Oral product

Abstract

A nicotine-containing oral product (10), comprising a water-permeable pouch (11) and a soluble substance (12) coated in the water-permeable bag, wherein the soluble substance comprises an active substance (121) and an orally soluble film substrate (122) that carries the active substance. By using the water-permeable pouch as an inner packaging material for the soluble substance, the soluble substance is prevented from being directly attached to an application site, and oral irritation during the utilization of the soluble substance can be alleviated.

Description

oral products

[0001] Cross-reference to related applications

[0002] This application claims priority to Chinese Patent Application No. 202520161990.0, filed on January 22, 2025, entitled "Oral Product", the entire contents of which are incorporated herein by reference. Technical Field

[0003] This application belongs to the field of oral tobacco technology, specifically relating to an oral product containing nicotine. Background Technology

[0004] Nicotine oral dissolving film (ODF) is a rapidly dissolving film used to deliver nicotine, commonly found in smoking cessation aids. This film dissolves quickly in the mouth, releasing nicotine to help smokers alleviate withdrawal symptoms and thus aid the smoking cessation process.

[0005] Because nicotine oral films are highly adhesive, they cannot be moved once placed in specific application areas such as between the oral cavity wall and gums. This means they can only be released in specific locations. Furthermore, due to the good adhesion between the oral film and the application site and the rapid release rate, the local concentration is high and the irritation is strong, resulting in a strong discomfort at the contact site. The oral film cannot be moved or spat out, and it also causes the user to produce a lot of saliva, swallow more frequently, and experience discomfort such as a burning sensation in the throat and stomach, which seriously affects the customer experience. Summary of the Invention

[0006] The purpose of this application is to provide an oral product that at least solves the problem in the related art that nicotine oral dissolving films cannot move during use and easily cause excessively strong local oral irritation.

[0007] This application provides an oral product comprising a water-permeable bag and a soluble substance encapsulated within the water-permeable bag, wherein the soluble substance comprises an active substance and an orally dissolving membrane substrate carrying the active substance.

[0008] In one embodiment, the active substance is a nicotine agent.

[0009] In one embodiment, the permeable bag includes a bag body, which is a fabric bag body; the fabric bag body includes fibers, wherein the fibers include natural fibers and / or synthetic fibers.

[0010] In one embodiment, the synthetic fiber includes adhesive fibers.

[0011] In one embodiment, the permeable bag further includes a release modifier, which is adsorbed by at least a portion of the bag body, and / or the release modifier fills the fiber gaps of the permeable bag.

[0012] In one embodiment, the release modifier includes at least one of sodium alginate and sodium hyaluronate.

[0013] In one embodiment, the bag body of the permeable bag is made of filter material.

[0014] In one embodiment, the bag has micropores of less than 100 μm.

[0015] In one embodiment, the oral slurry membrane substrate extends along the length of the permeable bag.

[0016] In one embodiment, the thickness of the oral dissolution membrane substrate is 50 μm to 70 μm.

[0017] In one embodiment, the oral dissolution membrane substrate has a length of 1.5–2.5 cm and a width of 0.5–1.5 cm.

[0018] In one embodiment, the oral dissolving film substrate accounts for 30% to 80% of the weight of the soluble matter.

[0019] In one embodiment, the soluble material includes a single layer of the oral soluble membrane substrate, which is laid flat along the length of the permeable bag;

[0020] Alternatively, the soluble material may include multiple layers of the oral soluble film substrate, which are stacked together and laid flat along the length of the permeable bag. The total length of the multiple layers of oral soluble film substrate laid flat end to end along the length of the permeable bag is greater than the length of the permeable bag.

[0021] In one embodiment, the oral product further includes a sealed bag that covers the outside of the water-permeable bag.

[0022] In one embodiment, the oral dissolving film substrate includes a substrate, a film-forming agent, a sweetener, a flavoring agent, and a pH adjuster.

