Oral use of the product

Abstract

The embodiment of the application provides a kind of oral product, adopt the water-repellent sublayer and adhesive sublayer combined by composite process as load layer, both can enhance the combination stability of water-repellent sublayer and adhesive sublayer, to effectively improve the adhesion of load layer, surface friction and high temperature resistance, also can give load layer whole water-repellent oil-repellent characteristic;Again, functional layer is loaded on the surface of adhesive sublayer, both can form reliable barrier to block the penetration of coating material liquid oil and fat under the premise of using water-repellent sublayer, also can guarantee the adhesion between functional layer using adhesive sublayer, avoid delamination.

Description

Technical Field

[0001] This application belongs to the field of oral tobacco technology, specifically relating to an oral tobacco product. Background Technology

[0002] Oral lozenges are a new type of oral mucosal drug delivery formulation. They are made by combining functional substances with excipients to form a film, which is then applied to the oral mucosa during use. Nicotine is absorbed through the mucosa and enters the bloodstream, achieving rapid onset of action.

[0003] Oral lozenges require a water-repellent fabric as a load layer to carry functional substances and excipients to form a functional layer. In related technologies, the water-repellent fabric only has basic water-repellent function and cannot effectively resist the penetration of nicotine and other oily substances in the coating liquid. Moreover, it is easy to separate from the functional layer after processing, and cannot form a continuous and effective barrier structure, which affects the overall function of the oral lozenge. Summary of the Invention

[0004] The technical problem to be solved by this application is to provide a mouthpiece that improves the problem that the load layer in existing mouthpieces is difficult to balance adhesion and water repellency.

[0005] To address the aforementioned problems, this application provides the following technical solution: This application proposes a mouthpiece comprising a load layer and at least one functional layer, wherein the functional layer and the load layer are stacked in the thickness direction. The functional layer contains active substances; The load layer includes a water-repellent sublayer and an adhesive sublayer stacked on at least one surface of the water-repellent sublayer, wherein the adhesive sublayer is disposed between the water-repellent sublayer and the functional layer, and the water-repellent sublayer and the adhesive sublayer are combined and formed into the load layer by a composite process.

[0006] Furthermore, in the oral product, the material of the water-repellent sublayer includes at least one of polytetrafluoroethylene, polyethylene terephthalate, and polyvinyl alcohol.

[0007] Furthermore, the oral article satisfies at least one of the following conditions: (I) The water-repellent sublayer is a polytetrafluoroethylene film with a thickness of 5μm to 20μm; or, the water-repellent sublayer is a polyethylene film with a thickness of 10μm to 25μm; or, the water-repellent sublayer is a polyvinyl alcohol film with a thickness of 8μm to 15μm. (II) The thickness of the load layer is 0.3mm~0.7mm; (III) The water repellency level of the load layer is AATCC 22 5, and the oil repellency level is AATCC 118 3~4.

[0008] Furthermore, in the oral product, the adhesive sublayer is a polypropylene nonwoven fabric layer.

[0009] Furthermore, the oral article further includes at least one sustained-release layer disposed on the surface of the functional layer opposite to the adhesive sublayer.

[0010] Furthermore, in the oral product, the sustained-release layer is a non-woven fabric layer; And / or, both the sustained-release layer and the adhesive sublayer are polypropylene nonwoven fabric layers, and the basis weight of the sustained-release layer is greater than that of the adhesive sublayer; And / or, the oral article includes a first sustained-release layer, a first functional layer, the load layer, a second functional layer, and a second sustained-release layer disposed sequentially.

[0011] Furthermore, the oral article also includes a bonding structure, which is a structure formed by bonding at least a portion of the edge structure of the sustained-release layer and the load layer.

[0012] Furthermore, in the oral article, the molding process includes at least one of heat sealing, ultrasonic welding, and stamping. And / or, the combined structure is a structure in which at least a portion of the edges of the sustained-release layer, the functional layer, and the load layer are combined.

[0013] Furthermore, in the oral product, the functional layer further includes at least one of the following: film-forming agent, plasticizer, antioxidant, pH adjuster, sweetener, cooling agent, acidulant, salting agent, and flavoring.

[0014] Furthermore, in the oral product, the active substance includes at least one of nicotine and nicotine derivatives; and / or, The film-forming agent includes at least one of hydroxypropyl cellulose, hydroxypropyl methyl cellulose, ethyl cellulose, polyvinyl alcohol, and sodium alginate; and / or, The plasticizer includes at least one of glycerin, propylene glycol, and polyethylene glycol; and / or, The antioxidants include at least one of trisodium citrate, sodium ascorbate, vitamin E, and tea polyphenols; The pH adjuster includes at least one of sodium bicarbonate, sodium carbonate, sodium citrate, citric acid, and malic acid; and / or, The sweetener comprises at least one of xylitol, sorbitol, mannitol, iodine, lactitol, maltitol, isomaltitol, hydrogenated starch hydrolysate, erythritol, maltotriol, aspartame, acesulfame potassium, sodium saccharin, sucralose, neotame, cyclamate, alitane, steviol glycosides, arabinitol, and monk fruit sweetener; and / or, The cooling agent comprises at least one of menthol, N-ethyl-2-isopropyl-5-methylcyclohexaneformamide, menthyl lactate, menthyl acetate, and menthone glycerol ketal; and / or, The acidulant includes at least one of citric acid, succinic acid, maleic acid, trans-butenedioic acid, acetic acid, propionic acid, lactic acid, and malic acid; and / or The salting agent includes at least one of sodium chloride and potassium chloride.

