A mouth-held nicotine product and a method of making the same

Abstract

The patent discloses a kind of oral nicotine products and its preparation method, the oral nicotine product includes inner core, and hard shell that wraps inner core;Hard shell is solid, and includes nicotine component and base sugar;Inner core is semi-solid or liquid, and includes nicotine component.In the oral nicotine product according to the patent, hard shell slowly releases nicotine, and inner core quickly releases nicotine.User can bite shell according to own demand to release inner core, thereby autonomously controls nicotine quick release time, satisfies use flexibility.

Description

Technical Field

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

[0002] Smokeless nicotine products have become a hot trend in the industry due to their harm reduction and convenience, with oral nicotine products serving as an important sub-category experiencing continuous market demand growth. Currently, mainstream oral nicotine products include nicotine pouches, chewing gum, lozenges, and regular hard candy, whose core function is to absorb nicotine through the oral mucosa, satisfying users' needs for nicotine dependence or smoking cessation.

[0003] However, existing products have obvious technical shortcomings: First, they are all of the same form, mostly homogeneous structures (such as sheets, bags, and ordinary blocks), lacking innovative forms with layered designs, making it difficult to meet users' needs for product diversity; second, the controllability of nicotine release is poor, either releasing too quickly, causing mucosal irritation and gastrointestinal discomfort, or releasing too slowly, failing to meet the immediate need for withdrawal, and users cannot adjust the timing of release themselves; third, the experience is insufficient, with some products having a monotonous taste and lacking interactivity during use, making it difficult to match users' diverse expectations for the consumption experience.

[0004] Although a small number of sugar products containing tobacco components already exist, they are not optimized for the immediate release characteristics of nicotine and lack products that can meet the core need for users to trigger release independently. Therefore, developing a novel, controlled-release, and superior oral nicotine product has become an urgent problem for the industry to solve. Summary of the Invention

[0005] To solve the above-mentioned technical problems, this patent provides the following technical solution: In a first aspect, a nicotine-containing product is provided, comprising an inner core and a rigid outer shell enclosing the inner core; the rigid outer shell is solid and contains nicotine and a sugar base; the inner core is semi-solid or liquid and contains nicotine and a solvent.

[0006] Furthermore, the inner core can release 70%~80%, 80%~90%, or ≥90% of the nicotine content within 30 seconds after the outer shell is crushed; Furthermore, the core also contains one or more of the following: sweeteners, flavorings, colorings, thickeners, stabilizers, and bittering agents; Furthermore, the solvent is selected from water or polyols.

[0007] Furthermore, the thickness of the hard outer shell is 0.5mm~0.8mm, 0.8mm~1.5mm, or 1.5mm~2.0mm; Furthermore, the hard outer shell also contains one or more of the following: flavoring agents, coloring agents, gelling agents, and stabilizers.

[0008] Furthermore, the basic sugar is selected from sugars or sugar substitutes; Furthermore, the sugar or sugar substitute is selected from one or more of sucrose, dextrose, maltose, dextrin, xylose, ribose, glucose, mannose, galactose, fructose, lactose, invert sugar, fructooligosaccharides, partially hydrolyzed starch, isomaltulose, high-fructose corn syrup, polydextrose, erythritol, galactitol, hydrogenated starch hydrolysate, isomaltulitol, lactitol, maltitol, mannitol, polydextrose, sorbitol, and xylitol.

[0009] Furthermore, the nicotine component is selected from nicotine free base and nicotine salt.

[0010] In a second aspect, a method for preparing the oral nicotine product of the first aspect is provided, comprising the following steps: S1. Pre-preparation of hard outer shell: Add the base sugar and purified water to a sugar boiling pot, heat, and stir until dissolved without particles; add other auxiliary materials, maintain the temperature, and boil until the sugar concentration reaches 85-99%; add flavoring agent and nicotine, stir evenly, and then cool for later use. S2. Preparation of the inner core: Heat the solvent, add nicotine, and stir until completely dissolved; add the excipients sequentially and stir at a constant temperature; filter to remove impurities and cool to room temperature for later use. S3. Sandwich molding: Using a dual-channel sandwich candy molding machine, pouring process, filling process or wrapping process, the initial finished product is obtained; S4. Post-processing: The initial product is aged at a constant temperature and humidity; defective products are removed, and the product is packaged to obtain the finished nicotine-containing product.

[0011] Further, step S1 specifically includes: adding the base sugar and purified water to a sugar-boiling pot, heating to 115-120℃, and stirring at a rate of 50-80 r / min until dissolved without particles; adding other excipients, maintaining the temperature at 105-110℃, and cooking at a rate of 60-70 r / min for 15-20 minutes until the sugar concentration reaches 85-99%; adding flavoring agent, stirring evenly at 50 r / min, and then cooling down to 80-85℃ at a rate of 5-8℃ / min for later use; Further, step S2 specifically includes: heating the solvent to 40-50℃, adding nicotine, and stirring at a rate of 100-150r / min until completely dissolved; adding sweetener, flavoring agent, stabilizer, and bittering agent in sequence, and stirring at a constant temperature for 10-15 minutes; filtering through a 200-mesh filter to remove impurities, and cooling to room temperature at a rate of 3-5℃ / min for later use.

