Oral product

Abstract

An oral product, comprising an orally soluble film and a support layer. The support layer is water-insoluble. The support layer is arranged on at least one surface of the orally soluble film or embedded in the orally soluble film. The support layer is provided with at least one channel, and the channel is used for passing saliva through the support layer. The support layer can provide support, reducing the probability of the orally soluble film shrinking or even directly disintegrating during attachment, so that a user can smoothly attach the oral product in place when using the oral product, reducing the cost of using the oral product. Moreover, the support layer can retain the form for a relatively long time, and the oral product can be displaced or removed from the oral cavity at will as needed, thereby improving the usability of the oral product.

Description

A dental product Technical Field

[0001] This application relates to the field of oral care products technology, specifically to an oral care product. Background Technology

[0002] Orally dissolving films are dosage forms that utilize a dissolving membrane to absorb drugs in the oral cavity (buccal or sublingual). Currently, orally dissolving films are typically prepared using hydrophilic polymers, which rapidly dissolve on the tongue or buccal cavity upon contact with liquid (saliva), thereby delivering the dissolved drug into the systemic circulation via the oral mucosa.

[0003] Oral dissolving films are typically manufactured by pharmaceutical companies, which usually only focus on the water solubility of the film, requiring it to dissolve quickly to release the drug. Therefore, during the process of placing the film in the desired location in the mouth, it may encounter oral fluids and prematurely dissolve, shrink, or deform, preventing it from reaching the intended placement area. Summary of the Invention

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

[0005] One embodiment of this application provides an oral product, including an orofacial membrane and a support layer, wherein the support layer is non-water-soluble, the support layer is disposed on at least one surface of the orofacial membrane or embedded within the orofacial membrane, and the support layer has at least one channel for allowing saliva to pass through the support layer.

[0006] The oral product provided in this application has a support layer that is liquid-permeable, allowing saliva to come into contact with the orofacial membrane, thereby enabling the orofacial membrane to disintegrate in the saliva and be carried into the oral cavity to exert its effects. The support layer supports the orofacial membrane, reducing the risk of the orofacial membrane shrinking or even disintegrating directly during the application process. Users can easily apply the oral product to the desired location using only one piece, reducing the cost of using the oral product. In addition, the support layer can maintain its shape for a longer period of time, allowing the oral product to be moved or removed from the oral cavity as needed, thereby improving the usability of the oral product.

[0007] According to some embodiments of this application, the number of support layers is at least two, and the at least two support layers are respectively disposed on two opposite surfaces of the oral dissolution film. The two support layers disposed on the two surfaces of the oral dissolution film not only provide support but also act as a barrier, reducing the risk of the oral dissolution film adhering to the hands or mouth during application, making it easier for users to move the oral product, and improving the usability of the oral product.

[0008] According to some embodiments of this application, the at least two support layers include a first support layer and a second support layer. The first support layer is configured on the side of the ortholytic membrane facing the oral mucosa, and the second support layer is configured on the side of the ortholytic membrane facing the oral cavity. The permeability of the first support layer is greater than that of the second support layer. The first support layer has higher permeability than the second support layer, allowing more of the substances released after the ortholytic membrane dissolves to be absorbed by the oral mucosa.

[0009] According to some embodiments of this application, the second support layer has higher stiffness than the first support layer. The higher stiffness of the second support layer allows the oral product to adhere easily to the oral mucosa via the first support layer, while maintaining appropriate stiffness via the second support layer.

[0010] According to some embodiments of this application, the oral product includes a waterproof layer covering the side of the second support layer facing away from the orofacial membrane. The waterproof layer prevents substances released from the orofacial membrane from entering the oral cavity and subsequently the digestive tract. Instead, the substances released from the orofacial membrane leave the containing space only through a support layer facing the oral mucosa, allowing for greater absorption of the substances by the oral mucosa.

[0011] According to some embodiments of this application, the number of support layers is two, and the two support layers enclose a receiving space. The support layers are hydrophilic, and at least a portion of the orally dissolving film is placed within the receiving space. Because the support layers are hydrophilic, when the oral product enters the mouth and comes into contact with saliva, the support layers preferentially absorb water and wet the oral product, delaying the dissolution of at least a portion of the orally dissolving film placed within the receiving space. During this time, the oral product can be moved freely as needed; and the dissolved orally dissolving film can remain within the receiving space without contacting or adhering to the oral cavity, reducing the risk of physiological discomfort caused by the rapid dispersion of a large amount of dissolved or disintegrated orally dissolving film in the oral cavity, and facilitating the removal of the oral product from the mouth, thus improving the usability of the oral product.

