Oral cavity product

Abstract

The invention discloses an oral cavity product, which comprises an oral soluble film and a support layer, the support layer has water-insoluble property, the support layer is arranged on at least one surface of the oral soluble film or embedded in the oral soluble film, the support layer is provided with at least one channel, and the channel is used for saliva to pass through the support layer. The supporting layer can play a supporting role, the probability that the oral dissolving film shrinks and even directly disintegrates in the attaching process is reduced, a user can smoothly attach the oral dissolving film to the position where the oral dissolving film needs to be placed when using an oral product, the use cost of the oral product is reduced, the supporting layer can keep the shape for a long time, and the service life of the oral dissolving film is prolonged. The oral product can be moved or withdrawn from the oral cavity at will according to requirements, so that the usability of the oral product is improved.

Description

Technical Field

[0001] The present application relates to the technical field of oral products, and in particular to an oral product. Background Art

[0002] Orodispersible film is a dosage form that uses a dissolving film to absorb drugs in the oral cavity (buccal or sublingual). At present, hydrophilic polymers are usually used to prepare orodispersible films. Hydrophilic polymers will quickly dissolve on the tongue or buccal cavity when in contact with liquid (saliva), so that the dissolved drug is delivered to the systemic circulation through the oral mucosa.

[0003] Orodispersible films are usually produced by pharmaceutical companies, which usually only focus on the water solubility of orodispersible films and require them to dissolve quickly to release drugs. Therefore, when placing the orodispersible film in the oral cavity where it needs to be placed, the orodispersible film may encounter the liquid in the oral cavity and dissolve, shrink or deform in advance, so that the orodispersible film cannot smoothly reach the position where the user needs to place the product. Summary of the invention

[0004] In view of this, the present application provides an oral product, which can reduce the risk of shrinkage or even disintegration of the orodissolving film during the attachment process, thereby reducing the use cost of the oral product.

[0005] One embodiment of the present application provides an oral product, including an orodispersible film and a supporting layer, wherein the supporting layer is water-insoluble, is disposed on at least one surface of the orodispersible film or is embedded in the orodispersible film, and is provided with at least one channel for allowing saliva to pass through the supporting layer.

[0006] The oral product provided in the embodiment of the present application has a support layer that is liquid-permeable, allowing saliva to pass through and contact with the oral-dissolving film, so that the oral-dissolving film can disintegrate in the saliva and be brought into the oral cavity by the saliva to exert its effect; the support layer is used to support the oral-dissolving film, which reduces the risk of shrinkage or even direct disintegration of the oral-dissolving film during the attachment process, and the user can use only one piece of the oral product to successfully attach it to the position where it is required to be placed, thereby reducing the use cost of the oral product; in addition, the support layer can maintain its shape for a long time, and the oral product can be moved or removed from the oral cavity at will according to needs, thereby improving the usability of the oral product.

[0007] According to some embodiments of the present application, the number of the support layers is at least two, and at least two support layers are respectively disposed on two opposite surfaces of the orodissolving film. The two support layers are disposed on two surfaces of the orodissolving film, which can not only play a supporting role but also an isolating role, thereby reducing the risk of the orodissolving film adhering to the hands or the oral cavity during the attachment process, making it more convenient for users to move the oral product, and improving the usability of the oral product.

[0008] According to some embodiments of the present application, the at least two supporting layers include a first supporting layer and a second supporting layer, the first supporting layer is configured to be located on the side of the orodissolving film facing the oral mucosa, the second supporting layer is configured to be located on the side of the orodissolving film facing the oral cavity, and the water permeability of the first supporting layer is greater than the water permeability of the second supporting layer. The first supporting layer has a higher water permeability than the second supporting layer, so that the substances released after the orodissolving film is dissolved can be more absorbed by the oral mucosa.

[0009] According to some embodiments of the present application, the second support layer has a higher stiffness than the first support layer. The second support layer has a higher stiffness than the first support layer, so that the oral product can be easily attached to the oral mucosa through the first support layer and maintain a suitable stiffness through the second support layer.

[0010] According to some embodiments of the present application, the oral product includes a waterproof layer, and the waterproof layer covers the surface of the second supporting layer on one side away from the oral dissolving film. The waterproof layer can prevent the substances released by the oral dissolving film from entering the oral cavity and then the digestive tract. The substances released by the oral dissolving film only leave the accommodation space through a supporting layer facing the oral mucosa, so that more substances released by the oral dissolving film are absorbed by the oral mucosa.

