Caryophyllene-containing composition

Abstract

A composition for treating or preventing respiratory diseases, a composition for improving sleep or promoting sleep onset, a composition for reducing fatigue, a composition for improving complexion, a composition for improving skin texture, a composition for treating or preventing periodontal disease, and a composition for controlling halitosis, each composition containing caryophyllene.

Description

Caryophyllene-containing composition

[0001] The present invention relates to caryophyllene-containing compositions, etc. More specifically, the present invention relates to caryophyllene-containing compositions for treating respiratory diseases, preventing respiratory diseases, improving sleep, reducing fatigue, improving complexion, improving skin quality, treating periodontal disease, and suppressing bad breath.

[0002] β-Caryophyllene is known to have an effect of relieving anxiety (Japanese Patent Laid-Open No. 2006-342062 (Patent Document 1)). It is also known that feed containing β-caryophyllene has the effect of alleviating stress in poultry and livestock (Japanese Patent Laid-Open No. 2008-19251 (Patent Document 2)).

[0003] JP 2006-342062 A JP 2008-19251 A

[0004] Under these circumstances, there is a demand for compositions that can treat or prevent respiratory diseases, compositions that can improve sleep or promote sleep onset, compositions that can reduce fatigue, compositions that can improve complexion, compositions that can improve skin quality, compositions that can treat or prevent periodontal disease, or compositions that can suppress bad breath. There is also a demand for methods that can treat or prevent respiratory diseases, methods that can improve sleep or promote sleep onset, methods that can reduce fatigue, methods that can improve complexion, methods that can improve skin quality, methods that can treat or prevent periodontal disease, or methods that can suppress bad breath.

[0005] The present invention includes the following aspects. [1] A composition for treating or preventing respiratory diseases, comprising caryophyllene. [2] The composition according to [1], in which caryophyllene improves vital capacity or forced expiratory volume in one second. [3] A composition for improving sleep or promoting sleep induction, comprising caryophyllene. [4] A composition for reducing fatigue, comprising caryophyllene. [5] A composition for improving complexion, comprising caryophyllene. [6] A composition for improving skin quality, comprising caryophyllene. [7] A composition for treating or preventing periodontal disease, comprising caryophyllene. [8] A composition for suppressing bad breath, comprising caryophyllene. [9] The composition according to any one of [1] to [8], in which the caryophyllene is a chemically synthesized compound.

[10] The composition according to any one of [1] to [8], further comprising one or more members selected from the group consisting of solvents and fragrances.

[11] The composition according to any one of [1] to [8], in which the dosage form is a capsule.

[12] A cigarette filter containing the composition described in any one of [1] to [8].

[13] A cigarette filter incorporating the capsule described in

[11] .

[14] A cigarette comprising the cigarette filter described in

[12] .

[15] A smoking device comprising the cigarette filter described in

[12] .

[16] A cigarette containing the composition described in any one of [1] to [8].

[17] A food or drink containing the composition described in any one of [1] to [8].

[18] A pharmaceutical containing the composition described in any one of [1] to [8].

[19] The pharmaceutical described in

[18] , which is an oral composition or a pulmonary composition.

[20] A method for treating or preventing a respiratory disease, comprising administering a composition containing caryophyllene.

[21] The method described in

[20] , in which caryophyllene improves vital capacity or forced expiratory volume in one second to treat or prevent a respiratory disease.

[22] A method for improving sleep or a method for promoting sleep onset, comprising administering a composition containing caryophyllene.

[23] A method for reducing fatigue, comprising administering a composition containing caryophyllene.

[24] A method for improving complexion, comprising administering a composition containing caryophyllene.

[25] A method for improving skin quality, comprising administering a composition containing caryophyllene.

[26] A method for treating or preventing periodontal disease, comprising administering a composition containing caryophyllene.

[27] A method for suppressing bad breath, comprising administering a composition containing caryophyllene.

[28] The method according to any of

[20] to

[27] , wherein the administration is by pulmonary or oral ingestion.

[29] The method according to

[28] , wherein the pulmonary administration is by inhalation through a filter of an inhaler.

[30] A composition containing caryophyllene for use in treating or preventing respiratory diseases.

[31] A composition containing caryophyllene for use in improving sleep or promoting sleep induction.

[32] A composition containing caryophyllene for use in reducing fatigue.

[33] A composition containing caryophyllene for use in improving complexion.

[34] A composition containing caryophyllene for use in improving skin quality.

[35] A composition containing caryophyllene for use in treating or preventing periodontal disease.

[36] A composition containing caryophyllene for use in suppressing bad breath. In this specification, "%" refers to percent by mass unless otherwise specified.

[0006] According to a preferred embodiment of the present invention, there can be provided a composition capable of treating or preventing respiratory diseases, a composition capable of improving sleep or promoting sleep onset, a composition capable of reducing fatigue, a composition capable of improving complexion, a composition capable of improving skin quality, a composition capable of treating or preventing periodontal disease, a composition capable of suppressing bad breath, etc. Furthermore, according to a preferred embodiment of the present invention, there can be provided a method capable of treating or preventing respiratory diseases, a method capable of improving sleep or promoting sleep onset, a method capable of reducing fatigue, a method capable of improving complexion, a method capable of improving skin quality, a method capable of treating or preventing periodontal disease, and a method capable of suppressing bad breath.

[0007] Regarding the numerical ranges described herein, the upper and lower limits can be arbitrarily combined. For example, when a numerical range is described as "preferably 3.0 to 15, more preferably 3.2 to 13," the ranges "3.0 to 13" and "3.2 to 15" are also included in the numerical ranges described herein. Furthermore, when a numerical range is described as "preferably 30 or more, more preferably 40 or more, and preferably 100 or less, more preferably 80 or less," the ranges "30 to 80" and "40 to 100" are also included in the numerical ranges described herein. Furthermore, as a numerical range described herein, for example, "60 to 100" means a range of "60 or more (60 or more) and 100 or less (100 or less)." Furthermore, when specifying the upper and lower limits described herein, the numerical range from the lower limit to the upper limit can be specified by appropriately selecting from the respective options and arbitrarily combining them. In addition, the various features described as preferred embodiments in this specification can be combined in multiple ways.

[0008] [Caryophyllene] The composition of one embodiment of the present invention contains caryophyllene.

[0009] Examples of caryophyllene include β-caryophyllene, α-caryophyllene, isocaryophyllene, metabolites or derivatives of caryophyllene (e.g., caryophyllene oxides such as β-caryophyllene oxide), etc. The composition of one embodiment of the present invention may contain these alone or in combination of two or more.

[0010] Typically, caryophyllene preferably contains β-caryophyllene, and may further contain caryophyllene other than β-caryophyllene [e.g., at least one selected from α-caryophyllene, isocaryophyllene, and metabolites or derivatives of caryophyllene]. In such a composition containing β-caryophyllene, the proportion of β-caryophyllene in the total caryophyllene may be, for example, 30% by mass or more, 50% by mass or more, 70% by mass or more, 80% by mass or more, 90% by mass or more, 95% by mass or more, or 100% by mass (substantially 100% by mass). In this specification, the term "β-caryophyllene" may be used to collectively refer to caryophyllene other than β-caryophyllene.

[0011] Caryophyllene such as β-caryophyllene may be derived from, but is not limited to, clove, caraway, basil, oregano, hops, cinnamon, Cinnamon, rosemary, cannabis, hemp, marijuana, black pepper, lavender, malabathrum, ylang-ylang, copaiba, Guinea ginger, curry leaf, or essential oils thereof (e.g., extracted or concentrated).

[0012] Caryophyllene may be a commercially available product, or may be produced (purified) by a conventional method (chemically synthesized). An example of commercially available β-caryophyllene is caryophyllene AKY-2348 (trade name: Rilac Phyton (registered trademark)) manufactured by Inabata Fragrance Co., Ltd.

[0013] The content of caryophyllene in the composition of one embodiment of the present invention is not particularly limited, and can be appropriately selected depending on the desired function (e.g., volatilization promotion, dissolution promotion, freeze resistance, and other caryophyllene functions), dosage form, etc. For example, in the composition of one embodiment of the present invention, the content (proportion, concentration) of caryophyllene may be 0.01% by mass or more, 0.05% by mass or more, 0.1% by mass or more, 0.5% by mass or more, 1% by mass or more, 2% by mass or more, 3% by mass or more, 4% by mass or more, 5% by mass or more, 6% by mass or more, 7% by mass or more, 8% by mass or more, 9% by mass or more, 10% by mass or more, 11% by mass or more, 12% by mass or more, 13% by mass or more, 14% by mass or more, etc. 15% by mass or more, 16% by mass or more, 17% by mass or more, 18% by mass or more, 19% by mass or more, 20% by mass or more, 21% by mass or more, 22% by mass or more, 23% by mass or more, 24% by mass or more, 25% by mass or more Above, 26% by mass or more, 27% by mass or more, 28% by mass or more, 29% by mass or more, 30% by mass or more, 35% by mass or more, 40% by mass or more, 45% by mass or more, 50% by mass or more, 55% by mass or more, 60% by mass or more , 65% by mass or more, 70% by mass or more, 75% by mass or more, 80% by mass or more, 85% by mass or more, 90% by mass or more, 95% by mass or more, etc., and 99.9% by mass or less, 99.5% by mass or less, 9 9% by mass or less, 95% by mass or less, 90% by mass or less, 80% by mass or less, 70% by mass or less, 60% by mass or less, 50% by mass or less, 40% by mass or less, 30% by mass or less, 29% by mass or less, 28% by mass or less, 27 mass% or less, 26 mass% or less, 25 mass% or less, 24 mass% or less, 23 mass% or less, 22 mass% or less, 21 mass% or less, 20 mass% or less, 19 mass% or less, 18 mass% or less, 17 mass% or less, 16 qualities % or less, 15% by mass or less, 14% by mass or less, 13% by mass or less, 12% by mass or less, 11% by mass or less, 10% by mass or less, 9% by mass or less, 8% by mass or less, 7% by mass or less, 6% by mass or less.

[0014] The range of the caryophyllene concentration (proportion) may be set by appropriately combining the lower limit and upper limit of the above range (e.g., 0.1 to 90% by mass, 10 to 50% by mass, etc.) (the same applies to all ranges described in this specification.) Thus, the caryophyllene content in the composition of one embodiment of the present invention can be, for example, 1% by mass or more, 3 to 99% by mass, 5 to 80% by mass, 5 to 90% by mass, 15 to 30% by mass, etc.

