Oral soluble film and preparation method thereof

Abstract

The invention discloses an oral soluble film and a preparation method thereof.The oral soluble film comprises a functional layer and a taste masking layer which are stacked in the thickness direction, and the functional layer comprises a first film forming base material, an active substance and a pH regulator; the taste masking layer comprises a second film forming base material and a flavoring agent, and the flavoring agent comprises at least one of essence, a sweetening agent, an acidulant and a cooling agent; the preparation method comprises the following steps: preparing a functional layer solution, wherein the functional layer solution comprises a first film-forming substrate, an active substance and a pH regulator; a taste masking layer solution is prepared, the taste masking layer solution comprises a second film forming base material and a flavoring agent, and the flavoring agent comprises at least one of essence, a sweetening agent, an acidulant and a cooling agent; coating: coating and drying the taste masking layer solution to obtain a taste masking layer; and coating the functional layer solution on the surface of the taste masking layer, and drying to obtain the oral soluble film. The oral soluble film can cover the bitter taste of the active substances, the active substances are rapidly released, the essence is relatively slowly released, and the taste is improved.

Description

Technical Field

[0001] The present application relates to the technical field of oral products, and in particular to an orally dissolving film and a preparation method thereof. Background Art

[0002] Nicotine replacement products (such as patches, chewing gums, lozenges, etc.) are widely used in smoking cessation adjuvant therapy. However, such products have the following problems: chewing gums or lozenges need to be chewed or sucked, which may affect the user's speech and have limited usage scenarios (such as inconvenient in social situations); nicotine patches have a slow onset of action due to being applied on the skin surface and cannot meet the user's demand for immediate nicotine release. Orally dissolving films are more and more popular among users because they can be attached to the gums and are convenient to use.

[0003] However, the orally dissolving films in the related art have the following defects: the orally dissolving films usually directly mix all ingredients, and when nicotine is directly mixed with flavors, it is easy to cause residual bitterness, resulting in the inability to effectively mask the bitterness of nicotine, poor user experience, and all ingredients are in direct contact, which may cause ingredient interaction during long-term storage and affect its stability. Summary of the Invention

[0004] The technical problem to be solved by the present application is how to effectively inhibit the bitterness of the active substances in the orally dissolving film, and provide an orally dissolving film and a preparation method thereof.

[0005] The technical solution adopted by the present application to solve its technical problem is: an orally dissolving film, which includes a functional layer and a taste masking layer laminated in the thickness direction. The functional layer includes a first film-forming substrate, an active substance, and a pH regulator; the taste masking layer includes a second film-forming substrate and a flavoring agent, and the flavoring agent includes at least one of an essence, a sweetening agent, an acidifying agent, and a cooling agent.

[0006] In some embodiments, the first film-forming substrate is a water-soluble substrate.

[0007] In some embodiments, the first film-forming substrate includes at least one of hydroxypropyl methylcellulose, polyvinyl alcohol, and sodium alginate.

[0008] In some embodiments, the second film-forming substrate is a water-insoluble substrate.

[0009] In some embodiments, the second film-forming substrate includes an ethyl cellulose aqueous dispersion.

[0010] In some embodiments, the taste masking layer further includes a plasticizer, and the plasticizer includes at least one of glycerol, polyethylene glycol, phthalate, citrate, and fatty acid ester.

[0011] In some embodiments, the active substance includes at least one of nicotine and nicotine derivatives; and / or, the pH regulator includes at least one of sodium bicarbonate, sodium carbonate, sodium citrate and citric acid; and / or, the sweetener includes at least one of sucralose, erythritol and acesulfame potassium; and / or, the souring agent includes at least one of malic acid, citric acid, acetic acid and tartaric acid; and / or, the cooling agent includes at least one of menthol, menthone, menthyl lactate, WS-23, WS-3 and WS-12.

[0012] In some embodiments, the thickness of the taste masking layer is 30 μm to 100 μm, and the thickness of the functional layer is 50 μm to 100 μm.

