Nicotine jelly and preparation method thereof

Abstract

The invention discloses nicotine jelly and a preparation method thereof. The nicotine jelly comprises a nicotine source and a jelly substrate, wherein the nicotine source is dispersed in the jelly substrate; wherein the nicotine source comprises a non-embedded nicotine source and a nicotine source embedded in the microcapsule particles. The nicotine jelly can adapt to different release scenes by adjusting the embedding proportion, safety and portability are both considered, and an innovative solution is provided for nicotine replacement therapy.

Description

Technical Field

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

[0002] It is well known that both active and passive smoking pose serious health risks, and the nicotine in cigarettes is highly addictive. Despite increasingly stringent bans on smoking in public places, restrictions on occupational settings, and tightening social norms, many nicotine addicts still face significant difficulties when attempting to quit or reduce their tobacco intake. This difficulty stems from two main factors: the highly addictive nature of nicotine itself and the pronounced withdrawal symptoms that occur after deprivation of exogenous nicotine—especially persistent and intermittent intense cravings. Both of these symptoms are major drivers of relapse. Intermittent cravings are often triggered by visual or olfactory cues related to smoking or exposure to others smoking. Therefore, withdrawal management requires both maintaining a certain baseline nicotine level to alleviate persistent cravings and providing immediate relief for acute cravings within a short period.

[0003] To address the aforementioned issues, nicotine replacement therapy (NRT), based on the concept of alternative drug delivery, has been developed and commercialized for many years. Common dosage forms include nicotine chewing gum, transdermal patches, nicotine tablets, inhalers, and lozenges. Existing NRTs have played a positive role in reducing withdrawal discomfort and improving smoking cessation success rates, and have been applied in both clinical and non-clinical populations (e.g., commercially available nicotine chewing gum, transdermal patches, and various tablet formulations).

[0004] However, existing NRT formulations still have significant shortcomings in practical use, which to some extent limit patient adherence and efficacy. First, their use is limited by specific scenarios and cumbersome: chewing gum requires continuous chewing and spitting or proper disposal after use, causing inconvenience in public places or office environments; while transdermal patches provide a stable baseline nicotine release, their sustained-release properties cannot meet the immediate relief needs of induced acute cravings; lozenges or tablets are often complained about by users for being "too medicinal" or "too clinical" in terms of dissolution rate, taste, and oral irritation, affecting long-term acceptance. Second, many existing formulations are bulky, have slow dissolution onset times, or their release curves do not match the timescale of smokers' sudden cravings, thus failing to quickly relieve strong cravings at critical moments, leaving the risk of relapse still present. Third, the sensory experience of the products (such as taste, texture, and flavor) does not match users' subjective preferences, especially among young people, where traditional NRT is often seen as "medical" or lacking in fun, making it difficult to gain widespread acceptance.

[0005] As global tobacco control policies tighten and smoking bans expand in public places, the need for discreet and portable smoking has become increasingly prominent. Modern smokers, especially those in high-intensity social, professional, and academic environments, prefer to obtain nicotine relief without attracting attention: they need small, quiet forms of administration that require no special processing (such as spitting out); at the same time, products with simple packaging, easy portability, and an appearance that does not prominently resemble "medicine" or "smoking alternatives" are more popular.

[0006] Furthermore, younger consumers are highly receptive to novel product formats, diverse flavors, and personalized experiences, preferring to view products as part of their lifestyle rather than simply as medical supplies. Jelly (or gel / soft lozenge) formats, with their soft and palatable texture, varied flavors, and engaging user experience, have the potential to better replace traditional NRT formats on both sensory and behavioral levels, thereby improving compliance and user satisfaction.

[0007] Considering the above factors, there is an urgent market and clinical need for a new type of nicotine product that can quickly relieve acute cravings while providing a good sensory experience and high concealment. An ideal product should be: small and portable, easy to use discreetly in public; rapidly dissolve or provide quick-acting transmucosal absorption to address intermittent cravings; have a pleasant taste and selectable flavors to increase acceptance among younger users; and achieve a controllable kinetic balance between maintaining baseline relief and rapid onset of action.

