Nicotine pouch filler and method for manufacturing the same

Abstract

The present invention relates to a nicotine pouch filler comprising a release-controlled excipient, a binder, a pH adjuster, and a flavoring agent, wherein the release-controlled excipient comprises cellulose and a sugar alcohol, the cellulose and sugar alcohol being mixed in a weight ratio of 1:9 to 5:5, the cellulose comprising one or more of microcrystalline cellulose and methylcellulose, and the sugar alcohol comprising at least one or more of the group comprising erythritol, xylitol, mannitol, sorbitol, maltitol, and isomalt.

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 one type of smoking article, and the nicotine pouch is used in a user's oral cavity to provide nicotine satisfaction to the user. For example, the nicotine pouch can be used by the user placing the pouch between the upper or lower gums and the lips and maintaining it for a limited time.

[0003] The nicotine pouch is composed of a filler wrapped in a packaging material. The packaging material fixes the nicotine pouch filler in a predetermined position so that saliva can pass through the nicotine pouch filler, and the fragrance and nicotine released from the nicotine pouch filler are diffused into the user's mouth.

[0004] Therefore, there is a requirement 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 is effectively absorbed.

Prior Art Documents

Patent Documents

[0005]

Patent Document 1

Summary of the Invention

Problems to be Solved by the Invention

[0006] An object of the present invention is to provide a nicotine pouch filler with improved elution rate and absorption rate of nicotine.

[0007] However, the problems to be solved by the present invention are not limited to those mentioned above, and for other problems not mentioned, they will be clearly understood by those skilled in the art in the relevant field from the following description. [Means for solving the problem]

[0008] According to one embodiment of the present invention, nicotine, Release-controlled excipients, Binder, pH adjuster, and Contains fragrances, The release-controlled excipient comprises cellulose and sugar alcohol, The cellulose and sugar alcohols mentioned above are mixed in a weight ratio of 1:9 to 5:5. The cellulose mentioned above comprises one or more of microcrystalline cellulose and methylcellulose. The present invention provides a nicotine pouch filler, wherein the sugar alcohol comprises at least one selected from the group consisting of erythritol, xylitol, mannitol, sorbitol, maltitol, and isomalt.

[0009] According to another embodiment of the present invention, a nicotine pouch filler, and Including packaging materials, The aforementioned nicotine pouch filler is nicotine, Release-controlled excipients, Binder, pH adjuster, and Contains fragrances, The release-controlled excipient comprises cellulose and sugar alcohol, The cellulose and sugar alcohols mentioned above are mixed in a weight ratio of 1:9 to 5:5. The cellulose mentioned above comprises one or more of microcrystalline cellulose and methylcellulose. The present invention provides a nicotine pouch in which the sugar alcohol comprises at least one selected from the group consisting of erythritol, xylitol, mannitol, sorbitol, maltitol, and isomalt.

[0010] According to another embodiment of the present invention, there is provided a step S1 of mixing at least one selected from the group consisting of nicotine, a release control excipient, a binder, a pH adjuster, and a fragrance, a step S2 of injecting a solvent, and a step S3 of granulating, including In the step S1, the release control excipient contains cellulose and sugar alcohol, The cellulose and sugar alcohol are mixed at a weight ratio of 1:9 to 5:5, The cellulose contains any one or more of microcrystalline cellulose and methylcellulose, The sugar alcohol contains at least one selected from the group consisting of erythritol, xylitol, mannitol, sorbitol, maltitol, and isomalt. A method for producing a nicotine pouch filler is provided.

Effect of the Invention

[0011] The nicotine pouch filler of the present invention can effectively elute nicotine from the nicotine pouch, promote the absorption of the eluted nicotine, and provide smoking satisfaction to users.

[0012] The effects of the present invention are not limited to the above effects, and it should be understood to include all effects inferable from the configuration of the invention described in the detailed description or claims of the present invention.