[0012] Furthermore, in step S3, a dual-channel sandwich candy molding machine is used to inject the outer shell sugar liquid at 80-85℃ into the outer layer of the mold, and simultaneously inject the room temperature inner core into the inner layer of the mold. The inner core accounts for 10-15% of the total weight of the product. The temperature is then reduced to 30-35℃ at a cooling rate of 4-6℃ / min to set the shape, and the product is demolded to obtain the initial finished product.

[0013] Further, step S4 specifically includes: placing the initial product in a constant temperature and humidity chamber at 30-35℃ and 40-50% humidity for 24-48 hours to mature; removing defective products with damage or leakage of the inner core; vacuum packaging with aluminum foil composite film (the oxygen permeability of the aluminum foil composite film is ≤5cm³ / (m²·24h·atm) and the moisture permeability is ≤3g / (m²·24h)) to obtain the finished nicotine product.

[0014] The beneficial effects of this patent include: This invention enriches the form and experience of oral nicotine products, breaking through the limitations of the homogeneous structure of existing oral nicotine products. It provides a sandwich form of "hard outer shell + soft inner core," enriching product types and meeting the market's demand for differentiated products. This invention overcomes the defects of existing products where the nicotine release rate is fixed and uncontrollable. Through the design of "breaking the outer shell to trigger the release of the inner core," users can independently control the timing of nicotine action according to their own needs, balancing immediate gratification and usage flexibility. Attached Figure Description

[0015] The above content of this patent 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 solution.

[0016] Figure 1 The nicotine release curves were measured for experimental groups 1 and 2. Detailed Implementation

[0017] 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.

[0018] 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 "approximately". Therefore, the numerical values ​​presented herein are approximate and may vary depending on the desired properties sought to be obtained by this patent. 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.

[0019] All other terms used herein for special definition are intended to have the general meaning understood by one of ordinary skill in the art, and in particular, meaning that one of ordinary skill in the art, upon reading the claims, specification and drawings of this patent, can directly and without doubt determine how the technical solution of this patent can be implemented.

[0020] 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 patent, a person 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 patent.

[0021] 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.

[0022] Unless otherwise specified, all embodiments and preferred embodiments mentioned herein can be combined to form new technical solutions.

[0023] Unless otherwise specified, all the technical features and preferred features mentioned herein can be combined to form new technical solutions.

[0024] 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.

[0025] 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.

[0026] 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.

[0027] 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).

[0028] Unless otherwise specified, percentages (%) in this document refer to percentages by mass relative to the composition.

[0029] Unless otherwise stated herein, the sum of the contents of the components in the composition is 100%.

[0030] 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.

[0031] Unless otherwise specified, the term "a" as used in this specification means "at least one".

[0032] 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.

[0033] 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.

[0034] 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.

[0035] Oral nicotine products

[0036] This patent provides a nicotine-containing product, which includes an inner core and a hard outer shell that encloses the inner core; the hard outer shell is solid and contains nicotine and basic sugars; the inner core is semi-solid or liquid and contains nicotine and a solvent.

[0037] Filled candy products have been around for many years. These products are typically in the form of hard candy with cavities and a filling (core) inserted into the cavities. The candy shell can be sugar (glucose and / or sucrose) or sugar-based substitutes (such as isomaltitol and / or maltitol).

[0038] There are no restrictions on the overall shape of the candy; it can be any three-dimensional shape. In one embodiment, the shape is a three-dimensional shape that can be achieved by a casting molding method, such as a sphere, cube, cuboid (three-dimensional rectangle), hemisphere, cone, truncated cone, trihedral pyramid, tetrahedral pyramid, polyhedral pyramid (five-sided, six-sided, seven-sided, eight-sided or more-sided), etc.

[0039] In some embodiments, the oral nicotine product of the present invention may comprise, by weight of the oral nicotine product, about 60% to about 95%, or about 70% to about 85% of a rigid outer shell and about 5% to about 40%, or about 15% to about 30% of an inner core.

[0040] As used herein, nicotine composition refers to any suitable form of nicotine intended to provide at least a portion of the oral absorption of nicotine, such as nicotine including nicotine and nicotine derivatives, specifically including: free base nicotine, nicotine salts, nicotine in a matrix such as a glycobase or organometallic complex, nicotine-ion exchange resin combinations, nicotine inclusion complexes, and non-covalently bound nicotine, said non-covalently bound nicotine including nicotine lactate, nicotine malate, nicotine salicylate, nicotine cyclodextrin encapsulated complexes, nicotine hydrochloride, nicotine dihydrochloride, nicotine tartrate, nicotine tartrate dihydrate, nicotine sulfate, nicotine zinc chloride, and nicotine benzoate.

[0041] As used herein, "base sugar" is the core ingredient constituting the hard outer shell, providing sweetness, hardness, and formability, and forming the basis of the product's texture and structure. In this patent, the conventional version may use "sucrose + maltose syrup (1:1)" to balance hardness and stability; the sugar-free version may use "maltitol + isomaltitol (1:1)" to replace sucrose and avoid the risk of tooth decay. In some embodiments, the base sugar suitable for the hard outer shell may contain about 30% to about 85% glucose syrup and about 15% to about 70% sucrose. Alternatively, a sugar-free matrix may be used in the outer shell. Suitable sugar-free matrices include nutritional sweeteners such as isomaltitol, maltitol, and sorbitol. Isomaltitol and maltitol are preferred.

