Self-emulsifying composition and oral composition

Abstract

The present invention provides a self-emulsifying composition containing cannabidiol and exhibiting excellent stability, as well as an oral composition using the same. [Solution] The present invention is a self-emulsifying composition containing cannabidiol and two or more polyglycerin fatty acid esters.

Description

Technical Field

[0001] The present invention relates to a self-emulsifying composition and an oral composition.

Background Art

[0002] Cannabidiol (CBD) has attracted attention as a component expected to have a new pharmacological action. Cannabidiol is one of the cannabinoids contained in hemp, and for example, therapeutic agents for epilepsy seizures and compositions for treating tuberous sclerosis have been developed. Various forms of oral administration of cannabidiol have been proposed. Patent Document 1 describes a lipid-based particle composition, which is nanoparticles containing cannabidiol, phosphatidylcholine, sterol, and medium-chain triglyceride, having an average size in the range of about 75 nm to about 200 nm, and when stored for a period of one month, the change in the average size of the nanoparticles is less than about 20%.

[0003] Patent Document 2 describes a method for treating chemotherapy-induced nausea and vomiting by administering to a patient in need thereof a formulation containing a pharmaceutically effective amount of cannabidiol and delta-9-tetrahydrocannabinol, wherein the weight ratio of cannabidiol to delta-9-tetrahydrocannabinol in the formulation is from 2:0:0.5 to 0.5 to 2.0, the formulation includes a solid oral dosage form, and the administering is performed before and / or after the patient undergoes chemotherapy treatment.

Prior Art Documents

Patent Documents

[0004]

Patent Document 1

Patent Document 2

Summary of the Invention

[0005] However, cannabidiol has a low melting point and is difficult to emulsify. Even with conventional cannabidiol-containing preparations, the stability, including emulsification stability, is not sufficient. In particular, when added to beverages containing large amounts of water to induce self-emulsification, the rapid dispersibility and emulsification stability are insufficient. [Means for solving the problem]

[0006] The present invention provides a self-emulsifying composition containing cannabidiol and two or more polyglycerol fatty acid esters, and an oral composition containing the same. [Effects of the Invention]

[0007] According to the present invention, the above-mentioned problems are solved, and the self-emulsifying composition of the present invention can be stably and sufficiently self-emulsified and dispersed in the aqueous phase by containing a specific plurality of emulsifiers. Furthermore, it is possible to provide an oral composition that is easy to ingest with suppressed oily odor and other unpleasant tastes. [Modes for carrying out the invention]

[0008] The present invention will now be described in terms of preferred embodiments. In this specification, stability includes stability of the emulsified state, absence of separation, stability of the average particle size, low turbidity, low refractive index, and the like.

[0009] The inventors have discovered that, by using a specific composition with cannabidiol and a specific emulsifier, it is possible to surprisingly improve the dispersibility and stability when emulsified and dispersed in the aqueous phase, resulting in a highly palatable and excellent oral composition.

[0010] When the self-emulsifying composition of the present invention, which contains cannabidiol and two or more polyglycerol fatty acid esters, is brought into contact with water, a nanoscale oil-in-water emulsion is generated. The property of forming an emulsified composition by bringing oils and fats into a water-containing aqueous phase is called an emulsified composition, and this property is characteristically observed in systems where infinite aggregates are formed, such as bicontinuous emulsions where both the aqueous and oil phases are continuous phases. Although the detailed structure of the emulsified composition of the present invention is not clear, since the emulsified composition is formed by contact with the aqueous phase, it is presumed to be a system in which infinite aggregates are formed throughout the composition or locally within the composition, or a system having a similar state.

[0011] (A) Cannabidiol One of the features of the self-emulsifying composition of the present invention is that it contains cannabidiol (CBD, a compound of the following formula).

[0012] [ka]

[0013] Cannabidiol is a type of cannabinoid and is known to be found in hemp. Cannabidiol is known to have different pharmacological effects from tetrahydrocannabinol, another type of cannabinoid. Cannabidiol is known to have anti-aging, anti-inflammatory, antibacterial, anxiolytic, neuroprotective, bone growth promoting, sleep promoting, relaxation, hair growth promoting, skin care, fem care, and oral care effects. In the present invention, these effects can be obtained by using cannabidiol. Furthermore, the self-emulsifying composition of the present invention contains cannabidiol and a specific emulsifier. Since cannabidiol is oil-soluble, this composition allows for smooth oral absorption of cannabidiol, and the effects attributed to cannabidiol can be obtained effectively.