Brief Description of the Drawings

[0013] [Figure 1] It is a diagram showing a method for producing a nicotine pouch filler according to an embodiment of the present invention. [Figure 2] It is a diagram showing the dissolution rate according to the content of microcrystalline cellulose of a nicotine pouch filler according to an embodiment of the present invention. [Figure 3] It is a diagram showing the dissolution rate by adding sugar alcohol of a nicotine pouch filler according to an embodiment of the present invention. [Figure 4A]A diagram showing the cumulative nicotine concentration elution graph according to the mixing weight ratio of cellulose and sugar alcohol in a nicotine pouch filler according to an embodiment of the present invention. [Figure 4B] A diagram showing the nicotine concentration elution graph according to the mixing weight ratio of cellulose and sugar alcohol in a nicotine pouch filler according to an embodiment of the present invention. [Figure 5A] A diagram showing the cumulative nicotine elution graph according to the mixing weight ratio of cellulose and sugar alcohol in a nicotine pouch filler according to an embodiment of the present invention. [Figure 5B] A diagram showing the nicotine elution graph according to the mixing weight ratio of cellulose and sugar alcohol in a nicotine pouch filler according to an embodiment of the present invention. [Figure 6A] A diagram showing the cumulative nicotine elution graph according to the weight ratio of cellulose in a nicotine pouch filler according to an embodiment of the present invention. [Figure 6B] A diagram showing the nicotine elution graph according to the weight ratio of cellulose in a nicotine pouch filler according to an embodiment of the present invention.

Mode for Carrying Out the Invention

[0014] Hereinafter, embodiments will be described in detail with reference to the accompanying drawings. However, various changes can be made to the embodiments, and the scope of the patent application is not limited or restricted by these embodiments. It should be understood that all changes, equivalents, or alternatives to the embodiments are included in the scope of the rights.

[0015] The terms used in the embodiments are for illustrative purposes only and should not be construed as limiting. Singular expressions include plural expressions unless the context clearly indicates otherwise. In this specification, terms such as “includes” or “has” should be understood as specifying the presence of features, numbers, steps, operations, components, parts, or combinations thereof described in the specification, and not as preemptively excluding the presence or possibility of adding one or more other features, numbers, steps, operations, components, parts, or combinations thereof.

[0016] Unless otherwise defined, all terms used herein, including technical or scientific terms, have the same meaning as those generally understood by a person of ordinary skill in the art to which the embodiments belong. Terms defined in commonly used dictionaries, for example, should be interpreted as having the meaning they have in the context of the relevant art, and not as having an ideal or overly formal meaning unless explicitly defined herein.

[0017] Furthermore, when explaining with reference to the attached drawings, the same reference numerals will be used for identical components, regardless of the reference numerals in the drawings, and redundant explanations will be omitted. When describing embodiments, if it is determined that a specific explanation of related prior art may unnecessarily obscure the gist of the embodiment, such detailed explanation will be omitted.

[0018] Furthermore, when describing the components of the embodiment, terms such as first, second, A, B, (a), (b), etc., may be used. These terms are used to distinguish a component from other components, and the terms do not limit the nature, order, or sequence of the component.

[0019] Components that have functions common to components included in any embodiment will be described using the same name in other embodiments. Unless otherwise stated, the descriptions in one embodiment are applicable to other embodiments, and specific descriptions will be omitted to the extent that they overlap.

[0020] When a part of the specification is said to "include" a certain component, this does not mean that it excludes other components, but rather that it may further include other components.

[0021] According to one embodiment of the present invention, a nicotine pouch filler can be provided comprising nicotine, a release-controlling excipient, a binder, a pH adjuster, and a flavoring, wherein the release-controlling excipient comprises cellulose and a sugar alcohol, the cellulose and sugar alcohol being mixed in a weight ratio of 1:9 to 5:5, the cellulose comprising one or more of microcrystalline cellulose and methylcellulose, and the sugar alcohol comprising at least one selected from the group consisting of erythritol, xylitol, mannitol, sorbitol, maltitol, and isomalt.

[0022] In a nicotine pouch filler according to one embodiment of the present invention, the cellulose and sugar alcohol can be mixed in a weight ratio of 1:9 to 5:5. Nicotine can be sufficiently eluted within this weight ratio range, and more preferably, they can be mixed in a weight ratio of 2:8 to 4:6. That is, the release control excipient can play a role in adjusting the nicotine elution rate.

