WO2023073922A1 - Produit oral contenant de la dextrine indigestible et composition pour ledit produit - Google Patents

Produit oral contenant de la dextrine indigestible et composition pour ledit produit Download PDF

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Publication number
WO2023073922A1
WO2023073922A1 PCT/JP2021/040024 JP2021040024W WO2023073922A1 WO 2023073922 A1 WO2023073922 A1 WO 2023073922A1 JP 2021040024 W JP2021040024 W JP 2021040024W WO 2023073922 A1 WO2023073922 A1 WO 2023073922A1
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Prior art keywords
weight
product
composition
oral
indigestible dextrin
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PCT/JP2021/040024
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English (en)
Japanese (ja)
Inventor
健 濱本
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日本たばこ産業株式会社
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Priority to PCT/JP2021/040024 priority Critical patent/WO2023073922A1/fr
Publication of WO2023073922A1 publication Critical patent/WO2023073922A1/fr

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Classifications

    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23L—FOODS, FOODSTUFFS, OR NON-ALCOHOLIC BEVERAGES, NOT COVERED BY SUBCLASSES A21D OR A23B-A23J; THEIR PREPARATION OR TREATMENT, e.g. COOKING, MODIFICATION OF NUTRITIVE QUALITIES, PHYSICAL TREATMENT; PRESERVATION OF FOODS OR FOODSTUFFS, IN GENERAL
    • A23L33/00—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof
    • A23L33/20—Reducing nutritive value; Dietetic products with reduced nutritive value
    • A23L33/21—Addition of substantially indigestible substances, e.g. dietary fibres
    • A—HUMAN NECESSITIES
    • A24—TOBACCO; CIGARS; CIGARETTES; SIMULATED SMOKING DEVICES; SMOKERS' REQUISITES
    • A24B—MANUFACTURE OR PREPARATION OF TOBACCO FOR SMOKING OR CHEWING; TOBACCO; SNUFF
    • A24B13/00—Tobacco for pipes, for cigars, e.g. cigar inserts, or for cigarettes; Chewing tobacco; Snuff
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/70—Carbohydrates; Sugars; Derivatives thereof
    • A61K31/715—Polysaccharides, i.e. having more than five saccharide radicals attached to each other by glycosidic linkages; Derivatives thereof, e.g. ethers, esters
    • A61K31/716—Glucans
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/22—Heterocyclic compounds, e.g. ascorbic acid, tocopherol or pyrrolidones
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
    • A61K9/0056—Mouth soluble or dispersible forms; Suckable, eatable, chewable coherent forms; Forms rapidly disintegrating in the mouth; Lozenges; Lollipops; Bite capsules; Baked products; Baits or other oral forms for animals
    • A61K9/0058—Chewing gums
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/007—Pulmonary tract; Aromatherapy
    • A61K9/0073—Sprays or powders for inhalation; Aerolised or nebulised preparations generated by other means than thermal energy
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/70—Web, sheet or filament bases ; Films; Fibres of the matrix type containing drug

Definitions

  • the present invention relates to oral compositions containing indigestible dextrin and compositions for such products.
  • Type II diabetes is a typical adult disease, and it is known that it is important to prevent a rapid increase in blood sugar levels as a preventive measure.
  • ingestion of indigestible dextrin after a meal suppresses a rapid increase in blood sugar level.
  • Non-Patent Document 1 discloses that a beverage containing indigestible dextrin can suppress the increase in postprandial blood glucose level.
  • an object of the present invention is to provide a novel form of product containing indigestible dextrin.
  • Aspect 1 nicotine or a nicotine-containing raw material (A) and an indigestible dextrin (B), A composition for oral products, in which 3 to 7 parts by weight of the indigestible dextrin can be ingested with respect to 100 parts by weight of the glucose during or after the ingestion of glucose.
  • Aspect 2 An oral product containing the composition according to aspect 1, wherein the weight of the indigestible dextrin (B) per product is 3-9 g.
  • Aspect 3 An oral product containing the composition according to aspect 1, wherein the weight of the indigestible dextrin (B) per product is 0.5-1 g.
  • Aspect 4 a main material containing nicotine or a nicotine-containing raw material (A); and an exterior material provided outside the main material, The exterior material or the main material further contains indigestible dextrin (B), The amount of the indigestible dextrin (B) is 3 to 9 g in the product, oral products.
  • Aspect 5 a main material containing nicotine or a nicotine-containing raw material (A); and an exterior material provided outside the main material, The exterior material or the filling further contains a non-digestible dextrin (B), The amount of the indigestible dextrin (B) is 0.5 to 1 g in the product, oral products.
  • Aspect 6 4.
  • Aspect 7 An oral product according to aspect 2 or 4 in the form of a gum or tablet.
  • Aspect 8 An oral product according to aspect 3 or 5, which is in the form of a pouch.
  • Aspect 9 A method of ingesting a product according to any of aspects 2-8, comprising: A method of ingestion, comprising ing 3 to 7 parts by weight of the indigestible dextrin with respect to 100 parts by weight of the glucose during or after the ingestion of glucose.
  • a new form of product containing indigestible dextrin can be provided by the present invention.
  • X to Y includes X and Y which are the end values.