[0013] In some embodiments, the raw materials for preparing the functional layer include, by mass: 20 to 30 parts of a first film-forming substrate, 1 to 10 parts of an active substance, and 1 to 10 parts of a pH regulator; the raw materials for preparing the taste masking layer include, by mass: 10 to 50 parts of a second film-forming substrate, 1 to 30 parts of a flavor, and 1 to 6 parts of a sweetener.

[0014] The present application also provides a method for preparing an orally dissolving film, which is used to prepare the orally dissolving film according to any one of the above, and the preparation method includes: preparing a functional layer solution, the functional layer solution including a first film-forming substrate, an active substance and a pH regulator; preparing a taste masking layer solution, the taste masking layer solution including a second film-forming substrate and a flavoring agent, the flavoring agent including at least one of a flavor, a sweetener, a souring agent and a cooling agent; coating: coating and drying the taste masking layer solution to obtain a taste masking layer; coating the functional layer solution on the surface of the taste masking layer and drying to obtain an orally dissolving film, the orally dissolving film including a functional layer and a taste masking layer stacked in the thickness direction.

[0015] Advantages of the present application:

[0016] The orally dissolving film of the present application includes a functional layer and a taste masking layer stacked in the thickness direction. By physically isolating the active substance from the flavor, it is possible to mask the bitterness of the active substance, improve the taste, reduce the interaction between the active substance and other components, improve the stability of the orally dissolving film, and also achieve staged release, that is, the active substance in the functional layer is rapidly released, while the flavor in the taste masking layer is slowly released relative to the active substance.

[0017] In the method for preparing the orally dissolving film of the present application, the taste masking layer solution and the functional layer solution are respectively prepared, and the taste masking layer is first coated and then the functional layer is coated on its surface. The prepared double-layer orally dissolving film can effectively mask the bitterness of the active substance, regulate the overall release rate of each component of the orally dissolving film, and the preparation method is simple and feasible, suitable for large-scale production. Description of the drawings

[0018] The present application will be further described below in conjunction with the drawings and embodiments. In the drawings:

[0019] Figure 1 It is the dissolution test result diagram of Examples 1 to 3 and Comparative Example 1 of the present application. Detailed implementation manners

[0020] For a clearer understanding of the technical features, objectives, and effects of the present application, the present application will be further described in detail below in conjunction with embodiments. These embodiments are only used to explain the present application and do not constitute a limitation on the protection scope of the present application.

[0021] The present application provides an orally dissolving film, which includes a functional layer and a taste masking layer stacked in the thickness direction. The functional layer includes a first film-forming substrate, an active substance, and a pH regulator; the taste masking layer includes a second film-forming substrate and a flavoring agent, and the flavoring agent includes at least one of essence, sweetener, acidulant, and cooling agent.

[0022] The first film-forming substrate in the functional layer is a water-soluble substrate, and the first film-forming substrate includes at least one of hydroxypropyl methylcellulose (such as E5 grade), polyvinyl alcohol, and sodium alginate. The second film-forming substrate in the taste masking layer is a water-insoluble substrate, and the second film-forming substrate can be ethyl cellulose. Ethyl cellulose is insoluble in water but soluble in ethanol, and an ethyl cellulose aqueous dispersion or an ethanol solution of ethyl cellulose can be used. The molecular weight of ethyl cellulose is 60,000 to 300,000, and the particle size of ethyl cellulose is 1 μm to 10 μm, such as 1 μm, 3 μm, 5 μm, 8 μm, or 10 μm, etc. The orally dissolving film of the present application is a double-layer film, and the components of the first film-forming substrate of the functional layer and the second film-forming substrate of the taste masking layer are different, making the sense of hierarchy of the orally dissolving film better.

