Buccal product

Abstract

The invention provides a buccal product. The buccal product comprises a first contact layer, a functional layer and a second contact layer which are sequentially stacked, wherein the first contact layer is a water-impermeable contact layer in an initial state, and the first contact layer is converted into a water-permeable contact layer after being exposed to a trigger medium; and the second contact layer is a permeable contact layer. The buccal product provided by the invention has good slow-release performance, the release rate is diversified, and the use experience of a user is remarkably improved.

Description

TECHNICAL FIELD

[0001] The present application relates to the technical field of oral preparations, in particular to a mouth product. BACKGROUND

[0002] With the improvement of people's health awareness, the demand for nicotine substitutes is gradually increasing. As a convenient nicotine delivery method, mouth smoke has become the choice of many users. However, the existing mouth smoke generally has the problems of poor slow-release effect and single release rate, which cannot well meet the user's use experience. SUMMARY

[0003] Therefore, the technical problem to be solved by the present application is to provide a mouth product with good slow-release performance and diversified release rate, so as to improve the user's use experience.

[0004] To solve the above technical problems, the present application provides a mouth product, which comprises a first contact layer, a functional layer and a second contact layer which are sequentially stacked; wherein the first contact layer is a water-impermeable contact layer in an initial state, and the first contact layer is converted into a water-permeable contact layer after being exposed to a trigger medium; the second contact layer is a water-permeable contact layer.

[0005] In some embodiments, the first contact layer is a hydrophobic contact layer in an initial state, and the first contact layer is converted into a hydrophilic contact layer after being exposed to an enzyme as a trigger medium.

[0006] In some embodiments, the first contact layer comprises at least one of octenyl succinate starch-poly lactic acid composite fiber, acetylated gelatin fiber, polyvinyl alcohol-esterified cyclodextrin composite film.

[0007] In some embodiments, the functional layer comprises at least two film structures.

[0008] In some embodiments, the functional layer comprises at least a first functional film and a second functional film, wherein the first functional film comprises a first film-forming base and a first active ingredient, and the second functional film comprises a second film-forming base and a second active ingredient.

[0009] In some embodiments, an isolation film is further arranged between the first functional film and the second functional film, and the isolation film is used to isolate the first functional film and the second functional film.

[0010] In some embodiments, the first functional film comprises a first flavor, and the second functional film comprises a second flavor different from the first flavor.

[0011] In some embodiments, the first functional film further comprises at least one of a sweetener, a cooling agent, an acid-base adjusting agent and a solubilizing agent.

[0012] In some embodiments, the second functional film further comprises at least one of a sweetener, a cooling agent, an acid-base adjusting agent, and a cosolvent.

[0013] In some embodiments, the first active ingredient comprises at least one of nicotine and a nicotine derivative.

[0014] In some embodiments, the second active ingredient comprises at least one of nicotine and a nicotine derivative.

[0015] In some embodiments, the first film-forming base comprises at least one of hydroxypropyl methylcellulose, ethyl cellulose, sodium alginate, chitosan, gelatin, and sodium carboxymethylcellulose.

[0016] In some embodiments, the second film-forming base comprises at least one of hydroxypropyl methylcellulose, ethyl cellulose, sodium alginate, chitosan, gelatin, and sodium carboxymethylcellulose.

[0017] In some embodiments, the sweetener comprises at least one of xylitol, sorbitol, mannitol, isomalt, lactitol, maltitol, isomaltulose, hydrogenated starch hydrolysate, erythritol, maltotriitol, aspartame, acesulfame potassium, sodium saccharin, sucralose, neotame, cyclamate, thaumatin, mogroside, and arabitol.

[0018] In some embodiments, the cooling agent comprises at least one of menthol, isomenthol, WS-3, WS-5, WS-23, WS-27, and WS-12.

[0019] In some embodiments, the acid-base adjusting agent comprises at least one of sodium citrate, sodium carbonate, disodium hydrogen phosphate, and sodium bicarbonate.

[0020] In some embodiments, the cosolvent comprises at least one of glycerol, propylene glycol, 1,4-butanediol, sorbitol, and polyvinyl alcohol.

[0021] In some embodiments, the second contact layer has a porous structure.

[0022] The beneficial effects of the present application are: by covering the first contact layer on one side of the functional layer, the buccal preparation can only release components from the side of the second contact layer at the initial stage of buccal administration, thereby effectively improving the sustained-release performance of the buccal preparation; as the first contact layer changes to water permeability, the components of the functional layer on this side are also released. This structure design synchronously realizes the technical effects of enhancing the sustained-release performance and diversifying the release rate, which is beneficial to improving the user experience. BRIEF DESCRIPTION OF DRAWINGS

[0023] In order to more clearly illustrate the technical solutions in the embodiments of the present application, the drawings needed to be used in the embodiments will be briefly introduced. Obviously, the drawings in the following description only constitute some of the embodiments of the present application. Based on these drawings, other drawings can be obtained by those skilled in the art without any creative effort.