[0012] According to some embodiments of this application, the support layer includes a sheet with at least one through-hole, and the channel is formed within the through-hole. Processing the through-hole to form the channel on the sheet simplifies the manufacturing process and helps reduce production costs.

[0013] According to some embodiments of this application, the oral product includes a water-swellable layer disposed on at least one surface of the support layer. After absorbing water and swelling, the water-swellable layer can improve the overall rigidity of the oral product, making it easier for the user to move the oral product and improving its usability.

[0014] According to some embodiments of this application, the water-swellable layer is disposed on the surface of the support layer facing the oral membrane.

[0015] According to some embodiments of this application, the support layer has at least one through-hole for saliva to pass through, and the oral product includes a porous layer that is detachably connected to the support layer and covers the through-hole. In use, the user can choose to open the porous layer, allowing more of the substances released by the orofacial membrane to be absorbed by the oral mucosa through the through-hole, resulting in stronger stimulation.

[0016] According to some embodiments of this application, the oral care product includes a handle disposed on the support layer, the handle being for a user to hold. The user can hold the handle to insert or remove the oral care product from their mouth, improving the usability of the oral care product.

[0017] According to some embodiments of this application, the support layer includes at least one of foamed resin, mesh resin, porous resin, woven fabric, cloth, single-layer nonwoven fabric, multi-layer nonwoven fabric, paper, and inorganic fibers. The support layer has a porous structure, which forms channels for saliva to pass through, giving the support layer good liquid permeability, which is beneficial for the oral membrane to contact with saliva and release substances that act on the oral mucosa.

[0018] According to some embodiments of this application, the support layer comprises a water-swellable polymer. When the support layer comes into contact with saliva, the water-swellable polymer absorbs water and swells, further delaying the dissolution of at least a portion of the orofacial membrane placed within the receiving space upon contact with saliva. During this time, the oral product can be moved freely as needed, improving the usability of the oral product.

[0019] According to some embodiments of this application, the oral dissolving film includes nicotine or nicotine salts. Attached Figure Description

[0020] Figure 1 is a cross-sectional schematic diagram of an oral product provided in one embodiment of this application.

[0021] Figure 2 is a cross-sectional schematic diagram of an oral product provided in another embodiment of this application.

[0022] Figure 3 is a cross-sectional schematic diagram of an oral product provided in another embodiment of this application.

[0023] Figure 4 is a schematic diagram of an oral product provided in another embodiment of this application.

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

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

[0026] Figure 7 is a front view of an oral product provided in another embodiment of this application.

[0027] Figure 8 is a cross-sectional schematic diagram of an oral product provided in another embodiment of this application.

[0028] Figure 9 is a cross-sectional schematic diagram of an oral product provided in another embodiment of this application.

[0029] Figure 10 is a front view of an oral product provided in another embodiment of this application.

[0030] Figure 11 is a front view of an oral product provided in another embodiment of this application.

[0031] Figure 12 is a graph showing the relative nicotine dissolution rate of the products in the embodiments and comparative examples of this application.

[0032] Figure 13 is a graph showing the relative nicotine dissolution rate of the products in the embodiments and comparative examples of this application during the 0-4 min time period.

[0033] Explanation of key component symbols: Oral product 100; Support layer 10; Channel 101; Oral membrane 20; First opening 11; Second opening 12; Through-hole 13; Water-swellable layer 30; Waterproof layer 40; Receptacle space 102; Porous layer 50

[0034] The following specific embodiments will further illustrate this application in conjunction with the above-described accompanying drawings. Detailed Implementation

[0035] The following specific embodiments are exemplary and not limiting, and are intended to provide a basic understanding of this application, and are not intended to identify key or decisive elements of this application or limit the scope of protection. As long as there is no structural conflict, the technical features mentioned in the various embodiments can be combined in any manner.

[0036] Unless otherwise defined, the term "multiple" in this document, when used to describe the number of components, specifically means that the component is two or more.