[0008] While existing chewing gums and patches each have their advantages and disadvantages, they have not fully addressed the integrated need for "rapid onset of action + good taste + discreet and portable + high compliance". Therefore, there is an urgent need to develop a nicotine product that has an improved taste, is easy to use discreetly, better suits the consumption preferences of young people, and can significantly improve compliance and effectiveness of NRT programs. Summary of the Invention

[0009] The purpose of this patent is to provide a nicotine jelly that meets the concealment requirements of smokers' nicotine intake. During withdrawal management, it is necessary to maintain a certain baseline nicotine level to alleviate persistent cravings, and it is also necessary to provide immediate relief for acute nicotine cravings in a short period of time. At the same time, it meets the pursuit of young people for novel product forms and personalized experiences.

[0010] To solve the above-mentioned technical problems, this patent adopts the following technical solution:

[0011] In a first aspect, the present invention provides a nicotine jelly comprising a nicotine source and a jelly matrix, wherein the nicotine source is dispersed in the jelly matrix; wherein the nicotine source comprises an unencapsulated nicotine source and a nicotine source encapsulated in microcapsule particles.

[0012] Furthermore, based on the weight of nicotine sources, the ratio of unencapsulated to encapsulated nicotine sources ranges from 3:7 to 9:1.

[0013] Furthermore, nicotine jelly also includes a pH adjuster.

[0014] Furthermore, the pH adjuster is selected from organic acids; the pH of the nicotine jelly is adjusted to 4.0-5.5.

[0015] Furthermore, nicotine jelly is a gel jelly, in a gel-like state; or, nicotine jelly is a sippy jelly, in a semi-fluid gel-like state, which can be directly sucked out using a straw or mouthpiece.

[0016] Furthermore, the jelly matrix is ​​prepared from animal-derived gelling agents or plant-derived gelling agents.

[0017] Furthermore, animal-derived gelling agents include gelatin.

[0018] Furthermore, plant-derived gelling agents include one or more of pectin, agar, and gellan gum.

[0019] Furthermore, nicotine jelly also includes one or more of the following: flavoring agents, sweeteners, stabilizers, and preservatives.

[0020] Furthermore, the nicotine source is nicotine salt, and each nicotine jelly contains 2-4 mg of nicotine based on the mass of free nicotine.

[0021] Furthermore, the carrier material for the microcapsule particles is selected from one or more of porous starch, cyclodextrin, sodium alginate, or polylactic acid.

[0022] In a second aspect, a method for preparing the nicotine jelly of the first aspect is provided, the method comprising the following steps:

[0023] Step A: Microencapsulation of nicotine source involves mixing the nicotine source solution with a carrier and then performing high-speed shearing and stirring to form an emulsion; the emulsion is then spray-dried or freeze-dried to form microcapsule particles.

[0024] Step B: Prepare the jelly matrix by adding the gelling agent to cold water to swell, then dissolving it in hot water heated to 80-90℃ to obtain a gel solution and keeping it warm for later use.

[0025] Step C: Slowly add the microcapsule particles obtained in Step A and the unencapsulated nicotine source to the gel solution obtained in Step B, and stir at low speed to obtain a mixture;

[0026] Step D: While the mixture obtained in step C is still hot, pour it into the mold and let it solidify at room temperature or under refrigeration. After solidification, remove the nicotine jelly from the mold.

[0027] Furthermore, step B also includes adding a pH adjuster to the gel solution to adjust the pH to 3.5-4.0, and adding one or more of flavoring agents, sweeteners, preservatives, and stabilizers.

[0028] Furthermore, the method is carried out under aseptic conditions; or, the method further includes step E: sterilizing the nicotine jelly.

[0029] Furthermore, the method also includes step F1: the nicotine jelly is a gel jelly, and the gel jelly is packaged using blister packaging; or step F2: the nicotine jelly is a squeezable jelly, and the squeezable jelly is packaged using aluminum foil bags.

[0030] The beneficial effects of this patent include:

[0031] This patent optimizes nicotine release by dividing the nicotine source into two parts: a non-encapsulated portion and a microencapsulated portion. Combined with the characteristics of a jelly matrix, the non-encapsulated portion rapidly releases nicotine to relieve acute cravings, while the microencapsulated portion provides sustained release to maintain basal nicotine levels, meeting the dual needs of immediate and sustained release during smoking cessation. Furthermore, the jelly form offers both concealment and sensory advantages, making it particularly suitable for younger individuals and public settings. The nicotine jelly preparation process is simple and can be adapted to different release scenarios by adjusting the encapsulation ratio, while also ensuring safety and portability, providing an innovative solution for nicotine replacement therapy. Detailed Implementation

[0032] The detailed features and advantages of this application are described below in the specific embodiments. The content 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 and claims disclosed in this specification, a person skilled in the art can easily understand the related objectives and advantages of this application.

