such as, but not limited to2H (deuterium, D),3H (tritium),11C,13C, and14C. Unless otherwise stated, when a position is designated specifically as “H” or “hydrogen”, the position is understood to have hydrogen at its natural abundance isotopic composition or its isotopes, such as deuterium (D) or tritium (3H). Certain isotopically- labelled compounds of the present disclosure (e.g. those labelled with3H and14C) are useful in compound and / or substrate tissue distribution assays. Tritiated (i.e.3H) and carbon-14 (i.e.14C) isotopes are useful for their ease of preparation and detectability. Further, substitution with heavier isotopes such as deuterium (i.e.2H) may afford certain therapeutic advantages resulting from greater metabolic stability (e.g. increased in vivo half-life or reduced dosage requirements) and hence may be preferred in some circumstances. Isotopically labelled compounds of the present disclosure may generally be prepared by following procedures analogous to those for the non-isotopically labelled compounds, by substituting an isotopically labelled reagent for a non-isotopically labelled reagent.

[0082] Compositions

[0083] In accordance with an embodiment of the present invention, there is provided a composition, comprising: cannabidiol (CBD) and / or (-)-trans-A9-tetrahydrocannabinol (THC); and a pharmaceutically acceptable carrier.

[0084] In a preferred embodiment, the composition may comprise: cannabidiol (CBD);

[0085] (-)-trans-A9-tetrahydrocannabinol (THC); and a pharmaceutically acceptable carrier.

[0086] In some embodiments, the composition may consist of: cannabidiol (CBD) and / or (-)-trans-A9-tetrahydrocannabinol (THC); and a pharmaceutically acceptable carrier.

[0087] In a preferred embodiment, the composition may consist of: cannabidiol (CBD);

[0088] (-)-trans-A9-tetrahydrocannabinol (THC); and a pharmaceutically acceptable carrier.

[0089] In accordance with another embodiment of the present invention, there is provided a composition for use in an inhalation device, comprising: cannabidiol (CBD) and / or (-)-trans-A9-tetrahydrocannabinol (THC); and a pharmaceutically acceptable carrier.

[0090] In a preferred embodiment, the composition for use in an inhalation device may comprise: cannabidiol (CBD);

[0091] (-)-trans-A9-tetrahydrocannabinol (THC); and a pharmaceutically acceptable carrier.

[0092] In some embodiments, the composition for use in an inhalation device may consist of: cannabidiol (CBD) and / or (-)-trans-A9-tetrahydrocannabinol (THC); and a pharmaceutically acceptable carrier.

[0093] In a preferred embodiment, the composition for use in an inhalation device may consist of: cannabidiol (CBD);

[0094] (-)-trans-A9-tetrahydrocannabinol (THC); and a pharmaceutically acceptable carrier. Compositions as described herein may provide a good balance between fine particle dose and fine particle fraction, and thus are suited for delivery of the CBD and THC via inhalation. In addition, compositions as described herein may provide good stability and dose durability (in particular, maintaining a constant ratio of CBD to THC between doses), good lifecycle consistency and / or batch consistency. Furthermore, compositions as described herein may exhibit high efficacy in pain management.

[0095] Compositions as described herein comprise active pharmaceutical ingredients (CBD and / or THC, preferably CBD and THC) and a pharmaceutically acceptable carrier. These components are described in further detail below.

[0096] Active pharmaceutical ingredients

[0097] Compositions as described herein comprise CBD and / or THC (preferably CBD and THC). In other words, the composition may comprise an active pharmaceutical ingredient, wherein the active pharmaceutical ingredient comprises CBD and / or THC (preferably CBD and THC). In some embodiments, the active pharmaceutical ingredient consists of CBD and / or THC (preferably CBD and THC).

[0098] In one embodiment, a content of the CBD may be at least about 0.1 wt%, preferably at least about 0.25 wt%, more preferably at least about 0.5 wt%, even more preferably at least about 0.75 wt%, yet even more preferably at least about 1 .0 wt%, or most preferably at least about 1 .3 wt%, based on a total wt% content of the composition.

[0099] In a preferred embodiment, a content of the CBD may be about 0.1 wt% to about 5.0 wt%, preferably about 0.25 wt% to about 3.0 wt%, more preferably about 0.5 wt% to about 2.0 wt%, even more preferably about 0.75 wt% to about 1 .75 wt%, yet even more preferably about 1.0 wt% to about 1.5 wt%, or most preferably about 1.3 wt% to about 1 .4 wt%, based on a total wt% content of the composition.

[0100] In one embodiment, a content of the THC may be at least about 0.1 wt%, preferably at least about 0.25 wt%, more preferably at least about 0.5 wt%, even more preferably at least about 0.75 wt%, yet even more preferably at least about 1 .0 wt%, or most preferably at least about 1 .3 wt%, based on a total wt% content of the composition. In a preferred embodiment, a content of the THC may be about 0.1 wt% to about 5.0 wt%, preferably about 0.25 wt% to about 3.0 wt%, more preferably about 0.5 wt% to about 2.0 wt%, even more preferably about 0.75 wt% to about 1 .75 wt%, yet even more preferably about 1 .0 wt% to about 1 .5 wt%, or most preferably about 1 .3 wt% to about 1 .4 wt%, based on a total wt% content of the composition.

[0101] In one embodiment, a combined content of the CBD and THC may be at least about 0.2 wt%, preferably at least about 0.5 wt%, more preferably at least about 1.0 wt%, even more preferably at least about 1.5 wt%, yet even more preferably at least about 2.0 wt%, or most preferably at least about 2.6 wt%, based on a total wt% content of the composition.

[0102] In a preferred embodiment, a combined content of the CBD and THC may be about 0.2 wt% to about 10 wt%, preferably about 0.5 wt% to about 6.0 wt%, more preferably about 1.0 wt% to about 4.0 wt%, even more preferably about 1.5 wt% to about 3.5 wt%, yet even more preferably about 2.0 wt% to about 3.0 wt%, or most preferably about 2.6 wt% to about 2.8 wt%, based on a total wt% content of the composition.

[0103] These amounts of CBD and / or THC may provide an optimal balance between fine particle dose and fine particle fraction. Thus, such concentrations of CBD and / or THC provide compositions that are typically most suited to delivery by inhalation.

[0104] In one embodiment, a wt% ratio of CBD:THC may be about 6:1 to about 1 :6, preferably about 3:1 to about 1 :3, more preferably about 2:1 to about 1 :2, even more preferably about 1.5:1 to about 1 :1.5, yet even more preferably about 1.2:1 to about 1 :1.2, or most preferably about 1 :1.

[0105] These ratios of CBD:THC may provide improved efficacy in terms of pain management, in particular, in an inhalation setting.

[0106] In one embodiment, the purity of CBD may be at least about 90%, preferably at least about 95%, more preferably at least about 96%, even more preferably at least about 97%, yet even more preferably at least about 98%, most preferably at least about 99%. The purity of CBD may be measured by high performance liquid chromatography (HPLC). In one embodiment, the purity of THC may be at least about 90%, preferably at least about 95%, more preferably at least about 96%, even more preferably at least about 97%, yet even more preferably at least about 98%, most preferably at least about 99%. The purity of THC may be measured by high performance liquid chromatography (HPLC). carriers

[0107] Compositions as described herein comprise a pharmaceutically acceptable carrier.

[0108] In one embodiment, the pharmaceutically acceptable carrier may comprise a solvent.

[0109] The solvent may be an organic solvent.

[0110] Preferably, the solvent is an alcohol (e.g. ethanol, isopropanol, glycerol, propylene glycol, benzyl alcohol, polyethylene glycol). More preferably, the solvent is C1-C12 alkyl alcohol (e.g. C2-C12 alkyl alcohol). Even more preferably, the solvent is a Ci-Ce alkyl alcohol (e.g. C2-C6 alkyl alcohol). Yet even more preferably, the solvent is a C1-C4 alkyl alcohol (e.g. C2-C4 alkyl alcohol). It is especially preferred that the solvent is ethanol.

[0111] In one embodiment, the solvent may be anhydrous. For example, the solvent may comprise less than 0.1 wt% water, preferably less than 0.05 wt% water, more preferably less than 0.02 wt% water, or even more preferably less than 0.01 wt% water, based on a total wt% content of the solvent. In a preferred embodiment where the solvent is an alcohol (e.g. a C1-C12 alkyl alcohol, a Ci-Ce alkyl alcohol, a C1-C4 alkyl alcohol, a C2-C12 alkyl alcohol, a C2-C6 alkyl alcohol, a C2-C4 alkyl alcohol, or ethanol), the alcohol may comprise less than 0.1 wt% water, preferably less than 0.05 wt% water, more preferably less than 0.02 wt% water, or even more preferably less than 0.01 wt% water, based on a total wt% content of the alcohol.

[0112] In one embodiment, a content of the solvent may be at least about 2 wt%, preferably at least about 3 wt%, more preferably at least about 4 wt%, even more preferably at least about 5 wt%, yet even more preferably at least about 6 wt%, or most preferably at least about 7 wt%, based on a total wt% content of the composition. Any one of these wt% content values or ranges can be combined with any other feature disclosed herein. For example, in a preferred embodiment where the solvent is an alcohol (e.g. a C1-C12 alkyl alcohol, a Ci-Ce alkyl alcohol, a C1-C4 alkyl alcohol, a C2-C12 alkyl alcohol, a C2-C6 alkyl alcohol, a C2-C4 alkyl alcohol, or ethanol), a content of the alcohol may be at least about 2 wt%, preferably at least about 3 wt%, more preferably at least about 4 wt%, even more preferably at least about 5 wt%, yet even more preferably at least about 6 wt%, or most preferably at least about 7 wt%, based on a total wt% content of the composition. In another, more preferred, example, the solvent may be a C1-C12 alkyl alcohol and a content of the alcohol may be at least about 2 wt%, preferably at least about 3 wt%, more preferably at least about 4 wt%, even more preferably at least about 5 wt%, yet even more preferably at least about 6 wt%, or most preferably at least about 7 wt%, based on a total wt% content of the composition.

