WO2023106389A1

WO2023106389A1 - Composition to be used in mouth, and pouch product to be used in mouth

Info

Publication number: WO2023106389A1
Application number: PCT/JP2022/045419
Authority: WO
Inventors: 雅之古越; 正人宮内; 慶小林; 啓佑佐々木
Original assignee: 日本たばこ産業株式会社
Priority date: 2021-12-09
Filing date: 2022-12-09
Publication date: 2023-06-15

Abstract

A composition to be used in the mouth which contains nicotine, an acid and a substrate, wherein said acid is an external additive, and water in which said composition to be used in the mouth is dispersed is acidic at 25°C.

Description

Oral compositions and oral pouch products

The present invention relates to an oral composition and an oral pouch product.

Oral pouch products are known which are formed by packaging an oral composition such as an oral tobacco composition with a material such as a non-woven fabric. A user puts the oral pouch product into the oral cavity and uses it.
When the oral pouch product is put into the oral cavity of the user, the flavor component such as nicotine contained in the oral composition of the contents seeps out of the packaging material, thereby The flavor component is delivered to the

In oral pouch products, it is important to adjust the flavor sensation given to the user during use. There is known a technique of adjusting the content of the acid in a predetermined range to obtain a desired flavor feeling.

International Publication No. 2016-63423

The flavor sensation that a user receives when using an oral pouch product is greatly influenced by the composition of the oral composition contained in the oral pouch product. In order to adjust such a feeling of flavor, Patent Document 1 describes adjusting the amount ratio of nicotine contained in an oral composition and a specific acid to a specific range. However, the invention described in Patent Document 1 describes adjusting the pH of the oral tobacco composition to be neutral to basic. It was necessary to adjust the pH of the oral tobacco composition to neutral to basic.
In addition, the amount of moisture in the oral cavity is also an important factor that determines the amount of flavor component (here, nicotine) released into the oral cavity when using oral pouch products, and it is desirable to increase the moisture content as much as possible. There is a request. However, when the water content of the oral composition contained in the oral pouch product is increased, problems may occur in terms of manufacturing restrictions, product stability, and the like.

Therefore, an object of the present invention is to provide an oral composition and an oral pouch product that release nicotine well to the user.

The present inventors have found that an oral composition exhibiting acidity when dispersed in artificial saliva under specific conditions increases the amount of moisture in the user's mouth, thereby increasing the release of nicotine contained in the oral composition. The present invention was arrived at by discovering that it becomes good.

[1] An oral composition containing nicotine, an acid, and a base material, wherein the acid is externally added, and artificial saliva in which the oral composition is dispersed exhibits acidity at 25°C. , oral compositions.
[2] The oral composition according to [1], wherein the oral composition contains a tobacco material and the nicotine is derived from the tobacco material.
[3] In [1], wherein the oral composition contains an ion exchange resin carrying nicotine, and the nicotine contained in the oral composition is derived from the ion exchange resin carrying nicotine. Oral composition as described.
[4] The base material is one or more selected from the group consisting of cellulose, microcrystalline cellulose, spherical cellulose, and porous cellulose, and the content of the base material is 50 wt. % or more, the composition for oral cavity according to any one of [1] to [3].
[5] The oral composition according to any one of [1] to [4], wherein the acid is one or more selected from organic acids and salts thereof.
[6] The acid is an organic acid, and the organic acid is malic acid, citric acid, succinic acid, acetic acid, formic acid, levulinic acid, pyruvic acid, tartaric acid, adipic acid, lactic acid, butyric acid, L-ascorbic acid, The oral composition according to any one of [1] to [5], which is one or more selected from the group consisting of glutamic acid and aspartic acid.
[7] The oral composition according to any one of [1] to [6], wherein the oral composition has a whiteness of 10 or more and 100 or less.
[8] The oral composition according to any one of [1] to [7], wherein the oral composition comprises a plurality of solid particles.
[9] An oral pouch product comprising a packaging material for packaging an oral composition, and the oral composition according to any one of [1] to [8] packaged in the packaging material.
[10] The pouch product for oral cavity according to [9], wherein an acid is added to the packaging material.

According to the present invention, it is possible to provide an oral composition and a pouch product for oral cavity in which the flavor component contained in the composition for oral cavity is well released.

FIG. 4 is a graph showing the amount of nicotine released from an oral pouch product by artificial saliva over time.

Embodiments of the present invention will be described in detail below, but these descriptions are examples (representative examples) of embodiments of the present invention, and the present invention is not limited to these contents as long as they do not exceed the gist of the present invention.
In the present specification, the numerical range represented using "to" means a range including the numerical values described before and after "to" as lower and upper limits, and "A to B" is A or more B or less.

