Buccal product and preparation method thereof

Abstract

The embodiment of the invention provides a buccal product and a preparation method thereof.The buccal product comprises a first supporting layer, a first functional layer and a load layer which are sequentially arranged in a stacked mode, the first functional layer comprises an active agent, and the first functional layer comprises a first body area and a first activity enrichment area; the first active enrichment area is arranged on the side, away from the load layer, of the first body area, and the concentration of the active agent in the first active enrichment area is larger than that of the active agent in the first body area. According to the embodiment of the invention, the first functional layer is composed of a first body region with an active agent and a first active enrichment region, and the concentration of the active agent in the first active enrichment region is controlled to be greater than the concentration of the active agent in the first body region; therefore, the volatilization loss of the active agent caused by links such as high-temperature drying in the preparation process of the first body area is complemented, so that the content of the active agent in the final product is relatively high, and the requirements of users can be effectively met.

Description

Technical Field

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

[0002] Oral dissolving products are a novel type of oral mucosal drug delivery formulation, which can be in the form of orally dissolving films or other forms. Orally dissolving films are made by combining functional substances with excipients to form a thin film, which is then applied to the oral mucosa during use. Nicotine is absorbed into the bloodstream through the mucosa, achieving rapid onset of action.

[0003] In related technologies, the preparation process of oral products often includes drying. For example, in the preparation of oral films, the active ingredients are usually formulated together with other ingredients in a film-forming solution, and then coated, dried, and slit. Among these, active ingredients such as nicotine are prone to significant volatilization, inaccurate content, poor uniformity, and insufficient irritation in the final product due to the high temperature during the drying process. Summary of the Invention

[0004] The technical problem to be solved by this application is to provide a mouth-held product and a method for preparing the same, so as to improve the problem of insufficient active ingredient content in mouth-held products made by existing processes.

[0005] To address the aforementioned problems, this application provides the following technical solution: This application proposes a mouth-held article, wherein the mouth-held article includes a first support layer, a first functional layer and a load layer stacked sequentially, the first functional layer includes an active agent, the first functional layer includes a first body region and a first active enrichment region, the first active enrichment region is disposed on the side of the first body region opposite to the load layer, and the concentration of the active agent in the first active enrichment region is greater than the concentration of the active agent in the first body region.

[0006] Furthermore, the oral article also includes a second support layer and a second functional layer. The second functional layer includes an active substance and is disposed on the side of the load layer opposite to the first functional layer, and is disposed between the second support layer and the load layer.

[0007] Furthermore, in the oral product, the second functional layer includes a second body region and a second active enrichment region, the second active enrichment region being disposed on the side of the second body region away from the load layer, and the concentration of the active substance in the second active enrichment region being greater than the concentration of the active substance in the second body region.

[0008] Furthermore, in the oral product, the active substance is disposed on the second support layer; And / or, the second support layer is a liquid-permeable layer; And / or, the second support layer is a non-woven fabric layer; 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.

[0009] Furthermore, in the oral product, the first support layer is provided with the active agent; And / or, the first support layer is a liquid-permeable layer; And / or, the first support layer is a non-woven fabric layer; And / or, the active agent includes at least one of nicotine and nicotine derivatives; And / or, the active agent includes at least one of caffeine and caffeine derivatives; And / or, the water content of the oral product does not exceed 10 wt%.

[0010] This application discloses a method for preparing an oral product, wherein the preparation method includes: A first functional liquid is coated onto the first surface of a load layer and subjected to a first drying process to form a first prefabricated body region; the first functional liquid includes a first activator and a first film-forming agent. A first spraying liquid is sprayed onto the surface of the first prefabricated body area to form a first prefabricated functional layer, wherein the first spraying liquid includes the second activator; A first support layer is covered on the surface of the first prefabricated functional layer and a second drying process is performed to obtain the oral article, wherein the activator includes a first activator and a second activator, the first body region is formed by at least a portion of the structure of the first prefabricated body region, and the first functional layer is made of the first prefabricated functional layer.

[0011] Furthermore, in the preparation method, the water content of the first prefabricated body region does not exceed 10 wt%; And / or, the first functional liquid further includes at least one of the following: a flow aid, a plasticizer, a sugar alcohol filler, an antioxidant, a pH adjuster, and a flavoring agent; And / or, the first spray liquid further includes a flavoring agent; And / or, the content of the second surfactant in the first spraying liquid is 40wt%~80wt%; And / or, the surfactant is provided on the first support layer; And / or, the first support layer is a liquid-permeable layer; And / or, the first support layer is a non-woven fabric layer; And / or, the active agent includes at least one of nicotine and nicotine derivatives; And / or, the active agent includes at least one of caffeine and caffeine derivatives.

[0012] Furthermore, after covering the surface of the first prefabricated functional layer with a first support layer and performing a second drying treatment, the preparation method further includes: The second functional liquid is coated on the second surface of the load layer and then dried to form the second prefabricated body region; wherein the second functional liquid includes a first active substance and a second film-forming agent, and the first surface and the second surface are disposed opposite to each other; Cover with a second support layer and perform a fourth drying process.

[0013] Furthermore, prior to covering the second support layer and performing the fourth drying process, the preparation method further includes: A second spraying liquid is sprayed onto the surface of the second prefabricated body area, the second spraying liquid comprising the second active substance.

[0014] Furthermore, in the preparation method, the water content of the second prefabricated body region does not exceed 10 wt%; And / or, the second functional liquid further includes at least one of the following: a flow aid, a plasticizer, a sugar alcohol filler, an antioxidant, a pH adjuster, and a flavoring agent; And / or, the second spray liquid further includes a flavoring agent; And / or, the content of the second active substance in the second spraying liquid is 40wt%~80wt%; And / or, the active substance is provided on the second support layer; And / or, the second support layer is a liquid-permeable layer; And / or, the second support layer is a non-woven fabric layer; 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.

