Buccal tablet

Abstract

The buccal tablet comprises a flavor enhancement layer, and a first supporting layer, a functional layer and a second supporting layer which are arranged in sequence, the flavor enhancement layer is arranged on one side, back to the functional layer, of the first supporting layer and / or one side, back to the functional layer, of the second supporting layer; the flavor enhancement layer comprises flavor substances, and the flavor substances comprise at least one of a sweetening agent, a cooling agent and an aromatic; the functional layer contains a functional substance. The buccal tablet disclosed by the invention has multiple functions, and can better meet user requirements.

Description

Technical Field

[0001] This application relates to the field of oral lozenges, and in particular to an oral lozenge. Background Technology

[0002] Oral products, such as nicotine lozenges, are products containing functional substances (nicotine or its derivatives). They are usually placed in the mouth in the form of powder, oral films, lozenges, or sachets. They then dissolve and release the functional substances, which are absorbed through the oral mucosa, thereby relieving nicotine withdrawal symptoms when quitting smoking.

[0003] Lozenges are tablet or film-like products, typically made from soluble materials and containing a certain amount of functional substances. When used, they are placed in the mouth and come into contact with saliva, releasing the functional substances. However, current lozenges usually have a single-layer structure, offering limited functionality and failing to better meet user needs. Summary of the Invention

[0004] This application provides a lozenge to address the problem of poor user experience in existing lozenge products.

[0005] This application discloses a lozenge, comprising a flavor enhancement layer, and a first support layer, a functional layer, and a second support layer disposed sequentially; the flavor enhancement layer is disposed on the side of the first support layer opposite to the functional layer and / or the side of the second support layer opposite to the functional layer; the flavor enhancement layer comprises flavor substances, the flavor substances comprising at least one of sweeteners, cooling agents, and aroma agents; the functional layer contains functional substances.

[0006] In one implementation of this application, the flavor enhancement layer includes a plurality of dispersed flavor particles, wherein the flavor particles satisfy at least one of the following conditions: (I) the flavor particles include a first flavor particle and a second flavor particle, wherein the flavor substances in the first flavor particle are of different types than those in the second flavor particle; (II) at least a portion of the plurality of dispersed flavor particles are deposited by spraying; (III) at least a portion of the plurality of dispersed flavor particles are deposited by powder spraying.

[0007] In one implementation of this application, the lozenge further includes a functional enhancement layer, which comprises a functional substance and is disposed on the side of the first support layer opposite to the functional layer and / or the side of the second support layer opposite to the functional layer.

[0008] In one implementation of this application, the functional enhancement layer is disposed on the side of the flavor enhancement layer facing the functional layer; and / or, the content of functional substances in the functional enhancement layer is lower than the content of functional substances in the functional layer; and / or, the functional enhancement layer comprises a plurality of dispersed functional particles; and / or, the functional enhancement layer is formed by spray molding or liquid spray molding.

[0009] In one implementation of this application, the functional enhancement layer further includes at least one of a moisturizing lubricant and a thickener; and / or, the flavor enhancement layer further includes at least one of a moisturizing lubricant and a thickener.

[0010] In one implementation of this application, the moisturizing lubricant includes at least one of the following: sodium hyaluronate, sodium alginate; and / or, the tackifier includes at least one of the following: polyvinyl alcohol, hydroxypropyl cellulose, xanthan gum, gum arabic.

[0011] In one implementation of this application, at least one of the first support layer and the second support layer includes a support substrate and a lubricating layer that at least wets a portion of the structure of the support substrate, wherein the support substrate has a liquid-permeable porous structure.

[0012] In one implementation of this application, the supporting substrate is a non-woven fabric; and / or,

[0013] The lubricating layer comprises a gel matrix material and a crosslinking agent, which form a three-dimensional crosslinked network structure. The three-dimensional crosslinked network structure can swell to form a gel structure upon contact with moisture.

[0014] In one implementation of this application, the gel matrix material comprises at least one of the following: sodium alginate, pectin, carrageenan, polyacryl alcohol; and / or, the crosslinking agent comprises at least one of the following: Ca 2+ Al 3+ Fe 3+ ; and / or, the nonwoven fabric includes at least one of the following: natural fiber nonwoven fabric, synthetic fiber nonwoven fabric, electrospun nanofiber membrane.

[0015] In one implementation of this application, the functional layer includes at least two sub-functional layers, wherein the functional layer satisfies at least one of the following conditions: (1) an isolation layer is provided between at least one set of two adjacent sub-functional layers; (2) the types and / or concentrations of functional substances in at least two sub-functional layers are different; (3) the types and / or concentrations of flavor substances in at least two sub-functional layers are different; and (4) the release rates of functional substances in at least two sub-functional layers are different.

[0016] The beneficial effects of this application are as follows:

[0017] The lozenge of this application has a multi-layered structure and multiple functions, which can better meet the needs of users. The first support layer and the second support layer can provide support and protection for the functional layer. The functional layer can provide functional substances to meet the needs of users. The flavor enhancement layer can preferentially provide flavor substances to improve the aroma and taste experience. Attached Figure Description

[0018] Figure 1 A schematic diagram of the structure of a lozenge according to a specific embodiment of this application is shown.

[0019] Figure 2 A schematic diagram of the structure of a lozenge according to another specific embodiment of this application is shown.

[0020] Figure 3 A schematic diagram of the structure of a lozenge according to another specific embodiment of this application is shown.

[0021] Figure 4 A schematic diagram of the structure of a lozenge according to another specific embodiment of this application is shown. Detailed Implementation

[0022] The present invention will now be described in further detail with reference to specific embodiments and accompanying drawings. In the following embodiments, many details are described to facilitate a better understanding of the present application. However, those skilled in the art will readily recognize that some features may be omitted in different situations, or may be replaced by other materials or methods. In some cases, certain operations related to the present application are not shown or described in the specification. This is to avoid obscuring the core parts of the present application with excessive description. For those skilled in the art, detailed description of these related operations is not necessary; they can fully understand the related operations based on the description in the specification and general technical knowledge in the art.

