Buccal tablet and preparation method thereof

Abstract

The invention discloses a buccal tablet and a preparation method thereof, the buccal tablet comprises at least one load layer and at least one film-shaped functional layer which are stacked in the thickness direction, and the adjacent load layer and / or functional layer are combined through a pressure forming process; the film-like functional layer comprises a film-forming agent and a functional substance; the functional substance comprises at least one of an active agent and a flavoring agent; the loading layer is made of an insoluble sheet-shaped base material; the preparation method comprises the following steps: obtaining a film-like functional layer, wherein the film-like functional layer comprises a film-forming agent and a functional substance; obtaining a load layer, wherein the load layer is selected from an insoluble sheet-shaped base material; at least two materials are placed in a stacked mode, pressure is applied to enable the materials to be combined, the material layers are selected from film-shaped functional layers, load layers and module layers, the module layers are prepared by combining any number of film-shaped functional layers and / or load layers in a stacked mode, and the buccal tablet finished product is prepared. The load layer and the functional layer are combined through the pressure forming technology, and the technology is simple.

Description

Technical Field

[0001] The present application relates to the field of food or pharmaceutical technology, and in particular to a buccal tablet and a preparation method thereof. Background Art

[0002] Related technologies provide bag-shaped oral products, which are formed into powders of active substances and filled into non-woven bags, such as nicotine bags. When used, the nicotine bag is directly held in the mouth. However, this type of product has a strong foreign body sensation when used, and powder is easily precipitated on the surface of the non-woven bag, resulting in a poor taste. Summary of the Invention

[0003] The present application provides a buccal tablet and a preparation method thereof, so as to solve the problem of poor taste of bagged buccal products during use.

[0004] The technical solution adopted by the present application to solve its technical problems is: a buccal tablet, including at least one load layer and at least one film-like functional layer stacked in the thickness direction, and adjacent load layers and / or functional layers are combined by a pressure forming process; the film-like functional layer contains a film-forming agent and a functional substance; the functional substance includes at least one of an active agent and a flavoring agent; the load layer uses an insoluble sheet substrate.

[0005] In some embodiments, the support layer includes a bottom support layer disposed at the bottommost layer, and the at least one functional layer is disposed on the bottom support layer.

[0006] In some embodiments, there are multiple functional layers, the load layer further includes an intermediate load layer arranged between the functional layers, and the functional layers and the intermediate load layers are alternately arranged one by one on the bottom load layer; or, there are multiple functional layers, the load layer further includes an intermediate load layer arranged between the functional layers, and at least one functional layer is arranged between two adjacent load layers; and / or, the load layer further includes a top load layer located at the top.

[0007] In some embodiments, the buccal tablet comprises at least two functional layers, and the types and / or concentrations of functional substances loaded in the at least two functional layers are different.

[0008] In some embodiments, the middle carrier layer is water-repellent; and / or the bottom carrier layer is made of a saliva-permeable substrate; and / or the top carrier layer is made of a saliva-permeable substrate.

[0009] In some embodiments, the pressure forming process is a rolling process; and / or the thickness of a single functional layer is 25 μm to 300 μm; and / or the load layer is made of non-woven fabric; and / or the functional layer also includes a softener; and / or the functional layer also includes a pH regulator; and / or the flavoring agent includes at least one of a flavor, a cooling agent, and a sweetener; and / or, in parts by mass, the raw materials for preparing the functional layer include: 5 to 90 parts of a film-forming agent, 1 to 10 parts of an active agent, 0.1 to 30 parts of a softener, 1 to 10 parts of a pH regulator, and a flavoring agent, and the flavoring agent includes 1 to 10 parts of a flavor, 1 to 3 parts of a sweetener, and 0.5 to 1 part of a cooling agent.

[0010] In some embodiments, the film-forming agent includes at least one of hydroxypropyl methylcellulose, polyvinyl alcohol, sodium alginate, gelatin, gum arabic and starch; and / or the active agent includes at least one of nicotine and nicotine derivatives; and / or the softener includes at least one of glycerin, polyethylene glycol and propylene glycol; and / or the pH adjuster includes at least one of sodium bicarbonate, sodium carbonate and sodium citrate; and / or the flavor includes at least one of mint flavor, lemon flavor, green tea flavor and coffee flavor; and / or the sweetener includes at least one of sucralose, maltose, trehalose and lactose; and / or the cooling agent includes at least one of WS-23, WS-3, WS-12 and menthol.

[0011] The present application also proposes a method for preparing an oral tablet, which includes the following steps: obtaining a film-like functional layer, the film-like functional layer includes a film-forming agent and a functional substance; obtaining a load layer, the load layer is selected from an insoluble sheet-like substrate; stacking and combining: stacking at least two materials and applying pressure to combine them, wherein the material layer is selected from a film-like functional layer, a load layer, and a module layer, wherein the module layer is prepared by stacking and combining any number of film-like functional layers and / or load layers to obtain a finished oral tablet, wherein the finished oral tablet includes at least one load layer and at least one film-like functional layer.

[0012] In some embodiments, in obtaining the film-like functional layer, a semi-dry film-like functional layer attached to the release film is obtained; in the lamination and bonding, the following steps are included: S1, laminating the support layer on the surface of the film-like functional layer facing away from the release film, and rolling the back of the release film with a roller until the film-like functional layer is completely transferred to the support layer to obtain a finished oral tablet or module layer.

[0013] In some embodiments, the lamination process further includes the following steps after step S1: S2, laminating the surface of a membrane-like functional layer facing away from its release film on the surface of the module layer obtained in step S1 on which the release film has been peeled off, and applying pressure to laminate and bond the two to obtain a finished oral tablet or module layer; or, laminating a load layer on the surface of the module layer obtained in step S1 on which the release film has been peeled off, and applying pressure to laminate and bond the two to obtain a finished oral tablet or module layer.

[0014] In some embodiments, during the lamination process, step S2 is followed by the following steps: S3, repeating step S2, or laminating the surface of a membrane-like functional layer facing away from the release film on a surface of the exposed load layer in the module layer obtained in step S2, and applying pressure to laminate the two to obtain a finished oral tablet or module layer; S4, repeating step S2 or step S3 several times until a finished oral tablet with a set number of material layers is obtained.

[0015] In some embodiments, in the stacking combination, the membrane functional layer and the load layer satisfy at least one of the following stacking arrangement conditions: the load layer includes a bottom load layer arranged at the bottom layer, and at least one membrane functional layer is arranged on the bottom load layer; there are multiple membrane functional layers, and the load layer also includes an intermediate load layer arranged between the membrane functional layers, and the membrane functional layers and the intermediate load layers are alternately arranged one by one on the bottom load layer; or there are multiple membrane functional layers, and the load layer also includes an intermediate load layer arranged between the membrane functional layers, and at least one membrane functional layer is arranged between two adjacent load layers; the load layer also includes a top load layer located at the top.

