Oral cavity product

Abstract

The utility model 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 The oral product can be moved or withdrawn from the oral cavity at will according to requirements, so that the usability of the oral product is improved.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] Orally disintegrating films are dosage forms that absorb drugs through the oral cavity (buccal or sublingual) using a dissolving film. Currently, orally disintegrating films are typically made using hydrophilic polymers, which rapidly dissolve on the tongue or buccal cavity upon contact with liquid (saliva), allowing the dissolved drug to be delivered to the systemic circulation via the oral mucosa.

[0003] Orally dissolving films are typically manufactured by pharmaceutical companies, who typically prioritize their water solubility, requiring them to dissolve quickly to release the drug. Consequently, during placement, the film can encounter oral fluids and prematurely dissolve, shrink, or deform, preventing it from reaching the desired location. Utility Model Content

[0004] In view of this, the present application provides an oral product, which can reduce the risk of shrinkage or even disintegration of the orally disintegrating 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, comprising an orally disintegrating film and a support layer, wherein the support layer is water-insoluble, is disposed on at least one surface of the orally disintegrating film or is embedded in the orally disintegrating film, and is provided with at least one channel for allowing saliva to pass through the support layer.

[0006] The oral product provided in the embodiment of the present application has a liquid-permeable support layer, which allows saliva to pass through and contact the orally disintegrating film, so that the orally disintegrating film can disintegrate in the saliva and be carried into the oral cavity by the saliva to exert its effect; the support layer is used to support the orally disintegrating film, reducing the risk of the orally disintegrating film shrinking or even directly disintegrating during the attachment process. The user only needs to use one piece of the oral product to successfully attach it to the required position, reducing the cost of using 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 the at least two support layers are disposed on two opposing surfaces of the orally dissolving film. The two support layers disposed on the two surfaces of the orally dissolving film not only provide support but also provide isolation, thereby reducing the risk of the orally dissolving 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 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 orally dissolving film facing the oral mucosa, and the second supporting layer is configured to be located on the side of the orally dissolving film facing the oral cavity. The water permeability of the first supporting layer is greater than that of the second supporting layer. The first supporting layer has a higher water permeability than the second supporting layer, so that the substance released after the orally dissolving film dissolves 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 an appropriate stiffness through the second support layer.

[0010] According to some embodiments of the present application, the oral product includes a waterproof layer that covers the surface of the second supporting layer facing away from the orally dissolving membrane. The waterproof layer prevents substances released from the orally dissolving membrane from entering the oral cavity and the digestive tract. Substances released from the orally dissolving membrane exit the containment space only through the supporting layer facing the oral mucosa, allowing more substances released from the orally dissolving membrane to be absorbed by the oral mucosa.

[0011] According to some embodiments of the present application, the number of the support layers is two, and the two support layers are arranged to form a receiving space. The support layers are hydrophilic, and at least a portion of the orally disintegrating film is placed in the receiving space. The support layer is hydrophilic, and when the oral product enters the oral cavity and comes into contact with saliva, the support layer can preferentially absorb water and infiltrate, delaying the dissolution of at least a portion of the orally disintegrating film placed in the receiving space from contact with saliva. During this time, the oral product can be moved freely as needed; and the dissolved orally disintegrating film can remain in the receiving space without contacting and 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 disintegrating film in the oral cavity, and facilitating the removal 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 having at least one through hole, and the channel is formed in the through hole. Processing the through hole on the sheet material to form the channel simplifies the processing technology and helps reduce production costs.

[0013] According to some embodiments of the present application, the oral product includes a water-swellable layer disposed on at least one surface of the support layer. Swelling of the water-swellable layer upon absorption of water can improve the overall stiffness of the oral product, facilitate user movement of the oral product, and enhance 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 orally disintegrating film.

[0015] According to some embodiments of the present application, the support layer is provided with at least one through-hole for passage of saliva, and the oral product includes a porous layer that is detachably connected to the support layer and covers the through-hole. During use, the user can choose to open the porous layer to allow the substance released by the orally dissolving film to be more absorbed by the oral mucosa through the through-hole, thereby achieving stronger stimulation.

[0016] According to some embodiments of the present application, the oral product includes a handheld portion, the handheld portion being disposed on the support layer and configured for a user to hold. The user can hold the handheld portion to place the oral product in the oral cavity or remove the oral product from the oral cavity, thereby improving the usability of the oral product.