[0024] Figure 1 is a structural schematic diagram of a first embodiment of the oral use product provided by the embodiments of the present application;

[0025] Figure 2 is a structural schematic diagram of a second embodiment of the oral use product provided by the embodiments of the present application;

[0026] Figure 3 is a structural schematic diagram of a third embodiment of the oral use product provided by the embodiments of the present application;

[0027] Figure 4 is a flow schematic diagram of a preparation method of the oral use product provided by an embodiment of the present application.

[0028] Main drawing mark explanation:

[0029] Oral use product 100; functional layer 10; first functional film 11; second functional film 12; first contact layer 20; second contact layer 30; isolation film 40. DETAILED DESCRIPTION

[0030] The technical solutions in the embodiments of the present application will be described clearly and completely in combination with the drawings in the embodiments of the present application. Obviously, the described embodiments are only some of the embodiments of the present application, rather than all the embodiments. Based on the embodiments in the present application, all other embodiments obtained by those skilled in the art without any creative effort belong to the scope of protection of the present application.

[0031] In the description of the present application, the meaning of "a plurality of" is at least two, such as two, three, etc., unless otherwise explicitly and specifically limited. All directionality indications (such as up, down, left, right, front, back, etc.) in the embodiments of the present application are only used to explain the relative position relationship, movement condition, etc. between components in a certain posture (as shown in the drawings). If the certain posture changes, the directionality indications also change accordingly. In addition, the terms "include" and "have" and any variations thereof are intended to cover non-exclusive inclusion. For example, a process, method, system, product or device that includes a series of steps or units is not limited to the listed steps or units, but can optionally include steps or units that are not listed, or can optionally include other steps or units inherent to the process, method, product or device.

[0032] In this document, the term "embodiment" means that a particular feature, structure, or characteristic described in connection with an embodiment may be included in at least one embodiment of this application. The appearance of this phrase in various places throughout the specification does not necessarily refer to the same embodiment, nor is it a separate or alternative embodiment mutually exclusive with other embodiments. It will be explicitly and implicitly understood by those skilled in the art that the embodiments described herein can be combined with other embodiments.

[0033] In the description of the embodiments in this application, the term "and / or" is merely a description of the relationship between related objects, indicating that three relationships can exist. For example, A and / or B can represent: A existing alone, A and B existing simultaneously, and B existing alone. Additionally, the character " / " in this document generally indicates that the preceding and following related objects have an "or" relationship.

[0034] In the description of the embodiments of this application, unless otherwise expressly specified and limited, technical terms such as "installation," "connection," "joining," and "fixing" should be interpreted broadly. For example, they can refer to a fixed connection, a detachable connection, or an integral part; they can refer to a mechanical connection or an electrical connection; they can refer to a direct connection or an indirect connection through an intermediate medium; they can refer to the internal communication of two components or the interaction between two components. For those skilled in the art, the specific meaning of the above terms in the embodiments of this application can be understood according to the specific circumstances.

[0035] As people become more health-conscious, the demand for nicotine alternatives is gradually increasing. Oral cigarettes, as a convenient way to deliver nicotine, have become a popular choice for many users. However, existing oral cigarettes generally suffer from poor sustained-release effects and relatively uniform release rates, failing to adequately meet user experience requirements.

[0036] To solve the above problem, please refer to Figure 1 , Figure 1 This is a schematic diagram of the structure of a first embodiment of the oral article 100 provided in this application. The oral article 100 includes a first contact layer 20, a functional layer 10, and a second contact layer 30 stacked sequentially. The first contact layer 20 is initially a waterproof contact layer, and transforms into a waterproof contact layer after exposure to a triggering medium. The second contact layer 30 is a waterproof contact layer.

[0037] In the technical solution of this application embodiment, the first contact layer 20 transforms into a water-permeable contact layer after being exposed to the triggering medium. It can be understood that the material of the first contact layer 20 can gradually transform from impermeable to water-permeable under the induction of a specific triggering medium (such as enzymes, temperature, pH, etc.) through changes in molecular structure or physical state.

[0038] Specifically, when the oral preparation 100 is contained in the oral cavity, since the second contact layer 30 is a water-permeable contact layer, saliva will first pass through the layer to reach the functional layer 10, and the first contact layer 20 is water-impermeable in the initial state, that is, saliva cannot pass through the first contact layer 20 to reach the functional layer 10, which makes the components of the functional layer 10 only released from the side of the second contact layer 30 at the initial stage of the oral preparation 100, thereby effectively improving the sustained-release performance of the oral preparation 100. Subsequently, when the first contact layer 20 is exposed to the trigger medium, the first contact layer 20 will be converted from water-impermeable to water-permeable within a predetermined time, at which time saliva can penetrate through the first contact layer 20 to the side of the functional layer 10 covered, and cause the components of the functional layer 10 on this side to be released. It can be understood that there will be at least two peaks of release rate during the oral preparation 100. In summary, the technical scheme of the embodiment of the present application not only effectively improves the sustained-release performance of the oral preparation 100, but also achieves the technical effect of diversification of the release rate, thereby significantly improving the user experience.