[0015] Compared with the prior art, the embodiments of this application have the following advantages: In this embodiment, the provided oral article includes a first support layer, a first functional layer, and a load layer stacked sequentially. The first functional layer includes an active agent and comprises a first body region and a first active enrichment region. The first active enrichment region is located on the side of the first body region away from the load layer, and the concentration of the active agent in the first active enrichment region is greater than the concentration of the active agent in the first body region. In this embodiment, the first functional layer consists of a first body region containing the active agent and a first active enrichment region. The concentration of the active agent in the first active enrichment region is controlled to be greater than the concentration of the active agent in the first body region. This compensates for the loss of active agent due to high-temperature drying and other processes during the preparation of the first body region, resulting in a higher active agent content in the final product, effectively meeting user needs. Furthermore, covering the surface of the first functional layer with the first support layer and the load layer provides support for the functional layer, ensuring a certain degree of softness and rigidity in the oral article, facilitating morphological stability during processing and use. It also encapsulates and protects the active agent, reducing oxidation and dissipation during storage.

[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 oral article structure 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 in the traditional manufacturing process of oral products such as cigarettes, the entire dose of nicotine and other active substances, along with other ingredients, is typically formulated together in a film-forming solution, followed by coating, drying, and slitting. During the high-temperature drying process, the active substances and flavor compounds are highly volatile and thermally degraded, resulting in an actual content in the final product that is far lower than the designed dosage. This reduces the irritation experienced upon ingestion, and also leads to poor content uniformity and low product efficiency. These problems are particularly pronounced for oral products with a designed active substance content (e.g., 20mg / tablet or higher).

[0021] In addition, flavorings and other flavor substances may also be lost during high-temperature drying, making it impossible to flexibly adjust the ratio of flavorings and active substances in the final product.

[0022] Therefore, there is an urgent need for a new preparation process to solve the problem of low active ingredient content in oral products made by existing processes.

[0023] To address the aforementioned issues, this application provides an oral article 100, comprising a first support layer 30, a first functional layer 20, and a load layer 10 stacked sequentially. The first functional layer 20 includes an active agent and comprises a first body region 21 and a first active enrichment region 22. The first active enrichment region 20 is disposed on the side of the first body region 21 opposite to the load layer 10, and the concentration of the active agent in the first active enrichment region 22 is greater than the concentration of the active agent in the first body region 21.

[0024] The active agent is an ingredient that can help smokers alleviate withdrawal symptoms and can be directly absorbed through the oral mucosa; the first functional layer, as the core layer, mainly undertakes the functions of loading and releasing the active substance; the first support layer has water permeability and water-locking functions, which can lock in some saliva and reduce the burning sensation in the throat and stomach; the load layer is used to support the first functional layer, both to receive the functional liquid or spray liquid containing the active agent in the preparation process such as coating and spraying, and to provide support for the first functional layer, so that the oral product can maintain a certain softness and firmness, and facilitate the stability of its shape during processing and use.

[0025] In some embodiments, the first body region is a coating layer, and the first active enrichment region is a sprayed surface or sprayed layer, formed on the surface or outer layer of the first body region, meaning the thickness of the first body region is significantly greater than the thickness of the first active enrichment region. An active enrichment region can be formed after the first prefabricated body region is formed by coating a first functional liquid including an active agent onto the surface of a load layer, followed by spraying a first spray liquid including an active agent onto the surface of the first prefabricated body region. In other words, the first active enrichment region is the combination of the outer layer of the first prefabricated body region and the film layer obtained after drying the first spray liquid, while the remaining portion of the first prefabricated body region forms the aforementioned first body region.

[0026] The specific type of surfactant in the first active enrichment region can be the same as or different from the type of surfactant in the first bulk region. That is, the specific type of surfactant in the first spray liquid can be the same as or different from the type of surfactant in the first functional liquid. When the specific type of surfactant in the first active enrichment region is different from the type of surfactant in the first bulk region, the concentration of active groups in the first active enrichment region is greater than the concentration of active groups in the first bulk region.

[0027] In this embodiment, the first functional layer consists of a first body region containing an active agent and a first active enrichment region. The concentration of the active agent in the first active enrichment region is controlled to be greater than that in the first body region, thereby compensating for the loss of active agent due to high-temperature drying and other processes during the preparation of the first body region. This results in a higher active agent content in the final product, effectively meeting the user's needs. In addition, a first support layer and a load layer are covered on the surface of the first functional layer. These layers serve to support the functional liquid containing the active substance during the preparation process, such as coating, and also provide support for the functional layer. This ensures that the oral product maintains a certain degree of softness and firmness, facilitating morphological stability during processing and use. Furthermore, the active agent is encapsulated and protected, reducing oxidation and dissipation during storage.

[0028] In some embodiments, the first support layer is a liquid-permeable layer, that is, the first support layer has water permeability and water-locking functions, which can lock in some saliva and reduce the burning sensation in the throat and stomach.

[0029] In some implementations, the first support layer is a non-woven fabric layer, 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 to initiate a controlled release reaction.

[0030] In some embodiments, the first support layer is provided with an active agent. The active agent can be attached to the first support layer by means of molecular diffusion, adsorption, etc. When the first support layer is used as an interface for direct contact with the oral mucosa, it can quickly guide saliva to penetrate into the middle layer and initiate the controlled release reaction of the active agent, thereby reducing the burning sensation in the throat and stomach and improving the user experience.

[0031] In some embodiments, the aforementioned active agent 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.

[0032] The aforementioned active agents can not only dissolve rapidly in the oral cavity to release active substances and help smokers alleviate withdrawal symptoms, but also achieve a long-lasting and continuous stimulating effect.

[0033] In some implementations, to meet various user needs, the active agent may include substances with specific medical properties, such as vitamins; the active agent may include substances with specific active properties, such as at least one of caffeine and caffeine derivatives, theophylline, capsaicin, etc.

[0034] In some embodiments, the water content of the oral product does not exceed 10 wt%, which can effectively prevent some components of the oral product from penetrating to the surface of the oral product with water, and at the same time reduce the growth of bacteria.

[0035] In some embodiments, the water content of the oral product is 1wt% to 7.5wt%, which not only effectively prevents water from seeping into the surface of the product, but also prevents the product from being too dry and prone to breakage.

[0036] In some embodiments, the water content of the oral product can be a range of one or both of 1wt%, 2wt%, 3wt%, 4wt%, 5wt%, 6wt%, 7wt%, and 7.5wt%.

[0037] In some implementations, the load layer may be waterproof or non-waterproof. When the load layer is waterproof, it prevents liquids such as saliva from passing through or only allows micro-permeability, preventing the active substance from seeping out into non-oral areas and ensuring targeted drug release to the oral mucosa, thereby improving the user experience.

