Buccal product and preparation method thereof

Abstract

The embodiment of the invention provides a buccal product and a preparation method thereof.The buccal product provided by the embodiment of the invention comprises at least two liquid permeable layers, at least two functional layers and at least two bearing layers, and the buccal product is symmetrically arranged about a first plane in the first direction; wherein the two sides of the first plane are each provided with a liquid permeable layer, a functional layer and a bearing layer, and the functional layers are provided with flavor substances and / or active substances; the liquid-permeable layer, the functional layer and the bearing layer are symmetrically arranged along the first plane, convenient manufacturing in a folding mode is facilitated, the existence of the liquid-permeable layer not only can relieve the stimulation feeling of an oral cavity when soluble substances are used, but also enables the buccal product to easily move and release the position and avoid over-stimulation, and the liquid-permeable layer has a water locking function and can lock part of saliva, so that the oral product is convenient to use. Spicy throat and stomach burning heat are relieved, and therefore the use experience of a user is improved.

Description

Oral products and their preparation methods Technical Field

[0001] This application belongs to the field of oral product technology, specifically relating to a lozenge and its preparation method. Background Technology

[0002] Nicotine oral dissolving film (ODF) is a rapidly dissolving film used to deliver nicotine, commonly found in smoking cessation aids. This film dissolves quickly in the mouth, releasing nicotine to help smokers alleviate withdrawal symptoms and thus aid the smoking cessation process.

[0003] Existing nicotine oral films are mostly made by solution casting and drying. This method not only involves complex manufacturing processes when preparing double-layer films, but also results in highly adhesive nicotine oral films that cannot be moved after being placed in specific application areas such as between the oral cavity wall and the gums. This causes strong discomfort at the contact site and seriously affects the customer experience. Summary of the Invention

[0004] The technical problem to be solved by this application is to provide a mouthpiece and a method for preparing the same, so as to improve the problem that the preparation process of existing double-layer mouthpieces is complicated and that they are prone to causing excessively strong local irritation in the oral cavity.

[0005] To improve the above problems, this application provides the following technical solution: This application proposes a mouth-held product, wherein the mouth-held product includes at least two liquid-permeable layers, at least two functional layers, and at least two support layers, wherein the mouth-held product is symmetrically arranged about a first plane in a first direction; wherein the liquid-permeable layer, the functional layer, and the support layer are provided on both sides of the first plane, and the functional layer is provided with flavor substances and / or active substances.

[0006] In one embodiment, the oral article satisfies at least one of the following conditions: (I) a functional layer is disposed between adjacent liquid-permeable layers and the support layer, and at least two support layers are in contact along the first plane; (II) a functional layer is disposed between adjacent liquid-permeable layers and the support layer, and between adjacent support layers; (III) a functional layer is disposed between adjacent liquid-permeable layers and the support layer, and two functional layers are disposed between adjacent support layers. In one embodiment, in the oral article, each of the liquid-permeable layer, the functional layer, and the support layer is connected to a corresponding layer at a symmetrical position.

[0007] In one embodiment, in the oral article, except for the connecting portion, the other portions of the circumferential edges of the liquid-permeable layer, the functional layer, and the bearing layer are formed into a joint.

[0008] In one embodiment, the oral article has a circumferential edge-formed joint for the liquid-permeable layer, the functional layer, and the load-bearing layer.

[0009] In one embodiment, the flavoring substance in the oral product includes at least one of a sweetener, a cooling agent, a flavoring agent, an acidulant, and a salting agent; and / or, the active substance includes at least one of nicotine and nicotine derivatives; and / or, the active substance includes at least one of caffeine and caffeine derivatives; and / or, the supporting layer is a water-repellent fabric layer; and / or, the liquid-permeable layer is a non-woven fabric layer; and / or, the water content of the oral product does not exceed 10%; and / or, the pH value of the oral product is 4 to 9; and / or, the functional layer further includes at least one of a film-forming matrix, a softener, a pH adjuster, and an antioxidant; and / or, the liquid-permeable layer has pores with a pore size of 0.01 mm to 2 mm and a porosity of 1% to 10%.

[0010] This application discloses a method for preparing a mouth-held product, wherein the method includes: stacking at least one liquid-permeable layer, at least one functional layer and at least one carrier layer to obtain a single-layer product; wherein the functional layer is provided with flavor substances and / or active substances; and symmetrically folding the single-layer product to obtain the mouth-held product.

[0011] In one embodiment, the preparation method involves stacking at least one liquid-permeable layer, at least one functional layer, and at least one carrier layer, including: coating a functional liquid containing active substances onto a first surface of the carrier layer and drying it to a semi-dry state to form a pre-fabricated functional layer on the first surface of the carrier layer; covering the surface of the pre-fabricated functional layer with the liquid-permeable layer, and then drying the pre-fabricated functional layer to a dry state to obtain a single-layer product; symmetrically folding the single-layer product to obtain the oral product includes: folding the single-layer product with the liquid-permeable layer facing outwards and the second surface of the carrier layer facing inwards, and then sealing the edges to obtain the oral product; wherein the first surface and the second surface are arranged opposite to each other.

[0012] In one embodiment, the edge sealing process in the preparation method includes heat sealing and cutting.

[0013] In one embodiment, in the preparation method, the thickness of the carrier layer is 20 μm to 200 μm; and / or, the thickness of the liquid-permeable layer is 100 μm to 150 μm; and / or, the thickness of the functional layer is 25 μm to 300 μm.