[0113] In a preferred embodiment, a content of the solvent may be about 2 wt% to about 20 wt%, preferably about 3 wt% to about 15 wt%, more preferably about 4 wt% to about 12 wt%, even more preferably about 5 wt% to about 10 wt%, yet even more preferably about 6 wt% to about 9 wt%, or most preferably about 7 wt% to about 8 wt%, based on a total wt% content of the composition. Any one of these wt% content values or ranges can be combined with any other feature disclosed herein. For example, in a further preferred embodiment where the solvent is an alcohol (e.g. a C1-C12 alkyl alcohol, a Ci-Ce alkyl alcohol, a C1-C4 alkyl alcohol, a C2-C12 alkyl alcohol, a C2-C6 alkyl alcohol, a C2-C4 alkyl alcohol, or ethanol), a content of the alcohol may be about 2 wt% to about 20 wt%, preferably about 3 wt% to about 15 wt%, more preferably about 4 wt% to about 12 wt%, even more preferably about 5 wt% to about 10 wt%, yet even more preferably about 6 wt% to about 9 wt%, or most preferably about 7 wt% to about 8 wt%, based on a total wt% content of the composition. In another, more preferred, example, the solvent may be a C1-C12 alkyl alcohol and a content of the alcohol may be about 2 wt% to about 20 wt%, preferably about 3 wt% to about 15 wt%, more preferably about 4 wt% to about 12 wt%, even more preferably about 5 wt% to about 10 wt%, yet even more preferably about 6 wt% to about 9 wt%, or most preferably about 7 wt% to about 8 wt%, based on a total wt% content of the composition. In an even more preferred example, the solvent may be a Ci-Ce alkyl alcohol and a content of the alcohol may be about 2 wt% to about 20 wt%, preferably about 3 wt% to about 15 wt%, more preferably about 4 wt% to about 12 wt%, even more preferably about 5 wt% to about 10 wt%, yet even more preferably about 6 wt% to about 9 wt%, or most preferably about 7 wt% to about 8 wt%, based on a total wt% content of the composition. In a yet even more preferred example, the solvent may be a C2-C4 alkyl alcohol and a content of the alcohol may be about 2 wt% to about 20 wt%, preferably about 3 wt% to about 15 wt%, more preferably about 4 wt% to about 12 wt%, even more preferably about 5 wt% to about 10 wt%, yet even more preferably about 6 wt% to about 9 wt%, or most preferably about 7 wt% to about 8 wt%, based on a total wt% content of the composition. In a most preferred example, the alcohol in the embodiments above may be ethanol.

[0114] In a more preferred embodiment, a content of the solvent may be about 6 wt% to about 20 wt%, preferably about 6 wt% to about 18 wt%, more preferably about 6 wt% to about 16 wt%, even more preferably about 6 wt% to about 14 wt%, yet even more preferably about 6 wt% to about 12 wt%, yet even more preferably about 6 wt% to about 10 wt%, or most preferably about 6 wt% to about 8 wt%, based on a total wt% content of the composition. Any one of these wt% content values or ranges can be combined with any other feature disclosed herein. For example, in a preferred embodiment where the solvent is an alcohol (e.g. a C1-C12 alkyl alcohol, a Ci-Ce alkyl alcohol, a C1-C4 alkyl alcohol, a C2-C12 alkyl alcohol, a C2-C6 alkyl alcohol, a C2-C4 alkyl alcohol, or ethanol), a content of the alcohol may be about 6 wt% to about 20 wt%, preferably about 6 wt% to about 18 wt%, more preferably about 6 wt% to about 16 wt%, even more preferably about 6 wt% to about 14 wt%, yet even more preferably about 6 wt% to about 12 wt%, yet even more preferably about 6 wt% to about 10 wt%, or most preferably about 6 wt% to about 8 wt%, based on a total wt% content of the composition. In a more preferred example, the solvent may be a C1-C12 alkyl alcohol and a content of the alcohol may be about 6 wt% to about 20 wt%, preferably about 6 wt% to about 18 wt%, more preferably about 6 wt% to about 16 wt%, even more preferably about 6 wt% to about 14 wt%, yet even more preferably about 6 wt% to about 12 wt%, yet even more preferably about 6 wt% to about 10 wt%, or most preferably about 6 wt% to about 8 wt%, based on a total wt% content of the composition. In an even more preferred example, the solvent may be a Ci-Ce alkyl alcohol and a content of the alcohol may be about 6 wt% to about 20 wt%, preferably about 6 wt% to about 18 wt%, more preferably about 6 wt% to about 16 wt%, even more preferably about 6 wt% to about 14 wt%, yet even more preferably about 6 wt% to about 12 wt%, yet even more preferably about 6 wt% to about 10 wt%, or most preferably about 6 wt% to about 8 wt%, based on a total wt% content of the composition. In a yet more preferred example, the solvent may be a C2-C4 alkyl alcohol and a content of the alcohol may be about 6 wt% to about 20 wt%, preferably about 6 wt% to about 18 wt%, more preferably about 6 wt% to about 16 wt%, even more preferably about 6 wt% to about 14 wt%, yet even more preferably about 6 wt% to about 12 wt%, yet even more preferably about 6 wt% to about 10 wt%, or most preferably about 6 wt% to about 8 wt%, based on a total wt% content of the composition. In a most preferred example, the alcohol in the embodiments above may be ethanol.

[0115] In a preferred embodiment, a content of the solvent may be about 7.5 wt % based on a total wt% content of the composition. This wt% content value can be combined with any other feature disclosed herein. For example, in a more preferred embodiment where the solvent is an alcohol (e.g. a C1-C12 alkyl alcohol, a Ci-Ce alkyl alcohol, a C1-C4 alkyl alcohol, a C2-C12 alkyl alcohol, a C2-C6 alkyl alcohol, a C2-C4 alkyl alcohol, or ethanol), a content of the alcohol may be about 7.5 wt% based on a total wt% content of the composition. In an even more preferred example, the solvent may be a C1-C12 alkyl alcohol and a content of the alcohol may be about 7.5 wt% based on a total wt% content of the composition. In a yet even more preferred example, the solvent may be a Ci-Ce alkyl alcohol and a content of the alcohol may be about 7.5 wt% based on a total wt% content of the composition. In a yet further preferred example, the solvent may be a C2- C4 alkyl alcohol and a content of the alcohol may be about 7.5 wt% based on a total wt% content of the composition. In a most preferred example, the solvent may be ethanol and a content of the ethanol may be about 7.5 wt% based on a total wt% content of the composition.

[0116] These amounts of solvent (particularly ethanol) may provide an optimal balance between fine particle dose and fine particle fraction. These amounts of solvent (particularly ethanol) may also promote the rapid phase transition from liquid to gas. Thus, such concentrations of solvent provide compositions that are typically most suited to delivery by inhalation. In addition, these amounts and types of solvent (particularly ethanol) may help solubilise CBD and THC, and may help prevent or reduce the tendency of CBD and / or THC from “oiling” out of the composition, thus maintaining a stable dose profile.

[0117] In one embodiment, a wt% ratio of solvent:CBD may be about 1 :1 to about 20:1 , preferably about 2: 1 to about 15:1 , more preferably about 3: 1 to about 10:1 , even more preferably about 4:1 to about 8:1 , yet even more preferably about 5:1 to about 7:1 , or most preferably about 5.5:1 to about 6:1. In a preferred embodiment where the solvent is an alcohol (e.g. a C1-C12 alkyl alcohol, a Ci-Ce alkyl alcohol, a C1-C4 alkyl alcohol, a C2-C12 alkyl alcohol, a C2-C6 alkyl alcohol, a C2-C4 alkyl alcohol, or ethanol), a wt% ratio of alcohokCBD may be about 1 :1 to about 20:1 , preferably about 2:1 to about 15:1 , more preferably about 3:1 to about 10:1 , even more preferably about 4:1 to about 8:1 , yet even more preferably about 5:1 to about 7:1 , or most preferably about 5.5:1 to about 6:1.

[0118] In one embodiment, a wt% ratio of solvent:THC may be about 1 :1 to about 20:1 , preferably about 2: 1 to about 15:1 , more preferably about 3: 1 to about 10:1 , even more preferably about 4:1 to about 8:1 , yet even more preferably about 5:1 to about 7:1 , or most preferably about 5.5:1 to about 6:1. In a preferred embodiment where the solvent is an alcohol (e.g. a C1-C12 alkyl alcohol, a Ci-Ce alkyl alcohol, a C1-C4 alkyl alcohol, a C2-C12 alkyl alcohol, a C2-C6 alkyl alcohol, a C2-C4 alkyl alcohol, or ethanol), a wt% ratio of alcohokTHC may be about 1 : 1 to about 20: 1 , preferably about 2: 1 to about 15:1 , more preferably about 3:1 to about 10:1 , even more preferably about 4:1 to about 8:1 , yet even more preferably about 5:1 to about 7:1 , or most preferably about 5.5:1 to about 6:1.

[0119] In one embodiment, a wt% ratio of solvent:(CBD+THC) may be about 0.5:1 to about 10:1 , preferably about 1 : 1 to about 7.5:1 , more preferably about 1 .5: 1 to about 15:1 , even more preferably about 2:1 to about 4:1 , yet even more preferably about 2.5:1 to about 3.5:1 , or most preferably about 2.75:1 to about 3:1. In a preferred embodiment where the solvent is an alcohol (e.g. a C1-C12 alkyl alcohol, a Ci-Ce alkyl alcohol, a C1-C4 alkyl alcohol, a C2-C12 alkyl alcohol, a C2-C6 alkyl alcohol, a C2-C4 alkyl alcohol, or ethanol), a wt% ratio of alcohok(CBD+THC) may be about 0.5:1 to about 10:1 , preferably about 1 :1 to about 7.5:1 , more preferably about 1.5:1 to about 15:1 , even more preferably about 2:1 to about 4:1 , yet even more preferably about 2.5:1 to about 3.5:1 , or most preferably about 2.75: 1 to about 3: 1.

[0120] In one embodiment, the pharmaceutically acceptable carrier may comprise a propellant.

[0121] The propellant may be selected from a hydrofluorocarbon (e.g. hydrofluoroalkanes such as 1 ,1 ,1 ,2-tetrafluoroethane (HFA 134a), 1 ,1 ,1 ,2,3,3,3-heptafluoropropane (HFA 227),

[0122] 1.1 -difluoroethane (HFA 152a); or hydrofluoroolefins such as 2,3,3, 3-tetrafluoropropene, 1 ,3,3,3-tetrafluoropropene), a hydrochlorofluorocarbon (e.g. 1 , 1 -dichloro-1 - fluoroethane), chlorofluorocarbon (e.g. trichlorofluoromethane, dichlorodifluoromethane,

[0123] 1.2-dichlorotetrafluoroethane), a hydrocarbon (e.g. propane, n-butane, isobutane, n- pentane, isopentane, neopentane), an ether (e.g. dimethyl ether), or a combination thereof. Where an ether is used in a solvent as described herein, the ether in the propellant as described herein may be different from the ether in the solvent.