[0037] Oral dissolving films only become effective after dissolving or disintegrating in the oral cavity. This creates a technological bias, requiring the film to dissolve as quickly as possible upon entering the mouth. The inventors of this application have discovered that when users apply oral dissolving films, they typically hold the film directly and place it into or attach it to the desired location. During this process, the film may prematurely dissolve, shrink, or deform upon contact with oral fluids, requiring the user to replace it or move it while it's still attached to their hand. In other words, for successful placement or application, faster dissolution is not necessarily better. Furthermore, the inventors of this application have also found that existing oral dissolving films do not consider the need for premature removal.

[0038] This application provides an oral product comprising a support layer and an orally disintegrating film. The support layer is disposed on at least one surface of the orally disintegrating film or embedded within the orally disintegrating film. The support layer is water-insoluble and has at least one channel for saliva to pass through it. During the placement of the oral product in the mouth, the water-insoluble support layer may hinder the dissolution of the orally disintegrating film in saliva, thereby slowing down the rate at which the film dissolves or disintegrates and releases its active ingredients. However, the support layer provides support, reducing the risk of the orally disintegrating film shrinking or even disintegrating during use. This allows the user to smoothly adhere the oral product to the desired location, and the user can remove the product midway through use, overcoming the technical bias that orally disintegrating films dissolved as quickly as possible upon entering the mouth are desirable. For orally disintegrating films, which are more effective at delivery to the systemic circulation via the oral mucosa, the support layer prevents rapid disintegration and swallowing into the stomach, allowing the film to be delivered to the systemic circulation via the oral mucosa as much as possible, thus improving the absorption effect of the orally disintegrating film.

[0039] Some embodiments of this application will now be described with reference to the accompanying drawings. Unless otherwise specified, the following embodiments and features can be combined with each other.

[0040] Please refer to Figure 1. One embodiment of this application provides an oral product 100 for placement in the oral cavity at desired locations, such as the gums or under the tongue. The oral product 100 includes a support layer 10 and an orally dissolving film 20. The orally dissolving film 20 is designed to contact saliva and dissolve within the oral cavity. The support layer 10 is non-water-soluble and is disposed on at least one surface of the orally dissolving film 20. Figure 1 shows the support layer 10 disposed on one surface of the orally dissolving film 20. The support layer 10 has at least one channel 101 for allowing saliva to pass through the support layer 10 to contact the orally dissolving film 20, enabling the orally dissolving film 20 to disintegrate in saliva and be carried into the oral cavity by the saliva to exert its effects.

[0041] The support layer 10 provides support for the oral dissolution membrane 20, reducing the risk of shrinkage or even disintegration during application. Users can easily apply a single oral product 100 to the desired location, lowering the cost of using the product. Furthermore, the support layer 10 maintains its shape for a longer period, allowing the oral dissolution membrane 20 to be moved or removed from the mouth as needed, thus improving usability. Additionally, the support layer 10 acts as an insulator, separating the oral dissolution membrane 20 from the user's hands and / or mouth, reducing the risk of adhesion during application and use, and making it easier for users to move the oral product 100, further enhancing its usability.

[0042] When the support layer 10 is positioned on the side of the orofacial membrane 20 facing the oral mucosa, saliva needs a certain amount of time to wet the support layer 10 or pass through the channel 101. This reduces the contact speed between the orofacial membrane 20 and saliva, thus slowing down the release of substances from the orofacial membrane 20 and reducing the probability of it disintegrating before reaching the designated location in the oral cavity. This allows the orofacial membrane 20 to release as much substance as possible to the desired placement location, improving the usability of the oral product 100. Furthermore, the time required for saliva to wet the support layer 10 or pass through the channel 101 also allows time for correcting the application position, making it easier to successfully apply the oral product 100 to the desired location.

[0043] Referring to Figure 2, in some embodiments, the number of support layers 10 is two, and the two support layers 10 are disposed on two opposite surfaces of the oral dissolution film 20. The two support layers 10 are disposed on two opposite surfaces of the oral dissolution film 20 so that both surfaces of the oral dissolution film 20 can be isolated from the hand or mouth, further reducing the risk of the oral dissolution film 20 adhering to the hand or mouth during the application process.

[0044] Optionally, the support layer 10 disposed on each surface of the oral dissolution membrane 20 may be multi-layered.

[0045] Optionally, the support layer 10 may cover the entire surface of the ortholytic membrane 20.

