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 dosage product and oral film product

[0001] Priority information

[0002] The present disclosure claims priority to and the benefit of Chinese Patent Application No. 2024217709368, filed July 24, 2024, Chinese Patent Application No. 2024110057071, filed July 24, 2024, Chinese Patent Application No. 2024119996179, filed December 31, 2024, and Chinese Patent Application No. 2024233228910, filed December 31, 2024, and incorporates by reference the entire contents of each of the foregoing. TECHNICAL FIELD

[0003] The present disclosure relates to the technical field of film dosage products, in particular to a film dosage product and an oral film product. BACKGROUND

[0004] Film dosage products have attracted much attention due to their advantages of convenient use, light weight, local effect, fast onset, high efficiency, etc. and gradually move from simple medicaments to various consumer and health care product scenarios. When using the film dosage product, the user usually directly holds the film dosage product and then places or adheres it to the target position using fingers. During this process, once the film dosage product comes into contact with liquid such as sweat or saliva, it will absorb water and start releasing active ingredients, resulting in the film dosage product dissolving or showing wrinkling, deformation, adhesion, etc. before reaching the target position, which greatly affects the use effect of the film dosage product.

[0005] SUMMARY

[0006] The present disclosure aims to solve one of the technical problems in the related art, i.e., the film dosage product starts dissolving before reaching the target position, the film dosage product is prone to wrinkling, deformation, and adhesion and is difficult to adhere to the target position, and the film dosage product rapidly disintegrates after contacting liquid. To this end, the present disclosure provides a film dosage product and an oral film product which are not prone to wrinkling and deformation, not prone to adhesion and sticking, can control the release speed of active ingredients, or are easy to package and store.

[0007] In a first aspect, the present disclosure provides a film product. According to embodiments of the present disclosure, the film product comprises: a functional film layer, the functional film layer containing an active ingredient, the active ingredient being adapted to be released from the functional film layer and act on a target position; a sheet layer, the sheet layer comprising a first sheet layer, the first sheet layer being arranged on at least part of a surface of the functional film layer; and / or, the first sheet layer being embedded in the functional film layer. Specifically, by arranging the sheet layer, the tensile strength of the film product can be improved, the sheet layer which can maintain its shape for a long time can improve the problem of the film product being prone to wrinkling and deformation, and the degree of deformation of the film product before reaching the target position can be reduced; at the same time, due to the improvement of the tensile strength, the film product will not disintegrate rapidly after being placed at the target position, and the effect of withdrawing the relatively complete film product from the target position during use can be achieved; the film product can also effectively improve the situation that the film product is prone to rapid deformation, adhesion, fragmentation or disintegration when contacting liquid, which makes it difficult to be placed at the target position; during the placement process, the film product can be moved by the user multiple times until it is aligned with the target position, and the film product can be basically attached to the target position using one sheet, and the use cost of the film product can be significantly reduced.

[0008] According to embodiments of the present disclosure, the first sheet layer covers one side surface of the functional film layer.

[0009] According to embodiments of the present disclosure, the sheet layer further comprises a second sheet layer, the first sheet layer and the second sheet layer being arranged on two opposite surfaces of the functional film layer.

[0010] According to embodiments of the present disclosure, the edges of at least two of the first sheet layer, the functional film layer and the second sheet layer are arranged in alignment.

[0011] According to embodiments of the present disclosure, the edges of the first sheet layer and the second sheet layer are connected to form a first bag-like structure having an opening on at least one side edge, a first accommodating space being arranged in the first bag-like structure, and at least part of the functional film layer being arranged in the first accommodating space.

[0012] According to embodiments of the present disclosure, the edges of the first sheet layer and the second sheet layer are connected to form a second bag-like structure having no opening on the edge, a second accommodating space being arranged in the second bag-like structure, and the functional film layer being arranged in the second accommodating space.

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

[0014] According to embodiments of the present disclosure, the first sheet layer comprises a plurality of first sub-sheet layers arranged in layers.

[0015] According to embodiments of the present disclosure, the second sheet layer comprises a plurality of second sub-sheet layers arranged in layers.

[0016] Different piece layer arrangement modes can meet the needs of different use scenarios and provide more diversified experiences.

[0017] According to an embodiment of the present disclosure, the adjacent first sub-piece layers are detachably connected; and / or the adjacent second sub-piece layers are detachably connected.

[0018] According to an embodiment of the present disclosure, the first sub-piece layer is provided with a first detachable part.

[0019] According to an embodiment of the present disclosure, the partial edges of the two first sub-piece layers connected together are not sealed.

[0020] According to an embodiment of the present disclosure, the second sub-piece layer is provided with a second detachable part.

[0021] According to an embodiment of the present disclosure, the partial edges of the two second sub-piece layers connected together are not sealed.

[0022] According to an embodiment of the present disclosure, the first piece layer comprises a first detachable area and a first non-detachable area, and the first detachable area and the first non-detachable area are connected through a first weak connection structure.

[0023] According to an embodiment of the present disclosure, the second piece layer comprises a second detachable area and a second non-detachable area, and the second detachable area and the second non-detachable area are connected through a second weak connection structure.

[0024] Specifically, through the detachable connection, the user can adjust the number of piece layers according to the actual experience in the actual use process, such as selecting different stimulation intensities, so as to better meet the use needs of different users.

[0025] According to an embodiment of the present disclosure, the film product further comprises a waterproof layer.

[0026] In some embodiments, the film product comprises a functional film layer and a first piece layer, and the waterproof layer is arranged on the surface of the first piece layer away from the functional film layer or the surface of the functional film layer not covered by the first piece layer.

[0027] In some embodiments, the film product comprises a functional film layer, a first piece layer and a second piece layer, the functional film layer is arranged between the first piece layer and the second piece layer, and the waterproof layer is arranged on the surface of the first piece layer away from the functional film layer, the surface of the second piece layer away from the functional film layer, or the surface of the functional film layer not covered by the first piece layer and the second piece layer.

[0028] The arrangement of the waterproof layer can reduce the delivery of the active ingredients released by the functional film layer to non-target positions, such as through the oral cavity and then into the digestive tract, promote the active ingredients released by the functional film layer to play a role through the side facing the target position, and make the active ingredients be more absorbed by the target position.

[0029] According to embodiments of the present disclosure, the film product further comprises a water-swellable substance, the water-swellable substance being arranged on at least one of the following: a surface of the first sheet layer, a surface of the second sheet layer, a pore of the first sheet layer, and a pore of the second sheet layer. The water-swellable substance can increase the overall tensile strength of the film product after absorbing water and swelling, facilitating the user to move the film product and improving the usability of the film product.

[0030] According to embodiments of the present disclosure, the first sheet layer and the second sheet layer are the same.

[0031] According to embodiments of the present disclosure, at least one of the water permeability, the porosity, the thickness, the material, the tensile strength, and the number of layers of the first sheet layer and the second sheet layer is different. In this way, the two side surfaces of the film product can provide different release speeds of the active ingredients, enrich the user experience, and meet more use scenarios and personalized use requirements of more users.

[0032] According to embodiments of the present disclosure, the first sheet layer and the second sheet layer each independently has water permeability; or does not have water permeability and is provided with a water-permeable passage. In this way, the active ingredients in the functional film layer can be effectively and conveniently applied to the target position.

[0033] According to embodiments of the present disclosure, the water-permeable passage comprises a through hole, or the water-permeable passage comprises a through hole and a porous layer arranged on the through hole.

[0034] According to embodiments of the present disclosure, the first sheet layer and the second sheet layer each independently comprises at least one of a non-woven fabric, a special paper, a wood pulp paper, a polylactic acid paper, a fiber cloth, a mesh cloth, a foamed resin film, a reticular resin film, a porous resin film, a swellable sheet, a swellable mesh, a plastic sheet provided with a water-permeable passage, and a rubber sheet provided with a water-permeable passage.

[0035] According to embodiments of the present disclosure, the functional film layer comprises a plurality of sub-functional film layers. In some embodiments, the plurality of sub-functional film layers are the same. Specifically, in the case that the thickness of a single functional film layer is limited, a greater thickness and a greater dose of active ingredients can be achieved by arranging a plurality of sub-functional film layers. In other embodiments, at least one of the types and concentrations of active ingredients contained in the plurality of sub-functional film layers is different. In this way, a plurality of different active ingredients or active ingredients with different concentrations can be used in combination in one film product, achieving flexible combinations between the types of active ingredients and the concentrations of active ingredients, and providing a more diverse experience for customers.

[0036] In some embodiments, the sub-functional film layer comprises at least one of a first sub-functional film layer and a second sub-functional film layer, a plurality of first sub-functional film layers are arranged in layers, and / or a plurality of second sub-functional film layers are arranged in a flat manner on the first surface.

[0037] According to embodiments of the present disclosure, the first sub-functional film layers are detachably connected to each other; and / or the second sub-functional film layers are detachably connected to the sheet layers. In this way, the user can flexibly adjust the types and quantities of the sub-functional film sheets according to the actual needs of the individual, and better meet the individual needs of the user.

[0038] According to embodiments of the present disclosure, the first sub-functional film layers are provided with third detachable parts.

[0039] According to embodiments of the present disclosure, the two first sub-functional film layers connected to each other have unsealed edges.

[0040] According to embodiments of the present disclosure, the second sub-functional film layers are provided with fourth detachable parts.

[0041] According to embodiments of the present disclosure, the second sub-functional film layers and the sheet layers have unsealed edges.

[0042] According to embodiments of the present disclosure, the first sheet layer includes a plurality of third sub-sheet layers, the plurality of third sub-sheet layers are substantially parallel to the first surface, and the orthographic projection of each third sub-sheet layer on the first surface and the orthographic projection of at least one second sub-functional film layer on the first surface have an overlapping area; and at least one of the water permeability, the material, the porosity, the tensile strength, the thickness, and the number of layers of the plurality of third sub-sheet layers is different. In this way, different second sub-functional film layers can have different release speeds of active ingredients, better meet the needs of the user, and enrich the user experience.

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

[0044] According to embodiments of the present disclosure, at least one of the water permeability, the material, the porosity, the thickness, the tensile strength, and the number of layers of the plurality of third sheet layers is different.

[0045] According to embodiments of the present disclosure, the film product further includes a holding part. The user can hold the holding part by hand to attach the film product to the target position or take it out halfway, thereby improving the usability of the film product.

[0046] According to embodiments of the present disclosure, the holding part includes at least one of a traction line and a handle.

[0047] According to embodiments of the present disclosure, the holding part is located at the edge of the film product.

[0048] According to embodiments of the present disclosure, the holding part includes part of the sheet layer.

[0049] According to embodiments of the present disclosure, the holding part includes part of the sheet layer and part of the functional film layer.

[0050] According to the embodiments of the present disclosure, the film product is printed with graphic information. In this way, the user can easily identify the graphic information and brand information, and the use is more convenient.

[0051] According to the embodiments of the present disclosure, the film product includes at least one of a buccal film product, a sublingual film product, a lingual film product, an intraoral film product, a gingival film product, a dental film product, and a nasal cavity film product.

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

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

[0054] According to the embodiments of the present disclosure, the functional film layer includes at least one of a completely dissolving film layer, a partially dissolving film layer, and a swelling film layer.

[0055] According to the embodiments of the present disclosure, the active ingredient includes at least one of a drug ingredient, a nutrition and health ingredient, a food ingredient, a daily chemical ingredient, and an alkaloid.

[0056] According to the embodiments of the present disclosure, the drug ingredient includes at least one of a mouth ulcer drug, a psychotropic drug, an analgesic, an anti-inflammatory drug, a cannabinoid and its derivative, a nasal drug, a respiratory tract drug, and sildenafil.

[0057] According to the embodiments of the present disclosure, the nutrition and health ingredient includes at least one of American ginseng extract, Schisandra extract, Ganoderma extract, arginine, propolis, melatonin, glutathione, and taurine.

[0058] According to the embodiments of the present disclosure, the food ingredient includes at least one of tea extract, coffee extract, and vitamin.

[0059] According to the embodiments of the present disclosure, the daily chemical ingredient includes at least one of papain, catalase, a tooth whitening ingredient, an oral repair ingredient, and an anti-aging ingredient.

[0060] According to the embodiments of the present disclosure, the alkaloid includes at least one of nicotine and its derivative, caffeine and its analog, arecoline and its analog, and hexamethyl nicotine.

[0061] In this way, the film product has a wide range of uses and can play different roles to meet the use needs of different use scenarios.

[0062] In a second aspect, the present disclosure provides a film product for oral use. According to an embodiment of the present disclosure, the film product for oral use comprises: a film for oral use, the film for oral use containing an active ingredient, the active ingredient being adapted to be released from the film for oral use and act on a target site; a sheet, the sheet comprising a first sheet, the first sheet being arranged on at least a part of a surface of the film for oral use; and / or, the first sheet being embedded in an interior of the film for oral use. The sheet can be the same as the sheet layer described above, and the film for oral use can be the same as the functional film layer described above. Specifically, by arranging the sheet, the tensile strength of the film product for oral use can be improved, the sheet which can maintain a shape for a long time can improve the problem that the film product for oral use is prone to wrinkle and deformation, and the degree of deformation of the film product for oral use when not reaching the target site can be reduced. Meanwhile, the film product for oral use will not disintegrate quickly after being placed at the target site, and the film product for oral use can be easily withdrawn from the target site during use. The film product for oral use can be effectively improved to contact liquid, quickly deform, adhere, break or disintegrate, and thus the film product for oral use can be more easily adhered to the target site. The film product for oral use can be moved multiple times and more easily adhered to the target site. Basically, one film product for oral use can be adhered to the target site, and the use cost can be significantly reduced.

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

[0064] By arranging the sheet layer / sheet, the tensile strength of the film product for oral use can be improved, the sheet which can maintain a shape for a long time can improve the problem that the film product for oral use is prone to wrinkle and deformation, and the degree of deformation of the film product for oral use when not reaching the target site can be reduced. Meanwhile, the film product for oral use will not disintegrate quickly after being placed at the target site, and the film product for oral use can be easily withdrawn from the target site during use. The film product for oral use can be effectively improved to contact liquid, quickly deform, adhere, break or disintegrate, and thus the film product for oral use can be more easily adhered to the target site. The film product for oral use can be moved multiple times and more easily adhered to the target site. Basically, one film product for oral use can be adhered to the target site, and the use cost can be significantly reduced. BRIEF DESCRIPTION OF DRAWINGS

[0065] FIG. 1 is a structural schematic diagram of a film product according to an embodiment of the present disclosure, wherein the upper drawing is a plan view of the film product, and the lower drawing is a sectional view along the line A-A in the upper drawing.

