Oral composition containing inorganic porous material

Abstract

To provide an oral composition and an oral pouch product having excellent storage stability.SOLUTION: An oral composition comprises: an inorganic porous material having an average particle diameter of 60 μm or greater as a base material; and nicotine, wherein the pore volume of pores in the inorganic porous material, the pore diameter of which is 2 nm or greater and smaller than 50 nm as measured by a nitrogen adsorption method and calculated using the BJH method, is 0.50 cm3 / g or more.SELECTED DRAWING: None

Description

[Technical Field]

[0001] The present invention relates to an oral composition comprising an inorganic porous material. [Background technology]

[0002] The oral composition used to fill oral pouch products contains moisture, which can lead to the composition becoming lumpy during storage, potentially reducing its stability.

[0003] By the way, porous silica materials are used as pharmaceutical carriers and the like, taking advantage of the properties of their pores (see Patent Documents 1 and 2). [Prior art documents] [Patent documents]

[0004] [Patent Document 1] Special Publication No. 2015-536939 [Patent Document 2] Special Publication No. 2006-518761 Summary of the Invention [Problem to be solved by the invention]

[0005] The above-mentioned patent documents do not disclose the use of a porous silica material in an oral composition containing nicotine, much less the storage stability of the oral composition. In view of these circumstances, an object of the present invention is to provide an oral composition and an oral pouch product that are excellent in storage stability. [Means for solving the problem]

[0006] The above problems are solved by the present invention described below. Aspect 1 an inorganic porous material having an average particle size of 60 μm or more as a substrate; Nicotine, In the inorganic porous material, the pore volume of pores having a pore diameter of 2 nm or more and less than 50 nm as measured by a nitrogen adsorption method and calculated using the BJH method is 0.50 cm 3 / g or more, Oral composition. Aspect 2 the inorganic porous material is selected from the group consisting of silica, silicates, alumina, zeolites, hydroxyapatite, hydrotalcite, and combinations thereof; 2. The oral composition according to claim 1. Aspect 3 The inorganic porous material has a BET specific surface area of 200 to 1200 m 2 / g, 3. The oral composition according to claim 1 or 2. Aspect 4 V1 is the pore volume of pores having a pore diameter of less than 2 nm measured by the nitrogen adsorption method and calculated using the HK method; V2 is the pore volume of pores with a pore diameter of 2 nm or more and less than 50 nm measured by the nitrogen adsorption method and calculated using the BJH method. When the pore volume of pores with a pore diameter of 50 nm or more measured by mercury intrusion porosimetry is V3, V2 / (V1+V2+V3)≧35% by volume; The oral composition according to any one of aspects 1 to 3. Aspect 5 5. The oral composition according to any one of Aspects 1 to 4, having a water content of 10% by weight or more. Aspect 6 6. The oral composition according to any one of Aspects 1 to 5, comprising 6% by weight or more of the inorganic porous material. Aspect 7 The oral composition according to any one of aspects 1 to 6, A packaging material for packaging the oral composition; An oral pouch product comprising: [Effects of the Invention]

[0007] The present invention can provide an oral composition and an oral pouch product that have excellent storage stability. DETAILED DESCRIPTION OF THE INVENTION

[0008] The present invention will be described in detail below. In the present invention, "X to Y" includes the end values, i.e., X and Y. An oral product is a product in which the active ingredient is ingested through the oral mucosa via saliva while the product is held in the oral cavity. An oral composition is a composition used in an oral product.

[0009] 1. Oral composition The oral composition according to this embodiment (hereinafter also simply referred to as the "composition") contains a specific inorganic porous material as a base material and nicotine. The base material is a material that constitutes the matrix of the composition and is also called an excipient.

[0010] (1) Inorganic porous material The inorganic porous material has pores with a pore diameter of 2 nm or more and less than 50 nm (hereinafter also referred to as "mesopores"), and the pore volume of the pores is 0.50 cm 3 / g or more. The pore volume of the pores is calculated by applying the BJH method to a nitrogen adsorption isotherm obtained by measurement using a nitrogen adsorption method. Specifically, the nitrogen gas adsorption isotherm of the inorganic porous material is obtained, and the pore volumes within a predetermined pore diameter range analyzed using the BJH method are accumulated to determine the pore volume (hereinafter also referred to as "mesopore volume"). The nitrogen adsorption method can be performed as known, but it is preferable to pretreat the inorganic porous material before the measurement. Examples of pretreatment include heating at 200 to 250°C for 2 hours for silica and heating at 105°C for 1 hour for cellulose. The BJH method is an analytical method that assumes that mesopores are cylindrical based on Kelvin's capillary condensation theory.

