Nicotine buccal film containing coated pellets

Abstract

The utility model provides a kind of nicotine mouth dissolving film containing coating micro-pellets, belong to tobacco product technical field.The nicotine mouth dissolving film includes base layer and the coating micro-pellets in base layer, coating micro-pellets include core, slow-release layer and immediate-release layer from inside to outside in order;Among them, base layer, slow-release layer and immediate-release layer each independently include nicotine release;Base layer, slow-release layer and immediate-release layer are dissolved in the case of contacting saliva, the dissolution rate of immediate-release layer is greater than the dissolution rate of base layer, and the dissolution rate of slow-release layer is less than the dissolution rate of base layer.

Description

Technical Field

[0001] This utility model relates to the field of tobacco product technology, and in particular to a nicotine oral dissolving film containing coated microparticles. Background Technology

[0002] As people become more health-conscious, the market demand for traditional tobacco products such as cigarettes is gradually declining, while new tobacco products, such as e-cigarettes and heated tobacco products, are gaining popularity. Among these, oral tobacco products, as a new form of tobacco product, offer advantages such as ease of use, no combustion required, and no secondhand smoke pollution, and are gradually becoming a research hotspot in the tobacco industry.

[0003] However, in related technologies, oral smoking fails to meet users' needs in terms of smoking experience. Utility Model Content

[0004] In view of this, in order to at least partially solve at least one of the aforementioned technical problems, the present invention provides a nicotine oral dissolving film containing coated microparticles.

[0005] According to one embodiment of the present invention, a nicotine oral dissolving membrane containing coated microparticles is provided. The nicotine oral dissolving membrane includes a base layer and coated microparticles located within the base layer. The coated microparticles, from the inside out, include a core, a sustained-release layer, and an immediate-release layer. Each of the base layer, the sustained-release layer, and the immediate-release layer independently includes nicotine release products. The base layer, the sustained-release layer, and the immediate-release layer dissolve upon contact with saliva, with the dissolution rate of the immediate-release layer being greater than the dissolution rate of the base layer, and the dissolution rate of the sustained-release layer being less than the dissolution rate of the base layer.

[0006] According to embodiments of this invention, a multi-layer coating film design of coated microcapsules provides a controllable nicotine delivery system that combines rapid onset of action and sustained release. The immediate-release layer dissolves faster than the base layer, allowing for rapid nicotine release upon contact with saliva, providing initial nicotine stimulation. The sustained-release layer dissolves slower than the base layer, providing continuous and slow nicotine release, extending the usability of the nicotine oral dissolution film. The coated microcapsule structure protects the active ingredients of nicotine, improving stability and taste. The oral dissolution film dissolves completely in the oral cavity without causing any irritation, increasing product acceptability. It is portable, easy to use, provides accurate dosage, is environmentally friendly, and has a simple manufacturing process, making it suitable for large-scale industrial production. Attached Figure Description

[0007] The above and other objects, features and advantages of the present invention will become clearer from the following description of embodiments of the present invention with reference to the accompanying drawings, in which:

[0008] Figure 1A schematic diagram of a nicotine oral dissolving film containing coated microparticles according to an embodiment of the present invention is shown;

[0009] Figure 2 A schematic diagram of coated microcapsules according to an embodiment of the present invention is shown;

[0010] The meanings of the reference numerals in the above figures are as follows:

[0011] 1-Grassroots level;

[0012] 2-Coated microcapsules;

[0013] 21-kernel;

[0014] 22-Sustained-release layer;

[0015] 23-Immediate release layer. Detailed Implementation

[0016] The embodiments of the present invention will now be described with reference to the accompanying drawings. However, it should be understood that these descriptions are exemplary only and are not intended to limit the scope of the present invention. In the following detailed description, numerous specific details are set forth to provide a comprehensive understanding of the embodiments of the present invention for ease of explanation. However, it will be apparent that one or more embodiments may be practiced without these specific details. Furthermore, descriptions of well-known structures and techniques are omitted in the following description to avoid unnecessarily obscuring the concept of the present invention.

[0017] The terminology used herein is for the purpose of describing particular embodiments only and is not intended to limit the scope of the invention. The term "comprising" as used herein indicates the presence of features, steps, or operations, but does not exclude the presence or addition of one or more other features.