[0011] According to some embodiments of the present application, the number of the support layer is two, and the two support layers are arranged to form a receiving space, and the support layer is hydrophilic, and at least part of the orodissolving film is placed in the receiving space. The support layer is hydrophilic, and when the oral product enters the oral cavity and contacts the saliva, the support layer can preferentially absorb water and infiltrate, delaying the contact and dissolution of at least part of the orodissolving film placed in the receiving space with the saliva, during which time, the oral product can be moved at will according to demand; and the dissolved orodissolving film can be kept in the receiving space without contacting and adhering to the oral cavity, reducing the risk of physiological discomfort caused by a large amount of dissolved or disintegrated orodissolving film quickly dispersing in the oral cavity, and facilitating the withdrawal of the oral product from the oral cavity, thereby improving the usability of the oral product.

[0012] According to some embodiments of the present application, the support layer includes a sheet material with at least one through hole, and the channel is formed in the through hole. The through hole is processed on the sheet material to form the channel, and the processing technology is simple, which is conducive to reducing production costs.

[0013] According to some embodiments of the present application, the oral product includes a water-swellable layer, and the water-swellable layer is disposed on at least one surface of the support layer. After the water-swellable layer absorbs water and swells, the overall stiffness of the oral product can be improved, which facilitates the user to move the oral product and improves the usability of the oral product.

[0014] According to some embodiments of the present application, the water-swellable layer is disposed on a surface of the support layer facing the orosoluble film.

[0015] According to some embodiments of the present application, the support layer is provided with at least one through hole, the through hole is used for the saliva to pass through, and the oral product includes a porous layer, the porous layer is detachably connected to the support layer and covers the through hole. When in use, the user can choose to open the porous layer so that the substance released by the orodispersible film can be more absorbed by the oral mucosa through the through hole, thereby obtaining a stronger stimulation.

[0016] According to some embodiments of the present application, the oral product includes a handheld portion, which is disposed on the support layer and is used for a user to hold. The user can put the oral product into the oral cavity or take the oral product out of the oral cavity by holding the handheld portion, thereby improving the usability of the oral product.

[0017] According to some embodiments of the present application, the support layer includes at least one of a foamed resin, a mesh resin, a porous resin, a braid, a woven fabric, a single-layer non-woven fabric, a multi-layer non-woven fabric, paper, and an inorganic fiber. The support layer has a porous structure, and the porous structure forms a channel for saliva to pass through, so that the support layer has good liquid permeability, which is conducive to the orodispersible film contacting with saliva to release substances to act on the oral mucosa.

[0018] According to some embodiments of the present application, the support layer includes a water-swellable polymer. When the support layer contacts saliva, the water-swellable polymer absorbs water and swells, further delaying the dissolution of at least part of the orodispersible film placed in the accommodation space from contacting with saliva. During this time, the oral product can be moved at will according to demand, thereby improving the usability of the oral product.

[0019] According to some embodiments of the present application, the orodispersible film comprises nicotine or nicotine salt. BRIEF DESCRIPTION OF THE DRAWINGS

[0020] Figure 1 This is a schematic cross-sectional view of an oral product provided in one embodiment of the present application.

[0021] Figure 2 This is a schematic cross-sectional view of an oral product provided in another embodiment of the present application.

[0022] Figure 3 This is a schematic cross-sectional view of an oral product provided in yet another embodiment of the present application.

[0023] Figure 4 This is a schematic diagram of an oral product provided in yet another embodiment of the present application.

[0024] Figure 5 This is a front view of an oral product provided in one embodiment of the present application.

[0025] Figure 6This is a front view of an oral product provided in another embodiment of the present application.

[0026] Figure 7 This is a front view of an oral product provided in yet another embodiment of the present application.

[0027] Figure 8 This is a schematic cross-sectional view of an oral product provided in yet another embodiment of the present application.

[0028] Fig. 9 This is a schematic cross-sectional view of an oral product provided in yet another embodiment of the present application.

[0029] Fig.10 This is a front view of an oral product provided in yet another embodiment of the present application.

[0030] Fig.11 This is a front view of an oral product provided in yet another embodiment of the present application.

[0031] Fig.12 The figure is a curve diagram of the relative dissolution rate of nicotine of the products of the examples and comparative examples of the present application.

[0032] Fig.13 The figure is a curve diagram of the relative dissolution rate of nicotine in the time period of 0-4 min for the products of the examples and comparative examples of the present application.