[0023] In one embodiment, the substrate comprises at least one selected from pectin, gum arabic, gelatin, starch, and xanthan gum; and / or,

[0024] The film-forming agent includes at least one of hydroxypropyl cellulose, hydroxypropyl methylcellulose, ethyl cellulose, and polyvinyl alcohol; and / or,

[0025] The sweetener comprises at least one of xylitol, sorbitol, mannitol, iodine, lactitol, maltitol, isomaltitol, hydrogenated starch hydrolysate, erythritol, maltotriol, aspartame, acesulfame potassium, sodium saccharin, sucralose, neotame, cyclamate, alitane, steviol glycosides, arabinitol, and monk fruit sweetener; and / or,

[0026] The pH adjuster includes at least one of citric acid and sodium bicarbonate.

[0027] In one embodiment, the oral dissolving film substrate further includes a preservative, wherein the preservative is benzalkonium chloride.

[0028] In one embodiment, the soluble material comprises 30-80% hydroxypropyl methylcellulose, 0-20% polyvinyl alcohol, and 0-20% xanthan gum.

[0029] In one embodiment, the soluble substance contains 1 to 10% nicotine.

[0030] In one embodiment, the water content of the soluble substance is less than 5%.

[0031] In this embodiment, the oral product includes a water-permeable bag and a soluble substance encapsulated within the water-permeable bag. The soluble substance includes an active ingredient and an orally dissolving film substrate carrying the active ingredient. By using a water-permeable bag as the inner packaging material for the soluble substance, direct contact between the soluble substance and the application site is avoided, reducing oral irritation during application. Furthermore, the water-permeable bag has a water-locking function, which can retain some saliva, reducing throat irritation and stomach burning. Simultaneously, the release position of the soluble substance can be moved by shifting the water-permeable bag, preventing excessive irritation and thus improving the user experience. Attached Figure Description

[0032] Figure 1 shows a schematic diagram of the structure of an oral product provided in some embodiments of this application;

[0033] Figure 2 shows a schematic diagram of the structure of an oral product provided in some embodiments of this application in the CC direction of Figure 1;

[0034] Figure 3 shows a schematic diagram of the structure of an oral product provided in some embodiments of this application in the CC direction of Figure 1;

[0035] Figure 4 shows a schematic diagram of the structure of an oral product provided in some embodiments of this application in the CC direction of Figure 1;

[0036] Figure 5 shows a schematic diagram of the structure of an oral product provided in another embodiment of this application;

[0037] Figure 6 shows a schematic diagram of the DD-direction structure in Figure 5;

[0038] Figure 7 shows a comparison of the nicotine dissolution curves of the orally disintegrating film and the oral product in Example 1 of this application;

[0039] Figure 8 shows a comparison of the nicotine dissolution curves of the orally disintegrating film and the oral product in Example 2 of this application.

[0040] Figure reference numerals: 10: Oral product; 11: Water-permeable bag; 12: Soluble substance; 121: Active substance; 122: Oral dissolving film substrate; 13: Sealing bag. Specific Implementation

[0041] The terms "first" and "second" in the specification and claims of this application may explicitly or implicitly include one or more of the features. In the description of this application, unless otherwise stated, "multiple" means two or more. Furthermore, "and / or" in the specification and claims indicates at least one of the connected objects, and the character " / " generally indicates that the preceding and following objects are in an "or" relationship.

[0042] In the description of this application, it should be understood that the terms "center", "longitudinal", "lateral", "length", "width", "thickness", "upper", "lower", "front", "rear", "left", "right", "vertical", "horizontal", "top", "bottom", "inner", "outer", "clockwise", "counterclockwise", "axial", "radial", "circumferential", etc., indicating the orientation or positional relationship based on the orientation or positional relationship shown in the accompanying drawings, are only for the convenience of describing this application and simplifying the description, and do not indicate or imply that the device or element referred to must have a specific orientation, or be constructed and operated in a specific orientation, and therefore should not be construed as a limitation of this application.

[0043] In the description of this application, it should be noted that, unless otherwise expressly specified and limited, the terms "installation," "connection," and "linking" should be interpreted broadly. For example, they can refer to a fixed connection, a detachable connection, or an integral connection; they can refer to a mechanical connection or an electrical connection; they can refer to a direct connection or an indirect connection through an intermediate medium; and they can refer to the internal connection between two components. Those skilled in the art can understand the specific meaning of the above terms in this application based on the specific circumstances.