[0124] Preferably, the propellant is a hydrofluorocarbon. More preferably, the hydrofluorocarbon is a hydrofluoroalkane or a hydrofluoroolefin. Even more preferably, the hydrofluorocarbon is a hydrofluoroalkane. It is especially preferred that the propellant is 1 ,1 ,1 ,2-tetrafluoroethane.

[0125] In one embodiment, a content of the propellant may be a balance amount to make up to 100 wt% of the final wt% of the composition, based on the wt% amounts of the CBD and / or THC and / or solvent as described herein. For example, the content of the propellant may be a balance amount to make up to 100 wt% of the final wt% of the composition, based on the wt% amounts of the CBD, THC and solvent as described herein.

[0126] In one embodiment, a content of the propellant may be at least about 50 wt%, preferably at least about 60 wt%, more preferably at least about 70 wt%, even more preferably at least about 80 wt%, yet even more preferably at least about 82 wt%, or most preferably at least about 85 wt%, based on a total wt% content of the composition. For example, in a preferred embodiment where the propellant is a hydrofluorocarbon (e.g. a hydrofluoroalkane, a hydrofluoroolefin, or 1 ,1 ,1 ,2-tetrafluoroethane), a content of the hydrofluorocarbon may be at least about 50 wt%, preferably at least about 60 wt%, more preferably at least about 70 wt%, even more preferably at least about 80 wt%, yet even more preferably at least about 82 wt%, or most preferably at least about 85 wt%, based on a total wt% content of the composition.

[0127] In a preferred embodiment, a content of the propellant may be about 50 wt% to about 99.5 wt%, preferably about 60 wt% to about 99 wt%, more preferably about 70 wt% to about 98 wt%, even more preferably about 80 wt% to about 97 wt%, yet even more preferably about 82 wt% to about 96 wt%, or most preferably about 85 wt% to about 95 wt%, based on a total wt% content of the composition. For example, in a further preferred embodiment where the propellant is a hydrofluorocarbon (e.g. a hydrofluoroalkane, a hydrofluoroolefin, or 1 ,1 ,1 ,2-tetrafluoroethane), a content of the hydrofluorocarbon may be about 50 wt% to about 99.5 wt%, preferably about 60 wt% to about 99 wt%, more preferably about 70 wt% to about 98 wt%, even more preferably about 80 wt% to about 97 wt%, yet even more preferably about 82 wt% to about 96 wt%, or most preferably about 85 wt% to about 95 wt%, based on a total wt% content of the composition.

[0128] In one embodiment, a wt% ratio of propellant:CBD may be about 10:1 to about 100:1 , preferably about 20: 1 to about 90: 1 , more preferably about 30: 1 to about 85: 1 , even more preferably about 40:1 to about 80:1 , yet even more preferably about 50:1 to about 75:1 , or most preferably about 60:1 to about 70:1. For example, in a preferred embodiment where the propellant is a hydrofluorocarbon (e.g. a hydrofluoroalkane, a hydrofluoroolefin, or 1 ,1 ,1 ,2-tetrafluoroethane), a wt% ratio of hydrofluorocarbon:CBD may be about 10:1 to about 100:1 , preferably about 20:1 to about 90:1 , more preferably about 30: 1 to about 85: 1 , even more preferably about 40: 1 to about 80: 1 , yet even more preferably about 50:1 to about 75:1 , or most preferably about 60:1 to about 70:1.

[0129] In one embodiment, a wt% ratio of propellant:THC may be about 10:1 to about 100:1 , preferably about 20: 1 to about 90: 1 , more preferably about 30: 1 to about 85: 1 , even more preferably about 40:1 to about 80:1 , yet even more preferably about 50:1 to about 75:1 , or most preferably about 60:1 to about 70:1. For example, in a preferred embodiment where the propellant is a hydrofluorocarbon (e.g. a hydrofluoroalkane, a hydrofluoroolefin, or 1 ,1 ,1 ,2-tetrafluoroethane), a wt% ratio of hydrofluorocarbon:THC may be about 10:1 to about 100:1 , preferably about 20:1 to about 90:1 , more preferably about 30: 1 to about 85: 1 , even more preferably about 40: 1 to about 80: 1 , yet even more preferably about 50: 1 to about 75: 1 , or most preferably about 60: 1 to about 70: 1 .

[0130] In one embodiment, a wt% ratio of propellant:(CBD+THC) may be about 5:1 to about 50:1 , preferably about 10:1 to about 45:1 , more preferably about 15:1 to about 42.5:1 , even more preferably about 20:1 to about 40:1 , yet even more preferably about 25:1 to about 37.5:1 , or most preferably about 30:1 to about 35:1. For example, in a preferred embodiment where the propellant is a hydrofluorocarbon (e.g. a hydrofluoroalkane, a hydrofluoroolefin, or 1 ,1 ,1 ,2-tetrafluoroethane), a wt% ratio of hydrofluorocarbon:(CBD+THC) may be about 5:1 to about 50:1 , preferably about 10:1 to about 45:1 , more preferably about 15:1 to about 42.5:1 , even more preferably about 20:1 to about 40:1 , yet even more preferably about 25:1 to about 37.5:1 , or most preferably about 30:1 to about 35:1. In one embodiment, a content of the pharmaceutically acceptable carrier (e.g. a combined amount of the solvent as described herein and the propellant as described herein) may be at least about 50 wt%, preferably at least about 60 wt%, more preferably at least about 70 wt%, even more preferably at least about 80 wt%, yet even more preferably at least about 90 wt%, or most preferably at least about 95 wt%, based on a total wt% content of the composition. In a preferred embodiment, a combined content of the solvent as described herein and the propellant as described herein may be at least about 50 wt%, preferably at least about 60 wt%, more preferably at least about 70 wt%, even more preferably at least about 80 wt%, yet even more preferably at least about 90 wt%, or most preferably at least about 95 wt%, based on a total wt% content of the composition.

[0131] In a preferred embodiment, a content of the pharmaceutically acceptable carrier (e.g. a combined amount of the solvent as described herein and the propellant as described herein) may be about 50 wt% to about 99.5 wt%, preferably about 60 wt% to about 99 wt%, more preferably about 70 wt% to about 98.5 wt%, even more preferably about 80 wt% to about 98 wt%, yet even more preferably about 90 wt% to about 97.8 wt%, or most preferably about 95 wt% to about 97.5 wt%, based on a total wt% content of the composition. In a preferred embodiment, a combined content of the solvent as described herein and the propellant as described herein may be about 50 wt% to about 99.5 wt%, preferably about 60 wt% to about 99 wt%, more preferably about 70 wt% to about 98.5 wt%, even more preferably about 80 wt% to about 98 wt%, yet even more preferably about 90 wt% to about 97.8 wt%, or most preferably about 95 wt% to about 97.5 wt%, based on a total wt% content of the composition.

[0132] In one embodiment, a wt% ratio of pharmaceutically acceptable carrierCBD may be about 20:1 to about 500:1 , preferably about 30:1 to about 250:1 , more preferably about 50:1 to about 150:1 , even more preferably about 55:1 to about 100:1 , yet even more preferably about 65:1 to about 90:1 , or most preferably about 70:1 to about 75:1. In a preferred embodiment, a wt% ratio of (solvent as described herein + propellant as described herein):CBD may be about 20:1 to about 500:1 , preferably about 30:1 to about 250:1 , more preferably about 50:1 to about 150:1 , even more preferably about 55:1 to about 100: 1 , yet even more preferably about 65: 1 to about 90: 1 , or most preferably about 70:1 to about 75:1. In one embodiment, a wt% ratio of pharmaceutically acceptable carrierTHC may be about 20:1 to about 500:1 , preferably about 30:1 to about 250:1 , more preferably about 50:1 to about 150:1 , even more preferably about 55:1 to about 100:1 , yet even more preferably about 65:1 to about 90:1 , or most preferably about 70:1 to about 75:1. In a preferred embodiment, a wt% ratio of (solvent as described herein + propellant as described herein):THC may be about 20:1 to about 500:1 , preferably about 30:1 to about 250:1 , more preferably about 50:1 to about 150:1 , even more preferably about 55:1 to about 100: 1 , yet even more preferably about 65: 1 to about 90: 1 , or most preferably about 70:1 to about 75:1.

[0133] In one embodiment, a wt% ratio of pharmaceutically acceptable carrier: (CBD+THC) may be about 10:1 to about 250:1 , preferably about 15:1 to about 125:1 , more preferably about 25:1 to about 75:1 , even more preferably about 27.5:1 to about 50:1 , yet even more preferably about 32.5:1 to about 45:1 , or most preferably about 35:1 to about 37.5:1. In a preferred embodiment, a wt% ratio of (solvent as described herein + propellant as described herein):(CBD+THC) may be about 10:1 to about 250:1 , preferably about 15:1 to about 125:1 , more preferably about 25:1 to about 75:1 , even more preferably about 27.5:1 to about 50:1 , yet even more preferably about 32.5:1 to about 45:1 , or most preferably about 35:1 to about 37.5:1.

[0134] In one embodiment, the pharmaceutically acceptable carrier may comprise a solvent (e.g. a solvent as described herein) and a propellant (e.g. a propellant as described herein).