[0015] Compared with the prior art, the embodiments of this application have the following advantages: In this embodiment, the provided oral article includes a load layer and at least one functional layer stacked in the thickness direction; the functional layer includes a film-forming agent and an active substance; the load layer includes a water-repellent sublayer and an adhesive sublayer stacked on at least one surface of the water-repellent sublayer, with the adhesive sublayer disposed between the water-repellent sublayer and the functional layer, and the water-repellent sublayer and the adhesive sublayer being combined through a composite process. Using the water-repellent sublayer and adhesive sublayer combined through a composite process as the load layer can enhance the bonding stability between the water-repellent sublayer and the adhesive sublayer, thereby effectively improving the adhesion, surface friction, and high-temperature resistance of the load layer, and also imparting overall water and oil repellency to the load layer; furthermore, by loading the functional layer onto the surface of the adhesive sublayer, the water-repellent sublayer can form a reliable barrier to prevent the penetration of coating liquid oils, while the adhesive sublayer can ensure adhesion between itself and the functional layer, preventing delamination.

[0016] It should be understood that the above general description and the following detailed description are exemplary and explanatory only, and do not limit this application. Attached Figure Description

[0017] Figure 1 This is a schematic diagram of the structure of the oral article provided in the embodiments of this application; Figure 2 This is a flowchart of the preparation method of the oral product provided in the embodiments of this application. Detailed Implementation

[0018] To make the above-mentioned objectives, features and advantages of this application more apparent and understandable, the application will be further described in detail below with reference to the accompanying drawings and specific embodiments.

[0019] The terms "first" and "second" in the specification and claims of this application may explicitly or implicitly include one or more of the features. In the description of this application, unless otherwise stated, "multiple" means two or more. Furthermore, "and / or" in the specification and claims indicates at least one of the connected objects, and the character " / " generally indicates that the preceding and following objects are in an "or" relationship.

[0020] The inventors discovered that traditional water-repellent fabrics mostly possess only basic water-repellent properties and cannot effectively resist the penetration of nicotine and other oily substances in the coating solution. Their adhesion and water / oil repellency are difficult to balance. Although ordinary non-woven fabrics can form good adhesion with functional layers and films, they do not possess water / oil repellency properties at all when used as a load-bearing layer. After oil penetration, they can easily cause equipment adhesion and interlayer bonding failure, further aggravating the risk of uneven component release and structural delamination, thus affecting the release effect of active ingredients. If non-woven fabrics are treated to be water / oil repellent, their adhesion to other substrates will be damaged, making it difficult to achieve both goals simultaneously. Traditional SMS (Spunbond-Meltblown-Spunbond) non-woven fabrics often improve water resistance by composite polyethylene film, but polyethylene material has poor high-temperature resistance. During the necessary heat-sealing process of lozenges, melting and flow can easily occur, leading to substrate deformation, structural damage, reduced production qualification rate, and difficulty in meeting stable production requirements.

[0021] In response to the above problems, such as Figure 1 As shown, this application provides an oral article 100 including a load layer 10 and at least one functional layer 20, wherein the functional layer 10 and the load layer 10 are stacked in the thickness direction; the functional layer 20 contains an active substance; the load layer 10 includes a water-repellent sublayer 11 and an adhesive sublayer 12 stacked on at least one surface of the water-repellent sublayer 11, and the adhesive sublayer 12 is disposed between the water-repellent sublayer 11 and the functional layer 20, wherein the water-repellent sublayer 11 and the adhesive sublayer 12 are combined by an ultrasonic composite process, wherein the functional layer 20 can be a single-layer or multi-layer structure.

[0022] Among them, the active substance is a component that can help smokers alleviate withdrawal symptoms and can be directly absorbed through the oral mucosa; the functional layer 20, as the core layer, mainly undertakes the function of loading and releasing the active substance; the load layer 10 is used to support the functional layer 20, both to receive the functional liquid containing the active substance in the preparation process such as coating process, and to provide support for the functional layer 20, so that the oral product can maintain a certain softness and firmness, and facilitate the stability of its shape during processing and use.

[0023] The water-repellent sublayer 11 has a waterproof function, preventing liquids such as saliva from passing through or allowing only micro-permeability. In addition, the water-repellent sublayer 11 can prevent active substances from seeping out into non-oral areas, ensuring that the drug is released directionally to the oral mucosa, thereby improving the user experience. The adhesive sublayer 12 has water-permeable and water-locking functions, which can lock in some functional liquids during the preparation process and improve the bonding force between the functional layer 20 and the load layer 10. The load layer 10 is formed by combining the water-repellent sublayer 11 and the adhesive sublayer 12 through an ultrasonic composite process, which can improve the bonding stability between the water-repellent sublayer 11 and the adhesive sublayer 12, enhance the high temperature resistance, adhesion and surface friction of the composite structure, avoid delamination, and form a reliable barrier.

[0024] In this embodiment, because a water-repellent sublayer 11 and an adhesive sublayer 12, which are combined by ultrasonic and other composite processes, are used as the load layer 10, and the functional layer 20 is loaded on the surface of the side where the adhesive sublayer 12 is located in the load layer 10, the water-repellent sublayer 11 can form a reliable barrier to block the penetration of coating liquid oil, while the adhesive sublayer 12 can ensure the adhesion between the adhesive sublayer 11 and the functional layer 20 and avoid delamination. Therefore, it can improve the problem that the load layer 10 in existing oral products is difficult to balance adhesion and water repellency.

[0025] In one embodiment, the material of the aforementioned water-repellent sublayer 11 includes at least one of polytetrafluoroethylene (PTFE), polyethylene terephthalate (PET), and polyvinyl alcohol (PVA), that is, the water-repellent sublayer 11 can be a PTFE film, a PET film, or a PVA film. By ultrasonically bonding the aforementioned water-repellent sublayer 11 film with the adhesive sublayer 12, a dense structure can be formed at the composite interface, creating a water- and oil-repellent barrier that blocks the dual penetration of saliva and oil.

[0026] In one embodiment, the aforementioned water-repellent sublayer 11 can be a polytetrafluoroethylene (PTFE) membrane with a thickness of 5 μm to 20 μm, which not only naturally repels water and oil but also withstands temperatures above 260°C and has low surface energy, preventing grease from adhering and penetrating. In some embodiments, the thickness of the PTFE membrane can be one or any combination of 5 μm, 8 μm, 10 μm, 12 μm, 15 μm, and 20 μm.