  • Oral products are products in which active ingredients are ingested through the oral mucosa via saliva while the product is contained in the oral cavity. Oral products do not involve burning or heating or atomization by devices when used.
  • composition for oral products contains nicotine or a nicotine-containing raw material as component (A) and indigestible dextrin as component (B).
  • Compositions for oral products contain nicotine or nicotine-containing raw materials as component (A).
  • the compound may contain nicotine as a compound, or nicotine-containing raw materials such as nicotine salts and stabilized nicotine.
  • Examples of stabilized nicotine include nicotine-carrying substances such as nicotine carried on ion-exchange resins.
  • ion exchange resins include weakly acidic cation exchange resins.
  • As the nicotine-supported ion exchange resin a resin complex containing nicotine in an amount of 10% by weight or more and 20% by weight or less, specifically called nicotine polacrilex, can be used.
  • the ion exchange resin used in nicotine polacrilex is a weakly acidic cation exchange resin.
  • the amount added to the 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.
  • 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 10.0% by weight or less. is more preferable.
  • the nicotine-containing raw material may be a tobacco material containing, for example, tobacco powder obtained by pulverizing tobacco leaves.
  • Tobacco powder may include dried tobacco leaf lamina cuts, fines, or fibers, and is prepared, for example, by the method described below.
  • tobacco leaves may include mesophyll (lamina), veins (stem), or roots.
  • the tobacco material may contain tobacco powder, which is basically obtained from tobacco leaf lamina, as well as elements derived from tobacco leaf backbones and roots.
  • the particle size of the tobacco powder is not limited, but from the viewpoint of improving the familiarity in the oral cavity and enhancing the feeling of use, and from the viewpoint of improving the release of the flavoring ingredients contained in the tobacco powder into the oral cavity, it is recommended to use a particle size of 1.2 mm. It is preferably one that has passed through a mesh, and more preferably one that has passed through a 1.0 mm mesh.
  • the tobacco species used as the raw material for the tobacco powder is not particularly limited, and examples thereof include Nicotiana tabacum yellow variety, Burley variety, and Nicotiana rustica Brasilia variety. The same species can be used for tobacco materials and tobacco leaves, which will be described later.
  • tobacco powder is preferably prepared as follows. First, a base is added to and mixed with tobacco powder obtained by pulverizing tobacco leaves. Examples of the base to be added include potassium carbonate and sodium carbonate, which are preferably added as an aqueous solution. Also, a pH adjuster such as sodium dihydrogen phosphate may be added, for example, to stabilize nicotine during the production of oral pouch products. The pH of the mixture after addition of the base is preferably adjusted to 8.0-9.0. The content of tobacco powder in this mixture is preferably 60 to 90% by weight.
  • a base is added to and mixed with tobacco powder obtained by pulverizing tobacco leaves. Examples of the base to be added include potassium carbonate and sodium carbonate, which are preferably added as an aqueous solution.
  • a pH adjuster such as sodium dihydrogen phosphate may be added, for example, to stabilize nicotine during the production of oral pouch products.
  • the pH of the mixture after addition of the base is preferably adjusted to 8.0-9.0.
  • the content of tobacco powder in this mixture is preferably 60
  • the mixture After adding the base, the mixture is heated, for example, for 0.5 to 3 hours, preferably 0.8 to 2 hours, under conditions such that the product temperature is 65 to 90°C, preferably 70 to 80°C.
  • Heating can be accomplished by steam injection heating, jacket heating, or both.
  • 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.
  • the 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.
  • the amount added to the composition is usually 0.001% by weight or more, preferably 0.01% by weight or more, and 0.05% by weight or more. is more preferred.
  • the amount 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. It is below.
  • the nicotine-containing raw material may be a nicotine-containing extract obtained by extracting nicotine-containing substances such as tobacco leaves.
  • a nicotine-carrying substance from the viewpoint of accurate nicotine supply and ease of handling.
  • the composition or oral product generally tends to take on the color of tobacco leaves.
  • a colorless nicotine-containing compound it is possible to provide white compositions and oral products.
  • Such an aspect is an advantage for users who prefer white oral products.
  • One of the raw materials described above as the component (A) may be used alone, or two or more thereof may be used in combination.
  • the content of total nicotine in the composition is not limited, it is usually 0.1 to 15.0% by weight from the viewpoint of user's preference. Therefore, when a nicotine-containing raw material is used as component (A), the amount of the raw material is adjusted so that the total nicotine content falls within this range.
  • the above content is the content as nicotine ions.
  • 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.
  • the oral product composition contains indigestible dextrin as component (B).
  • Indigestible dextrin is obtained by 1) adding a trace amount of acid to starch and heat-treating it to obtain roasted dextrin, 2) allowing an enzyme that cleaves the bond between glucose to act on the roasted dextrin, and 3) by the treatment. It can be produced by purifying the dextrin portion that has not been decomposed into glucose (Tomoko Sasaki, Sugar/Starch Information 2018.2, p2).
  • the indigestible dextrin is a dextrin having an average molecular weight of about 2000 and a DE (dextrose equivalent) of about 20 or less, which is an index of starch hydrolysis.
  • Specific examples of indigestible dextrin include "Fibersol 2" commercially available from Matsutani Chemical Industry Co., Ltd., and the like.