[0015] Similarly, when the composition contains an oil or fat (or when caryophyllene is combined with an oil or fat), the proportion (concentration) of caryophyllene relative to the total amount (total amount) of caryophyllene and the oil or fat (when the total amount is 100% by mass) may also be selected from the caryophyllene concentration range in the above composition (e.g., 1% by mass or more, 10% by mass or more, 5 to 90% by mass, etc.).

[0016] The daily intake amount of caryophyllene is not particularly limited, but may be, for example, 0.1 mg or more, 0.5 mg or more, 1.0 mg or more, 2.0 mg or more, 3.0 mg or more, 4.0 mg or more, 5.0 mg or more, 6.0 mg or more, 7.0 mg or more, 10.0 mg or more, 15.0 mg or more, 20.0 mg or more, 30.0 mg or more, 40.0 mg or more, 50.0 mg or more, 60.0 mg or more, 70.0 mg or more, 80.0 mg or more, 90.0 mg or more, 100.0 mg or more, 150.0 mg or more, 200.0 mg or more, 250.0 mg or more, 300.0 mg or more, 350.0 mg or more, 400.0 mg or more, 500.0 mg or more, 600.0 mg or more, 700.0 mg or more, 800.0 mg or more, 900.0 mg or more, 1000 mg or more, 1500 mg or more, 2000 mg or more, 2500 mg or more, 3000 mg or more, 350.0 mg or more, 400.0 mg or more, 500 mg or more, 600.0 mg or more, 700.0 mg or more, 800.0 mg or more, 900 mg or more, 1000 mg or more, 1500 mg or more, 2000 mg or more, 2500 mg or more, 3000 mg or more, 350.0 mg or more, 400.0 mg or more, 500 mg or more, 600.0 mg or more, 700 mg or more, 800 mg 0 mg or more, 400.0 mg or more, 450.0 mg or more, 500.0 mg or more, 550.0 mg or more, 600.0 mg or more, 650.0 mg or more, 700.0 mg or more, 750.0 mg or more, 800.0 mg or more, 850.0 mg or more, 900.0 mg or more, 950.0 mg or more, 1000.0 mg or more, 1100.0 mg or more, 1200.0 mg or more, 1300.0 mg or more, 1400.0 mg or more, 1500.0 mg or more, 1600.0 mg or more, 1700.0 mg or more, 1800.0 mg or more, 1900.0 mg or more, 2000.0 mg or more and may be 5000.0 mg or less, 4500.0 mg or less, 4000.0 mg or less, 3500 mg or less, 3000.0 mg or less, 2500.0 mg or less, 2000.0 mg or less, 1900.0 mg or less, 1800.0 mg or less, 1700.0 mg or less, 1600.0 mg or less, 1500.0 mg or less, 1400.0 mg or less, 1300.0 mg or less, 1200.0 mg or less, 1100.0 mg or less, 1000.0 mg or less, 950.0 mg or less, 900.0 mg or less, 850.0 mg or less, 800.0 mg or less, 750.0 mg or less, 700.0 mg less than, 650.0 mg or less, 600.0 mg or less, 550.0 mg or less, 500.0 mg or less, 450.0 mg or less, 400.0 mg or less, 350.0 mg or less, 300.0 mg or less, 250.0 mg or less, 200.0 mg or less, 150.0 mg or less, 100.0 mg or less, 90.0 mg or less, 80.0 mg or less, 70.0 mg or less, 60.0 mg or less, 50.0 mg or less, 40.0 mg or less, 30.0 mg or less, 20.0 mg or less, 15.0 mg or less, 14.0 mg or less, 13.0 mg or less, 12.0 mg or less, 11.0 mg or less, 10.0 mg or less,It may be 9.0 mg or less, 8.0 mg or less, 7.0 mg or less, 6.0 mg or less, 5.0 mg or less, 4.0 mg or less, 3.0 mg or less, 2.0 mg or less, 1.0 mg or less, 0.9 mg or less, 0.8 mg or less, 0.7 mg or less, 0.6 mg or less, 0.5 mg or less, 0.4 mg or less, 0.3 mg or less, 0.2 mg or less, or 0.1 mg or less.

[0017] [Composition] The composition of one embodiment of the present invention may contain other ingredients depending on its form, use, target of application, etc., and examples thereof include oils and fats, carriers, excipients, binders, disintegrants, lubricants, coating agents, colorants, stabilizers, emulsifiers (surfactants), absorption enhancers, gelling agents, pH adjusters, preservatives, antioxidants, refreshing agents, physiologically active substances, bioactive substances, microorganisms, foods and beverages, plants, sweeteners, acidulants, seasonings, tonics, fragrances, etc. These ingredients may be used alone or in combination of two or more.

[0018] Examples of fats and oils include vegetable oils (e.g., soybean oil, rapeseed oil, corn oil, sesame oil, linseed oil, cottonseed oil, perilla oil, olive oil, rice oil, palm oil, jojoba oil, sunflower oil, camellia oil, etc.), animal oils (e.g., beef tallow, lard, chicken fat, milk fat, fish oil, horse oil, etc.), medium-chain triglycerides (MCT), etc. The number of carbon atoms of the fatty acids contained in MCT is preferably 5 to 15, more preferably 6 to 14, and even more preferably 6 to 12.

[0019] The oils and fats may be used alone or in combination of two or more.

[0020] Among these fats and oils, MCT may be particularly preferably used. Therefore, the fat and oil may contain at least MCT. When the fat and oil contains MCT, the ratio of MCT to the total fat and oil may be, for example, 10% by mass or more, 30% by mass or more, 50% by mass or more, 70% by mass or more, 80% by mass or more, 90% by mass or more, 100% by mass (MCT only), etc.

[0021] Fats and oils can function as a medium (solvent, carrier) for the composition, and depending on the type (e.g., MCT, etc.), they are often relatively good (or do not significantly reduce) in terms of the volatility and solubility of the flavoring, the freeze resistance of the flavoring and the fat and oil themselves, etc. From this perspective, caryophyllene and the like can be suitably substituted for a portion of the fat and oil (particularly, MCT, etc.). Furthermore, the use of fat and oil (MCT, etc.) can be advantageous in terms of encapsulation, etc. Furthermore, fat and oil appear to have little effect on the fragrance, making them easy to use in combination with flavoring and caryophyllene.

[0022] In the composition of one embodiment of the present invention, the proportion (amount, concentration) of the oil or fat may be, for example, 0.1% by mass or more (e.g., 0.5% by mass or more), 1% by mass or more (e.g., 5% by mass or more), 10% by mass or more (e.g., 15% by mass or more), 20% by mass or more (e.g., 25% by mass or more), 30% by mass or more (e.g., 35% by mass or more), 40% by mass or more (e.g., 45% by mass or more), 50% by mass or more (e.g., 55% by mass or more), 60% by mass or more (e.g., 65% by mass or more), 70% by mass or more (e.g., 75% by mass or more), 80% by mass or more (e.g., 85% by mass or more), 90% by mass or more (e.g., 95% by mass or more), or 99% by mass or less (e.g., 95% by mass or less), 90% by mass or less, 80% by mass or less, 70% by mass or less, 60% by mass or less, 50% by mass or less, 40% by mass or less, 30% by mass or less, 20% by mass or less, etc.

[0023] The carrier that may be included in the composition of one embodiment of the present invention is not particularly limited, and examples thereof include acids (e.g., fatty acids such as caprylic acid, capric acid, eicosapentaenoic acid, docosahexaenoic acid, oleic acid, and linoleic acid), hydrocarbons (e.g., liquid paraffin, squalane, and petrolatum), silicones (e.g., silicone oil, etc.), synthetic polymers (e.g., polyacrylic acid, carboxyvinyl polymer, polyethylene glycol, and polyvinylpyrrolidone), natural polymers and derivatives thereof (e.g., carrageenan, alginic acid, cellulose, guar gum, xanthan gum, quince seed, dextran, gellan gum, hyaluronic acid, ethyl cellulose, hydroxypropyl cellulose, hydroxypropylmethylcellulose, cationized guar gum, acetylated hyaluronic acid, and sodium alginate), lower alcohols (e.g., ethanol and isopropanol), polyhydric alcohols (e.g., ethylene glycol, glycerin, propylene glycol, butylene glycol, diglycerin, and dipropylene glycol), and water.

[0024] The nature of the carrier can be selected depending on the form of the composition, etc., and may be solid, liquid, etc., and may be non-volatile or volatile. A liquid carrier can also be called a solvent.

[0025] The emulsifier (surfactant) that may be contained in the composition of one embodiment of the present invention is not particularly limited, and examples thereof include nonionic surfactants [e.g., sugar fatty acid esters (e.g., sucrose fatty acid esters, maltose fatty acid esters, lactose fatty acid esters), propylene glycol fatty acid esters, glycerin fatty acid esters, sorbitan fatty acid esters, polyglycerin fatty acid esters, and organic acid monoglycerides].

[0026] When an emulsifier is used, the proportion (concentration) of the emulsifier in the composition can be selected depending on the form and application of the composition, and is not particularly limited, but can be selected, for example, from a range of about 40% by mass or less (e.g., 35% by mass or less), and may be, for example, 30% by mass or less (e.g., 25% by mass or less), preferably 20% by mass or less (e.g., 15% by mass or less), more preferably 10% by mass or less (e.g., 8% by mass or less), or 5% by mass or less (e.g., 4% by mass or less, 3% by mass or less, 1% by mass or less, etc.).

[0027] The lower limit of the proportion (concentration) of the emulsifier can be selected depending on the form and application of the composition, and is not particularly limited, but may be, for example, 0.01 mass%, 0.1 mass%, 0.5 mass%, 0.7 mass%, 1 mass%, 1.2 mass%, 1.5 mass%, 2 mass%, 3 mass%, etc.

[0028] An emulsifier can significantly reduce the interfacial tension of a composition. Therefore, when the composition is used as the content of a capsule (e.g., a seamless capsule produced by a dropping method, etc.), encapsulation is likely to be hindered. From this perspective, when the composition is used as the content of a capsule, it is desirable to use no emulsifier (or substantially no emulsifier). Even if an emulsifier is used, it is desirable to use a relatively small amount (e.g., 5% by mass or less, 3% by mass or less, etc., of the composition).

