Film dosage product and oral film product

Abstract

The present disclosure relates to the technical field of film dosage products, and in particular to a film dosage product and an oral film product. The film dosage product comprises a functional film layer and sheet layers; the functional film layer contains an active ingredient, the active ingredient being adapted to be released from the functional film layer and act at a target position; and the sheet layers include a first sheet layer, the first sheet layer being arranged on at least part of the surface of the functional film layer, and / or the first sheet layer being embedded within the functional film layer.

Description

Film products and oral film products

[0001] Priority information

[0002] This disclosure claims priority and benefits to patent applications filed with the China National Intellectual Property Administration (CNIPA) on July 24, 2024, No. 2024217709368, No. 2024110057071, No. 2024119996179, and No. 2024233228910, all of which are incorporated herein by reference in their entirety. Technical Field

[0003] This disclosure relates to the field of film products technology, specifically to film products and oral film products. Background Technology

[0004] Film-type products have gained widespread attention due to their advantages such as ease of use, lightweight, localized effect, rapid onset of action, and high efficiency, and are gradually expanding from simple pharmaceuticals to various consumer and health product scenarios. When using film-type products, users typically hold the product directly and place or adhere it to the target area using their fingers. During this process, if the film-type product comes into contact with liquids such as sweat or saliva, it will absorb moisture and begin releasing active ingredients. This can cause the film-type product to dissolve before reaching the target area, or it may shrink, deform, or stick together, significantly affecting its effectiveness.

[0005] Public content

[0006] This disclosure aims to address, to some extent, the technical problems in related technologies, such as film products dissolving before reaching the target location, easily shrinking, deforming, sticking and being difficult to adhere to the target location, and rapidly disintegrating upon contact with liquid. To this end, this disclosure proposes a film product and oral film product that are less prone to wrinkling and deformation, less prone to adhesion, allow for controllable release of active ingredients, or are easy to package and store.

[0007] In a first aspect, this disclosure provides a film-forming product. According to embodiments of this disclosure, the film-forming product includes: a functional film layer containing an active ingredient adapted to be released from the functional film layer and act on a target location; a sheet layer including a first sheet layer disposed on at least a portion of the surface of the functional film layer; and / or, the first sheet layer being embedded within the functional film layer. Specifically, by providing the sheet layer, the tensile strength of the film-forming product can be improved. The sheet layer, which can maintain its shape for a longer period, mitigates the problems of wrinkling and deformation of the film-forming product, reducing the degree of deformation when the film-forming product fails to reach the target location. Simultaneously, due to the increased tensile strength, the film-forming product will no longer rapidly disintegrate after being placed at the target location, allowing for the relatively intact removal of the film-forming product from the target location during use. It also effectively improves situations where the film-forming product rapidly deforms, adheres, breaks, or disintegrates upon contact with liquid, making it difficult to place at the target location. During placement, the film-forming product can be moved multiple times by the user until aligned with the target location; essentially, one sheet of film-forming product is sufficient to adhere to the target location, significantly reducing the cost of using the film-forming product.

[0008] According to an embodiment of this disclosure, a first sheet covers one side surface of the functional film layer.

[0009] According to embodiments of the present disclosure, the sheet further includes a second sheet, and the first and second sheets are disposed on two opposing surfaces of the functional film layer.

[0010] According to embodiments of this disclosure, at least two of the first sheet, the functional film layer, and the second sheet are arranged with their edges aligned.

[0011] According to an embodiment of the present disclosure, the edges of the first layer and the second layer are connected to form a first bag-shaped structure with an opening on at least one side edge. The first bag-shaped structure has a first receiving space, and at least a portion of the functional membrane layer is disposed in the first receiving space.

[0012] According to an embodiment of the present disclosure, the edges of the first layer and the second layer are connected to form a second bag-shaped structure without openings at the edges. The second bag-shaped structure has a second receiving space, and the functional membrane layer is received in the second receiving space.

[0013] According to embodiments of this disclosure, at least one of the first layer and the second layer is provided with a through hole.

[0014] According to embodiments of the present disclosure, the first layer includes a plurality of first sub-layers stacked together.

[0015] According to embodiments of the present disclosure, the second layer includes a plurality of stacked second sub-layers.

[0016] By using different layer settings, we can meet the needs of different usage scenarios and provide a more diverse experience.

[0017] According to embodiments of this disclosure, adjacent first sub-layers are detachably connected; and / or adjacent second sub-layers are detachably connected.

[0018] According to an embodiment of this disclosure, a first disassembly portion is provided in the first sub-layer.

[0019] According to an embodiment of this disclosure, the edges of the two connected first sub-layer portions are not sealed.

[0020] According to an embodiment of this disclosure, the second sub-layer is provided with a second disassembly portion.

[0021] According to an embodiment of this disclosure, the edges of the two connected second sub-layer portions are not sealed.

[0022] According to an embodiment of the present disclosure, the first layer includes a first removable region and a first non-removable region, and the first removable region and the first non-removable region are connected by a first weak connection structure.

[0023] According to an embodiment of this disclosure, the second layer includes a second removable region and a second non-removable region, and the second removable region and the second non-removable region are connected by a second weak connection structure.

[0024] Specifically, through the detachable connection, users can adjust the number of layers according to their own experience during actual use, such as choosing different stimulation intensities, thereby better meeting the needs of different users.

[0025] According to embodiments of this disclosure, the film product further includes a waterproof layer.

[0026] In some embodiments, the film product includes a functional film layer and a first sheet layer, with the waterproof layer disposed on the surface of the first sheet layer away from the functional film layer or on the surface of the functional film layer not covered by the first sheet layer.

[0027] In some embodiments, the film agent product includes a functional film layer, a first sheet layer and a second sheet layer, the functional film layer being sandwiched between the first sheet layer and the second sheet layer, and a waterproof layer being disposed on the surface of the first sheet layer away from the functional film layer, the surface of the second sheet layer away from the functional film layer, or the surface of the functional film layer not covered by the first sheet layer and the second sheet layer.

[0028] Setting a waterproof layer can reduce the delivery of active ingredients released from the functional membrane to non-target locations, such as through the mouth and into the digestive tract, and promote the active ingredients released from the functional membrane to exert their effects through the side facing the target location, so that more active ingredients are absorbed by the target location.

[0029] According to embodiments of this disclosure, the membrane product further includes a water-swellable substance disposed at at least one of the following locations: the surface of the first layer, the surface of the second layer, and the pores of the first and second layers. After absorbing water and swelling, the water-swellable substance can improve the overall tensile strength of the membrane product, facilitating user movement of the membrane product and enhancing its usability.

[0030] According to embodiments of this disclosure, the first layer and the second layer are identical.

[0031] According to embodiments of this disclosure, at least one of the following characteristics of the first and second layers is different: water permeability, porosity, thickness, material, tensile strength, and number of layers. Therefore, the two surfaces of the membrane product can provide different release rates of active ingredients, enriching the user experience and meeting the personalized needs of more usage scenarios and users.

[0032] According to embodiments of this disclosure, the first and second layers are each independently water-permeable; or they are not water-permeable but have water-permeable channels. This allows the active ingredients in the functional membrane layers to effectively and conveniently reach the target location.

[0033] According to embodiments of this disclosure, the water-permeable channel includes a through hole, or the water-permeable channel includes a through hole and a porous layer removably covered on the through hole.

[0034] According to embodiments of this disclosure, the first layer and the second layer each independently include at least one of the following: nonwoven fabric, specialty paper, wood pulp paper, polylactic acid paper, fiber cloth, mesh fabric, foamed resin film, mesh resin film, porous resin film, swellable sheet, swellable mesh, plastic sheet with water-permeable channels, and rubber sheet with water-permeable channels.

[0035] According to embodiments of this disclosure, the functional film layer includes multiple sub-functional film layers. In some embodiments, the multiple sub-functional film layers are identical. Specifically, when the thickness of a single functional film layer is limited, a greater thickness and a greater dose of active ingredient can be achieved by setting multiple sub-functional film layers. In other embodiments, the multiple sub-functional film layers contain at least one different type and concentration of active ingredient. Therefore, multiple different active ingredients or different concentrations of active ingredients can be combined in a single film-forming product, achieving flexible combinations between the types and concentrations of active ingredients, providing customers with a richer experience.

[0036] In some embodiments, the subfunctional membrane layer includes at least one of a first subfunctional membrane layer and a second subfunctional membrane layer, with multiple first subfunctional membrane layers stacked on top of each other, and / or multiple second subfunctional membrane layers laid flat on the first surface.

[0037] According to embodiments of this disclosure, adjacent first sub-functional membrane layers are detachably connected; and / or the second sub-functional membrane layer is detachably connected to the sheet layer. Therefore, users can flexibly adjust the type and quantity of sub-functional membranes according to their actual needs, better meeting their personalized requirements.

[0038] According to an embodiment of this disclosure, the first subfunctional membrane layer is provided with a third disassembly portion.

[0039] According to an embodiment of this disclosure, the edges of the two connected first sub-functional membrane layers are not sealed.

[0040] According to an embodiment of this disclosure, the second subfunctional membrane layer is provided with a fourth disassembly portion.

[0041] According to an embodiment of this disclosure, the edges of the second subfunctional membrane layer and the sheet portion are not sealed.

[0042] According to embodiments of this disclosure, the first layer includes a plurality of third sub-layers, which are substantially parallel to the first surface. The orthographic projection of each third sub-layer onto the first surface overlaps with the orthographic projection of at least one second sub-functional membrane layer onto the first surface. At least one of the water permeability, material, porosity, tensile strength, thickness, and number of layers differs among the plurality of third sub-layers. Therefore, different second sub-functional membrane layers can have different release rates of active ingredients, better meeting user needs and enriching the user experience.

[0043] According to embodiments of the present disclosure, the sheet further includes at least one third sheet, which is sandwiched between two adjacent first sub-functional membrane layers.

[0044] According to embodiments of this disclosure, at least one of the following is different among the multiple third layers: water permeability, material, porosity, thickness, tensile strength, and number of layers.

[0045] According to embodiments of this disclosure, the film-forming product also includes a gripping portion. Users can use the gripping portion to apply the film-forming product to the target location or remove it midway, improving the usability of the film-forming product.

[0046] According to embodiments of this disclosure, the grip portion includes at least one of a traction cable and a handle.

[0047] According to an embodiment of this disclosure, the gripping portion is located at the edge of the film product.

[0048] According to an embodiment of this disclosure, the gripping portion includes a partial sheet.

[0049] According to embodiments of this disclosure, the gripping portion includes a partial sheet layer and a partial functional film layer.

[0050] According to embodiments of this disclosure, the film-forming product is printed with graphic and textual information. This allows users to easily identify graphic and textual information, brand information, etc., making it more convenient to use.

[0051] According to embodiments of this disclosure, the film products include at least one of buccal film products, sublingual film products, supralingual film products, oral cavity lining film products, gingival film products, dental veneer products, and nasal film products.

[0052] According to embodiments of this disclosure, the outer contour shape of the film-forming product includes at least one of a square, rectangle, circle, triangle, polygon, and irregular shape.

[0053] According to embodiments of this disclosure, the maximum dimension of the outer contour of the film-forming product is 0.1 cm to 8 cm, and the minimum dimension is 0.1 cm to 1.5 cm. In some embodiments, the maximum dimension of the film-forming product is 0.8 cm to 3 cm, and the minimum dimension is 0.6 cm to 1.2 cm.

[0054] According to embodiments of this disclosure, the functional film layer includes at least one of a fully dissolved film layer, a partially dissolved film layer, and a swollen film layer.

[0055] According to embodiments of this disclosure, the active ingredient includes at least one of pharmaceutical ingredients, nutritional and health care ingredients, food ingredients, daily chemical ingredients, and alkaloids.

[0056] According to embodiments of this disclosure, the drug ingredients include at least one of oral ulcer drugs, psychotropic drugs, analgesics, anti-inflammatory drugs, cannabinoids and their derivatives, nasal drugs, respiratory drugs, and sildenafil.

[0057] According to embodiments of this disclosure, the nutritional and health-promoting ingredients include at least one of the following: American ginseng extract, Schisandra chinensis extract, Ganoderma lucidum extract, arginine, propolis, melatonin, glutathione, and taurine.

[0058] According to embodiments of this disclosure, the food ingredients include at least one of tea extract, coffee extract, and vitamins.

[0059] According to embodiments of this disclosure, the daily chemical ingredients include at least one of papain, catalase, teeth whitening ingredients, oral repair ingredients, and anti-aging ingredients.

[0060] According to embodiments of this disclosure, the alkaloids include at least one of nicotine and its derivatives, caffeine and its analogs, arecoline and its analogs, and hexamethylnicotine.

[0061] Therefore, this film agent has a wide range of applications and can play different roles to meet the needs of different usage scenarios.

[0062] A second aspect of this disclosure provides an oral film product. According to an embodiment of this disclosure, the oral film product includes: an oral film containing an active ingredient adapted to be released from the oral film and act on a target location; a sheet including a first sheet disposed on at least a portion of the surface of the oral film; and / or, the first sheet being embedded within the oral film, wherein the sheet may be the same as the previously described sheet layer, and the oral film may be the same as the previously described functional film layer. Specifically, by using sheet material, the tensile strength of oral diaper products can be improved. The sheet material, which can maintain its shape for a longer period, mitigates the problems of wrinkling and deformation, reducing the degree of deformation before reaching the target position. Simultaneously, the oral diaper product will not quickly disintegrate after being placed in the target position, making it easy to remove during use. It also effectively prevents the oral diaper product from deforming, sticking, breaking, or disintegrating rapidly upon contact with liquids, thus avoiding difficulty in adhering to the target position. The oral diaper product can be moved multiple times, making it easier to adhere to the target position; essentially, one sheet is sufficient for adhering to the target position, significantly reducing usage costs.

[0063] This disclosure has at least the following beneficial effects:

[0064] By incorporating layers / sheets, the tensile strength of the film / oral membrane product can be improved. The use of layers / sheets that maintain their shape for a longer period mitigates the problems of wrinkling and deformation, reducing the degree of deformation before reaching the target position. Simultaneously, the film / oral membrane product will not rapidly disintegrate after being placed in the target position, allowing for easy removal during use. It also effectively addresses situations where the film / oral membrane product deforms, adheres, breaks, or disintegrates rapidly upon contact with liquids, making it difficult to adhere to the target position. The film / oral membrane product can be moved multiple times, making it easier to adhere to the target position. Essentially, one sheet of film / oral membrane product is sufficient for adhesion, significantly reducing usage costs. Attached Figure Description

[0065] Figure 1 is a schematic diagram of the structure of a film-forming product according to one embodiment of the present disclosure, wherein the upper figure is a schematic diagram of the planar structure of the film-forming product, and the lower figure is a schematic diagram of the cross-sectional structure along line AA in the upper figure.