[0016] In some embodiments, obtaining a film-like functional layer includes the following steps: obtaining a functional layer membrane liquid containing a film-forming agent and a functional substance, applying the functional layer membrane liquid to a release film, heating it to a semi-dry state, and obtaining a film-like functional layer attached to the release film; and / or, stacking at least two materials and applying pressure to combine them, stacking at least two materials and applying pressure through a rolling process to combine the two materials; and / or, after stacking and combining, further including the following steps: cutting the finished oral tablet obtained by stacking and combining into set specifications to obtain oral tablets; and / or, after stacking and combining, further including the following steps: heating the finished oral tablet obtained by stacking and combining to a dry state; and / or, after obtaining the oral tablets, further including the following steps: installing the oral tablets into a packaging bag.

[0017] In some embodiments, obtaining a functional layer membrane liquid containing a film-forming agent and a functional substance further comprises the following steps: adding water to the film-forming agent and stirring until the film-forming agent is completely dissolved to prepare a film-forming agent solution, adding the functional substance to the film-forming agent solution and stirring until the functional substance is completely dissolved to prepare a functional layer membrane liquid; adding a pH regulator to adjust the pH value of the functional layer membrane liquid to 4-9; stirring and vacuuming to defoam; and / or, obtaining a functional layer membrane liquid containing a film-forming agent and a functional substance further comprises the following steps: controlling the solid content of the functional layer membrane liquid to 10-30%; and / or, obtaining a functional layer membrane liquid containing a film-forming agent and a functional substance further comprises the following steps: controlling the viscosity of the functional layer membrane liquid to 100mPa.s-50000mPa.s; and / or, the semi-dry state is the state in which the functional layer membrane liquid is initially formed into a non-flowing state; and / or, in the semi-dry state, the water content of the functional layer membrane liquid is 10%-40%.

[0018] Beneficial effects of this application:

[0019] The buccal tablets provided in the present application improve the problem of powder precipitation in bagged buccal products by forming the functional substance on a film-like functional layer; in addition, the release rate of the functional substance can be controlled by controlling the load layer to avoid the functional substance being released too quickly and causing stomach discomfort; at the same time, the load layer and the functional layer are combined using a pressure forming process, which is relatively simple and does not require the addition of additional adhesives, thereby avoiding the impact of other additional adhesives on the taste or other adverse effects.

[0020] In the present invention's method for preparing a buccal tablet, a film-forming functional layer and a support layer containing a film-forming agent and a functional substance are first separately prepared. Several of these film-forming functional layers and support layers are then stacked and pressure is applied to bond them together. This process is relatively simple and does not require the addition of additional adhesives, thus preventing any adverse effects such as the impact of additional adhesives on taste or other adverse effects. Furthermore, compared to processes that directly apply a functional layer film solution to a support layer, the present invention's functional layer film solution does not seep through the support layer, affecting taste or appearance. This method for preparing a buccal tablet is more controllable, and the stacking process is simpler and more modular. BRIEF DESCRIPTION OF THE DRAWINGS

[0021] The present application will be further described below with reference to the accompanying drawings and embodiments, in which:

[0022] Figure 1 Schematic diagram of the structure of the buccal tablet according to the first embodiment of the present application;

[0023] Figure 2 Schematic diagram of the structure of the buccal tablet according to the second embodiment of the present application;

[0024] Figure 3 1 is a schematic structural diagram of a buccal tablet according to a third embodiment of the present application;

[0025] Figure 41 is a schematic structural diagram of a buccal tablet according to a fourth embodiment of the present application;

[0026] Figure 5 Flowchart of the preparation method of the buccal tablets of some embodiments of the present application. DETAILED DESCRIPTION

[0027] In order to have a clearer understanding of the technical features, purposes and effects of the present application, the present application will be further described in detail below in conjunction with examples. The examples are only used to explain the present application and do not constitute a limitation on the scope of protection of the present application.

[0028] This application proposes a lozenge comprising at least one support layer and at least one film-like functional layer stacked in the thickness direction. Adjacent support layers and / or functional layers are bonded together via a pressure forming process. The film-like functional layer comprises a film-forming agent and a functional substance, wherein the functional substance comprises at least one of an active agent and a flavoring agent. The support layer is constructed from an insoluble sheet-like substrate, where "insoluble" refers to maintaining structural integrity (e.g., no significant change in morphology or mechanical properties) when placed in water.

[0029] The present application improves the problem of powder precipitation in bagged oral products by forming the functional substance on a film-like functional layer. In addition, the release rate of the functional substance can be controlled by controlling the load layer to avoid stomach discomfort caused by too rapid release of the functional substance. At the same time, the load layer and the functional layer are combined using a pressure forming process, which is relatively simple and does not require the addition of additional adhesives, thus avoiding the impact of other additional adhesives on the taste or other adverse effects. In addition, the adjacent load layer and / or functional layer of the present application are combined through a pressure forming process. Compared with the process of directly coating the functional layer membrane liquid on the load layer, the functional layer membrane liquid of the present application will not penetrate the load layer and affect the taste or appearance.

[0030] In a first embodiment of the buccal tablet of the present application, the support layer includes a bottom support layer disposed at the bottom layer of the buccal tablet, and at least one functional layer is disposed on the bottom support layer. The total number of functional layers may be N layers, where N is a positive integer. For example, the total number of functional layers may be one, two, three, four, etc. In some embodiments, the structure of the buccal tablet may be bottom support layer-functional layer, bottom support layer-functional layer-functional layer, or bottom support layer-functional layer-functional layer-functional layer. For example, Figure 1 As shown, the buccal tablet includes a bottom support layer 1a, a functional layer 2a, a functional layer 3a, and a functional layer 4a, stacked sequentially in the thickness direction. Positioning the support layer at the bottom allows it to contact the tongue or mucosal surface during use, while the functional layer does not directly contact the tongue or mucosa, helping to reduce irritation. Furthermore, the release rate of the functional substance in the functional layer can be controlled by adjusting the water permeability of the support layer.

[0031] In some embodiments, the buccal tablet includes at least two functional layers, and the types and / or concentrations of functional substances loaded in at least two functional layers are different. For example, multiple functional layers contain different concentrations of nicotine, so that the release gradient can be controlled. Alternatively, multiple functional layers are provided, some of which are loaded with nicotine, some are loaded with cooling agents, and some are loaded with flavors, so that a rich taste and flavor layer can be provided. The buccal tablet can have functional layers with a variety of different tastes to enhance the user experience. In addition, during preparation, it is also more convenient for modular production, and functional layers of various flavors can be prefabricated, and the required functional layers can be selected and combined later.