[0018] When using expressions such as "at least one of A, B, and C," the expression should generally be interpreted in accordance with the meaning commonly understood by a person skilled in the art (e.g., "a system having at least one of A, B, and C" should include, but is not limited to, systems having A alone, having B alone, having C alone, having A and B, having A and C, having B and C, and / or having A, B, and C, etc.). When using expressions such as "at least one of A, B, or C," the expression should generally be interpreted in accordance with the meaning commonly understood by a person skilled in the art (e.g., "a system having at least one of A, B, or C" should include, but is not limited to, systems having A alone, having B alone, having C alone, having A and B, having A and C, having B and C, and / or having A, B, and C, etc.).

[0019] It should also be noted that the directional terms mentioned in the embodiments, such as "up," "down," "front," "back," "left," and "right," are only for reference to the directions in the accompanying drawings and are not intended to limit the scope of protection of this utility model. Throughout the drawings, the same elements are represented by the same or similar reference numerals. Conventional structures or constructions will be omitted where they may cause confusion in understanding this utility model.

[0020] Oral cigarettes are a type of tobacco product. They are small fibrous pouches containing nicotine, typically placed between the gums and upper lip during use, allowing the nicotine to be absorbed through the palate mucosa. The nicotine pouches do not require heating or combustion. Compared to traditional tobacco, e-cigarettes, and heated tobacco products, oral cigarettes are inherently less harmful. Furthermore, oral cigarettes allow for nicotine absorption directly through the oral mucosa, providing a smoke-free and tar-free smoking experience. The method is more private and convenient, not limited by environment, and suitable for any location. However, the inventors discovered several shortcomings in oral cigarettes regarding the rate and stability of nicotine release.

[0021] In the process of realizing this utility model, it was discovered that a nicotine oral dissolving membrane can be developed, in which nicotine release products are added to the oral dissolving membrane, and through the multi-layer design of coated microcapsules, at least one of the many problems such as the nicotine release rate and stability in the nicotine oral dissolving membrane can be solved.

[0022] In view of this, the present invention provides a nicotine oral dissolving film containing coated microparticles, such as... Figure 1 and Figure 2 As shown, the nicotine oral dissolving membrane containing coated microparticles includes a base layer 1 and coated microparticles 2 located within the base layer 1. The coated microparticles 2, from the inside out, comprise a core 21, a sustained-release layer 22, and an immediate-release layer 23. Each of the base layer 1, sustained-release layer 22, and immediate-release layer 23 independently contains nicotine release material. The base layer 1, sustained-release layer 22, and immediate-release layer 23 dissolve upon contact with saliva, with the immediate-release layer 23 dissolving at a faster rate than the base layer 1, and the sustained-release layer 22 dissolving at a slower rate than the base layer 1.

[0023] According to embodiments of this invention, a controlled nicotine delivery system with both rapid onset and sustained release is provided through the multi-layer coating film design of the coated microcapsules 2. The immediate-release layer 23 dissolves at a faster rate than the base layer 1, allowing for rapid nicotine release upon contact with saliva, providing initial nicotine stimulation. The sustained-release layer 22 dissolves at a slower rate than the base layer 1, allowing for continuous and slow nicotine release, extending the usability of the nicotine oral dissolution film. The structure of the coated microcapsules 2 protects the active ingredients of nicotine, improving stability and taste. The oral dissolution film dissolves completely in the oral cavity without causing any irritation, increasing the product acceptability of the nicotine oral dissolution film. It is portable, easy to use, provides accurate dosage, is environmentally friendly, and has a simple manufacturing process, making it suitable for large-scale industrial production.

[0024] It should be noted that the dissolution rate of base layer 1 indicates the time required for base layer 1 to completely dissolve. The dissolution rate of slow-release layer 22 indicates the time required for slow-release layer 22 to completely dissolve. The dissolution rate of immediate-release layer 23 indicates the time required for immediate-release layer 23 to completely dissolve. If the dissolution rate of immediate-release layer 23 is greater than the dissolution rate of base layer 1, it means that the time required for immediate-release layer 23 to completely dissolve is greater than the time required for base layer 1 to completely dissolve. If the dissolution rate of slow-release layer 22 is less than the dissolution rate of base layer 1, it means that the time required for slow-release layer 22 to completely dissolve is less than the time required for base layer 1 to completely dissolve.