[0017] According to some embodiments of the present application, the support layer comprises at least one of a foamed resin, a reticulated 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 that forms channels for saliva to pass through, thus providing the support layer with good liquid permeability, thereby facilitating contact between the orally dissolving film and saliva and releasing 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 comes into contact with saliva, the water-swellable polymer absorbs water and swells, further delaying the dissolution of at least a portion of the orally dissolving film within the receiving space. During this time, the oral product can be moved as needed, thereby improving the usability of the oral product.

[0019] According to some embodiments of the present application, the orally disintegrating 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 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 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] Figure 9 This is a schematic cross-sectional view of an oral product provided in yet another embodiment of the present application.

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

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

[0031] Figure 12 Graph showing the relative dissolution rates of nicotine for the products of the examples and comparative examples of the present application.

[0032] Figure 13 Graph showing the relative dissolution rate of nicotine in the 0-4 min time period for the products of the examples and comparative examples of the present application.

[0033] Description of main component symbols:

[0034] Oral Products 100

[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 detailed description is illustrative and non-limiting. It is intended to provide a basic understanding of the present application and is 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 the various embodiments can be combined in any manner.

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

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

[0049] The present 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 is embedded within the orally disintegrating film. The support layer is water-insoluble and has at least one channel for saliva to pass through the support layer. During the process of placing the oral product in the mouth, the water-insoluble support layer may hinder the dissolution of the orally disintegrating film in saliva, thereby slowing the rate at which the orally disintegrating film dissolves or disintegrates in saliva to release its active ingredients. However, the support layer can provide support, reducing the risk of the orally disintegrating film shrinking or even directly disintegrating during use. This allows the user to smoothly attach the oral product to the desired location when using it, and the user can remove the oral product midway through use, overcoming the technical bias that the faster the orally disintegrating film dissolves after entering the mouth, the better. For orally disintegrating films that are more effectively delivered from the oral mucosa to the systemic circulation, the support layer prevents the orally disintegrating film from rapidly disintegrating and being swallowed into the stomach, allowing the orally disintegrating film to be delivered to the systemic circulation as much as possible through the oral mucosa, thereby improving the absorption effect of the orally disintegrating film.

[0050] The following will describe some embodiments of the present application 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 1One embodiment of the present application provides an oral product 100 for placement in the oral cavity, such as on 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 in the oral cavity. The support layer 10 is water-insoluble and is disposed on at least one surface of the orally dissolving film 20. Figure 1 The support layer 10 is shown disposed on one surface of the orally disintegrating film 20. The support layer 10 has at least one channel 101, which is used for saliva to pass through the support layer 10 and contact the orally disintegrating film 20, so that the orally disintegrating film 20 can be disintegrated in the saliva and carried into the oral cavity by the saliva to exert its effect.

[0052] The support layer 10 serves as a support for the orally disintegrating film 20, reducing the risk of the orally disintegrating film 20 shrinking or even disintegrating during the application process. Users can use only one piece of the oral product 100 to smoothly apply it to the desired location, reducing the cost of using the oral product 100. Furthermore, the support layer 10 can maintain its shape for a long time. The orally disintegrating film 20 is constrained by the support layer 10, allowing the oral product 100 to be freely moved or removed from the oral cavity as needed, thereby improving the usability of the oral product 100. Furthermore, the support layer 10 also serves as an isolation layer, separating the orally disintegrating film 20 from the user's hands and / or oral cavity, reducing the risk of the orally disintegrating film 20 adhering to the hands and / or oral cavity during application and use. This makes it more convenient for users to move the oral product 100 at any time, thereby improving the usability of the oral product 100.

[0053] When the support layer 10 is positioned on the side of the orally dissolving film 20 facing the oral mucosa, saliva requires a certain amount of time to wet the support layer 10 or pass through the channel 101. This reduces the contact speed between the orally dissolving film 20 and saliva, thereby slowing down the release of substances from the orally dissolving film 20 to a certain extent and reducing the probability of the orally dissolving film 20 disintegrating before reaching the designated location in the oral cavity. This allows the orally dissolving film 20 to release as much substance as possible to the location where the user needs to place the product, thereby 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 attachment position, further facilitating smooth attachment of the oral product 100 to the desired location.

