Nicotine oral soluble film containing coated pellets

Abstract

The invention provides a nicotine oral soluble film containing coated pellets, and belongs to the technical field of tobacco products. The nicotine oral soluble film comprises a base layer and a coating pellet located in the base layer, wherein the coating pellet sequentially comprises an inner core, a slow release layer and a quick release layer from inside to outside; wherein the base layer, the slow release layer and the quick release layer respectively and independently comprise nicotine release substances; the base layer, the slow-release layer and the quick-release layer are dissolved under the condition of contacting with saliva, the dissolution rate of the quick-release layer is higher than that of the base layer, and the dissolution rate of the slow-release layer is lower than that of the base layer.

Description

Technical Field

[0001] The present disclosure relates to the technical field of tobacco products, and in particular to a nicotine orally dissolving film containing coated micropellets. Background Art

[0002] As people's health awareness increases, the market demand for traditional tobacco products such as smoking cigarettes is gradually declining, while new tobacco products, such as electronic cigarettes and heat-not-burn tobacco products, are gradually gaining favor among users. Among them, snus, as a new form of tobacco product, has the advantages of being easy to use, no burning, and no secondhand smoke pollution, and has gradually become a research hotspot in the tobacco industry.

[0003] However, in the related art, snus is difficult to meet the needs of users in terms of smoking experience. Summary of the invention

[0004] In view of this, in order to at least partially solve at least one of the above-mentioned technical problems, the present disclosure provides a nicotine orally dissolving film containing coated pellets.

[0005] According to an embodiment of one aspect of the present disclosure, a nicotine orally dissolving film containing coated pellets is provided, the nicotine orally dissolving film comprising a base layer and coated pellets located in the base layer, the coated pellets comprising, from the inside to the outside, an inner core, a sustained-release layer and a quick-release layer; wherein the base layer, the sustained-release layer and the quick-release layer each independently comprise a nicotine releasing substance; the base layer, the sustained-release layer and the quick-release layer dissolve when in contact with saliva, the dissolution rate of the quick-release layer is greater than the dissolution rate of the base layer, and the dissolution rate of the sustained-release layer is less than the dissolution rate of the base layer.

[0006] According to the embodiments of the present disclosure, a controllable nicotine delivery system with both rapid onset and sustained release is provided through the multi-layer coating film design of the coated micropellets, wherein the dissolution rate of the immediate-release layer is greater than the dissolution rate of the base layer, and nicotine can be quickly released in contact with saliva to provide an initial stimulation of nicotine; the dissolution rate of the sustained-release layer is less than the dissolution rate of the base layer, and nicotine can be continuously and slowly released to extend the use time of the nicotine oral dissolving film. The structure of the coated micropellets protects the active ingredients of tobacco, improves stability and taste, and the oral dissolving film completely dissolves in the oral cavity without any irritation, thereby improving the product acceptance of the nicotine oral dissolving film, which is portable and easy to use, accurate in dosage, and simple in green and environmentally friendly process, and can be applied to large-scale industrial production. BRIEF DESCRIPTION OF THE DRAWINGS

[0007] The above and other objects, features and advantages of the present disclosure will become more apparent through the following description of the embodiments of the present disclosure with reference to the accompanying drawings, in which:

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

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

[0010] In the above drawings, the meanings of the reference numerals are as follows:

[0011] 1- Grassroots;

[0012] 2- Coated pellets;

[0013] 21- kernel;

[0014] 22- sustained release layer;

[0015] 23-Immediate release layer. DETAILED DESCRIPTION

[0016] Hereinafter, embodiments of the present disclosure will 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 disclosure. In the following detailed description, for ease of explanation, many specific details are set forth to provide a comprehensive understanding of the embodiments of the present disclosure. However, it is apparent that one or more embodiments may also be implemented without these specific details. In addition, in the following description, descriptions of known structures and technologies are omitted to avoid unnecessary confusion of the concepts of the present disclosure.

[0017] The terms used herein are only for describing specific embodiments and are not intended to limit the present disclosure. The term "comprising" used herein indicates the existence of features, steps, operations, but does not exclude the existence or addition of one or more other features.