[0023] In a nicotine pouch filler according to one embodiment of the present invention, the cellulose may be one or more of microcrystalline cellulose (MCC) or methyl cellulose, and more preferably microcrystalline cellulose may be used. The nicotine is supported on the cellulose. That is, the cellulose can serve as a carrier for nicotine.

[0024] Furthermore, as a diluent, cellulose has high water-holding capacity and can promote wetting of powdered mixtures through swelling and wicking, thereby facilitating the rapid release of saliva and nicotine.

[0025] Furthermore, cellulose provides a pleasant user experience. Without cellulose, the nicotine pouch filler may dissolve.

[0026] In a nicotine pouch filler according to one embodiment of the present invention, the sugar alcohol may be at least one selected from the group consisting of erythritol, xylitol, mannitol, sorbitol, maltitol, and isomalt, and maltitol may be more preferably used.

[0027] Sugar alcohols dissolve well in saliva and bind more loosely to solvents than cellulose, allowing for a more rapid release of nicotine during use, suppressing bitterness, and providing a cooling effect when dissolved in the mouth.

[0028] Furthermore, sugar alcohols can promote nucleation and granule growth in the high-shear wet granulation process of nicotine pouch fillers.

[0029] In a nicotine pouch filler according to one embodiment of the present invention, the cellulose content may be 10 to 30% by weight relative to the total solid contents of the nicotine pouch filler.

[0030] If the cellulose content is below the above numerical range, the nicotine pouch filler may dissolve quickly. On the other hand, if the cellulose content exceeds the above numerical range, the water-insoluble properties of cellulose may actually delay the nicotine dissolution rate.

[0031] In a nicotine pouch filler according to one embodiment of the present invention, the content of the sugar alcohol may be 45 to 65% by weight relative to the solid content weight of the nicotine pouch filler. If the content of the sugar alcohol is less than the above numerical range, the nuclei of the nicotine pouch filler particles may not be sufficiently formed. On the other hand, if the content of the sugar alcohol exceeds the above numerical range, clumping may become severe or powder clumps may occur, making it difficult to manufacture the nicotine pouch filler.

[0032] In a nicotine pouch filler according to one embodiment of the present invention, the nicotine includes a nicotine salt, and the nicotine salt may include at least one selected from the group consisting of nicotine salt benzoate, nicotine salt tartrate, nicotine salt malate, and nicotine salt salicylate.

[0033] 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 solid content weight of the nicotine pouch filler. The nicotine content can be determined by the desired strength of the nicotine pouch. If the nicotine content is below the above range, it is difficult to give smokers a sense of satisfaction from smoking. On the other hand, if the nicotine content exceeds the above range, the nicotine stimulation may become excessive.

[0034] 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 becomes difficult to provide the user with sufficient cooling experience.

[0035] 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, it may not dissolve sufficiently in the user's mouth. On the other hand, if the solubility of the sugar alcohol exceeds the above numerical range, an excessive amount of nicotine may be released.

[0036] The type and content of the binder can affect the distribution of particle sizes in the nicotine pouch filler.

[0037] In a nicotine pouch filler according to one embodiment of the present invention, the binder may include at least one selected from the group consisting of povidone K-25, hydroxypropylcellulose (HPC), low-substituted hydroxypropylcellulose (L-HPC), 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, relative to the total weight of the solid content of the nicotine pouch filler.

[0039] If the type and content of the binder deviate from those described above, it becomes difficult to achieve the required particle size, which can negatively affect initial elution.

[0040] pH adjusters can adjust the pH of the nicotine pouch filling to a pH at which nicotine is absorbed, so that when the nicotine pouch is inserted into the mouth, the nicotine switches to a free-based nicotine form that is rapidly absorbed.

[0041] Free base nicotine is a nonionic substance obtained by removing hydrogen ions from nicotine salts. It is rapidly absorbed through mucous membranes and can have 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 7.0 to 8.8. When the pH is 8.02 or higher, nicotine is converted to free base nicotine, which is 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), allowing nicotine to be easily absorbed and providing a strong impact on consumers.