[0014] This application also proposes an oral article prepared by the above-described preparation method.

[0015] Compared with the prior art, the embodiments of this application have the following advantages: In the embodiments of this application, the oral article includes at least two liquid-permeable layers, at least two functional layers, and at least two carrier layers, wherein the oral article is symmetrically arranged about a first plane in a first direction; wherein, a liquid-permeable layer, a functional layer, and a carrier layer are provided on both sides of the first plane, and the functional layer is provided with flavor substances and / or active substances; the symmetrical arrangement of the liquid-permeable layer, functional layer, and carrier layer along the first plane facilitates convenient manufacturing by folding, and the presence of the liquid-permeable layer can not only reduce the oral irritation when using soluble substances, but also make the oral article easy to move to the release position to avoid excessive stimulation, and the liquid-permeable layer has a water-locking function, which can lock in some saliva, reduce the burning sensation in the throat and stomach, thereby improving the user experience.

[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 is a schematic diagram of one structure of the oral article provided in the embodiment of this application; Figure 2 is a schematic diagram of another structure of the oral article provided in the embodiment of this application; Figure 3 is a schematic diagram of yet another structure of the oral article provided in the embodiment 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 existing nicotine oral films are mostly made using a solution casting and drying film-forming method. This method not only presents a complex manufacturing process when preparing the double-layer film, but also results in strong adhesion, making it difficult to move once placed in specific application areas such as between the oral cavity wall and gums. Furthermore, the good adhesion and rapid release rate of the oral film lead to high local concentrations and strong irritation, causing significant discomfort at the contact site. In addition, the double-layer structure is easily collapsed by saliva, further prompting users to produce excessive saliva, increase swallowing frequency, and experience discomfort such as a burning sensation in the throat and stomach, severely impacting the customer experience.

[0021] To address the aforementioned issues, as shown in Figure 1, this application provides an oral article 100. As shown in Figure 1, the oral article 100 includes at least two liquid-permeable layers 11, at least two functional layers 12, and at least two carrier layers 13. The oral article is symmetrically arranged about a first plane in a first direction. The liquid-permeable layer 11, the functional layer 12, and the carrier layer 13 are provided on both sides of the first plane. The functional layer 12 is provided with flavor substances and / or active substances.

[0022] The first direction can be the thickness direction of the oral product, that is, the liquid permeable layer, the functional layer and the support layer are folded and arranged with the first plane as the symmetry plane in the thickness direction. The first plane can be between two functional layers, inside one functional layer or between two support layers.

[0023] Among them, the active substance is a substance that can provide a stimulating sensation through contact with saliva, and this active substance can be directly absorbed through the oral mucosa.

[0024] Flavor substances are substances that can provide a special flavor.

[0025] In this embodiment, a liquid-permeable layer, a functional layer, and a support layer are symmetrically arranged along the first plane, which facilitates convenient manufacturing through folding. The presence of the liquid-permeable layer not only reduces oral irritation when using soluble substances, but also makes it easy to move the oral product to the release position to avoid excessive irritation. In addition, the liquid-permeable layer has a water-locking function, which can lock in some saliva, reduce the burning sensation in the throat and stomach, thereby improving the user experience.

[0026] In some embodiments, the active substance includes active agents with medical properties, such as cannabidiol (CBD), vitamins, nicotine, caffeine, etc.; in some embodiments, the active substance includes other active agents with specific properties, such as tea polyphenols, capsaicin, etc.

[0027] In some embodiments, the active substance is at least one of nicotine or a nicotine derivative, which is released in the oral cavity and provides a pleasurable experience to the user, thereby helping smokers alleviate withdrawal symptoms.

[0028] In some embodiments, 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.

[0029] 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.

[0030] In some implementations, to meet various user needs, the active substance may include substances with specific medical properties, such as CBD; the active substance may include substances with specific active properties, such as caffeine or caffeine derivatives, theophylline, capsaicin, etc.

[0031] In some embodiments, the flavoring agent includes at least one of sweeteners, cooling agents, flavorings, acidulants, and salting agents.

[0032] 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 secretion, and help nicotine be released more quickly and absorbed through the mouth, enhancing its effect. Furthermore, the diverse flavor profiles of flavorings (such as coffee, chocolate, and cinnamon) can satisfy different consumer preferences and increase product appeal. In some embodiments, the aforementioned flavorings can be mint flavorings, menthol, fruit flavorings, etc.

[0033] The aforementioned sweeteners can mask the bitter or pungent taste of nicotine, tobacco, or plant fibers, enhancing the palatability of the product. Simultaneously, sweeteners can also increase pleasure and reduce user aversion. Furthermore, sweeteners work synergistically with flavorings to enhance the expression of fruity, minty, and other flavors. In some embodiments, the aforementioned sweeteners include at least one of xylitol, sorbitol, mannitol, yigerol, lactitol, maltitol, isomaltitol, hydrogenated starch hydrolysate, erythritol, maltotriol, aspartame, acesulfame potassium, sodium saccharin, sucralose, neotame, cyclamate, alitane, steviol glycosides, arabinitol, and monk fruit sweetener.

[0034] 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,2,3-trimethyl-2-isopropylbutyramide (WS-23), N-ethyl-2-isopropyl-5-methylcyclohexaneformamide, menthyl lactate, menthyl acetate, and menthone glycerol ketal.