[0044] Nicotine oral dissolving film (ODF) is a rapidly dissolving film used to deliver nicotine, commonly found in smoking cessation aids. When placed in the mouth, the ODF dissolves quickly with the help of saliva, releasing nicotine to help smokers alleviate withdrawal symptoms and thus aid the smoking cessation process.

[0045] Because nicotine oral films are highly adhesive, they cannot be moved once placed in specific application areas such as between the oral cavity wall and gums. This means they can only be released in specific locations. Furthermore, due to the good adhesion between the oral film and the application site and the rapid release rate, the local concentration is high and the irritation is strong, resulting in a strong discomfort at the contact site. The oral film cannot be moved or spat out, and it also causes the user to produce a lot of saliva, swallow more frequently, and experience discomfort such as a burning sensation in the throat and stomach, which seriously affects the customer experience.

[0046] In related technologies, orally dissolving membranes address taste issues through flavor-correcting and masking techniques, such as adding sweeteners, NaCl, and flavorings. However, these methods cannot resolve the intense oral irritation, and the orally dissolving membrane is immobile, failing to alleviate the burning sensation in the throat and stomach.

[0047] This application provides an oral product, as shown in Figures 1 to 4. The oral product 10 includes a water-permeable bag 11 and a soluble substance 12 encapsulated within the water-permeable bag 11. The soluble substance 12 includes an active substance 121 and an orally dissolving film substrate 122 carrying the active substance 121. The soluble substance 12 is in the form of an orally dissolving film.

[0048] The surface of the permeable bag 11 has pores that allow liquids such as saliva to pass through; the active substance 121 is a component that can help smokers alleviate withdrawal symptoms and can be directly absorbed through the oral mucosa; the orally dissolving film substrate 122 is a soluble matrix that serves as a carrier for the active substance 121. It can dissolve rapidly in the oral cavity and then directly absorb the active substance 121 it carries through the oral mucosa, helping smokers alleviate nicotine withdrawal symptoms during the smoking cessation process.

[0049] In this embodiment, by using a water-permeable bag 11 as the inner packaging material of the soluble substance 12, the soluble substance 12 is prevented from directly adhering to the application site, which can slow down the early release of the active substance 121. In addition, the water-permeable bag 11 has a water-locking function, which can lock in some saliva and reduce the burning sensation in the throat and stomach. At the same time, the release position of the soluble substance 12 can be moved by moving the water-permeable bag 11 to avoid excessive stimulation, thereby improving the user experience and avoiding the problem that existing nicotine oral dissolving films cannot be moved during use and easily produce a strong oral irritation.

[0050] In some embodiments, the permeable bag 11 includes a bag body, which is a woven fabric bag body. In this embodiment, the woven fabric bag body is formed by weaving or other methods using fibers, or the bag body is directly made using a fiber web. This not only achieves a water-permeable effect but also provides good durability in moist environments such as the mouth. It effectively prevents soluble substances 12 from directly adhering to the application area, locks in some saliva, and allows the release position of soluble substances 12 to be moved by moving the permeable bag. In some embodiments, the fibers can be selected from natural fibers and synthetic fibers, that is, the permeable bag 11 can be made using at least one of natural fibers and synthetic fibers through the above manufacturing method.

[0051] In addition, in some embodiments, the aforementioned natural fiber can be cellulose fiber or the like. In this embodiment, using cellulose fiber to make the bag body of the aforementioned permeable bag 11 not only achieves good water permeability and durability in moist environments such as the oral cavity, but also has better skin-friendly properties, which can avoid the bag body itself causing irritation and discomfort to the oral mucosa, further improving the user experience.

[0052] In some embodiments, the synthetic fibers include thermoplastic adhesive fibers. In this embodiment, adhesive fibers are added to the material used to make the permeable bag 11, allowing the bag body to be directly heat-sealed without the need for additional adhesives, thus facilitating production and processing, as well as user assembly, disassembly, and even reuse. In some embodiments, the bag body of the permeable bag 11 is made of adhesive fibers and fabric fibers. In some embodiments, the main body of the permeable bag 11 is made of fabric fibers, while the edges of the bag body are made of adhesive fibers, achieving both direct heat sealing and a better skin-friendly effect.