  • Indigestible dextrin can exert its function as dietary fiber. That is, it is understood that ingredients that are quantified as dietary fiber work as active ingredients, although ingredients that do not function as dietary fiber may exist in commercially available raw material products. Therefore, the term "indigestible dextrin" in the present invention refers to indigestible dextrin that functions as dietary fiber. For example, in a mixture such as a commercial product, the indigestible dextrin detected as dietary fiber is the "indigestible dextrin" in the present invention. Since the main component of the indigestible dextrin that functions as dietary fiber can be trisaccharide, the average molecular weight of the indigestible dextrin is 500-2000 in one embodiment. A method for analyzing indigestible dextrin will be described in detail separately.
  • the indigestible dextrin used as dietary fiber has a low molecular weight as described above, it can be quantified relatively easily from the composition by the enzyme-HPLC method.
  • the method for analyzing and quantifying the indigestible dextrin is not limited as long as it can be appropriately analyzed and quantified, and a person skilled in the art can quantify using any method. A method that goes through each step is preferable.
  • thermostable ⁇ -amylase After dissolving the sample, it is digested with thermostable ⁇ -amylase. It is then further digested with amyloglucosidase. If necessary, the protein in the sample is degraded by protease. After that, ethanol is added to generate a precipitate, which is separated into a filtrate and a precipitate by suction filtration. After concentrating the filtrate with a rotary evaporator, protein degradation products, organic acids, inorganic salts and the like are removed with an ion exchange resin, and subjected to high performance liquid chromatography (HPLC).
  • HPLC high performance liquid chromatography
  • the dietary fiber fraction (trisaccharides or higher) from the monosaccharide and disaccharide fractions on the obtained chromatograph, and determine the peak area ratio of the dietary fiber fraction and glucose.
  • glucose as an internal standard substance, the amount of low-molecular-weight water-soluble dietary fiber is calculated by multiplying the peak area ratio by the weight of glucose.
  • the peak elution position of maltotriose, one of the trisaccharides is used as an indicator, and the dietary fiber fraction is quantified by eluting at or before this peak.
  • composition for oral products contains an amount of indigestible dextrin that allows ingestion of 3 to 7 parts by weight of indigestible dextrin per 100 parts by weight of glucose during or after ingestion of glucose.
  • the amount of component (B) is the amount of indigestible dextrin that functions as dietary fiber.
  • the content of component (B) in the composition should be an amount that allows 3 to 7 parts by weight of component (B) to be ingested per 100 parts by weight of glucose.
  • the content of component (B) in the composition is preferably 300 to 700 parts by weight with respect to 1 part by weight of nicotine.
  • the composition preferably contains a substrate.
  • the substrate is not particularly limited, and examples thereof include polysaccharides and porous structures capable of adsorbing and retaining moisture.
  • the substrate is preferably one or more selected from the group consisting of cellulose, microcrystalline cellulose (MCC), spherical cellulose, and porous cellulose.
  • MCC microcrystalline cellulose
  • spherical cellulose a polysaccharide
  • porous cellulose preferably one or more selected from the group consisting of cellulose, microcrystalline cellulose (MCC), spherical cellulose, and porous cellulose.
  • MCC microcrystalline cellulose
  • spherical cellulose spherical cellulose
  • porous cellulose cellulose is more preferable from the viewpoint of flexibility in adjusting the bulk density of the composition and exhibiting white color.
  • One type of these substances may be used alone, or two or more types may be used in combination at any ratio.
  • the content of the base material in the composition is not limited. However, from the viewpoint of improving quality by suppressing the elution of water during manufacturing or product storage, and from the viewpoint of imparting a desirable appearance to users by increasing the whiteness of the product, the content is usually 10% by weight. % or more, preferably 15% by weight or more, more preferably 20% by weight or more.
  • the upper limit of the content is not limited, it is usually 70% by weight or less, preferably 68% by weight or less, more preferably 65% by weight or less, from the viewpoint of the limit that can be blended with other raw materials. preferable.
  • the composition preferably contains a sugar alcohol.
  • the type of sugar alcohol is not particularly limited, and examples thereof include xylitol, maltitol, erythritol, sorbitol, mannitol, and lactitol. Among these, maltitol is preferable from the viewpoint of imparting good flavor.
  • One type of these substances may be used alone, or two or more types may be used in combination at any ratio.
  • the content of sugar alcohols in the composition is not limited, but from the viewpoint of flavor adjustment, it is usually 1% by weight or more. % or more, and more preferably 10% or more by weight. Moreover, the upper limit is usually 80% by weight or less, preferably 70% by weight or less, and more preferably 60% by weight or less.
  • the composition preferably contains a polyglycerin fatty acid ester.
  • the degree of polymerization of glycerin in the polyglycerol fatty acid ester is preferably 2-10.
  • Polyglycerin fatty acid ester functions as an emulsifier. Therefore, by containing the polyglycerol fatty acid ester, a uniform mixing state of each component of the composition can be maintained, and the flavor component can be kept stable, so that the flavor of the composition can be improved.
  • the polyglycerol fatty acid ester imparts an appropriate viscosity to the composition, and can bind each component together, thereby suppressing dryness of the composition and improving the feeling of use, flavor, etc. be able to.
  • composition is a dry type with a low water content (moisture content)
  • moisture content moisture content
  • scattering of the composition can be suppressed when filling the composition into an exterior material such as a pouch.