[0033] In this specification and claims, several terms will be used, and unless otherwise indicated, these terms will be defined to have the following meanings:

[0034] 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.

[0035] 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 and specification of this patent, can directly and without doubt determine how the technical solution of this patent can be implemented.

[0036] Even if there are incomplete descriptions, omissions, or ambiguities in the grammar, words, punctuation, graphics, symbols, etc. of the claims and specification of this patent, a person skilled in the art can still arrive at the only correct understanding by reading the claims and specification as a whole without extensive reasoning or experimentation, and effectively eliminate various incorrect interpretations that are not aimed at achieving the purpose of this patent.

[0037] 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.

[0038] Unless otherwise specified, all embodiments and preferred embodiments mentioned herein can be combined to form new technical solutions.

[0039] Unless otherwise specified, all the technical features and preferred features mentioned herein can be combined to form new technical solutions.

[0040] 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.

[0041] 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.

[0042] 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.

[0043] 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).

[0044] Unless otherwise specified, percentages (%) in this document refer to percentages by mass relative to the composition.

[0045] Unless otherwise stated herein, the sum of the contents of the components in the composition is 100%.

[0046] 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.

[0047] Unless otherwise specified, the term "a" as used in this specification means "at least one".

[0048] 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.

[0049] 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.

[0050] Nicotine jelly

[0051] This invention provides a nicotine jelly, comprising a nicotine source and a jelly matrix, wherein the nicotine source is dispersed in the jelly matrix. The nicotine source includes non-encapsulated nicotine sources and nicotine sources encapsulated in microcapsule particles.

[0052] The nicotine jelly according to the present invention can be provided in various forms. In some embodiments, the nicotine jelly is a gel jelly, which is gel-like and retains its original shape substantially after being poured from the packaging container. In other embodiments, the nicotine jelly is a sippy jelly, which is semi-fluid gel-like and can be directly consumed using a straw or mouthpiece.

[0053] Jelly base

[0054] In some embodiments, the jelly matrix is ​​prepared from animal-derived gelling agents or plant-derived gelling agents.

[0055] In some implementations, the animal-derived gelling agent is selected from gelatin.

[0056] As used in this article, "gelatin" is a natural protein gelling agent extracted from animal bones, skin, and connective tissue, with its main component being collagen hydrolysates. It is widely used in the food industry, especially in dessert making, where it imparts a unique, bouncy, and smooth texture to mousses, puddings, jellies, and gummies. Due to its unique gelling properties, it is often referred to as an animal-derived gel. Gelatin sheets and gelatin powder are its two forms, widely used in desserts, mousses, and other Western-style pastries, as well as Hong Kong-style desserts. When using gelatin, it is important to note that it must first be softened in cold water, then heated in a double boiler to 50-60°C to dissolve, and finally mixed with liquid and refrigerated to solidify. The solidification process is reversible; the gel will liquefy again upon heating. Therefore, gelatin products must be refrigerated and are not heat-resistant.

[0057] There is an important prerequisite for using gelatin: "pre-hydration." This means that before adding gelatin, it needs to be thoroughly mixed with a cold liquid so that it can fully expand. This method applies to various cold liquids, such as cold water, juice, or milk. Gelatin powder needs to be mixed with 5-10 times its volume of cold liquid, while gelatin sheets need to be soaked in cold water below 21°C until softened before gently squeezing. For some juices rich in proteases, such as pineapple, kiwi, and papaya, they need to be heated first and then cooled to inactivate the proteases and ensure a good gelling effect. In addition, when combined with acidic ingredients, the amount of gelatin used should be increased accordingly.

[0058] In some embodiments, the plant-derived gelling agent is selected from one or more of pectin (high methoxyl pectin, which requires acidic conditions for gelation), agar (thermally reversible, suitable for room temperature storage), and gellan gum (which can be formed with low dosage and has high transparency).

