Buccal product

Abstract

The invention discloses a buccal product, and relates to the technical field of food. The buccal product comprises a supporting layer, a functional layer and a disintegrating layer which are arranged in sequence, wherein the supporting layer is insoluble, the functional layer comprises an active agent, and the disintegration speed of the disintegration layer is higher than that of the functional layer. According to the embodiment of the invention, the supporting layer has insolubility and can slow down the speed of saliva permeating to the functional layer through the supporting layer, so that the release rate of the surfactant on the side, close to the disintegrating layer, in the functional layer is higher than that of the surfactant on the side, close to the supporting layer, in the functional layer, and long-acting slow release of the active agent is realized; the long-acting active agent satisfaction is provided for a user, and the buccal experience of the buccal product is improved; the disintegration speed of the disintegration layer is higher than that of the functional layer, and the disintegration layer is rapidly disintegrated and released in the buccal process, so that the irritation of the active agent is reduced, and the taste of the buccal product is improved.

Description

Technical Field

[0001] The present application relates to the field of food technology, and in particular to an oral product. Background Art

[0002] Oral preparations, as a dosage form that can dissolve in the mouth and release active ingredients, are widely used in oral care, nutritional supplements, and tobacco substitutes.

[0003] In the related art, oral products are mostly single-layer structures or bag-packed structures. The simple structure not only makes the release rate of the active ingredient poorly controllable, but also leads to a simple oral experience of the oral product. Summary of the Invention

[0004] The present application provides an oral product for solving the problems of the oral products in the related art such as single oral experience and poor taste.

[0005] In order to solve the above technical problems, the present application provides an oral product, which includes a support layer, a functional layer and a disintegration layer arranged in sequence; wherein, the support layer is insoluble, the functional layer includes an active agent, and the disintegration rate of the disintegration layer is greater than the disintegration rate of the functional layer.

[0006] In one embodiment, the oral product further includes a sustained-release regulating layer, which is disposed between the disintegrating layer and the functional layer, and the disintegration rate of the disintegrating layer is greater than the disintegration rate of the sustained-release regulating layer.

[0007] In one embodiment, the sustained-release regulating layer includes a first film-forming agent, and the sustained-release regulating layer further includes at least one of a controlled-release agent, a pH regulator, and an auxiliary regulator.

[0008] In one embodiment, the sustained-release regulating layer includes at least two sub-regulating layers; and / or the sustained-release regulating layer has a thickness of 0.2 mm to 0.5 mm; and / or the first film-forming agent includes at least one of hydroxypropyl methylcellulose, gum arabic, sodium alginate and gelatin; and / or the controlled-release agent includes at least one of cross-linked sodium carboxymethyl cellulose, sodium carboxymethyl starch, low-substituted hydroxypropyl cellulose, lactose and mannitol; and / or the auxiliary regulating agent includes at least one of a flavoring agent and a flavoring agent; and / or the auxiliary regulating agent includes at least one of tea polyphenols, menthol, ginger extract, eucalyptus extract, turmeric extract, licorice extract, inulin, anthocyanin, lycopene, sunflower seed lecithin, rosemary extract, rose extract, matcha powder, cinnamon extract, acacia resin extract, whey protein, fish oil extract, beeswax, honey, royal jelly, amylase, lactic acid bacteria fermentation product, red yeast rice, astaxanthin, spirulina powder, fish collagen peptide, shiitake mushroom extract and vanilla pod extract.

[0009] In one embodiment, the oral product further comprises a composite sustained-release membrane; wherein the composite sustained-release membrane is at least partially disposed between the functional layer and the disintegrating layer to control the release rate of the active agent.

[0010] In one embodiment, the composite sustained-release membrane is selected from at least one of sodium alginate-chitosan composite membrane, artemisia seaweed crude polysaccharide-chitosan composite membrane, regenerated cellulose-polyvinyl alcohol-chitosan-titanium dioxide composite membrane, regenerated silk fibroin-carboxymethyl chitosan composite membrane, silk fibroin-chitosan composite membrane, sodium lactate-chitosan composite membrane, pectin-chitosan composite membrane and tea polyphenol-chitosan composite membrane; and / or the thickness of the composite sustained-release membrane is 80 μm to 150 μm.

[0011] In one embodiment, the support layer includes a second film-forming agent, and the support layer also includes at least one of a structural stabilizer and a filler; and / or, the functional layer also includes at least one of a sustained-release substrate, a humectant, a carrier and a fluidity improver; and / or, the disintegration layer includes a third film-forming agent, and the disintegration layer also includes at least one of a binder, a flavoring agent, a seasoning, a pH adjuster and a humectant.

[0012] In one embodiment, the second film-forming agent includes at least one of polyvinyl butyral, ethyl cellulose, cellulose acetate and starch; and / or, the third film-forming agent includes at least one of modified chitosan, hydroxypropyl methylcellulose, hydroxypropyl cellulose, sodium carboxymethyl starch, sodium alginate, polysorbate and micro-powdered silica gel; and / or, the structural stabilizer includes at least one of polyvinyl pyrrolidone, ethylene-vinyl acetate copolymer, hydroxypropyl methylcellulose, sodium carboxymethyl cellulose, polyacrylic acid resin, triacetin, diethyl phthalate and glycerol; and / or, the filler includes microcrystalline cellulose, ethyl cellulose, micro-powdered silica gel, calcium phosphate, calcium sulfate, slip At least one of stone powder, calcium carbonate, hydroxyapatite and starch; and / or, the active agent includes at least one of nicotine and nicotine derivatives; and / or, the sustained-release matrix includes at least one of hypromellose, hydroxypropyl cellulose and polyvinyl resin; and / or, the humectant includes at least one of glycerol, propylene glycol, sorbitol, sodium alginate, chitosan, starch, starch derivatives, polysorbate and sucrose fatty acid ester; and / or, the carrier includes at least one of microcrystalline cellulose, starch and cyclodextrins; and / or, the flowability improver includes at least one of silicon dioxide, talc, magnesium stearate, microcrystalline cellulose, starch and anhydrous lactose.

[0013] In one embodiment, the thickness of the support layer is 0.2 mm to 0.5 mm; and / or the thickness of the functional layer is 0.5 mm to 1.5 mm; and / or the thickness of the disintegration layer is 0.1 mm to 0.3 mm; and / or the thickness of the oral product is 1 mm to 3 mm.

[0014] In one embodiment, a marking structure and / or an anti-slip structure is provided on a surface of the support layer that is away from the functional layer.

[0015] The oral product provided in the present application includes a support layer, a functional layer, and a disintegrating layer arranged in sequence. The support layer is insoluble and can slow down the rate at which saliva penetrates the support layer into the functional layer, so that the release rate of the surfactant on the side of the functional layer near the disintegrating layer is greater than the release rate of the surfactant on the side of the functional layer near the support layer. This is beneficial for improving the effect of the active agent on the target site in the oral cavity, improving bioavailability, and thereby improving the user's satisfaction with the active agent. Moreover, the release rate of the surfactant on the side of the functional layer near the disintegrating layer is greater than the release rate of the surfactant on the side of the functional layer near the support layer. This can also slow down the disintegration rate of the functional layer, which is beneficial for extending the duration of action of the active agent in the functional layer, achieving long-term sustained release of the active agent, providing the user with long-term satisfaction with the active agent, and improving the oral experience of the oral product. Furthermore, the disintegration rate of the disintegrating layer is greater than the disintegration rate of the functional layer. During the oral confinement process, the disintegrating layer quickly disintegrates and releases, which can regulate the oral microenvironment, help mask the bitterness of the active agent subsequently released from the functional layer, reduce the irritation of the active agent, and improve the mouthfeel of the oral product. BRIEF DESCRIPTION OF THE DRAWINGS

[0016] Figure 1 A schematic diagram of the cross-sectional structure of an oral product provided in this application Figure 1 ;

[0017] Figure 2 A schematic diagram of the cross-sectional structure of an oral product provided in this application Figure 2 ;

[0018] Figure 3 A schematic diagram of the cross-sectional structure of an oral product provided in this application Figure 3 ;

[0019] Figure 4 A schematic diagram of the cross-sectional structure of an oral product provided in this application Figure 4 ;

[0020] Figure 5 A schematic diagram of the cross-sectional structure of an oral product provided in this application Figure 5 ;

[0021] Figure 6A schematic diagram of the cross-sectional structure of an oral product provided in this application Figure 6 ;

[0022] Figure 7 A schematic diagram of the cross-sectional structure of an oral product provided in this application Figure 7 ;

[0023] Figure 8 A schematic diagram of the cross-sectional structure of an oral product provided in this application Figure 8 ;

[0024] Figure 9 A schematic diagram of the cross-sectional structure of an oral product provided in this application Figure 9 ;

[0025] Figure 10 A schematic diagram of the cross-sectional structure of an oral product provided in this application Figure 10 ;

[0026] Figure 11 A schematic diagram of the cross-sectional structure of an oral product provided in this application Figure 10 one;

[0027] Figure 12 A schematic diagram of the cross-sectional structure of an oral product provided in this application Figure 10 two;

[0028] Figure 13 A schematic diagram of the cross-sectional structure of an oral product provided in this application Figure 10 three;

[0029] Figure 14 This is a flow chart of the steps of a method for preparing an oral product provided in this application.