[0135] In one embodiment, when the pharmaceutically acceptable carrier comprises a solvent as described herein and a propellant as described herein, a wt% ratio of solventpropellant may be about 5:1 to about 25:1 , preferably about 7:1 to about 20:1 , more preferably about 8:1 to about 18:1 , even more preferably about 9:1 to about 16:1 , yet even more preferably about 10:1 to about 15:1 , or most preferably about 11 :1 to about 14:1. For example, in a preferred embodiment where the solvent is an alcohol (e.g. a C1-C12 alkyl alcohol, a Ci-Ce alkyl alcohol, a C1-C4 alkyl alcohol, a C2-C12 alkyl alcohol, a C2-C6 alkyl alcohol, a C2-C4 alkyl alcohol, or ethanol) and the propellant is a hydrofluorocarbon (e.g. a hydrofluoroalkane, a hydrofluoroolefin, or 1 , 1 ,1 ,2- tetrafluoroethane), a wt% ratio of alcohokhydrofluorocarbon may be about 5:1 to about 25: 1 , preferably about 7: 1 to about 20: 1 , more preferably about 8: 1 to about 18: 1 , even more preferably about 9:1 to about 16:1 , yet even more preferably about 10:1 to about 15:1 , or most preferably about 11 :1 to about 14:1. In particular, a wt% ratio of ethanokhydrofluorocarbon may be about 5:1 to about 25:1 , preferably about 7:1 to about 20:1 , more preferably about 8:1 to about 18:1 , even more preferably about 9:1 to about 16:1 , yet even more preferably about 10:1 to about 15:1 , or most preferably about 11 :1 to about 14:1 ; a wt% ratio of alcohol: 1 ,1 ,1 , 2-tetrafluoroethane may be about 5:1 to about 25:1 , preferably about 7:1 to about 20:1 , more preferably about 8:1 to about 18:1 , even more preferably about 9:1 to about 16:1 , yet even more preferably about 10:1 to about 15:1 , or most preferably about 11 :1 to about 14:1 ; or a wt% ratio of ethanol: 1 ,1 , 1 ,2- tetrafluoroethane may be about 5:1 to about 25:1 , preferably about 7:1 to about 20:1 , more preferably about 8:1 to about 18:1 , even more preferably about 9:1 to about 16:1 , yet even more preferably about 10:1 to about 15:1 , or most preferably about 11 :1 to about 14:1.

[0136] Other aspects of the compositions

[0137] The composition may comprise CBD, THC, a solvent and a propellant. For example, the composition may consist of CBD, THC, a solvent and a propellant.

[0138] In one embodiment, a content of the CBD may be about 0.1 wt% to about 5.0 wt%, a content of the THC may be about 0.1 wt% to about 5.0 wt%, and a content of the solvent may be about 2 wt% to about 20 wt%, based on a total wt% content of the composition (with propellant making up the balance to 100 wt%). Preferably, a content of the CBD may be about 0.25 wt% to about 3.0 wt%, a content of the THC may be about 0.25 wt% to about 3.0 wt%, and a content of the solvent may be about 3 wt% to about 15 wt%, based on a total wt% content of the composition (with propellant making up the balance to 100 wt%). More preferably, a content of the CBD may be about 0.5 wt% to about 2.0 wt%, a content of the THC may be about 0.5 wt% to about 2.0 wt%, and a content of the solvent may be about 4 wt% to about 12 wt%, based on a total wt% content of the composition (with propellant making up the balance to 100 wt%). Even more preferably, a content of the CBD may be about 0.75 wt% to about 1.75 wt%, a content of the THC may be about 0.75 wt% to about 1.75 wt%, and a content of the solvent may be about 5 wt% to about 10 wt%, based on a total wt% content of the composition (with propellant making up the balance to 100 wt%). Yet even more preferably, a content of the CBD may be about 1 .0 wt% to about 1.5 wt%, a content of the THC may be about 1.0 wt% to about 1.5 wt%, and a content of the solvent may be about 6 wt% to about 9 wt%, based on a total wt% content of the composition (with propellant making up the balance to 100 wt%). Most preferably, a content of the CBD may be about 1.3 wt% to about 1.4 wt%, a content of the THC may be about 1.3 wt% to about 1.4 wt%, and a content of the solvent may be about 7 wt% to about 8 wt%, based on a total wt% content of the composition (with propellant making up the balance to 100 wt%).

[0139] In a preferred embodiment, the composition may comprise CBD, THC, an alcohol (e.g. a C1-C12 alkyl alcohol, a Ci-Ce alkyl alcohol, a C1-C4 alkyl alcohol, a C2-C12 alkyl alcohol, a C2-C6 alkyl alcohol, a C2-C4 alkyl alcohol, or ethanol) and a propellant. For example, the composition may consist of CBD, THC, an alcohol (e.g. a C1-C12 alkyl alcohol, a C1- Ce alkyl alcohol, a C1-C4 alkyl alcohol, a C2-C12 alkyl alcohol, a C2-C6 alkyl alcohol, a C2- C4 alkyl alcohol, or ethanol) and a propellant.

[0140] In one embodiment, a content of the CBD may be about 0.1 wt% to about 5.0 wt%, a content of the THC may be about 0.1 wt% to about 5.0 wt%, and a content of the alcohol may be about 2 wt% to about 20 wt%, based on a total wt% content of the composition (with propellant making up the balance to 100 wt%). Preferably, a content of the CBD may be about 0.25 wt% to about 3.0 wt%, a content of the THC may be about 0.25 wt% to about 3.0 wt%, and a content of the alcohol may be about 3 wt% to about 15 wt%, based on a total wt% content of the composition (with propellant making up the balance to 100 wt%). More preferably, a content of the CBD may be about 0.5 wt% to about 2.0 wt%, a content of the THC may be about 0.5 wt% to about 2.0 wt%, and a content of the alcohol may be about 4 wt% to about 12 wt%, based on a total wt% content of the composition (with propellant making up the balance to 100 wt%). Even more preferably, a content of the CBD may be about 0.75 wt% to about 1 .75 wt%, a content of the THC may be about 0.75 wt% to about 1 .75 wt%, and a content of the alcohol may be about 5 wt% to about 10 wt%, based on a total wt% content of the composition (with propellant making up the balance to 100 wt%). Yet even more preferably, a content of the CBD may be about 1.0 wt% to about 1.5 wt%, a content of the THC may be about 1 .0 wt% to about 1 .5 wt%, and a content of the alcohol may be about 6 wt% to about 9 wt%, based on a total wt% content of the composition (with propellant making up the balance to 100 wt%). Most preferably, a content of the CBD may be about 1.3 wt% to about 1 .4 wt%, a content of the THC may be about 1.3 wt% to about 1.4 wt%, and a content of the alcohol may be about 7 wt% to about 8 wt%, based on a total wt% content of the composition (with propellant making up the balance to 100 wt%).

[0141] Alternatively, the composition may comprise CBD, THC, a solvent and a hydrofluorocarbon (e.g. a hydrofluoroalkane, a hydrofluoroolefin, or 1 , 1 ,1 ,2- tetrafluoroethane). For example, the composition may consist of CBD, THC, a solvent and a hydrofluorocarbon (e.g. a hydrofluoroalkane, a hydrofluoroolefin, or 1 , 1 ,1 ,2- tetrafluoroethane).

[0142] In one embodiment, a content of the CBD may be about 0.1 wt% to about 5.0 wt%, a content of the THC may be about 0.1 wt% to about 5.0 wt%, and a content of the solvent may be about 2 wt% to about 20 wt%, based on a total wt% content of the composition (with hydrofluorocarbon making up the balance to 100 wt%). Preferably, a content of the CBD may be about 0.25 wt% to about 3.0 wt%, a content of the THC may be about 0.25 wt% to about 3.0 wt%, and a content of the solvent may be about 3 wt% to about 15 wt%, based on a total wt% content of the composition (with hydrofluorocarbon making up the balance to 100 wt%). More preferably, a content of the CBD may be about 0.5 wt% to about 2.0 wt%, a content of the THC may be about 0.5 wt% to about 2.0 wt%, and a content of the solvent may be about 4 wt% to about 12 wt%, based on a total wt% content of the composition (with hydrofluorocarbon making up the balance to 100 wt%). Even more preferably, a content of the CBD may be about 0.75 wt% to about 1.75 wt%, a content of the THC may be about 0.75 wt% to about 1.75 wt%, and a content of the solvent may be about 5 wt% to about 10 wt%, based on a total wt% content of the composition (with hydrofluorocarbon making up the balance to 100 wt%). Yet even more preferably, a content of the CBD may be about 1.0 wt% to about 1.5 wt%, a content of the THC may be about 1.0 wt% to about 1.5 wt%, and a content of the solvent may be about 6 wt% to about 9 wt%, based on a total wt% content of the composition (with hydrofluorocarbon making up the balance to 100 wt%). Most preferably, a content of the CBD may be about 1 .3 wt% to about 1 .4 wt%, a content of the THC may be about 1.3 wt% to about 1.4 wt%, and a content of the solvent may be about 7 wt% to about 8 wt%, based on a total wt% content of the composition (with hydrofluorocarbon making up the balance to 100 wt%).

[0143] In a further preferred embodiment, the composition may comprise CBD, THC, an alcohol (e.g. a C1-C12 alkyl alcohol, a Ci-Ce alkyl alcohol, a C1-C4 alkyl alcohol, a C2-C12 alkyl alcohol, a C2-C6 alkyl alcohol, a C2-C4 alkyl alcohol, or ethanol) and a hydrofluorocarbon (e.g. a hydrofluoroalkane, a hydrofluoroolefin, or 1 ,1 ,1 ,2-tetrafluoroethane). For example, the composition may consist of CBD, THC, an alcohol (e.g. a C1-C12 alkyl alcohol, a Ci-Ce alkyl alcohol, a C1-C4 alkyl alcohol, a C2-C12 alkyl alcohol, a C2-C6 alkyl alcohol, a C2-C4 alkyl alcohol, or ethanol) and a hydrofluorocarbon (e.g. a hydrofluoroalkane, a hydrofluoroolefin, or 1 ,1 ,1 ,2-tetrafluoroethane).

