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 functional layer, the functional layer comprises a film-forming base material and an active substance and an essence microcapsule dispersed in the film-forming base material, the wall material of the essence microcapsule comprises Arabic gum, the core material of the essence microcapsule comprises oil-soluble essence, and the oil-soluble essence is an oil-soluble essence. The volatile oil-soluble essence serving as the core material is wrapped in the microcapsule taking the Arabic gum as the wall material, and the volatile oil-soluble essence and the active substance are integrated into the functional layer, so that the essence can be slowly released by utilizing a compact wall material structure formed by the Arabic gum, and the essence can be continuously utilized to cover the peculiar smell of the active substance.

Description

Oral products and their preparation methods Technical Field

[0001] This application belongs to the field of food or pharmaceutical technology, and specifically relates to an oral product. Background Technology

[0002] Currently, smoking cessation typically involves using nicotine lozenges or other products containing active substances that alleviate cravings. These lozenges often contain nicotine and other active substances such as caffeine, which usually have a bitter taste, making it easy to cause discomfort when these active substances are released into the mouth.

[0003] To improve the natural bitterness of nicotine, existing oral products have added flavoring ingredients to mask the odor of nicotine and other active substances.

[0004] However, the flavoring in existing oral products is released too quickly, which can easily lead to insufficient flavor in the later stages and an inability to effectively mask the off-flavor of active substances, seriously affecting the user experience. Summary of the Invention

[0005] The technical problem to be solved by this application is to provide a mouth-held product and its preparation method, so as to improve the problem that the flavoring in existing mouth-held products is released too quickly and cannot continuously mask the odor of active substances.

[0006] To improve the above problems, this application is achieved through the following technical solution: This application proposes an oral article, which includes a functional layer, the functional layer including a film-forming substrate and active substances and fragrance microcapsules dispersed in the film-forming substrate, the wall material of the fragrance microcapsules including gum arabic, and the core material of the fragrance microcapsules including an oil-soluble fragrance.

[0007] Furthermore, in the oral product, the thickness of the wall material is 0.5μm~5μm; and / or, the mass percentage of the flavor microcapsules in the functional layer is 0.5%~8%; and / or, the particle size distribution range of the flavor microcapsules is less than 1; and / or, the flavor microcapsules are spray-granulated microcapsules; and / or, the mass ratio of gum arabic to oil-soluble flavor in the flavor microcapsules is (0.25~1):1.

[0008] Furthermore, in the oral product, the functional layer includes a first sub-functional layer and a second sub-functional layer, wherein at least one of the first sub-functional layer and the second sub-functional layer includes the flavor microcapsule.

[0009] Furthermore, in the oral product, an isolation layer is provided between the first sub-functional layer and the second sub-functional layer.

[0010] Furthermore, the oral article further includes a first support layer and a second support layer, with the functional layer disposed between the first support layer and the second support layer.

[0011] Furthermore, in the oral article, both the first support layer and the second support layer are permeable membranes; and / or, the first support layer and / or the second support layer are nonwoven fabric layers.

[0012] Furthermore, in the oral product, the functional layer further includes at least one of the following: filler, plasticizer, antioxidant, pH adjuster, sweetener, cooling agent, and thickener.

[0013] This application also proposes a method for preparing a mouth-held product, wherein the method for preparing the mouth-held product as described above includes: separately obtaining flavor microcapsules and a mixture containing active substances, wherein the wall material of the flavor microcapsules includes gum arabic and the core material of the flavor microcapsules includes an oil-soluble flavor; mixing the flavor microcapsules and the mixture to obtain a functional liquid; coating and drying the functional liquid to form a functional layer, thereby obtaining the mouth-held product.

[0014] Further, in the preparation method, the flavor microcapsules are prepared by the following method: dissolving a portion of the gum arabic in water to form an aqueous solution; adding the oil-soluble flavor to another portion of the gum arabic to form an oil solution; mixing the oil solution and the aqueous solution under shearing action and homogenizing and emulsifying to obtain an emulsion; spray-drying the emulsion to obtain the flavor microcapsules; obtaining a film-forming substrate, adding water to the film-forming substrate and swelling it into a colloid, and adding the active substance and the flavor microcapsules to the colloid to obtain a functional liquid; coating with the functional liquid to form a functional layer to obtain a lozenge.