[0043] In a nicotine pouch filling agent 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 ratio (a relatively lower proportion of sodium carbonate), the pH will become low, and nicotine may not be absorbed sufficiently. On the other hand, if sodium bicarbonate is added in a lower proportion than the described ratio (a relatively higher proportion of sodium carbonate), the pH will become higher than the desired range, and may not be suitable for oral dissolution.

[0045] Flavorings are used to provide taste that satisfies the preferences of smokers.

[0046] In a nicotine pouch filler according to one embodiment of the present invention, the flavoring 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, keraway, cognac, jasmine, chamomile, cinnamon, ylang-ylang, sage, spearmint, peppermint, ginger, coriander, and coffee. However, it is not limited to the examples given.

[0047] The nicotine pouch filler according to one embodiment of the present invention is not limited to containing the components described, and may optionally further contain humectants, antioxidants, preservatives, etc.

[0048] The aforementioned humectant may, for example, include one or more of glycerin and propylene glycol.

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

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

[0051] The nicotine pouch filler according to one embodiment of the present invention may contain particles having a size of 150 to 300 μm. The nicotine pouch filler does not have to contain fine particles having a size of 50 μm or less. When the size of the nicotine pouch filler satisfies the above numerical range, nicotine can be released efficiently. If the nicotine pouch filler contains too many small particles, there may be a problem that nicotine does not dissolve initially. On the other hand, if the nicotine pouch filler contains too many large particles, there may be a problem that all the nicotine dissolves initially, and nicotine is not provided to the user in the latter half of use.

[0052] A nicotine pouch filler according to one embodiment of the present invention is characterized by having a moisture content of 5% or less. The filler according to the present invention has a moisture content of 5% or less and can be manufactured as granules in a form suitable for consumption.

[0053] A nicotine pouch filler according to one embodiment of the present invention can have a nicotine elution performance of 10% or more within 4 minutes.

[0054] Furthermore, the nicotine pouch filler according to one embodiment of the present invention can have a nicotine elution performance of 50-80% within 16 minutes.

[0055] If the nicotine release performance falls below the above numerical range, it may be difficult to provide user satisfaction. On the other hand, if the nicotine release performance exceeds the above numerical range, it may be irritating to the user.

[0056] According to one embodiment of the present invention, a nicotine pouch can be provided that includes the aforementioned nicotine pouch filler and packaging material.

[0057] The packaging material can package a certain amount of the nicotine pouch filler. The packaging material can be manufactured to prevent leakage of the nicotine pouch filler inside during transportation and use, and to prevent smokers from feeling a foreign body sensation in their mouths when using it.

[0058] The packaging material is safe for the human body, effectively retains saliva, possesses sufficient strength to prevent tearing, and has sealing properties.

[0059] 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 examples given. The packaging material may further contain a binder.

[0060] The packaging material may be nonwoven or woven.

[0061] The method for manufacturing the packaging material may include the steps of forming a web and joining the webs together.

[0062] The process of forming the web may be a dry-laid, wet-laid, or spinning method, and the dry method may be a carding method or an air-ray method. The wet method may be a general paper manufacturing method or a manufacturing method partially modified therefrom. The spinning method may be a spun-bonded method or a melt-blown method.

[0063] On the other hand, the step of joining the webs may be a mechanical bonding method, a chemical bonding method, or a thermal bonding method. The mechanical bonding method may be a needle-punching method or a spun-lacing method. The chemical bonding method may be a polymer dispersion method or a polymer solution method. The thermal bonding method may be a calendering method, a hot air method, or an ultrasonic method, etc.

[0064] Preferably, the packaging material may be manufactured by a spunlace method and / or a wet method. The spunlace method may include the steps of forming a web in the form of a sheet of a certain thickness from solidified fibrous material, spraying water to cause the fibers to intertwine and form the material of the packaging material, and drying. The wet method may include the steps of dispersing fibrous material in water to produce a dispersion, moving the dispersion in a paper machine to form the material of the packaging material, and dewatering and drying. However, the spunlace method and the wet method are not limited to including only the steps described above.

[0065] The packaging material may be porous in order to release the nicotine pouch filler contained inside.