[0032] In some embodiments, there are multiple functional layers, and the load layer also includes an intermediate load layer arranged between the functional layers; the intermediate load layer can enhance the mechanical strength of the overall structure; in addition, it can also isolate the functional layers, prevent the substances in the functional layers from migrating to other functional layers, affecting the taste, and extending the shelf life.

[0033] In the second embodiment of the buccal tablet of the present application, there are multiple functional layers, and the load-bearing layer further includes an intermediate load-bearing layer disposed between the functional layers, and the functional layers and the intermediate load-bearing layers are alternately disposed on the bottom load-bearing layer one by one. In some embodiments, the total number of functional layers can be N layers, where N is a positive integer, and an intermediate load-bearing layer is disposed between adjacent functional layers. For example, the structure of the buccal tablet can be bottom load-bearing layer-functional layer-intermediate load-bearing layer-functional layer, bottom load-functional layer-intermediate load-bearing layer-functional layer-intermediate load-bearing layer-functional layer, and so on. For example, Figure 2 As shown, the buccal tablet includes a bottom support layer 1 b , a functional layer 2 b , an intermediate support layer 3 b and a functional layer 4 b which are sequentially stacked in the thickness direction.

[0034] In the third embodiment of the buccal tablet of the present application, there are multiple functional layers, the support layer further includes an intermediate support layer disposed between the functional layers, and at least one functional layer is disposed between two adjacent support layers. For example, the structure of the buccal tablet may be bottom support layer-functional layer-functional layer-intermediate support layer-functional layer. For example, Figure 3 As shown, the buccal tablet includes a bottom support layer 1c, a functional layer 2c, a functional layer 3c, an intermediate support layer 4c, and a functional layer 5c which are sequentially stacked in the thickness direction.

[0035] In a fourth embodiment of the buccal tablet of the present application, the support layer further comprises a top support layer located at the top of the buccal tablet. For example, the structure of the buccal tablet may be bottom support layer-functional layer-functional layer-top support layer, bottom support layer-functional layer-functional layer-middle support layer-functional layer-top support layer. For example, Figure 4As shown, the buccal tablet comprises a bottom support layer 1d, a functional layer 2d, a functional layer 3d, an intermediate support layer 4d, a functional layer 5d, and a top support layer 6d, stacked sequentially in the thickness direction. This arrangement of the functional layer between the bottom and top support layers provides enhanced mechanical strength and facilitates control of release rate by manipulating properties such as the water permeability of the support layers.

[0036] In some embodiments, the middle carrier layer of the carrier layer is water-repellent, providing enhanced barrier properties. In some embodiments, the bottom carrier layer and the top carrier layer are made of a saliva-permeable substrate. Thus, when a user takes the lozenge, saliva can penetrate the bottom or top carrier layer to dissolve at least a portion of the substance in the functional layer.

[0037] In some embodiments, the supporting layer may be made of non-woven fabric, which absorbs water and prevents excessive saliva from carrying nicotine into the stomach, causing stomach discomfort. Figure 4 As shown, the bottom load-bearing layer 1d and the top load-bearing layer 6d are both non-woven fabrics, and the middle load-bearing layer 4d is a water-repellent isolation fabric.

[0038] In some embodiments, the pressure forming process is a roller pressing process; the roller pressing process is easy to design for continuous production, and has a simple process and a high production rate.

[0039] In some embodiments, the thickness of a single functional layer is 25 μm to 300 μm, for example, 25 μm, 50 μm, 100 μm, 200 μm, or 300 μm. By adjusting the thickness of the functional layer, the overall release rate of the ingredients in the buccal tablet can be controlled. Generally speaking, the thicker the functional layer, the slower the overall release rate of the buccal tablet.

[0040] In some embodiments, the functional layer further comprises a softener, so that the functional layer is softer, more easily combined with other layers, and has a better taste.

[0041] In some embodiments, the functional layer further comprises a pH adjuster, which is used to adjust the overall pH value to make the pH value more suitable for oral administration and to facilitate absorption of the functional substance.

[0042] In some embodiments, the flavoring agent in the functional substance includes at least one of a flavor, a sweetener, and a cooling agent. The flavoring agent may include one, i.e., a flavor, a sweetener, or a cooling agent; or the flavoring agent may include two, such as a flavor and a sweetener, a flavor and a cooling agent, or a sweetener and a cooling agent; or the flavoring agent may include three, i.e., a flavor, a sweetener, and a cooling agent.

[0043] In some embodiments, the functional layer includes a film-forming agent, a functional substance (including an active agent and a flavoring agent), a softener, and a pH adjuster. The raw materials for preparing the functional layer include, by weight, 5 to 90 parts of a film-forming agent, 1 to 10 parts of an active agent, 0.1 to 30 parts of a softener, 1 to 10 parts of a pH adjuster, and a flavoring agent. The flavoring agent includes 1 to 10 parts of an essence, 1 to 3 parts of a sweetener, and 0.5 to 1 part of a cooling agent. In some embodiments, the film-forming agent may be 5 parts, 20 parts, 50 parts, 70 parts, or 90 parts, etc., the active agent may be 1 part, 3 parts, 5 parts, 8 parts, or 10 parts, etc., the softener may be 0.1 parts, 5 parts, 10 parts, 15 parts, or 30 parts, etc., and the pH adjuster may be 1 part, 4 parts, 6 parts, 8 parts, or 10 parts, etc. The flavor in the seasoning can be 1 part, 3 parts, 5 parts, 7 parts or 10 parts, the sweetener can be 1 part, 2 parts or 3 parts, and the cooling agent can be 0.5 part, 0.6 part, 0.8 part or 1 part.

[0044] The film-forming agent is the base material of the functional layer and is used to form the functional layer film material. In some embodiments, the film-forming agent includes at least one of hydroxypropyl methylcellulose (such as E5 grade), polyvinyl alcohol (PVA), sodium alginate, gelatin, gum arabic and starch, wherein the starch can be pregelatinized starch.

[0045] In some embodiments, the active agent in the functional material of the functional layer includes at least one of nicotine and a nicotine derivative. Nicotine includes, but is not limited to, natural nicotine and synthetic nicotine. Nicotine derivatives include, but are not limited to, 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, but is not limited to, nicotine lactate, nicotine malate, nicotine salicylate, nicotine cyclodextrin inclusion 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.

[0046] In some embodiments, the active agent may also include other substances with specific active properties, such as caffeine, tea polyphenols, amino acids, vitamins, tobacco extracts, or other plant extracts, to meet the different needs of users.

[0047] In some embodiments, the flavoring in the functional layer is used to enhance the flavor, and is an edible flavor. For example, the flavor includes at least one of mint flavor, lemon flavor, green tea flavor, and coffee flavor. The flavor can also be edible flavors of other flavors, which will not be described in detail in this application.

[0048] In some embodiments, the sweetener of the flavoring in the functional layer is used for mouthfeel optimization and includes at least one of sucralose, maltose, trehalose, and lactose.

