Nicotine pouch filler and method for manufacturing the same

Abstract

The present invention relates to a nicotine pouch filler comprising nicotine, a release-controlled excipient containing at least one selected from the group consisting of cellulose and sugar alcohols, a binder, a pH adjuster, and a flavoring agent, wherein the nicotine content is 2.5% to 10% by weight relative to the total solid contents of the nicotine pouch filler, and the content of the release-controlled excipient is 5.5 to 36 times the nicotine content.

Description

Technical Field

[0001] The present invention relates to a nicotine pouch filler and a method for manufacturing the same.

Background Art

[0002] A nicotine pouch is a type of smoking article, and the nicotine pouch is used in the user's oral cavity to give the user a sense of satisfaction by nicotine intake. For example, the nicotine pouch can be used by placing the pouch between the upper or lower gum and the lip and holding it for a limited time.

[0003] The nicotine pouch is constituted by a filler being packaged in a packaging material. The packaging material fixes the nicotine pouch filler in place so that saliva can pass through to the nicotine pouch filler, and the fragrance and nicotine released from the nicotine pouch filler spread in the user's mouth.

[0004] Therefore, there is a need for a nicotine pouch in which most or all of the nicotine can be released from the nicotine pouch filler in an appropriate amount and the nicotine can be effectively absorbed.

Summary of the Invention

Problems to be Solved by the Invention

[0005] An object of the present invention is to provide a nicotine pouch filler with improved elution rate and absorption rate of nicotine.

[0006] However, the problems to be solved by the present invention are not limited to the above-described problems, and other problems not mentioned should be clearly understood by those skilled in the art from the following description.

Means for Solving the Problems

[0007] According to an embodiment of the present invention, nicotine, and A release-controlled excipient comprising at least one selected from the group consisting of cellulose and sugar alcohols, A binder and pH adjuster, Fragrances and, Includes, The nicotine content is 2.5% to 10% by weight relative to the total solid contents of the nicotine pouch filler. The present invention provides a nicotine pouch filler in which the content of the release-controlling excipient is 5.5 to 36 times the content of the nicotine.

[0008] According to another embodiment of the present invention, a nicotine pouch filler and Packaging materials and Includes, The aforementioned nicotine pouch filler is Nicotine and, A release-controlled excipient comprising at least one selected from the group consisting of cellulose and sugar alcohols, A binder and pH adjuster, Fragrances and, Includes, The nicotine content is 2.5% to 10% by weight relative to the total solid contents of the nicotine pouch filler. The present invention provides a nicotine pouch in which the content of the release-controlling excipient is 5.5 to 36 times the content of the nicotine.

[0009] According to yet another embodiment of the present invention, the steps include mixing nicotine, a release control excipient, a binder, and at least one selected from the group consisting of pH adjusters and flavorings (S1), Step (S2) involves spraying the solvent, The granulation step (S3), Includes, In step S1, the release control excipient comprises at least one selected from the group consisting of cellulose and sugar alcohols. The present invention provides a method for producing a nicotine pouch filler, wherein in step S2, the solvent is at least one selected from the group consisting of water and alcohol, the content of the solvent is 10% to 60% by weight of the cellulose content, and the L / S ratio is 8 to 15%. [Effects of the Invention]

[0010] The nicotine pouch filler of the present invention can effectively dissolve nicotine from the nicotine pouch and promote the absorption of the dissolved nicotine, thereby providing users with the satisfaction of smoking.

[0011] The effects of the present invention are not limited in any way to those described above, and should be understood to include all effects that can be inferred from the configuration of the invention as described in the detailed description or claims. [Brief explanation of the drawing]

[0012] [Figure 1] This figure shows a method for manufacturing a nicotine pouch filler according to one embodiment of the present invention. [Figure 2] This figure shows the elution rate of a nicotine pouch filler according to one embodiment of the present invention, depending on the content of microcrystalline cellulose. [Figure 3] This figure shows the dissolution rate of a nicotine pouch filler according to one embodiment of the present invention, upon the addition of a sugar alcohol. [Modes for carrying out the invention]

[0013] The embodiments are described in detail below with reference to the attached drawings. However, various modifications can be made to the embodiments, and the scope of the patent application is not limited or restricted by such embodiments. Any modifications, equivalents, or substitutions to the embodiments should be understood to be included within the scope of the patent.