[0023] Furthermore, the features, operations, or characteristics described in the specification can be combined in any suitable manner to form various embodiments. At the same time, the steps or actions in the method description can be rearranged or adjusted in a manner obvious to those skilled in the art. Therefore, the various orders in the specification and drawings are only for the clear description of a particular embodiment and do not imply a necessary order, unless otherwise stated that a particular order must be followed.

[0024] The serial numbers assigned to components in this article, such as "first" and "second", are used only to distinguish the objects being described and have no sequential or technical meaning.

[0025] This application provides a lozenge 100.

[0026] Figure 1This paper shows a schematic diagram of the structure of a lozenge 100 according to a specific embodiment of the present application. Figure 2 A schematic diagram of the structure of a lozenge 100 according to another specific embodiment of this application is shown. Figure 3 This illustration shows a structural schematic diagram of a lozenge 100 according to another specific embodiment of this application. Figure 4 A schematic diagram of the structure of a lozenge 100 according to another specific embodiment of this application is shown. It should be noted that, to more intuitively demonstrate the interlayer structure of the lozenge 100, Figures 1 to 4 The diagram shows the structure of each layer separately, but in the actual product, the layers are in contact with each other.

[0027] In one specific embodiment, the lozenge 100 may include a first support layer 10, a functional layer 30, and a second support layer 20 sequentially disposed therefrom. The functional layer 30 contains a functional substance. The first support layer 10 and the second support layer 20 provide support and protection for the functional layer 30.

[0028] In one specific embodiment, at least one of the first support layer 10 and the second support layer 20 includes a support matrix and a lubricating layer that at least wets a portion of the support matrix structure. In other words, the first support layer 10 includes a support matrix and a lubricating layer that at least wets a portion of the support matrix structure, and / or, the second support layer 20 includes a support matrix and a lubricating layer that at least wets a portion of the support matrix structure. It should be noted that the lubricating layer can improve the roughness of the support layer it is located on, reduce damage to the user's oral cavity, and thus improve the user experience.

[0029] In one specific embodiment, both the first support layer 10 and the second support layer 20 include a support substrate and a lubricating layer that at least partially wets the structure of the support substrate. It should be noted that in some embodiments, the lubricating layer wets the support substrate, which can be understood as the lubricating layer encapsulating the support substrate.

[0030] In one specific embodiment, the lubricating layer completely wets the support substrate.

[0031] In one specific embodiment, the support substrate has a liquid-permeable porous structure. This allows saliva to pass through and enter the functional layer 30.

[0032] In one specific embodiment, the support substrate is a nonwoven fabric. The nonwoven fabric includes at least one of the following: natural fiber nonwoven fabric, synthetic fiber nonwoven fabric, and electrospun nanofiber membrane. The synthetic fiber nonwoven fabric can be PVA nonwoven fabric. It should be noted that in some embodiments of this application, the nonwoven fabric, as the support substrate, provides both physical support and liquid permeability. Using a lubricating layer to wet the support substrate reduces the hardness of the support layer, making it less likely to damage the oral mucosa upon contact; the lubricating layer also has a moisturizing effect, reducing oral dryness and discomfort caused by the water absorption of the functional layer and the support substrate; furthermore, the lubricating layer wets the support substrate, reducing the adsorption of flavor molecules by the support substrate, avoiding insufficient release of flavor substances, and thus preventing any impact on the aroma or taste before or during consumption.

[0033] In one specific embodiment, the lubricating layer comprises a gel matrix material and a crosslinking agent. The gel matrix material and the crosslinking agent form a three-dimensional crosslinked network structure. Upon contact with moisture, the three-dimensional crosslinked network structure swells to form a gel structure. Thus, when the oral lozenge 100 is used, the gel structure formed by the lubricating layer can improve the surface roughness of the support layer and reduce oral friction damage.

[0034] In one specific embodiment, the gel matrix material includes at least one of the following: sodium alginate, pectin, carrageenan, and polyacryl alcohol.

[0035] In one specific embodiment, the crosslinking agent includes at least one of the following: Ca 2+ Al 3+ Fe 3+ Therefore, a gel matrix material can be cross-linked to form a gel structure using a cross-linking agent.

[0036] In one specific embodiment, the thickness of the first support layer 10 can be 0.1 mm to 0.2 mm. For example, the thickness of the first support layer 10 can be 0.1 mm, 0.13 mm, 0.15 mm, 0.17 mm or 0.2 mm.

[0037] In one specific embodiment, the thickness of the second support layer 20 can be 0.1 mm to 0.2 mm. For example, the thickness of the second support layer 20 can be 0.1 mm, 0.13 mm, 0.15 mm, 0.17 mm or 0.2 mm.

[0038] In one embodiment, the lozenge 100 may include a flavor-enhancing layer 40. The flavor-enhancing layer includes flavor substances. The flavor substances include at least one of sweeteners, cooling agents, and flavoring agents.

[0039] In one specific embodiment, the sweetener may include at least one selected from xylitol, sorbitol, mannitol, iodine, lactitol, maltitol, isomaltitol, hydrogenated starch hydrolysate, erythritol, maltodextrin, aspartame, acesulfame potassium, sodium saccharin, sucralose, neotame, cyclamate, alitane, steviol glycosides, arabinitol, and monk fruit sweetener. Other edible-grade substances may also be selected, which will not be detailed here.

[0040] In one specific embodiment, the flavoring agent may include at least one of fragrance, natural essential oil, and natural extract. The fragrance is an edible fragrance, which may include at least one of bergamot fragrance, eucalyptus fragrance, citrus fragrance, lemon fragrance, peppermint fragrance, peppermint fragrance, menthol, licorice fragrance, wintergreen fragrance, tobacco fragrance, coffee fragrance, vanilla fragrance, lime fragrance, apple fragrance, peach fragrance, mango fragrance, cherry fragrance, blueberry fragrance, strawberry fragrance, cola fragrance, cinnamon fragrance, pandan fragrance, and watermelon fragrance. Other types of edible fragrances may also be included, which will not be detailed here.

[0041] In one specific embodiment, the cooling agent may include at least one of menthol, menthol derivatives, WS-3, and WS-23.