[0033] Description of main component symbols:

[0034] Oral Products100

[0035] Support layer 10

[0036] Channel 101

[0037] Oral dissolving film 20

[0038] First opening 11

[0039] Second opening 12

[0040] Through hole 13

[0041] Water swellable layer 30

[0042] Waterproof layer 40

[0043] Accommodation space 102

[0044] Porous layer 50

[0045] The following specific embodiments will further illustrate the present application in conjunction with the above-mentioned drawings. DETAILED DESCRIPTION

[0046] The following specific embodiments are exemplary and non-limiting, and are intended to provide a basic understanding of the present application, and are not intended to identify the key or decisive elements of the present application or to limit the scope of protection. As long as there is no structural conflict, the various technical features mentioned in each embodiment can be combined in any way.

[0047] Unless otherwise defined, when the term "plurality" is used to describe the number of components, it specifically means that the components are two or more.

[0048] The oral-dissolving film can only be effective after it dissolves or disintegrates in the oral cavity. In this case, there is a technical bias that requires the oral-dissolving film to dissolve as quickly as possible after entering the oral cavity. The inventors of the present application have found that when users use the oral-dissolving film, they usually hold the oral-dissolving film directly and put it in or fit it to the position where it needs to be placed. During this process, the oral-dissolving film may encounter the liquid in the oral cavity and dissolve, shrink or deform in advance. The user can only replace the oral-dissolving film with a new one or move the oral-dissolving film with a sticky hand. In other words, in order to smoothly put the oral-dissolving film in or fit it to the position where it needs to be placed, the oral-dissolving film does not dissolve as quickly as possible. In addition, the inventors of the present application have also found that the existing oral-dissolving films do not take into account the need to exit midway.

[0049] The present application provides an oral product, including a support layer and an orodissolving film, wherein the support layer is arranged on at least one surface of the orodissolving film or is embedded in the orodissolving film, and the support layer is water-insoluble and is provided with at least one channel for saliva to pass through the support layer. In the process of placing the oral product in the oral cavity, the water-insoluble support layer may hinder the dissolution of the orodissolving film in the saliva, thereby slowing down the speed at which the orodissolving film dissolves or disintegrates in the saliva to release the effective substance, but the support layer can play a supporting role, reducing the risk of shrinkage or even direct disintegration of the orodissolving film during use, so that the user can smoothly attach the oral product to the position where it needs to be placed when using it, and the user can take out the oral product in the middle of using the oral product, overcoming the technical prejudice that the faster the orodissolving film entering the oral cavity dissolves, the better. For orodissolving films with better effects of being delivered from the oral mucosa to the systemic circulation, the support layer is used to prevent the orodissolving film from disintegrating quickly and being swallowed into the stomach by swallowing, so that the orodissolving film can be delivered to the systemic circulation through the oral mucosa as much as possible, thereby facilitating the improvement of the absorption effect of the orodissolving film.

[0050] Some embodiments of the present application will be described below in conjunction with the accompanying drawings. In the absence of conflict, the following embodiments and features in the embodiments may be combined with each other.

[0051] See also Figure 1In one embodiment of the present application, an oral product 100 is provided, which is used to be placed in a desired position in the oral cavity, such as gums, under the tongue, etc. The oral product 100 includes a support layer 10 and an orodissolving film 20. The orodissolving film 20 is used to contact saliva and dissolve in the oral cavity. The support layer 10 is water-insoluble and is disposed on at least one surface of the orodissolving film 20. Figure 1 The support layer 10 is shown to be disposed on one surface of the orodissolving film 20. The support layer 10 is provided with at least one channel 101, and the channel 101 is used for saliva to pass through the support layer 10 to contact the orodissolving film 20, so that the orodissolving film 20 can be disintegrated in the saliva and brought into the oral cavity by the saliva to exert its effect.

[0052] The support layer 10 plays a supporting role, and is used to support the oral-dissolving film 20, which reduces the risk of shrinkage or even direct disintegration of the oral-dissolving film 20 during the attachment process. The user can use only one piece of the oral product 100 to smoothly attach it to the position where it needs to be placed, reducing the use cost of the oral product 100. In addition, the support layer 10 can maintain its shape for a long time, and the oral-dissolving film 20 is constrained by the support layer 10. The oral product 100 can be moved or withdrawn from the oral cavity at will according to needs, thereby improving the usability of the oral product 100. In addition, the support layer 10 also plays an isolating role, separating the oral-dissolving film 20 from the user's hands and / or oral cavity, reducing the risk of the oral-dissolving film 20 adhering to the hands and / or oral cavity during attachment and use, making it more convenient for the user to move the oral product 100 at any time, and improving the usability of the oral product 100.

