A nicotine composition, a nicotine pouch, and a method of preparing the same

Abstract

This application discloses a nicotine composition, a nicotine pouch, and a method for preparing the same. The nicotine composition uses soluble sugar as its core matrix and, by weight (100%) includes 82-95% soluble sugar, 0.1-5.0% nicotine source, 0.1-3.0% flavoring, and 0.3-10.0% additives; but does not include a pH adjuster. The soluble sugars include one or a combination of rapidly soluble sugar alcohols and slowly soluble sugars. The rapidly soluble sugar alcohols have a solubility rate ≥90% within 3 minutes in the oral cavity, and the slowly soluble sugars have a solubility rate ≥90% within 6 minutes in the oral cavity. This application utilizes a novel controlled-release system based on a matrix dissolution-release synchronous coupling mechanism, eliminating irreversible adsorption loss of the insoluble matrix to improve the effective utilization rate of nicotine and flavoring, optimize the oral experience, eliminate solid residue and foreign body sensation in the mouth, and reduce mucosal irritation.

Description

Technical Field

[0001] This application belongs to the technical field of oral nicotine products, specifically relating to a nicotine composition, a nicotine bag, and a method for preparing the same. Background Technology

[0002] Nicotine pouches are currently the mainstream smokeless tobacco product. Their core structure consists of a saliva-permeable packaging material and an internal matrix composition, with their core performance primarily determined by the matrix system. Currently, commercially available products and published patent documents primarily use water-insoluble materials as the core matrix of nicotine pouches, mainly microcrystalline cellulose (MCC), plant fibers, and sodium carboxymethyl cellulose. Their controlled-release mechanism relies on the pore adsorption, swelling diffusion, pH adjustment, and ion exchange of the insoluble matrix. While some existing technologies add sugar alcohols such as xylitol and erythritol, these are only used as sweeteners, flavoring agents, or secondary fillers, with addition amounts generally below 10% of the total matrix mass. They have never been used as the core controlled-release matrix; the core of controlled release remains the insoluble fiber material, failing to break through the traditional technological framework.

[0003] Under traditional technology, nicotine release from insoluble matrices follows a multi-stage mechanism of saliva penetration, internal dissolution, outward diffusion, and matrix desorption. This process is lengthy and subject to numerous interfering factors, easily leading to situations where, after ingestion, there is a prolonged wait for saliva penetration and dissolution, with no effective substance released for an extended period (2 minutes). Following dissolution, nicotine is released in a burst, concentrated within 2-5 minutes, accounting for over 80% of the total release, causing oral irritation, coughing, and the risk of nicotine overdose. The release rate rapidly declines later, with effective release essentially ceasing after 10 minutes, resulting in a short effective duration and an inability to achieve linear and stable release. Furthermore, insoluble matrices such as microcrystalline cellulose have highly developed porous structures, exhibiting strong irreversible adsorption of nicotine and flavorings. This causes a large amount of active ingredients to be locked within the matrix pores, preventing release. Commercially available products generally have an effective nicotine release rate of less than 60% and a flavoring release rate of less than 50%. To compensate for this loss, manufacturers need to significantly increase the amount of nicotine and flavorings used, not only significantly increasing production costs but also further exacerbating oral irritation and odor problems. Meanwhile, traditional insoluble matrix leaves a large amount of solid residue after use, which poses a significant foreign body sensation in the mouth and the risk of aspiration; in order to improve the absorption efficiency of nicotine mucosa, high concentrations of pH adjusters need to be added, which can easily cause the local pH to be too high, leading to problems such as oral mucosal burns and dryness.

[0004] For example, patent document CN121014900A discloses a nicotine composition, a nicotine pouch, and its preparation method, including an acid-sensitive sugar alcohol complex. This complex comprises a first sugar alcohol and a second sugar alcohol, capable of releasing hydroxyl groups under acidic conditions to reduce oral irritation. However, the proportion of the acid-sensitive sugar alcohol complex is only 25-50%, still relying on plant fiber as the core controlled-release matrix to regulate the stable release of nicotine. Patent document CN119999953A discloses a nicotine composition, its preparation method, and a lozenge, including polysaccharides. However, the content of polysaccharides is only 1-3%, used as sweeteners to adjust the taste of the lozenge, and cannot be used as a filling matrix to regulate the dissolution rate of the active ingredient in the nicotine pouch and the stable release of nicotine. Therefore, existing technologies still rely on insoluble matrices as carriers for nicotine adsorption, making it difficult to directly use soluble sugars or sugar alcohols as matrix carriers in the preparation of nicotine pouches.

[0005] Therefore, it is necessary to develop a novel technical framework that breaks through the limitations of traditional insoluble core matrices. This new controlled-release system, based on a matrix dissolution-release synchronous coupling mechanism, eliminates irreversible adsorption losses of the insoluble matrix, significantly improves the effective utilization rate of nicotine and flavorings, optimizes the oral experience, eliminates solid residue and foreign body sensation in the mouth, and reduces mucosal irritation. By precisely controlling the release curves of nicotine and flavorings, it addresses industry pain points such as no release upon ingestion, mid-term burst release, and insufficient late-stage release, further improving the overall taste experience for users. Summary of the Invention

[0006] The purpose of this application is to provide a nicotine composition, a nicotine pouch, and its preparation method, breaking through the traditional technical framework of insoluble core matrices. Based on a novel controlled-release system with a matrix dissolution-release synchronous coupling mechanism, this system eliminates irreversible adsorption loss of the insoluble matrix, significantly improves the effective utilization rate of nicotine and flavorings, optimizes the oral experience, eliminates solid residue and foreign body sensation in the mouth, and reduces mucosal irritation. This invention uses soluble sugar as the core carrier matrix, with nicotine and flavorings uniformly dispersed in the molecular gaps of the soluble sugar matrix. When the matrix comes into contact with saliva, the soluble sugar molecules dissolve layer by layer, simultaneously releasing the encapsulated nicotine and flavorings. The release rate is completely positively correlated with the matrix dissolution rate. Unlike the traditional multi-stage, long-path release mechanism of insoluble matrices involving "saliva penetration - internal dissolution - outward diffusion - matrix desorption," this invention eliminates the irreversible adsorption of active ingredients by matrix pores and avoids the problems of delayed release in the early stage, sudden release in the middle stage, and insufficient release in the later stage caused by excessively long diffusion paths. By controlling the ratio of fast / slow soluble sugars, the matrix dissolution rate can be precisely customized, thereby linearly controlling the nicotine release curve and achieving zero-level stable release. This solves industry pain points and further improves the overall taste experience for users.

[0007] To solve the above-mentioned technical problems, this application provides the following technical solution: A nicotine composition using soluble sugar as a core matrix for controlled release of nicotine and flavoring; The nicotine composition comprises, by weight 100%, 82-95% soluble sugar, 0.1-5.0% nicotine source, 0.1-3.0% flavoring and fragrance, and 0.3-10.0% additives; the nicotine composition does not include pH adjusters. Soluble sugars include one or a combination of fast-dissolving sugar alcohols and slow-dissolving sugars; fast-dissolving sugar alcohols have a solubility rate of ≥90% within 3 minutes in the oral cavity, which is used to achieve rapid release of nicotine and flavorings; slow-dissolving sugars have a solubility rate of ≥90% within 6 minutes in the oral cavity, which is used to achieve continuous and stable release of nicotine and flavorings, so as to prolong the effective duration.

[0008] Furthermore, the pH adjuster in this application refers to an alkaline substance used to adjust the pH of the composition system to above 8.0 or an acidic substance to below 6.0. The effect of pH between 6.0 and 8.0 on the nicotine bag composition system is negligible and is not considered a pH adjuster.