[0053] In some embodiments, the permeable bag 11 further includes a release modifier, which is adsorbed by at least a portion of the bag body. By adsorbing the release modifier into the bag body of the permeable bag 11, the initial release of the active substance 121 can be further slowed down, avoiding the burning sensation in the throat and stomach caused by the concentrated release of the active substance 121 in a short period of time, thereby improving the user experience. The release modifier may be at least one selected from sodium alginate, sodium hyaluronate, etc.

[0054] In some embodiments, the release modifier is filled into the fiber gaps of the permeable bag 11. In this embodiment, the bag body of the permeable bag 11 is made of fiber, which obviously has gaps. By filling the fiber gaps with the release modifier, not only can the release modifier be firmly loaded onto the bag body, but the initial release of the active substance 121 in the bag can also be more effectively slowed down without affecting the water permeability.

[0055] In addition, in some embodiments, the bag body of the above-mentioned permeable bag 11 is made of filter material, such as cotton fiber or hemp fiber, so that the bag body itself has filtering properties, preventing large particles of the bag contents from dissolving out of the bag body, thereby reducing the discomfort of traditional oral dissolving membrane products.

[0056] In addition, in some embodiments, the bag body of the above-mentioned water-permeable bag 11 has micropores of less than 100μm, which can achieve water permeability and make the pore density on the bag body relatively large, resulting in good water-locking effect.

[0057] In some embodiments, the active substance 121 is a nicotine agent, that is, a substance containing nicotine, which can provide an appropriate amount of nicotine to alleviate withdrawal symptoms and help smokers gradually reduce their dependence on nicotine, thereby achieving the goal of quitting smoking. In this embodiment, by loading the nicotine agent as the active substance 121 onto the oral dissolving membrane substrate 122 and then encapsulating it in the permeable bag 11, it can not only help smokers alleviate nicotine withdrawal symptoms during the smoking cessation process, but also effectively slow down the initial release of nicotine. The permeable bag 11 has a water-locking function, which can lock in some saliva and reduce the burning sensation in the throat and stomach. At the same time, the release position of the soluble substance 12 can be moved by moving the permeable bag 11 to avoid excessive stimulation, thereby improving the user experience.

[0058] In some embodiments, the material of the oral dissolving film substrate 122 includes a substrate, a film-forming agent, a sweetener, a flavoring, and a pH adjuster; wherein the substrate serves as the framework of the oral dissolving film substrate 122; the film-forming agent is used to promote film formation; the sweetener is used to provide sweetness; the flavoring is used to improve taste; and the pH adjuster is used to adjust the pH value to improve taste.

[0059] In some embodiments, the substrate includes at least one of pectin, gum arabic, gelatin, starch, and xanthan gum.

[0060] In some embodiments, the film-forming agent includes at least one of hydroxypropyl cellulose, hydroxypropyl methylcellulose, ethyl cellulose, and polyvinyl alcohol.

[0061] In some embodiments, the sweeteners mentioned above include at least one of xylitol, sorbitol, mannitol, iodine, lactitol, maltitol, isomaltitol, hydrogenated starch hydrolysate, erythritol, maltotriol, aspartame, acesulfame potassium, sodium saccharin, sucralose, neotame, cyclamate, alitane, steviol glycosides, arabinitol, and monk fruit sweetener.

[0062] In some embodiments, the pH adjuster includes at least one of citric acid and sodium bicarbonate.

[0063] In addition, in some embodiments, the material of the oral dissolution membrane substrate 122 may also include a preservative, such as benzalkonium chloride.

[0064] In some embodiments, the oral dissolving film substrate 122 extends along the length of the permeable bag 11, which not only makes it easy for the user to put it in their mouth, but also adapts to the shape of the tongue, making the contact between the active substance 121 and the oral cavity more uniform, and further improving the user experience.

[0065] In some embodiments, the oral dissolution membrane substrate 122 and the permeable bag 11 may be square, elliptical, rectangular, or circular. The oral dissolution membrane substrate 122 may also be other shapes, which will not be described in detail in this application.