[0042] Non-limiting examples of solvents used for the core include water, low molecular weight alcohols, polyols, and mixtures thereof, preferably polyols. Non-limiting examples of polyols suitable for use in this invention include glycerol, low molecular weight (i.e., less than 1000 MW) polyethylene glycol, propylene glycol, and mixtures thereof, preferably glycerol. The core of this invention preferably contains about 30% to about 95%, more preferably about 40% to about 90%, even more preferably about 50% to about 85%, and still more preferably about 40% to about 60% of the solvent by weight of the filler. In some embodiments, the solvent is selected from water, glycerol, and propylene glycol.

[0043] Hard shell

[0044] The hard outer shell also contains one or more of the following: flavoring, coloring, gelling agent, cooling agent, acidity regulator, and stabilizer.

[0045] Non-limiting examples of flavorings include 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, peppermint, deer hoof grass, 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 flavorings.

[0046] Suitable pigments include annatto extract (E160b), annatto orange, deannatto orange, astaxanthin, dehydrated beetroot (beet powder), beetroot red / betaine (E162), ultramarine, canthaxanthin (E161g), cryptoxanthin (E161c), rutin (E161d), violet-xanthin (E161e), rose-xanthin (E161f), caramel (E150(ad)), β-aporpho-8′-carotene (E160e), β-carotene (E160a), α-carotene, γ-carotene, β-aporpho-8′-carotene. Ethyl ester of 8-carotene (E160f), lutein (E161a), lutein (E161b), cochineal extract (E120); carmine (E132), acid red / azorubin (E122), sodium copper chlorophyllin (E141), chlorophyll (E140), roasted partially defatted cottonseed flour, ferrous gluconate, ferrous lactate, grape pigment extract, grape skin extract (grape anthocyanins), anthocyanins (E163), Haematococcus pluvialis powder, synthetic iron oxides, iron oxides and hydroxides (E172) Fruit juice, vegetable juice, dried algae powder, marigold (Aztec marigold) powder and extract, carrot oil, corn endosperm oil, red pepper, capsicum oleoresin, Fabry red yeast, riboflavin (E101), crocin, titanium dioxide, turmeric (E100), turmeric oleoresin, amaranth (E123), capsicum red pigment / capsicum rubigin (E160c), lycopene (E160d), FD&C Blue 1, FD&C Blue 2, FD&C Green 3, FD&C Red 3, FD&C Red 40, FD&C... C Yellow 5 and FD&C Yellow 6, Tartrazine Yellow (E102), Quinoline Yellow (E104), Sunset Yellow (E110), Carmine (E124), Edible Cherry Red (E127), Patent Blue V (E131), Titanium Dioxide (E171), Aluminum (E173), Silver (E174), Gold (E175), Pigment Ruby Red / Lisol Ruby Red BK (E180), Calcium Carbonate (E170), Carbon Black (E153), Black PN / Glossy Black BN (E151), Green S / Acid Brilliant Green BS (E142), or combinations thereof.

[0047] In some embodiments, the cooling agent includes one or more of menthol, WS-23, WS-3, menthone glycerol acetal, and menthyl lactate.

[0048] As used in this article, gelling agents, such as gum arabic, gelatin, and carrageenan, are food-grade colloidal substances that enhance the viscosity and molding ability of the sugar solution, improve the structural stability and breakage resistance of the hard outer shell, and prevent leakage of the inner core. Gum arabic is suitable for pH 4.0-7.0, gelatin for pH 5.0-6.5, and carrageenan for pH 4.5-7.5. They need to be added alternately with acidity regulators to prevent precipitation from affecting the molding effect.

[0049] As used in this article, stabilizers, such as vitamin C and disodium EDTA, are additives that can delay the oxidation of raw materials and maintain the stability of product components. Their core function is to prevent nicotine from oxidizing and deteriorating, thus extending the product's shelf life. Vitamin C has both antioxidant and mild flavoring effects, while disodium EDTA focuses on chelating metal ions to prevent heavy metals from accelerating nicotine oxidation.

[0050] In some embodiments, the acidity regulator may be citric acid, lactic acid, malic acid and their salts, or combinations thereof.

[0051] In some embodiments, the thickness of the rigid outer shell is 0.5mm~0.8mm, 0.8mm~1.5mm, or 1.5mm~2.0mm.

[0052] inner core

[0053] In some embodiments, the core also includes one or more of sweeteners, flavorings, colorings, thickeners, stabilizers, and bittering agents.

[0054] Non-limiting examples of 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 sugars and lactose, sorbitol, maltitol, isomaltitol, palaginitol, xylitol, lactitol, mannitol, erythritol and dextran.

[0055] Non-limiting examples of flavorings include 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, peppermint, deer hoof grass, 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 flavorings.