[0066] FIG. 2 is a structural schematic diagram of a film product according to an embodiment of the present disclosure, wherein the upper drawing is a plan view of the film product, and the lower drawing is a sectional view along the line B-B in the upper drawing.

[0067] FIG. 3 is a sectional view of a film product according to an embodiment of the present disclosure.

[0068] FIG. 4 is a schematic diagram of a cross-sectional structure of a film dosage form according to one embodiment of the present disclosure.

[0069] FIG. 5 is a schematic diagram of a cross-sectional structure of a film dosage form according to one embodiment of the present disclosure.

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

[0071] FIG. 7 is a schematic diagram of a cross-sectional structure of a film dosage form according to one embodiment of the present disclosure.

[0072] FIG. 8 is a schematic diagram of a cross-sectional structure of a film dosage form according to one embodiment of the present disclosure.

[0073] FIG. 9 is a schematic diagram of a cross-sectional structure of a film dosage form according to one embodiment of the present disclosure.

[0074] FIG. 10 is a schematic diagram of a cross-sectional structure of a film dosage form according to one embodiment of the present disclosure.

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

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

[0077] FIG. 13 is a schematic diagram of a cross-sectional structure of a film dosage form according to one embodiment of the present disclosure.

[0078] FIG. 14 is a schematic diagram of a cross-sectional structure of a film dosage form according to one embodiment of the present disclosure.

[0079] FIG. 15 is a schematic diagram of a cross-sectional structure of a film dosage form according to one embodiment of the present disclosure.

[0080] FIG. 16 is a schematic diagram of a cross-sectional structure of a film dosage form according to one embodiment of the present disclosure.

[0081] FIG. 17 is a schematic diagram of a cross-sectional structure of a film dosage form according to one embodiment of the present disclosure.

[0082] FIG. 18 is a schematic diagram of a cross-sectional structure of a film dosage form according to one embodiment of the present disclosure.

[0083] FIG. 19 is a schematic diagram of a cross-sectional structure of a film dosage form according to one embodiment of the present disclosure.

[0084] FIG. 20 is a schematic diagram of a cross-sectional structure of a film dosage form according to one embodiment of the present disclosure.

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

[0086] FIG. 22 is a schematic diagram of a cross-sectional structure of a film dosage form according to one embodiment of the present disclosure.

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

[0088] FIG. 24 is a photograph of a nicotine functional film layer according to embodiment 1.

[0089] FIG. 25 is a photograph of a film product for oral use according to embodiment 1.

[0090] FIG. 26 is a photograph of a film product for oral use according to embodiment 1.

[0091] FIG. 27 is a nicotine relative dissolution rate-time curve according to embodiment 1.

[0092] FIG. 28 is a nicotine relative dissolution rate-time curve according to embodiment 1.

[0093] FIG. 29 is a photograph of a propolis film according to embodiment 2.

[0094] FIG. 30 is a photograph of a propolis film product packaged with nonwoven fabric according to embodiment 2.

[0095] FIG. 31 is a schematic diagram of a propolis film application site according to embodiment 2.

[0096] FIG. 32 is a photograph of a soluble dental patch according to embodiment 3.

[0097] FIG. 33 is a photograph of a soluble dental patch product packaged with nonwoven fabric according to embodiment 3.

[0098] FIG. 34 is a photograph of a nicotine film product packaged with nonwoven fabric according to embodiment 5.

[0099] FIG. 35 is a photograph of a nicotine film product packaged with nonwoven fabric according to embodiment 5.

[0100] FIG. 36 is a photograph of a nicotine film product packaged with nonwoven fabric according to embodiment 5.

[0101] FIG. 37 is a photograph of a nicotine film product packaged with nonwoven fabric according to embodiment 5.

[0102] FIG. 38 is a photograph of a nicotine film product packaged with nonwoven fabric according to embodiment 5.

[0103] FIG. 39 is a photograph of a swelling film according to embodiment 6.

[0104] FIG. 40 is a photograph of a swelling film product according to embodiment 6, after packaging and printing of graphic information.

[0105] FIG. 41 is a photograph of a swelling film product according to embodiment 6, after packaging and printing of graphic information.

[0106] Figure 42 is a photograph of a swelled film product after packaging and printing in embodiment 6.

[0107] Figure 43 is a photograph of a swelled film product after partial collapse in embodiment 6.

[0108] Figure 44 is a photograph of a nose patch product in embodiment 9.

[0109] Figure 45 is a schematic diagram of a film product set in one embodiment of the present disclosure.

[0110] Figure 46 is a cross-sectional schematic diagram of an oral product in one embodiment of the present disclosure.

[0111] Figure 47 is a cross-sectional schematic diagram of an oral product in another embodiment of the present disclosure.

[0112] Figure 48 is a cross-sectional schematic diagram of an oral product in yet another embodiment of the present disclosure.

[0113] Figure 49 is a schematic diagram of an oral product in yet another embodiment of the present disclosure.

[0114] Figure 50 is a front view of an oral product in one embodiment of the present disclosure.

[0115] Figure 51 is a front view of an oral product in another embodiment of the present disclosure.

[0116] Figure 52 is a front view of an oral product in yet another embodiment of the present disclosure.

[0117] Figure 53 is a cross-sectional schematic diagram of an oral product in still another embodiment of the present disclosure.

[0118] Figure 54 is a cross-sectional schematic diagram of an oral product in yet another embodiment of the present disclosure.

[0119] Figure 55 is a front view of an oral product in still another embodiment of the present disclosure.

[0120] Figure 56 is a front view of an oral product in still another embodiment of the present disclosure.

[0121] 11: first sheet layer 110: third sub-sheet layer 111: first sub-sheet layer 112: first detachable part 113: first detachable area 114: first non-detachable area 115: first weak connection structure 12: second sheet layer 121: second sub-sheet layer 122: second detachable part 123: second detachable area 124: second non-detachable area 125: second weak connection structure 13: third sheet layer 14: first opening 15: porous layer 16: through hole 100: first accommodation space 20: functional film layer 21: first sub-functional film layer 22: second sub-functional film layer 200: second accommodation space 30: waterproof layer 40: water-swellable substance 50: holding part 100a: oral product 10a: support layer 101a: channel 20a: mouth dissolving film 11a: first opening 12a: second opening 13a: through hole 30a: water-swellable layer 40a: waterproof layer 102a: accommodation space 50a: porous layer DETAILED DESCRIPTION

[0122] Embodiments of the present application are described in detail below with reference to examples shown in the attached drawings. The embodiments described below by reference to the attached drawings are exemplary and are intended to explain the present application, and cannot be understood as a limitation of the present application.

[0123] The present disclosure is based on the following findings and recognitions of the inventors:

[0124] The film product can only exert its efficacy after dissolving or disintegrating at the target site. In this case, there is a technical bias that the faster the film product dissolves, the better. The present inventors have found that when a user uses a film product, the user usually directly holds the film product and places or adheres it to the target site (e.g., oral mucosa, teeth, gums, the tongue, under the tongue, nasal mucosa, etc.). During this process, the film product may encounter liquid in the environment and prematurely dissolve, shrink, or deform. The user can only replace the new film product or move the film product with the hand. That is, in order to successfully adhere the film product to the target site, the film product is not necessarily the faster the better. In addition, the present inventors have found that existing film products do not take into account the need to withdraw midway. Therefore, the current film product cannot meet the use requirements of multiple scenarios and needs to be further improved.

[0125] The present inventors have long studied and proposed, by a physical method, adding a sheet layer to improve the tensile strength of the film product, so that the ability of the film product to maintain its shape is improved, and the problems of shrinkage, deformation, difficulty in adhering to the target site, and difficulty in withdrawing midway during use are improved.

[0126] Therefore, in a first aspect, the present disclosure provides a film product. According to embodiments of the present disclosure, the film product comprises a functional film layer and a sheet layer, the functional film layer contains an active ingredient, the active ingredient is suitable to be released from the functional film layer and act on a target site. In some embodiments, the sheet layer comprises a first sheet layer, the first sheet layer is arranged on at least part of the surface of the functional film layer. In other embodiments, the first sheet layer is embedded in the functional film layer.

[0127] In the film product, by arranging the sheet layer, the functional film layer can be supported, thereby improving the tensile strength of the film product, the ability of the film product to maintain its shape is improved, and the film product is less likely to deform, shrink, break, adhere, and the like, and can be moved flexibly to adjust the position, so that the film product can be more accurately attached to the target site, and the film product is easy to exit during use.

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

[0129] Further, the sheet layer arranged on the surface of the functional film layer can have a certain isolation effect, thereby improving the adhesion problem between multiple film products, and reducing the packaging cost. During use, the user can hold the position of the film product surface provided with the sheet layer, so that the functional film layer is less likely to directly contact the liquid on the user's hand to cause early dissolution, deformation, shrinkage, breakage, adhesion, and the like, which is beneficial to the accurate placement or attachment of the film product, and can improve the usability of the film product.

[0130] In addition, after the first sheet layer arranged on the surface of the functional film layer contacts liquid such as saliva and body fluid, the time for the liquid to reach the functional film layer can be delayed, so that the possibility of loss of the active ingredient due to dissolution of the functional film layer before reaching the target site is reduced, and the risk of discomfort caused by the user due to the rapid disintegration of the functional film layer to release a large amount of active ingredient after reaching the target site is also reduced.

[0131] It can be understood that the functional film layer refers to a film-shaped preparation prepared by processing an active ingredient (such as a raw drug) and a suitable film-forming material, and 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 play a role. The film product herein refers to a product containing a functional film layer and a sheet layer, and the active ingredient in the functional film layer is suitable to be released from the functional film layer and act on a target site.

[0132] Specifically, part of the surface of the functional film layer can be exposed (i.e. not covered by the sheet layer) to allow the active ingredient to be released and act on the target position. The sheet layer can also have water permeability, which can be that the sheet layer itself has water permeability, or that the sheet layer does not have water permeability but has water permeable channels. In this way, body fluids, saliva and other liquids can infiltrate the functional film layer through the sheet layer or the water permeable channels, so that the active ingredient in the functional film layer can be dissolved and released to act on the target position.

[0133] Specifically, in some embodiments, the first sheet layer can only cover part of the surface of the functional film layer. At this time, the first sheet layer can be located at the edge of the functional film layer, or can be located in the middle of the functional film layer. In this way, during use, the position of the functional film layer where the first sheet layer is arranged can be used for holding, and the first sheet layer can delay the liquid from reaching the functional film layer, thereby reducing the risk of wrinkles, deformation and adhesion of the film product during attachment, while part of the functional film layer not covered by the first sheet layer can ensure rapid dissolution and release of the active ingredient.

[0134] In other embodiments, the first sheet layer can also cover the entire surface of the functional film layer. In one specific example, referring to FIG. 1, the lower drawing is a schematic diagram of the cross-sectional structure of the A-A section in the upper drawing, it can be seen that the first sheet layer 11 covers one side surface of the functional film layer 20. In this way, the user can hold the film product on the side where the first sheet layer 11 is arranged, which is convenient for moving the film product and improves the problem that the film product is easy to stick to the hand, while the surface of the functional film layer 20 not covered by the first sheet layer 11 still maintains good adhesion and can be more easily attached to the target position.

[0135] According to the embodiments of the present disclosure, referring to FIG. 2, the lower drawing is a schematic diagram of the cross-sectional structure of the B-B section in the upper drawing, it can be found that the sheet layer can also include a second sheet layer 12, and the first sheet layer 11 and the second sheet layer 12 are arranged on the opposite surfaces of the functional film layer 20. In this way, the first sheet layer 11 and the second sheet layer 12 work together to increase the tensile strength of the film product, which can better improve the problem that the film product is easy to wrinkle and deform; and the first sheet layer 11 and the second sheet layer 12 are located on the 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 two film products, thereby reducing the risk of adhesion of the functional film layer 20 during attachment, transportation and storage, making it more convenient for the user to move the film product during use, and also reducing the risk of loss of active ingredients due to dissolution of the film product before reaching the target position, thereby improving the usability of the film product. When the first sheet layer 11 and the second sheet layer 12 are not arranged, the adjacent two functional film layers 20 need to be isolated by packaging structures such as aluminum foil to prevent adhesion, so the arrangement of the first sheet layer 11 and the second sheet layer 12 can also reduce the packaging cost of the film product.

[0136] It can be understood that the relative sizes, specific arrangements, etc. of the first sheet layer 11, the functional film layer 20, and the second sheet layer 12 can be flexibly adjusted according to actual use needs.

[0137] In some embodiments, the edges of at least two of the first sheet layer 11, the functional film layer 20, and the second sheet layer 12 are arranged in alignment. Specifically, the edges of the first sheet layer 11 and the functional film layer 20 can be arranged in alignment, the edges of the second sheet layer 12 and the functional film layer 20 can be arranged in alignment, the first sheet layer and the second sheet layer can be arranged in alignment, or the edges of the first sheet layer 11, the functional film layer 20, and the second sheet layer 12 can be arranged in alignment (see FIG. 2). In this way, the first sheet layer 11 and the second sheet layer 12 can effectively improve the performance of the film agent product, while being relatively low in cost and easy to implement.

[0138] In some embodiments, the first sheet layer 11 and the second sheet layer 12 are connected at part of their edges to jointly form a first bag-like structure with at least one side edge open, a first containing space 100 is provided in the first bag-like structure, and at least part of the functional film layer is arranged in the first containing space 100. Specifically, referring to FIG. 3, part of the functional film layer 20 can be contained in the first containing space 100, and another part of the functional film layer 20 can be located outside the first containing space 100. The functional film layer 20 can also be entirely contained in the first containing space 100 (see FIG. 4).

[0139] Through the structure provided by the present embodiment, when the film agent product comes into contact with a liquid such as a body fluid or saliva, the sheet layer can preferentially absorb and infiltrate the liquid or isolate the liquid, delaying the contact between the functional film layer 20 placed in the first containing space 100 and the liquid. While the active ingredients in the functional film layer 20 are rapidly and massively released, the film agent product can also be moved at will according to needs to accurately move to a 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 containing space 100 is wrinkled, deformed, broken, disintegrated, etc. due to contact with the liquid, the first bag-like structure can play a certain limiting role on this part of the functional film layer 20, so that the functional film layer 20 is less likely to come into contact and adhere with non-target positions outside, can reduce the risk of user physiological discomfort caused by rapid dispersion of a large amount of dissolved or disintegrated functional film layer 20, and enables the film agent product to exit the target position at any time during use, thereby improving the usability of the film agent product.

