Nicotine pouch filler and manufacturing method therefor

Abstract

The present invention relates to a nicotine pouch filler comprising: nicotine; a release control excipient including at least one selected from the group consisting of cellulose and a sugar alcohol; a binder; a pH adjuster; and a flavoring, wherein the content of nicotine is 2.5-10 wt% with respect to the total solid content of the nicotine pouch filler, and the content of the release control excipient is 5.5-36 times that of nicotine.

Description

Nicotine pouch filler and method for manufacturing the same

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

[0002] Nicotine pouches are a type of smoking device used in the mouth to provide nicotine gratification. For example, nicotine pouches can be used by placing the pouch between the upper or lower gums and the lips and holding it there for a limited period of time.

[0003] A nicotine pouch consists of a filler encased in a packaging material. The packaging material holds the nicotine pouch filler in place, allowing saliva to pass through the nicotine pouch filler, and the flavor and nicotine released from the nicotine pouch filler are distributed into 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.

[0005] The purpose of the present invention is to provide a nicotine pouch filler having improved nicotine dissolution rate and absorption rate.

[0006]

[0007] However, the problems to be solved by the present invention are not limited to those mentioned above, and other problems not mentioned will be clearly understood by those skilled in the art from the description below.

[0008] According to one embodiment of the present invention, nicotine;

[0009] A controlled-release excipient comprising at least one selected from the group consisting of cellulose and sugar alcohols;

[0010] binder;

[0011] pH adjuster; and

[0012] Contains fragrance;

[0013] The content of the above nicotine is 2.5 to 10 wt% based on the weight of the total solid contents of the nicotine pouch filler,

[0014] A nicotine pouch filler is provided, wherein the content of the above-mentioned release controlling excipient is 5.5 to 36 times the content of the above-mentioned nicotine.

[0015]

[0016] According to another embodiment of the present invention, a nicotine pouch filler; and

[0017] packaging materials; including;

[0018] The above nicotine pouch filler is,

[0019] nicotine;

[0020] A controlled-release excipient comprising at least one selected from the group consisting of cellulose and sugar alcohols;

[0021] binder;

[0022] pH adjuster; and

[0023] Contains fragrance;

[0024] The content of the above nicotine is 2.5 to 10 wt% based on the weight of the total solid contents of the nicotine pouch filler,

[0025] A nicotine pouch is provided in which the content of the above-mentioned release controlling excipient is 5.5 to 36 times the content of the above-mentioned nicotine.

[0026]

[0027] 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-controlling excipient, a binder, a pH regulator, and a flavoring agent;

[0028] Step of spraying the solvent (S2); and

[0029] comprising a granulating step (S3);

[0030] In the above step S1, the release-controlling excipient comprises at least one selected from the group consisting of cellulose and sugar alcohol,

[0031] In the above step S2, a method for producing a nicotine pouch filler is provided, wherein the solvent is at least one selected from the group consisting of water and alcohol, the content of the solvent is 10 to 60 wt% of the content of the cellulose, and the L / S ratio is 8 to 15%.

[0032] The nicotine pouch filler of the present invention can effectively extract nicotine from a nicotine pouch and promote absorption of the extracted nicotine, thereby providing a smoking satisfaction to the user.

[0033]

[0034] The effects of the present invention are not limited to the effects described above, and should be understood to include all effects that can be inferred from the detailed description of the present invention or the composition of the invention described in the claims.

[0035] FIG. 1 is a drawing showing a method for manufacturing a nicotine pouch filler according to one embodiment of the present invention.

[0036] FIG. 2 is a diagram showing the dissolution rate according to the microcrystalline cellulose content of a nicotine pouch filler according to one embodiment of the present invention.

[0037] Figure 3 is a drawing showing the dissolution rate according to the addition of sugar alcohol to a nicotine pouch filler according to one embodiment of the present invention.

[0038] Below, embodiments are described in detail with reference to the attached drawings. However, the embodiments may be modified in various ways, and the scope of the patent application is not limited or restricted by these embodiments. It should be understood that all modifications, equivalents, or alternatives to the embodiments are included within the scope of the patent application.