[0025] It should be noted that this invention does not limit the inhalation location of the nicotine oral dissolving film containing coated microparticles; users can choose the inhalation method according to their own needs. Optionally, when inhaling the nicotine oral dissolving film containing coated microparticles provided in this embodiment of the invention, the film can be brought into contact with the palate, the center of the tongue, the sublingual region, the upper gum, or the area between the lips and cheeks for inhalation. For example, a user can bring the nicotine oral dissolving film containing coated microparticles into contact with the palate for inhalation.

[0026] According to embodiments of this invention, the nicotine releaser can be chemically synthesized or extracted from tobacco plants. The nicotine releaser can be nicotine or a pharmaceutically acceptable salt thereof. The nicotine releaser includes at least one selected from nicotine, nicotine microcapsules, nicotine liposomes, citrate nicotine salt, malate nicotine salt, and tartrate nicotine salt.

[0027] According to an embodiment of this utility model, the base layer 1 may include a first water-soluble polymer material. The first water-soluble polymer material includes at least one selected from hydroxypropyl methylcellulose, carboxymethyl cellulose, povidone, pectin, sodium alginate, and sodium seaweed. Based on the mass of the base layer 1, the mass content of the first water-soluble polymer material can be 20% to 50%. Exemplarily, the mass content of the first water-soluble polymer material can be within any two values ​​of 20%, 25%, 30%, 35%, 40%, 45%, 50%, or more.

[0028] According to an embodiment of this utility model, based on the mass of the base layer 1, the mass content of nicotine release can be 5% to 15%. Exemplarily, the mass content of the first water-soluble polymer material can be any two values ​​between 5%, 8%, 10%, 12%, 14%, 15%, or more.

[0029] According to embodiments of the present invention, the base layer 1 may further include at least one of a plasticizer, a flavoring agent, a pH adjuster, and an adhesive.

[0030] According to embodiments of this invention, the plasticizer may include at least one selected from polyethylene glycol, glycerin, polysorbate, propylene glycol, hexanediol, and polypropylene glycol. Based on the mass of the base layer 1, the mass content of the plasticizer may be 10% to 30%. Exemplarily, the mass content of the first water-soluble polymer material may be within any two of the following values: 10%, 12%, 14%, 15%, 17%, 18%, 20%, 22%, 24%, 25%, 28%, 30%, or more.

[0031] According to embodiments of this utility model, the flavoring agent may include at least one of fruit flavoring and sweetener. Based on the mass of base layer 1, the mass content of the flavoring agent may be 5% to 15%. Exemplarily, the mass content of the flavoring agent may be within any two values ​​of 5%, 8%, 10%, 12%, 14%, 15%, or more.

[0032] According to embodiments of this invention, the pH adjuster may include at least one of sodium lactate and compound sodium lactate sorbitol. Based on the mass of base layer 1, the mass content of the pH adjuster may be 5% to 15%. Exemplarily, the mass content of the pH adjuster may be within any two values ​​of 5%, 8%, 10%, 12%, 14%, 15%, or more.

[0033] According to embodiments of this invention, the adhesive may include at least one of polyacrylic acid, sodium alginate, guar gum, sodium carboxymethyl cellulose, 5-methylpyrrolidone chitosan, polyglutamic acid, polycarbohydrate, and dextran sulfate. Based on the mass of the base layer 1, the mass content of the adhesive may be 1% to 15%. Exemplarily, the mass content of the adhesive may be 1%, 3%, 5%, 8%, 10%, 12%, 14%, 15%, or any two of the above values.

[0034] According to an embodiment of the present invention, the thickness of the base layer 1 can be 70~200μm. Exemplarily, the thickness of the base layer 1 can be 70μm, 80μm, 90μm, 100μm, 110μm, 120μm, 130μm, 140μm, 150μm, 160μm, 170μm, 180μm, 190μm, 200μm, or any two of the above values.

[0035] According to an embodiment of this utility model, the core 21 may include a nicotine-releasing agent and an excipient. The excipient may include at least one selected from carboxymethyl cellulose, polyvinyl alcohol, and hydroxypropyl methyl cellulose. The mass ratio of the nicotine-releasing agent to the excipient may be (1~5):(15~19). Exemplarily, the mass ratio of the nicotine-releasing agent to the excipient may be 1:19, 2:18, 3:17, 4:16, 5:15, or any two of the above ratios.

[0036] According to an embodiment of the present invention, the particle size of the core 21 can be 10~30μm. Exemplarily, the particle size of the core 21 can be 10μm, 12μm, 15μm, 18μm, 20μm, 22μm, 25μm, 28μm, 30μm or any two of the above values.