[0066] Figure 2 is a schematic diagram of the structure of a film agent product according to one embodiment of the present disclosure, wherein the upper figure is a schematic diagram of the planar structure of the film agent product, and the lower figure is a schematic diagram of the cross-sectional structure along line BB in the upper figure.

[0067] Figure 3 is a cross-sectional structural diagram of a film product according to one embodiment of the present disclosure.

[0068] Figure 4 is a cross-sectional structural diagram of a film product according to one embodiment of the present disclosure.

[0069] Figure 5 is a cross-sectional structural diagram of a film product according to one embodiment of the present disclosure.

[0070] Figure 6 is a schematic planar structure diagram of a film product according to one embodiment of the present disclosure.

[0071] Figure 7 is a cross-sectional structural diagram of a film product according to one embodiment of the present disclosure.

[0072] Figure 8 is a cross-sectional structural diagram of a film product according to one embodiment of the present disclosure.

[0073] Figure 9 is a cross-sectional structural diagram of a film product according to one embodiment of the present disclosure.

[0074] Figure 10 is a cross-sectional structural diagram of a film product according to one embodiment of the present disclosure.

[0075] Figure 11 is a schematic planar structure diagram of a film product according to one embodiment of the present disclosure.

[0076] Figure 12 is a schematic planar structure diagram of a film product according to one embodiment of the present disclosure.

[0077] Figure 13 is a cross-sectional structural diagram of a film product according to one embodiment of the present disclosure.

[0078] Figure 14 is a cross-sectional structural diagram of a film product according to one embodiment of the present disclosure.

[0079] Figure 15 is a cross-sectional structural diagram of a film product according to one embodiment of the present disclosure.

[0080] Figure 16 is a cross-sectional structural diagram of a film product according to one embodiment of the present disclosure.

[0081] Figure 17 is a cross-sectional structural diagram of a film product according to one embodiment of the present disclosure.

[0082] Figure 18 is a cross-sectional structural diagram of a film product according to one embodiment of the present disclosure.

[0083] Figure 19 is a cross-sectional structural diagram of a film product according to one embodiment of the present disclosure.

[0084] Figure 20 is a cross-sectional structural diagram of a film product according to one embodiment of the present disclosure.

[0085] Figure 21 is a schematic planar structure diagram of a film product according to one embodiment of the present disclosure.

[0086] Figure 22 is a cross-sectional structural diagram of a film product according to one embodiment of the present disclosure.

[0087] Figure 23 is a schematic planar structure diagram of a film product according to one embodiment of the present disclosure.

[0088] Figure 24 is a photograph of the nicotine functional membrane layer in Embodiment 1.

[0089] Figure 25 is a photograph of the n1 oral membrane product in Embodiment 1.

[0090] Figure 26 is a photograph of the n2 oral membrane product in Embodiment 1.

[0091] Figure 27 is the nicotine relative dissolution rate-time curve in Implementation Method 1.

[0092] Figure 28 is the nicotine relative dissolution rate-time curve in Implementation Method 1.

[0093] Figure 29 is a photograph of the propolis film in Embodiment 2.

[0094] Figure 30 is a photograph of the propolis film product encapsulated with non-woven fabric in Embodiment 2.

[0095] Figure 31 is a schematic diagram of the position of the propolis film in Embodiment 2.

[0096] Figure 32 is a photograph of the soluble dental strip in Embodiment 3.

[0097] Figure 33 is a photograph of the soluble dental strip product encapsulated with nonwoven fabric in Embodiment 3.

[0098] Figure 34 is a photograph of the nicotine film product encapsulated with nonwoven fabric in Embodiment 5.

[0099] Figure 35 is a photograph of the nicotine film product encapsulated with nonwoven fabric in Embodiment 5.

[0100] Figure 36 is a photograph of the nicotine film product encapsulated with nonwoven fabric in Embodiment 5.

[0101] Figure 37 is a photograph of the nicotine film product encapsulated with nonwoven fabric in Embodiment 5.

[0102] Figure 38 is a photograph of the nicotine film product encapsulated with nonwoven fabric in Embodiment 5.

[0103] Figure 39 is a photograph of the swelling membrane in Embodiment 6.

[0104] Figure 40 is a photograph of the swelling film product after encapsulation and printed with graphic information in Embodiment 6.

[0105] Figure 41 is a photograph of the swelling film product after encapsulation and printed with graphic information in Embodiment 6.

[0106] Figure 42 is a photograph of the swelling film product after encapsulation and printed with graphic information in Embodiment 6.

[0107] Figure 43 is a photograph of the localized shrinkage of the swollen membrane after it comes into contact with water in Embodiment 6.

[0108] Figure 44 is a photograph of the nose strip product in Embodiment 9.

[0109] Figure 45 is a schematic diagram of the structure of a film-forming product group according to one embodiment of the present disclosure.

[0110] Figure 46 is a cross-sectional schematic diagram of an oral product provided in one embodiment of this application.

[0111] Figure 47 is a cross-sectional schematic diagram of an oral product provided in another embodiment of this application.

[0112] Figure 48 is a cross-sectional schematic diagram of an oral product provided in another embodiment of this application.

[0113] Figure 49 is a schematic diagram of an oral product provided in another embodiment of this application.

[0114] Figure 50 is a front view of an oral product provided in one embodiment of this application.

[0115] Figure 51 is a front view of an oral product provided in another embodiment of this application.

[0116] Figure 52 is a front view of an oral product provided in another embodiment of this application.

[0117] Figure 53 is a cross-sectional schematic diagram of an oral product provided in another embodiment of this application.

[0118] Figure 54 is a cross-sectional schematic diagram of an oral product provided in another embodiment of this application.

[0119] Figure 55 is a front view of an oral product provided in another embodiment of this application.

[0120] Figure 56 is a front view of an oral product provided in another embodiment of this application.

[0121] Reference numerals: 11: First layer; 110: Third sub-layer; 111: First sub-layer; 112: First detachable part; 113: First detachable area; 114: First non-detachable area; 115: First weak connection structure; 12: Second layer; 121: Second sub-layer; 122: Second detachable part; 123: Second detachable area; 124: Second non-detachable area; 125: Second weak connection structure; 13: Third layer; 14: First opening; 15: Porous layer; 16: Through. 100: First receiving space; 20: Functional membrane layer; 21: First sub-functional membrane layer; 22: Second sub-functional membrane layer; 200: Second receiving space; 30: Waterproof layer; 40: Water-swellable substance; 50: Grip portion; 100a: Oral product; 10a: Support layer; 101a: Channel; 20a: Oral membrane; 11a: First opening; 12a: Second opening; 13a: Through hole; 30a: Water-swellable layer; 40a: Waterproof layer; 102a: Receiving space; 50a: Porous layer. Detailed Implementation

[0122] Embodiments of the present invention are described in detail below, examples of which are illustrated in the accompanying drawings. The embodiments described below with reference to the accompanying drawings are exemplary and intended to explain the present invention, and should not be construed as limiting the present invention.

[0123] This disclosure is based on the inventor's following discoveries and understandings:

[0124] Film-based products only become effective after dissolving or disintegrating at the target location. In such cases, there's a technological bias that dictates the faster the film-based product dissolves, the better. The inventors of this disclosure have discovered that when users apply film-based products, they typically hold the product directly and place it onto or attach it to the target location (e.g., oral mucosa, teeth, gums, supra- or sublingual tongue, nasal mucosa, etc.). During this process, the film-based product may encounter liquids in the environment and prematurely dissolve, shrink, or deform. Users then have to replace the film-based product or move it while it's still sticking to their hand. In other words, for successful application, faster dissolution is not necessarily better. Furthermore, the inventors of this disclosure have also found that existing film-based products do not consider the need for mid-application withdrawal. Therefore, current film-based products cannot meet the usage needs of multiple scenarios and require further improvement.

[0125] After long-term research, the inventors of this disclosure proposed to improve the tensile strength of film products by adding layers through physical means, thereby enhancing the ability of film products to maintain their shape and improving the problems of film products shrinking, deforming, not being able to adhere to the target position, and not being able to be withdrawn midway during use.

[0126] In view of the above, the first aspect of this disclosure provides a film-forming product. According to embodiments of this disclosure, the film-forming product includes a functional film layer and a sheet layer. The functional film layer contains an active ingredient adapted to be released from the functional film layer and act on a target site. In some embodiments, the sheet layer includes a first sheet layer disposed on at least a portion of the surface of the functional film layer. In other embodiments, the first sheet layer is embedded within the functional film layer.

[0127] In this film product, the sheet layer provides support for the functional film layer, thereby improving the tensile strength of the film product and enhancing its ability to maintain its shape. This makes it less prone to problems such as deformation, shrinkage, breakage, and adhesion. It can be moved flexibly to adjust its position, thus allowing it to fit more accurately to the target location, and it is easy to remove during use.

[0128] In this article, tensile strength, also known as tensile strength or fracture strength, refers to the maximum stress a material can withstand without breaking when subjected to tensile force.

[0129] Furthermore, the sheets on the surface of the functional film layer can provide a certain degree of isolation, thereby improving the adhesion problem between multiple film products and reducing packaging costs. During use, users can hold the film product with the sheets on its surface, preventing the functional film layer from directly contacting the liquid on the user's hand and causing premature dissolution, deformation, shrinkage, breakage, or adhesion. This facilitates accurate placement or adhesion of the film product and improves its usability.

[0130] In addition, the first layer on the surface of the functional membrane can delay the time it takes for the liquid to reach the functional membrane after it comes into contact with saliva, body fluids, etc. This reduces the possibility of the functional membrane dissolving before reaching the target location, thus reducing the risk of loss of active ingredients. It also reduces the risk of causing excessive stimulation and discomfort to the user due to rapid disintegration and release of a large amount of active ingredients after reaching the target location.

[0131] As can be understood, a functional film layer refers to a film-like formulation made by processing an active ingredient (such as a drug substance) and a suitable film-forming material. During use, the active ingredient in the functional film layer can be released from the functional film layer and act on the target site to exert its effect. The film-forming products mentioned in this article refer to products containing a functional film layer and a sheet layer, and where the active ingredient in the functional film layer is suitable for release from the functional film layer and act on the target site.

[0132] Specifically, a portion of the surface of the functional membrane can be exposed (i.e., not covered by the sheets), allowing the active ingredients to be released and act on the target site. The sheets can also be water-permeable; specifically, the sheets themselves can be water-permeable, or the sheets may not be water-permeable but have water-permeable channels. Thus, bodily fluids, saliva, and other liquids can permeate the functional membrane through the sheets or water-permeable channels, allowing the active ingredients in the functional membrane to dissolve, be released, and act on the target site.

[0133] Specifically, in some embodiments, the first sheet may only cover a portion of the surface of the functional film layer. In this case, the first sheet may be located at the edge or the middle of the functional film layer. With this configuration, during use, the portion of the functional film layer covered by the first sheet can be used for gripping, and the first sheet can delay the liquid from reaching the functional film layer, thereby reducing the risk of wrinkles, deformation, and adhesion of the film product during application. Furthermore, the portion of the functional film layer not covered by the first sheet ensures rapid dissolution and release of the active ingredients.

[0134] In other embodiments, the first layer may also cover the entire surface of the functional film layer. In a specific example, referring to Figure 1, the lower figure is a cross-sectional view of section AA in the upper figure. It can be seen that the first layer 11 covers one side of the functional film layer 20. Therefore, the user can hold the side of the film product with the first layer 11, easily moving the film product and improving the problem of the film product being sticky to the hand. Meanwhile, the surface of the functional film layer 20 not covered by the first layer 11 still maintains good adhesion and can be more easily bonded to the target location.

[0135] According to the embodiments of this disclosure, referring to FIG2, the following figure is a cross-sectional view of section BB in the above figure. It is not difficult to see that the sheet may further include a second sheet 12. The first sheet 11 and the second sheet 12 are disposed on two opposite surfaces of the functional film layer 20. Thus, the first sheet 11 and the second sheet 12 work together to increase the tensile strength of the film product, which can better improve the problem of the film product being prone to wrinkling and deformation. Moreover, the first sheet 11 and the second sheet 12 are located on two opposite surfaces of the functional film layer 20, which can delay the time for liquid to reach the functional film layer and isolate the functional film layers 20 of adjacent film products. This can reduce the risk of adhesion of the functional film layers 20 during application, transportation and storage, making it more convenient for users to move the film product during use. It can also reduce the risk of the film product dissolving before reaching the target position and losing active ingredients, thereby improving the usability of the film product. Without the first layer 11 and the second layer 12, two adjacent functional film layers 20 need to be separated by packaging structures such as aluminum foil to prevent adhesion. Therefore, by setting the first layer 11 and the second layer 12, the packaging cost of the film product can also be reduced.

[0136] It is understandable that the relative size and specific arrangement of the first layer 11, the functional film layer 20 and the second layer 12 can be flexibly adjusted according to actual usage needs.

[0137] In some embodiments, at least two of the first layer 11, the functional film layer 20, and the second layer 12 are edge-aligned. Specifically, the edges of the first layer 11 and the functional film layer 20 may be aligned, or the edges of the second layer 12 and the functional film layer 20 may be aligned, with the first and second layers aligned. Alternatively, the edges of the first layer 11, the functional film layer 20, and the second layer 12 may be aligned (see Figure 2). Thus, the first layer 11 and the second layer 12 can effectively improve the performance of the film agent product, while also being cost-effective and easy to implement.

[0138] In some embodiments, the edges of the first layer 11 and the second layer 12 are partially connected to form a first bag-like structure with an opening on at least one side edge. The first bag-like structure has a first receiving space 100, and at least a portion of the functional film layer is disposed within the first receiving space 100. Specifically, referring to FIG3, a portion of the functional film layer 20 may be contained within the first receiving space 100, while another portion of the functional film layer 20 may be located outside the first receiving space 100. Alternatively, all of the functional film layer 20 may be contained within the first receiving space 100 (see FIG4).