[0029] The composition of one embodiment of the present invention may contain at least one component selected from dicarboxylic acid esters, diol esters, monocarboxylic acid esters, esters of polyols having three or more hydroxy groups, esters of polycarboxylic acids having three or more carboxy groups, polyol ethers, polyamines, and alcohols having six or more carbon atoms. Such components can function as a medium (solvent, carrier), and are often relatively good in terms of solubility of fragrances (e.g., menthol-containing fragrances) and freeze resistance of the fragrances and fats and oils themselves. In particular, such components, when combined with caryophyllene, may further improve the solubility of fragrances and the freeze resistance of the fragrances and fats and oils themselves.

[0030] Administration of the compositions of one aspect of the present invention may be by a wide variety of routes of administration, including, but not limited to, oral, parenteral, pulmonary, intraperitoneal, intravenous, intraarterial, transdermal, sublingual, intramuscular, rectal, transbuccally, intranasal, via inhalation, intravaginally, intraocularly, via topical delivery, subcutaneous, intraadipose, intraarticular, and intrathecal. In one particular variation, administration is oral or pulmonary.

[0031] Oral administration can involve swallowing, where the composition enters the bloodstream via the digestive tract. Alternatively, or in addition, oral administration can involve mucosal administration (e.g., buccal, sublingual, supralingual), where the compound enters the bloodstream via the oral mucosa.

[0032] Formulations suitable for oral administration include solid, semi-solid, and liquid systems, such as tablets; soft or hard capsules containing multiparticulates or nanoparticles, liquids, powders, or liposomes; troches that may be liquid-filled; chews; gels; fast-dispersing dosage forms; films; ovules; sprays; and buccal or mucoadhesive patches. Liquid formulations include suspensions, solutions, syrups, and elixirs. Such formulations may be used as fillers for soft or hard capsules (e.g., made of gelatin or hydroxypropylmethylcellulose), and typically contain a carrier (e.g., water, ethanol, polyethylene glycol, propylene glycol, methylcellulose, or a suitable oil) and one or more emulsifiers, suspending agents, or both. Liquid formulations can also be prepared by reconstituting a solid (e.g., from a sachet).

[0033] Pulmonary ingestion can be achieved by any method that allows caryophyllene to be ingested. Examples include breathing in a space where caryophyllene has been vaporized, inhalation through an inhaler, etc. An example of inhalation through an inhaler is inhalation through a filter of the inhaler (e.g., smoking a cigarette with a caryophyllene-containing capsule in the filter).

[0034] Caryophyllene may also be in a fast-dissolving, fast-disintegrating dosage form.

[0035] For tablet dosage forms, depending on the dose, the active pharmaceutical ingredient (API) comprises from about 1% to about 80% by weight of the dosage form, more typically from about 5% to about 60% by weight of the dosage form. In addition to the API, tablets may contain one or more disintegrants, binders, diluents, surfactants, glidants, lubricants, antioxidants, colorants, flavorings, preservatives, and taste-masking agents. Examples of disintegrants include sodium starch glycolate, sodium carboxymethylcellulose, calcium carboxymethylcellulose, croscarmellose sodium, crospovidone, polyvinylpyrrolidone, methylcellulose, microcrystalline cellulose, C1-6 alkyl-substituted hydroxypropylcellulose, starch, pregelatinized starch, and sodium alginate. Generally, the disintegrant comprises from about 1% to about 25% by weight or from about 5% to about 20% by weight of the dosage form.

[0036] Binders are generally used to give tablet formulations cohesion.Suitable binders include microcrystalline cellulose, gelatin, sugar, polyethylene glycol, natural and synthetic gums, polyvinylpyrrolidone, pregelatinized starch, hydroxypropyl cellulose, and hydroxypropyl methylcellulose.Tablets can also contain diluents such as lactose (monohydrate, spray-dried monohydrate, anhydrous), mannitol, xylitol, dextrose, sucrose, sorbitol, microcrystalline cellulose, starch, and calcium hydrogen phosphate dihydrate.

[0037] Tablets may also include surfactants, such as sodium lauryl sulfate and polysorbate 80, and glidants, such as silicon dioxide and talc. If included, surfactants may comprise from about 0.2% to about 5% by weight of the tablet, and glidants may comprise from about 0.2% to about 1% by weight of the tablet.

[0038] Tablets may also contain lubricants, such as magnesium stearate, calcium stearate, zinc stearate, sodium stearyl fumarate, and mixtures of magnesium stearate with sodium lauryl sulfate. Lubricants may comprise from about 0.25% to about 10%, or from about 0.5% to about 3% by weight of the tablet.

[0039] Tablet blends may be compressed directly or by roller compaction to form tablets. Alternatively, tablet blends or portions of blends may be wet-, dry-, or melt-granulated, melt congealed, or extruded before tableting. If desired, one or more of the ingredients may be fractionated by sieving, milling, or both, before blending. The final dosage form may comprise one or more layers and may be coated, uncoated, or encapsulated.

[0040] Consumable oral films for human or animal use are flexible, water-soluble or water-swellable thin-film dosage forms that can be fast-dissolving or mucoadhesive. In addition to the API, typical films contain one or more film-forming polymers, binders, humectants, plasticizers, stabilizers or emulsifiers, viscosity modifiers, and solvents. Other film ingredients may include antioxidants, colorants, flavors and flavor enhancers, preservatives, salivary gland stimulants, cooling agents, cosolvents (including oils), emollients, bulking agents, antifoaming agents, surfactants, and taste-masking agents. Some components of the formulation may serve more than one function.

[0041] In addition to dosage requirements, the amount of API in the film may depend on its solubility. If water-soluble, the API typically comprises from about 1% to about 80% by weight of the non-solvent components (solutes) of the film, or from about 20% to about 50% by weight of the solutes of the film. Less soluble APIs may comprise a larger proportion of the composition, typically up to about 88% by weight of the non-solvent components of the film.

[0042] The film-forming polymer may be selected from natural polysaccharides, proteins, or synthetic hydrocolloids and typically comprises from about 0.01% to about 99% or from about 30% to about 80% by weight of the film.

[0043] Film dosage forms are typically prepared by evaporative drying of thin aqueous films applied to a peelable support or backing paper, which may be carried out in a drying oven or drying passage (e.g., a combined coater-dryer), a freeze-dryer, or a vacuum oven.

[0044] Formulations suitable for pulmonary administration include solid, semisolid, and liquid systems, such as tablets; multiparticulate or nanoparticles; liquids; powders; or liposomes. Liquid formulations are preferably used for pulmonary administration, including suspensions, solutions, syrups, and elixirs. These formulations can be used as fillers for soft capsules (including seamless capsules) or hard capsules. Pulmonary administration can be achieved using cigarettes (cigarette filters), smoking devices, inhalers, etc.

[0045] [Capsule] The dosage form of the composition of one embodiment of the present invention may be a capsule. The capsule may be composed of only a membrane (shell), but preferably comprises a core and a shell.

[0046] The capsule may be a soft capsule, a hard capsule, or a seamless capsule (capsule without seams), etc. In particular, capsules for tobacco, etc. may be seamless capsules.

[0047] In the capsule, the form of the composition is not particularly limited and may be a shell, a core, or both of these, but particularly in a capsule having a core (seamless capsule), the core (at least the core) may contain the composition.

[0048] The shell may usually contain a film-forming component (film-forming base, film-forming agent). The shell-forming component is not particularly limited and can be appropriately selected depending on the intended use of the capsule, and examples thereof include polysaccharides (or derivatives thereof) {for example, seaweed-derived polysaccharides [for example, agar, carrageenan, alginic acid or a salt thereof (for example, metal salts such as alkali metal salts (sodium salt, potassium salt, etc.), alkaline earth metal salts (calcium salt, magnesium salt, etc.), iron salt, tin salt, etc.), furcellaran, curdlan, etc.], resin-derived polysaccharides (for example, gum ghatti, gum arabic, etc.), microbial-derived polysaccharides (for example, pullulan, welan gum, xanthan gum, gellan gum, etc.), plant-derived polysaccharides (for example, tragacanth gum, pectin, glucomannan, starch, polydextrose, dextrin, maltodextrin, cyclodextrin, indigestible dextrin, etc.), seed-derived polysaccharides [ Examples of the film-forming component include guar gum or its derivatives (e.g., hydroxypropyl guar gum, cationized guar gum, guar gum hydrolysates (e.g., guar gum enzymatic hydrolysates), tara gum, tamarind seed gum, locust bean gum, psyllium seed gum, and flax seed gum), fermented polysaccharides (e.g., diutan gum), cellulose derivatives (e.g., hydroxypropyl cellulose, hydroxypropylmethyl cellulose, methyl cellulose, and carboxymethyl cellulose), chitosan, and the like), synthetic resins (e.g., polyvinyl alcohol), proteins (e.g., gelatin, casein, and zein), and sugar alcohols (e.g., sorbitol, maltitol, lactitol, palatinit, xylitol, mannitol, galactitol, and erythritol). The film-forming component may be used alone or in combination of two or more.

[0049] The film-forming component may be capable of forming a hydrophilic colloid, and depending on the type, may function as a plasticizer, sweetener, dietary fiber, bulking agent, etc. Commercially available film-forming components may be used.

[0050] The coating may contain plasticizers, colorants, sweeteners, flavorings, antioxidants, preservatives, and the like.

[0051] For example, the coating may contain a plasticizer to adjust the coating strength, etc. Examples of the plasticizer include polyhydric alcohols (e.g., (poly)alkylene glycols such as ethylene glycol, propylene glycol, polyethylene glycol, and polypropylene glycol; polyols having three or more hydroxyl groups such as glycerin), sugars [e.g., monosaccharides (e.g., glucose, fructose, glucose, and galactose), disaccharides (e.g., sucrose, maltose, trehalose, and coupling sugar), oligosaccharides (e.g., maltooligosaccharides)], sugar alcohols (e.g., sorbitol, maltitol, and lactitol), and the like. Examples of suitable plasticizers include sugar alcohols such as those exemplified above, such as ethanol, palatinite, xylitol, mannitol, galactitol, and erythritol, polysaccharides or derivatives thereof [for example, starch, starch derivatives (for example, polydextrose, dextrin, maltodextrin, indigestible dextrin, cyclodextrin (α, β, or γ)), cellulose derivatives (for example, hydroxypropyl cellulose, hydroxypropylmethyl cellulose, methyl cellulose, carboxymethyl cellulose)], polyvinyl alcohol, and triacetin. Plasticizers may be used alone or in combination of two or more. As mentioned above, sugar alcohols, starch, and starch derivatives may also be used as film-forming components.

