A nicotine oral product and a method of making the same

Abstract

The application discloses a nicotine oral product and a preparation method thereof, and belongs to the technical field of novel tobacco products. The nicotine oral product comprises a nicotine bag inner core, a liquid-permeable bag body, and a first composition filled in the liquid-permeable bag body; and a mouth dissolving film shell, which is a closed shell made of a mouth dissolving film sheet, wherein the mouth dissolving film sheet comprises a second composition; wherein the mouth dissolving film shell is wrapped outside the nicotine bag inner core; and the first composition and the second composition both contain nicotine components. The nicotine oral product of the application realizes the dual-phase release characteristics of shell fast release and inner core slow release by organically combining the independent mouth dissolving film shell with the nicotine bag inner core, can quickly reach the effective concentration of nicotine, instantly meet the needs of consumers, maintain long-time stable release, and continuously satisfy the consumers, and simultaneously improves the storage stability and sensory experience.

Description

Technical Field

[0001] This invention belongs to the field of novel tobacco product technology, specifically relating to a nicotine oral product and its preparation method. Background Technology

[0002] Influenced by the international tobacco control movement, cigarette consumption has shown a downward trend year by year, making the regulation of tobacco products and the demand for alternative products more urgent than ever before. Smokeless tobacco products, due to their obvious advantages such as not burning and producing no smoke, are gaining momentum against this trend and are gradually becoming an important supplement to tobacco consumption in a tobacco control environment, attracting widespread attention from major tobacco companies worldwide. Among many potential smokeless tobacco alternatives, nicotine pouches, as a new type of nicotine product, are gradually entering consumers' field of vision and are developing rapidly due to their significant characteristics such as convenience and low harm.

[0003] Nicotine pouches have a broad market base globally, particularly in Northern Europe and the United States, and their market share is gradually expanding with the rise of new tobacco products. Globally, in 2023, nicotine pouches (modern oral cigarettes), as a rapidly emerging tobacco product in recent years, continued their high-speed growth, with sales volume increasing by 43.5% year-on-year to 15.51 billion pouches and sales revenue increasing by 61.1% year-on-year to US$7.86 billion. The United States accounted for 75.8% of global nicotine pouch sales. With the continuous development of market trade and the expansion of the new tobacco product market, the production and sales of nicotine pouches are gradually showing a global trend. More and more international tobacco companies are beginning to establish a global presence in the nicotine pouch market, driving the globalization of nicotine pouch production.

[0004] Nicotine pouches are the best-selling type of oral nicotine product. Their main components include nicotine salts, fillers, and additives, with nicotine salts being the core ingredient. After being processed by pH adjusters and converted in bodily fluids, nicotine salts form free nicotine, which then enters the bloodstream and produces the sensation of nicotine spikes and physiological satisfaction. On March 15, 2022, the revised Tobacco Control Act in the United States came into effect, amending the definition of tobacco products and redefining them as "any product made or derived from tobacco, or containing nicotine of any origin, intended for human consumption," further highlighting the unique and crucial role of nicotine in oral nicotine products. Furthermore, in 2015, Shihadeh et al. proposed using the concept of nicotine flux, or nicotine release rate, as a characterizing indicator of the speed of nicotine release; its fluctuations can be used to characterize the stability of nicotine delivery. Furthermore, in May 2016, the U.S. FDA's Center for Tobacco Products proposed increasing regulatory requirements for the nicotine dissolution index in oral tobacco products, meaning that new oral tobacco products must undergo an equivalence assessment for this index before they can be marketed.

[0005] Traditional nicotine pouches are made of permeable materials such as non-woven fabric and filled with a granular composition containing nicotine, fillers, pH adjusters, and flavoring agents. When used, they are placed between the lips and teeth, allowing saliva to penetrate the pouch and gradually dissolve the nicotine and other components. Due to the barrier effect of the pouch and the slow-release properties of the filling, nicotine pouches can achieve a stable release for 20 to 30 minutes, providing consumers with a continuous sensory experience. However, a significant drawback of traditional nicotine pouches is their slow onset of action. It takes time for nicotine to diffuse from the pouch into the mouth and reach an effective blood concentration, typically several minutes, before consumers experience noticeable physiological satisfaction, failing to meet consumers' psychological and physiological expectations of "instant gratification."

[0006] Oral dissolving films are typically composed of water-soluble polymer film-forming materials, nicotine, plasticizers, and flavoring agents. When used, they adhere to the roof of the mouth or the tongue, rapidly disintegrating and releasing nicotine upon contact with saliva. A significant advantage of oral dissolving films is their extremely rapid onset of action, quickly increasing oral nicotine concentration within tens of seconds, providing consumers with a short-term sense of satisfaction. However, precisely because of this rapid disintegration, the nicotine in oral dissolving films is often completely released within minutes, resulting in a short duration of action that fails to meet consumers' needs for prolonged and sustained satisfaction. Furthermore, the drug loading capacity of a single oral dissolving film is limited by the mechanical strength and taste of the film material; increasing the nicotine content often leads to excessively thick films, a decreased taste, or increased irritation.