[0042] In one specific embodiment, the flavor enhancement layer 40 may be located on the side of the first support layer 10 opposite to the functional layer 30 and / or on the side of the second support layer 20 opposite to the functional layer 30. This allows flavor substances to be preferentially released through the flavor enhancement layer 40, thereby enhancing the aroma and taste experience.

[0043] like Figure 1 As shown, in a specific embodiment, the lozenge 100 may sequentially include a flavor enhancement layer 40, a first support layer 10, a functional layer 30, and a second support layer 20.

[0044] In one specific embodiment, there can be multiple flavor enhancement layers 40. For example, it may include flavor enhancement layer 41 and flavor enhancement layer 42. Flavor enhancement layer 41 and flavor enhancement layer 42 may be located on opposite sides of the first support layer 10 and the second support layer 20, respectively. Thus, flavor substances can be provided simultaneously through flavor enhancement layer 41 and flavor enhancement layer 42, improving aroma and taste experience.

[0045] like Figure 2 As shown, in a specific embodiment, the lozenge 100 may sequentially include a flavor enhancement layer 41, a first support layer 10, a functional layer 30, a second support layer 20, and a flavor enhancement layer 42.

[0046] In one specific embodiment, the flavor enhancement layer 40 may include multiple dispersed flavor particles. In another specific embodiment, the flavor enhancement layer 40 may be composed of multiple dispersed flavor particles. It should be noted that the flavor enhancement layer 40, composed of multiple dispersed flavor particles, can reduce the diffusion and transfer of flavor substances within the flavor particles, as well as reduce the adsorption of flavor substances within the flavor particles by other layers. The flavor enhancement layer 40 of this application, through the form of flavor particles, can improve the retention rate and release rate of flavor substances, thereby improving the taste.

[0047] In one specific embodiment, the flavor particles may include a first flavor particle and a second flavor particle. The types of flavor substances in the first flavor particle and the second flavor particle may be different. Thus, by placing different flavor substances in different flavor particles, intermolecular interference between different flavor substances can be reduced. For example, different flavor substances may compete for adsorption, thereby affecting the uniformity of aroma or taste.

[0048] In one specific embodiment, at least some of the multiple dispersed flavor particles are deposited by spraying, which is a simple molding process and is conducive to industrial production.

[0049] In one specific embodiment, at least some of the multiple dispersed flavor particles are obtained by spraying powder, which is a simple molding process and is conducive to industrial production.

[0050] In one specific embodiment, the first flavor particles are obtained by spray deposition. The second flavor particles are obtained by spray deposition.

[0051] In one specific embodiment, the flavor particles may include flavoring substances, thickeners, and moisturizing lubricants.

[0052] In one specific embodiment, the thickener may include at least one of the following: polyvinyl alcohol, hydroxypropyl cellulose, xanthan gum, and gum arabic. This enhances the viscosity of the first flavor particles, reduces flow after spraying, and thus facilitates the obtaining of a plurality of dispersed first flavor particles.

[0053] In one specific embodiment, the moisturizing lubricant may include at least one of the following: sodium hyaluronate and sodium alginate. This reduces roughness and makes the mouthfeel smoother when in contact with flavor particles.

[0054] In one specific embodiment, the first flavor particles may include a fragrance, a thickener, and a moisturizing lubricant.

[0055] In one specific embodiment, the first flavor particle may include 10 to 15 parts of a thickener. For example, it may include 10, 11, 12, 13, 14, or 15 parts of a thickener.

[0056] In one specific embodiment, the first flavor particle may include 1 to 3 parts of a moisturizing lubricant. For example, it may include 1 part, 1.5 parts, 2 parts, 2.5 parts, or 3 parts of a moisturizing lubricant.

[0057] In one specific embodiment, the first flavor particle may include 4 to 7 parts of a flavoring agent.

[0058] In one specific embodiment, the second flavor particles may include a cooling agent, a carrier, and a flow aid.

[0059] In one specific embodiment, the carrier may include lactitol and mannitol. Thus, flavoring agents can be adsorbed in dry powder form, and the carrier itself can also function as a sweetener.

[0060] In one specific embodiment, the flow aid may include silica. This improves flowability and facilitates the smooth operation of the powder coating process.

[0061] In one specific embodiment, the second flavor particle may include 50 to 80 parts of a carrier. For example, it may include 50, 60, 70, or 80 parts of a carrier.

[0062] In one specific embodiment, the second flavor particles may include 1 to 3 parts of a flow aid. For example, it may include 1 part, 1.5 parts, 2 parts, 2.5 parts, or 3 parts of a flow aid.

[0063] In one specific embodiment, the second flavor particles may include 0.2 to 1 part of a cooling agent. For example, it may include 0.2 parts, 0.5 parts, 0.75 parts, or 1 part of a cooling agent.

[0064] In one specific embodiment, first flavor particles can be formed in a support layer by spraying and then dried; subsequently, second flavor particles can be further formed by spraying. This reduces the impact of undried droplets from the first flavor particle preparation process on the second flavor particles.

[0065] In one specific embodiment, the functional layer 30 may include functional materials.

[0066] In one specific embodiment, the functional substance may include at least one of nicotine and nicotine derivatives, used to provide a sense of satisfaction.

[0067] In one specific embodiment, nicotine may include natural nicotine and synthetic nicotine. Nicotine derivatives may include one or more of the following: nicotine salts, nicotine in a matrix such as a glycobase or an organometallic complex, nicotine-resin combinations, nicotine inclusion complexes, and non-covalently bound nicotine. Non-covalently bound nicotine includes nicotine lactate, nicotine malate, nicotine salicylate, nicotine cyclodextrin-encapsulated complexes, nicotine hydrochloride, nicotine dihydrochloride, nicotine tartrate, nicotine tartrate dihydrate, nicotine sulfate, nicotine zinc chloride, and nicotine benzoate. Nicotine derivatives also include nicotine containing substituents, such as one or more mixtures of hexamethylnicotine, hexamethylnicotine lactate, hexamethylnicotine malate, hexamethylnicotine salicylate, hexamethylnicotine cyclodextrin encapsulated complex, hexamethylnicotine hydrochloride, hexamethylnicotine dihydrochloride, hexamethylnicotine tartrate, hexamethylnicotine tartrate dihydrate, hexamethylnicotine sulfate, hexamethylnicotine zinc chloride, and hexamethylnicotine benzoate.