[0059] Nicotine source

[0060] In some implementations, the nicotine source is nicotine salt, and each nicotine jelly contains 2-4 mg of nicotine by weight of free nicotine.

[0061] Nicotine salts include nicotine hydrochloride, nicotine phosphate, nicotine sulfate, nicotine pyruvate, nicotine formate, nicotine oxalate, nicotine ascorbate, nicotine glycolate, nicotine acetate, nicotine isovalerate, nicotine valerate, nicotine propionate, nicotine caprylate, nicotine lactate, nicotine levulinate, nicotine sorbate, nicotine malate, nicotine fumarate, nicotine salicylate, nicotine glycinate, nicotine tartrate, nicotine succinate, nicotine citrate, nicotine benzoate, and nicotine oleic acid. The following are one or more of the following: 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, and nicotine 3-phenylpropionate.

[0062] In the nicotine jelly according to the present invention, the nicotine source includes an unencapsulated nicotine source and a nicotine source encapsulated in microcapsule particles. In some embodiments, the ratio of the unencapsulated nicotine source to the encapsulated nicotine source, by weight, ranges from 3:7 to 9:1.

[0063] The carrier material for the microcapsule particles is selected from one or more of porous starch, cyclodextrin, sodium alginate, or polylactic acid.

[0064] additive

[0065] In some embodiments, the nicotine jelly according to the present invention may contain a variety of additives to achieve better technical effects or taste.

[0066] In some embodiments, the nicotine jelly further includes a pH adjuster. In some embodiments, the pH adjuster is selected from organic acids. In some embodiments, the pH adjuster is added to adjust the pH of the nicotine jelly to 4.0-5.5, thereby stabilizing the nicotine salt and promoting gel solidification. Non-limiting examples of pH adjusters include, but are not limited to, acetic acid, adipic acid, citric acid, fumaric acid, gluconic acid-δ-lactone, gluconic acid, lactic acid, malic acid, maleic acid, tartaric acid, succinic acid, propionic acid, and ascorbic acid.

[0067] In some embodiments, the additive also includes one or more of flavoring agents, sweeteners, stabilizers, and preservatives.

[0068] Non-limiting examples of flavorings include, but are not limited to, peppermint flavorings, cinnamon flavorings, cherry flavorings, coconut flavorings, coffee flavorings, chocolate flavorings, vanilla flavorings, citrus flavorings (such as grapefruit flavorings, orange flavorings, lime flavorings, bergamot flavorings, or lemon flavorings), menthol flavorings, licorice flavorings, caramel flavorings, honey flavorings, peanut flavorings, walnut flavorings, cashew flavorings, hazelnut flavorings, almond flavorings, pineapple flavorings, strawberry flavorings, raspberry flavorings, tropical fruit flavorings, and cherry flavorings. Flavorings include cinnamon, mint, deer antler velvet, spearmint, eucalyptus, apple, pear, peach, strawberry, apricot, raspberry, cherry, pineapple, lemongrass, lime, chili, capsaicin, citrus, tobacco, bergamot, smoked, plum, eucalyptus, clove, bay leaf, fennel, thyme, cedar leaf, and nutmeg. Alternatively, fruit juice can be added directly for flavoring.

[0069] Non-limiting examples of sweeteners include, but are not limited to, 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. Preferably, the sweetener is selected from sorbitol, xylitol, etc., which are calorie-free and avoid affecting gelation.

[0070] Non-limiting examples of preservatives include, but are not limited to, ethylparaben, benzoic acid, benzoates, sorbic acid, sorbates, calcium propionate, sodium diacetate, sodium lactate, propylparaben, and sodium dehydroacetate. Typically, the amount of preservative used is ≤0.05% by mass.

[0071] Non-limiting examples of stabilizers include, but are not limited to, EDTA. As used herein, "EDTA" (ethylenediaminetetraacetic acid) and its salts (such as disodium EDTA) are widely used metal ion chelating agents in the food industry, primarily exerting multiple effects by chelating metal ions such as iron and copper. They inhibit metal ion-catalyzed oxidation reactions, delay rancidity of oils and fats, pigment fading, and vitamin C loss, maintain the bright colors of fruit juices, canned goods, and other foods, reduce the metal ion nutrient source required for microbial growth, indirectly inhibiting reproduction, and enhance the effects of preservatives such as potassium sorbate. Furthermore, EDTA can prevent sedimentation in dairy products, browning in beverages, and the formation of off-flavors, maintaining the structural stability of food.