[0007] In summary, the urgent technical problem to be solved in the existing technology is: how to provide a new type of nicotine delivery product that can achieve rapid onset of action and immediate satisfaction of consumer needs, while maintaining a stable release over a long period of time and ensuring continuous satisfaction. Summary of the Invention

[0008] In a first aspect, the present invention provides a nicotine oral article comprising: a nicotine pouch core 1, including a liquid-permeable pouch body and a first composition filled within the liquid-permeable pouch body; and an oral slurry film shell 2, which is a closed shell made of an oral slurry film sheet containing a second composition; wherein the oral slurry film shell 2 is wrapped around the nicotine pouch core 1; wherein both the first composition and the second composition contain nicotine.

[0009] Furthermore, the outer shell 2 completely disintegrates within 30 seconds after being placed in the mouth, and the first composition in the inner core 1 requires more than 5 minutes to release 50% of the nicotine after being placed in the mouth.

[0010] Furthermore, the outer shell 2 is formed by wrapping the inner core 1 with a pre-formed oral fusion film sheet through heat sealing or pressing.

[0011] Furthermore, there is a gap layer 3 between the outer shell 2 and the inner core 1, and the gap layer 3 is filled with gas.

[0012] Furthermore, the liquid-permeable bag body is made of non-woven fabric.

[0013] Furthermore, the first composition also includes one or more of the following: filler, pH adjuster, cooling agent, sweetener, flavoring agent, fragrance, preservative, thickener, film-forming agent, adhesive, anti-adhesion agent, flow aid, wetting agent, surfactant, colorant, and lubricant.

[0014] Furthermore, the second composition also includes one or more of the following: film-forming material, sweetener, cooling agent, pH adjuster, flavoring, and plasticizer.

[0015] In a second aspect, a method for preparing a nicotine oral article according to the first aspect is provided, comprising the following steps: S1: The first composition is filled into a liquid-permeable bag and sealed to prepare the nicotine bag core 1; S2: The second composition is made into an oral dissolving film sheet; S3: The oral soluble film sheet is formed into an oral soluble film shell 2, the nicotine pouch inner core 1 is placed inside the oral soluble film shell 2, and then sealed to form a closed shell, thereby obtaining a nicotine oral product.

[0016] Furthermore, in step S3, before sealing to form a closed shell, gas is introduced into the shell to form a gap layer 3.

[0017] Compared with the prior art, the present invention has the following beneficial effects: This invention achieves a dual-phase release kinetics of immediate and sustained release by combining an independent orally disintegrating membrane shell with a nicotine pouch core. The orally disintegrating membrane shell rapidly disintegrates upon contact with saliva, releasing the first dose of nicotine, providing consumers with an immediate and noticeable physiological satisfaction, effectively addressing the drawback of slow onset of traditional nicotine pouches. Simultaneously, the first composition in the nicotine pouch core continuously releases nicotine under the sustained-release effect of the liquid-permeable pouch, effectively compensating for the short duration of action of a single orally disintegrating membrane.

[0018] In this invention, the outer shell and the inner core are two independent physical entities. Gas can be filled between them, which to some extent avoids the problem of direct contact and reaction or component migration during storage, significantly improving the product's shelf-life stability. Furthermore, by adjusting the ratio of the inner and outer layers, products with different nicotine strengths can be flexibly produced to meet the needs of different consumer groups. Attached Figure Description

[0019] The above description of this application and the following detailed embodiments will be better understood when read in conjunction with the accompanying drawings. It should be noted that the drawings are merely examples of the claimed technical solutions.

[0020] Figure 1 A schematic diagram of the structure of a nicotine oral article according to one embodiment of the present invention is shown; Figure 2 The dissolution concentration-time curve in the nicotine dissolution test is shown. Detailed Implementation

[0021] The detailed features and advantages of this application are described below in the specific embodiments. The content of this description is sufficient to enable any person skilled in the art to understand the technical content of this application and implement it accordingly. Based on the specification, claims and drawings disclosed in this specification, a person skilled in the art can easily understand the related objectives and advantages of this application.

[0022] In this specification and claims, several terms will be used, and unless otherwise indicated, these terms will be defined to have the following meanings: All figures used to represent component amounts, properties (e.g., weight-average molecular weight), reaction conditions, etc., should be considered in all cases modified by the terms "within the unavoidable margin of error" or "about". Therefore, the numerical values ​​set forth herein are approximate and may vary depending on the desired properties sought to be obtained by the present invention. The principle of equivalents, which is applied to a minimum and not intended to limit the scope of the claims, should be applied, for example, each value should be interpreted at least according to the reported significant digits and by applying conventional rounding techniques.

