Buccal product and production process thereof

Abstract

The invention provides a buccal product and a production process thereof. The production process comprises the following steps: acquiring a base material; sequentially laminating a plurality of flavor layers and a slow release layer on the base material to obtain the buccal product, wherein the flavor layers and the slow-release layers are alternately arranged, and the flavor layers comprise active substances. By constructing a plurality of groups of alternately arranged flavor layers and slow-release layers, the total release time can be prolonged by the physical barrier of the multiple slow-release layers, so that the problem that the release rate is too high is solved; the active substances of the multiple flavor layers are slowly released in a layered manner, so that the purpose of clear release layers can be achieved, and in addition, each flavor layer can contain different or same active substances, so that the buccal product is rich in taste, and the taste experience is improved.

Description

TECHNICAL FIELD

[0001] The present application belongs to the technical field of food or medicine, and particularly relates to a mouth product and a production process thereof. BACKGROUND

[0002] At present, the mouth product has become a new hot spot in the consumer market due to its convenience and low invasiveness, and widely exists in the form of a mouth bag, a mouth dissolving film, a mouth tablet and the like.

[0003] In the prior art, in order to improve the flavor performance and release effect of the mouth product, various preparation methods are often used, but the release rate of the flavor component in the prepared mouth product is too fast and the levels are unclear, which leads to poor mouthfeel experience, so that the consumers are prone to taste fatigue, and thus the product repurchase rate is reduced. SUMMARY

[0004] The technical problem to be solved by the present application is to provide a mouth product and a production process thereof, so as to solve the problem that the release rate of the flavor component in the existing mouth product is too fast and the levels are unclear, which leads to poor mouthfeel.

[0005] In order to solve the above problems, the present application is realized through the following technical scheme: The present application provides a production process of a mouth product, which comprises the following steps: obtaining a base material; stacking a plurality of flavor layers and release layers on the base material in sequence to obtain the mouth product; wherein the flavor layers and the release layers are arranged alternately, and the flavor layers comprise active substances.

[0006] In one embodiment, the obtaining of the base material comprises: obtaining a bottom layer of film-forming liquid, taking a release film as a substrate, and coating the bottom layer of film-forming liquid on the substrate to obtain the base material, wherein the bottom layer of film-forming liquid comprises at least one of polyvinyl alcohol, hydroxypropyl methyl cellulose, polyethylene glycol, polyvinylpyrrolidone and sorbitol.

[0007] In one embodiment, the stacking of the plurality of flavor layers and release layers on the base material in sequence comprises: obtaining a flavor film-forming liquid comprising the active substances; coating the flavor film-forming liquid on the base material, shaping the flavor layer, and shaping the release layer on the flavor layer; cycling the plurality of flavor layers and release layers.

[0008] In one embodiment, the shaping of the release layer on the flavor layer comprises: printing a release film-forming liquid on the flavor layer after the flavor layer is cured to shape the release layer on the flavor layer.

[0009] In an embodiment, the sustained-release film-forming solution comprises at least one of hydroxypropyl methylcellulose, acrylate copolymer, polyethylene glycol, and glycerol.

[0010] In an embodiment, the forming the sustained-release layer on the flavor layer comprises: adhering the sustained-release film to the semi-solidified flavor layer to form the sustained-release layer on the flavor layer.

[0011] In an embodiment, the substrate is one of a polytetrafluoroethylene film, a silica gel film, a polylactic acid film, and a polyethylene film; and / or, the active substance comprises at least one of nicotine and a nicotine derivative; and / or the sustained-release layer comprises at least one of a gelatin film, a non-woven fabric, and a polyvinyl alcohol film.

[0012] In an embodiment, the substrate has a thickness of 20 µm to 60 µm; and / or, each layer of the flavor layer has a thickness of 20 µm to 30 µm; and / or, each layer of the sustained-release layer has a thickness of 10 µm to 1000 µm.

[0013] In an embodiment, the flavor layer further comprises one or more of an essence, a sweetener, a cooling agent, an antioxidant, a thickening agent, an adhesive, and a sustained-release aid.

[0014] The present application provides a smokeless tobacco product obtained by the above production process.

[0015] Compared with the prior art, the embodiments of the present application have the following advantages: In the embodiments of the present application, a substrate is obtained; a plurality of layers of flavor layers and sustained-release layers are sequentially stacked on the substrate to obtain a smokeless tobacco product; wherein the flavor layers and the sustained-release layers are alternately arranged, and the flavor layers comprise active substances. By constructing a plurality of groups of alternately arranged “flavor layers and sustained-release layers”, the physical barrier of the plurality of layers of sustained-release layers can prolong the total release time, thereby solving the problem of excessively fast release rate; the active substances in the plurality of layers of flavor layers are released by layering, thereby achieving the purpose of clear release levels; in addition, each layer of flavor layer can contain different or the same active substances, thereby enriching the taste of the smokeless tobacco product and improving the taste experience.

[0016] It should be understood that the foregoing general description and the following detailed description are only exemplary and explanatory, and cannot limit the present application. BRIEF DESCRIPTION OF DRAWINGS

[0017] Figure 1 A production process flowchart of a smokeless tobacco product provided by the embodiments of the present application is shown; Figure 2 A structure diagram of a mouth piece provided by the present application is shown; Figure 3 Another structure diagram of a mouth piece provided by the present application is shown; Figure 4 Another structure diagram of a mouth piece provided by the present application is shown; Figure 5 A process flow diagram of a mouth piece provided by the present application is shown; Figure 6 A structure diagram of a mouth piece provided by the present application is shown; Figure 7 A process flow diagram of a mouth piece provided by the present application is shown; Figure 8 A process flow diagram of a mouth piece provided by the present application is shown.

[0018] Reference signs: 1-substrate, 2-first flavor layer, 3-first slow-release layer, 4-second flavor layer, 5-second slow-release layer, 6-third flavor layer, 7-third slow-release layer, 8-fourth flavor layer, 9-fourth slow-release layer, 10-fifth flavor layer, 11-fifth slow-release layer. DETAILED DESCRIPTION

[0019] In order to make the technical problems, technical solutions and beneficial effects of the present application clearer, the present application will be further described in detail below in combination with embodiments. It should be understood that the specific embodiments described herein are only used to explain the present application and not to limit the present application.