[0046] The two support layers 10 can be made of the same or different materials. 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 on the side of the orofacial membrane 20 facing the oral mucosa, and the second support layer is configured on the side of the orofacial membrane 20 facing the oral cavity. The first support layer has a higher water permeability than the second support layer. In use, the first support layer is attached to the oral mucosa. The first support layer can have a higher water permeability than the second support layer, allowing more of the substances released after the orofacial membrane 20 dissolves to be released through the first support layer and absorbed by the oral mucosa to which the first support layer is attached.

[0047] In some embodiments, the stiffness of the second support layer is greater than that of the first support layer. The second support layer may have higher stiffness than the first support layer, allowing the oral product 100 to be easily adhered to the oral mucosa through the first support layer and to maintain appropriate stiffness through the second support layer.

[0048] The active ingredient in the orally dissolving film 20 can dissolve in saliva and act on the oral mucosa. In some embodiments, the active ingredient includes pharmaceutical or cosmetic ingredients, such as at least one of drugs, antigens, allergens, oral cleaning components, enzymes, and vitamins.

[0049] In some implementations, the active ingredient may include components for providing a tobacco-like flavor, such as nicotine or nicotine salts.

[0050] In some embodiments, the active ingredient may also include at least one of flavoring agents, flavoring agents, preservatives, sweeteners, and coloring agents.

[0051] In some embodiments, the support layer 10 has a porous structure that forms channels 101 for saliva to pass through, giving the support layer 10 good liquid permeability. The support layer 10 includes at least one of foamed resin, mesh resin, porous resin, woven fabric, cloth, single-layer nonwoven fabric, multi-layer nonwoven fabric, paper, or inorganic fibers. The material of the support layer 10 may include at least one of polyolefins, polyesters, synthetic fibers, semi-synthetic fibers, regenerated fibers, and other natural or inorganic fibers.

[0052] Polyolefins include polyethylene and polypropylene. Polyesters include polyethylene terephthalate and polybutylene terephthalate. Synthetic fibers include polyurethane, nylon, polyvinyl chloride, polyvinylidene chloride, fluoropolymers, vinylon, aromatic polyamides, acrylic polymers, and cellulose acetate. Regenerated fibers include rayon. Natural fibers include cotton, linen, and silk.

[0053] Optionally, the support layer 10 can be a nylon mesh or a non-woven fabric. When the support layer 10 is a multi-layer non-woven fabric, by adjusting the number of non-woven fabric layers, the effect of the support layer 10 in delaying the dissolution rate of the active ingredients in the oral dissolution film 20 can be controlled, allowing users to obtain different experiences, such as a stimulating taste or a mild taste.

[0054] In some embodiments, the support layer 10 includes a sheet with through-holes that form channels for saliva to pass through. The through-holes can be obtained by punching holes in the sheet, a simple process that helps reduce production costs. Punching can be performed using equipment such as laser drilling machines or needle rollers.

[0055] Referring to Figure 3, in some embodiments, the support layer 10 is embedded within the orofacial membrane 20. The support layer 10 embedded within the orofacial membrane 20 can provide support, reducing the risk of the orofacial membrane 20 shrinking or even disintegrating during application; moreover, the support layer 10 can maintain its shape for a longer period of time, allowing the oral product 100 to be moved or removed from the oral cavity as needed, thereby improving the usability of the oral product 100.

[0056] Referring to Figures 4 and 8, in some embodiments, the support layer 10 is hydrophilic, and the two support layers 10 are arranged to form a receiving space 102, in which the oral dissolving membrane 20 is placed. The receiving space 102 has a first opening 11 through which the oral dissolving membrane 20 is placed into or removed from the receiving space 102. The support layer 10 is hydrophilic. When the oral product 100 enters the oral cavity and comes into contact with saliva, the support layer 10 can preferentially absorb water and wet itself, delaying the dissolution of the ortholytic membrane 20 placed in the receiving space 102 upon contact with saliva. During this time, the oral product 100 can be moved freely as needed. Moreover, the dissolved ortholytic membrane 20 can remain in the receiving space 102 without contacting or adhering to the oral cavity, reducing the risk of physiological discomfort caused by the rapid dispersion of a large amount of dissolved or disintegrated ortholytic membrane in the oral cavity. It also facilitates the removal of the oral product 100 from the oral cavity, improving the usability of the oral product 100. Furthermore, the ortholytic membrane 20 is placed in the receiving space 102, allowing the support layer 10 to cover the entire ortholytic membrane 20, thereby providing better support and isolation effects.

[0057] In some embodiments, the first opening 11 may be open or closed, and this application does not impose any restrictions.