[0014] The terms used in the embodiments are for illustrative purposes only and are not to be construed as intending to limit the present invention. Singular expressions include plural expressions unless the context clearly indicates otherwise. In this specification, terms such as "comprising," "including," or "having" merely specify the presence of the features, numbers, steps, operations, components, parts, or combinations thereof described in the specification, and do not preclude the presence or addition of one or more other features, numbers, steps, operations, components, parts, or combinations thereof.

[0015] Also, unless otherwise specifically noted or clearly inconsistent with the context, all terms used in this disclosure, including technical and scientific terms, have the same meaning as commonly understood by those of ordinary skill in the technical field to which the present invention pertains. Commonly used terms defined in a dictionary should be construed as having a meaning consistent with the meaning in the context of the related art, and should not be construed as having an ideal or overly formal meaning unless specifically defined in this application.

[0016] Furthermore, in the description with reference to the accompanying drawings, the same reference numerals are assigned to the same components regardless of the reference signs, and redundant descriptions thereof are omitted. When describing the embodiments, if the specific description of such known technologies is determined to obscure the gist of the embodiments disclosed in this specification, the detailed description thereof is omitted.

[0017] Moreover, when describing the components of the embodiments, expressions such as first, second, A, B, (a), (b), etc. can be used. These expressions are merely used to distinguish the components from other components, and do not limit the essence, order, or sequence of the components.

[0018] Components included in one embodiment, and components with common functions, will be described using the same names in other embodiments. Unless otherwise specified, descriptions in one embodiment are applicable to other embodiments, and specific descriptions to the extent of duplication will be omitted.

[0019] Throughout the specification, when a part of it is said to "include" a certain component, it means that it may include other components, rather than excluding other components.

[0020] According to one embodiment of the present invention, a nicotine pouch filler can be provided that comprises nicotine, a release control excipient comprising at least one selected from the group consisting of cellulose and sugar alcohols, a binder, a pH adjuster, and a flavoring agent, wherein the nicotine content is 2.5% to 10% by weight relative to the total solid contents of the nicotine pouch filler, and the content of the release control excipient is 5.5 to 36 times the nicotine content.

[0021] In a nicotine pouch filler according to one embodiment of the present invention, the nicotine comprises a nicotine salt, and the nicotine salt may comprise at least one selected from the group consisting of nicotine salt benzoate, nicotine salt tartrate, nicotine salt malate, and nicotine salt salicylate.

[0022] In a nicotine pouch filler according to one embodiment of the present invention, the nicotine content may be 2.5% to 10% by weight relative to the total solid contents of the nicotine pouch filler. The nicotine content may be determined according to the desired strength of the nicotine pouch. If the nicotine content is below the above range, it will be difficult to provide smokers with the satisfaction of smoking. On the other hand, if the nicotine content exceeds the above range, there is a risk that the nicotine stimulation will be excessively strong.

[0023] The release control excipient plays a role in regulating the nicotine dissolution rate, and can provide a nicotine pouch that can supply an appropriate amount of nicotine when used. Preferably, the content of the release control excipient may be 5.5 to 36 times the nicotine content. If the content of the release control excipient deviates from the above range, the pouch filler may dissolve in a short time or the nicotine dissolution rate may decrease. Furthermore, the nuclei of the filler particles may not be sufficiently formed, leading to severe clumping or powder crushing, which not only makes it difficult to manufacture the nicotine pouch filler but also causes problems such as the nicotine stimulation being excessively strong or excessively weak.

[0024] In a nicotine pouch filler according to one embodiment of the present invention, the release control excipient may include cellulose, and the nicotine may be supported on the cellulose. That is, the cellulose can serve as a carrier for nicotine.