[0020] Most of the existing oral dissolving films or mouth pieces are based on single-layer structure design. The single-layer structure is difficult to balance the needs of rapid and sustained release. Either the release is too fast, causing strong irritation and short action time, or the effect is slow, making it difficult to meet the immediate needs. Moreover, the traditional coating or tabletting process lacks micro-scale layering control capability, and cannot precisely layout the flavors and active ingredients, resulting in uneven aroma volatilization, unclear tailing, and seriously affecting the use comfort and product recognition. In addition, the existing product homogeneous system lacks physical isolation design, and multiple components are released at the same time, making it difficult to build an ideal release curve of “fast onset – long duration – clear tailing”, which greatly limits the product innovation in flavor precise expression and user experience upgrade.

[0021] The present application aims to solve the problem that the existing mouth piece has too fast release rate and unclear layers, resulting in flat taste experience, serious flavor interference before and after, and difficulty in achieving the ideal experience of “fast onset + sustained stability + clear tailing”. The present application provides a production process of a mouth piece, Figure 1 A production process flow diagram of a mouth piece provided by the present application is shown, asFigure 1 As shown, the production process includes the following steps: Step 101, obtaining a substrate; Step 102, sequentially stacking a plurality of flavor layers and release layers on the substrate to obtain a snus product; Wherein, the flavor layers and the release layers are alternately arranged, and the flavor layers comprise active substances.

[0022] It should be noted that the substrate is at the bottom and plays a supporting role to ensure good form stability and structural adhesion in the subsequent production process. The flavor layer is a functional release layer, which not only provides flavor experience, but also is the main carrier for the release of active substances. The release layer is a controlled release regulating layer, which is arranged on each flavor layer. Its role is to regulate the diffusion rate of active substances or active ingredients (such as nicotine or its derivatives), prevent instantaneous release from being too fast and cause irritation or flavor imbalance, and prolong the action time of the flavor layer.

[0023] In specific implementation, a substrate is obtained; a first flavor layer is formed on the substrate, and a first release layer is formed on the first flavor layer; a plurality of second flavor layers and a plurality of second release layers are sequentially stacked on the first release layer to obtain a snus product; wherein, the flavor layers and the release layers are alternately arranged, and the flavor layers all comprise active substances; the uppermost layer of the snus product can be a flavor layer or a release layer, which is not limited in the present application.

[0024] In the embodiments of the present application, by constructing a plurality of groups of alternately arranged "flavor layers and release layers", the physical barrier of the plurality of release layers can prolong the total release time, thereby solving the problem of too fast release rate; the active substances in the plurality of flavor layers are released by layering, thereby achieving the purpose of clear release levels. In addition, each flavor layer can independently select active substances, fragrances and other ingredients, that is, each flavor layer can contain different or same active substances, thereby enriching the taste of the snus product and improving the taste experience.

[0025] In one embodiment, the substrate is selected from a directly cut finished film. For example, the substrate can be one of a polytetrafluoroethylene film, a silicone film, a polylactic acid film, and a polyethylene film.

[0026] In one embodiment, obtaining the substrate comprises: Obtaining a bottom film-forming liquid, taking a release film as a substrate, and coating the bottom film-forming liquid on the substrate to obtain the substrate, wherein the bottom film-forming liquid comprises at least one of polyvinyl alcohol, hydroxypropyl methyl cellulose, polyethylene glycol, polyvinylpyrrolidone, and sorbitol.

[0027] It should be noted that the above release film can be a polyethylene terephthalate polyester release film (PET polyester release film), and the thickness of the release film can be 40-50 µm. For example, the thickness of the release film can be any value or a range value of any two of 40 µm, 45 µm, and 50 µm.

[0028] For example, the bottom layer of the film-forming solution can be polyvinyl alcohol (PVA): hydroxypropyl methyl cellulose (HPMC) with a mass ratio of 1:1 to 2:1. The above-mentioned bottom layer of the film-forming solution is covered on the PET polyester release film by printing, and is cured to form a substrate.

[0029] For example, the bottom layer of the film-forming solution can also include sorbitol, polyethylene glycol, polyvinylpyrrolidone, etc. The solid content in the above-mentioned bottom layer of the film-forming solution is 3-8%, which can be any value or a range value of any two of 3%, 5%, and 8%. The thickness of the printing of the above-mentioned bottom layer of the film-forming solution is 20-40 µm, which can be any value or a range value of any two of 20 µm, 25 µm, 30 µm, 35 µm, and 40 µm, that is, taking the release film as the substrate, the thickness of the obtained substrate is the thickness of the bottom layer of the film-forming solution. The curing temperature is 45-55°C, which can be any value or a range value of any two of 45°C, 48°C, 50°C, 52°C, and 55°C, and the curing time is 1-3 min, which can be any value or a range value of any two of 1 min, 2 min, and 3 min.

[0030] In the embodiments of the present application, when the release film is used as the substrate to prepare the substrate, on the one hand, the release film can be supplied in rolls, reducing production costs; on the other hand, the release film can optimize the adhesion of the flavor layer and the slow-release layer by adjusting the surface tension, avoiding problems such as peeling and delamination caused by poor combination of the substrate with the flavor layer and the slow-release layer. By printing the bottom layer of the film-forming solution on the substrate, the thickness of the flavor layer and the slow-release layer is prevented from being uneven or cracked due to deformation of the substrate during printing, and the composite film formed on the release film substrate has high toughness.

[0031] It should also be noted that the bottom layer of the film-forming solution is coated on the substrate to obtain the substrate, and before obtaining the oral product, the substrate is subjected to a release treatment, and the temperature of the release treatment is 40-55°C.

[0032] The release film is a temporary support for the substrate, and needs to complete the “release” (i.e., peeling of the release film) operation in the subsequent process to release the target material. The temperature of the release treatment is 40-55°C, which can be any value or a range value of any two of 40°C, 42°C, 45°C, 48°C, 50°C, 52°C, and 55°C.

[0033] In a specific implementation, the production process of the oral product includes the following steps: obtaining a bottom film-forming solution, taking a release film as a substrate, coating the bottom film-forming solution on the substrate by printing to obtain a substrate, and forming a first flavor layer on the substrate; forming a first release layer on the first flavor layer; sequentially stacking a plurality of second flavor layers and a plurality of second release layers on the first release layer; and performing a release treatment on the substrate to obtain the oral product; wherein the flavor layers and the release layers are alternately arranged, and each of the flavor layers includes an active substance.