[0027] In one embodiment, the aforementioned water-repellent sublayer 11 is a polyethylene terephthalate film with a thickness of 10 μm to 25 μm, and it is modified with a fluorocarbon coating, achieving an oil repellency rating of AATCC118 Grade 5, high strength, and temperature resistance above 180°C. In some embodiments, the thickness of the polyethylene terephthalate film can be one or any combination of 10 μm, 12 μm, 15 μm, 18 μm, 20 μm, and 25 μm.

[0028] In one embodiment, the aforementioned water-repellent sublayer 11 is a polyvinyl alcohol film with a thickness of 8 μm to 15 μm, and its surface is modified with silane, making it not only biodegradable but also possessing basic water and oil repellency capabilities, and resistant to temperatures of 120°C to 150°C. In some embodiments, the thickness of the polyvinyl alcohol film can be one or any combination of 8 μm, 10 μm, 12 μm, and 15 μm.

[0029] In one embodiment, the surface of the water-repellent sublayer 11 is subjected to polarity modification treatment, which can effectively enhance the bonding potential between the surface of the water-repellent sublayer 11 film and the adhesive sublayer 12, while retaining the water-repellent and oil-repellent properties of the film itself.

[0030] In one embodiment, the material of the adhesive sublayer 12 is non-woven fabric, specifically a polypropylene non-woven fabric layer. The load layer 10, formed by ultrasonic composite of the above-mentioned water-repellent sublayer 11 film and the polypropylene non-woven fabric layer, forms a dense structure at the composite interface, which can form a water-repellent and oil-repellent barrier, blocking the dual penetration of saliva and oil.

[0031] In some embodiments, the aforementioned load layer 10 is composed of the aforementioned polytetrafluoroethylene film, polyethylene terephthalate film, or polyvinyl alcohol film with a basis weight of 10 g / m³. 2 ~15g / m 2 It is made of polypropylene bonded to nonwoven fabric and ultrasonically composited. In some embodiments, the load layer 10 is an SMS waterproof fabric, specifically 20g / m². 2 ~25g / m 2 It is made of polypropylene material combined with a PTFE film with a thickness of 8μm~12μm, and its temperature resistance is above 200℃, which can improve the structural strength and overall oil repellency.

[0032] In some embodiments, the water repellency rating of the above-mentioned load layer is AATCC 22 5, which can ensure that water droplets are completely non-wetting and roll without residue to facilitate the coating of functional layers and ensure targeted drug release; the oil repellency rating of the above-mentioned load layer is AATCC 118 3~4, which can effectively block the penetration of oils in the coating liquid.

[0033] In practical applications, the nonwoven fabric basis weight in the adhesive sublayer 12 is set to 10 g / m². 2~35g / m 2 Furthermore, the thickness of the water-repellent sublayer 11 is 5μm~20μm, which can achieve a balance between softness and firmness, improve oral fit by 40%, and increase the processing qualification rate to over 98%. At the same time, the thickness combination does not affect the stability of water and oil repellency performance.

[0034] In some embodiments, the nonwoven fabric basis weight in the adhesive sublayer 12 is set to 10 g / m². 2 ~15g / m 2 Furthermore, the thickness of the water-repellent sublayer 11 is 5μm~8μm to achieve the requirement of high softness; the nonwoven fabric in the adhesive sublayer 12 is set to have a basis weight of 25g / m². 2 ~35g / m 2 Furthermore, the thickness of the water-repellent sublayer 11 is 15μm~20μm, achieving the requirement of high rigidity.

[0035] In some embodiments, the thickness of the adhesive sublayer 12 is set to 0.15~0.25mm, so that the total thickness of the load layer is 0.3mm~0.7mm, which can ensure the overall taste of the oral product while ensuring that the load layer is not easily torn. In one embodiment, the oral product comprises a two-layer structure: a load layer 10 and a functional layer 20, which are in the form of a film or sheet. When a user ingests the oral product, the active substances in the functional layer 20 directly permeate into the user's saliva and are absorbed by the user.

[0036] In one embodiment, the oral product further includes at least one sustained-release layer 30, which is disposed on the surface of the functional layer 20 away from the adhesive sublayer 12, that is, the functional layer 20 is disposed between the sustained-release layer 30 and the adhesive sublayer 12. The sustained-release layer 30 can be used as an interface for direct contact with the oral mucosa, which can avoid the active substance from directly irritating the oral cavity, while guiding saliva to penetrate into the middle layer to initiate the controlled-release reaction. In addition, the sustained-release layer 30 has a water-locking function, which can lock in some saliva and reduce the burning sensation in the throat and stomach. Furthermore, the sustained-release layer 30 can prevent the active substance from seeping out into non-oral areas, ensuring that the drug is released directionally to the oral mucosa, thereby improving the user experience.

[0037] In one embodiment, the oral product comprises a three-layer structure consisting of a sustained-release layer 30, a functional layer 20, and a load layer 10 disposed sequentially. The load layer 10 is water- and oil-repellent and cannot be permeated by saliva. When a user ingests the oral product, saliva can pass through the sustained-release layer 30, dissolving the active substances in the functional layer 20 and allowing them to be absorbed by the user through the sustained-release layer 30. The load layer 10 can be positioned close to the gums to reduce irritation to the gums.

[0038] In some embodiments, the aforementioned sustained-release layer 30 is a non-woven fabric layer; specifically, it can be a spunlace non-woven fabric or a polypropylene non-woven fabric layer, so that the sustained-release layer 30 can not only assist in the sustained release of active substances, but also participate in the adjustment of softness and stiffness.

[0039] In this embodiment, the oral product is formed by stacking a load layer 10, a functional layer 20, and a sustained-release layer 30 in sequence. It can achieve a triple synergistic effect of saliva directional flow, stable release of active substances, and prevention of leakage of active substances, so that the release of active substances is controllable and improves the problem of excessively strong local oral irritation that existing oral products are prone to: assisting the release of active ingredients, participating in the adjustment of softness and firmness, and providing release of active substances.