[0052] In capsules having a core, the core may be solid, liquid, or the like, but in particular, capsules containing the composition of the present invention may be liquid. The liquid state also includes colloidal, emulsion, jelly, and the like.

[0053] The core preferably contains caryophyllene and may further contain other ingredients as described above (disintegrants, binders, diluents, surfactants, glidants, lubricants, antioxidants, colorants, flavoring agents, preservatives, taste masking agents, etc.).

[0054] The core may generally be non-dissolving (non-eroding) relative to the coating (or the portion in contact with the coating).

[0055] The diameter (diameter, average diameter) of the capsule (or shell) can be appropriately selected depending on the type of capsule, application, etc., and may be, for example, 0.1 mm or more, 0.5 mm or more, 1 mm or more, 1.5 mm or more, 2 mm or more, etc., or 30 mm or less, 25 mm or less, 20 mm or less, 18 mm or less, 15 mm or less, 12 mm or less, 10 mm or less, 8 mm or less, etc. Specific capsule diameters include, but are not limited to, 2.8 mm, 3.0 mm, 3.4 mm, 3.5 mm, 4.0 mm, etc.

[0056] In a capsule having a core, the shell ratio (the ratio of the shell to the entire capsule (total amount of the shell and encapsulation)) may be selected, for example, from a range of about 0.1 to 99% by mass (e.g., 0.5 to 95% by mass), and may be about 1 to 90% by mass, preferably about 1.5 to 80% by mass (e.g., 2 to 70% by mass), and more preferably about 2.5 to 60% by mass (e.g., 3 to 50% by mass).

[0057] In a capsule having a core, the thickness of the shell is not particularly limited and may be, for example, 1 to 200 μm, 3 to 150 μm, or 5 to 100 μm.

[0058] The capsule (e.g., a capsule having a core) may be breakable (disintegrable) (e.g., easily disintegrable, easily frangible). In such capsules, the breaking strength depends on the capsule diameter and the like, and may be, for example, 100 g or more, 200 g or more, 300 g or more, 400 g or more, 500 g or more, 600 g or more, 700 g or more, 800 g or more, 900 g or more, 1000 g or more, etc. The upper limit of the capsule breaking strength is not particularly limited, and may be, for example, 20,000 g or less, 15,000 g or less, 12,000 g or less, 10,000 g or less, etc. The breaking strength (g) can be measured, for example, at 22°C and 60% RH using a rheometer CR-500DX (measuring instrument, manufactured by Sun Scientific Co., Ltd.) and analyzed using a rheological data analyzer (Rheo Data analyzer for Win, automatic physical property data analysis software, manufactured by Sun Scientific Co., Ltd.).

[0059] In a capsule (e.g., a capsule having a content), the ratio of breaking strength (g) to outer diameter (mm) (breaking strength / outer diameter) is not particularly limited, but may be, for example, 200 or more (e.g., more than 200), preferably 210 or more (e.g., 220 or more), more preferably 230 or more (e.g., 240 or more), or may be 250 or more, 300 or more, 400 or more, etc. The upper limit of the ratio of breaking strength to outer diameter (breaking strength / outer diameter) is not particularly limited, and may be, for example, 20,000, 15,000, 10,000, 8,000, 6,000, 5,000, etc.

[0060] It is conceivable that a capsule may be easily broken even if it has a high breaking strength (for example, when the outer diameter is large), and therefore, the ratio of breaking strength to outer diameter can be said to be an index that reflects the actual ease of breaking a capsule.

[0061] The rupture distance of the capsule may vary depending on the outer diameter, etc., but may be, for example, 0.1 mm or more, 0.2 mm or more, 0.5 mm or more, 1.0 mm or more, etc. The upper limit of the rupture distance of the soft capsule is not particularly limited, but may be, for example, 15 mm or less, 10 mm or less, 8 mm or less, etc. The rupture distance can be measured, for example, using a rheometer CR-3000EX (manufactured by Sun Scientific Co., Ltd.).

[0062] In the capsule, the ratio of the breaking distance (mm) to the outer diameter (mm) (breaking distance / outer diameter) is not particularly limited, but may be, for example, 0.1 or more, preferably 0.12 or more, more preferably 0.15 or more, or may be 0.18 or more, 0.2 or more, etc. The upper limit of the ratio of the breaking distance to the outer diameter (breaking distance / outer diameter) is not particularly limited, and may be, for example, 1.0, 0.98, 0.97, 0.96, 0.95, etc.

[0063] Depending on the application, the capsules may be used as they are, or may be used in combination with other capsules, or may be incorporated into a filter as described below.

[0064] Other capsules may be capsules that do not contain caryophyllene, such as capsules that are composed of a core and a shell and contain no caryophyllene in either the core or the shell.

[0065] A known method can be used to manufacture a capsule (for example, a seamless capsule). Examples of the manufacturing method include those described in Japanese Patent No. 5047285, Published Japanese Translation of PCT International Application No. 10-506841, and Japanese Patent No. 5581446. For example, a submerged dropping method using a double or more nozzle can be used. Using this method, a capsule content liquid is filled into the capsule shell, and the shell is then hardened and dried, thereby manufacturing a seamless capsule.

[0066] The capsules can be used in medicines, foods and beverages, tobacco, tobacco filters, smoking implements, inhalers, and the like.

[0067] [Food and Drink] A food and drink according to one embodiment of the present invention comprises the composition of the present invention. The food and drink may be prepared as a functional food, health food, food for specified health uses, food with nutrient function claims, or other health-promoting food, a food for special dietary uses (e.g., food for patients), a health supplement, a supplement, or the like. As a supplement, the composition may be in the form of, for example, a tablet, a pill, a capsule (including hard capsules, soft capsules, microcapsules, and seamless capsules), a powder, a granule, a fine granule, a lozenge, or a liquid (including a syrup, milk, or suspension) together with various additives commonly used in the manufacture of supplements. Furthermore, in addition to caryophyllene, the food and drink such as supplements of one embodiment of the present invention may contain other ingredients such as GABA, L-theanine, milk protein hydrolysate, chamomile extract, bacopa monniera extract, St. John's wort extract, lemon balm extract, yuzu seed extract, artichoke extract, Skeletium tortuosum extract, Rhodiola rosea extract, hesperidin (monoglucosyl hesperidin), holy basil extract, guanzhou extract, valerian extract, passion flower extract, longan extract, saffron extract, horsetail extract, elastin, black soybean seed coat extract, long pepper extract, cinnamon bark powder, cinnamon bark extract, rutin, quercetin, star fruit leaf extract, shell ginger leaf extract, black turmeric extract, ginger (extract, powder), pine bark extract, black currant extract, plum extract, amla extract, camellia seed extract, nuts, Vitamin E, L-arginine, L-citrulline, tocotrienols, vitamin E, garlic, cocoa, chili pepper extract, French maritime pine bark extract, seaweed extract, Rahmania extract, crocetin, silkworm bark extract, tart cherry extract, okra seed extract, French oak extract, coenzyme Q10, moringa extract, olive leaf extract, royal jelly, imidazole dipeptide, lychee polyphenols, black plum extract, oyster extract, arginine, ornithine, ginseng, soft-shelled turtle, maca, chive seed extract, Cistanche Tubulosa, astaxanthin, vitamin B complex, American ginseng extract, Eleuthero extract, L-carnitine, caffeine, ceramide, hyaluronic acid, lactic acid bacteria, mangosteen extract, proteoglycan, placenta extract, cherry blossom extract, tomato seed extract, Centella asiatica extract, strawberry seed extract,Eggshell membrane powder, lingonberry extract, Atractylodes macrocarpa extract, passion fruit extract, dragon's head extract, berry mix, collagen, citrus and rosemary extract, water chestnut extract, purple chrysanthemum powder, rosemary, olive leaf, lemon verbena, sophora leaf extract, hibiscus, fennel, fenugreek extract, blackcurrant polyphenol, grape seed extract, Job's tears extract, β-cryptoxanthin, hydroxylated isoflavone, broccoli sprout extract, Houttuynia cordata, hawthorn, Roman chamomile, grape leaf extract, red paprika-derived xanthophyll, It may contain one or more ingredients selected from the group consisting of copine, golden tomato extract, red orange extract, melon extract, maquillage extract, pfaffia extract, fulvic acid, houttuynia cordata extract, kiwi seed extract, bird's nest extract, rooibos extract, bay laurel extract, champignon extract, lactoferrin / lactoperoxidase, white curcumin, pumice extract, persimmon tannin, manuka honey, phosphorylated oligosaccharide calcium, cyclic isomaltooligosaccharide, tea catechin, green tea fluoride, polyglutamic acid, mastic, cranberry, theaflavin, parsley seed oil, perilla fruit extract, vitamin C, lactic acid bacteria BLIS K12, lactic acid bacteria BLIS M18, spore-forming lactic acid bacteria (sporus) Bacillus coagulans Unique IS-2, and hydroxyapatite.

[0068] The food and beverage products of the present invention are not particularly limited, but examples include confectioneries such as candy, gummy candies, chewing gum, etc.; confectioneries such as cookies, crackers, biscuits, chocolate, pudding, jelly, snacks, rice crackers, buns, yokan, etc.; frozen desserts such as ice cream, popsicles, sorbet, gelato, etc.; bakery foods such as donuts, cakes, bread, French baguettes, croissants, etc.; noodles such as udon, soba, Chinese noodles, and Kishimen noodles, etc.; cooked rice dishes such as white rice, red rice, and pilaf, etc.; sauces such as curry, stew, and dressing, etc.; paste products such as ham, sausage, kamaboko, chikuwa, and fish sausage, etc.; various prepared dishes such as tempura, croquettes, and hamburger steaks, etc.; and beverages such as juice and tea.

[0069] For example, the composition for treating or preventing respiratory diseases according to the present invention can be used in a food with functional claims, such as "suppresses respiratory diseases" or "relieves throat or lung discomfort." For example, the composition for improving sleep or promoting sleep induction according to the present invention can be used in a food with functional claims, such as "improves sleep onset" or "improves or alleviates insomnia symptoms." For example, the composition for reducing fatigue according to the present invention can be used in a food with functional claims, such as "relieves fatigue" or "for those who have difficulty recovering from fatigue." For example, the composition for improving complexion according to the present invention can be used in a food with functional claims, such as "for those who are concerned about facial complexion." For example, the composition for improving skin quality according to the present invention can be used in a food with functional claims, such as "improves rough skin." For example, the composition for treating or preventing periodontal disease according to the present invention can be used in a food with functional claims, such as "for those who are concerned about bleeding from the gums." For example, the composition for suppressing bad breath according to the present invention can be used in a food with functional claims, such as "for those who are concerned about bad breath" or "prevents bad breath."