[0066] In one embodiment, the oral dissolving film substrate 122 and the permeable bag 11 are generally rectangular. In some embodiments, the length and width of the oral dissolving film substrate 122 are 1.5-2.5 cm and 0.5-1.5 cm, respectively, so that the overall size of the soluble substance 12 is moderate, the content of active ingredients carried is appropriate, and the taste is comfortable during use. In some embodiments, the length of the oral dissolving film substrate 122 can be one or a range of 1.5 cm, 1.6 cm, 1.8 cm, 2 cm, 2.2 cm, 2.5 cm, and the width of the oral dissolving film substrate 122 can be one or a range of 0.5 cm, 0.6 cm, 0.8 cm, 1 cm, 1.2 cm, 1.5 cm, and the range of 1 cm * 2 cm. In some embodiments, the length and width of the oral dissolving film substrate 122 are 1 cm * 2 cm. In some embodiments, the thickness of the oral dissolution film substrate 122 is 50 μm to 70 μm, for example, it can be one of 50 μm, 52 μm, 55 μm, 60 μm, 70 μm or any value between two of them.

[0067] In some embodiments, the oral disintegrating film substrate 122 accounts for 30% to 80% of the weight of the soluble substance 12. It not only effectively loads the active substance 121, but also maintains a moderate concentration of the active substance 121, effectively relieving withdrawal symptoms while avoiding excessive stimulation, thereby reducing throat burning and stomach aches. For example, the oral disintegrating film substrate 122 accounts for one or more of 30%, 40%, 50%, 60%, 70%, and 80% of the weight of the soluble substance 12, or any combination thereof.

[0068] In some embodiments, as shown in Figures 1 and 2, the soluble substance 12 includes a single-layer oral dissolution membrane substrate 122, and the oral dissolution membrane substrate is laid flat along the length of the permeable bag, so that the soluble substance 12 is easy to process and manufacture and for the user to put into the mouth.

[0069] In some embodiments, as shown in Figures 1, 3, and 4, the soluble material 12 includes a multilayer oral soluble film substrate 122. The multilayer oral soluble film substrate 122 is stacked on top of each other and laid flat along the length of the water-permeable bag 11. The total length of the multilayer oral soluble film substrate 122 laid flat end to end along the length of the water-permeable bag 11 is greater than the length of the water-permeable bag 11, so that the water-permeable bag 11 can hold more soluble material 12, thereby ensuring that the oral product contacts the oral cavity or releases from the oral cavity, and extending the usage time.

[0070] In some embodiments, the multilayer ortholytic membrane substrate 122 can be formed by directly stacking individual single-layer ortholytic membrane substrates 122, as shown in FIG3. The total length of the multilayer ortholytic membrane substrate 122 when unfolded along the length direction is greater than the length of the water-permeable bag 11, or the total width of the multilayer ortholytic membrane substrate 122 when unfolded along the width direction is greater than the width of the water-permeable bag 11.

[0071] In some embodiments, the multilayer ortholytic membrane substrate 122 can be formed by folding a single-layer ortholytic membrane substrate 122, for example, by folding along the width direction of the permeable bag 11, as shown in FIG4. The total width of the multilayer ortholytic membrane substrate 122 when unfolded along the width direction is greater than the width of the permeable bag 11.

[0072] In other embodiments, the multilayer ortholytic membrane substrate 122 can be formed by folding a single-layer ortholytic membrane substrate 122, for example, by folding along the length direction of the permeable bag 11. The total length of the multilayer ortholytic membrane substrate 122 when unfolded along the length direction is greater than the length of the permeable bag 11.

[0073] In some embodiments, the multilayer oral solution film substrates 122 can be independent of each other, as shown in Figure 3; in some embodiments, the multilayer oral solution film substrates 122 can also be integrally formed, as shown in Figure 4.

[0074] In some embodiments, as shown in Figures 5 and 6, the oral product 10 further includes a sealing bag 13, which covers the outside of the permeable bag 11 and can seal and preserve the permeable bag 11 and the soluble contents 12 inside. In some embodiments, the sealing bag is an aluminum foil bag.

[0075] In some embodiments, the basic formulation of the oral product is shown in Table 1 below.

[0076] Table 1

[0077] Based on Table 1 above, the above oral products are manufactured according to the following process steps:

[0078] (1) Solution preparation

[0079] ① Pour an appropriate amount of water into the mixing tank and start stirring at a speed of 50-200 rpm. Slowly pour hydroxypropyl methylcellulose into the mixing tank and start homogenizing at a speed of 10,000-20,000 rpm. After the cellulose is completely dissolved, turn off the homogenizer.