[0139] With the structure provided in this embodiment, when the film product comes into contact with bodily fluids, saliva, or other liquids, the sheet can preferentially absorb and wet the liquid or isolate it, delaying the contact between the functional film layer 20 placed in the first receiving space 100 and the liquid. While delaying the rapid and large-scale release of active ingredients in the functional film layer 20, the film product can also be moved freely as needed to accurately move to the target position, so that the active ingredients contained in the functional film layer 20 can mainly act on the target position. Even if the functional film layer 20 in the first receiving space 100 wrinkles, deforms, breaks, or disintegrates due to contact with the liquid, the first bag-like structure can play a certain limiting role for this part of the functional film layer 20, making it less likely for the functional film layer 20 to come into contact with and adhere to non-target positions. This reduces the risk of physiological discomfort caused by the rapid dispersion of a large amount of dissolved or disintegrated functional film layer 20, and allows the film product to be removed from the target position at any time during use, improving the usability of the film product.

[0140] In some embodiments, the edges of the first sheet 11 and the second sheet 12 are connected to form a second bag-shaped structure without openings at the edges. The second bag-shaped structure has a second receiving space 200, in which the functional film layer 20 is received (see Figure 5).

[0141] With the structure provided in this embodiment, when the film product comes into contact with bodily fluids, saliva, or other liquids, the sheet can preferentially absorb and wet the liquid or isolate it, delaying the contact between the functional film layer 20 placed in the second containment space 200 and the liquid. While delaying the rapid and large-scale release of active ingredients in the functional film layer 20, the film product can also be moved freely as needed to accurately move to the target position, allowing the active ingredients contained in the functional film layer 20 to primarily act on the target position. Even if the functional film layer 20 in the second containment space 200 wrinkles, deforms, breaks, or disintegrates due to contact with the liquid, the second bag-like structure can provide a certain degree of restraint for the functional film layer 20, making it less likely for the functional film layer 20 to come into contact with and adhere to non-target positions. This reduces the risk of rapid dispersion of a large amount of dissolved or disintegrated functional film layer 20, which could cause physiological discomfort to the user. Furthermore, it allows the film product to be removed from the target position at any time during use, improving the usability of the film product.

[0142] According to embodiments of this disclosure, at least one of the first sheet 11 and the second sheet 12 has a first opening 14, which exposes a portion of the functional film layer 20, depending on the needs of different application locations. Thus, the portion of the functional film layer 20 at the location corresponding to the first opening 14 is not covered by the sheet, resulting in better adhesion to the target location. Simultaneously, the exposure of the functional film layer 20 at the location corresponding to the first opening 14 can appropriately increase the release rate of the active ingredients in the functional film layer 20, meeting different application requirements.

[0143] It is understood that the first opening 14 may be provided only on the first layer 11 (see Figure 6), only on the second layer 12, or both on the first layer 11 and the second layer 12.

[0144] In addition, there are no particular restrictions on the specific size, outline shape, and number of the first opening 14. For example, the outline shape can be a rectangle, square, circle, rhombus, triangle, polygon, or irregular shape, and the number can be 1, 2, 3, 4, 5, etc., which can be flexibly adjusted according to actual usage needs.

[0145] According to embodiments of this disclosure, depending on the required release rate of the active ingredient, the first layer 11 and the second layer 12 can each be a single-layer structure or a multi-layer structure. Specifically, both the first layer 11 and the second layer 12 can be single-layer structures (see Figure 5).

[0146] In some embodiments, at least one of the first layer 11 and the second layer 12 includes a multilayer structure. In some embodiments, the first layer 11 includes a plurality of stacked first sub-layers. In some embodiments, the second layer 12 includes a plurality of stacked second sub-layers.

[0147] Specifically, the first layer 11 can be a single-layer structure, and the second layer 12 can be a multi-layer structure (see Figure 7). Alternatively, the first layer 11 can be a multi-layer structure, and the second layer 12 can be a single-layer structure (see Figure 8). Furthermore, both the first layer 11 and the second layer 12 can be multi-layer structures (see Figure 9).

[0148] Specifically, by setting the number of layers in the first layer 11 and the second layer 12, the release rate of the active ingredient can be adjusted. It can be understood that the more layers in the first layer 11 and / or the second layer 12, the greater the resistance encountered by the active ingredient when it is released from the functional membrane layer 20 to the outside, and the slower the release rate. Conversely, the fewer layers in the first layer 11 and / or the second layer 12, the less resistance encountered by the active ingredient when it is released from the functional membrane layer 20 to the outside, and the faster the release rate. For multi-layered first layers 11 and / or second layers 12, the sustained and controlled release of the active ingredient can be achieved by adjusting the specific number of layers when designing film-forming products.

[0149] According to embodiments of this disclosure, adjacent first sub-layers 111 are detachably connected; and / or adjacent second sub-layers 121 are detachably connected. Specifically, through detachable connections, users can adjust the number of layers of the first sub-layers 111 and / or the second sub-layers 121 according to their own experience during actual use, thereby better meeting the usage needs of different users.

[0150] It's understandable that there are no particular restrictions on the specific method of detachable connection, as long as the detachable function can be achieved.

[0151] In some embodiments, referring to FIG10, the first sub-layer 111 is provided with a first removal portion 112. Thus, the user can easily remove the first sub-layer 111 by holding the first removal portion 112.

[0152] In the text, "first disassembly part" refers to a structure suitable for a user to hold and clamp, and for which the first sub-layer 111 connected to the first disassembly part 112 can be torn off by applying external force to the first disassembly part 112. Similarly, the second disassembly part, third disassembly part, fourth disassembly part, fifth disassembly part, and sixth disassembly part mentioned later are the same as the first disassembly part, and will not be described in detail later.

[0153] In some implementations, the edges of two adjacent first sub-layers 111 are partially unsealed, meaning some edges are exposed. Therefore, the user can clearly identify the number of layers in the first sub-layers 111 by observing the unsealed edges, and can use these unsealed edges to remove the first sub-layers 111.

[0154] In some embodiments, referring to FIG10, the second sub-layer 121 is provided with a second removal portion 122. Thus, the user can conveniently remove the second sub-layer 121 by holding the second removal portion 122.

[0155] In some embodiments, the edges of two adjacent second sub-layers 121 are partially unsealed, i.e., the edges are partially open. Therefore, the user can clearly identify the number of layers in the second sub-layers 121 by the unsealed edges and can grasp and tear off the second sub-layers 121 from the unsealed edges.

[0156] In some embodiments, referring to FIG11, the first layer 11 includes a first removable region 113 and a first non-removable region 114, which are connected by a first weak connection structure 115. Thus, the user can tear off the first removable region 113 along the first weak connection structure.

[0157] In this article, the first removable area 113 refers to the area on the first sheet 11 that is suitable for removal through certain operations, and the first non-removable area 114 refers to the area on the first sheet 11 that is fixedly connected to other parts of the film product and is not suitable for removal. The second removable area 123, the second non-removable area 124, the fifth removable area, the fifth non-removable area, the sixth removable area, and the sixth non-removable area mentioned below have the same meaning and will not be described in detail below.

[0158] In some embodiments, referring to FIG12, the second layer 121 includes a second removable region 123 and a second non-removable region 124, the second removable region 123 and the second non-removable region 124 being connected by a second weak connection structure 125. Thus, the user can tear off the second removable region 123 along the second weak connection structure.

[0159] In this text, the first and second weak connection structures refer to structures with weak connection strength or stability, which can be destroyed by simple tearing during use. As examples, the first and second weak connection structures can each be independently indentations, grooves, or multiple spaced holes distributed along a contour line.

[0160] According to embodiments of this disclosure, the film product further includes a waterproof layer 30. The waterproof layer can reduce the possibility of active ingredients released from the functional film layer 20 entering non-target locations and causing discomfort, allowing the active ingredients to be absorbed more by the target locations.

[0161] According to the embodiments of this disclosure, the specific location of the waterproof layer can be selected according to actual needs. Specifically, in actual use, the user can choose to place the waterproof layer at a corresponding non-target location so that the waterproof layer is isolated between the non-target location and the functional membrane layer.

[0162] In this article, the target location refers to the location where the active ingredient is desired to act; the non-target location refers to a location other than the target location, i.e., a location where the active ingredient is not desired to act. For example, taking a film-based product for treating oral ulcers as an example, the location where the oral ulcer occurs is the target location, and the location other than the oral ulcer is the non-target location.

[0163] In some embodiments, the film-forming product includes a functional film layer 20 and a first sheet layer 11, with a waterproof layer 30 disposed on the surface of the first sheet layer 11 away from the functional film layer 20 or on the surface of the functional film layer 20 not covered by the first sheet layer 11. Specifically, the waterproof layer 30 is disposed on the surface of the functional layer 20 away from the first sheet layer 11 (see Figure 13) or on the surface of the functional film layer 20 not covered by the first sheet layer 11.

[0164] In some embodiments, the film product includes a functional film layer 20, a first sheet 11, and a second sheet 12, with the functional film layer 20 sandwiched between the first sheet 11 and the second sheet 12. The waterproof layer 30 is disposed on the surface of the first sheet 11 away from the functional film layer 20 (see Figure 14), the surface of the second sheet 12 away from the functional film layer 20 (see Figure 15), or the surface of the functional film layer 20 not covered by the first sheet 11 and the second sheet 12.

[0165] The waterproof layer 30 reduces the delivery of active ingredients released from the functional membrane layer 20 to non-target locations. For example, it reduces the amount of active ingredients from the functional membrane layer 20 that need to be absorbed through the oral mucosa from entering the digestive tract with saliva. This ensures that the active ingredients released from the functional membrane layer 20 primarily act on the target location.

[0166] According to embodiments of this disclosure, the membrane product further includes a water-swellable substance 40, which is disposed at at least one of the following locations: the surface of the first layer 11, the surface of the second layer 12, in the pores of the first layer 11, and in the pores of the second layer 12. Specifically, the water-swellable substance 40 may be disposed on the surface of the first layer 11 near the functional membrane layer 20 and / or on the surface of the second layer 12 near the functional membrane layer 20 (see Figure 16). After absorbing water and swelling, the water-swellable substance 40 can improve the overall tensile strength of the membrane product, making it easier for users to move the membrane product and improving its usability.

[0167] According to embodiments of this disclosure, the first layer 11 and the second layer 12 are identical. Therefore, the release rate of the surfactant components on both sides of the film-forming product is consistent, providing a smooth user experience.

[0168] According to embodiments of this disclosure, in order to meet the needs of different usage scenarios and enrich the user experience, the first layer 11 and the second layer 12 can have different properties, thereby achieving different user experiences and effects. According to embodiments of this disclosure, at least one of the following properties of the first layer 11 and the second layer 12 is different: water permeability, porosity, thickness, material, tensile strength, and number of layers. Therefore, the two sides of the membrane product can provide different release rates of active ingredients, enriching the user experience and meeting the personalized usage needs of more usage scenarios and more users.

[0169] According to the embodiments of this disclosure, the materials of the first layer 11 and the second layer 12 are not particularly limited, as long as they meet the usage requirements of the target location. For example, for film products used in the oral cavity, the first layer 11 and the second layer 12 can be made of flexible materials so that the film product can conform to the shape of the oral cavity as much as possible and avoid causing discomfort to the user.

[0170] Specifically, the choice of material varies depending on the arrangement of the first layer 11 and the second layer 12. If at least part of the functional membrane layer 20 is not covered by the first layer 11 and the second layer 12, there is no restriction on the water permeability of the first layer 11 and the second layer 12. The first layer 11 and the second layer 12 may or may not be water permeable. However, if the first layer 11 and the second layer 12 completely cover the functional membrane layer 20, then at least one of the first layer 11 and the second layer 12 must be water permeable, or the first layer 11 and the second layer 12 may not be water permeable but may have water-permeable channels. These water-permeable channels can be used to allow saliva to pass through the layers, for example, through-holes can be provided on a non-water-permeable plastic layer. This ensures that the active ingredients in the functional membrane layer 20 can be effectively released and act on the target location.

[0171] According to embodiments of this disclosure, the water-permeable channel includes a through-hole 16, or includes a through-hole 16 and a porous layer 15 removably covering the through-hole 16. Figure 17 shows the case where the porous layer 15 completely covers the through-hole 16. In use, the user can choose whether to open the porous layer 15. When the porous layer 15 is open, the active ingredients released by the functional membrane layer 20 can be absorbed more by the target location through the through-hole 16, resulting in stronger stimulation. When the porous layer 15 is not open, the active ingredients released by the functional membrane layer 20 need to pass through the porous layer 15 to be released and act on the target location, and the release rate of the active ingredients is relatively slow.

[0172] According to embodiments of this disclosure, the first layer 11 and the second layer 12 each independently include at least one of the following: nonwoven fabric, specialty paper, wood pulp paper, polylactic acid paper, fiber cloth, mesh fabric, woven fabric, foamed resin film, mesh resin film, porous resin film, swellable sheet, swellable mesh, plastic sheet with the water-permeable channels, and rubber sheet with the water-permeable channels. Therefore, the layers have good liquid permeability, which facilitates the release of active ingredients from the functional membrane layer 20 upon contact with the liquid, allowing them to act on the target location.

[0173] In this article, "swellable sheet" refers to a sheet with swelling properties, and "swellable mesh" refers to a mesh with swelling properties. Both can absorb and retain liquid, that is, they can absorb liquid and lock it within the sheet or mesh. Examples include edible films and edible meshes, such as carrageenan sheets and carrageenan meshes.

[0174] According to embodiments of this disclosure, to better meet usage needs, the functional membrane layer 20 may include multiple sub-functional membrane layers. These multiple sub-functional membrane layers may be identical, or at least differ in the type and concentration of the active ingredient contained within them. Thus, given the limited thickness of a single functional membrane layer, a greater thickness and a larger dose of active ingredient can be achieved by setting multiple sub-functional membrane layers. Furthermore, when the multiple sub-functional membrane layers are different, the membrane product can have multiple effects or offer different user experiences. Specifically, if the active ingredients in the multiple sub-functional membrane layers are different, different efficacy can be achieved. If the concentrations of the active ingredients in the multiple sub-functional membrane layers are different, different release rates of the active ingredient can be achieved at different stages of use, enriching the user experience and the overall effect.

[0175] According to embodiments of this disclosure, the specific arrangement of the multiple sub-functional membrane layers is not particularly limited; they can be stacked or arranged flat on one surface. In some embodiments, the sub-functional membrane layer includes at least one of a first sub-functional membrane layer 21 and a second sub-functional membrane layer 22, wherein multiple first sub-functional membrane layers 21 are stacked sequentially, and multiple second sub-functional membrane layers 22 are arranged flat on the first surface. Specifically, the functional membrane layer 20 may include only multiple first sub-functional membrane layers 21 (see Figure 18); the functional membrane layer may include only multiple second sub-functional membrane layers 22 (see Figure 19); or the functional membrane layer may simultaneously include multiple first sub-functional membrane layers 21 and at least one second sub-functional membrane layer 22 (see Figure 20).