[0018] In the case of using expressions such as "at least one of A, B, and C, etc.", it should generally be interpreted in accordance with the meaning of the expression generally understood by those skilled in the art (for example, "a system having at least one of A, B, and C" should include but is not limited to a system having A alone, B alone, C alone, A and B, A and C, B and C, and / or A, B, C, etc.). In the case of using expressions such as "at least one of A, B, or C, etc.", it should generally be interpreted in accordance with the meaning of the expression generally understood by those skilled in the art (for example, "a system having at least one of A, B, or C" should include but is not limited to a system having A alone, B alone, C alone, A and B, A and C, B and C, and / or A, B, C, etc.).

[0019] It should also be noted that the directional terms mentioned in the embodiments, such as "upper", "lower", "front", "back", "left", "right", etc., are only reference directions of the drawings and are not intended to limit the scope of protection of the present disclosure. Throughout the drawings, the same elements are represented by the same or similar reference numerals. Conventional structures or configurations will be omitted when they may cause confusion in the understanding of the present disclosure.

[0020] Snus is a tobacco product. They are small fiber bags containing nicotine. During use, these small bags are usually placed between the gums and the upper lip, and the nicotine is absorbed by the human body through the palate mucosa. The nicotine bag does not need to be heated or burned. Compared with traditional tobacco, e-cigarettes and heated tobacco, snus is more harmless in nature. Secondly, snus can absorb nicotine through the oral mucosa, achieving a smoke-free and tar-free smoking experience. The smoking method is more private and convenient, not restricted by the environment, and suitable for any place. However, the inventors found that snus has many shortcomings in terms of nicotine release speed and stability.

[0021] In the process of realizing the present disclosure, it is found that a nicotine orally dissolving film can be developed, nicotine releasers are added to the orally dissolving film, and at least one of the many problems of nicotine release rate and stability in the orally dissolving nicotine film can be solved through a multi-layer design of coated micropellets.

[0022] In view of this, the present disclosure provides a nicotine orally dissolving film containing coated pellets, such as Figure 1 and Figure 2 As shown, the nicotine orally dissolving film containing coated pellets includes a base layer 1 and coated pellets 2 located in the base layer 1, and the coated pellets 2 include a core 21, a sustained-release layer 22, and a quick-release layer 23 from the inside to the outside. The base layer 1, the sustained-release layer 22, and the quick-release layer 23 each independently include nicotine releasers. The base layer 1, the sustained-release layer 22, and the quick-release layer 23 dissolve when in contact with saliva, and the dissolution rate of the quick-release layer 23 is greater than the dissolution rate of the base layer 1, and the dissolution rate of the sustained-release layer 22 is less than the dissolution rate of the base layer 1.

[0023] According to the embodiments of the present disclosure, a controllable nicotine delivery system with both rapid onset and sustained release is provided through the multi-layer coating film design of the coated pellets 2, wherein the dissolution rate of the immediate release layer 23 is greater than the dissolution rate of the base layer 1, and nicotine can be quickly released in contact with saliva to provide an initial stimulation of nicotine; the dissolution rate of the sustained release layer 22 is less than the dissolution rate of the base layer 1, and nicotine can be continuously and slowly released to extend the use time of the nicotine oral dissolving film. The structure of the coated pellets 2 protects the active ingredients of tobacco, improves stability and taste, and the oral dissolving film completely dissolves in the oral cavity without any stimulation, thereby improving the product acceptance of the nicotine oral dissolving film, which is portable and easy to use, accurate in dosage, and simple in green and environmentally friendly process, and can be applied to large-scale industrial production.

[0024] It should be noted that the dissolution rate of the base layer 1 may indicate the time required for the base layer 1 to be completely dissolved. The dissolution rate of the sustained-release layer 22 may indicate the time required for the sustained-release layer 22 to be completely dissolved. The dissolution rate of the immediate-release layer 23 may indicate the time required for the immediate-release layer 23 to be completely dissolved. The dissolution rate of the immediate-release layer 23 being greater than the dissolution rate of the base layer 1 indicates that the time required for the immediate-release layer 23 to be completely dissolved is greater than the time required for the base layer 1 to be completely dissolved. The dissolution rate of the sustained-release layer 22 being less than the dissolution rate of the base layer 1 indicates that the time required for the sustained-release layer 22 to be completely dissolved is less than the time required for the base layer 1 to be completely dissolved.

[0025] It should be noted that the present disclosure does not limit the position of inhalation of the nicotine orodissolving film containing coated micropellets, and users can choose the inhalation method according to their own needs. Optionally, when inhaling the nicotine orodissolving film containing coated micropellets provided in the embodiments of the present disclosure, the nicotine orodissolving film containing coated micropellets can be brought into contact with the upper palate, the center of the tongue, under the tongue, between the upper gums and the lips and cheeks for inhalation. For example, the user can bring the nicotine orodissolving film containing coated micropellets into contact with the upper palate for inhalation.