[0014] In particular, the present invention, which uses cannabidiol and a specific emulsifier, exhibits excellent stability. Although the reason is not entirely clear, it is thought that even if cannabidiol, an oily substance that is difficult to emulsify, is included together with two or more polyglycerol fatty acid esters, the fine emulsified particles containing cannabidiol that self-emulsify when added to the aqueous phase are more stable.

[0015] In this invention, cannabidiol can be extracted and purified from plants such as hemp or citrus fruit peels, or synthesized. It is preferable to use cannabidiol that has been purified from natural sources or synthesized, and it is even more preferable to use cannabidiol that has been purified from natural sources, in order to enhance safety and the anti-aging, anti-inflammatory, antibacterial, anti-anxiety, neuroprotective, bone growth promoting, sleep promoting, relaxation, hair growth promoting, skin care, fem care, and oral care effects of cannabidiol.

[0016] The cannabidiol contained in the self-emulsifying composition is preferably present in an amount of 40% by mass or less, more preferably 30% by mass or less, even more preferably 25% by mass or less, particularly preferably 20% by mass or less, particularly more preferably 18% by mass or less, and even more preferably 15% by mass or less, in the solid content of the self-emulsifying composition, in order to further enhance stability. The cannabidiol contained in the self-emulsifying composition is preferably present in an amount of 0.1% by mass or more, more preferably 0.5% by mass or more, even more preferably 1% by mass or more, particularly preferably 2% by mass or more, and particularly more preferably 5% by mass or more, in the solid content of the self-emulsifying composition, in order to further enhance its stability. In this specification, any description of an amount with "solids content of the self-emulsifying composition" as the denominator can be interpreted as "in the solids content of the self-emulsifying composition." Here, "solids content" refers to the amount excluding solvents such as water and ethanol, and it is preferable that the self-emulsifying composition of the present invention does not contain solvents.

[0017] In addition, from the perspective of further enhancing stability, cannabidiol contained in the self-emulsifying composition is preferably 15% by mass or less, more preferably 12% by mass or less, still more preferably 10% by mass or less, particularly preferably 8% by mass or less, even more preferably 6% by mass or less, still even more preferably 5% by mass or less, more preferably 4% by mass or less, and especially preferably 3% by mass or less in the self-emulsifying composition. From the perspective of enhancing its effects, cannabidiol contained in the self-emulsifying composition is preferably 0.001% by mass or more, more preferably 0.01% by mass or more, still more preferably 0.05% by mass or more, especially preferably 0.1% by mass or more, particularly preferably 0.5% by mass or more, more preferably 0.6% by mass or more, even more preferably 0.7% by mass or more, and especially preferably 0.8% by mass or more in the self-emulsifying composition.

[0018] From the perspective of further enhancing stability when cannabidiol is contained in the self-emulsifying composition, it is preferably 400 parts by mass or less, more preferably 350 parts by mass or less, still more preferably 300 parts by mass or less, particularly preferably 250 parts by mass or less, most preferably 200 parts by mass or less, even more preferably 150 parts by mass or less, and especially preferably 130 parts by mass or less with respect to 100 parts by mass of the emulsifier.

[0019] Cannabidiol is preferably 1 part by mass or more, more preferably 10 parts by mass or more, still more preferably 20 parts by mass or more, particularly preferably 30 parts by mass or more, most preferably 40 parts by mass or more, even more preferably 60 parts by mass or more, and especially preferably 90 parts by mass or more with respect to 100 parts by mass of the emulsifier.