[0176] It is understandable that in actual use, the release of active ingredients in membrane products proceeds from the outside to the inside and from the periphery to the center. Based on this, a richer user experience and better performance can be achieved by setting different components, concentrations, and settings for sub-functional membrane layers.

[0177] It should be noted that the description "tiled in a plane" used in this article can mean tiled in a plane or tiled in a curved surface.

[0178] According to embodiments of this disclosure, adjacent first sub-functional membrane layers 21 are detachably connected; and / or the second sub-functional membrane layer 22 is detachably connected to the sheet. Therefore, users can flexibly adjust the type and number of sub-functional membrane layers according to their actual needs, better meeting their personalized requirements.

[0179] According to an embodiment of this disclosure, the first sub-functional membrane layer 21 is provided with a third removal part. Therefore, the user can easily remove the first sub-functional membrane layer 21 through the third removal part, better meeting the user's personalized needs.

[0180] According to an embodiment of this disclosure, the edges of two adjacent first sub-functional membrane layers 21 are not sealed. Therefore, the user can clearly identify the number of layers of the first sub-functional membrane layer 21 through the unsealed area, and can grasp the unsealed area to tear off the first sub-functional membrane layer 21.

[0181] According to an embodiment of this disclosure, the second sub-functional membrane layer 22 is provided with a fourth removal part. Therefore, the user can easily remove the second sub-functional membrane layer 22 via the fourth removal part, better meeting the user's personalized needs.

[0182] According to an embodiment of this disclosure, the edges of the second sub-functional film layer 22 and the sheet portion are not sealed. Therefore, the user can clearly identify the number of layers in the second sub-functional film layer 22 through the unsealed edge and can tear off the second sub-functional film layer 22 by holding the unsealed edge.

[0183] According to embodiments of this disclosure, referring to FIG21, the first sheet 11 includes a plurality of third sub-sheets 110, which are substantially parallel to the first surface. The orthographic projection of each third sub-sheet 110 on the first surface overlaps with the orthographic projection of at least one second sub-functional membrane layer 22 on the first surface. At least one of the following characteristics of the plurality of third sub-sheets 110 is different: water permeability, material, porosity, tensile strength, thickness, and number of layers. Therefore, different second sub-functional membrane layers 22 can have different release rates of active ingredients, better meeting user needs and enriching the user experience.

[0184] In the text, "the third sub-layer 110 is basically parallel to the first surface" means that the third sub-layer 110 is parallel to the first surface, or that the distance between any position on the third sub-layer 110 and the first surface fluctuates within a small, reasonable range, such as reasonable measurement errors. Specifically, for example, the percentage difference between the distances between any two points on the third sub-layer 110 and the first surface (the absolute value of the difference between the two values ​​ / the average value of the two values ​​× 100%) is no greater than 5%.

[0185] According to an embodiment of this disclosure, referring to FIG22, the sheet further includes at least one third sheet 13, which is sandwiched between two adjacent first sub-functional membrane layers 21. Thus, the third sheet 13 can act as an isolation layer between adjacent first sub-functional membrane layers 21, and the presence of the third sheet also increases resistance to the release of the active ingredient, thereby controlling the different release rates of the active ingredient in different first sub-functional membrane layers.

[0186] According to embodiments of this disclosure, at least one of the following characteristics of the plurality of third layers 13 is different: water permeability, material, porosity, thickness, tensile strength, and number of layers. Therefore, the different parameters of the third layers result in different resistances to the permeation of active ingredients, thereby enabling different release rates of active ingredients and enriching the user experience.

[0187] According to embodiments of this disclosure, referring to FIG23, the film-forming product may further include a grip portion 50. Thus, the user can move the film-forming product by holding the grip portion, enabling accurate placement of it at the target location during use, and allowing the user to remove the film-forming product in advance during use. This allows the film-forming product to adapt to diverse usage needs, greatly improving its usability.

[0188] According to embodiments of this disclosure, the specific form of the grip portion is not particularly limited, as long as it facilitates gripping during the application of the film-forming product. In some embodiments, the grip portion includes at least one of a traction thread and a handle. Specifically, the traction thread can be sewn or glued onto the sheet to form a tea bag-like structure; alternatively, the handle can be formed by the sheet or a sheet and a functional film layer together. Thus, the structure is simple and easy to use.

[0189] According to an embodiment of this disclosure, referring to FIG23, the gripping portion 50 is located at the edge of the film product. Specifically, the gripping portion may be located at one end of the film product, at both opposite ends, or multiple spaced gripping portions may be provided on one side edge of the film product. Therefore, the film product can be moved more flexibly via the gripping portion, thereby improving the mobility of the film product.

[0190] According to embodiments of this disclosure, the gripping portion includes a portion composed of sheets, or the gripping portion includes a portion of sheets and a portion of functional film layers. Specifically, by providing sheets, the tensile strength of the film product is enhanced, and its mechanical strength is higher, allowing direct gripping of a portion of the film product; that is, the sheets and functional film layers together constitute the gripping portion. In other embodiments, the gripping portion can be formed by extending the sheets beyond the functional film layer by a portion.

[0191] According to embodiments of this disclosure, the film-forming product is printed with graphic and textual information. This facilitates use. Specifically, the graphic and textual information may include any images, textures, and text. As an example, the graphic and textual information may include the types of active ingredients in the functional film layer, the concentration of active ingredients, flavor, expiration date, instructions for use, brand logo, decorative patterns, etc. Users can identify the purpose and dosage of the film-forming product based on the graphic and textual information such as the types of active ingredients, the concentration of active ingredients, and the flavor; the brand logo can help businesses establish brand awareness; and the decorative patterns can enhance the aesthetic appeal of the film-forming product.

[0192] Specifically, graphic information can be formed on the sheet, or simultaneously on the sheet and the functional film layer. In some embodiments, the graphic information can be printed on or formed by ultrasonic embossing. The marks can include at least one of indentation, embossing, or perforation, and can be used to represent graphic information.

[0193] According to embodiments of this disclosure, the film products include at least one of buccal film products, sublingual film products, supralingual film products, oral cavity lining film products, gingival film products, dental veneer products, and nasal film products.

[0194] In this article, buccal membrane products refer to film-based products that are adhered to the oral mucosa behind the corners of the mouth and exert local or systemic effects after absorption through the mucosa. Sublingual membrane products refer to film-based products designed for rapid absorption through the sublingual mucosa. Supralingual membrane products refer to film-based products designed for rapid absorption through the supralingual mucosa. Intraoral lining membrane products refer to film-based products that can be placed on the intraoral mucosa of the mouth, allowing the active ingredients to be absorbed through the intraoral mucosa, thereby exerting local or systemic therapeutic effects. Gingival membrane products refer to film-based products that can be applied to the gums. Dental veneers refer to film-based products that can be applied to the teeth. Nasal membranes refer to film-based products that can be placed inside the nasal cavity, allowing the active ingredients to be absorbed through the nasal mucosa, thereby exerting local or systemic therapeutic effects.

[0195] According to embodiments of this disclosure, the outer contour shape of the film product includes at least one of a square, rectangle, circle, triangle, polygon, and irregular shape. It is understood that the shape of the film product can be designed for different application sites based on ergonomics and convenience. For example, buccal films and sublingual films, which have wider mucosal areas, can use round or square film products; elongated film products are used for the gums; and wider film products are used for the alveolar ridge, etc.

[0196] According to the embodiments of this disclosure, the maximum dimension of the outer contour of the film-forming product is 0.1–8 cm, specifically 0.8 cm–3 cm, and more specifically 0.1 cm, 0.5 cm, 1 cm, 1.5 cm, 2 cm, 2.5 cm, 3 cm, 3.5 cm, 4 cm, 4.5 cm, 5 cm, 5.5 cm, 6 cm, 6.5 cm, 7 cm, 7.5 cm, 8 cm, etc.; the minimum dimension is 0.1–1.5 cm, specifically 0.6 cm–1.2 cm, and more specifically 0.1 cm, 0.2 cm, 0.3 cm, 0.4 cm, 0.5 cm, 0.6 cm, 0.7 cm, 0.8 cm, 0.9 cm, 1 cm, 1.1 cm, 1.2 cm, 1.3 cm, 1.4 cm, 1.5 cm, etc. It should be noted that the maximum dimension refers to the maximum distance between any two points on the outer contour line of the film-forming product, and the minimum dimension refers to the minimum distance between any two points on the outer contour line of the film-forming product. Within the above size range, it can meet the usage needs of multiple parts such as the oral cavity and nasal cavity.

[0197] According to embodiments of this disclosure, the functional film layer includes at least one of a fully dissolved film layer, a partially dissolved film layer, or a swollen film layer. Specifically, the film agent product provided by this disclosure can employ the above-mentioned different types of functional film layers, thus having a wider range of applications and meeting the needs of different usage scenarios, while offering greater ease of use.

[0198] In this article, "completely dissolved film layer" refers to a functional film layer that is completely dissolved in the application environment of the film-forming product, no longer existing in its original functional film layer form, but instead becoming a molecular or ionic state uniformly dispersed in the solvent. "Partially dissolved film layer" means that only a portion of the functional film layer dissolves, while another portion retains a relatively intact structure; this may be due to different chemical properties in different regions of the functional film layer or varying degrees of interaction with the solvent. "Swelling film layer" refers to a functional film layer that, upon contact with the liquid in the application environment of the film-forming product, absorbs the liquid and expands in volume, but does not truly dissolve. The functional film layer still retains a certain degree of integrity; only its size increases, and its basic structure and properties may be altered.

[0199] According to embodiments of this disclosure, the functional membrane layer contains active ingredients, including at least one of pharmaceutical ingredients, nutritional and health care ingredients, food ingredients, daily chemical ingredients, and alkaloids. The structure provided by this embodiment can effectively exert therapeutic, nutritional and health care, edible, cosmetic and skincare, and fatigue-relieving effects, among others.

[0200] In this document, "drug ingredient" refers to a drug with a certain therapeutic effect. According to embodiments of this disclosure, the drug ingredient includes at least one of the following: oral ulcer medication, psychotropic drug, analgesic, anti-inflammatory drug, cannabinoids and their derivatives, nasal medication, respiratory medication, and sildenafil.

[0201] In this document, nutritional and health-promoting ingredients refer to components that can supplement the human body with nutrients and help maintain health. According to embodiments of this disclosure, the nutritional and health-promoting ingredients include at least one of the following: American ginseng extract, Schisandra chinensis extract, Ganoderma lucidum extract, arginine, propolis, melatonin, glutathione, and taurine.

[0202] In this document, food ingredients refer to substances ingested orally that can sustain life and development, i.e., provide energy and form or replace tissues. According to embodiments of this disclosure, food ingredients include at least one of tea extract, coffee extract, and vitamins.

[0203] In this article, "daily chemical ingredients" refers to ingredients used in daily life such as beauty and skincare, and teeth whitening. According to embodiments of this disclosure, the daily chemical ingredients include at least one of papain, catalase, teeth whitening ingredients, oral repair ingredients, and anti-aging ingredients.

[0204] In this document, alkaloids are a class of nitrogen-containing organic compounds found in many plants, animals, and microorganisms in nature. They are generally alkaline and can react with acids to form salts. According to embodiments of this disclosure, alkaloids include at least one of nicotine and its derivatives, caffeine and its analogs, arecoline and its analogs, and hexamethylnicotine.

[0205] It is important to note that when multiple active ingredients are used simultaneously in a film-forming product, it is crucial that these ingredients do not have any mutually exclusive relationships. This means that the active ingredients do not have any side effects that could adversely affect the efficacy, do not have opposing effects, or their combined action will not cause any adverse effects on the human body. Specifically, when multiple active ingredients are used simultaneously in a film-forming product, they must comply with the therapeutic guidelines for these active ingredients, such as those stipulated in pharmacopoeias, to ensure that the product meets industry compliance or mandatory standards.

[0206] Therefore, film-forming products have a wide range of applications and can meet the needs of diverse usage scenarios.

[0207] It is understood that film-forming products are independent entities, and multiple film-forming products can be packaged into one box. In some embodiments, multiple independent film-forming products can be directly packaged into one box. In other embodiments, multiple film-forming products can be linked together to form a film-forming product group, and then one or more film-forming product groups can be packaged into one box.

[0208] In some embodiments, multiple film-forming products can be connected by weakly connected structures to form a film-forming product group. In other embodiments, multiple film-forming products can be connected to a support via weakly connected structures to form a film-forming product group. In still other embodiments, multiple film-forming products are connected to each other, as well as to the support via weakly connected structures, to form a film-forming product group. This facilitates the packaging, storage, and counting of the film-forming products. As an example, Figure 45 shows a case where multiple film-forming products are connected to a film-forming product group via weakly connected structures in one embodiment.

[0209] Specifically, the film-forming product group can be a series of film-forming products linked together, multiple film-forming products arranged in a matrix, or multiple film-forming products forming other irregular shapes, such as a tree-like shape (with branches as the support and leaves as film-forming products), etc. In addition, the film-forming product group can be laid flat in the packaging box, folded and placed in the packaging box, or rolled up and placed in the packaging box.

[0210] In this article, the support refers to a structure that connects multiple membrane products together, linking them to form a membrane product group. As an example, membrane products can be formed by cutting and encapsulating large sheets of sheet-like preforms and functional membrane layer preforms. This cutting process creates both the shape of the membrane product and the support, with the membrane products and support connected by a weak connection structure. A weak connection structure refers to a structure with relatively weak strength or stability, which can be easily destroyed by simple tearing during use. Examples of weak connection structures include indentations, grooves, and multiple spaced holes distributed along a contour line. Weak connection structures can be formed through methods such as ultrasonic embossing.

[0211] A second aspect of this disclosure provides an oral film product. According to embodiments of this disclosure, the oral film product includes an oral film and a sheet. The oral film contains an active ingredient adapted to be released from the oral film and act on a target location. In some embodiments, the sheet includes a first sheet that may be disposed on at least a portion of the surface of the oral film. In other embodiments, the first sheet may also be embedded within the oral film.