[0015] Further, in the preparation method, the mass percentage of gum arabic in the aqueous solution is 10%~30%; and / or, the shear rate of the shearing action is 5000rpm~20000rpm; and / or, the pressure of the homogenization emulsification is 20MPa~60MPa; and / or, the inlet temperature of the spray drying is 160℃~180℃, and the outlet temperature is 70℃~90℃.

[0016] Compared with the prior art, the embodiments of this application have the following advantages: In the embodiments of this application, the oral article provided includes a functional layer, which includes a film-forming substrate and active substances and fragrance microcapsules dispersed in the film-forming substrate. The wall material of the fragrance microcapsules includes gum arabic, and the core material of the fragrance microcapsules includes an oil-soluble fragrance. Specifically, by encapsulating the volatile oil-soluble fragrance as a core material in microcapsules with gum arabic as the wall material, and integrating it with the active substances into the functional layer, the dense wall structure formed by gum arabic can be utilized to achieve slow release of the fragrance, thereby continuously masking the odor of the active substances with the fragrance.

[0017] 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

[0018] Figure 1 is a schematic diagram of the first structure of the oral product provided in the embodiments of this application; Figure 2 is a schematic diagram of the second structure of the oral product provided in the embodiments of this application; Figure 3 is a schematic diagram of the third structure of the oral product provided in the embodiments of this application; Figure 4 is a scanning electron microscope image of the water-in-oil type fine emulsion in Example 1; Figure 5 is a scanning electron microscope image of the microcapsule powder in Example 1. Detailed Implementation

[0019] 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.

[0020] 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.

[0021] The inventors discovered that in existing technologies, flavorings are added to oral products through simple blending to mask the taste. This results in the flavoring being released too quickly, which can lead to insufficient flavor in the later stages and an inability to effectively mask the off-flavors of active substances, seriously affecting the customer experience.

[0022] To address the aforementioned issues, as shown in Figure 1, this application provides an oral product 100 comprising a functional layer 10, the functional layer 10 comprising a film-forming substrate 101 and an active substance 102 and a fragrance microcapsule 103 dispersed in the film-forming substrate 101, the wall material of the fragrance microcapsule 103 comprising gum arabic and the core material of the fragrance microcapsule comprising an oil-soluble fragrance.

[0023] Among them, the active substance is a component that can help smokers alleviate withdrawal symptoms and can be directly absorbed through the oral mucosa.

[0024] In this embodiment, a volatile oil-soluble flavoring is encapsulated in a microcapsule with gum arabic as the wall material. The dense wall structure formed by gum arabic allows for the slow release of the flavoring, avoiding an "explosive" release upon ingestion and enabling the flavoring to continuously mask any off-flavors of the active ingredients. Furthermore, integrating the flavoring microcapsules and active ingredients into the functional layer further enables the targeted and slow release of the flavoring, resulting in a gentle, long-lasting, and stable flavor experience.

[0025] In some embodiments, the active substance in the functional layer 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.

[0026] 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.

[0027] 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 also include substances with specific active properties, such as caffeine, theophylline, capsaicin, etc.

[0028] In some embodiments, the film-forming substrate includes at least one of soluble starch, hydroxypropyl cellulose, hydroxypropyl methyl cellulose, 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 effectively disperse active substances and fragrance microcapsules, accelerate saliva penetration, and increase the release rate of active substances in the early stage, thereby meeting the user's immediate needs.

[0029] In some embodiments, the oil-soluble flavoring includes at least one of peppermint flavoring and fruit flavoring, which can effectively mask the odor caused by active substances such as nicotine, and also easily form microcapsule structures with gum arabic that have a narrow particle size distribution and extremely high stability.

[0030] In some implementations, the wall material thickness is 0.5μm to 5μm, which can effectively balance the release behavior of fragrance and processing performance.

[0031] In some embodiments, the particle size distribution span of the flavor microcapsules is less than 1, thereby forming microcapsule powder with a narrow particle size distribution and extremely high stability, achieving slow release of the flavor and avoiding the "explosive" release of the flavor upon ingestion. Optionally, the particle size distribution span of the flavor microcapsules is less than 0.5, resulting in better particle size uniformity and higher stability of the flavor microcapsules, enabling a longer-lasting release of the flavor.