[0038] In some embodiments, the aforementioned load layer is a water-repellent fabric, the material of which includes at least one of polytetrafluoroethylene (PTFE), polyethylene terephthalate (PET), and polyvinyl alcohol (PVA), that is, the load layer can be a polytetrafluoroethylene film, a polyethylene terephthalate film, or a polyvinyl alcohol film.

[0039] In some embodiments, the aforementioned load layer is a nonwoven fabric, specifically a food-grade soluble nonwoven fabric. This nonwoven fabric can be a nonwoven fabric produced by spunbonded cellulose fibers or a hot-air spunbonded nonwoven fabric, possessing superior skin-friendly properties. This avoids irritation and discomfort to the oral mucosa caused by the permeable membrane itself, further enhancing the user experience. The nonwoven fabric material can be natural cellulose, synthetic cellulose, natural cotton, polyester, polypropylene, polyethylene terephthalate (PET), polyethylene (PE), etc.

[0040] In some embodiments, the oral article 100 further includes a second support layer 50 and a second functional layer 40. The second functional layer 40 includes an active substance and is disposed on the side of the load layer 10 away from the first functional layer 20. The second functional layer 40 is disposed between the second support layer 50 and the load layer 10. That is, the oral article in this embodiment is a structure of at least five layers, consisting of the first support layer 30, the first functional layer 20, the load layer 10, the second functional layer 40, and the second support layer 50 stacked in sequence.

[0041] In this embodiment, the load layer can be waterproof, preventing liquids such as saliva from passing through. For example, it can be a water-repellent cloth or a release film. In this case, placing the load layer between the first functional layer containing the surfactant and the second functional layer containing the active substance can not only increase the overall loading of the functional substance in the oral product, but also reduce the interaction between the first and second functional layers. It also helps to prevent the collapse of the double-layer structure, maintain the clear distinction between the first and second functional layers, and improve stability.

[0042] In this embodiment, the load layer can also have liquid permeability and liquid locking functions, which can lock in some saliva. For example, it can be non-woven fabric. In this case, the load layer is placed between the first functional layer with surfactant and the second functional layer with active substance. This can not only increase the overall loading of functional substances in the oral product, but also independently regulate the release rate of surfactant in the first functional layer and active substance in the second functional layer, thus forming multiple tastes and making the irritation levels more distinct.

[0043] In some embodiments, the second functional layer 40 includes a second body region 41 and a second active enrichment region 42. The second active enrichment region 42 is disposed on the side of the second body region 41 away from the load layer 10, and the concentration of active substances in the second active enrichment region 42 is greater than the concentration of active substances in the second body region 41.

[0044] The active substance is an ingredient that can help smokers alleviate withdrawal symptoms and can be directly absorbed through the oral mucosa. The second functional layer, as the core layer, mainly undertakes the functions of loading and releasing the active substance. The second support layer has water permeability and water-locking functions, which can lock in some saliva and reduce the burning sensation in the throat and stomach. The load layer is used to support the second functional layer. It is used to receive the functional liquid or spray liquid containing the active substance in the preparation process such as coating and spraying, and it can also provide support for the second functional layer, so that the oral product can maintain a certain softness and firmness, and facilitate the stability of its shape during processing and use.

[0045] The second active enrichment region can be formed by coating the surface of the load layer with a second functional liquid containing active substances to form a second preform body region, and then by spraying a second spray liquid containing active substances onto the surface of the second preform body region. That is, the second active enrichment region is the combination of the surface layer of the second preform body region and the film layer obtained after the second spray liquid is dried, while the remaining part of the second preform body region forms the aforementioned second body region.

[0046] The specific types of active substances in the second active enrichment region can be the same as or different from those in the second body region. That is, the specific types of active substances in the second spray liquid can be the same as or different from those in the second functional liquid. If the specific types of active substances in the second active enrichment region are different from those in the second body region, then the concentration of active groups in the second active enrichment region is greater than the concentration of active groups in the second body region.

[0047] In this embodiment, the second functional layer consists of a second body region containing active substances and a second active enrichment region. The concentration of active substances in the second active enrichment region is controlled to be greater than that in the second body region, thereby compensating for the loss of active substances caused by high-temperature drying and other processes during the preparation of the second body region. This results in a higher content of active substances in the final product, effectively meeting the needs of users. In addition, a second support layer and a load layer are covered on the surface of the second functional layer. These layers serve to support the functional liquid containing active substances during the preparation of the functional layer in processes such as coating. They also provide support for the functional layer, ensuring a certain degree of softness and firmness in the oral product, facilitating morphological stability during processing and use. Furthermore, they encapsulate and protect the active substances, reducing oxidation and dissipation during storage.

[0048] In some embodiments, the second support layer is a liquid-permeable layer, that is, the second support layer has water-permeable and water-locking functions, which can lock in some saliva and reduce the burning sensation in the throat and stomach.

[0049] In some implementations, the second support layer is a non-woven fabric layer, 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 to initiate a controlled release reaction.

[0050] In some embodiments, the second support layer is provided with an active substance. This active substance can be attached to the second support layer by means of molecular diffusion, adsorption, etc. When the second support layer is used as an interface for direct contact with the oral mucosa, it can quickly guide saliva to penetrate into the middle layer and initiate the controlled release reaction of the active substance, thereby reducing the burning sensation in the throat and stomach and improving the user experience.

[0051] In some embodiments, the aforementioned 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.

[0052] 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.

[0053] In some implementations, to meet various user needs, the active substance may include substances with specific medical properties, such as vitamins; the active substance may include substances with specific active properties, such as at least one of caffeine and caffeine derivatives, theophylline, capsaicin, etc.

[0054] This application provides a method for preparing a mouth-held product, such as... Figure 2 As shown, steps 101 to 103 are included: Step 101: Apply the first functional liquid to the first surface of the load layer and perform the first drying to form the first prefabricated body region; the first functional liquid includes a first activator and a first film-forming agent.

[0055] In this step, a first functional liquid, including a first film-forming agent and a first activator, is applied to the first surface of the load layer, and then sent to a drying device and dried in a waterproof manner such as by drying until the moisture content is less than or equal to 10 wt%, thereby forming the first prefabricated body area; the aforementioned drying device can be a drying oven, specifically such as a tunnel oven.