[0039] The terms used in the examples are for illustrative purposes only and should not be construed as limiting. Singular expressions include plural expressions unless the context clearly dictates otherwise. In this specification, terms such as "comprise" or "have" are intended to indicate the presence of a feature, number, step, operation, component, part, or combination thereof described in the specification, but should be understood to not preclude the possibility of the presence or addition of one or more other features, numbers, steps, operations, components, parts, or combinations thereof.

[0040] Unless otherwise defined, all terms used herein, including technical or scientific terms, have the same meaning as commonly understood by a person of ordinary skill in the art to which the embodiments pertain. Terms defined in commonly used dictionaries should be interpreted as having a meaning consistent with their meaning in the context of the relevant technology, and shall not be interpreted in an idealized or overly formal sense unless explicitly defined herein.

[0041] In addition, when describing with reference to the attached drawings, identical components will be assigned the same reference numerals regardless of the drawing numbers, and redundant descriptions thereof will be omitted. When describing embodiments, if a detailed description of a related known technology is judged to unnecessarily obscure the gist of the embodiment, the detailed description will be omitted.

[0042] Additionally, in describing components of an embodiment, terms such as first, second, A, B, (a), (b), etc. may be used. These terms are only intended to distinguish the components from other components, and the nature, order, or sequence of the components are not limited by the terms.

[0043] Components included in one embodiment and components with common functions will be described using the same names in other embodiments. Unless otherwise stated, the descriptions given in one embodiment can be applied to other embodiments, and detailed descriptions will be omitted to the extent of overlap.

[0044] Throughout the specification, when a part is said to "include" a component, this does not mean that it excludes other components, but rather that it may include other components.

[0045]

[0046] According to one embodiment of the present invention, a nicotine pouch filler can be provided, comprising: nicotine; a release-controlling excipient including at least one selected from the group consisting of cellulose and sugar alcohols; a binder; a pH regulator; and a flavoring; wherein the content of the nicotine is 2.5 to 10 wt% based on the weight of the total solid contents of the nicotine pouch filler, and the content of the release-controlling excipient is 5.5 to 36 times the content of the nicotine.

[0047]

[0048] 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.

[0049] In one embodiment of the nicotine pouch filler according to the present invention, the nicotine content may be 2.5 to 10 wt% based on the total solid contents of the nicotine pouch filler. The nicotine content may be determined depending on the desired strength of the nicotine pouch. If the nicotine content is below the above-described range, it is difficult to provide a smoker with a satisfying feeling from smoking. On the other hand, if the nicotine content exceeds the above-described range, the nicotine stimulation may be excessive.

[0050]

[0051] The release-controlling excipient controls the nicotine dissolution rate, and can provide a nicotine pouch capable of supplying an appropriate amount of nicotine when used. Preferably, the content of the release-controlling excipient may be 5.5 to 36 times the nicotine content. If the content of the release-controlling excipient is outside the above-described range, the pouch filler may melt quickly or the nicotine dissolution rate may be delayed, and further, the nuclei of the filler particles may not be sufficiently formed, severe clumping may occur, or the powder may be crushed, making it difficult to manufacture the nicotine pouch filler, and problems may arise in that the stimulation of nicotine may be too strong or too weak.

[0052]

[0053] In a nicotine pouch filler according to one embodiment of the present invention, the release-controlling excipient may include cellulose, and the nicotine may be supported on the cellulose. That is, the cellulose may serve as a carrier for nicotine.

[0054] Additionally, cellulose can act as a diluent, has a high water holding capacity, promotes wetting of powdered mixtures through swelling and wicking, and can act to rapidly release saliva and nicotine.

[0055] Additionally, cellulose may provide a pleasant sensation. Without cellulose, the nicotine pouch filler may dissolve.

[0056]

[0057] In a nicotine pouch filler according to one embodiment of the present invention, the cellulose may be at least one of microcrystalline cellulose (MCC) and methyl cellulose.