[0026] According to an embodiment of the present disclosure, the nicotine releaser may be chemically synthesized or extracted from tobacco plants. The nicotine releaser may be nicotine or a pharmaceutically acceptable salt thereof. The nicotine releaser includes at least one of nicotine, nicotine microcapsules, nicotine liposomes, nicotine citrate salt, nicotine malate salt, and nicotine tartrate salt.

[0027] According to an embodiment of the present disclosure, the base layer 1 may include a first water-soluble polymer material. The first water-soluble polymer material includes at least one of hydroxypropyl methylcellulose, carboxymethyl cellulose, polyvinylpyrrolidone, pectin, sodium alginate, and sodium alginate. Based on the mass of the base layer 1, the mass content of the first water-soluble polymer material may be 20% to 50%. Exemplarily, the mass content of the first water-soluble polymer material may be 20%, 25%, 30%, 35%, 40%, 45%, 50%, or a range between any two of the above values.

[0028] According to an embodiment of the present disclosure, the mass content of the nicotine releaser may be 5% to 15% based on the mass of the base layer 1. For example, the mass content of the first water-soluble polymer material may be 5%, 8%, 10%, 12%, 14%, 15% or a range between any two of the above values.

[0029] According to an embodiment of the present disclosure, 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 an embodiment of the present disclosure, the plasticizer may include at least one of polyethylene glycol, glycerol, polysorbate, propylene glycol, hexylene glycol, 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 10%, 12%, 14%, 15%, 17%, 18%, 20%, 22%, 24%, 25%, 28%, 30%, or a range between any two of the above values.

[0031] According to an embodiment of the present disclosure, the flavoring agent may include at least one of a fruit flavor and a sweetener. Based on the mass of the 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 5%, 8%, 10%, 12%, 14%, 15%, or a range between any two of the above values.

[0032] According to an embodiment of the present disclosure, the pH regulator may include at least one of sodium lactate and compound sodium lactate sorbitol. Based on the mass of the base layer 1, the mass content of the pH regulator may be 5% to 15%. Exemplarily, the mass content of the pH regulator may be 5%, 8%, 10%, 12%, 14%, 15% or a range between any two of the above values.

[0033] According to an embodiment of the present disclosure, the adhesive may include at least one of polyacrylic acid, sodium alginate, guar gum, sodium carboxymethyl cellulose, 5-methylpyrrolidone chitosan, polyglutamic acid, polycarbophil, 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 a range between any two of the above values.

[0034] According to an embodiment of the present disclosure, the thickness of the base layer 1 may be 70-200 μm. For example, the thickness of the base layer 1 may be 70 μm, 80 μm, 90 μm, 100 μm, 110 μm, 120 μm, 130 μm, 140 μm, 150 μm, 160 μm, 170 μm, 180 μm, 190 μm, 200 μm or a range between any two of the above values.

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

[0036] According to an embodiment of the present disclosure, the particle size of the core 21 may be 10-30 μm. For example, the particle size of the core 21 may be 10 μm, 12 μm, 15 μm, 18 μm, 20 μm, 22 μm, 25 μm, 28 μm, 30 μm or a range between any two of the above values.

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

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

[0039] According to an embodiment of the present disclosure, in the sustained-release layer 22, the mass ratio of the nicotine releaser to the second water-soluble polymer material may be (1-4): (8-16). Exemplarily, in the sustained-release layer 22, the mass ratio of the nicotine releaser to the second water-soluble polymer material may be 1:16, 1:12, 1:8, 1:4, 1:2, or a range between any two of the above ratios. In the sustained-release layer 22, the mass ratio of the nicotine releaser to the plasticizer may be (1-4): (2-6). Exemplarily, in the sustained-release layer 22, the mass ratio of the nicotine releaser to the plasticizer may be 1:6, 1:4, 1:2, 1:1, 2:1, 3:2, or a range between any two of the above ratios.

[0040] According to an embodiment of the present disclosure, the thickness of the sustained-release layer 22 may be 20-50 μm. For example, the thickness of the sustained-release layer 22 may be 20 μm, 22 μm, 25 μm, 28 μm, 30 μm, 32 μm, 35 μm, 38 μm, 40 μm, 42 μm, 45 μm, 48 μm, 50 μm or a range between any two of the above values.