[0030] Description of reference numerals:

[0031] 10-oral product; 11-first intermediate piece; 101-disintegrating layer; 102-functional layer; 103-support layer; 104-sustained-release regulating layer; 1041-sub-regulating layer; 105-composite sustained-release membrane. DETAILED DESCRIPTION

[0032] The present application is further described in detail below by means of specific embodiments in conjunction with the accompanying drawings. In the following embodiments, many detailed descriptions are provided to enable the present application to be better understood. However, those skilled in the art will readily appreciate that some of the features may be omitted under different circumstances, or may be replaced by other materials or methods. In some cases, some operations related to the present application are not shown or described in the specification. This is to avoid overwhelm the core of the present application with excessive descriptions, and for those skilled in the art, it is not necessary to describe these related operations in detail. They will fully understand the related operations based on the description in the specification and the general technical knowledge in the art.

[0033] In addition, the features, operations, or characteristics described in the specification may be combined in any appropriate manner to form various embodiments. Furthermore, the steps or actions in the method description may be reordered or adjusted in a manner readily apparent to those skilled in the art. Therefore, the various sequences in the specification and drawings are provided solely for the purpose of clearly describing a particular embodiment and are not intended to be mandatory, unless otherwise specified.

[0034] The serial numbers assigned to the components in this document, such as "first", "second", etc., are only used to distinguish the objects described and do not have any order or technical meaning.

[0035] In the related art, oral products are mostly single-layer tablets or pouches. These simple structures not only result in poor controllability of the active ingredient release rate and a monotonous oral experience, but also have a strong bitter taste for active ingredients such as nicotine, lacking effective flavor masking and taste optimization strategies. While currently available oral products can use sustained-release coatings to adjust the release rate of active ingredients and flavoring ingredients to improve taste, these coatings are still primarily made of non-edible materials that cannot disintegrate with saliva and be swallowed. Furthermore, the flavoring ingredients in oral products disintegrate and release simultaneously with the active ingredients, making it difficult to effectively mask the bitter taste of the active ingredients, and their effectiveness in optimizing the taste of oral products is limited.

[0036] In order to solve the above problems, the present invention provides an oral product. Figure 1 The oral product 10 includes a support layer 103, a functional layer 102 and a disintegration layer 101 arranged in sequence, wherein the functional layer 102 is arranged on any side surface of the support layer 103, and the disintegration layer 101 is arranged on the side of the functional layer 102 away from the support layer 103.

[0037] In the embodiment of the present application, the support layer 103 is insoluble, the functional layer 102 includes an active agent, and the disintegration rate of the disintegration layer 101 is greater than the disintegration rate of the functional layer 102 .

[0038] The disintegrating layer 101 comprises a water-soluble material and exhibits rapid water-soluble disintegration. During the initial period of oral confinement, the disintegrating layer 101 rapidly disintegrates and releases, thereby regulating the oral microenvironment and exposing the surface of the functional layer 102 on the side away from the support layer 103. This facilitates increasing the release rate of the surfactant on the side of the functional layer 102 near the disintegrating layer 101, thereby promoting a greater release rate of the surfactant on the side of the functional layer 102 near the disintegrating layer 101 than on the side of the functional layer 102 near the support layer 103. In an embodiment of the present application, the disintegrating layer 101 may include ingredients such as flavorings and flavorings. During the initial period of oral confinement, the disintegrating layer 101 rapidly disintegrates and releases, allowing the flavorings and flavorings to be rapidly released before the active agent is released, thereby masking the bitterness of the subsequently released active agent, reducing the irritation of the active agent, and improving the oral feel of the oral product 10.

[0039] The functional layer 102 includes an active agent, which may include but is not limited to nicotine compounds, oral care agents, anti-inflammatory agents, nutritional supplements, etc. In the embodiment of the present application, the functional layer 102 serves as a storage and release layer for the active agent. During the oral holding process of the oral product 10, the disintegration layer 101 quickly disintegrates and releases, exposing the surface of the functional layer 102 on the side away from the support layer 103, thereby promoting saliva to quickly penetrate in the direction from the disintegration layer 101 to the functional layer 102, so that the release rate of the surfactant on the side of the functional layer 102 close to the disintegration layer 101 is greater than the release rate of the surfactant on the side of the functional layer 102 close to the support layer 103. The release rate of the surfactant is beneficial to improving the effect of the active agent on the target site in the oral cavity (for example, the oral mucosa, the pharyngeal mucosa, etc.), improving the bioavailability, and thus improving the user's satisfaction with the active agent; further, the release rate of the surfactant on the side of the functional layer 102 close to the disintegration layer 101 is greater than the release rate of the surfactant on the side of the functional layer 102 close to the support layer 103, and can also slow down the disintegration speed of the functional layer 102, which is beneficial to prolonging the action time of the active agent in the functional layer 102, realizing long-term sustained release of the active agent, providing the user with long-term satisfaction with the active agent, and improving the oral experience of the oral product 10.

[0040] The support layer 103 may include a water-insoluble material, so that the support layer 103 prepared based on the water-insoluble material has insolubility. The insolubility of the support layer 103 means that liquid (e.g., saliva) cannot dissolve the support layer 103. During the oral holding process, it is helpful to slow down the rate at which saliva penetrates through the support layer 103 into the functional layer 102, so that the release rate of the surfactant on the side of the functional layer 102 close to the disintegrating layer 102 is greater than the release rate of the surfactant on the side of the functional layer 102 close to the support layer 103. In the embodiment of the present application, the support layer 103 has a stable structural morphology and can adhere to any position in the oral cavity (e.g., the gums), thereby improving the wearing stability of the oral product 10 in the oral cavity and preventing the problem of accidental swallowing of the oral product 10 during the oral holding process.

[0041] In some embodiments, the density of the support layer 103 can be increased, and the liquid impermeability of the support layer 103 can be increased, so that it is difficult for saliva to penetrate through the support layer 103 into the functional layer 102, thereby promoting the unidirectional release of the active agent in the functional layer 102 from the side surface of the functional layer 102 away from the support layer 103, which is beneficial to further improve the effect of the active agent on the target part in the oral cavity, improve the bioavailability, and thus improve the user's satisfaction with the active agent. In addition, the unidirectional release of the active agent from the side surface of the functional layer 102 away from the support layer 103 can further slow down the disintegration rate of the functional layer 102, further extend the duration of action of the active agent in the functional layer 102, achieve long-term sustained release of the active agent, provide the user with long-term satisfaction with the active agent, and improve the oral experience of the oral product 10.

[0042] In summary, the oral product 10 provided by the present application comprises a support layer 103, a functional layer 102 and a disintegrating layer 101 arranged in sequence, wherein the support layer 103 is insoluble and can slow down the speed at which saliva penetrates the support layer 103 into the functional layer 102, so that the release rate of the surfactant on the side of the functional layer 102 close to the disintegrating layer 101 is greater than the release rate of the surfactant on the side of the functional layer 102 close to the support layer 103, which is beneficial to improving the effect of the active agent on the target site in the oral cavity, improving the bioavailability, and thus improving the user's satisfaction with the active agent, and the release rate of the surfactant on the side of the functional layer 102 close to the disintegrating layer 101 is greater than the release rate of the surfactant on the side of the functional layer 102 close to the support layer 103. The release rate is greater than the release rate of the surfactant on the side of the functional layer 102 close to the support layer 103, and the disintegration rate of the functional layer 102 can also be slowed down, which is beneficial to prolonging the action time of the active agent in the functional layer 102, achieving long-term sustained release of the active agent, providing users with long-term active agent satisfaction, and improving the oral experience of the oral product 10; further, the disintegration rate of the disintegration layer 101 is greater than the disintegration rate of the functional layer 102. During the oral holding process, the disintegration layer 101 quickly disintegrates and releases, which can regulate the oral microenvironment, is beneficial to masking the bitter taste of the active agent subsequently released from the functional layer 102, reducing the irritation of the active agent, and improving the mouthfeel of the oral product 10.

[0043] In some embodiments, reference Figure 2 The oral product 10 provided in the present application further includes a sustained-release regulating layer 104 , which is disposed between the disintegrating layer 101 and the functional layer 102 , and the disintegration rate of the disintegrating layer 101 is greater than the disintegration rate of the sustained-release regulating layer 104 .

[0044] The sustained-release regulating layer 104 includes a water-soluble material, but the disintegration rate of the sustained-release regulating layer 104 is slower than that of the disintegrating layer 101. During contact with saliva, the disintegrating layer 101 rapidly disintegrates and releases, exposing the sustained-release regulating layer 104. The water-soluble material in the sustained-release regulating layer 104 can be dissolved by saliva, forming pores or channels in the sustained-release regulating layer 104, allowing saliva to penetrate into the functional layer 102 through the pores or channels, thereby facilitating control of the path and rate of saliva penetration into the functional layer 102. Furthermore, after the active agent in the functional layer 102 is dissolved by saliva, the concentration of the active agent on the side of the sustained-release regulating layer 104 closer to the functional layer 102 increases, forming an osmotic pressure of the active agent on both sides of the sustained-release regulating layer 104. Under the action of the osmotic pressure, the path and rate of directional diffusion of the active agent through the pores or channels within the sustained-release regulating layer 104 to the target site in the oral cavity where the active agent concentration is low can be regulated.