In the present specification, artificial saliva can be prepared by the following procedure.
(1) Prepare 1000 mL of distilled water.
(2) Add 2 mL of concentrated sulfuric acid to lower the pH to 2.5 or less.
(3) Measure out a predetermined amount of the following reagent and dissolve it in the above solution.
_K2HPO4.H2O _0.68 _g
NaCl (anhydrous) 0.33 g
_CaCl2.2H2O _0.15 g
KCl (anhydrous) 0.75 g
_K2CO3 ( _anhydrous ) 0.53g
0.17 _g of _MgCl2.6H2O
(4) Adjust the pH of the solution (25° C.) to 6.8±0.1 using 5N NaOH.

In the present specification, the pH of oral compositions and the like is measured according to the following procedure.
<Measurement of pH> 2.0 g of the oral composition to be measured (or a mixture containing tobacco powder described later) was weighed into a screw tube, 20 ml of the artificial saliva or distilled water was added, and the mixture was stirred at 200 rpm. Shake for 10 minutes for extraction. After allowing the resulting extract to stand still for 5 minutes, the pH is measured (25° C.) under the following conditions to determine the pH value of the tobacco filler.
<pH measurement conditions>
Measuring equipment: LAQUA F-72 flat ISFET pH electrode (Horiba Ltd.)
Instrument calibration: 3 using phthalic acid pH standard solution (pH 4.01), neutral phosphate pH standard solution (pH 6.86), borate pH standard solution (pH 9.18) (all Wako Pure Chemical Industries) Point calibration

<Oral composition>
The oral composition of the present invention is an oral composition containing nicotine, an acid, and a base material, wherein artificial saliva in which the oral composition is dispersed exhibits acidity at 25°C. is. The composition of the oral cavity composition is not particularly limited as long as it contains at least nicotine, an acid and a base material. The oral composition of the present invention is a composition preferably used in oral pouch products. In addition, from the viewpoint of preventing leakage to the outside of the pouch, the oral composition contained in the pouch product is preferably not liquid, and is preferably composed of a plurality of solid particles, for example.

(nicotine)
The oral composition contains nicotine. Embodiments containing nicotine are not particularly limited. For example, nicotine may be contained as a compound, and a nicotine-carrying substance such as a nicotine salt or stabilized nicotine (for example, nicotine supported on an ion exchange resin) may be contained. may

Examples of nicotine-carrying substances include substances in which nicotine is carried on ion-exchange resins as described above. Therefore, the nicotine contained in the oral composition may be derived from the nicotine-supported ion exchange resin.
When nicotine is supported on an ion exchange resin, the ion exchange resin is used as the carrier. Examples of ion exchange resins include weakly acidic cation exchange resins. As for the nicotine-supported ion exchange resin, a resin complex called nicotine polacrilex containing, for example, 10% by weight or more and 20% by weight or less of nicotine can be used. The ion exchange resin used in nicotine Polacrilex is a weakly acidic cation exchange resin.
When using nicotine polacrilex, the release of nicotine from the resin complex occurs through an ion exchange process with cations derived from the oral composition dissolved in saliva upon use of the oral composition. This releases free nicotine from the water-insoluble resin complex, which is then readily absorbed through the user's oral mucosa. The exchange groups of the ion exchange resin used in nicotine polacrilex are regenerated (reverted to --COOH) with acidity. Therefore, theoretically, nicotine molecules do not bind to -COOH of the ion exchange resin when acidic conditions are maintained. Conceivable. The present inventor presumes that this allows nicotine to be stably released into the oral cavity.
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 2.0% by weight or more. % by weight or more is more preferable. On the other hand, from the viewpoint of the flavor of the oral composition, the amount of nicotine polacrilex added to the oral composition is usually 15.0% by weight or less, preferably 12.0% by weight or less. , 10.0% by weight or less.

Also, as a nicotine source, tobacco materials including tobacco powder obtained by pulverizing tobacco leaves, for example, may be included. That is, the nicotine contained in the oral composition may be derived from tobacco materials.
Tobacco powder may include dried tobacco leaf lamina cuts, fines, fibers, etc., and may be prepared by the methods described below. As used herein, tobacco leaves may include mesophyll (lamina), leaf veins (stem), and roots. The above-mentioned tobacco filler may contain elements derived from tobacco leaf backbones and roots in addition to tobacco powder basically obtained from tobacco leaf lamina.
The particle size of the tobacco powder is not particularly limited. It is preferably passed through a mesh of 0.2 mm, more preferably passed through a mesh of 1.0 mm.
The tobacco species used as the raw material for the tobacco powder is not particularly limited, and examples thereof include Nicotiana genus Nicotiana tabacum yellow variety, Burley variety, and Nicotiana rustica Brasilia variety. The same species as these can also be used for tobacco materials and tobacco leaves, which will be described later.