[0039] In some embodiments, when the first contact layer 20 is exposed to the trigger medium, the first contact layer 20 will be converted from water-impermeable to water-permeable within a predetermined time, wherein the predetermined time is 1 min to 10 min. Exemplarily, the predetermined time can be 1 min, 2 min, 4 min, 5 min, 8 min, 10 min, etc. It can be understood that the length of the predetermined time is mainly affected by the strength of the trigger medium and the material of the first contact layer 20.

[0040] In some embodiments, the first contact layer 20 is a non-woven fabric including a water-permeable conversion material, wherein the water-permeable conversion material is water-impermeable in the initial state, and the water-permeable conversion material is converted to water-permeable after being exposed to the trigger medium. Exemplarily, the water-permeable conversion material can be attached to the non-woven fabric as a substrate by coating or impregnation, etc., the non-woven fabric can adopt a hydrophobic non-woven fabric, and the material of the hydrophobic non-woven fabric can include at least one of polypropylene, polyester, polyethylene, polytetrafluoroethylene and polylactic acid; or the water-permeable conversion material can be directly used as a raw material to prepare a non-woven fabric by melt blowing, electrospinning or other processes, and a person skilled in the art can flexibly select the preparation method according to actual needs.

[0041] In some other embodiments, the first contact layer 20 is a composite film including a water-permeable conversion material. Exemplarily, the composite film includes a base film with water-impermeability in addition to the water-permeable conversion material. A plurality of through holes can be uniformly or irregularly formed on the base film, and the material with conversion characteristics is covered or filled in the through holes, so as to maintain the water-impermeability of the composite film in the initial state.

[0042] In some embodiments, the first contact layer 20 is a hydrophobic contact layer in the initial state, and the first contact layer 20 is converted into a hydrophilic contact layer after being exposed to an enzyme as a trigger medium.

[0043] In the technical solution of this embodiment, the first contact layer 20 can be induced by a specific enzyme to change the molecular structure and achieve the conversion from hydrophobicity to hydrophilicity within a predetermined time.

[0044] In some other embodiments, the first contact layer 20 can also be converted into a hydrophilic contact layer after being exposed to temperature as a trigger medium, or the first contact layer 20 can also be converted into a hydrophilic contact layer after being exposed to pH as a trigger medium. Specifically, for the case of using temperature as a trigger medium, the material mainly depends on the conformational change or phase separation behavior of temperature-sensitive groups. When the temperature changes, the hydrophilic / hydrophobic groups in the molecular chain segment rearrange, thereby achieving the conversion from hydrophobicity to hydrophilicity. For the case of using pH as a trigger medium, the material contains dissociable acidic or basic groups. When the environmental pH value changes, the dissociation state of the groups changes, resulting in changes in the surface charge or polarity of the material, and finally achieving the switching of the hydrophobicity to the hydrophilicity.

[0045] In some embodiments, the first contact layer 20 includes at least one of octenyl succinate starch-polylactic acid composite fiber, acetylated gelatin fiber, polyvinyl alcohol-esterified cyclodextrin composite film.

[0046] In the technical solution of this embodiment, the above-mentioned materials can use the inherent enzymes in the oral cavity (such as α-amylase, protease, esterase, etc.) as a trigger medium, so that the first contact layer 20 achieves the conversion from hydrophobicity to hydrophilicity after contacting saliva. Specifically, for the octenyl succinate starch-polylactic acid composite fiber, the presence of ester bonds makes it hydrophobic. After being placed in the oral cavity, α-amylase reacts with the ester bonds of the esterified starch to generate hydroxyl groups, and esterase catalyzes the hydrolysis of the ester bonds of polylactic acid to generate carboxyl and hydroxyl groups. The two types of enzymes work together to gradually convert the hydrophobic first contact layer 20 into a hydrophilic one. For the acetylated gelatin fiber, the amino group of gelatin is replaced by an acetyl group (a hydrophobic group) to make it hydrophobic. After being placed in the oral cavity, protease recognizes and hydrolyzes the amide bond to remove the acetyl group and reduce the amino and carboxyl groups of gelatin, thereby gradually converting the hydrophobic first contact layer 20 into a hydrophilic one. For the polyvinyl alcohol-esterified cyclodextrin composite film, the presence of ester bonds makes it hydrophobic. After being placed in the oral cavity, esterase decomposes the ester bonds to restore the hydroxyl groups of cyclodextrin, and at the same time, the water absorption of polyvinyl alcohol promotes swelling, exposing more reaction sites to gradually convert the hydrophobic first contact layer 20 into a hydrophilic one.

[0047] In addition, the above-mentioned materials all have good biocompatibility, no irritation, no toxicity, and are suitable for long-term oral contact. At the same time, the enzymatic products of the above-mentioned materials, such as hydrophobic groups of ester groups, acetyl groups, etc., are harmless small molecules (such as lactic acid, acetic acid) generated after enzymatic hydrolysis, which do not belong to harmful substances and meet the requirements of oral hygiene.

[0048] In some embodiments, the functional layer 10 comprises at least two film structures.

[0049] In the technical scheme of this embodiment, the functional layer 10 comprises at least two film structures, that is, the functional layer 10 can comprise two film structures, or three, four or five film structures, and those skilled in the art can make corresponding settings according to needs.