[0040] In some embodiments, both the sustained-release layer 30 and the adhesive sublayer 11 are polypropylene nonwoven fabric layers. The basis weight of the sustained-release layer 30 is greater than that of the adhesive sublayer 11, which not only ensures that the sustained-release layer is suitable for coating processing, but also has better hydrophilicity to ensure the release of active substances.

[0041] In some embodiments, the oral article 100 further includes a bonding structure 40, which is a structure formed by bonding at least a portion of the edge of the sustained-release layer 30 and the load layer 10, and can firmly cover the functional layer 20 without easily delaminating.

[0042] In some embodiments, the aforementioned bonding structure 40 is a structure formed by bonding at least a portion of the edges of the sustained-release layer 30, the functional layer 20, and the load layer 10, thereby bonding the sustained-release layer 30, the functional layer 20, and the load layer 10 into a whole.

[0043] In some embodiments, the above-mentioned bonding molding includes at least one of heat sealing process, ultrasonic welding process and stamping process. That is, the edges of the sustained-release layer 30 and the load layer 10 can be bonded and molded by heat sealing process, ultrasonic welding process and stamping process, or the edges of the sustained-release layer 30, functional layer 20 and load layer 10 can be bonded and molded to ensure that the bonding between the layers is stable and not easy to delaminate.

[0044] In some embodiments, adhesive sublayers 12 are stacked on both surfaces of the water-repellent sublayer 11 in the load layer 10, namely a first adhesive sublayer 121 and a second adhesive sublayer 122. At least one functional layer 20 includes a first functional layer 21 and a second functional layer 22, which are respectively disposed on both sides of the load layer 10. At least one sustained-release layer 30 includes a first sustained-release layer 31 and a second sustained-release layer 32, which are respectively disposed on the surfaces of the first functional layer 21 and the second functional layer 22, so that the oral article is formed by sequentially stacking the first sustained-release layer 31, the first functional layer 21, the load layer 10, the second functional layer 22, and the second sustained-release layer 32.

[0045] In some embodiments, both the first sustained-release layer 31 and the second sustained-release layer 32 can be made of spunlace nonwoven fabric, which has good hydrophilicity. In some embodiments, the basis weight of the spunlace nonwoven fabric in the sustained-release layer 30 can be 10~35 g / m². 2 For example, it can be 10g / m 2 15g / m 2 20g / m 2 25g / m 2 30g / m 2 35g / m 2 The range of one or both of these values; the basis weight of the spunlace nonwoven fabric in the sustained-release layer 30 can be 12~45 g / m². 2 It can reach 12g / m 2 15g / m 2 20g / m 2 25g / m 2 30g / m 2 35g / m 2 45g / m 2 The range of one or both of these values ​​indicates that a larger basis weight is suitable for coating processing.

[0046] In some embodiments, both the first sustained-release layer 31 and the second sustained-release layer 32 include hydrophilic nonwoven fabric, which can effectively improve wearing comfort, prevent bitter components from directly irritating the oral cavity, and guide saliva to penetrate into the internal functional layer 20 to initiate a controlled-release reaction.

[0047] In some embodiments, the first sustained-release layer 31 and the second sustained-release layer 32 both include a non-woven fabric and a hydrophilic layer disposed on the surface of the non-woven fabric, so that the permeable membrane has hydrophilicity and biocompatibility, making it suitable as an interface for direct contact with the oral mucosa and effectively improving wearing comfort.

[0048] In some embodiments, the material of the hydrophilic layer includes at least one of chitosan and polyvinylpyrrolidone, which is attached to the surface of the nonwoven fabric to improve the hydrophilicity of the nonwoven fabric, so that the permeable membrane has good hydrophilicity and biocompatibility.

[0049] In some embodiments, the thickness of the hydrophilic layer is 0.1mm to 1.5mm, for example, a range of one or any two of 0.1mm, 0.2mm, 0.5mm, 0.8mm, 1.0mm, 1.2mm, and 1.5mm. This effectively improves the hydrophilicity of the nonwoven fabric while ensuring that the structure is soft and fits well during use, provides good concealment, and does not affect speech or chewing. This results in a permeable membrane with good hydrophilicity and biocompatibility.

[0050] In some embodiments, the aforementioned nonwoven fabric is a food-grade soluble nonwoven fabric, which can be a nonwoven fabric made by spunbonded cellulose or a hot-air spunbonded nonwoven fabric. It has excellent skin-friendly properties, avoiding irritation and discomfort to the oral mucosa caused by the permeable membrane itself, thus further enhancing the user experience. The material of the nonwoven fabric can be natural cellulose, synthetic cellulose, natural cotton, polyester, polypropylene, polyethylene terephthalate (PET), polyethylene (PE), etc.

[0051] In one embodiment, the edge of the oral product is treated by heat sealing, ultrasonic welding, and stamping. The edge of the oral product is treated by a combined process of heat sealing, ultrasonic welding, and stamping. Ultrasonic welding achieves molecular-level cross-linking, stamping strengthens the edge density, and the heat sealing process forms a fused bonding layer. This creates a three-dimensional constraint structure at the edge of the oral product, effectively solving the problem of the functional layer 20 easily detaching after dissolution in an unsealed oral product 100, reducing the risk of structural failure by more than 95%. Simultaneously, it blocks the leakage path of the functional layer 20, significantly reducing the amount of residual functional layer 20 in the oral cavity.

[0052] In some embodiments, the oral product may be in the form of a mouth pouch, oral dissolving film, tablet, or tearable strip.