[0009] Furthermore, the terms "rapidly dissolves sugar alcohols or slowly dissolves sugars" in this application refer to the internal comparison of water-soluble sugars and sugar alcohols, while still being much faster than the dissolution rate of other common contents in the nicotine pouch.

[0010] Furthermore, when soluble sugars include fast-dissolving sugar alcohols and slow-dissolving sugars, the amount of fast-dissolving sugar alcohols added to the soluble sugars is greater than the amount of slow-dissolving sugars added. Specifically, the proportion of fast-dissolving sugar alcohols in the soluble sugars is 60% or more, and the proportion of slow-dissolving sugars in the soluble sugars is 40% or less.

[0011] Furthermore, rapidly dissolving sugar alcohols include one or more combinations of erythritol, xylitol, mannitol, or sorbitol.

[0012] Furthermore, slow-dissolving sugars include one or more combinations of maltose, lactose, glucose, granulated sugar, or trehalose.

[0013] Furthermore, nicotine sources include one or more combinations of nicotine, nicotine salts, or tobacco extracts.

[0014] Furthermore, nicotine salts include nicotine hydrochloride, nicotine dihydrochloride, nicotine phosphate, nicotine sulfate, nicotine hydrogen tartrate, nicotine hydrogen tartrate dihydrate, 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, and nicotine citrate. Nicotine benzoate, nicotine resinate, nicotine oleate, nicotine aconitate, nicotine butyrate, nicotine cinnamate, nicotine caprate, nicotine 3,7-dimethyl-6-octenate, nicotine 1-glutamate, nicotine heptamate, 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, or nicotine 3-phenylpropionate, or one or more combinations thereof.

[0015] Furthermore, flavorings include one or more combinations of peppermint flavorings, fruit flavorings, herbal flavorings, or tobacco flavorings.

[0016] Furthermore, additives include one or more combinations of flavoring agents, cooling agents, antioxidants, stabilizers, penetration enhancers, or food colorings.

[0017] Furthermore, flavoring agents include one or more combinations of steviosides, sucralose, neotame, aspartame, acesulfame potassium, cyclamate, sodium saccharin, sodium cyclohexylsulfamate, disodium glycyrrhizate, or tripotassium and trisodium glycyrrhizate.

[0018] Furthermore, cooling agents include one or more combinations of menthol, mentholamide, or W23.

[0019] Furthermore, antioxidants include one or more combinations of vitamin C, vitamin E, or polyphenols.

[0020] Furthermore, stabilizers include one or more combinations of sodium citrate or disodium EDTA to inhibit nicotine oxidation and improve batch stability.

[0021] Furthermore, penetration enhancers include one or more combinations of propylene glycol or laurocapram to improve the absorption efficiency of nicotine through the oral mucosa.

[0022] Alternatively, the nicotine composition may also include an insoluble component, which may be added by reducing the amount of soluble sugars added, and the insoluble component may include microcrystalline cellulose.

[0023] Furthermore, the amount of insoluble components added is less than or equal to 15%, used for adsorbing nicotine and fragrances.

[0024] Furthermore, the particle size of soluble sugars, nicotine sources, and flavorings is 80-100 mesh, and the moisture content is ≤2%.

[0025] Another aspect of this application provides a nicotine pouch, which includes a saliva-permeable pouch and a nicotine composition.

[0026] Furthermore, the amount of nicotine composition added to each nicotine bag is 0.1~0.2 g, 0.2~0.3 g, 0.3-0.4 g, or 0.4-0.5 g; Furthermore, the saliva-permeable pouch is made of food-grade nonwoven fabric, lyocell, modal, or Tencel; the food-grade nonwoven fabric is one or more combinations of polypropylene fiber, polyester fiber, polyamide fiber, and polytetrafluoroethylene fiber.

[0027] This application also provides a method for preparing a nicotine bag, comprising the following steps: Step A: Place the nicotine source, flavoring, additives, and 1 / 3 of the soluble sugar in a mixer for premixing to obtain a premix. Step B: Add the remaining 2 / 3 of the soluble sugar to the premix and perform a total mixing process to obtain the nicotine composition; Step C: The nicotine composition is placed as the contents in a saliva-permeable pouch, and after heat sealing and ultraviolet sterilization, a nicotine pouch is obtained.

[0028] Furthermore, the premixing and total mixing conditions are as follows: mixing for 12-18 minutes at a speed of 18-25 r / min, so that the overall uniformity of the nicotine composition is ≤3% and the uniformity of the nicotine source is ≤5%.

[0029] Furthermore, the heat-sealing temperature is 130-150℃, and the heat-sealing time is 0.5-1.0 s.

[0030] Compared with the prior art, this application has the following beneficial technical effects: (1) This application provides a nicotine composition, a nicotine bag, and a method for preparing the same. The core matrix is ​​a compound of a rapidly dissolving sugar alcohol and a slowly dissolving water-soluble sugar, completely different from the multi-level diffusion mechanism of traditional insoluble matrices. By adjusting the ratio of insoluble / rapid / slow-dissolving components, different release curves such as rapid release, balanced release, and sustained release can be precisely customized, achieving a stable zero-level release of nicotine, far superior to traditional microcrystalline cellulose matrices, and completely solving the industry pain point of insufficient early-stage and late-stage release in existing technologies.

[0031] (2) The core matrix of this application does not have irreversible adsorption of nicotine, fragrances and flavors, etc. The effective release rate of effective components such as nicotine, fragrances and flavors is ≥90%, which is nearly 50% higher than that of traditional microcrystalline cellulose matrix. It significantly reduces the amount of nicotine and fragrances added, reduces production costs, and at the same time reduces oral irritation caused by high concentration of nicotine.

[0032] (3) After consumption in the mouth, the nicotine content is ≥70% soluble, and the preferred solution can achieve nearly 100% dissolution, leaving no residue in the mouth and completely eliminating the foreign body sensation and risk of aspiration associated with traditional products. Simultaneously, efficient nicotine absorption through the mucosa can be achieved without the need for high-concentration pH adjusters, avoiding problems such as burning and dryness of the oral mucosa caused by excessively high local pH. This improves the overall taste experience for users and reduces energy consumption and production costs. Attached Figure Description

[0033] 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.

[0034] Figure 1 This is a flowchart illustrating the preparation process of the nicotine bag in a specific embodiment of this application. Detailed Implementation

[0035] 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.

[0036] 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 to be modified in all cases 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 in this application. 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.

[0037] 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 solution of this application can be implemented after reading the claims, description and drawings of this application.

[0038] Even if there are incomplete descriptions, omissions, or ambiguities in the grammar, words, punctuation, graphics, symbols, etc. of the claims, description, and drawings of this application, those skilled in the art can still arrive at the only correct understanding by reading the claims, description, 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 application.

[0039] 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.

[0040] Unless otherwise specified, all embodiments and preferred embodiments mentioned herein can be combined to form new technical solutions.

[0041] Unless otherwise specified, all the technical features and preferred features mentioned herein can be combined to form new technical solutions.

[0042] 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.

[0043] 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.

[0044] 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.

[0045] 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).

[0046] Unless otherwise specified, percentages (%) in this document refer to percentages by mass relative to the composition.

[0047] Unless otherwise stated herein, the sum of the contents of the components in the composition is 100%.

[0048] 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.

[0049] Unless otherwise specified, the term "a" as used in this specification means "at least one".

[0050] 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.

[0051] 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.

[0052] 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.