[0023] All other terms used herein for special definition are intended to have the general meaning understood by one of ordinary skill in the art, in particular meaning that one of ordinary skill in the art can directly and without doubt determine how the technical solutions of the invention can be implemented after reading the claims, specification and drawings.

[0024] Even if there are incomplete descriptions, omissions, or ambiguities in the grammar, words, punctuation, graphics, symbols, etc. of the claims, specification, and drawings of this invention, those skilled in the art can still arrive at the only correct understanding by reading the claims, specification, and drawings as a whole without extensive reasoning or experimentation, and effectively exclude various incorrect interpretations that are not aimed at achieving the purpose of this invention.

[0025] The "range" disclosed herein is defined by a lower limit and an upper limit. A given range is defined by selecting a lower limit and an upper limit, which define the boundaries of a particular range. Ranges defined in this way can include or exclude endpoints and can be arbitrarily combined; that is, any lower limit can be combined with any upper limit to form a range. For example, if ranges of 60-120 and 80-110 are listed for a specific parameter, it is expected that ranges of 60-110 and 80-120 are also expected. Furthermore, if minimum range values ​​of 1 and 2 are listed, and if maximum range values ​​of 3, 4, and 5 are listed, then the following ranges are all expected: 1-3, 1-4, 1-5, 2-3, 2-4, and 2-5. In this application, unless otherwise stated, the numerical range "ab" represents a shortened representation of any combination of real numbers between a and b, where a and b are real numbers. For example, the numerical range "0-5" indicates that all real numbers between "0-5" have been listed in this article; "0-5" is simply a shortened representation of these numerical combinations. Furthermore, when a parameter is stated as an integer ≥2, it is equivalent to disclosing that the parameter is, for example, an integer such as 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, etc.

[0026] Unless otherwise specified, all embodiments and preferred embodiments mentioned herein can be combined to form new technical solutions.

[0027] Unless otherwise specified, all the technical features and preferred features mentioned herein can be combined to form new technical solutions.

[0028] Unless otherwise specified, all steps mentioned herein may be performed sequentially or randomly, but are preferably performed sequentially. For example, the method includes steps (a) and (b), indicating that the method may include steps (a) and (b) performed sequentially, or it may include steps (b) and (a) performed sequentially. For example, the mention that the method may also include step (c) indicates that step (c) may be added to the method in any order; for example, the method may include steps (a), (b), and (c), or it may include steps (a), (c), and (b), or it may include steps (c), (a), and (b), etc.

[0029] Unless otherwise specified, the terms "comprising" and "including" as used herein can be open-ended or closed-ended. For example, "comprising" and "including" may mean that other components not listed may also be included, or that only the listed components may be included.

[0030] In the description of this article, it should be noted that, unless otherwise stated, "above" and "below" include the number itself, and "several" in "one or more" means two or more.

[0031] In this description, unless otherwise stated, the term "or" is inclusive. For example, the phrase "A or B" means "A, B, or both A and B". More specifically, the condition "A or B" is satisfied by any of the following conditions: A is true (or exists) and B is false (or does not exist); A is false (or does not exist) and B is true (or exists); or both A and B are true (or exist).

[0032] Unless otherwise specified, percentages (%) in this document refer to percentages by mass relative to the composition.

[0033] Unless otherwise stated herein, the sum of the contents of the components in the composition is 100%.

[0034] In this document, unless otherwise stated, “combination of” means a multi-component mixture of the elements, such as two, three, four, and up to the maximum possible multi-component mixture.

[0035] Unless otherwise specified, the term "a" as used in this specification means "at least one".

[0036] The terms "first" and "second" are used for descriptive purposes only and should not be construed as indicating or implying relative importance or implicitly specifying the number of technical features indicated. Thus, a feature defined as "first" or "second" may explicitly or implicitly include at least one of that feature. In the description of this invention, "a plurality of" means at least two, such as two, three, etc., unless otherwise explicitly specified.

[0037] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention pertains. The terminology used herein in the description of the invention is for the purpose of describing particular embodiments only and is not intended to be limiting of the invention.

[0038] To make the objectives, technical solutions, and advantages of the present invention clearer, the embodiments of the present invention will be further described in detail below with reference to the accompanying drawings. Unless otherwise specified, the experimental methods described in the embodiments of the present invention are conventional methods, and the materials and reagents used in the following embodiments are commercially available unless otherwise specified.

[0039] refer to Figure 1The nicotine bag inner core (1) is a liquid-permeable nonwoven bag filled with the first composition; the oral soluble membrane outer shell (2) is a closed shell made of oral soluble membrane sheet, which is wrapped around the outer surface of the inner core; optionally, there is a nitrogen-filled gap layer (3) between the outer shell and the inner core.