[0140] In some embodiments, the first sheet layer 11 and the second sheet layer 12 are connected at their edges to jointly form a second bag-like structure with no open edge, a second containing space 200 is provided in the second bag-like structure, and the functional film layer 20 is contained in the second containing space 200 (see FIG. 5).

[0141] When the film product is in contact with a liquid such as a body fluid or saliva, the sheet layer can preferentially absorb and infiltrate the liquid or isolate the liquid, delaying the contact between the functional film layer 20 in the second containing space 200 and the liquid. While the active ingredient in the functional film layer 20 is rapidly and massively released, the film product can also be moved at will according to the needs to accurately move to the target position, so that the active ingredient contained in the functional film layer 20 can mainly act on the target position. Even if the functional film layer 20 in the second containing space 200 is wrinkled, deformed, broken, disintegrated, or the like due to contact with the liquid, the second bag-like structure can limit the functional film layer 20 to some extent, so that the functional film layer 20 is not easy to contact and adhere to the non-target position outside, the risk of rapid dispersion of a large amount of dissolved or disintegrated functional film layer 20 causing physiological discomfort of the user can be reduced, and the film product can be withdrawn from the target position at any time during use, thereby improving the usability of the film product.

[0142] According to an embodiment of the present disclosure, at least one of the first sheet layer 11 and the second sheet layer 12 has a first opening 14 according to different needs of different use positions, and part of the functional film layer 20 is exposed through the first opening 14. In this way, the part of the functional film layer 20 corresponding to the first opening 14 is not covered by the sheet layer, and has better adhesion to the target position. At the same time, the exposed functional film layer 20 corresponding to the first opening 14 can appropriately increase the release speed of the active ingredient in the functional film layer 20, thereby meeting different use needs.

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

[0144] In addition, the specific size, contour shape, and number of the first opening 14 are not particularly limited, for example, the contour shape can be a rectangular shape, a square shape, a circular shape, a diamond shape, a triangular shape, a polygonal shape, or an irregular shape, and the number can be one, two, three, four, five, or the like, which can be flexibly adjusted according to actual use needs.

[0145] According to an embodiment of the present disclosure, the first sheet layer 11 and the second sheet layer 12 are independently single-layer structures or multi-layer structures according to the needs of the release speed of the active ingredient. Specifically, both the first sheet layer 11 and the second sheet layer 12 can be single-layer structures (see FIG. 5).

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

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

[0148] Specifically, by adjusting the number of layers of the first sheet layer 11 and the second sheet layer 12, the release speed of the active ingredient can be adjusted. It can be understood that the more the number of layers of the first sheet layer 11 and / or the second sheet layer 12, the greater the resistance that the active ingredient encounters when being released from the functional film layer 20 to the outside, and the slower the release speed of the active ingredient. Conversely, the fewer the number of layers of the first sheet layer 11 and / or the second sheet layer 12, the smaller the resistance that the active ingredient encounters when being released from the functional film layer 20 to the outside, and the faster the release speed of the active ingredient. For the multi-layer first sheet layer 11 and / or the second sheet layer 12, the number of layers of the sheet layer can be adjusted to achieve the sustained release and controlled release of the active ingredient when designing the film product.

[0149] According to an embodiment of the present disclosure, the adjacent first sub-sheet layers 111 are detachably connected; and / or the adjacent second sub-sheet layers 121 are detachably connected. Specifically, through the detachable connection, the user can adjust the number of layers of the first sub-sheet layer 111 and / or the second sub-sheet layer 121 according to the actual experience in the actual use process, thereby better meeting the use requirements of different users.

[0150] It can be understood that the specific manner of detachable connection is not particularly limited as long as it can achieve the detachable function.

[0151] In some embodiments, referring to FIG. 10, the first sub-sheet layer 111 is provided with a first detachment part 112. Thus, the user can conveniently tear off the first sub-sheet layer 111 by holding the first detachment part 112.

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

[0153] In some embodiments, the partially exposed edges of the two connected first sub-sheet layers 111 are not sealed. Thus, the user can clearly identify the number of layers of the first sub-sheet layer 111 through the unsealed position, and can tear off the first sub-sheet layer 111 using the unsealed position.

[0154] In some embodiments, referring to FIG. 10, the second sub-layer 121 is provided with a second detachable part 122. In this way, the user can easily tear off the second sub-layer 121 by holding the second detachable part 122.

[0155] In some embodiments, referring to FIG. 10, the second sub-layer 121 is provided with a second detachable part 122. In this way, the user can easily tear off the second sub-layer 121 by holding the second detachable part 122.

[0156] In some embodiments, referring to FIG. 11, the first layer 11 includes a first detachable area 113 and a first non-detachable area 114, and the first detachable area 113 is connected to the first non-detachable area 114 through a first weak connection structure 115. In this way, the user can tear off the first detachable area 113 along the first weak connection structure.

[0157] In this article, the first detachable area 113 refers to an area on the first layer 11 that is suitable for being detached by a certain operation, and the first non-detachable area 114 refers to an area on the first layer 11 that is fixedly connected to other parts of the film agent product and is not suitable for being detached. The meanings of the second detachable area 123, the second non-detachable area 124, the fifth detachable area, the fifth non-detachable area, the sixth detachable area, and the sixth non-detachable area mentioned below are the same as this, and will not be described one by one below.

[0158] In some embodiments, referring to FIG. 12, the second layer 121 includes a second detachable area 123 and a second non-detachable area 124, and the second detachable area 123 is connected to the second non-detachable area 124 through a second weak connection structure 125. In this way, the user can tear off the second detachable area 123 along the second weak connection structure.

[0159] In this article, the first weak connection structure and the second weak connection structure refer to structures with weak connection strength or stability, which can be easily damaged by simple tearing during use. As an example, the first weak connection structure and the second weak connection structure can each independently be an indentation, a groove, a plurality of spaced holes distributed along a contour line, etc.

[0160] According to the embodiments of the present disclosure, the film agent product further includes a waterproof layer 30. The waterproof layer can reduce the possibility of the active ingredients released by the functional film layer 20 entering the non-target position and causing discomfort, so that the active ingredients are more absorbed by the target position.

[0161] According to embodiments of the present disclosure, the specific position of the waterproof layer can be selected according to actual needs. Specifically, in actual use, the user can select to set the waterproof layer at the corresponding non-target position, so as to isolate the waterproof layer from the non-target position and the functional film layer.

[0162] Herein, the target position refers to the position where the active ingredient is expected to act; the non-target position refers to the position other than the target position, i.e., the position where the active ingredient is not expected to act. For example, taking a film product for treating oral ulcer as an example, the position where the oral ulcer occurs is the target position, and the position other than the position where the oral ulcer occurs is the non-target position.

[0163] In some embodiments, the film product comprises the functional film layer 20 and the first sheet layer 11, and the waterproof layer 30 is arranged on the surface of the first sheet layer 11 away from the functional film layer 20 or the surface of the functional film layer 20 not covered by the first sheet layer 11. Specifically, the waterproof layer 30 is arranged on the surface of the functional layer 20 away from the first sheet layer 11 (see FIG. 13) or the surface of the functional film layer 20 not covered by the first sheet layer 11.

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

[0165] The arrangement of the waterproof layer 30 can reduce the delivery of the active ingredient released by the functional film layer 20 to the non-target position, for example, reduce the active ingredient in the functional film layer 20 that needs to be absorbed through the oral mucosa to enter the digestive tract with saliva. The active ingredient released by the functional film layer 20 mainly acts on the target position.

[0166] According to embodiments of the present disclosure, the film product further comprises a water-swellable substance 40, and the water-swellable substance 40 is arranged at at least one of the following positions: the surface of the first sheet layer 11, the surface of the second sheet layer 12, the pores of the first sheet layer 11, and the pores of the second sheet layer 12. Specifically, the water-swellable substance 40 can be arranged on the surface of the first sheet layer 11 close to the functional film layer 20 and / or the surface of the second sheet layer 12 close to the functional film layer 20 (see FIG. 16). The water-swellable substance 40 can improve the overall tensile strength of the film product after swelling, facilitate the user to move the film product, and improve the usability of the film product.

[0167] According to embodiments of the present disclosure, the first sheet layer 11 and the second sheet layer 12 are the same. In this way, the release speed of the active ingredient on both sides of the film product is consistent, which can provide a smooth experience for the user.

[0168] According to embodiments of the present disclosure, in order to meet the needs of different use scenarios and enrich the user experience, the first sheet layer 11 and the second sheet layer 12 can have different properties, thereby achieving different use experiences and use effects. According to embodiments of the present disclosure, at least one of the water permeability, the porosity, the thickness, the material, the tensile force and the number of layers of the first sheet layer 11 and the second sheet layer 12 is different. In this way, the two side surfaces of the film product can provide different release speeds of active ingredients, enrich the user experience, and meet more use scenarios and more personalized use needs of users.

[0169] According to embodiments of the present disclosure, the materials of the first sheet layer 11 and the second sheet layer 12 are not particularly limited, as long as the use needs of the target position are met. For example, for a film product used in the oral cavity, the first sheet layer 11 and the second sheet layer 12 can adopt a flexible material so that the film product can as much as possible conform to the shape of the oral cavity, thereby avoiding causing discomfort to the user.

[0170] Specifically, according to different setting modes of the first sheet layer 11 and the second sheet layer 12, the selection of the material is also different. If at least part of the functional film layer 20 is not wrapped by the first sheet layer 11 and the second sheet layer 12, the water permeability of the first sheet layer 11 and the second sheet layer 12 is not limited. The first sheet layer 11 and the second sheet layer 12 can have water permeability, or can not have water permeability. If the first sheet layer 11 and the second sheet layer 12 wrap the functional film layer 20 entirely, at least one of the first sheet layer 11 and the second sheet layer 12 is required to have water permeability, or the first sheet layer 11 and the second sheet layer 12 do not have water permeability but are provided with water permeable channels. The water permeable channels can be used for saliva to pass through the sheet layer, for example, a plastic sheet layer without water permeability is provided with through holes. In this way, the active ingredients in the functional film layer 20 can be effectively released and act on the target position.

[0171] According to embodiments of the present disclosure, the water permeable channel includes a through hole 16, or includes a through hole 16 and a porous layer 15 detachably arranged on the through hole 16. FIG. 17 shows a 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 opened, the active ingredients released by the functional film layer 20 can be more absorbed by the target position through the through hole 16, and a stronger stimulation can be obtained. When the porous layer 15 is not opened, the active ingredients released by the functional film layer 20 need to pass through the porous layer 15 to be released and act on the target position, and the release speed of the active ingredients is relatively slow.

[0172] According to embodiments of the present disclosure, the first sheet layer 11 and the second sheet layer 12 each independently comprises at least one of non-woven fabric, special paper, wood pulp paper, polylactic acid paper, fiber cloth, mesh cloth, woven fabric, foamed resin film, reticular resin film, porous resin film, swellable sheet, swellable mesh, plastic sheet provided with the water-permeable passage, and rubber sheet provided with the water-permeable passage. In this way, the sheet layer has good liquid permeability, which is conducive to the functional film layer 20 contacting the liquid to release the active ingredient to act on the target position.

[0173] Herein, the swellable sheet refers to a sheet having swelling property, and the swellable mesh refers to a mesh having swelling property, both of which can absorb and retain liquid, i.e., can absorb liquid and lock the liquid in the swellable sheet and the swellable mesh. As examples, edible gel sheet and edible gel mesh can be included, such as carrageenan sheet, carrageenan mesh, and the like.

[0174] According to embodiments of the present disclosure, in order to better meet the use requirements, the functional film layer 20 can comprise a plurality of sub-functional film layers, the plurality of sub-functional film layers are the same, or at least one of the types and concentrations of active ingredients contained in the plurality of sub-functional film layers is different. In this way, in the case that the thickness of a single functional film layer is limited, a greater thickness and a greater dose of active ingredient can be achieved by arranging a plurality of sub-functional film layers. While the plurality of sub-functional film layers are different, the film product can have multiple effects or different use experiences. Specifically, if the active ingredients in the plurality of sub-functional film layers are different, the film product can have different use effects. If the concentrations of the active ingredients in the plurality of sub-functional film layers are different, different release rates of the active ingredients can be achieved at different stages of use, enriching the user's experience and use effect.

[0175] According to embodiments of the present disclosure, the specific arrangement of the plurality of sub-functional film layers is not particularly limited, and can be arranged in a stacked manner or arranged in a tiled manner on one surface. In some embodiments, the sub-functional film layer comprises at least one of a first sub-functional film layer 21 and a second sub-functional film layer 22, wherein a plurality of first sub-film layers 21 are arranged in a stacked manner, and a plurality of second sub-functional film layers 22 are arranged in a tiled manner on the first surface. Specifically, the functional film layer 20 can only comprise a plurality of first sub-functional film layers 21 (see FIG. 18); the functional film layer can only comprise a plurality of second sub-functional film layers 22 (see FIG. 19); and the functional film layer can also comprise both a plurality of first sub-functional film layers 21 and at least one second sub-functional film layer 22 (see FIG. 20).

[0176] It can be understood that, in actual use, the release of the active ingredient of the film product is carried out in the order from the outside to the inside and from the periphery to the center. Based on this, different components, different concentrations, and different arrangement modes of the sub-functional film layers can be used to achieve a more diverse use experience and use effect.

[0177] It should be noted that the description manner "in one plane" adopted herein can be in a flat plane or in a curved plane.

[0178] According to the embodiments of the present disclosure, the adjacent first sub-functional film layers 21 are detachably connected; and / or the second sub-functional film layers 22 are detachably connected with the sheet layers. Thus, the user can flexibly adjust the types and quantities of the sub-functional film layers according to the actual needs of the individual, and better meet the individual needs of the user.

[0179] According to the embodiments of the present disclosure, the first sub-functional film layers 21 are provided with third detachable parts. Thus, the user can conveniently tear off the first sub-functional film layers 21 through the third detachable parts, and better meet the individual needs of the user.

