Composition for oral cavity containing granular regenerated cellulose

The oral composition with granular regenerated cellulose and nicotine maintains moisture stability, addressing the issue of foreign body sensation in oral pouch products by ensuring consistent moisture levels.

JP2025119060AInactive Publication Date: 2025-08-14JAPAN TOBACCO INC
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Patent Information

Application Number
JP2022074756
Authority / Receiving Office
JP · JP
Patent Type
Applications
Current Assignee / Owner
Filing Date
2022-04-28
Publication Date
2025-08-14
Estimated Expiration
Not applicable · inactive patent

AI Technical Summary

Technical Problem

Oral pouch products with high moisture content experience decreased moisture due to humidity changes, leading to increased foreign body sensation during use, which affects user experience.

Method used

An oral composition comprising granular regenerated cellulose with a water retention rate of 17% by weight or more under 25°C and 80% relative humidity, along with nicotine and other components, to maintain moisture stability and reduce foreign body sensation.

Benefits of technology

The composition provides excellent storage stability and reduces foreign body sensation by maintaining moisture levels, enhancing user experience.

✦ Generated by Eureka AI based on patent content.

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Abstract

To provide a composition for an oral cavity and a pouch product for an oral cavity excellent in storage stability.SOLUTION: A composition for an oral cavity includes nicotine and an organic material having a water retention value of 17 wt% or more under a condition of 25°C with relative humidity 80%, as a base material.SELECTED DRAWING: None
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Description

[Technical Field]

[0001] The present invention relates to oral compositions containing granular regenerated cellulose. [Background technology]

[0002] Oral compositions, which are the filling material of oral pouch products, are required to be designed with a high moisture content as a means of alleviating the initial foreign body sensation of the nonwoven fabric. However, in oral pouch products designed with a high moisture content, if the moisture-retaining base component has a high moisture desorption ability, the moisture content in the product can decrease due to humidity changes during storage, which can increase the foreign body sensation of the nonwoven fabric during use and potentially reduce the user experience.

[0003] Incidentally, Patent Document 1 discloses the use of microcrystalline cellulose as a carrier for a nicotine-containing pharmaceutical composition. [Prior art documents] [Patent documents]

[0004] [Patent Document 1] Special Publication No. 2014-530871 Summary of the Invention [Problem to be solved by the invention]

[0005] An object of the present invention is to provide an oral pouch product in which the foreign body sensation of the nonwoven fabric during use is reduced. [Means for solving the problem]

[0006] The above problems are solved by the present invention described below. Aspect 1 Nicotine and an organic material as a substrate having a water retention rate of 17% by weight or more under conditions of 25°C and 80% relative humidity; An oral composition comprising: Aspect 2 2. The oral composition of claim 1, wherein the organic material is granular regenerated cellulose. Aspect 3 The average particle size of the granular regenerated cellulose is 100 to 300 μm. An oral composition according to aspect 2. Aspect 4 The pore volume of the granular regenerated cellulose for pores with a diameter of 50 nm or more measured by mercury intrusion porosimetry is 1.80 to 2.20 cm 3 / g, 4. The oral composition according to claim 2 or 3. Aspect 5 5. The oral composition according to any one of Aspects 2 to 4, wherein the granular regenerated cellulose has an average pore diameter of 0.2 to 1.0 μm as measured by mercury porosimetry. Aspect 6 6. The oral composition according to any one of Aspects 1 to 5, having a water content of 30% by weight or more. Aspect 7 7. The oral composition according to any one of aspects 1 to 6, comprising 10% by weight or more of the organic material. Aspect 8 The oral composition according to any one of aspects 1 to 7, 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. [Brief explanation of the drawings]

[0008] [Figure 1] Adsorption / desorption isotherms of materials DETAILED DESCRIPTION OF THE INVENTION

[0009] 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.

[0010] 1.Oral composition The oral composition according to this embodiment (hereinafter simply referred to as the "composition") contains an organic material having a specific water retention rate and nicotine. The base material is a material that constitutes the matrix of the composition and is also called an excipient.

[0011] (1)Organic materials The composition contains, as a base material, an organic material having a moisture retention rate of 17% by weight or more under conditions of 25°C and 80% relative humidity. Because a composition containing this base material has a high moisture retention capacity, moisture in the product is less likely to decrease due to humidity changes during storage, etc. Therefore, when used as an oral product, the foreign body sensation of the nonwoven fabric during use can be reduced. From this perspective, the moisture retention rate is preferably 20% by weight or more. While there is no upper limit for the moisture retention rate, it is preferably 50% by weight or less.

[0012] The water retention rate of a material can be evaluated by measuring the moisture adsorption / desorption isotherm as shown in Figure 1. Specifically, a material with high water adsorption performance in a high humidity environment has a high ability to retain water. In the adsorption / desorption isotherm of the organic material, if the moisture retention rate differs between the adsorption mode and the desorption mode, the moisture retention rate in the mode with the lower moisture retention rate is defined as the "moisture retention rate." The moisture adsorption / desorption isotherm is measured as follows.

