WO2022174323A1

WO2022174323A1 - Clear cannabis-based nanoemulsion

Info

Publication number: WO2022174323A1
Application number: PCT/CA2021/050182
Authority: WO
Inventors: Jordan Thomas SILVER; Soheila HONARIKEZRBEIGI
Original assignee: CannTrust Inc.
Priority date: 2021-02-19
Filing date: 2021-02-19
Publication date: 2022-08-25

Abstract

Cannabis-based clear nanoemulsions and methods of preparing cannabis-based nanoemulsions without a homogenizer are described. In an aspect, a method of preparing a cannabis-based nanoemulsion includes combining a surfactant preparation with a cannabis-based preparation to create a mixture; combining the mixture with a solvent to create an organic phase; adding the organic phase to an aqueous phase; and evaporating the solvent. In another aspect, a phase inversion method of preparing a nanoemulsion is described.

Description

Clear Cannabis-Based Nanoemulsion

TECHNICAL FIELD

[OOOl] The present disclosure relates to cannabis and, more particularly, to cannabis products and preparations such as cannabis-based nanoemulsions and products prepared using such nanoemulsions.

BACKGROUND

[0002] Cannabinoids, such as tetrahydrocannabinol (THC) and cannabidiol (CBD), cannabinol (CBN) cannabigerol (CBG), tetrahydrocannabivarin (THCV), tetrahydrocannabinolic acid (THCA), tetrahydrocannabiphorol (THCP), tetrahydrocannabiorcol (THCC), cannabidiolic acid (CBDA), cannabivarin (CBV), cannabichromene (CBC) but not limited to this, cannabinoid extracts and other cannabis constituents, such as terpenes, are sometimes used for the treatment of various medical conditions. However, since cannabinoids and terpenes are strongly hydrophobic materials, water solubibty may present challenges when creating cannabinoid formulations. [0003] One strategy for solubilizing water-insoluble cannabinoids is oil in water nanoemulsion. Cannabinoid emulsification is typically a high-energy process such as high-pressure homogenization, microfluidization or ultrasound energy. Such techniques are complicated and require expensive and complicated machinery. Further, such techniques tend to be slow and can cause the active ingredients to become unstable. [0004] Thus, there is a need for improved techniques for creating cannabis-based nanoemulsions.

BRIEF DESCRIPTION OF THE DRAWINGS

[0005] Reference will now be made, by way of example, to the accompanying drawings which show embodiments of the present application, and in which: [0006] FIG. 1 is a flowchart of an example method of preparing a cannabis-based nanoemulsion in accordance with the present disclosure;

[0007] FIG. 2 is a graph illustrating the size distribution of droplets for a THC nanoemulsion; [0008] FIG. 3 is a graph illustrating the size distribution of droplets for a hemp oil nanoemulsion;

[0009] FIG. 4 is a graph illustrating the size distribution of droplets for a crystallized CBD nanoemulsion;

[0010] FIG. 5 is a graph illustrating the size distribution of droplets for a CBD resin distillate nanoemulsion;

[0011] FIG. 6 is a graph illustrating the size distribution of droplets for a CBD resin distillate and crystallized CBD nanoemulsion (1:1 ratio);

[0012] FIG. 7 is a graph illustrating the size distribution of droplets for a CBD resin distillate and crystallized CBD nanoemulsion (1:0.5 ratio); [0013] FIG. 8 is a flowchart of an example method of preparing a cannabis-based nanoemulsion in accordance with the present disclosure; and

[0014] FIG. 9 is a graph illustrating the size distribution of droplets for hemp oil in accordance with the present disclosure.

[0015] Like reference numerals are used in the drawings to denote like elements and features.