[0020] The self-emulsifying composition in the present invention may contain cannabinoids other than cannabidiol in addition to cannabidiol. Cannabinoid means a compound that can bind to a cannabinoid (CB) receptor. By using a cannabinoid as an active ingredient, the function of the ECS (endocannabinoid system) that maintains homeostasis in the body can be enhanced, and the ECS can be appropriately adjusted. Cannabinoids can be classified into phytocannabinoids, endogenous cannabinoids, synthetic cannabinoids, etc. Specific compounds include, for example, cannabichromene (CBC), cannabichromenic acid (CBCV), cannabidiol (CBD), cannabidiolic acid (CBDA), cannabidivarin (CBDV), cannabigerol (CBG), cannabigerol propyl variant (CBGV), cannabicyclol (CBL), cannabinol (CBN), cannabinol propyl variant (CBNV), cannabinotriol (CBO), tetrahydrocannabinol (THC), tetrahydrocannabinolic acid (THCA), tetrahydrocannabivarin (THCV), and tetrahydrocannabivarinic acid (THCVA), cannabidiol-C1 (CBD-C1), cannabidiol-C4 (CBD-C4) and cannabidiol-C6 (CBD-C6), etc.

[0021] When the self-emulsifying composition of the present invention contains cannabinoids other than cannabidiol, the ratio of cannabinoids other than cannabidiol is preferably 100 parts by mass or less, more preferably 80 parts by mass or less, still more preferably 60 parts by mass or less, particularly preferably 40 parts by mass or less, particularly more preferably 30 parts by mass or less, still more preferably 20 parts by mass or less, particularly preferably 10 parts by mass or less, still more preferably 5 parts by mass or less, particularly preferably 1 part by mass or less, and especially preferably 0.3 parts by mass or less, based on 100 parts by mass of cannabidiol.

[0022] (B) Polyglycerol fatty acid ester The self-emulsifying composition of the present invention contains two or more polyglycerin fatty acid esters for the production of the self-emulsifying composition. A polyglycerin fatty acid ester refers to a polyglycerin obtained by dehydration condensation of glycerin to which a fatty acid is esterified. The polyglycerin fatty acid ester used in the present invention is an ester of polyglycerin having an average degree of polymerization of 2 or more, preferably 6 to 15, more preferably 8 to 10, and a fatty acid having 8 to 18 carbon atoms, such as caprylic acid, capric acid, lauric acid, myristic acid, palmitic acid, stearic acid, oleic acid, and linoleic acid. Preferred examples of polyglycerol fatty acid esters include hexaglycerol monooleate, hexaglycerol monostearate, hexaglycerol monopalmitate, hexaglycerol monomyristate, hexaglycerol monolaurate, decaglycerol monooleate, decaglycerol monostearate, decaglycerol monomyristate, and decaglycerol monolaurate. Among these, more preferably are decaglycerin trioleate (decaglyceryl trioleate, HLB=7), decaglycerin monooleate (decaglyceryl monooleate, HLB=12), decaglycerin monostearate (HLB=12), decaglycerin monomyristate (HLB=14), decaglycerin monolaurate (HLB=16), and the like. These polyglycerol fatty acid esters are used in a mixture of two or more types.

[0023] The HLB value of the polyglycerin fatty acid ester used in the present invention is not particularly limited, but from the viewpoint of easily exhibiting emulsification stability and ease of handling, it is preferably 5 or higher, more preferably 6 or higher, particularly preferably 7 or higher, preferably 11 or lower, more preferably 10.5 or lower, and particularly preferably 10 or lower. The HLB value is an index that shows the hydrophilic-lipophilic balance, and represents the molecular weight of the hydrophilic group portion in the total molecular weight of the surfactant, and can be determined, for example, by Griffin's formula. If the HLB of the emulsifier is too low, creaming may occur, on the other hand, if the HLB of the emulsifier is too high, the emulsion may separate, causing oil to float and impairing the emulsified state.

[0024] In the present invention, when two or more polyglycerin fatty acid esters are used, the HLB value is the arithmetic mean of the HLB values ​​of each polyglycerin fatty acid ester based on their blending ratio. Therefore, even if the HLB value of individual polyglycerin fatty acid esters is less than 5 or greater than 11, if the mixed HLB value is between 5 and 11, it is a nonionic surfactant with an HLB value between 5 and 11 according to the present invention. In the present invention, it is preferable to combine polyglycerin fatty acid esters with HLB values ​​that differ by 4 or more, as this makes it easier to adjust the HLB value.