[0054] See also Figure 2 In some embodiments, the number of support layers 10 is two, and the two support layers 10 are disposed on two opposing surfaces of the orally dissolving film 20. The two support layers 10 disposed on two opposing surfaces of the orally dissolving film 20 isolate both surfaces of the orally dissolving film 20 from the hand or the oral cavity, further reducing the risk of the orally dissolving film 20 adhering to the hand or the oral cavity during the application process.

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

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

[0057] The materials of the two support layers 10 can be the same or different. In some embodiments, the 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 orally dissolving film 20 facing the oral mucosa, and the second support layer is configured to be located on the side of the orally dissolving film 20 facing the oral cavity. The water permeability of the first support layer is greater than that of the second support layer. During 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, so that the substances released after the orally dissolving film 20 dissolves can be released more through the first support layer, thereby being absorbed by the oral mucosa to which the first support layer is attached.

[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 active substance in the orally dissolving film 20 can be dissolved by saliva and act on the oral mucosa. In some embodiments, the active substance includes a pharmaceutical or cosmetic ingredient, such as at least one of a drug, an antigen, an allergen, an oral cleaning component, an enzyme, and a vitamin.

[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, a preservative, a sweetener, and a coloring agent.

[0062] In some embodiments, the support layer 10 has a porous structure, which forms channels 101 for saliva to pass through, making the support layer 10 highly liquid permeable. The support layer 10 comprises at least one of a foamed resin, a reticulated resin, a porous resin, a woven fabric, a woven cloth, a single-layer non-woven fabric, a multi-layer non-woven fabric, paper, or an inorganic fiber. The material of the support layer 10 may include at least one of polyolefins, polyesters, synthetic fibers, semi-synthetic fibers, regenerated fibers, or other natural or inorganic fibers.

[0063] Polyolefins include polyethylene and polypropylene. Polyesters include polyethylene terephthalate and polybutylene terephthalate. Synthetic fibers include polyurethane, nylon, polyvinyl chloride, polyvinylidene chloride, fluororesins, vinylon, aramid, polyacrylic polymers, and cellulose acetate. Regenerated fibers include rayon. Natural fibers include cotton, linen, and silk.

[0064] Optionally, the support layer 10 may be a nylon mesh or a non-woven fabric. In the case where the support layer 10 is a multi-layer non-woven fabric, the effect of the support layer 10 in slowing down the dissolution rate of the active ingredient in the orally dissolving film 20 can be controlled by adjusting the number of non-woven fabric layers in the multi-layer non-woven fabric, thereby providing users with different experiences, such as a stimulating taste or a mild taste.

[0065] In some embodiments, the support layer 10 comprises a sheet material having through-holes, which form passages for saliva to pass through. The through-holes can be formed by punching the sheet material, which simplifies the processing and helps reduce production costs. The punching can be performed using equipment such as a laser puncher or a needle roller.

[0066] See also Figure 3 In some embodiments, the support layer 10 is embedded in the orally disintegrating film 20. The support layer 10 embedded in the orally disintegrating film 20 can play a supporting role. The support layer 10 is used to support the orally disintegrating film 20, reducing the risk of the orally disintegrating film 20 shrinking or even directly disintegrating during the attachment process. In addition, the support layer 10 can maintain its shape for a long time, and the oral product 100 can be moved or removed 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, in which the orally disintegrating film 20 is placed. The receiving space 102 has a first opening 11, through which the orally disintegrating film 20 is placed in or taken out of 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 infiltrate, delaying the orally dissolving film 20 placed in the receiving space 102 from coming into contact with saliva and dissolving. During this time, the oral product 100 can be moved at will as needed; and the dissolved orally dissolving film 20 can remain in the receiving space 102 without contacting and adhering to the oral cavity, reducing the risk of physiological discomfort caused by a large amount of dissolved or disintegrated orally dissolving 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 orally dissolving film 20 is placed in the receiving space 102, so that the support layer 10 can cover the entire orally dissolving 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 this application.