[0072] Preparation method

[0073] In some specific embodiments, the method for preparing nicotine jelly according to the present invention includes:

[0074] I. Raw Material Preparation and Pretreatment

[0075] 1. Selection of core raw materials

[0076] Nicotine source: Nicotine salts, such as nicotine ditartrate and nicotine benzoate, are typically used, rather than free nicotine, because free nicotine is highly irritating and has poor stability. Nicotine salts must meet purity standards, such as ≥99%, and must pass "toxicity classification" certification to comply with the chemical control requirements of various countries.

[0077] Gel matrix: can be selected from animal sources, such as gelatin (300-500 Bloom value, providing elastic texture); or plant sources, such as pectin (high methoxyl pectin, requires acidic conditions for gelation), agar (thermally reversible, suitable for room temperature storage) and gellan gum (low dosage required for molding, high transparency).

[0078] Additives include, but are not limited to, pH adjusters, flavorings, sweeteners, stabilizers, and preservatives.

[0079] pH adjusters can be selected from citric acid and tartaric acid;

[0080] Flavorings can be selected from peppermint, cinnamon, cherry, coconut, coffee, chocolate, vanilla, citrus (such as grapefruit, orange, lime, bergamot, or lemon), menthol, licorice, caramel, honey, peanut, walnut, cashew, hazelnut, almond, pineapple, strawberry, raspberry, tropical fruit, cherry, cinnamon, and mint flavors. Flavorings include: deer hoof flavoring, spearmint flavoring, eucalyptus flavoring, apple flavoring, pear flavoring, peach flavoring, strawberry flavoring, apricot flavoring, raspberry flavoring, cherry flavoring, pineapple flavoring, lemongrass flavoring, lime flavoring, chili flavoring, capsaicin flavoring, citrus flavoring, tobacco flavoring, bergamot flavoring, smoked flavoring, plum flavoring, eucalyptus flavoring, clove flavoring, bay leaf flavoring, fennel flavoring, thyme flavoring, cedar leaf flavoring, and nutmeg flavoring; or fruit juice can be added directly.

[0081] Sweeteners may be selected from aspartame, acesulfame potassium, cyclamate, saccharin, sodium saccharin, sucralose, neotame, sodium cyclohexylsulfamate, stevia, licorice, disodium glycyrrhizate, tripotassium and trisodium glycyrrhizate, glucose, fructose, sucrose, maltose, corn syrup, starch sugar and lactose, sorbitol, maltitol, isomaltitol, palaginitol, xylitol, lactitol, mannitol, erythritol and dextran.

[0082] Preservatives can be selected from ethylparaben, benzoic acid, benzoate, sorbic acid, sorbate, calcium propionate, sodium diacetate, sodium lactate, propylparaben, and sodium dehydroacetate.

[0083] Stabilizers can be selected from EDTA to chelate metal ions and prevent oxidation.

[0084] 2. Raw material pretreatment

[0085] Nicotine salts need to be dissolved in deionized water at a temperature ≤40℃ to avoid high-temperature degradation, to prepare a 0.5%-2% nicotine solution. Stir until completely dissolved and set aside.

[0086] Some gelling agents (such as gelatin tablets) need to be soaked in cold water in advance to swell, for example, at a ratio of 1:5, to avoid clumping when heated;

[0087] Other solid additives (such as sweeteners and regulators) need to be sieved through an 80-mesh sieve to remove impurities and ensure uniform mixing.

[0088] II. Nicotine Microencapsulation

[0089] To control the release rate, some nicotine sources can be microencapsulated.

[0090] The carrier can be selected from porous starch, cyclodextrin, sodium alginate or polylactic acid (PLA) microspheres.

[0091] The process involves mixing a nicotine source solution with a carrier at a ratio of 1:5 to 1:10, followed by high-speed shearing (3000-5000 rpm) to form an emulsion. The emulsion is then cured using either spray drying or freeze drying. For spray drying, the inlet air temperature is 120-150℃ and the outlet air temperature is 60-80℃, yielding microcapsule particles with a diameter of 5-50 μm. The microcapsule encapsulation efficiency is then measured (e.g., ≥80%).