[0066] The packaging material can be packaged using a three-sided or back-packaging method, and the packaging material can be sealed using an ultrasonic sealing method or a heat sealing method. The packaging material has a longitudinal seal formed along the lateral direction of the packaging material and a cross seal formed along the longitudinal direction of the packaging material, and the longitudinal seal and / or cross seal can be sealed using a lip seal method or a fin seal method.

[0067] Packaging materials can be classified into original, slim, super slim, and mini forms according to their size and weight. The packaging material may have an appropriate internal volume depending on the capacity of the nicotine pouch filler, in order to provide appropriate rigidity and a comfortable user experience.

[0068] The final manufactured nicotine pouches can be wrapped in plastic and distributed.

[0069] 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 comprises the steps of: step S1 of mixing at least one selected from the group consisting of nicotine, a release control excipient, a binder, a pH adjuster, and a flavoring agent; step S2 of spraying a solvent; and step S3 of granulation. In step S1, the release control excipient comprises cellulose and a sugar alcohol, which are mixed in a weight ratio of 1:9 to 5:5, and the sugar alcohol comprises at least one selected from the group consisting of erythritol, xylitol, mannitol, sorbitol, maltitol, and isomalt.

[0070] The following explains each step in detail.

[0071] Step S1 is a step of mixing at least one selected from the group consisting of nicotine, release-controlling excipients, binders, pH adjusters, and flavorings. In this step, the components are prepared in powder form and can be uniformly blended.

[0072] The nicotine may include nicotine salts, the types of nicotine salts being the same as those exemplified above.

[0073] Among the release-controlled excipients, sugar alcohols can promote nucleation and granule growth during the granulation step.

[0074] The type of binder is the same as that exemplified above. The binder, in particular, can affect the granulation process depending on the method of addition. The binder may be added by a wet binder addition method or a dry binder addition method, preferably a dry binder addition method. When added by a dry binder addition method, it is easy to form particles of the desired size, the particle size distribution can be made uniform, and the manufacturing process may be easy.

[0075] The types of pH adjusters and fragrances are the same as those exemplified above.

[0076] 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.

[0077] In this case, the solvent may be at least one of water or alcohol, and preferably alcohol.

[0078] 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 be expressed as an L / S ratio. The L / S ratio is expressed as the total weight of the solvent / the total weight of the solid powder mixture, and the total weight of the solid powder mixture may be the total weight of at least one selected from the group consisting of nicotine, release-controlling excipients, binders, pH adjusters, and flavorings added in step S1. The L / S ratio may be 8 to 15%, preferably 10 to 12%. When the L / S ratio satisfies the above numerical range, only a small amount of fine particles with uniform size and a size of less than 100 μm are generated, or none at all, and particles with a porous structure are formed, which may be advantageous for nicotine release. When the L / S ratio is below the above numerical range, granule formation does not occur, and it can exist in the form of a fine powder. On the other hand, when the L / S ratio exceeds the above numerical range, irregularly shaped particles are formed, the particle size range becomes smaller, and clumps may occur during compounding.

[0079] 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 then the clumps of particles that have solidified during the stirring process can be broken up and separated into individual particles.

[0080] The granulated nicotine pouch filler particles may have a uniform distribution of size. For example, the nicotine pouch filler may contain particles with a size of 150 to 300 μm.

[0081] 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, the clumps of particles solidified in the drying step are broken up and separated into individual particles, and then particles having the desired size can be selected.

[0082] The present invention will be described in more detail below with reference to examples, but the present invention is not limited to the following examples.

[0083] 1. Example 1: Nicotine elution rate based on microcrystalline cellulose content

[0084] Manufacturing Example 1

[0085] A nicotine pouch containing a nicotine pouch filler was manufactured. The nicotine pouch filler contained 4.5% by weight of nicotine, 20% by weight of microcrystalline cellulose, 50-60% by weight of sugar alcohol, 10% by weight of pH adjuster, and 8% by weight of binder.

[0086] The specific manufacturing method is shown in Figure 1.

[0087] Comparative Example 1

[0088] Nicotine pouches were manufactured using the same method as in Manufacturing Example 1, except that the microcrystalline cellulose content was 25% by weight.

[0089] Comparative Example 2

[0090] Nicotine pouches were manufactured using the same method as in Manufacturing Example 1, except that the microcrystalline cellulose content was 40% by weight.