[0056] In this step, the first active agent is a substance that can provide a stimulating sensation through contact with saliva, and the first film-forming agent determines the mechanical strength, solubility, and drug diffusion rate of the oral product.

[0057] In some embodiments, the first active agent includes active agents with medical properties, such as cannabidiol (CBD), vitamins, nicotine, caffeine, and caffeine derivatives; in some embodiments, the active substance includes other active agents with specific properties, such as tea polyphenols and capsaicin.

[0058] In some embodiments, the first active agent 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.

[0059] The aforementioned primary activator can not only dissolve rapidly in the oral cavity to release the primary activator and help smokers alleviate withdrawal symptoms, but also achieve a long-lasting and continuous stimulating effect.

[0060] In some embodiments, the first 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 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 initial active substances, thereby meeting the user's immediate needs.

[0061] In this step, the load layer serves not only to support the first functional liquid, which includes the first active substance and the first film-forming agent, in the preparation process such as coating, to prepare the first preformed body region, but also to provide support for the first preformed body region, so that the oral product can maintain a certain degree of softness and rigidity, and facilitate the stability of its shape during processing and use.

[0062] In this step, the load layer can be waterproof or non-waterproof. When the load layer is waterproof, it prevents liquids such as saliva from passing through or only allows micro-permeability, thus preventing the active substance from seeping out into non-oral areas and ensuring that the drug is released specifically to the oral mucosa, thereby improving the user experience.

[0063] In some embodiments, the aforementioned load layer is a water-repellent fabric, the material of which includes at least one of polytetrafluoroethylene (PTFE), polyethylene terephthalate (PET), and polyvinyl alcohol (PVA), that is, the load layer can be a polytetrafluoroethylene film, a polyethylene terephthalate film, or a polyvinyl alcohol film.

[0064] In some embodiments, the aforementioned load layer is a nonwoven fabric, specifically a food-grade soluble nonwoven fabric. This nonwoven fabric can be a nonwoven fabric produced by spunbonded cellulose fibers or a hot-air spunbonded nonwoven fabric, possessing superior skin-friendly properties. This avoids irritation and discomfort to the oral mucosa caused by the permeable membrane itself, further enhancing the user experience. The nonwoven fabric material can be natural cellulose, synthetic cellulose, natural cotton, polyester, polypropylene, polyethylene terephthalate (PET), polyethylene (PE), etc.

[0065] In some embodiments, during the process of coating the first functional liquid onto the first surface of the load layer, the coating thickness is 0.6 mm to 1 mm, which can ensure that the active agent is within a better content range (e.g., 12 mg / tablet), ensure a better taste, and reduce the water content to less than 10 wt% within 15 minutes, thus avoiding affecting production efficiency.

[0066] In some embodiments, during the second drying process to form the first prefabricated body area, the drying temperature is 70°C to 90°C, for example, it can be one of 70°C, 75°C, 80°C, 85°C, 90°C or any range between two of them. Drying at the above temperature and wind speed can reduce the moisture content to less than 10 wt% within 15 minutes.

[0067] Step 102: Spray a first coating liquid onto the surface of the first prefabricated body area to form a first prefabricated functional layer, wherein the first coating liquid includes the second activator.

[0068] In this step, the first spraying liquid is a solution of the second surfactant, and its solvent can be water, ethanol, etc. The first surfactant, in solution form, is precisely sprayed onto the surface of the dried first prefabricated body area using a precision spraying device, avoiding the high-temperature drying process of the sprayed second surfactant, thus minimizing evaporation loss. Furthermore, the dosage control of the first surfactant during spraying is more precise, resulting in minimal differences in the first surfactant content between oral products. The precision spraying device can be a microfluidic or high-precision atomizing spraying device.

[0069] In this step, the first spray liquid sprayed onto the dried surface of the first preformed body area combines with the surface layer of the first preformed body area to form a preform of the first active enrichment area. The first active enrichment area can be formed through subsequent drying treatment, and the concentration of the surfactant in the first active enrichment area is greater than the concentration of the surfactant in the rest of the first preformed body area. The rest of the first preformed body area forms a preform of the first body area, which can be formed into the first body area through subsequent drying treatment. Therefore, the concentration of the surfactant in the first body area is less than the concentration of the surfactant in the first active enrichment area.

[0070] In some embodiments, the spraying process is carried out by an ultrasonic spraying system. Specifically, an ultrasonic nozzle can be used, with a nozzle height of 5-15cm, an ultrasonic frequency of 80-150kHz, a spraying angle of 75°-90°, a nozzle moving speed of 10-50cm / s, and an overlap rate of 20%-40%, which can uniformly spray the first spray liquid onto the dried surface of the first functional layer.

[0071] In some embodiments, the mass percentage of the second activator in the first spray liquid is 40% to 80%, which can effectively avoid excessive wetting of the functional layer caused by spraying, thus requiring a longer time or higher temperature to evaporate the solvent, and also avoids problems such as crystallization risk and nozzle clogging.

[0072] In some embodiments, the first spray liquid may also include flavoring agents such as sweeteners, cooling agents, salting agents, acidifying agents, and flavorings, which allows for flexible adjustment of the taste and flavor of the final product at the later stage of production without affecting the stability of the functional liquid.

[0073] Step 103: Cover the surface of the first prefabricated functional layer with a first support layer and perform a second drying treatment to obtain a mouth-held product, wherein the mouth-held product includes a first support layer, a first functional layer and a load layer stacked sequentially, the first functional layer includes an active agent, the first functional layer includes a first body region and a first active enrichment region, the active agent includes a first active agent and a second active agent, the first body region is formed by at least a portion of the structure of the first prefabricated body region, and the first functional layer is made of the first prefabricated functional layer.

[0074] In this step, the first support layer is a liquid-permeable layer with both liquid permeability and liquid-locking functions. Immediately after the first coating liquid is sprayed, the first support layer is covered and dried at low temperature to gently remove the solvent introduced during spraying and ensure a firm bond between the first support layer and the first functional layer. By covering the surface of the first pre-fabricated functional layer with the first support layer, the active agent is not only sealed between the load layer and the first support layer, but the first functional layer is also prevented from directly adhering to the application site. This reduces oral irritation when using soluble substances and makes it easier to move the oral product to the release position, avoiding excessive irritation. Furthermore, the first support layer has a water-locking function, which can lock in some saliva, reducing throat irritation and stomach burning sensation, thereby improving the user experience.