[0070] [Tobacco] The composition of one embodiment of the present invention can be used in tobacco, and for example, the composition can be incorporated into (or attached to) various parts of tobacco (tobacco leaves, filters, etc.). By using the composition in tobacco, caryophyllene can be administered via the lungs.

[0071] Examples of such embodiments include those in which the composition is incorporated into tobacco leaf parts or the like (e.g., cigarettes, cigars, pipes, hookahs, smokeless tobacco (e.g., chewing tobacco, snuff (snus, snuff, etc.)), those in which a filter containing the composition is used in a cigarette, and those in which a capsule containing the composition (preferably a destructible (disintegrable) capsule) is disposed in a filter. When a capsule is provided in a filter, it is preferable that the capsule be disintegrated during smoking, allowing vaporized caryophyllene to be inhaled along with the tobacco smoke, etc. Capsules used in cigarettes preferably comprise a core (contents, liquid contents, inclusions) and a shell (film, coating, capsule coating). Cigarettes using the composition of one embodiment of the present invention are not particularly limited, and may be combustible tobacco (e.g., cigarettes, cigars, pipes, hookahs, bongs) or non-combustible tobacco (e.g., heated tobacco (direct heating, air heating, etc.), smokeless tobacco, etc.).

[0072] In a more specific embodiment, a composition (caryophyllene, menthol, etc.), which may be encapsulated, is contained in an inhalable substance (e.g., the liquid portion of a smoking device) in a tobacco. By using the composition in an inhalable substance in this manner, caryophyllene (and also menthol) can be efficiently ingested through the lungs.

[0073] When used in such inhalants (liquids, etc.), the compositions of the present invention may contain other ingredients in addition to caryophyllene (and also oils and / or menthol), and may typically contain a carrier [a liquid carrier, for example, a polyhydric alcohol (e.g., glycerin, propylene glycol, etc.)], and may further contain a fragrance (flavor liquid) if necessary.

[0074] In the inhalant (liquid, etc.), the proportion of caryophyllene, etc. may be selected from the same range as above.

[0075] [Inhalation Device] In the inhalation device of one embodiment of the present invention, the manner of use of the composition is not particularly limited, and examples include embodiments in which the composition is contained in (attached to) various parts of the inhalation device. The inhalation device may contain the composition in the form of a capsule containing the composition. By using the inhalation device, caryophyllene can be administered via the lungs.

[0076] The inhalation device is not particularly limited, but examples thereof include smoking devices. Examples of smoking devices include heated tobacco (vapor heated, etc.), electronic cigarettes, pipes, hookahs, bongs (water pipes, hookahs), vaporizers, etc. Heat-not-burn tobacco allows nicotine to be ingested, while electronic cigarettes do not contain nicotine. Examples of heated tobacco include, but are not limited to, iQOS (Philip Morris), GLO (British American Tobacco), Ploom S, Ploom TECH (Japan Tobacco), and PULZ (Imperial Tobacco). Examples of electronic cigarettes include, but are not limited to, ego AIO (Joyetech) and ICE VAPE (Commonwealth).

[0077] In a more specific embodiment, an optionally encapsulated composition (caryophyllene, menthol, etc.) is contained in an inhalation device (e.g., a smoking device such as a heated tobacco product (e.g., a vapor-heated tobacco product), an electronic cigarette, or a bong) to be inhaled (e.g., the liquid portion of the smoking device). By using the composition in an inhalation device in this manner, caryophyllene (and also menthol) can be efficiently ingested via pulmonary ingestion.

[0078] When used in such inhalants (liquids, etc.), the composition of the present invention may contain other ingredients in addition to caryophyllene (and also oils and / or menthol), just as with tobacco, and may typically contain a carrier [a liquid carrier, for example, a polyhydric alcohol (e.g., glycerin, propylene glycol, etc.)], and may further contain a fragrance (flavor liquid) if necessary.

[0079] In the inhalant (liquid, etc.), the proportion of caryophyllene, etc. may be selected from the same range as above.

[0080] [Filter] In a filter, the mode of use of the composition of the present invention is not particularly limited, and examples include modes in which the composition is contained in (adhered to) various parts of the filter (filter material, filter member).

[0081] In particular, such a filter may be a filter containing a capsule (a filter having a capsule built in, a filter composed of a filter member having a capsule built in).

[0082] That is, such a filter includes a capsule (first capsule) containing the composition (caryophyllene, menthol, oil). As the first capsule, the capsules described in the above section on capsules can be used, and in particular, the capsule (first capsule) is preferably a capsule composed of a core and a shell, the core (content) of which contains the composition of the present invention (the composition of the present invention).

[0083] It should be noted that such a filter is sufficient as long as it includes at least a first capsule as a capsule, and may also include a second capsule that is different from the first capsule.

[0084] The second capsule may be any capsule different from the first capsule, for example, the second capsule may be a capsule containing a content different from the content of the first capsule.

[0085] Examples of such second capsules include capsules that are composed of a core and a shell, and the core (and shell) contains at least one of a carrier and a flavoring (particularly, does not contain caryophyllene).

[0086] The capsules contained in the filter as described above can be those described in the capsule section above, and the capsules that do not contain caryophyllene (second capsules, etc.) can be those described in the capsule section above, except for the presence or absence of caryophyllene.

[0087] The filter is not particularly limited, and may be, for example, a filter for cigarettes, inhalers, air conditioners, air purifiers, etc.

[0088] In particular, filters containing the capsules are suitable for use as cigarette filters, etc. By using the capsules in cigarette filters, etc., caryophyllene (and menthol) can be efficiently ingested via pulmonary ingestion.

[0089] The number of capsules in a filter or the like can be appropriately selected depending on the application, and may be 1 or 2 or more. For example, as described above, the filter may be composed of only a first capsule (one type of capsule), or may further include a second capsule different from the first capsule. The number of such first capsules and the number of such second capsules may each be 1 or 2 or more.

[0090] As used herein, "respiratory disease" refers to a disease, disorder, or injury of the respiratory tract. The respiratory tract is composed of the airways, which are the passageways for air, and the alveoli, which are the sites of gas exchange. The airways consist of the nasal cavity, pharynx, laryngotrachea, and bronchi. Respiratory diseases include chronic obstructive pulmonary disease (COPD), bronchitis, emphysema, interstitial pneumonia, bronchial asthma, and respiratory failure. As used herein, "chronic obstructive pulmonary disease (COPD)" refers to a pulmonary disease caused by long-term inhalation exposure to harmful substances, primarily tobacco smoke, and exhibits airflow obstruction in respiratory function tests. Airflow obstruction refers to a condition in which the patient is unable to exhale smoothly due to narrowing of the airways during forced expiration. Airflow obstruction occurs when peripheral airway lesions and emphysematous lesions are combined in varying proportions. Clinically, COPD presents with gradually progressive exertional dyspnea and chronic cough and phlegm, but these symptoms may be absent. Diagnosis requires a spirometry test to determine a forced expiratory volume in one second (FEV1) of less than 70% after inhaling a bronchodilator, and the exclusion of other diseases that may cause airflow obstruction. Treatment options include smoking cessation, drug therapy, and exercise therapy. Spirometry is a test that measures the amount of air moving in and out of the lungs, and can be performed using a device called a spirometer, for example.

[0091] In this specification, "improving sleep" refers to an increase in non-REM sleep time, an increase in sleep time per day, and improved waking the next morning, and "promoting sleep onset" refers to a shortening of sleep onset latency, etc.

[0092] In this specification, "fatigue relief" includes improvement of specific discomfort, improvement of decreased physical activity capacity accompanied by a desire for rest, improvement of thinking ability, improvement of activity level, improvement of attention, improvement of muscle stiffness, tension, improvement of tension, promotion of blood flow, increase in vitality, relaxation, unwinding, refreshment, etc.

[0093] As used herein, "improving complexion" refers to improving skin color and luster.

[0094] As used herein, "skin quality" refers to the degree of skin translucency, stratum corneum delamination, skin elasticity, and skin moisture retention, and improving skin quality refers to an improvement in these. [Periodontal disease] As used herein, "periodontal disease" refers to a condition in which any of the periodontal tissues that support the teeth, namely, the gingiva, alveolar bone, cementum, or periodontal ligament, is impaired, and typical examples of such diseases include chronic marginal periodontitis. Periodontal disease is a lifestyle-related disease that affects approximately 80% of adults and is caused by bacterial infection.

[0095] [Bad breath] In this specification, "bad breath" is a general term for all bad breath odors that come out of the mouth, and can be caused by anything from odorous food remaining in the mouth to systemic illness. The main components of bad breath include hydrogen sulfide, methyl mercaptan, and dimethyl disulfide, and these sulfur-containing compounds are said to be the main causes of bad breath.

[0096] [Vital capacity] In this specification, "vital capacity" refers to the volume of air when one takes a deep breath and then slowly exhales it all. Vital capacity can be measured, for example, using a device called a spirometer. When measured using a spirometer, vital capacity refers to the volume of air from the maximum inhalation position to the maximum exhalation position. If vital capacity is reduced, it is possible that the lungs have become stiff or the respiratory muscles have weakened, reducing the amount of air the lungs can take in. Diseases such as interstitial pneumonia, schizoidosis, pulmonary fibrosis, and pleurisy are suspected.

[0097] [1-second rate] In this specification, "1-second rate" refers to the percentage of the total amount of air exhaled in one second after inhaling fully and then exhaling it all at once with maximum force. The 1-second rate can be measured, for example, using a device called a spirometer. When measured with a spirometer, the 1-second rate refers to the percentage of the forced vital capacity (FV) in one second. FV refers to the amount of air exhaled in the first second of the forced vital capacity. A normal FV is 70% or higher. A decreased FV is thought to indicate a condition in which the bronchi are narrowed and the patient is unable to exhale all at once, suggesting obstructive ventilation disorders. Obstructive ventilation disorders include chronic obstructive pulmonary disease and bronchial asthma.