[0053] like Figure 1 As shown, this application provides a nicotine composition, a nicotine pouch, and a method for preparing the same, comprising the following steps: S1. Raw material pretreatment, details and steps are as follows: The fast-dissolving components, slow-dissolving components, insoluble components, nicotine sources, fragrances and flavorings, and functional additives are each passed through an 80-100 mesh sieve, with moisture content controlled at ≤2%, production environment temperature at 20-25℃, and relative humidity at ≤45% to prevent the raw materials from absorbing moisture and clumping, thus obtaining the pretreated raw materials for the corresponding components.

[0054] The rapidly dissolving component includes commercially available food-grade sugar alcohols, which include one or more combinations of erythritol, xylitol, mannitol, or sorbitol. The rapidly dissolving component has a solubility of ≥90% within 3 minutes in the oral cavity, enabling rapid release of nicotine and flavorings to meet the user's initial nicotine intake needs and flavor experience.

[0055] The slow-dissolving component includes food-grade water-soluble sugars (commercially available), which include one or more combinations of maltose, lactose, glucose, granulated sugar, or trehalose. The slow-dissolving component has a solubility of ≥90% in the oral cavity within 6 minutes, which is used to achieve a continuous and stable release of nicotine and flavorings, prolong the effective duration, and avoid rapid decline in potency and flavor in the later stages.

[0056] The insoluble component includes food-grade microcrystalline cellulose (commercially available). This food-grade microcrystalline cellulose is used only as an optional skeletal support material to ensure that the dissolution rate of nicotine and flavorings adsorbed by the food-grade microcrystalline cellulose in the oral cavity is ≤50% within 6 minutes and ≥90% within 10 minutes. Optionally, the food-grade microcrystalline cellulose has a particle size of 50-100 μm, conforms to GB1886.103 standard, and is designated as PH101 (a linear polysaccharide composed of β-1,4-glucosidic bonds).

[0057] Nicotine sources include nicotine salts and / or tobacco extracts. Nicotine salts include nicotine hydrochloride, nicotine dihydrochloride, nicotine phosphate, nicotine sulfate, nicotine hydrogen tartrate, nicotine hydrogen tartrate dihydrate, 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, and so on. Nicotine citrate, nicotine benzoate, nicotine resinate, nicotine oleate, nicotine aconitate, nicotine butyrate, nicotine cinnamate, nicotine caprate, nicotine 3,7-dimethyl-6-octenate, nicotine 1-glutamate, nicotine heptarate, 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, or nicotine 3-phenylpropionate, or one or more combinations thereof.

[0058] Edible flavorings include one or more combinations of food-grade peppermint flavorings, fruit flavorings, herbal flavorings, or tobacco flavorings; fruit flavorings are a non-exhaustive list of examples, including coconut, green apple, blueberry, mango, grapefruit, orange, lime, bergamot, lemon, pineapple, strawberry, raspberry, cherry, watermelon, pear, peach, apricot, raspberry, lime, plum, etc.; herbal flavorings include cinnamon, cumin, pepper, deer hoof grass, eucalyptus, clove, bay leaf, fennel, thyme, cedar leaf oil, nutmeg, vanilla, licorice, etc.

[0059] Functional additives include one or more combinations of flavoring agents, cooling agents, antioxidants, stabilizers, penetration enhancers, or food colorings. Flavoring agents include one or more combinations of steviol glycosides, sucralose, neotame, aspartame, acesulfame potassium, cyclamate, sodium saccharin, sodium cyclohexylsulfamate, disodium glycyrrhizate, or tripotassium and trisodium glycyrrhizate; cooling agents include one or more combinations of menthol, mentholamide, or W23; antioxidants include one or more combinations of vitamin C, vitamin E, or polyphenols; stabilizers include one or more combinations of sodium citrate or disodium EDTA to inhibit nicotine oxidation and improve batch stability; penetration enhancers include one or more combinations of propylene glycol or laurocapram to improve the efficiency of nicotine absorption through the oral mucosa.

[0060] S2. Preparation of nicotine contents, the specific steps are as follows: (1) Premixing treatment: Based on the mass percentage of nicotine contents as 100%, 0.1-5.0% of nicotine source, 0.1-3.0% of flavoring and fragrance, 0.3-10.0% of functional additives, and approximately 1 / 3 of the total mass of soluble sugars (the total amount of soluble sugars added to the nicotine contents is 82-95%, and the amount of soluble sugars added here is the mass percentage of nicotine contents) are added. The ratio of fast-dissolving components to slow-dissolving components in soluble sugars is 28-35%, and the mixing ratio of fast-dissolving components to slow-dissolving components in soluble sugars is (60-100):(0-40). This can be understood as the proportion of fast-dissolving components added in soluble sugars being within the range of 60-100, while the proportion of slow-dissolving components added is below 40. When the proportion of fast-dissolving components added is 100, it does not include slow-dissolving components. All components are placed together in a three-dimensional motion mixer (commercially available) for premixing. The premixing speed is 18-25 r / min, and the time is 12-18 min to ensure that each component can be evenly dispersed to obtain a premix.

[0061] (2) Blending: Add approximately 2 / 3 of the remaining total soluble sugar (60-65% by mass) to the premix obtained in step (1) above for blending. The blending speed is 18-25 r / min, and the time is 12-18 min to obtain a fast-release matrix, which is the nicotine content. The overall uniformity RSD of the nicotine content is kept below 3%, and the uniformity RSD of the nicotine source content is kept below 5%.

[0062] The nicotine contents obtained in step (2) above do not contain insoluble components, so as to achieve a cumulative nicotine release rate of ≥20% within 1 minute and a cumulative nicotine release rate of ≥70% within 3 minutes. The fast-release matrix has a solubility rate of ≥98% in the oral cavity within 10 minutes, which is suitable for use scenarios with high nicotine demand and rapid relief of smoking addiction. Furthermore, no pH adjuster is added to the nicotine contents, and nicotine release is regulated only through soluble sugars.

[0063] In some other specific embodiments, the total mass of soluble sugars in the nicotine contents can be reduced, and an insoluble component (food-grade microcrystalline cellulose) can be added, so that the mass ratio of soluble sugars to insoluble components is (12-18):1. In this case, the soluble sugars can be only the rapidly dissolving component and exclude the slowly dissolving component, or only the slowly dissolving component and exclude the rapidly dissolving component, or the rapidly dissolving component and the slowly dissolving component can be mixed in a ratio of (0.5-1.0):(0.5-1.0). After the above premixing and total mixing treatments, a balanced matrix is ​​obtained, which is the nicotine contents. This achieves a cumulative nicotine release rate of ≥17% within 1 minute, a cumulative nicotine release rate of 50%~70% within 3 minutes, a cumulative nicotine release rate of ≥80% within 6 minutes, and a balanced matrix dissolution rate of ≥87% in the oral cavity within 10 minutes, achieving stable zero-order release and adapting to daily routine use scenarios.

[0064] In other specific embodiments, based on the above-mentioned specific embodiments, the total mass of soluble sugars in the nicotine contents can be further reduced, and the amount of insoluble components (food-grade microcrystalline cellulose) can be further increased, so that the mass ratio of soluble sugars to insoluble components is (7.0-9.0):(1.0-3.0). In this case, the soluble sugars can be only the slowly dissolving components and not include the rapidly dissolving components, or the rapidly dissolving components and the slowly dissolving components can be mixed in a ratio of (1.5-2.0):(2.5-3.5). After the above premixing and total mixing treatments, a sustained-release matrix is ​​obtained, which is the nicotine contents. This achieves a cumulative nicotine release rate of ≥15% within 1 minute, a cumulative nicotine release rate of 40%~60% within 3 minutes, a cumulative nicotine release rate of ≥70% within 6 minutes, and a sustained-release matrix dissolution rate of ≥65% in the oral cavity within 10 minutes, suitable for low-irritation, long-lasting sustained-release applications.