[0050] In some embodiments, please refer to Figure 2 , Figure 2 is a structural schematic diagram of a second embodiment of the oral product 100 provided in the present application, and the functional layer 10 comprises at least a first functional film 11 and a second functional film 12, wherein the first functional film 11 comprises a first film-forming base and a first active ingredient, and the second functional film 12 comprises a second film-forming base and a second active ingredient.

[0051] The active ingredient can be an effective substance released by oral contact and exerting physiological effects, and is a component for realizing the core function of the oral product 100; the film-forming base is used to provide support and can form a gel network to wrap the active ingredient and control the swelling rate.

[0052] In the technical scheme of this embodiment, the first contact layer 20 can cover the first functional film 11 or the second functional film 12. Taking the case that the first contact layer 20 covers the first functional film 11 and the second contact layer 30 covers the second functional film 12 as an example, in this structure, the release order of each functional film can be as follows: in the initial stage, since the second contact layer 30 is water-permeable, the second functional film 12 can quickly contact saliva and dissolve, and release its components first, while the first functional film 11 cannot effectively contact saliva in the initial stage because one side of it is covered by the water-impermeable first contact layer 20 and the other side is blocked by the second functional film 12, so that the release of its components is temporarily slowed down; then, the second functional film 12 is gradually dissolved by saliva, and the blocking of the first functional film 11 is removed, and its surface also starts to gradually contact saliva, and then gradually dissolves and releases components.

[0053] The release order of each functional film can also be as follows: before the second functional film 12 is gradually completely dissolved by saliva, the first contact layer 20 is converted from water-impermeable to water-permeable in response to the trigger medium, at which time the first functional film 11 is able to contact saliva and gradually dissolve and release the ingredients. It can be understood that regardless of the order in which the functional films are released, the design of the technical solution achieves phased release of the ingredients of the two different functional films, thereby facilitating improvement in the level and continuity of the lozenge experience.

[0054] In some embodiments, referring to Figure 3 , Figure 3 is a structural schematic diagram of a third embodiment of the lozenge 100 provided by the present application, and a separation film 40 is further arranged between the first functional film 11 and the second functional film 12, and the separation film 40 is used to separate the first functional film 11 and the second functional film 12.

[0055] In the technical solution of this embodiment, by arranging the separation film 40 between the first functional film 11 and the second functional film 12, not only can the probability of mixing of ingredients between different functional films be reduced, but also the release phases of the ingredients of different functional films can be further effectively controlled. Specifically, when the first contact layer 20 covers the first functional film 11, the second functional film 12 will first contact saliva, and after the second functional film 12 is substantially completely dissolved by saliva, the saliva will still not contact the first functional film 11 due to the blocking of the separation film 40 and the first contact layer 20. It can be understood that after the first contact layer 20 is converted from water-impermeable to water-permeable, the saliva can contact the first functional film 11 through the first contact layer 20, so that the first functional film 11 begins to dissolve and release the ingredients.

[0056] In some embodiments, the separation film 40 includes a hydrophobic non-woven fabric. The material of the hydrophobic non-woven fabric includes at least one of polypropylene, polyester, polyethylene, polytetrafluoroethylene, and polylactic acid.

[0057] In some embodiments, the first functional film 11 includes a first flavor, and the second functional film 12 includes a second flavor different from the first flavor.

[0058] In the technical solution of this embodiment, the second flavor is different from the first flavor, which can be that the type of the second flavor is different from the first flavor, or the mass fraction of the second flavor in the second functional film 12 is different from the mass fraction of the first flavor in the first functional film 11. Taking the example of the first functional film 11 and the second functional film 12 using different types of flavors, in combination with the structural design of the lozenge 100, phased release of different types of flavors can be achieved, so that the user can obtain a multi-section taste experience with distinct levels, thereby significantly improving the sensory comfort and functionality during use.

[0059] In some embodiments, the first functional film 11 further comprises at least one of a sweetener, a cooling agent, an acid-base regulator, and a cosolvent.

[0060] In some embodiments, the second functional film 12 further comprises at least one of a sweetener, a cooling agent, an acid-base regulator, and a cosolvent.

[0061] The cosolvent reduces the dissolution threshold by breaking the hydrogen bonds of the matrix, and the higher the content of the cosolvent, the faster the swelling speed; the acid-base regulator can stabilize the chemical structure of the active ingredient and reduce the probability of degradation; the sweetener and the cooling agent are used to provide a certain specific taste and improve the taste experience of the user.

[0062] In some embodiments, the first functional film 11 comprises, in mass fraction: 0.1-3 parts of the first active ingredient, 10-40 parts of the first film-forming matrix, 10-35 parts of the cosolvent, 1-10 parts of the first flavoring agent, 0.1-5 parts of the acid-base regulator, 0.01-1 part of the sweetener, and 0.1-1 part of the cooling agent.

[0063] In some embodiments, the second functional film 12 comprises, in mass fraction: 0.1-3 parts of the second active ingredient, 10-40 parts of the second film-forming matrix, 10-35 parts of the cosolvent, 1-10 parts of the second flavoring agent, 0.1-5 parts of the acid-base regulator, 0.01-1 part of the sweetener, and 0.1-1 part of the cooling agent.