[0035] 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.

[0036] Acidulants provide or enhance the acidic taste of the product, balance the sweetness, and make the flavor fresher, more natural, and more layered. In some embodiments, acidulants include at least one of citric acid, malic acid, tartaric acid, lactic acid, and phosphoric acid.

[0037] In one embodiment, the functional layer further includes at least one of a film-forming matrix, a softener, a pH adjuster, and an antioxidant. That is, the functional layer is made of an active substance, a film-forming matrix, a softener, a flavoring agent, a pH adjuster, and an antioxidant.

[0038] Among them, the film-forming matrix serves as the framework of the functional layer; the softener can absorb moisture and promote the penetration of moisture into the interior of the film, thereby accelerating the initial wetting, disintegration and dissolution rate of the film in saliva.

[0039] In some embodiments, the film-forming matrix includes at least one of pectin, gum arabic, gelatin, starch, xanthan gum, pullulan, hydroxypropyl cellulose, hydroxypropyl methylcellulose, ethyl cellulose, polyvinyl alcohol, and sodium alginate. It can utilize hydroxyl groups and other groups on the molecular chain to form covalent bonds, weaving the originally linear molecular chains into a three-dimensional network structure. This results in a film layer with 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.

[0040] In some embodiments, the softener includes at least one of glycerin, propylene glycol, and polyethylene glycol (PEG).

[0041] 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 may include at least one of sodium bicarbonate, sodium carbonate, and calcium carbonate.

[0042] Antioxidants can improve the chemical stability of a product during storage and prevent the degradation of active ingredients. In some embodiments, antioxidants include at least one of vitamin E, butylated hydroxyanisole, and ascorbic acid.

[0043] In some embodiments, the functional layer further includes a solvent, which includes at least one of water and ethanol.

[0044] In some embodiments, the functional layer, by weight parts, includes: 0.5 to 20 parts of active substance, 5 to 90 parts of substrate, 5 to 90 parts of film-forming agent, 0 to 30 parts of softener, 0.1 to 5 parts of pH adjuster, 1 to 3 parts of sweetener, 0.5 to 1 part of cooling agent, and 1 to 10 parts of flavoring. Appropriate solvents may also be added to control the humidity or water content of the oral product according to taste requirements.

[0045] Excessive thickness of the functional layer leads to an overall larger thickness of the oral product, negatively impacting user experience. Conversely, insufficient thickness can cause significant deviations and errors in the production formula and process, affecting product consistency. In some implementations, the thickness of the functional layer can range from 25μm to 300μm, balancing both product consistency and user experience. For example, it can be any value within the range of 25μm, 30μm, 50μm, 100μm, 200μm, and 300μm.

[0046] In some implementations, the liquid-permeable layer has water-permeable and water-locking functions, which can lock in some saliva and reduce the burning sensation in the throat and stomach.

[0047] In some embodiments, the permeable layer has pores with a pore size of 0.01 mm to 2 mm and a porosity of 1% to 10%. This not only allows saliva to pass through to facilitate the release of active substances in the functional layer, but also has a certain water-locking function to prevent the release rate of active substances from being too rapid and causing strong irritation and oral discomfort. The pore size can be one or a range of any two of 0.01 mm, 0.02 mm, 0.05 mm, 0.1 mm, 0.2 mm, 0.5 mm, 1 mm, 1.5 mm, and 2 mm, and the porosity can be one or a range of any two of 1%, 2%, 3%, 4%, 5%, 6%, 7%, 8%, 9%, and 10%.

[0048] In this embodiment, the carrier layer is used not only to receive the functional liquid containing active substances during the preparation process such as coating, but also to provide support for the functional layer, so that the oral product can maintain a certain degree of softness and firmness, and facilitate the stability of its shape during processing and use.

[0049] In this embodiment, the supporting layer may or may not be waterproof. When the supporting layer is waterproof, it prevents liquids such as saliva from passing through or only allows micro-permeability. This can prevent the functional layers on both sides from reacting with each other after folding, and also helps to prevent the collapse of the double-layer structure and maintain the clear distinction between the functional layers.

[0050] In some embodiments, the aforementioned support layer is a waterproof membrane, specifically a water-repellent fabric layer or a release film, the material of which includes at least one of polytetrafluoroethylene (PTFE), polyethylene terephthalate (PET), and polyvinyl alcohol (PVA). That is, the support layer can be a PTFE film, a PET film, or a PVA film. The aforementioned waterproof membrane is suitable for heat sealing by methods such as ultrasound, which can form a dense structure at the composite interface, achieving a sealing and seepage-proof effect.

[0051] In some implementations, the liquid-permeable layer can be formed by creating openings in a water-impermeable membrane.

[0052] In some embodiments, the liquid-permeable layer is a non-woven fabric layer. This non-woven fabric layer can be a food-grade soluble non-woven fabric, a non-woven fabric made through spunbonded cellulose fibers, or a hot-air spunbonded non-woven fabric. This not only achieves good water permeability and durability in relieving moisture in the mouth, but also has excellent skin-friendly properties, preventing the bag itself from irritating or causing discomfort to the oral mucosa, further enhancing the user experience. The non-woven fabric material can be natural cellulose, synthetic cellulose, polyethylene terephthalate (PET), polyethylene (PE), etc.