DETAILED DESCRIPTION OF EXAMPLE EMBODIMENTS

[0016] In an aspect a method of preparing a cannabis-based nanoemulsion is described. In an aspect, the method may include: combining a surfactant preparation with a cannabis-based preparation to create a mixture; combining the mixture with a solvent to create an organic phase; adding the organic phase to an aqueous phase; and evaporating the solvent. This method may be referred to as a spontaneous nanoemulsification method. [0017] The surfactant preparation may include polysorbate 80. The surfactant preparation may include poloxamer 407. For example, the surfactant preparation may include polysorbate 80 and poloxamer 407 in a ratio of between 3 parts polysorbate 80 to 0.75 part poloxamer 407 (3:0.75) and 4 parts polysorbate 80 to 1 part poloxamer 407 (4:1). [0018] The surfactant preparation may include a co- surfactant. The co-surfactant may be diethylene glycol monoethyl ether. The co-surfactant may be combined in the surfactant preparation with one or more surfactants in a ratio of between 4.5 parts surfactant to 0.75 parts co-surfactant and 5 parts surfactant to 1.6 parts co-surfactant. [0019] The cannabis-based preparation may include one or more of: tetrahydrocannabinol (TF1C) distilled resin; hemp oil; cannabidiol (CBD) distilled resin; [0020] cannabidiol (CBD) distilled crystalline; or terpenes.

[0021] The cannabis-based preparation may include an antioxidant. The antioxidant may be alpha tocopherol. The cannabis-based preparation may include alpha tocopherol without any other oily carrier.

[0022] In at least some implementations, the solvent used in the method may be water- miscible. The solvent may, for example, be ethanol or acetone.

[0023] In some implementations, the method may include, prior to adding the organic phase to the aqueous phase, filtering the mixture. The filtering may be performed using a 0.22 to 0.45 micrometer membrane filter.

[0024] In some implementations, the method may include, prior to adding the organic phase to the aqueous phase, preparing the aqueous phase by combining a preservative with water. The preservative may be benzoic acid, a benzoic acid derivative, cetylpyridium chloride or sorbic acid [0025] In some implementations, the organic phase may be added to the aqueous phase in a dropwise manner.

[0026] In some implementations, the organic phase may be added to the aqueous phase at a rate of not faster than 1.4 mL per minute to make lOOmL batch of concentrated nanoemulsion.

[0027] In some implementations, the mixture organic phase be added to the aqueous phase using a peristaltic pump.

[0028] In some implementations, the cannabis-based nanoemulsion may be prepared without the use of any of a homogenizer, sonicator and microfluidizer. [0029] Also described is a cannabis-based nanoemulsion produced according to the described methods.

[0030] In another aspect, the present application describes a further method of preparing a cannabis-based nanoemulsion. The further method may include: preparing a surfactant preparation by melting one or more surfactants; combining the surfactant preparation with a cannabis-based preparation to create an organic phase; and adding an aqueous phase to the organic phase. Such a method may be referred to as a phase inversion method.

[0031] In some implementations, preparing the surfactant preparation may include, after melting, stirring the melted surfactants until the surfactant preparation becomes clear. [0032] In some implementations, preparing the surfactant preparation may include, after the surfactant becomes clear, cooling the surfactant to room temperature prior to adding the aqueous phase to the organic phase.

[0033] In some implementations, the one or more surfactants may include polysorbate 80. Ins some implementations, the one or more surfactants includes poloxamer 407. [0034] In some implementations the one or more surfactants includes polysorbate 80 and poloxamer 407 in a ratio of between 3 parts polysorbate 80 to 0.75 part poloxamer 407 (3:0.75) and four parts polysorbate 80 to one part poloxamer 407 (4:1).

[0035] The cannabis-based preparation may be a terpene-based preparation.

[0036] In some implementations, the method may include, prior to adding the aqueous phase to the organic phase, preparing the aqueous phase by combining a preservative with water. The preservative may be benzoic acid, a benzoic acid derivative, cetylpyridium chloride or sorbic acid.

[0037] The aqueous phase may be added to the organic phase in a dropwise manner. For example, the aqueous phase may be added to the organic phase at a rate of not faster than 1.4 mL per minute to make 100 mL batch of concentrated nanoemulsion. The aqueous phase may be added to the organic phase using a peristaltic pump.

[0038] The cannabis-based nanoemulsion may be prepared without the use of any of a homogenizer, sonicator and microfluidizer.

[0039] Also described is a cannabis-based nanoemulsion produced according to the described methods.