[0065] S3. Prepare the nicotine pouch, the specific steps of which are as follows: Saliva-permeable food-grade packaging material is made of food-grade non-woven fabric (commercially available), with a basis weight of 30-50 g / m³. 2It has a porosity of 10-20μm and a heat-sealing strength of ≥10 N / 15 mm, meeting the requirements of the National Food Safety Standard GB4806.8 for paper and paperboard materials and products for food contact.

[0066] Using a commercially available fully automatic nicotine bag filling machine, the nicotine contents (also known as nicotine composition) prepared in step S2 above are placed in saliva-permeable food-grade packaging material. The nicotine contents are precisely filled to a level of 0.1-0.5 g per nicotine bag. The bags are then heat-sealed on all four sides at a temperature of 130-140℃, 140-145℃, or 145-150℃ for a time of 0.5-0.7 s, 0.7-0.8 s, or 0.8-1.0 s. After UV sterilization, the nicotine bags are obtained.

[0067] Food-grade nonwoven fabrics include one or more combinations of polypropylene fibers, polyester fibers, polyamide fibers, polytetrafluoroethylene fibers, and glass fibers.

[0068] In some other embodiments, the saliva-permeable food-grade packaging material may also be one of Lyocell, Modal, or Tencel.

[0069] Example 1

[0070] (1) Erythritol (commercially available, food grade, GB 28307), nicotine tartrate (commercially available, pharmaceutical grade, purity ≥99.0%, GB 28374), peppermint flavor (commercially available, food grade, GB 30616), steviol glycosides (commercially available, food grade, GB 8270) and menthol (commercially available, food grade, GB 29938) were each passed through an 80-mesh sieve, and the moisture content was controlled to be ≤2%.

[0071] (2) Taking the mass percentage of nicotine contents as 100%, 3% of sieved nicotine tartrate, 1.5% of sieved peppermint flavoring, 0.3% of sieved steviol glycosides, 0.2% of sieved menthol, and 31% of sieved erythritol were placed together in a three-dimensional motion mixer (commercially available) for premixing. The premixing speed was 20 r / min and the time was 15 min to ensure that each component could be evenly dispersed to obtain a premix.

[0072] (3) Then, 64% by mass of the sieved erythritol is added to the premix obtained in step (2) above, and the mixture is further mixed in a three-dimensional motion mixer at a speed of 20 r / min for 15 min to ensure that the components are evenly dispersed and to obtain a fast-release matrix, which is the nicotine content. The overall uniformity RSD of the nicotine content is ≤3%, and the uniformity RSD of the nicotine source content is ≤5%.

[0073] (4) Using a fully automatic nicotine bag filler (commercially available), place the nicotine contents prepared in step (3) above into a food-grade non-woven fabric, accurately fill each nicotine bag with 0.4 g of nicotine contents, and then heat seal the four sides at a temperature of 130°C for 1.0 s. After ultraviolet sterilization, the nicotine bag is obtained.

[0074] Example 2

[0075] (1) Erythritol (commercially available, food grade, GB 28307), maltose (commercially available, food grade, GB 28308), nicotine tartrate (commercially available, pharmaceutical grade, purity ≥99.0%, GB 28374), peppermint flavor (commercially available, food grade, GB 30616), steviol glycosides (commercially available, food grade, GB 8270) and menthol (commercially available, food grade, GB 29938) were each passed through an 80-mesh sieve, and the moisture content was controlled to be ≤2%.

[0076] (2) Taking the mass percentage of nicotine contents as 100%, 3% of sieved nicotine tartrate, 1.5% of sieved peppermint flavoring, 0.3% of sieved steviol glycosides, 0.2% of sieved menthol, 28% of sieved erythritol, and 3% of sieved maltose were placed together in a three-dimensional motion mixer (commercially available) for premixing. The premixing speed was 20 r / min and the time was 15 min to ensure that each component could be evenly dispersed to obtain a premix.

[0077] (3) Then, 57% by mass of sieved erythritol and 7% by mass of sieved maltose are placed together in the premix obtained in step (2) above, and the mixture is further mixed in a three-dimensional motion mixer at a speed of 20 r / min for 15 min to ensure that the components are evenly dispersed and to obtain a fast-release matrix, which is the nicotine content. The overall uniformity RSD of the nicotine content is ≤3%, and the uniformity RSD of the nicotine source content is ≤5%.

[0078] (4) Using a fully automatic nicotine bag filler (commercially available), place the nicotine contents prepared in step (3) above into a food-grade non-woven fabric, accurately fill each nicotine bag with 0.4 g of nicotine contents, and then heat seal the four sides at a temperature of 130°C for 1.0 s. After ultraviolet sterilization, the nicotine bag is obtained.

[0079] Example 3

[0080] (1) Erythritol (commercially available, food grade, GB 28307), maltose (commercially available, food grade, GB 28308), nicotine malate (commercially available, pharmaceutical grade, purity ≥99.0%, GB 28374), peppermint flavor (commercially available, food grade, GB 30616), steviol glycosides (commercially available, food grade, GB 8270) and menthol (commercially available, food grade, GB 29938) were each passed through a 100-mesh sieve, and the moisture content was controlled to be ≤2%.

[0081] (2) Taking the mass percentage of nicotine contents as 100%, 1% of sieved nicotine malate, 0.1% of sieved peppermint flavoring, 2.5% of sieved steviol glycosides, 2.5% of sieved menthol, 30% of sieved erythritol, and 4% of sieved maltose were placed together in a three-dimensional motion mixer (commercially available) for premixing. The premixing speed was 25 r / min and the time was 12 min to ensure that each component could be evenly dispersed to obtain a premix.

[0082] (3) Then, 54% by mass of sieved erythritol and 5.9% by mass of sieved maltose are placed together in the premix obtained in step (2) above, and the mixture is further mixed in a three-dimensional motion mixer at a speed of 25 r / min for 12 min to ensure that the components are evenly dispersed and to obtain a fast-release matrix, which is the nicotine content. The overall uniformity RSD of the nicotine content is ≤3%, and the uniformity RSD of the nicotine source content is ≤5%.

[0083] (4) Using a fully automatic nicotine bag filler (commercially available), place the nicotine contents prepared in step (3) above into a food-grade non-woven fabric, accurately fill each nicotine bag with 0.5 g of nicotine contents, and then heat seal the four sides at a temperature of 140°C for 0.8 s. After ultraviolet sterilization, the nicotine bag is obtained.

[0084] Example 4

[0085] (1) Erythritol (commercially available, food grade, GB 28307), maltose (commercially available, food grade, GB 28308), nicotine citrate (commercially available, pharmaceutical grade, purity ≥99.0%, GB 28374), peppermint flavor (commercially available, food grade, GB 30616), steviol glycosides (commercially available, food grade, GB 8270) and menthol (commercially available, food grade, GB 29938) were each passed through a 100-mesh sieve, and the moisture content was controlled to be ≤2%.

[0086] (2) Taking the mass percentage of nicotine contents as 100%, 5% of sieved nicotine citrate, 3.0% of sieved peppermint flavoring, 5% of sieved steviol glycosides, 5% of sieved menthol, 24% of sieved erythritol, and 4% of sieved maltose were placed together in a three-dimensional motion mixer (commercially available) for premixing. The premixing speed was 18 r / min and the time was 18 min to ensure that each component could be evenly dispersed to obtain a premix.