[0045] In the embodiment of the present application, the sustained-release regulating layer 104 controls the path for saliva to penetrate into the functional layer 102, the rate at which saliva penetrates into the functional layer 102, and the path for the active agent to diffuse to the target site in the oral cavity, and the rate at which the active agent diffuses to the target site in the oral cavity through the sustained-release regulating layer 104. By utilizing the osmotic pressure of the active agent formed on both sides of the sustained-release regulating layer 104, not only can the amount of the active agent released in the oral microenvironment be increased in the initial stage of oral confinement, but also the release rate of the active agent in the functional layer 102 can be slowed down in the middle and late stages of oral confinement, thereby further extending the release time of the active agent in the functional layer 102 and achieving long-term sustained release of the active agent. It can be understood that in the initial stage of oral confinement, the concentration of the active agent in the target part of the oral cavity is low, and the osmotic pressure of the active agent formed on both sides of the sustained-release regulating layer 104 is high. Under the action of the higher osmotic pressure, the active agent dissolved by saliva in the functional layer 102 can be promoted to diffuse directionallly through the sustained-release regulating layer 104 to the side with low active agent concentration where the target part of the oral cavity is located, thereby improving the release rate and effect of the active agent in the initial stage of oral confinement, thereby improving the user's satisfaction with the active agent in the initial stage of oral confinement; in the middle and late stages of oral confinement, as the concentration of the active agent in the target part of the oral cavity increases, the osmotic pressure of the active agent formed on both sides of the sustained-release regulating layer 104 is reduced compared to the initial stage of oral confinement, which can slow down the release rate of the active agent in the functional layer 102, thereby extending the release time of the active agent in the functional layer 102, achieving long-term sustained release of the active agent, and providing the user with long-term satisfaction with the active agent.

[0046] In some embodiments, the sustained-release regulating layer 104 includes a first film-forming agent, and the sustained-release regulating layer 104 further includes at least one of a controlled-release agent, a pH regulator, and an auxiliary regulator.

[0047] In some embodiments, the sustained-release regulating layer 104 includes, by weight, 35 to 45 parts of a first film-forming agent, 20 to 60 parts of a controlled-release agent, 5 to 15 parts of a pH regulator, and 5 to 20 parts of an auxiliary regulator.

[0048] The first film-forming agent in the sustained-release regulating layer 104 can be selected from a hydrophilic polymer compound. The first film-forming agent can include hydrophilic groups such as hydroxyl (-OH) and carboxyl (-COOH) groups, which can form hydrogen bonds with water molecules. After dissolution, the first film-forming agent can form a viscous colloid, thereby forming pores or channels in the sustained-release regulating layer 104 for saliva and the active agent to pass through. This helps control the path and rate of saliva permeation into the functional layer 102. Under the action of osmotic pressure, the path and rate of directional diffusion of the active agent through the sustained-release regulating layer 104 to the side with low active agent concentration where the oral target area is located are regulated. The osmotic pressure of the active agent formed on both sides of the sustained-release regulating layer 104 can not only increase the release amount of the active agent in the oral microenvironment in the early stage of oral holding, but also slow down the release rate of the active agent in the functional layer 102 in the middle and late stages of oral holding, thereby extending the release time of the active agent in the functional layer 102 and achieving long-term sustained release of the active agent.

[0049] In some embodiments, the first film-forming agent includes at least one of hydroxypropyl methylcellulose (HPMC), gum arabic, sodium alginate (ALG), and gelatin. HPMC and sodium alginate have high viscosities, which can increase the osmotic pressure formed on both sides of the sustained-release regulating layer 104 and are suitable for oral products 10 requiring long-lasting sustained release and strong adhesion. Gelatin has medium viscosity, which facilitates the formation of medium osmotic pressure on both sides of the sustained-release regulating layer 104 and is suitable for chewable or soft oral products 10. Gum arabic has low viscosity, which facilitates the formation of low osmotic pressure on both sides of the sustained-release regulating layer 104 and primarily serves to assist in regulating osmotic pressure.

[0050] The controlled-release agent in the sustained-release regulating layer 104 can be selected from at least one of a hydrophilic polymer compound and a water-soluble excipient; the hydrophilic polymer compound-type controlled-release agent rapidly absorbs water and swells after contacting saliva, and can form a three-dimensional network pore structure inside the sustained-release regulating layer 104, while the water-soluble excipient-type controlled-release agent can be dissolved by saliva to form pores or channels inside the sustained-release regulating layer 104, thereby promoting the active agent to be released through the pores or channels under the action of osmotic pressure. By controlling the type and content of the controlled-release agent in the sustained-release regulating layer 104, the present application can improve the control accuracy of the release rate of the active agent in the functional layer 102.

[0051] In some embodiments, the controlled release agent includes at least one of Croscarmellose Sodium (CCNa), Carboxymethyl Starch Sodium (CMS-Na), Low-Substituted Hydroxypropyl Cellulose (L-HPC), lactose and mannitol.

[0052] The pH regulator in the sustained-release regulating layer 104 is used to adjust the pH value of the sustained-release regulating layer 104 to 7-8, which is beneficial for adjusting the oral microenvironment to a weak alkaline state through the sustained-release regulating layer 104. When the active agent includes a nicotine compound, it is beneficial for improving the release rate and absorption efficiency of the nicotine compound, thereby improving the effect of the active agent in the initial oral administration and enhancing the user's satisfaction with the active agent in the initial oral administration.

[0053] In some embodiments, the pH adjuster includes at least one of sodium citrate (Na3C6H5O7), sodium tartrate (Na2C4H4O6), sodium dihydrogen phosphate (NaH2PO4), sodium lactate (C3H5NaO3), sodium bicarbonate (NaHCO3), and sodium carbonate (Na2CO3).

[0054] The auxiliary regulating agent in the sustained-release regulating layer 104 includes at least one of a seasoning and a flavoring agent.

[0055] The flavoring agent can mask the bitterness of the active agent, adjust the taste level of the oral product 10, and improve the mouthfeel of the oral product 10. In some embodiments, the flavoring agent may include, but is not limited to, sweeteners, salting agents, cooling agents, etc. Among them, the sweetener may include at least one of sucralose, neotame, aspartame, acesulfame potassium, steviol glycosides, xylitol, iglete, mannitol, sorbitol, erythritol, maltitol, lactitol, saccharin sodium, mongoose, sukra, agave sugar, maple syrup, fructose, alitame, cyclamate, monk fruit sweet, glycoside advantam and ammonium glycyrrhizate; the salting agent may include at least one of sodium chloride and potassium chloride; the cooling agent may include N-ethyl- (2-isopropyl-5-methyl)cyclohexaneamide (WS-3), N,2,3-trimethyl-2-(1-methylethyl)butyramide (WS-23), N-(ethoxycarbonylmethyl)-p-menthane-3-carboxamide (WS-5), N-ethyl-2,2-diisopropylbutyramide (WS-27), N-(4-methoxyphenyl)-p-menthyl-3-carboxamide (WS-12), at least one of menthols and isomenthol.

[0056] Flavoring agents include essences, which are edible flavors of any flavor, and are not specifically limited in this application. Flavours can include naturally extracted essences, synthetic essences, and compound essences. Naturally extracted essences include, but are not limited to, peppermint oil, lemon oil, linalool, licorice extract, tea polyphenols, and clove oil; synthetic essences include, but are not limited to, ethyl acetate, vanillin, vanillin, menthol, geraniol, and coumarin; and compound essences can include essences obtained by secondary blending of various essences.

[0057] In some embodiments, the auxiliary regulator includes at least one of tea polyphenols, menthol, ginger extract, eucalyptus extract, turmeric extract, licorice extract, inulin, anthocyanin, lycopene, sunflower seed lecithin, rosemary extract, rose extract, matcha powder, cinnamon extract, acacia resin extract, whey protein, fish oil extract, beeswax, honey, royal jelly, amylase, lactic acid bacteria fermentation, red yeast rice, astaxanthin, spirulina powder, fish collagen peptide, shiitake mushroom extract and vanilla pod extract.

[0058] In some embodiments, reference Figure 3 In the oral product 10 provided in the present application, the sustained-release regulating layer 104 includes at least two sub-regulating layers 1041, and the types of auxiliary regulating agents in each sub-regulating layer 1041 are different. Therefore, not only can the control accuracy of the active agent release rate through the sustained-release regulating layer 104 be further improved, but also the different types of auxiliary regulating agents in each sub-regulating layer 1041 can be used to improve the taste of the oral product 10, avoid mutual interference between different types of auxiliary regulating agents, and improve the taste level and taste richness of the oral product 10.

[0059] in, Figure 3 Where n is an integer greater than or equal to 2.

[0060] In some embodiments, the thickness of the sustained-release regulating layer 104 is 0.2 mm to 0.5 mm. Within this range, the sustained-release regulating layer 104 can fully play its role in controlling the diffusion rate of the active agent. In some embodiments, the thickness of the sustained-release regulating layer 104 can be one of or any two of 0.2 mm, 0.3 mm, 0.4 mm, 0.45 mm, and 0.5 mm.

[0061] In some embodiments, the pH value of the sustained-release regulating layer 104 and / or the disintegrating layer 101 is detected to be 7-8.

[0062] The pH value herein refers to the pH value obtained by mixing the sustained-release regulating layer 104 or the disintegrating layer 101 in the oral product 10 with water or other suitable solution, and then measuring the pH using a pH electrode, pH test paper, or an acid-base titration solution. For example, the pH value of the sustained-release regulating layer 104 and / or the disintegrating layer 101 can be measured according to the test method in the national standard GB / T 12456-2008, Determination of Total Acid in Foods.