[0040] Conveniently, nanoemulsions prepared according to the described techniques may be clear nanoemulsions. Further, such nano-emulsions may be prepared without using a homogenizer. The described techniques may allow nanoemulsions to be prepared at a low cost and without the need for specialized equipment, such as a homogonizer. [0041 ] Nanoemulsions produced using techniques described herein may, for example, be diluted in a matrix of choice. For example, nanoemulsions may be used in beverages, sublingual strips, nasal sprays, cosmetics, or topical products. By way of example, one milliliter of a 1% stock solution of nanoemulsion may be diluted with a 354 milliliter beverage to produce a 355 milliliter beverage with 10 milligrams of cannabinoid. [0042] Reference is first made to FIG. 1, which illustrates a method 100 of preparing a cannabis-based nanoemulsion. The method 100 may, in at least some embodiments, be used to create a clear nanoemulsion. That is, the nanoemulsion obtained using the method 100 may be transparent. For example, the nanoemulsion may be clear and may resemble water in appearance.

[0043] The method 100 may, in at least some embodiments, be used to produce a cannabis-based nanoemulsion that has small droplet sizes. A small droplet size may enhance the bioavailability of the nanoemulsion.

[0044] For example, the nanoemulsion may have droplets in a diameter range that is less than 100 nanometers.

[0045] At step 102, a surfactant preparation is combined with a cannabis-based preparation to create a mixture. The surfactant preparation may include polysorbate 80. The surfactant preparation may include poloxamer 407. In at least some embodiments, the surfactant preparation includes polysorbate 80 and poloxamer 407 in a ratio of between 3 parts polysorbate 80 to one part poloxamer 407 (3:1) to four parts polysorbate 80 to one part poloxamer 407 (4:1). In at least some embodiments, the surfactant preparation includes polysorbate 80 and poloxamer 407 in a ratio of between three parts polysorbate 80 to 0.75 parts poloxamer 407 and four parts polysorbate 80 to one part poloxamer 407 (4:1).

[0046] The total percent surfactant is preferentially 5% w/v or more in the final non- diluted solution. However, 5% to 10% w/v may, for example, be used to generate a concentrated nanoemulsion containing more than 1% active substance.

[0047] In at least some embodiments, the surfactant preparation includes a co surfactant. The co-surfactant may be a diethylene glycol derivative such as ethylene- series of glycol ether; for example, a diethylene glycol monoethyl ether such as Transcutol HP(TM) or Carbitol. The co-surfactant may take other forms. The co-surfactant may be combined in the surfactant preparation with the one or more surfactants in a ratio of between 4.5 parts surfactant to 0.75 parts co-surfactant and 5 parts surfactant to 1.6 parts co-surfactant.

[0048] In at least some embodiments, a concentrated nanoemulsion produced according to a method described herein may preferentially contain: 0.5% to 1% w/v active substance, 5% surfactant and 94% water. Higher concentrations of surfactant may be used to load more active substance.

[0049] The surfactants described above have been found to create a clear nanoemulsion when used according to the techniques described herein. Other surfactants may be used to create a nanoemulsion having a small droplet size, but at least some such surfactants may not yield a clear nanoemulsion.

[0050] For example, other forms of polysorbates and/or poloxomers may be used instead of or in addition to polysorbate 80 and poloxamer 407. For example, the surfactant preparation may contain any of polysorbates 20, 40, 60, 80, 85 and/or any of poloxamers 105, 188, 238, 331, 333, 334, 335, 338, 407 and/or any of and polyethylene glycols 200, 300, 400, 600.

[0051] The cannabis-based preparation may be or include tetrahydrocannabinol (THC) resin. Additionally or alternatively, the cannabis-based preparation may be or include hemp oil, cannabidiol (CBD) resin, cannabidiol (CBD) or THC distilled, THC or CBD crystalline, any kinds of rare cannabinoids such as but not limited to cannabinol (CBN), cannabigerol (CBG), tetrahydrocannabivarin (THCV), tetrahydrocannabinolic acid (THCA), tetrahydrocannabiphorol (THCP), Tetrahydrocannabinol (THCC), cannabidiolic acid (CBDA), cannabivarin (CBV), cannabichromene (CBC) and combinations thereof and/or terpenes. [0052] The cannabis-based preparation may include an antioxidant. The antioxidant may be or include alpha tocopherol (which may also be referred to as Vitamin E). Other antioxidants may be used instead of or in addition to alpha tocopherol. For example, the cannabis-based preparation may include any one or a combination of: ascorbyl palmitate, butylated hydroxytoluene, or butylated hydroxyanisole.