[0041] According to an embodiment of the present disclosure, the immediate-release layer 23 may include a third water-soluble polymer material, which 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 disclosure, the immediate-release layer 23 may further include a plasticizer, and the plasticizer in the immediate-release layer 23 may include at least one of polyethylene glycol, glycerin, polysorbate, propylene glycol, hexylene glycol, and polypropylene glycol.

[0043] According to an embodiment of the present disclosure, in the immediate-release layer 23, the mass ratio of the nicotine releaser to the third water-soluble polymer material may be (1-4): (8-16). Exemplarily, in the sustained-release layer 22, the mass ratio of the nicotine releaser to the third water-soluble polymer material may be 1:16, 1:12, 1:8, 1:4, 1:2, or a range between any two of the above ratios. In the sustained-release layer 22, the mass ratio of the nicotine releaser to the plasticizer may be (1-4): (2-6). Exemplarily, in the sustained-release layer 22, the mass ratio of the nicotine releaser to the plasticizer may be 1:6, 1:4, 1:2, 1:1, 2:1, 3:2, or a range between any two of the above ratios.

[0044] According to an embodiment of the present disclosure, the thickness of the immediate-release layer 23 may be 30-50 μm. For example, the thickness of the immediate-release layer 23 may be 30 μm, 32 μm, 35 μm, 38 μm, 40 μm, 42 μm, 45 μm, 48 μm, 50 μm or a range between any two of the above values.

[0045] According to an embodiment of the present disclosure, the particle size of the coated pellets 2 may be 60 to 130 μm. For example, the particle size of the coated pellets 2 may be 60 μm, 70 μm, 80 μm, 90 μm, 100 μm, 110 μm, 120 μm, 130 μm, or a range between any two of the above values.

[0046] According to the embodiments of the present disclosure, based on the mass of the nicotine release material in the nicotine oral dissolving film, when the nicotine oral dissolving film contacts saliva, more than 60 wt % of the nicotine release material in the nicotine oral dissolving film is released within 60 seconds, thereby providing instant satisfaction to the user.

[0047] According to the embodiments of the present disclosure, based on the mass of the nicotine release material in the nicotine oral dissolving film, when the nicotine oral dissolving film contacts saliva, less than 80 wt % of the nicotine release material in the nicotine oral dissolving film is released within 120 seconds, thereby providing the user with a continuous sense of satisfaction and extending the use time of the nicotine oral dissolving film.

[0048] According to an embodiment of the present disclosure, in the coated pellet 2, the quick-release layer 23 can quickly release nicotine when in contact with saliva, providing the user with instantaneous satisfaction; the sustained-release layer 22 can continuously and slowly release nicotine, providing the user with a continuous sense of satisfaction, and prolonging the use time of the nicotine oral dissolving film. The dissolution rates of the base layer 1, the quick-release layer 23, and the sustained-release layer 22 can be regulated by selecting a suitable first water-soluble polymer material, a second water-soluble polymer material, and a third water-soluble polymer material, so that the dissolution rate of the quick-release layer 23 is greater than the dissolution rate of the base layer 1, and the dissolution rate of the sustained-release layer 22 is less than the dissolution rate of the base layer 1. Exemplarily, for the same type of first water-soluble polymer material, second water-soluble polymer material, and third water-soluble polymer material, 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 made greater than the relative molecular mass of the third water-soluble polymer material, and the relative molecular mass of the first water-soluble polymer material can be made smaller than the relative molecular mass of the second water-soluble polymer material, so that the dissolution rate of the quick-release layer 23 is greater than the dissolution rate of the base layer 1, and the dissolution rate of the sustained-release layer 22 is less than the dissolution rate of the base layer 1.

[0049] According to an embodiment of the present disclosure, based on the mass of the nicotine orodissolving film, the content of the coated pellet 2 may be 5wt% to 40wt%. For example, based on the mass of the nicotine orodissolving film, the content of the coated pellet 2 may be 5wt%, 8wt%, 10wt%, 15wt%, 20wt%, 25wt%, 30wt%, 35wt%, 40wt% or a range between any two of the above values.