[0212] Specifically, by using sheet materials, the tensile strength of oral diaper products can be improved. The sheet material, which can maintain its shape for a longer period, mitigates the problems of wrinkling and deformation, reducing the degree of deformation before reaching the target position. Simultaneously, the oral diaper product will not quickly disintegrate after being placed in the target position, allowing for easy removal during use. It also effectively prevents the oral diaper product from deforming, sticking, breaking, or disintegrating rapidly upon contact with liquids, thus avoiding difficulties in adhering to the target position. The oral diaper product can be moved multiple times, making it easier to adhere to the target position. Essentially, one sheet of oral diaper product is sufficient to adhere to the target position, significantly reducing usage costs.

[0213] Furthermore, the sheet material on the surface of the oral film can provide a certain degree of isolation, thereby improving the adhesion problem between multiple oral film products and reducing packaging costs. During use, users can hold the oral film product with the sheet material on its surface, preventing the oral film from directly contacting the liquid on the user's hand and causing premature dissolution, deformation, shrinkage, breakage, or adhesion. This facilitates accurate placement or attachment of the oral film product and improves its usability.

[0214] In addition, the first layer on the surface of the oral membrane, after contacting liquids such as saliva and bodily fluids, can delay the time it takes for the liquid to reach the oral membrane. This reduces the possibility of the oral membrane dissolving before reaching the target location, thus reducing the risk of loss of active ingredients. It also reduces the risk of causing excessive stimulation and discomfort to the user due to rapid disintegration and release of a large amount of active ingredients after reaching the target location.

[0215] Oral films are understood to be film-forming agents that act on the oral cavity. They include "orally dissolving films, buccal films, sublingual films, supralingual films, oral lining films, gingival films, and dental veneers," etc. Specifically, oral films are film-like preparations made from active ingredients (such as raw pharmaceutical materials) and suitable film-forming materials, and can be used in the oral cavity. During use, the active ingredients in the oral film are released and act on the target site to exert their effect. Orally dissolving films, in particular, are dosage forms in which the active ingredients are absorbed in the oral cavity (buccal or sublingual) through a dissolving membrane.

[0216] The oral membrane products discussed in this article refer to products containing both an oral membrane and a sheet, wherein the active ingredients in the oral membrane are suitable for release from the membrane and action on the target site. Specifically, a portion of the oral membrane surface may be exposed (i.e., not covered by the sheet) to allow the active ingredients to be released and act on the target site; alternatively, the sheet may be water-permeable, either water-permeable or non-water-permeable but with water-permeable channels. Thus, saliva can wet the oral membrane through the sheet, causing the membrane to dissolve and release the active ingredients, which then act on the target site.

[0217] Specifically, in some embodiments, the first sheet may only cover a portion of the oral membrane's surface. In this case, the first sheet can be located at either the edge or the center of the oral membrane. With this configuration, during use, the portion of the oral membrane with the first sheet can be used for gripping, and the first sheet can delay liquid from reaching the oral membrane, thereby reducing the risk of wrinkles, deformation, and adhesion during application. Furthermore, the portion of the oral membrane not covered by the first sheet ensures rapid dissolution and release of the active ingredients.

[0218] In other embodiments, the first sheet may also cover the entire surface of the oral film. In one specific example, the first sheet covers one side of the oral film. This allows the user to hold the oral film product with the side containing the first sheet, making it easy to move the product and mitigating the problem of the product being sticky to the hand. Meanwhile, the surface of the oral film not covered by the first sheet still maintains good adhesion and can be more easily adhered to the target location.

[0219] According to embodiments of this disclosure, the sheet further includes a second sheet, with the first and second sheets placed on opposite surfaces of the oral film. Thus, the first and second sheets work together to increase the tensile strength of the oral film, effectively mitigating the problems of wrinkling and deformation. Furthermore, the first and second sheets, located on opposite surfaces, delay the arrival time of liquids on the oral film and isolate it from adjacent oral film products, reducing the risk of adhesion during application, transportation, and storage, and making it easier for users to move the oral film during use. It also reduces the risk of dissolution and loss of active ingredients before reaching the target location, thereby improving the usability of the oral film. Without the first and second sheets, adjacent oral films would require separation using packaging structures such as aluminum foil to prevent adhesion; therefore, the inclusion of the first and second sheets also reduces packaging costs for the oral film.

[0220] It is understandable that the relative size and specific arrangement of the first sheet, oral membrane, and second sheet can be flexibly adjusted according to actual usage needs.

[0221] In some embodiments, at least two of the first sheet, the oral diaphragm, and the second sheet are aligned at their edges. Specifically, the edges of the first sheet and the oral diaphragm may be aligned; the edges of the second sheet and the oral diaphragm may be aligned; or the edges of the first sheet, the oral diaphragm, and the second sheet may be aligned. Thus, the first sheet and the second sheet can effectively improve problems such as wrinkles, deformation, adhesion, and rapid dissolution of the oral diaphragm, while also being low-cost and easy to implement.

[0222] In some embodiments, the edges of the first sheet and the second sheet are connected to form a third bag-like structure with an opening on at least one side edge. The third bag-like structure has a third receiving space, and at least a portion of the oral film is disposed within this third receiving space. Specifically, a portion of the oral film may be contained within the third receiving space, while another portion may be located outside the third receiving space. Alternatively, the entire oral film may be contained within the third receiving space.

[0223] With the structure provided in this embodiment, when the oral film product comes into contact with bodily fluids, saliva, or other liquids, the sheet can preferentially absorb and wet the liquid or isolate it, delaying the dissolution of the oral film placed in the third containment space upon contact with saliva. While delaying the rapid and large-scale release of active ingredients in the oral film, the oral film product can also be moved freely as needed to accurately move to the target location, allowing the active ingredients contained in the oral film to primarily act on the target location. Even if the oral film in the third containment space wrinkles, deforms, breaks, or disintegrates due to contact with liquid, the third bag-like structure can provide a certain degree of restraint, preventing the oral film from easily contacting and adhering to non-target locations. This reduces the risk of physiological discomfort caused by the rapid dispersion of a large amount of dissolved or disintegrated oral film, and allows the oral film product to be removed from the target location at any time during use, improving the usability of the oral film product.

[0224] In some embodiments, the edges of the first sheet and the second sheet are connected to form a fourth bag-like structure with no openings at the edges. The fourth bag-like structure has a fourth receiving space, in which the oral membrane is received.

[0225] When oral membrane products come into contact with bodily fluids, saliva, or other liquids, the sheet material can preferentially absorb and wet the liquid or isolate it, delaying the dissolution of the oral membrane placed in the third containment space upon contact with saliva. While delaying the rapid and large-scale release of active ingredients in the oral membrane, the product can also be moved freely as needed to accurately move to the target location, ensuring that the active ingredients primarily act on that target area. Even if the oral membrane in the third containment space wrinkles, deforms, breaks, or disintegrates due to contact with liquid, the third pouch structure can provide some restraint, preventing the membrane from contacting and adhering to non-target areas. This reduces the risk of physiological discomfort caused by the rapid dispersion of large amounts of dissolved or disintegrated oral membrane, and allows the product to be removed from the target location at any time during use, improving its usability.

[0226] According to embodiments of this disclosure, at least one of the first sheet and the second sheet has a second opening, which exposes a portion of the oral film, depending on the needs of different usage locations. Thus, the oral film at the location corresponding to the second opening is not covered by the sheet, resulting in better adhesion to the target location. Simultaneously, the exposure of the oral film at the second opening location can appropriately increase the release rate of the active ingredients in the oral film, meeting different usage requirements.

[0227] It is understandable that the second opening can be set only on the first sheet, only on the second sheet, or on both the first and second sheets.

[0228] In addition, there are no particular restrictions on the specific size, outline shape, and number of the second opening. For example, the outline shape can be a rectangle, square, circle, rhombus, triangle, polygon, or irregular shape, and the number can be 1, 2, 3, 4, 5, etc., which can be flexibly adjusted according to actual usage needs.

[0229] According to embodiments of this disclosure, depending on the required release rate of the active ingredient, the first sheet and the second sheet can each independently have a single-layer structure or a multi-layer structure. Specifically, both the first sheet and the second sheet can be single-layer structures.

[0230] In some embodiments, at least one of the first sheet and the second sheet includes a multilayer structure. In some embodiments, the first sheet includes a plurality of stacked first sub-sheets. In some embodiments, the second sheet includes a plurality of stacked second sub-sheets.

[0231] Specifically, the first sheet can be a single-layer structure, and the second sheet can be a multi-layer structure. Alternatively, the first sheet can be a multi-layer structure, and the second sheet can be a single-layer structure. Or, both the first and second sheets can be multi-layer structures.

[0232] Specifically, by setting the number of layers in the first and second sheets, the release rate of the active ingredient can be adjusted. It can be understood that the more layers the first and / or second sheets have, the greater the resistance the active ingredient encounters when released from the oral film to the outside, resulting in a slower release rate. Conversely, the fewer layers the first and / or second sheets have, the less resistance the active ingredient encounters when released from the oral film to the outside, resulting in a faster release rate. For multi-layered first and / or second sheets, the sustained and controlled release of the active ingredient can be achieved by adjusting the specific number of layers when designing oral film products.

[0233] According to embodiments of this disclosure, adjacent first sub-sheets are detachably connected; and / or adjacent second sub-sheets are detachably connected. Specifically, through detachable connections, users can adjust the number of layers of the first and / or second sub-sheets according to their own experience during actual use, thereby better meeting the usage needs of different users.

[0234] It's understandable that there are no particular restrictions on the specific method of detachable connection, as long as the detachable function can be achieved.

[0235] In some embodiments, the first sub-sheet is provided with a fifth disassembly part. This allows the user to easily tear off the first sub-sheet by grasping the fifth disassembly part.

[0236] In some implementations, the edges of two adjacent first sub-sheets are not sealed, meaning that some edges are open. This allows the user to clearly identify the number of layers in the first sub-sheet by looking at the unsealed edges, and to grasp and tear off the first sub-sheet from the unsealed edges.

[0237] In some embodiments, the second sub-sheet is provided with a sixth disassembly part. This allows the user to easily tear off the second sub-sheet by grasping the sixth disassembly part.

[0238] In some implementations, the edges of two adjacent second sub-sheets are not sealed, meaning that some edges are open. This allows the user to clearly identify the number of layers in the second sub-sheet by looking at the unsealed areas, and to grasp and tear off the second sub-sheet from the unsealed areas.

[0239] In some embodiments, the first sheet includes a fifth removable region and a fifth non-removable region, which are connected by a fifth weak connection structure. Thus, the user can tear off the fifth removable region along the fifth weak connection structure.

[0240] In some embodiments, the second sheet includes a sixth removable region and a sixth non-removable region, which are connected by a sixth weak connection structure. Thus, the user can tear off the sixth removable region along the sixth weak connection structure.

[0241] In the text, the fifth and sixth weak connection structures refer to structures with weak connection strength or stability, which can be destroyed by simple tearing during use. As examples, the fifth and sixth weak connection structures can each be independently indentations, grooves, or multiple spaced holes distributed along a contour line.

[0242] According to embodiments of this disclosure, the oral film product further includes a waterproof layer. The waterproof layer reduces discomfort caused by the active ingredients released from the oral film entering non-target locations, allowing the active ingredients to be absorbed more effectively at the target locations.

[0243] According to embodiments of this disclosure, the specific location of the waterproof layer can be selected according to actual needs. Specifically, in actual use, the user can choose to place the waterproof layer at a corresponding non-target location, so that the waterproof layer isolates the non-target location from the oral membrane.

[0244] In some embodiments, the oral film product includes an oral film and a first sheet, with a waterproof layer disposed on the surface of the first sheet away from the oral film or on the surface of the oral film not covered by the first sheet.

[0245] In some embodiments, the oral film product includes an oral film, a first sheet and a second sheet, with the oral film sandwiched between the first sheet and the second sheet, and a waterproof layer disposed on the surface of the first sheet away from the oral film, the surface of the second sheet away from the oral film, or the surface of the oral film not covered by the first sheet and the second sheet.

[0246] The waterproof layer reduces the delivery of active ingredients released from the oral film to non-target sites, such as by reducing the amount of medication that needs to be absorbed through the oral mucosa and enters the digestive tract with saliva. The active ingredients released from the oral film primarily target the intended site, allowing for greater absorption at that location.

[0247] According to embodiments of this disclosure, the oral membrane product further includes a water-swellable substance disposed at at least one of the following locations: the surface of a first sheet, the surface of a second sheet, the pores of the first sheet, and the pores of the second sheet. Specifically, the water-swellable substance may be disposed on the surface of the first sheet near the oral membrane and / or the surface of the second sheet near the oral membrane. After absorbing water and swelling, the water-swellable substance can improve the overall tensile strength of the oral membrane product, making it easier for users to move the oral membrane product and improving its usability.

[0248] According to embodiments of this disclosure, the first sheet and the second sheet are identical. Therefore, the release rate of the surfactant on both sides of the oral film product is consistent.

[0249] According to embodiments of this disclosure, in order to meet the needs of different usage scenarios and enrich the user experience, the first sheet and the second sheet can have different properties, thereby achieving different user experiences and effects. According to embodiments of this disclosure, at least one of the water permeability, porosity, thickness, material, tensile strength, and number of layers of the first sheet and the second sheet is different. Therefore, the two sides of the oral membrane product can provide different release rates of active ingredients, enriching the user experience and meeting the personalized usage needs of more usage scenarios and more users.

[0250] According to embodiments of this disclosure, the materials of the first and second sheets are not particularly limited, as long as they meet the usage requirements of the target location. For example, the first and second sheets can be made of flexible materials so that the oral film product can conform as closely as possible to the shape of the oral cavity, avoiding user discomfort.

[0251] Specifically, the choice of materials varies depending on the arrangement of the first and second sheets. If at least part of the oral membrane is not covered by the first and second sheets, there are no restrictions on the water permeability of the first and second sheets. The first and second sheets may or may not be water permeable. However, if the first and second sheets completely cover the oral membrane, at least one of the first and second sheets must be water permeable, or the first and second sheets must not be water permeable but must have water-permeable channels, such as through holes or openings on a non-water permeable plastic sheet. This ensures that the active ingredients in the oral membrane can be effectively released and act on the target location.

[0252] According to embodiments of this disclosure, the permeable channel includes a through-hole, or includes a through-hole and a porous layer removably covering the through-hole. During use, the user can choose whether to open the porous layer. When the porous layer is open, the active ingredient released by the oral membrane can be absorbed more strongly by the target location through the through-hole, resulting in a more intense stimulation. When the porous layer is closed, the active ingredient released by the oral membrane needs to pass through the porous layer to be released and act on the target location, resulting in a relatively slower release rate.