[0098] The present invention will be described in more detail below with reference to examples, but the present invention is not limited to these examples. The examples in this specification demonstrate the adverse effects induced by nicotine intake, but these effects are not limited to the adverse effects of nicotine intake. For example, the following effects are also anticipated: a respiratory disease treatment effect for respiratory diseases induced by other factors such as age, sex, passive smoking, and air pollution; a respiratory disease prevention effect; a sleep improvement effect and sleep induction promotion effect for sleep disorders, insomnia, etc.; a fatigue reduction effect for fatigue, etc.; a complexion improvement effect for poor complexion; a skin quality improvement effect for rough skin, dry skin, etc.; a periodontal disease treatment effect and periodontal disease prevention effect for periodontal disease, etc.; and a halitosis suppression effect for bad breath, etc.

[0099] Furthermore, in the examples of this specification, pulmonary ingestion of β-caryophyllene has been described, for example, by smoking a cigarette containing a β-caryophyllene-containing capsule in the filter. However, this is not limited to this, and any method that results in the ingestion of β-caryophyllene can be used. Examples include pulmonary ingestion using an inhaler that inhales volatilized β-caryophyllene without burning it, and pulmonary ingestion by dispersing β-caryophyllene into the air using an aromatic agent containing β-caryophyllene. Oral ingestion also includes mixing β-caryophyllene with food or beverages and orally ingesting it.

[0100] [Preparation of Easily Disintegrating Capsules] In order to manufacture a capsule-containing cigarette filter, the following four types of easily disintegrating capsules were prepared by the dropping method as capsules to be placed inside the filter. The specific preparation methods were as follows.

[0101] The content liquids of Capsules 1 to 4 were prepared. The weights of the content liquids of Capsules 1 to 4 were all 19.3 mg. Content liquid of Capsule 1: 100% by mass of MCT; Content liquid of Capsule 2: 5% by mass of β-caryophyllene, 95% by mass of MCT; Content liquid of Capsule 3: 15% by mass of β-caryophyllene, 85% by mass of MCT; Content liquid of Capsule 4: 30% by mass of β-caryophyllene, 70% by mass of MCT. The β-caryophyllene in the content liquid of the capsules was caryophyllene AKY-2348 (trade name: Lilac Phyton (registered trademark)) manufactured by Inabata Fragrance Co., Ltd., and the MCT was a compressed fruit product of Elaeis guineensis manufactured by Kao Corporation. The content liquids of Capsules 1 to 4 prepared in this manner were filled into seamless capsules (easily disintegrating capsules) by the dropping method. The diameter of Capsules 1 to 4 was 3.4 mm (shell thickness 50 μm, content liquid mass 19.3 mg).

[0102] The capsule shell had the following formulation: Gellan gum (Kelcogel; manufactured by CP Kelco) 35% by weight, pork gelatin (BCN250SC; manufactured by Nitta Gelatin) 55% by weight, reduced starch hydrolysate (PO10; manufactured by Toa Kasei) 5% by weight, glycerin (food additive glycerin; manufactured by Sakamoto Yakuhin) 4.5% by weight, Blue No. 1 (manufactured by San-ei Gen FFI) 0.5% by weight. Capsules 1 to 4 had a breaking strength of 1,530 g and a breaking distance of 1.4 mm.

[0103] [Example 1] 1. Preparation of Cigarettes Containing Capsules The four types of capsules prepared were inserted into the center of the cigarette filters of the following commercially available cigarettes: Cigarettes using Capsule 1 (Comparative Examples 1-1 to 1-3) Cigarettes using Capsule 2 (Examples 1-1 to 1-5) Cigarettes using Capsule 3 (Examples 1-6 to 1-9) Cigarettes using Capsule 4 (Examples 1-10 to 1-12)

[0104] Cigarettes using Capsule 1 (Comparative Examples 1-1 to 1-3) Cigarette 1: Lark Ultra 1mg KS box (nicotine 0.1mg, tar 1mg) Cigarette 2: Winston Cabin Red 8 100's box (nicotine 0.7mg, tar 8mg) Cigarette 3: Lark Super Mild 100's box (nicotine 0.5mg, tar 6mg) Cigarettes using Capsule 2 (Examples 1-1 to 1-5) Cigarette 4: Marlboro Black Menthol 8 box (nicotine 0.6mg, tar 8mg) Cigarette 5: Lark Mild 100 box (nicotine 0.7mg, tar 9mg) Cigarette 6: Natural American Spirit Organic Mint ONE (nicotine 0.1mg, tar 1mg) Cigarette 7: Marlboro Medium box (nicotine 0.7mg, tar 8mg) Cigarette 8: Cigarette using Hi-Lite (nicotine 1.4 mg, tar 17 mg) capsule 3 (Examples 1-6 to 1-9) Cigarette 9: Lark Extra 3 mg 100 box (nicotine 0.2 mg, tar 3 mg) Cigarette 10: Winston Castor White 5 box (nicotine 0.4 mg, tar 5 mg) Cigarette 11: Virginia S Duo Menthol 10's (nicotine 0.1 mg, tar 1 mg) Cigarette 12: Marlboro Medium box (nicotine 0.7 mg, tar 8 mg) cigarette using capsule 4 (Examples 1-10 to 1-12) Cigarette 13: Natural American Spirit Organic Leaf Turquoise (nicotine 1.5 mg, tar 12 mg) Cigarette 14: Winston Castor White 5 box (nicotine 0.4 mg, tar 5 mg) Cigarette 15: Cool Lite box (nicotine 0.4 mg, tar 5 mg)

[0105] 2. Pulmonary Intake of β-Caryophyllene (Vital Capacity, Forced Exercise in 1 Second) The capsules in the filters of these cigarettes were compressed and ruptured, and the cigarettes were lit. Healthy subjects smoked the number of cigarettes listed in Tables 1 to 4 per day for 12 weeks. The subjects' vital capacity and forced expiratory volume in 1 second were measured using a spirometer immediately before the start of the study (initial stage) and every four weeks thereafter. The vital capacity and forced expiratory volume in 1 second were measured using a Chestograph HI-105 manufactured by Chest Co., Ltd.

[0106] Specifically, the subjects' vital capacity and forced expiratory volume in one second were measured before the start of the 12-week smoking experiment. Thereafter, each subject smoked the number of cigarettes per day listed in Tables 1 to 4 for 12 consecutive weeks. The vital capacity and forced expiratory volume in one second were measured immediately before the start of the experiment (initial stage), and 4, 8, and 12 weeks after the start of the experiment, and the rate of change in these values ​​from the start of the experiment was also calculated. The results obtained are shown in Tables 1 to 4.

[0107]

[0108] The average and standard deviation of the rate of change in vital capacity and forced expiratory volume in one second for the groups taking capsules 1 to 4 in Tables 1 to 4 are shown in Table 5.

[0109] As shown in Table 5, the group receiving Capsules 2 to 4 (Examples 1-1 to 1-12) had a better change in vital capacity than the group receiving Capsule 1 (Comparative Examples 1-1 to 1-3). Thus, it was found that by pressurizing and breaking the caryophyllene-containing capsules and ingesting caryophyllene via the lungs, the decline in vital capacity was more suppressed than when non-caryophyllene-containing capsules were used. Furthermore, as shown in Table 5, the group receiving Capsules 2 to 4 (Examples 1-1 to 1-12) had a better change in forced expiratory volume in one second than the group receiving Capsule 1 (Comparative Examples 1-1 to 1-3). Thus, it was found that by pressurizing and breaking the caryophyllene-containing capsules and ingesting caryophyllene via the lungs, the decline in forced expiratory volume in one second was more suppressed than when non-caryophyllene-containing capsules were used. The mechanism of the effect on respiratory function is thought to be that β-caryophyllene acts on cannabinoid type 2 receptors (CB2 receptors) present in immune cells, thereby suppressing inflammation in the lungs. From the above, it was found that taking β-caryophyllene while smoking suppresses the decline in vital capacity and forced expiratory volume in one second.

[0110] ​Example 2 Pulmonary Intake of β-Caryophyllene (Shortness of Breath / Difficulty in Breathing) Four types of Capsules 1 to 4 were inserted into the center of the cigarette filters of the following commercially available cigarettes (Tables 6 to 9): Cigarettes using Capsule 1 (Comparative Examples 2-1 to 2-6) Cigarettes using Capsule 2 (Examples 2-1 to 2-7) Cigarettes using Capsule 3 (Examples 2-8 to 2-14) Cigarettes using Capsule 4 (Examples 2-15 to 2-21)

[0111]

[0112] The capsules in the filters of these cigarettes were compressed and destroyed, and the cigarettes were lit. Healthy subjects smoked the number of cigarettes per day listed in Tables 6 to 9 for 12 weeks. A questionnaire survey was conducted immediately before the start of the study (initial stage) and every four weeks regarding shortness of breath and difficulty breathing during exercise. Specifically, the questionnaire survey was conducted before the start of the 12-week smoking experiment, and then each subject smoked the number of cigarettes per day listed in Tables 6 to 9 for 12 weeks. Thus, the questionnaire survey was conducted immediately before the start of the experiment (initial stage), and four, eight, and 12 weeks after the start of the experiment. The questionnaire asked, "Have you recently experienced shortness of breath or difficulty breathing when exercising vigorously?" Five response options were provided: "Never," "Almost never," "No change," "A little," and "Always," and scores were assigned. ・Never (5 points), ・Almost never (4 points), ・Always (3 points), ・A little (2 points), ・Always (1 point).

[0113] Scores were calculated using the value calculated by dividing the evaluation score after the start of the experiment by the initial evaluation score x 100, and scores were calculated for the questionnaire results regarding shortness of breath, etc. 4 weeks, 8 weeks, and 12 weeks later, with the score at the start of the experiment set at 100. The results are shown in Table 10.

[0114] As shown in Table 10, the groups taking Capsules 2 to 4 (Examples 2-1 to 2-21) scored better in questionnaires regarding shortness of breath and other symptoms than the group taking Capsule 1 (Comparative Examples 2-1 to 2-6). Thus, it was found that by compressing and destroying caryophyllene-containing capsules and ingesting caryophyllene via the lungs, shortness of breath and breathlessness were alleviated compared to the use of non-caryophyllene-containing capsules. These results demonstrate that caryophyllene intake maintains the respiratory organs in a healthier state and is effective in treating and preventing respiratory diseases. The mechanism of the improvement in shortness of breath and breathlessness is thought to be, similar to its effect on respiratory function, that β-caryophyllene acts on cannabinoid type 2 receptors (CB2 receptors) present in immune cells, thereby suppressing inflammation in the lungs.