[0053] In some embodiments, the thickness of the liquid permeable layer is 100 μm to 150 μm, for example, it can be one of 100 μm, 110 μm, 120 μm, 130 μm, 140 μm, 150 μm or any value between two of them.

[0054] In some embodiments, as shown in Figure 1, a functional layer is disposed between adjacent permeable layers and carrier layers, and at least two carrier layers are in contact along a first plane. In this embodiment, at least two carrier layers are in contact along the first plane, and functional layers and permeable layers are sequentially stacked on the surfaces of the carrier layers on both sides, forming a symmetrical multilayer oral product structure of permeable layer-functional layer-carrier layer-carrier layer-functional layer-permeable layer. This not only facilitates convenient manufacturing by folding after a single coating to form the functional layer, but also reduces the interaction between the functional layers and improves stability by placing the carrier layer between the two functional layers and the two permeable layers. Furthermore, placing the functional layer between the two permeable layers avoids direct contact between the functional layer and the application site, which not only reduces oral irritation when using soluble substances, but also makes it easy to move the oral product to the release position to avoid excessive irritation. In addition, the permeable layer has a water-locking function, which can lock in some saliva, reduce the burning sensation in the throat and stomach, thereby improving the user experience.

[0055] In this embodiment, the structure before folding is a liquid-permeable layer-functional layer-bearing layer. By folding with the bearing layer as the inner folding surface, the above-mentioned oral product structure can be obtained.

[0056] In some embodiments, as shown in FIG2, a functional layer 12 is provided between adjacent liquid-permeable layers 11 and support layers 13, and between adjacent support layers 13. In this embodiment, the plane where the functional layer between adjacent support layers is located is designated as the aforementioned first plane, and support layers, functional layers, and liquid-permeable layers are sequentially stacked on the surface of the functional layer to form a symmetrical multilayer oral article structure of liquid-permeable layer-functional layer-support layer-functional layer-support layer-functional layer-liquid-permeable layer.

[0057] In this embodiment, the structure before folding is a liquid-permeable layer-functional layer-bearing layer-functional layer. The surface functional layer is used as the inner folding surface for folding. The two functional layers at the inner folding surface are folded and bonded together to form a single layer, thus obtaining the above-mentioned oral product structure.

[0058] In some embodiments, as shown in FIG3, a functional layer 12 is disposed between adjacent liquid-permeable layers 11 and support layers 13, and two functional layers 12 are disposed between adjacent support layers 13. In this embodiment, the plane containing the functional layers between adjacent support layers is designated as the aforementioned first plane, and support layers, functional layers, and liquid-permeable layers are sequentially stacked on the surface of the functional layers to form a symmetrical multilayer oral article structure of liquid-permeable layer-functional layer-support layer-functional layer-support layer-functional layer-liquid-permeable layer-functional layer-liquid-permeable layer.

[0059] In this embodiment, the structure before folding is a liquid-permeable layer-functional layer-bearing layer-functional layer. The surface functional layer is used as the inner folding surface for folding. The two functional layers at the inner folding surface are not bonded together after folding, thus obtaining the above-mentioned oral product structure.

[0060] In some embodiments, the circumferential edges of the liquid permeable layer 11, the functional layer 12 and the carrier layer 13 are formed with a joint 15, that is, the circumferential edges of the liquid permeable layer, the functional layer and the carrier layer are joined together into an integral structure through the joint, which enhances the interlayer bonding force and makes the membrane layer less prone to separation and cracking.

[0061] In some embodiments, each of the aforementioned liquid-permeable layer, functional layer, and support layer is provided with a connecting portion 14 between itself and a corresponding layer at a symmetrical position. That is, the liquid-permeable layer 11, functional layer 12, and support layer 13 are connected to their respective symmetrically positioned counterparts via their connecting portions 14. The corresponding connecting portions 14 are the bending portions of the liquid-permeable layer 11, functional layer 12, and support layer 13 during the folding process. In this embodiment, retaining these connecting portions simplifies the manufacturing process and enhances interlayer bonding, making the membrane less prone to breakage.

[0062] In some embodiments, in addition to the connecting portion 14, the other circumferential edges of the liquid permeable layer 11, the functional layer 12 and the carrier layer 13 are formed into a joint portion 15. That is, the other circumferential edges of the liquid permeable layer, the functional layer and the carrier layer are joined into an integral structure through the joint portion, which enhances the interlayer bonding force and makes the membrane layer less prone to separation and cracking.

[0063] In some embodiments, the moisture content of the oral product is no more than 10%, which can effectively prevent some components of the oral product from penetrating to the surface of the oral product with moisture. Optionally, the moisture content of the oral product is not less than 3% to ensure that the oral product has a certain elasticity or flexibility and to prevent it from being too hard and affecting the taste.

[0064] In some embodiments, the pH value of the oral product is 4 to 9, which is moderately acidic and alkaline, and not only has a better taste, but also can effectively promote the rapid absorption of active substances through the oral mucosa.

[0065] To address the aforementioned issues, this application also provides a method for preparing a mouth-held product, comprising steps 101 to 102: Step 101, stacking at least one liquid-permeable layer, at least one functional layer, and at least one carrier layer to obtain a single-layer product; wherein the functional layer contains flavor substances and / or active substances; Step 102, symmetrically folding the single-layer product to obtain the mouth-held product.