[0068] In one specific embodiment, the functional substance may also be selected from other substances with medical or other specific uses, such as vitamins, capsaicin, caffeine, etc., to meet the needs of different users.

[0069] In one specific embodiment, the functional substance may also be selected from other alkaloids or amino acids. For example, alkaloids such as tobacco, coffee, and tea.

[0070] In one specific embodiment, the functional layer 30 may or may not include flavor substances.

[0071] In one specific embodiment, the functional layer 30 may include a film-forming agent. The film-forming agent may include at least one of hydroxypropyl methylcellulose (HPMC), polyvinyl alcohol, pullulan, gelatin, chitosan, polyvinylpyrrolidone, and sodium carboxymethyl cellulose.

[0072] In one specific embodiment, the functional layer 30 may include a thickener. The thickener is used to increase viscosity, which is beneficial for the sustained-release effect and also helps to improve interlayer bonding. The thickener may include at least one of a polycarboxylated polymer, a starch ether derivative, or a sodium hyaluronate-chitosan polyelectrolyte complex.

[0073] In one embodiment, the functional layer 30 may include a plasticizer. The plasticizer can be used to improve the toughness of the membrane of the functional layer 30, preventing the membrane from becoming too brittle. The plasticizer may include at least one of glycerol, sorbitol, propylene glycol, polyethylene glycol, and xylitol.

[0074] In one specific embodiment, the functional layer 30 may include a sustained-release agent. The sustained-release agent is used to slow the release of the functional substance. The sustained-release agent includes at least one of sodium alginate, carrageenan (κ type), and mesoporous silica.

[0075] In one embodiment, functional layer 30 may include a pH adjuster. The pH adjuster may include at least one selected from citric acid, sodium carbonate, sodium bicarbonate, potassium carbonate, potassium bicarbonate, and magnesium carbonate.

[0076] In one embodiment, functional layer 30 may include an antioxidant. The antioxidant may include at least one selected from ethylparaben, ascorbic acid, vitamin E, butylated hydroxytoluene, and butylated hydroxyanisole.

[0077] In one specific embodiment, the functional layer 30 may include a solubilizer. The solubilizer may include at least one of the following: polyethylene glycol (e.g., PEG-200, PEG-400, PEG-600, etc.), Tween (e.g., Tween-20, Tween-80, etc.), and poloxamer, to improve the solubility of the raw materials.

[0078] In one specific embodiment, the functional layer 30 may include 10 to 50 parts by weight of a film-forming agent. For example, the functional layer 30 may include 10, 20, 30, 40, or 50 parts by weight of a film-forming agent.

[0079] In one specific embodiment, the functional layer 30 may include 8 to 12 parts by weight of functional material. For example, the functional layer 30 may include 8, 9, 10, 11, or 12 parts by weight of functional material.

[0080] In one specific embodiment, the functional layer 30 may include 0 to 10 parts by weight of thickener. For example, the functional layer 30 may include 0, 2, 4, 6, 8, or 10 parts by weight of thickener.

[0081] In one specific embodiment, the functional layer 30 may include 2 to 15 parts by weight of plasticizer. For example, the functional layer 30 may include 2, 5, 7.5, 10, 12.5, or 15 parts by weight of plasticizer.

[0082] In one specific embodiment, the functional layer 30 may include 0 to 1 parts by weight of a pH adjuster. For example, the functional layer 30 may include 0, 0.05, 0.1, 0.5, or 1 part by weight of a pH adjuster.

[0083] In one specific embodiment, the functional layer 30 may include 0 to 0.5 parts by weight of antioxidant. For example, the functional layer 30 may include 0, 0.1, 0.2, 0.3, 0.4, or 0.5 parts by weight of antioxidant.

[0084] In one specific embodiment, the functional layer 30 is formed by coating to form a film.

[0085] In one specific embodiment, the thickness of the functional layer 30 can be 50 μm to 200 μm. For example, the thickness of the functional layer 30 can be 50 μm, 100 μm, 150 μm or 200 μm.

[0086] In one specific embodiment, functional layer 30 may include multiple sub-functional layers. For example, such as Figure 3 As shown, functional layer 30 may include sub-functional layer 31 and sub-functional layer 32. Functional layer 30 may also include three, four or more sub-functional layers, which will not be described in detail in this application.

[0087] In one specific embodiment, at least two sub-functional layers have different types and / or concentrations of functional substances. It should be noted that when functional layer 30 includes three or more sub-functional layers, at least two of the sub-functional layers have different types and / or concentrations of functional substances. In some embodiments, within functional layer 30, some sub-functional layers have the same type and concentration of functional substances; others have different types and / or concentrations. For example, functional layer 30 includes at least sub-functional layer 31 and sub-functional layer 32. The types of functional substances contained in sub-functional layer 31 and sub-functional layer 32 may be different, or the types of functional substances contained in sub-functional layer 31 and sub-functional layer 32 may be the same but their concentrations may differ. Therefore, by setting different sub-functional layers, more diverse user needs can be met.

[0088] In one specific embodiment, at least two sub-functional layers have different types and / or concentrations of flavor substances. It should be noted that when functional layer 30 includes three or more sub-functional layers, at least two sub-functional layers have different types and / or concentrations of flavor substances. In some embodiments, within functional layer 30, some sub-functional layers have the same type and concentration of flavor substances compared to each other; others have different types and / or concentrations of flavor substances compared to each other. For example, functional layer 30 includes at least sub-functional layer 31 and sub-functional layer 32. The types of flavor substances contained in sub-functional layer 31 and sub-functional layer 32 may be different, or the types of flavor substances contained in sub-functional layer 31 and sub-functional layer 32 may be the same but their concentrations may differ. Therefore, by setting different sub-functional layers, more diverse user needs can be met.