[0091] Comparative Example 3

[0092] Nicotine pouches were manufactured using the same method as in Manufacturing Example 1, except that the microcrystalline cellulose content was 55% by weight.

[0093] The nicotine elution rates of Production Example 1 and Comparative Examples 1-3 were analyzed. Nicotine elution rates were evaluated by using a USP paddle apparatus to allow Production Example and Comparative Examples to stand for 1 minute in 1 liter of phosphate buffer maintained at 37°C and pH 7.4, and then measuring the amount of nicotine released. The results are shown in Figure 2 and Table 1.

[0094] [Table 1]

[0095] Production Example 1 showed the highest elution rate at 17.5% after the initial 4 minutes. However, as the microcrystalline cellulose content increased, the elution rate after the initial 4 minutes tended to decrease due to the water-insoluble properties of microcrystalline cellulose (Comparative Examples 1-3).

[0096] 2. Example 2: Nicotine elution rate by sugar alcohol addition

[0097] Manufacturing Example 2

[0098] A nicotine pouch containing a nicotine pouch filler was manufactured. The nicotine pouch filler contained nicotine, microcrystalline cellulose, and maltitol, with maltitol content at 70% by weight of the total solids and microcrystalline cellulose content at 5% by weight of the total solids.

[0099] Manufacturing Example 3

[0100] Nicotine pouches were manufactured using the same method as in Manufacturing Example 2, except that the maltitol content was 55% by weight relative to the total solid weight, which resulted in a microcrystalline cellulose content of 20% by weight relative to the total solid weight.

[0101] The nicotine elution rates of manufacturing examples 2 and 3 were analyzed. The nicotine elution rates were evaluated using the same method as in the previously described examples. The results are shown in Figure 3.

[0102] 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. It is judged that the higher dissolution rate of Production Example 2 compared to Production Example 3 is due to the higher sugar alcohol content.

[0103] 3. Example 3: Particle size distribution and nicotine elution rate depending on the type of binder

[0104] Manufacturing Example 4

[0105] 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 being hydroxypropyl cellulose, and the binder content being 8% by weight relative to the total solids weight.

[0106] The nicotine pouch filler was manufactured using a dry binder addition method. Specifically, nicotine, microcrystalline cellulose, maltitol, binder, pH adjuster, and flavoring were first mixed, and then the product was manufactured by spraying water alone, water + alcohol, or alcohol alone as a solvent, followed by a granulation step.

[0107] Manufacturing Example 5

[0108] Nicotine pouches were manufactured using the same method as in Manufacturing Example 4, except that povidone K-25 was used as a binder and alcohol was applied as a solvent.

[0109] Manufacturing Example 6

[0110] Nicotine pouches were manufactured using the same method as in Manufacturing Example 4, except that low-substituted hydroxypropyl cellulose was used as a binder.

[0111] The nicotine elution rates of the products manufactured in the above-mentioned production examples 2, 4-6 were analyzed. The nicotine elution rates were evaluated using the same method as in the previously mentioned examples, and the results are shown in Table 2.

[0112] [Table 2]

[0113] In production examples 2 and 4, 66.7% or more of the nicotine pouch filler particles were 200 μm or larger in size compared to production examples 5 and 6, and no nicotine pouch filler particles were present that were 50 μm or smaller. Production examples 2 and 4 had a higher nicotine elution rate not only initially but also after 20 minutes compared to production examples 5 and 6.

[0114] 4. Example 4: Free base nicotine production ratio based on pH range and pH adjusting agent ratio

[0115] Manufacturing example 7

[0116] Nicotine pouch filler was manufactured. The nicotine pouch filler contained a pH adjuster, and sodium bicarbonate and sodium carbonate were used as the pH adjuster in a ratio of 6:4.

[0117] Manufacturing Example 8

[0118] Nicotine pouch filler was prepared using the same method as in Production Example 7, except that sodium bicarbonate and sodium carbonate were used as pH adjusters in a 7:3 ratio.

[0119] Comparative Example 4

[0120] Nicotine pouch filler was prepared using the same method as in Production Example 7, except that sodium bicarbonate and sodium carbonate were used as pH adjusters in an 8:2 ratio.