[0013] Known devices can be used to measure moisture adsorption / desorption isothermal behavior, such as the MicrotracBEL (MicrotracBEL Corporation) BELSORP MAX II. Pretreatment is preferably performed by vacuum drying the sample at 105°C until the leakage reaches 1 Pa / min or less. Next, the adsorption isothermal behavior is measured at relative pressures (humidity) of 0.025 to 0.3 at 0.025 intervals, and at 0.05 intervals from 0.3 to 0.95. After the relative pressure reaches 0.95, the desorption isothermal behavior is measured at the same relative pressure intervals down to 0.1, and an adsorption / desorption isotherm is created. The equilibration conditions are a pressure change of 0.3% or less over 300 seconds at relative pressures of 0.9 or less, and a pressure change of 0.3 Pa or less over 300 seconds at relative pressures of 0.9 or more.

[0014] Examples of the organic material include organic fibers and natural polymers, with cellulose being preferred, and granular regenerated cellulose being more preferred. Examples of regenerated cellulose include viscose rayon, cuprammonium rayon, and nitrocellulose rayon. The average particle size of the granular regenerated cellulose is preferably 100 to 300 μm. 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 reaches 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 composition may swell upon contact with water, forming lumps and resulting in uneven distribution of the composition. From this viewpoint, the lower limit of the average particle size is preferably 60 μm or more, and the upper limit thereof is preferably 500 μm or less.

[0015] The pore volume of pores with a diameter of 50 nm or more of the granular regenerated cellulose measured by mercury intrusion porosimetry is preferably 1.80 to 2.20 cm 3 / g. If the pore volume is less than the lower limit, the water retention rate may decrease. If the pore volume exceeds the upper limit, the strength of the granular material may decrease, which may cause deterioration in manufacturing suitability due to crushing of raw materials during manufacturing. From this viewpoint, the lower limit is more preferably 1.50 cm. 3 / g or more, and the upper limit is more preferably 2.50 cm 3 Mercury intrusion porosimetry is a method in which mercury is forced into the pores on the surface of a solid, and the pore distribution and pore volume are determined from the relationship between the pressure applied and the volume of mercury forced in.

[0016] The average pore diameter of the granular regenerated cellulose measured by mercury porosimetry is preferably 0.2 to 1.0 μm. If the average pore diameter is below the lower limit, the water retention rate may decrease. If the average pore diameter exceeds the upper limit, components adsorbed in the pores may be suddenly released into the oral cavity during use, which may impair the sustained taste of the product. From this perspective, the lower limit is more preferably 0.35 μm or more, and the upper limit is more preferably 0.6 μm or less.

[0017] The content of the organic material in the composition is preferably 10% 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 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, and 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 release agent. The release agent can improve production efficiency by reducing the inconvenience of components adhering to manufacturing equipment such as mixers and kneaders during the production of the composition, or to filling machines when the composition is filled into packaging materials such as pouches. The release agent can also reduce adhesion between the components of the composition, inhibiting caking (aggregation and solidification between the components), and suppress stickiness of the composition. As a result, the appearance, usability (feel in the mouth), flavor, and other properties of oral products containing the composition are improved. Furthermore, the release agent can inhibit leakage of the composition outside the packaging material, thereby improving the properties of the oral product.

[0034] The release agent is not limited as long as it exhibits the above-mentioned effects. Examples of the release agent include compounds such as fine silicon dioxide, magnesium oxide, calcium silicate, magnesium silicate, calcium phosphate, calcium stearate, and magnesium stearate. Among these, silicon dioxide is preferred as the release agent because it has a high effect and has little effect on the flavor. One type of release agent may be used alone, or two or more types may be used in combination in any ratio.

[0035] The release agent is preferably particulate in order to fully exert the above-mentioned effects. From the viewpoint of improving production efficiency, the average particle size of the particles is typically 20.0 μm or less, preferably 15.0 μm or less, and more preferably 10.0 μm or less, and typically 0.2 μm or more, preferably 0.3 μm or more, more preferably 0.4 μm or more, and even more preferably 1.0 μm or more. In the present invention, the average particle size of the release agent particles refers to the particle size at 50% cumulative volume (D50) in the particle size distribution determined by laser diffraction particle size distribution measurement. A general-purpose device such as the "Mastersizer 3000" manufactured by Malvern Panalytical can be used to measure the laser diffraction particle size distribution. Furthermore, in the present invention, silicon dioxide having such an average particle size may be referred to as "fine silicon dioxide."

[0036] The content of the release agent in the composition (when two or more types of release agents are contained, the total content of these agents) is not limited, but from the viewpoint of ensuring a good flavor and fully exerting the above-mentioned effects, it is usually 0.05% by weight or more, preferably 0.1% by weight or more, and more preferably 0.5% by weight or more, and is usually 3.0% by weight or less, preferably 2.5% by weight or less, and more preferably 2.0% by weight or less.