[0080] ② Add nicotine, xanthan gum, polyvinyl alcohol, sweetener, and flavoring to the cellulose solution and stir at 50-200 rpm until completely dissolved, controlling the solid content to 10-50%;

[0081] ③ Under the condition of stirring speed of 50-100 rpm, the pH of the system is adjusted to 4-9 using citric acid and sodium bicarbonate;

[0082] ④ Adjust the stirring speed to 10-20 rpm, apply vacuum (-0.06-0.08 MPa) to defoam, and turn off the vacuum after the bubbles are completely eliminated. Set aside for later use.

[0083] (2) Coating

[0084] ① Add the material to the hopper of the coating machine, lay a layer of release film, and start coating. Control the material thickness to be 50μm~70μm and the coating rate to be 30~80mm / s.

[0085] ② Turn on the heating and dry the material at a temperature of 50-60℃ until the moisture content is below 5%;

[0086] ③ By cutting and trimming the oral soluble material, a soluble substance in the form of an oral soluble film with a water content of less than 5% can be obtained. The length and width of each film should be controlled to be 1cm*2cm, and the nicotine content should be controlled to be 2±0.2mg / film.

[0087] (3) Fiber bag packaging

[0088] Pack the nicotine oral solution film into a fiber bag and seal it.

[0089] (4) Packaging

[0090] Pack the nicotine oral soluble film pouch into an aluminum foil bag or other packaging material, and then seal it.

[0091] To make the purpose, technical solution, and beneficial effects of this application clearer, the application is further described below with reference to embodiments. It should be understood that these embodiments are for illustrative purposes only and are not intended to limit the scope of this application.

[0092] The present application will be described in detail below through embodiments.

[0093] Dissolution test

[0094] The sample was placed in 60 mL of artificial saliva at pH 6.8 and subjected to a dissolution reaction at 37 °C and 100 r / min. Samples were taken at 0.5 min, 1 min, 2 min, 3 min, 5 min, 10 min, 15 min, 20 min and 30 min, and the nicotine content was detected by high performance liquid chromatography.

[0095] Example 1

[0096] (1) Solution preparation

[0097] ① Pour an appropriate amount of water into the mixing tank and start stirring at a speed of 50-200 rpm. Slowly pour 62 parts by weight of hydroxypropyl methylcellulose into the mixing tank and start homogenizing at a speed of 10,000-20,000 rpm. After the cellulose is completely dissolved, turn off the homogenizer.

[0098] ② By weight, add 2 parts nicotine, 15 parts xanthan gum, 15 parts polyvinyl alcohol, 5 parts sucralose, and 0.5 parts benzalkonium chloride to the cellulose solution, and stir at 50-200 rpm until completely dissolved, controlling the solid content to 10-30%.

[0099] ③ Under the condition of stirring speed of 50-100 rpm, the pH of the system is adjusted to 7 using citric acid and sodium bicarbonate;

[0100] ④ Adjust the stirring speed to 10-20 rpm, apply vacuum (-0.06-0.08 MPa) to defoam, and turn off the vacuum after the bubbles are completely eliminated. Set aside for later use.

[0101] (2) Coating

[0102] ① Add the material to the hopper of the coating machine, lay a layer of release film, and start coating. Control the material thickness to be 50μm~70μm and the coating rate to be 30~80mm / s.

[0103] ② Turn on the heating and dry the material at a temperature of 50-60℃ until the moisture content is below 5%;

[0104] ③ Cut and trim into nicotine oral dissolving films, controlling the length and width of each film to be 1cm*2cm, and controlling the nicotine content to be 2±0.2mg / film.

[0105] (3) Packaging in fiber fabric bags

[0106] The nicotine oral solution film is placed into a woven fabric bag, sealed, and an oral product is obtained.

[0107] (4) Packaging

[0108] Oral products are packaged in aluminum foil bags and then sealed.

[0109] Example 2

[0110] (1) Solution preparation

[0111] ① Pour an appropriate amount of water into the mixing tank and start stirring at a speed of 50-200 rpm. By weight, slowly pour 52 parts of hydroxypropyl methylcellulose and 20 parts of hydroxypropyl cellulose into the mixing tank and start homogenizing at a speed of 10,000-20,000 rpm. After the cellulose is completely dissolved, turn off the homogenizer.