[0034] In the embodiments of the present application, the release temperature is a core parameter for regulating the peeling force and the stability of the substrate. By setting the release temperature to 40-55°C, the peeling is performed at a low temperature, thereby avoiding damage to the flavor layer and the release layer caused by high temperature, and the stress distribution of the substrate is more uniform during peeling. In addition, low-temperature peeling has low energy consumption and is suitable for green process manufacturing lines.

[0035] In one embodiment, a plurality of flavor layers and release layers are sequentially stacked on the substrate, including: obtaining a flavor film-forming solution including an active substance; coating the flavor film-forming solution on the substrate, and forming a flavor layer, forming a release layer on the flavor layer; cycling the formation of a plurality of flavor layers and release layers.

[0036] In a specific implementation, the flavor film-forming solution including an active substance is coated on the substrate by a doctor blade or other methods, and a first flavor layer is formed by a curing process. The processing temperature of the curing process is 55-65°C, and for example, can be any value or a range value of any two of 55°C, 58°C, 60°C, 52°C, and 65°C. The processing time of the curing process is 1-5 min, and for example, can be any value or a range value of any two of 1 min, 2 min, 3 min, and 5 min. The above process parameters are only examples and are not limiting. In a specific implementation, the process parameters can be adjusted accordingly according to the specific production conditions.

[0037] The solvent of the flavor film-forming solution can be a mixed solvent with a mass ratio of ethanol to water of (1:1)-(7:3). The mass ratio of ethanol to water is controlled in the range of (1:1)-(7:3) to adjust the viscosity, volatilization rate, and essence dispersibility of the flavor film-forming solution. The solvent of the flavor film-forming solution is only an example and is not limited. The solvent of the flavor film-forming solution can also be other suitable solvents. The preparation and printing process of the second flavor layer are the same as those of the first flavor layer, except that the second flavor layer is printed on the first release layer, and a plurality of flavor layers and release layers are cycled to form.

[0038] In the embodiments of the present application, the flavor layer is formed by printing a flavor film-forming solution containing an active substance; the sustained-release layer is formed on the flavor layer; the multi-layer flavor layer and the sustained-release layer are formed in cycles; and the long-acting controlled release of the active substance (such as nicotine) is realized through the multi-layer synergy of "flavor-sustained release", that is, the release rhythm is controllable, and a hierarchical mouthfeel experience is provided at the same time.

[0039] In an embodiment, forming the sustained-release layer on the flavor layer comprises: After the flavor layer is solidified, the sustained-release film-forming solution is printed to form the sustained-release layer on the flavor layer.

[0040] It should be noted that the solidification can be performed by air drying, hot air drying, far infrared drying, infrared drying, etc. The solidification temperature is 55-65℃, and for example, can be any value or a range value of any two of 55℃, 58℃, 60℃, 52℃ and 65℃. The solidification time is 1-5min, and for example, can be any value or a range value of any two of 1min, 2min, 3min and 5min.

[0041] It should also be noted that since the sustained-release film-forming solution needs to be printed and coated on the flavor layer, the flavor layer must be solidified first, and then the sustained-release film-forming solution is printed and coated. If solidification is not performed, the surface of the flavor layer may be damaged, that is, solidification is a "precondition" for printing and coating. Only after the flavor layer is solidified, a stable surface can be formed to ensure that the sustained-release layer is precisely formed by printing and coating, while avoiding mutual interference between the two layers of functions, and finally ensuring the integrity of the multi-layer structure and the controllability of flavor release.

[0042] In specific implementation, when the first flavor layer is formed on the substrate, the sustained-release film-forming solution is printed on the first flavor layer after the first flavor layer is solidified to form the first sustained-release layer; the multi-layer second flavor layer and the multi-layer second sustained-release layer are sequentially stacked on the first sustained-release layer after solidification again, and the oral product is obtained after complete solidification.

[0043] In the embodiments, the thickness of the sustained-release layer is controlled by the process of printing and coating after the flavor layer is solidified, so that uniform coating of the sustained-release film-forming solution can be realized, and the release speed of the active ingredient is adjusted in coordination with the thickness of the sustained-release layer and the sustained-release film-forming solution.

[0044] In an embodiment, the sustained-release film-forming solution comprises at least one of hydroxypropyl methyl cellulose, acrylate copolymer, polyethylene glycol, and glycerol.

[0045] It should be noted that, based on the mass of the sustained-release film-forming liquid, the proportion of hydroxypropyl methyl cellulose (HPMC) or acrylate copolymer (Eudragit) is 1% to 2%, for example, it can be any value or a range value of any two of 1%, 1.3%, 1.5%, 1.8%, and 2%. The HPMC can be HPMC-E15, and the acrylate copolymer can be Eudragit RL. The above-mentioned sustained-release film-forming liquid can also include polyethylene glycol (PEG) or glycerol, the mass proportion of PEG400 or glycerol is 0 to 1%, for example, it can be any value or a range value of any two of 0%, 0.1%, 0.3%, 0.5%, 0.8%, and 1.0%, and the rest of the above-mentioned sustained-release film-forming liquid is water.

[0046] In the embodiments of the present application, when the sustained-release film-forming liquid adopts a mixed system containing hydroxypropyl methyl cellulose (HPMC), the HPMC swells upon contact with water and gradually forms a viscous gel layer. When the oral product comes into contact with saliva, the HPMC wraps around the active ingredient (API) to form a physical barrier. In addition, the mesh structure of the gel layer formed by the HPMC can limit the diffusion speed of the API, allowing the active ingredient to be released slowly into the oral cavity and prolonging the action time. When the sustained-release liquid adopts a mixed system containing acrylate copolymer, the acrylate copolymer forms a continuous and flexible film after drying. The film is semi-permeable to moisture, and when saliva penetrates, it dissolves the API, limiting the diffusion rate of the API. At the same time, the acrylate copolymer film can reduce the hygroscopicity of the flavor layer, further preventing the evaporation of the flavor or the degradation of the API.

[0047] In one embodiment, forming the sustained-release layer on the flavor layer comprises: adhering the sustained-release film to the semi-solidified flavor layer to form the sustained-release layer on the flavor layer.

[0048] It should be noted that semi-solidification can be achieved by air drying, hot air drying, far infrared drying, infrared drying, etc. The temperature for semi-solidification is 55 to 65°C, for example, it can be any value or a range value of any two of 55°C, 58°C, 60°C, 52°C, and 65°C. The time for semi-solidification is 1 to 5 minutes, for example, it can be any value or a range value of any two of 1 minute, 2 minutes, 3 minutes, and 5 minutes.