Tobacco powder is preferably obtained as follows. First, a basic pH adjuster is added to tobacco powder obtained by pulverizing tobacco leaves and mixed. Potassium carbonate and/or sodium carbonate can be mentioned as the pH adjuster exhibiting basicity to be added, and is preferably added as an aqueous solution. Moreover, you may further add another pH adjuster. It is preferable to adjust the pH of the mixture after adding the pH adjuster to 8.0 to 9.0.
The content of tobacco powder in this mixture can be 60 to 90% by weight.
After adding the pH adjuster, for example, the product temperature is 65 to 90 ° C., preferably under conditions where the product temperature is 70 to 80 ° C., for example, for 0.5 to 3 hours, preferably 0.8 to 2 hours. . Thus, the tobacco powder is sterilized.
Heating can be accomplished 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 water content of the mixture after heating is preferably 10 to 50% by weight.
After heating, if necessary, steam injection is stopped and only the jacket is heated to dry the treated tobacco powder obtained.
After that, it can be cooled at about 15 to 25° C. for about 1 hour.

When a tobacco material containing tobacco powder is used, the amount added to the oral composition is usually 0.001% by weight or more, preferably 0.01% by weight or more, and 0 More preferably, it is at least 0.05% by weight. On the other hand, from the viewpoint of the flavor of the oral composition, the amount of the tobacco material containing tobacco powder added to the oral composition is usually 90% by weight or less, preferably 80% by weight or less, and 70% by weight. % by weight or less is more preferable. Furthermore, the amount of tobacco material containing tobacco powder added to the oral composition may be 45% by weight or less, 40% by weight or less, or 30% by weight or less. .

As a source of nicotine, a nicotine-containing extract obtained by extracting nicotine-containing substances such as tobacco leaves may be included.
Among the above modes, the addition of a nicotine-carrying substance is preferable from the viewpoint of accurate supply of nicotine and ease of handling. Generally, when tobacco powder is added, the color of oral compositions and pouch products tends to be the color of tobacco leaves, whereas when colorless nicotine-containing compounds are used, white compositions and pouch products can be provided. Such an aspect is an advantage for users who prefer white pouch products.
One of the above aspects may be applied alone, or two or more aspects may be applied in combination.

The content of nicotine in the oral composition is not particularly limited, but from the viewpoint of user's preference, it is usually 0.1% by weight or more and usually 15.0% by weight or less.
Regarding the content of nicotine, the same range can be applied to the nicotine supply source, for example, the substance in which nicotine is supported on the ion-exchange resin, the tobacco material including tobacco powder, or the nicotine-containing extract. . The amount of nicotine contained does not affect the amount of nicotine released during use of the product.
In addition, when nicotine exists as an ion, said content rate is a content rate as a nicotine ion.
The content of nicotine in the composition can be measured by gas chromatography-mass spectrometer (GC-MS), liquid chromatography (LC, UV detection), or the like.

(acid)
The oral composition of the present invention contains an acid. The acid contained in the oral composition promotes the secretion of saliva in the oral cavity and the elution of nicotine from the oral composition in the oral cavity during use by the user. The acid may be a Bronsted acid that is a proton donor, a Lewis acid that is an electron pair acceptor, an inorganic acid and/or a salt thereof, or an organic acid and/or a salt thereof. good.
The inorganic acid and/or salt thereof can be used without particular limitation as long as it exhibits acidity in the composition, and preferred examples include phosphoric acid, sodium dihydrogen phosphate, and potassium dihydrogen phosphate. , calcium dihydrogen phosphate, sodium pyrophosphate, potassium pyrophosphate, calcium pyrophosphate, and the like. Among these, it is preferable to use sodium dihydrogen phosphate.
Examples of organic acids include carboxylic acids such as malic acid, citric acid, succinic acid, acetic acid, formic acid, levulinic acid, pyruvic acid, tartaric acid, adipic acid, lactic acid and butyric acid, L-ascorbic acid, glutamic acid and aspartic acid. One or more selected from the group consisting of acidic amino acids can be mentioned.
Among the above carboxylic acids, one or more selected from the group consisting of citric acid, malic acid, succinic acid, acetic acid, and formic acid can be preferably used.
As the salt of the organic acid, any metal salt of the organic acid listed above and exhibiting acidity in the composition can be used without particular limitation. Alkali metals can be mentioned as metals constituting the salt. Alkali metals include sodium and potassium, preferably potassium.
These acids and/or salts thereof are externally added during the preparation of the oral composition, and when using a source of nicotine derived from tobacco leaves such as tobacco materials, It has a different origin from the acid and/or its salt derived from tobacco leaves.
It is preferable to add a non-salt-forming organic acid to the oral composition. Moreover, an organic acid and/or its salt can be used in combination with the inorganic acid and/or its salt.

The amount of acid to be added is usually 1.0% by weight or more and 6.0% by weight relative to the oral composition, from the viewpoint of exhibiting acidity when the oral composition is dispersed in a predetermined artificial saliva. % or more, more preferably 10% by weight or more, and even more preferably 20% by weight or more. On the other hand, from the viewpoint of the flavor of the oral composition, it is usually 60% by weight or less, preferably 55% by weight or less, more preferably 50% by weight or less, relative to the oral composition. This addition amount range can be applied to any of the above acids.