[0011] Inorganic porous materials having a mesopore volume within the above range have excellent fluidity. The reason for this is not limited, but it is thought that water is adsorbed into the mesopores, preventing aggregation of inorganic porous materials with each other or with other materials. Therefore, oral compositions containing the inorganic porous material do not experience uneven distribution of the composition during storage, and are therefore less likely to form lumps. Therefore, oral compositions containing the inorganic porous material have excellent storage stability. From this perspective, the lower limit of the mesopore volume is preferably 0.70 cm. 3 The upper limit is not limited, but is preferably 1.5 cm 3 / g or less.

[0012] The BET specific surface area of the inorganic porous material is preferably 200 to 1200 m 2 / g. When the BET specific surface area is in this range, the liquid components contained in the oral composition, such as flavors and sweeteners, can be efficiently adsorbed, and the taste of the product can be maintained. From this viewpoint, the BET specific surface area is more preferably 200 to 500 m 2 / g.

[0013] When the volume of micropores measured by the nitrogen adsorption method and calculated using the HK method, which have a pore diameter of less than 2 nm, is defined as V1, the volume of mesopores measured by the nitrogen adsorption method and calculated using the BJH method, which have a pore diameter of 2 nm or more but less than 50 nm, is defined as V2, and the volume of macropores measured by mercury intrusion porosimetry, which have a pore diameter of 50 nm or more, is defined as V3, it is preferable that the following relationship be satisfied: V2 / (V1+V2+V3)≧35vol% When the volume fraction is in this range, the effect of improving fluidity becomes more pronounced.From this viewpoint, the volume fraction is more preferably 35 to 99% by volume.

[0014] Mercury intrusion porosimetry is a method in which mercury is forced into the pores of a solid surface, and the pore distribution and pore volume are determined from the relationship between the pressure applied and the volume of mercury forced in. The HK method is used to measure micropores, and determines the pore size distribution from calculations of the interactions between adsorbed molecules and between adsorbed molecules and pore wall atoms.

[0015] The average particle size of the inorganic porous material is 60 μm or more. The average particle size of each material is the particle size at 50% cumulative volume (D50) in the particle size distribution determined by laser diffraction particle size distribution measurement. Laser diffraction particle size distribution measurement can be performed using, for example, a Mastersizer 3000 (manufactured by Malvern Panalytical). Unless otherwise specified, the average particle size refers to the particle size (D50) at which the volume cumulative value in the particle size distribution is 50%. If the average particle size is below the lower limit, the fluidity of the oral composition decreases. Furthermore, if the average particle size is excessively high, the user may easily perceive the roughness of the inorganic porous material particles, which may cause the product to have an unpleasant mouthfeel. From this perspective, the lower limit of the average particle size is preferably 60 μm or more, more preferably 100 μm or more, and the upper limit is preferably 500 μm or less, more preferably 300 μm or less.

[0016] The inorganic porous material is preferably selected from the group consisting of silica, silicates, alumina, zeolites, hydroxyapatite, hydrotalcite, and combinations thereof. Among these, silica is preferred from the viewpoints of availability and minimal effect on flavor.

[0017] The content of the inorganic porous material in the composition is preferably 6% by weight or more. In the present invention, the content refers to the amount in an absolutely dry state unless otherwise specified. The lower limit of the content is preferably 10% by weight or more, more preferably 15% by weight or more. The upper limit of the content is not limited, but is usually 70% by weight or less, preferably 68% by weight or less, more preferably 65% by weight or less, in consideration of the limit of the amount of other raw materials that can be blended.

[0018] (2) Nicotine The composition contains nicotine. Nicotine may be contained in the form of nicotine alone or in the form of a nicotine-containing raw material. The nicotine-containing raw material refers to a raw material containing nicotine, such as a nicotine salt or stabilized nicotine. Examples of stabilized nicotine include nicotine-carrying substances such as nicotine supported on an ion exchange resin. Examples of ion exchange resins include weakly acidic cation exchange resins. Specific examples of nicotine-carrying ion exchange resins include a resin complex called nicotine polacrilex, which contains, for example, 10% by weight or more and 20% by weight or less of nicotine. The ion exchange resin used in nicotine polacrilex is a weakly acidic cation exchange resin. When nicotine polacrilex is used, the amount added to the oral composition is usually 0.5% by weight or more, preferably 1.0% by weight or more, and more preferably 2.0% by weight or more. On the other hand, from the viewpoint of flavor, the amount of nicotine polacrilex added to the composition is usually 15.0% by weight or less, preferably 12.0% by weight or less, and more preferably 10.0% by weight or less.

[0019] The nicotine-containing raw material may also be a tobacco material containing tobacco powder obtained by pulverizing tobacco leaves. The tobacco powder may contain shredded, finely divided, or fiber of dried tobacco leaf lamina, and may be prepared, for example, by the method described below. In the present invention, the tobacco leaf may contain mesophyll (lamina), leaf veins (stems), or roots. The tobacco material may contain, in addition to tobacco powder obtained primarily from tobacco leaf lamina, elements derived from the midrib or roots of tobacco leaves.