[0180] According to the embodiments of the present disclosure, the partially edge-unsealed of the two first sub-functional film layers 21 connected. Thus, the user can clearly identify the number of layers of the first sub-functional film layers 21 through the unsealed position, and can hold the unsealed position to tear off the first sub-functional film layers 21.

[0181] According to the embodiments of the present disclosure, the second sub-functional film layers 22 are provided with fourth detachable parts. Thus, the user can conveniently tear off the second sub-functional film layers 22 through the fourth detachable parts, and better meet the individual needs of the user.

[0182] According to the embodiments of the present disclosure, the partially edge-unsealed of the second sub-functional film layers 22. Thus, the user can clearly identify the number of layers of the second sub-functional film layers 22 through the unsealed position, and can hold the unsealed position to tear off the second sub-functional film layers 22.

[0183] According to the embodiments of the present disclosure, referring to FIG. 21, the first sheet layer 11 includes a plurality of third sub-sheet layers 110, the plurality of third sub-sheet layers 110 are substantially parallel to the first plane, and the orthographic projection of each third sub-sheet layer 110 on the first plane and the orthographic projection of at least one second sub-functional film layer 22 on the first plane have an overlapping area; at least one of the water permeability, the material, the porosity, the tensile force, the thickness and the number of layers of the plurality of third sub-sheet layers 110 is different. Thus, different second sub-functional film layers 22 can have different active ingredient release rates, better meet the needs of the user, and enrich the user experience.

[0184] In the present disclosure, the third sub-sheet layer 110 substantially parallel to the first plane means that the third sub-sheet layer 110 is parallel to the first plane, or the distance between any position on the third sub-sheet layer 110 and the first plane fluctuates within a reasonable range, such as a reasonable measurement error, etc. For example, the percentage difference between the distances between any two points on the third sub-sheet layer 110 and the first plane (the absolute value of the difference between the two values / the average of the two values x 100%) is not greater than 5%.

[0185] According to an embodiment of the present disclosure, referring to FIG. 22, the sheet layer further comprises at least one third sheet layer 13, which is sandwiched between two adjacent first sub-functional film layers 21. Thus, the third sheet layer 13 can play a role of isolation between adjacent first sub-functional film layers 21, and the presence of the third sheet layer can also increase the resistance to the release of the active ingredient, thereby achieving the effect of controlling the different release rates of the active ingredient in different first sub-functional film layers.

[0186] According to an embodiment of the present disclosure, at least one of the water permeability, material, porosity, thickness, tensile force and number of layers of the plurality of third sheet layers 13 is different. Thus, the above parameters of the third sheet layer are different, the resistance of the active ingredient to pass through the third sheet layer is different, and different release rates of the active ingredient can be achieved, thereby enriching the user experience.

[0187] According to an embodiment of the present disclosure, referring to FIG. 23, the film product can further comprise a holding portion 50. Thus, the user can move the film product by holding the holding portion with hands, so as to accurately place it at the target position during use, and can take out the film product in advance during use by holding the holding portion with hands, so as to adapt to diversified use requirements, thereby greatly improving the usability of the film product.

[0188] According to an embodiment of the present disclosure, the specific form of the holding portion can not be particularly limited, as long as it is convenient to hold during the process of attaching the film product. In some embodiments, the holding portion comprises at least one of a pulling line and a handle. Specifically, the pulling line can be sewn or pasted on the sheet layer to form a structure similar to a tea bag, or the handle can be formed by the sheet layer or the sheet layer and the functional film layer together. Thus, the structure is simple and convenient to use.

[0189] According to an embodiment of the present disclosure, referring to FIG. 23, the holding portion 50 is located at the edge of the film product. Specifically, the holding portion can be located at one end of the film product, at opposite ends, or a plurality of spaced holding portions can be provided at the side edge of the film product, etc. Thus, the film product can be moved more flexibly by the holding portion, thereby improving the mobility of the film product.

[0190] According to an embodiment of the present disclosure, the holding portion comprises part of the sheet layer, or the holding portion comprises part of the sheet layer and part of the functional film layer. Specifically, by providing the sheet layer, the tensile force of the film product is enhanced, and the mechanical strength is higher, so that a part of the film product, i.e. the sheet layer and the functional film layer together, can be directly held as the holding portion. In some other embodiments, the sheet layer can be made to exceed the functional film layer by a part, and the exceeding part can constitute the holding portion.

[0191] According to embodiments of the present disclosure, the film dosage product is printed with graphic information. Thus, the film dosage product is convenient to use. Specifically, the graphic information can include any picture, texture, and text information. As an example, the graphic information can include the active ingredient type of the functional film layer, the active ingredient concentration, the taste, the effective date, the usage instruction, the brand logo, the decorative pattern, and the like. The user can identify the purpose and dosage of the film dosage product according to the graphic information such as the active ingredient type, the active ingredient concentration, and the taste; the brand logo can be suitable for the establishment of brand awareness of the merchant; and the decorative pattern can increase the aesthetic appearance of the film dosage product.

[0192] Specifically, the graphic information can be formed on the tablet layer, or can be formed on both the tablet layer and the functional film layer. In some embodiments, the graphic information can be printed, or can be a trace formed by ultrasonic embossing. The trace can include at least one of a concave trace, a convex trace, and a hollow trace, and the trace can be used to represent the graphic information.

[0193] According to embodiments of the present disclosure, the film dosage product includes at least one of a buccal film product, a sublingual film product, a lingual film product, an intraoral film product, a gingival film product, a dental film product, and a nasal cavity film product.

[0194] Herein, the buccal film product refers to a film dosage product that is adhered to the posterior position of the two sides of the mouth corner, and that has a local or systemic effect after being absorbed through the oral mucosa. The sublingual film product refers to a film dosage product designed for rapid absorption through the sublingual mucosa. The lingual film product refers to a film dosage product designed for rapid absorption through the lingual mucosa. The intraoral film product refers to a film dosage product that can be placed on the intraoral mucosa, and that has a local or systemic therapeutic effect by absorbing the active ingredient through the intraoral mucosa. The gingival film product refers to a film dosage product that can be applied to the gingiva. The dental film product refers to a film dosage product that can be applied to the teeth. The nasal cavity film product refers to a film dosage product that can be placed in the nasal cavity, and that has a local or systemic therapeutic effect by absorbing the active ingredient through the nasal mucosa.

[0195] According to embodiments of the present disclosure, the outer contour shape of the film dosage product includes at least one of a square, a rectangle, a circle, a triangle, a polygon, and an irregular shape. It can be understood that the shape of the film dosage product can be designed according to ergonomics and convenience for different use sites, such as the mucosal position of the buccal film product and the sublingual film product, which can use a circular or square film dosage product, the narrow film dosage product for the gingiva, the wide film dosage product for the dental alveolus, and the like.

[0196] According to the embodiments of the present disclosure, the maximum size of the film product outer contour is 0.1-8 cm, specifically, it can be 0.8 cm-3 cm, more specifically, it can be 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 size is 0.1-1.5 cm, specifically, it can be 0.6 cm-1.2 cm, more specifically, it can be 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 size refers to the maximum distance between any two points on the film product contour line, and the minimum size refers to the minimum distance between any two points on the film product contour line. Within the above size range, the use requirements of multiple parts such as oral cavity and nasal cavity can be met.

[0197] According to the embodiments of the present disclosure, the functional film layer includes at least one of a completely dissolving film layer, a partially dissolving film layer, or a swelling film layer. Specifically, the film product provided by the present disclosure can use the above-mentioned different types of functional film layers, which have a wider range of functions, can meet the use requirements of different use scenarios, and have higher use convenience.

[0198] Herein, the completely dissolving film layer refers to the entire functional film layer completely dissolving in the use environment of the film product, no longer existing in the original functional film layer form, but becoming a molecular or ionic state uniformly dispersed in the solvent. The partially dissolving film layer means that only a part of the functional film layer dissolves, and the other part maintains a relatively complete structure; this may be due to different chemical properties or different degrees of interaction with the solvent in different regions of the functional film layer. The swelling film layer means that the functional film layer absorbs the liquid and swells in volume when it is in contact with the liquid in the use environment of the film product, but it does not really dissolve, and the functional film layer still maintains a certain integrity, only the size becomes larger, and its basic structure and performance may change.

[0199] According to the embodiments of the present disclosure, the functional film layer contains active ingredients, which include at least one of pharmaceutical ingredients, nutritional and health ingredients, food ingredients, daily chemical ingredients, and alkaloids. Through the structure provided by the present embodiments, the effects of treatment, nutrition and health, eating, beauty and skin care, fatigue relief, etc. can be effectively exerted.

[0200] In this context, the pharmaceutical ingredient refers to a drug with a certain therapeutic effect. According to embodiments of the present disclosure, the pharmaceutical ingredient includes at least one of a mouth ulcer drug, a psychotropic drug, an analgesic, an anti-inflammatory drug, a cannabinoid and its derivative, a nasal drug, a respiratory tract drug, and sildenafil.

[0201] In this context, the nutraceutical ingredient refers to an ingredient that can supplement the body with nutrients and help the body maintain health. According to embodiments of the present disclosure, the nutraceutical ingredient includes at least one of American ginseng extract, Schisandra chinensis extract, Ganoderma lucidum extract, arginine, propolis, melatonin, glutathione, and taurine.

[0202] In this context, the food ingredient refers to a substance that can be taken orally to maintain life and development, i.e., to provide energy and form or replace tissues. According to embodiments of the present disclosure, the food ingredient includes at least one of tea extract, coffee extract, and vitamin.

[0203] In this context, the daily chemical ingredient refers to an ingredient for daily use such as skin care, tooth whitening, etc. According to embodiments of the present disclosure, the daily chemical ingredient includes at least one of papain, catalase, a tooth whitening ingredient, an oral repair ingredient, and an anti-aging ingredient.

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

[0205] It should be noted that when multiple active ingredients are used simultaneously in a film product, attention should be paid to the fact that the multiple active ingredients cannot have a mutual exclusion relationship. The inability to have a mutual exclusion relationship can mean that the multiple active ingredients do not have side reactions that can adversely affect the use effect, or that the multiple active ingredients do not have opposite effects, or that the multiple active ingredients do not adversely affect the human body when they act together. Specifically, when multiple active ingredients are used simultaneously in a film product, the active ingredients need to comply with the therapeutic specifications, such as the provisions of the pharmacopoeia, so that the product meets the industry compliance or mandatory standard requirements.

[0206] Thus, the film product has a wide range of uses and can meet the needs of various use scenarios.

[0207] It can be understood that the film product is an independent individual, and multiple film products can be packaged into one packaging box. In some embodiments, multiple independent film products can be directly packaged into one packaging box. In other embodiments, multiple film products can be connected to form a film product group, and then one or more film product groups can be packaged into one packaging box.

[0208] In some embodiments, a plurality of film products can be connected by a weak connection structure to form a film product group. In other embodiments, a plurality of film products can be connected by a weak connection structure to a support to form a film product group. In yet other embodiments, a plurality of film products can be connected by a weak connection structure to each other and to a support to form a film product group. In this way, the film products can be conveniently packaged, stored, and counted. As an example, FIG. 45 shows a film product group in which a plurality of film products are connected by a weak connection structure in an embodiment.

[0209] Specifically, the film product group can be a string of film products connected together, a matrix arrangement of a plurality of film products connected together, or a plurality of film products connected together in other irregular shapes, such as a tree shape (trunk as support, leaves as film products), and the like. In addition, the film product group can be laid flat in a packaging box, folded and placed in a packaging box, or wound and placed in a packaging box.

[0210] Herein, the support refers to a structure that connects a plurality of film products together to form a film product group. As an example, the film products can be formed by cutting and packaging a large sheet of base material and a functional film layer material. In this case, the film product shape and the support shape can be cut, and the film product and the support can be connected by a weak connection structure. The weak connection structure refers to a structure with weak strength or stability of connection, which can be easily broken by simple tearing during use. As an example, the weak connection structure can be an indentation, a groove, a plurality of spaced holes distributed along a contour line, or the like. The weak connection structure can be formed by ultrasonic embossing or the like.

[0211] In a second aspect, the present disclosure provides an oral film product. According to embodiments of the present disclosure, the oral film product includes an oral film and a sheet, the oral film containing an active ingredient, the active ingredient being adapted to be released from the oral film and to act on a target site. In some embodiments, the sheet includes a first sheet, which can be disposed on at least a portion of a surface of the oral film. In other embodiments, the first sheet can also be embedded inside the oral film.

[0212] Specifically, by setting the sheet, the tensile strength of the oral film product can be improved, the sheet layer which can maintain the shape for a long time can improve the problem of easy folding and deformation of the oral film product, and the degree of deformation of the oral film product when it does not reach the target position can be reduced. At the same time, the oral film product will not disintegrate quickly after being placed in the target position, and the effect of withdrawing the oral film product from the target position during use can be achieved. It can also effectively improve the problem that the oral film product quickly deforms, adheres, breaks or disintegrates when it contacts with liquid, which makes it difficult to adhere to the target position. The oral film product can be moved multiple times and more easily adhere to the target position. Basically, one piece of oral film product can be adhered to the target position, and the use cost can be significantly reduced.

[0213] Further, the sheet arranged on the surface of the oral film can play a certain isolation role, thereby improving the adhesion problem between multiple oral film products and reducing the packaging cost. During use, the user can hold the position of the oral film product where the sheet is arranged on the surface, so that the oral film is not easy to directly contact with the liquid on the user's hand to cause phenomena such as dissolution, deformation, shrinkage, breakage and adhesion in advance, which is beneficial to the accurate placement or adhesion of the oral film product and can improve the usability of the oral film product.

[0214] In addition, after the first sheet layer arranged on the surface of the oral film contacts with liquid such as saliva and body fluid, the time for the liquid to reach the oral film can be delayed, so that the possibility of loss of active ingredients due to dissolution of the oral film before reaching the target position is reduced, and the risk of discomfort caused by strong stimulation of the user due to rapid disintegration and release of a large amount of active ingredients after reaching the target position is also reduced.

[0215] It can be understood that the oral film is a film preparation whose action site is in the oral cavity, which includes "oral dissolving film, buccal film, sublingual film, lingual film, oral cavity wall film, gum film, toothpaste film" and the like. Specifically, the oral film can be a film-shaped preparation for the oral cavity which is prepared from active ingredients (such as raw medicinal materials) and suitable film-forming materials, and during use, the active ingredients in the oral film can be released and act on the target position to play a role. Among them, the oral dissolving film is a dosage form which uses a dissolving film to absorb active ingredients in the oral cavity (buccal or sublingual).