  • Polyglycerin fatty acid ester is a fatty acid ester of a dehydration condensate of glycerin, and the degree of polymerization of glycerin is usually 2 or more, may be 3 or more, and is usually 10 or less, and may be 8 or less. good.
  • the fatty acid ester group (RCOO- group) of polyglycerin fatty acid ester is derived from fatty acid.
  • the fatty acid is not limited and may be a saturated fatty acid or an unsaturated fatty acid.
  • the carbon number of the fatty acid is usually 10 or more, preferably 12 or more, more preferably 14 or more, and further preferably 16 or more, from the viewpoint of good flavor and production efficiency. Also, it 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.
  • the number of fatty acid ester groups possessed by one polyglycerin fatty acid ester molecule is not limited as long as the polyglycerin fatty acid ester has a structure capable of exhibiting a function as an emulsifier, depending on the degree of polymerization of glycerin and the number of hydroxyl groups derived from glycerin. It can be selected as appropriate.
  • a structure capable of functioning as an emulsifier is a structure having both a fatty acid portion serving as a lipophilic group and a polyhydric alcohol portion serving as a hydrophilic group.
  • the number of fatty acid ester groups per molecule of polyglycerol fatty acid ester is usually 1 or more.
  • the number of hydroxyl groups derived from glycerin should be 1 or more.
  • the degree of polymerization of glycerin in the polyglycerin fatty acid ester and the type and number of fatty acid ester groups can be arbitrarily combined with those described above. More specifically, the alcohol component of the polyglycerin fatty acid ester can be diglycerin, triglycerin, tetraglycerin, pentaglycerin, hexaglycerin, heptaglycerin, octaglycerin, nonaglycerin, or decaglycerin.
  • the acid component of the polyglycerol fatty acid ester can be a fatty acid such as lauric acid, myristic acid, palmitic acid, stearic acid, oleic acid, linoleic acid, or ⁇ -linolenic acid.
  • the polyglycerin fatty acid ester may be a monoester, diester, triester, tetraester, pentaester, or the like.
  • one type may be used alone, or two or more types may be used in combination at any ratio.
  • the polyglycerin fatty acid ester is preferably one or more selected from diglycerin mono-fatty acid ester and decaglycerin fatty acid ester from the viewpoint of good flavor and workability during production.
  • the diglycerin monofatty acid ester is preferably selected from the group consisting of diglycerin monolaurate, diglycerin monomyristate, diglycerin monopalmitate, diglycerin monostearate and diglycerin monooleate. Oleate is more preferred.
  • the decaglycerin fatty acid ester is preferably selected from the group consisting of decaglycerin laurate, decaglycerin myristate, decaglycerin palmitate, decaglycerin stearate and decaglycerin oleate, and decaglycerin monolaurate, decaglycerin mono More preferably, it is selected from the group consisting of myristate, decaglycerin monopalmitate, decaglycerin monostearate and decaglycerin monooleate.
  • the content of the polyglycerol fatty acid ester in the composition is not limited, but from the viewpoint of obtaining a good flavor and improving the production efficiency. Therefore, it is usually 0.1% by weight or more, preferably 0.2% by weight or more, more preferably 0.3% by weight or more, further preferably 0.5% by weight or more.
  • the content of the polyglycerin fatty acid ester is usually 20.0% by weight or less, preferably 15.0% by weight or less, from the viewpoint of imparting an appropriate viscosity to the composition, and 10.0% by weight or less. It is more preferably 8.0% by weight or less, more preferably 8.0% by weight or less.
  • the HLB value of the polyglycerin fatty acid ester is not limited, but is usually 6.0 or more, preferably 7.0 or more, and usually 20.0 or less, preferably from the viewpoint of obtaining good flavor and improving production efficiency. It is 18.0 or less, more preferably 16.0 or less.
  • the composition preferably contains a release agent.
  • the release agent is such that when the composition is manufactured, the components adhere to a manufacturing device such as a mixer or kneader, or when the composition is filled into an exterior material such as a pouch, the components may adhere to a filling machine or the like. Problems such as adhesion can be reduced, and manufacturing efficiency can be improved.
  • the release agent can reduce adhesion between materials constituting the composition to suppress caking (aggregation and solidification between the materials), and can also suppress stickiness of the composition.
  • the oral product containing the composition is improved in appearance, feeling of use such as mouthfeel, flavor, and the like.
  • the composition can be prevented from leaking out of the exterior material, and the properties of the oral product can be improved.
  • Mold release agents include, for example, compounds such as particulate silicon dioxide, magnesium oxide, calcium silicate, magnesium silicate, calcium phosphate, calcium stearate, and magnesium stearate.
  • silicon dioxide is preferred as the release agent because it has a high effect and little influence on flavor.
  • One release agent may be used alone, or two or more release agents may be used in combination at any ratio.
  • the release agent is preferably particulate.
  • the average particle diameter of the particles is usually 20.0 ⁇ m or less, preferably 15.0 ⁇ m or less, more preferably 10.0 ⁇ m or less, and usually 0.2 ⁇ m. That is, it is preferably 0.3 ⁇ m or more, more preferably 0.4 ⁇ m or more, and even more preferably 1.0 ⁇ m or more.