[0032] In some embodiments, the mass ratio of gum arabic to oil-soluble fragrance in the fragrance microcapsule is (0.25~1):1, for example, it can be one of 0.25:1, 0.5:1, 1:1 or any two of them, so that gum arabic can effectively encapsulate the oil-soluble fragrance and form a fragrance microcapsule with a dense wall structure.

[0033] In some embodiments, the fragrance microcapsules are spray-granulated microcapsules, which can use spray to instantly dry droplets into solid powder, thus obtaining microcapsule powder with gum arabic as the wall material and encapsulating fragrance, making the wall material structure dense and intact, ensuring the continuous and slow release of fragrance.

[0034] In some implementations, the flavor microcapsules account for 0.5% to 8% of the mass of the functional layer. For example, they can be one or any two of the following values: 0.5%, 0.6%, 0.8%, 1.0%, 1.5%, 2.0%, 3.0%, 5.0%, and 8.0%. This balances the aroma and irritation, thereby ensuring a better taste.

[0035] In some embodiments, the functional layer further includes at least one of fillers, plasticizers, antioxidants, pH adjusters, sweeteners, cooling agents, flavorings, and thickeners, that is, the functional layer is made of active substances, film-forming substrates, pH adjusters, sweeteners, cooling agents, flavoring microcapsules, and thickeners.

[0036] Fillers can effectively fill the surface of active substances and fragrances, prolonging their duration of action. Fillers can include substances such as xylitol, mannitol, lactitol, erythritol, isomaltitol, and sorbitol.

[0037] Plasticizers can make the texture of the functional layer softer, thereby improving its solubility and moisture absorption in the mouth.

[0038] In some embodiments, the plasticizer includes at least one of glycerol, propylene glycol, and polyethylene glycol (PEG), which can promote the penetration of moisture into the interior of the film, thereby accelerating the initial wetting, disintegration, and dissolution of the functional layer in saliva.

[0039] Antioxidants such as ethylparaben, vitamin E acetate, and ascorbic acid can inhibit the oxidation of nicotine, vegetable oils, or flavorings, preventing rancidity, discoloration, or inactivation, slowing down component degradation, and maintaining product stability and flavor consistency.

[0040] 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.

[0041] 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.

[0042] 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 (WS-3), N-(ethoxycarbonylmethyl)-p-menthane-3-carboxamide (WS-5), (1R,2S,5R)-N-(4-methoxyphenyl)-5-methyl-2-(1-methylethyl)cyclohexaneformamide (WS-12), menthyl lactate, menthyl acetate, and menthone glycerol ketal.

[0043] 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.

[0044] In some embodiments, the sweeteners mentioned above include at least one of xylitol, sorbitol, mannitol, iodine, lactitol, maltitol, isomaltitol, hydrogenated starch hydrolysate, erythritol, maltotriol, aspartame, acesulfame potassium, sodium saccharin, sucralose, neotame, cyclamate, alitane, steviol glycosides, arabinitol, and monk fruit sweetener.

[0045] In some embodiments, the cooling agent 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.

[0046] Thickeners can construct a three-dimensional framework structure, effectively improving the texture and morphological stability of the functional layer, making the flavor more lasting, and allowing active substances to be slowly released in the throat. In some embodiments, thickeners include at least one of gelatin, pectin, carrageenan, starch, gum arabic, xanthan gum, gellan gum, sodium carboxymethyl cellulose, microcrystalline cellulose, and hydroxypropyl methylcellulose.

[0047] In some embodiments, the oral article further includes a solvent, which includes at least one of water and ethanol.

[0048] In some embodiments, the functional layer 10, by weight, includes: 1-5 parts of active substance, 25-55 parts of film-forming substrate, 0.5-3 parts of flavor microcapsules, 1-5 parts of filler, 3-10 parts of plasticizer, 1-2 parts of pH adjuster, 0.5-2 parts of sweetener, and 0.5-8 parts of cooling agent. Appropriate solvents may also be added to control the humidity or water content of the oral product according to taste requirements.

[0049] In some embodiments, functional layer 10 includes at least two sub-functional layers. In some embodiments, the formulations of the sub-functional layers may be the same; in other embodiments, the formulations may be different, specifically in terms of the type or concentration of active substances, the type or concentration of ion exchange resins, etc. In one embodiment, as shown in FIG2 or 3, functional layer 10 includes a first sub-functional layer 11 and a second sub-functional layer 12. The formulations of the first sub-functional layer 11 and the second sub-functional layer 12 are different, thereby independently regulating the release rate of active substances in the first sub-functional layer 11 and the second sub-functional layer 12, which can create multiple tastes and make the stimulating layers more distinct.