[0087] (3) Then, 50% by mass of sieved erythritol and 4% by mass of sieved maltose are placed together in the premix obtained in step (2) above, and the mixture is further mixed in a three-dimensional motion mixer at a speed of 18 r / min for 18 min to ensure that the components are evenly dispersed and to obtain a fast-release matrix, which is the nicotine content. The overall uniformity RSD of the nicotine content is ≤3%, and the uniformity RSD of the nicotine source content is ≤5%.

[0088] (4) Using a fully automatic nicotine bag filler (commercially available), place the nicotine contents prepared in step (3) above into a food-grade non-woven fabric, accurately fill each nicotine bag with 0.1 g of nicotine contents, then heat seal the four sides at a temperature of 150°C for 0.5 s, and obtain the nicotine bag after UV sterilization.

[0089] Example 5

[0090] (1) Maltose (commercially available, food grade, GB 28308), nicotine tartrate (commercially available, pharmaceutical grade, purity ≥99.0%, GB 28374), peppermint flavor (commercially available, food grade, GB 30616), steviol glycosides (commercially available, food grade, GB 8270) and menthol (commercially available, food grade, GB 29938) were each passed through an 80-mesh sieve, and the moisture content was controlled to be ≤2%.

[0091] (2) Taking the mass percentage of nicotine contents as 100%, 3% of sieved nicotine tartrate, 1.5% of sieved peppermint flavoring, 0.3% of sieved steviol glycosides, 0.2% of sieved menthol, and 31% of sieved maltose were placed together in a three-dimensional motion mixer (commercially available) for premixing. The premixing speed was 20 r / min and the time was 15 min to ensure that each component could be evenly dispersed to obtain a premix.

[0092] (3) Then, 64% by mass of the sieved maltose is placed into the premix obtained in step (2) above, and the mixture is further mixed in a three-dimensional motion mixer at a speed of 20 r / min for 15 min to ensure that the components are evenly dispersed and to obtain a fast-release matrix, which is the nicotine content. The overall uniformity RSD of the nicotine content is ≤3%, and the uniformity RSD of the nicotine source content is ≤5%.

[0093] (4) Using a fully automatic nicotine bag filler (commercially available), place the nicotine contents prepared in step (3) above into a food-grade non-woven fabric, accurately fill each nicotine bag with 0.4 g of nicotine contents, and then heat seal the four sides at a temperature of 130°C for 1.0 s. After ultraviolet sterilization, the nicotine bag is obtained.

[0094] Example 6

[0095] (1) Xylitol (commercially available, food grade, GB 1886.234), maltose (commercially available, food grade, GB 28308), microcrystalline cellulose (commercially available, PH101, food grade, GB 1886.103), free nicotine (commercially available, pharmaceutical grade, purity ≥99.0%, GB28374), tobacco flavoring (commercially available, food grade, GB 30616), sucralose (commercially available, food grade, GB 25531), sodium citrate (stabilizer, commercially available, food grade, GB 1886.25) and propylene glycol (penetration enhancer, commercially available, food grade, GB 2760) were each passed through an 80-mesh sieve, and the moisture content was controlled to be ≤2%.

[0096] (2) Taking the mass percentage of nicotine contents as 100%, 3% of sieved free nicotine, 5% of sieved microcrystalline cellulose, 1.2% of sieved tobacco flavoring, 0.2% of sieved sucralose, 0.4% of sieved sodium citrate, 0.2% of sieved propylene glycol, 15% of sieved xylitol, and 15% of sieved maltose were placed together in a three-dimensional motion mixer (commercially available) for premixing. The premixing speed was 20 r / min and the time was 15 min to ensure that each component could be evenly dispersed to obtain a premix.

[0097] (3) Then, 30% by mass of sieved xylitol and 30% by mass of sieved maltose are placed together in the premix obtained in step (2) above, and the mixture is further mixed in a three-dimensional motion mixer at a speed of 20 r / min for 15 min to ensure that the components are evenly dispersed and a balanced matrix is ​​obtained, which is the nicotine content. The overall uniformity RSD of the nicotine content is ≤3%, and the uniformity RSD of the nicotine source content is ≤5%.

[0098] (4) Using a fully automatic nicotine bag filler (commercially available), place the nicotine contents prepared in step (3) above into a food-grade non-woven fabric, accurately fill each nicotine bag with 0.4 g of nicotine contents, and then heat seal the four sides at a temperature of 130°C for 1.0 s. After ultraviolet sterilization, the nicotine bag is obtained.

[0099] Example 7

[0100] (1) Xylitol (commercially available, food grade, GB 1886.234), maltose (commercially available, food grade, GB 28308), microcrystalline cellulose (commercially available, PH101, food grade, GB 1886.103), free nicotine (commercially available, pharmaceutical grade, purity ≥99.0%, GB28374), tobacco flavoring (commercially available, food grade, GB 30616), sucralose (commercially available, food grade, GB 25531), sodium citrate (stabilizer, commercially available, food grade, GB 1886.25) and propylene glycol (penetration enhancer, commercially available, food grade, GB 2760) were each passed through an 80-mesh sieve, and the moisture content was controlled to be ≤2%.

[0101] (2) Taking the mass percentage of nicotine contents as 100%, 1% of sieved free nicotine, 5.7% of sieved microcrystalline cellulose, 3.0% of sieved tobacco flavoring, 0.1% of sieved sucralose, 0.1% of sieved sodium citrate, 0.1% of sieved propylene glycol, 15% of sieved xylitol, and 15% of sieved maltose were placed together in a three-dimensional motion mixer (commercially available) for premixing. The premixing speed was 25 r / min and the time was 12 min to ensure that each component could be evenly dispersed to obtain a premix.

[0102] (3) Then, 30% by mass of sieved xylitol and 30% by mass of sieved maltose are placed together in the premix obtained in step (2) above, and the mixture is further mixed in a three-dimensional motion mixer at a speed of 25 r / min for 12 min to ensure that the components are evenly dispersed and a balanced matrix is ​​obtained, which is the nicotine content. The overall uniformity RSD of the nicotine content is ≤3%, and the uniformity RSD of the nicotine source content is ≤5%.

[0103] (4) Using a fully automatic nicotine bag filler (commercially available), place the nicotine contents prepared in step (3) above into a food-grade non-woven fabric, accurately fill each nicotine bag with 0.5 g of nicotine contents, and then heat seal the four sides at a temperature of 140°C for 0.8 s. After ultraviolet sterilization, the nicotine bag is obtained.

[0104] Example 8

[0105] (1) Xylitol (commercially available, food grade, GB 1886.234), maltose (commercially available, food grade, GB 28308), microcrystalline cellulose (commercially available, PH101, food grade, GB 1886.103), free nicotine (commercially available, pharmaceutical grade, purity ≥99.0%, GB28374), tobacco flavoring (commercially available, food grade, GB 30616), sucralose (commercially available, food grade, GB 25531), sodium citrate (stabilizer, commercially available, food grade, GB 1886.25) and propylene glycol (penetration enhancer, commercially available, food grade, GB 2760) were each passed through an 80-mesh sieve, and the moisture content was controlled to be ≤2%.

[0106] (2) Taking the mass percentage of nicotine contents as 100%, 5% of the sieved free nicotine, 6% of the sieved microcrystalline cellulose, 3.0% of the sieved tobacco flavoring, 4% of the sieved sucralose, 3% of the sieved sodium citrate, 3% of the sieved propylene glycol, 13% of the sieved xylitol, and 13% of the sieved maltose were placed together in a three-dimensional motion mixer (commercially available) for premixing. The premixing speed was 18 r / min and the time was 18 min to ensure that each component could be evenly dispersed to obtain a premix.