[0053] In at least some embodiments, the cannabis preparation includes alpha tocopherol without any other oily carrier. Alpha tocopherol may be added to prevent oxidation. The amount of alpha tocopherol may, for example, be approximately 0.04% by volume of the amount of the cannabis-based preparation, but the concentration may be varied.

[0054] At step 104, an organic phase is prepared. More specifically, the mixture created at step 102 is combined with a solvent.

[0055] For example, the mixture may be dissolved in a water miscible solvent such as ethanol or acetone. Ethanol has been used for reasons of volatility and safety but other solvents may be used. In some embodiments, the mixture may be dissolved in ethanol which is, conveniently, safe to use and easy to evaporate.

[0056] At step 106, the mixture that includes the solvent is passed through a filter to remove insoluble material. The mixture may be passed through a 0.22 to 0.45 micrometer membrane filter. Any material separated out by the filter may be discarded.

[0057] At step 108, an aqueous phase is prepared. The aqueous phase is prepared by measuring an appropriate volume of water by calculating the volume of all ingredients based on the formulation and then calculating an amount of water required for the formulation. A chelating agent and a preservative may be included in the aqueous phase. For example, Ethylenediaminetetraacetic acid (EDTA) is a chelating agent that can chelate a small amount of metal to prevent oxidation and increase the effects of the antioxidant. The preservative may, for example, be benzoic acid or sorbic acid. Other preservatives may be used. By way of example, the preservative may be any one or a combination of: 1) Sorbic acid and its salts like sodium sorbate, potassium sorbate; 2) Benzoic acid and Benzoic acid derivatives like sodium benzoate; 3) Parabens: Methyl paraben, Propyl paraben; 4) Benzalkonium chloride; and 5) Cetylpryidinium bromide [0058] EDTA may have a concentration of approximately 0.005% to 0.01% and the benzoic acid may have a concentration of approximately 0.02% to 0.5% and the sorbic acid may have a concentration of 0.1 -0.2%.

[0059] At step 110, the organic phase (i.e. the mixture that includes the solvent) is slowly added to the aqueous phase (e.g., in a dropwise manner). The organic phase is added to the aqueous phase dropwise, preferably at a rate of no faster than 1.4 milliliters per minute (organic phase) to make 100 milliliter batch of concentrated nanoemulsion. If the organic phase is added to the aqueous phase too rapidly, there may not be enough time for the solvent to diffuse into the water which may result in a final product having a larger droplet size and/or that may not be clear.

[0060] The organic phase may be added to the aqueous phase using a peristaltic pump, a syringe or mist. The organic phase may be added to the aqueous phase under stirring. The stirring may, for example, be performed with any kind of mechanical agitator. [0061] After the organic phase is completely added to the aqueous phase, stirring may continue to ensure diffusion of the organic phase is complete. For example, stirring may continue for thirty minutes or more.

[0062] At step 112, evaporation is performed on the mixture that includes the organic phase and the aqueous phase. For example, the water miscible solvent, such as ethanol or acetone, may be evaporated at 35 to 40 degrees Celsius by rotary evaporator. The evaporation may continue for 30 minutes or more. The evaporation step may end when all of the solvent is evaporated. While the evaporation step could continue even after the solvent is completely removed, continuing the evaporation after the solvent is removed may have an adverse effect on stability of the nanoemulsion and/or may unnecessarily use energy or equipment.

[0063] At step 114, the volume of the mixture remaining after evaporation may be measured and water may be added to adjust the volume. For example, for a 100 mL batch of nanoemulsion, if 1 to 2 mL were lost on evaporation (at step 112), as may be determined using a graduated cylinder, the volume may be adjusted 1 to 2 mL with water to account for the loss of volume due to evaporation.

[0064] At step 116, the nanoemulsion may be added to and stored in one or more closed containers. The container may be configured to block external light and/or may prevent oxygen from entering the container. In some embodiments, the container may be an amber tinted or colored container. In at least some embodiments, the container may be nitrogen flushed or vacuum sealed to remove any gaseous oxygen from within the container.