[0050] In some embodiments, functional layer 101 includes a first sub-functional layer 11 and a second sub-functional layer 12, wherein at least one of the first sub-functional layer 11 and the second sub-functional layer 12 includes a fragrance microcapsule.

[0051] In this embodiment, flavor microcapsules and active substances are integrated into at least one sub-functional layer, which can not only create multiple tastes and make the irritation levels more distinct, but also achieve the directional and slow release of flavor, thereby bringing a mild, long-lasting and stable flavor experience.

[0052] In some embodiments, an isolation layer 20 is provided between the first sub-functional layer 11 and the second sub-functional layer 12, forming a stacked article structure of the first sub-functional layer 11-isolation layer 20-second sub-functional layer 12.

[0053] In this embodiment, the isolation layer has a waterproof function, preventing liquids such as saliva from passing through; by placing the isolation layer between the first sub-functional layer 11 and the second sub-functional layer 12 containing active substances, the interaction between the first sub-functional layer 11 and the second sub-functional layer 12 can be reduced, thereby improving stability.

[0054] In some embodiments, the isolation layer is set as a water-repellent cloth or release film, which can prevent the first sub-functional layer 11 and the second sub-functional layer 12 on both sides from reacting with each other, and also helps to prevent the collapse of the double-layer structure and maintain the clear distinction between the first sub-functional layer 11 and the second sub-functional layer 12.

[0055] In some embodiments, as shown in FIG3, the oral article further includes a first support layer 31 and a second support layer 32, and a functional layer is disposed between the first support layer 31 and the second support layer 32. That is, the oral article in the embodiments of this application is a multi-layer structure consisting of the first support layer 31, the functional layer 10 and the second support layer 32 stacked in sequence. The functional layer can be a single layer or a multi-layer structure.

[0056] In some embodiments, the second support layer 32 is waterproof, preventing liquids such as saliva from passing through or allowing only micro-permeability; the first support layer is permeable and water-locking, able to lock in some saliva, reducing the burning sensation in the throat and stomach.

[0057] In this embodiment, the functional layer 10 is disposed between the first support layer 31 and the second support layer 32. The first support layer can be used as the interface for direct contact with the oral mucosa, which can avoid the active substances from directly irritating the oral cavity. At the same time, it guides saliva to penetrate into the middle layer, initiates the controlled release reaction, reduces the burning sensation in the throat and stomach, and thus improves the user experience.

[0058] In some embodiments, the thickness of the functional layer 12 is controlled between 0.1 mm and 0.8 mm, so that the content of the active substances it carries is appropriate and the taste is pleasant when used. Optionally, the thickness of the functional layer can be one or more of the range of 0.1 mm, 0.2 mm, 0.3 mm, 0.5 mm, and 0.8 mm, or a range between any two of them.

[0059] In some embodiments, the first support layer is a water-permeable membrane, which not only improves wearing comfort and prevents bitter components from directly irritating the oral cavity, but also guides saliva to penetrate into the internal functional layer to initiate a controlled-release reaction. In addition, the first support layer has a water-locking function, which can lock in some saliva and reduce the burning sensation in the throat and stomach.

[0060] In some embodiments, the first support layer can be formed by creating openings in an impermeable membrane.

[0061] In some embodiments, 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.

[0062] In some embodiments, the first support layer is a water-permeable membrane and a hydrophilic membrane layer, which makes the first support layer hydrophilic and biocompatible, suitable as an interface for direct contact with the oral mucosa, effectively improving wearing comfort.

[0063] In some embodiments, 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.

[0064] In some embodiments, both the first and second support layers are waterproof membranes, which can effectively prevent moisture evaporation from the functional layers as protective films. The waterproof membrane can be made of at least one of polyvinyl chloride (PVC), polyurethane, and polytetrafluoroethylene. These materials have good film-forming properties and biological stability, and can be tightly bonded to the functional layers through processes such as coating or calendering.

[0065] In some embodiments, both the first support layer and the second support layer are water-permeable membranes, which can achieve bidirectional release of active substances without directly irritating the oral cavity with bitter components.

[0066] In some embodiments, the aforementioned permeable membrane includes a hydrophilic nonwoven fabric, which can effectively improve wearing comfort, prevent bitter components from directly irritating the oral cavity, and guide saliva to penetrate into the internal functional layer to initiate a controlled-release reaction.