[0037] (6)Water In one embodiment, the water content (moisture content) in the composition is preferably 30% 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 anti-caking properties, suppressing stickiness, etc., the lower limit of the water content is 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 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 may be adjusted appropriately depending on the type of product (moist or dry). For example, in the case of a moist type, the water content is 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.

[0038] 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.

[0039] (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.

[0040] 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.

[0041] 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.

[0042] 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.

[0043] 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.

[0044] 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.

[0045] 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.

[0046] 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.

[0047] 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.

[0048] 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.

[0049] 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.

[0050] 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.

[0051] 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.

[0052] 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.

[0053] 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.

[0054] 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.

[0055] (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.

[0056] 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.).

[0057] (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.

[0058] 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.

[0059] 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.

[0060] 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.

[0061] (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.

[0062] 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.

[0063] 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.

[0064] 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.

[0065] 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.

[0066] 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.

[0067] (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.

[0068] (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]

[0069] [Example 1] Oral composition Preparation of composition 100.0 g of granular regenerated cellulose (Rengo Co., Ltd., Viscopal Mini) was added as a base material, 3.87 g of nicotine, 45.1 g of anhydrous sodium phosphate solution, 4.79 g of anhydrous citric acid solution, 14.03 g of sodium chloride solution, and 23.4 g of acesulfame potassium solution were mixed until uniform, yielding Mixture A. 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 solution, 28.5 g of trisodium phosphate solution, 20 g of gellan gum 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).

[0070] [Comparative Example 1] An oral composition was produced in the same manner as in Example 1, except that 100.0 g of silica (SIPERNAT2200, manufactured by Evonic) was used as the base material. Table 1 shows the composition, and Table 2 shows the physical properties of the base material.

[0071] Comparative Example 2 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.

[0072] [Table 1]

[0073] [Table 2]

[0074] Figure 1 shows the moisture adsorption and desorption isotherms for each material. Compared to silica, the granular regenerated cellulose used in the examples tends to have higher moisture adsorption and desorption properties under both low and high humidity conditions, making it less susceptible to product denaturation due to the storage environment. Even in oral products designed for high moisture content, the moisture content of the product can be maintained until use, thereby improving product stability. Furthermore, as described in the previous paragraph, the large number of macropores allows for rapid release of moisture retained within the product in the oral environment, improving the initial foreign body sensation of nonwoven fabrics and providing users with a pleasant mouthfeel and taste.

[0075] The various measurements are 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).

[0076] <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.

[0077] <Micropore analysis by nitrogen adsorption method> The pretreatment was carried out under the following conditions: Silica: 250℃, 2 hours heating Cellulose: 105℃, 1 hour Nitrogen adsorption isotherms were then obtained and the micropore volumes were determined by the HK method. The measurement was performed using a gas adsorption measurement device AutoSorb-1 (manufactured by Quantachrome).

[0078] <Macropore analysis by mercury intrusion porosimetry> The measurement was carried out using a fully automatic pore size distribution measuring device (PoreMaster60-GT (manufactured by Quanta Chrome Co.)).

[0079] <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).

[0080] <Moisture adsorption / desorption isotherm> Measurement equipment: A MicrotracBEL (MicrotracBEL Corporation) BELSORP MAX II was used. As a pretreatment, the sample was vacuum dried at 105°C until the leakage reached 1 Pa / min or less. Measurement conditions were as follows: adsorption isotherms were measured at 0.025 relative pressure intervals from 0.025 to 0.3 relative pressure (humidity), and at 0.05 relative pressure intervals from 0.3 to 0.95 relative pressure intervals. Once the relative pressure reached 0.95, desorption isotherms were measured at the same relative pressure intervals down to 0.1 relative pressure. (For TSP, the measurement time was long and measurement accuracy decreased, so the pressure was measured up to 0.5 relative pressure.) Equilibration conditions were as follows: a pressure change of 0.3% or less over 300 seconds at relative pressures below 0.9, and a pressure change of 0.3 Pa or less over 300 seconds at relative pressures above 0.9.< / ph>

Claims

1. Nicotine and an organic material as a substrate having a water retention rate of 17% by weight or more under conditions of 25°C and a relative humidity of 80%; An oral composition comprising:

2. The oral composition of claim 1 , wherein the organic material is granular regenerated cellulose.

3. The average particle size of the granular regenerated cellulose is 100 to 300 μm. The oral composition according to claim 2.

4. The pore volume of the granular regenerated cellulose, which is measured by mercury intrusion porosimetry, for pores with a diameter of 50 nm or more is 1.80 to 2.20 cm 3 / g, The oral composition according to claim 2 or 3.

5. 5. The oral composition according to claim 2, wherein the granular regenerated cellulose has an average pore diameter of 0.2 to 1.0 μm as measured by mercury intrusion porosimetry.

6. The oral composition according to any one of claims 1 to 5, which has a water content of 30% by weight or more.

7. The oral composition according to any one of claims 1 to 6, comprising 10% by weight or more of the organic material.

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

Citation Information

Patent Citations

  • Excipients for nicotine-containing therapeutic compositions

    JP2014530871A