[0121] The pH and free base nicotine generation ratio of the nicotine pouch fillers for manufacturing examples 7 and 8, and comparative example 4 were investigated, and the results are shown in Table 3.

[0122] [Table 3]

[0123] Unlike Comparative Example 4, Production Examples 7 and 8 showed saliva pH values ​​of 8.8 and 8.4, respectively, and a free base nicotine production rate of 76% or higher. This confirms that when saliva with a pH of 6.5-7.7 flows in, the pH rises to 8.02 or higher, resulting in the production of more free base nicotine.

[0124] 5. Example 5: Nicotine elution rate based on the weight ratio of cellulose and sugar alcohol mixture

[0125] Manufacturing Example 9

[0126] A nicotine pouch containing a nicotine pouch filler was manufactured. The nicotine pouch filler contained 4.5% by weight of nicotine, 10% by weight of a pH adjuster, and 8% by weight of a binder, and also contained microcrystalline cellulose and maltitol as release control excipients, with the ratio of microcrystalline cellulose to maltitol being 3:7.

[0127] Manufacturing Example 10

[0128] Nicotine pouches were manufactured using the same method as in Manufacturing Example 9, except that the ratio of microcrystalline cellulose to maltitol was 5:5.

[0129] Comparative Example 5

[0130] Nicotine pouches were manufactured using the same method as in Manufacturing Example 9, except that the ratio of microcrystalline cellulose to maltitol was 7:3.

[0131] Physical property analysis was performed on the nicotine pouches of manufacturing examples 9 and 10 and comparative example 5, and the results are shown in Table 4 below.

[0132] [Table 4]

[0133] The nicotine elution rates of Production Examples 9 and 10 and Comparative Example 5 were analyzed. The nicotine elution rates were evaluated using the same method as in the above-mentioned examples and are shown in Table 5 below.

[0134] [Table 5]

[0135] Furthermore, Figure 4A shows the cumulative nicotine concentration elution graphs for Production Examples 9 and 10 and Comparative Example 5, and Figure 4B shows the nicotine concentration elution graphs for Production Examples 9 and 10 and Comparative Example 5. Simultaneously, Figure 5A shows the cumulative nicotine elution graphs for Production Examples 9 and 10 and Comparative Example 5, and Figure 5B shows the nicotine elution graphs for Production Examples 9 and 10 and Comparative Example 5.

[0136] As can be seen in Table 5 and Figures 4A, 4B, 5A, and 5B, the 1-hour elution results and total nicotine elution values ​​vary depending on the filler composition ratio. It was confirmed that the composition ratio of Production Example 9 (MCC:maltitol = 3:7) is the most preferable for all nicotine to be eluted within 1 hour.

[0137] 6. Example 6: Nicotine elution rate based on cellulose ratio in release-controlled excipients

[0138] Manufacturing Example 11

[0139] A nicotine pouch containing a nicotine pouch filler was manufactured. The nicotine pouch filler contained nicotine, 25% by weight of microcrystalline cellulose, 51% by weight of maltitol, and a total of 76% by weight of release-controlled excipients.

[0140] Manufacturing Example 12

[0141] Nicotine pouches were manufactured in the same manner as in Production Example 11, except that the microcrystalline cellulose was present in an amount of 20% by weight and maltitol in an amount of 56% by weight.

[0142] Manufacturing Example 13

[0143] Nicotine pouches were manufactured using the same method as in Production Example 11, except that the microcrystalline cellulose was present in an amount of 15% by weight and maltitol in an amount of 61% by weight.

[0144] Physical property analysis was performed on the nicotine pouches of the above manufacturing examples 11 to 13, and the results are shown in Table 6 below.

[0145] [Table 6]

[0146] The nicotine elution rates of the above manufacturing examples 11-13 were analyzed. The nicotine elution rates were evaluated using the same method as in the above examples and are shown in Table 7 below.

[0147] [Table 7]

[0148] Furthermore, Figure 6A shows the cumulative nicotine concentration elution graphs for manufacturing examples 11 to 13, and Figure 6B shows the nicotine concentration elution graphs for manufacturing examples 11 to 13.