[0023] The active substance in the functional layer includes at least one of nicotine and nicotine derivatives. Nicotine includes but is not limited to natural nicotine and synthetic nicotine. Nicotine derivatives include but are not limited to nicotine salts, nicotine in a matrix such as a sugar matrix or an organometallic complex, nicotine-resin combinations, nicotine inclusion complexes, and non-covalently bound nicotine. Among them, non-covalently bound nicotine includes but is not limited to nicotine lactate, nicotine malate, nicotine salicylate, nicotine cyclodextrin inclusion complex, nicotine hydrochloride, nicotine dihydrochloride, nicotine tartrate, nicotine tartrate dihydrate, nicotine sulfate, nicotine zinc chloride, nicotine benzoate, etc. Nicotine derivatives also include nicotine with substituents, such as hexamethyl nicotine, hexamethyl nicotine lactate, hexamethyl nicotine malate, hexamethyl nicotine salicylate, hexamethyl nicotine cyclodextrin inclusion complex, hexamethyl nicotine hydrochloride, hexamethyl nicotine dihydrochloride, hexamethyl nicotine tartrate, hexamethyl nicotine tartrate dihydrate, hexamethyl nicotine sulfate, hexamethyl nicotine zinc chloride, hexamethyl nicotine benzoate, or a mixture of one or more of them.

[0024] In some embodiments, the active substance may further include other substances with specific active properties, such as caffeine, tea polyphenols, etc., to meet different needs of users.

[0025] The pH regulator in the functional layer includes at least one of sodium bicarbonate, sodium carbonate, sodium citrate, and citric acid.

[0026] Among the flavoring agents in the taste-masking layer, the sweetening agent includes at least one of sucralose, erythritol, and acesulfame potassium. The souring agent includes at least one of malic acid, citric acid, acetic acid, and tartaric acid. The cooling agent includes at least one of menthol, menthone, menthyl lactate, WS-23 (N,2,3-trimethyl-2-isopropylbutyramide), WS-3 (N-ethyl-p-menthane-3-carboxamide), and WS-12 (N-(4-methoxyphenyl)-p-menthane-3-carboxamide). The essence is an edible essence. For example, the essence includes at least one of mint essence, mango essence, lemon essence, blueberry essence, and coffee essence. The essence can also be other flavors of edible essence, which will not be elaborated one by one in this application.

[0027] In some embodiments, the taste-masking layer further includes a plasticizer, and the plasticizer includes at least one of glycerol, polyethylene glycol (PEG), phthalate, citrate, and fatty acid ester. Among them, the polyethylene glycol can be PEG 400, PEG 600, or PEG1500, the phthalate can be diethyl phthalate (DEP) or dibutyl phthalate (DBP), the citrate can be triethyl citrate (TEC) or tributyl citrate (TBC), and the fatty acid ester can be sorbitan monostearate (such as Span60, Span80) or polysorbate (such as Tween 80).

[0028] The functional layer is designed to dissolve quickly and release the active substance preferentially; while the taste-masking layer dissolves slightly slower, and components such as the essence in the taste-masking layer are released later than the active substance, which can prolong the fresh taste. The thickness of the taste-masking layer is 30μm to 100μm. For example, 30μm, 50μm, 70μm, 80μm, or 100μm can be selected, etc. The thickness of the functional layer is 50μm to 100μm. For example, 50μm, 60μm, 70μm, 80μm, 90μm, or 100μm can be selected, etc. By adjusting the thicknesses of the taste-masking layer and the functional layer, the overall release rate of each component in the orally dissolving film is controlled. Generally speaking, the larger the thickness, the slower the overall release of the orally dissolving film.

[0029] In some embodiments, the raw materials for preparing the functional layer include, by mass, 20 to 30 parts of a first film-forming substrate, 1 to 10 parts of an active substance, and 1 to 10 parts of a pH adjuster, wherein the first film-forming substrate may be 20 parts, 23 parts, 25 parts, 28 parts, or 30 parts, etc., the active substance may be 1 part, 3 parts, 5 parts, 7 parts, or 10 parts, etc., and the pH adjuster may be 1 part, 2 parts, 4 parts, 6 parts, 8 parts, or 10 parts, etc.

[0030] The raw materials for preparing the taste-masking layer include, by weight, 10-50 parts of a second film-forming substrate, 1-30 parts of a flavoring, and 1-6 parts of a sweetener. The second film-forming substrate can be present in 10, 20, 30, 40, or 50 parts, the flavoring can be present in 1, 10, 15, 20, 25, or 30 parts, and the sweetener can be present in 1, 2, 4, or 6 parts. The raw materials for preparing the taste-masking layer also include 0.5-6 parts of a plasticizer, which can be present in 0.5, 1, 2, 4, or 6 parts.