[0253] According to embodiments of this disclosure, the first sheet and the second sheet each independently include at least one of the following: nonwoven fabric, specialty paper, wood pulp paper, polylactic acid paper, fiber cloth, mesh fabric, woven fabric, foamed resin film, mesh resin film, porous resin film, swellable sheet, swellable mesh, plastic sheet with water-permeable channels, and rubber sheet with water-permeable channels. This gives the sheet good liquid permeability, which is beneficial for the oral membrane to contact with liquid and release the active ingredient to act on the target location.

[0254] According to embodiments of this disclosure, to better meet usage needs, an oral membrane may include multiple sub-oral membranes. These sub-oral membranes may be identical, or they may contain at least one different type and concentration of active ingredient. Thus, given the limited thickness of a single oral membrane, using multiple sub-oral membranes allows for greater thickness and a larger dosage of active ingredient. Furthermore, when the multiple sub-oral membranes are different, the oral membrane product can have multiple effects or offer different user experiences. Specifically, different active ingredients in the multiple sub-oral membranes can result in different efficacy, and different concentrations of active ingredients in the multiple sub-oral membranes can achieve different release rates of active ingredients at different stages of use, enriching the user experience and effectiveness.

[0255] According to embodiments of this disclosure, the specific arrangement of the plurality of sub-mouth membranes is not particularly limited; they can be stacked or laid flat on one surface. In some embodiments, the sub-mouth membrane includes at least one of a first sub-mouth membrane and a second sub-mouth membrane, wherein the plurality of first sub-mouth membranes are stacked, and the plurality of second sub-mouth membranes are laid flat on a first surface. Specifically, the mouthpiece may include only a plurality of first sub-mouth membranes; the mouthpiece may include only a plurality of second sub-mouth membranes; or the mouthpiece may include both a plurality of first sub-mouth membranes and at least one second sub-mouth membrane.

[0256] It is understandable that in actual use, the release of active ingredients in oral films occurs from the outside to the inside and from the periphery to the center. Based on this, a richer user experience and better results can be achieved by setting different ingredients, concentrations, and settings for the oral films.

[0257] It should be noted that the description "tiled in a plane" used in this article can mean tiled in a plane or tiled in a curved surface.

[0258] According to embodiments of this disclosure, adjacent first sub-aperture membranes are detachably connected; and / or the second sub-aperture membrane is detachably connected to the sheet. Thus, users can flexibly adjust the type and quantity of sub-functional membranes according to their actual needs, better meeting their personalized requirements.

[0259] According to an embodiment of this disclosure, the first sub-aperture film is provided with a seventh removal part. Therefore, the user can easily remove the first sub-aperture film via the seventh removal part, better meeting the user's personalized needs.

[0260] According to an embodiment of this disclosure, the edges of the two adjacent first sub-aperture film portions are not sealed. Therefore, the user can clearly identify the number of layers of the first sub-aperture film through the unsealed edge and can tear off the first sub-aperture film by holding the unsealed edge.

[0261] According to an embodiment of this disclosure, the second sub-mouth membrane is provided with an eighth removal part. Therefore, the user can easily remove the second sub-mouth membrane via the eighth removal part, better meeting the user's personalized needs.

[0262] According to an embodiment of this disclosure, the edges of the second sub-sealing film and the sheet portion are not sealed. Therefore, the user can clearly identify the number of layers of the second sub-sealing film through the unsealed edge and can tear off the second sub-sealing film by holding the unsealed edge.

[0263] According to embodiments of this disclosure, the first sheet includes a plurality of third sub-sheets, which are parallel to the first surface. The orthographic projection of each third sub-sheet onto the first surface overlaps with the orthographic projection of at least one second sub-membrane onto the first surface. At least one of the water permeability, material, porosity, tensile strength, thickness, and number of layers of the plurality of third sub-sheets differs. Therefore, different second sub-membranes can have different active ingredient release rates, better meeting user needs and enriching the user experience.

[0264] According to embodiments of this disclosure, the sheet further includes at least one third sheet sandwiched between two adjacent first sub-terminal membranes. Thus, the third sheet can act as a separator between adjacent first sub-terminal membranes, and its presence also increases resistance to the release of the active ingredient, thereby regulating the release rate of the active ingredient.

[0265] According to embodiments of this disclosure, at least one of the following characteristics of the third sheets is different: water permeability, material, porosity, thickness, tensile strength, and number of layers. Therefore, the different parameters of the third sheets result in different resistance to the active ingredients passing through them, thereby enabling different release rates of the active ingredients and enriching the user experience.

[0266] According to embodiments of this disclosure, the oral film product may further include a gripping portion. This allows users to easily move the oral film product by holding it, enabling accurate placement at the target location during use and allowing for early removal of the oral film product during use. This adapts the oral film product to diverse usage needs and significantly improves its usability.

[0267] According to embodiments of this disclosure, the specific form of the grip portion is not particularly limited, as long as it facilitates gripping during the application of the oral film product. In some embodiments, the grip portion includes at least one of a traction thread and a handle. Specifically, the traction thread can be sewn or glued onto the sheet to form a tea bag-like structure; alternatively, the handle can be formed from the sheet or a sheet and the oral film together. Thus, the structure is simple and easy to use.

[0268] According to embodiments of this disclosure, the grip portion is located at the edge of the oral film product. Specifically, the grip portion may be located at one end of the oral film product, at both opposite ends, or multiple spaced grip portions may be provided on one side edge of the oral film product. Therefore, the oral film product can be moved more flexibly via the grip portion, thereby improving the mobility of the oral film product and making it easier to manufacture and use.

[0269] According to embodiments of this disclosure, the gripping portion is composed of a sheet, or a sheet and an oral film together. Specifically, by providing a sheet, the tensile strength of the oral film product is enhanced, and its mechanical strength is higher, allowing direct gripping of a portion of the oral film product, i.e., the sheet and the oral film together constitute the gripping portion; in other embodiments, the sheet can extend beyond the oral film by a portion, with the extended portion constituting the gripping portion.

[0270] According to embodiments of this disclosure, the oral mask product is printed with graphic and textual information. This facilitates use. Specifically, the graphic and textual information may include any images, textures, and text. As an example, the graphic and textual information may include the types of active ingredients, concentrations of active ingredients, flavor, expiration date, instructions for use, brand logo, etc. Users can identify the purpose and dosage of the oral mask product based on the graphic and textual information such as the types of active ingredients, concentrations of active ingredients, and flavor; the brand logo can help businesses establish brand awareness; and decorative patterns can enhance the aesthetic appeal of the oral mask product.

[0271] Specifically, the graphic information can be formed on the sheet material, or simultaneously on the sheet material and the oral film. In some embodiments, the graphic information can be printed on or formed by ultrasonic embossing. The imprint (text, pattern) can include at least one of indentation, embossing, or perforation, and can be used to represent the graphic information.

[0272] According to embodiments of this disclosure, the outer contour shape of the oral membrane includes at least one of a square, rectangle, circle, triangle, and polygon. It is understood that the shape of the oral membrane can be designed for different application sites based on ergonomics and convenience. For example, for mucosal areas such as the buccal membrane and sublingual membrane, which are wider, round or square oral membrane products can be used; for the gums, narrow and elongated oral membrane products are used; and for the alveolar ridge, wider oral membrane products are used, and so on.

[0273] According to the embodiments of this disclosure, the maximum dimension of the outer contour of the oral film product is 0.1–8 cm (specifically, 0.1 cm, 0.5 cm, 1 cm, 1.5 cm, 2 cm, 2.5 cm, 3 cm, 3.5 cm, 4 cm, 4.5 cm, 5 cm, 5.5 cm, 6 cm, 6.5 cm, 7 cm, 7.5 cm, 8 cm, etc.), and the minimum dimension is 0.1–1.5 cm (specifically, 0.1 cm, 0.2 cm, 0.3 cm, 0.4 cm, 0.5 cm, 0.6 cm, 0.7 cm, 0.8 cm, 0.9 cm, 1 cm, 1.1 cm, 1.2 cm, 1.3 cm, 1.4 cm, 1.5 cm, etc.). It should be noted that the maximum dimension refers to the maximum distance between any two points on the outer contour line of the oral film product, and the minimum dimension refers to the minimum distance between any two points on the outer contour line of the oral film product. Within the above dimension range, it can meet the usage needs of different parts of the oral cavity.

[0274] According to embodiments of this disclosure, the oral membrane includes at least one of a completely dissolved membrane layer, a partially dissolved membrane layer, or a swollen membrane layer. Specifically, the oral membrane product provided by this disclosure can employ the above-mentioned different types of membrane layers, thus having a wider range of functions and meeting the usage needs of different application scenarios, resulting in greater ease of use.

[0275] It should be noted that the main difference between fully dissolved film layers, partially dissolved film layers, and swollen film layers is the swelling ratio. Fully dissolved film layers have the lowest swelling ratio, while partially dissolved film layers have a swelling ratio between that of fully dissolved film layers and swollen film layers. Swollen film layers can be hydrogels.

[0276] Therefore, oral films have a wide range of uses and can meet the needs of diverse usage scenarios.

[0277] In some embodiments, the oral film product described above can specifically be an orally dissolving film, and the sheet can specifically be a support layer. Therefore, this application also provides an oral product including a support layer and an orally dissolving film. The support layer is disposed on at least one surface of the orally dissolving film or embedded within the orally dissolving 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 dissolving film in saliva, thereby slowing down the rate at which the orally dissolving film disintegrates and releases its active ingredients. However, the support layer provides support, reducing the risk of the orally dissolving 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 oral product midway through use, overcoming the technical bias that the faster the orally dissolving film enters the mouth, the better. For ortholytic membranes, which are more effective at being delivered to the systemic circulation via the oral mucosa, the support layer prevents the ortholytic membrane from rapidly disintegrating and being swallowed into the stomach, allowing it to be delivered to the systemic circulation via the oral mucosa as much as possible, thus improving the absorption effect of the ortholytic membrane.

[0278] Referring to Figure 46, one embodiment of this application provides an oral product 100a for placement in the oral cavity at desired locations, such as the gums or under the tongue. The oral product 100a includes a support layer 10a and an orally dissolving film 20a. The orally dissolving film 20a is designed to contact saliva and dissolve within the oral cavity. The support layer 10a is non-water-soluble and is disposed on at least one surface of the orally dissolving film 20a. Figure 46 shows the support layer 10a disposed on one surface of the orally dissolving film 20a. The support layer 10a has at least one channel 101a for allowing saliva to pass through the support layer 10a to contact the orally dissolving film 20a, enabling the orally dissolving film 20a to disintegrate in saliva and be carried into the oral cavity to exert its effects.

[0279] The support layer 10a provides support for the oral dissolution membrane 20a, reducing the risk of shrinkage or even disintegration during application. Users can easily apply a single oral product 100a to the desired location, lowering the cost of use. Furthermore, the support layer 10a maintains its shape for a longer period, allowing the oral dissolution membrane 20a to be moved or removed from the mouth as needed, thus improving usability. Additionally, the support layer 10a acts as an insulator, separating the oral dissolution membrane 20a 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 100a, further enhancing its usability.

[0280] When the support layer 10a is positioned on the side of the orofacial membrane 20a facing the oral mucosa, saliva needs a certain amount of time to wet the support layer 10a or pass through the channel 101a. This reduces the contact speed between the orofacial membrane 20a and saliva, thus slowing down the release of substances from the orofacial membrane 20a and reducing the probability of it disintegrating before reaching the designated location in the oral cavity. This allows the orofacial membrane 20a to release as much substance as possible to the desired placement location, improving the usability of the oral product 100a. Furthermore, the time required for saliva to wet the support layer 10a or pass through the channel 101a also allows time for correcting the application position, further facilitating the successful application of the oral product 100a to the desired location.

[0281] Referring to Figure 47, in some embodiments, there are two support layers 10a, which are disposed on two opposite surfaces of the oral fusion film 20a. The two support layers 10a on the opposite surfaces of the oral fusion film 20a allow both surfaces of the oral fusion film 20a to be isolated from the hand or mouth, further reducing the risk of the oral fusion film 20a adhering to the hand or mouth during application.

[0282] In some embodiments, the support layer 10a disposed on each surface of the oral dissolution membrane 20a may be multiple layers.

[0283] In some embodiments, the support layer 10a may cover the entire surface of the ortholytic membrane 20a.

[0284] The two support layers 10a can be made of the same or different materials. In some embodiments, at least two support layers 10a include a first support layer and a second support layer. The first support layer is configured on the side of the orofacial membrane 20a facing the oral mucosa, and the second support layer is configured on the side of the orofacial membrane 20a 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 20a dissolves to be released through the first support layer and absorbed by the oral mucosa to which the first support layer is attached.

[0285] 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 100a to be easily adhered to the oral mucosa through the first support layer and to maintain appropriate stiffness through the second support layer.

[0286] The active ingredient in the orally dissolving film 20a can be released and act on the oral mucosa upon dissolution by saliva. 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.

[0287] In some implementations, the active ingredient may include components for providing a tobacco-like flavor, such as nicotine or nicotine salts.

[0288] In some embodiments, the active ingredient may also include at least one of flavoring agents, flavoring agents, preservatives, sweeteners, and coloring agents.

[0289] In some embodiments, the support layer 10a has a porous structure that forms channels 101a for saliva to pass through, giving the support layer 10a good liquid permeability. The support layer 10a 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 10a may include at least one of polyolefins, polyesters, synthetic fibers, semi-synthetic fibers, regenerated fibers, and other natural or inorganic fibers.

[0290] 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.

[0291] Optionally, the support layer 10a can be a nylon mesh or a non-woven fabric. When the support layer 10a is a multi-layer non-woven fabric, by adjusting the number of non-woven layers in the multi-layer non-woven fabric, the effect of the support layer 10a in delaying the dissolution rate of the active ingredients in the oral dissolution film 20a can be controlled, allowing users to obtain different experiences, such as obtaining a stimulating taste or a mild taste.

[0292] In some embodiments, the support layer 10a 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.

[0293] Referring to Figure 48, in some embodiments, the support layer 10a is embedded within the orofacial membrane 20a. The support layer 10a embedded within the orofacial membrane 20a can provide support, reducing the risk of the orofacial membrane 20a shrinking or even disintegrating during application; moreover, the support layer 10a can maintain its shape for a longer period of time, allowing the oral product 100a to be moved or removed from the oral cavity as needed, thereby improving the usability of the oral product 100a.