[0058]

[0059] In a nicotine pouch filler according to one embodiment of the present invention, the content of the cellulose may be 5 to 20 wt% based on the weight of the total solid contents of the nicotine pouch filler.

[0060] If the cellulose content falls below the numerical range described above, the nicotine pouch filler may rapidly dissolve. Conversely, if the cellulose content exceeds the numerical range described above, the nicotine release rate may be delayed due to the water-insoluble nature of cellulose.

[0061]

[0062] Sugar alcohols dissolve well in saliva and bind more loosely to solvents than cellulose, allowing for faster release of nicotine within the use period, suppressing bitterness, and providing a cooling effect as they dissolve in the mouth.

[0063] Additionally, sugar alcohols can promote nucleation and granule growth in the high-shear wet granulation process of nicotine pouch fillers.

[0064]

[0065] In the 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 numerical range described above, it is difficult to provide a sufficient cooling experience to the user.

[0066] In the nicotine pouch filler according to one embodiment of the present invention, the solubility of the sugar alcohol may be 10 g / 100g to 80 g / 100g, preferably 20 g / 100g to 65 g / 100g, and more preferably 60 g / 100g to 65 g / 100g at 20°C. If the solubility of the sugar alcohol is below the numerical range described above, it may not be sufficiently dissolved in the user's oral cavity. On the other hand, if the solubility of the sugar alcohol exceeds the numerical range described above, excessive nicotine may be released.

[0067]

[0068] 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 to the examples described.

[0069]

[0070] In the nicotine pouch filler according to one embodiment of the present invention, the content of the sugar alcohol may be 50 to 70 wt%, preferably 60 to 70 wt%, based on the total solid contents of the nicotine pouch filler. If the content of the sugar alcohol is less than the numerical range described above, 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 numerical range described above, severe clumping or crushing of the powder may occur, making it difficult to manufacture the nicotine pouch filler.

[0071]

[0072] The type and content of the binder can affect the size distribution formation of the nicotine pouch filler particles.

[0073] 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. Meanwhile, the low substituted hydroxypropylcellulose may mean that the content of hydroxypropyl groups is 5.0 to 16.0%.

[0074] In a nicotine pouch filler according to one embodiment of the present invention, the content of the binder may be 10 wt% or less, preferably 8 to 15 wt%, based on the weight of the total solid contents of the nicotine pouch filler.

[0075] If the type and content of the binder described above are exceeded, it is difficult to secure the required particle size and may have a negative effect on the initial dissolution.

[0076]

[0077] The pH adjuster can adjust the pH of the nicotine pouch filler to a pH at which nicotine can be absorbed, so that when the nicotine pouch is inserted into the oral cavity, the nicotine can be converted into a rapidly absorbable free-based nicotine form.

[0078] Free-base nicotine is a non-ionic substance with hydrogen ions removed from the nicotine salt, which can be rapidly absorbed through the mucous membrane and have a strong impact on the consumer.

[0079] In one embodiment of the nicotine pouch filler according to 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 into a free-base nicotine form, which can be rapidly absorbed through the mucosa. Therefore, when the pH of the nicotine pouch filler satisfies the above-described numerical range, when mixed with saliva (pH 6.5 to 7.7), the pH becomes 8.02 or higher, so that nicotine can be easily absorbed and have a strong impact on the consumer.

[0080] 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.

[0081] At this time, the pH adjusting agent includes sodium bicarbonate and sodium carbonate, and the weight ratio of the sodium bicarbonate and sodium carbonate may be 7:3 to 6:4, preferably 6:4. If sodium bicarbonate is added in a greater proportion than the ratio described above (sodium carbonate in a relatively smaller proportion), the pH may be lowered, resulting in insufficient absorption of nicotine. On the other hand, if sodium bicarbonate is added in a lesser proportion than the ratio described above (sodium carbonate in a relatively larger proportion), the pH may be higher than the desired range, resulting in insufficient dissolution in the oral cavity.

[0082]

[0083] Flavoring may be used to provide flavor to suit the smoker's preferences.