[0056] Suitable pigments include, but are not limited to, annatto extract (E160b), annatto orange, de-annatto orange, astaxanthin, dehydrated beetroot (beet powder), beetroot red / betaine (E162), ultramarine, canthaxanthin (E161g), cryptoxanthin (E161c), rutin (E161d), violet-xanthin (E161e), rose-xanthin (E161f), caramel (E150(ad)), β-apo-8′-carotene (E160e), β-carotene (E160a), α-carotene, γ-carotene, Ethyl β-apo-8-carotene (E160f), lutein (E161a), lutein (E161b), cochineal extract (E120); carmine (E132), acid red / azorubin (E122), sodium copper chlorophyllin (E141), chlorophyll (E140), roasted partially defatted cottonseed flour, ferrous gluconate, ferrous lactate, grape pigment extract, grape peel extract (grape anthocyanins), anthocyanins (E163), Haematococcus pluvialis powder, synthetic iron oxides, iron oxides and hydroxides (E1 72) Fruit juice, vegetable juice, dried algae powder, marigold (Aztec marigold) powder and extract, carrot oil, corn endosperm oil, red pepper, capsicum oleoresin, Fabry red yeast, riboflavin (E101), crocin, titanium dioxide, turmeric (E100), turmeric oleoresin, amaranth (E123), capsicum red pigment / capsicum rubigin (E160c), lycopene (E160d), FD&C Blue 1, FD&C Blue 2, FD&C Green 3, FD&C Red 3, FD&C Red 40, FD &C Yellow 5 and FD&C Yellow 6, Tartrazine Yellow (E102), Quinoline Yellow (E104), Sunset Yellow (E110), Carmine (E124), Edible Cherry Red (E127), Patent Blue V (E131), Titanium Dioxide (E171), Aluminum (E173), Silver (E174), Gold (E175), Pigment Ruby Red / Lisol Ruby Red BK (E180), Calcium Carbonate (E170), Carbon Black (E153), Black PN / Glossy Black BN (E151), Green S / Acid Brilliant Green BS (E142), or combinations thereof.

[0057] Thickeners used in this article must be absorbable by humans. Non-limiting examples of suitable thickeners include xanthan gum, carrageenan and its derivatives, glucan gum, hydroxypropyl methylcellulose, fungal gums and their derivatives, pullulan, rhamnose gum, Brunei gum, konjac, gelling polysaccharides, carbomer, alginate, alginic acid, alginate and its derivatives, hydroxyethyl cellulose and its derivatives, hydroxypropyl cellulose and its derivatives, starch phosphate derivatives, guar gum and its derivatives, starch and its derivatives, copolymers of maleic anhydride and olefins and their derivatives, ethylene glycol / propylene glycol copolymers, long-chain alcohols such as docosyl alcohol, poloxamer and its derivatives, polyacrylates and their derivatives, methylcellulose and its derivatives, ethylcellulose and its derivatives. Agar and its derivatives, gum arabic and its derivatives, pectin and its derivatives, chitosan and its derivatives, high molecular weight polyethylene glycols such as polyethylene glycol (molecular weight of 10,000 and above), ebony gum, carob gum, natto gum, copolymers of ethylene pyrrolidone and olefins, tragacanth gum, polyacrylamide, chitin derivatives, gelatin, β-glucan, dextrin, dextran, cyclodextrin, methacrylates, microcrystalline cellulose, polyquaternium salts, D-galactose gum, Indian gum, psyllium gum, tung oil, tamarind gum, larch gum, talc, kaolin clay, bentonite, cellulose, pyrolytic silica, and mixtures thereof. Preferred ingredients include xanthan gum, carrageenan and its derivatives, glycan gum, hydroxypropyl methylcellulose, fungal gums and their derivatives, pullulan, rhamnose gum, Brunei gum, konjac, gelling polysaccharides, carbomer, alginate, alginic acid, alginate and its derivatives, hydroxyethyl cellulose and its derivatives, hydroxypropyl cellulose and its derivatives, starch phosphate derivatives, guar gum and its derivatives, starch and its derivatives, copolymers of maleic anhydride and olefins and their derivatives, cellulose gums and their derivatives, poloxamer and its derivatives, gelatin, and mixtures thereof. More preferred ingredients include xanthan gum, carrageenan and its derivatives, glycan gum, hydroxypropyl methylcellulose, gelatin, and mixtures thereof, and even more preferred ingredients include xanthan gum.

[0058] As used in this article, stabilizers, such as vitamin C and disodium EDTA, are additives that can delay the oxidation of raw materials and maintain the stability of product components. Their core function is to prevent nicotine from oxidizing and deteriorating, thus extending the product's shelf life. Vitamin C has both antioxidant and mild flavoring effects, while disodium EDTA focuses on chelating metal ions to prevent heavy metals from accelerating nicotine oxidation.

[0059] As used in this article, bittering agents, such as benzyldenafil, can prevent children from accidentally ingesting them.

[0060] In some embodiments, the inner core can release 70%~80%, 80%~90% or ≥90% of the nicotine component within 30 seconds after the outer shell is crushed; In one specific embodiment, the raw material ratio (by weight) of the oral nicotine product of this patent is as follows: 1. Hard outer shell material (including regular and sugar-free versions) Standard version: 60-80 parts base sugar (30-40 parts sucrose + 30-40 parts malt syrup, weight ratio 1:1), 1-3 parts gelling agent (gum arabic suitable for pH 4.0-7.0, gelatin suitable for pH 5.0-6.5, carrageenan suitable for pH 4.5-7.5), 0.1-0.5 parts acidity regulator (citric acid, malic acid, or lactic acid; add at least 5 minutes after the gelling agent to avoid direct mixing and precipitation), 0.5-2 parts flavoring agent (natural flavoring, complementary to the core flavor), 0.01-0.05 parts coloring agent (food-grade natural coloring agent; avoid adding in the same batch as high-concentration acidity regulators), 0.02-0.08 parts preservative (potassium sorbate), 10-15 parts purified water.