[0050] The present disclosure also provides a method for preparing the above-mentioned nicotine orally dissolving film containing coated micropellets, comprising: using fluidized bed coating technology to sequentially coat the inner core, the sustained-release layer and the immediate-release layer to obtain coated micropellets; dispersing the coated micropellets in a substrate slurry to obtain a substrate slurry containing the coated micropellets; and converting the substrate slurry containing the coated micropellets into a nicotine orally dissolving film containing the coated micropellets by a casting method. The coated micropellets sequentially include an inner core, a sustained-release layer and an immediate-release layer from the inside to the outside; the base layer, the sustained-release layer and the immediate-release layer each independently include a nicotine releaser; the base layer, the sustained-release layer and the immediate-release layer dissolve in contact with saliva, the immediate-release layer dissolving at a rate greater than the base layer, and the sustained-release layer dissolving at a rate less than the base layer.

[0051] According to an embodiment of the present disclosure, converting the substrate slurry containing coated micropellets into a nicotine orally dissolving film containing coated micropellets by a casting method comprises: coating the substrate slurry containing coated micropellets on a substrate, and obtaining the nicotine orally dissolving film containing coated micropellets after drying. The drying temperature may be 40° C. to 90° C., and the drying time may be 1 to 4 hours.

[0052] The present disclosure will be described in detail below in conjunction with specific embodiments. It should be noted that the embodiments and features in the embodiments of the present disclosure may be combined with each other without conflict.

[0053] Example 1

[0054] This embodiment provides a nicotine orally dissolving film containing coated pellets, the nicotine orally dissolving film comprises a base layer and coated pellets located in the base layer, the coated pellets sequentially comprise a core, a sustained-release layer and a quick-release layer from the inside to the outside; wherein the base layer, the sustained-release layer and the quick-release layer each independently comprise a nicotine releaser; the base layer, the sustained-release layer and the quick-release layer dissolve when in contact with saliva, the dissolution rate of the quick-release layer is greater than the dissolution rate of the base layer, and the dissolution rate of the sustained-release layer is less than the dissolution rate of the base layer. The thickness of the nicotine orally dissolving film is about 200 μm. The content of the coated pellets in the nicotine orally dissolving film is 30 wt%.

[0055] Among them, the base layer includes nicotine tartrate, hypromellose, glycerin, and mint flavor, and the mass ratio of the four is 10:40:15:2. The particle size of the coated micropellets is about 90μm. The particle size of the inner core of the coated micropellets is about 20μm, including 25wt% nicotine tartrate and 75wt% polyvinyl pyrrolidone; the thickness of the sustained-release layer is about 30μm, including 15wt% nicotine tartrate, 75wt% hypromellose E15 and 10wt% propylene glycol. The thickness of the immediate-release layer is about 30μm, including 15wt% nicotine tartrate, 75wt% hypromellose E3 and 10wt% propylene glycol. Among them, the relative molecular mass of carboxymethyl cellulose in the sustained-release layer is higher than the relative molecular mass of carboxymethyl cellulose in the immediate-release layer.

[0056] The nicotine orally dissolving film containing coated pellets provided in this embodiment is prepared by the following method:

[0057] (1) The fluidized bed coating technology is used to coat the inner core, sustained-release layer and immediate-release layer in sequence to obtain coated micropellets.

[0058] (2) Dispersing the coated micropellets in the base material slurry to obtain the base material slurry containing the coated micropellets.

[0059] (3) coating the substrate slurry containing the coated micropellets on the substrate, and drying the substrate to obtain a nicotine orally dissolving film containing the coated micropellets.

[0060] Comparative Example 1

[0061] This comparative example provides a nicotine orodispersible film and a preparation method thereof, referring to Example 1, except that: the nicotine orodispersible film does not include coated pellets.

[0062] Comparative Example 2

[0063] This comparative example provides a nicotine orodispersible film and a preparation method thereof, with reference to Example 1, except that: the coated pellets in the nicotine orodispersible film only include a core and a sustained-release layer.

[0064] Comparative Example 3

[0065] This comparative example provides a nicotine orodispersible film and a preparation method thereof, with reference to Example 1, except that: the coated pellets in the nicotine orodispersible film only include a core and a quick-release layer.

[0066] The nicotine orally dissolving films with multi-layer structures provided in Example 1 and Comparative Examples 1 to 3 were placed in a nicotine extract (artificial saliva) to test the cumulative dissolution of nicotine. The test results are shown in Table 1.

[0067] Table 1

[0068]

[0069] From the analysis of Table 1, it can be seen that the nicotine oral dissolving film with a multi-layer structure provided by the embodiments of the present disclosure can release nicotine release materials continuously and stably, and can quickly release nicotine within 1 minute of contact with the nicotine extract, and the nicotine release time can last for 5 minutes.