[0065] Referring now to FIG. 2, a graph illustrating the size distribution of droplets for a TF1C nanoemulsion containing 7.5 mg of TF1C per milliliter is illustrated. It may be noted that the nanoemulsion could have other amounts of TF1C. For example, the nanoemulsion may preferably contain 5 mg to 7.5 mg of TF1C per m though other amounts of TF1C are also possible. For example, a stable nanoemulsion may be made up to at least 10 mg/mL if the starting material is pure isolate. The nanoemulsion has been prepared using the techniques described herein and it may be seen that the droplet size is relatively small (e.g., less than 100 nanometers). [0066] Similar results to those illustrated in FIG. 2 for TF1C are also illustrated for hemp oil (FIG. 3) containing 1% weight by volume Flemp Oil, and for CBD crystallized nanoemulsion (FIG. 4) containing 7.5 mg of crystallized CBD per milliliter, and for CBD resin nanoemulsion (FIG. 5) containing 10 mg CBD resin per milliliter, and for CBD resin and CBD crystallized nanoemulsion (FIG. 6) containing 5 mg of CBD resin and CBD crystallized per milliliter and CBD crystallized nanoemulsion (FIG. 7) containing 7.5 mg of CBD resin and CBD crystallized per milliliter.

[0067] Reference will now be made to FIG. 8 which illustrates a further method 800 of preparing a cannabis-based nanoemulsion. The method 800 may, for example, be used to prepare a terpene-based nanoemulsion. Conveniently, the method 800 of FIG. 8 does not use a solvent and does not require an evaporation step. The method 800 of FIG. 8 may avoid evaporation of certain ingredients, such as terpenes.

[0068] The technique described above with reference to FIG. 8 could also be used for non-terpene based nanoemulsions. Flowever, this technique may produce larger droplets than the solvent-based method (i.e., the phase inversion method) described above with reference to FIG. 1. The solvent may help to diffuse oil allowing for smaller droplet sizes. [0069] At step 802, a surfactant preparation may be prepared by melting one or more surfactants. For example, one or more surfactants may be melted at approximately forty five (45) degrees Celsius. For example, the one or more surfactants may be melted at above forty three (43) degrees Celsius. By way of further example, the one or more surfactants may be melted at between 43 and 46 degrees Celsius. While greater temperatures may be used to melt the surfactant(s), lower temperatures may prevent instability of the preparation. Further, melting of surfactants may not be required for all implementations. For example, melting may not be required if the surfactants used are liquid at room temperature. [0070] The surfactants used in the surfactant preparation may preferably include polysorbate 80 and poloxamer 407. The surfactant preparation preferentially contains polysorbate 80, and may also include (but not limited to) various forms of: polysorbates (20, 40, 60, 85), any kinds of poloxamers (105, 188, 238, 331, 333, 334, 335, 338, 407) and polyethylene glycols (200, 300, 400, 600). The surfactant preparation may include poloxamer 407. In at least some embodiments, the surfactant preparation includes polysorbate 80 and poloxamer 407 in a ratio of between three 3 parts polysorbate 80 to 0.75 part poloxamer 407 (3:0.75) to four (4) parts polysorbate 80 to one (1) part poloxamer 407 (4:1).

[0071] In at least some embodiments, the surfactant preparation includes a co surfactant. The co- surfactant may be a diethylene glycol derivative such as an ethylene- series of glycol ether. For example, it may be or include diethylene glycol monoethyl ether such as Transcutol FIP(TM) or Carbitol. Other co- surfactants may be used. The co surfactant may be combined in the surfactant preparation with the one or more surfactants in a ratio of between 4.5 parts surfactant to 0.5 parts co-surfactant and 5 parts surfactant to 1.6 parts co-surfactant.

[0072] After the surfactants are melted, the surfactants may be stirred (during step 802) until the mixture (which may also be referred to as the surfactant preparation) becomes clear. It has been found that clarity occurs after approximately five minutes of stirring in laboratory environments. Flowever, the length of time required may vary. Most typically, the length of time is less than 15 minutes at 45 degrees Celsius depending on the level of impurities in the cannabis extract, with resins containing waxes taking longer.