[0089] In one specific embodiment, the functional substances in at least two sub-functional layers have different release rates. It should be noted that when functional layer 30 includes three or more sub-functional layers, the functional substances in at least two of the sub-functional layers have different release rates. Release rate can refer to the rate at which a substance enters the oral cavity from the functional layer. In some embodiments, within functional layer 30, some sub-functional layers have the same release rate of their functional substances; others have different release rates. For example, functional layer 30 includes at least sub-functional layer 31 and sub-functional layer 32, wherein the functional substances in sub-functional layer 31 and sub-functional layer 32 have different release rates; for instance, the release rate of the functional substances in sub-functional layer 31 is greater than that in sub-functional layer 32. Therefore, the functional substances in the lozenge 100 can have different release rates to meet diverse user needs, such as the user's need for immediate satiating effect combined with long-lasting absorption.

[0090] In one specific embodiment, an isolation layer 60 is provided between at least one set of two adjacent sub-functional layers. It should be noted that when the functional layer 30 includes three or more sub-functional layers, an isolation layer 60 is provided between at least two of the sub-functional layers. For example, as... Figure 3 As shown, an isolation layer 60 is provided between sub-functional layer 31 and sub-functional layer 32.

[0091] In one specific embodiment, the isolation layer 60 can be a hydrophobic membrane or a water-repellent membrane. The isolation layer 60 can be impermeable to water. The isolation layer 60 is hydrophobic, capable of blocking, controlling, or delaying the passage of moisture.

[0092] In one specific embodiment, the isolation layer 60 can separate two adjacent sub-functional layers. For example, the isolation layer 60 can separate sub-functional layer 31 and sub-functional layer 32.

[0093] In one specific embodiment, the lozenge 100 may sequentially include a flavor enhancement layer 40, a first support layer 10, a sub-functional layer 31, an isolation layer 60, a sub-functional layer 32, and a second support layer 20.

[0094] In one specific embodiment, the lozenge 100 may sequentially include a flavor enhancement layer 41, a first support layer 10, a sub-functional layer 31, an isolation layer 60, a sub-functional layer 32, a second support layer 20, and a flavor enhancement layer 42.

[0095] In one specific embodiment, the isolation layer 60 can be at least one of a polytetrafluoroethylene film, a polyethylene film, a polyvinylidene fluoride film, a polyurethane film, a silicone rubber film, or a silicone-coated fabric. It should be noted that the isolation layer 60 can block and regulate the entry of moisture from both sides of the lozenge 100 into the functional layer 30 simultaneously, which helps prevent the lozenge 100 from dissolving too quickly in the mouth. Furthermore, in some embodiments, the isolation layer 60 can be used as a coating substrate to directly coat the surface of the isolation layer 60 to form the functional layer 30.

[0096] In one specific embodiment, the thickness of the isolation layer 60 can be 50 μm to 100 μm. For example, the thickness of the isolation layer 60 can be 50 μm, 75 μm, or 100 μm.

[0097] In one embodiment, the lozenge 100 may include a functional enhancement layer 50. The functional enhancement layer includes a functional substance.

[0098] In one specific embodiment, the functional enhancement layer 50 is disposed on the side of the first support layer 10 opposite to the functional layer 30 and / or the side of the second support layer 20 opposite to the functional layer 30.

[0099] In one specific embodiment, the functional enhancement layer 50 is disposed on the side of the flavor enhancement layer 40 facing the functional layer 30. For example, as Figure 4 As shown, the functional enhancement layer 50 is disposed between the flavor enhancement layer 40 and the first support layer 10 (or between the flavor enhancement layer 40 and the second support layer 20).

[0100] In one specific embodiment, there may be multiple functional enhancement layers 50. For example, the functional enhancement layers 50 may include functional enhancement layer 51 and functional enhancement layer 52. Functional enhancement layer 51 is disposed between flavor enhancement layer 40 and first support layer 10, and functional enhancement layer 52 is disposed between flavor enhancement layer 40 and second support layer 20.

[0101] In one specific embodiment, the functional enhancement layer 50 includes multiple dispersed functional particles. It should be noted that by providing the functional enhancement layer 50, a rapid onset of action can be achieved, avoiding the restriction of functional substance diffusion caused by the obstruction effect of the support matrix and lubrication layer of the first support layer 10 (or the second support layer 20) on the functional substances in the functional layer 50, thus preventing delayed onset of action. Furthermore, the functional substances in the functional layer 30 located within the first support layer 10 and the second support layer 20 can have their release delayed due to the obstruction effect of the support matrix and lubrication layer. This gives the lozenge 100 the dual effect of rapid release and prolonged effect.

[0102] In one specific embodiment, the functional enhancement layer is formed by spray molding or liquid spraying, which is a simple molding process and is conducive to industrial production.

[0103] In one specific embodiment, the functional enhancement layer is formed by depositing multiple dispersed functional particles in the form of spray or liquid spray.

[0104] In one specific embodiment, the functional particles may include functional substances, thickeners, and moisturizing lubricants.

[0105] In one specific embodiment, the thickener may include at least one of the following: polyvinyl alcohol, hydroxypropyl cellulose, xanthan gum, and gum arabic. This enhances the viscosity of the functional particles, reduces flow after spraying or atomizing, and thus facilitates the obtaining of a dispersed distribution of multiple functional particles.

[0106] In one specific embodiment, the moisturizing lubricant may include at least one of the following: sodium hyaluronate and sodium alginate. This reduces roughness and makes the texture smoother when in contact with functional particles.

[0107] In one specific embodiment, the content of functional substances in the functional enhancement layer 50 is lower than that in the functional layer 30. Most of the functional substances are continuously released through the functional layer 30, while a small portion is provided with an immediate release through the functional enhancement layer 40 to meet the user's immediate needs. A high instantaneous release concentration may cause user discomfort.

[0108] In one specific embodiment, the functional enhancement layer 50 may include 10 to 15 parts of a tackifier. For example, it may include 10, 11, 12, 13, 14, or 15 parts of a tackifier.

[0109] In one specific embodiment, the functional enhancement layer 50 may include 1 to 3 parts of a moisturizing lubricant. For example, it may include 1 part, 1.5 parts, 2 parts, 2.5 parts, or 3 parts of a moisturizing lubricant.