[0061] Sugar-free version: 60-80 parts base sugar (30-40 parts maltitol + 30-40 parts isomaltitol, weight ratio 1:1), the rest of the ingredients are the same as the regular version, except for the sucrose-related ratios.

[0062] 2. Nicotine core raw materials

[0063] Nicotine 0.5-2 parts (purity ≥99.5%, heavy metal content ≤0.1mg / kg), solvent 10-20 parts (propylene glycol and glycerin in a 1:1 ratio, nicotine to solvent weight ratio ≤1:10), sweetener 1-3 parts (steviol / erythritol / aspartame for regular version, same for sugar-free version), flavoring agent 0.3-1 part (to match the flavor of the outer shell), stabilizer 0.05-0.2 parts (vitamin C or disodium EDTA), optional bittering agent 0.001-0.003 parts (benzyl benzoate, to prevent accidental ingestion by children).

[0064] The pH value of the inner core is controlled between 5.5 and 6.5, which is suitable for the tolerance range of the oral mucosa.

[0065] Preparation method

[0066] This patent provides a method for preparing oral nicotine products, including the following steps: S1. Pre-preparation of hard outer shell: Add the base sugar and purified water to a sugar boiling pot, heat, and stir until dissolved without particles; add other auxiliary materials, maintain the temperature, and boil until the sugar concentration reaches 85-99%; add flavoring agent and nicotine, stir evenly, and then cool for later use. S2. Preparation of the inner core: Heat the solvent, add nicotine, and stir until completely dissolved; add the excipients sequentially and stir at a constant temperature; filter to remove impurities and cool to room temperature for later use. S3. Sandwich molding: Using a dual-channel sandwich candy molding machine, pouring process, filling process or wrapping process, the initial finished product is obtained; S4. Post-processing: The initial product is aged at a constant temperature and humidity; defective products are removed, and the product is packaged to obtain the finished nicotine-containing product.

[0067] As used in this article, constant temperature and humidity curing is a post-processing step after product demolding, where the product is placed in a stable temperature and humidity environment. Its purpose is to balance the product's moisture distribution and enhance the sealing and structural stability of the outer shell. Curing for 24-48 hours can prevent cracking and sanding of the outer shell due to uneven moisture distribution, while further ensuring that the inner core does not leak.

[0068] In some embodiments, the sugar boiling temperature of the outer shell is 115-120℃, the stirring rate is 50-80r / min, the cooling rate is 5-8℃ / min, and the sugar concentration is 85-90%, ensuring that the outer shell meets the technical requirements of "1-3mm thickness and 20-30HA hardness" after molding.

[0069] In some embodiments, the inner core is prepared and melted at a temperature of 40-50°C, with a stirring rate of 100-150 r / min, filtered through a 200-mesh screen, and cooled at a rate of 3-5°C / min, to ensure that the inner core is uniform and stable and does not affect subsequent sealing and wrapping.

[0070] In some implementations, a dual-channel molding machine is used for sandwich molding, with a cooling rate of 4-6℃ / min and post-treatment curing conditions of 30-35℃, humidity of 40-50%, for 24-48 hours, to ensure that the outer shell completely seals the inner core and there is no leakage under normal conditions.

[0071] In one specific embodiment, the method for preparing the oral nicotine product according to this patent is as follows: S1. Add the base sugar and purified water to a sugar boiling pot, heat to 115-120℃, and stir at a rate of 50-80 r / min until dissolved and free of particles; add other excipients, maintain the temperature at 105-110℃, and cook at a rate of 60-70 r / min for 15-20 minutes until the sugar concentration reaches 85-99%; add flavoring agent, stir evenly at 50 r / min, and then cool down to 80-85℃ at a rate of 5-8℃ / min for later use. S2. Heat the solvent to 40-50℃, add nicotine, and stir at 100-150r / min until completely dissolved; add sweetener, flavoring agent, stabilizer, and bittering agent in sequence, and stir at a constant temperature for 10-15 minutes; filter through a 200-mesh filter to remove impurities, and cool to room temperature at a rate of 3-5℃ / min for later use. S3. Using a dual-channel sandwich candy molding machine, the outer shell sugar liquid at 80-85℃ is injected into the outer layer of the mold, and the room temperature inner core is injected into the inner layer of the mold simultaneously. The inner core accounts for 10-15% of the total weight of the product. The temperature is reduced to 30-35℃ at a cooling rate of 4-6℃ / min to set the shape, and the product is demolded to obtain the initial finished product. S4. Place the initial product in a constant temperature and humidity chamber at 30-35℃ and 40-50% humidity for 24-48 hours to mature; remove defective products with damage or leakage of the inner core, and vacuum package it with aluminum foil composite film (the oxygen permeability of the aluminum foil composite film is ≤5cm³ / (m²·24h·atm) and the moisture permeability is ≤3g / (m²·24h)) to obtain the finished nicotine product.

[0072] Preferably, the storage conditions are: temperature ≤25℃, relative humidity ≤60%, sealed and protected from light, and kept away from areas accessible to children. When using, users can choose to bite down on the outer shell (instant release of the inner core) or hold it in their mouth (slow release of the outer shell), depending on their needs.