[0031] The orally dissolving film of the present application comprises a functional layer and a flavor-masking layer stacked in the thickness direction. By physically isolating the active substance from the flavor, it can mask the bitterness of the active substance, improving the mouthfeel. It also reduces the interaction of the active substance with other ingredients, increasing the stability of the orally dissolving film. It can also achieve phased release, i.e., the active substance in the functional layer is rapidly released, while the flavor in the flavor-masking layer is relatively slowly released. By providing a flavor-masking layer of a certain thickness and dissolving slowly, the problem of the orally dissolving film being unable to move can be solved.

[0032] The present application also provides a method for preparing an orally disintegrating film, which is used to prepare the orally disintegrating film. The preparation method comprises:

[0033] S1. Prepare a functional layer solution, wherein the functional layer solution includes a first film-forming substrate, an active substance, and a pH adjuster.

[0034] In step S1, 30 to 90 parts of a first solvent, 20 to 30 parts of a first film-forming substrate, 1 to 10 parts of an active substance, and 1 to 10 parts of a pH regulator are mixed and dissolved, and then vacuum is applied to remove bubbles to obtain a functional layer solution. The first solvent may be water. Specifically, first, the first solvent is added to a stirring container (such as a stirring tank) and stirred at a first stirring rate, and then the first film-forming substrate is added for homogenization. After the first film-forming substrate is completely dissolved, the homogenization is stopped; then the active substance is added and stirred at the first stirring rate, and the solid content is controlled to be 10% to 50%. The solid content may be 10%, 20%, 30%, 40%, or 50%, etc.; a pH regulator is added to adjust the pH value to 4 to 9. The pH value may be 4, 6, 8, or 9, etc., and it is stirred at a second stirring rate; it is adjusted to a third stirring rate to apply vacuum to remove bubbles. After the bubbles are completely eliminated, the vacuum is turned off to obtain the functional layer solution. It should be noted that the specific process parameters for preparing the functional layer solution can be dynamically adjusted according to specific production conditions, and will not be limited one by one in this application.

[0035] S2. Prepare a taste-masking layer solution. The taste-masking layer solution includes a second film-forming substrate, a flavoring agent, and a plasticizer. The flavoring agent includes at least one of an essence, a sweetening agent, an acidifying agent, and a cooling agent.

[0036] In step S2, for example, the flavoring agent includes an essence and a sweetening agent. 10 to 50 parts of a second film-forming substrate, 1 to 30 parts of an essence, 1 to 6 parts of a sweetening agent, and 0.5 to 6 parts of a plasticizer are mixed and dissolved, homogenized, and vacuum is applied to remove bubbles to obtain a taste-masking layer solution. The effective component of the second film-forming substrate is ethyl cellulose, and an ethyl cellulose aqueous dispersion (suspension) or an ethanol solution of ethyl cellulose can be prepared. Then, the preparation of the taste-masking layer solution in step S2 is divided into the following two implementation manners.

[0037] The first implementation manner: The second film-forming substrate is an ethyl cellulose aqueous dispersion. The preparation method of one part of the ethyl cellulose aqueous dispersion is as follows: 5 to 10 parts of ethyl cellulose are added to 90 to 95 parts of an ammonia water solution, and then 1 to 3 parts of a plasticizer (such as PEG 400) are added and stirred with a homogenizer to obtain a white suspension, which is the ethyl cellulose aqueous dispersion. In the ethyl cellulose aqueous dispersion, the ammonia water solution serves as a stabilizer and has an emulsifying effect, causing smaller layers to form in the suspension. The mass fraction of the ammonia water solution is preferably 20% to 40%, such as 20%, 25%, 30%, or 40%, etc. Step S2 may be: adding the prepared ethyl cellulose aqueous dispersion, the flavoring agent (such as an essence, a sweetening agent), and the plasticizer (such as glycerol) to a stirring container, homogenizing, stopping homogenization after mixing evenly, applying vacuum to remove bubbles, and turning off the vacuum after the bubbles are completely eliminated to obtain the taste-masking layer solution. The plasticizer glycerol can adjust the nicotine release rate and the hardness and softness of the orally disintegrating film. In some embodiments, the plasticizer glycerol may not be added.