[0025] Furthermore, cellulose acts as a diluent, possessing high water-holding capacity, and can promote wetting of powdered mixtures through swelling and wicking, thereby facilitating the rapid release of saliva and nicotine.

[0026] Furthermore, cellulose may also contribute to a comfortable user experience. Without the addition of cellulose, there is a risk that the nicotine pouch filler may dissolve.

[0027] In a nicotine pouch filler according to one embodiment of the present invention, the cellulose may be one or more of either microcrystalline cellulose (MCC) or methyl cellulose.

[0028] In a nicotine pouch filler according to one embodiment of the present invention, the cellulose content may be 5% to 20% by weight relative to the total solid contents of the nicotine pouch filler.

[0029] If the cellulose content is below the above-mentioned numerical range, the nicotine pouch filler may dissolve too quickly. Conversely, if the cellulose content exceeds the above-mentioned numerical range, the water-insoluble properties of cellulose may actually decrease the nicotine dissolution rate.

[0030] Sugar alcohols are easily soluble in saliva and bind more loosely to solvents than cellulose, allowing for a faster release of nicotine during use, suppressing bitterness, and providing a cooling effect as they dissolve in the mouth.

[0031] Furthermore, sugar alcohols can promote nucleation and granule growth in the high-shear wet granulation process of nicotine pouch filling materials.

[0032] In a nicotine pouch filler according to one embodiment of the present invention, the heat of dissolution of the sugar alcohol may be -190 J / g to -10 J / g. For example, the heat of dissolution of the sugar alcohol may be -185 J / g to -20 J / g, -125 J / g to -20 J / g, -40 J / g to -23 J / g, or -23 J / g. If the heat of dissolution of the sugar alcohol exceeds the above numerical range, it is difficult to provide the user with sufficient cooling experience.

[0033] In a nicotine pouch filler according to one embodiment of the present invention, the solubility of the sugar alcohol may be 10g / 100g to 80g / 100g at 20°C, preferably 20g / 100g to 65g / 100g, and more preferably 60g / 100g to 65g / 100g. If the solubility of the sugar alcohol is below the above numerical range, there is a risk that it will not dissolve sufficiently in the user's mouth. On the other hand, if the solubility of the sugar alcohol exceeds the above numerical range, there is a risk that an excessive amount of nicotine will be released.

[0034] In a nicotine pouch filler according to one embodiment of the present invention, the sugar alcohol may include at least one selected from the group consisting of erythritol, xylitol, mannitol, sorbitol, maltitol, and isomalt. However, the present invention is not limited in any way to the above examples.

[0035] In a nicotine pouch filler according to one embodiment of the present invention, the content of the sugar alcohol may be 50% to 70% by weight, preferably 60% to 70% by weight, based on the total solid contents of the nicotine pouch filler. If the sugar alcohol content is below the above numerical range, there is a risk that the nuclei of the nicotine pouch filler particles will not be sufficiently formed. On the other hand, if the sugar alcohol content exceeds the above numerical range, there is a concern that clumping will become severe or powder crushing will occur, making it difficult to manufacture the nicotine pouch filler.

[0036] The type and content of the binder may affect the formation of the particle size distribution of nicotine pouch filler particles.

[0037] In a nicotine pouch filler according to one embodiment of the present invention, the binder may include povidone K-25, hydroxypropylcellulose (HPC), low-substituted hydroxypropylcellulose (L-HPC), and at least one selected from the group consisting of hydroxypropylmethylcellulose (HPMC) and carboxymethylcellulose (CMC). Preferably, the binder may be hydroxypropylcellulose. On the other hand, low-substituted hydroxypropylcellulose may mean that the hydroxypropyl group content is 5.0% to 16.0%.

[0038] In a nicotine pouch filler according to one embodiment of the present invention, the content of the binder may be 10% by weight or less, preferably 8% to 15% by weight, based on the total solid contents of the nicotine pouch filler.

[0039] If the type and content of the binder deviate from the range described above, it may become difficult to secure the required particle size, potentially negatively affecting the initial elution.