[0049] It should be noted that the adhesion is achieved by hot pressing, and the temperature for hot pressing is 45 to 70°C, for example, the adhesion temperature can be any value or a range value of any two of 45°C, 50°C, 55°C, 60°C, 65°C, and 70°C. The time for hot pressing is 5 to 30 seconds, for example, the adhesion time can be any value or a range value of any two of 5 seconds, 10 seconds, 15 seconds, 20 seconds, 25 seconds, and 30 seconds.

[0050] It should be noted that the flavor layer is in a semi-solid state at this time, that is, the flavor layer has lost the fluidity of a complete liquid state and formed a soft gel state with a preliminary shape, but the surface still retains a certain stickiness, and then is laminated with the slow-release film to realize compounding through physical pressing of the slow-release film and the semi-solid flavor layer. That is, the semi-solid state of the flavor layer not only retains the "active adhesion ability" of the flavor layer to the slow-release film, but also avoids the defects of the completely uncured or completely cured state, thereby synchronously improving the lamination efficiency and stability.

[0051] It should be noted that the slow-release film can be one of a gelatin film, a non-woven fabric, and a polyvinyl alcohol film (PVA film).

[0052] In a specific implementation, when the first flavor layer is formed on the substrate in a semi-solid manner, the slow-release film is laminated on the first flavor layer to form a first slow-release layer; and a plurality of second flavor layers and a plurality of second slow-release layers are sequentially stacked on the first slow-release layer, and after complete curing, a smokeless product is obtained.

[0053] In the embodiments of the present application, the ordered layers are formed by lamination when the flavor layer is semi-solid, so as to realize directional release and sensory progression of different flavors and improve user experience.

[0054] In an embodiment, the substrate is one of a polytetrafluoroethylene film, a silica gel film, a polylactic acid film, and a polyethylene film.

[0055] It should be noted that the substrate is one of a polytetrafluoroethylene film, a silica gel film, a polylactic acid film, and a polyethylene film. The polytetrafluoroethylene film (PTFE film) can be a medical-grade PTFE film; the silica gel film can be a food-grade silica gel film; and the polyethylene film (PE film) can be a food-grade polyethylene film.

[0056] In the embodiments of the present application, the substrate is located at the bottom and plays a role of bearing and supporting, so as to ensure good form stability and structural adhesion in the production process of the smokeless product. The PTFE film has chemical inertness, and enzymes such as amylase and lysozyme and electrolytes (such as NaCl) in saliva cannot erode the PTFE film. There is no chemical change after long-term contact, and the smokeless product can avoid adhesion to the oral mucosa or the inner wall of the package, and can be used as a non-stick isolation layer. The silica gel film has high biocompatibility and can directly contact the oral mucosa. The degradation product of the polylactic acid film (PLA film) is lactic acid, and the degradation rate is slow in a moist oral environment, which is suitable for short-term contact of the smokeless product in the oral cavity. The PE film has the advantages of good heat sealing and low cost.

[0057] In an embodiment, the active substance includes at least one of nicotine and a nicotine derivative.

[0058] It should be noted that the active substance includes nicotine or a nicotine derivative, nicotine includes natural nicotine and / or synthetic nicotine, and the nicotine derivative includes one or more of nicotine salt, nicotine in a matrix such as a sugar matrix or an organic metal complex, nicotine-resin combination, nicotine inclusion complex, and non-covalently bound nicotine. Among them, the non-covalently bound nicotine includes nicotine lactate, nicotine malate, nicotine salicylate, nicotine cyclodextrin inclusion complex, nicotine hydrochloride, nicotine dihydrochloride, nicotine tartrate, nicotine tartrate dihydrate, nicotine sulfate, nicotine zinc chloride, nicotine benzoate, etc. The nicotine derivative also includes nicotine containing a substituent, such as one or more of hexamethyl nicotine, hexamethyl nicotine lactate, hexamethyl nicotine malate, hexamethyl nicotine salicylate, hexamethyl nicotine cyclodextrin inclusion complex, hexamethyl nicotine hydrochloride, hexamethyl nicotine dihydrochloride, hexamethyl nicotine tartrate, hexamethyl nicotine tartrate dihydrate, hexamethyl nicotine sulfate, hexamethyl nicotine zinc chloride, and hexamethyl nicotine benzoate. The active substances in the above-mentioned flavor layer can be the same or different. By taking nicotine or its derivative as the active substance of the oral preparation, the core effect is to achieve precise pharmacological intervention through oral mucosa absorption, while optimizing the use experience and safety.

[0059] In an embodiment, the active substance can also include substances with medical properties or other specific active properties, such as chlorhexidine, cetirizine, doxifluridine, benzocaine, lidocaine, acyclovir, ribavirin, guaifenesin, probiotics, zinc salt, caffeine, melatonin, vitamin B, iron agent, honeysuckle extract, ginsenoside, etc.

[0060] In an embodiment, the sustained-release layer includes at least one of gelatin film, non-woven fabric, and polyvinyl alcohol film.

[0061] It should be noted that the sustained-release layer includes at least one of gelatin film, non-woven fabric, and polyvinyl alcohol film. The gelatin film, non-woven fabric, and PVA film as the sustained-release layer material respectively realize the release control of the API in the oral preparation through the mechanisms of dissolution, diffusion, and swelling. The gelatin film has good water solubility, biodegradability, and biocompatibility. After the gelatin film contacts saliva, it absorbs water and swells to form a gel network, and the API diffuses and releases through the network pores. With the gradual dissolution (dissolution) of the gelatin, the release rate of the active ingredient transitions from “fast swelling release” to “slow dissolution release”, showing a biphasic release characteristic. The fiber network of the non-woven fabric forms a “sieve effect”, and the API needs to diffuse and release through the pores. The PVA film can realize the release rate adjustment of the active ingredient and mucosal adhesion.

[0062] In an embodiment, the thickness of the substrate is 20 µm~60 µm.

[0063] It should be noted that the thickness of the substrate is 20-60 pm, and for example, the thickness of the substrate can be any value or a range value of any two of 20 pm, 25 pm, 30 pm, 35 pm, 40 pm, 45 pm, 50 pm, 55 pm, 60 pm. By controlling the thickness of the substrate to be 20-60 pm, this thickness has good oral comfort (too thin substrate is easy to break, too thick has a foreign body sensation) and biocompatibility, the thickness can adjust the diffusion path of the flavor layer and the sustained-release layer to achieve precise release of active substances, and at the same time, controlling the thickness to be 20-60 pm can match the tolerance range of the production process (such as printing, lamination), avoiding batch failures caused by thickness fluctuations.