[0063] In an embodiment of the present application, the active agent may be a nicotine compound. In this embodiment of the present application, by controlling the pH value of the sustained-release regulating layer 104 and / or the disintegrating layer 101 to be 7-8, the disintegrating layer 101 can be rapidly disintegrated and released, allowing saliva to quickly contact the disintegrating layer 101 and the sustained-release regulating layer 104, thereby adjusting the oral microenvironment to a weakly alkaline environment in the early stage of oral holding. This is conducive to promoting the release of nicotine in the active agent in the form of a free base, thereby improving the absorption efficiency of the active agent. Experiments have shown that by controlling the pH value of the sustained-release regulating layer 104 and / or the disintegrating layer 101 to be 7-8, the oral microenvironment is adjusted to a weakly alkaline environment, which can increase the release rate of the free base to more than 35%, significantly improving the absorption efficiency of nicotine by the oral mucosa, and further improving the effect of the active agent in the early stage of oral holding, thereby enhancing the user's satisfaction with the active agent in the early stage of oral holding.

[0064] In some embodiments, reference Figures 4 to 13 The oral product 10 provided in the present application further includes a composite sustained-release membrane 105, and the composite sustained-release membrane 105 is at least partially arranged between the functional layer 102 and the disintegrating layer 101. The composite sustained-release membrane 105 is used to control the release rate of the active agent. The present application utilizes the composite sustained-release membrane 105 to further slow down the release rate of the active agent in the functional layer 102 in the middle and late stages of oral confinement, extend the release time of the active agent in the functional layer 102, achieve long-term sustained release of the active agent, and extend the release time of the active agent to more than 20 minutes.

[0065] In one embodiment, Figure 4 As shown, the composite sustained-release film 105 is stacked between the functional layer 102 and the disintegrating layer 101; in the application scenario where the oral product 10 also includes a sustained-release regulating layer 104, such as Figure 5 As shown, the composite slow-release membrane 105 can be stacked between the functional layer 102 and the slow-release regulating layer 104, as shown in FIG. Figure 6 As shown, the composite sustained-release membrane 105 can also be stacked between the sustained-release regulating layer 104 and the disintegrating layer 101, as shown in FIG. Figure 7 As shown, the composite sustained-release membrane 105 may also be laminated between the functional layer 102 and the sustained-release regulating layer 104 and laminated between the sustained-release regulating layer 104 and the disintegrating layer 101 .

[0066] In one embodiment, reference Figure 8 and Figure 9 The composite sustained-release film 105 is coated on the outside of the functional layer 102. In the application scenario where the oral product 10 also includes a sustained-release regulating layer 104, such as Figure 10 As shown, the composite slow-release membrane 105 can also be coated on the outside of the first middle piece 11 , wherein the first middle piece 11 includes a functional layer 102 and a slow-release regulating layer 104 .

[0067] In one embodiment, reference Figures 11 and 12 The composite sustained-release film 105 is coated on the outer surface of the functional layer 102 other than the first surface, wherein the first surface is the surface of the functional layer 102 stacked on the support layer 103. In the application scenario where the oral product 10 also includes a sustained-release regulating layer 104, such as Figure 13 As shown, the composite sustained-release membrane 105 can also be coated on the outer surface of the first intermediate component 11 other than the first surface.

[0068] It should be noted that the specific configuration of the composite sustained-release membrane 105 in the oral product 10 can be selected according to the preparation process and actual application needs, and the embodiments of the present application do not specifically limit this.

[0069] In some embodiments, the composite sustained-release membrane 105 can be selected from at least one of sodium alginate-chitosan composite membrane, artemisia seaweed crude polysaccharide-chitosan composite membrane, regenerated cellulose-polyvinyl alcohol-chitosan-titanium dioxide composite membrane, regenerated silk fibroin-carboxymethyl chitosan composite membrane, silk fibroin-chitosan composite membrane, sodium lactate-chitosan composite membrane, pectin-chitosan composite membrane, and tea polyphenol-chitosan composite membrane.

[0070] In an embodiment of the present application, a composite sustained-release membrane 105 having a "natural polysaccharide-chitosan" core framework is formed by compounding natural polysaccharides with chitosan. The natural polysaccharides in the composite sustained-release membrane 105 can provide a water-soluble skeleton and bioadhesion. The chitosan in the composite sustained-release membrane 105, as a cationic polymer, can form a network structure with anionic polysaccharides through electrostatic interaction. Under the joint action of natural polysaccharides and chitosan, the swelling rate of the composite sustained-release membrane 105 and the diffusion path of the active agent can be effectively regulated, so that the composite sustained-release membrane 105 can fully play its role in slowing down the release rate of the active agent in the functional layer 102 and achieving long-term sustained release of the active agent.

[0071] In some embodiments, the thickness of the composite sustained-release membrane 105 is 80 μm to 150 μm. Within this range, the composite sustained-release membrane 105 can fully play its role in controlling the release rate of the active agent and achieving long-term sustained release of the active agent while reducing the extent to which the composite sustained-release membrane 105 increases the size of the oral product 10.

[0072] In some embodiments, the thickness of the composite sustained-release membrane 105 may be within the range of one or any two of 80 μm, 95 μm, 110 μm, 120 μm, 135 μm, and 150 μm.

[0073] In some embodiments, the support layer 103 in the oral product 10 provided herein includes a second film-forming agent, and the support layer 103 further includes at least one of a structural stabilizer and a filler.

[0074] In some embodiments, the support layer 103 includes, by weight, 45 to 75 parts of a second film-forming agent, 20 to 40 parts of a structural stabilizer, and 5 to 15 parts of a filler.

[0075] The second film-forming agent in the support layer 103 can be selected from a water-insoluble polymer compound. The second film-forming agent serves as the film-forming skeleton of the support layer 103, and is used to carry the structural stabilizer and / or filler to form a uniform and continuous support layer 103, thereby providing the support layer 103 with film-forming properties, corrosion resistance, insolubility, density, and mechanical toughness. It should be noted that water-insolubility in this application refers to water-insolubility at the ambient temperature of the oral cavity (e.g., 36.5°C to 37.5°C).

[0076] In some embodiments, the second film-forming agent includes at least one of polyvinyl butyral (PVB), ethyl cellulose (EC), cellulose acetate (CA), and starch. PVB and starch can form a continuous film layer through intermolecular hydrogen bonding, while EC and CA can form a continuous film layer through hydrophobic interactions and van der Waals forces. EC and CA can increase the rigidity of the support layer 103, PVB can increase the toughness of the support layer 103, and starch can increase the strength of the support layer 103. Furthermore, EC, CA, PVB, and starch are all water-insoluble at the ambient temperature of the oral cavity, resisting dissolution by saliva and improving the insolubility of the support layer 103.

[0077] The structural stabilizer in the support layer 103 includes a polymer compound. The structural stabilizer can fill the matrix network through intermolecular interactions (such as hydrogen bonds and van der Waals forces), reduce the pores and crack defects in the support layer 103, improve the mechanical toughness, ductility and tear resistance of the support layer 103, and prevent the support layer 103 from being broken due to saliva dissolution and / or mechanical friction during oral holding, thereby improving the reliability of the support layer 103.

[0078] In some embodiments, the structural stabilizer includes at least one of polyvinylpyrrolidone (PVP), ethylene-vinyl acetate copolymer (EVA), hydroxypropyl methylcellulose, carboxymethylcellulose sodium (CMC-Na), polyacrylic acid resin (Polyacrylic Acid Resin), glycerol triacetate (GTA), diethyl phthalate (DEP) and glycerol.

[0079] Among them, polyvinyl pyrrolidone can be mixed with the water-insoluble second film-forming agent to reduce the glass transition temperature of the support layer 103 and prevent the support layer 103 from being broken due to saliva flushing in the mouth; the molecular chain of ethylene-vinyl acetate copolymer has good flexibility and can form a stable blending system with the second film-forming agent through physical entanglement, thereby enhancing the mechanical properties of the support layer 103; although hydroxypropyl methylcellulose is partially soluble in water, when mixed with the water-insoluble second film-forming agent, it can enhance the flexibility and tear resistance of the support layer 103 through intermolecular hydrogen bonds, thereby preventing the support layer 103 from being brittle; low-substituted sodium carboxymethyl cellulose can be evenly dispersed with the water-insoluble second film-forming agent to form a network structure, thereby improving the density of the support layer 103 and thereby improving the support The insolubility of the support layer 103; when polyacrylic acid resin is compounded with ethyl cellulose, etc., the swelling property and resistance to saliva erosion of the support layer 103 can be adjusted; triacetin can be inserted between the molecular chains of the water-insoluble second film-forming agent to weaken the intermolecular force and prevent the hardening and brittle cracking of the support layer 103; diethyl phthalate has good compatibility with the water-insoluble second film-forming agent, which can improve the flexibility and bending resistance of the support layer 103 and reduce the probability of the support layer 103 breaking in the oral cavity; although glycerol has strong water solubility, a small amount of addition (for example, 5% to 10%) can be mixed with the water-insoluble second film-forming agent to increase the ductility of the support layer 103 through hydrogen bonding without significantly affecting the insolubility of the support layer 103.

[0080] The filler in the support layer 103 may be selected from water-insoluble compounds. The filler is used to enhance the strength of the support layer 103 and control the film density and mechanical strength of the support layer 103 .

[0081] In some embodiments, the filler includes microcrystalline cellulose (MCC), ethyl cellulose, micropowdered silica, calcium phosphate (Ca3(PO4)2), calcium sulfate (CaSO4), talc (3MgO·4SiO2·H2O), calcium carbonate (CaCO3), hydroxyapatite (Ca 10 (PO4)6(OH)2) and at least one of starch.

[0082] In some embodiments, the functional layer 102 in the oral product 10 provided herein further includes at least one of a sustained-release substrate, a humectant, a carrier, and a flowability improver.

[0083] In some embodiments, the functional layer 102 includes, by weight, 1 to 5 parts of active agent, 2 to 50 parts of sustained-release matrix, 1 to 20 parts of humectant, 20 to 70 parts of carrier, and 1 to 5 parts of flowability improver.