[0064] In some embodiments, the first contact layer 20 covers the first functional film 11, and the mass fraction of the cosolvent of the second functional film 12 is greater than that of the first functional film 11.

[0065] In the technical solution of this embodiment, the second functional film 12 has a higher content of the cosolvent, so that it can rapidly swell after contacting saliva and release a large amount of ingredients in a short time, providing an instant functional experience for the user; and the first functional film 11 has a lower content of the cosolvent, so that its release speed is further delayed, thereby effectively realizing the phased release of the ingredients of different sub-active layers. Taking nicotine as an example, the nicotine of the second functional film 12 can be rapidly released to timely relieve the withdrawal reaction of the user, and the nicotine of the first functional film 11 has a low content of the cosolvent and cooperates with the delayed release characteristics of the first contact layer 20 (i.e., the transition from impermeable to permeable), so as to maintain a certain blood concentration for a long time. This design of rapid onset plus persistent maintenance not only reduces the number of intakes of the user, but also improves the comfort and effectiveness of the use process through precise timing control, significantly optimizing the use experience of the user.

[0066] In some embodiments, the first active ingredient includes at least one of nicotine and nicotine derivatives. In some other embodiments, the first active ingredient can also include active ingredients with specific medical properties, such as caffeine, etc., or the first active ingredient can also include other active ingredients with specific properties, such as capsaicin or theophylline, etc. substances with promoting psychoactive effects.

[0067] In some embodiments, the second active ingredient includes at least one of nicotine and nicotine derivatives. In some other embodiments, the second active ingredient can also include active ingredients with specific medical properties, such as caffeine, etc., or the first active ingredient can also include other active ingredients with specific properties, such as capsaicin or theophylline, etc. substances with promoting psychoactive effects.

[0068] In some embodiments, the first film-forming base includes at least one of hydroxypropyl methylcellulose, ethyl cellulose, sodium alginate, chitosan, gelatin, and sodium carboxymethylcellulose.

[0069] In some embodiments, the second film-forming base includes at least one of hydroxypropyl methylcellulose, ethyl cellulose, sodium alginate, chitosan, gelatin, and sodium carboxymethylcellulose.

[0070] In some embodiments, the first flavoring includes at least one of lemon flavoring, mint flavoring, liquorice flavoring, raspberry flavoring, vanilla flavoring, lime flavoring, apple flavoring, mango flavoring, cherry flavoring, blueberry flavoring, strawberry flavoring, cinnamon flavoring, and watermelon flavoring. The first flavoring can also be other flavors of edible flavorings, which will not be repeated here.

[0071] In some embodiments, the second flavoring includes at least one of lemon flavoring, mint flavoring, liquorice flavoring, raspberry flavoring, vanilla flavoring, lime flavoring, apple flavoring, mango flavoring, cherry flavoring, blueberry flavoring, strawberry flavoring, cinnamon flavoring, and watermelon flavoring. The second flavoring can also be other flavors of edible flavorings, which will not be repeated here.

[0072] In some embodiments, the sweetener includes at least one of xylitol, sorbitol, mannitol, isomalt, lactitol, maltitol, isomaltulose, hydrogenated starch hydrolysate, erythritol, maltotriitol, aspartame, acesulfame, sodium saccharin, sucralose, neotame, cyclamate, thaumatin, rebaudioside, arabitol, and momordica grosvenori.

[0073] In some embodiments, the cooling agent includes at least one of menthol, isomenthol, WS-3, WS-5, WS-23, WS-27, and WS-12.

[0074] In some embodiments, the acid-base regulator includes at least one of sodium citrate, sodium carbonate, disodium hydrogen phosphate, and sodium bicarbonate.

[0075] In some embodiments, the co-solvent includes at least one of glycerol, propylene glycol, 1,4-butanediol, sorbitol, and polyvinyl alcohol.

[0076] In some embodiments, the second contact layer 30 has a porous structure. Optionally, the second contact layer 30 includes a hydrophilic non-woven fabric. The material of the hydrophilic non-woven fabric includes at least one of cotton fiber, hemp fiber, viscose fiber, and Tencel fiber. By using the above-mentioned hydrophilic non-woven fabric as the second contact layer 30, its fiber interlaced structure can provide mechanical support for the functional layer 10, reduce the probability of structural collapse of the functional layer 10 due to moisture absorption and softening during storage, and facilitate the oral preparation 100 to maintain the integrity of the shape. At the same time, the above-mentioned natural or regenerated fiber materials all have soft and skin-friendly properties, can closely fit the oral mucosa, reduce the foreign body sensation, and improve the comfort of long-term sucking.

[0077] In some embodiments, the thickness of the first contact layer 20 is 80 μm to 200 μm. Illustratively, the thickness of the first contact layer 20 can be 80 μm, 100 μm, 120 μm, 140 μm, 160 μm, 180 μm, 200 μm, etc., or a range composed of any two of the above-mentioned values, for example, 80 μm to 120 μm, 120 μm to 160 μm, 160 μm to 200 μm, etc.