(Base material)
The oral composition of the present invention contains a substrate. The type of substrate is not particularly limited, and examples thereof include one or more selected from the group consisting of cellulose, microcrystalline cellulose, spherical cellulose and porous cellulose. Cellulose is preferred from the viewpoint of exhibiting One type of these substances may be used alone, or two or more types may be used in combination in an arbitrary type and ratio.
The content of the base material in the oral composition is not particularly limited, but it improves the quality by suppressing the elution of water during manufacturing or product storage, and gives the desired appearance to the user by increasing the whiteness of the product. From the viewpoint of doing so, it is usually 5% by weight or more, preferably 15% by weight or more, more preferably 20% by weight or more, and there is no need to limit the upper limit, but other raw materials are blended. From the viewpoint of possible limits, it is usually 70% by weight or less, preferably 50% by weight or less, and more preferably 35% by weight or less.

(water)
It is preferred that the oral composition contains a moderate amount of moisture.
The water content (moisture content) in the oral composition is preferably 5% by weight or more. If the water content is less than 5% by weight, it may be difficult to produce the oral composition. Furthermore, from the viewpoint of ensuring good fluidity and adhesion of the oral composition and facilitating the production of the composition, the water content is preferably 30% by weight or more, and 45% by weight or more. is more preferable, and it is usually 60% by weight or less, preferably 50% by weight or less. Also, the water content may be 40% by weight or less, 30% by weight or less, or 20% by weight or less. The water content can be adjusted by adjusting the amount of water to be added or by providing heat treatment or drying treatment in the production stage.
The water content of the oral composition can be adjusted accordingly depending on the product type (moist or dry). For example, in the case of a moist type, the water content is usually 20% by weight or more and 60% by weight or less, preferably 30% by weight or more and 50% by weight or less. On the other hand, in the case of the dry type, the water content is usually 5% by weight or more and 20% by weight or less, preferably 10% by weight or more and 15% by weight or less.

The water content (moisture content) of the above composition is measured using a heat drying moisture meter (for example, HB 43-S manufactured by METER TOLEDO). At the time of measurement, the sample is placed in a predetermined container and heated to reach a temperature of 100°C. The measurement is terminated when the amount of change becomes 1 mg or less in 60 seconds, and the moisture content is calculated from the weighed values before and after heating.

(other substances)
Other substances that may be included in the oral composition include, for example, flavors, pH adjusters, sweeteners, humectants, bitterness suppressants, whitening agents, polysaccharide thickeners, emulsifiers, and the like.
The content of other substances in the oral cavity composition is not particularly limited, and the formulation can be appropriately adjusted according to the product design.

The type of fragrance is not particularly limited, and examples thereof include menthol, leaf tobacco extract, natural plant fragrance (e.g., cinnamon, sage, herb, chamomile, arrowroot, sweet tea, clove, lavender, cardamom, clove, nutmeg, bergamot, Geranium, Honey Essence, Rose Oil, Lemon, Orange, Cinnamon, 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., acetic acid isoamyl, 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.), hydrocarbons (e.g., limonene) , pinene, etc.). One type of these substances may be used alone, or two or more types may be used in combination in an arbitrary type and ratio.

The type of pH adjuster is not particularly limited, and examples thereof include sodium carbonate, sodium hydrogencarbonate, potassium carbonate, potassium hydrogencarbonate, anhydrous sodium phosphate, sodium citrate, etc. From the viewpoint of the effect on the taste of the product, Therefore, sodium carbonate and potassium carbonate are preferred. One type of these substances may be used alone, or two or more types may be used in combination in an arbitrary type and ratio. However, although it can be used as a pH adjuster, the substance that can also be used as an acid is treated as an acid in the present specification.

The type of sweetener is not particularly limited, and examples thereof include sugar alcohols such as xylitol, maltitol, and erythritol, and sweeteners such as acesulfame potassium, sucralose, and aspartame. Sugar alcohols are preferred from the viewpoint of taste control. . One type of these substances may be used alone, or two or more types may be used in combination in an arbitrary type and ratio. By adding a sweetener, it is possible to reduce the sour taste exhibited by the acid contained in the oral composition and to obtain a desired flavor. The content of the sweetener in the oral composition is usually 5.0% by weight or more and 40.0% by weight or less, preferably 10.0% by weight or more and 30.0% by weight or less. can be done.

The bitterness inhibitor is not particularly limited, and examples thereof include soybean lecithin. Soybean lecithin is a phospholipid and includes phosphatidylcholine, phosphatidylethanolamine, phosphatidic acid and the like. One type of these substances may be used alone, or two or more types may be used in combination in an arbitrary type and ratio.

The type of moisturizing agent is not particularly limited, and examples thereof include glycerin, propylene glycol, etc. Glycerin is preferable from the viewpoint of product storage stability. One type of these substances may be used alone, or two or more types may be used in combination in an arbitrary type and ratio.