[0058] In some embodiments, a portion of the orofacid membrane 20 is placed within the receiving space 102, while a portion of the orofacid membrane 20 is exposed outside the receiving space 102. As shown in FIG. 5, the orofacid membrane 20 extends beyond the first opening 11. As shown in FIG. 6, the receiving space includes a second opening 12 located on the opposite side of the first opening 11 along the length direction of the orofacid membrane 10, and the orofacid membrane 20 extends beyond both the first opening 11 and the second opening 12. As shown in FIG. 7, the support layer 10 is provided with a through-hole 13 exposing the orofacid membrane 20, the through-hole 13 for allowing saliva to pass through.

[0059] As shown in Figure 8, in some embodiments, the oral product 100 includes a waterproof layer 40 that covers a support layer 10 disposed on the side of the orofacial membrane 20 facing the oral cavity, away from the surface of the orofacial membrane 20. The waterproof layer 40 is liquid-impermeable, preventing substances released from the orofacial membrane 20 from passing through the oral cavity and into the digestive tract. The substances released from the orofacial membrane 20 leave the receiving space 102 only through the support layer 10 facing the oral mucosa, allowing more of the substances released from the orofacial membrane 20 to be absorbed by the oral mucosa.

[0060] In some embodiments, the waterproof layer 40 may be a film of thermoplastic resins such as polyethylene, polypropylene, polyvinyl acetate, and polyester.

[0061] Referring to Figure 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-holes 13. The porous layer 50 can be one or more layers. The porous layer 50 has a porous structure. The porous layer 50 can prevent substances released from the orofacial membrane 20 from flowing directly out of the receiving space 102 through the through-holes 13. When the support layer 10 with the porous layer 50 is attached to the oral mucosa, the user can choose to open the porous layer 50, allowing more of the substances released from the orofacial membrane 20 to be absorbed by the oral mucosa through the through-holes 13, resulting in stronger stimulation. The porous layer 50 can be detachably connected to the support layer 10 by adhesive.

[0062] In some embodiments, the support layer 10 includes a water-swellable polymer. A water-swellable polymer refers to a polymer that can absorb water and 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 oral film 20 and the saliva, giving the user more time to move the oral film 20 to the desired location without dissolving, thus improving the usability of the oral product 100.

[0063] In some embodiments, the water-swellable polymer includes cellulose-based water-swellable polymers and / or non-cellulose-based water-swellable polymers. Cellulose-based neutral polymers may include at least one selected from polymers such as methylcellulose, ethylcellulose, hydroxymethylcellulose, hydroxyethylcellulose, hydroxypropylcellulose, hydroxybutylcellulose, hydroxyethylmethylcellulose, and hydroxypropylmethylcellulose. Non-cellulose-based neutral polymers may include at least one selected from polymers such as polyvinyl alcohol, polyvinylpyrrolidone, combinations of polyvinyl alcohol and polyvinylpyrrolidone, combinations of polyvinylpyrrolidone and vinyl acetate, and polyepoxides.

[0064] Referring to Figure 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 orofacial membrane 20, with the orofacial membrane 20 located on the side of the water-swellable layer 30 away from the support layer 10. The water-swellable layer 30 comprises a water-swellable polymer. After absorbing water and swelling, the water-swellable layer 30 is more effective in retaining the dissolved or disintegrated orofacial membrane 20 within the receiving space 102, and is more effective in preventing physiological discomfort caused by the rapid dispersion of a large amount of dissolved or disintegrated orofacial membrane 20 in the oral cavity. Furthermore, the support layer 10 can isolate the water-swellable layer 30 from the hand or the oral cavity, reducing the risk of adhesion between the water-swellable layer 30 and the hand or oral cavity. It should be noted that, in order to clearly show the positional relationship between the water-swellable layer 30 and the support layer 10 having the receiving space 102, Figure 10 does not show the surface contact between the water-swellable layer 30 and the support layer 10.

[0065] In some embodiments, the water-swellable layer 30 covers the entire surface of the support layer 10 facing the orthosol membrane 20.

[0066] In some embodiments, the water-swellable layer 30 is also disposed on the surface of the support layer 10 away from the orthosol membrane 20.

[0067] In some embodiments, the water-swellable layer 30 disposed on the surface of the support layer 10 away from the ortholytic membrane 20 and the water-swellable layer 30 disposed on the surface of the bag-shaped support layer 10 facing the ortholytic membrane 20 can be connected as one unit, so that the support layer 10 having the receiving space 102 is embedded in the water-swellable layer 30.