[0049] In some embodiments, the cooling agent of the flavoring in the functional layer is used to adjust and improve the taste, and includes at least one of WS-23 (N,2,3-trimethyl-2-isopropylbutanamide), WS-3 (N-ethyl-p-menthyl-3-carboxamide), WS-12 (N-(4-methoxyphenyl)-p-menthyl-3-carboxamide) and menthol.

[0050] In some embodiments, the softener in the functional layer is used to improve the flexibility of the buccal tablet, and includes at least one of glycerin, polyethylene glycol (PEG), and propylene glycol, wherein the polyethylene glycol may be PEG 400, PEG 600, or PEG 1500.

[0051] In some embodiments, the pH adjuster in the functional layer is used to adjust the pH value (acidity or alkalinity) of the functional layer, and includes at least one of sodium bicarbonate, sodium carbonate, and sodium citrate.

[0052] In some embodiments, the raw materials for preparing the functional layer include, by weight, 2-30 parts of hydropropyl methylcellulose, 1-15 parts of sodium alginate, 1-30 parts of starch, and 1-15 parts of gelatin; the active agent includes 0.5-5 parts of nicotine and 0.5-5 parts of nicotine salt; the softener includes 0.1-15 parts of glycerin and 0-15 parts of polyethylene glycol; the pH adjuster includes 0.5-5 parts of sodium bicarbonate and 0.5-5 parts of sodium carbonate; the flavoring includes 1-10 parts of flavor, 1-3 parts of sweetener, and 0.5-1 part of cooling agent, wherein the flavor includes 0.5-5 parts of mint flavor and 0.5-5 parts of lemon flavor; the sweetener includes 0.5-2 parts of sucralose and 0.5-1 part of maltose; and the cooling agent includes 0.5-1 part of WS-23.

[0053] In some embodiments, if the total number of functional layers in the buccal tablet is at least two, the components and weight fractions of each functional layer may be the same or different.

[0054] This application also proposes a method for preparing a buccal tablet, which is used to prepare the buccal tablet. Figure 5 As shown, the preparation method comprises the following steps:

[0055] obtaining a film-like functional layer, wherein the film-like functional layer comprises a film-forming agent and a functional substance;

[0056] obtaining a supporting layer, wherein the supporting layer is an insoluble sheet-like substrate;

[0057] Stacking and combining: stacking at least two materials and applying pressure to combine them, wherein the material layer is selected from the film-like functional layer, the load layer, and the module layer, wherein the module layer is prepared by stacking and combining any number of the film-like functional layers and / or the load layers to obtain a finished oral tablet, wherein the finished oral tablet comprises at least one load layer and at least one film-like functional layer.

[0058] In some embodiments, the pressure is applied by rolling the material, which can achieve continuous production and improve production efficiency.

[0059] In some embodiments, in obtaining the film-like functional layer, a semi-dried film-like functional layer attached to the release film is obtained;

[0060] The stacking process includes the following steps:

[0061] S1. Laminating a support layer on the surface of the film-like functional layer facing away from the release film, and rolling the back of the release film with a rolling wheel until the film-like functional layer is completely transferred to the support layer to obtain a finished oral tablet or module layer.

[0062] In some embodiments, the stacking process further includes the following steps after step S1:

[0063] S2. Lay the surface of a membrane-like functional layer facing away from its release film on the surface of the module layer obtained in step S1 on which the release film has been peeled off, and apply pressure to laminate and combine the two to obtain a finished oral tablet or module layer; or, laminate a load layer on the surface of the module layer obtained in step S1 on which the release film has been peeled off, and apply pressure to laminate and combine the two to obtain a finished oral tablet or module layer.

[0064] In some embodiments, the stacking process further includes the following steps after step S2:

[0065] S3, repeating step S2, or laminating a surface of a film-like functional layer facing away from the release film onto one surface of the exposed support layer in the module layer prepared in step S2, and applying pressure to laminate the two layers to obtain a finished buccal tablet or module layer;

[0066] S4. Repeat step S2 or step S3 several times until a finished buccal tablet with a set number of material layers is obtained.

[0067] In some embodiments, obtaining a film-like functional layer includes the following steps: obtaining a functional layer film liquid comprising a film-forming agent and a functional substance, applying the functional layer film liquid to a release film, and heating the film liquid to a semi-dry state, thereby producing a film-like functional layer attached to the release film. The semi-dry state refers to the state in which the functional layer film liquid is initially formed into a non-flowing state. In the semi-dry state, the water content of the functional layer film liquid is 10%-40%, for example, 10%, 20%, 30%, or 40%. In this embodiment, the semi-dry functional layer does not penetrate the support layer and has suitable viscosity, allowing it to adhere to the support layer without falling off.

[0068] In some embodiments, obtaining a functional layer membrane liquid containing a film-forming agent and a functional substance further comprises the following steps: adding water to the film-forming agent and stirring until it is completely dissolved to prepare a film-forming agent solution, adding the functional substance to the film-forming agent solution and stirring until it is completely dissolved to prepare a functional layer membrane liquid; adding a pH adjuster to adjust the pH value of the functional layer membrane liquid to 4 to 9, and the pH value can be 4, 6, 8 or 9, etc.; stirring and vacuuming to defoam.

[0069] In some embodiments, when the functional substance is added to the film former solution, a softener is also added to the film former solution.

[0070] In some embodiments, a functional layer membrane liquid containing a film-forming agent and a functional substance is obtained: the solid content of the functional layer membrane liquid is controlled to be 10-30%, for example, the solid content can be 10%, 15%, 20%, 25% or 30%, etc. Controlling the solid content of the functional layer membrane liquid can better balance the viscosity and the maximum loading amount of other substances.

[0071] In some embodiments, the viscosity of the functional layer membrane liquid is controlled to be 100 mPa.s to 50,000 mPa.s, and the viscosity can be 100 mPa.s, 1,000 mPa.s, 10,000 mPa.s, 25,000 mPa.s, or 50,000 mPa.s.

[0072] In some embodiments, the film-forming agent is selected from at least one of hypromellose, sodium alginate, gelatin, gum arabic, and pregelatinized starch.

[0073] In some embodiments, the functional substance is selected from at least one of an active agent and a flavoring agent.

[0074] In some embodiments, the active agent is selected from at least one of nicotine and nicotine derivatives; in some embodiments, the active agent can also be selected from other substances with specific active properties, such as caffeine, tea polyphenols, amino acids, vitamins, tobacco extracts, or other plant extracts, etc., to meet the different needs of users.

[0075] In some embodiments, the flavoring agent is selected from at least one of a sweetener, a cooling agent, and a flavor.

[0076] In some embodiments, the softener is selected from at least one of glycerin and propylene glycol.