[0067] In some embodiments, the aforementioned nonwoven fabric is a food-grade soluble nonwoven fabric, which can be a nonwoven fabric made by spunbonded cellulose or a hot-air spunbonded nonwoven fabric. It has better skin-friendly properties, avoiding irritation and discomfort to the oral mucosa caused by the first support layer itself, thus further improving the user experience. The material of the nonwoven fabric can be natural cellulose, synthetic cellulose, natural cotton, polyester, polypropylene, polyethylene terephthalate (PET), polyethylene (PE), etc.

[0068] This application embodiment also provides a method for preparing a mouth-held product, which is used to prepare the mouth-held product as described above. The preparation method includes steps 201 to 203: Step 201: Obtaining flavor microcapsules and a mixture containing active substances, wherein the wall material of the flavor microcapsules includes gum arabic and the core material of the flavor microcapsules includes oil-soluble flavor; Step 202: Mixing the flavor microcapsules and the mixture to obtain a functional liquid; Step 203: Coating and drying the functional liquid to form a functional layer, thereby obtaining the mouth-held product.

[0069] In this embodiment, flavor microcapsules with gum arabic as the wall material and oil-soluble flavoring as the core material are first obtained, along with a mixture containing active substances. The two are then mixed evenly by stirring and other methods, coated, and dried to form a functional layer, thereby producing a mouth-held product. This allows for the slow release of flavoring in the mouth-held product, avoiding the "explosive" release of flavoring upon ingestion, and enabling the flavoring to continuously mask the odor of the active substances. Furthermore, integrating the flavor microcapsules and active substances into the functional layer further enables the directional and slow release of flavoring, resulting in a mild, long-lasting, and stable flavor experience.

[0070] In some embodiments, during the process of mixing the fragrance microcapsules with the mixture to obtain the functional liquid, the mixture can be stirred evenly at a speed of less than 5000 rbm, for example, 3000 rbm to 4500 rbm. This can quickly mix the fragrance microcapsules with the mixture while preventing the microcapsules from breaking due to stirring.

[0071] In some embodiments, the flavor microcapsules are prepared by the following method: Step 211, dissolving a portion of the gum arabic in water to form an aqueous solution; Step 212, adding the oil-soluble flavor to another portion of the gum arabic to form an oil solution; Step 213, mixing the oil solution and the aqueous solution under shear and homogenizing and emulsifying to obtain an emulsion; Step 214, spray-drying the emulsion to obtain the flavor microcapsules.

[0072] In this embodiment, the aqueous solution of gum arabic is first mixed with the oil-phase solution of oil-soluble fragrance using shearing action, followed by high-pressure homogenization for emulsification, resulting in fine and uniformly distributed emulsion droplets. Then, spray drying is performed to form fragrance microcapsules with dense wall material. These fragrance microcapsules and active substances are added to a colloid swollen by a film-forming substrate to create a functional layer and form a mouth-held product. This achieves slow release of the fragrance, avoiding an "explosive" release of the fragrance upon ingestion, and allows the fragrance to continuously mask any off-flavors of the active substances. Furthermore, integrating the fragrance microcapsules and active substances into the functional layer further enables directional and slow release of the fragrance, resulting in a mild, long-lasting, and stable flavor experience.

[0073] In some embodiments, during the process of dissolving a portion of gum arabic in water to form an aqueous solution, heating at 50°C to 60°C can effectively accelerate the dissolution without damaging the gum arabic structure, resulting in a clear and homogeneous aqueous solution.

[0074] In some embodiments, the mass percentage of gum arabic in the aqueous solution is 10% to 30%, for example, it can be one of 10%, 20%, 30% or any two of them, which can ensure effective emulsification and system stability.

[0075] In some embodiments, the shear rate of the shearing action is 8000 rpm to 15000 rpm, for example, it can be one or any two of 8000 rpm, 10000 rpm, 12000 rpm, 15000 rpm, which can effectively disperse the oil phase and form a basically stable crude emulsion system that is easy to follow up with high-pressure homogenization, while avoiding a sharp rise in emulsion temperature and the introduction of a large number of bubbles.