[0040] Nicotine pouch inner core

[0041] As used herein, a “nicotine pouch” refers to a product in the form of a mixture of one or more components contained in a liquid-permeable container (e.g., a liquid-permeable pouch). Such mixtures in the form of liquid-permeable delivery pouches are typically used by placing a delivery pouch containing the mixture in the mouth of a human subject / user. Typically, the delivery pouch is placed somewhere in the user’s mouth, such as below the lips, in the same manner as commonly used oral tobacco products. The pouch is preferably not chewed or swallowed. Exposure to saliva then allows some components of the mixture (e.g., flavorings and / or nicotine) to pass through the, for example, water-permeable pouch, providing the user with flavor and satisfaction, and the user does not need to spit out any part of the mixture. After approximately 10 to 60 minutes of use / enjoyment, typically approximately 15 to 45 minutes, a significant portion of the mixture has been ingested by the human subject, and the delivery pouch can be removed from the consumer’s mouth for disposal. Nicotine pouches typically do not contain tobacco but contain nicotine directly.

[0042] In this invention, the nicotine bag serves as the inner core and includes a liquid-permeable bag body and a first composition filled within the liquid-permeable bag body.

[0043] As used in this article, "nicotine," also known as nicotine alkaloid, is an organic compound with the chemical formula C. 10 H 14 N2, with the structural formula shown in Formula I. Nicotine belongs to the alkaloid class of compounds. Alkaloids are a class of nitrogen-containing basic organic molecules that exhibit base-like chemical properties, forming salt solutes in water or reacting with acids. The nicotine structure contains a pyridine ring and a pyrrolidine ring, and its nitrogen atom readily accepts protons (H). + Nicotine is alkaline and can neutralize acids to form salt compounds. Free nicotine has a high pH (approximately 8.0-10.0) and causes strong irritation to the mucous membranes of the mouth and throat. Nicotine salts significantly reduce irritation and provide a gentler user experience by lowering the pH (approximately 5.0-7.0).

[0044] (I)

[0045] In this invention, the nicotine component may include one or more of nicotine and nicotine derivatives.

[0046] Nicotine derivatives include one or more of nicotine salts, nicotine-ion exchange resins, nicotine complexes, and non-covalently bonded nicotine.

[0047] Nicotine salts can be selected from nicotine hydrochloride, nicotine phosphate, nicotine sulfate, nicotine pyruvate, nicotine formate, nicotine oxalate, nicotine ascorbate, nicotine glycolate, nicotine acetate, nicotine isovalerate, nicotine valerate, nicotine propionate, nicotine caprylate, nicotine lactate, nicotine levulinate, nicotine sorbate, nicotine malate, nicotine fumarate, nicotine salicylate, nicotine glycinate, nicotine tartrate, nicotine succinate, nicotine citrate, nicotine benzoate, and nicotine oil. Nicotine aconitate, nicotine butyrate, nicotine cinnamate, nicotine caprate, nicotine 3,7-dimethyl-6-octenate, nicotine 1-glutamate, nicotine heptaate, nicotine hexanoate, nicotine 3-hexenoate, nicotine trans-2-hexenoate, nicotine isobutyrate, nicotine laurate, nicotine 2-methylbutyrate, nicotine 2-methylvalerate, nicotine myristate, nicotine nonanoate, nicotine palmitate, nicotine 4-pentenoate, nicotine phenylacetate, and nicotine 3-phenylpropionate are among one or more of these.

[0048] Based on the total weight of the first composition, the weight percentage of the nicotine component can be 0.05%~0.10%, 0.05%~0.07%, 0.07%~0.09%, 0.09%~0.10%, 0.10%~0.20%, 0.20%~0.50%, 0.50%~0.75%, 0.75%~1%, or 1%~5%. In some embodiments, the nicotine component may be present in the form of a popping bead.

[0049] Additional ingredients that may include the compositions disclosed herein or representative types that may be used to manufacture the bagged products disclosed herein include fillers, thickeners, film-forming agents, binders, buffers and pH control agents, anti-adhesion agents, flow aids, sweeteners, humectants, preservatives and antioxidants, surfactants, colorants, lubricants and processing aids.

[0050] In one embodiment of the present invention, the pH adjuster is selected from acetic acid, adipic acid, citric acid, fumaric acid, gluconic acid-δ-lactone, gluconic acid, lactic acid, malic acid, maleic acid, tartaric acid, succinic acid, propionic acid, ascorbic acid, phosphoric acid, sodium orthophosphate, potassium orthophosphate, calcium orthophosphate, sodium diphosphate, potassium diphosphate, calcium diphosphate, pentasodium triphosphate, pentapotassium triphosphate, sodium polyphosphate, potassium polyphosphate, carbonic acid, sodium carbonate, sodium bicarbonate, potassium carbonate, calcium carbonate, magnesium carbonate, magnesium oxide, glycerol, phosphate buffer, amino acids, or any combination thereof.