[0092] III. Preparation of Jelly Matrix

[0093] 1. Gel solution preparation:

[0094] If using gelatin, add the swollen gelatin to deionized water at 80-90℃, for example, with a solid-liquid ratio of 1:10, stir until completely dissolved, and keep warm at 60℃ for later use.

[0095] If using pectin, dry mix the pectin and sucrose to prevent clumping, add 70°C water, stir until dissolved, add citric acid to adjust the pH to 3.5-4.0, and keep warm at 50°C for later use.

[0096] 2. Mixed additives:

[0097] Add flavoring agents, sweeteners, preservatives, and stabilizers to the gel solution and stir for 10-15 minutes at 500 rpm to ensure uniform dispersion and avoid the formation of bubbles.

[0098] IV. Mixing Nicotine Source with Matrix

[0099] The pre-encapsulated nicotine source solution (microcapsule particles) and the unencapsulated nicotine source solution are slowly added to the gel matrix in a certain proportion, and stirred at a low speed of 300 rpm for 5-10 minutes to avoid excessive shear force that could damage the microcapsule structure.

[0100] After mixing, the nicotine concentration can be tested. Each jelly usually contains 2-4mg of nicotine, which meets the safety standard of ≤60mg maximum daily intake. If necessary, deionized water can be added to adjust the concentration.

[0101] V. Shaping and Solidification

[0102] Mold preparation: Use food-grade silicone molds with a single cavity capacity of 5-10g. Disinfect and dry them with alcohol in advance.

[0103] Filling: Pour the mixture into the mold while it is still hot (e.g., 50-60℃) to avoid overflow, and the liquid surface should be level;

[0104] Setting: Gelatin matrix can be set faster by standing at room temperature (25℃) for 30 minutes or by refrigerating at 4℃ for 15 minutes; pectin / gellan gum needs to be set under acidic conditions and can be set by standing at room temperature for 20-30 minutes.

[0105] VI. Demolding and Sterilization

[0106] Demolding: After solidification, gently tap the mold to remove the jelly intact, avoiding breakage;

[0107] Sterilization: Irradiation sterilization can be used, such as using γ-rays with a dose of 2-5 kGy, which is suitable for heat-sensitive products; if the entire process is carried out in a sterile workshop (Class 10000), the sterilization step can be omitted, but environmental microorganisms must be controlled, for example, the total number of colonies ≤100 CFU / g.

[0108] VII. Packaging and Quality Inspection

[0109] Packaging: Individual gel jelly is packaged in aluminum-plastic blister packs to prevent oxygen and moisture from entering; squeezable jelly can be packaged in individual aluminum foil bags.

[0110] The outer packaging can indicate the nicotine content, warnings such as "nicotine addiction, not for use by pregnant women," production date, and shelf life. Shelf life is typically 6-12 months, which can be extended by refrigeration.

[0111] After packaging, the nicotine jelly can be tested for quality, such as to ensure it meets the GB19299-2015 standard.

[0112] Physicochemical indicators: Nicotine content (deviation ≤ ±10%), pH value (4.0-5.5), water activity (aw ≤ 0.85, inhibiting microorganisms);

[0113] Sensory indicators: uniform color, no odor, and elastic texture (neither soft nor mushy, neither hard nor brittle).

[0114] Safety indicators: heavy metals (lead ≤ 0.1 mg / kg), microorganisms (E. coli and mold must not be detected).

[0115] Example

[0116] Source of materials and equipment used

[0117] Table 1 Experimental Materials

[0118]

[0119] Table 2. Microcapsule / Drying Equipment

[0120]

[0121] Table 3. Irradiation sterilization equipment

[0122]

[0123] Table 4. Molding and Packaging Equipment / Materials

[0124]

[0125] Example 1

[0126] Prepare gel nicotine jelly according to the following procedure:

[0127] All operations were performed using a 1000 mL glass beaker, an IKA RW20 stirrer, and a BUCHI B-290 spray dryer. A single feed of 100 g of gel solution could yield 20 capsules (5 g / capsule).

[0128] Product: 2.5 mg / capsule mint-flavored nicotine gel jelly

[0129] I. Raw materials and weighing (accuracy 0.1 mg)

[0130] Table 5. Raw Material Formula Table

[0131]

[0132] II. Microencapsulation (spray drying)

[0133] 1. Carrier swelling: 0.150 g porous starch + 3.0 g deionized water, magnetically stirred at 25°C for 30 min (300 rpm).