[0216] The oral film product herein refers to a product containing an oral film and a sheet, and the active ingredients in the oral film are suitable for being released from the oral film and acting on the target position. Specifically, part of the surface of the oral film can be exposed (i.e. not covered by the sheet) to enable the active ingredients to be released to act on the target position; or the sheet can have water permeability, specifically the sheet can have water permeability, or the sheet does not have water permeability but has water permeable channels arranged thereon. In this way, saliva can infiltrate the oral film through the sheet, so that the oral film dissolves to release active ingredients and act on the target position.

[0217] Specifically, in some embodiments, the first sheet can only cover part of the surface of the oral film. At this time, the first sheet can be located at the edge of the oral film or in the middle of the oral film. In this way, during use, the position of the oral film surface provided with the first sheet can be used for holding, and the first sheet can delay the liquid from reaching the oral film, thereby reducing the risk of wrinkles, deformation and adhesion of the oral film product during attachment, while part of the oral film not covered by the first sheet can ensure rapid dissolution and release of active ingredients.

[0218] In other embodiments, the first sheet can also cover the entire surface of the oral film. In one specific example, the first sheet covers one side surface of the oral film. In this way, the user can hold the side of the oral film product provided with the first sheet to facilitate the movement of the oral film product and improve the problem of easy sticking of the oral film product, while the surface of the oral film not covered by the first sheet still maintains good adhesion and can be more easily attached to the target position.

[0219] According to embodiments of the present disclosure, the sheet further comprises a second sheet, and the first sheet and the second sheet are arranged on the two opposite surfaces of the oral film. In this way, the first sheet and the second sheet work together to increase the tensile strength of the oral film product and better improve the problem of easy wrinkles and deformation of the oral film product; and the first sheet and the second sheet are located on the two opposite surfaces of the oral film, which can delay the time for liquid to reach the oral film and isolate the oral films between adjacent two oral film products, thereby reducing the risk of adhesion of the oral film during attachment, transportation and storage, and making it more convenient for the user to move the oral film product during use; it can also reduce the risk of loss of active ingredients due to dissolution of the oral film product before reaching the target position, thereby improving the usability of the oral film product. When there is no first sheet and second sheet, the adjacent two oral films need to be isolated by packaging structures such as aluminum foil to prevent adhesion, so the arrangement of the first sheet and the second sheet can also reduce the packaging cost of the oral film product.

[0220] It can be understood that the relative size, specific arrangement and the like of the first sheet, the oral film and the second sheet can be flexibly adjusted according to actual use needs.

[0221] In some embodiments, the edges of at least two of the first sheet, the oral film and the second sheet are arranged in alignment. Specifically, the edges of the first sheet and the oral film can be arranged in alignment; the edges of the second sheet and the oral film can be arranged in alignment; or the edges of the first sheet, the oral film and the second sheet can be arranged in alignment. In this way, the first sheet and the second sheet can effectively improve the problems of wrinkles, deformation, adhesion and rapid dissolution of the oral film, while being low in cost and easy to implement.

[0222] In some embodiments, the first sheet and the second sheet are connected at the edge to jointly form a third bag-shaped structure with at least one open side edge, and a third accommodating space is arranged in the third bag-shaped structure, and at least part of the oral film is arranged in the third accommodating space. Specifically, part of the oral film can be accommodated in the third accommodating space, and another part of the oral film can be located outside the third accommodating space. The oral film can also be entirely accommodated in the third accommodating space.

[0223] When the oral film product contacts liquid such as body fluid or saliva, the sheet can preferentially absorb liquid and infiltrate or isolate the liquid, thereby delaying the contact between the oral film in the third accommodating space and saliva and delaying the dissolution of the oral film. While the active ingredient in the oral film is rapidly and massively released, the oral film product can also be moved at will according to the needs to accurately move to the target position, so that the active ingredient contained in the oral film can mainly act on the target position. Even if the oral film in the third accommodating space is wrinkled, deformed, broken, disintegrated or the like due to contact with the liquid, the third bag-shaped structure can limit the oral film to a certain extent, so that the oral film is not easy to contact and adhere to the non-target position outside, thereby reducing the risk of physiological discomfort of the user caused by the rapid dispersion of a large amount of dissolved or disintegrated oral film, and enabling the oral film product to exit the target position at any time during use, thereby improving the usability of the oral film product.

[0224] In some embodiments, the first sheet and the second sheet are connected at the edge to jointly form a fourth bag-shaped structure with no open edge, and a fourth accommodating space is arranged in the fourth bag-shaped structure, and the oral film is accommodated in the fourth accommodating space.

[0225] When the oral film product contacts liquid such as body fluid or saliva, the sheet can preferentially absorb liquid and infiltrate or isolate the liquid, thereby delaying the contact between the oral film in the third accommodating space and saliva and delaying the dissolution of the oral film. While the active ingredient in the oral film is rapidly and massively released, the oral film product can also be moved at will according to the needs to accurately move to the target position, so that the active ingredient contained in the oral film can mainly act on the target position. Even if the oral film in the third accommodating space is wrinkled, deformed, broken, disintegrated or the like due to contact with the liquid, the third bag-shaped structure can limit the oral film to a certain extent, so that the oral film is not easy to contact and adhere to the non-target position outside, thereby reducing the risk of physiological discomfort of the user caused by the rapid dispersion of a large amount of dissolved or disintegrated oral film, and enabling the oral film product to exit the target position at any time during use, thereby improving the usability of the oral film product.

[0226] According to the embodiments of the present disclosure, at least one of the first sheet and the second sheet has a second opening according to the needs of different use positions, and the partial mouth film is exposed through the second opening. Thus, the mouth film at the position corresponding to the second opening is not covered by the sheet layer, and the adhesion performance at the target position is better. Meanwhile, the exposed mouth film at the position of the second opening can appropriately increase the release speed of the active ingredient in the mouth film, so as to meet different use requirements.

[0227] It can be understood that the second opening can be provided only on the first sheet, only on the second sheet, or on both the first sheet and the second sheet.

[0228] In addition, the specific size, contour shape, and number of the second opening are not particularly limited. For example, the contour shape can be a rectangular shape, a square shape, a circular shape, a diamond shape, a triangular shape, a polygonal shape, or an irregular shape, and the number can be 1, 2, 3, 4, 5, or the like, which can be flexibly adjusted according to actual use requirements.

[0229] According to the embodiments of the present disclosure, the first sheet and the second sheet are independently single-layer structures or multi-layer structures according to the needs of the release speed of the active ingredient. Specifically, the first sheet and the second sheet can both be single-layer structures.

[0230] In some embodiments, at least one of the first sheet and the second sheet comprises a multi-layer structure. In some embodiments, the first sheet comprises a plurality of first sub-sheets arranged in layers. In some embodiments, the second sheet comprises a plurality of second sub-sheets arranged in layers.

[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. Alternatively, the first sheet and the second sheet can both be multi-layer structures.

[0232] Specifically, by adjusting the number of layers of the first sheet and the second sheet, the release speed of the active ingredient can be adjusted. It can be understood that the more the number of layers of the first sheet and / or the second sheet, the greater the resistance of the active ingredient to release from the mouth film to the outside, and the slower the release speed of the active ingredient. Conversely, the fewer the number of layers of the first sheet and / or the second sheet, the smaller the resistance of the active ingredient to release from the mouth film to the outside, and the faster the release speed of the active ingredient. For the multi-layer first sheet and / or the second sheet, the specific number of layers of the sheet can be adjusted to achieve the sustained release and controlled release of the active ingredient when designing the mouth film product.

[0233] According to embodiments of the present disclosure, the first sub-sheets are detachably connected to each other; and / or the second sub-sheets are detachably connected to each other. Specifically, through the detachable connection, the user can adjust the number of layers of the first sub-sheets and / or the second sub-sheets according to the user's experience during actual use, thereby better meeting the use requirements of different users.

[0234] It can be understood that the specific manner of detachable connection is not particularly limited as long as the detachable function can be achieved.

[0235] In some embodiments, the first sub-sheets are provided with a fifth detachment part. In this way, the user can conveniently tear off the first sub-sheets by holding the fifth detachment part.

[0236] In some embodiments, the connected two first sub-sheets have a part of the edges unsealed, i.e., the part of the edges is in an open structure. In this way, the user can clearly identify the number of layers of the first sub-sheets through the unsealed position, and can hold the unsealed position to tear off the first sub-sheets.

[0237] In some embodiments, the second sub-sheets are provided with a sixth detachment part. In this way, the user can conveniently tear off the second sub-sheets by holding the sixth detachment part.

[0238] In some embodiments, the connected two second sub-sheets have a part of the edges unsealed, i.e., the part of the edges is in an open structure. In this way, the user can clearly identify the number of layers of the second sub-sheets through the unsealed position, and can hold the unsealed position to tear off the second sub-sheets.

[0239] In some embodiments, the first sheet includes a fifth detachable region and a fifth non-detachable region, and the fifth detachable region and the fifth non-detachable region are connected through a fifth weak connection structure. In this way, the user can tear off the fifth detachable region along the fifth weak connection structure.

[0240] In some embodiments, the second sheet includes a sixth detachable region and a sixth non-detachable region, and the sixth detachable region and the sixth non-detachable region are connected through a sixth weak connection structure. In this way, the user can tear off the sixth detachable region along the sixth weak connection structure.

[0241] In the text, the fifth weak connection structure and the sixth weak connection structure refer to structures with weak connection strength or stability, which can be easily damaged by simple tearing during use. As an example, the fifth weak connection structure and the sixth weak connection structure can each independently be an indentation, a groove, a plurality of spaced holes distributed along a contour line, etc.

[0242] According to embodiments of the present disclosure, the oral film product further comprises a waterproof layer. The waterproof layer can reduce the discomfort caused by the active ingredients released from the oral film entering non-target positions, and make the active ingredients be more absorbed by the target positions.

[0243] According to embodiments of the present disclosure, the specific setting position of the waterproof layer can be selected according to actual needs. Specifically, in actual use, the user can select to set the waterproof layer at the corresponding non-target position, so as to isolate the waterproof layer from the non-target position and the oral film.

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

[0245] In some embodiments, the oral film product comprises an oral film, a first sheet and a second sheet, the oral film is arranged between the first sheet and the second sheet, and the waterproof layer is arranged 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] By arranging the waterproof layer, the delivery of the active ingredient released by the oral film to the non-target position can be reduced, for example, by reducing the drug in the oral film that needs to be absorbed through the oral mucosa into the digestive tract with saliva. The active ingredient released by the oral film mainly acts on the target position, so that more active ingredients are absorbed by the target position.

[0247] According to embodiments of the present disclosure, the oral film product further comprises a water-swellable substance, and the water-swellable substance is arranged at least one of the following positions: the surface of the first sheet, the surface of the second sheet, the pores of the first sheet, and the pores of the second sheet. Specifically, the water-swellable substance can be arranged on the surface of the first sheet close to the oral film and / or the surface of the second sheet close to the oral film. After the water-swellable substance swells by absorbing water, the overall tensile strength of the oral film product can be improved, which facilitates the user to move the oral film product and improves the usability of the oral film product.

[0248] According to embodiments of the present disclosure, the first sheet and the second sheet are the same. Thus, the release speed of the active ingredient on both sides of the oral film product is consistent.

[0249] According to embodiments of the present disclosure, in order to meet the needs of different use scenarios and enrich the user experience, the first sheet and the second sheet can have different properties, thereby achieving different use experiences and use effects. According to embodiments of the present 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. Thus, the two sides of the oral film product can provide different release speeds of the active ingredient, enrich the user experience, and meet more use scenarios and more personalized use needs of users.

[0250] According to embodiments of the present disclosure, the material of the first sheet and the second sheet is not particularly limited, as long as the use requirements of the target position are met. For example, the first sheet and the second sheet can adopt a flexible material so that the oral use film product can be as close as possible to the shape of the oral cavity, thereby avoiding causing discomfort to the user.

[0251] Specifically, according to different setting modes of the first sheet and the second sheet, the selection of the material is also different. If at least part of the oral use film is not wrapped by the first sheet and the second sheet, there is no limitation on the water permeability of the first sheet and the second sheet. The first sheet and the second sheet can have water permeability, or can not have water permeability. If the first sheet and the second sheet wrap the oral use film entirely, at least one of the first sheet and the second sheet is required to have water permeability, or the first sheet and the second sheet do not have water permeability but are provided with water permeable channels, such as through holes, openings, etc. on the plastic sheet without water permeability. In this way, it can be ensured that the active ingredients in the oral use film can be effectively released and act on the target position.

[0252] According to embodiments of the present disclosure, the water permeable channel includes a through hole, or includes a through hole and a porous layer provided on the through hole. In use, the user can choose whether to open the porous layer. When the porous layer is opened, the active ingredients released by the oral use film can be more absorbed by the target position through the through hole, and a stronger stimulation can be obtained. When the porous layer is not opened, the active ingredients released by the oral use film need to pass through the porous layer to be released and act on the target position, and the release speed of the active ingredients is relatively slow.

[0253] According to embodiments of the present disclosure, the first sheet and the second sheet each independently include at least one of non-woven fabric, special paper, wood pulp paper, polylactic acid paper, fiber cloth, mesh cloth, woven fabric, foamed resin film, net-shaped resin film, porous resin film, swellable sheet, swellable mesh, plastic sheet provided with water permeable channels, and rubber sheet provided with water permeable channels. In this way, the sheet has good liquid permeability, which is beneficial to the contact of the oral use film with the liquid to release the active ingredients to act on the target position.

[0254] According to embodiments of the present disclosure, in order to better meet the use requirements, the oral use film can include a plurality of sub oral use films, the plurality of sub oral use films are the same, or at least one of the types and concentrations of the active ingredients contained in the plurality of sub oral use films is different. In this way, in the case that the thickness of a single oral use film is limited, a greater thickness and a greater dose of active ingredients can be achieved by setting a plurality of sub oral use films. If the plurality of sub oral use films are different, the oral use film product can have multiple effects or different use experiences. Specifically, if the active ingredients in the plurality of sub oral use films are different, the oral use film product can have different use effects. If the concentrations of the active ingredients in the plurality of sub oral use films are different, different release speeds of the active ingredients can be achieved at different stages of use, thereby enriching the user's experience and use effect.