[0073] After the surfactant mixture becomes clear, the mixture may be cooled. For example, the mixture may be cooled to room temperature (about 20 to 25 degrees Celsius) during step 802. Cooling of the mixture may prevent loss of the terpenes. [0074] The surfactant preparation that is prepared at step 802 may be combined with a cannabis-based preparation at step 804 to create a mixture, which may be referred to as the organic phase. In some embodiments, the cannabis-based preparation may be a terpene-based preparation such as a terpene concentrate. Terpenes are organic compounds that impart aroma and flavor to cannabis plants. The term terpene concentrate pertains to the concentrated terpenes rendered from different cannabis strains. The described method should be compatible with terpene concentrates from any cannabis strain, terpene isolates (single terpenes isolated from a concentrated mixture), and formulated terpene mixtures derived from the combination of a set of desired terpene isolates. The phase inversion method has been used to make different kinds of cannabinoid nanoemulsions including those containing terpenes. In some embodiments, nanoemulsions with 1-2% terpene concentrates are made with different types of terpenes using the method 800, and diluted into different water based mixtures such as beverages. This method may be particularly useful for preparation of terpene nanoemulsions because of the volatile nature of terpenes, which makes the use of evaporation and heat inappropriate.

[0075] At step 806, an aqueous phase is prepared. The aqueous phase is prepared by measuring an appropriate volume of water (e.g., by calculating the volume of all ingredients based on the formulation and then calculating how much water is needed for the formulation and adding EDTA and a preservative in at least some embodiments. The preservative may, for example, be benzoic acid, such as benzoic acid at a concentration of 0.05%. The preservative may, for example, aid in avoiding microbial growth and prevent oxidation. Other preservatives may be used. By way of example, the preservative may be any one or a combination of: 1) Sorbic acid and its salts like sodium sorbate, potassium sorbate; 2) Benzoic acid and Benzoic acid derivatives like sodium benzoate; 3) Parabens: Methyl paraben, Propyl paraben; 4) Benzalkonium chloride (for non-oral applications); and 5) Cetylpryidinium bromide

[0076] At step 808, the aqueous phase is slowly added to the organic phase (i.e., the mixture that includes the surfactant preparation and the cannabis-based preparation). For example, the aqueous phase may be added in a dropwise manner. For example, the aqueous phase may preferably be added no faster than 1.4 mL per minute to make 100 mL batch of concentrated nanoemulsion. If the aqueous phase is added to the organic phase too rapidly, there may not be enough time for the organic phase to diffuse in the water which may result in a final product having a large droplet size and/or that may not be clear. [0077] The aqueous phase may be added to the organic phase using a peristaltic pump or with a syringe.

[0078] After the aqueous phase is completely added to the organic phase, stirring may occur to ensure that diffusion of the organic phase is complete. For example, stirring may continue for thirty minutes or more.

[0079] At step 810, the nanoemulsion may be added to and stored in one or more closed containers. The container may be configured to block external light and/or may prevent oxygen from entering the container. In some embodiments, the container may be an amber tinted or coloured container. In at least some embodiments, the container may be nitrogen flushed or vacuum sealed to remove any gaseous oxygen from within the container.

[0080] Conveniently, the nanoemulsions prepared according to the methods 100, 800 described herein may be prepared without the use of a homogenizer or other sophisticated equipment (e.g., without the use of a homogenizer, sonicator or microfluidizer). Conveniently, in at least some embodiments, the nanoemulsions may be clear and/or may have a small droplet size. A small droplet size may allow for a faster onset for active ingredients in the nanoemulsions. That is, the effects of the CBD, THC and/or terpenes may occur more rapidly where the droplet size is relatively small.

[0081] The nanoemulsions prepared using the techniques described herein may be in liquid form. However, such nanoemulsions may be processed into another form, such as a solid form. For example, the liquids may be processed to create a sublingual film or spray, lotions, ointments and cosmetics, or a foam.

[0082] Conveniently, the nanoemulsions prepared according to the methods described herein may be stable in water or soda. This may, for example, allow the nanoemulsion to be added to water or a soda before being ingested or otherwise consumed.