[0112] ② By weight, add 2 parts nicotine, 20 parts carboxymethyl cellulose, 5 parts sucralose, and 0.5 parts benzalkonium chloride to the cellulose solution, and stir at 50-200 rpm until completely dissolved, controlling the solid content to 10-30%.

[0113] ③ Under the condition of stirring speed of 50-100 rpm, the pH of the system is adjusted to 7 using citric acid and sodium bicarbonate;

[0114] ④ Adjust the stirring speed to 10-20 rpm, apply vacuum (-0.06-0.08 MPa) to defoam, and turn off the vacuum after the bubbles are completely eliminated. Set aside for later use.

[0115] (2) Coating

[0116] ① Add the material to the hopper of the coating machine, lay a layer of release film, and start coating. Control the material thickness to be 50μm~70μm and the coating rate to be 30~80mm / s.

[0117] ② Turn on the heating and dry the material at a temperature of 50-60℃ until the moisture content is below 5%;

[0118] ③ Cut and trim into nicotine oral dissolving films, controlling the length and width of each film to be 1cm*2cm, and controlling the nicotine content to be 2±0.2mg / film.

[0119] (3) Packaging in fiber fabric bags

[0120] The nicotine oral solution film is placed into a woven fabric bag, sealed, and an oral product is obtained.

[0121] (4) Packaging

[0122] Oral products are packaged in aluminum foil bags and then sealed.

[0123] Example 3

[0124] The difference between Example 3 and Example 1 is that a layer of sodium alginate is sprayed onto the surface of the fibrous fabric bag.

[0125] Dissolution tests were performed on the nicotine oral films in Examples 1-2 and the oral products in Examples 1-3, and the test results are shown in Table 2.

[0126] Table 2

[0127] Figure 7 shows a comparison of the nicotine dissolution curves of the oral dissolution film and the oral product in Example 1. In this figure, a represents the nicotine dissolution curve of the oral dissolution film in Example 1, and A represents the nicotine dissolution curve of the oral product in Example 1.

[0128] Figure 8 shows a comparison of the nicotine dissolution curves of the oral dissolution film and the oral product in Example 2. In this figure, b represents the nicotine dissolution curve of the oral dissolution film in Example 2, and B represents the nicotine dissolution curve of the oral product in Example 2.

[0129] As can be seen from Figure 7, the orally disintegrating film in Example 1 showed a faster nicotine release, reaching a plateau within 5 minutes, indicating that the nicotine release was rapid and quickly reached a stable state; the oral product in Example 1 showed a slower nicotine release, reaching a plateau within 5 to 10 minutes, indicating that the fiber bag played a sustained-release role, which can reduce oral irritation and maintain a longer-lasting effect.

[0130] As can be seen from Figure 8, the orally disintegrating film in Example 1 showed a faster nicotine release, reaching a plateau within 5 minutes, indicating that the nicotine release was rapid and quickly reached a stable state; the oral product in Example 1 showed a slower nicotine release, reaching a plateau within 5 to 10 minutes, indicating that the fiber bag played a sustained-release role, which can reduce oral irritation and maintain a longer-lasting effect.

[0131] The experimental data above show that the fiber fabric bag has a good release effect, can reduce oral irritation, and maintain a longer-lasting experience.

[0132] In summary, in this embodiment, the oral product includes a water-permeable bag and a soluble substance encapsulated within the water-permeable bag. The soluble substance includes an active ingredient and an orally dissolving film substrate carrying the active ingredient. By using a water-permeable bag as the inner packaging material for the soluble substance, direct contact between the soluble substance and the application site is avoided, reducing oral irritation during application. Furthermore, the water-permeable bag has a water-locking function, which can retain some saliva, reducing throat irritation and stomach burning. Simultaneously, the release position of the soluble substance can be moved by shifting the water-permeable bag, preventing excessive irritation and thus improving the user experience.

[0133] It should be noted that the various embodiments in this specification are described in a progressive manner, with each embodiment focusing on the differences from other embodiments. The same or similar parts between the various embodiments can be referred to each other.