[0025] The emulsifier contained in the self-emulsifying composition is preferably contained in an amount of 40% by mass or less, more preferably 30% by mass or less, even more preferably 25% by mass or less, particularly preferably 20% by mass or less, particularly more preferably 18% by mass or less, and even more preferably 15% by mass or less, of the solid content of the self-emulsifying composition, in order to further enhance stability. The cannabidiol contained in the self-emulsifying composition is preferably present in an amount of 0.1% by mass or more, more preferably 0.5% by mass or more, even more preferably 1% by mass or more, particularly preferably 2% by mass or more, and particularly more preferably 5% by mass or more, in the solid content of the self-emulsifying composition, in order to further enhance its stability.

[0026] The polyglycerin fatty acid ester content in the self-emulsifying composition is preferably 0.01% by mass or more in terms of achieving excellent effects of the present invention, more preferably 0.1% by mass or more, particularly preferably 0.5% by mass or more, particularly preferably 0.7% by mass or more, and particularly preferably 1.0% by mass or more. Furthermore, the polyglycerin fatty acid ester content in the self-emulsifying composition is preferably 20% by mass or less in terms of emulsification stability, more preferably 10% by mass or less, even more preferably 5% by mass or less, particularly preferably 2% by mass or less, and particularly preferably 1.5% by mass or less.

[0027] The polyglycerin fatty acid ester content is preferably 0.1% by mass or more in the solid content of the self-emulsifying composition in terms of achieving excellent effects of the present invention, more preferably 0.5% by mass or more, particularly preferably 1.0% by mass or more, particularly preferably 2.0% by mass or more, particularly preferably 3.0% by mass or more, and especially preferably 5.0% by mass or more. Furthermore, the polyglycerin fatty acid ester content is preferably 30% by mass or less in the self-emulsifying composition in terms of emulsification stability, more preferably 20% by mass or less, even more preferably 15% by mass or less, particularly preferably 10% by mass or less, and especially preferably 9% by mass or less.

[0028] (C)Oils and fats The self-emulsifying composition of the present invention contains oils and fats in addition to a specific emulsifier. There are no particular restrictions on the oils and fats, and they may be animal oils such as fish oil, beef tallow, pork tallow, milk fat (butter or anhydrous butter), horse oil, snake oil, egg oil, egg yolk oil, turtle oil, mink oil, etc., but vegetable oils are preferred, such as soybean oil, corn oil, cottonseed oil, rapeseed oil, sesame oil, perilla oil, rice oil, sunflower oil, peanut oil, olive oil, palm oil, palm kernel oil, rice germ oil, wheat germ oil, brown rice germ oil, Job's tears oil, garlic oil, macadamia nut oil, avocado oil, and moon oil. Vegetable oils such as primrose oil, flower oil, camellia oil, coconut oil, castor oil, linseed oil, and cocoa oil; and those obtained by hydrogenation or transesterification of these, for example, processed oils such as MCT (medium-chain triglyceride oil), hydrogenated coconut oil, hydrogenated palm kernel oil, and other hydrogenated oils and processed oils obtained by refining, deodorizing, fractionating, hardening, and transesterification of these liquid or solid vegetable oils; and liquid oils, solid fats, etc. obtained by fractionating these oils; medium-chain triglycerides, etc. Of these, vegetable oil, or oils obtained by fractionation, hardening, or transesterification of vegetable oil, is preferred from a cost standpoint, and MCT (medium-chain triglyceride oil) is particularly preferred from the viewpoint of flavor when added to beverages. The self-emulsifying composition of the present invention may contain only one of these oils, or it may contain two or more.

[0029] The oil and fat content in the self-emulsifying composition is preferably 0.01% by mass or more in terms of achieving excellent effects of the present invention, more preferably 0.1% by mass or more, particularly preferably 0.5% by mass or more, particularly preferably 0.7% by mass or more, and particularly preferably 1.0% by mass or more. Furthermore, the oil and fat content in the self-emulsifying composition is preferably 20% by mass or less in terms of emulsification stability, more preferably 10% by mass or less, even more preferably 5% by mass or less, particularly preferably 2% by mass or less, and particularly preferably 1.5% by mass or less.