[0255] According to embodiments of the present disclosure, the specific arrangement mode of the plurality of sub-port films is not particularly limited, and the plurality of sub-port films can be arranged in a stacked manner or arranged in a tiled manner on a surface. In some embodiments, the sub-port film includes at least one of a first sub-port film and a second sub-port film, wherein the plurality of first sub-port films are arranged in a stacked manner, and the plurality of second sub-port films are arranged in a tiled manner on the first surface. Specifically, the port film can include only the plurality of first sub-port films; the port film can include only the plurality of second sub-port films; and the port film can include both the plurality of first sub-port films and the at least one second sub-port film.

[0256] It can be understood that, in actual use, the active ingredients of the port film product are released in an order from outside to inside and from periphery to center. Based on this, different components, different concentrations, and different arrangement modes of the sub-port films can be used to achieve a more diverse use experience and use effect.

[0257] It should be noted that the description "arranged in a tiled manner on a surface" herein can refer to an arrangement in a planar surface or an arrangement in a curved surface.

[0258] According to embodiments of the present disclosure, the adjacent first sub-port films are detachably connected, and / or the second sub-port film is detachably connected to the sheet. Thus, the user can flexibly adjust the types and quantities of the sub-function film sheets according to actual needs, and better meet the individualized needs of the user.

[0259] According to embodiments of the present disclosure, the first sub-port film is provided with a seventh detachment portion. Thus, the user can conveniently tear off the first sub-port film through the seventh detachment portion, and better meet the individualized needs of the user.

[0260] According to embodiments of the present disclosure, the partially edge of the two first sub-port films connected is not sealed. Thus, the user can clearly identify the number of layers of the first sub-port film through the unsealed position, and can hold the unsealed position to tear off the first sub-port film.

[0261] According to embodiments of the present disclosure, the second sub-port film is provided with an eighth detachment portion. Thus, the user can conveniently tear off the second sub-port film through the eighth detachment portion, and better meet the individualized needs of the user.

[0262] According to embodiments of the present disclosure, the partially edge of the second sub-port film and the sheet is not sealed. Thus, the user can clearly identify the number of layers of the second sub-port film through the unsealed position, and can hold the unsealed position to tear off the second sub-port film.

[0263] According to an embodiment of the present disclosure, the first sheet comprises a plurality of third sub-sheets, the plurality of third sub-sheets are parallel to the first surface, and a projection of each third sub-sheet on the first surface overlaps with a projection of at least one second sub-mouth film on the first surface; at least one of water permeability, material, porosity, tensile force, thickness, and number of layers of the plurality of third sub-sheets is different. In this way, different sub-second mouth films can have different active ingredient release rates, better meet user needs, and enrich user experience.

[0264] According to an embodiment of the present disclosure, the sheet further comprises at least one third sheet, and the third sheet is sandwiched between two adjacent first sub-mouth films. In this way, the third sheet can play a role of isolation between adjacent first sub-mouth films, and the existence of the third sheet will also increase the resistance to the release of active ingredients, which can play a role of adjusting the release rate of active ingredients.

[0265] According to an embodiment of the present disclosure, at least one of water permeability, material, porosity, thickness, tensile force, and number of layers of the plurality of third sheets is different. In this way, the above parameters of the third sheet are different, the resistance of the active ingredient to the third sheet is different, and different active ingredient release rates can be achieved, enriching user experience.

[0266] According to an embodiment of the present disclosure, the mouth film product can further comprise a holding portion. In this way, the user can conveniently move the mouth film product by holding the holding portion by hand, so as to accurately place the mouth film product at a target position during use, and take out the mouth film product in advance during use by holding the holding portion by hand, so that the mouth film product can adapt to diversified use requirements, greatly improving the usability of the mouth film product.

[0267] According to an embodiment of the present disclosure, the specific form of the holding portion can not be particularly limited, as long as it is convenient to hold during the process of attaching the mouth film product. In some embodiments, the holding portion comprises at least one of a pulling line and a handle. Specifically, a pulling line can be sewn or pasted on the sheet to form a structure similar to a tea bag; or the handle can be formed by the sheet or the sheet and the mouth film together. In this way, the structure is simple and convenient to use.

[0268] According to an embodiment of the present disclosure, the holding portion is located at the edge of the mouth film product. Specifically, the holding portion can be located at one end of the mouth film product, opposite ends, or a plurality of spaced holding portions are arranged at the side edge of the mouth film product, etc. In this way, the mouth film product can be moved more flexibly through the holding portion, thereby improving the movable line of the mouth film product, and being more convenient to prepare and use.

[0269] According to embodiments of the present disclosure, the holding portion is formed by the sheet, or formed by the sheet and the oral film together. Specifically, by arranging the sheet, the tensile strength of the oral film product is enhanced, and the mechanical strength is higher, so that a part of the oral film product can be directly held, i.e., the holding portion is formed by the sheet and the oral film together; in some other embodiments, the holding portion can be formed by the sheet exceeding a part of the oral film.

[0270] According to embodiments of the present disclosure, the oral film product is printed with graphic information. Thus, the use is facilitated. Specifically, the graphic information can include any picture, texture, and text information, etc. As an example, the graphic information can include the active ingredient type of the oral film, the active ingredient concentration, the taste, the effective date, the use instruction, the brand logo, etc. The user can identify the purpose and the dosage of the oral film product according to the graphic information such as the active ingredient type, the active ingredient concentration, and the taste; the brand logo can be suitable for the establishment of brand awareness of the merchant; and the decorative pattern can increase the aesthetic appearance of the oral film product.

[0271] Specifically, the graphic information can be formed on the sheet, or formed on the sheet and the oral film together. In some embodiments, the graphic information can be printed, or can be the trace formed by ultrasonic embossing, and the trace (text, pattern) can include at least one of the concave trace, the convex trace, and the hollow trace, which can be used to represent the graphic information.

[0272] According to embodiments of the present disclosure, the outer contour shape of the oral film includes at least one of a square, a rectangle, a circle, a triangle, and a polygon. It can be understood that the shape of the oral film can be designed according to ergonomics and convenience for different use sites, such as the oral mucosa position of the buccal film and the sublingual film, etc. For example, the oral film product with a circular or square shape can be used for the wide mucosa position, the oral film product with a narrow and long shape can be used for the gum, the oral film product with a wide shape can be used for the alveolar socket, etc.

[0273] According to embodiments of the present disclosure, the maximum size 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 size 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 size refers to the maximum distance between any two points on the outer contour line of the oral film product, and the minimum size refers to the minimum distance between any two points on the outer contour line of the oral film product. Within the above size range, the use requirements of different parts of the oral cavity can be met.

[0274] According to embodiments of the present disclosure, the oral film includes at least one of a fully dissolving film layer, a partially dissolving film layer, or a swelling film layer. Specifically, the oral film product provided by the present disclosure can use the above-mentioned different types of film layers, has a wider range of use functions, and can meet the use requirements of different use scenarios, and has higher use convenience.

[0275] It should be noted that the main difference between the fully dissolving film layer, the partially dissolving film layer, and the swelling film layer is the swelling rate. The swelling rate of the fully dissolving film layer is the lowest, the swelling rate of the partially dissolving film layer is between that of the fully dissolving film layer and the swelling film layer, and the swelling film layer can be a hydrogel.

[0276] Therefore, the oral film product has a wide range of uses and can meet the needs of various use scenarios.

[0277] In some embodiments, the oral film product described above, the oral film can be a mouth dissolving film, and the sheet can be a support layer. Therefore, the present application also provides an oral product including a support layer and a mouth dissolving film, the support layer is arranged on at least one surface of the mouth dissolving film or embedded in the mouth dissolving film, and the support layer has non-water solubility and is provided with at least one channel for saliva to pass through the support layer. During the process of placing the oral product in the oral cavity, the support layer with non-water solubility can hinder the dissolution of the mouth dissolving film in saliva, thereby slowing down the speed of the dissolution or disintegration of the mouth dissolving film in saliva to release the efficacy substance, but the support layer can play a supporting role, reduce the risk of the mouth dissolving film shrinking or even directly disintegrating during use, so that the user can smoothly attach the oral product to the position where it needs to be placed, and the user can take out the oral product in the middle of use, overcoming the technical prejudice that the faster the mouth dissolving film dissolves in the oral cavity, the better. For the mouth dissolving film with better delivery effect from the oral mucosa to the systemic circulation, the support layer avoids the rapid disintegration of the mouth dissolving film, which is swallowed by the swallowing action and enters the stomach, so that the mouth dissolving film can be delivered to the systemic circulation through the oral mucosa as much as possible, thereby facilitating the improvement of the absorption effect of the mouth dissolving film.

[0278] Referring to FIG. 46, an embodiment of the present application provides an oral product 100a for placing in the oral cavity at a position where it needs to be placed, such as the gum, the sublingual, etc. The oral product 100a includes a support layer 10a and a mouth dissolving film 20a. The mouth dissolving film 20a is used to contact saliva and dissolve in the oral cavity. The support layer 10a has non-water solubility, and the support layer 10a is arranged on at least one surface of the mouth dissolving film 20a. FIG. 46 shows that the support layer 10a is arranged on one surface of the mouth dissolving film 20a. The support layer 10a is provided with at least one channel 101a for saliva to pass through the support layer 10a to contact the mouth dissolving film 20a, so that the mouth dissolving film 20a can disintegrate in saliva and be taken into the oral cavity by saliva to exert efficacy.

[0279] The support layer 10a plays a supporting role for supporting the orally dissolving film 20a, reduces the risk of the orally dissolving film 20a being wrinkled or even directly disintegrated during the attaching process, and enables the user to successfully attach the oral product 100a to the desired location using only one piece of the oral product 100a, thereby reducing the use cost of the oral product 100a. In addition, the support layer 10a can maintain the shape for a relatively long time, the orally dissolving film 20a is constrained by the support layer 10a, and the oral product 100a can be moved or removed from the oral cavity at will according to the needs, thereby improving the usability of the oral product 100a. In addition, the support layer 10a also plays an isolation role, isolates the orally dissolving film 20a from the hands and / or oral cavity of the user, reduces the risk of the orally dissolving film 20a adhering to the hands and / or oral cavity during the attaching and using process, and makes it more convenient for the user to move the oral product 100a at any time, thereby improving the usability of the oral product 100a.

[0280] When the support layer 10a is arranged on the side of the orally dissolving film 20a facing the oral mucosa, saliva needs a certain time to wet the support layer 10a or pass through the channel 101a, thereby reducing the contact speed of the orally dissolving film 20a with saliva by arranging the support layer 10a, and slowing down the release of substances in the orally dissolving film 20a to a certain extent, reducing the probability of the orally dissolving film 20a being disintegrated before reaching the designated location in the oral cavity, enabling the orally dissolving film 20a to release as many substances as possible to the location where the user needs to place the product, and improving the usability of the oral product 100a. In addition, saliva needs a certain time to wet the support layer 10a or pass through the channel 101a, which also reserves time for correcting the attached position, and is more conducive to successfully attaching the oral product 100a to the desired location.

[0281] Please refer to FIG. 47. In some embodiments, the number of support layers 10a is two layers, and the two layers of support layers 10a are arranged on the opposite surfaces of the orally dissolving film 20a. The two layers of support layers 10a are arranged on the opposite surfaces of the orally dissolving film 20a, so that both surfaces of the orally dissolving film 20a can be isolated from the hands or oral cavity, further reducing the risk of the orally dissolving film 20a adhering to the hands or oral cavity during the attaching process.

[0282] In some embodiments, the support layer 10a arranged on each surface of the orally dissolving film 20a can be multiple layers.

[0283] In some embodiments, the support layer 10a can cover the entire surface of the orally dissolving film 20a.

[0284] The materials of the two support layers 10a can be the same or different. In some embodiments, the at least two support layers 10a include a first support layer configured to be located on the side of the orally dissolving film 20a facing the oral mucosa and a second support layer configured to be located on the side of the orally dissolving film 20a facing the oral cavity, the first support layer having 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 substance released by the orally dissolving film 20a to be released through the side of the first support layer and thus be absorbed by the oral mucosa to which the first support layer is attached.

[0285] In some embodiments, the second support layer has a higher stiffness than the first support layer. The second support layer can have a higher stiffness than the first support layer, allowing the oral product 100a to be conveniently attached to the oral mucosa through the first support layer and to maintain a suitable stiffness through the second support layer.

[0286] The efficacy substance in the orally dissolving film 20a can be dissolved by saliva to act on the oral mucosa. In some embodiments, the efficacy substance includes a pharmaceutical or cosmetic ingredient. For example, at least one of a drug, an antigen, an allergen, an oral cleaning component, an enzyme, and a vitamin.

[0287] In some embodiments, the efficacy substance can include an ingredient for providing a tobacco-like taste, such as nicotine or a nicotine salt.

[0288] In some embodiments, the efficacy substance can further include at least one of a flavoring agent, a fragrance, a preservative, a sweetener, and a coloring agent.

[0289] In some embodiments, the support layer 10a has a porous structure that forms a passage 101a for saliva to pass through, allowing the support layer 10a to have good liquid permeability. The support layer 10a includes at least one of a foamed resin, a reticular resin, a porous resin, a woven fabric, a knitted fabric, a single-layer nonwoven fabric, a multi-layer nonwoven fabric, paper, or an inorganic fiber. The material of the support layer 10a can include at least one of a polyolefin, a polyester, a synthetic fiber, a semi-synthetic fiber, a regenerated fiber, a natural fiber, or an inorganic fiber.

[0290] The polyolefin includes polyethylene, polypropylene, and the like. The polyester includes polyethylene terephthalate, polybutylene terephthalate, and the like. The synthetic fiber includes polyurethane, nylon, polyvinyl chloride, polyvinylidene chloride, fluororesin, vinylon, aramid, polyacrylic polymer, cellulose acetate, and the like. The regenerated fiber includes rayon and the like. The natural fiber includes cotton, hemp, silk, and the like.

[0291] Optionally, the support layer 10a can be a nylon mesh or a non-woven fabric. In the case where the support layer 10a is a multi-layer non-woven fabric, by adjusting the number of layers of non-woven fabric in the multi-layer non-woven fabric, the effect of the support layer 10a on delaying the dissolution rate of the active ingredient in the mouth-dissolving film 20a can be controlled, so that the user can have different experiences, such as stimulating mouthfeel or mild mouthfeel.