[0037] According to an embodiment of the present invention, the sustained-release layer 22 may include a second water-soluble polymer material. The second water-soluble polymer material may include at least one selected from polyvinyl alcohol, povidone, polyethylene glycol, carboxymethyl cellulose, hydroxypropyl cellulose, and maltodextrin.

[0038] According to an embodiment of the present invention, the sustained-release layer 22 may further include a plasticizer, which may include at least one of polyethylene glycol, glycerin, polysorbate, propylene glycol, hexanediol, and polypropylene glycol.

[0039] According to an embodiment of this utility model, in the sustained-release layer 22, the mass ratio of nicotine releaser to the second water-soluble polymer material can be (1~4):(8~16). Exemplarily, the mass ratio of nicotine releaser to the second water-soluble polymer material in the sustained-release layer 22 can be within the range of any two ratios above 1:16, 1:12, 1:8, 1:4, 1:2, or more. In the sustained-release layer 22, the mass ratio of nicotine releaser to plasticizer can be (1~4):(2~6). Exemplarily, the mass ratio of nicotine releaser to plasticizer in the sustained-release layer 22 can be within the range of any two ratios above 1:6, 1:4, 1:2, 1:1, 2:1, 3:2, or more.

[0040] According to an embodiment of the present invention, the thickness of the sustained-release layer 22 can be 20~50μm. Exemplarily, the thickness of the sustained-release layer 22 can be 20μm, 22μm, 25μm, 28μm, 30μm, 32μm, 35μm, 38μm, 40μm, 42μm, 45μm, 48μm, 50μm, or any two of the above values.

[0041] According to an embodiment of this invention, the immediate-release layer 23 may include a third water-soluble polymer material. The third water-soluble polymer material may include at least one of pullulan, hydroxypropyl methylcellulose, povidone, polyethylene glycol, carboxymethyl cellulose, hydroxypropyl cellulose, polyethylene oxide, and polyvinyl alcohol.

[0042] According to an embodiment of the present invention, the immediate-release layer 23 may further include a plasticizer, which may include at least one of polyethylene glycol, glycerin, polysorbate, propylene glycol, hexanediol, and polypropylene glycol.

[0043] According to embodiments of this invention, in the immediate-release layer 23, the mass ratio of nicotine releaser to the third water-soluble polymer material can be (1~4):(8~16). Exemplarily, in the sustained-release layer 22, the mass ratio of nicotine releaser to the third water-soluble polymer material can be within the range of any two ratios above 1:16, 1:12, 1:8, 1:4, 1:2, or more. In the sustained-release layer 22, the mass ratio of nicotine releaser to plasticizer can be (1~4):(2~6). Exemplarily, in the sustained-release layer 22, the mass ratio of nicotine releaser to plasticizer can be within the range of any two ratios above 1:6, 1:4, 1:2, 1:1, 2:1, 3:2, or more.

[0044] According to an embodiment of the present invention, the thickness of the immediate-release layer 23 can be 30~50μm. Exemplarily, the thickness of the immediate-release layer 23 can be 30μm, 32μm, 35μm, 38μm, 40μm, 42μm, 45μm, 48μm, 50μm, or any two of the above values.

[0045] According to an embodiment of the present invention, the particle size of the coated microparticles 2 can be 60~130μm. Exemplarily, the particle size of the coated microparticles 2 can be 60μm, 70μm, 80μm, 90μm, 100μm, 110μm, 120μm, 130μm or any two of the above values.

[0046] According to embodiments of this invention, based on the mass of nicotine released within the nicotine oral solution membrane, when the nicotine oral solution membrane comes into contact with saliva, more than 60 wt% of the nicotine released within the nicotine oral solution membrane is released within 60 seconds. This provides the user with instant gratification.

[0047] According to embodiments of this invention, based on the mass of nicotine released within the nicotine oral solution membrane, less than 80 wt% of the nicotine released within the membrane is released within 120 seconds when the membrane comes into contact with saliva. This provides the user with sustained satisfaction and extends the usage time of the nicotine oral solution membrane.