[0053] When the support layer 10 is disposed on the side of the oral dissolving film 20 facing the oral mucosa, saliva needs a certain amount of time to wet the support layer 10 or pass through the channel 101, so that the contact speed between the oral dissolving film 20 and the saliva is reduced by the provision of the support layer 10, thereby slowing down the release of substances in the oral dissolving film 20 to a certain extent, reducing the probability of the oral dissolving film 20 disintegrating before reaching the designated position in the oral cavity, so that the oral dissolving film 20 can release as much substance as possible to the position where the user needs to place the product, thereby improving the usability of the oral product 100. Moreover, the saliva needs a certain amount of time to wet the support layer 10 or pass through the channel 101, which also reserves time for correcting the attachment position, and is more conducive to smoothly attaching the oral product 100 to the position where it needs to be placed.

[0054] See also Figure 2 In some embodiments, the number of the support layer 10 is two, and the two support layers 10 are disposed on two opposite surfaces of the orodissolving film 20. The two support layers 10 are disposed on two opposite surfaces of the orodissolving film 20, so that both surfaces of the orodissolving film 20 can be isolated from the hand or the oral cavity, further reducing the risk of the orodissolving film 20 adhering to the hand or the oral cavity during the attachment process.

[0055] Optionally, the support layer 10 disposed on each surface of the orally dissolving film 20 may be a multi-layered layer.

[0056] Optionally, the support layer 10 may cover the entire surface of the orally dissolving film 20 .

[0057] The materials of the two support layers 10 may be the same or different. In some embodiments, at least two support layers 10 include a first support layer and a second support layer, the first support layer is configured to be located on the side of the oral dissolving film 20 facing the oral mucosa, and the second support layer is configured to be located on the side of the oral dissolving film 20 facing the oral cavity, and the water permeability of the first support layer is greater than the water permeability of the second support layer. When in use, the first support layer is attached to the oral mucosa. The first support layer may have a higher water permeability than the second support layer, so that the substances released after the oral dissolving film 20 is dissolved can be released more through one side of the first support layer, thereby being absorbed by the oral mucosa attached to the first support layer.

[0058] In some embodiments, the second support layer has a stiffness greater than that of the first support layer. The second support layer may have a higher stiffness than the first support layer, so that the oral product 100 can be easily attached to the oral mucosa through the first support layer and maintain a suitable stiffness through the second support layer.

[0059] The functional substance in the orodispersible film 20 can be dissolved by saliva and act on the oral mucosa. In some embodiments, the functional substance includes pharmaceutical or cosmetic ingredients, such as at least one of drugs, antigens, allergens, oral cleaning components, enzymes, and vitamins.

[0060] In some embodiments, the efficacy substance may include an ingredient for providing a tobacco-like taste, such as nicotine or nicotine salt.

[0061] In some embodiments, the functional substance may further include at least one of a flavoring agent, a fragrance agent, a preservative, a sweetener, and a coloring agent.

[0062] In some embodiments, the support layer 10 has a porous structure, and the porous structure forms a channel 101 for saliva to pass through, so that the support layer 10 has good liquid permeability. The support layer 10 includes at least one of foamed resin, mesh resin, porous resin, woven fabric, woven fabric, single-layer non-woven fabric, multi-layer non-woven fabric, paper or inorganic fiber. The material of the support layer 10 may include at least one of polyolefin, polyester, synthetic fiber, semi-synthetic fiber, regenerated fiber, natural fiber or inorganic fiber.

[0063] Among them, polyolefins include polyethylene, polypropylene, etc. Polyesters include polyethylene terephthalate, polybutylene terephthalate, etc. Synthetic fibers include polyurethane, nylon, polyvinyl chloride, polyvinylidene chloride, fluororesin, vinylon, aramid, polyacrylic polymers, cellulose acetate, etc. Regenerated fibers include rayon, etc. Natural fibers include cotton, linen, silk, etc.

[0064] Optionally, the support layer 10 may be a nylon mesh or a nonwoven fabric. When the support layer 10 is a multi-layer nonwoven fabric, the effect of the support layer 10 in delaying the dissolution rate of the active ingredient in the orodispersible film 20 can be controlled by adjusting the number of layers of the nonwoven fabric in the multi-layer nonwoven fabric, so that the user can obtain different experiences, such as obtaining a stimulating taste or a mild taste.