[0144] In one embodiment, a content of the CBD may be about 0.1 wt% to about 5.0 wt%, a content of the THC may be about 0.1 wt% to about 5.0 wt%, and a content of the alcohol may be about 2 wt% to about 20 wt%, based on a total wt% content of the composition (with hydrofluorocarbon making up the balance to 100 wt%). Preferably, a content of the CBD may be about 0.25 wt% to about 3.0 wt%, a content of the THC may be about 0.25 wt% to about 3.0 wt%, and a content of the alcohol may be about 3 wt% to about 15 wt%, based on a total wt% content of the composition (with hydrofluorocarbon making up the balance to 100 wt%). More preferably, a content of the CBD may be about 0.5 wt% to about 2.0 wt%, a content of the THC may be about 0.5 wt% to about 2.0 wt%, and a content of the alcohol may be about 4 wt% to about 12 wt%, based on a total wt% content of the composition (with hydrofluorocarbon making up the balance to 100 wt%). Even more preferably, a content of the CBD may be about 0.75 wt% to about 1.75 wt%, a content of the THC may be about 0.75 wt% to about 1.75 wt%, and a content of the alcohol may be about 5 wt% to about 10 wt%, based on a total wt% content of the composition (with hydrofluorocarbon making up the balance to 100 wt%). Yet even more preferably, a content of the CBD may be about 1.0 wt% to about 1.5 wt%, a content of the THC may be about 1.0 wt% to about 1.5 wt%, and a content of the alcohol may be about 6 wt% to about 9 wt%, based on a total wt% content of the composition (with hydrofluorocarbon making up the balance to 100 wt%). Most preferably, a content of the CBD may be about 1 .3 wt% to about 1 .4 wt%, a content of the THC may be about 1.3 wt% to about 1.4 wt%, and a content of the alcohol may be about 7 wt% to about 8 wt%, based on a total wt% content of the composition (with hydrofluorocarbon making up the balance to 100 wt%).

[0145] In an even further preferred embodiment, the composition may comprise CBD, THC, ethanol and a hydrofluorocarbon (e.g. a hydrofluoroalkane, a hydrofluoroolefin, or 1 ,1 ,1 ,2-tetrafluoroethane). For example, the composition may consist of CBD, THC, ethanol and a hydrofluorocarbon (e.g. a hydrofluoroalkane, a hydrofluoroolefin, or 1 ,1 ,1 ,2-tetrafluoroethane).

[0146] In one embodiment, a content of the CBD may be about 0.1 wt% to about 5.0 wt%, a content of the THC may be about 0.1 wt% to about 5.0 wt%, and a content of the ethanol may be about 2 wt% to about 20 wt%, based on a total wt% content of the composition (with hydrofluorocarbon making up the balance to 100 wt%). Preferably, a content of the CBD may be about 0.25 wt% to about 3.0 wt%, a content of the THC may be about 0.25 wt% to about 3.0 wt%, and a content of the ethanol may be about 3 wt% to about 15 wt%, based on a total wt% content of the composition (with hydrofluorocarbon making up the balance to 100 wt%). More preferably, a content of the CBD may be about 0.5 wt% to about 2.0 wt%, a content of the THC may be about 0.5 wt% to about 2.0 wt%, and a content of the ethanol may be about 4 wt% to about 12 wt%, based on a total wt% content of the composition (with hydrofluorocarbon making up the balance to 100 wt%). Even more preferably, a content of the CBD may be about 0.75 wt% to about 1.75 wt%, a content of the THC may be about 0.75 wt% to about 1.75 wt%, and a content of the ethanol may be about 5 wt% to about 10 wt%, based on a total wt% content of the composition (with hydrofluorocarbon making up the balance to 100 wt%). Yet even more preferably, a content of the CBD may be about 1.0 wt% to about 1.5 wt%, a content of the THC may be about 1 .0 wt% to about 1.5 wt%, and a content of the ethanol may be about 6 wt% to about 9 wt%, based on a total wt% content of the composition (with hydrofluorocarbon making up the balance to 100 wt%). Most preferably, a content of the CBD may be about 1 .3 wt% to about 1 .4 wt%, a content of the THC may be about 1.3 wt% to about 1.4 wt%, and a content of the ethanol may be about 7 wt% to about 8 wt%, based on a total wt% content of the composition (with hydrofluorocarbon making up the balance to 100 wt%).

[0147] Alternatively, the composition may comprise CBD, THC, an alcohol (e.g. a C1-C12 alkyl alcohol, a Ci-Ce alkyl alcohol, a C1-C4 alkyl alcohol, a C2-C12 alkyl alcohol, a C2-C6 alkyl alcohol, a C2-C4 alkyl alcohol, or ethanol) and a 1 ,1 ,1 ,2-tetrafluoroethane. For example, the composition may consist of CBD, THC, an alcohol (e.g. a C1-C12 alkyl alcohol, a C1- Ce alkyl alcohol, a C1-C4 alkyl alcohol, a C2-C12 alkyl alcohol, a C2-C6 alkyl alcohol, a C2- C4 alkyl alcohol, or ethanol) and a 1 ,1 ,1 ,2-tetrafluoroethane. In one embodiment, a content of the CBD may be about 0.1 wt% to about 5.0 wt%, a content of the THC may be about 0.1 wt% to about 5.0 wt%, and a content of the alcohol may be about 2 wt% to about 20 wt%, based on a total wt% content of the composition (with 1 ,1 ,1 ,2-tetrafluoroethane making up the balance to 100 wt%). Preferably, a content of the CBD may be about 0.25 wt% to about 3.0 wt%, a content of the THC may be about 0.25 wt% to about 3.0 wt%, and a content of the alcohol may be about 3 wt% to about 15 wt%, based on a total wt% content of the composition (with 1 ,1 ,1 ,2-tetrafluoroethane making up the balance to 100 wt%). More preferably, a content of the CBD may be about 0.5 wt% to about 2.0 wt%, a content of the THC may be about 0.5 wt% to about 2.0 wt%, and a content of the alcohol may be about 4 wt% to about 12 wt%, based on a total wt% content of the composition (with 1 ,1 ,1 ,2-tetrafluoroethane making up the balance to 100 wt%). Even more preferably, a content of the CBD may be about 0.75 wt% to about 1.75 wt%, a content of the THC may be about 0.75 wt% to about 1.75 wt%, and a content of the alcohol may be about 5 wt% to about 10 wt%, based on a total wt% content of the composition (with 1 ,1 ,1 ,2-tetrafluoroethane making up the balance to 100 wt%). Yet even more preferably, a content of the CBD may be about 1.0 wt% to about 1.5 wt%, a content of the THC may be about 1 .0 wt% to about 1 .5 wt%, and a content of the alcohol may be about 6 wt% to about 9 wt%, based on a total wt% content of the composition (with 1 ,1 ,1 ,2-tetrafluoroethane making up the balance to 100 wt%). Most preferably, a content of the CBD may be about 1 .3 wt% to about 1 .4 wt%, a content of the THC may be about 1 .3 wt% to about 1 .4 wt%, and a content of the alcohol may be about 7 wt% to about 8 wt%, based on a total wt% content of the composition (with 1 ,1 ,1 ,2-tetrafluoroethane making up the balance to 100 wt%).

[0148] In an even further preferred embodiment, the composition may comprise CBD, THC, ethanol and 1 ,1 ,1 ,2-tetrafluoroethane. For example, the composition may consist of CBD, THC, ethanol and 1 ,1 ,1 ,2-tetrafluoroethane.

[0149] In one embodiment, a content of the CBD may be about 0.1 wt% to about 5.0 wt%, a content of the THC may be about 0.1 wt% to about 5.0 wt%, and a content of the ethanol may be about 2 wt% to about 20 wt%, based on a total wt% content of the composition (with 1 ,1 ,1 ,2-tetrafluoroethane making up the balance to 100 wt%). Preferably, a content of the CBD may be about 0.25 wt% to about 3.0 wt%, a content of the THC may be about 0.25 wt% to about 3.0 wt%, and a content of the ethanol may be about 3 wt% to about 15 wt%, based on a total wt% content of the composition (with 1 ,1 ,1 ,2-tetrafluoroethane making up the balance to 100 wt%). More preferably, a content of the CBD may be about 0.5 wt% to about 2.0 wt%, a content of the THC may be about 0.5 wt% to about 2.0 wt%, and a content of the ethanol may be about 4 wt% to about 12 wt%, based on a total wt% content of the composition (with 1 ,1 ,1 ,2-tetrafluoroethane making up the balance to 100 wt%). Even more preferably, a content of the CBD may be about 0.75 wt% to about 1.75 wt%, a content of the THC may be about 0.75 wt% to about 1 .75 wt%, and a content of the ethanol may be about 5 wt% to about 10 wt%, based on a total wt% content of the composition (with 1 ,1 ,1 ,2-tetrafluoroethane making up the balance to 100 wt%). Yet even more preferably, a content of the CBD may be about 1.0 wt% to about 1.5 wt%, a content of the THC may be about 1 .0 wt% to about 1 .5 wt%, and a content of the ethanol may be about 6 wt% to about 9 wt%, based on a total wt% content of the composition (with 1 ,1 ,1 ,2-tetrafluoroethane making up the balance to 100 wt%). Most preferably, a content of the CBD may be about 1.3 wt% to about 1 .4 wt%, a content of the THC may be about 1 .3 wt% to about 1 .4 wt%, and a content of the ethanol may be about 7 wt% to about 8 wt%, based on a total wt% content of the composition (with 1 ,1 ,1 ,2-tetrafluoroethane making up the balance to 100 wt%).

[0150] In one embodiment, the composition may comprise less than 0.1 wt% water, preferably less than 0.05 wt% water, more preferably less than 0.02 wt% water, or even more preferably less than 0.01 wt% water, based on a total wt% content of the composition.

[0151] Medical uses

[0152] Compositions as described herein are typically used for treatment methods, for example in the treatment or prophylaxis of pain.

[0153] Thus, in accordance with another embodiment of the present invention, there is provided a composition as described herein for use as a medicament.

[0154] In accordance with another embodiment of the present invention, there is provided a composition as described herein for use in the treatment or prophylaxis of pain (e.g. neuralgia, such as trigeminal neuralgia).

[0155] In accordance with another embodiment of the present invention, there is provided a use of a composition as described herein in the manufacture of a medicament. In accordance with another embodiment of the present invention, there is provided a use of a composition as described herein in the manufacture of a medicament for the treatment or prophylaxis of pain.

[0156] In accordance with another embodiment of the present invention, there is provided a method for the treatment or prophylaxis of pain comprising administering an effective amount of a composition as described herein to a subject (e.g. patient) in need thereof.

[0157] As used herein, the terms “treat” and “treatment” and like terms refer to the administration of material, e.g., compositions as described herein, in an amount effective to prevent, alleviate, or ameliorate a medical condition (e.g. pain) in the subject being treated.

[0158] As used herein, the term “therapeutically effective” or "effective amount" indicates that an amount of a substance (e.g. compositions as described herein) when administered is sufficient or effective to prevent, alleviate, or ameliorate a medical condition (e.g. pain) in the subject being treated. The therapeutically effective amount will vary depending on the condition, its severity and the age, weight, etc., of the mammal to be treated. In general, satisfactory results in subjects are indicated to be obtained at a daily dosage of from about 0.1 to about 10 g / kg subject body weight. The dosage can be conveniently administered, e.g., in divided doses up to four times a day or in sustained-release form.