The type of whitening agent is not particularly limited and includes, for example, silica, fine silicon dioxide, titanium dioxide, calcium carbonate, etc. Silica and fine silicon dioxide are preferred from the viewpoint of their influence on the taste of the product. One type of these substances may be used alone, or two or more types may be used in combination in an arbitrary type and ratio.

The type of polysaccharide thickener is not particularly limited, and examples thereof include polysaccharide thickeners added to foods. Examples of polysaccharide thickeners include one or more selected from the group consisting of xanthan gum, guar gum, carrageenan, pectin, carob bean gum (locust bean gum), and curdlan. When the oral composition contains a thickening polysaccharide, the effect of improving the mouthfeel during use by the user is obtained.
The content of the thickening polysaccharide in the oral composition is usually 1.0% by weight or more and 25.0% by weight or less, preferably 5.0% by weight or more and 20.0% by weight or less. be able to.

The type of emulsifier is not particularly 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 and sucrose stearate. Examples of the organic acid glycerol fatty acid ester include succinic acid glycerol fatty acid ester and diacetyltartaric acid glycerol fatty acid ester. Examples of polyglycerin fatty acid esters include diglycerin fatty acid esters and decaglycerin fatty acid esters.
The content of the emulsifier in the oral composition is usually 1.0% by weight or more and 20.0% by weight or less, preferably 5.0% by weight or more and 15.0% by weight or less. can.

The content of each component above (excluding water content) can also be calculated from the amount of raw materials charged.

(pH of oral composition when dispersed in artificial saliva at 25°C)
The pH of the oral cavity composition dispersed in artificial saliva at a measurement temperature of 25°C is not particularly limited as long as it is acidic. In this specification, the term "acidic" refers to a pH of less than 6.7. From the viewpoint of stabilizing the release of nicotine into the oral cavity, the pH of the oral cavity composition dispersed in artificial saliva at a measurement temperature of 25° C. is less than 6.7, preferably 6.0 or less, and 5.0. It is more preferably 4.0 or less, particularly preferably 3.0 or less. Moreover, it is usually 1.5 or more, preferably 1.8 or more. The pH can be adjusted by controlling the amount of addition of a pH adjusting agent or the like. In addition to the above pH values, the pH values in this specification are values measured at a measurement temperature of 25°C.

The pH of the composition at the above measurement temperature of 25 ° C. is measured using a pH analyzer (for example, LAQUA F-72 flat ISFET pH electrode manufactured by Horiba Ltd.). , measure the supernatant.
For calibration of the device, for example, phthalic acid pH standard solution (pH 4.01), neutral phosphate pH standard solution (pH 6.86), borate pH standard solution (pH 9.18) (all Wako Pure Chemical Industries) Perform a three-point calibration using

(Whiteness of oral composition)
As the whiteness of the oral composition, the whiteness determined by ASTM E313-73 is adopted in the present invention. A perfect diffuse reflection surface (ideal white) is assumed to have a whiteness of 100.
Measurement method color difference meter (manufactured by Koniminolta: CR-5)
The measurement method is de: 8° (SCE: regular reflection light removal, diffuse reflection), and the reflectance is obtained. From the obtained reflectance, X, Y, and Z (the tristimulus values in the XYZ color system of the sample) are determined using information on the type of light source and viewing angle (viewing angle 2°, light source C).
This value is substituted into the following formula to obtain the whiteness (WI).
WI=4×(0.847·Z)−3·Y
The sample to be measured is placed on a petri dish, and the diffuse reflection excluding the specular reflection of the petri dish (glass) is measured.
The whiteness index of the oral cavity composition of the present invention is usually 10 or more and 100 or less, preferably 20 or more and 40 or less, as measured by the above measuring method. When the degree of whiteness is 20 or more and 40 or less, the white color gives a particularly favorable impression to users.
When the oral cavity composition satisfies the numerical range of the above color system, it is possible to give the user a desirable white impression.
Regarding the whiteness of the oral composition, it is necessary to select a substance with a high degree of whiteness as a nicotine supply source to be added to the oral composition, adjust the type and amount of the base material, and use a whitening agent that exhibits whiteness. For example, it can be adjusted by adding fine particles of silicon dioxide, titanium dioxide, calcium carbonate, etc. exemplified above.