[0048] According to an embodiment of this invention, in the coated microcapsule 2, the immediate-release layer 23 can rapidly release nicotine upon contact with saliva, providing the user with instant gratification; the sustained-release layer 22 can continuously and slowly release nicotine, providing the user with sustained gratification and extending the usage time of the nicotine oral film. The dissolution rates of the base layer 1, the immediate-release layer 23, and the sustained-release layer 22 can be controlled by selecting suitable first, second, and third water-soluble polymer materials, so that the dissolution rate of the immediate-release layer 23 is greater than that of the base layer 1, and the dissolution rate of the sustained-release layer 22 is less than that of the base layer 1. For example, for the same type of first, second, and third water-soluble polymer materials, generally speaking, the water-soluble polymer material with a lower relative molecular mass has a higher dissolution rate. Therefore, the relative molecular mass of the first water-soluble polymer material can be greater than that of the third water-soluble polymer material, and the relative molecular mass of the first water-soluble polymer material can be less than that of the second water-soluble polymer material, so that the dissolution rate of the immediate-release layer 23 is greater than that of the base layer 1, and the dissolution rate of the slow-release layer 22 is less than that of the base layer 1.

[0049] According to an embodiment of the present invention, the content of the coated microcapsules 2 can be 5wt% to 40wt% based on the mass of the nicotine oral dissolving film. For example, based on the mass of the nicotine oral dissolving film, the content of the coated microcapsules 2 can be 5wt%, 8wt%, 10wt%, 15wt%, 20wt%, 25wt%, 30wt%, 35wt%, 40wt%, or any two of the above values.

[0050] This invention also provides a method for preparing the above-mentioned nicotine oral soluble film containing coated microparticles, comprising: using fluidized bed coating technology to sequentially coat a core, a sustained-release layer, and an immediate-release layer to obtain coated microparticles; dispersing the coated microparticles in a substrate slurry to obtain a substrate slurry containing coated microparticles; and converting the substrate slurry containing coated microparticles into a nicotine oral soluble film containing coated microparticles by a casting method. The coated microparticles, from the inside out, comprise a core, a sustained-release layer, and an immediate-release layer; each of the core, sustained-release layer, and immediate-release layer independently contains nicotine release products; the core, sustained-release layer, and immediate-release layer dissolve upon contact with saliva, with the dissolution rate of the immediate-release layer being greater than that of the core, and the dissolution rate of the sustained-release layer being less than that of the core.

[0051] According to an embodiment of this utility model, converting a substrate slurry containing coated microspheres into a nicotine oral solution film containing coated microspheres by a casting method includes: coating a substrate slurry containing coated microspheres onto a substrate, and drying to obtain a nicotine oral solution film containing coated microspheres. The drying temperature can be 40℃~90℃, and the drying time can be 1~4 hours.

[0052] The present invention will be described in detail below with reference to specific embodiments. It should be noted that, unless otherwise specified, the embodiments and features in the embodiments of the present invention can be combined with each other.

[0053] Example 1

[0054] This embodiment provides a nicotine oral dissolving membrane containing coated microparticles. The nicotine oral dissolving membrane includes a base layer and coated microparticles located within the base layer. The coated microparticles, from the inside out, comprise a core, a sustained-release layer, and an immediate-release layer. Each of the base layer, sustained-release layer, and immediate-release layer independently contains nicotine release products. Upon contact with saliva, the base layer, sustained-release layer, and immediate-release layer dissolve, with the immediate-release layer dissolving at a faster rate than the base layer, and the sustained-release layer dissolving at a slower rate than the base layer. The thickness of the nicotine oral dissolving membrane is approximately 200 μm. The content of the coated microparticles in the nicotine oral dissolving membrane is 30 wt%.

[0055] The coating consists of a base layer comprising nicotine tartrate, hydroxypropyl methylcellulose, glycerin, and peppermint flavor in a mass ratio of 10:40:15:2. The coated microcapsules have a particle size of approximately 90 μm. The core of the coated microcapsules has a particle size of approximately 20 μm and comprises 25 wt% nicotine tartrate and 75 wt% polyvinylpyrrolidone. The sustained-release layer has a thickness of approximately 30 μm and comprises 15 wt% nicotine tartrate, 75 wt% hydroxypropyl methylcellulose E15, and 10 wt% propylene glycol. The immediate-release layer has a thickness of approximately 30 μm and comprises 15 wt% nicotine tartrate, 75 wt% hydroxypropyl methylcellulose E3, and 10 wt% propylene glycol. The relative molecular mass of carboxymethyl cellulose in the sustained-release layer is higher than that in the immediate-release layer.