[0066] In this embodiment, by stacking at least one liquid-permeable layer, at least one functional layer, and at least one carrier layer, and then symmetrically folding them, a mouthpiece with at least two functional layers can be formed, whose membrane is not easily broken. At the same time, the carrier layer is placed between the two functional layers and the two liquid-permeable layers, which can reduce the interaction between the functional layers and improve stability. Placing the functional layer between the two liquid-permeable layers avoids the functional layer from directly adhering to the application site, which not only reduces the oral irritation when using soluble substances, but also makes the mouthpiece easy to move to the release position, avoiding excessive irritation. In addition, the liquid-permeable layer has a water-locking function, which can lock in some saliva, reduce the burning sensation in the throat and stomach, thereby improving the user experience.

[0067] In some embodiments, step 101 includes steps 111 to 112, and step 102 includes step 113: Step 111, applying a functional liquid containing active substances to the first surface of the carrier layer and drying it to a semi-dry state to form a prefabricated functional layer on the first surface of the carrier layer.

[0068] In this step, the semi-dry state is characterized by a surface that is not sticky but still retains plasticity internally, specifically a moisture content of 10% to 50%. By coating a functional liquid containing active substances onto the first surface of the carrier layer, and then sending it into a drying device and drying it to a semi-dry state through methods such as baking, a pre-fabricated functional layer can be formed. This facilitates thermal bonding with the liquid-permeable layer during subsequent lamination, avoiding interface delamination after complete drying. The aforementioned drying device can be a drying oven, such as a tunnel oven.

[0069] In this step, the film-forming material, including the active substance, is dissolved in an appropriate amount of purified water, the viscosity is controlled at 100 mPa·s to 50000 mPa·s, the solid content is 10% to 30%, the pH is adjusted to 4 to 9, and the mixture is stirred with a homogenizer to prepare a suspension, thereby obtaining the above-mentioned functional liquid.

[0070] In this step, the prefabricated functional layer in a semi-dry state has a moisture content of 10% to 50% and a viscosity of 1000 mPa·s to 50000 mPa·s, which can effectively ensure that the prefabricated functional layer in this state has strong adhesion and will not permeate the load-bearing layer.

[0071] In some implementations, the thickness of the prefabricated functional layer can be 25μm to 300μm, for example, it can be one of 25μm, 30μm, 50μm, 100μm, 200μm, 300μm or any value between two of them.

[0072] In one embodiment, the functional liquid further includes at least one of a substrate, a film-forming agent, a softener, a pH adjuster, a sweetener, a cooling agent, and a fragrance. That is, the functional liquid is made from an active substance, a substrate, a film-forming agent, a softener, a pH adjuster, a sweetener, a cooling agent, and a fragrance.

[0073] In some embodiments, the functional liquid further includes a solvent, which includes at least one of water and ethanol.

[0074] In some embodiments, the functional liquid, by mass parts, includes: 0.5 to 20 parts of active substance, 5 to 90 parts of substrate, 5 to 90 parts of film-forming agent, 0 to 30 parts of softener, 0.1 to 5 parts of pH adjuster, 1 to 3 parts of sweetener, 0.5 to 1 part of cooling agent, and 1 to 10 parts of flavoring. Appropriate solvents may also be added to control the humidity or water content of the oral product according to taste requirements.

[0075] In some embodiments, the basic formulation of the functional liquid is shown in Table 1 below.

[0076] Table 1

[0077] In some embodiments, during the process of coating the functional liquid onto the first surface of the carrier layer, the coating thickness is 25μm~300μm, which can ensure that the active substance is within a better content range (e.g., 12mg / tablet), ensure a better taste, and reduce the water content to less than 50wt% within 30 minutes, thus avoiding affecting production efficiency.

[0078] In some embodiments, during the drying process to semi-dry, the temperature is 50°C to 70°C and the time is 15 min to 30 min. The drying temperature can be, for example, one of 50°C, 55°C, 60°C, 65°C, 70°C or any two of them. Drying at the above temperature and wind speed can reduce the moisture content to less than 50 wt% within 15 min to 30 min.

[0079] Step 112: Cover the surface of the prefabricated functional layer with a liquid-permeable layer, and then bake the prefabricated functional layer to a dry state to obtain a single-layer product.

[0080] In this step, the moisture content of the prefabricated functional layer in the dry state is 3% to 15%; the liquid permeable layer is covered on the surface of the semi-dry prefabricated functional layer, and then it is dried to a dry state, so that the liquid permeable layer can be firmly bonded to the surface of the functional layer.

[0081] In some embodiments, during the drying process to form a single-layer product, the drying temperature is 50°C to 70°C, for example, it can be one of 50°C, 55°C, 60°C, 65°C, 70°C or any range between two of them. Drying at the above temperature and wind speed can reduce the moisture content to less than 15 wt% within 15 minutes.

[0082] Step 113: Fold the single-layer product with the liquid-permeable layer facing outward and the second surface of the bearing layer facing inward, and seal the edges to obtain the oral product; wherein the first surface and the second surface are arranged opposite to each other.

[0083] In this step, the single-layer product is folded and sealed with the liquid-permeable layer facing outward and the second surface of the bearing layer facing inward, forming a double-layer functional layer structure that can be released from both sides, as the above-mentioned oral product.

[0084] In some embodiments, step 101 includes steps 121 to 122, and step 102 includes step 123: Step 121, sequentially coating the functional liquid containing active substances onto both sides of the carrier layer and drying it to a semi-dry state to form a prefabricated functional layer on both sides of the carrier layer.