[0083] Conveniently, the nanoemulsions prepared according to the methods described herein may be sterilized using filtration (i.e., by passing the nanoemulsions through a filter such as a 0.45 micrometer filter). Filtration is possible due to the small droplet size associated with nanoemulsions. Sterilization by filtration may be used instead of, for example, thermal sterilization techniques. In at least some embodiments, methods described herein may include sterilizing a nanoemulsion prepared according to the techniques described herein using filtration.

[0084] The cannabis-based concentrated stock nanoemulsions described herein can be diluted in a matrix of choice like beverages, sublingual strips, nasal sprays, cosmetic or topical products. For example, 1 ml of 1% stock solution could be diluted with 354 ml beverage for a 355 ml can with 10 mg cannabinoid.

[0085] The nanoemulsions described herein may be used by a human or animal. For example, the nanoemulsions may be used as oral, buccal, topical, rectal, nasal solution and/or spray, eyedrops, etc. The nanoemulsion may be administered, for example, for medicinal benefits. The nanoemulsions may, for example, be added to a food product such as a baked good or a beverage, such as water, soda, non-alcoholic beer, breezers, or coolers. Accordingly, methods of creating products, such as beverages, edibles, cosmetics, topicals, sublingual sprays, nasal sprays, eye drops, etc. using concentrated nanoemulsions prepared using techniques described herein are contemplated. In some implementations, preparing such products may include diluting the concentrated nanoemulsions.

[0086] The nanoemulsions described herein may be used, for example, to treat a variety of medical conditions. For example, the nanoemulsions may be used to treat one or more of: multiple sclerosis (MS), nausea, vomiting, loss of appetite for F1IV patients and/or seizures. The nanoemulsions may be used to treat other conditions apart from those specifically recited herein.

[0087] The nanoemulsions described herein may be used by a human or animal. For example, the nanoemulsions may be ingested (i.e., used orally). The nanoemulsions may be administered, for example, for medicinal benefits.

[0088] The nanoemulsions described herein may be used, for example, to treat a variety of medical conditions. For example, the nanoemulsions described herein may be used for the treatment or amelioration of symptoms of medical conditions. Such symptoms may include any one or a combination of inflammation, lack of appetite, nausea, vomiting, pain including chronic pain, or muscle spasms. For example, the cannabis based products described herein may be used as part of a treatment plan (including to manage symptoms) for conditions such as multiple sclerosis, glaucoma, acquired immunodeficiency syndrome (AIDS), neuropathic conditions, cancer, acne, diseases of malnutrition, arthritis, or spinal cord injury. It can be appreciated that cannabis based products can be used for treatment of other symptoms or other conditions. Accordingly, the nanoemulsions described herein may be used for the treatment of any one or more medical conditions or systems, such as those listed above. For example, the nanoemulsions may be ingested by a patient suffering from such a symptom or condition. [0089] The various embodiments presented above are merely examples. Variations of the innovations described herein will be apparent to persons of ordinary skill in the art, such variations being within the intended scope of the present application. In particular, features from one or more of the above-described example embodiments may be selected to create alternative example embodiments including a sub-combination of features which may not be explicitly described above. In addition, features from one or more of the above- described example embodiments may be selected and combined to create alternative example embodiments including a combination of features which may not be explicitly described above. Features suitable for such combinations and sub-combinations would be readily apparent to persons skilled in the art upon review of the present application as a whole. The subject matter described herein and in the recited claims intends to cover and embrace all suitable changes in technology.

Claims

What is claimed is:

1. A method of preparing a cannabis-based nanoemulsion, the method comprising: combining a surfactant preparation with a cannabis-based preparation to create a mixture; combining the mixture with a solvent to make an organic phase; adding the organic phase to an aqueous phase; and evaporating the solvent.

2. The method of claim 1 , wherein the surfactant preparation includes polysorbate 80.

3. The method of claim 1 , wherein the surfactant preparation includes poloxamer 407.

4. The method of claim 1, wherein the surfactant preparation includes polysorbate 80 and poloxamer 407 in a ratio of between 3 parts polysorbate 80 to 0.75 parts poloxamer 407 (3:0.75) to 4 parts polysorbate 80 to 1 part poloxamer 407 (4:1).