[0038] The second implementation mode: The second film-forming substrate is ethyl cellulose, and the taste-masking layer further includes 50 to 90 parts of a second solvent, and the second solvent is ethanol. The S2 step may be: adding the second solvent ethanol into a stirring container, stirring at a first stirring rate, then adding the second film-forming substrate ethyl cellulose, flavoring agents (such as essence, sweeteners) and plasticizers, and performing homogenization. After the second film-forming substrate is completely dissolved, stop homogenization, perform vacuum defoaming, and close the vacuum after the bubbles are completely eliminated to obtain the taste-masking layer solution.

[0039] In the S1 and S2 steps, the first stirring rate is 50 rpm to 200 rpm, the homogenization rate is 10,000 rpm to 20,000 rpm, the second stirring rate is 50 rpm to 100 rpm, and the third stirring rate is 10 rpm to 20 rpm; the vacuum degree for vacuum defoaming is -0.06 Mpa to -0.08 Mpa. Among them, the first stirring rate may be 100 rpm, the homogenization rate may be 15,000 rpm, the second stirring rate may be 75 rpm, and the third stirring rate may be 15 rpm; the vacuum degree for vacuum defoaming may be -0.07 Mpa. It should be noted that the specific process parameters for preparing the functional layer solution and the taste-masking layer solution can be dynamically adjusted according to specific production conditions, and are not limited one by one in this application.

[0040] S3. Coating: Coating and drying the taste-masking layer solution to obtain the taste-masking layer; coating the functional layer solution on the surface of the taste-masking layer and drying to obtain the orally dissolving film, and the orally dissolving film includes a functional layer and a taste-masking layer stacked in the thickness direction.

[0041] In the S3 step, coating is carried out using a coater. Before starting coating, first lay a release film, and this release film can adopt the prior art. First, coat the taste-masking layer solution, control the material thickness to be 30 μm to 100 μm, and then heat and dry until the moisture content of the taste-masking layer is lower than 5%; then coat the functional layer solution on the surface of the dried taste-masking layer, control the material coating thickness to be 50 μm to 100 μm, and the total thickness to be 80 μm to 200 μm, and then heat and dry until the moisture content of the functional layer is lower than 5%. Both the taste-masking layer and the functional layer contain water. After drying, the taste-masking layer is insoluble in water, while the components of the functional layer are soluble in water. Coating the taste-masking layer first can avoid the mixing of the double-layer film. Specifically, the drying and coating rate is 30 mm / s to 80 mm / s, and 30 mm / s, 40 mm / s, 50 mm / s, 70 mm / s or 80 mm / s, etc. can be selected; the heating temperature for drying is 50 °C to 60 °C, and 50 °C, 53 °C, 55 °C, 58 °C or 60 °C, etc. can be selected; it is only necessary that the moisture content of both the taste-masking layer and the functional layer is lower than 5%, and no specific limitation is made. Among them, it should be noted that the specific process parameters for coating can be dynamically adjusted according to specific production conditions, and are not limited one by one in this application.

[0042] S4. Packaging: Cut, bag, and seal the orally dissolving film obtained in step S3. The length and width of each orally dissolving film can be (1.5 cm - 2.5 cm) × (0.5 cm - 1.5 cm). The nicotine content of the orally dissolving film is 2 ± 0.2 mg per tablet. The packaging bag can be an aluminum foil bag or a polyethylene bag.

[0043] In the preparation method of the orally dissolving film of the present application, the taste masking layer solution and the functional layer solution are respectively prepared. First, the taste masking layer is coated and then the functional layer is coated on its surface. The prepared double-layer orally dissolving film can effectively mask the bitterness of the active substance, regulate the overall release rate of each component of the orally dissolving film, and the preparation method is simple and feasible, suitable for large-scale production.

[0044] The following is illustrated by specific examples:

[0045] The orally dissolving films of Examples 1 - 5 and Comparative Example 1 are prepared by using the above-mentioned preparation method of the orally dissolving film of the present application. Among them, the orally dissolving film of Comparative Example 1 does not add the second film-forming substrate and only has a functional layer. The components and their mass fractions of the orally dissolving films of Examples 1 - 5 and Comparative Example 1 are shown in Tables 1 and 2.