[0085] In this step, a pre-formed functional layer is formed on the first surface of the carrier layer by coating a functional liquid containing active substances onto the first surface of the carrier layer, and then sending it into a drying equipment and drying it to a semi-dry state by drying or other means. Then, a pre-formed functional layer is formed on the second surface by coating a functional liquid containing active substances onto the second surface of the carrier layer, and then sending it into a drying equipment and drying it to a semi-dry state by drying or other means.

[0086] Step 122: Cover the surface of the prefabricated functional layer on one side with a liquid-permeable layer, and then bake the prefabricated functional layer to a dry state to obtain a single-layer product.

[0087] In this step, the moisture content of the prefabricated functional layers on both sides in the dry state is 3% to 15%; the liquid permeable layer is covered on the surface of the prefabricated functional layer in the semi-dry state on one side, and then it is continued to be dried to firmly bond the liquid permeable layer to the surface of the functional layer on one side.

[0088] Step 123: Fold the single-layer product with the liquid permeable layer facing outwards and the functional layer facing inwards, and seal the edges to obtain the oral product.

[0089] In this step, if the functional layer fails to bond into a single layer after folding, the single-layer product is folded and sealed with the liquid permeable layer facing outward and the prefabricated functional layer facing inward, forming a symmetrical multi-layer oral product structure of liquid permeable layer-functional layer-bearing layer-functional layer-bearing layer-functional layer-liquid permeable layer-as described above, which is the oral product.

[0090] In this step, when the functional layer can be bonded into one layer after being folded, the single-layer product is folded and sealed with the liquid permeable layer facing outward and the prefabricated functional layer facing inward, forming a symmetrical multi-layer oral product structure of liquid permeable layer-functional layer-bearing layer-functional layer-bearing layer-functional layer-liquid permeable layer, which is the oral product mentioned above.

[0091] In some embodiments, during the edge sealing process, the folded single-layer product is heat-sealed and cut. This not only cuts the double-layer functional structure to the required size and shape but also seals the cut edges. The dimensions can be 1cm x 2cm, and specific dimensions can be arbitrarily set according to user needs; these will not be elaborated upon here. In some embodiments, the heat-sealing and cutting is ultrasonic heat-sealing and cutting. This process uses high-frequency vibration heating and compression to achieve a sealed and formed joint at the edges. The equipment used in the ultrasonic heat-sealing and cutting process can specifically be an ultrasonic rolling cutter or an ultrasonic cutting device.

[0092] In some implementations, the ultrasonic frequency of ultrasonic heat sealing cutting is 10KHz~20KHz, for example, it can be one of 10KHz, 12KHz, 15KHz, 18KHz, 20KHz or any value between two of them, which can quickly achieve sealing between the support layers at the cutting edge without damaging the functional layer structure.

[0093] In this embodiment, the functional liquid is coated onto the carrier layer and dried until semi-dry. After covering with the liquid-permeable layer, the bond is tight and it is not easy to fall off. Then, it is dried again and folded and sealed. No secondary coating is required to form a mouthpiece with two functional layers, and its film layer is not easy to break. At the same time, the carrier layer is placed between the two functional layers and the two liquid-permeable layers, which can reduce the interaction between the functional layers and improve stability. Placing the functional layer between the two liquid-permeable layers avoids the functional layer directly adhering to the use site. This not only reduces the oral irritation when using soluble substances, but also makes it easy to move the mouthpiece to the release position to avoid excessive irritation. In addition, the liquid-permeable layer has a water-locking function, which can lock in some saliva, reduce the burning sensation in the throat and stomach, thereby improving the user experience.

[0094] In this embodiment of the application, after sealing, standard processes such as curing, cutting, testing, and packaging are carried out to obtain the final oral product.

[0095] In some embodiments, the oral product may be in the form of a mouth pouch, oral dissolving film, tablet, or tearable strip.

[0096] 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.

[0097] 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.

[0098] Based on Table 1 above, the above oral products are prepared according to the following process steps: (1) Preparation of functional liquid: Pour an appropriate amount of water into a mixing tank, turn on the stirring (50rpm~200rpm), raise the water temperature to 60℃, first add gelatin to the aqueous solution to dissolve, then slowly pour the above gelatin, hydroxypropyl methylcellulose, sodium alginate, and starch into the mixing tank, and homogenize at a rate of 10000rpm~20000rpm until completely dissolved; then add nicotine / salt, flavoring, cooling agent, sweetener, and softener to the above solution, stir (50rpm~200rpm) until completely dissolved, and control the solid content to 10%~30%; adjust the pH to 4~9 with sodium bicarbonate, stirring rate: 50rpm~100rpm; adjust the stirring rate to 10rpm~20rpm, vacuum (-0.06MPa-0.08MPa) to defoam, and close the vacuum after the bubbles are completely eliminated, and set aside for use; (2) Table Topcoating: Add the functional liquid to the hopper of the coating machine, lay a layer of water-repellent fabric (carrier layer), and begin coating the first surface of the water-repellent fabric. Control the thickness of the functional liquid film to be 25μm~300μm, and the coating rate to be 0.1m / min~0.3m / min. Turn on the heating and circulating air, maintain the temperature at 50℃~70℃, and dry for 15min~20min to obtain a pre-fabricated functional layer in a semi-dry state (it will not permeate the coated nonwoven fabric, and its adhesion is suitable, enabling...). (3) Heat sealing and cutting: Fold the coated film with the non-woven fabric layer on the outside and use ultrasonic rolling to heat seal and cut; cut and cut the film to dissolve the film, control the length and width of each film: 1cm*2cm, and the content is 2±10%mg / piece per side.