[0040] The pH adjuster can adjust the pH of the nicotine pouch filling to a pH at which nicotine can be absorbed, so that when the nicotine pouch is inserted into the oral cavity, the nicotine is converted into a form of free-based nicotine that can be rapidly absorbed.

[0041] Free base nicotine is a nonionic substance obtained by removing hydrogen ions from nicotine salts. It can be rapidly absorbed through mucous membranes and has a strong impact on consumers.

[0042] In a nicotine pouch filler according to one embodiment of the present invention, the pH of the nicotine pouch filler may be 8.3 to 8.5. When the pH is 8.02 or higher, nicotine is converted to the form of free basic nicotine, which can be rapidly absorbed through the mucous membrane. Therefore, when the pH of the nicotine pouch filler satisfies the above numerical range, the pH becomes 8.02 or higher when mixed with saliva (pH 6.5 to 7.7), making nicotine easily absorbed and providing a strong impact on consumers.

[0043] In a nicotine pouch filler according to one embodiment of the present invention, the pH adjusting agent may be at least one selected from the group consisting of sodium bicarbonate and sodium carbonate.

[0044] In this case, the pH adjusting agent contains sodium bicarbonate and sodium carbonate, and the weight ratio of sodium bicarbonate to sodium carbonate may be 7:3 to 6:4, preferably 6:4. If sodium bicarbonate is added in a higher proportion than the above proportion (a relatively lower proportion of sodium carbonate), the pH may become too low, and nicotine may not be absorbed sufficiently. On the other hand, if sodium bicarbonate is added in a lower proportion than the above proportion (a relatively higher proportion of sodium carbonate), the pH may become too high, which may be unsuitable for dissolution in the oral cavity.

[0045] Flavorings may be added to provide flavor to satisfy the smoker's preferences.

[0046] In a nicotine pouch filler according to one embodiment of the present invention, the fragrance may include at least one selected from the group consisting of menthol, licorice, sucrose, fructose syrup, isosweet, cocoa, lavender, cinnamon, cardamom, celery, fenugreek, cascarilla, sandalwood, bergamot, geranium, honey essence, rose oil, vanilla, lemon oil, orange oil, mint oil, caraway, cognac, jasmine, chamomile, cinnamon, ylang-ylang, sage, spearmint, peppermint, ginger, coriander, and coffee. However, the above examples are not limiting.

[0047] The nicotine pouch filler according to one embodiment of the present invention is not limited to containing the above-mentioned components, but may optionally further include humectants, antioxidants, preservatives, and the like.

[0048] The aforementioned dehumidifying agent may, for example, include at least one of glycerin and propylene glycol.

[0049] The aforementioned antioxidant may, for example, include one or more of ascorbyl palmitate and sodium ascorbate.

[0050] The aforementioned preservative may include, for example, xylitol.

[0051] The nicotine pouch filler according to one embodiment of the present invention may have a nicotine leaching ability of 10% to 25% within 4 minutes, preferably 15% to 25% or 18% to 22%.

[0052] Furthermore, the nicotine pouch filler according to one embodiment of the present invention may have a nicotine elution ability of 50 to 90% within 20 minutes, and preferably has a nicotine elution ability of 70 to 80%.

[0053] If the nicotine release capacity is below the above-mentioned numerical range, it may be difficult to provide users with the satisfaction they feel from smoking. Conversely, if the nicotine release capacity exceeds the above-mentioned numerical range, it may be too stimulating for users.

[0054] According to one embodiment of the present invention, a nicotine pouch can be provided that includes the above-mentioned nicotine pouch filler and packaging material.

[0055] The packaging material can package a certain amount of the nicotine pouch filler. The packaging material can be designed to prevent the nicotine pouch filler inside from leaking out during transportation and use after it has been packaged, and can be manufactured so that smokers do not experience any discomfort in their mouths when using it.

[0056] The packaging material may be harmless to the human body, capable of effectively accumulating saliva, possessing a certain strength to prevent bursting, and having sealing properties.