[0064] In an embodiment, the thickness of each flavor layer is 20-30 pm.

[0065] It should be noted that the thickness of each flavor layer is 20-30 pm, and for example, the thickness of each flavor layer can be any value or a range value of any two of 20 pm, 22 pm, 25 pm, 28 pm, 30 pm. By controlling the thickness of each flavor layer to be 20-30 pm, the diffusion path of the active ingredient is appropriate (too long will reduce the dissolution rate of the active ingredient), and the flavor release curve and nicotine absorption curve are synchronized, while physical comfort is also considered. The thickness of each flavor layer is independent of each other, that is, the thickness of each flavor layer can be designed and controlled according to its functional requirements, and is not directly limited by the thickness of other flavor layers. In actual application, it can be set arbitrarily according to user requirements. For example, the first flavor layer can be 25 pm, the second flavor layer can be 25 pm, or 20 pm or 28 pm or 30 pm, etc.

[0066] In an embodiment, the thickness of each sustained-release layer is 10-1000 pm.

[0067] It should be noted that the thickness of each sustained-release layer is 10-1000 pm, and for example, the thickness of each sustained-release layer can be any value or a range value of any two of 10 pm, 20 pm, 30 pm, 40 pm, 50 pm, 60 pm, 80 pm, 100 pm, 200 pm, 400 pm, 500 pm, 800 pm, and 1000 pm. The thickness of the sustained-release layer directly affects the diffusion path length of the active ingredient (such as nicotine in the flavor layer). By controlling the thickness of each sustained-release layer to be 10-1000 pm, a balance can be achieved in the dimensions of release rate, physical properties, mouthfeel, dose safety, etc., to ensure that the oral product achieves the expected functional effect and use experience. The thickness of each sustained-release layer is independent of each other, and the thickness does not need to be constrained to each other. Each sustained-release layer is responsible for the release rhythm of a specific active substance, and the thickness only needs to match the release needs of the carried substance, i.e., the thickness of the front layer does not affect the setting of the rear layer. In actual application, it can be completely set flexibly according to user needs. For example, the first sustained-release layer is 30 pm, and the second sustained-release layer can be 30 pm, 10 pm, 50 pm, or 100 pm, etc.

[0068] It should be noted that the thickness of the above substrate, each flavor layer, and each sustained-release layer is the wet film thickness before drying. The thickness of the above substrate, each flavor layer, and each sustained-release layer after drying treatment is 30-80% of the wet film thickness before drying, i.e., the final dry film thickness is 30-80% of the original wet film thickness. For example, it can be any value or a range value of any two of 30%, 40%, 50%, 55%, 70%, and 80%.

[0069] It should be noted that the working principle of the sustained-release layer is mainly based on the diffusion barrier mechanism. The nicotine active ingredient in the flavor layer usually has a certain water solubility and will be rapidly dissolved under the action of saliva during the swallowing process. If it is directly exposed to the saliva environment, it may cause problems such as too fast release, increased irritation, unclear flavor layer, etc. A sustained-release layer is set on the surface of the flavor layer, which is equivalent to establishing a diffusion barrier or a “speed control channel”. The sustained-release layer is an independent layer of structure, and the action position is outside the flavor layer, which belongs to the external barrier mechanism, and is equivalent to building a “shield door” to adjust the contact rate and path of saliva and the flavor layer, effectively delaying the speed of saliva entering the flavor layer.

[0070] In one embodiment, the flavor layer further comprises one or more of a flavoring agent, a sweetener, a cooling agent, an antioxidant, a thickening agent, an adhesive, and a sustained-release aid.

[0071] Flavors can improve mouthfeel and flavor, mask the odor of tobacco or nicotine agents and other chemicals, and enhance the user experience. At the same time, flavors such as menthol and spicy spices can stimulate the oral mucosa, promote saliva secretion, help nicotine release faster and be absorbed through the oral cavity, enhance the effect, match the release curve of active ingredients (API), and achieve synchronization of "flavor-satisfaction".

[0072] The sweetener includes at least one of xylitol, sorbitol, mannitol, isomalt, lactitol, maltitol, isomaltulose, hydrogenated starch hydrolysate, erythritol, maltotriitol, aspartame, acesulfame, sodium saccharin, sucralose, neotame, thaumatin, rebaudioside, and momordica grosvenorii. The sweetener can mask the bitter or pungent taste of active substances such as nicotine, and enhance the palatability of the product. At the same time, the sweetener can also enhance the sense of pleasure, making the product closer to the experience of snacks or candies, and reducing the resistance to use. In addition, the sweetener can synergize with flavors to strengthen the expression of fruit flavors, menthol flavors, and other flavors.

[0073] The cooling agent can include at least one of menthol, N-ethyl-2-isopropyl-5-methylcyclohexanecarboxamide, menthyl lactate, menthyl acetate, and menthone glycerol ketal. The cooling agent can improve the user experience by simulating a cooling sensation, effectively neutralizing or masking the odor of active substances, reducing the direct irritation of active substances to the oral mucosa, and reducing the burning or numbness after use.

[0074] The antioxidant includes at least one of ascorbic acid, tocopherol, tea polyphenol, rosemary extract, licorice extract, propyl gallate, and butylated hydroxyanisole. The antioxidant can inhibit the oxidative degradation of flavor ingredients (such as unsaturated fatty acids in flavors) and active substances, and prolong the shelf life of the product.

[0075] The thickening agent includes at least one of gum arabic, guar gum, xanthan gum, starch, sodium carboxymethyl starch, pectin, and carrageenan. The thickening agent can increase the viscosity of the flavor film-forming liquid, adjust the thickness, hardness, and ductility of the flavor layer, and delay the release of flavor ingredients and active substances.

[0076] The adhesive includes one or more of gelatin, gum arabic, starch, sodium carboxymethyl cellulose, and polyvinyl alcohol. The adhesive can achieve physical form fixation and support. The adhesive forms a gel network by absorbing water to swell, prevents the flavor layer from rapidly disintegrating or fragmenting in the oral cavity, and can slow down the diffusion of API.