5. The method of claim 1 , wherein the surfactant preparation includes a co- surfactant.

6. The method of claim 5, wherein the co-surfactant is diethylene glycol monoethyl ether.

7. The method of claim 5, wherein the co-surfactant is combined in the surfactant preparation with one or more surfactants in a ratio of between 4.5 parts surfactant to 0.75 parts co-surfactant and 5 parts surfactant to 1.6 parts co-surfactant.

8. The method of claim 1, wherein the cannabis-based preparation includes one or more of: tetrahydrocannabinol (THC) distilled resin; hemp oil; cannabidiol (CBD) distilled resin; cannabidiol (CBD) distilled crystalline; or terpenes.

9. The method of claim 1, wherein the cannabis-based preparation includes an antioxidant.

10. The method of claim 9, wherein the antioxidant is alpha tocopherol.

11. The method of claim 1, wherein the cannabis-based preparation includes alpha tocopherol without any other oily carrier.

12. The method of claim 1, wherein the solvent is water- miscible.

13. The method of claim 1, wherein the solvent is ethanol.

14. The method of claim 1, wherein the solvent is acetone.

15. The method of claim 1, further comprising, prior to adding the organic phase to the aqueous phase, filtering the mixture.

16. The method of claim 15, wherein the filtering is performed using a 0.22 to 0.45 micrometer membrane filter.

17. The method of claim 1, further comprising, prior to adding the organic phase to the aqueous phase, preparing the aqueous phase by combining a preservative with water.

18. The method of claim 17, wherein the preservative is benzoic acid, a benzoic acid derivate, or sorbic acid.

19. The method of claim 1, wherein the organic phase is added to the aqueous phase in a dropwise manner.

20. The method of claim 19, wherein the organic phase is added to the aqueous phase at a rate of not faster than 1.4 mL per minute to make 100 mL batch of concentrated nanoemulsion.

21. The method of claim 1, wherein the organic phase is added to the aqueous phase using a peristaltic pump.

22. The method of claim 1, wherein the cannabis-based nanoemulsion is prepared without the use of any of a homogenizer, sonicator and microfluidizer.

23. A cannabis-based nanoemulsion produced according to the method of any one of claims 1 to 22.

24. A method of preparing a cannabis-based nanoemulsion, the method comprising: preparing a surfactant preparation by melting one or more surfactants; combining the surfactant preparation with a cannabis-based preparation to create an organic phase; and adding an aqueous phase to the organic phase.

25. The method of claim 24, wherein preparing the surfactant preparation includes: after melting, stirring the melted surfactants until the surfactant preparation becomes clear.

26. The method of claim 25, wherein preparing the surfactant preparation includes: after the surfactant becomes clear, cooling the surfactant to room temperature prior to adding the aqueous phase to the organic phase.

27. The method of claim 24, wherein the one or more surfactants include polysorbate 80.

28. The method of claim 24, wherein the one or more surfactants includes poloxamer 407.

29. The method of claim 24, wherein the one or more surfactants includes polysorbate 80 and poloxamer 407 in a ratio of between 3 parts polysorbate 80 to one part poloxamer 407 (3:0.75) and four parts polysorbate 80 to one part poloxamer 407 (4:1).

30. The method of claim 24, wherein the cannabis-based preparation is a terpene-based preparation.

31. The method of claim 24, further comprising, prior to adding the aqueous phase to the organic phase, preparing the aqueous phase by combining a preservative with water.

32. The method of claim 31, wherein the preservative is benzoic acid, a benzoic acid derivative or sorbic acid.

33. The method of claim 24, wherein the aqueous phase is added to the organic phase in a dropwise manner.

34. The method of claim 33, wherein the aqueous phase is added to the organic phase at a rate of not faster than 1.4 mL per minute to make 100 mL batch of concentrated nanoemulsion.

35. The method of claim 24, wherein the aqueous phase is added to the organic phase using a peristaltic pump.

36. The method of claim 24, wherein the cannabis-based nanoemulsion is prepared without the use of any of a homogenizer, sonicator and microfluidizer.

37. A cannabis-based nanoemulsion produced according to the method of any one of claims 1 to 36.