[0084] In the 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, iso-sweetener, 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, but is not limited to the examples described.

[0085]

[0086] The nicotine pouch filler according to one embodiment of the present invention is not limited to containing only the described components, and may optionally additionally contain a moisturizer, an antioxidant, a preservative, etc.

[0087] The above moisturizer may include, for example, one or more of glycerin and propylene glycol.

[0088] The above antioxidant may include, for example, one or more of ascorbyl palmitate and sodium ascorbate.

[0089] The above preservative may include, for example, xylitol.

[0090]

[0091] The nicotine pouch filler according to one embodiment of the present invention can have a nicotine release performance of 10 to 25% within 4 minutes, and preferably can have a nicotine release performance of 15 to 25%, 18 to 22%.

[0092] In addition, the nicotine pouch filler according to one embodiment of the present invention can have a nicotine release performance of 50 to 90% within 20 minutes, and preferably can have a nicotine release performance of 70 to 80%.

[0093] If the nicotine release performance falls below the aforementioned numerical range, it may be difficult to provide the user with a satisfying smoking experience. Conversely, if the nicotine release performance exceeds the aforementioned numerical range, it may be irritating to the user.

[0094]

[0095] According to one embodiment of the present invention, a nicotine pouch can be provided, including the nicotine pouch filler described above; and a packaging material.

[0096] The packaging material can contain a certain amount of the nicotine pouch filler. The packaging material can be designed to prevent the nicotine pouch filler inside from leaking during transportation and use after being packaged, and can be manufactured to prevent smokers from experiencing a foreign body sensation in their mouths during use.

[0097] The packaging material may be safe for the human body, able to retain saliva well, have a certain strength to prevent tearing, and have sealing properties.

[0098] The packaging material may be composed of cellulose fibers, thermoplastic fibers, or a combination thereof. For example, the cellulose fibers may include rayon, and the thermoplastic fibers may include nylon, polyethylene, polylactic acid, polypropylene, polyethersulfone, or the like, but are not limited to the examples described. The packaging material may further include a binder.

[0099] The packaging material may be of a nonwoven type or a woven type.

[0100] A method for manufacturing a packaging material may include a process for forming a web and a process for bonding the web.

[0101] The process for forming the above web may be a dry-laid method, a wet-laid method, or a 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 modified therefrom. The spinning method may be a spun-bonded method or a melt-blown method.

[0102] Meanwhile, the process for bonding the webs may include 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.

[0103] Preferably, the packaging material can be manufactured by a spun-lacing method and / or a wet method. The spun-lacing method may include a step of forming a web in the form of a sheet having a certain thickness from a clumped fiber raw material; a step of spraying moisture to entangle the fibers to form a packaging material; and a drying step. The wet method may include a step of dispersing a fiber raw material in water to produce a dispersion; a step of moving the dispersion to a press to form a packaging material; and a dehydration and drying step. However, the spun-lacing method and the wet method are not limited to including only the steps described above.

[0104] The packaging material may be porous to release the nicotine pouch filler contained therein.

[0105] The packaging material may be packaged in a three-sided packaging or a double-sided packaging manner, and the sealing of the packaging material may be performed by ultrasonic sealing or heat sealing. The packaging material has a longitudinal seal formed along the width of the packaging material and a cross seal formed along the length of the packaging material, and the cross seal and / or the longitudinal seal may be sealed by a lip seal or a fin seal.

[0106] Packaging materials can be categorized into original, slim, super slim, and mini types based on their size and weight. Packaging materials can have an appropriate internal volume based on the capacity of the nicotine pouch filler to provide appropriate hardness and a comfortable user experience.

[0107] The final manufactured nicotine pouch can be wrapped and distributed.

[0108]

[0109] According to one embodiment of the present invention, a method for manufacturing a nicotine pouch filler may be provided. The method for manufacturing the nicotine pouch filler includes a step (S1) of mixing at least one selected from the group consisting of nicotine, a release-controlling excipient, a binder, a pH regulator, and a flavoring; a step (S2) of spraying a solvent; and a step (S3) of granulating; wherein, in the step S1, the release-controlling excipient includes at least one selected from the group consisting of cellulose and a sugar alcohol, and in the step S2, the solvent is at least one selected from the group consisting of water and an alcohol, and the content of the solvent may be 10 to 60 wt% of the content of the cellulose, and the L / S ratio may be 8 to 15%.