[0076] In some embodiments, the homogenization emulsification pressure is 20 MPa to 60 MPa, for example, it can be one or any two of 20 MPa, 30 MPa, 40 MPa, 50 MPa, and 60 MPa. This can effectively reduce the droplet size without compromising the stability of the emulsion, forming a water-in-oil (O / W) type fine emulsion with a narrow particle size distribution and extremely high stability.

[0077] In some embodiments, the inlet temperature of the spray dryer is 160°C to 180°C, and the outlet temperature is 70°C to 90°C, which can instantly dry droplets into solid powder, thus obtaining microcapsule powder containing fragrance with gum arabic as the wall material. In some embodiments, the inlet temperature of the spray dryer can be one or more of 160°C, 170°C, and 180°C, or any two of them, and the outlet temperature can be one or more of 70°C, 80°C, and 90°C, or any two of them.

[0078] In some embodiments, the functional liquid comprises, by weight, 1-5 parts of active substance, 25-55 parts of film-forming substrate, 0.5-3 parts of fragrance microcapsules, 1-5 parts of filler, 3-10 parts of plasticizer, 1-2 parts of pH adjuster, 0.5-2 parts of sweetener, 0.5-8 parts of cooling agent, and solvent.

[0079] In some embodiments, in step 203 above, the functional liquid can be coated onto the first support layer, and after drying to form the functional layer, a second support layer is covered with the surface of the functional layer to obtain a mouth-held product.

[0080] In some embodiments, the drying temperature is 55°C to 65°C, for example, it can be a range of one or any two of 55°C, 56°C, 58°C, 60°C, 62°C, and 65°C.

[0081] In some embodiments, the oral product can be prepared by the following process steps: (1) Aqueous phase preparation: Selected gum arabic powder is slowly added to a certain amount of deionized water under continuous stirring, and moderately heated (e.g., 50~60°C) to accelerate dissolution and form a clear and homogeneous aqueous solution.

[0082] (2) Preparation of oil phase: Mix the selected oil-soluble fragrance (such as peppermint oil, fruit fragrance) with gum arabic, heat slightly and stir to form a homogeneous oil phase solution.

[0083] (3) Preparation of crude emulsion: Under high-speed shearing (e.g., 10,000 rpm) stirring, the oil phase solution is slowly and dropwise added to the aqueous phase solution to form a crude emulsion.

[0084] (4) High-pressure homogenization: The crude emulsion is transferred to a high-pressure homogenizer and homogenized in a cycle (2 to 4 times) under a specific pressure (20 MPa to 60 MPa) to form a water-in-oil (O / W) type fine emulsion with a narrow particle size distribution and extremely high stability.

[0085] (5) High-pressure homogenization: The fine emulsion is dried by spray drying tower to obtain microcapsule powder with gum arabic as wall material and fragrance encapsulated; wherein the inlet temperature is controlled at 160°C~180°C and the outlet temperature is controlled at 70°C~90°C.

[0086] (6) Assembly of oral products: a. Preparation of functional liquid: Dissolve nicotine, film-forming substrate, plasticizer, sweetener, etc. in water, then add the prepared microcapsule powder, and stir and disperse evenly at 3000 rpm; b. Coating and drying: Coat the functional liquid onto the release film and dry it to form a drug-loaded film; c. Lamination: Cover the two drug-loaded films on the top and bottom sides of the water-repellent cloth respectively, press them together lightly, and finally cover with the outer protective film; d. Slitting: Cut into tablets of the predetermined shape and size.

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

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

[0089] Test methods (1) Physicochemical tests 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 before being injected for analysis to determine the nicotine content; Nicotine content uniformity test: The relative standard deviation (RSD) of the content of 10 tablets was calculated.

[0090] pH test: Dissolve the sample in 100mL of pure water, stir until completely dissolved, and measure the pH value of the solution using a precision pH meter.

[0091] Microstructure testing: Scanning electron microscopy (SEM) was used to observe the surface and cross-section of the sample film.

[0092] (2) Flavor dissolution and stability tests simulated the release behavior of oral products in the oral cavity to examine the release rate and release curve of flavor: The sample was placed in a dissolution tester (paddle method) with 900 mL of pH 6.8 phosphate buffer (simulating saliva) as the dissolution medium. The temperature was maintained at 37±0.5°C and the rotation speed was 50 rpm (simulating slight oral movement). 5 mL samples were taken at 1, 3, 5, 10, 15, and 20 minutes (5 mL of fresh medium was added at the same time). After filtration, the menthol in the sample was determined by HPLC, and the cumulative release percentage was calculated.