[0030] From the viewpoint of the above, the oil and fat content is preferably 0.01% by mass or more of the solid content of the self-emulsifying composition, more preferably 0.1% by mass or more, particularly preferably 0.3% by mass or more, and even more preferably 0.8% by mass or more. Furthermore, the oil and fat content is preferably 20% by mass or less of the solid content of the self-emulsifying composition in terms of obtaining a stable composition, more preferably 10% by mass or less, even more preferably 5% by mass or less, particularly preferably 3% by mass or less, and especially preferably 2.4% by mass or less.

[0031] The turbidity of the emulsified composition obtained by adding the self-emulsifying composition of the present invention to an aqueous phase such as water is not particularly limited, but in order to make the emulsified composition easier to take orally and to further enhance the effect when taken, it is preferably 3.5 or less, more preferably 3 or less, particularly preferably 2.8 or less, preferably 1.2 or more, more preferably 1.5 or more, and particularly preferably 1.8 or more, as measured by an absorbance at 660 nm using a spectrophotometer. The turbidity of the self-emulsifying composition of the present invention can be measured, for example, with an ultraviolet-visible spectrophotometer (UV-1800, manufactured by Shimadzu Corporation).

[0032] The refractive index of the emulsion composition obtained by adding the self-emulsifying composition of the present invention to an aqueous phase such as water is not particularly limited, but from the viewpoint of easily exhibiting emulsifying stability and ease of handling, it is preferably 1.45 or less, more preferably 1.40 or less, particularly preferably 1.35 or less, preferably 1.330 or more, more preferably 1.331 or more, and particularly preferably 1.332 or more. The refractive index of the self-emulsifying composition of the present invention can be measured, for example, with a refractometer (Atago DR-A1).

[0033] The method for producing the self-emulsifying composition of the present invention is not particularly limited and can be produced according to known methods.

[0034] The following describes a preferred method for producing the self-emulsifying composition of the present invention. The self-emulsifying composition of the present invention comprises the step of preparing a self-emulsifying composition by mixing a first liquid containing cannabidiol and specific oils and fats with a second liquid containing polyglycerin fatty acid ester and specific oils and fats. The method then comprises the step of adding the obtained self-emulsifying composition to an aqueous phase to prepare an emulsifying composition.

[0035] (1) First, prepare the self-emulsifying composition by the following method. First, the polyglycerin fatty acid ester and the specific oil are stirred and mixed to prepare the first liquid. To successfully obtain a self-emulsifying composition, the preparation of the first liquid is preferably carried out at 80-90°C, and more preferably at 80-85°C. Known conditions can be used for the mixing speed and stirring means based on the desired particle size, etc.

[0036] Next, the second liquid is prepared. Cannabidiol and the specified oil and fat are stirred and mixed to prepare the second liquid. To successfully obtain a self-emulsifying composition, it is preferable to prepare the second liquid at room temperature. Known conditions can be used for the mixing speed and stirring means based on the desired particle size, etc.

[0037] The obtained first liquid is allowed to return to room temperature, the second liquid is added and stirred to obtain a self-emulsifying composition. Known conditions can be used for the mixing speed and stirring method based on the desired particle size, etc.

[0038] If a self-emulsifying composition is obtained as described above, the obtained self-emulsifying composition may be used as an oral composition as is, or it may be dried by a known method and used as an oral composition, or it may be mixed with other components in these states to form an oral composition.

[0039] In addition to the cannabidiol, two or more polyglycerin fatty acid esters, and specific oils and fats mentioned above, the self-emulsifying composition of the present invention may contain various active ingredients, pH adjusters, thickeners, fragrances, colorants, antioxidants, antibacterial and antifungal agents, alcohols, inorganic salts, solvents, and other components commonly used in oral compositions, as long as they do not impair the effects of the present invention, depending on the application and purpose.

[0040] In this invention, the inclusion of cannabidiol in a self-emulsifying composition offers the advantage of increased solubility in water when orally ingested compared to cases where a self-emulsifying composition is not used. Furthermore, the excellent stability of the self-emulsifying composition in this invention is expected to improve absorption when orally ingested.