[0149] As can be seen in Table 7, Figures 6A and 6B, the 1-hour dissolution results showed that when the MCC ratio was 30% or less, the nicotine dissolution rate increased as the MCC content decreased.

[0150] Based on the above examples, it is predicted that using the nicotine pouch filler described in the claims will allow for easy dissolution of nicotine and promote the absorption of the dissolved nicotine.

[0151] As described above, the embodiments have been illustrated with limited drawings, but a person with ordinary skill in the art can apply various technical modifications and variations based on the above. For example, the described techniques may be performed in a different order than described, and / or the components of the described systems, structures, devices, circuits, etc. may be combined or assembled in a different manner than described, or substituted or replaced by other components or equivalents, and still achieve the desired results.

[0152] Therefore, other implementations, other embodiments, and those equivalent to the claims described below also fall within the scope of the claims.

Claims

1. nicotine, Release-controlled excipients, Binder, pH adjusters, and Contains fragrances, The release-controlled excipient comprises cellulose and sugar alcohol, The cellulose and sugar alcohols are mixed in a weight ratio of 1:9 to 5:

5. The cellulose mentioned above comprises one or more of microcrystalline cellulose and methylcellulose. The sugar alcohol comprises at least one selected from the group consisting of erythritol, xylitol, mannitol, sorbitol, maltitol, and isomalt, in a nicotine pouch filler.

2. The nicotine pouch filler according to claim 1, wherein the cellulose is microcrystalline cellulose.

3. The nicotine pouch filler according to claim 1, wherein the cellulose content is 10 to 30% by weight relative to the total solid contents of the nicotine pouch filler.

4. The nicotine pouch filler according to claim 1, wherein the content of the sugar alcohol is 45 to 65% by weight relative to the solid content weight of the nicotine pouch filler.

5. 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.

6. The nicotine pouch filler according to claim 1, wherein the nicotine is supported on the cellulose.

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

8. The nicotine pouch filling agent according to claim 1, wherein the pH adjusting agent is at least one selected from the group consisting of sodium bicarbonate and sodium carbonate.

9. The pH adjusting agent comprises sodium bicarbonate and sodium carbonate. The nicotine pouch filler according to claim 8, wherein the weight ratio of sodium bicarbonate to sodium carbonate is 7:3 to 6:

4.

10. The nicotine pouch filler according to claim 1, wherein the pH of the nicotine pouch filler is 7.0 to 8.

8.

11. The nicotine pouch filler according to claim 1, wherein the nicotine pouch filler contains particles having a size of 150 to 300 μm.

12. The nicotine pouch filler according to claim 1, wherein the filler has a moisture content of 5% or less.

13. The nicotine pouch filler according to claim 1, wherein the nicotine pouch filler can have a nicotine dissolution performance of 10% or more within 4 minutes and a nicotine dissolution performance of 50-70% within 16 minutes.

14. Nicotine pouch filler, and Including packaging materials, The aforementioned nicotine pouch filler is nicotine, Release-controlled excipients, Binder, pH adjusters, and Contains fragrances, The release-controlled excipient comprises cellulose and sugar alcohol, The cellulose and sugar alcohols are mixed in a weight ratio of 1:9 to 5:

5. The cellulose mentioned above comprises one or more of microcrystalline cellulose and methylcellulose. The nicotine pouch contains at least one sugar alcohol selected from the group consisting of erythritol, xylitol, mannitol, sorbitol, maltitol, and isomalt.

15. Step S1 involves mixing at least one selected from the group consisting of nicotine, release-controlling excipients, binders, pH adjusters, and flavorings. Step S2 involves spraying the solvent, and The step includes granulation step S3, In step S1, the release control excipient comprises cellulose and sugar alcohol. The cellulose and sugar alcohols are mixed in a weight ratio of 1:9 to 5:

5. The cellulose mentioned above comprises one or more of microcrystalline cellulose and methylcellulose. A method for producing a nicotine pouch filler, wherein the sugar alcohol comprises at least one selected from the group consisting of erythritol, xylitol, mannitol, sorbitol, maltitol, and isomalt.

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