[0065] In some embodiments, the support layer 10 includes a sheet with through holes, and the through holes constitute a channel for saliva to pass through. The through holes can be obtained by punching the sheet, which has a simple processing technology and is conducive to reducing production costs. The punching can be performed using equipment such as a laser puncher and a needle roller.

[0066] See also Figure 3 In some embodiments, the support layer 10 is embedded in the orodissolving film 20. The support layer 10 embedded in the orodissolving film 20 can play a supporting role. The support layer 10 is used to support the orodissolving film 20, which reduces the risk of shrinkage or even direct disintegration of the orodissolving film 20 during the attachment process; and the support layer 10 can maintain its shape for a long time, and the oral product 100 can be moved or withdrawn from the oral cavity as needed, thereby improving the usability of the oral product 100.

[0067] See also Figure 4 and Figure 8 In some embodiments, the support layer 10 is hydrophilic, and two layers of support layers 10 are arranged to form a receiving space 102, and the orodissolving film 20 is placed in the receiving space 102. The receiving space 102 has a first opening 11, and the orodissolving film 20 is placed in the receiving space 102 or taken out of the receiving space 102 through the first opening 11. The support layer 10 is hydrophilic. When the oral product 100 enters the oral cavity and contacts saliva, the support layer 10 can preferentially absorb water and infiltrate, delaying the orodissolving film 20 placed in the receiving space 102 from contacting with saliva and dissolving. During this time, the oral product 100 can be moved at will as needed; and the dissolved orodissolving film 20 can be kept in the receiving space 102 without contacting and adhering to the oral cavity, thereby reducing the risk of physiological discomfort caused by a large amount of dissolved or disintegrated orodissolving film quickly dispersing in the oral cavity, and facilitating the withdrawal of the oral product 100 from the oral cavity, thereby improving the usability of the oral product 100; and the orodissolving film 20 is placed in the receiving space 102, so that the support layer 10 can cover the entire orodissolving film 20, thereby providing better support and isolation effects.

[0068] In some embodiments, the first opening 11 may be open or closed, which is not limited in the present application.

[0069] In some embodiments, part of the orodissolving film 20 is placed in the accommodation space 102, and part of the orodissolving film 20 is exposed outside the accommodation space 102. Figure 5 As shown, the orally dissolving film 20 extends out of the first opening 11. Figure 6 As shown, the accommodating space includes a second opening 12 located on the opposite side of the first opening 11 in the length direction of the orodissolving film 10, and the orodissolving film 20 extends out of the first opening 11 and the second opening 12. Figure 7 As shown, the support layer 10 is provided with through holes 13 exposing the orodissolving membrane 20 , and the through holes 13 are used for saliva to pass through.

[0070] like Figure 8 As shown, in some embodiments, the oral product 100 includes a waterproof layer 40, which covers the surface of a support layer 10 disposed on the side of the oral-dissolving film 20 facing the oral cavity away from the oral-dissolving film 20. The waterproof layer 40 is liquid-impermeable, and can prevent the substances released by the oral-dissolving film 20 from passing through the oral cavity and then entering the digestive tract. The substances released by the oral-dissolving film 20 leave the accommodation space 102 only through the support layer 10 facing the oral mucosa, so that more substances released by the oral-dissolving film 20 are absorbed by the oral mucosa.

[0071] In some embodiments, the waterproof layer 40 may be a film of thermoplastic resin such as polyethylene, polypropylene, polyvinyl acetate, polyester, etc.

[0072] See also Fig. 9 In some embodiments, the oral product 100 includes a porous layer 50, which is detachably connected to the support layer 10 and covers the through hole 13. The number of the porous layer 50 is one or more layers. The porous layer 50 has a porous structure. The porous layer 50 can prevent the substance released by the oral dissolving film 20 from directly flowing out of the accommodation space 102 through the through hole 13. When the support layer 10 provided with the porous layer 50 is attached to the oral mucosa, the user can choose to open the porous layer 50 so that the substance released by the oral dissolving film 20 can be more absorbed by the oral mucosa through the through hole 13 to obtain a stronger stimulation. The porous layer 50 can be detachably connected to the support layer 10 by gluing.