[0046] Table 1 Components and their mass fractions of the orally dissolving films of Examples 1 - 5

[0047]

[0048] Table 2 Components and their mass fractions of the orally dissolving film of Comparative Example 1

[0049]

[0050]

[0051] It can be understood that in the above Examples 1 - 5 and their alternative schemes, the components of the active substance, the first film-forming substrate, and the pH regulator in the functional layer can be replaced with other components of the corresponding components in the aforementioned orally dissolving film, which will not be elaborated here; the components of the second film-forming substrate, the flavoring agent (flavor and sweetener), and the plasticizer in the taste masking layer can be replaced with other components of the corresponding components in the aforementioned orally dissolving film. The flavoring agent can be replaced with at least one of flavor, sweetener, acidulant, and cooling agent, which will not be elaborated here.

[0052] Comparative experiment:

[0053] I. Taste evaluation

[0054] The orally dissolving films of Examples 1 - 3 and Comparative Example 1 of the present application are subjected to taste evaluation. The evaluation items include spiciness at the entrance, sweetness at the entrance, aroma, and bitterness. Each item is scored from 1 to 10 points, and the higher the score, the higher the intensity. The time represents the duration of the continuous feeling. The results are shown in Table 3.

[0055] Table 3 Results of Taste Evaluation

[0056]

[0057] The disintegration times of the orally disintegrating films of Examples 1 to 3 and Comparative Example 1 were 12 min, 35 min, 48 min, and 5 min, respectively. Disintegration means that the orally disintegrating film breaks into small particles (particle size about 0.42 mm) or completely dissolves. According to Table 3, the orally disintegrating films of Examples 1 to 3 have a taste-masking layer, and the spiciness, sweetness, and aroma of nicotine are more persistent, and the bitterness is less. This may be related to the dissolution time of the film-forming substrate in the mouth. The thicker the taste-masking layer, the longer the dissolution time of the film-forming substrate in the oral cavity and the more stable it is. The orally disintegrating film of Comparative Example 1 has only a functional layer, and the spiciness, sweetness, and aroma of this orally disintegrating film are not persistent enough and have a certain bitterness.

[0058] II. Dissolution Test

[0059] Equipment: 708-DS Dissolution Tester - paddle method

[0060] Samples: Orally disintegrating films of Examples 1 to 3 and Comparative Example 1

[0061] Dissolution medium: 500 mL of artificial saliva (pH 6.8), and its composition is as follows: 0.400 g of NaCl (sodium chloride), 0.400 g of KCl (potassium chloride), 0.690 g of NaH2PO4·2H2O (sodium dihydrogen phosphate dihydrate), 0.500 g of Na2HPO4 (disodium hydrogen phosphate), 0.100 g of CaCl2 (calcium chloride), 1.000 g of urea (CH4N2O), 1000 mL of distilled water or deionized water, optional component (to increase viscosity) 0.2% sodium carboxymethylcellulose (CMC-Na).

[0062] The preparation steps of artificial saliva are as follows:

[0063] (1) Weigh the reagents: Weigh each component using an analytical balance.

[0064] (2) Dissolve the salts: In about 800 mL of distilled water, add NaCl, KCl, NaH2PO4·2H2O, and Na2HPO4 in sequence, and continuously stir until completely dissolved.

[0065] (3) Add calcium chloride: Add CaCl2 and stir evenly to avoid precipitation.

[0066] (4) Add urea: Add urea while stirring to make it fully dissolve.

[0067] (5) Adjust the pH: Adjust the pH value to 6.8 with 0.1 M NaOH or 0.1 M HCl.

[0068] (6) Volume fixing: Add distilled water to make the volume up to 1000 mL and stir evenly. If a clearer medium is needed, it can be filtered through a 0.45 μm filter membrane.

[0069] (7) Storage: Store the prepared artificial saliva at 4 °C and shake well before use.

[0070] Sampling points: 0.5 min, 1 min, 2 min, 3 min, 5 min, 10 min, 15 min, 20 min, 30 min, 60 min

[0071] Test conditions: Heating temperature 37 °C, rotation speed 100 r / min.