[0069] In some embodiments, part of the orally disintegrating film 20 is placed in the accommodation space 102, and part of the orally disintegrating film 20 is exposed outside the accommodation space 102. Figure 5 As shown, the orally disintegrating 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 longitudinal direction of the orally disintegrating film 10, and the orally disintegrating 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 orally disintegrating membrane 20 , and the through holes 13 are used for allowing 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 the support layer 10 located on the side of the orally dissolving film 20 facing the oral cavity, facing away from the orally dissolving film 20. The waterproof layer 40 is liquid-impermeable and can prevent substances released from the orally dissolving film 20 from passing through the oral cavity and then entering the digestive tract. Substances released from the orally dissolving film 20 only exit the accommodation space 102 through the support layer 10 facing the oral mucosa, allowing more substances released from the orally dissolving film 20 to be 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, or the like.

[0072] See also 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 number of porous layers 50 is one or more. The porous layer 50 has a porous structure. The porous layer 50 can prevent the substances released by the orally dissolving film 20 from directly flowing out of the accommodation space 102 through the through-holes 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 substances released by the orally dissolving film 20 can be more absorbed by the oral mucosa through the through-holes 13, thereby obtaining 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 is a polymer that absorbs water or other liquids and swells. When the support layer 10 comes into contact with saliva, the water-swellable polymer absorbs water and swells, further delaying contact between the orally dissolving film 20 and saliva. This gives the user more time to move the orally dissolving film 20 to the desired location without dissolving the film, thereby improving the usability of the oral product 100.

[0074] In some embodiments, the water-swellable polymer includes a cellulosic water-swellable polymer and / or a non-cellulosic water-swellable polymer. The cellulosic neutral polymer may include at least one of methyl cellulose, ethyl cellulose, hydroxymethyl cellulose, hydroxyethyl cellulose, hydroxypropyl cellulose, hydroxybutyl cellulose, hydroxyethyl methyl cellulose, hydroxypropyl methyl cellulose, and the like. The non-cellulosic neutral polymer may include at least one of 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 Figure 10 In some embodiments, the oral product 100 further includes a water-swelling layer 30, which is laminated on the surface of the support layer 10 facing the orally disintegrating film 20, and the orally disintegrating film 20 is located on the side of the water-swelling layer 30 facing away from the support layer 10. The water-swelling layer 30 includes a water-swelling polymer. After the water-swelling layer 30 absorbs water and swells, it is more conducive to keeping the dissolved or disintegrated orally disintegrating film 20 in the accommodation space 102, and is more conducive to avoiding the phenomenon of physiological discomfort caused by a large amount of dissolved or disintegrated orally disintegrating film 20 quickly dispersing in the oral cavity. In addition, the support layer 10 can isolate the water-swelling layer 30 from the hands or isolate the water-swelling layer 30 from the oral cavity, reducing the risk of adhesion of the water-swelling layer 30 to the hands or the oral cavity. It should be noted that Figure 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 disintegrating 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 disintegrating film 20 .

[0078] In some embodiments, the water-swelling layer 30 provided on the surface of the support layer 10 facing away from the orally disintegrating film 20 and the water-swelling layer 30 provided on the surface of the bag-shaped support layer 10 facing the orally disintegrating film 20 can be connected as one, so that the support layer 10 having the accommodating space 102 is embedded in the water-swelling layer 30.

[0079] See also 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 place the oral product 100 in or remove it from the oral cavity, thereby improving the usability of the oral product 100. The handle 60 can be integral with the support layer 10 or separate from the support layer 10. The handle 60 can be a cord.

[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 commercially available orally dissolving nicotine film (FASTA, available from Shenzhen Ruxin Technology Co., Ltd.) was enclosed in a pouch made of non-woven fabric (FDA30, available from Huzhou Ruilan New Materials Co., Ltd.) to produce an oral product. The orally dissolving film contained 4 mg of nicotine.

[0083] Example 2

[0084] The difference from Example 1 is that the non-woven fabric is FDA34, which is commercially available from Huzhou Ruilan New Materials Co., Ltd. The physical and chemical properties of the non-woven fabrics in Examples 1 and 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 disintegrating film containing nicotine is not enclosed in a small bag formed of non-woven fabric.

[0089] Nicotine dissolution rate test in orally disintegrating 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. 100 μl 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] Nicotine concentration in the sample was determined according to the current standard for artificial saliva (GB / T 18886-2019). The sample was dissolved to 800 μl and the nicotine content was determined using high-performance liquid chromatography (HPLC). The relative cumulative nicotine release was calculated and a nicotine dissolution curve was generated using the relative cumulative release as the vertical axis.