[0077] In some embodiments, the flavor is selected from at least one of mint flavor, lemon flavor, green tea flavor, and coffee flavor;

[0078] In some embodiments, the pH adjuster is selected from at least one of sodium bicarbonate, sodium carbonate, and sodium citrate;

[0079] In some embodiments, at least one of WS-23, WS-3, WS-12, and menthol;

[0080] In some embodiments, the raw materials for preparing the functional layer include, by weight: 5 to 90 parts of film-forming agent, 1 to 10 parts of active agent, 0.1 to 30 parts of softener, 1 to 10 parts of pH regulator and flavoring agent, wherein the flavoring agent includes 1 to 10 parts of flavor, 1 to 3 parts of sweetener and 0.5 to 1 part of cooling agent.

[0081] In some embodiments, the raw materials for preparing the functional layer include, by weight, 2-30 parts of hydropropyl methylcellulose, 1-15 parts of sodium alginate, 1-30 parts of starch, and 1-15 parts of gelatin; the active agent includes 0.5-5 parts of nicotine and 0.5-5 parts of nicotine salt; the softener includes 0.1-15 parts of glycerin and 0-15 parts of polyethylene glycol; the pH adjuster includes 0.5-5 parts of sodium bicarbonate and 0.5-5 parts of sodium carbonate; the flavoring includes 1-10 parts of flavor, 1-3 parts of sweetener, and 0.5-1 part of cooling agent, wherein the flavor includes 0.5-5 parts of mint flavor and 0.5-5 parts of lemon flavor; the sweetener includes 0.5-2 parts of sucralose and 0.5-1 part of maltose; and the cooling agent includes 0.5-1 part of WS-23.

[0082] In some embodiments, the steps for obtaining the film-like functional layer are as follows: first, water (such as purified water) is added to a stirring container (such as a stirring tank), stirred at a first stirring rate, the water temperature is raised to 50-70° C., and then a film-forming agent is added and homogenized until completely dissolved;

[0083] Add active agent, softener and flavoring, stir at the second stirring rate until completely dissolved, and control the solid content to be 10-30%;

[0084] A pH regulator is then added to adjust the pH value to 4-9, and stirring is performed at the third stirring rate; the stirring rate is adjusted to the fourth stirring rate to perform vacuum defoaming, and the vacuum is closed after the bubbles are completely eliminated to obtain a functional layer membrane liquid.

[0085] In this embodiment, the water temperature can be increased to 50°C, 55°C, 60°C, 65°C or 70°C, etc., the first stirring rate and the second stirring rate can be 50rpm~200rpm, such as 50rpm, 100rpm, 150rpm or 200rpm; the homogenization rate can be 10000rpm~20000rpm, such as 10000rpm, 12000rpm, 15000rpm or 20000rpm; the third stirring rate can be 50rpm~100rpm, such as 50rpm, 70rpm, 90rpm or 100rpm, etc.; the fourth stirring rate can be 10rpm~20rpm, such as 10rpm, 15rpm or 20rpm, etc.; the vacuum degree of vacuum defoaming can be -0.06Mpa~-0.08Mpa, such as -0.06Mpa, -0.07Mpa or -0.08Mpa, etc.

[0086] In some embodiments, to obtain a film-like functional layer, the functional layer solution obtained in any of the above embodiments is coated onto a release film, controlling the material thickness to be 25 μm to 300 μm. Heating and circulating air are then activated to dry the coated material, resulting in a semi-dried film-like functional layer attached to the release film. Coating can be performed using a coating machine. Prior to coating, a release film is first applied, which can be manufactured using conventional technology.

[0087] In this embodiment, the coating rate can be 0.1~0.3m / min, for example, 0.1m / min, 0.2m / min or 0.3m / min can be selected; the heating temperature can be 50℃~70℃, for example, 50℃, 55℃, 60℃, 65℃ or 70℃ can be selected, and the heating time can be 15min~20min, for example, 15min, 17min, 18min or 20min can be selected.

[0088] It should be noted that the specific process parameters for obtaining the membrane-like functional layer can be dynamically adjusted according to the specific production conditions, and this application will not limit them one by one.

[0089] In some embodiments, when obtaining the support layer, the support layer is selected from an insoluble sheet-like substrate and a non-woven fabric.

[0090] In some embodiments, in the lamination bonding: at least two material layers are stacked and pressure is applied to bond them, wherein the material layer is selected from a film-like functional layer, a load layer, and a module layer, wherein the module layer is a module layer made by stacking and bonding any number of film-like functional layers and / or load layers to produce a finished oral tablet, wherein the finished oral tablet comprises at least one load layer and at least one film-like functional layer.

[0091] In some embodiments, at least two materials are stacked and pressure is applied to bond them together. Alternatively, at least two materials are stacked and pressure is applied to bond them together using a rolling process. The rolling process can utilize existing technology, and specific process parameters can be dynamically adjusted based on specific production conditions and are not specifically limited in this application.

[0092] In some embodiments, the stacking process includes the following steps:

[0093] S1. Laminating the support layer onto the surface of the film-like functional layer facing away from the release film, and rolling the back of the release film with a roller until the film-like functional layer is completely transferred to the support layer, thereby producing a finished oral tablet or module layer. For example, a support layer 1-functional layer 1 structure is formed.

[0094] After step S1, the following step is further included: S2, laminating the surface of a film-like functional layer facing away from its release film onto the surface of the module layer obtained in step S1 from which the release film has been peeled (i.e., the surface of the film-like functional layer), and applying pressure to laminate and bond the two together to produce a finished oral tablet or module layer; or laminating a support layer onto the surface of the module layer obtained in step S1 from which the release film has been peeled, and applying pressure to laminate and bond the two together to produce a finished oral tablet or module layer. For example, a support layer 1-functional layer 1-functional layer 2 structure or a support layer 1-functional layer 1-support layer 2 structure is formed.

[0095] After step S2, the following step is further included: S3, repeating step S2, or laminating the surface of a film-like functional layer facing away from the release film onto one surface of the exposed support layer in the module layer produced in step S2, and applying pressure to laminate the two layers to produce a finished oral tablet or module layer. For example, a structure of support layer 1-functional layer 1-functional layer 2-functional layer 3, a structure of support layer 1-functional layer 1-functional layer 2-support layer 2, or a structure of support layer 1-functional layer 1-support layer 2-functional layer 2 is formed.

[0096] After step S3, the following step is further included: S4, repeating step S2 or step S3 several times until a finished oral tablet with a set number of material layers is obtained. In some embodiments, during the lamination, the membrane-like functional layer and the support layer meet at least one of the following lamination arrangement conditions:

[0097] The support layer includes a bottom support layer disposed at the bottom layer, and at least one membrane-like functional layer is disposed on the bottom support layer;

[0098] There are multiple membranous functional layers, the support layer further includes an intermediate support layer disposed between the membranous functional layers, and the membranous functional layers and the intermediate support layers are alternately disposed one by one on the bottom support layer; or there are multiple membranous functional layers, the support layer further includes an intermediate support layer disposed between the membranous functional layers, and at least one membranous functional layer is disposed between the support layers;

[0099] The load-bearing layer also includes a top load-bearing layer located at the uppermost position.