(Particle size of components of oral composition)
The oral composition is preferably composed of a plurality of solid particles, but the size of the particles is not particularly limited. For example, it is preferable that the constituents of the dried oral composition satisfy the following classification conditions.
The dried oral composition is preferably classified by a sieve having the following meshes. From the viewpoint of the user's texture during use, ease of handling during manufacturing, and control of quality variation, it is usually passed through a sieve with a 15 mm mesh (<15 mm), and a 10 mm sieve. It preferably passes through a sieve with openings (<10 mm), more preferably through a sieve with 5 mm mesh (<5 mm), and more preferably through a sieve with 3.2 mm mesh. It is even more preferred that it passes through (<3.2 mm). For example, if all of the dried oral composition passed through a sieve with a mesh size of 3.2 mm, this indicates that the maximum dry particle size of the constituents of the oral composition is 3.2 mm or less.
Although it is not necessary to set the lower limit of the particle size of the constituents of the oral composition when dried, it is usually 3 μm or more from the viewpoint of preventing leakage from the pouch.
The above dried oral composition is obtained by drying the oral composition at 70° C. to 80° C. for about 3 hours.
The maximum particle size of the constituents of the oral composition can be increased/decreased accordingly by adjusting the particle size of the material comprising the nicotine source, such as tobacco material or nicotine-loaded ion exchange resin. If the oral composition does not contain tobacco material and contains nicotine-loaded ion exchange resin, its particle size is greatly influenced by the particle size of the ion exchange resin. The nicotine-supported ion exchange resin may have a median particle size (D50) of 30 μm or more and 80 μm or less, 40 μm or more and 70 μm or less, or 40 μm or more and 65 μm, as measured by a Mastersizer. It may be below.

Another embodiment of the present invention is the use of the oral composition described above in an oral pouch product.
[Pouch]
The pouch (packaging material) can pack the above composition, is insoluble in water, and is permeable to liquids (water, saliva, etc.) and water-soluble components in the composition. If there is, it is not particularly limited, and a known one can be used. Materials for the pouch include, for example, cellulose-based nonwoven fabrics, and commercially available nonwoven fabrics may be used. A pouch product can be produced by forming a sheet made of such a material into a bag shape, putting the above composition into the bag, and sealing the bag by a means such as heat sealing.
The basis weight of the sheet is not particularly limited, and is usually 12 gsm or more and 54 gsm or less, preferably 24 gsm or more and 30 gsm or less.
The thickness of the sheet is not particularly limited, and is usually 100 μm or more and 300 μm or less, preferably 175 μm or more and 215 μm or less.

At least one of the inner and outer surfaces of the pouch may be partially coated with a water-repellent material. A water-repellent fluorine-based resin is suitable as the water-repellent material. Specifically, this type of water-repellent fluororesin includes Asahi Guard (registered trademark) manufactured by Asahi Glass Co., Ltd. Water-repellent fluorine-based resins are applied to packaging materials for foods and products containing oils and fats, such as confectionery, dairy products, side dishes, fast food, and pet food. Therefore, this type of water-repellent fluororesin is safe even when applied to pouches placed in the oral cavity. The water-repellent material is not limited to the fluorine-based resin, and may be, for example, a paraffin resin, a silicon-based resin, an epoxy-based resin, or the like, as long as it has a water-repellent action.

The pouch may contain optional ingredients, such as raw materials for adjusting fragrance and taste, flavors, additives, tobacco extracts, pigments, and the like. In addition, there are no particular restrictions on the manner in which these components are contained, and examples include the manner in which they are applied to the surface of the pouch, the manner in which they are impregnated, and the manner in which they are contained in the fibers when they are made of fibers.
Furthermore, the appearance of the pouch is not particularly limited, and may be not only non-transparent but also translucent or transparent, in which case the composition packed in the pouch can be seen through.

The acid contained in the oral composition described above may be added to the pouch (packaging material). The addition method is not particularly limited, and for example, a method of immersing a pouch (packaging material) in a solution of the above-mentioned acid and then drying it can be mentioned. By adding an acid to the packaging material, it is possible to adjust the pH value at 25° C. of the artificial saliva in which the pouch product described later is dispersed. Specifically, the pH of the pouch product can be adjusted to be lower than the pH of the oral composition in the pouch. The measurement of the pH of the pouch product can be performed under the same conditions as the measurement of the pH of the oral composition after adjusting the weight of the oral composition to be enclosed.
The pH range when the pouch product is dispersed in artificial saliva at 25° C. is preferably the same as the pH range of the oral composition described above. That is, it is less than 6.7, preferably 6.0 or less, more preferably 5.0 or less, further preferably 4.0 or less, and particularly preferably 3.0 or less. preferable. Moreover, it is usually 1.5 or more, preferably 1.8 or more. In addition, when the acid is also added to the pouch (packaging material), even if the pH of the oral composition is not within the above particularly preferable range, the pH of the pouch product is within the above particularly preferable range. Aspects are preferred aspects.

[Pouch products]
The pouch product is not particularly limited as long as it has the oral composition and the pouch for packaging the oral composition (the oral composition is enclosed in the pouch). .
The size and weight of the pouch product are not particularly limited. The short side may be 10 mm or more and 20 mm or less, or 14 mm or more and 18 mm or less. Moreover, the weight of the pouch product before use may be 0.1 g or more and 2.0 g or less, or may be 0.3 g or more and 1.0 g or less.
The ratio of the weight of the oral composition to the total weight of the pouch product is not particularly limited, but is usually 80% by weight or more, preferably 85% by weight or more, more preferably 90% by weight or more, Moreover, it is usually 99% by weight or less, preferably 97% by weight or less, and more preferably 95% by weight or less.