[0073] In some embodiments, the support layer 10 includes a water-swellable polymer. A water-swellable polymer refers to a polymer that can absorb water or other liquids and swell. When the support layer 10 comes into contact with saliva, the water-swellable polymer absorbs water and swells, further delaying the contact between the orodissolving film 20 and the saliva, so that the user has more time to move the orodissolving film 20 to a desired position without dissolving, thereby improving the usability of the oral product 100.

[0074] In some embodiments, the water-swellable polymer includes a cellulose-based water-swellable polymer and / or a non-cellulose-based water-swellable polymer. The cellulose-based neutral polymer may include at least one of polymers such as methyl cellulose, ethyl cellulose, hydroxymethyl cellulose, hydroxyethyl cellulose, hydroxypropyl cellulose, hydroxybutyl cellulose, hydroxyethyl methyl cellulose, and hydroxypropyl methyl cellulose. The non-cellulose-based neutral polymer may include at least one of polymers such as polyvinyl alcohol, polyvinyl pyrrolidone, a combination of polyvinyl alcohol and polyvinyl pyrrolidone, a combination of polyvinyl pyrrolidone and vinyl acetate, and polyalkylene oxide.

[0075] See also Fig.10 In some embodiments, the oral product 100 further includes a water-swellable layer 30, which is stacked on the surface of the support layer 10 facing the oral-dissolving film 20, and the oral-dissolving film 20 is located on the side of the water-swellable layer 30 away from the support layer 10. The water-swellable layer 30 includes a water-swellable polymer. After the water-swellable layer 30 absorbs water and swells, it is more conducive to keeping the dissolved or disintegrated oral-dissolving film 20 in the receiving space 102, and is more conducive to avoiding the phenomenon of physiological discomfort caused by a large amount of dissolved or disintegrated oral-dissolving film 20 quickly dispersing in the oral cavity. In addition, the support layer 10 can isolate the water-swellable layer 30 from the hands or isolate the water-swellable layer 30 from the oral cavity, thereby reducing the risk of adhesion between the water-swellable layer 30 and the hands or the oral cavity. It should be noted that Fig.10 In order to clearly show the positional relationship between the water-swellable layer 30 and the support layer 10 having the accommodation space 102 , the state in which the water-swellable layer 30 contacts the surface of the support layer 10 is not shown.

[0076] In some embodiments, the water-swellable layer 30 covers the entire surface of the support layer 10 facing the orally dissolving film 20 .

[0077] In some embodiments, the water-swellable layer 30 is also disposed on the surface of the support layer 10 facing away from the orally dissolving film 20 .

[0078] In some embodiments, the water-swellable layer 30 disposed on the surface of the support layer 10 facing away from the oro-dissolving film 20 and the water-swellable layer 30 disposed on the surface of the bag-shaped support layer 10 facing the oro-dissolving film 20 can be connected as a whole, so that the support layer 10 with the accommodating space 102 is embedded in the water-swellable layer 30.

[0079] See also Fig.11 In some embodiments, the oral product 100 includes a handheld portion 60, which is disposed on the support layer 10 and is used for a user to hold. The user can put the oral product 100 into the oral cavity or take the oral product 100 out of the oral cavity through the handheld portion 60, thereby improving the usability of the oral product 100. The handheld portion 60 can be integrally or separately disposed with the support layer 10. The handheld portion 60 can be a rope.

[0080] The performance of the oral product provided in this application is described below through specific examples and comparative examples.

[0081] Example 1

[0082] A nicotine-containing oral dissolving film (FASTA, commercially available from Shenzhen Ruxin Technology Co., Ltd.) on the market was sealed in a small bag formed of non-woven fabric (FDA30, commercially available from Huzhou Ruilan New Materials Co., Ltd.) to obtain an oral product. The nicotine content in the oral dissolving film was 4 mg.

[0083] Example 2

[0084] The difference from Example 1 is that the nonwoven fabric is FDA34, which is commercially available from Huzhou Ruilan New Materials Co., Ltd. The physical and chemical properties of the nonwoven fabrics in Example 1 and Example 2 are shown in Table 1.

[0085] Table 1

[0086] Example 1 Example 2 Weight 30±2g / m 34±2g / m thickness 0.2±0.03mm 0.28±0.03mm Strong (MD) 70N / 5cm 90N / 5cm Powerful (CD) 10N / 5cm 10N / 5cm Elongation(MD) 10N / 5cm 12N / 5cm Elongation(CD) 60N / 5cm 70N / 5cm Air permeability <![CDATA[4000L / m 2 .S]]> <![CDATA[4200L / m 2 .S]]> Material 100% CV 80%CV+20%PET

[0087] Comparative Example 1

[0088] The difference from Example 1 is that the orally dissolving film containing nicotine is not enclosed in a small bag formed of non-woven fabric.