[0041] In this invention, examples of cannabidiol intake for adults include approximately 1-20 mg, 5-18 mg, and 10-15 mg per day.

[0042] The self-emulsifying composition may be an oral composition, and the oral composition of the present invention can be ingested in one or more doses (preferably two to three doses). The target of application is preferably humans, but it may also be non-human mammals. When the target of application is a non-human mammal (for example, pets or livestock, more specifically dogs, cats, monkeys, cows, pigs, sheep, etc.), the dosage or intake for humans can be appropriately set by referring to the dosage for humans.

[0043] Oral compositions can preferably be used as pharmaceutical compositions or food compositions (including beverage compositions and food additive compositions).

[0044] When used as a pharmaceutical composition, other components may include pharmaceutically acceptable bases, carriers, and / or additives (e.g., solvents, dispersants, emulsifiers, buffers, stabilizers, excipients, binders, disintegrants, lubricants, etc.). Furthermore, the form of the pharmaceutical composition is not particularly limited, and examples include tablets, pills, powders, liquids, suspensions, emulsions, granules, capsules, etc. Pharmaceutical preparations in these forms can be prepared by conventional methods by combining the self-emulsifying composition with the other components as needed.

[0045] When used as a food composition, other components may include food hygiene-permissible bases, carriers, additives, and other components and materials that can be used as food. Furthermore, the form of the food composition is not particularly limited; examples include processed foods, health foods (nutritional supplements, functional foods, foods for the sick, foods for specified health uses, functional food products, etc.), supplements, and foods for the sick (hospital meals, sick person meals, or nursing care meals, etc.). These can be prepared by conventional methods. In particular, when preparing a food composition as a health food (nutritional supplement, functional food, food for the sick, food for specified health uses, functional food, etc.) or supplement, it is preferable to prepare it in a form such as granules, capsules, tablets (including chewable tablets, etc.), or beverages (packaged beverages, beverage powders, drinks, etc.) to facilitate continuous intake. Among these, capsules, tablets, beverage powders, and drinks are preferred in terms of ease of intake, but the composition is not limited to these. Furthermore, when using a food composition as a food additive, examples of its forms include liquid, powder, flake, granular, and paste forms. [Examples]

[0046] The present invention will be described below based on examples, but the present invention is not limited to the following examples.

[0047] [Test Example 1. Test for Selection of Emulsifiers] First, in order to verify suitable combinations of emulsifiers, reference examples were prepared with the compositions shown in Table 1. The preparation procedure for each composition was as follows. (Test substance) As emulsifiers, commercially available sorbitan monooleate (HLB 4.5), polyoxyethylene sorbitan monooleate (HLB 15), decaglyceryl monooleate (HLB 12), decaglyceryl trioleate (HLB 7), decaglyceryl pentaoleate (HLB 3.5), pentaglycerin dioleate (HLB 12), and pentaglycerin dioleate (HLB 7) were used. As the fat, commercially available MCT oil was used. (Preparation method) (1) The emulsifier was stirred and mixed in a beaker using a hot stirrer (550-1,000 rpm, 55°C for 3 minutes). (2) The emulsifier mixed in (1) was mixed with MCT oil and stirred (550 rpm, 55 ℃ for 10 minutes) to obtain the composition.

[0048] The reference composition was evaluated using the following method. The results are shown in Table 1. (1) Add 2g of the composition to 100g of cold water (10℃) and stir by gently shaking the container by hand. (2) Dispersibility in water was evaluated based on the following three evaluation criteria. • ○: Disperses quickly throughout the container. •△: Disperses, but does not disperse throughout the entire container. ×: Not distributed (3) Dispersion stability was evaluated by checking for creaming in the solution after it had been left to stand at room temperature for 30 minutes following the dispersibility evaluation in (2), and based on the following four-level evaluation criteria. • ◎: No creaming has occurred. • ○: A small amount of creaming has occurred. • △: Excessive creaming is occurring. ×: A creamy layer has formed.