　In the measurement of each characteristic in this specification, the measurement sample is kept in the same environment as the environment to be measured for 48 hours or more before the measurement. In addition, the measurement temperature, measurement humidity, and measurement pressure are normal temperature (22 ± 2 ° C), normal humidity (60 ± 5% RH), and normal pressure (atmospheric pressure) unless otherwise specified. .

As a pouch product, there is also an embodiment in which the above acid-free oral composition is sealed in a pouch (packaging material) containing an acid. The composition of the oral composition in that case can apply the conditions explained above except that it does not contain an acid. In this case, the amount of acid added to the pouch is not particularly limited. 30% by weight or less, preferably 25% by weight or less.

<Method for manufacturing oral pouch products>
A method for manufacturing an oral pouch product (also simply referred to as a “manufacturing method”) is a manufacturing method having a composition manufacturing step for manufacturing a composition containing at least nicotine, an acid, and a base material.

[Manufacturing process of oral composition]
The production process of the oral cavity composition is not particularly limited as long as the composition can be produced. An example of the method for producing the composition is shown below. Each raw material mentioned below can be used for each raw material shown below.
First, a nicotine source, an acid, a base material, and optionally a sweetener and a whitening agent such as silicon dioxide are mixed in a mixer to obtain a mixture. Water may be added and heating may be applied as necessary.
Next, optional ingredients such as fragrance and moisturizer are added, and the mixture is stirred to obtain a composition. The acid may be added at the time of stirring and mixing later.
The mixture is preferably pH-adjusted, and it is preferable to adjust the type and amount of acid added so that the mixture becomes acidic. Specifically, the pH of the mixture is preferably 1.5 or more and 6.0 or less, more preferably 1.7 or more and 4.0 or less.
By adjusting the pH of the oral cavity composition to 6.0 or less, the nicotine contained in the mixture can be maintained in a stable state.

If necessary, the pre-heating mixture may be subjected to a heating treatment, for example, in the case of producing a moist type product.
Moreover, after preparation of the mixture, the mixture may be dried (drying step). After that, a cooling process may be performed. Cooling may be natural cooling, or may be performed using some cooling means (cooling step). By drying it is possible, for example, to adjust the water content of the mixture to a desired value between 5 and 55% by weight. This facilitates adjustment of the water content in the oral composition as a target product.

An aqueous solution containing a pH adjuster may be added to the mixture obtained in the above steps (or drying step, cooling step).
The addition amount can also be adjusted by the pH adjuster so that the mixture becomes acidic. Specifically, the pH of the mixture is preferably 6.0 or less, more preferably 4.0 or less, and particularly preferably 3.0 or less. On the other hand, the pH of the mixture is preferably 1.5 or higher, more preferably 1.7 or higher.
A sweetener such as acesulfame potassium, a flavoring agent such as menthol, a bitterness inhibitor such as soybean lecithin, and a humectant such as glycerin are added (the step of adding additives to the gel particle-containing mixture) to obtain a desired composition.
When adding the above-mentioned additives, etc., they may be solid or may be added in the form of an aqueous solution dissolved in water. When it is added in the form of an aqueous solution, it may be dissolved in a predetermined amount of water in advance and added so as to obtain the final moisture content of the pouch product.

[Packaging process]
A pouch product is obtained by packaging the composition obtained in the manufacturing process of the oral composition described above with a packaging material (packaging process). The packaging method is not particularly limited, and a known method can be applied. For example, a known method such as a method of putting the above composition into a bag-shaped nonwoven fabric and then sealing can be used.
In the packaging process, after the composition is put into the packaging material and after the packaging material is sealed, water may be further added in order to obtain a composition having a desired moisture content (water addition step). For example, when the target composition has a water content of 50% by weight and the composition obtained in the above composition preparation step has a water content of 15% by weight, the remaining 35% by weight Add water.

<Uses of pouch products>
Applications (modes of use) of pouch products are not particularly limited. These are inserted between the lips and gums in the oral cavity to enjoy the taste and aroma.

Hereinafter, the present invention will be described more specifically with reference to examples. However, the present invention should not be construed as being limited to the following examples.

<Experiment 1>
[Preparation of oral composition] (Example 1, Comparative Example 1 and Comparative Example 2)
First, an oral composition of Comparative Example 2 was prepared at the blending ratio shown in Table 1. Next, oral compositions of Example 1 and Comparative Example 1 were prepared by adding citric acid in the amounts shown in Table 1 to the oral compositions. Table 1 also shows the pH and whiteness (WI E313-73 (2° field of view, C light source)) of the resulting oral composition.

<Production of pouch products>
For example, each of the above compositions is put into a nonwoven fabric (manufactured by BFF technical fabrics, basis weight 27.0 g/m ² ) so as to be 0.65 g / piece, and then sealed by heat sealing. A pouch product was made.