[0075] In some implementations, the first support layer is a non-woven fabric, which not only provides good water permeability and durability in moist environments such as the oral cavity, but also has excellent skin-friendly properties, preventing the bag itself from irritating or causing discomfort to the oral mucosa, thus further enhancing the user experience. The non-woven fabric can be made of natural cellulose, synthetic cellulose, polyethylene terephthalate (PET), polyethylene (PE), etc.

[0076] In some embodiments, the thickness of the first support layer is 100μm to 150μm, for example, it can be one of 100μm, 110μm, 120μm, 130μm, 140μm, 150μm or any value between two of them.

[0077] In some embodiments, during the second drying process of covering the surface of the first prefabricated functional layer with the first support layer, the drying temperature is 50°C to 60°C, for example, it can be one of 50°C, 55°C, 60°C or any value between two of them, so as to gently remove the solvent introduced during spraying and quickly reduce the moisture to less than 10 wt%, that is, the surface is free of adhesive penetration and not damp.

[0078] In this embodiment, a portion of the surfactant (first surfactant) is added to the interior of the first functional layer (first body region) by coating and drying with the first functional liquid. The other portion of the surfactant (second surfactant) is precisely sprayed onto the dried surface of the first prefabricated body region in the form of a spray after the first functional liquid is coated and dried. This avoids the externally sprayed second surfactant undergoing a high-temperature drying process, thereby reducing volatilization loss and resulting in a higher and more precise surfactant content in the final product, improving content uniformity and effectively meeting user needs. In addition, covering the surface of the first prefabricated functional layer with a first support layer can encapsulate and protect the externally sprayed surfactant, reducing oxidation and dissipation during storage.

[0079] In one embodiment, before spraying the first coating liquid onto the surface of the first prefabricated body area, the moisture content of the first prefabricated functional layer is measured and controlled to be less than 10 wt%, ensuring that the first prefabricated functional layer is in an optimal state to receive and fix the solution of the externally sprayed second activator, thereby ensuring the stability and consistency of product quality.

[0080] In one embodiment, the preparation method provided in this application, after covering the surface of the first prefabricated functional layer with a first support layer and performing a second drying treatment, further includes steps 104 to 106: Step 104: The second functional liquid is coated onto the second surface of the load layer and dried in the third step to form the second prefabricated body region; wherein, the second functional liquid includes a first active substance and a second film-forming agent, and the first surface and the second surface are disposed opposite to each other; Step 106: Cover the surface of the second prefabricated body area with a second permeable membrane and perform a fourth drying process.

[0081] In this embodiment, the second surface (back side) opposite to the first surface in the load layer is also coated and dried to form the second prefabricated body area, and then covered with the second support layer and dried again to form the second functional layer, thereby realizing that functional layers are set on both the front and back surfaces of the load layer, which can increase the overall loading of functional materials.

[0082] In step 104 above, the second functional layer is formed by coating the second functional liquid, which includes the second film-forming agent and the first active substance, onto the second surface of the load layer, and then sending it into a drying device and drying it in a waterproof manner such as drying until the moisture content is less than or equal to 10 wt%. The drying device can be a drying oven, specifically a tunnel oven.

[0083] In step 104 above, the first active substance is a substance that can provide a stimulating sensation through contact with saliva, and the second film-forming agent determines the mechanical strength, solubility and drug diffusion rate of the oral product.

[0084] In some embodiments, the first 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.

[0085] In some embodiments, the first 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.

[0086] In some embodiments, the first active substance includes at least one of caffeine and caffeine derivatives.

[0087] The aforementioned primary active substance can not only dissolve rapidly in the oral cavity to release the primary active substance and help smokers alleviate withdrawal symptoms, but also achieve a long-lasting and continuous stimulating effect.

[0088] In the embodiments of this application, the type of the first active agent in the first functional liquid may be the same as or different from the type of the first active substance in the second functional liquid, and the relative content of the first active agent in the first functional liquid may be the same as or different from the relative content of the second active substance in the first functional liquid.

[0089] The relative content of the first active agent in the first functional liquid refers to the mass fraction of the first active agent in the first functional liquid, and the relative content of the second active substance in the second functional liquid refers to the mass fraction of the first active substance in the second functional liquid.

[0090] In one embodiment, the type and / or relative content of the first surfactant in the first functional liquid differs from that of the first active substance in the second functional liquid. That is, the first surfactant in the first functional liquid is not entirely the same as the first active substance in the second functional liquid, which helps to enrich the user experience.

[0091] In this embodiment, by preparing two different functional liquids, the first functional layer and the second functional layer can be designed with different concentrations of nicotine, different types of active substances, or different flavors of membrane materials, thereby helping to enrich the user experience.

[0092] In some embodiments, the second 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 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 initial active substances, thereby meeting the user's immediate needs.

[0093] In some embodiments, during the process of coating the second functional liquid onto the second surface of the support layer, the coating thickness is 0.6 mm to 1 mm, which can ensure that the active substance is within a better content range (e.g., 12 mg / tablet), ensure a better taste, and reduce the water content to less than 10 wt% within 15 minutes, thus avoiding affecting production efficiency.

[0094] In some embodiments, during the fourth drying process to form the second functional layer, the drying temperature is 70°C to 90°C, for example, it can be one of 70°C, 75°C, 80°C, 85°C, 90°C or any range between two of them. Drying at the above temperature and wind speed can reduce the moisture content to less than 10 wt% within 15 minutes.

[0095] In some embodiments, the preparation method provided in this application, after step 104, further includes: Step 105: Spray a second spray liquid onto the surface of the second functional layer, the second spray liquid comprising the second active substance.

[0096] In step 105 above, the second spraying liquid is a solution of the second active substance, and its solvent can be water, ethanol, etc. The second active substance, in solution form, is precisely sprayed onto the surface of the dried second prefabricated body area using a precision spraying device in the form of a spray, avoiding the high-temperature drying process of the sprayed active substance, thereby minimizing volatilization loss. Furthermore, the dosage control of the second active substance during the spraying process is more precise, resulting in minimal differences in the content of the second active substance between oral products. The precision spraying device can be a microfluidic or high-precision atomizing spraying device.