[0292] In some embodiments, the support layer 10a comprises a sheet material having through-holes, which constitute channels for saliva to pass through. The through-holes can be obtained by punching the sheet material, which is a simple processing technique and is conducive to reducing production costs. The punching can be performed using a laser punch, a needle roller, or other equipment.

[0293] Referring to FIG. 48, in some embodiments, the support layer 10a is embedded in the mouth-dissolving film 20a. The support layer 10a embedded in the mouth-dissolving film 20a can serve a supporting function, and the support layer 10a is used to support the mouth-dissolving film 20a, thereby reducing the risk of wrinkles or even direct disintegration of the mouth-dissolving film 20a during the attachment process; and the support layer 10a can maintain its shape for a relatively long time, and the oral product 100a can be moved or removed at will according to the needs, thereby improving the usability of the oral product 100a.

[0294] Referring to FIGS. 49 and 53, in some embodiments, the support layer 10a is hydrophilic, and the two layers of support layer 10a surround to form a containing space 102a, and the mouth-dissolving film 20a is placed in the containing space 102a. The containing space 102a has a first opening 11a, and the mouth-dissolving film 20a is put into or taken out of the containing space 102a through the first opening 11a. The support layer 10a is hydrophilic, and when the oral product 100a enters the oral cavity and contacts saliva, the support layer 10a can preferentially absorb water and become wet, thereby delaying the contact between the mouth-dissolving film 20a placed in the containing space 102a and saliva, and delaying the dissolution of the mouth-dissolving film 20a. Within this time, the oral product 100a can be moved at will according to the needs; and the dissolved mouth-dissolving film 20a can be kept in the containing space 102a without contacting the oral cavity and adhering, thereby reducing the risk of physiological discomfort caused by a large amount of dissolved or disintegrated mouth-dissolving film rapidly dispersing in the oral cavity, and facilitating the removal of the oral product 100a from the oral cavity, thereby improving the usability of the oral product 100a; and the placement of the mouth-dissolving film 20a in the containing space 102a enables the support layer 10a to cover the entire mouth-dissolving film 20a, thereby providing better support and isolation effects.

[0295] In some embodiments, the first opening 11a can be open or closed, which is not limited in the present application.

[0296] In some embodiments, part of the orally dissolving film 20a is placed in the accommodation space 102a and part of the orally dissolving film 20a is exposed outside the accommodation space 102a. As shown in FIG. 50, the orally dissolving film 20a extends outside the first opening 11a. As shown in FIG. 51, the accommodation space includes a second opening 12a opposite the first opening 11a in the length direction of the orally dissolving film 10a, and the orally dissolving film 20a extends outside 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 orally dissolving film 20a, and the through hole 13a is used for saliva to pass through.

[0297] As shown in FIG. 53, in some embodiments, the oral product 100a includes a water-proof layer 40a covering the surface of the support layer 10a facing away from the orally dissolving film 20a, which is configured to be located on the side of the orally dissolving film 20a facing the oral cavity. The water-proof layer 40a has liquid impermeability, which can prevent the substances released by the orally dissolving film 20a from passing through and entering the digestive tract through the oral cavity, so that the substances released by the orally dissolving film 20a only exit the accommodation space 102a through the support layer 10a facing the oral mucosa, and the substances released by the orally dissolving film 20a are more absorbed by the oral mucosa.

[0298] In some embodiments, the water-proof layer 40a can be a thin film of thermoplastic resin such as polyethylene, polypropylene, polyvinyl acetate, polyester, etc.

[0299] As shown in FIG. 54, in some embodiments, the oral product 100a includes a porous layer 50a detachably connected with the support layer 10a and covering the through hole 13a. The porous layer 50a can be one layer or multiple layers. The porous layer 50a has a porous structure. The porous layer 50a can hinder the substances released by the orally dissolving film 20a from directly flowing out of the accommodation space 102a through the through hole 13a. When the support layer 10a provided with the porous layer 50a is attached to the oral mucosa, the user can choose to open the porous layer 50a, so that the substances released by the orally dissolving film 20a can pass through the through hole 13a and be more absorbed by the oral mucosa, obtaining a stronger stimulation. The porous layer 50a can be detachably connected with the support layer 10a by adhesion.

[0300] In some embodiments, the support layer 10a includes a water-swellable polymer. The water-swellable polymer refers to a polymer that can absorb other liquids such as water and swell. When the support layer 10a is in contact with saliva, the water-swellable polymer absorbs water and swells, further delaying the contact between the orally dissolving film 20a and the saliva, so that the user has more time to move the orally dissolving film 20a to the desired position without dissolving, improving the usability of the oral product 100a.

[0301] In some embodiments, the water-swellable polymer includes a cellulose-based water-swellable polymer and / or a non-cellulose-based water-swellable polymer. The cellulose-based neutral polymer can include at least one of methyl cellulose, ethyl cellulose, hydroxymethyl cellulose, hydroxyethyl cellulose, hydroxypropyl cellulose, hydroxybutyl cellulose, hydroxyethyl methyl cellulose, hydroxypropyl methyl cellulose, and the like. The non-cellulose-based neutral polymer can include at least one of polyvinyl alcohol, polyvinylpyrrolidone, a combination of polyvinyl alcohol and polyvinylpyrrolidone, a combination of polyvinylpyrrolidone and vinyl acetate, polyalkylene oxide, and the like.

[0302] Referring to FIG. 55, in some embodiments, the oral product 100a further includes a water-swellable layer 30a, which is laminated to the surface of the support layer 10a facing the mouth dissolving film 20a, and the mouth dissolving film 20a is located on the side of the water-swellable layer 30a away from the support layer 10a. The water-swellable layer 30a includes a water-swellable polymer. The water-swellable layer 30a is more conducive to keeping the dissolved or disintegrated mouth dissolving film 20a in the accommodation space 102a after water absorption and swelling, and is more conducive to avoiding the physiological discomfort caused by the rapid dispersion of a large amount of dissolved or disintegrated mouth dissolving film 20a in the oral cavity. In addition, the support layer 10a can isolate the water-swellable layer 30a from the hand or the oral cavity, thereby reducing the risk of adhesion between the water-swellable layer 30a and the hand or the 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 having the accommodation space 102a, the case where the water-swellable layer 30a is in contact with the surface of the support layer 10a is not shown in FIG. 55.

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

[0304] In some embodiments, the water-swellable layer 30a is also provided on the surface of the support layer 10a away from the mouth dissolving film 20a.

[0305] In some embodiments, the water-swellable layer 30a provided on the surface of the support layer 10a away from the mouth dissolving film 20a and the water-swellable layer 30a provided on the surface of the bag-shaped support layer 10a toward the mouth dissolving film 20a can be connected as a whole, so that the support layer 10a having the accommodation space 102a is embedded in the water-swellable layer 30a.

[0306] Referring to FIG. 56, in some embodiments, the oral product 100a includes a hand holding portion 60a, which is provided on the support layer 10a and is used for the user to hold. The user can put the oral product 100a into the oral cavity or take the oral product 100a out of the oral cavity through the hand holding portion 60a, thereby improving the usability of the oral product 100a. The hand holding portion 60a can be provided integrally with the support layer 10a or separately from the support layer 10a. The hand holding portion 60a can be a string.

[0307] Embodiments of the present disclosure are described in detail below.

[0308] Example 1

[0309] A slow-release nicotine functional film layer (FASTA, commercially available from Shenzhen Mist Core Technology Co., Ltd., see Figure 24) was provided: nicotine content was 4 mg / pcs, tablet weight was 70 mg, thickness was 120 pm, length was 3 cm, and width was 1 cm; the main film-forming agents were pullulan, gelatin, PEG, water, nicotine, and flavoring substances.

[0310] In the experimental group, the nicotine functional film layer was completely enclosed in a permeable fabric, and two types of non-woven fabric, n1 (FDA30, commercially available from Huzhou Ruilan New Material Co., Ltd.) and n2 (FDA34, commercially available from Huzhou Ruilan New Material Co., Ltd.), as well as polylactic acid film (S05020, commercially available from Dongguan Rich Fiber Co., Ltd.), special paper (item number 789, Guangzhou Xili Industry Co., Ltd.), and food-grade nylon filter screen (item number HN-NLWD, Zhejiang Huannai Screen Co., Ltd.) were used for packaging, to obtain multiple oral film products, which were set as the n1 oral film product (see Figure 25) group, the n2 oral film product (see Figure 26) group, the polylactic acid film oral film product group, the special paper oral film product group, the food-grade nylon filter screen oral film product group, and the control group was only the original nicotine functional film layer.

[0311] The physical and chemical parameters of n1 non-woven fabric, n2 non-woven fabric, polylactic acid film, special paper, and food-grade nylon filter screen are as follows:

[0312] Dissolution test method:

[0313] The multiple oral film products were placed on a mesh carrier and suspended on the surface of a beaker containing 100 ml of artificial saliva solution, ensuring that they were immersed. The beaker was placed on a temperature-controlled magnetic stirrer, set to 130 revolutions, 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 pl of sample was collected, and the concentration of active ingredients was determined. The dissolution amount of active ingredients was calculated, and the content determination results were combined to draw a curve of the release characteristics of active ingredients, as shown in Figures 27 and 28.

[0314] From the dissolution data, it can be seen that after adding the non-woven fabric, the release of the nicotine active ingredient is more moderate, but the overall release rate is not greatly affected. In particular, in 0-1 min, the experimental group has no release within 30 s, and the release amount is low at 1 min. It can be considered that this process is the non-woven fabric soaking and infiltrating, which buffers the rapid release of the nicotine functional film layer in contact with saliva, and this process gives the user an opportunity to move the film to the best body feeling position.

[0315] Then, the n1 oral film product which is closer to the release of the original nicotine functional film layer is selected for user experience test with the original nicotine functional film layer:

[0316] Before starting, the subjects are guided on the correct attachment method:

[0317] Now make sure that the subject's hands are dry, without obvious sweat and other liquids, and take out the film;

[0318] The subject holds the film with one hand and lifts or pries the buccal mucosa near the upper gum or the upper lip with the other hand;

[0319] Attach the film to the gum, and put down the buccal mucosa and the lip;

[0320] Record the use time and frequency of the subjects successfully attaching to the gum and buccal mucosa, as well as the number of movements, and ask the subjects about the convenience, adhesion (the stronger the adhesion, the lower the score), nicotine onset time, throat irritation, and ask the subjects to record and score their experience during use, 0-6 points. Among them, the stronger the adhesion, the lower the score, and the better the convenience, the higher the score.

[0321] Overall, during the attachment process, the subjects need to move 2-3 times. With the addition of non-woven fabric, almost all subjects can attach one film product to the appropriate position. Without the addition of non-woven fabric, on average, the subjects are allowed to move once, and the user needs to waste 1.83 original nicotine functional film layers to possibly attach to the appropriate position. After adding the non-woven fabric, the nicotine onset time is slowed down by 1.5 min, improving the convenience of the user's mid-way exit, achieving a certain slow-release and controlled-release effect.

[0322] Because the non-woven fabric has a certain water retention property, after adding the non-woven fabric, the speed of dissolving nicotine functional film layer into saliva and entering the throat can be reduced, thereby causing strong irritation. The addition of non-woven fabric greatly improves the convenience of use and reduces the discomfort caused by the adhesion and residue of the nicotine film product.

[0323] Example 2

[0324] Experimental group, the commercially available propolis film is completely enclosed in a non-woven fabric, and the propolis film and the non-woven fabric wrapped propolis film are shown in Figures 29 and 30, respectively. In this test, the subjects are required to remove the propolis film and attach it to the buccal film position. The target position of the propolis film is the oral ulcer, as shown in Figure 31.

[0325] Six subjects were counted, and the number of times they successfully attached the film to the target position was counted.

[0326] After adding a non-woven fabric with permeability, it is easier for users to attach the film to the appropriate position. When using the original propolis film directly, most subjects find it difficult to detach the film from their hands after it has been placed in the mouth and deformed due to moisture. The film cannot be placed in the target position, or after multiple attempts, the film absorbs water and breaks.

[0327] Example 3

[0328] A soluble dental film (see Figure 32) is added with a non-fully-enclosed non-woven fabric sleeve (see Figure 33), and a dental film product is obtained. The attachment position is the lower dental surface.

[0329] The number of times the subjects successfully attached the film was counted.

[0330] The addition of a non-woven fabric sleeve can better protect the dental film from sticking to the inside of the lips during the attachment process, reducing the waste caused by the film curling and sticking to the inside of the lips or gums during the attachment process, and greatly facilitating the use of the film by the subjects.

[0331] Example 4

[0332] Experimental group: Ten pieces of nicotine functional film layers from Example 1 wrapped in non-woven fabric were placed in an aluminum foil bag with barrier properties.

[0333] Control group: Ten pieces of nicotine functional film layers from Example 1 without non-woven fabric wrapping were directly packaged in an aluminum foil bag.

[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 film layers in the control group had adhered together and could not be peeled apart, while the experimental group could be easily separated and peeled apart.

[0336] Example 5

[0337] The nicotine functional film layer from Example 1 was used, and different forms of non-woven fabric were used to wrap the nicotine functional film layer, as follows:

[0338] Non-woven fabric constitutes a bag-like structure with one side opening, and the nicotine oral film is entirely contained in the containing space of the bag-like structure, as shown in Fig. 34;

[0339] Non-woven fabric constitutes a bag-like structure with opposite two sides opening, and the nicotine oral film is entirely contained in the containing space of the bag-like structure, as shown in Fig. 35;

[0340] Non-woven fabric constitutes a bag-like structure with opposite two sides opening, and the middle part of the nicotine oral film is contained in the containing space of the bag-like structure, and the two ends exceed the non-woven fabric, as shown in Fig. 36;

[0341] Non-woven fabric constitutes a bag-like structure with one side opening, and the nicotine oral film is partially contained in the containing space of the bag-like structure, and one end exceeds the non-woven fabric from the opening, as shown in Fig. 37;

[0342] Non-woven fabric constitutes a bag-like structure with no opening around, and the nicotine oral film is contained in the containing space of the bag-like structure, and three openings are arranged on one side surface of the bag-like structure, as shown in Fig. 38.

[0343] Example 6

[0344] A swollen oral film is provided (as shown in Fig. 39, the swollen oral film presents uniform swelling into a gel state after fully contacting with water): the nicotine content is 2 mg / pcs, the tablet weight is 70 mg, the thickness is 120 μm, the length is 3 cm, the width is 1 cm, and the main film-forming agent is chitosan, gelatin, PEG, water, nicotine and flavoring substances.