[0100] The structure of the lozenge can be bottom load layer-functional layer-functional layer, bottom load layer-functional layer-functional layer-top load layer, bottom load layer-functional layer-functional layer-middle load layer-functional layer, bottom load layer-functional layer-functional layer-middle load layer-functional layer-top load layer, etc.

[0101] In some embodiments, obtaining a functional layer membrane liquid containing the film-forming agent and the functional substance includes the following steps: obtaining at least two functional layer membrane liquids, wherein the functional substances contained in at least two functional layer membrane liquids differ in type and / or concentration. For example, the multiple functional layer membrane liquids may contain different concentrations of nicotine, thereby enabling a controlled release gradient. Alternatively, the multiple functional layer membrane liquids may include some containing nicotine and / or nicotine derivatives, some containing cooling agents, and some containing flavors, thereby enabling a variety of mouthfeel and flavor levels.

[0102] In some embodiments, a water-repellent material is selected as the middle support layer of the acquisition support layer. In some embodiments, a saliva-permeable substrate is selected as the bottom support layer, and in some embodiments, a saliva-permeable substrate is selected as the top support layer. For example, the bottom and top support layers are both non-woven fabrics, and the middle support layer is a water-repellent non-woven fabric.

[0103] It should be noted that the specific process parameters of the stacking combination can be dynamically adjusted according to the specific production conditions, and this application will not limit them one by one.

[0104] In some embodiments, after lamination and bonding, the following steps are further included: cutting the finished buccal tablet obtained by lamination and bonding into set specifications, heating to a dry state, and obtaining the buccal tablet.

[0105] In some embodiments, after preparing the buccal tablet, the step of placing the buccal tablet into a packaging bag is further included. In some embodiments, the length and width of each buccal tablet can be (0.5 cm to 1.5 cm) x (1.5 cm to 2.5 cm), and the nicotine content of the buccal tablet is 2 ± 0.2 mg / tablet. In some embodiments, the packaging bag can be an aluminum foil bag or a polyethylene bag, etc.

[0106] In the preparation method of the buccal tablets of the present application, a film-shaped functional layer and a support layer containing a film-forming agent and a functional substance are first obtained separately, and then several film-shaped functional layers and support layers are stacked and pressure is applied to combine them. The process is relatively simple and does not require the addition of additional adhesives, thereby avoiding the impact of other additional adhesives on the taste or other adverse effects. The preparation method of the buccal tablets of the present application is more controllable, and the stacking process is simpler and more modular. In addition, compared with other processes in which the functional layer film liquid is directly coated on the support layer, the functional layer substances of the preparation method of the present application will not penetrate into the support layer.

[0107] The following is described by specific examples:

[0108] The components and weight fractions of the functional layers in the buccal tablets of Examples 1 to 5 of the present application are shown in Table 1.

[0109] Table 1 Composition and mass fraction of the functional layers of Examples 1 to 5

[0110]

[0111] Note: “ / ” in the table means the ingredient does not exist.

[0112] It can be understood that in the above-mentioned embodiments 1 to 5 and their alternatives, the components of the film-forming agent, active agent, softener, pH regulator and flavoring agent (sweetener and cooling agent) in the functional layer can be replaced by other components of the corresponding components in the aforementioned lozenges, and the flavoring agent can be replaced by at least one of the flavor, sweetener and cooling agent, which will not be repeated here.

[0113] It should be noted that, unless there is any conflict, the embodiments and features in the embodiments of this application can be combined with each other.

[0114] The materials for the buccal tablets of Examples 1 to 5 above were used to prepare buccal tablets using the preparation method of the present application. The preparation method comprises the following steps:

[0115] R1. Obtain a film-like functional layer, which includes a film-forming agent and a functional substance.

[0116] In obtaining the film-like functional layer, a semi-dry film-like functional layer attached to the release film is obtained. Specifically, obtaining the film-like functional layer comprises the following steps: obtaining a functional layer film liquid comprising a film-forming agent and a functional substance, applying the functional layer film liquid to the release film, and heating the film-like functional layer to a semi-dry state, thereby obtaining the film-like functional layer attached to the release film. In the semi-dry state, the functional layer film liquid has a water content of 20%.

[0117] More specifically, obtaining a functional layer membrane solution containing a film-forming agent and a functional substance further comprises the following steps: adding the film-forming agent to water and stirring until completely dissolved to prepare a film-forming agent solution; adding the functional substance to the film-forming agent solution and stirring until completely dissolved to prepare a functional layer membrane solution; adding a pH adjuster to adjust the pH of the functional layer membrane solution to 7; and stirring and vacuuming to defoam. The solids content of the functional layer membrane solution is controlled to be 15%, and the viscosity of the functional layer membrane solution is controlled to be 10,000 mPa.s.

[0118] Step R1 is as follows: first, add purified water to a mixing tank and stir at a first stirring rate. Raise the water temperature to 60°C, then add a film-forming agent and homogenize until completely dissolved; add an active agent, a softener, and a flavoring agent and stir at a first stirring rate until completely dissolved, controlling the solid content to 15%; then add a pH adjuster to adjust the pH value to 7 and stir at a second stirring rate; adjust to a third stirring rate and vacuum defoam. After the bubbles are completely eliminated, close the vacuum to obtain a functional layer film liquid. In some embodiments, if the film-forming agent includes gelatin, the addition of the film-forming agent is divided into two steps: first, the gelatin is added to water and dissolved, and then the other components of the film-forming agent are slowly added. Further, the functional layer film liquid is coated on a release film, controlling the material thickness to 100μm. Then, heating and circulating air are turned on to dry the coated material to obtain a semi-dry film-like functional layer attached to the release film. The moisture content of the functional layer is 20%. The coating is performed using a coating machine. Before starting the coating, the release film is first laid.

[0119] The first stirring rate was 150 rpm, the homogenization rate was 15,000 rpm, the second stirring rate was 800 rpm, the third stirring rate was 15 rpm, the vacuum degree of the vacuum defoaming was -0.07 MPa, the coating rate was 0.2 m / min, the heating temperature was 60° C., and the heating time was 18 min.

[0120] R2. Obtain a support layer, which is an insoluble sheet-like substrate and a non-woven fabric.

[0121] R3. Lamination and Bonding: At least two materials are stacked and pressure is applied to bond them, wherein the materials are selected from a film-like functional layer, a support layer, and a module layer made by stacking and bonding any number of film-like functional layers and / or support layers, to produce a finished buccal tablet. At least two materials are stacked and pressure is applied to bond them, and at least two materials are stacked and pressure is applied to bond them using a rolling process. The buccal tablets of Examples 1-5 have a support layer-functional layer-support layer-functional layer-support layer-support layer structure, wherein the two functional layers have the same composition and weight fraction.