[0159] As used herein, the term “subject” refers to a living organism that is treated with compounds as described herein, including, but not limited to, any mammal, such as a human, other primates, sports animals, animals of commercial interest such as cattle, farm animals such as horses, or pets such as dogs and cats.

[0160] The compositions for use herein are typically used in therapy for human subjects. However, they may also be used to treat similar or identical indications in other animal subjects.

[0161] Inhalation devices

[0162] The compositions of the present disclosure are typically delivered by inhalation. As such, in accordance with another embodiment of the present invention, there is provided a pressurised canister comprising a composition as described herein.

[0163] The pressurised canister may be suitable for delivering pharmaceutical aerosol formulations.

[0164] The pressurised canister may be configured to withstand an internal pressure higher than atmospheric pressure (1 atm); for example, the pressurised canister may be configured to withstand an internal pressure of greater than 1 atm to about 10 atm, about 2 atm to about 8 atm, or about 3 atm to about 5 atm. The pressurised canister may have an internal pressure higher than atmospheric pressure (1 atm); for example, the pressurised canister may have an internal pressure of greater than 1 atm to about 10 atm, about 2 atm to about 8 atm, or about 3 atm to about 5 atm.

[0165] The pressurised canister may comprise a can. The can may be made of metal, plastic or glass, preferably metal. For example, the can may be made of aluminium or stainless steel.

[0166] The pressurised canister may comprise an outlet. The outlet may be adapted to release some of the contents of the canister (e.g. a dose of the composition) on actuation.

[0167] In addition, in accordance with another embodiment of the present invention, there is provided an inhalation device comprising a composition as described herein or a pressurised canister as described herein.

[0168] When the inhalation device comprises a pressurised canister described herein, the pressurised canister may be attached to the inhalation device.

[0169] The inhalation device may be an inhaler. In particular, inhalers may come in different forms. Preferably, the inhaler is a metered-dose inhaler (e.g. a pressurised metered- dose inhaler).

[0170] Kits In accordance with another embodiment of the present invention, there is provided a composition as described herein and instructions for use in the composition in the treatment or prophylaxis of pain. In accordance with another embodiment of the present invention, there is provided a pressurised canister as described herein and an inhalation device configured to receive the pressurised canister.

[0171] The inhalation device may be an inhaler. In particular, inhalers may come in different forms. Preferably, the inhaler is a metered-dose inhaler (e.g. a pressurised metered- dose inhaler).

[0172] The present invention will now be described by way of the following non-limiting examples.

[0173] Examples

[0174] Example 1 - solubility tests for CBD

[0175] Solubility and dose tests of CBD over varying amounts of solvent: The solubility of CBD in ethanol / 1 ,1 ,1 ,2-tetrafluoroethane (HFA 134a) was tested over different wt% values of ethanol. The data is shown in Tables 1 and 2 below.

[0176] Table 1 - Doses of CBD over varying amounts of solvent (1.0 mg metered dose)

[0177] Table 2 - Doses of CBD over varying amounts of solvent (2.0 mg metered dose)

[0178] (MMAD = median mass aerodynamic diameter)

[0179] These data show that the solubility of CBD reaches a plateau at approximately 10 wt% of ethanol at both metered doses. Thus, whilst greater amounts of CBD can be dissolved at higher wt% values of solvent (e.g. ethanol), there were diminishing returns with using higher concentrations of solvent. At higher concentrations of ethanol (e.g. 15 % w / w), the effective dose of CBD tends to decrease (Tables 1 and 2). Accordingly, a balance is to be struck between optimising solubility of the active ingredients (e.g. CBD) and amounts that can delivered by aerosol.

[0180] Solubility tests for CBD over varying temperature: The solubility of CBD in ethanol / 1 ,1 ,1 ,2-tetrafluoroethane (HFA 134a) was tested at two different temperatures (room temperature at 21 °C, and at fridge temperature at 5 °C). The data is shown in Figures 1 and 2, and Table 3 below. Table 3 - Solubility of CBD at 21 °C

[0181] These data demonstrate that the solubility of CBD in ethanol / 1 ,1 ,1 ,2-tetrafluoroethane (HFA 134a) was not significantly affected by refrigeration temperatures.

[0182] Example 2 - performance tests for optimising delivery of CBD / THC

[0183] Effect of changing CBD / THC amounts and ethanol on particle size and drug loading: The effect of changing concentration of CBD / THC and ethanol in the composition was investigated. The data is shown in Figure 3 and Table 4 below.

[0184] Table 4 - Vehicle-dependent effect on dose and particle mass

[0185] (FPD = fine particle dose)

[0186] These data demonstrate that an increase in concentration of CBD / THC (keeping the amount of ethanol / 1 ,1 ,1 ,2-tetrafluoroethane (HFA 134a) constant) leads to an increase in the particle diameter (Figure 3A). Thus, too high of a concentration of CBD / THC compared to the solvent (e.g. ethanol) can lead to a reduction in the proportion of particles that have a particle size of <5 pm. Particle sizes of <5 pm tend to be more suitable for delivery to the lower / upper respiratory tract, whereas larger particle sizes tend to be delivered to the oropharyngeal cavity.

[0187] Meanwhile, an increase in concentration of ethanol (keeping the amount of CBD / THC constant) leads to a decrease in the fine particle fraction (Figure 3B). Thus, too high of a concentration of solvent (e.g. ethanol) can also lead to a reduction in the proportion of particles that have a particle size of <5 pm.

[0188] At the same time, an increase in the concentration of ethanol (keeping the amount of CBD / THC constant) leads to an increase in drug loading (Figure 3C, Table 4). Thus, whilst a high concentration of solvent (e.g. ethanol) leads to a reduction of particles that have a particle size of <5 pm as mentioned above, it also improves overall drug loading properties.

[0189] Optimising solvent content for fine particle dose and fraction: The effect of changing the concentration of ethanol on the fine particle dose and fraction was investigated. The data is shown in Figure 4, and Tables 5 and 6 below.

[0190] Table 5 - Optimal particle size and API delivery for CBD over solvent content

[0191] (MMAD = median mass aerodynamic diameter; MDI = metered-dose inhaler)

[0192] Table 6 - Optimal particle size and API delivery for THC over solvent content

[0193] (MMAD = median mass aerodynamic diameter; MDI = metered-dose inhaler) The fine particle dose was maximised at concentrations of 7.5% w / w ethanol, generally in the region of -400 pg for both CBD and THC; however, the fine particle fraction steadily decreased at higher concentrations of ethanol. Thus, solvent concentrations (e.g. ethanol concentrations) that are close to 7.5% w / w appear to provide the best balance between fine particle dose and fine particle fraction, and as such, these compositions are most suited to delivery of CBD / THC by inhalation. In addition, such solvent concentrations seem to maintain a constant desired ratio of CBD / THC (e.g. 1 :1).

[0194] Optimising CBD / THC content for fine particle dose and fraction: The effect of changing the concentration of CBD / THC on the fine particle dose and fraction was investigated. The data is shown in Table 7 below.

[0195] Table 7 - Optimal particle size and API delivery for CBD / THC over API concentration

[0196] The fine particle dose was maximised at concentrations of 1 mg:1 mg CBD:THC, with no change when higher doses of CBD:THC were used (e.g. 2 mg:2 mg); however, the fine particle fraction decreased at higher concentrations of CBD:THC. Thus, total API concentrations (e.g. total CBD / THC concentrations) that are close to 2 mg combined mass appear to provide the best balance between fine particle dose and fine particle fraction, and as such, these compositions are most suited to delivery of CBD / THC by inhalation. Example 3 - consistency and stability testing

[0197] The following composition was used for consistency and stability testing (Table 8), based on the results in Example 2:

[0198] Table 8 - Composition components

[0199] (API = active pharmaceutical ingredient) Consistency testing over lifetime: The consistency of the dosing for the composition (7.5% w / w ethanol) was tested from the BOL (beginning of life) to the EOL (end of life). The data is shown in Figure 5, and Tables 9 and 10 below.

[0200] Table 9 - Aerodynamic particle size distribution (APSD) of CBD over lifetime

[0201] Table 10 - Aerodynamic particle size distribution (APSD) of THC (DBN in table) over lifetime

[0202] The specification requirements for the metered-dose inhaler were to achieve a consistent fine particle dose of 352-476 pg and fine particle fraction of 45-61%. The mean fine particle doses for both CBD (411 pg) and THC (411 pg) were found to satisfy these specification requirements, and the maximum (442 pg for CBD; 436 pg for THC) and minimum (393 pg for CBD; 401 pg for THC) fine particle doses also were well within these limits (Tables 9 and 10). Furthermore, the mean fine particle fraction for both CBD (52%) and THC (52%) were found to satisfy these specification requirements, and the maximum (54% for CBD; 54% for THC) and minimum (49% for CBD; 49% for THC) fine particle fractions also were well within these limits (Tables 9 and 10). No significant change in properties were found between the BOL and EOL (Figure 5). Furthermore, the fine particle doses and fractions for CBD and THC were essentially identical, providing a constant desired ratio of CBD:THC (e.g. 1 :1)

[0203] Overall, these data show that solvent concentrations (e.g. ethanol concentrations) that are close to 7.5% w / w provide highly consistent fine particle doses and fine particle fractions over the lifetime of the metered-dose inhaler, as well as maintaining a constant ratio of CBD / THC throughout the lifetime.

[0204] Consistency testing over batches: The variability in dose delivered over different batches was tested. The data is shown in Figures 6 and 7.

[0205] For all batches, the BOB (beginning of batch) and the EOB (end of batch) doses all stayed within ±25% of the average dose, indicating that there was high consistency between batches and actuations for both CBD (Figure 6A) and THC (Figure 6B). There was also high consistency in shot weight between different actuations for the BOB (beginning of batch), MOB (middle of batch) and EOB (end of batch) (Figure 7).

[0206] Overall, these data show that solvent concentrations (e.g. ethanol concentrations) that are close to 7.5% w / w also provide highly consistent doses and shot weight across different batches and actuations. Stability testing: The stability of the composition (7.5% w / w ethanol) was tested over 3 months under accelerated degradation conditions (40 °C). This data is shown in Table 11 below.