[0057] The packaging material may be cellulose fiber, thermoplastic fiber, or a combination thereof. For example, the cellulose may include rayon, and the thermoplastic fiber may be nylon, polyethylene, polylactic acid, polypropylene, polyethersulfone, etc., but is not limited to the above examples. The packaging material may further contain a binder.

[0058] The packaging material may be either non-woven or woven.

[0059] The method for manufacturing the packaging material may include steps of forming a web and joining the webs.

[0060] The process of forming the web may be carried out by a dry-laid method, a wet-laid method, or a spinning method, and the dry-laid method may be a carding method or an air-ray method. The wet-laid method may be a conventional papermaking method or a manufacturing method that is a modified version thereof. The spinning method may be a spun-bonded method or a melt-blown method.

[0061] On the other hand, the process for joining the webs can be carried out by mechanical, chemical, or thermal bonding methods. Examples of mechanical bonding methods include needle-punching or spun-lace. Examples of chemical bonding methods include polymer dispersion or polymer solution. Examples of thermal bonding methods include calendering, hot air, or ultrasonic bonding.

[0062] Preferably, the packaging material can be manufactured by the spunlace method and / or the wet-laid method. The spunlace method may include the steps of forming a sheet-like web of a certain thickness from a mass of fibrous raw material, spraying water to intertwine the fibers and form the material for the packaging material, and drying. The wet-laid method may include the steps of dispersing the fibrous raw material in water to produce a dispersion, transferring the dispersion to a paper machine to form the material for the packaging material, and dewatering and drying. However, the spunlace method and the wet-laid method are not limited to including only the steps described above.

[0063] The packaging material may be porous in order to release the nicotine pouch filler contained inside.

[0064] Nicotine pouches can be packaged using a three-sided or back-packaging method, and the packaging material can be sealed by ultrasonic sealing or heat sealing. The packaging material has a longitudinal seal formed along the transverse direction of the packaging material and a cross seal formed along the longitudinal direction of the packaging material, and the transverse seal and / or cross seal can be sealed by a lip seal or a fin seal.

[0065] Packaging materials can be classified into original, slim, super slim, and mini shapes according to their size and weight. The packaging material may have an appropriate internal volume depending on the volume of the nicotine pouch filler, in order to achieve appropriate rigidity and a comfortable user experience.

[0066] The final manufactured nicotine pouches may be wrapped in plastic and distributed.

[0067] According to one embodiment of the present invention, a method for producing a nicotine pouch filler can be provided. The method for producing the nicotine pouch filler includes the steps of: mixing nicotine, a release control excipient, a binder, and at least one selected from the group consisting of a pH adjuster and a flavoring agent (S1); spraying a solvent (S2); and granulating (S3). In step S1, the release control excipient includes at least one selected from the group consisting of cellulose and sugar alcohols. In step S2, the solvent is at least one selected from the group consisting of water and alcohols, and the content of the solvent is 10% to 60% by weight of the content of cellulose, and the L / S ratio may be 8 to 15%.

[0068] The following explains each step in detail.

[0069] Step S1 is a step of mixing nicotine, release-controlling excipients, binders, pH adjusters, and flavorings, at least one selected from the group. At this time, the components are prepared in powder form and can be uniformly blended.

[0070] The nicotine may include nicotine salts, the type of nicotine salt being the same as in the example above.

[0071] The release-controlled excipient may include at least one selected from the group consisting of cellulose and sugar alcohols. The sugar alcohol in the release-controlled excipient can promote nucleation and granule growth during the granulation step.

[0072] The type of binder is the same as in the example above. The binder, in particular, may affect the granulation process depending on the method of addition. The binder can be added by either a wet binder addition method or a dry binder addition method, and preferably by a dry binder addition method. When a dry binder is added, it is easier to form particles having the desired particle size, the particle size distribution can be made uniform, and the manufacturing process is easier.

[0073] The types of pH adjusters and fragrances are the same as in the example described above.

[0074] Step S2 is a step in which a solvent is sprayed. At this time, the solvent can be sprayed and mixed with the powder mixture produced in step S1.