[0078] In some embodiments, the thickness of the second contact layer 30 is 80 μm to 200 μm. Illustratively, the thickness of the second contact layer 30 can be 80 μm, 100 μm, 120 μm, 140 μm, 160 μm, 180 μm, 200 μm, etc., or a range composed of any two of the above-mentioned values, for example, 80 μm to 120 μm, 120 μm to 160 μm, 160 μm to 200 μm, etc.

[0079] In some embodiments, the thickness of the first functional film is 30 μm to 300 μm. Illustratively, the thickness of the first functional film 11 can be 30 μm, 70 μm, 100 μm, 150 μm, 200 μm, 250 μm, 300 μm, etc., or a range composed of any two of the above-mentioned values, for example, 30 μm to 100 μm, 100 μm to 200 μm, 200 μm to 300 μm, etc.

[0080] In some embodiments, the thickness of the second functional film 12 is 30 μm to 300 μm. Exemplarily, the thickness of the second functional film 12 can be 30 μm, 70 μm, 100 μm, 150 μm, 200 μm, 250 μm, 300 μm, or a range between any two of the above values, for example, 30 μm to 100 μm, 100 μm to 200 μm, 200 μm to 300 μm, etc.

[0081] In some embodiments, the thickness of the isolation film 40 is 100 μm to 300 μm. Exemplarily, the thickness of the isolation film 40 can be 100 μm, 130 μm, 160 μm, 190 μm, 220 μm, 250 μm, 300 μm, or a range between any two of the above values, for example, 100 μm to 160 μm, 160 μm to 220 μm, 220 μm to 300 μm, etc.

[0082] Please refer to Figure 4 , Figure 4 is a flowchart of a method for preparing the oral use article 100 according to an embodiment of the present application, which specifically comprises:

[0083] S110: mixing raw materials to obtain a first film solution and a second film solution, wherein the raw materials include, in terms of mass fraction, active ingredients 0.1 to 3 parts, film-forming bases 10 to 40 parts, co-solvents 10 to 35 parts, essences 1 to 10 parts, acid-base adjusting agents 0.1 to 5 parts, and sweeteners 0.01 to 1 part, and the essences of the first film solution and the second film solution are different;

[0084] S120: coating the second film solution to one side surface of the isolation film 40 and performing drying treatment to obtain the second functional film 12;

[0085] S130: adhering the surface of the second functional film 12 to one side surface of the second contact layer 30;

[0086] S140: coating the first film solution to the other side surface of the isolation film 40 and performing drying treatment to obtain the first functional film 11;

[0087] S150: adhering the surface of the first functional film 11 to one side surface of the first contact layer 20 to obtain the oral use article 100.

[0088] In some embodiments, the moisture content of the second functional film 12 is 10% to 40% based on the total mass of the second functional film 12. Exemplarily, the moisture content of the second functional film 12 can be 10%, 15%, 20%, 25%, 30%, 35%, 40%, or a range between any two of the above values, for example, 10% to 20%, 20% to 30%, 30% to 40%, etc.

[0089] In some embodiments, the moisture content of the first functional film 11 is 10% to 40% based on the total mass of the first functional film 11. Illustratively, the moisture content of the first functional film 11 can be 10%, 15%, 20%, 25%, 30%, 35%, 40%, or the like, or a range between any two of the foregoing values, such as 10% to 20%, 20% to 30%, 30% to 40%, and the like.

[0090] In some embodiments, the drying treatment is performed at a temperature of 40°C to 50°C. Illustratively, the drying treatment can be performed at a temperature of 40°C, 42°C, 44°C, 45°C, 47°C, 49°C, 50°C, or the like, or a range between any two of the foregoing values, such as 40°C to 44°C, 44°C to 47°C, 47°C to 50°C, and the like.

[0091] In some embodiments, the first film solution is applied at a thickness of 30 μm to 300 μm. Illustratively, the first film solution can be applied at a thickness of 30 μm, 50 μm, 100 μm, 150 μm, 200 μm, 250 μm, 300 μm, or the like, or a range between any two of the foregoing values, such as 30 μm to 100 μm, 100 μm to 200 μm, 200 μm to 300 μm, and the like.

[0092] In some embodiments, the second film solution is applied at a thickness of 30 μm to 300 μm. Illustratively, the second film solution can be applied at a thickness of 30 μm, 50 μm, 100 μm, 150 μm, 200 μm, 250 μm, 300 μm, or the like, or a range between any two of the foregoing values, such as 30 μm to 100 μm, 100 μm to 200 μm, 200 μm to 300 μm, and the like.

[0093] In some embodiments, the step of adhering the surface of the second functional film 12 to the one surface of the second contact layer 30 further comprises drying the second functional film 12 to have a moisture content of less than 5%.

[0094] In some embodiments, the step of adhering the surface of the first functional film 11 to the one surface of the first contact layer 20 to obtain the oral product 100 further comprises drying the first functional film 11 to have a moisture content of less than 5%.

[0095] In some embodiments, the step of adhering the surface of the first functional film 11 to the one surface of the first contact layer 20 to obtain the oral product 100 is followed by a step of covering the surface of the oral product 100 with an encapsulation layer.