[0122] In the buccal tablets of Examples 1 to 5, the support layer includes a bottom support layer disposed at the bottom, and two membrane-like functional layers are disposed on the bottom support layer; the support layer also includes an intermediate support layer disposed between the membrane-like functional layers, and the membrane-like functional layers and the intermediate support layers are alternately disposed one by one on the bottom support layer; and the support layer also includes a top support layer located at the top. Figure 4 As shown, the buccal tablet includes a bottom support layer 1d, a functional layer 2d, a functional layer 3d, an intermediate support layer 4d, a functional layer 5d and a top support layer 6d which are sequentially stacked in the thickness direction.

[0123] After lamination, the process also includes cutting the finished buccal tablets into predetermined specifications, heating them to a dry state, and then placing the buccal tablets into packaging bags. Each buccal tablet measures 1 cm by 2 cm in length and width, and contains a nicotine content of 2 ± 0.2 mg / tablet. The packaging is an aluminum foil bag.

[0124] Comparative Example 1

[0125] The difference between this comparative example and Example 1 is that the buccal tablet includes a structure of support layer-functional layer-support layer-functional layer-support layer stacked in sequence in the thickness direction.

[0126] The preparation method of the buccal tablet of this comparative example comprises the following steps:

[0127] Obtain a supporting layer, wherein the supporting layer is an insoluble sheet-like substrate and a non-woven fabric.

[0128] Obtain a membrane-like functional fluid.

[0129] Lamination and bonding. In this step, the functional layer is not formed separately and then bonded to the support layer. Instead, the functional layer film liquid is directly coated onto the surface of the support layer, dried, and a film-like functional layer is formed, simultaneously bonding the underlying support layer and the functional layer. A support layer is then laminated on top of this functional layer and pressed together. Then, another functional layer film liquid is applied on top to form a functional layer, and then a support layer is laminated on top and pressed together. This produces a support layer-functional layer-support layer-functional layer-support layer buccal tablet.

[0130] The rest is the same as in Example 1 and will not be described again here.

[0131] Comparing Example 1 with Comparative Example 1, it was found that visual observation revealed that the functional layer membrane solution in Comparative Example 1 penetrated the support layer and seeped onto the uncoated side of the support layer, whereas the functional layer membrane solution in Example 1 did not seep onto the uncoated side of the support layer. During oral administration, the buccal tablet of Comparative Example 1 felt sticky and easily adhered to the oral cavity.

[0132] Comparative Example 2

[0133] The difference between this comparative example and Example 1 is that the R1 step in the preparation method of the buccal tablet is as follows:

[0134] R1. Obtain a film-like functional layer, which includes a film-forming agent and a functional substance.

[0135] In obtaining the film-like functional layer, a completely dry film-like functional layer attached to the release film is obtained. Specifically, obtaining the film-like functional layer comprises the following steps: obtaining a functional layer film liquid containing a film-forming agent and a functional substance, applying the functional layer film liquid to the release film, and heating the film liquid to a completely dry state to obtain the film-like functional layer attached to the release film.

[0136] The rest is the same as in Example 1 and will not be described again here.

[0137] By comparing Example 1 with Comparative Example 2, it can be found that the functional layer and the support layer cannot be combined in Comparative Example 2 and are easily detached; the buccal tablet of Example 1 requires a certain peeling force to separate the support layer and the functional layer.

[0138] Performance testing:

[0139] 1. Dissolution test

[0140] The lozenge samples of Examples 1 to 5 were each placed in 500 mL of artificial saliva at pH 6.8, and dissolution reaction was carried out at a temperature of 37° C. and a rotation speed of 100 r / min. Samples were taken at 0.5 min, 1 min, 2 min, 3 min, 5 min, 10 min, 15 min, 20 min, 30 min, 45 min, and 60 min, respectively. The nicotine content was then determined by high performance liquid chromatography, and the nicotine dissolution percentage was calculated. The results are shown in Table 2.

[0141] Table 2 Dissolution test results

[0142]

[0143] 2. Peel force test

[0144] Instrument: Universal material testing machine

[0145] Test method:

[0146] 1. Confirm whether the peeling jig is correct. The upper chuck is a small jig, and the lower chuck is divided into a 90° peel force jig and a 180° peel force jig. Confirm the test method and select the appropriate lower chuck;

[0147] 2. Confirm the push and pull letters on the electronic push-pull force gauge, "pull" and "push", select the upward pull "pull" and install it on the bracket downward;

[0148] 3. The samples of lozenge of examples 1-5 were respectively installed on the fixture, and the peeling force was measured.

[0149] Note: The peeling force test is to test the peeling force required to peel the top layer from the underlying layer.

[0150] Table 3 Peeling force test results

[0151] Example 1 Example 2 Example 3 Example 4 Example 5 Peel force N 6.07 5.05 4.02 4.05 4.87

[0152] According to the dissolution test results in Table 2 and the peeling force test results in Table 3, the nicotine dissolution rate of the lozenges (multi-layer) of examples 1-5 of the present application is relatively slow, the adhesion and mechanical properties of the lozenges are good, and the lozenges of example 1 have the best effect, are not sticky, are soft and not easy to fall off; the lozenges of example 2 are slightly soft; the lozenges of examples 3 and 4 are not easy to form a film; and the lozenges of example 5 are slightly hard.

[0153] It can be understood that the above examples only express the preferred embodiments of the present application, which are described in detail, but cannot be construed as limiting the scope of the patent of the present application; it should be pointed out that the above technical features can be freely combined without departing from the concept of the present application for those skilled in the art, and a number of modifications and improvements can be made, which all belong to the protection scope of the present application; therefore, any equivalent transformation and modification within the scope of the claims of the present application shall belong to the scope of the claims of the present application.

Claims

1. A buccal tablet, characterized in that: The invention comprises at least one supporting layer and at least one film-like functional layer stacked in the thickness direction, wherein the adjacent supporting layers and / or the functional layers are combined by a pressure forming process; the film-like functional layer contains a film-forming agent and a functional substance; the functional substance includes at least one of an active agent and a flavoring agent; and the supporting layer is made of an insoluble sheet-like substrate.

2. The buccal tablet according to claim 1, wherein The support layer includes a bottom support layer disposed at the bottommost layer, and at least one functional layer is disposed on the bottom support layer.

3. The buccal tablet according to claim 2, wherein There are multiple functional layers, the load layer further includes an intermediate load layer disposed between the functional layers, and the functional layers and the intermediate load layers are alternately disposed one by one on the bottom load layer; or there are multiple functional layers, the load layer further includes an intermediate load layer disposed between the functional layers, and at least one functional layer is disposed between two adjacent load layers; And / or, the load-bearing layer further includes a top load-bearing layer located at the top.