[0099] (4) Packaging: Pack the oral soluble film into an aluminum foil bag or other packaging material and seal it.

[0100] 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.

[0101] The present application will be described in detail below through embodiments.

[0102] Test method (1) Dissolution test: The sample was placed in 500 mL of artificial saliva at pH 6.8 and the dissolution reaction was carried out at a temperature of 37℃ and a rotation speed of 100 r / min. Samples were taken at 0.5 min, 1 min, 2 min, 3 min, 5 min, 10 min, 15 min, 20 min, 30 min, 45 min and 60 min respectively, and the nicotine content was detected by high performance liquid chromatography.

[0103] (2) Taste evaluation test: Subjective evaluation data of the product in terms of irritation, comfort and other dimensions. The sensory evaluation scoring method (0~10 points) is adopted and 10 evaluators conduct blind test scoring: Among them, irritation (0~10 points): the higher the score, the stronger the irritation.

[0104] Example 1 (1) Functional layer solution preparation: Pour an appropriate amount of water into a mixing tank, turn on the stirring (50 rpm ~ 200 rpm), raise the water temperature to 60°C, and by mass, first add 15 parts of gelatin to the aqueous solution to dissolve, then slowly pour the above gelatin, 17.5 parts of hydroxypropyl methylcellulose E5, 15 parts of sodium alginate, and 15 parts of starch into the mixing tank, and homogenize at a rate of 10000 rpm ~ 20000 rpm until completely dissolved; then add 10 parts of nicotine, 0.5 parts of cooling agent WS-23, 1 part of sucralose, and 25 parts of softening agent glycerin to the above solution, and stir (50 rpm ~ 200 rpm) until completely dissolved, controlling the solid content to 10 ~ 30%; adjust the pH to 7 with sodium bicarbonate, stirring rate: 50 rpm ~ 100 rpm; adjust the stirring rate to 10 rpm ~ 20 rpm, and vacuum (-0.06M) (1) Defoaming with Pa-0.08MPa) and closing the vacuum after the bubbles are completely eliminated; (2) Surface coating: Add the functional liquid to the hopper of the coating machine, lay a layer of water-repellent cloth, and start coating the first surface of the water-repellent cloth. Control the thickness of the functional liquid film to 150μm and the coating rate to 0.1m / min~0.3m / min. Turn on the heating and circulating air, set the temperature to 50℃~70℃, and bake for 15min~20min to obtain a pre-made functional layer in a semi-dry state. Cover the surface of the pre-made functional layer with non-woven fabric, and pull the water-repellent cloth-pre-made functional layer-non-woven fabric in the oven for about 10min until the moisture content is less than or equal to 15%. (3) Heat sealing and cutting: Fold the coated film with the non-woven fabric layer on the outside, and heat seal and cut with an ultrasonic roller cutter. Cut and cut the film to control the length and width of each film: 1cm*2cm, and the content is 2±10%mg / piece per side.

[0105] (4) Packaging: Pack the nicotine oral solution bag (oral product) into an aluminum foil bag and seal it.

[0106] The difference between Example 2 and Example 1 is that in step (1): an appropriate amount of water is poured into a mixing tank, stirring is started (50 rpm ~ 200 rpm), the water temperature is raised to 60°C, and by mass, 38 parts of pullulan are first dissolved in the aqueous solution, and then the pullulan and 30 parts of polyvinyl alcohol are slowly poured into the mixing tank and homogenized at a rate of 10,000 rpm ~ 20,000 rpm until completely dissolved; then 10 parts of nicotine, 10 parts of flavoring, Add 0.5 parts of cooling agent WS-23, 0.5 parts of sucralose, and 10 parts of softening agent glycerin to the above solution, and stir (50 rpm to 200 rpm) until completely dissolved, controlling the solid content to 10% to 30%; adjust the pH to 7 with sodium bicarbonate, and stir at a speed of 50 rpm to 100 rpm; adjust the stirring speed to 10 rpm to 20 rpm, and apply a vacuum (-0.06 MPa to 0.08 MPa) to defoam. After the bubbles are completely eliminated, turn off the vacuum and set aside for later use.

[0107] The difference between Comparative Example 1 and Example 1 is that in steps (2) and (3): (2) Surface coating: Add the functional liquid to the hopper of the coating machine, lay a release film, start coating, control the thickness of the functional liquid film to be 25μm~300μm, and the coating rate to be 0.1m / min~0.3m / min; turn on the heating and circulating air, the temperature to be 50℃~70℃, and dry until the moisture content is less than 10%; (3) Heat sealing and cutting: peel off the complete film, cut and cut the film pieces, control the length and width of each film piece to be 1cm*2cm, and the content to be 2±10%mg per layer of film material.