[0294] Referring to Figures 49 and 53, in some embodiments, the support layer 10a is hydrophilic, and the two support layers 10a surround a receiving space 102a, within which the oral dissolving membrane 20a is placed. The receiving space 102a has a first opening 11a through which the oral dissolving membrane 20a is placed into or removed from the receiving space 102a. The support layer 10a is hydrophilic. When the oral product 100a enters the oral cavity and comes into contact with saliva, the support layer 10a can preferentially absorb water and wet itself, delaying the dissolution of the ortholytic membrane 20a placed in the receiving space 102a upon contact with saliva. During this time, the oral product 100a can be moved freely as needed. Moreover, the dissolved ortholytic membrane 20a can remain in the receiving space 102a 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 100a from the oral cavity, improving the usability of the oral product 100a. Furthermore, the ortholytic membrane 20a being placed in the receiving space 102a allows the support layer 10a to cover the entire ortholytic membrane 20a, thereby providing better support and isolation effects.

[0295] In some embodiments, the first opening 11a may be open or closed, and this application does not impose any restrictions.

[0296] In some embodiments, a portion of the orofacial membrane 20a is placed within the receiving space 102a, while a portion of the orofacial membrane 20a is exposed outside the receiving space 102a. As shown in FIG. 50, the orofacial membrane 20a extends outside the first opening 11a. As shown in FIG. 51, the receiving space includes a second opening 12a located on the opposite side of the first opening 11a along the length direction of the orofacial membrane 10a, and the orofacial membrane 20a extends outside both the first opening 11a and the second opening 12a. As shown in FIG. 52, the support layer 10a is provided with a through-hole 13a for exposing the orofacial membrane 20a, and the through-hole 13a is used for the passage of saliva.

[0297] As shown in Figure 53, in some embodiments, the oral product 100a includes a waterproof layer 40a that covers a support layer 10a disposed on the oral mucosa 20a facing away from the oral mucosa 20a. The waterproof layer 40a is liquid-impermeable, preventing substances released from the oral mucosa 20a from passing through the oral cavity and into the digestive tract. Instead, the substances released from the oral mucosa 20a leave the receiving space 102a only through the support layer 10a facing the oral mucosa, allowing more of the substances released from the oral mucosa 20a to be absorbed by the oral mucosa.

[0298] In some embodiments, the waterproof layer 40a can be a film of thermoplastic resins such as polyethylene, polypropylene, polyvinyl acetate, and polyester.

[0299] Referring to Figure 54, in some embodiments, the oral product 100a includes a porous layer 50a, which is detachably connected to the support layer 10a and covers the through-holes 13a. The porous layer 50a can be one or more layers. The porous layer 50a has a porous structure. The porous layer 50a can prevent substances released from the orofacial membrane 20a from flowing directly out of the receiving space 102a through the through-holes 13a. When the support layer 10a with the porous layer 50a is attached to the oral mucosa, the user can choose to open the porous layer 50a, allowing more of the substances released from the orofacial membrane 20a to be absorbed by the oral mucosa through the through-holes 13a, resulting in stronger stimulation. The porous layer 50a can be detachably connected to the support layer 10a by adhesive.

[0300] In some embodiments, the support layer 10a comprises 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 10a comes into contact with saliva, the water-swellable polymer absorbs water and swells, further delaying the contact between the oral film 20a and saliva, giving the user more time to move the oral film 20a to the desired location without dissolving, thus improving the usability of the oral product 100a.

[0301] 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.

[0302] Referring to Figure 55, in some embodiments, the oral product 100a further includes a water-swellable layer 30a, which is stacked on the surface of the support layer 10a facing the orofacial membrane 20a. The orofacial membrane 20a is located on the side of the water-swellable layer 30a away from the support layer 10a. The water-swellable layer 30a comprises a water-swellable polymer. After absorbing water and swelling, the water-swellable layer 30a is more effective in retaining the dissolved or disintegrated orofacial membrane 20a within the containment space 102a, and is more effective in avoiding physiological discomfort caused by the rapid dispersion of a large amount of dissolved or disintegrated orofacial membrane 20a in the oral cavity. Furthermore, the support layer 10a can isolate the water-swellable layer 30a from the hand or the oral cavity, reducing the risk of adhesion between the water-swellable layer 30a and the hand or oral cavity. It should be noted that, in order to clearly show the positional relationship between the water-swellable layer 30a and the support layer 10a with the accommodating space 102a, Figure 55 does not show the situation where the surfaces of the water-swellable layer 30a and the support layer 10a are in contact.

[0303] In some embodiments, the water-swellable layer 30a covers the entire surface of the support layer 10a facing the orthosol membrane 20a.

[0304] In some embodiments, the water-swellable layer 30a is also disposed on the surface of the support layer 10a away from the orthosol membrane 20a.

[0305] In some embodiments, the water-swellable layer 30a disposed on the surface of the support layer 10a facing away from the orthosolution membrane 20a and the water-swellable layer 30a disposed on the surface of the bag-shaped support layer 10a facing the orthosolution membrane 20a can be connected as one unit, so that the support layer 10a having the accommodating space 102a is embedded in the water-swellable layer 30a.

[0306] Referring to Figure 56, in some embodiments, the oral product 100a includes a handle 60a disposed on the support layer 10a, for the user to hold. The user can use the handle 60a to insert or remove the oral product 100a from the mouth, improving the usability of the oral product 100a. The handle 60a can be integrally formed with or separate from the support layer 10a. The handle 60a can be a rope.

[0307] The embodiments of this disclosure are described in detail below.

[0308] Example 1

[0309] Provides a sustained-release nicotine functional film layer (FASTA, commercially available from Shenzhen Wuxin Technology Co., Ltd., see Figure 24): nicotine content is 4mg / pcs, tablet weight is 70mg, thickness is 120μm, length is 3cm, width is 1cm, and the main film-forming agents are pullulan, gelatin, PEG, water, nicotine, and flavoring substances.

[0310] In the experimental group, the nicotine functional membrane was completely encapsulated in a permeable fabric. Two types of nonwoven fabrics, n1 (FDA30, commercially available from Huzhou Ruilan New Materials Co., Ltd.) and n2 (FDA34, commercially available from Huzhou Ruilan New Materials Co., Ltd.), were used for encapsulation with polylactic acid film (S05020, commercially available from Dongguan Rifu Fiber Co., Ltd.), specialty paper (item number 789, Guangzhou Xili Industrial Co., Ltd.), and food-grade nylon filter (item number HN-NLWD, Zhejiang Huana Mesh Co., Ltd.). Multiple oral membrane products were obtained and set up as the n1 oral membrane product group (see photo 25), the n2 oral membrane product group (see photo 26), the polylactic acid film oral membrane product group, the specialty paper oral membrane product group, and the food-grade nylon filter oral membrane product group. The control group only had the original nicotine functional membrane.

[0311] The physicochemical parameters of N1 nonwoven fabric, N2 nonwoven fabric, polylactic acid film, specialty paper, and food-grade nylon filter mesh are as follows:

[0312] Dissolution test method:

[0313] Multiple oral membrane products were placed on a mesh carrier and suspended on the surface of a beaker containing 100 ml of artificial saliva, ensuring immersion. The beaker was placed on a temperature-controlled magnetic stirrer set to 130 rpm and 37 degrees Celsius. At specified time points, such as 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, and 35 min, 100 μl samples were collected, and the concentration of the active ingredient was determined. The dissolution rate of the active ingredient was calculated. Based on the content determination results, a curve of the release characteristics of the active ingredient was plotted, as shown in Figures 27 and 28.

[0314] The dissolution data clearly show that the addition of nonwoven fabric resulted in a more moderate release of the active nicotine ingredient, but the overall release rate was not significantly affected. Particularly in the 0-1 minute range, the experimental group showed no release within 30 seconds, and the release was low at 1 minute. This can be attributed to the nonwoven fabric absorbing water and buffering the rapid release of nicotine from saliva, giving the user an opportunity to move the membrane to the optimal position for optimal comfort.

[0315] Then, user experience tests were conducted using the n1 oral membrane product, which has a release rate closer to that of the original nicotine functional membrane, in comparison with the original nicotine functional membrane.

[0316] Before starting, participants will be instructed on the correct way to attach the patch:

[0317] Now ensure the subject's hands are dry and free of obvious sweat or other liquids, then remove the film.

[0318] The subject held the membrane in one hand and used the other hand to lift or push open the buccal mucosa near the upper gum or the upper lip;

[0319] Apply the film to the gums, then place it on the buccal mucosa and lips;

[0320] Record the time and number of times the patch was successfully applied to the gums and buccal mucosa, as well as the number of times it was moved. Ask subjects about ease of use, stickiness (the stronger the stickiness, the lower the score), nicotine onset time, and throat irritation. Ask subjects to record their experience during use and rate it on a scale of 0 to 6. The stronger the stickiness, the lower the score, and the better the ease of use, the higher the score.

[0321] In summary, during the application process, subjects needed to move 2-3 times. With the addition of non-woven fabric, almost all subjects could apply the film to the correct position with a single application. Without the non-woven fabric, on average, each subject was allowed one movement, and the user would need to waste 1.83 original nicotine functional film layers to achieve the correct position. Adding non-woven fabric slowed the onset of nicotine by 1.5 minutes, improving the convenience of users discontinuing the application midway and achieving a certain degree of sustained-release and controlled-release effect.

[0322] Because non-woven fabrics have a certain water-retention capacity, adding them can reduce the rate at which the nicotine functional film dissolves and enters the throat with saliva, thus reducing the likelihood of strong irritation. Adding non-woven fabrics greatly improves ease of use and reduces the discomfort caused by the stickiness and residue of nicotine film products.

[0323] Example 2

[0324] In the experimental group, commercially available propolis membranes were completely sealed in a non-woven fabric. Photos of the propolis membrane and the propolis oral mask product wrapped in non-woven fabric are shown in Figures 29 and 30, respectively. In this test, the subjects were required to remove the propolis oral mask product and apply it to the buccal membrane of the mouth. The target area of ​​the propolis oral mask product was the oral ulcer, as shown in Figure 31.

[0325] A survey of six participants showed that they were able to successfully attach the sticker to the target location several times.

[0326] Adding a permeable nonwoven fabric makes it easier for users to apply oral membrane products to the appropriate position. However, when using the original propolis membrane directly, most test subjects found that the original propolis membrane became damp and deformed after entering the mouth, stuck to their hands, and was difficult to remove, making it impossible to place in the target position. Or, after multiple attempts, the membrane absorbed water and broke.

[0327] Example 3

[0328] Soluble dental veneers (see photo 32) are then covered with a non-enclosed non-woven fabric sleeve (see photo 33) to obtain the dental veneer product, which is applied to the lower tooth surface.

[0329] The number of times the subject successfully applied the adhesive was recorded.

[0330] Adding a non-woven fabric sleeve can better protect the dental veneer from adhesion to the inside of the lip during the application process, reducing the curling and adhesion of the veneer to the inside of the lip or gums, thus minimizing waste and greatly facilitating the use of the test subjects.

[0331] Example 4

[0332] Experimental group: Ten pieces of the nicotine functional film layer from Example 1, which were wrapped in non-woven fabric, were then placed into a barrier aluminum foil bag for sealing.

[0333] Control group: 10 pieces of the nicotine functional film layer from Example 1, which were not wrapped in non-woven fabric, were directly packaged into aluminum foil bags.

[0334] Both the experimental and control groups were placed in a constant temperature and humidity chamber (37 degrees Celsius and 75% humidity) for testing.

[0335] After 45 days of testing, it was found that the nicotine functional membrane in the control group had stuck together and could not be peeled off, while the experimental group could be well dispersed and peeled off.

[0336] Example 5

[0337] Using the nicotine functional film layer from Example 1, the nicotine functional film layer was encapsulated in different ways using non-woven fabric, as detailed below:

[0338] The non-woven fabric forms a bag-like structure with an opening on one side, and the nicotine oral solution membrane is completely contained in the containment space of the bag-like structure. See Figure 34 for the photo.

[0339] The non-woven fabric forms a bag-like structure with openings on both sides, and the nicotine ortholytic membrane is completely contained in the containment space of the bag-like structure. See Figure 35 for the photo.

[0340] The nonwoven fabric forms a bag-like structure with openings on both sides. The middle part of the nicotine ortholytic membrane is contained in the containment space of the bag-like structure, and the two ends extend beyond the nonwoven fabric. See Figure 36 for the photo.

[0341] The nonwoven fabric forms a bag-like structure with an opening on one side. The nicotine ortholytic membrane is partially contained in the containment space of the bag-like structure, with one end extending beyond the nonwoven fabric from the opening. See Figure 37 for the photo.

[0342] The non-woven fabric forms a bag-like structure without openings on all sides. The nicotine oral solution membrane is contained in the containment space of the bag-like structure. Three openings are provided on one side surface of the bag-like structure. See Figure 38 for the photo.

[0343] Example 6

[0344] A swollen oral film is provided (see Figure 39 for a photo; the swollen oral film, after being fully contacted with water, exhibits a uniform swelling into a gel state): nicotine content is 2 mg / pcs, tablet weight is 70 mg, thickness is 120 μm, length is 3 cm, width is 1 cm, and the main film-forming agents are chitosan, gelatin, PEG, water, nicotine, and flavoring substances.

[0345] Oral films were encapsulated in non-woven fabric using ultrasonic encapsulation to obtain oral film products of different shapes. The photos are shown in Figures 40, 41 and 42. As can be seen from the figures, the oral film products are printed with different brand logos and other graphic information.

[0346] When the oral membrane and the oral membrane product encapsulated with non-woven fabric are partially exposed to water, it can be found that the original oral membrane is prone to local shrinkage after partial contact with water (see Figure 43). If it is encapsulated with non-woven fabric, the water can be evenly diffused, reducing the shrinkage and clumping caused by uneven swelling. At the same time, the rigidity of the oral membrane can be improved, and the problem caused by the shrinkage of the oral membrane can also be improved.

[0347] Example 7

[0348] Using a common plastic film with polyethylene as the main component and a thickness of 100 μm, pores (i.e., water-permeable channels) are formed on the surface as needed. Then, a hot air blower or an ultrasonic encapsulation machine is used to encapsulate the nicotine functional film layer in Example 1 in the plastic film.