[0077] The sustained-release aid includes one or more of chitosan, sodium alginate, hydroxypropyl methyl cellulose, polyvinyl pyrrolidone, and glycerol. The addition of the sustained-release aid in the flavor layer can delay the dissolution of the API through physical or chemical action. The sustained-release aid acts on the matrix structure inside the flavor layer, reduces the dissolution rate of the API through binding with the active ingredient, increasing the viscosity, changing the hydrophilicity, and the like, which belongs to the internal sustained-release mechanism, and emphasizes internal control diffusion.

[0078] In specific implementation, the components included in the flavor layer can be the same or different. For example, when the first flavor layer includes nicotine tartrate, essence, sodium carboxymethyl cellulose (CMC-Na), and polyvinyl pyrrolidone (PVP), the second flavor layer can include nicotine tartrate, essence, CMC-Na, and PVP, or can include nicotine tartrate, food essence, CMC, glycerol, or other combinations.

[0079] In the embodiments of the present application, the essence, sweetener, cooling agent, antioxidant, thickening agent, adhesive, and sustained-release aid in the flavor layer achieve flavor optimization, structure support, and active ingredient (API) controlled release through synergistic action, and realize the full-chain function implementation from "active ingredient carrying" to "user experience design".

[0080] The embodiments of the present application also provide a chewing article obtained by the above production process.

[0081] For example, Figures 2-4 The structure of the chewing article provided in the present application is shown in FIG. 1. Figures 2-4 As shown in FIG. 1, the structure of the chewing article can be substrate-first flavor layer-first sustained-release layer-second flavor layer-second sustained-release layer, or can be substrate-first flavor layer-first sustained-release layer-second flavor layer-second sustained-release layer-third flavor layer-third sustained-release layer-fourth flavor layer, or can be substrate-first flavor layer-first sustained-release layer-second flavor layer. That is, the uppermost layer of the chewing article can be a flavor layer or a sustained-release layer.

[0082] In the embodiments of the present application, the chewing article includes, from bottom to top, a substrate layer and a plurality of groups of alternately arranged flavor layers and sustained-release layers. The structure design aims to achieve the simultaneous release of active ingredients (such as nicotine) and flavor substances. The physical barrier of the multiple sustained-release layers can prolong the total release time, thereby solving the problem of too fast release rate. The active substances in the multiple flavor layers are released through layering, thereby achieving the purpose of clear release levels. In addition, each flavor layer can include different or the same active substances, thereby enriching the taste of the chewing article, improving the taste experience, and significantly improving the user experience and market differentiation competitiveness.

[0083] In order to make the purposes, technical schemes and beneficial effects of the present application clearer, the present application will be further described below in conjunction with examples. It should be understood that these examples are only used to illustrate the present application and not used to limit the scope of the present application.

[0084] The present application will be described in detail below through examples.

[0085] Test method: The obtained oral products were tested as follows: (1) Total nicotine content test 0.5 g of the oral product was taken, ultrasonically extracted, filtered to obtain a sample, and then the sample was sent to high performance liquid chromatography (HPLC) for total nicotine content determination under the condition that the detection wavelength was 260 nm, a C18 reverse phase column was used, and the mobile phase was a mixture of phosphoric acid buffer and methanol (70:30). The chromatogram was obtained and analyzed, and the total nicotine content was calculated according to the area of the nicotine peak in the chromatogram.

[0086] (2) pH value test At room temperature (25°C), a pH precision electrode was used to dissolve each oral product in 20 mL of pure water, shake and dissolve, and then read the pH value. The average value was calculated by taking 3 pieces of data.

[0087] (3) Total thickness detection The total thickness of the oral product was measured by a micrometer at a constant temperature and humidity condition at the middle position of 3 sample pieces, and the average value was taken.

[0088] (4) User taste test Five oral product taste evaluation engineers were used to sequentially consume the oral product and record their perception of each design flavor layer, i.e., whether the flavor could be identified and the flavor clarity score (1-5 points). The higher the score, the clearer the flavor. Each taste evaluation engineer independently completed the evaluation, and a special person recorded and arranged the data for judging the presentation effect of each layer of flavor and the overall progressive performance of the product.

[0089] Example 1 Figure 5 A process flow chart of the oral product provided by Example 1 of the present application is shown, as shown in Figure 5 The specific production process is as follows: (1) Preparation of the first flavor layer: Using a 50µm thick medical PTFE membrane as the substrate, a flavor film-forming liquid was formed with 1.5% nicotine tartrate, 2.0% food flavoring, 3.0% CMC-Na, 1.5% PVP-K30, 5.0% glycerol, and 87.0% purified water. The flavor film-forming liquid was then uniformly coated onto the medical PTFE membrane using a doctor blade printing method, with a thickness of 30µm. After curing by hot air drying at 60℃ for 2 minutes, the first flavor layer was formed. (2) Preparation of the first sustained-release layer: A sustained-release film-forming solution was prepared by using HPMC with a mass fraction of 2.0%, PEG400 with a mass fraction of 0.5%, and purified water with a mass fraction of 97.5%. The sustained-release film-forming solution was uniformly coated onto the first flavor layer by printing. The thickness of the sustained-release film-forming solution was 20~30µm. After curing by hot air drying at 50℃ for 3min, the first sustained-release layer was formed. (3) Preparation of multi-layered second flavor layer and multi-layered second sustained-release layer: The flavor film-forming liquid in step (1) above is uniformly coated on the first sustained-release layer by printing. The thickness of the flavor film-forming liquid is 30µm. After curing by hot air drying at 60℃ for 2min, the second flavor layer is formed. The slow-release film-forming liquid in step (2) above is evenly coated onto the second flavor layer by printing. The thickness of the slow-release film-forming liquid is 20~30µm. After curing by drying with hot air at 50℃ for 3min, the second slow-release layer is formed. The steps of forming the second flavor layer and the second sustained-release layer are repeated on the second sustained-release layer. From bottom to top, the third flavor layer, the third sustained-release layer, the fourth flavor layer, the fourth sustained-release layer, the fifth flavor layer, and the fifth sustained-release layer are formed in sequence. Multiple layers of second flavor layers and multiple layers of second sustained-release layers are stacked. The flavor sequence of each layer is as follows: first layer: cooling mint, second layer: lime, third layer: blueberry, fourth layer: vanilla, fifth layer: green tea. The whole sheet is obtained. The whole sheet is die-cut, dried, and packaged in an aluminum-plastic bag to obtain a mouthpiece. The size of a single mouthpiece is 20mm×10mm×0.6mm.