[0020] The particle size of the tobacco powder is not limited, but from the standpoint of improving compatibility in the oral cavity to enhance usability and improving the release of flavor components contained in the tobacco powder into the oral cavity, it is preferable that the powder has passed through a 1.2 mm mesh, and more preferably has passed through a 1.0 mm mesh.

[0021] The tobacco species used as the raw material for tobacco powder are not particularly limited, and examples include the genus Nicotiana, such as the flue-cured Nicotiana tabacum, the Burley variety, and the Brasilia variety of Nicotiana rustica. The same species can also be used for the tobacco material and tobacco leaves described below.

[0022] The tobacco powder is preferably prepared as follows. First, a base is added to tobacco powder obtained by grinding tobacco leaves and mixed. The base to be added may be potassium carbonate or sodium carbonate, and is preferably added as an aqueous solution. Furthermore, a pH adjuster such as sodium dihydrogen phosphate may be added, for example, to stabilize nicotine during the production of oral pouch products. After the addition of the base, the pH of the mixture is preferably adjusted to 8.0 to 9.0. The tobacco powder content in this mixture is preferably 60 to 90% by weight.

[0023] After the base is added, the mixture is heated, for example, under conditions such that the product temperature is 65 to 90°C, preferably 70 to 80°C, for 0.5 to 3 hours, preferably 0.8 to 2 hours. This sterilizes the tobacco powder. Heating can be carried out by either or both of steam injection heating and jacket heating. The pH of the mixture after heating is preferably 8.0 to 9.0, and the moisture content of the mixture after heating is preferably 10 to 50% by weight.

[0024] After heating, the resulting treated tobacco powder is dried by stopping steam injection as needed and heating only the jacket, followed by cooling at about 15 to 25°C for about 1 hour.

[0025] When a tobacco material containing tobacco powder is used, the amount of the tobacco material added to the oral composition is usually 0.001% by weight or more, preferably 0.01% by weight or more, and more preferably 0.05% by weight or more. On the other hand, from the viewpoint of flavor, the amount of the tobacco material added to the composition is usually 90% by weight or less, preferably 80% by weight or less, 70% by weight or less, 45% by weight or less, 40% by weight or less, or 30% by weight or less.

[0026] The nicotine-containing raw material may be a nicotine-containing extract obtained by extracting a nicotine-containing substance such as tobacco leaves.

[0027] Among the above embodiments, it is preferable to use a nicotine-containing substance from the viewpoints of accurate nicotine supply and ease of handling. Furthermore, when tobacco powder is added, the color of the oral composition or oral product tends to be the color of tobacco leaves. On the other hand, when a colorless nicotine-containing compound is used, it is possible to provide a white composition or oral product. This embodiment is advantageous for users who prefer white oral products. The above raw materials may be used alone or in combination of two or more.

[0028] The total nicotine content in the composition is not limited, but is usually 0.1 to 20.0% by weight from the viewpoint of user preference. Therefore, when a nicotine-containing raw material is used as a plant-derived alkaloid, the amount of the raw material is adjusted so that the total nicotine content falls within this range. When nicotine exists as an ion, the above content is the content of the nicotine ion. The nicotine content in the composition can be measured by gas chromatography-mass spectrometry (GC-MS), liquid chromatography (LC, UV detection), or the like.

[0029] (3) pH adjuster The composition contains a pH adjuster. The pH adjuster is not limited, and is preferably one that is permitted to be added to foods. Examples include sodium carbonate, sodium bicarbonate, potassium carbonate, potassium bicarbonate, potassium phosphate, anhydrous sodium phosphate, sodium dihydrogen phosphate, and sodium citrate. Among these, sodium phosphate, potassium carbonate, or sodium dihydrogen phosphate is preferred from the viewpoint of the effect on the taste of the product and the product stability during storage. One type of pH adjuster may be used alone, or two or more types may be used in combination in any ratio.

[0030] (4) Gelling agents and gelling aids The composition may contain a known gelling agent or the like. The gelling agent alleviates the foreign body sensation caused by the nonwoven fabric or the like when the product is taken into the oral cavity, particularly at the initial stage of administration, and provides a favorable impression to the user. As the gelling agent, polysaccharides having a carboxyl group are preferred, and examples thereof include carrageenan, pectin, gum arabic, xanthan, gellan gum, and tragacanth gum. Furthermore, carrageenan, pectin, and gellan gum are preferred because they are easily gelled in the presence of calcium ions and can form a junction zone between the carboxyl group and the cation to form a crosslinked structure. These may be used alone or in combination of two or more types in any ratio.

[0031] Examples of gelling aids include calcium ions, and their sources (gelling aids) are not limited, but include, for example, calcium halides (chlorides, etc.), citric acid, carbonates, sulfates, phosphates, and lactates. Among these, calcium lactate, calcium chloride, and calcium phosphate are preferred, with calcium lactate being particularly preferred, from the standpoints of their minimal effect on taste, high solubility, and pH after dissolution. These may be used alone, or two or more may be used in combination in any ratio.