[0073] Example

[0074] Table 1. Names of Raw Materials and Suppliers

[0075] Table 2. Instruments used in the experiment and their suppliers

[0076] Example 1

[0077] Raw material ratio (by weight)

[0078] Hard outer shell: 1.2 parts nicotine, 35 parts sucrose, 35 parts malt syrup, 2 parts gum arabic, 1.2 parts nicotine, 0.3 parts citric acid (added 5 minutes after gum arabic), 1 part peppermint flavoring, 0.03 parts betaine, 0.05 parts potassium sorbate, 12 parts purified water

[0079] Core: Nicotine 1.2 parts (99.8% purity, heavy metals 0.08 mg / kg), propylene glycol 10 parts, glycerin 10 parts, steviol 2 parts, menthol 0.6 parts, vitamin C 0.1 parts; core pH 6.0

[0080] Preparation process

[0081] Hard outer shell: Boil sugar at 118℃, stirring speed 60r / min, boil for 18 minutes, sugar concentration 88%; cooling rate 6℃ / min, reduce to 82℃ for later use (acidity regulator is added 5 minutes after gelling agent is added).

[0082] Inner core: Heat the solvent to 45℃, stir at 120r / min to dissolve nicotine, and stir for 12 minutes; filter through a 200-mesh filter, cool at 4℃ / min, and set aside at 25℃.

[0083] Sandwich molding: The sugar syrup is injected into the double-channel molding machine at 82°C for the outer shell and 25°C for the inner core; the cooling rate is 5°C / min, and the temperature is reduced to 32°C for shaping and demolding (outer shell thickness 2mm).

[0084] Post-treatment: Curing at 32℃ and 45% humidity for 36 hours; vacuum packaging using aluminum foil composite film with oxygen permeability of 4cm³ / (m²·24h·atm) and moisture permeability of 2g / (m²·24h).

[0085] Sample 1 of oral nicotine product was obtained, with a single tablet weight of 3g and a shell thickness of 2mm.

[0086] Example 2

[0087] Raw material ratio (by weight)

[0088] Hard outer shell: 30 parts sucrose, 30 parts malt syrup, 1 part gelatin, 0.5 parts nicotine, 0.1 parts malic acid (added 5 minutes after gelatin), 0.5 parts strawberry flavoring, 0.01 parts turmeric, 0.02 parts potassium sorbate, 10 parts purified water

[0089] Core: Nicotine 0.5 parts (99.6% purity, heavy metals 0.06 mg / kg), propylene glycol 5 parts, glycerin 5 parts, erythritol 1 part, strawberry flavoring agent 0.3 parts, disodium EDTA 0.05 parts; core pH 5.8

[0090] Preparation process

[0091] Hard outer shell: Boil sugar at 115℃, stirring speed 50r / min, boil for 15 minutes, sugar concentration 85%; cooling rate 5℃ / min, cool to 80℃ for later use.

[0092] Inner core: Heat the solvent to 40°C, stir at 100r / min to dissolve nicotine, and stir for 10 minutes; filter through a 200-mesh filter, cool at 3°C / min, and set aside at 23°C.

[0093] Sandwich molding: Injected into a dual-channel molding machine, cooled at a rate of 4℃ / min, cooled to 30℃ for shaping, and then demolded (outer shell thickness 1.5mm).

[0094] Post-treatment: Curing at 30℃ and 40% humidity for 24 hours; vacuum packaging using aluminum foil composite film (oxygen permeability 3.5cm³ / (m²·24h·atm), moisture permeability 1.8g / (m²·24h)).

[0095] Sample 2 of the oral nicotine product was obtained, with a single tablet weight of 2.5g and a shell thickness of 1.5mm.

[0096] Example 3

[0097] Raw material ratio (by weight)

[0098] Hard outer shell: 40 parts sucrose, 40 parts malt syrup, 3 parts carrageenan, 2 parts nicotine, 0.5 parts lactic acid (added 5 minutes after carrageenan), 2 parts blueberry flavoring, 0.05 parts beetroot red, 0.08 parts potassium sorbate, 15 parts purified water

[0099] Core: Nicotine 2 parts (99.7% purity, heavy metals 0.09 mg / kg), propylene glycol 10 parts, glycerin 10 parts, steviol glycosides 3 parts, blueberry flavoring agent 1 part, vitamin C 0.2 parts; core pH 6.2

[0100] Preparation process

[0101] Hard outer shell: Boil sugar at 120℃, stirring speed 70r / min for 20 minutes until the sugar concentration is 90%; cool down at 8℃ / min until it reaches 85℃ for later use.

[0102] Inner core: Heat the solvent to 50°C, stir at 150 r / min to dissolve nicotine, and stir for 15 minutes; filter through a 200-mesh filter, cool at 5°C / min, and set aside at 28°C.

[0103] Sandwich molding: Injected into a dual-channel molding machine, cooled at a rate of 6℃ / min, cooled to 35℃ for shaping, and then demolded (outer shell thickness 2.5mm).

[0104] Post-treatment: Curing at 35℃ and 50% humidity for 48 hours; vacuum packaging using aluminum foil composite film (oxygen permeability 4.5cm³ / (m²·24h·atm), moisture permeability 2.5g / (m²·24h)).

[0105] Sample 3 of oral nicotine products was obtained, with a single tablet weight of 4g and a shell thickness of 2.5mm.