[0107] (3) Then, 25% by mass of sieved xylitol and 25% by mass of sieved maltose are placed together in the premix obtained in step (2) above, and the mixture is further mixed in a three-dimensional motion mixer at a speed of 18 r / min for 18 min to ensure that the components are evenly dispersed and a balanced matrix is ​​obtained, which is the nicotine content. The overall uniformity RSD of the nicotine content is ≤3%, and the uniformity RSD of the nicotine source content is ≤5%.

[0108] (4) Using a fully automatic nicotine bag filler (commercially available), place the nicotine contents prepared in step (3) above into a food-grade non-woven fabric, accurately fill each nicotine bag with 0.1 g of nicotine contents, then heat seal the four sides at a temperature of 150°C for 0.5 s, and obtain the nicotine bag after UV sterilization.

[0109] Example 9

[0110] (1) Sorbitol (commercially available, food grade, GB 1886.187), lactose (commercially available, food grade, GB 25595), microcrystalline cellulose (commercially available, PH101, food grade, GB 1886.103), nicotine alkaloids (commercially available, pharmaceutical grade, purity ≥99.0%), lemon flavoring (commercially available, food grade, GB 30616), mentholamide (commercially available, food grade, GB 2760) and vitamin C (antioxidant, commercially available, food grade, GB 14754) were each passed through an 80-mesh sieve, and the moisture content was controlled to be ≤2%.

[0111] (2) Taking the mass percentage of nicotine contents as 100%, 3% by mass of sieved nicotine alkaloids, 15% by mass of sieved microcrystalline cellulose, 1.5% by mass of sieved lemon flavoring, 0.3% by mass of sieved mentholamide, 0.2% by mass of sieved vitamin C, 24% by mass of sieved lactose, and 5% by mass of sieved sorbitol were placed together in a three-dimensional motion mixer (commercially available) for premixing. The premixing speed was 20 r / min and the time was 15 min to ensure that each component could be evenly dispersed to obtain a premix.

[0112] (3) Then, 41% by mass of sieved lactose and 10% by mass of sieved sorbitol are added to the premix obtained in step (2) above, and the mixture is further mixed in a three-dimensional motion mixer at a speed of 20 r / min for 15 min to ensure that the components are evenly dispersed and to obtain a slow-release matrix, which is the nicotine content. The overall uniformity RSD of the nicotine content is ≤3%, and the uniformity RSD of the nicotine source content is ≤5%.

[0113] (4) Using a fully automatic nicotine bag filler (commercially available), place the nicotine contents prepared in step (3) above into a food-grade non-woven fabric, accurately fill each nicotine bag with 0.4 g of nicotine contents, and then heat seal the four sides at a temperature of 130°C for 1.0 s. After ultraviolet sterilization, the nicotine bag is obtained.

[0114] Example 10

[0115] (1) Sorbitol (commercially available, food grade, GB 1886.187), lactose (commercially available, food grade, GB 25595), microcrystalline cellulose (commercially available, PH101, food grade, GB 1886.103), nicotine alkaloids (commercially available, pharmaceutical grade, purity ≥99.0%), lemon flavoring (commercially available, food grade, GB 30616), mentholamide (commercially available, food grade, GB 2760) and vitamin C (antioxidant, commercially available, food grade, GB 14754) were each passed through an 80-mesh sieve, and the moisture content was controlled to be ≤2%.

[0116] (2) Taking the mass percentage of nicotine contents as 100%, 1% of sieved nicotine alkaloids, 11.9% of sieved microcrystalline cellulose, 0.1% of sieved lemon flavoring, 2% of sieved mentholamide, 3% of sieved vitamin C, 21% of sieved lactose, and 6% of sieved sorbitol were placed together in a three-dimensional motion mixer (commercially available) for premixing. The premixing speed was 25 r / min and the time was 12 min to ensure that each component could be evenly dispersed to obtain a premix.

[0117] (3) Then, 43% by mass of sieved lactose and 12% by mass of sieved sorbitol are added to the premix obtained in step (2) above, and the mixture is further mixed in a three-dimensional motion mixer at a speed of 25 r / min for 12 min to ensure that the components are evenly dispersed and to obtain a slow-release matrix, which is the nicotine content. The overall uniformity RSD of the nicotine content is ≤3%, and the uniformity RSD of the nicotine source content is ≤5%.

[0118] (4) Using a fully automatic nicotine bag filler (commercially available), place the nicotine contents prepared in step (3) above into a food-grade non-woven fabric, accurately fill each nicotine bag with 0.5 g of nicotine contents, and then heat seal the four sides at a temperature of 140°C for 0.8 s. After ultraviolet sterilization, the nicotine bag is obtained.

[0119] Example 11

[0120] (1) Sorbitol (commercially available, food grade, GB 1886.187), lactose (commercially available, food grade, GB 25595), microcrystalline cellulose (commercially available, PH101, food grade, GB 1886.103), nicotine alkaloids (commercially available, pharmaceutical grade, purity ≥99.0%), grape flavoring (commercially available, food grade, GB 30616), mentholamide (commercially available, food grade, GB 2760) and vitamin C (antioxidant, commercially available, food grade, GB 14754) were each passed through an 80-mesh sieve, and the moisture content was controlled to be ≤2%.

[0121] (2) Taking the mass percentage of nicotine contents as 100%, 5% of sieved nicotine alkaloids, 10% of sieved microcrystalline cellulose, 3% of sieved grape flavoring, 4% of sieved mentholamide, 6% of sieved vitamin C, 18% of sieved lactose, and 4% of sieved sorbitol were placed together in a three-dimensional motion mixer (commercially available) for premixing. The premixing speed was 18 r / min and the time was 18 min to ensure that each component could be evenly dispersed to obtain a premix.

[0122] (3) Then, 39% by mass of sieved lactose and 10% by mass of sieved sorbitol are added to the premix obtained in step (2) above, and the mixture is further mixed in a three-dimensional motion mixer at a speed of 18 r / min for 18 min to ensure that the components are evenly dispersed and to obtain a slow-release matrix, which is the nicotine content. The overall uniformity RSD of the nicotine content is ≤3%, and the uniformity RSD of the nicotine source content is ≤5%.

[0123] (4) Using a fully automatic nicotine bag filler (commercially available), place the nicotine contents prepared in step (3) above into a food-grade non-woven fabric, accurately fill each nicotine bag with 0.1 g of nicotine contents, then heat seal the four sides at a temperature of 150°C for 0.5 s, and obtain the nicotine bag after UV sterilization.

[0124] Comparative Example 1

[0125] Compared with Example 1, the difference is that this comparative example uses a traditional matrix to adsorb nicotine to prepare a nicotine bag.

[0126] The nicotine content, calculated as 100% by weight, includes 65% microcrystalline cellulose (PH101), 15% sodium carboxymethyl cellulose, 12% xylitol as a sweetener, 3% free nicotine, 2% peppermint flavoring, 2% sodium carbonate as a pH adjuster, and 1% steviol glycosides.

[0127] Comparative Example 2

[0128] Compared with Example 4, the difference is that this comparative example uses the preparation method of nicotine composition disclosed in patent document CN119999953A to prepare nicotine contents, which are placed in food-grade non-woven fabric and precisely filled with 0.4 g of nicotine contents per nicotine bag. Then, the four sides are heat-sealed at 130°C for 1.0 s. After ultraviolet sterilization, the nicotine bags are obtained.

[0129] The nicotine content contains 10-20% nicotine, 3-6% reducing sugar, 1-3% polyols, 0.1-0.5% metal complexes, 0.2-0.8% organic acids, and 69.7-85.7% poloxamer.