[0134] 2. Adding nicotine: Add 0.150 g of nicotine benzoate (≈0.12 g of base) to the above slurry and continue stirring at 25°C for 1 h.

[0135] 3. Homogenization: High-speed shearing at 8000 rpm for 2 min (IKA T10).

[0136] 4. Spray drying parameters:

[0137] Inlet air temperature 135 ℃; outlet air temperature 75 ℃; feed rate 3 mL / min; atomized nitrogen 600 L / h

[0138] 0.28 g of microcapsules were obtained, with an encapsulation efficiency of 83.4% and a particle size D50 of 11.2 µm.

[0139] III. Gel Preparation

[0140] 1. Colloidal dispersion: 0.200 g gellan gum + 2 g sucrose (dry mix to prevent clumping) are added to 40 g 90 ℃ deionized water and stirred at 500 rpm for 10 min using an IKA RW20.

[0141] 2. Adjust pH: Add 0.012 g sodium citrate and measure pH = 4.2 (Mettler ToledoFiveEasy).

[0142] 3. Add the remaining additives: 0.1 g peppermint flavoring, 0.02 g sucralose, 0.004 g sodium benzoate, and 0.002 g EDTA-2Na. Keep warm at 60 ℃ and stir for 5 min.

[0143] 4. Nicotine:

[0144] Microencapsulation portion: 0.168 g (containing 0.09 g bases)

[0145] Non-embedded portion: 0.0125 g nicotine benzoate (containing 0.01 g bases)

[0146] Stir at 60 ℃ and 300 rpm for 5 minutes to avoid air bubbles.

[0147] 5. Add water: Use 55℃ deionized water to weigh to 100.0 g, and gently shake to mix.

[0148] IV. Filling and Solidification

[0149] 1. Mold: 20-hole food-grade silicone disc (5 g per cavity, ϕ 25 mm).

[0150] 2. Filling: Maintain the gel solution at 55 ℃ and quickly inject it into each well using a 50 mL glass dropper, 5.0 g ± 0.1 g.

[0151] 3. Solidification: Let stand at room temperature (25℃) for 20 minutes, then freeze at 4℃ for 10 minutes to accelerate solidification, and completely demold without sticking.

[0152] V. Demolding and Rapid Testing

[0153] Appearance: Colorless and transparent, elasticity index 0.82 (TA.XT Plus, P / 0.5 cylindrical probe, 5 mm pressure).

[0154] Nicotine content: HPLC external standard method, measured 2.48 mg / capsule (RSD 2.1%, n = 3).

[0155] Microorganisms: Total colony count < 10 CFU g⁻¹ (48 h, PCA).

[0156] Examples 2-6

[0157] The conditions were the same as in Example 1, except that the embedding / non-embedding ratio was adjusted. The specific ratio is shown in Table 6.

[0158] Examples 7 and 8 (suckable jelly)

[0159] Preparation method:

[0160] 1. Add 5 g of 90 ℃ water to the pectin-sucrose mixture and dissolve at 500 rpm for 5 min.

[0161] 2. Cool to 60℃, then add the remaining excipients, unencapsulated nicotine and nicotine microcapsules, and mix at 300 rpm for 3 minutes.

[0162] 3. Add water to a final weight of 10 g, and while still hot (55℃), pour into a 10 mL stand-up aluminum foil bag and seal.

[0163] 4. Let stand at room temperature for 15 minutes, then the pectin forms a weak gel at pH 3.8 with a viscosity of 4000 cP (25℃).

[0164] Product form: 10g absorbent jelly inside a self-standing aluminum foil bag.

[0165] Formula (1 sachet)

[0166] Nicotine tartrate salt and porous starch-encapsulated particles (specific ratios are shown in Table 6).