[0053] In one embodiment, the active substance includes at least one of nicotine and nicotine derivatives. Nicotine includes natural nicotine and / or synthetic nicotine, and nicotine derivatives include one or more of nicotine salts, nicotine in a matrix such as a glycobase or organometallic complex, nicotine-resin combinations, nicotine inclusion complexes, and non-covalently bound nicotine. Non-covalently bound nicotine includes nicotine lactate, nicotine malate, nicotine salicylate, nicotine cyclodextrin-encapsulated complexes, nicotine hydrochloride, nicotine dihydrochloride, nicotine tartrate, nicotine tartrate dihydrate, nicotine sulfate, nicotine zinc chloride, and nicotine benzoate. Nicotine derivatives also include nicotine containing substituents, such as one or more mixtures of 6-methylnicotine, 6-methylnicotine lactate, 6-methylnicotine malate, 6-methylnicotine salicylate, 6-methylnicotine cyclodextrin encapsulated complex, 6-methylnicotine hydrochloride, 6-methylnicotine dihydrochloride, 6-methylnicotine tartrate, 6-methylnicotine tartrate dihydrate, 6-methylnicotine sulfate, 6-methylnicotine zinc chloride, and 6-methylnicotine benzoate.

[0054] The aforementioned active substances can not only dissolve rapidly in the oral cavity, releasing active substances to help smokers alleviate withdrawal symptoms, but also achieve a long-lasting and continuous stimulating effect.

[0055] In some implementations, to meet various user needs, the active substance may include substances with specific medical properties; the active substance may include substances with specific active properties, such as caffeine, theophylline, capsaicin, etc.

[0056] In one embodiment, the functional layer 20 further includes at least one of a film-forming agent, a plasticizer, an antioxidant, a pH adjuster, a sweetener, a cooling agent, an acidulant, a salty agent, and a flavoring.

[0057] Among them, the film-forming agent determines the mechanical strength, solubility and drug diffusion rate of oral products; the film-forming agent includes at least one of hydroxypropyl cellulose, hydroxypropyl methyl cellulose, ethyl cellulose, polyvinyl alcohol and sodium alginate, which can form covalent bonds by using hydroxyl groups and other groups on the molecular chain to weave the originally linear molecular chain into a three-dimensional network structure, so that the formed film layer has ultra-high density water-absorbing material, which can accelerate saliva penetration and increase the release rate of the active substances in the early stage, thereby meeting the user's immediate needs.

[0058] The plasticizer includes at least one of glycerin, propylene glycol, and polyethylene glycol (PEG), which can reduce brittleness by retaining moisture or lubricating molecular chains, ensuring the flexibility of oral products, preventing cracking, and providing a soft and comfortable taste, while also regulating the release rate of functional substances. Antioxidants can effectively prevent the oxidation reaction of components; in some embodiments, antioxidants may include at least one of trisodium citrate, sodium ascorbate, vitamin E, and tea polyphenols.

[0059] The pH adjuster not only neutralizes the irritation of acidic components and reduces the burning sensation in the mouth, maintaining a slightly alkaline environment, but also ensures that nicotine, in an alkaline environment (pH 8-9), exists in a non-ionic state, making it less prone to degradation and more easily absorbed through the oral mucosa, thus enhancing bioavailability and extending shelf life. In some embodiments, the pH adjuster includes at least one of sodium bicarbonate, sodium carbonate, sodium citrate, citric acid, and malic acid.

[0060] Sweeteners can mask the bitter or pungent taste of active substances such as nicotine, enhancing the palatability of the product. Simultaneously, sweeteners can increase the sense of pleasure, making the product feel more like a snack or candy, reducing user resistance. Furthermore, sweeteners work synergistically with flavorings to enhance the expression of fruity, minty, and other flavors. In some embodiments, sweeteners may include at least one of xylitol, sorbitol, mannitol, yigerol, lactitol, maltitol, isomaltitol, hydrogenated starch hydrolysate, erythritol, maltodextrin, aspartame, acesulfame potassium, sodium saccharin, sucralose, neotame, cyclamate, alitane, steviol glycosides, arabinitol, and monk fruit sweetener.

[0061] Cooling agents can enhance the user experience by simulating a cooling sensation, effectively neutralizing or masking the odor of active ingredients, reducing direct irritation of the active ingredients to the oral mucosa, and minimizing burning or numbness after use. In some embodiments, cooling agents may include at least one of menthol, N-ethyl-2-isopropyl-5-methylcyclohexaneformamide, menthyl lactate, menthyl acetate, and menthone glycerol ketal.

[0062] Flavorings can improve taste and flavor, mask the odor of chemicals such as tobacco or nicotine, and enhance the user experience. Meanwhile, flavorings such as mint and spicy spices can stimulate the oral mucosa, promote saliva production, and help nicotine be released and absorbed through the mouth more quickly, enhancing its effect. In addition, the diverse flavor profiles of flavorings (such as coffee, chocolate, cinnamon, etc.) can satisfy different consumer preferences and increase product appeal. The aforementioned flavoring can be a type of mint flavoring.

[0063] The acidulant provides a sour taste, which strongly stimulates saliva production, aiding in the release and diffusion of flavor compounds, resulting in a moister and fuller mouthfeel, and preventing dry mouth. In some embodiments, the acidulant may include at least one of citric acid, succinic acid, maleic acid, trans-butenedioic acid, acetic acid, propionic acid, lactic acid, and malic acid.

[0064] Among them, saltiness agents can significantly enhance the overall flavor intensity of the product. A small amount added can stimulate saliva secretion, improve oral moisture, and suppress bitterness. It can also make sweetness sweeter, umami more savory, and aroma more intense. In some embodiments, saltiness agents may include at least one of sodium chloride and potassium chloride.

[0065] In some embodiments, the oral article further includes a solvent, which includes at least one of water and ethanol.

[0066] In some embodiments, the functional layer 20, by weight, includes: 2-5 parts of active substance, 50-60 parts of film-forming agent, 25-35 parts of plasticizer, and 0.5-1 part of antioxidant. Appropriate solvents may also be added to control the humidity or water content of the oral product according to taste requirements.

[0067] In some embodiments, the basic formulations of each functional layer 20 are shown in Table 1 below.

[0068] Table 1

[0069] In some embodiments, the shape of the oral article can be irregular, such as square, oval, rectangular or circular, and can be adjusted according to different design requirements.