  • the average particle size of the release agent particles means the particle size (D50) at 50% volume-based cumulative volume distribution in the particle size distribution determined by laser diffraction particle size distribution measurement.
  • a general-purpose device such as "Mastersizer 3000" manufactured by Malvern Panalytical can be used for laser diffraction particle size distribution measurement.
  • silicon dioxide having such an average particle diameter may be referred to as "fine silicon dioxide”.
  • the content of the release agent in the composition is not limited, but ensures good flavor and sufficiently exhibits the above effects. From the viewpoint of , preferably 2.5% by weight or less, more preferably 2.0% by weight or less.
  • Water The content of water (water content) in the composition is usually 5% by weight or more from the viewpoint of ease of production of the composition. Furthermore, the lower limit of the water content is preferably 30% by weight or more, more preferably 45% by weight or more, from the viewpoint of improving production efficiency of the composition, improving caking resistance, suppressing stickiness, etc.
  • the upper limit 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 composition is adjusted accordingly depending on the product type (moist or dry). For example, in the case of moist type, the water content is usually 20 to 60% by weight, preferably 30 to 50% by weight. On the other hand, in the dry type, the water content is usually 5-20% by weight, preferably 10-15% by weight.
  • the water content (moisture content) of the composition can be 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.
  • a heat drying moisture meter for example, HB 43-S manufactured by METER TOLEDO.
  • the composition may contain substances other than those mentioned above.
  • Other substances include, for example, flavors, pH adjusters, sweeteners (excluding sugar alcohols), humectants, bitterness inhibitors, whitening agents (excluding silicon dioxide), and emulsifiers (excluding polyglycerin fatty acid esters). is mentioned.
  • the content of the substance is not limited, and the composition can be appropriately adjusted according to the product design.
  • Fragrances Flavors are not limited, and examples include menthol, leaf tobacco extract, natural plant flavors (e.g., cinnamon, sage, herbs, chamomile, kudzu grass, sweet tea, cloves, 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.
  • natural plant flavors e.g., cinnamon, sage, herbs, chamomile, kudzu grass, sweet tea, cloves, lavender, cardamom, clove, nutmeg, bergamot, geranium.
  • 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., ⁇ -undecalactone, ⁇ -nonalactone, etc.), animal fragrances (e.g., musk
  • the pH adjuster is not limited, and examples thereof include sodium carbonate, sodium hydrogen carbonate, potassium carbonate, potassium hydrogen carbonate, potassium phosphate, anhydrous sodium phosphate, sodium dihydrogen phosphate, and sodium citrate. mentioned. Among them, sodium carbonate, potassium carbonate, or sodium dihydrogen phosphate is preferable from the viewpoint of influence on the taste of the product. As a pH adjuster, one type may be used alone, or two or more types may be used together in an arbitrary ratio.
  • Sweeteners include, but are not limited to, sugar alcohols such as xylitol, maltitol, erythritol; and acesulfame potassium, sucralose, aspartame, and the like. 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 combination at any ratio.
  • Bitterness inhibitors are not limited, but include, for example, soybean lecithin. Soybean lecithin is a phospholipid, specifically phosphatidylcholine, phosphatidylethanolamine, phosphatidic acid, and the like. As bitterness inhibitors, one type may be used alone, or two or more types may be used in combination at an arbitrary ratio.
  • Moisturizers are not limited, but examples thereof include polyhydric alcohols such as glycerin and propylene glycol. Glycerin is preferred from the viewpoint of product storage stability. As a moisturizing agent, one kind may be used alone, or two or more kinds may be used together in an arbitrary ratio.
  • the whitening agent is not limited, but examples thereof include fine silicon dioxide, titanium dioxide, calcium carbonate, and the like. From the point of view of the taste impact on the product, finely divided silicon dioxide is preferred. As the whitening agent, one kind may be used alone, or two or more kinds may be used together in an arbitrary ratio.
  • Emulsifiers are not limited, but include, for example, emulsifiers added to foods.
  • 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.
  • Sucrose fatty acid esters include sucrose palmitate and sucrose stearate.
  • the organic acid glycerol fatty acid ester include succinic acid glycerol fatty acid ester and diacetyltartaric acid glycerol fatty acid ester.
  • polyglycerin fatty acid esters examples include decaglycerin fatty acid esters.
  • the content of the emulsifier in the composition is preferably such that the total content of the polyglycerol fatty acid ester and the polyglycerol fatty acid ester is within the above range.
  • Gelling Agents and Gelling Aids As gelling agents, polysaccharides having carboxyl groups are preferred, such as carrageenan, pectin, gum arabic, xanthan, gellan, gum tragacanth, or alginic acid. Furthermore, carrageenan, pectin, gellan, or alginic acid is preferable from the viewpoints that gelation is likely to occur in the presence of calcium ions and that a junction zone can be formed between carboxyl groups and cations to form a crosslinked structure. Among these, LM pectin is preferred for reasons described later. One of these may be used alone, or two or more of them may be used in combination at any ratio.
  • the gelling aid component examples include calcium ions, and the source thereof (gelling aid) is not limited, but examples include calcium halides (chlorides, etc.), citric acid, carbonate, sulfuric acid, and the like. salts, phosphates, lactates, and the like.
  • calcium lactate, calcium carbonate, or calcium phosphate is preferable, and calcium lactate is particularly preferable, from the viewpoints of little influence on taste, high solubility, and pH after dissolution.