[0049] [Table 1]

[0050] [Test Example 2. Test of a self-emulsifying composition containing cannabidiol] In Test Example 1, Reference Examples 7 and 9, which exhibited excellent dispersibility and dispersion stability, were selected, and self-emulsifying compositions were prepared by incorporating the cannabidiols of the Examples and Comparative Examples with the compositions shown in Table 2. Reference Example 6 was not used because its dispersibility when incorporating cannabidiol was inferior to that of Reference Example 7. (Test substance) Cannabidiol was obtained using a commercially available powder. Decaglyceryl monooleate (HLB12) and decaglyceryl trioleate (HLB7), both commercially available products, were used as emulsifiers. As the fat, commercially available MCT oil was used. Sorbitan monooleate (HLB 4.5) was used as the emulsifier in the comparative example. (Preparation method) (1) The emulsifier was stirred and mixed in a beaker using a stirrer (500 rpm, while heating in a water bath at 80°C for 15 minutes). (2) Half the amount of MCT oil was added to the emulsifier mixed in (1), and after stirring and mixing (900 rpm, 80°C for 15 minutes), it was allowed to cool to room temperature while stirring until it returned to room temperature. (3) Cannabidiol was added to half the amount of MCT oil and stirred and mixed (600 rpm, 25°C for 30 minutes). (4) The mixture from (3) was added to the mixture from (2), and the mixture was stirred and mixed (500 rpm, 25°C for 15 minutes) to obtain a self-emulsifying composition.

[0051] The self-emulsifying compositions of the examples and comparative examples were evaluated by the following method. The results are shown in Table 2.

[0052] The dispersibility and dispersion stability in water, turbidity, and emulsification stability of the obtained examples and comparative examples were evaluated, and the presence or absence of oily odor, etc., was assessed by sensory testing.

[0053] (Dispersion and dispersion stability) (1) Add 2g of the self-emulsifying composition to 100g of cold water (10℃) and stir by gently shaking the container by hand. (2) Dispersibility in water was evaluated based on the following three-stage evaluation criteria. • ○: Disperses quickly throughout the container. •△: Disperses, but does not disperse throughout the entire container. ×: Not distributed (3) Dispersion stability was evaluated by checking for the presence or absence of oil floating in the solution after standing at room temperature for 30 minutes following the dispersibility evaluation in (2), and based on the following four-stage evaluation criteria. • ○: No creaming has occurred. • △: Creaming is occurring. ×: A creamy layer has formed.

[0054] (Turbidity) (1) Add 2g of the self-emulsifying composition to 200g of cold water (10℃) and stir by gently shaking the container by hand. (2) The absorbance at 660 nm was measured using a UV-Vis spectrophotometer (UV-1800, manufactured by Shimadzu Corporation).

[0055] (Emulsification stability) (1) Add 2g of the self-emulsifying composition to 100g of cold water (10℃) and stir by gently shaking the container by hand. (2) Emulsification stability was evaluated by checking for the presence or absence of oil separation in the solution after it had stood at room temperature for 30 minutes, based on the following three-stage evaluation criteria. • No oil droplets are floating. • △: Some oil droplets are suspended. ×: A large amount of oil droplets are floating.

[0056] (Sensory testing) For each example of a self-emulsifying composition, 1 g of the self-emulsifying material was added dropwise to 9 mL of cold water (6°C), gently stirred, and then evaluated. The oily odor was evaluated based on the following three-level evaluation criteria. • No oily smell. • I can smell oil. • × I strongly smell oil.

[0057] [Table 2]

[0058] As shown in Table 2, Examples 1-6, which contained cannabidil and the polyglycerin fatty acid esters decaglyceryl monooleate and decaglyceryl trioleate, all exhibited excellent dispersibility, dispersion stability, emulsification stability, and absence of oily odor. Comparative Examples 1-2, which contained one type of polyglycerin fatty acid ester and a surfactant that was not a polyglycerin fatty acid ester, had problems with dispersion stability and emulsification stability, and in particular, Comparative Example 2, which had a high mixed HLB, had problems in terms of oily odor. [Industrial applicability]

[0059] The self-emulsifying composition and oral composition of the present invention are industrially useful because, despite using cannabidiol, they exhibit excellent stability and palatability.

Claims

1. a) Cannabidiol and b) A self-emulsifying composition comprising two or more polyglycerol fatty acid esters.

2. The self-emulsifying composition according to claim 1, which is an oral composition.

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