[0075] In this case, the solvent may be at least one of water and alcohol, and preferably alcohol.

[0076] The solvent content may be 10% to 60% by weight, preferably 40% to 50% by weight, of the cellulose content. The amount of solvent added can also be indicated by the L / S ratio. The L / S ratio is indicated by the total weight of the solvent / the total weight of the solid powder mixture, where the total weight of the solid powder mixture may be the total weight of at least one selected from the group consisting of nicotine added in step S1, a release control excipient, a binder, a pH adjuster, and a flavoring. The L / S ratio may be 8% to 15%, preferably 10% to 12%. When the L / S ratio satisfies the above numerical range, the particle sizes are uniform, and very few or no fine particles with a particle size of less than 100 μm are generated, and particles with a porous structure can be formed, which is advantageous for nicotine release. If the L / S ratio is below the above numerical range, granule formation may not occur, and the mixture may remain in the state of fine powder. Conversely, if the L / S ratio exceeds the aforementioned numerical range, irregularly shaped particles are formed, resulting in a narrower particle size range, which may lead to clumping during the blending process.

[0077] Step S3 is a granulation step. At this time, the powder mixture and solvent produced in step S2 are stirred for 5 to 30 minutes, and the clumps of particles that have formed during the stirring process can be broken up and separated into individual particles.

[0078] The granulated nicotine pouch filler particles may have a uniform distribution of particle sizes. For example, the nicotine pouch filler may contain 70% or more particles with a particle size of 200 μm or larger, and less than 30% particles with a particle size of 100 μm or larger but less than 200 μm.

[0079] Step S3 may further include a low-temperature drying step (S4) after step S3. In this case, the nicotine pouch filler granulated in step S3 is dried at 50°C for 1 to 3 hours, and the clumps of particles that have formed in the drying step are broken up and separated into individual particles, after which particles having the desired particle size can be selected.

[0080] The present invention will be described in more detail below with reference to examples, but the present invention is not limited in any way to the following examples.

[0081] 1. Example 1: Nicotine elution rate according to the content of microcrystalline cellulose

[0082] [Manufacturing Example 1] Nicotine pouches containing a nicotine pouch filler were manufactured. The nicotine pouch filler contained 4.5% by weight of nicotine, 20% by weight of microcrystalline cellulose, 50% to 60% by weight of sugar alcohol, 10% by weight of a pH adjuster, and 8% by weight of a binder. The specific manufacturing method is shown in Figure 1.

[0083] [Comparative Example 1] It was produced in the same manner as in Production Example 1, except that the microcrystalline cellulose content was 25% by weight.

[0084] [Comparative Example 2] It was manufactured in the same manner as in Manufacturing Example 1, except that the microcrystalline cellulose content was 40% by weight.

[0085] [Comparative Example 3] It was manufactured in the same manner as in Manufacturing Example 1, except that the microcrystalline cellulose content was 55% by weight.

[0086] The nicotine dissolution rates of Production Example 1 and Comparative Examples 1 to 3 were analyzed. Nicotine dissolution rates were evaluated by using a USP (United States Pharmacopeia) paddle apparatus to measure the content of released nicotine after leaving Production Example and Comparative Examples in 1 liter of phosphate buffer maintained at 37°C and pH 7.4 for 1 minute. The results are shown in Figure 2 and Table 1.

[0087] [Table 1]

[0088] In Production Example 1, the initial elution rate after 4 minutes was 17.5%, showing the highest elution rate. However, as the microcrystalline cellulose content increased further, the initial elution rate after 4 minutes tended to decrease due to the water-insoluble properties of microcrystalline cellulose (Comparative Examples 1 to 3).

[0089] 2. Example 2: Nicotine elution rate upon addition of sugar alcohols

[0090] [Manufacturing Example 2] A nicotine pouch containing a nicotine pouch filler was manufactured. The nicotine pouch filler contained nicotine, microcrystalline cellulose, and maltitol. The maltitol content was 70% by weight of the total solids, and the microcrystalline cellulose content was 5% by weight of the total solids.