  • One of these may be used alone, or two or more of them may be used in combination at any ratio.
  • Gelation aids other than calcium ions include, for example, metal ions such as magnesium, silver, zinc, copper, gold, and aluminum that can bind gelling agents with ionic bonds in the same manner as calcium ions, and cationic Examples include ions of macromolecules. Sources of these (other gelling aids) include, for example, halides (chlorides, etc.) of these metal ions, citric acid, carbonates, sulfates, phosphates, cationic polymers, and the like. are mentioned. One of these may be used alone, or two or more of them may be used in combination at any ratio.
  • Fluidity The fluidity of the composition allows evaluation of the viscosity, adhesion to production equipment, caking resistance, and stickiness of the composition.
  • the fluidity is evaluated by relatively comparing shear stress values at a measurement temperature of 22° C. and a normal stress of 5.0 kPa.
  • the normal stress of 5.0 kPa is a pressure load assumed to be applied to the composition by its own weight during manufacturing, transportation, storage, etc., as a condition that may cause adhesion, caking, and stickiness of the composition to the manufacturing apparatus. be.
  • the shear stress is preferably 4.15 kPa or more, more preferably 4.20 kPa or more, still more preferably 4.25 kPa or more, and preferably 5.85 kPa or less, more preferably 5.80 kPa or less.
  • the shear stress of the composition at the above normal stress of 5.0 kPa can be measured using a rheometer.
  • a rheometer For example, when powder rheometer FT4 manufactured by Freeman Technology Co., Ltd. is used as the rheometer, measurement is performed under the following measurement conditions.
  • ⁇ Measurement mode standard program (25mm_shear_9kPa) ⁇ Measurement temperature: 22°C ⁇ Measurement humidity: 60% RH ⁇ Measurement container: Cylindrical container with an inner diameter of 25 mm and a volume of 10 ml ⁇ Vertical load: 3 to 9 kPa Each raw material to be measured is passed through a sieve (1.18 mm mesh size) to make fine and uniform particles, which is used as a measurement sample, and the measurement is performed according to the procedure of the rheometer described above.
  • the composition is preferably composed of a plurality of solid particles, but the size of the particles is not limited.
  • the dried composition is usually passed through a sieve having a 15 mm mesh ( ⁇ 15 mm) size in terms of user mouthfeel, ease of handling during manufacturing, and control of quality variability.
  • the maximum particle size of the composition when dried is 3.2 mm or less. show.
  • it is not necessary to set the lower limit of the particle size of the dry composition it is usually 3 ⁇ m or more from the viewpoint of preventing leakage from the pouch.
  • the method for preparing the above dried composition is not limited as long as the water content can be reduced to 5% by weight or less.
  • a method of preparing by allowing to stand can be mentioned.
  • the maximum particle size of the composition can be appropriately adjusted, for example, by adjusting the particle size of the nicotine-supported ion exchange resin, the moisture content, and the like.
  • the pH of the composition is not limited, it is usually 7.0 or higher, preferably 7.5 or higher, more preferably 8.0 or higher, from the viewpoint of influence on taste. It is 10.0 or less, preferably 9.5 or less, more preferably 9.0 or less.
  • the pH is a measured value at 25°C.
  • the pH of the composition at a measurement temperature of 25° C. was measured using a pH analyzer (for example, LAQUA F-72 flat ISFET pH electrode manufactured by Horiba Ltd.). It can be measured by measuring the supernatant.
  • a pH analyzer for example, LAQUA F-72 flat ISFET pH electrode manufactured by Horiba Ltd.
  • phthalic acid pH standard solution pH 4.01
  • neutral phosphate pH standard solution pH 6.86
  • borate pH standard solution pH 9.18
  • Oral products are products shaped so that the composition can be contained in the mouth.
  • the product form can be as known. Examples include chewing tobacco, pouches, tablets, gums, films, and liquid forms.
  • a chewing tobacco product is a product in which the nicotine contained in the composition is mixed with saliva and ingested by chewing.
  • Pouch products include a composition (also referred to as a main material or filler) within a sealed water-insoluble exterior material (also referred to as a pouch), and saliva permeates through the pouch and is contained within the pouch. It is a product that can dissolve the ingredients of the product and then pass through the pouch and be carried into the oral cavity.
  • a tablet product refers to a product that is slowly dissolved or disintegrated in the mouth and the components of the composition are ingested from the oral cavity, pharynx, or the like. Tablet products include types such as troches, chewables, or drops.
  • the term "gum product” refers to a product in which the ingredients contained in the composition are mixed with saliva and absorbed through the oral mucosa by chewing by the user. Gum products include types such as chewable gum or bubble gum.
  • a film product refers to a product that adheres to the oral mucosa due to moisture such as saliva when applied to the oral cavity. Ingredients contained in the composition are ingested through the mucous membrane.
  • a liquid product refers to a product that is applied to the oral cavity by spraying or dripping and ingests the ingredients in the composition through the oral mucosa.
  • the main material is preferably the above composition.
  • the indigestible dextrin which is the component (B)
  • the main material may be the above composition or a composition similar thereto, but the total amount of component (B) is 3 to 9 g per product or 0.5 to 1 g per product. Adjusted for quantity.