[0097] In this embodiment, the second surface (back side) opposite the first surface in the load layer is also sequentially coated and dried to form a second prefabricated body area. Then, a second spray liquid containing the second active substance is sprayed onto the surface, followed by a second support layer and a fourth drying process. This process allows a portion of the active substance (the first active substance) to be added to the interior of the second functional layer through coating and drying with the second functional liquid. The remaining portion of the active substance (the second active substance) is precisely sprayed onto the dried surface of the second functional layer after coating and drying with the second functional liquid. This avoids the externally sprayed second active substance undergoing a high-temperature drying process, thus reducing evaporation loss and ensuring precise content and uniformity of the second active substance in the final product, effectively meeting user needs. Furthermore, covering the surface of the second functional layer with a second water-permeable membrane can encapsulate and protect the externally sprayed second active substance, reducing oxidation and dissipation during storage.

[0098] In this embodiment, the second spray liquid sprayed onto the dried surface of the second preform body region combines with the surface layer of the second preform body region to form a preform of the second active enrichment region. The second active enrichment region can be formed through subsequent drying treatment, and the concentration of active substances in the second active enrichment region is greater than the concentration of active substances in the remaining part of the second preform body region. The remaining part of the second preform body region forms a preform of the second body region, which can be formed through subsequent drying treatment. Therefore, the concentration of active substances in the second body region is less than the concentration of active substances in the second active enrichment region.

[0099] In some embodiments, the spraying process is carried out by an ultrasonic spraying system, specifically using an ultrasonic nozzle with a nozzle height of 5-15cm, an ultrasonic frequency of 80-150kHz, a spraying angle of 75°-90°, a nozzle moving speed of 10-50cm / s, and an overlap rate of 20%-40%, which can uniformly spray the second spray liquid onto the dried surface of the second functional layer.

[0100] In some embodiments, the mass percentage of the second active substance in the second spray liquid is 40% to 80%, which can effectively avoid excessive wetting of the functional layer caused by spraying, thus requiring a longer time or higher temperature to evaporate the solvent, and also avoids problems such as crystallization risk and nozzle clogging.

[0101] In some embodiments, the second spray liquid may also include flavoring agents such as sweeteners, cooling agents, salting agents, acidifying agents, and flavorings, which allows for flexible adjustment of the taste and flavor of the final product at the later stage of production without affecting the stability of the functional liquid.

[0102] In one embodiment, before spraying the second coating liquid onto the surface of the second functional layer, the moisture content of the second prefabricated body area is measured and controlled to be less than 10 wt%, ensuring that the second prefabricated body area is in an optimal state to receive and fix the solution of the externally sprayed second active substance, thereby ensuring the stability and consistency of product quality.

[0103] In step 106 above, the second permeable membrane is a liquid-permeable layer with both liquid permeability and liquid-locking functions. Immediately after spraying the second coating liquid, the surface of the second prefabricated body area is covered with the second support layer and dried at low temperature to gently remove the solvent introduced during spraying and to ensure a firm bond between the second support layer and the second functional layer. By covering the surface of the second functional layer with the second permeable membrane, not only is the second active substance sealed between the second functional layer and the second support layer, but the second functional layer is also prevented from directly adhering to the application site. This reduces oral irritation when using soluble substances and makes it easier to move the oral product to the release position, avoiding excessive irritation. Furthermore, the second support layer has a water-locking function, which can lock in some saliva, reducing throat irritation and stomach burning sensation, thereby improving the user experience.

[0104] In some embodiments, the second support layer is a non-woven fabric, which not only achieves good liquid permeability and durability in moist conditions such as the oral cavity, but also has excellent skin-friendly properties, preventing the bag itself from irritating or causing discomfort to the oral mucosa, thus further enhancing the user experience. The non-woven fabric can be made of natural cellulose, synthetic cellulose, polyethylene terephthalate (PET), polyethylene (PE), etc.

[0105] In some embodiments, the thickness of the second support layer is 100μm to 150μm, for example, it can be one of 100μm, 110μm, 120μm, 130μm, 140μm, 150μm or any value between two of them.

[0106] In some embodiments, during the fourth drying process of covering the surface of the second prefabricated body area with a second support layer, the drying temperature is 50°C to 60°C, for example, it can be one of 50°C, 55°C, 60°C or any value between two of them, so as to gently remove the solvent introduced during spraying and quickly reduce the moisture to less than 10 wt%, that is, the surface is free of adhesive penetration and not damp.

[0107] In one embodiment, the first functional liquid and the second functional liquid further independently include at least one of a flow aid, a plasticizer, a sugar alcohol filler, an antioxidant, a pH adjuster, and a flavoring agent to meet the user's personalized needs. That is, the first functional layer further includes at least one of a flow aid, a plasticizer, a sugar alcohol filler, an antioxidant, a pH adjuster, and a flavoring agent, and the second functional layer further includes at least one of a flow aid, a plasticizer, a sugar alcohol filler, an antioxidant, a pH adjuster, and a flavoring agent.

[0108] The flow aid includes at least one of silica, talc, dicalcium phosphate, tricalcium phosphate, microcrystalline cellulose, and magnesium stearate, which can effectively improve the flowability of various functional liquids. In the following embodiments, the flow aid can be silica, whose particles are extremely fine, have a huge specific surface area and a porous microstructure, and can be adsorbed on the surface of raw material particles such as nicotine salts, fillers, pH adjusters, etc., like tiny "ball bearings," reducing the friction and electrostatic forces between particles, thereby greatly improving the overall flowability of the powder.

[0109] 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. Sugar alcohol fillers can effectively fill the surface of active substances and fragrances, prolonging their duration of action. Sugar alcohol fillers can include substances such as xylitol, mannitol, lactitol, erythritol, isomaltitol, and sorbitol.

[0110] Antioxidants can effectively prevent the oxidation reaction of components; in some embodiments, antioxidants may include at least one of ethylparaben, trisodium citrate, sodium ascorbate, vitamin E, and tea polyphenols.

[0111] 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.

[0112] Flavoring agents include at least one of sweeteners, cooling agents, salting agents, acidulants, and flavorings.

[0113] 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.

[0114] 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.

[0115] 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.

[0116] 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.

[0117] In some embodiments, the first functional liquid and the second functional liquid also independently include a solvent, which includes at least one of water and ethanol.