[0032] Examples of gelling aids other than calcium ions include metal ions such as magnesium, silver, zinc, copper, gold, and aluminum, which can bond with gelling agents via ionic bonds like calcium ions, as well as ions of cationic polymers. Sources of these (other gelling aids) include, for example, halide salts (chlorides, etc.) of these metal ions, citric acid, carbonates, sulfates, phosphates, and cationic polymers. These may be used alone or in combination of two or more in any ratio.

[0033] (5) Release agent The composition may contain a known mold release agent. However, since the inorganic porous material, particularly silica, also functions as a mold release agent, the composition does not necessarily contain any mold release agent other than the inorganic porous material.

[0034] (6)Water The water content (moisture content) in the composition is 10% by weight or more from the viewpoint of ease of production of the composition. Furthermore, from the viewpoints of improving the production efficiency of the composition, improving the anti-caking properties, suppressing stickiness, etc., the lower limit of the water content is preferably 30% by weight or more, more preferably 45% by weight or more, and the upper limit is usually 60% by weight or less, preferably 50% by weight or less. The water content may be 40% by weight or less, 30% by weight or less, or even 20% by weight or less. The water content can be adjusted by adjusting the amount of water added or by performing a heating treatment or drying treatment during the production stage. The water content of the composition is appropriately adjusted depending on the type of product (moist or dry). For example, in the case of a moist type, the water content is usually 20 to 60% by weight, preferably 30 to 50% by weight. On the other hand, in the case of a dry type, the water content is usually 5 to 20% by weight, preferably 10 to 15% by weight.

[0035] The water content of the composition (moisture content) can be measured using a heat-drying moisture meter (e.g., HB 43-S manufactured by METTER TOLEDO). For measurement, a sample is placed in a designated container and heated to a temperature of 100°C. The measurement is terminated when the change in weight is 1 mg or less in 60 seconds, and the moisture content is calculated from the weighed values before and after heating.

[0036] (7) Other The composition may contain other substances in addition to those described above. Examples of other substances include flavorings, sweeteners, humectants, bitterness suppressants, and emulsifiers. The content of these substances is not limited, and the formulation can be adjusted appropriately depending on the product design.

[0037] 1)Fragrance The flavoring agent is not limited, and examples thereof include menthol, tobacco leaf extract, natural plant flavorings (e.g., cinnamon, sage, herbs, chamomile, kudzu, sweet tea, cloves, lavender, cardamom, cloves, nutmeg, bergamot, geranium, honey essence, rose oil, lemon, orange, cinnamon bark, caraway, jasmine, ginger, coriander, vanilla extract, spearmint, peppermint, cassia, coffee, celery, cascarilla, sandalwood, cocoa, ylang-ylang, fennel, anise, licorice, St. John's bread, plum extract, peach extract, etc.), sugars (e.g., glucose, fructose, isomerized sugar), , caramel, honey, molasses, etc.), cocoa (powder, extract, etc.), esters (e.g., isoamyl acetate, linalyl acetate, isoamyl propionate, linalyl butyrate, etc.), ketones (e.g., menthone, ionone, damascenone, ethyl maltol, etc.), alcohols (e.g., geraniol, linalool, anethole, eugenol, etc.), aldehydes (e.g., vanillin, benzaldehyde, anisaldehyde, etc.), lactones (e.g., γ-undecalactone, γ-nonalactone, etc.), animal fragrances (e.g., musk, ambergris, civet, castoreum, etc.), and hydrocarbons (e.g., limonene, pinene, etc.). One type of fragrance may be used alone, or two or more types may be used in combination in any ratio.

[0038] 2) Sweeteners Examples of sweeteners include, but are not limited to, sugar alcohols such as xylitol, maltitol, and erythritol; and acesulfame potassium, sucralose, and aspartame. Sugar alcohols are preferred from the viewpoint of taste control. One type of sweetener may be used alone, or two or more types may be used in any ratio.

[0039] The type of sugar alcohol is not particularly limited, and examples thereof include xylitol, maltitol, erythritol, sorbitol, mannitol, and lactitol. Among these, maltitol is preferred from the viewpoint of imparting a good flavor. These substances may be used alone or in combination of two or more kinds in any ratio.

[0040] The sugar alcohol content in the composition (total content when two or more types of sugar alcohols are contained) is not limited, but from the viewpoint of flavor regulation, it is usually 1% by weight or more, preferably 5% by weight or more, and more preferably 10% by weight or more. The upper limit is usually 80% by weight or less, preferably 70% by weight or less, and more preferably 60% by weight or less.

[0041] 3) Bitterness suppressant The bitterness suppressing agent is not limited, but may be, for example, soybean lecithin. Soybean lecithin is a phospholipid, specifically, phosphatidylcholine, phosphatidylethanolamine, phosphatidic acid, etc. As the bitterness suppressing agent, one type may be used alone, or two or more types may be used in combination in any ratio.