[0089] Dissolution rate test of nicotine in orally dissolving film

[0090] The products of Example 1, Example 2 and Comparative Example 1 were respectively placed on a mesh carrier and suspended on the surface of the solution in a beaker containing 100 ml of artificial saliva to ensure infiltration; the beaker was placed on a temperature-controlled magnetic stirrer with a stirring speed of 130 rpm and a temperature of 37 degrees, and 100 ul of sample was collected at each specified time (0.1 min, 0.3 min, 0.5 min, 1 min, 2 min, 3 min, 5 min, 8 min, 12 min, 18 min, 25 min, 35 min) after the start of stirring.

[0091] The nicotine concentration in the sample was determined according to the current standard of artificial saliva GB / T18886-2019. The sample was dissolved to 800ul, and the nicotine content was detected by high performance liquid chromatography (HPLC). The relative cumulative release of nicotine was calculated, and the curve of nicotine dissolution characteristics was obtained with the relative cumulative release as the ordinate.

[0092] like Fig.12As shown, compared with Comparative Example 1, the non-woven fabric is provided in Example 1 and Example 2, and the dissolution of nicotine is more moderate, and the total dissolution rate of nicotine in Example 1, Example 2 and Comparative Example 1 is substantially the same. Compared with Example 2, the thickness of the non-woven fabric in Example 1 is smaller, the dissolution rate of nicotine in Example 1 is closer to the dissolution rate of nicotine in Comparative Example 1, and the curve of the dissolution rate of nicotine and time in Example 2 is flatter than that in Example 1.

[0093] like Fig.13 As shown in the figure, in the time period of 0-1min, nicotine was not dissolved in the orodispersible films of Example 1 and Example 2 in the first 30s, and the dissolution amount at 1min was relatively low. This is because the non-woven fabric needs to be soaked in saliva before the orodispersible film can contact with the saliva for dissolution, thereby providing a buffer between the orodispersible film and the saliva. In this time period, the user can move the oral product or the orodispersible film to the position where it needs to be placed.

[0094] User Experience Testing

[0095] Each user attached the products of Example 1 and Comparative Example 1 to the gums, respectively, and recorded the number of pieces of the product and the number of times the product was moved when each user successfully attached the product to the gums. The user experience was also interviewed, including the time when the nicotine began to take effect, the strength of the nicotine stimulation felt in the throat, whether to quit using it, the strength of adhesion, and the convenience score. Among them, the convenience score ranges from 0 to 6 points. The stronger the adhesion, the lower the score; the better the convenience, the higher the score. The test results of Example 1 are shown in Table 2, and the test results of Comparative Example 1 are shown in Table 3.

[0096] The attachment method is: make sure your hands are dry and free of obvious sweat or other liquids; the user holds the product in one hand and lifts or pushes up the cheek or upper lip near the gums with the other hand; attach the product to the gums and put down the cheeks and lips.

[0097] Table 2

[0098]

[0099]

[0100] Table 3

[0101]

[0102] It can be seen from Tables 2 and 3 that when non-woven fabric is provided, the user only needs to use one piece of the product and move it in the mouth multiple times to attach it to the desired position; when non-woven fabric is not provided, the user is allowed to move the product once on average, and the user needs to use an average of 1.67 pieces of the product to attach it to the appropriate position.

[0103] It can be seen from Tables 2 and 3 that the non-woven fabric delays the nicotine effect by 1.5 minutes, and the user can quit at any time, which reduces the phenomenon of strong irritation caused by a large amount of dissolved or disintegrated orodispersible film entering the throat with saliva, and reduces the discomfort caused by the adhesion and residue of the orodispersible film.

[0104] Example 3

[0105] A commercial propolis oral film (available from China Resources Zizhu Pharmaceutical Co., Ltd.) was sealed in a small bag formed of non-woven fabric (FDA30, available from Huzhou Ruilan New Materials Co., Ltd.) to obtain an oral product.

[0106] Comparative Example 2

[0107] The difference from Example 3 is that the propolis oral film is not enclosed in a small bag formed by non-woven fabric.