4. The buccal tablet according to claim 3, wherein In the supporting layer, the intermediate supporting layer has water repellency; and / or, The bottom support layer is made of a substrate that is permeable to saliva; and / or the top support layer is made of a substrate that is permeable to saliva.

5. The buccal tablet according to claim 1, wherein The buccal tablet comprises at least two functional layers, and the functional substances loaded on at least two functional layers are of different types and / or concentrations.

6. The buccal tablet according to any one of claims 1 to 5, characterized in that The pressure forming process is a roller pressing process; and / or, The thickness of a single functional layer is 25 μm to 300 μm; and / or, The load-bearing layer is made of non-woven fabric; and / or, The functional layer further comprises a softener; and / or, The functional layer further comprises a pH regulator; and / or, The flavoring agent includes at least one of a flavor, a cooling agent, and a sweetener; and / or, The raw materials for preparing the functional layer include, by weight, 5 to 90 parts of a film-forming agent, 1 to 10 parts of an active agent, 0.1 to 30 parts of a softener, 1 to 10 parts of a pH regulator, and a flavoring agent, wherein the flavoring agent includes 1 to 10 parts of an essence, 1 to 3 parts of a sweetener, and 0.5 to 1 part of a cooling agent.

7. The buccal tablet according to claim 6, wherein The film-forming agent includes at least one of hydroxypropyl methylcellulose, polyvinyl alcohol, sodium alginate, gelatin, gum arabic and starch; and / or, the active agent includes at least one of nicotine and nicotine derivatives; and / or, The softener comprises at least one of glycerol, polyethylene glycol and propylene glycol; and / or, The pH regulator comprises at least one of sodium bicarbonate, sodium carbonate and sodium citrate; and / or, The flavor includes at least one of mint flavor, lemon flavor, green tea flavor and coffee flavor; and / or, The sweetener comprises at least one of sucralose, maltose, trehalose and lactose; and / or, The cooling agent includes at least one of WS-23, WS-3, WS-12 and menthol.

8. A method for preparing a buccal tablet, characterized in that: The preparation method comprises the following steps: obtaining a film-like functional layer, wherein the film-like functional layer comprises a film-forming agent and a functional substance; obtaining a supporting layer, wherein the supporting layer is an insoluble sheet-like substrate; Stacking and combining: stacking at least two materials and applying pressure to combine them, wherein the material layer is selected from the film-like functional layer, the load layer, and the module layer, wherein the module layer is prepared by stacking and combining any number of the film-like functional layers and / or the load layers to obtain a finished oral tablet, wherein the finished oral tablet comprises at least one load layer and at least one film-like functional layer.

9. The method for preparing the buccal tablet according to claim 8, wherein: In the step of obtaining the film-like functional layer, a semi-dried film-like functional layer attached to the release film is obtained; The stacking process includes the following steps: S1. Laminating the support layer on the surface of the film-like functional layer facing away from the release film, and rolling the back of the release film with a rolling wheel until the film-like functional layer is completely transferred to the support layer to obtain a finished oral tablet or module layer.

10. The method for preparing the buccal tablet according to claim 9, wherein: In the stacking process, the following steps are further included after step S1: S2. Lay the surface of one of the film-like functional layers facing away from the release film on the surface of the module layer obtained in step S1 on which the release film has been peeled off, and apply pressure to laminate and combine the two to obtain a finished oral tablet or module layer; or, laminate one of the support layers on the surface of the module layer obtained in step S1 on which the release film has been peeled off, and apply pressure to laminate and combine the two to obtain a finished oral tablet or module layer.

11. The method for preparing the buccal tablet according to claim 10, wherein: In the stacking process, the following steps are further included after step S2: S3, repeating step S2, or laminating the surface of one of the film-like functional layers facing away from the release film onto the exposed surface of the support layer in the module layer prepared in step S2, and applying pressure to laminate the two layers to obtain a finished buccal tablet or module layer; S4. Repeat step S2 or step S3 several times until a finished buccal tablet with a set number of material layers is obtained.

12. The method for preparing the buccal tablet according to claim 8, wherein: In the stacking combination, the membrane-like functional layer and the support layer meet at least one of the following stacking arrangement conditions: The support layer includes a bottom support layer arranged at the bottom layer, and at least one membrane-like functional layer is arranged on the bottom support layer; There are multiple membrane-like functional layers, the support layer further includes an intermediate support layer disposed between the membrane-like functional layers, and the membrane-like functional layers and the intermediate support layers are alternately disposed one by one on the bottom support layer; or there are multiple membrane-like functional layers, the support layer further includes an intermediate support layer disposed between the membrane-like functional layers, and at least one membrane-like functional layer is disposed between two adjacent support layers; The load-bearing layer further includes a top load-bearing layer located at the uppermost position.

13. The method for preparing the buccal tablet according to any one of claims 8 to 12, characterized in that: The obtaining of the film-like functional layer comprises the following steps: obtaining a functional layer film liquid containing the film-forming agent and the functional substance, applying the functional layer film liquid to a release film, and heating to a semi-dry state to obtain the film-like functional layer attached to the release film; and / or, In the step of stacking at least two materials and applying pressure to combine them, at least two materials are stacked and pressure is applied by a rolling process to combine the two materials; and / or, After the lamination and combination, the following steps are further included: cutting the finished buccal tablet obtained by lamination and combination into set specifications to obtain buccal tablets; and / or, After the lamination and bonding, the following steps are further included: heating the finished oral tablet obtained by lamination and bonding to a dry state; and / or, After the buccal tablets are prepared, the method further comprises the following steps: installing the buccal tablets into a packaging bag.

14. The method for preparing the buccal tablet according to claim 13, wherein: The obtaining of the functional layer membrane liquid containing the film-forming agent and the functional substance further comprises the following steps: adding water to the film-forming agent and stirring until it is completely dissolved to prepare a film-forming agent solution, adding the functional substance to the film-forming agent solution and stirring until it is completely dissolved to prepare a functional layer membrane liquid; adding a pH regulator to adjust the pH value of the functional layer membrane liquid to 4-9; stirring and vacuuming to defoam; and / or, The obtaining of the functional layer membrane solution containing the film-forming agent and the functional substance further comprises the following steps: Controlling the solid content of the functional layer membrane liquid to be 10-30%; and / or, The obtaining of the functional layer membrane solution containing the film-forming agent and the functional substance further comprises the following steps: Controlling the viscosity of the functional layer membrane liquid to be 100 mPa.s to 50,000 mPa.s; and / or, The semi-dry state is a state in which the functional layer membrane liquid is initially formed into a non-flowing state; and / or, in the semi-dry state, the water content of the functional layer membrane liquid is 10%-40%.

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