[0042] 4) Moisturizer The moisturizing agent is not limited, but examples thereof include polyhydric alcohols such as glycerin and propylene glycol. From the viewpoint of product preservation, glycerin is preferred. As the moisturizing agent, one type may be used alone, or two or more types may be used in any ratio.

[0043] 5) Emulsifiers, surfactants The emulsifier is not limited, and examples thereof include emulsifiers added to foods. Examples of emulsifiers include one or more selected from the group consisting of sucrose fatty acid esters, organic acid glycerin fatty acid esters, polyglycerin fatty acid esters, and lecithin. Examples of sucrose fatty acid esters include sucrose palmitate ester and sucrose stearate ester. Examples of organic acid glycerin fatty acid esters include succinic acid glycerin fatty acid ester and diacetyltartaric acid glycerin fatty acid ester. Examples of polyglycerin fatty acid esters include decaglycerin fatty acid ester. The content of the emulsifier in the composition is preferably such that the total content with the polyglycerin fatty acid ester falls within the above-mentioned range for the polyglycerin fatty acid ester content.

[0044] The degree of polymerization of glycerin in the polyglycerin fatty acid ester is preferably 2 to 10. The polyglycerin fatty acid ester functions as an emulsifier. Therefore, by including the polyglycerin fatty acid ester, the components of the composition are maintained in a uniform mixed state, and flavor components are stabilized, thereby improving the flavor of the composition. Furthermore, the polyglycerin fatty acid ester imparts appropriate viscosity to the composition and binds the components together, thereby reducing the dryness of the composition and improving the feel and flavor of the composition. Furthermore, even if the composition is a dry type with a low water content (moisture content), scattering of the composition can be prevented when the composition is filled into an outer packaging material such as a pouch. Thus, by including the polyglycerin fatty acid ester in the composition, production efficiency, such as work efficiency and yield, can be improved in the production of oral care products.

[0045] The polyglycerol fatty acid ester is a fatty acid ester of a dehydration condensation product of glycerol, and the degree of polymerization of glycerol is usually 2 or more, and may be 3 or more, and is usually 10 or less, and may be 8 or less.

[0046] The fatty acid ester group (RCOO- group) of the polyglycerol fatty acid ester is derived from a fatty acid. The fatty acid is not limited and may be a saturated fatty acid or an unsaturated fatty acid. From the viewpoints of good flavor and production efficiency, the number of carbon atoms in the fatty acid is usually 10 or more, preferably 12 or more, more preferably 14 or more, and even more preferably 16 or more, and is usually 30 or less, preferably 26 or less, more preferably 22 or less, and even more preferably 20 or less. The fatty acid may have a substituent or may be unsubstituted.

[0047] Furthermore, the number of fatty acid ester groups in one molecule of polyglycerol fatty acid ester is not limited as long as the structure allows the polyglycerol fatty acid ester to function as an emulsifier, and can be appropriately selected depending on the degree of polymerization of glycerol and the number of hydroxyl groups derived from glycerol. A structure that can function as an emulsifier is a structure that has both a fatty acid moiety that serves as a lipophilic group and a polyhydric alcohol moiety that serves as a hydrophilic group. Specifically, the number of fatty acid ester groups in one molecule of polyglycerol fatty acid ester is usually one or more. Furthermore, the number of hydroxyl groups derived from glycerol is also one or more.

[0048] The degree of polymerization of glycerin and the type and number of fatty acid ester groups in the polyglycerol fatty acid ester can be any combination of those described above. More specifically, the alcohol component of the polyglycerol fatty acid ester may be diglycerol, triglycerol, tetraglycerol, pentaglycerol, hexaglycerol, heptaglycerol, octaglycerol, nonaglycerol, or decaglycerol. The acid component of the polyglycerol fatty acid ester may be a fatty acid such as lauric acid, myristic acid, palmitic acid, stearic acid, oleic acid, linoleic acid, or α-linolenic acid. The polyglycerol fatty acid ester may be a monoester, diester, triester, tetraester, pentaester, or the like. One type of polyglycerol fatty acid ester may be used alone, or two or more types may be used in any ratio.

[0049] From the viewpoint of good flavor and ease of production, the polyglycerol fatty acid ester is preferably one or more selected from diglycerol mono-fatty acid esters and decaglycerol fatty acid esters. The diglycerol mono-fatty acid ester is preferably selected from the group consisting of diglycerol monolaurate, diglycerol monomyristate, diglycerol monopalmitate, diglycerol monostearate, and diglycerol monooleate, and more preferably diglycerol monooleate. The decaglycerol fatty acid ester is preferably selected from the group consisting of decaglycerol laurate, decaglycerol myristate, decaglycerol palmitate, decaglycerol stearate, and decaglycerol oleate, and more preferably selected from the group consisting of decaglycerol monolaurate, decaglycerol monomyristate, decaglycerol monopalmitate, decaglycerol monostearate, and decaglycerol monooleate.