[0118] In some embodiments, the first functional liquid and the second functional liquid independently comprise, by weight parts: 1-5 parts of active substance, 15-55 parts of film-forming agent, 1-5 parts of sugar alcohol filler, 3-10 parts of flow aid, 0.2-0.5 parts of antioxidant, 0.5-8 parts of cooling agent, 0.5-3 parts of flavoring, 0.5-2 parts of sweetener, 1-2 parts of pH adjuster, and 30-45 parts of solvent.

[0119] In some embodiments, the basic formulations of the first functional liquid and the second functional liquid are shown in Table 1 below.

[0120] Table 1

[0121] In some embodiments, the first and second spraying liquids, by weight, independently comprise: 40-80 parts of active substance, 5-25 parts of cooling agent, 10-30 parts of flavoring, and the remainder is solvent.

[0122] In some embodiments, the basic formulations of the first spraying liquid and the second spraying liquid are shown in Table 2 below.

[0123] Table 2

[0124] In this embodiment, after double-sided film coating is completed, standard processes such as curing, cutting, testing, and packaging are performed to obtain the final oral product.

[0125] This application also proposes an oral preparation, which is prepared by the above-described preparation method.

[0126] In some embodiments, the oral product may be in the form of a mouth pouch, oral dissolving film, tablet, or tearable strip.

[0127] 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.

[0128] 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.

[0129] The present application will be described in detail below through embodiments.

[0130] Test methods (1) Nicotine content test: According to the high performance liquid chromatography (HPLC) method in the Chinese Pharmacopoeia, 10 tablets of each sample were randomly selected, crushed, dissolved and diluted to a certain volume and then injected for analysis to determine the nicotine content.

[0131] (2) Content uniformity test: Calculate the relative standard deviation (RSD) of nicotine content in 10 samples.

[0132] (3) pH test: Dissolve one sample in 100mL of pure water, stir until completely dissolved, and measure the pH value of the solution using a precision pH meter.

[0133] (4) Nicotine dissolution test: The sample was placed in 900 mL of pH 6.8 phosphate buffer and the dissolution reaction was carried out at a temperature of 37±0.5°C and a rotation speed of 50 r / min. 5 mL samples were taken at 1 min, 3 min, 5 min, 10 min, 15 min and 20 min respectively and an equal amount of fresh phosphate buffer was added. The nicotine concentration was detected by high performance liquid chromatography and the cumulative release percentage was calculated.

[0134] (5) Taste test Subjective evaluation data on the product in terms of irritation, flavor intensity, and overall likability were assessed using a sensory evaluation scoring method (0-10 points), with 10 evaluators conducting blind testing and scoring. Each evaluator rinsed their mouth with water after tasting each sample, waited 5 minutes, and then tasted the next sample. They used a 5-minute linear scale (0-10 points) to score the samples, with higher scores indicating a better experience. Among them, the level of stimulation (0~10 points): the higher the score, the stronger the stimulation; Flavor intensity (0~10 points): The higher the score, the more intense the flavor; Overall liking level (0~10 points): The higher the score, the more you like it.

[0135] Examples 1-2 (1) Based on the formulation ratio in Table 3, PVA, polyvinyl alcohol, hydroxypropyl methylcellulose, soluble starch, mannitol, silicon dioxide, ethylparaben, WS-23, peppermint flavor, sucralose and sodium bicarbonate were dissolved in deionized water and stirred until completely dissolved and homogeneous. Nicotine was stirred evenly to form a uniform functional liquid. (2) Prepare the active substance solution based on the formulation ratio in Table 4; (3) The prepared film-forming liquid is evenly coated onto a sterile nonwoven fabric carrier using a precision coating machine to form a wet film as the first prefabricated body area; (4) The coated wet film is sent into a tunnel oven and dried at a set temperature of 80℃ and a wind speed of 2m / s to remove most of the moisture. (5) Test the moisture content of the dried film to ensure that its moisture content is reduced to <10 wt%; (6) Using an ultrasonic nozzle, the active substance solution is evenly sprayed onto the dried front film surface. The nozzle height is 10cm, the ultrasonic frequency is 120kHz, the spraying angle is 80°, the nozzle moving speed is 30cm / s, and the overlap rate is 30%.

[0136] (7) Immediately cover the wet film surface after spraying with another layer of non-woven fabric, and then perform a second drying at a low temperature of 55°C.

[0137] (8) Turn the above semi-finished product over and repeat steps (3) to (7) on its reverse side. (9) After completing the double-sided processing, standard procedures such as ripening, cutting, testing, and packaging are carried out to obtain the finished oral product.

[0138] Comparative Example 1 (1) Based on the formulation ratio in Table 3, PVA, polyvinyl alcohol, hydroxypropyl methylcellulose, soluble starch, mannitol, silicon dioxide, ethylparaben, WS-23, peppermint flavor, sucralose and sodium bicarbonate were dissolved in deionized water and stirred until completely dissolved and homogeneous. Nicotine was stirred evenly to form a uniform functional liquid. (2) The prepared film-forming solution is evenly coated onto a sterile nonwoven fabric carrier using a precision coating machine to form a wet film as the first prefabricated body area. (3) The coated wet film is placed in a tunnel oven and dried at a set temperature of 80℃ and a wind speed of 2m / s to reduce the moisture content to 20wt%; (4) Cover the film surface with another layer of nonwoven fabric, and then perform a second drying at a low temperature of 55°C.

[0139] (5) Turn the above semi-finished product over and repeat steps (2) to (4) on its reverse side. (6) After completing the double-sided processing, standard procedures such as ripening, cutting, testing, and packaging are carried out to obtain the finished oral product.

[0140] Table 3

[0141] Table 4

[0142] The oral products in Examples 1-2 and Comparative Example 1 were tested for nicotine content, content uniformity, and pH. The results are shown in Table 5.

[0143] Table 5

[0144] As shown in Table 5, the nicotine content of the oral products in Examples 1 and 2 is very close to the theoretical value (20 mg / g), and the RSD is less than 5%, indicating excellent uniformity. However, in Comparative Example 1, the nicotine content of the oral product was significantly lower than the theoretical value due to the large amount of nicotine volatilization caused by high-temperature drying, and the RSD was much higher than 10%, indicating unqualified uniformity. In addition, the oral products in Examples 1 and 2 and Comparative Example 1 are all alkaline, which is conducive to the absorption of nicotine in the oral cavity, and there is no significant difference.