[0051] In some embodiments, the sweeteners include aspartame, acesulfame potassium, cyclamate, saccharin, sodium saccharin, sucralose, neotame, sodium cyclohexylsulfamate, stevia, licorice, disodium glycyrrhizate, tripotassium and trisodium glycyrrhizate, glucose, fructose, sucrose, maltose, corn syrup, starch sugar and lactose, sorbitol, maltitol, isomaltitol, palaginitol, xylitol, lactitol, mannitol, erythritol and dextran.

[0052] In some embodiments, the filler includes one or more of cellulose and cellulose derivatives, starch, maltodextrin, and cyclodextrin. In some embodiments, the filler includes microcrystalline cellulose.

[0053] In some embodiments, the humectant includes one or more of glycerol and ethylene glycol.

[0054] In some embodiments, the cooling agent includes one or more of menthol, WS-23, WS-3, menthone glycerol acetal, and menthyl lactate.

[0055] In some embodiments, the preservative includes one or more of benzoic acid, sodium benzoate, sorbic acid, and potassium sorbate.

[0056] In some implementations, the fragrance is selected from peppermint, cinnamon, cherry, coconut, coffee, chocolate, vanilla, citrus (such as grapefruit, orange, lime, bergamot, or lemon), menthol, licorice, caramel, honey, peanut, walnut, cashew, hazelnut, almond, pineapple, strawberry, raspberry, tropical fruit, cherry, cinnamon, mint, deer antler, spearmint, eucalyptus, apple, pear, peach, strawberry, apricot, raspberry, cherry, pineapple, lemongrass, lime, chili, capsaicin, citrus, tobacco flavor, bergamot, smoky flavoring, plum, eucalyptus, clove, bay leaf, fennel, thyme, cedar leaf, and nutmeg.

[0057] The liquid-permeable bag according to the present invention can be made of woven materials, non-woven materials, and / or composite materials including woven and non-woven materials, or cotton paper. The bag according to the present invention is a saliva-permeable bag. Preferably, the bag is a non-woven bag. The bag can be prepared using methods known in the art, and its sealing can be achieved by heat sealing, cold sealing, or ultrasonic sealing, etc.

[0058] Oral dissolving membrane shell

[0059] In this invention, the oral dissolving film serves as the outer shell (2), which is a closed shell made of an oral dissolving film sheet containing a second composition. The second composition contains a film-forming material and a nicotine component.

[0060] In some embodiments, the film-forming material includes at least one selected from hydroxypropyl cellulose, hydroxypropyl methylcellulose, hydroxyethyl cellulose, pullulan, amylose, fructose, polyvinyl alcohol, polyethylene glycol, povidone, gelatin, and chitosan. In some embodiments, the amylose includes corn starch, potato starch, rice starch, and glutinous rice starch, etc.

[0061] In this invention, the nicotine component may include one or more of nicotine and nicotine derivatives.

[0062] Nicotine derivatives include one or more of nicotine salts, nicotine-ion exchange resins, nicotine complexes, and non-covalently bonded nicotine.

[0063] Nicotine salts can be selected from nicotine hydrochloride, nicotine phosphate, nicotine sulfate, nicotine pyruvate, nicotine formate, nicotine oxalate, nicotine ascorbate, nicotine glycolate, nicotine acetate, nicotine isovalerate, nicotine valerate, nicotine propionate, nicotine caprylate, nicotine lactate, nicotine levulinate, nicotine sorbate, nicotine malate, nicotine fumarate, nicotine salicylate, nicotine glycinate, nicotine tartrate, nicotine succinate, nicotine citrate, nicotine benzoate, and nicotine oil. Nicotine aconitate, nicotine butyrate, nicotine cinnamate, nicotine caprate, nicotine 3,7-dimethyl-6-octenate, nicotine 1-glutamate, nicotine heptaate, nicotine hexanoate, nicotine 3-hexenoate, nicotine trans-2-hexenoate, nicotine isobutyrate, nicotine laurate, nicotine 2-methylbutyrate, nicotine 2-methylvalerate, nicotine myristate, nicotine nonanoate, nicotine palmitate, nicotine 4-pentenoate, nicotine phenylacetate, and nicotine 3-phenylpropionate are among one or more of these.

[0064] In some embodiments, the second composition of the oral dissolving film further includes at least one of a sweetener, a cooling agent, a pH adjuster, a flavoring agent, and a plasticizer.

[0065] In some embodiments, the sweeteners include aspartame, acesulfame potassium, cyclamate, saccharin, sodium saccharin, sucralose, neotame, sodium cyclohexylsulfamate, stevia, licorice, disodium glycyrrhizate, tripotassium and trisodium glycyrrhizate, glucose, fructose, sucrose, maltose, corn syrup, starch sugar and lactose, sorbitol, maltitol, isomaltitol, palaginitol, xylitol, lactitol, mannitol, erythritol and dextran.

[0066] In some embodiments, the cooling agent includes one or more of menthol, WS-23, WS-3, menthone glycerol acetal, and menthyl lactate.