[0050] The content of polyglycerol fatty acid ester in the composition (when two or more types of polyglycerol fatty acid esters are contained, the total content thereof) is not limited, but from the viewpoints of obtaining a good flavor and improving production efficiency, it is usually 0.1% by weight or more, preferably 0.2% by weight or more, more preferably 0.3% by weight or more, and even more preferably 0.5% by weight or more. Furthermore, from the viewpoint of imparting an appropriate viscosity to the composition, the content of the polyglycerol fatty acid ester is usually 20.0% by weight or less, preferably 15.0% by weight or less, more preferably 10.0% by weight or less, and even more preferably 8.0% by weight or less.

[0051] The HLB value of the polyglycerol fatty acid ester is not limited, but from the viewpoint of obtaining a good flavor and improving production efficiency, it is usually 6.0 or more, preferably 7.0 or more, and usually 20.0 or less, preferably 18.0 or less, more preferably 16.0 or less.

[0052] (8) Characteristics of the composition 1) pH The pH of the composition is not limited, but from the viewpoint of the effect on taste, it is usually 7.0 or higher, preferably 7.5 or higher, more preferably 8.0 or higher, and usually 10.0 or lower, preferably 9.5 or lower, more preferably 9.0 or lower. The pH is measured at 25°C.

[0053] The pH of the composition at a measurement temperature of 25°C can be measured using a pH analyzer (e.g., HORIBA's LAQUA F-72 flat ISFET pH electrode) by adding 20 mL of water to 2 g of the composition, shaking for 10 minutes, and measuring the supernatant. Calibration of the instrument is preferably performed using three-point calibration, for example, using a phthalic acid pH standard solution (pH 4.01), a neutral phosphate pH standard solution (pH 6.86), and a borate pH standard solution (pH 9.18) (all from Wako Pure Chemical Industries, Ltd.).

[0054] 2) Liquidity The oral composition according to this embodiment has excellent fluidity. Fluidity is also an index of the viscosity of the composition, adhesion to manufacturing equipment, caking resistance, and stickiness. A composition with excellent fluidity exhibits low adhesion to manufacturing equipment, caking resistance, and stickiness, and is easy to handle. The fluidity of a composition is evaluated by relative comparison of the shear stress value at a normal stress of 5.0 kPa at a measurement temperature of 22°C. A normal stress of 5.0 kPa is a value that simulates the pressure load applied to the composition due to its own weight during production, transportation, storage, etc., which may cause adhesion to manufacturing equipment, caking, or stickiness of the composition. The shear stress is preferably 4.15 kPa or more, more preferably 4.20 kPa or more, even more preferably 4.25 kPa or more, and preferably 5.85 kPa or less, more preferably 5.80 kPa or less. The shear stress value of the composition measured at a normal stress of 5.0 kPa is preferably 1.5 to 6 kPa.

[0055] The shear stress of the composition at a normal stress of 5.0 kPa can be measured using a rheometer. For example, when a Powder Rheometer FT4 manufactured by Freeman Technology is used as the rheometer, the measurement is carried out under the following conditions. Measurement mode: Standard program (25mm_shear_9kPa) Measurement temperature: 22℃ Measurement humidity: 60%RH Measurement container: Cylindrical container with an inner diameter of 25 mm and a volume of 10 ml Vertical load: 3 to 9 kPa Each measurement raw material is sieved (1.18 mm opening) to make the particles fine and uniform, which is used as the measurement sample, and measurements are carried out according to the rheometer procedure described above.

[0056] 3) Adhesion of the composition As mentioned above, the adhesiveness of a composition is indicated by the shear stress at a normal stress of 0 kPa at a measurement temperature of 22° C. A normal stress of 0 kPa is the pressure exerted when a user crushes a pouch product in the thickness direction after placing the pouch product in their mouth and before saliva seeps in, i.e., a value assuming a state in which no pressure is applied in any direction other than the thickness direction.

[0057] As with the above fluidity measurement, the shear stress of the composition is measured at normal stresses of 3 kPa, 4 kPa, 5 kPa, 6 kPa, and 7 kPa, and a graph is created by plotting normal stress on the horizontal axis and shear stress on the vertical axis. Since shear stress varies linearly with normal stress, this graph is fitted, and the shear stress at a normal stress of 0 kPa is calculated from the fitting results. The fitting conditions are as follows: A linear regression line is calculated from the shear stress values for each normal stress (3 kPa, 4 kPa, 5 kPa, 6 kPa, 7 kPa). The slope and Y-intercept are calculated. The calculated Y-intercept is taken as the shear stress at a normal stress of 0 kPa.