[0090] Figure 6 The diagram shows the structure of the oral article provided in Embodiment 1 of this application, as follows: Figure 6 As shown, the oral product in Example 1 has a total of 11 layers, including a base material 1, a first flavor layer 2, a first sustained-release layer 3, a second flavor layer 4, a second sustained-release layer 5, a third flavor layer 6, a third sustained-release layer 7, a fourth flavor layer 8, a fourth sustained-release layer 9, a fifth flavor layer 10, and a fifth sustained-release layer 11; the flavor layers and sustained-release layers are alternately arranged.

[0091] In this embodiment, by constructing a plurality of groups of "flavor layer and sustained-release layer" arranged alternately, the uppermost flavor layer and sustained-release layer, close to the user's oral cavity, can quickly take effect; the middle flavor layer and sustained-release layer can be in the middle and control the release rhythm; the lowermost flavor layer and sustained-release layer, located at the bottom of the oral product, serve as the end sustained-release, with the latest release time, thereby solving the problems of too fast release rate of flavor components of the oral product and unclear hierarchy, resulting in poor taste.

[0092] Example 2 Figure 7 The process flow chart of the oral product provided by Example 2 of the present application is shown as follows: Figure 7 As shown in the figure, the specific production process is as follows: (1) Preparation of the first flavor layer: PLA film with a thickness of 40 µm was used as the substrate, nicotine tartrate with a mass fraction of 1.2%, edible flavor with a mass fraction of 2.5%, CMC-Na with a mass fraction of 2.0%, glycerol with a mass fraction of 4.0%, and purified water with a mass fraction of 90.3% were used to form a flavor film-forming solution, which was uniformly coated on the PLA film by means of doctor blade printing, and the thickness of the flavor film-forming solution was 30 µm. After semi-curing at 60°C for 1~2 min by hot air drying, the first flavor layer was formed; (2) Preparation of the first sustained-release layer: A gelatin film with a thickness of 60 µm was used to form a sustained-release film, which contained gelatin with a mass fraction of 4%, glycerol with a mass fraction of 2%, and purified water with a mass fraction of 94%. The sustained-release film was hot-pressed and bonded at a temperature of 60°C for 15 s to form the first sustained-release layer; (3) Preparation of the second flavor layer and the second sustained-release layer: The flavor film-forming solution in step (1) was uniformly coated on the first sustained-release layer by printing, and the thickness of the flavor solution was 30 µm. After semi-curing at 60°C for 2 min by hot air drying, the second flavor layer was formed; The sustained-release film in step (2) was covered on the second flavor layer by bonding, and the thickness of the sustained-release film was 60 µm. After hot-pressing and bonding at 60°C for 15 s, the second sustained-release layer was formed; The steps of forming the second flavor layer and the second slow-release layer are sequentially cycled on the second slow-release layer to form a third flavor layer and a third slow-release layer, a fourth flavor layer and a fourth slow-release layer from bottom to top, and a plurality of second flavor layers and a plurality of second slow-release layers are alternately arranged, and the order of each layer of flavor is first layer: grapefruit, second layer: raspberry, third layer: orange flower, and fourth layer: honeydew. After complete curing, an overall sheet is obtained, and the overall sheet is formed into a lozenge product by die cutting, drying, aluminum plastic bag packaging, and the like. The size of a single lozenge product is 22 mm x 12 mm x 0.5 mm.

[0093] The structure of the lozenge product is similar to that in Example 1, except that the lozenge product in Example 2 has a total of 9 layers.

[0094] Example 3 Figure 8 A process flow diagram of the lozenge product provided in Example 3 of the present application is shown as follows. Figure 8 As shown in the figure, the specific production process is as follows: (1) Preparation of the base material: A bottom layer film forming solution is formed with a thickness of 50 µm PET release film as a substrate, 2.0% by mass fraction of PVA, 1.0% by mass fraction of HPMC, 3.0% by mass fraction of sorbitol, and 94.0% by mass fraction of purified water. The bottom layer film forming solution is uniformly coated on the substrate by printing, the coating thickness of the bottom layer film forming solution is 20 µm, and after curing by hot air drying at 50°C for 2 min, the base material is formed. (2) Preparation of the first flavor layer: A flavor film forming solution is formed with 1.0% by mass fraction of nicotine tartrate, 2.0% by mass fraction of essence, 2.0% by mass fraction of CMC-Na, 5.0% by mass fraction of glycerol, and 90.0% by mass fraction of purified water. The thickness of the flavor film forming solution is 25 µm. The flavor film forming solution is uniformly coated on the base material of step (1) by printing, and after curing by air drying at 50°C for 2 min, the first flavor layer is formed. (3) Preparation of the first slow-release layer: A slow-release film forming solution is formed with 1.5% by mass fraction of Eudragit RL, 0.5% by mass fraction of PEG400, and 98.0% by mass fraction of purified water. The slow-release film forming solution is uniformly coated on the first flavor layer by printing, the thickness of the slow-release film forming solution is 25 µm, and after curing by hot air drying at 55°C for 3 min, the first slow-release layer is formed. (4) Preparation of the plurality of second flavor layers and the plurality of second slow-release layers: The flavor film-forming solution in step (2) above is uniformly coated on the first sustained-release layer by printing, with a thickness of 25 pm. After curing by air drying at 50°C for 2 min, a second flavor layer is formed. The sustained-release film-forming solution in step (3) above is uniformly coated on the second flavor layer by printing, with a thickness of 25 pm. After curing by hot air drying at 55°C for 3 min, a second sustained-release layer is formed. The steps of forming the second flavor layer and the second sustained-release layer are repeated in sequence on the second sustained-release layer, to form a third flavor layer and a third sustained-release layer from bottom to top. The multiple second flavor layers and the multiple second sustained-release layers are arranged alternately, and the order of the flavors in each layer is as follows: the first layer: cola, the second layer: lemon tea, and the third layer: jasmine. The overall sheet is obtained, and the sheet is subjected to a release treatment, with the release temperature being 50°C. The overall sheet after the release treatment is subjected to die cutting, drying, and packaging in an aluminum plastic bag to obtain a lozenge product. The size of a single lozenge product is 18 mm x 10 mm x 0.4 mm.

[0095] The structure of the lozenge product is similar to that in Example 1, except that the lozenge product in Example 3 has a total of 7 layers.