[0067] In some implementations, the fragrance is selected from peppermint, cinnamon, cherry, coconut, coffee, chocolate, vanilla, citrus (such as grapefruit, orange, lime, bergamot, or lemon), menthol, licorice, caramel, honey, peanut, walnut, cashew, hazelnut, almond, pineapple, strawberry, raspberry, tropical fruit, cherry, cinnamon, mint, deer antler, spearmint, eucalyptus, apple, pear, peach, strawberry, apricot, raspberry, cherry, pineapple, lemongrass, lime, chili, capsaicin, citrus, tobacco flavor, bergamot, smoky flavoring, plum, eucalyptus, clove, bay leaf, fennel, thyme, cedar leaf, and nutmeg.

[0068] In some embodiments, the plasticizer includes at least one of propylene glycol, glycerol, polyethylene glycol, and sorbitol.

[0069] In one embodiment, the method for preparing an oral dissolving film includes: obtaining a film-forming liquid, the film-forming liquid comprising a film-forming material, a nicotine component, and a solvent; injecting the film-forming liquid into a preset mold, and injection molding to obtain a film sheet; and drying the film sheet to obtain an oral dissolving film. In another embodiment, the film-forming liquid is formed by a coating method. The solvent may be water.

[0070] Preparation method

[0071] The method for preparing the nicotine oral product of the present invention includes the following steps: S1: The first composition is filled into a liquid-permeable bag and sealed to prepare a nicotine bag core (1). S2: The second composition is made into an oral dissolving film sheet; S3: The oral dissolving film sheet is formed into an oral dissolving film shell (2), the nicotine bag inner core (1) is inserted into the oral dissolving film shell (2), and then sealed to form a closed shell, thereby obtaining the nicotine oral product.

[0072] In some embodiments, gas is introduced into the housing before sealing to form a gap layer (3).

[0073] In one specific embodiment, the preparation method of the nicotine oral product of the present invention is as follows: First, a first composition containing nicotine (including fillers, pH adjusters, sweeteners, and flavorings, etc.) is mixed evenly, filled into a liquid-permeable bag (such as a non-woven fabric pouch), and sealed to obtain a nicotine pouch core. Second, a second composition containing nicotine and a film-forming material (such as hydroxypropyl methylcellulose) is formulated into a film-forming liquid, coated, and dried to obtain an oral dissolving film sheet. Finally, the above-mentioned oral dissolving film sheet is wrapped around the nicotine pouch core, and the edges are sealed by heat sealing or pressing to form a closed oral dissolving film shell. Optionally, a gas (such as nitrogen, carbon dioxide, or an inert gas) is introduced into the shell before sealing to form a gas gap layer between the shell and the core, thereby obtaining the nicotine oral product.

[0074] Example

[0075] Experimental materials and instruments

[0076] Table 1. Names of Raw Materials and Suppliers

[0077] Table 2. Instruments used in the experiment and their suppliers

[0078] Example 1

[0079] (I) Preparation of the inner core (nicotine bag)

[0080] Weigh each raw material according to the following parts by weight: Table 3. Composition of Nicotine Bag Raw Materials

[0081] After mixing the above solid raw materials, add an appropriate amount of deionized water to wet them, and stir to mix evenly to obtain wet granules. Place the wet granules in a vacuum drying oven and dry them for about 4 hours at a temperature of 50℃ and a vacuum degree of ≤133Pa until the moisture content is ≤5%. After drying, pass the granules through a 20-mesh sieve to obtain the first composition.

[0082] Take nonwoven fabric and cut it into rectangular sheets of 50mm × 30mm. Fold the sheets in half and heat-seal both sides at 140℃ using a heat-sealing machine to form a bag with the opening facing upwards. Fill the bag with approximately 0.5g of the first composition prepared in step S1-1, and then heat-seal the top opening at 140℃, which is the nicotine bag core. The resulting core has an external dimension of approximately 25mm long × 15mm wide × 4mm thick, and is in the shape of a flat cuboid.

[0083] (II) Preparation of the outer shell (oral dissolving membrane)

[0084] Weigh each raw material according to the following parts by weight: Table 4. Composition of Oral Dissolution Film Raw Materials

[0085] Heat deionized water to approximately 70°C. While stirring with a magnetic stirrer, slowly add hydroxypropyl methylcellulose (HPMC) and continue stirring until completely dissolved to form a homogeneous and transparent HPMC solution. After cooling the solution to room temperature, add glycerol, citric acid, sweetener, and nicotine tartrate in sequence, stirring continuously until completely dissolved. Let stand for 2 hours to remove bubbles, and the oral film-forming solution is obtained.

[0086] Take the above film-forming solution and apply it to a stainless steel plate using a coating applicator, setting the coating thickness to 800 μm. Place the coated stainless steel plate in a vacuum drying oven and dry it at 60°C and a vacuum degree ≤133 Pa for approximately 2 hours. After drying, peel it off to obtain the oral soluble film sheet. The obtained oral soluble film sheet has a thickness of approximately 100–120 μm and is cut into 40 mm × 40 mm square sheets for later use.