  • the oral product of the present invention contains an amount of indigestible dextrin (B) of 3 to 9 g per product (first oral product).
  • the average amount of carbohydrates per meal is about 116 g.
  • the amount of component (B) is 3.6-8.1 g for an average carbohydrate amount of 116 g. Therefore, the first oral product containing indigestible dextrin (B) in an amount of 3 to 9 g per product is 3 g per 100 parts by weight of glucose if one product is used during or after ingestion of glucose. It becomes possible to ingest ⁇ 7 parts by weight of component (B). Since the first oral product weighs 3g or more per piece, tablet or gum form is particularly suitable.
  • the oral product of the present invention contains indigestible dextrin (B) in an amount of 0.5 to 1 g per product (second oral product).
  • second oral product contains indigestible dextrin (B) in an amount of 0.5 to 1 g per product (second oral product).
  • the amount of component (B) is 3.6-8.1 g for an average carbohydrate amount of 116 g. Therefore, a second oral product containing indigestible dextrin (B) in an amount of 0.5-1 g per product can be used for 100 wt. It is possible to take 3 to 7 parts by weight of component (B) per part.
  • the second oral product is a double or quadruple type in which one product is continuously connected, it is highly convenient to use. Therefore, the second oral product is particularly suitable in the form of a pouch, which is easy to use as a multi-slot type. Since the second oral product is particularly preferable in the present invention, the product will be described below as an example.
  • the second oral product is also called an oral pouch product.
  • An oral pouch product comprises a main material (also called a filler) and an exterior material (also called a pouch) for packaging the main material.
  • Pouch Pouches are not limited to known ones, as long as they can pack a filling, do not dissolve in water, and can permeate liquids (water, saliva, etc.) and water-soluble components in the filling. 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, filling the bag with a filler, and sealing the bag by means of heat sealing or the like.
  • 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 ⁇ m or more and 300 ⁇ m or less, preferably 175 ⁇ m or more and 215 ⁇ m 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.
  • this type of water-repellent fluorine-based resin 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 material having a water-repellent action such as a paraffin resin, a silicon-based resin, or an epoxy-based resin.
  • the pouch can contain indigestible dextrin (component (B)).
  • component (B) indigestible dextrin
  • a pouch containing component (B) can be prepared by coating, spraying, or impregnating a pouch with a dispersion in which component (B) is dispersed.
  • the pouch may also contain optional ingredients. Examples of such components include raw materials that adjust aroma and taste, flavors, additives, tobacco extracts, pigments, and the like.
  • the manner in which these components are contained is not limited, and examples thereof 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.
  • the appearance of the pouch is also not limited. Pouches may be non-transparent, translucent, or transparent. The filling can be seen through if the pouch is translucent or transparent.
  • the size of oral pouch products is not limited.
  • the size of the product before use may have a lower long dimension of 25 mm or greater, 28 mm or greater, 35 mm or greater, or 38 mm or greater.
  • 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 ratio of the weight of the filler to the total weight of the oral pouch product is not limited, but is usually 80% by weight or more, preferably 85% by weight or more, more preferably 90% by weight or more, and It is usually 99% by weight or less, preferably 97% by weight or less, more preferably 95% by weight or less.
  • the amount of filling per oral pouch product is preferably 0.5 mg to 25 mg.
  • Oral pouch products can contain component (B) in the outer packaging, filler, or both.
  • the final amount of component (B) is the desired amount (0.5 to 1 g per product for oral pouch products, the same for other products ) is adjusted to be
  • Production method Production of oral product composition It is preferably produced through a step of mixing a base material, sugar alcohol, polyglycerin fatty acid ester, and a release agent. Mixing can be accomplished by placing all ingredients in a mixer and mixing.
  • nicotine component (A)
  • indigestible dextrin component (B)
  • base material sugar alcohol, release agent, and optionally water and other substances (sweetener, flavor , moisturizing agent, etc.)
  • sweetener, flavor , moisturizing agent, etc. a substance that is sweetened by the user
  • the order of mixing each raw material is not limited, and they may be put into a mixer in any order or at the same time and mixed, or after uniformly mixing the solid raw materials, the liquid raw materials may be added and further mixed. good. From the viewpoint of workability, the latter mode is preferred.
  • the polyglycerin fatty acid ester solution is sprayed onto the first mixture to mix the first mixture and the polyglycerin fatty acid ester to obtain a second mixture. Since the polyglycerol fatty acid ester exerts an anti-caking effect, caking is less likely to occur in subsequent steps.
  • the solvent for the polyglycerin fatty acid ester solution is not limited as long as it can dissolve the polyglycerin fatty acid ester, but alcoholic solvents such as ethanol are preferred. In order not to leave a large amount of the solvent of the polyglycerin fatty acid ester solution in the second mixture, heat treatment may be performed during or after spraying the polyglycerin fatty acid ester solution to the first mixture.
  • a process of drying the second mixture may be performed (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). Drying can be used to adjust the moisture content of the second mixture to a desired value, for example between 5 and 60% by weight. This facilitates adjustment of the moisture content in the composition.
  • an aqueous solution containing a pH adjuster, a sweetener such as acesulfame potassium, a flavoring agent such as menthol, a bitterness inhibitor such as soybean lecithin, or a humectant such as glycerin is added (addition agent addition step).