[0108] Example 4

[0109] A fast-dissolving sustained-release tooth paste (available from Qing Jiuye) on the market was sealed in a small bag formed of non-woven fabric (FDA30, available from Huzhou Ruilan New Materials Co., Ltd.) to obtain an oral product.

[0110] Comparative Example 3

[0111] The difference from Example 4 is that the fast-dissolving sustained-release tooth paste is not enclosed in a small bag formed by non-woven fabric.

[0112] Each user sticks the products of Examples 3 and 4 and Comparative Examples 2 and 3 to oral ulcers or teeth, respectively, and the number of times each user successfully sticks the product to the desired position in the oral cavity is recorded.

[0113] Table 4

[0114] Example 3 Comparative Example 2 Example 4 Comparative Example 3 User 1 1 3 1 3 User 2 1 2 1 4 User 3 1 3 1 2 User 4 1 1 1 1 User 5 1 4 1 3 User 6 1 1 1 2 Mean 1 2.33 1 2.5

[0115] By comparing Example 3 with Comparative Example 2, it can be seen that when the non-woven fabric is provided, the user can attach the product to the desired location by applying it once. In Comparative Example 2, since the non-woven fabric is not provided, the propolis oral film is deformed by moisture after entering the oral cavity and is easily attached to the hands, resulting in the user having to apply it multiple times before the product can be attached to the desired location.

[0116] By comparing Example 4 with Comparative Example 3, it can be seen that when non-woven fabric is provided, the user can attach the product to the desired location by applying it once. In Comparative Example 3, since no non-woven fabric is provided, the quick-dissolving sustained-release tooth paste is deformed by moisture after entering the oral cavity, and is easily adhered to the inner side of the lips or gums, resulting in the user having to apply it multiple times before the product can be attached to the desired location.

[0117] Those skilled in the art should recognize that the above embodiments are only used to illustrate the present application, and are not used as limitations on the present application. As long as they are within the spirit of the present application, appropriate changes and modifications to the above embodiments are within the scope of the present application.

Claims

1. An oral product, characterized in that: include: Oral dissolving film; The support layer is water-insoluble and is disposed on at least one surface of the orodissolving film or embedded in the orodissolving film. The support layer is provided with at least one channel for allowing saliva to pass through the support layer.

2. The oral product according to claim 1, wherein: The number of the supporting layers is at least two, and the at least two supporting layers are respectively arranged on two opposite surfaces of the orodispersible film.

3. The oral product according to claim 2, characterized in that: The at least two supporting layers include a first supporting layer and a second supporting layer, wherein the first supporting layer is configured to be located on a side of the orodissolving film facing the oral mucosa, and the second supporting layer is configured to be located on a side of the orodissolving film facing the oral cavity, and the water permeability of the first supporting layer is greater than the water permeability of the second supporting layer.

4. The oral product according to claim 3, characterized in that: The second supporting layer has a stiffness greater than that of the first supporting layer.

5. The oral product according to claim 3, wherein: The oral product comprises a waterproof layer, and the waterproof layer covers a surface of the second supporting layer on a side away from the orodispersible film.

6. The oral product according to claim 1, wherein: The number of the supporting layers is two, and the two supporting layers are arranged to form a containing space. The supporting layers are hydrophilic, and at least a part of the orodispersible film is placed in the containing space.

7. The oral product according to claim 1, wherein: The support layer comprises a sheet material with at least one through hole, and the channel is formed in the through hole.

8. The oral product according to claim 1, wherein: The oral product includes a water-swellable layer disposed on at least one surface of the support layer.

9. The oral product according to claim 8, wherein: The water-swellable layer is arranged on the surface of the support layer facing the orally dissolving film.

10. The oral product according to claim 1, wherein: The support layer is provided with at least one through hole, and the through hole is used for the saliva to pass through. The oral product comprises a porous layer, and the porous layer is detachably connected to the support layer and covers the through hole.

11. The oral product according to any one of claims 1 to 10, characterized in that: The oral product comprises a hand-held portion, which is arranged on the supporting layer and is used for being held by a user.

12. The oral product according to any one of claims 1 to 10, characterized in that: The support layer includes at least one of foamed resin, mesh resin, porous resin film, woven fabric, woven cloth, single-layer non-woven fabric, multi-layer non-woven fabric, paper, and inorganic fiber.

13. The oral product according to any one of claims 1 to 10, characterized in that: The support layer includes a water-swellable polymer.

14. The oral product according to any one of claims 1 to 10, characterized in that: The orodispersible film comprises nicotine or nicotine salt.

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