[0130] Comparative Example 3

[0131] Compared with Example 7, the difference is that this comparative example uses the preparation method of nicotine composition disclosed in patent document CN121014900A to prepare nicotine contents, which are placed in food-grade non-woven fabric and precisely filled with 0.4 g of nicotine contents in each nicotine bag. Then, the four sides are heat-sealed at 130°C for 1.0 s. After ultraviolet sterilization, the nicotine bags are obtained.

[0132] Of which, based on the nicotine composition by mass percentage of 100%, the proportion of acid-sensitive nicotine carrier is 10-25%; the proportion of acid-sensitive sugar alcohol compound is 25-50%; the proportion of acid-stabilized fiber is 15-30%; the proportion of water is 15-35%; and the proportion of additives is 5-10%.

[0133] Test Example 1: Nicotine Dissolution Test

[0134] To further illustrate the advantages of the preparation method described in the embodiments of this application, the nicotine dissolution of the nicotine bags prepared in Examples 1-11 and Comparative Examples 1-3 was tested using a dissolution apparatus-paddle method. Simulated artificial saliva was used as the dissolution medium, with a pH of 6.8. The dissolution of nicotine in the nicotine bags was detected within 0.5-10.0 min at a temperature of 37±0.5℃ and a rotation speed of 50 r / min using a high-performance liquid chromatograph.

[0135] The results are shown in Table 1. The nicotine leaching from the nicotine bags in Examples 1-11 showed a significantly more stable release compared to the nicotine leaching from the nicotine bags in Comparative Examples 1-3. The nicotine leaching from the nicotine bags in Examples 3-4 was similar to that in Example 2. The nicotine leaching from the nicotine bags in Examples 7-8 was similar to that in Example 6. The nicotine leaching from the nicotine bags in Examples 10-11 was similar to that in Example 9. The nicotine leaching from the nicotine bags in Comparative Examples 2-3 was similar to that in Comparative Example 1. Therefore, Examples 3-4, 7-8, and 10-11 will not be described in detail in Table 1 and the results description.

[0136] The nicotine bag of Example 1 showed a cumulative nicotine release rate of 39.1% within 1 minute, 81.2% within 3 minutes with no early burst release of nicotine, a cumulative nicotine release rate of 92.8% within 6 minutes, and an effective nicotine release rate of 94.8% at 10 minutes, with a matrix dissolution rate of 99.6%.

[0137] The nicotine bag in Example 2 showed a cumulative nicotine release rate of 36.0% within 1 minute, 76.0% within 3 minutes with no initial burst release of nicotine, a cumulative nicotine release rate of 89.3% within 6 minutes, and an effective nicotine release rate of 94.5% and a matrix dissolution rate of 99.2% at 10 minutes.

[0138] The nicotine bag in Example 5 showed a cumulative nicotine release rate of 27.9% within 1 minute, 73.1% within 3 minutes with no initial burst release of nicotine, a cumulative nicotine release rate of 86.4% within 6 minutes, and an effective nicotine release rate of 93.9% and a matrix dissolution rate of 98.7% at 10 minutes.

[0139] The nicotine bag in Example 6 showed a cumulative nicotine release rate of 25.0% within 1 minute, 62.0% within 3 minutes, 86.0% within 6 minutes, and an effective nicotine release rate of 92.7% within 10 minutes, with a matrix dissolution rate of 94.3%.

[0140] The nicotine bag of Example 9 showed a cumulative nicotine release rate of 19.0% within 1 minute, 56.0% within 3 minutes, 78.5% within 6 minutes, and an effective nicotine release rate of 90.2% within 10 minutes, with a matrix dissolution rate of 83.5%.

[0141] In Comparative Example 1, the nicotine bag showed a cumulative nicotine release rate of 4.0% within 1 minute, 38.0% within 3 minutes, and 48.5% within 6 minutes. However, the matrix dissolution rate was only 19.5% at 10 minutes, resulting in an effective nicotine release rate of 57.3%. Release essentially ceased after 30 minutes, with an effective nicotine release rate of only 57.3% and a flavor release rate of 48.1%.

[0142] In Comparative Example 2, the nicotine bag showed a cumulative nicotine release rate of 1.2% within 1 minute, 14.3% within 3 minutes, and 31.6% within 6 minutes, with an effective nicotine release rate of 48.9%. The matrix dissolution rate reached 13.1% within 10 minutes. The extensive use of poloxamer reduced the nicotine dissolution rate and utilization, contrary to the effect of promoting the nicotine release rate in this example.

[0143] In Comparative Example 3, the nicotine bag showed a cumulative nicotine release rate of 6.8% within 1 minute, 14.1% within 3 minutes, 29.6% within 6 minutes, and a matrix dissolution rate of 26.1% within 10 minutes, resulting in an effective nicotine release rate of 44.5%. The addition of sugar alcohols to some extent compensated for the difficulty in nicotine release and the unpleasant taste under acidic pH conditions.

[0144] The above results indicate that a soluble sugar matrix, obtained by combining rapidly dissolving sugar alcohols and slowly dissolving water-soluble sugars, can completely replace the traditional water-insoluble microcrystalline cellulose matrix. This eliminates the traditional multi-stage release mechanism of pore adsorption-swelling diffusion, further achieving precise linear control of nicotine release. This makes the prepared nicotine pouch more suitable for scenarios requiring high nicotine release rates and rapid craving relief. Furthermore, replacing the traditional water-insoluble microcrystalline cellulose matrix with a soluble matrix effectively improves the final nicotine utilization rate of the nicotine pouch, whereas a large amount of nicotine in traditional formulations ultimately cannot be released into the mouth. However, by gradually reducing the proportion of soluble sugar matrix and gradually increasing microcrystalline cellulose, a stable control of the nicotine release rate can be achieved, making it suitable for more everyday use scenarios or low-irritation, long-lasting sustained-release scenarios. On the other hand, comparative studies have added more pH adjusters to maintain the alkaline pH in the nicotine pouch, or further added other substances to inhibit the negative effects of acidic nicotine pouches, whereas this application does not require the addition of pH-adjusting additives. In summary, this application proposes a novel mechanism based on 'matrix dissolution-release synchronous coupling', which directly drives nicotine release through matrix dissolution, fundamentally solving the shortcomings of existing nicotine bags in terms of low nicotine release rate and final release amount.

[0145] Table 1. Statistical table of nicotine leaching from nicotine bags in different embodiments and comparative examples.

[0146] Test Example 2: Taste Test

[0147] The taste test method is as follows: a professional evaluation team (n=5) conducts the evaluation, and the nicotine bags prepared in Examples 1 to 11 and Comparative Examples 1 to 3 are placed directly between the upper lip and the upper teeth, with a standard consumption time of 10 minutes.

[0148] The results showed that the nicotine pouches prepared by the methods shown in Examples 1-11 of this application had significantly lower levels of nicotine foreign body sensation and oral residue compared to the nicotine pouches prepared in Comparative Examples 1-3. Furthermore, the nicotine release was more stable and without strong irritation. In Examples 1-5, the nicotine pouches left no residue when ingested; in Examples 6-8, the residue was ≤5%; and in Examples 9-11, the residue was ≤15%. In contrast, the nicotine pouches prepared in Comparative Examples 1-3 left ≥80% residue and exhibited a noticeable foreign body sensation in the mouth.