[0145] The nicotine dissolution rate of the oral products in Examples 1-2 and Comparative Example 1 was tested, and the results are shown in Table 6.

[0146] Table 6

[0147] As can be seen from Table 6, the oral product in Example 1 exhibits explosive release, with a release rate as high as 65% in 1 minute, thanks to the high concentration of nicotine layer on its surface, which can produce a strong instantaneous stimulation. The oral product in Example 2 has a moderate release rate, combining the characteristics of rapid release and sustained release. In contrast, the oral product in Comparative Example 1 has the slowest release, with insufficient release in the early stage, making it difficult to meet the user's needs for rapid onset and stimulation.

[0148] Sensory evaluation tests were conducted on the oral products of Examples 1-2 and Comparative Example 1, and the results are shown in Table 7.

[0149] Table 7

[0150] As can be seen from Table 7, the oral product in Example 1 scored the highest in terms of irritation and flavor intensity, which is completely consistent with its design goal of high external spray ratio, and can provide a strong "hit-and-run" experience; Example 2 has a higher overall likability and a uniform and balanced taste; while the oral product in Comparative Example 1 has a bland taste and weak irritation.

[0151] In summary, the oral article provided in this application includes a first support layer, a first functional layer, and a load layer stacked sequentially. The first functional layer includes an active agent and comprises a first body region and a first active enrichment region. The first active enrichment region is located on the side of the first body region away from the load layer, and the concentration of the active agent in the first active enrichment region is greater than the concentration of the active agent in the first body region. Specifically, in this application embodiment, the first functional layer consists of a first body region containing the active agent and a first active enrichment region, and the concentration of the active agent in the first active enrichment region is controlled to be greater than the concentration of the active agent in the first body region. This compensates for the loss of active agent due to high-temperature drying and other processes during the preparation of the first body region, resulting in a higher active agent content in the final product, effectively meeting the user's needs.

[0152] 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.

[0153] 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 article includes a first support layer, a first functional layer, and a load layer stacked sequentially. The first functional layer contains an active agent and includes a first body region and a first active enrichment region. The first active enrichment region is located on the side of the first body region away from the load layer, and the concentration of the active agent in the first active enrichment region is greater than the concentration of the active agent in the first body region.

2. The oral article according to claim 1, characterized in that, The oral article further includes a second support layer and a second functional layer. The second functional layer includes an active substance and is disposed on the side of the load layer opposite to the first functional layer, and is located between the second support layer and the load layer.

3. The oral article according to claim 2, characterized in that, The second functional layer includes a second body region and a second active enrichment region. The second active enrichment region is located on the side of the second body region away from the load layer, and the concentration of the active substance in the second active enrichment region is greater than the concentration of the active substance in the second body region.

4. The oral article according to claim 2, characterized in that, The active substance is disposed on the second support layer; And / or, the second support layer is a liquid-permeable layer; And / or, the second support layer is a non-woven fabric layer; 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.

5. The oral article according to any one of claims 1 to 4, characterized in that, The surfactant is disposed on the first support layer; And / or, the first support layer is a liquid-permeable layer; And / or, the first support layer is a non-woven fabric layer; And / or, the active agent includes at least one of nicotine and nicotine derivatives; And / or, the active agent includes at least one of caffeine and caffeine derivatives; And / or, the water content of the oral product does not exceed 10 wt%.

6. A method for preparing a mouth-held product, characterized in that, The method for preparing the oral article as described in any one of claims 1 to 6 comprises: A first functional liquid is coated onto the first surface of a load layer and subjected to a first drying process to form a first prefabricated body region; the first functional liquid includes a first activator and a first film-forming agent. A first spraying liquid is sprayed onto the surface of the first prefabricated body area to form a first prefabricated functional layer, wherein the first spraying liquid includes the second activator; A first support layer is covered on the surface of the first prefabricated functional layer and a second drying treatment is performed to obtain a mouth-held product, wherein the mouth-held product includes a first support layer, a first functional layer and a load layer stacked sequentially, the first functional layer includes an active agent, the first functional layer includes a first body region and a first active enrichment region, the active agent includes a first active agent and a second active agent, the first body region is formed by at least a portion of the structure of the first prefabricated body region, and the first functional layer is made of the first prefabricated functional layer.

7. The preparation method according to claim 6, characterized in that, The moisture content of the first prefabricated body area does not exceed 10 wt%; And / or, the first functional liquid further includes at least one of the following: a flow aid, a plasticizer, a sugar alcohol filler, an antioxidant, a pH adjuster, and a flavoring agent; And / or, the first spray liquid further includes a flavoring agent; And / or, the content of the second surfactant in the first spraying liquid is 40wt%~80wt%; And / or, the surfactant is provided on the first support layer; And / or, the first support layer is a liquid-permeable layer; And / or, the first support layer is a non-woven fabric layer; And / or, the active agent includes at least one of nicotine and nicotine derivatives; And / or, the active agent includes at least one of caffeine and caffeine derivatives.

8. The preparation method according to claim 6 or 7, characterized in that, After covering the surface of the first prefabricated functional layer with a first support layer and performing a second drying treatment, the preparation method further includes: The second functional liquid is coated on the second surface of the load layer and then dried to form the second prefabricated body region; wherein the second functional liquid includes a first active substance and a second film-forming agent, and the first surface and the second surface are disposed opposite to each other; A second support layer is applied to the surface of the second prefabricated body area, followed by a fourth drying process.

9. The preparation method according to claim 8, characterized in that, Prior to covering the second support layer and performing the fourth drying process, the preparation method further includes: A second spraying liquid is sprayed onto the surface of the second prefabricated body area, the second spraying liquid comprising a second active substance.

10. The preparation method according to claim 9, characterized in that, The moisture content of the second prefabricated body area shall not exceed 10 wt%; And / or, the second functional liquid further includes at least one of the following: a flow aid, a plasticizer, a sugar alcohol filler, an antioxidant, a pH adjuster, and a flavoring agent; And / or, the second spray liquid further includes a flavoring agent; And / or, the content of the second active substance in the second spraying liquid is 40wt%~80wt%; And / or, the active substance is provided on the second support layer; And / or, the second support layer is a liquid-permeable layer; And / or, the second support layer is a non-woven fabric layer; 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.

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