[0110] In one specific embodiment, the functional enhancement layer 50 may include 4 to 7 parts of functional material. For example, it may include 4, 5, 6, or 7 parts of functional material.

[0111] This application also provides a method for preparing a lozenge, comprising: obtaining a support substrate, impregnating the support substrate with a lubricating liquid to form a lubricating layer on the support substrate, thereby obtaining a first support layer 10 and a second support layer 20; obtaining a film-forming liquid, coating the film-forming liquid to form a functional layer 30; obtaining a reagent containing flavor substances, depositing the reagent on the surface of the first support layer to obtain a flavor enhancement layer 40; and obtaining the lozenge 100 in which the flavor enhancement layer 40, the first support layer 10, the functional layer 30, and the second support layer 20 are sequentially arranged.

[0112] The present application will be further described in detail below through specific experimental procedures and experimental data examples. The following examples are for further illustration only and should not be construed as limiting the present application. In these examples, unless otherwise specified, all reagents and instruments used are commercially available, and all experimental operations are performed in accordance with product instructions and standard experimental procedures.

[0113] I. Preparation process:

[0114] Support layer preparation: A nonwoven fabric with a porosity of approximately 40% was soaked in a 15% sodium alginate solution at 25°C for 5 minutes. After removal, it was sprayed with a 0.5% CaCl2 solution at a spray rate of 5 mL / cm². 2 The material was then vacuum dried at 25°C (10 kPa) to obtain a support layer with a moisture content of ≤5%. The support layer exhibited the following crosslinking characteristics: calcium ion content 0.34 ± 0.02 mmol / g (EDTA titration); and mechanical testing showed an elongation at break ≥120% (ASTM D5035). A first and second support layer, each 100 μm thick, were obtained, and were identical to each other.

[0115] Isolation layer: The isolation layer is made of 50μm thick fluorinated polypropylene film.

[0116] Functional Layer Preparation: Preparing the Film Solution: HPMC E3 was dispersed in purified water at 60℃ and stirred until dissolved (500 rpm, 30 min). Glycerin and sucralose were added sequentially, followed by homogenization (50 bar pressure). Finally, nicotine tartrate was added, and the mixture was stirred in the dark for 15 min. Coating and Forming: A comma-knife coater was used. The isolation layer was placed on the coating plane, and the temperature of the coating plane was maintained at 25±1℃. The coating thickness was adjusted in real-time using a laser thickness gauge (accuracy ±1 μm). Coating speed: 2.5 m / min (film thickness controlled at 50±1 μm, CV≤2%). Gradient Drying: First stage: 40℃ hot air drying for 3 min (removing surface moisture); Second stage: 60℃ infrared drying for 5 min (curing the film structure). The drying curve consisted of a gradient temperature increase from 40℃ (10℃ / min) to 60℃ and maintained for 5 minutes. The isolation layer was flipped over, and the film solution was coated on the other side using the same coating and drying parameters. A first functional layer and a second functional layer were obtained, and the first and second functional layers were identical. The proportions of the film-forming solution are shown in the table below:

[0117]

[0118]

[0119] Composite: The first support layer and the second support layer are superimposed on both sides of the functional layer to obtain a composite membrane structure consisting of the first support layer, the first functional layer, the isolation layer, the second functional layer, and the second support layer.

[0120] Preparation of functional enhancement layers: High-pressure atomization was used to deposit atomized liquid onto the surfaces of the first and second support layers to obtain droplets containing functional substances. After drying, the first and second functional enhancement layers were obtained. The process included: atomization liquid preparation: PVA-217 was dissolved in water at 85℃ and cooled to 40℃; sodium hyaluronate and ethanol aqueous solution were added (magnetically stirred for 20 min); finally, nicotine was added (stirring speed ≤200 rpm); ultrasonic atomization: a 20kHz ultrasonic nozzle was used, with an atomization pressure of 0.4 MPa and a spray distance of 15 cm, and the coating was repeated 3 times (with an interval of 30 s); low-temperature curing: drying was carried out at 35℃ with circulating air at a wind speed of 0.5 m / s.

[0121] The formulation of the atomizing fluid is shown in the table below:

[0122]

[0123] Preparation of flavor enhancement layer:

[0124] ① Fragrance droplets are deposited on the surfaces of the first and second functional enhancement layers using high-pressure atomization technology. The process includes: preparation of the atomizing liquid; dissolving PVA-217 in water at 85℃ and cooling to 40℃; adding sodium hyaluronate and an ethanol aqueous solution (magnetically stirring for 20 min); finally adding fragrance microcapsules (stirring speed ≤200 rpm); ultrasonic atomization: using a 20kHz ultrasonic nozzle, atomization pressure of 0.4MPa, spray distance of 15cm, and reciprocating spraying 3 times (with an interval of 30s); low-temperature curing: drying with circulating air at 35℃ and an air velocity of 0.5m / s. The formulation of the atomizing liquid is shown in the table below:

[0125]

[0126]

[0127] ②Then, a spray coating process is performed to further deposit the cooling agent and sweetener dry powder. A quick-release system for the sweetener / cooling agent is constructed using freeze-drying-spray coating technology, achieving gradient release through mannitol / lactitol crystals. The process flow includes: freeze-dried powder preparation: pre-freezing the β-cyclodextrin inclusion complex and WS-23 solution to -40℃, and then gradient heating to 25℃ at 0.1mbar; particle size adjustment: pre-mixing mannitol (δ crystal form) and lactitol in a certain proportion (V-type mixer, 15min); adding freeze-dried powder and silica, and three-dimensional mixing for 5min; electrostatic spraying: spraying voltage 30kV, carrier gas pressure 0.2MPa. The β-cyclodextrin inclusion complex includes β-cyclodextrin and WS-23 encapsulated within the β-cyclodextrin. The formulation of the freeze-dried powder is shown in the table below:

[0128] Function Element Particle size Mass (grams) Cooling agent β-cyclodextrin inclusion complex - 22 Carriers and sweeteners Mannitol (δ crystal form) D50 = 50-100μm 35 Carriers and sweeteners lactitol D50 = 80-120μm 30 Cooling agent WS-23 D50 < 30μm 0.45 Flow aid silicon dioxide D50 = 15-30μm 2

[0129] II. Performance Testing

[0130] (1) Nicotine dissolution experiment:

[0131] Dissolution tester: RCZ-8M intelligent drug dissolution tester manufactured by Tianjin Tianda Tianfa Technology Co., Ltd.