[0115] Example 3 Pulmonary Intake of β-Caryophyllene (Sleep Quality) Four types of Capsules 1 to 4 were inserted into the center of the cigarette filters of the following commercially available cigarettes (Tables 11 to 14): Cigarettes using Capsule 1 (Comparative Examples 3-1 to 3-6) Cigarettes using Capsule 2 (Examples 3-1 to 3-7) Cigarettes using Capsule 3 (Examples 3-8 to 3-14) Cigarettes using Capsule 4 (Examples 3-15 to 3-21)

[0116]

[0117] The capsules in the filters of these cigarettes were pressed to break, and the cigarettes were lit. Healthy subjects smoked the number of cigarettes listed in Tables 11 to 14 per day for 12 weeks. A questionnaire survey on sleep quality was conducted immediately before the start of the study (initial stage) and every four weeks. Specifically, the questionnaire survey was conducted before the start of the 12-week smoking experiment, and then each subject smoked the number of cigarettes per day listed in Tables 11 to 14 for 12 weeks. Thus, the questionnaire surveys were conducted immediately before the start of the experiment (initial stage), and four, eight, and 12 weeks after the start of the experiment. The questionnaire asked, "Do you feel that your sleep quality has been good recently?" and provided five response options: "good," "somewhat good," "neither good nor bad," "somewhat bad," and "bad." Evaluation points were assigned based on the following: good (5 points), somewhat good (4 points), neither good nor bad (3 points), somewhat bad (2 points), and bad (1 point).

[0118] Scores based on the evaluation points after the start of the experiment were calculated in the same manner as in Example 2. The results obtained are shown in Table 15.

[0119] As shown in Table 15, the scores of the questionnaire regarding sleep quality were better in the group taking Capsules 2 to 4 (Examples 3-1 to 3-21) than in the group taking Capsule 1 (Comparative Examples 3-1 to 3-6). Thus, it was found that pulmonary ingestion of caryophyllene improves sleep quality. These results demonstrate that caryophyllene intake has the effect of improving sleep and promoting sleep onset. The mechanism of the effect on sleep quality is thought to be the action of β-caryophyllene on the cannabinoid type 2 receptor (CB2 receptor) present in the brain.

[0120] Example 4 Pulmonary Intake of β-Caryophyllene (Sleepiness, Fatigue, Complexion, Skin Texture and Firmness, Gum Swelling and Bleeding) Four types of Capsules 1 to 4 were inserted into the center of the cigarette filters of the following commercially available cigarettes (Tables 16 to 19). Cigarettes using Capsule 1 (Comparative Examples 4-1 to 4-6) Cigarettes using Capsule 2 (Examples 4-1 to 4-7) Cigarettes using Capsule 3 (Examples 4-8 to 4-14) Cigarettes using Capsule 4 (Examples 4-15 to 4-21)

[0121]

[0122] The capsules in the filters of these cigarettes were pressed to break, the cigarettes were lit, and healthy subjects smoked the number of cigarettes listed in Tables 16 to 19 per day for 12 weeks. Immediately before the start of the study (initial stage) and every four weeks, subjects were surveyed regarding their ability to fall asleep, fatigue, complexion, skin texture and firmness, and gum swelling and bleeding. Specifically, before the start of the 12-week smoking experiment, subjects were surveyed on the following five items, and then each subject continued to smoke the number of cigarettes per day listed in Tables 16 to 19 for 12 weeks. Thus, the surveys were conducted immediately before the start of the experiment (initial stage), and 4, 8, and 12 weeks after the start of the experiment.

[0123] (1) Falling asleep The questionnaire asked, "Have you been falling asleep at night recently?" and provided five answer options: "Good," "Somewhat good," "Neither good nor bad," "Somewhat bad," and "Bad," with evaluation points set. ・Good (5 points) ・Somewhat good (4 points) ・Neither good nor bad (3 points) ・Somewhat bad (2 points) ・Bad (1 point)

[0124] (2) Fatigue The questionnaire asked, "Have you been feeling tired recently?" and provided five answer options: "Never," "Hardly," "No change," "A little," and "Always," with evaluation points set. ・Never (5 points) ・Hardly (4 points) ・No change (3 points) ・A little (2 points) ・Always (1 point)

[0125] (3) Complexion The questionnaire asked the question, "Do you feel that your complexion has been good recently?" and provided five answer options: "Good," "Somewhat good," "Neither good nor bad," "Somewhat bad," and "Bad," and set evaluation points. ・Good (5 points) ・Somewhat good (4 points) ・Neither good nor bad (3 points) ・Somewhat bad (2 points) ・Bad (1 point)

[0126] (4) Skin Texture and Firmness The questionnaire asked the question, "Do you feel that the texture and firmness of your facial skin is good recently?" and provided five answer options: "Good," "Somewhat good," "Neither good nor bad," "Somewhat bad," and "Bad," and set evaluation points. ・Good (5 points) ・Somewhat good (4 points) ・Neither good nor bad (3 points) ・Somewhat bad (2 points) ・Bad (1 point)

[0127] (5) Swelling and bleeding of the gums In the questionnaire, the question "Have you been bothered by swelling and bleeding of the gums recently?" was asked, and five answer options were set: "Not bothering me," "Not really bothering me," "Neither," "Somewhat bothering me," and "Worried," and evaluation points were set. ・Not bothering me (5 points) ・Not really bothering me (4 points) ・Neither (3 points) ・Somewhat bothering me (2 points) ・Worried me (1 point)

[0128] Scores based on the evaluation points after the start of the experiment were calculated in the same manner as in Example 2. The results obtained are shown in Tables 20 to 24.

[0129] As shown in Table 20, the scores of the questionnaire regarding the ability to fall asleep were better in the groups receiving Capsules 2 to 4 (Examples 4-1 to 4-21) than in the group receiving Capsule 1 (Comparative Examples 4-1 to 4-6). Thus, it was found that pulmonary ingestion of caryophyllene improves the ability to fall asleep. These results demonstrate that caryophyllene has the effect of improving sleep and promoting sleep onset. The mechanism of the effect of falling asleep is thought to be the action of β-caryophyllene on the cannabinoid type 2 receptor (CB2 receptor) present in the brain.

[0130] As shown in Table 21, the questionnaire scores regarding fatigue were better in the groups taking Capsules 2 to 4 (Examples 4-1 to 4-21) than in the group taking Capsule 1 (Comparative Examples 4-1 to 4-6). Thus, it was found that pulmonary ingestion of caryophyllene improves fatigue. These results demonstrate that caryophyllene has the effect of reducing fatigue. The mechanism of its effect on respiratory function is thought to be that β-caryophyllene acts on cannabinoid type 2 receptors (CB2 receptors) present in immune cells, thereby suppressing systemic inflammation and improving blood flow, thereby suppressing the accumulation of waste products.

[0131] As shown in Table 22, the questionnaire scores regarding blood color were better in the group taking Capsules 2 to 4 (Examples 4-1 to 4-21) than in the group taking Capsule 1 (Comparative Examples 4-1 to 4-6). Thus, it was found that pulmonary ingestion of caryophyllene improves blood color. These results demonstrate that caryophyllene has the effect of improving blood color. The mechanism of its effect on blood color is thought to be that β-caryophyllene acts on the cannabinoid type 2 receptor (CB2 receptor) present in blood vessels, thereby inhibiting matrix metalloproteinase production in the vascular wall and improving vascular function, thereby restoring blood flow.

[0132] As shown in Table 23, the questionnaire scores regarding skin texture and firmness were better in the groups receiving Capsules 2 to 4 (Examples 4-1 to 4-21) than in the group receiving Capsule 1 (Comparative Examples 4-1 to 4-6). Thus, it was found that pulmonary ingestion of caryophyllene improves skin texture and firmness. These results demonstrate that caryophyllene has the effect of improving skin quality. The mechanism of its effect on skin texture and firmness is thought to be that β-caryophyllene acts on the cannabinoid type 2 receptor (CB2 receptor) present in skin cells, thereby inhibiting matrix metalloproteinase production in the skin and improving the skin's elasticity, thereby restoring skin texture and firmness.

[0133] As shown in Table 24, the groups receiving Capsules 2 to 4 (Examples 4-1 to 4-21) achieved better scores in the questionnaire regarding gum swelling and bleeding than the group receiving Capsule 1 (Comparative Examples 4-1 to 4-6). Thus, it was found that pulmonary ingestion of caryophyllene improves periodontal disease, which causes gum swelling and bleeding. These results demonstrate that caryophyllene is effective in treating and preventing periodontal disease. The mechanism of the therapeutic and preventive effects of periodontal disease is thought to be that β-caryophyllene acts on the cannabinoid type 2 receptor (CB2 receptor) present in gingival cells, thereby suppressing matrix metalloproteinase production in the gums and improving the elastic function of the gums, thereby enabling the treatment and prevention of periodontal disease.

[0134] [Example 5] Pulmonary ingestion of β-caryophyllene (bad breath) Four types of capsules 1 to 4 were inserted into the center of the cigarette filters of the following commercially available cigarettes (Tables 25 to 28). Cigarettes using capsule 1 (Comparative Examples 5-1 to 5-6) Cigarettes using capsule 2 (Examples 5-1 to 5-7) Cigarettes using capsule 3 (Examples 5-8 to 5-14) Cigarettes using capsule 4 (Examples 5-15 to 5-21)

[0135]

[0136] The capsules in the filters of these cigarettes were pressed to break, the cigarettes were lit, and healthy subjects smoked the number of cigarettes listed in Tables 25 to 28 per day for 12 weeks. A questionnaire survey on halitosis was conducted immediately before the start of the study (initial stage) and every four weeks. Specifically, the questionnaire survey on halitosis was conducted before the start of the 12-week smoking experiment, and then each subject smoked the number of cigarettes per day listed in Tables 16 to 19 for 12 consecutive weeks. In this way, the questionnaire survey on halitosis was conducted immediately before the start of the experiment (initial stage), and 4, 8, and 12 weeks after the start of the experiment.

[0137] The questionnaire asked, "Have you been bothered by bad breath after smoking recently?" and provided five answer options: "It bothers me," "It bothers me a little," "Neither," "It bothers me very little," and "It bothers me." Evaluation points were set. ・It bothers me (5 points) ・It bothers me very little (4 points) ・Neither (3 points) ・It bothers me a little (2 points) ・It bothers me (1 point)

[0138] Scores based on the evaluation points after the start of the experiment were calculated in the same manner as in Example 2. The results obtained are shown in Table 29.