[0056] The nicotine oral dissolving membrane containing coated microparticles provided in this embodiment was prepared by the following method:

[0057] (1) Using fluidized bed coating technology, the core, sustained-release layer and immediate-release layer are coated sequentially to obtain coated microspheres.

[0058] (2) Disperse the coated microparticles in the substrate slurry to obtain a substrate slurry containing the coated microparticles.

[0059] (3) A substrate slurry containing coated microparticles is coated on the substrate and dried to obtain a nicotine oral solution film containing coated microparticles.

[0060] Comparative Example 1

[0061] This comparative example provides a nicotine oral dissolving film and its preparation method, referring to Example 1, except that the nicotine oral dissolving film does not include coated microparticles.

[0062] Comparative Example 2

[0063] This comparative example provides a nicotine oral dissolving film and its preparation method. Referring to Example 1, the difference is that the coated microparticles in this nicotine oral dissolving film only include the core and the sustained-release layer.

[0064] Comparative Example 3

[0065] This comparative example provides a nicotine oral dissolving membrane and its preparation method. Referring to Example 1, the difference is that the coated microparticles in this nicotine oral dissolving membrane only include the core and the immediate release layer.

[0066] The nicotine oral dissolution membranes with multi-layered structures provided in Example 1 and Comparative Examples 1 to 3 were subjected to nicotine extraction solution (artificial saliva) to detect the cumulative nicotine dissolution amount. The test results are detailed in Table 1.

[0067] Table 1

[0068]

[0069] As can be seen from the analysis in Table 1, the nicotine oral solution membrane with a multi-layer structure provided by this utility model embodiment can continuously and stably release nicotine. It can rapidly release nicotine within 1 minute of contact with nicotine extract, and the nicotine release time can last for 5 minutes.

[0070] The nicotine oral soluble membranes with multilayer structures provided in Example 1 and Comparative Example 1 were placed in an open environment (40°C, 75%RH) for stability testing. The nicotine tartrate content is detailed in Table 2.

[0071] Table 2

[0072]

[0073] The nicotine oral solution film with a multi-layer structure provided in this embodiment of the invention has good stability.

[0074] The specific embodiments described above further illustrate the purpose, technical solution, and beneficial effects of this utility model. It should be understood that the above description is only a specific embodiment of this utility model and is not intended to limit this utility model. Any modifications, equivalent substitutions, improvements, etc., made within the spirit and principles of this utility model should be included within the protection scope of this utility model.

Claims

1. A nicotine oral dissolving film containing coated microparticles, characterized in that, The nicotine oral dissolving membrane includes a water-soluble base layer and coated microspheres located within the water-soluble base layer. The coated microspheres, from the inside out, include a core, a water-soluble sustained-release layer, and a water-soluble rapid-release layer. The water-soluble base layer, the water-soluble slow-release layer, and the water-soluble rapid-release layer each independently include nicotine release products; The water-soluble base layer, the water-soluble slow-release layer, and the water-soluble rapid-release layer dissolve upon contact with saliva. The dissolution rate of the water-soluble rapid-release layer is greater than that of the water-soluble base layer, and the dissolution rate of the water-soluble slow-release layer is less than that of the water-soluble base layer. The thickness of the water-soluble base layer is 70~200μm; The kernel has a particle size of 10~30μm; The thickness of the water-soluble slow-release layer is 20~50μm; The thickness of the water-soluble rapid-release layer is 30~50μm; The coated microspheres have a particle size of 60~130μm.

2. The nicotine oral dissolving film containing coated microparticles according to claim 1, characterized in that, Based on the mass of nicotine releases within the nicotine oral solution membrane, when the nicotine oral solution membrane comes into contact with saliva, more than 60 wt% of the nicotine releases within the nicotine oral solution membrane are released within 60 seconds.

3. The nicotine oral dissolving film containing coated microparticles according to claim 1, characterized in that, Based on the mass of nicotine release within the nicotine oral solution membrane, when the nicotine oral solution membrane comes into contact with saliva, less than 80 wt% of the nicotine release within the nicotine oral solution membrane is released within 120 seconds.

4. The nicotine oral dissolving film containing coated microparticles according to claim 1, characterized in that, Based on the mass of the nicotine oral dissolving film, the content of the coated microspheres is 5wt%~40wt%.

5. The nicotine oral dissolving film containing coated microparticles according to any one of claims 1 to 4, characterized in that, The core includes nicotine releasers.

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