  • the above additives may be added as solids or as an aqueous solution dissolved in water. When 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 achieve the final moisture content of the oral product.
  • composition can be processed by a known method to produce oral products.
  • the oral pouch product will be described below as an example.
  • An oral pouch product can be manufactured by packaging the composition with an exterior material (packaging process).
  • the packaging method is not limited, and known methods can be applied.
  • a known method can be used, such as a method in which the composition is put into a bag-shaped nonwoven fabric and then sealed.
  • additional water may be added as desired after sealing (water addition step). 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.
  • the product is used so that 3-7 parts by weight of the indigestible dextrin is ingested per 100 parts by weight of glucose during or after ingestion of glucose. Specifically, the product is used by placing it in the mouth during or after ingestion of glucose. Indigestible dextrin is expected to have the effect of suppressing blood sugar levels. For example, since many people enjoy smoking after meals, the oral product of the present invention is preferably used after meals. Postprandial refers in one aspect to 0 to 30 minutes after the end of a meal.
  • each characteristic in the present invention is carried out by holding the measurement sample in the same environment as the environment to be measured for 48 hours or more before measurement.
  • the temperature, humidity, and pressure to be measured are normal temperature (25 ⁇ 2° C.), normal humidity (60 ⁇ 5% RH), and normal pressure (atmospheric pressure).
  • Example 1 The following ingredients are mixed in a mixer to produce an oral product composition. Nicotine 2 parts by weight Indigestible dextrin 800 parts by weight Pectin 2.1 parts by weight Maltitol 37.8 parts by weight Cellulose 22.7 parts by weight Sodium phosphate 14.3 parts by weight Polyglycerin fatty acid ester 10.3 parts by weight Silica 2.1 parts by weight Parts by weight Acesulfame K 0.3 parts by weight
  • Example 2 0.7 g of the composition obtained in Example 1 is collected and packed in a known pouch to produce an oral pouch product.
  • the nicotine content per one product is 1.6 mg, and the amount of indigestible dextrin is 0.65 g.

Abstract

L'invention concerne une composition de produit oral qui contient de la nicotine ou une matière première contenant de la nicotine (A) et de la dextrine non digestible (B). En outre, pendant ou après l'ingestion de glucose, entre 3 et 7 parties en poids de la dextrine indigestible peuvent être absorbées pour 100 parties en poids du glucose.
PCT/JP2021/040024 2021-10-29 2021-10-29 Produit oral contenant de la dextrine indigestible et composition pour ledit produit WO2023073922A1 (fr)

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JP2010018528A (ja) * 2008-07-09 2010-01-28 Matsutani Chem Ind Ltd 食物繊維と希少糖を含む生体機能改善組成物。
JP2012528854A (ja) * 2009-06-25 2012-11-15 チャバイオ アンド ディオステク株式会社 不快味を効果的に隠蔽した経口用速溶フィルム
JP2013507105A (ja) * 2009-10-09 2013-03-04 フィリップ・モーリス・プロダクツ・ソシエテ・アノニム テクスチャ加工コーティングを備えた湿潤無煙タバコ製品
JP2015503931A (ja) * 2012-01-20 2015-02-05 アルトリア クライアント サービシーズ インコーポレイテッドＡｌｔｒｉａ Ｃｌｉｅｎｔ Ｓｅｒｖｉｃｅｓ Ｉｎｃ． オーラル製品
JP2016528930A (ja) * 2013-09-09 2016-09-23 アール・ジエイ・レイノルズ・タバコ・カンパニー 植物性材料を組み込む無煙タバコ組成物
CN106617262A (zh) * 2016-12-14 2017-05-10 湖北中烟工业有限责任公司 一种烟草口含片及其制备方法
JP2019202995A (ja) * 2018-05-17 2019-11-28 大正製薬株式会社 経口組成物

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* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2009046448A (ja) * 2007-08-22 2009-03-05 Japan Tobacco Inc 食後摂取用血糖値上昇抑制剤、およびそれを含む食後摂取用血糖値上昇抑制剤配合食品
JP2010018528A (ja) * 2008-07-09 2010-01-28 Matsutani Chem Ind Ltd 食物繊維と希少糖を含む生体機能改善組成物。
JP2012528854A (ja) * 2009-06-25 2012-11-15 チャバイオ アンド ディオステク株式会社 不快味を効果的に隠蔽した経口用速溶フィルム
JP2013507105A (ja) * 2009-10-09 2013-03-04 フィリップ・モーリス・プロダクツ・ソシエテ・アノニム テクスチャ加工コーティングを備えた湿潤無煙タバコ製品
JP2015503931A (ja) * 2012-01-20 2015-02-05 アルトリア クライアント サービシーズ インコーポレイテッドＡｌｔｒｉａ Ｃｌｉｅｎｔ Ｓｅｒｖｉｃｅｓ Ｉｎｃ． オーラル製品
JP2016528930A (ja) * 2013-09-09 2016-09-23 アール・ジエイ・レイノルズ・タバコ・カンパニー 植物性材料を組み込む無煙タバコ組成物
CN106617262A (zh) * 2016-12-14 2017-05-10 湖北中烟工业有限责任公司 一种烟草口含片及其制备方法
JP2019202995A (ja) * 2018-05-17 2019-11-28 大正製薬株式会社 経口組成物

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