[0096] Hereinafter, the examples of the present application will be described. The examples described below are exemplary and are for the purpose of explanation of the present application and cannot be construed to limit the present application. In the examples, the specific techniques or conditions not mentioned are performed in accordance with the techniques or conditions described in the literature in the art or in accordance with the product manual. The reagents or instruments not mentioned by the manufacturer are all conventional products that can be obtained commercially.

[0097] Example 1:

[0098] The components and contents used in the first functional film and the second functional film of the oral preparation of Example 1 are shown in Table 1:

[0099] Table 1: Formulation table of Example 1

[0100]

[0101] The preparation steps of the oral preparation of Example 1 are as follows: the raw materials are weighed according to the mass parts in the above table, the hydroxypropyl methyl cellulose and gelatin are mixed first, and stirred at 65°C until uniform, then cooled to 25°C, and then glycerol, propylene glycol, nicotine, lemon flavor, sucralose, sodium bicarbonate are added to obtain the first film solution; at the same time, the raw materials are weighed according to the mass parts in the above table, the hydroxypropyl methyl cellulose and gelatin are mixed first, and stirred at 65°C until uniform, then cooled to 25°C, and then glycerol, propylene glycol, nicotine, raspberry flavor, sucralose, sodium bicarbonate are added to obtain the second film solution; the second film solution is uniformly coated on one side surface of the hydrophobic non-woven fabric with a material of polypropylene, wherein the coating thickness is 200 μm, and the thickness of the hydrophobic non-woven fabric is 200 μm; dried in an oven at 45°C for 1 h to obtain the second functional film; the surface of the second functional film is laminated with one side surface of the second contact layer with a material of cotton fiber and a thickness of 150 μm by rolling, and dried in an oven at 45°C for 1 h; the first film solution is uniformly coated on the other side surface of the hydrophobic non-woven fabric with a coating thickness of 200 μm, and dried in an oven at 45°C for 1 h to obtain the first functional film; prepare octenyl succinate starch-poly lactic acid composite fiber: mix starch and octenyl succinic anhydride, and react at 65°C for 3.5 h to obtain esterified starch, then dry the esterified starch and cut into granules to mix and melt with poly lactic acid to obtain a uniform blend, heat the blend to 180°C, use a double screw extruder at high temperature to extrude the fiber, pull the fiber from the spinneret into cold water, set the tension and wind it up to obtain octenyl succinate starch-poly lactic acid composite fiber, cut it to obtain a first contact layer with a thickness of 150 μm, laminate the surface of the first functional film with one side surface of the first contact layer by rolling, and dry it in an oven at 45°C for 1 h to obtain the oral preparation.

[0102] Example 2:

[0103] The ingredients and contents of each component used in the first functional film and the second functional film of the oral product of Example 2 are shown in Table 2:

[0104] Table 2: Formula table of Example 2

[0105]

[0106] The preparation steps of the oral product of Example 2 are different from the preparation steps of the oral product of Example 1 in that the material of the first contact layer of Example 2 is acetylated gelatin fiber, wherein the preparation method of the acetylated gelatin fiber is as follows: a gelatin solution is prepared by dissolving gelatin in water and stirring at 40°C until clear; acetic anhydride is added dropwise to the gelatin solution, and the reaction is carried out at 50°C for 3h to obtain acetylated gelatin, and sodium hydroxide solution is added to neutralize it, followed by water washing to remove unreacted reagents and byproducts; vacuum drying is carried out at 45°C to obtain acetylated gelatin dry powder, which is then formed into acetylated gelatin fiber by a spinning process.

[0107] Example 3:

[0108] The ingredients and contents of each component used in the first functional film and the second functional film of the oral product of Example 3 are the same as those of Example 2.

[0109] The preparation steps of the oral product of Example 3 are different from the preparation steps of the oral product of Example 1 in that the material of the first contact layer of Example 3 is a polyvinyl alcohol-esterified cyclodextrin composite film, wherein the preparation method of the polyvinyl alcohol-esterified cyclodextrin composite film is as follows: polyvinyl alcohol with an alcoholysis degree of 92% is dissolved in purified water at 95°C, and stirring is carried out until clear to obtain a polyvinyl alcohol solution; β-cyclodextrin is dissolved in N,N-dimethylformamide, and acetic anhydride is added, and the reaction is carried out at 80°C for 8h to obtain esterified cyclodextrin; the esterified cyclodextrin is added to the polyvinyl alcohol solution, and stirring is carried out until clear, and glutaraldehyde is added to bridge the esterified cyclodextrin and the polyvinyl alcohol to obtain a mixed solution; the mixed solution is poured onto a glass plate, and drying is carried out at 25°C for 24h, and then drying is carried out at 50°C to constant weight to obtain a polyvinyl alcohol-esterified cyclodextrin composite film.