[0058] 4) Flow Function In the above adhesion evaluation, the Mohr's stress circle is fitted to the linear fitting used to calculate the shear stress at a normal stress of 0 kPa, the maximum principal stress and uniaxial collapse strength are determined, and the ratio of the maximum principal stress to the uniaxial collapse strength (maximum principal stress / uniaxial collapse strength) is calculated, allowing the flow function to be evaluated. The larger the value of the Flow Function (FF), the higher the liquidity.

[0059] (9) Method for producing the composition The composition may be produced by any method, but is preferably produced by mixing the base material, nicotine, and, if necessary, the above-mentioned components. The mixing can be carried out by putting all the raw materials into a mixer and mixing them.

[0060] In a preferred production method, the base material, nicotine, and, if necessary, water and other substances (sweeteners, flavors, humectants, etc.) are first mixed to obtain a first mixture. Heat may be applied at this time. The order in which the ingredients are mixed is not limited; they may be added to a mixer in any order or simultaneously and mixed, or the solid ingredients may be mixed uniformly, and then the liquid ingredients may be added and further mixed. From the viewpoint of workability, the latter embodiment is preferred.

[0061] To the mixture obtained as described above, an aqueous solution containing a pH adjuster, a sweetener such as acesulfame potassium, a flavoring such as menthol, a bitterness suppressant such as soybean lecithin, and a humectant such as glycerin can be added as needed (additive addition step). The additives may be added in solid form or as an aqueous solution dissolved in water. When added as an aqueous solution, they may be dissolved in a predetermined amount of water in advance so as to achieve the final moisture content of the oral product.

[0062] 2. Oral pouch products Oral products are used by being held in the mouth. An oral pouch product is a product that contains a composition (also called a base material or a filler) in a sealed water-insoluble packaging material (also called a pouch), and saliva penetrates through the pouch to dissolve the ingredients in the composition contained in the pouch, which can then be carried through the pouch and into the oral cavity.

[0063] (1) Pouch The pouch can be made of any known material, as long as it can package the filling, is insoluble in water, and is permeable to liquids (water, saliva, etc.) and water-soluble components in the filling. Examples of pouch materials include cellulose-based nonwoven fabrics, and commercially available nonwoven fabrics may also be used. A pouch product can be produced by forming a sheet made of such a material into a bag shape, filling it with the filling, and sealing it by means of heat sealing or the like.

[0064] The basis weight of the above sheets is not particularly limited, and is usually 12 gsm (g / m 2 The thickness of the sheet is not particularly limited, but is usually 100 μm or more and 300 μm or less, and preferably 175 μm or more and 215 μm or less.

[0065] A water-repellent material may be applied to at least one of the inner and outer surfaces of the pouch. A water-repellent fluororesin is preferably used as the water-repellent material. Specifically, an example of this type of water-repellent fluororesin is Asahi Guard (registered trademark) manufactured by Asahi Glass Co., Ltd. Water-repellent fluororesins are applied to packaging materials for foods and products containing fats and oils, such as confectioneries, dairy products, prepared foods, fast food, and pet food. Therefore, this type of water-repellent fluororesin is safe to apply to pouches placed in the oral cavity. The water-repellent material is not limited to fluororesins, and may be, for example, a water-repellent material such as paraffin resin, silicone resin, or epoxy resin.

[0066] The pouch may contain any ingredient, such as a scent- or taste-adjusting material, a flavoring, an additive, a tobacco extract, or a coloring. The manner in which these ingredients are contained is not limited, and examples include coating the pouch surface, impregnating the pouch, or, if the pouch is made of fiber, incorporating the ingredients into the fiber.

[0067] The appearance of the pouch is also not limited. The pouch may be opaque, translucent, or transparent. Translucent or transparent pouches allow the contents to be seen through.

[0068] The size of the oral pouch product is not limited. The size of the product before use may have a lower limit of the long side of 25 mm or more, 28 mm or more, 35 mm or more, or 38 mm or more. The upper limit may be 40 mm or less. The lower limit of the short side may be 10 mm or more or 14 mm or more. The upper limit may be 20 mm or less or 18 mm or less. The weight ratio of the filling to the total weight of the oral pouch product is not limited, but is usually 80 wt% or more, preferably 85 wt% or more, and more preferably 90 wt% or more, and usually 99 wt% or less, preferably 97 wt% or less, and more preferably 95 wt% or less.

[0069] (2) Filling The oral pouch product is filled with the composition as a filler. The amount of the filler per oral pouch product is preferably 0.4 to 1.5 g.