[0084] In some embodiments, the active agent in the functional layer 102 includes at least one of nicotine and a nicotine derivative, which is used to provide nicotine satisfaction to the user. Nicotine includes at least one of synthetic nicotine and natural nicotine. Nicotine derivatives include one or more of nicotine salts, nicotine in a matrix such as a sugar matrix or an organometallic complex, a nicotine-resin combination, a nicotine inclusion complex, and non-covalently bound nicotine. Non-covalently bound nicotine includes nicotine lactate, nicotine malate, nicotine salicylate, nicotine cyclodextrin embedded complex, nicotine hydrochloride, nicotine dihydrochloride, nicotine tartrate, nicotine tartrate dihydrate, nicotine sulfate, nicotine zinc chloride, nicotine benzoate, and the like. Nicotine derivatives also include nicotine containing substituents, such as hexamethyl nicotine, hexamethyl nicotine lactate, hexamethyl nicotine malate, hexamethyl nicotine salicylate, hexamethyl nicotine cyclodextrin embedded complex, hexamethyl nicotine hydrochloride, hexamethyl nicotine dihydrochloride, hexamethyl nicotine tartrate, hexamethyl nicotine tartrate dihydrate, hexamethyl nicotine sulfate, hexamethyl nicotine zinc chloride, and hexamethyl nicotine benzoate. One or more mixtures thereof.

[0085] The sustained-release matrix in the functional layer 102 can be selected from hydrophilic polymer compounds. During oral administration, the sustained-release matrix can absorb water and swell, thereby forming a viscous gel layer on the surface of the active agent, slowing down the diffusion process of the active agent and achieving a sustained-release effect of the active agent inside the functional layer 102.

[0086] In some embodiments, the sustained-release matrix includes at least one of hypromellose, hydroxypropyl cellulose (HPC), and polyvinyl resin.

[0087] The humectant in the functional layer 102 can be selected from hydrophilic compounds. The humectant can absorb moisture from the environment and fix the moisture inside the functional layer 102 through hydrogen bonds, thereby preventing the functional layer 102 from hardening, disintegrating and cracking due to moisture loss.

[0088] In some embodiments, the humectant includes at least one of glycerin, propylene glycol (PG), sorbitol, sodium alginate, chitosan (CTS), starch, starch derivatives, polysorbate, and sucrose fatty acid esters.

[0089] The carrier in the functional layer 102 can be selected from biodegradable compounds. The carrier can wrap the active agent through intermolecular hydrogen bonds to form a three-dimensional network structure. As the carrier gradually degrades in oral saliva, the active agent can be released at a controllable rate, which is beneficial to prolonging the duration of the active agent's action.

[0090] In some embodiments, the carrier comprises at least one of microcrystalline cellulose, starch, and cyclodextrins.

[0091] The fluidity improver in the functional layer 102 is water-absorbent and / or oil-absorbent, which can reduce the interfacial tension and adhesion between the powder particles in the functional layer 102, improve the fluidity of the powder particles in the functional layer 102, and reduce the probability of problems such as adhesion, bridging, and mold blocking between the powder particles in the functional layer 102, which is beneficial to improving the forming quality and structural stability of the functional layer 102.

[0092] In some embodiments, the flow improver includes at least one of silicon dioxide (SiO2), talc, magnesium stearate, microcrystalline cellulose, starch, and anhydrous lactose.

[0093] In some embodiments, the disintegrating layer 101 in the oral product 10 provided herein includes a third film-forming agent, and the disintegrating layer 101 further includes at least one of a binder, a flavoring agent, a flavoring agent, a pH adjuster, and a humectant.

[0094] In some embodiments, the disintegrating layer 101 includes, by weight, 20 to 30 parts of a third film-forming agent, 10 to 20 parts of a binder, 1 to 5 parts of a flavoring agent, 1 to 5 parts of a seasoning, 1 to 5 parts of a pH regulator, and 1 to 10 parts of a humectant.

[0095] The third film-forming agent in the disintegrating layer 101 is a high molecular compound with water solubility and low viscosity. When in contact with saliva, the third film-forming agent can quickly swell and dissolve, thereby achieving rapid disintegration and release of the disintegrating layer 101 .

[0096] In some embodiments, the third film-forming agent includes at least one of modified chitosan, hydroxypropyl methylcellulose, hydroxypropyl cellulose, sodium carboxymethyl starch, sodium alginate, polysorbate and micro-powdered silica gel. Among them, modified chitosan refers to chitosan that has been modified by carboxymethylation, hydroxyethylation, etc. Carboxymethylation, hydroxyethylation and other modifications to chitosan can introduce more hydrophilic groups, reduce the strength of intermolecular hydrogen bonds, and accelerate the swelling and dissolution process of the disintegration layer 101 in saliva; hydroxypropyl methylcellulose forms a gel network when it meets water and quickly swells and disintegrates, and the disintegration time can be adjusted by viscosity; hydroxypropyl cellulose has strong water solubility and its volume expands significantly after absorbing water, so that the disintegration layer 101 can be quickly dispersed in saliva, and has both bonding and disintegration functions; sodium carboxymethyl starch has high water absorption and its volume expands by 100% after absorbing water. The volume of the disintegrating layer 101 is more than 300 times of its original volume, so that the disintegrating layer 101 can quickly disintegrate after contact with saliva; sodium alginate can form a viscous colloid when it meets water, and under the action of electrolytes in saliva, the viscous colloid can gradually disperse, thereby realizing the disintegration of the disintegrating layer 101; polysorbate (for example, polysorbate-80) can promote the contact between the disintegrating layer 101 and saliva, accelerate the infiltration of water into the disintegrating layer 101, and shorten the disintegration time of the disintegrating layer 101; micropowder silica gel is a porous inorganic substance. When added to the disintegrating layer 101, it can form microscopic pores in the disintegrating layer 101, and saliva can quickly penetrate through the pores, thereby accelerating the disintegration of the disintegrating layer 101.

[0097] The binder in the disintegrating layer 101 can provide bonding, film-forming, thickening, and gelling effects, thereby enhancing the stability of the disintegrating layer 101. In some embodiments, the binder includes at least one of sodium carboxymethylcellulose, hydroxypropyl methylcellulose, sodium alginate, gum arabic, gelatin, pectin, xanthan gum, and maltodextrin.

[0098] The flavoring agent in the disintegrating layer 101 can provide the oral product 10 with fragrances with different flavors, thereby improving the taste richness of the oral product 10 .

[0099] The flavoring agent in the disintegrating layer 101 can mask the bitter taste of the active agent, adjust the taste level of the oral product 10 , and improve the mouthfeel of the oral product 10 .

[0100] The pH regulator in the disintegrating layer 101 is used to adjust the pH value of the disintegrating layer 101 to 7-8, which is beneficial for adjusting the oral microenvironment to a weak alkaline state through the disintegration and release process of the disintegrating layer 101, thereby improving the release rate and absorption efficiency of nicotine compounds, and further improving the effect of the active agent in the early stage of oral administration, thereby enhancing the user's satisfaction with the active agent in the early stage of oral administration.

[0101] The humectant in the disintegrating layer 101 can be selected from hydrophilic compounds. The humectant can absorb moisture from the environment and fix the moisture inside the disintegrating layer 101 through hydrogen bonds, thereby preventing the disintegrating layer 101 from hardening and cracking due to moisture loss.

[0102] In some embodiments, the thickness of the support layer 103 is 0.2 mm to 0.5 mm. Within this range, it is beneficial to improve the structural stability of the support layer 103, thereby improving the wearing stability of the oral product 10 in the oral cavity, and preventing the oral product 10 from being accidentally swallowed during the oral holding process; in some embodiments, the thickness of the support layer 103 can be one of or any two of 0.2 mm, 0.25 mm, 0.3 mm, 0.35 mm, 0.4 mm and 0.5 mm.

[0103] In some embodiments, the thickness of the functional layer 102 is 0.5 mm to 1.5 mm. Within this range, the content of the active agent in the functional layer 102 can be increased while ensuring that the overall size of the oral product 10 meets the requirements, thereby further extending the release time of the active agent in the functional layer 102. In some embodiments, the thickness of the functional layer 102 can be a range value of one or any two of 0.5 mm, 0.7 mm, 1 mm, 1.2 mm and 1.5 mm.

[0104] In some embodiments, the thickness of the disintegration layer 101 is 0.1 mm to 0.3 mm. Within this range, the disintegration layer 101 is conducive to fully exerting its role in rapid disintegration and regulating the oral microenvironment; in some embodiments, the thickness of the disintegration layer 101 can be one of or any two of 0.1 mm, 0.15 mm, 0.2 mm, 0.25 mm and 0.3 mm.

[0105] In some embodiments, the thickness of the oral product 10 is 1 mm to 3 mm. Within this range, the functions of the support layer 103, the functional layer 102, the disintegration layer 101, and the sustained-release adjustment layer 104 are fully exerted. Through the synergistic effect of the support layer 103, the functional layer 102, the disintegration layer 101, and the sustained-release adjustment layer 104, not only can the user be provided with a long-lasting active agent satisfaction and the oral experience of the oral product 10 be improved, but the irritation of the active agent can also be reduced and the mouthfeel of the oral product 10 can be improved; in some embodiments, the thickness of the oral product 10 can be a range of one or any two of 1 mm, 1.5 mm, 2.2 mm, 2.8 mm and 3 mm.