[0108] The difference between Comparative Example 2 and Example 1 is that in steps (2) and (3): (2) Surface coating: Add the functional liquid to the hopper of the coating machine, lay a layer of water-repellent cloth, start coating the first surface of the water-repellent cloth, control the thickness of the functional liquid film to be 25μm~300μm, and the coating rate to be 0.1m / min~0.3m / min; turn on the heating and circulating air, the temperature to be 50℃~70℃, and dry until the moisture content is less than 10%; start coating the second surface of the water-repellent cloth, control the thickness of the functional liquid film to be 25μm~300μm, and the coating rate to be 0.1m / min~0.3m / min; turn on the heating and circulating air, the temperature to be 50℃~70℃, and dry until the moisture content is less than 10%; (3) Heat sealing and cutting: cut and slit the film, control the length and width of each film to be 1cm*2cm, and the content to be 2±10%mg per layer of film material.

[0109] Taste evaluation tests were conducted on the oral products in each embodiment and comparative example, and the test results are shown in Table 2.

[0110] Table 2

[0111] The experimental data above show that the oral products prepared by single-layer coating and ultrasonic sealing and cutting in the embodiments of this application have better stimulation and comfort, and the process is simpler than double-sided coating; in addition, due to the support of the fabric, the film does not break, and the film preparation control is simpler.

[0112] In summary, by coating the functional liquid onto the carrier layer and drying it until semi-dry, then covering it with the permeable layer, a tight bond is formed that prevents it from falling off. After drying it again and folding and sealing the edges, a mouthwash with two functional layers can be formed without secondary coating, and the film layer is less prone to breakage. Simultaneously, the carrier layer, positioned between the two functional layers and the two permeable layers, reduces the interaction between the functional layers, improving stability. Furthermore, placing the functional layer between the two permeable layers avoids direct contact with the application site, reducing oral irritation from soluble substances and allowing the mouthwash to be easily moved to the release position, preventing excessive irritation. The permeable layer also has a water-locking function, retaining some saliva and reducing throat irritation and stomach burning, thus enhancing the user experience.

[0113] 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.

[0114] 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, The oral product comprises at least two liquid-permeable layers, at least two functional layers, and at least two carrier layers, wherein the oral product is symmetrically arranged about a first plane in a first direction; wherein the liquid-permeable layer, the functional layer, and the carrier layer are provided on both sides of the first plane, and the functional layer is provided with flavor substances and / or active substances.

2. The oral article according to claim 1, characterized in that, The oral article satisfies at least one of the following conditions: (I) a functional layer is disposed between adjacent liquid permeable layers and the support layer, and at least two support layers are in contact along the first plane; (II) A functional layer is provided between adjacent liquid permeable layers and the bearing layer, and between adjacent bearing layers respectively; (III) A functional layer is provided between adjacent liquid permeable layers and the bearing layer, and two functional layers are provided between adjacent bearing layers.

3. The oral article according to any one of claims 1 to 2, characterized in that, Each of the liquid-permeable layer, the functional layer, and the load-bearing layer is connected to a corresponding layer at a symmetrical position.

4. The oral article according to claim 3, characterized in that, Apart from the connecting portion, the other portions of the circumferential edges of the liquid-permeable layer, the functional layer, and the load-bearing layer are formed into joints.

5. The oral article according to any one of claims 1 to 2, characterized in that, The circumferential edges of the liquid-permeable layer, the functional layer, and the load-bearing layer are formed at the joint.

6. The oral article according to claim 1, characterized in that, The flavoring substance includes at least one of sweeteners, cooling agents, flavorings, acidulants, and salting agents; and / or, the active substance includes at least one of nicotine and nicotine derivatives; and / or, the active substance includes at least one of caffeine and caffeine derivatives; and / or, the supporting layer is a water-repellent fabric layer; and / or, the liquid-permeable layer is a non-woven fabric layer; and / or, the water content of the oral product does not exceed 10%; and / or, the pH value of the oral product is 4 to 9; and / or, the functional layer further includes at least one of a film-forming matrix, a softener, a pH adjuster, and an antioxidant; and / or, the liquid-permeable layer has pores with a pore size of 0.01 mm to 2 mm and a porosity of 1% to 10%.

7. A method for preparing a mouth-held product, characterized in that, The method for preparing a mouth-held product as described in any one of claims 1 to 6 comprises: stacking at least one liquid-permeable layer, at least one functional layer, and at least one carrier layer to obtain a single-layer product; wherein the functional layer is provided with flavor substances and / or active substances; and symmetrically folding the single-layer product to obtain the mouth-held product.

8. The preparation method according to claim 7, characterized in that, The process of stacking at least one liquid-permeable layer, at least one functional layer, and at least one carrier layer includes: coating a functional liquid containing an active substance onto a first surface of the carrier layer and drying it to a semi-dry state to form a pre-fabricated functional layer on the first surface of the carrier layer; covering the surface of the pre-fabricated functional layer with the liquid-permeable layer, and then drying the pre-fabricated functional layer to a dry state to obtain a single-layer product; symmetrically folding the single-layer product to obtain the oral product includes: folding the single-layer product with the liquid-permeable layer facing outward and the second surface of the carrier layer facing inward, and sealing the edges to obtain the oral product; wherein the first surface and the second surface are arranged opposite to each other.

9. The preparation method according to claim 8, characterized in that, The edge sealing process includes heat sealing and cutting.

10. The preparation method according to any one of claims 7 to 9, characterized in that, The thickness of the bearing layer is 20μm to 200μm; and / or, the thickness of the liquid-permeable layer is 100μm to 150μm; And / or, the thickness of the functional layer is 25μm~300μm.

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