[0070] This application provides a method for preparing a mouth-held product, such as... Figure 2As shown, steps 201 to 202 are included: Step 201: The adhesive sublayer is bonded to at least one surface of the water-repellent sublayer using an ultrasonic composite process to obtain the load layer.

[0071] In this step, after the adhesive sublayer is stacked on the surface of the water-repellent sublayer, high-frequency vibration energy is applied through an ultrasonic composite device to achieve ultrasonic composite processing. This process allows for molecular-level cross-linking through ultrasonic welding, thereby forming a dense structure at the composite interface. This structure can create a water- and oil-repellent barrier, blocking the dual penetration of saliva and oil.

[0072] In some embodiments, the ultrasonic composite process described above uses an ultrasonic frequency of 18~22kHz, a pressure of 0.4~0.6MPa, a temperature of 90~110℃, and a time of 1~10s. This enables the interface between the water-repellent sublayer film and the non-woven fabric or other adhesive sublayers to form a tight bond, constructing a dense barrier layer. This significantly improves the high-temperature resistance, adhesion, and surface friction of the composite structure, and achieves AATCC 22 water repellency and AATCC 118 oil repellency. This solves the problems of traditional water-repellent fabrics being unable to repel oil and non-woven fabric carrier layers lacking water and oil repellency, thus avoiding functional layer clumping and structural delamination caused by grease penetration.

[0073] In some embodiments, the material of the aforementioned water-repellent sublayer includes at least one of polytetrafluoroethylene (PTFE), polyethylene terephthalate (PET), and polyvinyl alcohol (PVA). That is, the water-repellent sublayer can be a PTFE film, a PET film, or a PVA film. By ultrasonically bonding the aforementioned water-repellent sublayer film with the adhesive sublayer, a dense structure can be formed at the composite interface, creating a water- and oil-repellent barrier that blocks the dual penetration of saliva and oil.

[0074] In some embodiments, the material of the adhesive sublayer is non-woven fabric, specifically a polypropylene non-woven fabric layer. The load layer is formed by the above-mentioned water-repellent sublayer film and the polypropylene non-woven fabric layer through the above-mentioned ultrasonic composite. The composite interface forms a dense structure, which can form a water-repellent and oil-repellent barrier, blocking the dual penetration of saliva and oil.

[0075] Experimental data show that the load layer formed by the above-mentioned water-repellent sublayer film and non-woven fabric layer through the above-mentioned ultrasonic composite, without deformation below 200°C, has a peel force that is more than 3 times higher and a surface friction force that is more than 50% higher.

[0076] In some embodiments, prior to bonding the adhesive sublayer to at least one surface of the water-repellent sublayer via an ultrasonic bonding process, the method further includes: The surface of the water-repellent sublayer is subjected to polarity modification treatment.

[0077] In this embodiment, before ultrasonically bonding the water-repellent sublayer and the adhesive sublayer, the surface of the water-repellent sublayer is subjected to polarity modification treatment, which can effectively improve the bonding potential between the surface of the water-repellent sublayer film and the adhesive sublayer, while retaining the water-repellent and oil-repellent properties of the film itself.

[0078] Step 202: Apply a functional liquid containing active substances to at least one side of the surface of the load layer containing the adhesive sublayer to form a functional layer, thereby obtaining a mouth-held product.

[0079] In this step, a functional layer is formed by coating at least one side of the adhesive sublayer with a functional liquid containing active substances on the surface of the load layer. The adhesive sublayer is positioned between the water-repellent sublayer and the functional layer. This allows the water-repellent sublayer to form a reliable barrier to prevent the penetration of oils and greases from the coating liquid, while the adhesive sublayer ensures adhesion between the coating and the functional layer and prevents delamination. Therefore, this step can improve the problem that the load layer in existing oral products is difficult to balance adhesion and water repellency.

[0080] In some embodiments, in step 202 above, after the functional layer is formed, a sustained-release layer is covered on the side of the functional layer opposite to the load layer, the load layer and the sustained-release layer are bonded by a pressure bonding process, and the edges are heat-sealed to obtain a mouth-held product.

[0081] In this embodiment, after the ultrasonic composite process, a pressure bonding process such as stamping is used, followed by a heat sealing process at the edges to produce an oral product. Ultrasonic welding achieves molecular-level cross-linking, stamping strengthens the edge density, and the heat sealing process forms a fused bonding layer, which can build a three-dimensional constraint structure at the edge of the oral product. This effectively solves the problem of easy detachment of the functional layer after dissolution in unsealed oral products, reducing the risk of structural failure by more than 95%, while blocking the leakage path of the functional layer and significantly reducing the amount of residual functional layer in the oral cavity.

[0082] In some embodiments, the above-mentioned load layer can be fabricated according to the following process steps: (1) Pretreatment of the water-repellent sublayer: The polytetrafluoroethylene membrane, polyethylene terephthalate membrane, or polyvinyl alcohol membrane used as the water-repellent layer is fed into the processing chamber of a plasma treatment machine and treated for 15 seconds at an argon flow rate of 10 L / min and a power of 400 W. After surface modification, it is wound up to avoid contamination. The plasma treatment machine model can be PT-300. (2) Substrate preparation: Using a nonwoven fabric slitting machine to cut 15g / m 2Polypropylene bonded nonwoven fabric is cut into 1.2m wide rolls, with a length of 50m / roll. After cutting, the surface of the nonwoven fabric is checked for impurities and damage. The tension is controlled at 5N to avoid stretching and deformation.

[0083] (3) Layered positioning: Stack the nonwoven fabric in the following order: "nonwoven fabric → water-repellent sublayer film → nonwoven fabric", ensuring that the film completely covers the edge of the nonwoven fabric. During the stacking process, a positioning platform XY-500 can be used, with a speed of 1m / min and an alignment accuracy of ±0.1mm.