[0132] Method: USPII paddle method, speed: 50 rpm, temperature: 37℃.

[0133] Samples: This embodiment of the lozenge and ordinary lozenge (ordinary lozenge refers to: the first and second support layers are both non-woven fabrics with a porosity of about 40%, without the use of sodium alginate and calcium chloride treatment; the functional layer is based on the functional layer of Example 1, with the same amount of cooling agent WS-23, flavoring agent menthol and sweetener sucralose as in Example 1; without flavor enhancement layer; without functional enhancement layer).

[0134] Dissolution medium: 900 mL PBS (pH 6.8) phosphate buffer (simulating saliva environment).

[0135] Sampling device: Equipped with an automatic sampler, which automatically completes sampling, filtration and liquid replenishment operations at set time points (0.5, 1, 3, 5, 7, 10 and 15 minutes) to reduce human error.

[0136] High-performance liquid chromatography (HPLC): An Agilent 1260 Infinity II HPLC system from Agilent Technologies, equipped with a C18 column (4.6 × 250 mm, 5 μm), was used for the accurate determination of nicotine content.

[0137] Sampling was carried out at the predetermined time, with a sample volume of 5 mL. The sample was filtered through a 0.22 μm microporous membrane and then analyzed by HPLC.

[0138] Data analysis: Cumulative release rate (%) = [(total nicotine content detection concentration × dissolution medium volume) ÷ total nicotine content] × 100%; the release curve was fitted using a first-order kinetic model (Weibull equation).

[0139] The release rates of nicotine at different dissolution time points are shown in the table below:

[0140] Time (min) This embodiment uses lozenges (%) Regular lozenges (%) 0.5 8.20％ 0.00％ 1 22.70％ 2.29％ 3 46.40％ 5.34％ 5 55.10％ 43.10％ 10 64.30％ 57.30％ 15 76.50％ 66.50％ 30 89.52％ 66.30％

[0141] As shown above, at 30 seconds (0.5 minutes), the nicotine release rate of the lozenge in this embodiment reached 8.20%, while that of ordinary lozenges was 0.00%. This indicates that the lozenge in this embodiment can initiate nicotine release in a very short time, quickly reaching the senses. At 1 minute, the release rate of the lozenge in this embodiment jumped to 22.70%, while that of ordinary lozenges was only 2.29%, further widening the gap. This demonstrates the high early release efficiency of the lozenge in this embodiment, allowing users to quickly perceive the active ingredient. At 3 minutes, the present invention achieved a release rate of 46.40% compared to 5.34%, further expanding its early release advantage and being much faster than ordinary lozenges. In summary, this embodiment, through innovative processes (such as double-sided coating and spraying), breaks through the limitations of traditional lozenge structure and composition, significantly improving the early dissolution rate of nicotine and solving the problem of "difficult to perceive early release" in traditional products. It achieves a significant technological breakthrough in nicotine delivery efficiency, providing users with a more efficient and tailored experience.

[0142] (2) Dissolution test of sweeteners, cooling agents and flavorings

[0143] 1. Experimental Objective

[0144] The release characteristics of sucralose, WS-23, and menthol in the lozenges of this embodiment were verified, and the release differences were compared with those of ordinary lozenges to analyze the sustained release effect of the taste components.

[0145] 2. Experimental Materials and Equipment

[0146] Samples: This embodiment of the lozenge and ordinary lozenge (ordinary lozenge refers to: the first and second support layers are both non-woven fabrics with a porosity of about 40%, without the use of sodium alginate and calcium chloride treatment; the functional layer is based on the functional layer of Example 1, with the same amount of cooling agent WS-23, flavoring agent menthol and sweetener sucralose as in Example 1; without flavor enhancement layer; without functional enhancement layer).

[0147] Reagent: Simulated saliva (pH 6.8, containing 0.5% SDS).

[0148] Instruments: Dissolution apparatus (USPⅡ paddle method, 37±0.5℃, 50rpm), HPLC system (C18 column, sucralose detection wavelength 210nm, WS-23 detection wavelength 275nm, menthol detection wavelength 215nm), 0.22μm filter membrane.

[0149] 3. Experimental Procedure

[0150] Dissolution test: Take 500 mL of simulated saliva, preheat it to 37°C, and add it to the dissolution vessel. Fix the sample to the bottom of the dissolution apparatus and start the instrument. Take 5 mL of sample at 0.5, 1, 3, 5, 7, 10, and 15 minutes (add 5 mL of simulated saliva at the same temperature at the same time). Filter the sample through a 0.22 μm filter membrane and wait for analysis.

[0151] Content determination: The concentrations of sucralose, WS-23, and menthol in the filtrate were determined by HPLC. Mobile phase: acetonitrile-phosphate buffer (pH 3.0, ratio 40:60), flow rate 1.0 mL / min, injection volume 20 μL.

[0152] Data calculation: Release rate (%) = (detected concentration × dissolution medium volume) ÷ total amount added × 100%.

[0153] The release rates of sweeteners, cooling agents, and flavorings at different dissolution time points are as follows:

[0154]

[0155] As shown above, the release of flavor, sweetness, and cooling substances in ordinary lozenges is significantly insufficient in the early stages. At 0.5 minutes, the release rate of sucralose in ordinary lozenges is only 3.2%, less than one-tenth of the 38.5% in the lozenge of this embodiment; the release rate of WS-23 is 2.8%, far lower than the 41.2% in the lozenge of this embodiment; and the release rate of menthol is 4.1%, also significantly lower than the 16.8% in the lozenge of this embodiment. By 3 minutes, the release rates of sucralose, WS-23, and menthol in ordinary lozenges are 14.2%, 13.1%, and 16.7%, respectively, while the corresponding values ​​in the lozenge of this embodiment have reached 67.3%, 69.8%, and 45.6%. It is evident that ordinary lozenges cannot meet the user's need for a rich taste experience immediately upon ingestion. At 15 minutes, the cumulative release rate of ordinary lozenges improves, but the slow release rate in the early stages prevents users from obtaining a good taste experience in the initial consumption, severely affecting the product's taste. The lozenge in this embodiment, through an innovative process, enables the rapid release and long-lasting maintenance of three taste substances.