[0091] [Manufacturing Example 3] The product was manufactured in the same manner as in Production Example 2, except that the maltitol content was 55% by weight of the total solids, and the microcrystalline cellulose content was 20% by weight of the total solids.

[0092] The nicotine dissolution rates of Production Example 2 and Production Example 3 were analyzed. The nicotine dissolution rates were evaluated in the same manner as in Example 1 described above. The results are shown in Figure 3.

[0093] As a result, Production Example 2 showed a nicotine dissolution rate of 20% after the initial 4 minutes and 80% after 20 minutes, while Production Example 3 showed a nicotine dissolution rate of 14% after the initial 4 minutes and 51.6% after 20 minutes. The fact that Production Example 2 showed an even higher dissolution rate than Production Example 3 is attributed to its higher sugar alcohol content.

[0094] 3. Example 3: Distribution of particle size and nicotine elution rate according to the type of binder

[0095] [Manufacturing Example 4] A nicotine pouch containing a nicotine pouch filler was manufactured. The nicotine pouch filler contained nicotine, microcrystalline cellulose, maltitol, a binder, a pH adjuster, and a flavoring agent. The binder was hydroxypropyl cellulose, and the content of the binder was 8% by weight relative to the total weight of the solids.

[0096] The nicotine pouch filler was manufactured using a dry binder addition method. Specifically, nicotine, microcrystalline cellulose, maltitol, a binder, a pH adjuster, and a flavoring were first mixed, and then water alone, water + alcohol, or alcohol alone was sprayed as a solvent, followed by a granulation step.

[0097] [Manufacturing Example 5] It was manufactured in the same manner as in Manufacturing Example 4, except that povidone K-25 was used as a binder and alcohol was used as a solvent.

[0098] [Manufacturing Example 6] The product was manufactured in the same manner as in Manufacturing Example 4, except that a low degree of substituted hydroxypropyl cellulose was used as the binder.

[0099] The nicotine elution rates of Production Example 2 and Production Examples 4-6, which were manufactured as described above, were analyzed. The nicotine elution rates were evaluated in the same manner as in Example 1 described above, and the results are shown in Table 2.

[0100] [Table 2]

[0101] In Production Examples 2 and 4, 66.7% or more of the nicotine pouch filler particles had a particle size of 200 μm or larger, and no nicotine pouch filler particles had a particle size of 50 μm or smaller. Compared to Production Examples 5 and 6, Production Examples 2 and 4 showed a higher nicotine elution rate not only initially but also after 20 minutes.

[0102] 4. Example 4: Production rate of free base nicotine according to pH range and pH adjusting agent ratio

[0103] [Manufacturing Example 7] Nicotine pouches containing nicotine pouch filler were manufactured. The nicotine pouch filler contained a pH adjuster, which consisted of sodium bicarbonate and sodium carbonate in a 6:4 ratio.

[0104] [Manufacturing Example 8] It was manufactured in the same manner as in Manufacturing Example 7, except that sodium bicarbonate and sodium carbonate were used as pH adjusters in a ratio of 7:3.

[0105] [Comparative Example 4] It was manufactured in the same manner as in Manufacturing Example 7, except that sodium bicarbonate and sodium carbonate were used as pH adjusters in an 8:2 ratio.

[0106] The pH and free basic nicotine generation rate of the nicotine pouch fillers for Production Example 7, Production Example 8, and Comparative Example 4 were investigated, and the results are shown in Table 3.

[0107] [Table 3]

[0108] Unlike Comparative Example 4, Production Examples 7 and 8 show results where the saliva pH was 8.8 and 8.4, respectively, and the free base nicotine production rate was 76% or higher. From this, it can be confirmed that if saliva with a pH of 6.5 to 7.7 flows in, the pH will rise to 8.02 or higher, resulting in the production of an even larger amount of free base nicotine.

[0109] From the above experimental examples, it can be inferred that using the nicotine pouch filler described in the patent claims allows for easy dissolution of nicotine and promotes the absorption of the dissolved nicotine.