[0106] Example 4

[0107] Raw material ratio (by weight)

[0108] Hard outer shell: 35 parts maltitol, 35 parts isomaltitol, 2 parts gum arabic, 1.2 parts nicotine, 0.3 parts citric acid (added 5 minutes after gum arabic), 1 part peppermint flavor, 0.03 parts betaine, 0.05 parts potassium sorbate, 12 parts purified water

[0109] Inner core: Nicotine 1.2 parts (99.8% purity, heavy metals 0.07 mg / kg), propylene glycol 10 parts, glycerin 10 parts, steviol glycosides 2 parts, menthol 0.6 parts, vitamin C 0.1 parts, denaphalonamine 0.002 parts (child-proof); inner core pH 6.0

[0110] Preparation process

[0111] Same as Example 1, only the base sugar is replaced.

[0112] Hard outer shell: Boil sugar at 118℃, stirring speed 60r / min, for 20 minutes (for sugar-free base sugar, extend the boiling time by 5 minutes), sugar concentration 88%; cooling rate 6℃ / min, reduce to 82℃ for later use.

[0113] The remaining steps (core preparation, sandwich molding, post-processing) are the same as in Example 1.

[0114] Four samples of oral nicotine products were obtained, with a single tablet weighing 3g and a shell thickness of 2mm.

[0115] Example 5

[0116] Raw material ratio (by weight)

[0117] Hard outer shell: 32 parts sucrose, 32 parts malt syrup, 2 parts gum arabic, 1.0 part nicotine, 0.2 parts citric acid (added 5 minutes after gum arabic), 0.8 parts chrysanthemum extract (water extract, 50% concentration), 0.5 parts monk fruit extract (alcohol extract, 60% concentration), 0.8 parts peppermint flavor (to blend with herbal flavors), 0.03 parts beetroot red, 0.05 parts potassium sorbate, 13 parts purified water.

[0118] Core: Nicotine 1.0 part (99.7% purity, heavy metals 0.07 mg / kg), propylene glycol 10 parts, glycerin 10 parts, steviol 1.5 parts, vitamin B6 0.08 parts (water-soluble, helps relieve fatigue), menthol 0.5 parts, vitamin C 0.12 parts (combines stabilizing and health-promoting functions); core pH 6.0

[0119] Preparation process

[0120] Hard outer shell: Heat the base sugar and purified water to 115°C and stir at 60 r / min to dissolve. Add gum arabic and stir for 5 minutes. Then add citric acid, chrysanthemum extract, and monk fruit extract (pre-dissolved in 5 parts of purified water). Maintain 108°C and cook for 18 minutes (sugar concentration 87%). Cool down to 82°C at 6°C / min. Add peppermint flavoring and stir well.

[0121] Inner core: Dissolve nicotine in solvent heated to 45°C with stirring at 120 r / min; after cooling to 40°C, add vitamin B6 (avoid high temperature damage), steviol glycosides, menthol, and vitamin C, and stir for 12 minutes; filter through a 200-mesh filter and cool to 25°C at a rate of 4°C / min for later use.

[0122] Sandwich molding: The sugar syrup is injected into the double-channel molding machine at 82°C for the outer shell and 25°C for the inner core; the cooling rate is 5°C / min to 32°C for shaping, and then demolded (outer shell thickness 2mm).

[0123] Post-treatment: 32℃ and 45% constant temperature and humidity curing for 36 hours; vacuum packaging with aluminum foil composite film (oxygen permeability 4cm³ / (m²·24h·atm)).

[0124] Four samples of oral nicotine products were obtained, with a single capsule weighing 3g.

[0125] Nicotine release curve determination

[0126] Sample 1 of the oral nicotine product prepared in Example 1 was used. The candy sample was crushed at different times to simulate biting the candy in the mouth, and the nicotine release was detected. Nicotine concentration was measured according to national standards (YC / T 160-2002 and YC / T 468-2013), and the nicotine release percentage curve was calculated.

[0127] Experimental Group 1 - Immediately crushed

[0128] Take one sample of nicotine product and place it in 50 mL of constant temperature ultrapure water at 37°C. Immediately break the outer shell. After 30 seconds, use a 1 mL pipette to take 0.5 mL of the solution into an EP tube. After sampling, centrifuge at 3000 rpm for 1 minute and take the supernatant as the dissolved sample to determine the nicotine content.

[0129] Experimental Group 2 - Shell Dissolves Naturally

[0130] Take one sample of nicotine product and place it in 50 mL of 37°C constant temperature ultrapure water. Start the constant temperature shaker (Changzhou Zhiborui Instrument Manufacturing Co., Ltd.). Every 30 seconds, use a 1 mL pipette to take 0.5 mL of the solution into an EP tube. After sampling, centrifuge at 3000 rpm for 1 minute and take the supernatant as the dissolved sample to determine the nicotine content.

[0131] The obtained nicotine release percentage curve is as follows Figure 1As shown in the diagram, Experiment 1 immediately breaks the outer shell, simulating the user immediately biting down on a nicotine-containing product upon ingestion, causing the core to flow out and rapidly releasing nicotine for quick gratification, followed by a slow release of nicotine from the hard outer shell. Experiment 2 simulates natural ingestion, initially with the hard outer shell slowly releasing nicotine, the shell walls becoming thinner until the core flows out, rapidly releasing nicotine. Users can also bite down on the outer shell at different times to release the core, thus controlling the timing of nicotine release.