[0156] (3) Surface roughness test of oral lozenges

[0157] 1. Experimental Objective

[0158] Verify whether the surface roughness (Ra) of the lozenge in this embodiment is ≤0.8μm (ISO 4287 standard) and compare it with the risk of frictional damage of ordinary lozenges.

[0159] 2. Experimental Materials and Equipment

[0160] Samples: Lozenges of this embodiment; Ordinary lozenges (Ordinary lozenges refer to: the first and second support layers are both non-woven fabrics with a porosity of about 40%, without the use of sodium alginate and calcium chloride treatment; the functional layer is based on the functional layer of Example 1, with the same amount of cooling agent WS-23, flavoring agent menthol and sweetener sucralose as in Example 1; without flavor enhancement layer; without functional enhancement layer).

[0161] Instrument: Laser roughness measuring instrument (model: Mitutoyo SJ-210, stylus type, accuracy ±0.01μm).

[0162] 3. Experimental Methods

[0163] Five test points were randomly selected on the surface of the lozenge (avoiding the edges), and each point was measured three times and the average value was taken. According to ISO4287 standard, the sampling length was set to 4 mm, the evaluation length to 20 mm, and the stylus speed to 0.5 mm / s.

[0164] The results are as follows:

[0165]

[0166] As shown above, the surface roughness Ra of the oral lozenge in this embodiment is 0.71±0.03μm, which is significantly lower than that of traditional oral lozenges (Ra=2.30±0.04μm), meeting the requirement of "Ra≤0.8μm" in ISO 4287 standard, and can reduce the risk of oral friction damage by more than 80% (data from mechanical friction test simulation experiment). The reduction in roughness is attributed to sodium alginate-Ca 2+ The cross-linked nanoscale lubricating layer (SEM observation shows that the fiber surface is covered with a uniform gel layer, and the roughness is reduced from the micrometer level to the nanometer level).

[0167] The above description, in conjunction with specific embodiments, provides a further detailed explanation of this application and should not be construed as limiting the specific implementation of this application to these descriptions. Those skilled in the art to which this application pertains can make several simple deductions or substitutions without departing from the concept of this application.

Claims

1. A lozenge, characterized in that, It includes a flavor enhancement layer, and a first support layer, a functional layer, and a second support layer arranged sequentially; the flavor enhancement layer is disposed on the side of the first support layer opposite to the functional layer and / or the side of the second support layer opposite to the functional layer; the flavor enhancement layer includes flavor substances, the flavor substances including at least one of sweeteners, cooling agents, and aroma agents; the functional layer contains functional substances.

2. The lozenge as described in claim 1, characterized in that, The flavor enhancement layer comprises a plurality of dispersed flavor particles, wherein the flavor particles satisfy at least one of the following conditions: (I) The flavor particles include a first flavor particle and a second flavor particle, wherein the flavor substances in the first flavor particle are different from those in the second flavor particle; (II) At least a portion of the plurality of dispersed flavor particles are obtained by spraying; (III) At least some of the plurality of dispersed flavor particles are obtained by spraying.

3. The lozenge as described in claim 1, characterized in that, The lozenge further includes a functional enhancement layer comprising a functional substance, and the functional enhancement layer is disposed on the side of the first support layer opposite to the functional layer and / or the side of the second support layer opposite to the functional layer.

4. The lozenge as described in claim 3, characterized in that, The functional enhancement layer is disposed on the side of the flavor enhancement layer facing the functional layer; and / or, The content of functional substances in the functional enhancement layer is lower than the content of functional substances in the functional layer; and / or, The functional enhancement layer comprises a plurality of dispersed functional particles; and / or, The functional enhancement layer is formed by spray molding or liquid spray molding.

5. The lozenge as described in claim 3, characterized in that, The functional enhancement layer further includes at least one of a moisturizing lubricant and a tackifier; and / or, The flavor-enhancing layer also includes at least one of a moisturizing lubricant and a thickener.

6. The lozenge as described in claim 5, characterized in that, The moisturizing lubricant includes at least one of the following: sodium hyaluronate, sodium alginate; and / or, The tackifier includes at least one of the following: polyvinyl alcohol, hydroxypropyl cellulose, xanthan gum, and gum arabic.

7. The lozenge as described in claim 1, characterized in that, At least one of the first support layer and the second support layer includes a support substrate and a lubricating layer that at least wets a portion of the structure of the support substrate, wherein the support substrate has a liquid-permeable porous structure.

8. The lozenge as described in claim 7, characterized in that, The supporting substrate is a nonwoven fabric; and / or, The lubricating layer comprises a gel matrix material and a crosslinking agent, which form a three-dimensional crosslinked network structure. The three-dimensional crosslinked network structure can swell to form a gel structure upon contact with moisture.

9. The lozenge as described in claim 8, characterized in that, The gel matrix material includes at least one of the following: sodium alginate, pectin, carrageenan, polyacryl alcohol; and / or, The crosslinking agent includes at least one of the following: Ca 2+ Al 3+ Fe 3+ ; and / or, The nonwoven fabric includes at least one of the following: natural fiber nonwoven fabric, synthetic fiber nonwoven fabric, and electrospun nanofiber membrane.

10. The lozenge as described in claim 1, characterized in that, The functional layer comprises at least two sub-functional layers, wherein the functional layer satisfies at least one of the following conditions: (1) An isolation layer is provided between at least one pair of adjacent sub-functional layers; (2) The types and / or concentrations of functional substances in at least two of the sub-functional layers are different; (3) The types and / or concentrations of flavor substances in at least two of the sub-functional layers are different; (4) The release rates of the functional substances in at least two of the sub-functional layers are different.

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