[0096] The actual total thickness of each example is 0.589 mm (5 layers), 0.489 mm (4 layers), and 0.421 mm (3 layers), respectively, which is consistent with the increasing relationship of the corresponding number of layers, and the thickness control is good. This indicates that the production process of the lozenge product is stable, the layers are uniformly superimposed, and the design goal of the structure is achieved.

[0097] The total nicotine content of each example is tested, and the test results are shown in Tables 1 and 2. As shown in Tables 1 and 2, the total nicotine content of the three examples is 6.23 mg / g, 5.12 mg / g, and 4.03 mg / g, respectively, which is consistent with the set nicotine addition amount of each layer and the control result of the sheet weight. This indicates that the formula ratio and the actual dry weight control are reasonable, and the release load meets the standard.

[0098] Table 1

[0099] The pH of each example is tested, and the test results are shown in Table 2. As shown in Table 2, the pH value of each example is controlled between 7.4 and 7.8, which meets the palatability range of the lozenge product. The pH value of all samples is in the weak alkaline safety range, which can support the existence of nicotine in the free state, is helpful for absorption, and has a mild taste. This indicates that the buffer system is designed properly.

[0100] Table 2

[0101] User taste tests were conducted on the buccal tablets prepared in each embodiment, and the test results are shown in Tables 3-5. As shown in Table 3, the identification rate of the flavor layer in Example 1 was high, most of the 5 users could perceive all 5 layers of flavor, especially the identification rate of "cooling-mint", "blueberry" and "green tea" reached 100%; the average clarity score was concentrated between 4 and 5, the flavor presented a sense of hierarchy, and the taste progression was obvious; "vanilla" was not perceived by 1 user, suggesting that the intensity or release rate in the middle and rear sections can be appropriately increased; in summary, the process of Example 1 performed best in achieving clear presentation of multiple layers of flavor, and the structure design and release control effect were remarkable.

[0102] Table 3

[0103] Table 4

[0104] As shown in Table 4, the overall flavor layer of the buccal product was well perceived, most users could identify 3-4 layers of flavor out of the 4 layers, and individual users did not identify "orange flower" or "melon"; the front and middle sections were prominent, and the "grapefruit" and "raspberry" layers had stable clarity and high average values; the tail flavor was slightly blurred, and some users had weak identification or low scores for "melon", which may have been caused by uneven release or insufficient diffusion of the adhesive film; in summary, the process of Example 2 is suitable for short-range delivery products that highlight 2-3 main flavors, and there is a large optimization space for the rear flavor.

[0105] Table 5

[0106] As shown in Table 5, there were differences in flavor perception, and some users could not perceive the "cola" flavor, and the identification rate of the initial layer was relatively low; the middle and rear flavors were good, and the identification rate and clarity of "lemon tea" and "jasmine" were high, indicating good control of the release of the rear flavor; the clarity was concentrated, and the overall score was mainly "3-5", but the difference was large, suggesting that the film thickness or ratio needs to be further balanced; in summary, the process of Example 3 is used for light and thin instant products, is suitable for highlighting "tail flavor" or aromatic formulas, and the initial release needs to be optimized.

[0107] In summary, the multi-layer structure of the buccal product not only has the advantages of controllable release rate, rich taste experience, stable tablet structure, etc., but also can be adapted to various production processes, and has good process adaptability and mass production feasibility.

[0108] Although the preferred embodiments of the present application have been described, those skilled in the art can make further changes and modifications to these embodiments once they understand the basic inventive concept. Therefore, the claims are intended to include the preferred embodiments and all changes and modifications falling within the scope of the present application.

[0109] The above has carried out the detailed introduction to the oral product and its production process provided by the application, the principle and implementation mode of the application are described in this paper by applying specific examples, the above example description is only used to help understand the method and core idea of the application; at the same time, for the general technical personnel in the art, according to the idea of the application, the specific implementation mode and application range will be changed, and the above is not understood as the limitation of the application.

Claims

1. A process for the production of a smokeless tobacco product, characterized in that, The production process comprises the following steps: obtaining a substrate; stacking a plurality of flavor layers and release layers on the substrate in sequence to obtain a mouth product; wherein the flavor layers and the release layers are arranged alternately, and the flavor layers comprise active substances.

2. The production process according to claim 1, characterized in that, The obtaining of the substrate comprises: obtaining a bottom layer of film-forming solution, taking a release film as a substrate, and coating the bottom layer of film-forming solution on the substrate to obtain the substrate, wherein the bottom layer of film-forming solution comprises at least one of polyvinyl alcohol, hydroxypropyl methyl cellulose, polyethylene glycol, polyvinylpyrrolidone, and sorbitol.

3. The production process according to claim 1, characterized in that, The stacking of a plurality of flavor layers and release layers on the substrate in sequence comprises: obtaining a flavor film-forming solution comprising the active substances; coating the flavor film-forming solution on the substrate, shaping the flavor layer, and then shaping the release layer on the flavor layer; and cycling to shape a plurality of the flavor layers and the release layers.

4. The production process according to claim 3, characterized in that, The shaping of the release layer on the flavor layer comprises: printing a release film-forming solution on the flavor layer after the flavor layer is cured to shape the release layer on the flavor layer.

5. The production process according to claim 4, characterized in that, The release film-forming solution comprises at least one of hydroxypropyl methyl cellulose, acrylic acid ester copolymer, polyethylene glycol, and glycerol.

6. The production process according to claim 3, characterized in that, The shaping of the release layer on the flavor layer comprises: adhering a release film to the flavor layer when the flavor layer is semi-cured to shape the release layer on the flavor layer.

7. The production process according to claim 1, characterized in that, The substrate is one of a polytetrafluoroethylene film, a silica gel film, a polylactic acid film, and a polyethylene film; and / or The active substances comprise at least one of nicotine and nicotine derivatives; and / or The release layer comprises at least one of gelatin film, non-woven fabric, and polyvinyl alcohol film.

8. The production process according to claim 1, characterized in that, The thickness of the substrate is 20 µm to 60 µm; and / or The thickness of each flavor layer is 20 µm to 30 µm; and / or The thickness of each release layer is 10 µm to 1000 µm.

9. The production process according to any one of claims 1 to 8, characterized in that, The flavor layer further comprises one or more of essence, sweetener, cooling agent, antioxidant, thickening agent, adhesive, and release aid.

10. A mouthpiece, characterized in that The mouth product is obtained by the production process of any one of claims 1 to 9.

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