[0087] (III) Assembly

[0088] Take the prepared oral fusion film sheet (40mm×40mm) and place the prepared inner core in the center of the film sheet. Fold the two sides of the film sheet upwards to wrap around the inner core. Use a LAVEZZINI SV300 heat sealer to heat seal both sides of the film sheet at 120°C to form a closed shell. The heat sealing pressure is about 0.3MPa and the heat sealing time is 1.5s. Before sealing the last side, nitrogen gas is injected between the oral fusion film sheet and the inner core to form a gas gap layer of about 0.3mm between the shell and the inner core.

[0089] Example 2

[0090] This embodiment is basically the same as Embodiment 1, except that: the inner core formula is adjusted: nicotine tartrate is increased from 0.8 parts to 1 part, microcrystalline cellulose is reduced by 0.2 parts accordingly, and other components remain unchanged; the outer shell formula is adjusted: nicotine tartrate is reduced from 3 parts to 1 part, and hydroxypropyl methylcellulose is increased from 60 parts to 62 parts.

[0091] Example 3

[0092] This embodiment is basically the same as Embodiment 1, except that the inner core formula is adjusted: 0.2 parts of nicotine tartrate are filled in the form of popping beads, and the remaining 0.6 parts are filled in as is; the outer shell formula is adjusted: the nicotine tartrate is reduced from 3 parts to 1 part, and the hydroxypropyl methylcellulose is increased from 60 parts to 62 parts.

[0093] Comparative Examples 1-4

[0094] Comparative Example 1: Nicotine oral dissolving film alone (prepared as in Example 1); Comparative Example 2: Peppermint flavored nicotine pouch alone (prepared as in Example 1); Comparative Example 3: Peach flavored nicotine pouch alone (prepared as in Example 1, the only difference being the use of a different flavoring); Comparative Example 4: Coffee flavored nicotine pouch alone (prepared as in Example 1, the only difference being the use of a different flavoring).

[0095] Test 1 - Nicotine Dissolution Test

[0096] Take a complete sample and place it in a 100mL beaker containing 50mL of distilled water. Incubate in a constant temperature water bath at 37℃±5℃. Sampling time points: every 10s in the first minute (10s, 20s, 30s, 40s, 50s, 60s), every 30s in the 2-3 minutes (90s, 120s, 150s, 180s), every minute in the 4-8 minutes (4min, 5min, 6min, 7min, 8min), and after 8 minutes, sample at 10min, 12min, 15min, 20min, 25min, and 30min. Take 0.5mL of sample each time and add an equal volume of distilled water at the same temperature. Measure the absorbance at 260nm using a UV spectrophotometer to calculate the dissolution concentration at each time point and plot the dissolution concentration-time curve.

[0097] Dissolution tests were performed on Examples 1, 2, and 3 (sample numbers 1, 2, and 3), and Comparative Examples 1 (sample number 4), 2 (sample number 5), 3 (sample number 6), and 4 (sample number 7), respectively. The test results are as follows: Figure 2 As shown.

[0098] like Figure 2 As shown, it can be seen that the nicotine dissolution rate of the embodiment of the present invention is very fast, and it will quickly reach the peak concentration and continue to be released for up to 30 minutes. Its effect is better than that of traditional nicotine pouch products, which have a slower nicotine dissolution rate and a longer time to reach the peak.

[0099] Test 2 - Sensory Evaluation

[0100] The evaluation was conducted by 10 professional oral swab testers. The samples were placed between the upper lip and gums and inhaled normally. The testers evaluated each sample according to the following evaluation index system, and the evaluation results are expressed using descriptive terms and evaluation scales.

[0101] Table 5. Evaluation Index System

[0102] The evaluators recorded the evaluation results item by item, and also recorded two quantitative indicators: "time of first physiological satisfaction" (the number of seconds from the insertion into the oral cavity to the first feeling of obvious satisfaction) and "total duration of satisfaction" (minutes).

[0103] Test Results

[0104] The sensory evaluation results of the 10 evaluators on each sample are summarized below: Table 6. Visual Feature Evaluation

[0105] Table 7. Evaluation of olfactory characteristics

[0106] Table 8. Evaluation of taste characteristics

[0107] Table 9. Overall Experience Evaluation and Quantitative Indicators

[0108] The embodiments of this invention are rated "excellent" in terms of appearance and color characteristics. Compared with traditional products, the oral dissolving film shell gives the product a smoother and more complete surface. In terms of olfactory and gustatory characteristics, the aroma intensity and flavor intensity of the embodiments of this invention are rated "strong," and the flavor persistence is rated "long," which is better than the "medium" rating of the comparative example. This indicates that the oral dissolving film shell rapidly releases flavor substances in the initial stage of consumption, bringing a stronger sensory impact, while the inner pouch provides continuous satisfaction.