[0093] (3) Taste evaluation: Subjective evaluation data of the product in terms of odor intensity, aroma intensity and overall acceptability were obtained by sensory evaluation scoring method (0-10 points). Subjects placed the sample under their tongue or cheek and scored it blindly at set time points (0-2 minutes, 2-5 minutes, 5-10 minutes, 10-20 minutes, 20-30 minutes). The scoring was based on a 10-point scale, with 1 being the worst and 10 being the best. The lower the score in the odor intensity dimension, the more obvious the odor. The higher the score in the aroma intensity dimension, the more intense the aroma.

[0094] Example 1 (1) Aqueous phase preparation: A portion of selected gum arabic powder was slowly added to deionized water under continuous stirring and heated to 55°C to dissolve, forming a clear and homogeneous aqueous solution; wherein, the mass concentration of gum arabic was controlled to be 20%.

[0095] (2) Preparation of oil phase: Mix peppermint essence with another part of gum arabic, heat slightly and stir to form a homogeneous oil phase solution.

[0096] (3) Preparation of crude emulsion: Under high-speed shearing and stirring at 10,000 rpm, the oil phase solution is slowly and dropwise added to the aqueous phase solution to form a crude emulsion.

[0097] (4) High-pressure homogenization: The crude emulsion is transferred to a high-pressure homogenizer and homogenized three times under a specific pressure of 40 MPa to form a water-in-oil (O / W) type fine emulsion with a narrow particle size distribution and extremely high stability.

[0098] (5) High-pressure homogenization: The fine emulsion is dried by spray drying tower to obtain microcapsule powder with gum arabic as wall material and fragrance encapsulated; wherein the inlet temperature is controlled at 170°C and the outlet temperature is controlled at 80°C.

[0099] (6) Assembly of oral products: a. Preparation of functional liquid: By weight, add 20 parts polyvinyl alcohol, 16 parts hydroxypropyl methylcellulose, 6 parts soluble starch, 3 parts mannitol, 6 parts glycerol, 0.3 parts ethylparaben, 2 parts N,2,3-trimethyl-2-isopropylbutyramide, 1 part sucralose, 1.7 parts sodium bicarbonate and 3 parts nicotine to 40 parts deionized water, then add 1 part of the prepared microcapsule powder, and stir and disperse evenly at 3000 rpm; b. Coating and drying: Coat the functional liquid onto the release film and dry to form a drug-loaded film; c. Lamination: Apply the two drug-loaded films to the top and bottom of the water-repellent cloth respectively, press lightly to adhere, and finally cover with the outer protective film; d. Slitting: Cut into tablets of the predetermined shape and size to obtain oral products.

[0100] Comparative Example 1: Assembly of the oral product: a. Preparation of the functional liquid: By weight, add 20 parts polyvinyl alcohol, 16 parts hydroxypropyl methylcellulose, 6 parts soluble starch, 3 parts mannitol, 6 parts glycerin, 0.3 parts ethylparaben, 2 parts N,2,3-trimethyl-2-isopropylbutyramide, 1 part sucralose, 1.7 parts sodium bicarbonate, and 3 parts nicotine to 40 parts deionized water, then add 1 part peppermint flavoring, and stir at low speed to disperse evenly; b. Coating and drying: Coat the functional liquid onto a release film and dry to form a drug-loaded film; c. Lamination: Apply the two drug-loaded films to the top and bottom of the water-repellent cloth respectively, press lightly to adhere, and finally cover with an outer protective film; d. Slitting: Cut into tablets of predetermined shape and size to obtain the oral product.

[0101] The water-in-oil fine emulsion and microcapsule powder in Example 1 were observed by scanning electron microscopy, and the results are shown in Figures 4 and 5, respectively.

[0102] Physicochemical tests were conducted on the oral products in the examples and comparative examples, and the test results are shown in Table 1.

[0103] Table 1

[0104] As can be seen from Table 1, the formulation of this application can form a film of uniform thickness, indicating that the addition of microcapsules has no adverse effect on the basic coating process and has good processing adaptability.

[0105] The flavor dissolution and flavor stability of the oral products in the examples and comparative examples were tested, and the test results are shown in Table 2.