[0084] (4) Ultrasonic Combination: The laminated structure obtained in step (3) is passed through a composite mold and subjected to high-frequency vibration by an ultrasonic composite machine or other ultrasonic equipment to cause the interface molecules to entangle and form a dense bond. The ultrasonic frequency is 18~22kHz, the pressure is 0.4~0.6MPa, the temperature is 90~110℃, and the time is 1~10s. The ultrasonic composite machine can be of model such as US-2000.

[0085] (5) Cooling and shaping: After ultrasonic lamination, the substrate is cooled by a cooling roller until the surface temperature drops below 40°C, and then wound up (tension 8N) to avoid wrinkles, thus obtaining the load layer. The cooling roller can be a combination of an air-cooled unit and a water-cooled roller, and the temperature of the water-cooled roller is controlled at 20~30°C and the traction speed is 0.5~2m / min.

[0086] The peel strength of the load layer produced in this application embodiment is ≥2.5N / mm, the water repellency grade is ≥90 points, and the oil repellency grade is ≥5. The peel strength can be tested by a tensile testing machine, and the water repellency grade and oil repellency grade can be determined by a water and oil repellency tester.

[0087] To make the inventive objectives, technical solutions, and beneficial effects of this application clearer, the application is further described below with reference to embodiments. It should be understood that these embodiments are for illustrative purposes only and are not intended to limit the scope of this application.

[0088] The present application will be described in detail below through embodiments.

[0089] Test methods (1) TGA test: thermogravimetric analyzer (TA Q500), nitrogen atmosphere, heating rate 10℃ / min, temperature range 30-300℃.

[0090] (2) Coating and drying simulation test: Drying in ovens at 120℃ and 150℃ for 3 minutes respectively, and measuring the change in sample size.

[0091] (3) Water and oil repellency test: After drying, the water repellency level is tested according to AATCC 22 and the oil repellency level is tested according to AATCC 118.

[0092] (4) Nicotine functional liquid coating - overall roll shrinkage and oil repellency penetration test: a. Nicotine functional liquid coating (wet film thickness 0.12mm, speed 1.2m / min), dry with hot air at 120℃ for 3min and observe the uniformity of the functional layer; b. Shrinkage test: Measure the length (L) and width (W) of the whole roll before and after drying, and calculate the shrinkage rate = (initial size - dried size) / initial size × 100%; c. Oil penetration test: Cut 20 pieces of the dried sample and soak them in simulated oral oil (olive oil: glycerin = 1:1) for 30 minutes to observe the clumping and layering of the functional layer.

[0093] (5) Peel force test: universal testing machine (Instron 5967), tensile speed 100 mm / min, ASTM D3330 standard; (6) Surface friction test: friction coefficient tester (XLW-500), pressure 200g, speed 100mm / min; (7) Oil repellency durability test: After the sample is soaked in oil 10 times (30 minutes each time), the peel force is retested.

[0094] Example 1 (1) Pretreatment of water-repellent sublayer: A PTFE film with a thickness of 10 μm was treated for 15 s using a plasma treatment machine under the conditions of argon flow rate of 10 L / min and power of 400 W to obtain a modified PTFE film and increase the surface tension to 32 mN / m. (2) Preparation of the load layer: according to "15g / m 2 Polypropylene nonwoven fabric → Modified PTFE film → 15g / m 2 The polypropylene nonwoven fabric is layered and ultrasonically laminated at 20kHz, 0.5MPa, and 100℃ for 3 seconds using an ultrasonic laminator. After cooling, it is rolled up, with the width controlled at 1.2m. (3) Preparation of functional liquid: In a mixing tank, add 5 parts of purified water and 5.5 parts of hydroxypropyl methylcellulose by weight, and stir at 25°C for 10 min until dissolved; then add 1.8 parts of PEG-400 and 1.2 parts of glycerin, and stir for 10 min; finally add 0.3 parts of nicotine and 0.05 parts of vitamin E, and stir for 5 min to obtain a functional liquid with a viscosity of 5500 cP. The functional liquid is used to coat and dry to form a functional layer. (4) Five-layer structure assembly: control the wet film thickness to 0.12 mm and the coating speed to 1.2 m / min, and use a coating machine at 20 g / m 2 A functional liquid is applied to the surface of a polypropylene nonwoven fabric; a load layer is then bonded using a roller press, with the pressure controlled at 0.3 MPa and the temperature at 40°C; the functional liquid is then applied again and another 20 g / m² layer is bonded on. 2 Polypropylene nonwoven fabric; (5) Edge sealing and cutting: The edges are heat sealed for 2 seconds using a heat sealing machine at a temperature of 135℃ and a pressure of 0.6MPa. Then, the edges are reinforced using an ultrasonic welding machine at an ultrasonic frequency of 20kHz. Finally, the edges are cut into 20×30mm pieces using a cutting machine, and a total of 1000 pieces are prepared.

[0095] Comparative Example 1 The difference from Example 1 is that step (1) is omitted, and in step (2), a 10μm thick PE film is taken and the width is controlled to be 1.2m to obtain the load layer.

[0096] The load layers in Example 1 and Comparative Example 1 were subjected to TGA testing, coating and drying simulation testing, and water and oil repellency testing, respectively. The results are shown in Table 2.

[0097] Table 2

[0098] As can be seen from Table 2, the load layer prepared in this application has a low weight loss rate and no deformation at the coating drying temperature, and maintains excellent water and oil repellency; while the load layer in Comparative Example 1 shrinks and deforms at high temperature, with an oil repellency level of only 2, and cannot block oil penetration.

[0099] The load layers in Example 1 and Comparative Example 1 were subjected to nicotine functional liquid coating-whole roll shrinkage and oil repellency penetration tests, and the results are shown in Table 3.

[0100] Table 3

[0101] As can be seen from Table 3, the load layer prepared in this application has a roll shrinkage rate of ≤1%, stable dimensions, and can effectively block grease penetration, avoiding clumping and delamination of the functional layer; while in Comparative Example 1, the load layer has a high shrinkage rate, grease easily penetrates, and the product performance is seriously affected.