[0109] In terms of overall experience, the release speed of the embodiments of the present invention is rated as "fast," with the initial physiological satisfaction occurring much faster than in the comparative examples, proving that the product of the present invention can achieve immediate satisfaction. Simultaneously, the duration of satisfaction is also superior to that of the comparative examples. None of the samples exhibited a noticeable foreign body sensation, indicating that the encapsulation structure of the present invention did not negatively impact oral comfort.

[0110] In the foregoing description of exemplary embodiments / specific implementations of the present invention, various features of the invention are sometimes combined in a single embodiment / specific implementation or its figures and description, with the aim of simplifying the disclosure and aiding in the understanding of one or more of the various aspects of the invention. However, the method of description of the invention should not be construed as reflecting an intention that the claimed features are more than expressly stated in each claim, except where explicitly stated otherwise or in obvious technical contradiction or exclusion. Rather, the inventive aspect reflected in the claims lies in not all the features of a single foregoing disclosed embodiment / specific implementation. Therefore, the claims following the detailed description are expressly incorporated herein by reference, each claim existing independently as a separate embodiment / specific implementation of the invention.

[0111] The terminology and expressions used in this specification are for illustrative purposes and not for limitation. Their use is not intended to exclude any equivalents of the shown and described features or portions thereof, but rather to facilitate the understanding that various modifications may be possible within the scope of the invention. Therefore, it should be understood that while the invention has been specifically disclosed through preferred embodiments, exemplary embodiments, and optional features, variations or modifications of the concepts disclosed herein may be adopted by those skilled in the art, and such variations and modifications are therefore considered to be within the scope of the invention as defined by the appended claims. The specific embodiments given in this specification are examples of useful embodiments of the invention, and it will be apparent to those skilled in the art that the invention can be practiced using many variations of the devices, device components, and method steps disclosed herein.

[0112] The foregoing description of specific embodiments has fully disclosed the general features of the invention, enabling others to easily modify and / or adapt such embodiments for various applications by applying knowledge within the scope of the art, without excessive experimentation and without departing from the general conception of the invention. Therefore, based on the teachings and guidance provided herein, it is intended that such modifications and alterations be included within the meaning and scope of equivalents of the disclosed embodiments. It should be understood that the wording or terminology used herein is for descriptive purposes and is not intended to be limiting; thus, the wording or terminology in this specification will be interpreted by those skilled in the art based on the foregoing teachings and guidance.

[0113] Furthermore, the scope of the invention should not be limited to any of the exemplary embodiments described above, but only to the appended claims and their equivalents.

Claims

1. A nicotine oral product, characterized in that, include: Nicotine bag core (1) includes a liquid-permeable bag body and a first composition filled in the liquid-permeable bag body; as well as Oral dissolving film shell (2) is a closed shell made of an oral dissolving film sheet, the oral dissolving film sheet comprising a second composition; The oral dissolving film shell (2) is wrapped around the nicotine bag core (1); Both the first composition and the second composition contain nicotine.

2. The nicotine oral product according to claim 1, characterized in that, The outer shell (2) is formed by wrapping the inner core (1) with a pre-formed oral dissolution film sheet through heat sealing or pressing.

3. The nicotine oral product according to claim 1, characterized in that, There is a gap layer (3) between the outer shell (2) and the inner core (1), and the gap layer (3) is filled with gas.

4. The nicotine oral product according to claim 1, characterized in that, The liquid-permeable bag is made of non-woven fabric.

5. The nicotine oral product according to claim 1, characterized in that, The first composition further comprises one or more of the following: filler, pH adjuster, cooling agent, sweetener, flavoring agent, fragrance, preservative, thickener, film-forming agent, adhesive, anti-adhesion agent, flow aid, humectant, surfactant, colorant, and lubricant.

6. The nicotine oral product according to claim 1, characterized in that, The second composition further includes one or more of the following: film-forming material, sweetener, cooling agent, pH adjuster, flavoring, and plasticizer.

7. The nicotine oral product according to claim 1, characterized in that, The outer shell (2) completely disintegrates within 30 seconds after being placed in the mouth, and the first composition in the inner core (1) requires more than 5 minutes to release 50% of the nicotine after being placed in the mouth.

8. A method for preparing a nicotine oral product as described in any one of claims 1 to 7, characterized in that, Includes the following steps: S1: The first composition is filled into a liquid-permeable bag and sealed to prepare a nicotine bag core (1). S2: The second composition is made into an oral dissolving film sheet; S3: The oral soluble film sheet is formed into an oral soluble film shell (2), the nicotine pouch inner core (1) is placed inside the oral soluble film shell (2), and then sealed to form a closed shell, thereby obtaining the nicotine oral product.

9. The preparation method according to claim 8, characterized in that, In step S3, gas is introduced into the shell before sealing to form a closed shell, so as to form a gap layer (3).

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