[0068] Referring to Figure 11, in some embodiments, the oral product 100 includes a handle 60 disposed on the support layer 10, for the user to hold. The user can use the handle 60 to insert or remove the oral product 100 from the mouth, improving the usability of the oral product 100. The handle 60 can be integrally formed with the support layer 10 or a separate component. The handle 60 can be a rope.

[0069] The performance of the oral products provided in this application will be described below through specific embodiments and comparative examples.

[0070] Example 1

[0071] A commercially available nicotine-containing oral dissolving film (FASTA, sold by Shenzhen Wuxin Technology Co., Ltd.) is sealed in a small bag made of non-woven fabric (FDA30, sold by Huzhou Ruilan New Materials Co., Ltd.) to obtain an oral product. The oral dissolving film contains 4 mg of nicotine.

[0072] Example 2

[0073] The difference from Example 1 is that the nonwoven fabric is FDA34 and commercially available from Huzhou Ruilan New Materials Co., Ltd. The physicochemical properties of the nonwoven fabrics in Examples 1 and 2 are shown in Table 1.

[0074] Table 1

[0075] Comparative Example 1

[0076] The difference from Example 1 is that the nicotine-containing oral film is not sealed in a small bag formed of nonwoven fabric.

[0077] Dissolution rate test of nicotine in oral dissolving membrane

[0078] The products of Example 1, Example 2 and Comparative Example 1 were placed on a mesh carrier and suspended on the surface of a solution in a beaker containing 100 ml of artificial saliva, ensuring immersion. The beaker was placed on a temperature-controlled magnetic stirrer at a stirring speed of 130 rpm and a temperature of 37 degrees Celsius. 100 μL of sample was collected at each specified time after stirring started (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).

[0079] The concentration of nicotine in the sample was determined according to the current standard GB / T18886-2019 for artificial saliva. The sample was diluted to 800 μL, and the nicotine content was detected by high performance liquid chromatography (HPLC). The relative cumulative release of nicotine was calculated, and the nicotine dissolution characteristics curve was obtained by plotting the relative cumulative release as the ordinate.

[0080] As shown in Figure 12, compared to Comparative Example 1, the use of nonwoven fabric in Examples 1 and 2 resulted in a more gradual nicotine leaching process, and the total nicotine leaching rate was approximately the same in Examples 1, 2, and 1. Compared to Example 2, the nonwoven fabric in Example 1 was thinner, and the nicotine leaching rate in Example 1 was closer to that in Comparative Example 1. Furthermore, the nicotine leaching rate versus time curve in Example 2 was flatter than that in Example 1.

[0081] As shown in Figure 13, during the 0-1 minute time period, neither the oral dissolving film of Example 1 nor Example 2 dissolved nicotine in the first 30 seconds. The amount of dissolution was low at 1 minute. This is because the non-woven fabric needs to be soaked in saliva first during this time period before the oral dissolving film can come into contact with saliva and undergo the dissolution process. This provides a buffer between the oral dissolving film and saliva. During this time period, the user can move the oral product or oral dissolving film to the desired location.

[0082] User experience testing

[0083] Each user applied the products of Example 1 and Comparative Example 1 to their gums. The number of times each user successfully applied the product to their gums, the number of times the product was moved, and their user experience were recorded. This included the time it took to first feel the nicotine kick, the intensity of the nicotine stimulation in the throat, whether they stopped using the product, the strength of the adhesion, and a convenience rating. The convenience rating ranged from 0 to 6 points; the stronger the adhesion, the lower the score; the better the convenience, the higher the score. The test results for Example 1 are shown in Table 2, and the test results for Comparative Example 1 are shown in Table 3.

[0084] The application method is as follows: Ensure your hands are dry and free of obvious sweat or other liquids; hold the product in one hand and use the other hand to lift or push open the cheek or upper lip near the gums; apply the product to the gums and then place it on the cheek and lips.

[0085] Table 2

[0086] Table 3

[0087] As can be seen from Tables 2 and 3, when non-woven fabric is used, the user only needs to use one piece of product to move it multiple times in the mouth to attach it to the desired position; when non-woven fabric is not used, the user is allowed to move the product once on average, and the user needs to use an average of 1.67 pieces of product to attach it to the appropriate position.