[0102] The load layers in Example 1 and Comparative Example 1 were subjected to peel force test, surface friction test and oil repellency durability test, respectively. The results are shown in Table 4.

[0103] Table 4

[0104] As can be seen from Table 4, the initial peel force of the load layer prepared in this application is 3 times that of the load layer in Comparative Example 1, and the peel force only decreases by 7% after immersion in grease, demonstrating excellent resistance to oil aging. In contrast, the peel force of the load layer in Comparative Example 1 decreases by 44% after immersion in grease, making the structure prone to failure. This further demonstrates the role of the oil-repellent properties of the load layer prepared in this application in ensuring structural stability.

[0105] In summary, the oral product provided in this application uses a water-repellent sublayer and an adhesive sublayer combined by an ultrasonic composite process as the load layer. This not only enhances the bonding stability between the water-repellent sublayer and the adhesive sublayer, thereby effectively improving the adhesion, surface friction, and high-temperature resistance of the load layer, but also endows the load layer with overall water- and oil-repellent properties. Furthermore, by loading the functional layer onto the surface of the adhesive sublayer, the water-repellent sublayer can form a reliable barrier to prevent the penetration of coating liquid and oil, while the adhesive sublayer can ensure the adhesion between the functional layer and the adhesive sublayer, avoiding delamination.

[0106] Although preferred embodiments of the present application have been described, those skilled in the art, upon learning the basic inventive concept, can make other changes and modifications to these embodiments. Therefore, the claims are intended to be interpreted as including the preferred embodiments as well as all changes and modifications falling within the scope of the embodiments of the present application.

[0107] The above provides a detailed description of an oral product and its preparation method provided in this application. Specific examples have been used to illustrate the principles and implementation methods of this application. The description of the above embodiments is only for the purpose of helping to understand the method and core ideas of this application. At the same time, for those skilled in the art, there will be changes in the specific implementation methods and application scope based on the ideas of this application. Therefore, the content of this specification should not be construed as a limitation of this application.

Claims

1. A mouth-held product, characterized in that, It includes a load layer and at least one functional layer, wherein the functional layer and the load layer are stacked in the thickness direction; The functional layer contains active substances; The load layer includes a water-repellent sublayer and an adhesive sublayer stacked on at least one surface of the water-repellent sublayer, wherein the adhesive sublayer is disposed between the water-repellent sublayer and the functional layer, and the water-repellent sublayer and the adhesive sublayer are bonded together by a composite process to form the load layer.

2. The oral article according to claim 1, characterized in that, The material of the water-repellent sublayer includes at least one of polytetrafluoroethylene, polyethylene terephthalate, and polyvinyl alcohol.

3. The oral article according to claim 1, characterized in that, The oral product meets at least one of the following conditions: (I) The water-repellent sublayer is a polytetrafluoroethylene film with a thickness of 5μm to 20μm; or, the water-repellent sublayer is a polyethylene film with a thickness of 10μm to 25μm; or, the water-repellent sublayer is a polyvinyl alcohol film with a thickness of 8μm to 15μm. (II) The thickness of the load layer is 0.3mm~0.7mm; (III) The water repellency level of the load layer is AATCC 22 5, and the oil repellency level is AATCC 118 3~4.

4. The oral article according to claim 1, characterized in that, The adhesive sublayer is a polypropylene nonwoven fabric layer.

5. The oral article according to claim 1, characterized in that, The oral article further includes at least one sustained-release layer disposed on the surface of the functional layer opposite to the adhesive sublayer.

6. The oral article according to claim 5, characterized in that, The sustained-release layer is a non-woven fabric layer; And / or, both the sustained-release layer and the adhesive sublayer are polypropylene nonwoven fabric layers, and the basis weight of the sustained-release layer is greater than that of the adhesive sublayer; And / or, the oral article includes a first sustained-release layer, a first functional layer, the load layer, a second functional layer, and a second sustained-release layer disposed sequentially.

7. The oral article according to claim 5, characterized in that, The oral article also includes a bonding structure, which is a structure formed by bonding at least a portion of the edge structure of the sustained-release layer and the load layer.

8. The oral article according to claim 7, characterized in that, The bonding process includes at least one of heat sealing, ultrasonic welding and stamping. And / or, the combined structure is a structure in which at least a portion of the edges of the sustained-release layer, the functional layer, and the load layer are combined.

9. The oral article according to any one of claims 1 to 8, characterized in that, The functional layer also includes at least one of the following: film-forming agent, plasticizer, antioxidant, pH adjuster, sweetener, cooling agent, acidulant, saltiness agent, and flavoring.

10. The oral article according to claim 8, characterized in that, The active substance includes at least one of nicotine and nicotine derivatives; and / or, The film-forming agent includes at least one of hydroxypropyl cellulose, hydroxypropyl methyl cellulose, ethyl cellulose, polyvinyl alcohol, and sodium alginate; and / or, The plasticizer includes at least one of glycerin, propylene glycol, and polyethylene glycol; and / or, The antioxidants include at least one of trisodium citrate, sodium ascorbate, vitamin E, and tea polyphenols; The pH adjuster includes at least one of sodium bicarbonate, sodium carbonate, sodium citrate, citric acid, and malic acid; and / or, The sweetener comprises at least one of xylitol, sorbitol, mannitol, iodine, lactitol, maltitol, isomaltitol, hydrogenated starch hydrolysate, erythritol, maltotriol, aspartame, acesulfame potassium, sodium saccharin, sucralose, neotame, cyclamate, alitane, steviol glycosides, arabinitol, and monk fruit sweetener; and / or, The cooling agent comprises at least one of menthol, N-ethyl-2-isopropyl-5-methylcyclohexaneformamide, menthyl lactate, menthyl acetate, and menthone glycerol ketal; and / or, The acidulant includes at least one of citric acid, succinic acid, maleic acid, trans-butenedioic acid, acetic acid, propionic acid, lactic acid, and malic acid; and / or The salting agent includes at least one of sodium chloride and potassium chloride.

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