[0106] In some embodiments, a marking structure and / or an anti-slip structure is provided on a surface of the support layer 103 that is away from the functional layer 102 .

[0107] In some embodiments, an identification structure is provided on the surface of the side of the support layer 103 away from the functional layer 102, and the identification structure is used to assist the user in correctly wearing the oral product 10 provided in the present application, and ensure that after the user correctly wears the oral product 10 provided in the present application according to the identification structure, the release rate of the surfactant on the side of the functional layer 102 close to the disintegration layer 102 is greater than the release rate of the surfactant on the side of the functional layer 102 close to the support layer 103, so as to improve bioavailability; the identification structure may include but is not limited to food coloring identification, engraved words, etc.; for example, a blue food coloring identification can be provided on the surface of the side of the support layer 103 away from the functional layer 102, and / or the word "DOWN" can be engraved on the surface of the side of the support layer 103 away from the functional layer 102.

[0108] In some embodiments, a non-slip structure is provided on the surface of the support layer 103 away from the functional layer 102, which is beneficial to increase the friction between the surface of the support layer 103 away from the functional layer 102 and the oral mucosa, thereby improving the stability of the oral product 10 when worn in the mouth, avoiding displacement of the oral product 10 due to saliva or tongue movement, and further reducing the risk of accidental swallowing of the oral product 10; wherein, the non-slip structure may include but is not limited to a convex structure, medical thermoplastic silicone attached particles, etc.

[0109] In some embodiments, the water content of the oral product 10 provided in the present application is 10% to 15%. Within this range, not only can the comfort of placing the oral product 10 in the oral cavity be improved, but the release rate of the active agent in the oral product 10 can also achieve the expected effect, thereby improving the effect of the active agent in the initial oral cavity, providing the user with a sense of satisfaction with the active agent, and extending the release time of the active agent in the functional layer 102, thereby achieving long-term sustained release of the active agent.

[0110] The present application provides a method for preparing an oral product, such as Figure 14 As shown, the method includes the following steps:

[0111] Step S101: Obtain a first slurry and use the first slurry to prepare a functional layer substrate; the first slurry includes an active agent.

[0112] Step S102: Obtain a second slurry, and use the second slurry to prepare a disintegration layer substrate on either side of the functional layer substrate.

[0113] Step S103: obtaining a third slurry, and using the third slurry to prepare a support layer substrate on a side of the functional layer substrate away from the disintegration layer substrate to obtain a formed part; the third slurry includes a water-insoluble material.

[0114] Step S104: Dry the formed part to prepare an oral product.

[0115] Among them, the oral product includes: a support layer formed after the support layer substrate is dried, a functional layer formed after the functional layer substrate is dried, and a disintegration layer formed after the disintegration layer substrate is dried, which are arranged in sequence, and the support layer is insoluble, the functional layer includes an active agent, and the disintegration rate of the disintegration layer is greater than the disintegration rate of the functional layer.

[0116] The method for preparing the oral product provided in the present application can realize the preparation of the oral product as described in any one of the above items.

[0117] The first slurry refers to a slurry formed by dissolving or swelling the raw materials corresponding to the functional layer in a solvent.

[0118] In some embodiments, the solvent includes an aqueous solvent and an oily solvent. The aqueous solvent may include, but is not limited to, purified water, glycerol, sorbitol, propylene glycol, ethanol, polyethylene glycol (PEG), plant extracts, etc.; the oily solvent may include, but is not limited to, olive oil, coconut oil, medium-chain triglycerides (MCT), caprylic glyceride, and capric glyceride.

[0119] Plant extracts may include, but are not limited to, green tea extracts, chrysanthemum extracts, etc., which have the functions of both solvents and effective ingredients (eg, clearing heat, protecting the throat), while increasing the natural flavor of the oral product.

[0120] In some embodiments, in step S101, 1 to 5 parts of an active agent, 2 to 50 parts of a sustained-release matrix, 1 to 20 parts of a humectant, 20 to 70 parts of a carrier, 1 to 5 parts of a flow improver, 5 to 30 parts of a binder, and 2 to 30 parts of a pH adjuster are dissolved in a solvent by weight and stirred at low temperature to form a viscous matrix, thereby obtaining a first slurry. The first slurry is then poured into a mold corresponding to the functional layer and cooled and solidified to form a functional layer substrate. In some embodiments, the functional layer can also be formed by coating, which will not be described in detail in this application.

[0121] The second slurry is a slurry formed by dissolving and mixing raw materials corresponding to the disintegration layer in a solvent.

[0122] In step S102, 20 to 30 parts of a third film-forming agent, 10 to 20 parts of an adhesive, 1 to 5 parts of a flavoring agent, 1 to 5 parts of a seasoning, 1 to 5 parts of a pH regulator, and 1 to 10 parts of a humectant can be added to a solvent in parts by mass, mixed and stirred evenly to form a second slurry; then, the second slurry is evenly coated on either side of the functional layer substrate, and solidified to form a disintegration layer substrate.

[0123] The third slurry refers to a slurry formed by dissolving and mixing raw materials corresponding to the support layer in a solvent.

[0124] In step S103, 45 to 75 parts of the second film-forming agent, 20 to 40 parts of the structural stabilizer and / or 5 to 15 parts of the filler can be mixed into a thin film liquid with an organic solvent according to their mass proportions to obtain a third slurry; then, the third slurry is evenly sprayed on the side of the functional layer substrate away from the disintegration layer substrate to obtain a supporting layer substrate, and then a formed part including the functional layer substrate, the disintegration layer substrate and the supporting layer substrate is obtained.

[0125] In the embodiment of the present application, the third slurry includes water-insoluble materials (eg, a second film-forming agent and a filler), which helps to improve the insolubility of the support layer prepared based on the third slurry.

[0126] In step S104, the formed part may be dried in a hot air circulation drying oven to dehydrate and solidify the functional layer substrate, the disintegrating layer substrate and the supporting layer substrate in the formed part to obtain an oral product.

[0127] In some embodiments, the temperature of the drying process is less than or equal to 60° C., and the duration of the drying process is 1 hour to 5 hours.

[0128] In some embodiments, when the oral product is obtained through step S104, a die-cutting machine can be used to cut the entire oral product into standard sizes (for example, 10 mm in diameter and 3 mm in thickness), and the product can be sealed in a desiccant packaging bag to improve the stability of the oral product.

[0129] In some embodiments, the oral products of standard size can be packaged individually or in aluminum-plastic blisters according to the usage scenario, and can be labeled with instructions and packaged externally.

[0130] In some embodiments, before step S102, the method may further include:

[0131] Step A11: Obtain a fourth slurry, and use the fourth slurry to prepare a slow-release regulating layer substrate on either side of the functional layer substrate.

[0132] In step S102, a second slurry is obtained, and the second slurry is used to prepare a disintegrating layer substrate on a surface of the sustained-release regulating layer substrate that is away from the functional layer substrate.

[0133] In an embodiment of the present application, the oral product prepared by step S104 also includes a sustained-release regulating layer formed after the sustained-release regulating layer substrate is dried. The sustained-release regulating layer is arranged between the disintegration layer and the functional layer, and the disintegration rate of the disintegration layer is greater than the disintegration rate of the sustained-release regulating layer.

[0134] The fourth slurry refers to a slurry formed by dissolving and mixing the raw materials corresponding to the sustained-release regulating layer in a solvent.

[0135] In step A11, 35 to 45 parts of the first film-forming agent, 20 to 60 parts of the controlled-release agent, 5 to 15 parts of the pH regulator, and 5 to 20 parts of at least one of the auxiliary regulators can be heated and dissolved in a solvent in parts by mass to form a homogeneous liquid, which is the fourth slurry; then, the fourth slurry is coated on either side of the functional layer substrate and rapidly cooled and solidified to obtain a sustained-release regulating layer substrate.

[0136] In some embodiments, the oral preparation further includes a composite sustained-release membrane. The preparation method of the oral preparation provided in the present application may further include:

[0137] Step A21: Obtain a fifth slurry corresponding to the composite sustained-release membrane.

[0138] Step A22: applying the fifth slurry to the target area to prepare a composite sustained-release membrane.

[0139] The fifth slurry refers to a slurry formed by dissolving and mixing the raw materials corresponding to the composite sustained-release membrane in a solvent.

[0140] Illustratively, when the composite sustained-release membrane is a sodium alginate-chitosan composite membrane, the fifth slurry includes sodium alginate, chitosan, calcium chloride and glycerol, and in the composite sustained-release membrane, measured in parts by mass, sodium alginate is 50 parts, chitosan is 30 parts, calcium chloride is 5 parts, and glycerol is 15 parts.

[0141] Before step S102, step A22 can be performed to apply the fifth slurry to the target area and dry it at low temperature (40°C to 60°C for 4 hours to 6 hours) to obtain a composite sustained-release membrane. In the case of obtaining a composite sustained-release membrane, in step S102, the second slurry can be used to prepare a disintegrating layer substrate on either side of the functional layer substrate covered with the composite sustained-release membrane; wherein the target area includes any one of the surfaces of the functional layer substrate, the entire outer surface of the functional layer substrate, and any surface of the functional layer substrate other than the second surface, the second surface being the surface of the functional layer substrate used to laminate the support layer substrate.

[0142] In the application scenario where the oral product also includes a sustained-release regulating layer, the target area can also include any one of the surfaces of the sustained-release regulating layer substrate away from the functional layer substrate, the entire outer surface of the second intermediate piece formed by the functional layer substrate and the sustained-release regulating layer substrate, and the outer surface other than the second surface of the second intermediate piece.