[0167] High-methoxyl pectin: 0.12 g (dry mix with 0.12 g sucrose)

[0168] Citric acid: 0.015 g (adjusts pH to 3.8, promotes pectin gelation)

[0169] Sodium citrate: 0.005 g (buffer)

[0170] Menthol crystals: 0.010 g

[0171] Sucralose: 0.005 g

[0172] Potassium sorbate: 0.004 g

[0173] Deionized water: Add to a total of 10,000 g

[0174] Table 6. Nicotine jelly forms and nicotine source ratios in different embodiments

[0175]

[0176] Artificial sensory evaluation experiment

[0177] The evaluation was conducted by 5 evaluators. During the experiment, each evaluator placed the nicotine jelly packet in their mouth and chewed it. They also filled out a questionnaire on the initial release intensity, release duration, overall release experience, and jelly taste of the nicotine. The questionnaires were rated on a scale of 1 to 10, and the average value was taken.

[0178] Table 7. Sensory Evaluation of Nicotine Jelly

[0179]

[0180] It can be seen from the above table:

[0181] When the ratio of unencapsulated to encapsulated nicotine sources is between 3:7 and 9:1, the gel jelly can better meet the subject's immediate need for nicotine release, while maintaining a certain basal nicotine level for sustained relief.

[0182] For squeezable jellies that are swallowed quickly, a low encapsulation rate is better able to meet the subjects' immediate need for nicotine release.

[0183] 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 inventive aspects. 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 expressly incorporated herein, each claim existing independently as a separate embodiment / specific implementation of this patent.

[0184] 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.

[0185] 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.

[0186] 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 jelly, characterized in that, The nicotine jelly includes a nicotine source and a jelly matrix, wherein the nicotine source is dispersed in the jelly matrix; wherein the nicotine source includes non-encapsulated nicotine sources and nicotine sources encapsulated in microcapsule particles.

2. The nicotine jelly according to claim 1, characterized in that, The ratio of the non-encapsulated nicotine source to the encapsulated nicotine source, based on the weight of the nicotine source, ranges from 3:7 to 9:

1. The nicotine jelly also includes a pH adjuster; the pH adjuster is selected from organic acids; the pH of the nicotine jelly is adjusted to 4.0-5.

5.

3. The nicotine jelly according to claim 1, characterized in that, The nicotine jelly is a gel jelly, in a gel-like state; or, the nicotine jelly is a sippable jelly, in a semi-fluid gel-like state, which can be directly sucked up using a straw or mouthpiece.

4. The nicotine jelly according to claim 1, characterized in that, The jelly matrix is ​​prepared from animal-derived gelling agents or plant-derived gelling agents; The animal-derived gelling agent includes gelatin; The plant-derived gelling agent includes one or more of pectin, agar, and gellan gum.

5. The nicotine jelly according to claim 1, characterized in that, The nicotine jelly also includes one or more of the following: flavoring agents, sweeteners, stabilizers, and preservatives.

6. The nicotine jelly according to claim 1, characterized in that, The nicotine source is nicotine salt, and each nicotine jelly contains 2-4 mg of nicotine based on the mass of free nicotine. The carrier material of the microcapsule particles is selected from one or more of porous starch, cyclodextrin, sodium alginate, or polylactic acid.

7. A method for preparing nicotine jelly according to any one of claims 1 to 6, characterized in that, The method includes the following steps: Step A: Microencapsulation of nicotine source is performed by mixing nicotine source solution with carrier and high-speed shearing and stirring to form emulsion; the emulsion is then spray-dried or freeze-dried to form microcapsule particles; Step B: Prepare the jelly matrix by adding the gelling agent to cold water to swell, then dissolving it in hot water heated to 80-90℃ to obtain a gel solution and keeping it warm for later use. Step C: Slowly add the microcapsule particles obtained in Step A and the unencapsulated nicotine source to the gel solution obtained in Step B, and stir at low speed to obtain a mixture; Step D: While the mixture obtained in step C is still hot, pour it into the mold and let it solidify at room temperature or under refrigeration. After solidification, remove the nicotine jelly from the mold.

8. The method according to claim 7, characterized in that, Step B further includes adding a pH adjuster to the gel solution to adjust the pH to 3.5-4.0, and adding one or more of flavoring agents, sweeteners, preservatives, and stabilizers.

9. The method according to claim 8, characterized in that, The method is performed under aseptic conditions; or, the method further includes step E: sterilizing the nicotine jelly.

10. The method according to claim 9, characterized in that, The method also includes Step F1: The nicotine jelly is a gel jelly, and the gel jelly is packaged using blister packaging; or Step F2: The nicotine jelly is a squeezable jelly, and the squeezable jelly is packaged in an aluminum foil bag.

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