[0110] As stated above, although embodiments have been described with limited drawings, a person with ordinary skill in the art can make a wide variety of modifications and variations based on such descriptions. For example, even if the described techniques are performed in a different order than described, and / or the components of the described systems, structures, devices, circuits, etc. are combined or assembled in a different manner than described, or replaced or substituted by other components or equivalents, suitable results can still be achieved.

[0111] Therefore, other manifestations, other embodiments, and equivalents to the claims also fall within the scope of the attached claims.

Claims

1. Nicotine and, A release-controlled excipient comprising at least one selected from the group consisting of cellulose and sugar alcohols, A binder and pH adjusters, Fragrances and, Includes, The nicotine content is 2.5% to 10% by weight relative to the total solid contents of the nicotine pouch filler. A nicotine pouch filler wherein the content of the release-controlling excipient is 5.5 to 36 times the content of the nicotine.

2. **Nicotine** contains nicotine salts. The nicotine pouch filler according to claim 1, wherein the nicotine salt comprises at least one selected from the group consisting of nicotine salt benzoate, nicotine salt tartrate, nicotine salt malate, and nicotine salt salicylate.

3. The release-controlled excipient comprises cellulose, The nicotine pouch filler according to claim 1, wherein the nicotine is supported on the cellulose.

4. The nicotine pouch filler according to claim 1, wherein the cellulose is one or more of microcrystalline cellulose and methylcellulose.

5. The nicotine pouch filler according to claim 1, wherein the cellulose content is 5% to 20% by weight relative to the total solid contents of the nicotine pouch filler.

6. The nicotine pouch filler according to claim 1, wherein the sugar alcohol comprises at least one selected from the group consisting of erythritol, xylitol, mannitol, sorbitol, maltitol, and isomalt.

7. The nicotine pouch filler according to claim 1, wherein the content of the sugar alcohol is 50% to 70% by weight with respect to the total solid contents of the nicotine pouch filler.

8. The binder comprises povidone K-25, hydroxypropyl cellulose, low-substituted hydroxypropyl cellulose, and at least one selected from the group consisting of hydroxypropyl methylcellulose (HPMC) and carboxymethylcellulose (CMC). The nicotine pouch filler according to claim 1, wherein the content of the binder is 8% to 10% by weight with respect to the total solid contents of the nicotine pouch filler.

9. The nicotine pouch filler according to claim 1, wherein the pH adjusting agent is one or more of sodium bicarbonate and sodium carbonate.

10. The pH adjusting agent comprises sodium bicarbonate and sodium carbonate. The nicotine pouch filler according to claim 9, wherein the weight ratio of sodium bicarbonate and sodium carbonate is 7:3 to 6:

4.

11. The nicotine pouch filler according to claim 1, wherein the pH of the nicotine pouch filler is 8.3 to 8.

5.

12. The nicotine pouch filler according to claim 1, wherein the nicotine pouch filler has a nicotine elution capacity of 15% to 25% within 4 minutes and a nicotine elution capacity of 70% to 80% within 20 minutes.

13. Nicotine pouch filler and Packaging materials and Includes, The aforementioned nicotine pouch filler is Nicotine and, A release-controlled excipient comprising at least one selected from the group consisting of cellulose and sugar alcohols, A binder and pH adjusters, Fragrances and, Includes, The nicotine content is 2.5% to 10% by weight relative to the total solid contents of the nicotine pouch filler. A nicotine pouch in which the content of the release-controlling excipient is 5.5 to 36 times the content of the nicotine.

14. Step (S1) involves mixing nicotine, a release-controlling excipient, a binder, a pH adjuster, and a flavoring agent, Step (S2) involves spraying the solvent, The step of granulation (S3), Includes, In step S1, the release control excipient comprises at least one selected from the group consisting of cellulose and sugar alcohols. A method for producing a nicotine pouch filler, wherein in step S2, the solvent is at least one selected from the group consisting of water and alcohol, the content of the solvent is 10% to 60% by weight of the cellulose content, and the L / S ratio is 8 to 15%.

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