[0143] The present application is further described in detail below through specific examples and comparative examples, so as to prepare an oral product by the above-mentioned method for preparing an oral product.

[0144] The following examples are only some examples of the present application and are not intended to limit the present application. In the examples and comparative examples, unless otherwise specified, the reagents and instruments used are all commercially available, and the experimental operations are carried out in accordance with the product instructions and conventional experimental specifications.

[0145] Example 1

[0146] (1) Preparation of functional layer substrate:

[0147] Dissolve 2 parts of nicotine tartrate, 35 parts of hypromellose, 10 parts of glycerin, 50 parts of microcrystalline cellulose, 3 parts of talc, 20 parts of gelatin, 10 parts of sodium bicarbonate, and 5 parts of sodium citrate in pure water according to their mass proportions, stir evenly at low temperature to form a viscous matrix, and obtain a first slurry; then, pour the first slurry into a mold corresponding to the functional layer and cool and solidify to form a functional layer substrate.

[0148] (2) Preparation of sustained-release regulating layer substrate:

[0149] 50 parts of mannitol, 10 parts of sodium citrate, 40 parts of gelatin, 2 parts of menthol, 3 parts of eucalyptus extract, and 5 parts of tea polyphenols are heated and dissolved in pure water to form a homogeneous liquid to obtain a fourth slurry; then, the fourth slurry is coated on either side of the functional layer substrate and rapidly cooled and solidified to obtain a sustained-release adjustment layer substrate.

[0150] (3) Preparation of colloid to prepare disintegration layer substrate:

[0151] 25 parts of modified chitosan, 10 parts of pectin, 5 parts of instant maltodextrin, 3 parts of menthol, 2 parts of ammonium glycyrrhizate, 2 parts of sodium citrate, 5 parts of glycerin, and 48 parts of purified water are mixed and stirred in parts by mass to form a second slurry; then, the second slurry is evenly coated on the side of the sustained-release regulating layer substrate away from the functional layer substrate, and formed into a disintegrating layer substrate after curing.

[0152] (4) Preparation of formed parts:

[0153] 40 parts of polyvinyl butyral, 20 parts of cellulose acetate, 30 parts of ethylene-vinyl acetate copolymer, and 10 parts of microcrystalline cellulose are mixed with ethanol in proportions by mass to form a thin film liquid to obtain a third slurry; then, the third slurry is evenly sprayed on the side of the functional layer substrate away from the sustained-release adjustment layer substrate to obtain a supporting layer substrate; a layer of phycocyanin with a proportion of 5 parts by mass is arranged on the surface of the supporting layer substrate away from the functional layer as a marking structure to obtain a formed part.

[0154] (5) Preparation of oral products:

[0155] The formed part is dried in a hot air circulation drying oven at 55°C for 3 hours to slowly dehydrate and solidify the functional layer substrate, sustained-release regulating layer substrate, disintegration layer substrate, support layer substrate, and phycocyanin layer in the formed part to obtain an orally contained product; the orally contained product includes a support layer formed after the support layer substrate is dried, a functional layer formed after the functional layer substrate is dried, a sustained-release regulating layer formed after the sustained-release regulating layer substrate is dried, and a disintegration layer formed after the disintegration layer substrate is dried.

[0156] Examples 2-3

[0157] The difference between Examples 2 and 3 and Example 1 is that:

[0158] In step (1), the weight fractions of nicotine tartrate, hypromellose, glycerin, microcrystalline cellulose, talc, gelatin, sodium bicarbonate, and sodium citrate, as well as the thickness of the functional layer substrate are adjusted;

[0159] In step (2), the mass fractions of mannitol, sodium citrate, gelatin, menthol, eucalyptus extract, and tea polyphenols, as well as the thickness of the sustained-release regulating layer substrate are adjusted;

[0160] In step (3), the weight fractions of modified chitosan, pectin, instant maltodextrin, menthol, ammonium glycyrrhizate, sodium citrate, glycerin and purified water, as well as the thickness of the disintegrating layer substrate are adjusted;

[0161] In step (4), the mass fractions of polyvinyl butyral, cellulose acetate, ethylene-vinyl acetate copolymer, and microcrystalline cellulose, as well as the thickness of the support layer substrate are adjusted.

[0162] The relevant parameters of the oral products prepared in Examples 1 to 3 are shown in Table 1.

[0163] Table 1

[0164]

[0165] Example 4

[0166] The difference between Example 4 and Example 1 is that:

[0167] Step (2) is not included;

[0168] In step (3), the second slurry is evenly coated on either side of the functional layer substrate and solidified to form a disintegration layer substrate;

[0169] In step (4), the third slurry is evenly sprayed on the side of the functional layer substrate away from the disintegration layer substrate to obtain a support layer substrate.

[0170] Example 5

[0171] The difference between Example 5 and Example 1 is that:

[0172] Prior to step (2): (i) dissolving 50 parts by weight of sodium alginate in deionized water to obtain a sodium alginate solution, and dissolving 30 parts by weight of chitosan in dilute acetic acid to obtain a chitosan solution; (ii) slowly adding the chitosan solution dropwise to the sodium alginate solution and stirring evenly to obtain a composite solution; (iii) adding 5 parts by weight of calcium chloride and 15 parts by weight of glycerol to the composite solution and stirring evenly to obtain a fifth slurry; (iv) coating the fifth slurry on either side of the functional layer substrate and drying at 50° C. for 5 hours to obtain a composite sustained-release membrane;

[0173] In step (2), the fourth slurry is coated on the side of the functional layer substrate covered with the composite slow-release membrane, and rapidly cooled and solidified to obtain a slow-release regulating layer substrate.

[0174] Examples 6-7

[0175] The difference between Examples 6 and 7 and Example 5 is that the thickness of the composite sustained-release membrane is 80 μm and 150 μm, respectively.

[0176] The relevant parameters of the oral preparations prepared in Examples 5 to 7 are shown in Table 2.

[0177] Table 2

[0178]

[0179]

[0180] Example 8

[0181] The difference between Example 8 and Example 1 is that:

[0182] In step (2), 50 parts of mannitol, 10 parts of sodium citrate, 40 parts of gelatin, 2 parts of matcha powder, 3 parts of ginger extract, and 5 parts of licorice extract are heated and dissolved in pure water according to their mass ratio to form a homogeneous liquid, which is the fourth slurry; then, the fourth slurry is coated on either side of the functional layer substrate and rapidly cooled and solidified to obtain a sustained-release adjustment layer substrate.

[0183] The relevant parameters of the oral product prepared in Example 8 are shown in Table 3.

[0184] Table 3

[0185]

[0186]

[0187] Example 9

[0188] The difference between Example 9 and Example 1 is that:

[0189] In step (5), the word "DOWN" is engraved on the surface of the support layer away from the functional layer.

[0190] Example 10

[0191] The difference between Example 10 and Example 1 is that:

[0192] In step (4), a beetroot red layer with a mass fraction of 5 parts is provided on the surface of the support layer substrate away from the functional layer as a marking structure to obtain a formed part;

[0193] In step (5), a gelatin layer is coated on the surface of the support layer away from the functional layer. Before the gelatin layer is dried, 50 parts by mass of thermoplastic silicone particles are evenly spread on the gelatin layer through a vibrating screen, and excess thermoplastic silicone particles are removed by negative pressure. The gelatin layer is then dried at 50°C for 10 minutes to solidify, thereby forming an anti-slip structure on the surface of the support layer away from the functional layer.

[0194] The relevant parameters of the oral product prepared in Example 10 are shown in Table 4.

[0195] Table 4

[0196]

[0197]

[0198] Example 11

[0199] The difference between Example 11 and Example 1 is that:

[0200] In step (1), 2 parts of nicotine tartrate, 35 parts of hypromellose, 10 parts of glycerin, 50 parts of microcrystalline cellulose, 3 parts of talc, 20 parts of gelatin, 2 parts of ascorbyl palmitate, 10 parts of sodium bicarbonate, and 5 parts of sodium citrate are dissolved in pure water according to their mass ratios, and stirred evenly at low temperature to form a viscous matrix to obtain a first slurry; then, the first slurry is poured into a mold corresponding to the functional layer and cooled and solidified to form a functional layer substrate.

[0201] In step (2), (i) 50 parts of mannitol, 10 parts of sodium citrate, 40 parts of gelatin, 2 parts of ginger extract, 3 parts of eucalyptus extract, and 5 parts of tea polyphenols are heated and dissolved in pure water to form a homogeneous liquid to obtain a fourth slurry; then, the fourth slurry is applied to the surface of either side of the functional layer substrate and rapidly cooled and solidified to obtain a first sub-regulation layer substrate; (ii) 50 parts of mannitol, 10 parts of sodium citrate, 40 parts of gelatin, 2 parts of lemongrass essential oil, 3 parts of rosemary extract, and 5 parts of cinnamon extract are heated and dissolved in pure water to form a homogeneous liquid to obtain a fourth slurry; then, the fourth slurry is applied to the surface of the first sub-regulation layer substrate away from the functional layer and rapidly cooled and solidified to obtain a second sub-regulation layer substrate.

[0202] The relevant parameters of the oral product prepared in Example 11 are shown in Table 5.

[0203] Table 5

[0204]

[0205]

[0206] Comparative Example 1

[0207] A nicotine oral product with the product model "RIF GO" in the related art was used as the oral product provided in Comparative Example 1.