[0207] Table 11 - Stability over 3 months at 40 °C

[0208] The content of CBD and THC stayed relatively high despite the accelerated degradation conditions. Overall, these data show that solvent concentrations (e.g. ethanol concentrations) that are close to 7.5% w / w also provide good stability and dose durability.

[0209] Example 4 - rat tail-flick study

[0210] In vivo testing: Rats were subjected to a tail-flick study using various ratios and concentrations of CBD:THC (Groups 2 to 7), as shown in Table 12 below. Standard vehicle was used as negative control (Group 1), whilst pregabalin was used as positive control (Group 8). The data is shown in Figure 8.

[0211] Table 12 - In vivo testing conditions for each rat patient group

[0212] (IP = intraperitoneal) Under the conditions of this in vivo study, treatment with CBD:THC at different concentrations affected the latency response without an obvious acute toxic reaction, indicating an analgesic effect. In particular, at a 1 :1 ratio of CBD:THC, the reaction was more pronounced than the positive control pregabalin.

[0213] In summary, the Examples show that particular concentrations of API (combined mass of CBD and THC) and concentrations of solvent (e.g. ethanol) in cannabinoid compositions lead to an optimal balance between fine particle dose and fine particle fraction. These compositions are thus more suited for delivery by inhalation. Such cannabinoid compositions also display other advantageous characteristics, such as good stability and dose durability, lifecycle consistency and batch consistency. Furthermore, various concentrations of API are shown to have efficacy for pain management.

[0214] Clauses

[0215] The present invention may be defined by reference to the following clauses:

[0216] Clause 1. A composition, comprising: cannabidiol (CBD) and / or (-)-trans-A9-tetrahydrocannabinol (THC); and a pharmaceutically acceptable carrier.

[0217] Clause 2. A composition for use in an inhalation device, comprising: cannabidiol (CBD) and / or (-)-trans-A9-tetrahydrocannabinol (THC); and a pharmaceutically acceptable carrier.

[0218] Clause 3. A composition according to clause 1 or clause 2, wherein the composition comprises: cannabidiol (CBD); and

[0219] (-)-trans-A9-tetrahydrocannabinol (THC); and a pharmaceutically acceptable carrier. Clause 4. A composition according to any one of clauses 1 to 3, wherein the pharmaceutically acceptable carrier comprises a solvent.

[0220] Clause 5. A composition according to clause 4, wherein a content of the solvent is at least about 2 wt%, preferably at least about 3 wt%, more preferably at least about 4 wt%, even more preferably at least about 5 wt%, yet even more preferably at least about 6 wt%, or most preferably at least about 7 wt%, based on a total wt% content of the composition.

[0221] Clause 6. A composition according to clause 4 or clause 5, wherein a content of the solvent is about 2 wt% to about 20 wt%, preferably about 3 wt% to about 15 wt%, more preferably about 4 wt% to about 12 wt%, even more preferably about 5 wt% to about 10 wt%, yet even more preferably about 6 wt% to about 9 wt%, or most preferably about 7 wt% to about 8 wt%, based on a total wt% content of the composition.

[0222] Clause 7. A composition according to clause 4 or clause 5, wherein a content of the solvent is about 6 wt% to about 20 wt% based on a total wt% content of the composition.

[0223] Clause 8. A composition according to any one of clauses 4 to 7, wherein a wt% ratio of solvent:CBD is about 1 :1 to about 20:1 , preferably about 2:1 to about 15:1 , more preferably about 3: 1 to about 10:1 , even more preferably about 4: 1 to about 8: 1 , yet even more preferably about 5:1 to about 7:1 , or most preferably about 5.5:1 to about 6:1.

[0224] Clause . A composition according to any one of clauses 4 to 8, wherein a wt% ratio of solvent:THC is about 1 :1 to about 20:1 , preferably about 2:1 to about 15:1 , more preferably about 3:1 to about 10:1 , even more preferably about 4:1 to about 8:1 , yet even more preferably about 5:1 to about 7:1 , or most preferably about 5.5:1 to about 6:1.

[0225] Clause 10. A composition according to any one of clauses 4 to 9, wherein a wt% ratio of solvent:(CBD+THC) is about 0.5:1 to about 10:1 , preferably about 1 :1 to about 7.5:1 , more preferably about 1.5:1 to about 15:1 , even more preferably about 2:1 to about 4:1 , yet even more preferably about 2.5:1 to about 3.5:1 , or most preferably about 2.75:1 to about 3:1. Clause H . A composition according to any one of clauses 4 to 10, wherein the solvent is an organic solvent.

[0226] Clause 12. A composition according to any one of clauses 4 to 11 , wherein the solvent is an alcohol.

[0227] Clause 13. A composition according to any one of clauses 4 to 12, wherein the solvent is a C1-C12 alkyl alcohol.

[0228] Clause 14. A composition according to any one of clauses 4 to 13, wherein the solvent is ethanol.

[0229] Clause 15. A composition according to any one of clauses 4 to 14, wherein the solvent is anhydrous.

[0230] Clause 16. A composition according to any one of clauses 4 to 15, wherein the solvent comprises less than 0.1 wt% water, preferably less than 0.05 wt% water, more preferably less than 0.02 wt% water, or even more preferably less than 0.01 wt% water, based on a total wt% content of the solvent.

[0231] Clause 17. A composition according to any one of clauses 1 to 16, wherein the pharmaceutically acceptable carrier comprises a propellant.

[0232] Clause 18. A composition according to clause 17, wherein a content of the propellant is at least about 50 wt%, preferably at least about 60 wt%, more preferably at least about 70 wt%, even more preferably at least about 80 wt%, yet even more preferably at least about 82 wt%, or most preferably at least about 85 wt%, based on a total wt% content of the composition.

[0233] Clause 19. A composition according to clause 17 or clause 18, wherein a content of the propellant is about 50 wt% to about 99.5 wt%, preferably about 60 wt% to about 99 wt%, more preferably about 70 wt% to about 98 wt%, even more preferably about 80 wt% to about 97 wt%, yet even more preferably about 82 wt% to about 96 wt%, or most preferably about 85 wt% to about 95 wt%, based on a total wt% content of the composition. Clause 20. A composition according to any one of clauses 17 to 19, wherein a wt% ratio of propellant:CBD is about 10:1 to about 100: 1 , preferably about 20: 1 to about 90: 1 , more preferably about 30:1 to about 85:1 , even more preferably about 40:1 to about 80:1 , yet even more preferably about 50:1 to about 75:1 , or most preferably about 60:1 to about 70:1.

[0234] Clause 21 . A composition according to any one of clauses 17 to 20, wherein a wt% ratio of propellant:THC is about 10:1 to about 100: 1 , preferably about 20: 1 to about 90: 1 , more preferably about 30:1 to about 85:1 , even more preferably about 40:1 to about 80:1 , yet even more preferably about 50:1 to about 75:1 , or most preferably about 60:1 to about 70:1.

[0235] Clause 22. A composition according to any one of clauses 17 to 21 , wherein a wt% ratio of propellant:(CBD+THC) is about 5:1 to about 50:1 , preferably about 10:1 to about 45:1 , more preferably about 15:1 to about 42.5:1 , even more preferably about 20:1 to about 40:1 , yet even more preferably about 25:1 to about 37.5:1 , or most preferably about 30: 1 to about 35: 1 .

[0236] Clause 23. A composition according to any one of clauses 17 to 22, wherein the propellant is selected from a hydrofluorocarbon, a hydrochlorofluorocarbon, chlorofluorocarbon, a hydrocarbon, an ether, or a combination thereof.

[0237] Clause 24. A composition according to any one of clauses 17 to 23, wherein the propellant is a hydrofluorocarbon.

[0238] Clause 25. A composition according to any one of clauses 17 to 24, wherein the propellant is 1 ,1 ,1 ,2-tetrafluoroethane.

[0239] Clause 26. A composition according to any one of clauses 1 to 25, wherein the pharmaceutically acceptable carrier comprises a solvent and a propellant, and a wt% ratio of solventpropellant is about 5:1 to about 25:1 , preferably about 7:1 to about 20:1 , more preferably about 8:1 to about 18:1 , even more preferably about 9:1 to about 16:1 , yet even more preferably about 10:1 to about 15:1 , or most preferably about 11 :1 to about 14:1. Clause 27. A composition according to any one of clauses 1 to 26, wherein a content of the CBD is at least about 0.1 wt%, preferably at least about 0.25 wt%, more preferably at least about 0.5 wt%, even more preferably at least about 0.75 wt%, yet even more preferably at least about 1.0 wt%, or most preferably at least about 1 .3 wt%, based on a total wt% content of the composition.

[0240] Clause 28. A composition according to any one of clauses 1 to 27, wherein a content of the CBD is about 0.1 wt% to about 5.0 wt%, preferably about 0.25 wt% to about 3.0 wt%, more preferably about 0.5 wt% to about 2.0 wt%, even more preferably about 0.75 wt% to about 1.75 wt%, yet even more preferably about 1.0 wt% to about 1.5 wt%, or most preferably about 1.3 wt% to about 1.4 wt%, based on a total wt% content of the composition.

[0241] Clause 29. A composition according to any one of clauses 1 to 28, wherein a content of the THC is at least about 0.1 wt%, preferably at least about 0.25 wt%, more preferably at least about 0.5 wt%, even more preferably at least about 0.75 wt%, yet even more preferably at least about 1 .0 wt%, or most preferably at least about 1 .3 wt%, based on a total wt% content of the composition.

[0242] Clause 30. A composition according to any one of clauses 1 to 29, wherein a content of the THC is about 0.1 wt% to about 5.0 wt%, preferably about 0.25 wt% to about 3.0 wt%, more preferably about 0.5 wt% to about 2.0 wt%, even more preferably about 0.75 wt% to about 1.75 wt%, yet even more preferably about 1.0 wt% to about 1.5 wt%, or most preferably about 1.3 wt% to about 1.4 wt%, based on a total wt% content of the composition.

[0243] Clause 31. A composition according to any one of clauses 1 to 30, wherein a wt% ratio of CBD:THC is about 6:1 to about 1 :6, preferably about 3:1 to about 1 :3, more preferably about 2:1 to about 1 :2, even more preferably about 1.5:1 to about 1 :1.5, yet even more preferably about 1.2:1 to about 1 :1.2, or most preferably about 1 :1.