[0070] The nicotine orally dissolving film with a multi-layer structure provided in Example 1 and Comparative Example 1 was opened and placed in a simulated extreme environment (40° C., 75% RH) for stability testing. The nicotine tartrate content is shown in Table 2.

[0071] Table 2

[0072]

[0073] The nicotine oral dissolving film with a multi-layer structure provided in the embodiments of the present disclosure has good stability.

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

Claims

1. A nicotine orally dissolving film containing coated pellets, characterized in that: The nicotine orally dissolving film comprises a base layer and coated pellets located in the base layer, wherein the coated pellets comprise a core, a sustained-release layer and a quick-release layer in sequence from the inside to the outside; Wherein, the base layer, the sustained-release layer and the immediate-release layer each independently comprise nicotine releasing substances; The base layer, the sustained-release layer and the quick-release layer dissolve when in contact with saliva, the quick-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.

2. The nicotine orally dissolving film containing coated pellets according to claim 1, characterized in that: Based on the mass of the nicotine releasing material in the nicotine oral dissolving film, when the nicotine oral dissolving film contacts saliva, more than 60 wt % of the nicotine releasing material in the nicotine oral dissolving film is released within 60 seconds.

3. The nicotine orally dissolving film containing coated pellets according to claim 1, characterized in that: Based on the mass of the nicotine releasing material in the nicotine oral dissolving film, when the nicotine oral dissolving film contacts saliva, less than 80 wt % of the nicotine releasing material in the nicotine oral dissolving film is released within 120 seconds.

4. The nicotine orally dissolving film containing coated pellets according to claim 1, characterized in that: Based on the mass of the nicotine orosoluble film, the content of the coated pellets is 5wt% to 40wt%.

5. The nicotine orally dissolving film containing coated pellets according to claim 1, characterized in that: The base layer includes a first water-soluble polymer material; The first water-soluble polymer material includes at least one of hydroxypropyl methylcellulose, carboxymethyl cellulose, povidone, pectin, sodium alginate, and sodium alginate; The sustained-release layer includes a second water-soluble polymer material; The second water-soluble polymer material includes at least one of polyvinyl alcohol, povidone, polyethylene glycol, carboxymethyl cellulose, hydroxypropyl cellulose, and maltodextrin; The quick-release layer includes a third water-soluble polymer material; The third water-soluble polymer material includes at least one of pullulan, hydroxypropyl methylcellulose, povidone, polyethylene glycol, carboxymethyl cellulose, hydroxypropyl cellulose, polyethylene oxide, and polyvinyl alcohol.

6. The nicotine orally dissolving film containing coated pellets according to any one of claims 1 to 5, characterized in that: The core includes a nicotine releaser and an excipient; The excipient includes at least one of carboxymethyl cellulose, polyvinyl alcohol, and hydroxypropyl methyl cellulose.

7. The nicotine orally dissolving film containing coated pellets according to any one of claims 1 to 5, characterized in that: The thickness of the base layer is 70-200 μm; The particle size of the core is 10-30 μm; The thickness of the sustained-release layer is 20-50 μm; The thickness of the quick-release layer is 30-50 μm; The particle size of the coated micropellets is 60-130 μm.

8. The nicotine orally dissolving film containing coated pellets according to any one of claims 1 to 5, characterized in that: The nicotine releaser comprises at least one of nicotine, nicotine microcapsules, nicotine liposomes, nicotine citrate salts, nicotine malate salts, and nicotine tartrate salts.

9. The nicotine orally dissolving film containing coated pellets according to any one of claims 1 to 5, characterized in that: The base layer also includes at least one of a plasticizer, a flavoring agent, a pH regulator, and an adhesive.

10. The nicotine orally dissolving film containing coated pellets according to claim 9, characterized in that: The pH regulator includes at least one of sodium lactate and compound sodium lactate sorbitol; The plasticizer includes at least one of polyethylene glycol, glycerol, polysorbate, propylene glycol, hexylene glycol, and polypropylene glycol; The flavoring agent includes at least one of a fruit flavor and a sweetener; The adhesive comprises at least one of polyacrylic acid, sodium alginate, guar gum, sodium carboxymethyl cellulose, 5-methylpyrrolidone chitosan, polyglutamic acid, polycarbophil, and dextran sulfate.

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