[0208] Test method:

[0209] Sustained-release effect test of oral preparations

[0210] (i) Test purpose: To verify the sustained release performance of nicotine in the oral preparations prepared in the Examples and Comparative Examples, and to fit the release kinetic function: y = 100a(1-e -bt ), the time when nicotine release reaches 80% is taken as the peak time;

[0211] (ii) Test materials and equipment

[0212] Samples: oral preparations prepared in Examples and oral preparations prepared in Comparative Examples;

[0213] Reagents: simulated saliva (pH 6.8, containing 0.5% SDS);

[0214] Apparatus: dissolution apparatus (paddle method, USPII), HPLC system (C18 column, detection wavelength 260 nm);

[0215] (iii) Test methods

[0216] Dissolution test design

[0217] Dissolution conditions: The oral preparations prepared in the examples and the oral preparations prepared in the comparative examples were immersed in 500 mL of simulated saliva, sealed, and placed in a constant temperature water bath at 37°C ± 0.5°C and stirred at 50 rpm.

[0218] Sampling time points included: 30 s, 1 min, 2 min, 3 min, 5 min, 7 min, 10 min, and 15 min, with 5 mL sampled and rehydrated each time;

[0219] Sample processing: Filter through a 0.22 μm filter membrane to obtain a filtrate, and use an HPLC system to detect the nicotine concentration in the filtrate.

[0220] Test results:

[0221] The oral preparations prepared in Examples 1 to 6, Example 11 and Comparative Example 1 were tested for sustained-release effects. The test results are shown in Table 6.

[0222] Table 6

[0223]

[0224]

[0225] According to the test data in Table 6, the oral preparation provided in the embodiments of the present application can improve the effect of the active agent on the target area in the oral cavity during the initial oral administration, thereby improving the user's satisfaction with the active agent. At the same time, it can also achieve long-term sustained release of the active agent, providing the user with long-term satisfaction with the active agent and improving the oral experience of the oral preparation.

[0226] Furthermore, after the sodium alginate-chitosan composite sustained-release membrane was introduced in Examples 5 to 7, the release rate of the active agent was further slowed down, the release process became smoother, and the release plateau period was significantly prolonged, proving that the composite sustained-release membrane has excellent sustained-release regulation capabilities; Example 11 achieved more precise two-phase release control through a double-layer sustained-release regulation layer, so that the active agent release rate of the oral product was faster in the early stage of oral administration and the active agent release rate tended to be stable in the later stage of oral administration.

[0227] In addition, in the oral preparations prepared by Examples 1 to 11, the pH regulators sodium bicarbonate and sodium citrate in the functional layer can generate microbubbles to promote the dissolution of the active agent, and the pigment (phycocyanin) in the supporting layer can assist the user in correctly wearing the oral preparation provided by the present application, ensuring the directional release of the active agent in the oral cavity; the auxiliary regulators matcha powder, ginger extract and licorice extract in the sustained-release regulating layer of Example 8 can have the effects of soothing, antibacterial and anti-inflammatory, and improving oral ecological sustained-release, and combined with the flavors and flavorings in the disintegration layer, the oral taste and comfort of the oral preparation can be further enhanced; in Example 9, the word "DOWN" is engraved on the surface of the supporting layer away from the functional layer to indicate the direction of wearing of the oral preparation, assist the user in correctly wearing the oral preparation provided by the present application, and ensure that after the user correctly wears the oral preparation provided by the present application according to the identification structure, the active agent on the surface of the functional layer close to the disintegration layer The release rate of the surfactant is greater than the release rate of the surfactant on the side of the functional layer close to the support layer, thereby improving bioavailability; the pigment (beetroot red) in the support layer of Example 10 can also assist users in correctly wearing the oral product provided by the present application, and the thermoplastic silicone particles in the support layer can form an anti-slip structure on the surface of the support layer away from the functional layer, thereby improving the stability of the oral product when worn in the mouth and reducing the risk of accidental swallowing of the oral product; the sustained-release regulating layer in Example 11 includes a first sub-regulating layer and a second sub-regulating layer, the auxiliary regulating agent in the first sub-regulating layer can provide an antibacterial and cooling effect, and the auxiliary regulating agent in the second sub-regulating layer can release fragrance, which not only avoids mutual interference between auxiliary regulating agents with different functions, but also improves the taste level and taste richness of the oral product. Furthermore, the functional layer of Example 11 also adds a vitamin C derivative, which is beneficial to strengthening the nutritional regulation of the functional layer.

[0228] The above content is a further detailed description of the present application in conjunction with specific implementation methods, and the specific implementation of the present application cannot be considered to be limited to these descriptions. For ordinary technicians in the technical field to which the present application belongs, several simple deductions or substitutions can be made without departing from the concept of the present application.

Claims

1. An oral product, characterized in that: It includes a supporting layer, a functional layer and a disintegrating layer arranged in sequence; The support layer is insoluble, the functional layer includes an active agent, and the disintegration rate of the disintegration layer is greater than the disintegration rate of the functional layer.

2. The oral product according to claim 1, wherein The oral product further includes a sustained-release regulating layer, which is disposed between the disintegrating layer and the functional layer. The disintegration rate of the disintegrating layer is greater than the disintegration rate of the sustained-release regulating layer.

3. The oral product according to claim 2, characterized in that The sustained-release regulating layer includes a first film-forming agent, and further includes at least one of a controlled-release agent, a pH regulator, and an auxiliary regulator.

4. The oral product according to claim 3, characterized in that The sustained-release regulating layer comprises at least two sub-regulating layers; and / or, The thickness of the sustained-release regulating layer is 0.2 mm to 0.5 mm; and / or, The first film-forming agent comprises at least one of hydroxypropyl methylcellulose, gum arabic, sodium alginate and gelatin; and / or, The controlled release agent comprises at least one of cross-linked sodium carboxymethyl cellulose, sodium carboxymethyl starch, low-substituted hydroxypropyl cellulose, lactose and mannitol; and / or, The auxiliary regulator includes at least one of a flavoring agent and a flavoring agent; and / or, The auxiliary regulator includes at least one of tea polyphenols, menthol, ginger extract, eucalyptus extract, turmeric extract, licorice extract, inulin, anthocyanin, lycopene, sunflower seed lecithin, rosemary extract, rose extract, matcha powder, cinnamon extract, acacia resin extract, whey protein, fish oil extract, beeswax, honey, royal jelly, amylase, lactic acid bacteria fermentation, red yeast rice, astaxanthin, spirulina powder, fish collagen peptide, shiitake mushroom extract and vanilla pod extract.

5. The oral product according to claim 1, wherein The oral product further comprises a composite sustained-release membrane; Wherein, the composite sustained-release membrane is at least partially disposed between the functional layer and the disintegrating layer to control the release rate of the active agent.

6. The oral product according to claim 5, characterized in that The composite sustained-release membrane is selected from at least one of sodium alginate-chitosan composite membrane, artemisia seaweed crude polysaccharide-chitosan composite membrane, regenerated cellulose-polyvinyl alcohol-chitosan-titanium dioxide composite membrane, regenerated silk fibroin-carboxymethyl chitosan composite membrane, silk fibroin-chitosan composite membrane, sodium lactate-chitosan composite membrane, pectin-chitosan composite membrane and tea polyphenol-chitosan composite membrane; and / or, The thickness of the composite sustained-release membrane is 80 μm to 150 μm.

7. The oral product according to any one of claims 1 to 6, characterized in that The support layer includes a second film-forming agent, and the support layer further includes at least one of a structural stabilizer and a filler; and / or, The functional layer further comprises at least one of a sustained-release substrate, a humectant, a carrier and a fluidity improver; and / or, The disintegrating layer includes a third film-forming agent, and the disintegrating layer further includes at least one of a binder, a flavoring agent, a seasoning, a pH adjuster, and a humectant.

8. The oral product according to claim 7, characterized in that The second film-forming agent comprises at least one of polyvinyl butyral, ethyl cellulose, cellulose acetate and starch; and / or, The third film-forming agent includes at least one of modified chitosan, hydroxypropyl methylcellulose, hydroxypropyl cellulose, sodium carboxymethyl starch, sodium alginate, polysorbate and micropowder silica gel; and / or, The structural stabilizer comprises at least one of polyvinyl pyrrolidone, ethylene-vinyl acetate copolymer, hydroxypropyl methylcellulose, sodium carboxymethyl cellulose, polyacrylic acid resin, triacetin, diethyl phthalate and glycerol; and / or, The filler comprises at least one of microcrystalline cellulose, ethyl cellulose, micropowdered silica gel, calcium phosphate, calcium sulfate, talc, calcium carbonate, hydroxyapatite and starch; and / or, The active agent comprises at least one of nicotine and a nicotine derivative; and / or, The sustained-release matrix comprises at least one of hypromellose, hydroxypropyl cellulose and polyvinyl resin; and / or, The humectant includes at least one of glycerol, propylene glycol, sorbitol, sodium alginate, chitosan, starch, starch derivatives, polysorbate and sucrose fatty acid ester; and / or, The carrier comprises at least one of microcrystalline cellulose, starch and cyclodextrin; and / or, The fluidity improver includes at least one of silicon dioxide, talc, magnesium stearate, microcrystalline cellulose, starch and anhydrous lactose.

9. The oral product according to any one of claims 1 to 6, characterized in that The thickness of the support layer is 0.2 mm to 0.5 mm; and / or the thickness of the functional layer is 0.5 mm to 1.5 mm; and / or the thickness of the disintegrating layer is 0.1 mm to 0.3 mm; and / or the thickness of the oral product is 1 mm to 3 mm.

10. The oral product according to any one of claims 1 to 6, characterized in that A marking structure and / or an anti-slip structure is provided on a surface of the support layer on a side away from the functional layer.

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