[0345] The oral film is packaged in non-woven fabric by ultrasonic packaging, and different shapes of oral film products are obtained, as shown in Figs. 40, 41 and 42. It can be seen from the figures that the obtained oral film products are printed with different brand logos and other graphic information.

[0346] The above oral film and the oral film product packaged by non-woven fabric are partially contacted with water, and it can be found that the above original oral film is prone to local shrinkage after partially contacting with water (as shown in Fig. 43). If the oral film is packaged by non-woven fabric, water can be uniformly diffused, the shrinkage caused by uneven swelling can be reduced, the rigidity of the oral film can be improved, and the problems caused by the shrinkage of the oral film can be improved.

[0347] Example 7

[0348] A common plastic film with polyethylene as the main component and a thickness of 100 μm is used, and holes (i.e. water permeable channels) are formed on the surface layer according to needs, and then a nicotine functional film layer in Example 1 is packaged in the plastic film by using a hot air machine or an ultrasonic packaging machine.

[0349] Example 8

[0350] A slow-release dental patch film (a dental patch film launched by Qingjiu, which uses papain, catalase and other bioactive enzymes as the main active ingredients, and acts on the bacteria on the surface of the teeth to achieve the effect of whitening teeth, and the recommended use time is 30 min-1 hour) is provided. After being sewn with non-woven fabric, a dental patch film product is obtained, wherein the opposite ends of the non-woven fabric protrude from the dental patch film by a part, which is used to form a holding part, so as to avoid direct contact of the hand with the dental patch film, reduce the influence of the hand fluid on the dental patch film, and even destroy the dental patch film itself. And after sticking, the user can move the dental patch film.

[0351] Six subjects respectively use three samples, stick to the upper teeth, record the number of times when the holding part does not wrinkle and deform, and the dental patch film is well fitted. The subjects are not limited to make slight movement in order to fit well.

[0352] After adding the holding part, the user can move the dental patch film product very well and fit smoothly, and the holding part is almost not damaged. Even if the subject needs to move to fit well, it can also meet the requirements.

[0353] Example 9

[0354] A special paper (the same as in Example 1) is provided, which is composed of wood pulp and a small amount of food-grade heat-sealing material, polypropylene. Ultrasonic packaging and pattern welding are used to encapsulate a piece of nicotine functional film layer in Example 1, and the photo of the obtained nose patch film product is shown in FIG. 44. The diameter of the circular nose patch film product is 0.8 cm, and the thickness is 120 μm.

[0355] The subjects respectively use the original nicotine functional film layer and the nose patch film product encapsulated by the special paper, and stick to the nasal cavity for nicotine absorption and aroma perception, and then exit after 10 min of use. The nasal cavity stimulation, nicotine perception, and ease of exit and convenience experienced by the subjects are counted.

[0356] The nose patch film product encapsulated by the special paper is attached to the inside of the nasal cavity with the help of a small amount of nasal mucus. The special paper is not damaged during movement, and at the same time, due to the good water buffering function, it promotes the nicotine functional film layer to absorb water in the early stage, helps the nicotine functional film layer to swell, dissolve, and reduces the liquid of the nicotine functional film layer from dripping into the nasal cavity to cause discomfort through the water storage and encapsulation functions. At the same time, the nicotine perception of the subjects is slightly slower than that of the original nicotine functional film layer, and it is more comfortable, avoiding the adverse reactions caused by too fast intake of nicotine.

[0357] Example 10

[0358] The tooth film was sandwiched between a plastic film (product code-DYM002, food preservation film, Dongguan Mingye Packaging Products Co., Ltd.) with polypropylene as the main component and a 25g polylactic acid film with permeability, and was fully encapsulated to obtain a tooth film product.

[0359] The degree of action of the active ingredient on the tooth surface during use by the subject was investigated by taking the whiteness of the teeth after 30 minutes of use of the product by the subject according to the operating instructions as an indicator.

[0360] Due to the use of a completely impermeable plastic film on one side, the active ingredients of the tooth film were successfully prevented from contacting the lips, and the excessive flow of saliva into non-tooth parts was avoided. On the other side, a polylactic acid film was used. The film has water permeability and can permeate saliva, helping to dissolve the tooth film, while slowing down the flow of active ingredients, allowing the active ingredients to act on the tooth surface for a longer time, which is beneficial to the effect.

[0361] In the description of the present application, it should be understood that the terms "center", "longitudinal", "transverse", "length", "width", "thickness", "upper", "lower", "front", "back", "left", "right", "vertical", "horizontal", "top", "bottom", "inner", "outer", "clockwise", "counterclockwise", "axial", "radial", "circumferential" and the like indicate the orientation or positional relationship based on the orientation or positional relationship shown in the drawings, and are only for the convenience of describing the present application and simplifying the description, and therefore cannot be understood as indicating or implying that the devices or elements referred to must have a particular orientation, be constructed and operated in a particular orientation, and therefore cannot be understood as limiting the present application.

[0362] In addition, the terms "first", "second" are only for descriptive purposes and cannot be understood as indicating or implying relative importance or implicitly indicating the number of the technical features indicated. Therefore, the features defined as "first", "second" can explicitly or implicitly include at least one of the features. In the description of the present application, the meaning of "a plurality of" is at least two, such as two, three, etc., unless otherwise specifically limited.

[0363] In the present application, unless otherwise specifically defined and limited, the terms "mounting", "connection", "connection", "fixing" and the like should be understood in a broad sense, for example, it can be fixedly connected, or it can be detachably connected, or it can be integrated; it can be mechanically connected, or it can be electrically connected or communicate with each other; it can be directly connected, or it can be indirectly connected through an intermediate medium; it can be the internal communication or interaction relationship of two elements, unless otherwise specifically limited. For those skilled in the art, the specific meaning of the above terms in the present application can be understood according to the specific circumstances.

[0364] In the present application, unless explicitly specified and limited, a first feature is "on" or "under" a second feature can mean that the first and second features are in direct contact, or the first and second features are in indirect contact through an intermediate medium. Also, the first feature "over", "above" and "on top of" the second feature can mean that the first feature is directly above or obliquely above the second feature, or simply means that the first feature is horizontally higher than the second feature. The first feature "under", "below" and "underneath" the second feature can mean that the first feature is directly below or obliquely below the second feature, or simply means that the first feature is horizontally lower than the second feature.

[0365] In the description of the present application, the description of the terms "one embodiment", "some embodiments", "one example", "some examples", "an example", "a specific example", or "some examples" etc. means that the specific feature, structure, material or characteristic described in connection with the embodiment or example is included in at least one embodiment or example of the present application. The illustrative expressions of the above terms in the present specification do not necessarily refer to the same embodiment or example. Also, the specific features, structures, materials or characteristics described can be combined in any appropriate manner in one or more embodiments or examples. In addition, the person skilled in the art can combine and combine the different embodiments or examples described in the present specification and the features of the different embodiments or examples without contradiction.

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

Claims

1. A film product, comprising: a functional film layer, wherein an active ingredient is contained in the functional film layer, and the active ingredient is adapted to be released from the functional film layer and act on a target site; a sheet layer, wherein a first sheet layer is arranged on at least a part of a surface of the functional film layer; and / or, the first sheet layer is embedded in the functional film layer.

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

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

4. The film dosage product according to claim 3, wherein, Edges of at least two of the first sheet layer, the functional film layer and the second sheet layer are arranged in alignment.

5. The film dosage product according to claim 3 or 4, wherein, The film product satisfies any one of the following conditions: The first sheet layer and the second sheet layer are connected at part of their edges to jointly form a first bag-like structure having an opening at at least one side edge, and a first accommodating space is arranged in the first bag-like structure, and at least part of the functional film layer is arranged in the first accommodating space; The first sheet layer and the second sheet layer are connected at their edges to jointly form a second bag-like structure having no opening at the edges, and a second accommodating space is arranged in the second bag-like structure, and the functional film layer is accommodated in the second accommodating space.

6. The film dosage product according to any one of claims 3 to 5, wherein, At least one of the first sheet layer and the second sheet layer is provided with a first opening.

7. The film dosage product according to any one of claims 3 to 6, wherein, The film product satisfies at least one of the following conditions: The first sheet layer comprises a plurality of first sub-sheet layers arranged in layers; The second sheet layer comprises a plurality of second sub-sheet layers arranged in layers.

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

9. The film dosage product according to claim 8, wherein, The film product satisfies at least one of the following conditions: The first sub-sheet layer is provided with a first detachable part; Part of edges of two adjacent first sub-sheet layers are not sealed; The second sub-sheet layer is provided with a second detachable part; Part of edges of two adjacent second sub-sheet layers are not sealed.

10. The film dosage product according to any one of claims 3 to 9, wherein, The film product satisfies at least one of the following conditions: The first sheet layer comprises a first detachable area and a first non-detachable area, and the first detachable area and the first non-detachable area are connected by a first weak connection structure; The second sheet layer comprises a second detachable area and a second non-detachable area, and the second detachable area and the second non-detachable area are connected by a second weak connection structure.

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

12. The film dosage product according to any one of claims 3 to 11, wherein, The film product further comprises a water-swellable substance arranged on at least one of the following positions: a surface of the first sheet layer; a surface of the second sheet layer; a pore of the first sheet layer; a pore of the second sheet layer.

13. The film dosage product according to any one of claims 3 to 12, wherein, The film product satisfies at least one of the following conditions: the first sheet layer and the second sheet layer are identical; at least one of water permeability, porosity, thickness, material, tensile force and number of layers of the first sheet layer and the second sheet layer is different.

14. The film dosage product according to any one of claims 3 to 13, wherein, The first sheet layer and the second sheet layer each independently satisfy at least one of the following conditions: having water permeability; not having water permeability and being provided with a water-permeable passage.

15. The film dosage product according to claim 14, wherein, The water-permeable passage comprises a through hole, or the water-permeable passage comprises the through hole and a porous layer arranged on the through hole.

16. The film dosage product according to claim 14 or 15, wherein, The first sheet layer and the second sheet layer each independently comprise at least one of non-woven fabric, special paper, wood pulp paper, polylactic acid paper, fiber cloth, mesh cloth, foamed resin film, reticular resin film, porous resin film, swellable sheet, swellable mesh, plastic sheet provided with the water-permeable passage, and rubber sheet provided with the water-permeable passage; and / or The first sheet layer and the second sheet layer each independently comprise a water-swellable polymer.

17. The film dosage product according to any one of claims 1 to 16, wherein, The functional film layer comprises a plurality of sub-functional film layers, the plurality of sub-functional film layers are identical; or at least one of the type and concentration of the active ingredient contained in the plurality of sub-functional film layers is different, and the sub-functional film layer comprises at least one of a first sub-functional film layer and a second sub-functional film layer, wherein the plurality of first sub-functional film layers are arranged in layers, and / or the plurality of second sub-functional film layers are arranged in a flat manner on the first surface.

18. The film dosage product of claim 17, wherein, The adjacent first sub-functional film layers are detachably connected; and / or the second sub-functional film layer is detachably connected with the sheet layer.

19. The film dosage product of claim 18, wherein, The film product satisfies at least one of the following conditions: the first sub-functional film layer is provided with a third detachable part; the connected two first sub-functional film layers have a part of edges not sealed; the second sub-functional film layer is provided with a fourth detachable part; a part of edges of the second sub-functional film layer and the sheet layer are not sealed.

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

21. The film dosage product according to any one of claims 17 to 20, wherein, The sheet layer further comprises at least one third sheet layer, the third sheet layer is arranged between two adjacent first sub-functional film layers.

22. The film dosage product of claim 21, wherein, At least one of water permeability, material, porosity, thickness, tensile force and number of layers of the plurality of third sheet layers is different.

23. The film dosage product according to any one of claims 1 to 22, wherein, The film product further comprises a holding part.

24. The film dosage product of claim 23, wherein, The holding part satisfies at least one of the following conditions: the holding part comprises at least one of a traction line and a handle; the holding part is located at an edge of the film product; the holding part comprises a part of the sheet layer; the holding part comprises a part of the sheet layer and a part of the functional film layer.

25. The film dosage product according to any one of claims 1 to 24, wherein, The film product is printed with graphic information.

26. The film dosage product according to any one of claims 1 to 25, wherein, The film product comprises at least one of a buccal film product, a sublingual film product, a lingual film product, an intraoral film product, a gingival film product, a dental film product, and a nasal film product.

27. The film dosage product according to any one of claims 1 to 26, wherein, The film product satisfies at least one of the following conditions: The outer contour shape of the film product comprises at least one of a square, a rectangle, a circle, a triangle, a polygon, and an irregular shape. The maximum dimension of the outer contour of the film product is 0.1-8 cm, and the minimum dimension is 0.1-1.5 cm. The functional film layer comprises at least one of a completely dissolving film layer, a partially dissolving film layer, and a swelling film layer.

28. The film dosage product according to any one of claims 1 to 27, wherein, The active ingredient comprises at least one of a pharmaceutical ingredient, a nutritional and health ingredient, a food ingredient, a daily chemical ingredient, and an alkaloid.

29. The film dosage product of claim 28, wherein, The pharmaceutical ingredient comprises at least one of an oral ulcer medicine, a psychotropic drug, an analgesic, an anti-inflammatory drug, a nasal drug, a cannabinoid and its derivative, a respiratory drug, and sildenafil. The nutritional and health ingredient comprises at least one of American ginseng extract, Schisandra chinensis extract, Ganoderma lucidum extract, arginine, propolis, melatonin, glutathione, and taurine. The food ingredient comprises at least one of tea extract, coffee extract, and vitamin. The daily chemical ingredient comprises at least one of papain, catalase, a tooth whitening ingredient, an oral repair ingredient, and an anti-aging ingredient. The alkaloid comprises at least one of nicotine and its derivative, caffeine and its analog, arecoline and its analog, and hexamethyl nicotine.

30. An oral film product, comprising: an oral film containing an active ingredient, the active ingredient being released from the oral film and acting on a target site; a sheet comprising a first sheet arranged on at least a part of the surface of the oral film; and / or, the first sheet being embedded in the interior of the oral film; wherein the sheet is the same as the sheet layer defined in any one of claims 1-27, and the oral film is the same as the functional film layer defined in any one of claims 1-25, 27-28.

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