[0149] Therefore, it can be concluded that this application provides a nicotine composition, a nicotine pouch, and a method for preparing the same. It uses a combination of a rapidly dissolving sugar alcohol and a slowly dissolving water-soluble sugar as the core matrix, completely different from the multi-level diffusion mechanism of traditional insoluble matrices. By adjusting the ratio of insoluble / rapid / slow-dissolving components, different release curves such as rapid release, balanced release, and sustained release can be precisely customized, achieving a stable zero-order release of nicotine, far superior to traditional microcrystalline cellulose matrices, and completely solving the industry pain point of insufficient early-stage and late-stage release in existing technologies. Furthermore, the core matrix of this application does not irreversibly adsorb nicotine, flavorings, etc., and the effective release rate of nicotine, flavorings, and other effective components is ≥90%, nearly 50% higher than traditional microcrystalline cellulose matrices. This significantly reduces the amount of nicotine and flavorings required, reduces production costs, and simultaneously reduces oral irritation caused by high concentrations of nicotine. Furthermore, after ingestion, the nicotine content dissolves at a rate of ≥70%, with optimized formulations achieving nearly 100% dissolution. This leaves no residue in the mouth, completely eliminating the foreign body sensation and risk of aspiration common with traditional products. Simultaneously, it achieves efficient nicotine absorption through the mucous membrane without the need for high-concentration pH adjusters, avoiding problems such as burning and dryness of the oral mucosa caused by excessively high local pH. This improves the overall taste experience for users while reducing energy consumption and production costs.

[0150] In the foregoing description of exemplary embodiments / specific implementations of this application, various features of this application are sometimes combined in a single embodiment / specification or its figures and description, with the aim of simplifying the disclosure and aiding in the understanding of one or more of the various inventive aspects. However, the descriptive approach of this application should not be construed as reflecting an intention that the claimed features are more than expressly stated in each claim, except where expressly stated otherwise or in obvious technical contradictions or exclusions are found. Rather, the inventive aspects reflected in the claims lie in not all features of a single foregoing disclosed embodiment / specification. Therefore, the claims following the detailed description are hereby expressly incorporated into this detailed description, each claim existing independently as a separate embodiment / specification of this application.

[0151] The terms and expressions used in this specification are illustrative and not limiting. 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 claims. Therefore, it should be understood that while this application 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 this application as defined by the appended claims. The specific embodiments given in this specification are examples of useful embodiments of this application, and it will be apparent to those skilled in the art that this application can be implemented using many variations of the devices, device components, and method steps disclosed herein.

[0152] The foregoing description of specific embodiments has fully disclosed the general features of this application, 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 or deviation from the general concept of this application. 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.

[0153] Furthermore, the scope of this application 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 composition, characterized in that, The nicotine composition uses soluble sugar as a core matrix to achieve controlled release of nicotine and flavoring; The nicotine composition comprises, by weight of 100%, 82-95% soluble sugar, 0.1-5.0% nicotine source, 0.1-3.0% flavoring, and 0.3-10.0% additives. The soluble sugar includes one or a combination of two types of rapidly soluble sugar alcohols or slowly soluble sugars; the rapidly soluble sugar alcohols have a solubility rate of ≥90% within 3 minutes in the oral cavity, which is used to achieve rapid release of nicotine and flavorings; the slowly soluble sugars have a solubility rate of ≥90% within 6 minutes in the oral cavity, which is used to achieve continuous and stable release of nicotine and flavorings, thereby prolonging the effective duration of action.

2. The nicotine composition according to claim 1, characterized in that, When the soluble sugar includes the fast-dissolving sugar alcohol and the slow-dissolving sugar, the amount of the fast-dissolving sugar alcohol added to the soluble sugar is greater than the amount of the slow-dissolving sugar added, wherein the proportion of the fast-dissolving sugar alcohol in the soluble sugar is 60% or more; and the proportion of the slow-dissolving sugar in the soluble sugar is 40% or less.

3. The nicotine composition according to claim 2, characterized in that, The rapidly dissolving sugar alcohols include one or more combinations of erythritol, xylitol, mannitol, or sorbitol; The slow-dissolving sugars include one or more combinations of maltose, lactose, glucose, granulated sugar, or trehalose.

4. The nicotine composition according to claim 3, characterized in that, The nicotine source includes one or more combinations of nicotine, nicotine salts, or tobacco extracts; The nicotine salts include nicotine hydrochloride, nicotine dihydrochloride, nicotine phosphate, nicotine sulfate, nicotine tartrate, nicotine tartrate dihydrate, nicotine pyruvate, nicotine formate, nicotine oxalate, nicotine ascorbate, nicotine glycolate, nicotine acetate, nicotine isovalerate, nicotine valerate, nicotine propionate, nicotine caprylate, nicotine lactate, nicotine acetylpropionate, nicotine sorbate, nicotine malate, nicotine fumarate, nicotine salicylate, nicotine glycinate, nicotine tartrate, nicotine succinate, nicotine citrate, and nicotine succinate. The nicotine benzoate, nicotine resinate, nicotine oleate, nicotine aconitate, nicotine butyrate, nicotine cinnamate, nicotine caprate, nicotine 3,7-dimethyl-6-octenate, nicotine 1-glutamate, nicotine heptamate, 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, or nicotine 3-phenylpropionate, or one or more combinations thereof.

5. The nicotine composition according to claim 4, characterized in that, The flavorings include one or more combinations of peppermint flavorings, fruit flavorings, herbal flavorings, or tobacco flavorings.

6. The nicotine composition according to claim 5, characterized in that, The additives include one or more combinations of flavoring agents, cooling agents, antioxidants, stabilizers, penetration enhancers, or food colorings; The flavoring agents include one or more combinations of steviol glycosides, sucralose, neotame, aspartame, acesulfame potassium, cyclamate, sodium saccharin, sodium cyclohexylsulfamate, disodium glycyrrhizate, or tripotassium and trisodium glycyrrhizate. The cooling agent includes one or more combinations of menthol, mentholamide, or W23; The antioxidants include one or more combinations of vitamin C, vitamin E, or polyphenols; The stabilizer includes one or more combinations of sodium citrate or disodium EDTA, used to inhibit nicotine oxidation and improve batch stability; The penetration enhancer includes one or more combinations of propylene glycol or laurocapram, used to improve the absorption efficiency of nicotine through the oral mucosa.

7. The nicotine composition according to any one of claims 1-6, characterized in that, The nicotine composition further includes an insoluble component, which is added by reducing the amount of the soluble sugar, and the insoluble component includes microcrystalline cellulose; The amount of the insoluble component added is less than or equal to 15%, and it is used to adsorb nicotine and the fragrance.

8. A nicotine bag, characterized in that, The nicotine pouch includes a saliva-permeable pouch and the nicotine composition as described in claim 7; The amount of the nicotine composition added to each nicotine bag is 0.1-0.2 g, 0.2-0.3 g, 0.3-0.4 g, or 0.4-0.5 g; The saliva-permeable pouch is made of food-grade nonwoven fabric, lyocell, modal, or Tencel; the food-grade nonwoven fabric is one or more of polypropylene fiber, polyester fiber, polyamide fiber, and polytetrafluoroethylene fiber.

9. A method for preparing a nicotine bag according to claim 8, characterized in that, Includes the following steps: Step A: The nicotine source, the flavoring, the additives, and 1 / 3 of the soluble sugar are placed in a mixer for premixing to obtain a premix. Step B: Add the remaining 2 / 3 of the soluble sugar to the premix for total mixing to obtain the nicotine composition; Step C: The nicotine composition is placed as the contents in the saliva-permeable pouch, and the pouch is obtained after heat sealing and ultraviolet sterilization.

10. The method for preparing a nicotine bag according to claim 9, characterized in that, The conditions for the premixing treatment and the total mixing treatment are as follows: mixing for 12-18 minutes at a rotation speed of 18-25 r / min, so that the overall uniformity of the nicotine composition is ≤3% and the uniformity of the nicotine source is ≤5%; The heat sealing temperature is 130-150℃, and the heat sealing time is 0.5-1.0 s.

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