[0244] Clause 32. A composition according to any one of clauses 1 to 31 , wherein a combined content of the CBD and THC is at least about 0.2 wt%, preferably at least about 0.5 wt%, more preferably at least about 1.0 wt%, even more preferably at least about 1.5 wt%, yet even more preferably at least about 2.0 wt%, or most preferably at least about 2.6 wt%, based on a total wt% content of the composition.

[0245] Clause 33. A composition according to any one of clauses 1 to 32, wherein a combined content of the CBD and THC is about 0.2 wt% to about 10 wt%, preferably about 0.5 wt% to about 6.0 wt%, more preferably about 1 .0 wt% to about 4.0 wt%, even more preferably about 1.5 wt% to about 3.5 wt%, yet even more preferably about 2.0 wt% to about 3.0 wt%, or most preferably about 2.6 wt% to about 2.8 wt%, based on a total wt% content of the composition.

[0246] Clause 34. A composition according to any one of clauses 1 to 33, wherein a content of the pharmaceutically acceptable carrier is at least about 50 wt%, preferably at least about 60 wt%, more preferably at least about 70 wt%, even more preferably at least about 80 wt%, yet even more preferably at least about 90 wt%, or most preferably at least about 95 wt%, based on a total wt% content of the composition.

[0247] Clause 35. A composition according to any one of clauses 1 to 34, wherein a content of the pharmaceutically acceptable carrier is about 50 wt% to about 99.5 wt%, preferably about 60 wt% to about 99 wt%, more preferably about 70 wt% to about 98.5 wt%, even more preferably about 80 wt% to about 98 wt%, yet even more preferably about 90 wt% to about 97.8 wt%, or most preferably about 95 wt% to about 97.5 wt%, based on a total wt% content of the composition.

[0248] Clause 36. A composition according to any one of clauses 1 to 35, wherein a wt% ratio of pharmaceutically acceptable carrierCBD is about 20: 1 to about 500: 1 , preferably about 30:1 to about 250:1 , more preferably about 50:1 to about 150:1 , even more preferably about 55: 1 to about 100: 1 , yet even more preferably about 65: 1 to about 90: 1 , or most preferably about 70:1 to about 75:1.

[0249] Clause 37. A composition according to any one of clauses 1 to 36, wherein a wt% ratio of pharmaceutically acceptable carrierTHC is about 20:1 to about 500:1 , preferably about 30:1 to about 250:1 , more preferably about 50:1 to about 150:1 , even more preferably about 55: 1 to about 100: 1 , yet even more preferably about 65: 1 to about 90: 1 , or most preferably about 70:1 to about 75:1. Clause 38. A composition according to any one of clauses 1 to 37, wherein a wt% ratio of pharmaceutically acceptable carrier: (CBD+THC) is about 10:1 to about 250:1 , preferably about 15:1 to about 125:1, more preferably about 25:1 to about 75:1, even more preferably about 27.5:1 to about 50:1, yet even more preferably about 32.5:1 to about 45: 1 , or most preferably about 35: 1 to about 37.5: 1.

[0250] Clause 39. A composition according to any one of clauses 1 to 38, wherein the composition comprises less than 0.1 wt% water, preferably less than 0.05 wt% water, more preferably less than 0.02 wt% water, or even more preferably less than 0.01 wt% water, based on a total wt% content of the composition.

[0251] Clause 40. A composition according to any one of clauses 1 to 39, for use as a medicament.

[0252] Clause 41. A composition according to any one of clauses 1 to 39, for use in the treatment or prophylaxis of pain.

[0253] Clause 42. Use of a composition according to any one of clauses 1 to 40 in the manufacture of a medicament.

[0254] Clause 43. Use of a composition according to any one of clauses 1 to 39 in the manufacture of a medicament for the treatment or prophylaxis of pain.

[0255] Clause 44. A method for the treatment or prophylaxis of pain comprising administering an effective amount of a composition according to any one of clauses 1 to 39 to a subject in need thereof.

[0256] Clause 45. A kit comprising a composition according to any one of clauses 1 to 39 and instructions for use in the composition in the treatment or prophylaxis of pain.

[0257] Clause 46. A pressurised canister comprising a composition according to any one of clauses 1 to 39.

[0258] Clause 47. A kit comprising a pressurised canister according to clause 46 and an inhalation device configured to receive the pressurised canister. Clause 48. An inhalation device comprising a composition according to any one of clauses 1 to 39 or a pressurised canister according to clause 46. Clause 49. An inhalation device according to clause 48, wherein the inhalation device is an inhaler.

[0259] Clause 50. An inhalation device according to clause 49, wherein the inhaler is a metered-dose inhaler.

Claims

CLAIMS:1 . A composition for use in an inhalation device, comprising: cannabidiol (CBD) and / or (-)-trans-A9-tetrahydrocannabinol (THC); and a pharmaceutically acceptable carrier.

2. A composition according to claim 1 , wherein the composition comprises: cannabidiol (CBD);(-)-trans-A9-tetrahydrocannabinol (THC); and a pharmaceutically acceptable carrier.

3. A composition according to claim 1 or claim 2, wherein the pharmaceutically acceptable carrier comprises a solvent.

4. A composition according to claim 3, wherein:(i) a content of the solvent is at least about 2 wt%, preferably at least about 3 wt%, more preferably at least about 4 wt%, even more preferably at least about 5 wt%, yet even more preferably at least about 6 wt%, or most preferably at least about 7 wt%, based on a total wt% content of the composition; or(ii) a content of the solvent is about 2 wt% to about 20 wt%, preferably about 3 wt% to about 15 wt%, more preferably about 4 wt% to about 12 wt%, even more preferably about 5 wt% to about 10 wt%, yet even more preferably about 6 wt% to about 9 wt%, or most preferably about 7 wt% to about 8 wt%, based on a total wt% content of the composition.

5. A composition according to claim 3 or claim 4, wherein a content of the solvent is about 6 wt% to about 20 wt% based on a total wt% content of the composition.

6. A composition according to any one of claims 3 to 5, wherein:(i) a wt% ratio of solvent:CBD is about 1 :1 to about 20:1 , preferably about 2:1 to about 15:1 , more preferably about 3:1 to about 10:1 , even more preferably about 4:1 to about 8:1 , yet even more preferably about 5:1 to about 7:1 , or most preferably about 5.5:1 to about 6:1 ; and / or(ii) a wt% ratio of solvent:THC is about 1 :1 to about 20:1 , preferably about 2:1 to about 15:1 , more preferably about 3:1 to about 10:1 , even more preferablyabout 4:1 to about 8:1 , yet even more preferably about 5:1 to about 7:1 , or most preferably about 5.5: 1 to about 6: 1.

7. A composition according to any one of claims 3 to 6, wherein a wt% ratio of solvent:(CBD+THC) is about 0.5:1 to about 10:1 , preferably about 1 :1 to about 7.5:1 , more preferably about 1.5:1 to about 15:1 , even more preferably about 2:1 to about 4:1 , yet even more preferably about 2.5:1 to about 3.5:1 , or most preferably about 2.75:1 to about 3:1.

8. A composition according to any one of claims 3 to 7, wherein the solvent is an organic solvent; preferably wherein the solvent is an alcohol; more preferably wherein the solvent is a C1-C12 alkyl alcohol; even more preferably wherein the solvent is ethanol.

9. A composition according to any one of claims 1 to 8, wherein:(i) a content of the CBD is at least about 0.1 wt%, preferably at least about 0.25 wt%, more preferably at least about 0.5 wt%, even more preferably at least about 0.75 wt%, yet even more preferably at least about 1.0 wt%, or most preferably at least about 1.3 wt%, based on a total wt% content of the composition; or(ii) a content of the CBD is about 0.1 wt% to about 5.0 wt%, preferably about 0.25 wt% to about 3.0 wt%, more preferably about 0.5 wt% to about 2.0 wt%, even more preferably about 0.75 wt% to about 1.75 wt%, yet even more preferably about 1 .0 wt% to about 1.5 wt%, or most preferably about 1 .3 wt% to about 1 .4 wt%, based on a total wt% content of the composition.

10. A composition according to any one of claims 1 to 9, wherein:(i) a content of the THC is at least about 0.1 wt%, preferably at least about 0.25 wt%, more preferably at least about 0.5 wt%, even more preferably at least about 0.75 wt%, yet even more preferably at least about 1.0 wt%, or most preferably at least about 1.3 wt%, based on a total wt% content of the composition; or(ii) a content of the THC is about 0.1 wt% to about 5.0 wt%, preferably about 0.25 wt% to about 3.0 wt%, more preferably about 0.5 wt% to about 2.0 wt%, even more preferably about 0.75 wt% to about 1.75 wt%, yet even morepreferably about 1 .0 wt% to about 1.5 wt%, or most preferably about 1 .3 wt% to about 1 .4 wt%, based on a total wt% content of the composition.

11. A composition according to any one of claims 1 to 10, wherein a wt% ratio of CBD:THC is about 6:1 to about 1 :6, preferably about 3:1 to about 1 :3, more preferably about 2:1 to about 1 :2, even more preferably about 1.5:1 to about 1 :1.5, yet even more preferably about 1.2:1 to about 1 :1.2, or most preferably about 1 :1.

12. A composition according to any one of claims 1 to 11 , wherein:(i) a combined content of the CBD and THC is at least about 0.2 wt%, preferably at least about 0.5 wt%, more preferably at least about 1.0 wt%, even more preferably at least about 1 .5 wt%, yet even more preferably at least about 2.0 wt%, or most preferably at least about 2.6 wt%, based on a total wt% content of the composition; or(ii) a combined content of the CBD and THC is about 0.2 wt% to about 10 wt%, preferably about 0.5 wt% to about 6.0 wt%, more preferably about 1 .0 wt% to about 4.0 wt%, even more preferably about 1 .5 wt% to about 3.5 wt%, yet even more preferably about 2.0 wt% to about 3.0 wt%, or most preferably about 2.6 wt% to about 2.8 wt%, based on a total wt% content of the composition.

13. A composition according to any one of claims 1 to 12, for use in the treatment or prophylaxis of pain.

14. A pressurised canister comprising a composition according to any one of claims 1 to 12.

15. A kit comprising a pressurised canister according to claim 14 and an inhalation device configured to receive the pressurised canister.

16. An inhalation device comprising a composition according to any one of claims 1 to 12 or a pressurised canister according to claim 12.

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