[0072] Analysis method: Place the orally disintegrating film samples in artificial saliva respectively, take samples and detect at different time points, use a high performance liquid chromatograph to detect the nicotine content, and establish a nicotine dissolution curve. The test results are shown in Table 4 and Figure 1 as follows.

[0073] Table 4 Dissolution test results

[0074] [[ID=2L]]

[0075] According to Table 4 and Figure 1 it can be seen that the nicotine dissolution rate of the orally disintegrating films (double-layer films) in Examples 1 to 3 of this application is slower than that of the orally disintegrating film (single-layer film) in Comparative Example 1, and as the content of the second film-forming substrate of the taste masking layer in Examples 1 to 3 gradually increases, the nicotine dissolution shows a decreasing trend.

[0076] It can be understood that the above embodiments only represent the preferred embodiments of this application, and their descriptions are relatively specific and detailed, but they should not be construed as limiting the patent scope of this application; it should be noted that for those of ordinary skill in the art, without departing from the concept of this application, the above technical features can be freely combined, and several deformations and improvements can also be made, which all belong to the protection scope of this application; therefore, all equivalent transformations and modifications made to the scope of the claims of this application shall fall within the scope covered by the claims of this application.

Claims

1. An orally disintegrating film, characterized in that, It includes a functional layer and a taste masking layer laminated in the thickness direction. The functional layer includes a first film-forming substrate, an active substance, and a pH regulator; the taste masking layer includes a second film-forming substrate and a flavoring agent, and the flavoring agent includes at least one of essence, sweetener, acidulant, and cooling agent.

2. The orally dissolving film according to claim 1, wherein The first film-forming substrate is a water-soluble substrate.

3. The orally disintegrating film according to claim 2, wherein The first film-forming substrate includes at least one of hydroxypropyl methylcellulose, polyvinyl alcohol, and sodium alginate.

4. The orally dissolving film according to claim 1, wherein, The second film-forming substrate is a water-insoluble substrate.

5. The orally disintegrating film according to claim 4, wherein, The second film-forming substrate includes ethyl cellulose aqueous dispersion.

6. The orally dissolving film according to claim 1, wherein, The taste masking layer further includes a plasticizer, and the plasticizer includes at least one of glycerol, polyethylene glycol, phthalate, citrate, and fatty acid ester.

7. The orally disintegrating film according to claim 1, wherein The active substance includes at least one of nicotine and nicotine derivatives; and / or, The pH regulator includes at least one of sodium bicarbonate, sodium carbonate, sodium citrate, and citric acid; and / or, The sweetener includes at least one of sucralose, erythritol, and acesulfame potassium; and / or, The acidulant includes at least one of malic acid, citric acid, acetic acid, and tartaric acid; and / or, The cooling agent includes at least one of menthol, menthone, menthyl lactate, WS-23, WS-3, and WS-12.

8. The orally disintegrating film according to any one of claims 1-7, characterized in that, The thickness of the taste masking layer is 30 μm to 100 μm, and the thickness of the functional layer is 50 μm to 100 μm.

9. The orally disintegrating film according to claim 1, wherein, The raw materials for preparing the functional layer include, by mass: 20 to 30 parts of the first film-forming substrate, 1 to 10 parts of the active substance, and 1 to 10 parts of the pH regulator; the raw materials for preparing the taste masking layer include, by mass: 10 to 50 parts of the second film-forming substrate, 1 to 30 parts of essence, and 1 to 6 parts of sweetener.

10. A preparation method of an orally disintegrating film, characterized in that, For preparing the orally dissolving film according to any one of claims 1-9, the preparation method includes: Preparing a functional layer solution, which includes the first film-forming substrate, the active substance, and the pH regulator; Preparing a taste masking layer solution, which includes the second film-forming substrate and the flavoring agent, and the flavoring agent includes at least one of essence, sweetener, acidulant, and cooling agent; Coating: Coating and drying the taste masking layer solution to obtain the taste masking layer; coating the functional layer solution on the surface of the taste masking layer and drying to obtain the orally dissolving film, which includes the functional layer and the taste masking layer laminated in the thickness direction.

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