[0106] Table 2

[0107] As can be seen from Table 2, the flavoring in the oral product prepared in Comparative Example 1 was released rapidly within 5 minutes, with a release rate of over 80%, and then entered a plateau period, indicating that the flavoring was released almost completely in the initial stage of ingestion; while the flavoring in the oral product prepared in Example 1 of this invention exhibited typical slow-release characteristics, with slow initial release (only 25% released in the first 10 minutes), followed by stable and continuous release, and basically complete release within 60 minutes, which can effectively delay the release of flavoring and achieve long-lasting fragrance.

[0108] Sensory evaluation tests were conducted on the oral products in the examples and comparative examples, and the test results are shown in Table 3.

[0109] Table 3

[0110] As can be seen from Table 3, the aroma of the oral product in Comparative Example 1 was too strong (even pungent) when it was ingested, but it quickly faded. After 5 minutes, the aroma intensity dropped sharply, the nicotine odor became prominent, and the overall acceptability was extremely poor. In contrast, the aroma of the oral product in Comparative Example 1 was moderate when it was ingested and remained stable throughout the 30-minute use process. It could effectively and continuously mask the nicotine odor, and the overall acceptability remained at a high level.

[0111] In summary, the oral product and preparation method provided in this application embodiment encapsulate a volatile oil-soluble fragrance as the core material in a microcapsule with gum arabic as the wall material, and integrates it with the active substance into the functional layer. The dense wall material structure formed by gum arabic can be used to achieve slow release of the fragrance, thereby continuously using the fragrance to mask the odor of the active substance.

[0112] 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.

[0113] 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 invention includes a functional layer comprising a film-forming substrate and active substances and fragrance microcapsules dispersed in the film-forming substrate. The wall material of the fragrance microcapsules includes gum arabic, and the core material of the fragrance microcapsules includes an oil-soluble fragrance.

2. The oral article according to claim 1, characterized in that, The wall material has a thickness of 0.5 μm to 5 μm; and / or, the flavor microcapsules account for 0.5% to 8% of the mass of the functional layer; and / or, the particle size distribution of the flavor microcapsules has a range of less than 1; and / or, the flavor microcapsules are spray-granulated microcapsules; and / or, the mass ratio of gum arabic to oil-soluble flavor in the flavor microcapsules is (0.25 to 1):

1.

3. The oral article according to claim 1, characterized in that, The functional layer includes a first sub-functional layer and a second sub-functional layer, wherein at least one of the first sub-functional layer and the second sub-functional layer includes the flavor microcapsule.

4. The oral article according to claim 3, characterized in that, An isolation layer is also provided between the first sub-functional layer and the second sub-functional layer.

5. The oral article according to claim 1, characterized in that, The oral article further includes a first support layer and a second support layer, and the functional layer is disposed between the first support layer and the second support layer.

6. The oral article according to claim 5, characterized in that, The first support layer and / or the second support layer are permeable membranes; and / or, the first support layer and / or the second support layer are nonwoven fabric layers.

7. The oral article according to any one of claims 1 to 6, characterized in that, The functional layer also includes at least one of the following: filler, plasticizer, antioxidant, pH adjuster, sweetener, cooling agent, and thickener.

8. A method for preparing a mouth-held product, characterized in that, The method for preparing the oral product according to any one of claims 1 to 7 comprises: obtaining flavor microcapsules and a mixture containing active substances, wherein the wall material of the flavor microcapsules comprises gum arabic and the core material of the flavor microcapsules comprises an oil-soluble flavor; mixing the flavor microcapsules and the mixture to obtain a functional liquid; coating and drying the functional liquid to form a functional layer, thereby obtaining the oral product.

9. The preparation method according to claim 8, characterized in that, The flavor microcapsules are prepared by the following method: dissolving a portion of the gum arabic in water to form an aqueous solution; adding the oil-soluble flavor to another portion of the gum arabic to form an oil solution; mixing the oil solution and the aqueous solution under shearing and homogenizing emulsification to obtain an emulsion; and spray drying the emulsion to obtain the flavor microcapsules.

10. The preparation method according to claim 9, characterized in that, The mass percentage of gum arabic in the aqueous solution is 10% to 30%; and / or, the shear rate of the shearing action is 8000 rpm to 15000 rpm; and / or, the pressure of the homogenization emulsification is 20 MPa to 60 MPa; and / or, the inlet temperature of the spray drying is 160℃ to 180℃, and the outlet temperature is 70℃ to 90℃.

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