[0134] Finally, it should be noted that in this document, relational terms such as "first" and "second" are used merely to distinguish one entity from another, and do not necessarily require or imply any such actual relationship or order between these entities. Furthermore, the terms "comprising," "including," or any other variations thereof are intended to cover non-exclusive inclusion, such that an article or terminal device that comprises a list of elements includes not only those elements but also other elements not expressly listed, or elements inherent to such an article or terminal device. Without further limitations, an element defined by the phrase "comprising one..." does not exclude the presence of other identical elements in the article or terminal device that includes that element.

Claims

1. An oral article, wherein, The oral product includes a water-permeable bag and a soluble substance encapsulated within the water-permeable bag, wherein the soluble substance includes an active substance and an orally disintegrating membrane substrate carrying the active substance.

2. The oral product according to claim 1, wherein, The active substance is nicotine.

3. The oral product according to any one of claims 1 or 2, wherein, The permeable bag includes a bag body, which is a fabric bag body; the fabric bag body includes fibers, wherein the fibers include natural fibers and / or synthetic fibers.

4. The oral article of claim 3, wherein, The synthetic fibers include adhesive fibers.

5. The oral preparation according to any one of claims 3 or 4, wherein, The permeable bag further includes a release modifier, which is adsorbed by at least a portion of the bag body, and / or the release modifier fills the fiber gaps of the permeable bag.

6. The oral article of claim 5, wherein, The release modifier includes at least one of sodium alginate and sodium hyaluronate.

7. The oral product according to any one of claims 1 to 6, wherein, The permeable bag is made of filter material.

8. The oral preparation according to any one of claims 1 to 7, wherein, The bag has micropores smaller than 100 μm.

9. The oral product according to any one of claims 1 to 8, wherein, The oral slurry membrane substrate extends along the length of the permeable bag.

10. The oral product according to any one of claims 1 to 9, wherein, The thickness of the oral dissolution membrane substrate is 50 μm to 70 μm.

11. The oral product according to any one of claims 1 to 10, wherein, The oral dissolution membrane substrate has a length of 1.5–2.5 cm and a width of 0.5–1.5 cm.

12. The oral product according to any one of claims 1 to 11, wherein, The oral dissolving film substrate accounts for 30% to 80% of the weight of the soluble substance.

13. The oral product according to any one of claims 1 to 12, wherein, The soluble material includes a single layer of the oral soluble membrane substrate, which is laid flat along the length of the permeable bag. Alternatively, the soluble material may include multiple layers of the oral soluble film substrate, which are stacked together and laid flat along the length of the permeable bag. The total length of the multiple layers of oral soluble film substrate laid flat end to end along the length of the permeable bag is greater than the length of the permeable bag.

14. The oral product according to any one of claims 1 to 13, wherein, The oral product also includes a sealed bag that covers the outside of the water-permeable bag.

15. The oral product according to any one of claims 1 to 14, wherein, The oral dissolving film substrate includes a substrate, a film-forming agent, a sweetener, a flavoring agent, and a pH adjuster.

16. The oral product according to claim 15, wherein, The substrate includes at least one of pectin, gum arabic, gelatin, starch, and xanthan gum; and / or, The film-forming agent includes at least one of hydroxypropyl cellulose, hydroxypropyl methylcellulose, ethyl cellulose, and polyvinyl alcohol; and / or, The sweetener comprises at least one of xylitol, sorbitol, mannitol, iodine, lactitol, maltitol, isomaltitol, hydrogenated starch hydrolysate, erythritol, maltotriol, aspartame, acesulfame potassium, sodium saccharin, sucralose, neotame, cyclamate, alitane, steviol glycosides, arabinitol, and monk fruit sweetener; and / or, The pH adjuster includes at least one of citric acid and sodium bicarbonate.

17. The oral product according to any one of claims 1 to 16, wherein the orally disintegrating film substrate further comprises a preservative, wherein the preservative is benzalkonium chloride.

18. The oral product according to any one of claims 1 to 17, wherein, The soluble substance comprises 30-80% hydroxypropyl methylcellulose, 0-20% polyvinyl alcohol, and 0-20% xanthan gum.

19. The oral product according to any one of claims 1 to 18, wherein, The soluble substance contains 1 to 10% nicotine.

20. The oral product according to any one of claims 1 to 19, wherein, The water content of the soluble substance is less than 5%.

Images