[0088] As can be seen from Tables 2 and 3, setting the non-woven fabric delays the onset of nicotine by 1.5 minutes, allowing users to exit at any time. This reduces the strong irritation caused by a large amount of dissolved or disintegrated oral film entering the throat with saliva, and also reduces the discomfort caused by the adhesion and residue of the oral film.

[0089] Example 3

[0090] Oral products are obtained by sealing commercially available propolis oral films (sold by China Resources Zizhu Pharmaceutical Co., Ltd.) in small bags made of non-woven fabric (FDA30, sold by Huzhou Ruilan New Materials Co., Ltd.).

[0091] Comparative Example 2

[0092] The difference from Example 3 is that the propolis oral membrane is not sealed in a small bag formed of nonwoven fabric.

[0093] Example 4

[0094] Oral products are obtained by sealing commercially available fast-dissolving and slow-release dental strips (commercially available from Qingjiuye) in a small bag formed from non-woven fabric (FDA30, commercially available from Huzhou Ruilan New Materials Co., Ltd.).

[0095] Comparative Example 3

[0096] The difference from Example 4 is that the fast-dissolving and slow-release dental strips are not sealed in a small bag formed of non-woven fabric.

[0097] Each user applied the products of Examples 3 and 4 and Comparative Examples 2 and 3 to the oral ulcers or teeth, and recorded the number of times each user successfully applied the product to the desired position in the oral cavity.

[0098] Table 4

[0099] Comparing Example 3 and Comparative Example 2, it can be seen that with the non-woven fabric in place, the user can attach the product to the desired location with a single application. In Comparative Example 2, because no non-woven fabric was used, the propolis oral film became damp and deformed after entering the mouth, easily sticking to the hands, requiring the user to apply it multiple times to attach the product to the desired location.

[0100] Comparing Example 4 and Comparative Example 3, it can be seen that with the non-woven fabric, the user can apply the product to the desired location in one go. In Comparative Example 3, because no non-woven fabric was used, the fast-dissolving and slow-release dental strip became damp and deformed after entering the oral cavity, easily sticking to the inside of the lips or gums, requiring the user to apply it multiple times to get the product to the desired location.

[0101] Those skilled in the art should recognize that the above embodiments are merely illustrative of this application and are not intended to limit this application. Any appropriate changes and variations made to the above embodiments within the spirit and essence of this application fall within the scope of this application's disclosure.

Claims

1. An oral product characterized in that, Comprise: a mouth dissolving film; a support layer having non-water solubility, the support layer being disposed on at least one surface of the mouth dissolving film or embedded in the mouth dissolving film, the support layer being provided with at least one passage for saliva to pass through the support layer.

2. The oral product of claim 1, wherein The number of the support layers is at least two, and the at least two support layers are respectively disposed on opposite surfaces of the mouth dissolving film.

3. The oral product of claim 2, wherein The at least two support layers comprise a first support layer and a second support layer, the first support layer being configured to be located on a side of the mouth dissolving film facing the oral mucosa, and the second support layer being configured to be located on a side of the mouth dissolving film facing the oral cavity, the first support layer having a water permeability greater than that of the second support layer.

4. The oral product of claim 3, wherein The stiffness of the second support layer is greater than that of the first support layer.

5. The oral product of claim 3, wherein The oral product comprises a waterproof layer covering a surface of the second support layer away from the mouth dissolving film.

6. The oral product of claim 1, wherein The number of the support layers is two, and the two support layers form an accommodation space, the support layers having hydrophilicity, and at least part of the mouth dissolving film being disposed in the accommodation space.

7. The oral product of claim 1, wherein The support layer comprises a sheet provided with at least one through hole, and the passage is formed in the through hole.

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

9. The oral product of claim 8, wherein The water-swellable layer is disposed on a surface of the support layer facing the mouth dissolving film.

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

11. The oral product of any one of claims 1 to 10, wherein The oral product comprises a hand-holding portion disposed on the support layer, the hand-holding portion being used for a user to hold.

12. The oral product of any one of claims 1 to 10, wherein The support layer comprises at least one of foamed resin, reticular resin, porous resin, woven fabric, woven cloth, single-layer non-woven fabric, multi-layer non-woven fabric, paper, and inorganic fiber.

13. The oral product of any one of claims 1 to 10, wherein The support layer comprises a water-swellable polymer.

14. The oral product of any one of claims 1 to 10, wherein The mouth dissolving film comprises nicotine or nicotine salt.

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