[0132] In the foregoing description of exemplary embodiments / specific implementations of this patent, various features of this patent 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, unless expressly stated otherwise or in obvious technical contradiction or exclusion, the descriptive method of this patent should not be construed as reflecting an intention that the claimed features of the invention are more than expressly stated in each claim. 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 hereby expressly incorporated into this detailed description, each claim existing independently as a separate embodiment / specific implementation of this patent.

[0133] The terms 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 this patent claim. Therefore, it should be understood that while this patent 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 patent as defined by the appended claims. The specific embodiments given in this specification are examples of useful embodiments of this patent, and it will be apparent to those skilled in the art that this patent can be implemented using many variations of the devices, device components, and method steps disclosed herein.

[0134] The foregoing description of specific embodiments fully discloses the general features of this patent, 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 patent. 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 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.

[0135] Furthermore, the scope of this patent 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-containing product, characterized in that, The oral nicotine product includes an inner core and a rigid outer shell that encloses the inner core; The hard outer shell is solid and contains nicotine and basic sugars; The inner core is semi-solid or liquid and contains nicotine and solvent.

2. The oral nicotine product according to claim 1, characterized in that, The inner core can release 70%~80%, 80%~90% or ≥90% of the nicotine content within 30 seconds after the outer shell is crushed; The core also contains one or more of the following: sweeteners, flavorings, colorings, thickeners, stabilizers, and bittering agents; The solvent is selected from water or polyols.

3. The oral nicotine product according to claim 2, The thickness of the rigid outer shell is 0.5mm~0.8mm, 0.8mm~1.5mm, or 1.5mm~2.0mm; The hard outer shell also contains one or more of flavoring agents, coloring agents, gelling agents, and stabilizers.

4. The oral nicotine product according to claim 3, characterized in that, The basic sugar is selected from sugars or sugar substitutes; The sugar or sugar substitute is selected from one or more of sucrose, dextrose, maltose, dextrin, xylose, ribose, glucose, mannose, galactose, fructose, lactose, invert sugar, fructooligosaccharides, partially hydrolyzed starch, isomaltulose, high-fructose corn syrup, polydextrose, erythritol, galactitol, hydrogenated starch hydrolysate, isomaltulitol, lactitol, maltitol, mannitol, polydextrose, sorbitol, and xylitol.

5. The oral nicotine product according to claim 4, characterized in that, The nicotine component is selected from nicotine free base and nicotine salt.

6. A method for preparing an oral nicotine product as described in any one of claims 1-5, characterized in that, Includes the following steps: S1. Pre-preparation of hard outer shell: Add the base sugar and purified water to a sugar boiling pot, heat, and stir until dissolved without particles; add other auxiliary materials, maintain the temperature, and boil until the sugar concentration reaches 85-99%; add flavoring agent and nicotine, stir evenly, and then cool for later use. S2. Preparation of the inner core: Heat the solvent, add nicotine, and stir until completely dissolved; add the excipients sequentially and stir at a constant temperature; filter to remove impurities and cool to room temperature for later use. S3. Sandwich molding: Using a dual-channel sandwich candy molding machine, pouring process, filling process or wrapping process, the initial finished product is obtained; S4. Post-processing: The initial product is aged at a constant temperature and humidity; defective products are removed, and the product is packaged to obtain the finished nicotine-containing product.

7. The method as described in claim 6, characterized in that, Step S1 specifically includes: adding the base sugar and purified water to a sugar boiling pot, heating to 115-120℃, and stirring at a rate of 50-80 r / min until dissolved without particles; adding other excipients, maintaining the temperature at 105-110℃, and cooking at a rate of 60-70 r / min for 15-20 minutes until the sugar concentration reaches 85-99%; adding flavoring agent, stirring evenly at 50 r / min, and then cooling down to 80-85℃ at a rate of 5-8℃ / min for later use.

8. The method according to claim 6, characterized in that, Step S2 specifically includes: heating the solvent to 40-50℃, adding nicotine, and stirring at a rate of 100-150r / min until completely dissolved; adding sweetener, flavoring agent, stabilizer, and bittering agent in sequence, and stirring at a constant temperature for 10-15 minutes; filtering through a 200-mesh filter to remove impurities, and cooling to room temperature at a rate of 3-5℃ / min for later use.

9. The method according to claim 6, characterized in that, Step S3 uses a dual-channel sandwich candy molding machine to inject the outer shell sugar liquid at 80-85℃ into the outer layer of the mold, and simultaneously inject the room temperature inner core into the inner layer of the mold. The inner core accounts for 10-15% of the total weight of the product. The temperature is reduced to 30-35℃ at a cooling rate of 4-6℃ / min to set the shape, and the product is demolded to obtain the initial finished product.

10. The method according to claim 6, characterized in that, Step S4 specifically includes: placing the initial product in a constant temperature and humidity chamber at 30-35℃ and 40-50% humidity for 24-48 hours to mature; removing defective products with damage or leakage of the inner core; and vacuum packaging the product using an aluminum foil composite film, wherein the oxygen permeability of the aluminum foil composite film is ≤5cm³ / (m²·24h·atm) and the moisture permeability is ≤3g / (m²·24h) to obtain the finished nicotine product.

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