[0092] like Figure 12As shown, compared to Comparative Example 1, the non-woven fabric provided in Examples 1 and 2 resulted in more moderate nicotine dissolution, and the total nicotine dissolution rates in Example 1, Example 2, and Comparative Example 1 were approximately the same. Compared to Example 2, the thickness of the non-woven fabric in Example 1 was smaller, resulting in a nicotine dissolution rate in Example 1 closer to that in Comparative Example 1. Furthermore, the nicotine dissolution rate versus time curve in Example 2 was flatter than that in Example 1.

[0093] like Figure 13 As shown, within the time period of 0-1 min, no nicotine was dissolved in the orally dissolving films of Example 1 and Example 2 within the first 30 s, and the dissolution amount at 1 min was relatively low. This is because the non-woven fabric needs to be soaked in saliva before the orally dissolving film can come into contact with saliva to undergo the dissolution process, thereby providing a buffer between the orally dissolving film and the saliva. During this time period, the user can move the oral product or orally dissolving film to the desired location.

[0094] User experience testing

[0095] Each user applied the product of Example 1 and Comparative Example 1 to their gums. The number of times each user successfully applied the product to their gums and the number of times the product was moved were recorded. The user's user experience was also reviewed, including the time they began to feel the nicotine hit, the intensity of the nicotine irritation in their throat, whether they stopped using the product, the level of stickiness, and a convenience score. The convenience score ranged from 0 to 6, with stronger stickiness indicating a lower score and greater convenience indicating a higher 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.

[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 product and move it in the mouth multiple times to attach it to the required position; when no non-woven fabric is 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 product to attach it to the appropriate position.

[0103] As can be seen from Tables 2 and 3, the use of non-woven fabric delayed the nicotine effect by 1.5 minutes, allowing users to quit at any time. This reduced the strong irritation caused by a large amount of dissolved or disintegrated orally disintegrating film entering the throat with saliva, and reduced the discomfort caused by the stickiness and residue of the orally disintegrating film.

[0104] Example 3

[0105] A commercially available 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 commercially available fast-dissolving sustained-release tooth strip (available from Qingjiuye) 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 attached 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 attached the product to the desired location in the oral cavity was 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] Comparing Example 3 with Comparative Example 2, it can be seen that when a non-woven fabric is provided, the user can apply the product to the desired location with a single application. In Comparative Example 2, since no non-woven fabric is provided, the propolis oral film deforms upon entering the mouth due to moisture and easily sticks to the hands, requiring the user to apply the product multiple times before the product is properly placed.

[0116] Comparing Example 4 with Comparative Example 3, it can be seen that when a non-woven fabric is provided, the user can attach the product to the desired location with a single application. In Comparative Example 3, since no non-woven fabric is provided, the fast-dissolving sustained-release tooth patch deforms upon entering the mouth due to moisture and easily adheres to the inside of the lips or gums, requiring the user to apply the product multiple times before it is properly located.

[0117] Those skilled in the art should recognize that the above embodiments are merely intended to illustrate the present application and are not intended to limit the present application. As long as they are within the spirit of the present application, appropriate changes and modifications to the above embodiments fall within the scope disclosed in 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 orally dissolving film or embedded in the orally dissolving 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 orally disintegrating film.

3. The oral product according to claim 2, wherein: 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 the side of the orally disintegrating film facing the oral mucosa, and the second supporting layer is configured to be located on the side of the orally disintegrating film facing the oral cavity, and the water permeability of the first supporting layer is greater than that of the second supporting layer.

4. The oral product according to claim 3, wherein: 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 includes a waterproof layer, which covers a surface of the second supporting layer on a side facing away from the orally disintegrating film.

6. The oral product according to claim 1, wherein There are two supporting layers, and the two supporting layers are arranged to form a receiving space. The supporting layers are hydrophilic, and at least a portion of the orally disintegrating film is placed in the receiving space.

7. The oral product according to claim 1, wherein The supporting layer includes 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 disintegrating film.

10. The oral product according to claim 1, wherein The support layer is provided with at least one through hole for allowing the saliva to pass through. The oral product comprises a porous layer, which 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, wherein: The oral product includes 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, wherein: The support layer includes at least one of foamed resin, mesh resin, porous resin, braided fabric, woven fabric, 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, wherein: The support layer includes a water-swellable polymer.

14. The oral product according to any one of claims 1 to 10, wherein: The orally disintegrating film comprises nicotine or nicotine salt.

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