[0110] In vitro dissolution experiment:

[0111] In-vitro dissolution experiments were performed on the lozenge products prepared in Examples 1-3 according to the following method: The lozenge products were fixed in a dissolution basket and immersed in 900 ml of simulated saliva with a liquid level 1 cm higher than the lozenge products, wherein the pH of the simulated saliva was 6.8, the concentration of α-amylase was 50 U / ml, and the concentration of esterase was 5 U / ml. At the same time, the initial wetting time, disintegration time and complete dissolution time of the first functional film and the second functional film of the lozenge products were recorded using a high-speed camera. At 0 min, 5 min, 10 min, 15 min, 20 min, 30 min, 40 min and 60 min, 5 ml of simulated saliva was taken out, and an equal amount of fresh simulated saliva was added. The content of the characteristic monomer methyl anthranilate of raspberry essence and the characteristic monomer citral of lemon essence was detected using a gas chromatograph-mass spectrometer. The above data was fitted with a release kinetic function to obtain the time T1 at which the release amount of raspberry essence reached half and the time T2 at which the release amount of lemon essence reached half, wherein ΔT = T1-T2. The test results are shown in Tables 3-5.

[0112] Table 3: Test results of the time at which the release amount of essence reached half for Examples 1-3

[0113]

[0114]

[0115] Table 4: Test results of the dissolution time of the second functional film for Examples 1-3

[0116]

[0117] Table 5: Test results of the dissolution time of the first functional film for Examples 1-3

[0118]

[0119] Based on Tables 3-5 above, the following brief analysis is provided:

[0120] From the in-vitro dissolution experiment results of Examples 1-3, it can be seen that when the first contact layer covers the first functional film, the time T2 for the first functional film to release half of the essence is significantly longer than the time T1 for the second functional film to release half of the essence. In addition, the dissolution time experiment of the first functional film and the second functional film recorded by high-speed photography further shows that compared with the second functional film, the initial wetting time, the disintegration time and the complete dissolution time of the first functional film are all longer. A series of experimental data fully prove that by setting the first contact layer, the slow-release performance of the oral product is enhanced, and the oral product can start to release the components of different functional films at different time stages, that is, the effect of diversified release rate is achieved, thereby greatly improving the user experience.

[0121] The above merely describes the preferred embodiments of the present application, and does not limit the patent scope of the present application. Any equivalent structural transformation made by using the content of the present application specification and drawings, or direct / indirect application in other related technical fields is included in the patent protection scope of the present application.

Claims

1. A mouthpiece, characterized in that Comprise: a first contact layer, a functional layer and a second contact layer arranged in sequence; the first contact layer is a water-impermeable contact layer in an initial state, and the first contact layer is converted into a water-permeable contact layer after being exposed to a trigger medium; the second contact layer is a water-permeable contact layer.

2. A smokeless tobacco product according to claim 1, wherein the first contact layer is a hydrophobic contact layer in an initial state, and the first contact layer is converted into a hydrophilic contact layer after being exposed to an enzyme as a trigger medium.

3. A smokeless tobacco product according to claim 1, wherein The first contact layer comprises at least one of octenyl succinate starch-polylactic acid composite fiber, acetylated gelatin fiber, polyvinyl alcohol-esterified cyclodextrin composite film.

4. A smokeless tobacco product according to claim 1, wherein The functional layer comprises at least two film structures.

5. A smokeless tobacco product according to claim 4, wherein The functional layer comprises at least a first functional film and a second functional film, wherein the first functional film comprises a first film-forming base and a first active ingredient, and the second functional film comprises a second film-forming base and a second active ingredient.

6. A smokeless tobacco product according to claim 5, wherein The first functional film and the second functional film are further provided with a separation film for isolating the first functional film and the second functional film.

7. A smokeless tobacco product according to claim 5, wherein The first functional film comprises a first fragrance, and the second functional film comprises a second fragrance different from the first fragrance.

8. A smokeless tobacco product according to claim 5, wherein The first functional film further comprises at least one of a sweetener, a cooling agent, an acid-base regulator and a cosolvent; and / or, The second functional film further comprises at least one of a sweetener, a cooling agent, an acid-base regulator and a cosolvent.

9. A smokeless tobacco product according to claim 8, wherein The first active ingredient comprises at least one of nicotine and nicotine derivatives; and / or, The second active ingredient comprises at least one of nicotine and nicotine derivatives; and / or, The first film-forming base comprises at least one of hydroxypropyl methylcellulose, ethyl cellulose, sodium alginate, chitosan, gelatin and sodium carboxymethyl cellulose; and / or, The second film-forming base comprises at least one of hydroxypropyl methylcellulose, ethyl cellulose, sodium alginate, chitosan, gelatin and sodium carboxymethyl cellulose; and / or, The sweetener comprises at least one of xylitol, sorbitol, mannitol, isomalt, lactitol, maltitol, isomaltulose, hydrogenated starch hydrolysate, erythritol, maltotriitol, aspartame, acesulfame, sodium saccharin, sucralose, neotame, cyclamate, rebaudioside, arabitol and momordica grosvenorii sweet; and / or, The cooling agent comprises at least one of menthol, isomenthol, WS-3, WS-5, WS-23, WS-27 and WS-12; and / or, The acid-base regulator comprises at least one of sodium citrate, sodium carbonate, disodium hydrogen phosphate and sodium bicarbonate; and / or, The cosolvent comprises at least one of glycerol, propylene glycol, 1,4-butanediol, sorbitol and polyvinyl alcohol.

10. A mouthpiece according to any one of claims 1 to 9, characterised in that, The second contact layer has a porous structure.

Images