[0070] (3) Manufacturing method of oral pouch products An oral pouch product can be produced by packaging the composition in an outer packaging material (packaging process). The packaging method is not limited, and known methods can be used. For example, known methods can be used, such as a method in which the composition is placed in a bag-shaped nonwoven fabric and then sealed. In the packaging process, additional water may be added as desired after sealing (water addition process). For example, if the water content of the final composition is 50% by weight and the water content of the filled composition is 15% by weight, the remaining 35% by weight of water is added. [Example]

[0071] [Example 1] Oral composition Preparation of composition 100.0 g of silica (Evonic, SIPERNAT 2200) as a base material, 3.87 g of nicotine, 45.1 g of anhydrous sodium phosphate aqueous solution, 4.79 g of anhydrous citric acid aqueous solution, 14.03 g of sodium chloride aqueous solution, and 23.4 g of acesulfame K aqueous solution were added and mixed until uniform, yielding Mixture A. The resulting Mixture A was jacket heated (can wall temperature: 100°C). It was then cooled for 30 minutes at an ambient temperature of 20°C, yielding Mixture B (water content after cooling: 11%). After cooling, 67.7 g of tripotassium phosphate aqueous solution, 28.5 g of trisodium phosphate aqueous solution, 20 g of gellan gum aqueous solution, and other ingredients were added to Mixture B to yield 263 g of an oral composition (water content: 41.2 wt %, pH 8.51).

[0072] [Example 2] An oral composition was produced in the same manner as in Example 1, except that 36.0 g of powdered cellulose (VITACEL L00, manufactured by Rettenmeyer) and 66.0 g of the silica were mixed and used as the base material.

[0073] [Comparative Example 1] An oral composition was produced in the same manner as in Example 1, except that 100.0 g of microcrystalline cellulose (VIVAPUR200, manufactured by Rettenmeyer) was used as the base material. Table 1 shows the composition, and Table 2 shows the physical properties of the base material.

[0074] [Table 1]

[0075] [Table 2]

[0076] The evaluation results of the workability and fluidity during the production of the compositions in the above examples are shown below. The compositions obtained in the examples showed good fluidity. The evaluation criteria were as follows: A: Good (excellent yield, excellent powder properties) B: Inferior to A, but can be used in the subsequent pouching process C: Cannot be used in the subsequent pouching process

[0077] [Table 3]

[0078] [Table 4]

[0079] Various measurements were carried out as follows. <Average particle size> The average particle size of each material is the particle size at 50% cumulative volume (D50) in the particle size distribution determined by laser diffraction particle size distribution measurement, which was performed using a Mastersizer 3000 (Malvern Panalytical).

[0080] <Moisture content> Measurements were performed using a heat-drying moisture meter (Metter Toledo: HB 43-S). The sample was placed in a designated container and heated to a temperature of 100°C. The measurement was stopped when the change in weight was 1 mg or less in 60 seconds, and the moisture content was calculated from the weighing values before and after heating.

[0081] <Mesopore analysis by nitrogen adsorption method> The pretreatment was carried out under the following conditions: Silica: 250℃, 2 hours heating Cellulose: 105℃, 1 hour Then, nitrogen adsorption isotherms were obtained and mesopore volumes were determined by the BJH method. The measurement was performed using a gas adsorption measurement device AutoSorb-1 (manufactured by Quantachrome).

[0082] <ph> Using a pH analyzer (HORIBA, Ltd.: LAQUA F-72 flat ISFET pH electrode), 20 ml of water was added to 2 g of the composition, and the mixture was shaken for 10 minutes, and the supernatant was measured. The instrument was calibrated using, for example, a three-point calibration using a phthalic acid pH standard solution (pH 4.01), a neutral phosphate pH standard solution (pH 6.86), and a borate pH standard solution (pH 9.18) (all from Wako Pure Chemical Industries).

[0083] <Liquidity> It was measured by the method described above.< / ph>

Claims

1. an inorganic porous material having an average particle size of 60 μm or more as a substrate; Nicotine, In the inorganic porous material, the pore volume of pores having a pore diameter of 2 nm or more and less than 50 nm, as measured by a nitrogen adsorption method and calculated using the BJH method, is 0.50 cm ３ / g or more, Oral composition.

2. the inorganic porous material is selected from the group consisting of silica, silicates, alumina, zeolites, hydroxyapatite, hydrotalcite, and combinations thereof; The oral composition according to claim 1.

3. The inorganic porous material has a BET specific surface area of 200 to 1200 m ２ / g, The oral composition according to claim 1 or 2.

4. V1 is the pore volume of pores having a pore diameter of less than 2 nm measured by the nitrogen adsorption method and calculated using the HK method; V2 is the pore volume of pores having a pore diameter of 2 nm or more and less than 50 nm measured by a nitrogen adsorption method and calculated using the BJH method; When the pore volume of pores having a pore diameter of 50 nm or more measured by mercury intrusion porosimetry is V3, V2 / (V1+V2+V3)≧35% by volume; The oral composition according to any one of claims 1 to 3.

5. The oral composition according to any one of claims 1 to 4, which has a water content of 10% by weight or more.

6. The oral composition according to any one of claims 1 to 5, comprising 6 wt% or more of the inorganic porous material.

7. The oral composition according to any one of claims 1 to 6, A packaging material for packaging the oral composition; An oral pouch product comprising:

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