[0139] As shown in Table 29, the groups taking Capsules 2 to 4 (Examples 5-1 to 5-21) had better scores on the questionnaire regarding bad breath than the group taking Capsule 1 (Comparative Examples 5-1 to 5-6). Thus, it was found that pulmonary ingestion of caryophyllene improves bad breath. These results demonstrate that caryophyllene has the effect of suppressing bad breath. The mechanism of the bad breath suppression effect is thought to be that the antibacterial effect of β-caryophyllene reduces the bacteria present in the oral cavity, thereby reducing the amount of odor-causing substances produced by these bacteria, thereby suppressing bad breath.

[0140] [Preparation of Soft Capsules] Two types of caryophyllene-containing soft capsules for oral ingestion (Capsules 5 and 6) were prepared by the rotary method. (Content Liquid Composition) Content liquid compositions for Capsules 5 and 6 were prepared. The weight of the content liquid composition for Capsules 5 and 6 was 300 mg. Content liquid composition for Capsule 5: 100% by mass of safflower salad oil. Content liquid composition for Capsule 6: 85% by mass of β-caryophyllene, 15% by mass of safflower salad oil. For the β-caryophyllene in the content liquid composition of the capsules, caryophyllene AKY-2348 (trade name: Lilac Phyton (registered trademark)) manufactured by Inabata Fragrance Co., Ltd. was used, and for the safflower salad oil, compressed seeds of Carthamus tinctorius manufactured by Summit Essential Oils Co., Ltd. was used. The content liquid compositions of Capsules 5 and 6 prepared in this manner were filled into soft capsules by the rotary method. The major axis, minor axis, and shell thickness of Capsules 5 and 6 were as follows: Long diameter: 14.0 mm Short diameter: 7.5 mm Shell thickness: 1.0 mm

[0141] (Coating Composition) The coating composition of capsules 5 and 6 had the following formulation: Starch 50% by weight, Iota carrageenan 15% by weight, Gum arabic 1% by weight, Glycerin 34% by weight, Purified water (appropriate amount)

[0142] The viscosity of the starch was 34±10 mPa·s. The starch viscosity was measured as follows. 15 g of starch and 135 g of purified water were added to a No. 12 standard bottle, mixed, and the starch was thoroughly dispersed. The mixture was then heated in a 95°C water bath for 90 minutes. The mixture was stirred every 10 minutes for the first 30 minutes, and every 30 minutes thereafter. A spatula, glass rod, or similar tool was used for stirring. The paste was then cooled to 70°C, and the viscosity was measured. The viscosity of the resulting 10% paste was measured using a Brookfield DV-E viscometer (70°C liquid temperature, rotor No. 2, value measured after 1 minute of rotation at 100 rpm).

[0143] The viscosity of the iota-carrageenan was 2,600±800 mPa·s. The viscosity of the iota-carrageenan was measured as follows: 5 g of iota-carrageenan and 12 g of glycerin were added to a No. 12 standard bottle and mixed thoroughly with a spatula. Then, 103 g of purified water was added and mixed thoroughly. The resulting mixture was heated in a 95°C water bath for 90 minutes. The mixture was stirred every 10 minutes for the first 30 minutes, and every 30 minutes thereafter. The mixture was then cooled to 70°C, and the viscosity was measured. The viscosity of the resulting 4% mixture was measured using a Brookfield DV-E viscometer (70°C liquid temperature, rotor No. 3, value measured after 1 minute of rotation at 12 rpm).

[0144] The viscosity of the gum arabic was 260±80 mPa·s. The viscosity of gum arabic was measured as follows: 25 g of gum arabic and 75 g of purified water were placed in a beaker and thoroughly mixed using a stirrer. The resulting mixture was transferred to a No. 12 standard bottle, and the mixture was adjusted to 25°C, after which the viscosity was measured. The viscosity of the resulting 25% mixture was measured using a Brookfield DV-E viscometer (measured after rotating at 60 rpm for 1 minute, with a No. 2 rotor at a liquid temperature of 25°C).

[0145] The glycerin used was food additive glycerin (manufactured by Sakamoto Pharmaceutical Industries).

[0146] (Preparation of Soft Capsules) Capsules 5 and 6 were produced using the above-described content liquid composition and coating composition using a rotary die-type filling machine for soft capsules. Specifically, in the rotary die-type filling machine, the stored coating liquid was poured into a spreader box via a supply hose, then cast by gravity onto a casting drum and cooled in the drum. In this manner, utilizing the sol-gel transition property of the coating composition, a coating film serving as the material for the coating (shell) of Capsules 5 and 6 was produced. The coating film was peeled from the drum and fed along rollers into a mold on two rolls. There, the two films were reheated by a segment, and the filling material was simultaneously injected. Utilizing the sol-gel transition property of the coating, the content liquid composition was filled and sealed using heat sealing while being punched. Furthermore, the net of the coating film after punching was pulled by a roller located at the bottom of the filling machine, applying appropriate tension to the coating film. The punched, undried capsules were then fed into a dryer and dried to produce the finished capsules 5 and 6).

[0147] Example 6 Oral Intake of β-Caryophyllene (Shortness of Breath / Difficulty in Breathing, Sleep Quality, Falling Asleep, Fatigue, Skin Texture / Firmness, Swelling / Bleeding of Gums, Bad Breath) Healthy subjects orally ingested one capsule of each of the two types of capsules, 5 and 6, twice daily. Immediately before the start of the study (initial stage) and one week later, a questionnaire survey was conducted regarding shortness of breath / difficulty in breathing during exercise, sleep quality, falling asleep, fatigue, skin texture / firmness, swelling / bleeding of gums, and bad breath. The questionnaire methods for each of these items were the same as those used in Examples 2 to 5.

[0148] Scores based on the evaluation points after the start of the experiment were calculated in the same manner as in Example 2. The results obtained are shown in Tables 30 to 36.

[0149]

[0150] As shown in Table 30, the group taking Capsule 6 (Example 6-1) scored better in the questionnaire regarding shortness of breath and other symptoms than the group taking Capsule 5 (Comparative Example 6-1). Thus, oral ingestion of caryophyllene demonstrated a greater reduction in shortness of breath and breathlessness than the use of capsules not containing caryophyllene. These results demonstrate that caryophyllene intake maintains the respiratory organs in a healthier state and is effective in treating and preventing respiratory diseases. The mechanism of the improvement in shortness of breath and breathlessness is thought to be, similar to its effect on respiratory function, that β-caryophyllene acts on cannabinoid type 2 receptors (CB2 receptors) present in immune cells, thereby suppressing inflammation in the lungs.

[0151] As shown in Table 31, the group taking Capsule 6 (Example 6-2) achieved better scores on the sleep quality questionnaire than the group taking Capsule 5 (Comparative Example 6-2). Thus, it was found that oral ingestion of caryophyllene improves sleep quality. These results demonstrate that caryophyllene intake has the effect of improving sleep and promoting sleep onset. The mechanism of this effect on sleep quality is thought to be the action of β-caryophyllene on cannabinoid type 2 receptors (CB2 receptors) present in the brain.

[0152] As shown in Table 32, the group taking Capsule 6 (Example 6-3) scored better in the questionnaire regarding the onset of sleep than the group taking Capsule 5 (Comparative Example 6-3). Thus, it was found that oral ingestion of caryophyllene improves the onset of sleep. These results demonstrate that caryophyllene has the effect of improving sleep and promoting sleep induction. The mechanism of the onset of sleep effect is thought to be the action of β-caryophyllene on the cannabinoid type 2 receptor (CB2 receptor) present in the brain.

[0153] As shown in Table 33, the group taking Capsule 6 (Example 6-4) achieved better scores on the questionnaire regarding fatigue than the group taking Capsule 5 (Comparative Example 6-4). Thus, it was found that oral ingestion of caryophyllene improves fatigue. These results demonstrate that caryophyllene has the effect of reducing fatigue. The mechanism of its effect on respiratory function is thought to be that β-caryophyllene acts on the cannabinoid type 2 receptor (CB2 receptor) present in immune cells, thereby suppressing systemic inflammation and improving blood flow, thereby suppressing the accumulation of waste products.

[0154] As shown in Table 34, the group taking Capsule 6 (Example 6-5) scored better in the questionnaire regarding skin texture and firmness than the group taking Capsule 5 (Comparative Example 6-5). Thus, it was found that oral ingestion of caryophyllene improves skin texture and firmness. These results demonstrate that caryophyllene has the effect of improving skin quality. The mechanism of its effect on skin texture and firmness is thought to be that β-caryophyllene acts on the cannabinoid type 2 receptor (CB2 receptor) present in skin cells, thereby inhibiting matrix metalloproteinase production in the skin and improving the skin's elastic function, thereby restoring skin texture and firmness.

[0155] As shown in Table 35, the group taking Capsule 6 (Example 6-6) achieved better scores in the questionnaire regarding gum swelling and bleeding than the group taking Capsule 5 (Comparative Example 6-6). Thus, it was found that oral ingestion of caryophyllene improves periodontal disease, which causes gum swelling and bleeding. These results demonstrate that caryophyllene is effective in treating and preventing periodontal disease. The mechanism of the therapeutic and preventive effects of periodontal disease is thought to be that β-caryophyllene acts on the cannabinoid type 2 receptor (CB2 receptor) present in gum cells, thereby suppressing matrix metalloproteinase production in the gums and improving the elastic function of the gums, thereby enabling the treatment and prevention of periodontal disease.

[0156] As shown in Table 36, the group taking Capsule 6 (Examples 6-7) scored better in the questionnaire regarding bad breath than the group taking Capsule 5 (Comparative Examples 6-7). Thus, it was found that oral intake of caryophyllene improves bad breath. These results demonstrate that caryophyllene has the effect of suppressing bad breath. The mechanism of the bad breath suppression effect is thought to be that the antibacterial effect of β-caryophyllene reduces the bacteria present in the oral cavity, thereby reducing the amount of malodor-causing substances produced by these bacteria, thereby suppressing bad breath.

Claims

1. A skin-improving composition containing caryophyllene.

2. The composition according to claim 1, wherein the caryophyllene is a chemically synthesized compound.

3. The composition according to claim 1, further comprising one or more selected from the group consisting of solvents and fragrances.

4. The composition according to claim 1, wherein the dosage form is a capsule.

5. A tobacco product containing the composition described in any one of claims 1 to 4.

6. Food and beverages containing the composition described in any one of claims 1 to 4.

7. A pharmaceutical product containing the composition described in any one of claims 1 to 4.

8. The pharmaceutical product according to claim 7, which is an oral composition or a pulmonary composition.