[0349] Example 8

[0350] This product offers slow-dissolving dental strips (a product from Qingjiuye that uses papain, catalase, and other bioactive enzymes as its main active ingredients to work on the bacteria on the tooth surface to achieve a whitening effect; recommended usage time is 30 minutes to 1 hour). After being sewn together with non-woven fabric, the dental strip product is obtained. The two ends of the non-woven fabric extend beyond the strip to form a grip, preventing direct hand contact and reducing the impact of hand fluids on the strip, which could even damage it. This also allows for easy movement of the strip after application.

[0351] Six subjects used three samples each, applying them to their upper teeth. The number of times the gripping area did not wrinkle or deform, and the number of times a good fit was achieved, was recorded. Subjects were not restricted from making slight movements to facilitate proper fit.

[0352] With the addition of the grip, users can move the dental veneer product very easily and apply it smoothly, and the grip is almost undamaged. Even if the subject needs to move it to apply it properly, it can still meet the requirements.

[0353] Example 9

[0354] Specialty paper (same as in Example 1) was provided, consisting of wood pulp and a small amount of food-grade heat-sealing material, polypropylene. Ultrasonic encapsulation and pattern welding were used to encapsulate an inner nicotine functional film layer as in Example 1. A photograph of the resulting nasal patch product is shown in Figure 44. The circular nasal patch product has a diameter of 0.8 cm and a thickness of 120 μm.

[0355] Subjects used either the original nicotine functional membrane or a nasal strip packaged in special paper, applying them to the nasal cavity for nicotine absorption and aroma perception, and removing them after 10 minutes. The subjects' perceived nasal irritation, nicotine sensation, removability, and convenience were statistically analyzed.

[0356] The nasal strip product, encapsulated in special paper, adheres to the nasal cavity with the help of a small amount of nasal mucus. The special paper remains intact during movement, and its excellent moisture-buffering function promotes early water absorption by the nicotine functional film, aiding in its swelling and dissolution. Through water retention and encapsulation, it reduces the amount of dissolved nicotine liquid that could cause discomfort when dripped into the nasal cavity. Furthermore, the nicotine sensation experienced by test subjects is slightly milder than with the original nicotine functional film, providing greater comfort and avoiding adverse reactions from excessively rapid nicotine intake.

[0357] Example 10

[0358] Similar to the dental veneer in Implementation Case 8, the dental veneer is sandwiched between a plastic film with polypropylene as the main component (item number-DYM002, food preservation film, Dongguan Mingye Packaging Products Co., Ltd.) and a 25g polylactic acid film with permeability, and then fully encapsulated to obtain the dental veneer product.

[0359] The study examined the extent to which the active ingredients acted on the tooth surface during the subjects' use of the product, primarily by using the whiteness of the teeth after 30 minutes of use according to the instructions as an indicator.

[0360] Because one side uses a completely impermeable plastic film, the active ingredients of the dental veneer successfully avoid contact with the lips, preventing excessive saliva from flowing into non-tooth areas. The other side uses a polylactic acid film. This film is water-permeable, allowing saliva to pass through and helping to dissolve the veneer, while also slowing down the outflow of the active ingredients. This allows the active ingredients to interact with the tooth surface for a longer period, enhancing the effectiveness of the treatment.

[0361] In the description of this invention, it should be understood that the terms "center," "longitudinal," "lateral," "length," "width," "thickness," "upper," "lower," "front," "rear," "left," "right," "vertical," "horizontal," "top," "bottom," "inner," "outer," "clockwise," "counterclockwise," "axial," "radial," and "circumferential" indicate the orientation or positional relationship based on the orientation or positional relationship shown in the accompanying drawings. They are used only for the convenience of describing this invention and simplifying the description, and are not intended to indicate or imply that the device or element referred to must have a specific orientation, or be constructed and operated in a specific orientation. Therefore, they should not be construed as limitations on this invention.

[0362] Furthermore, the terms "first" and "second" are used for descriptive purposes only and should not be construed as indicating or implying relative importance or implicitly specifying the number of technical features indicated. Thus, a feature defined as "first" or "second" may explicitly or implicitly include at least one of that feature. In the description of this invention, "a plurality of" means at least two, such as two, three, etc., unless otherwise explicitly specified.

[0363] In this invention, unless otherwise explicitly specified and limited, the terms "installation," "connection," "linking," and "fixing," etc., should be interpreted broadly. For example, they can refer to a fixed connection, a detachable connection, or an integral part; they can refer to a mechanical connection, an electrical connection, or a connection that allows communication between them; they can refer to a direct connection or an indirect connection through an intermediate medium; they can refer to the internal communication of two components or the interaction between two components, unless otherwise explicitly limited. Those skilled in the art can understand the specific meaning of the above terms in this invention according to the specific circumstances.

[0364] In this invention, unless otherwise explicitly specified and limited, "above" or "below" the second feature can mean that the first feature is in direct contact with the second feature, or that the first feature is in indirect contact with the second feature through an intermediate medium. Furthermore, "above," "over," and "on top" of the second feature can mean that the first feature is directly above or diagonally above the second feature, or simply that the first feature is at a higher horizontal level than the second feature. "Below," "below," and "under" the second feature can mean that the first feature is directly below or diagonally below the second feature, or simply that the first feature is at a lower horizontal level than the second feature.

[0365] In the description of this specification, the references to terms such as "one embodiment," "some embodiments," "one example," "some embodiments," "example," "specific example," or "some examples," etc., indicate that a specific feature, structure, material, or characteristic described in connection with that embodiment or example is included in at least one embodiment or example of the present invention. In this specification, the illustrative expressions of the above terms do not necessarily refer to the same embodiment or example. Furthermore, the specific features, structures, materials, or characteristics described may be combined in a suitable manner in any one or more embodiments or examples. Moreover, without contradiction, those skilled in the art can combine and integrate the different embodiments or examples described in this specification, as well as the features of different embodiments or examples.

[0366] Although embodiments of the present invention have been shown and described above, it is understood that the above embodiments are exemplary and should not be construed as limiting the present invention. Those skilled in the art can make changes, modifications, substitutions and variations to the above embodiments within the scope of the present invention.

Claims

1. A film-forming product, comprising: A functional membrane layer containing an active ingredient adapted to be released from the functional membrane layer and act on a target location; A sheet, the sheet including a first sheet disposed on at least a portion of the surface of the functional film layer; and / or, the first sheet being embedded within the functional film layer.

2. The film dosage product according to claim 1, wherein, The first sheet covers one side surface of the functional film layer.

3. The film dosage product according to claim 1 or 2, wherein, The sheet also includes a second sheet, and the first sheet and the second sheet are disposed on two opposite surfaces of the functional film layer.

4. The film-forming product according to claim 3, wherein, The edges of at least two of the first sheet, the functional film layer, and the second sheet are aligned.

5. The film-forming product according to claim 3 or 4, wherein, The film-forming product meets any one of the following conditions: The first sheet and the second sheet are partially connected at their edges to form a first bag-shaped structure with an opening on at least one side edge. The first bag-shaped structure has a first receiving space, and at least a portion of the functional membrane layer is disposed in the first receiving space. The first sheet and the second sheet are connected at their edges to form a second bag-shaped structure without an opening at the edge. The second bag-shaped structure has a second receiving space, and the functional film layer is received in the second receiving space.

6. The film-forming product according to any one of claims 3 to 5, wherein, At least one of the first layer and the second layer has a first opening.

7. The film-forming product according to any one of claims 3 to 6, wherein, The film-forming product meets at least one of the following conditions: The first layer includes multiple stacked first sub-layers; The second layer includes multiple stacked second sub-layers.

8. The film-forming product according to claim 7, wherein, The adjacent first sub-layers are detachably connected; and / or the adjacent second sub-layers are detachably connected.

9. The film-forming product according to claim 8, wherein, The film-forming product meets at least one of the following conditions: The first sub-layer is provided with a first disassembly part; The edges of two adjacent first sub-layer portions are not sealed; The second sub-layer is provided with a second disassembly section; The edges of two adjacent second sub-layer portions are not sealed.

10. The film-forming product according to any one of claims 3 to 9, wherein, The film-forming product meets at least one of the following conditions: The first layer includes a first removable region and a first non-removable region, and the first removable region and the first non-removable region are connected by a first weak connection structure; The second layer includes a second removable region and a second non-removable region, and the second removable region and the second non-removable region are connected by a second weak connection structure.

11. The film-forming product according to any one of claims 3 to 10, wherein, The film-forming product further includes a waterproof layer, which satisfies any one of the following conditions: The film product includes the functional film layer and the first sheet layer, and the waterproof layer is disposed on the surface of the first sheet layer away from the functional film layer or on the surface of the functional film layer not covered by the first sheet layer; The film product includes the functional film layer, the first sheet layer, and the second sheet layer, with the functional film layer sandwiched between the first sheet layer and the second sheet layer. The waterproof layer is disposed on at least one of the surface of the first sheet layer away from the functional film layer, the surface of the second sheet layer away from the functional film layer, and the surface of the functional film layer not covered by the first sheet layer and the second sheet layer.

12. The film-forming product according to any one of claims 3 to 11, wherein, The film-forming product further includes: a water-swellable substance disposed on at least one of the following locations: The surface of the first sheet; The surface of the second layer; In the pores of the first layer; In the pores of the second layer.

13. The film-forming product according to any one of claims 3 to 12, wherein, The film-forming product meets any one of the following conditions: The first layer and the second layer are the same; The first and second layers differ in at least one of the following: water permeability, porosity, thickness, material, tensile strength, and number of layers.

14. The film-forming product according to any one of claims 3 to 13, wherein, The first layer and the second layer each independently satisfy any one of the following conditions: It is water-permeable; It is not water-permeable and has water-permeable channels.

15. The film-forming product according to claim 14, wherein, The water-permeable channel includes a through hole, or the water-permeable channel includes the through hole and a porous layer that can be detachably covered on the through hole.

16. The film-forming product according to claim 14 or 15, wherein, The first layer and the second layer each independently comprise at least one of the following: nonwoven fabric, specialty paper, wood pulp paper, polylactic acid paper, fiber cloth, mesh fabric, foamed resin film, mesh resin film, porous resin film, swelling sheet, swelling mesh, plastic sheet with the water-permeable channels, and rubber sheet with the water-permeable channels; and / or The first layer and the second layer each independently comprise a water-swellable polymer.

17. The film-forming product according to any one of claims 1 to 16, wherein, The functional membrane layer includes multiple sub-functional membrane layers, and the multiple sub-functional membrane layers are identical; or The multiple sub-functional membrane layers contain at least one different type and concentration of the active ingredient, and the sub-functional membrane layer includes at least one of a first sub-functional membrane layer and a second sub-functional membrane layer, wherein the multiple first sub-functional membrane layers are stacked, and / or the multiple second sub-functional membrane layers are laid flat on a first surface.

18. The film-forming product according to claim 17, wherein, The adjacent first sub-functional membrane layers are detachably connected; and / or the second sub-functional membrane layer is detachably connected to the sheet layer.

19. The film-forming product according to claim 18, wherein, The film-forming product meets at least one of the following conditions: The first sub-functional membrane layer is provided with a third disassembly part; The edges of the two connected first sub-functional membrane layers were not sealed. The second sub-functional membrane layer is provided with a fourth disassembly part; The edges of the second sub-functional membrane layer and the sheet layer are not sealed.

20. The film-forming product according to any one of claims 17 to 19, wherein, The first sheet includes a plurality of third sub-sheets, which are substantially parallel to the first surface. The orthographic projection of each third sub-sheet on the first surface overlaps with the orthographic projection of at least one second sub-functional membrane layer on the first surface. At least one of the water permeability, material, porosity, tensile strength, thickness, and number of layers of the plurality of third sub-sheets is different.

21. The film-forming product according to any one of claims 17 to 20, wherein, The sheet also includes at least one third sheet, which is sandwiched between two adjacent first sub-functional membrane layers.

22. The film-forming product according to claim 21, wherein, The water permeability, material, porosity, thickness, tensile strength, and number of layers of the plurality of said third layers are different.

23. The film-forming product according to any one of claims 1 to 22, wherein, The film product also includes a gripping part.

24. The film-forming product according to claim 23, wherein, The grip portion satisfies at least one of the following conditions: The grip portion includes at least one of a traction cable and a handle; The gripping portion is located at the edge of the film-forming product; The gripping portion includes a portion of the sheet; The gripping portion includes a portion of the sheet layer and a portion of the functional film layer.

25. The film-forming product according to any one of claims 1 to 24, wherein, The film-forming product has printed graphic and textual information.

26. The film-forming product according to any one of claims 1 to 25, wherein, The film products include at least one of buccal film products, sublingual film products, supralingual film products, oral cavity lining film products, gingival film products, dental veneer products, and nasal film products.

27. The film-forming product according to any one of claims 1 to 26, wherein, The film-forming product meets at least one of the following conditions: The outer contour shape of the film-forming product includes at least one of the following: square, rectangle, circle, triangle, polygon, and irregular shape; The maximum outer contour of the film-forming product is 0.1–8 cm, and the minimum outer contour is 0.1–1.5 cm. The functional membrane layer includes at least one of a fully dissolved membrane layer, a partially dissolved membrane layer, and a swollen membrane layer.

28. The film-forming product according to any one of claims 1 to 27, wherein, The active ingredients include at least one of the following: pharmaceutical ingredients, nutritional and health care ingredients, food ingredients, daily chemical ingredients, and alkaloids.

29. The film-forming product according to claim 28, wherein, The drug ingredients include at least one of the following: oral ulcer medication, psychotropic drugs, analgesics, anti-inflammatory drugs, nasal medications, cannabinoids and their derivatives, respiratory medications, and sildenafil. The nutritional and health-promoting ingredients include at least one of the following: American ginseng extract, Schisandra chinensis extract, Ganoderma lucidum extract, arginine, propolis, melatonin, glutathione, and taurine. The food ingredients include at least one of tea extract, coffee extract, and vitamins; The daily chemical ingredients include at least one of papain, catalase, teeth whitening ingredients, oral repair ingredients, and anti-aging ingredients; The alkaloids include at least one of nicotine and its derivatives, caffeine and its analogues, arecoline and its analogues, and hexamethylnicotine.

30. An oral film product, comprising: An oral membrane containing an active ingredient that can be released from the oral membrane and act on a target location; A sheet, the sheet comprising a first sheet disposed on at least a portion of the surface of the oral membrane; and / or, the first sheet being embedded within the oral membrane; Wherein, the sheet is the same as the sheet layer defined in any one of claims 1 to 27, and the oral membrane is the same as the functional membrane layer defined in any one of claims 1 to 25 and 27 to 28.

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