[Characteristic evaluation]
(moisture content)
The water content (moisture content) of each composition was measured using a heat drying moisture meter (eg, HB 43-S manufactured by METER TOLEDO).
・Measurement mode: FAST
・Achievement temperature (when stable): 100°C
・ Measurement end condition: AUTO60 (amount of change of 1 mg or less in 60 seconds)
・Result display: Moisture%

(pH)
The pH of the oral cavity composition dispersed in artificial saliva at a measurement temperature of 25° C. was measured using a pH analyzer (eg, LAQUA F-72 flat ISFET pH electrode manufactured by Horiba Ltd.). Artificial saliva was prepared as described above.
For calibration of the device, for example, phthalic acid pH standard solution (pH 4.01), neutral phosphate pH standard solution (pH 6.86), borate pH standard solution (pH 9.18) (all Wako Pure Chemical Industries) A three-point calibration using

(Whiteness) The colorimetric operation was carried out by placing the sample on a glass petri dish and using the measuring apparatus and measurement principle described above.

(Measurement of nicotine release amount)
Each pouch product was measured for nicotine release using a dissolution tester. The dissolution tester is Agilent's BIO-DIS Reciprocating Cylinder Apparatus (conforms to USP Apparatus 3)
was used.
The test conditions were a temperature of 37° C., a reciprocating Dip speed of 6 DPM (Dip perminute), and a moving distance of 10 cm. Four pouches were set in one inner tube, and 240 mL of the artificial saliva described above was used as the test liquid. Sampling times of the eluate were 0.1, 2, 5, 7.5, 10, 20, 40 and 60 minutes.

(result)
FIG. 1 shows the results of the dissolution test for confirming the amount of nicotine released. FIG. 1 shows the ratio of the amount of eluted nicotine to the amount of nicotine contained in the pouch over time. The elution amount of nicotine Example 1 (acidic pouch) is greater than Comparative Example 1 (neutral pouch) and Comparative Example 2 (basic pouch), and the elution of nicotine is accelerated in Example 1 (acidic pouch). I was able to confirm that.

<Saliva release test>
An oral composition having the composition shown in Table 2 below was prepared. In the same manner as in Example 1 and the like, each oral composition was filled in a nonwoven fabric to prepare a pouch product. In Example 3, citric acid was added to the nonwoven fabric by immersing the nonwoven fabric in a 50% by weight citric acid solution and then drying the nonwoven fabric. The pH of the oral composition was measured in the same manner as in Example 1 and the like. In Example 3, the pH of the pouch product was also measured.

The absorbent cotton and the pouch product prepared above were placed in an empty disposable container, and the weight was measured with a balance (weight (A)). Absorbent cotton and pouch products were put into the panelists' mouths, and the time was measured with a timer. After 1 minute, the degreased surface and pouch product were removed from the panelist's mouth and placed in an empty container. The weight of this container (weight (B)) was measured with a balance.
Weight (B) - Weight (A) was defined as saliva volume.
It should be noted that the panelists' mouths were rinsed after each test and there was a 5 minute interval before the next test.
There were seven panelists. Table 3 shows the test results.

From the results in Table 3, it was found that the secretion of saliva in the oral cavity of the user was promoted when using an oral composition in which artificial saliva was acidic at 25°C. It is considered that the increase in saliva secretion in the oral cavity of the user contributes to the promotion of the release of nicotine contained in the oral composition.

As described above, according to the present invention, it is possible to provide an oral composition and an oral pouch product that release nicotine well to the user.

Claims

An oral composition comprising nicotine, an acid, and a base material, wherein the acid is externally added, and artificial saliva dispersed with the oral composition exhibits acidity at 25°C. Composition.
The oral composition according to claim 1, wherein the oral composition comprises a tobacco material and the nicotine is derived from the tobacco material.
The oral cavity according to claim 1, wherein the oral composition comprises an ion exchange resin carrying nicotine, and the nicotine contained in the oral composition is derived from the ion exchange resin carrying nicotine. composition.
The base material is one or more selected from the group consisting of cellulose, microcrystalline cellulose, spherical cellulose and porous cellulose, and the content of the base material is 5% by weight or more relative to the total amount of the oral composition. The oral composition according to any one of claims 1 to 3, wherein
The oral composition according to any one of claims 1 to 4, wherein the acid is one or more selected from organic acids and salts thereof.
The acid is an organic acid, and the organic acid is malic acid, citric acid, succinic acid, acetic acid, formic acid, levulinic acid, pyruvic acid, tartaric acid, adipic acid, lactic acid, butyric acid, L-ascorbic acid, glutamic acid, and asparagine. The oral composition according to any one of claims 1 to 5, which is one or more selected from the group consisting of acids.
The oral composition according to any one of claims 1 to 6, wherein the oral composition has a whiteness of 10 or more and 100 or less.
The oral composition according to any one of claims 1 to 7, wherein the oral composition is composed of a plurality of solid granules.
An oral pouch product comprising a packaging material for packaging an oral composition and the oral composition according to any one of claims 1 to 8 packaged in the packaging material.
The oral pouch product according to claim 9, wherein acid is added to the packaging material.