[0110] Below, each step is explained in detail.

[0111] Step S1 is a step of mixing at least one selected from the group consisting of nicotine, a release-controlling excipient, a binder, a pH regulator, and a flavoring agent. At this time, the components are prepared in powder form and can be uniformly mixed.

[0112] The above nicotine may include a nicotine salt, and the type of the nicotine salt is the same as the example described above.

[0113] The above-mentioned release-controlling excipient may include at least one selected from the group consisting of cellulose and sugar alcohols. Among the release-controlling excipients, the sugar alcohol may promote nucleus formation and granule growth during the granulation step.

[0114] The type of binder is the same as the previously described example. The method of adding the binder can particularly affect the granulation process. The binder can be added via a wet binder addition method or a dry binder addition method, preferably a dry binder addition method. When added via a dry binder method, it facilitates the formation of particles of the desired size, ensures a uniform particle size distribution, and facilitates manufacturing.

[0115] The types of the pH regulator and fragrance are the same as those in the examples described above.

[0116] Step S2 is a step of spraying a solvent. At this time, the solvent can be sprayed and mixed into the powder mixture prepared in step S1.

[0117] At this time, the solvent may be at least one of water and alcohol, and preferably alcohol.

[0118] The content of the solvent may be 10 to 60 wt%, preferably 40 to 50 wt%, of the content of the cellulose. The amount of the solvent added may also be expressed as the L / S ratio. The L / S ratio is expressed as the total weight of the solvent / 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, a release-controlling excipient, a binder, a pH regulator, and a flavoring added in step S1. The L / S ratio may be 8 to 15%, preferably 10 to 12%. When the L / S ratio satisfies the numerical range described above, fine particles having a uniform size and a size of less than 100 μm are generated in small amounts or not at all, and particles having a porous structure can be formed, which may be advantageous for nicotine release. When the L / S ratio is less than the numerical range described above, granule formation does not occur and may exist in the form of a fine powder. On the other hand, if the L / S ratio exceeds the numerical range described above, particles of irregular shape are formed, the particle size range becomes small, and clumping may occur during mixing.

[0119] Step S3 is the granulation step. At this time, the powder mixture and solvent prepared in step S2 are stirred for 5 to 30 minutes, and the clumps of particles formed during the stirring process can be broken up and separated into individual particles.

[0120] The granulated nicotine pouch filler particles may be evenly distributed in size. For example, the nicotine pouch filler may comprise at least 70% of particles having a size of 200 μm or greater and less than 30% of particles having a size of 100 μm or greater and less than 200 μm.

[0121] The above step S3 may further include a low-temperature drying step (S4) after step S3. At this time, the nicotine pouch filler granulated in step S3 is dried at 50°C for 1 to 3 hours, and the clumps of particles formed in the drying step are separated into individual particles, and then particles having a desired size can be selected.

[0122]

[0123] Hereinafter, the present invention will be described in more detail with reference to examples, but the present invention is not limited to the following examples.

[0124]

[0125] 1. Example 1: Nicotine release rate according to the content of microcrystalline cellulose

[0126] Manufacturing Example 1

[0127] A nicotine pouch containing a nicotine pouch filler was manufactured. At this time, the nicotine pouch filler contained 4.5 wt% of nicotine, 20 wt% of microcrystalline cellulose, 50 to 60 wt% of sugar alcohol, 10 wt% of pH adjuster, and 8 wt% of binder.

[0128] The specific manufacturing method is as shown in Fig. 1.

[0129]

[0130] Comparative Example 1

[0131] It was manufactured in the same manner as Manufacturing Example 1, except that the content of microcrystalline cellulose was 25 wt%.

[0132]

[0133] Comparative Example 2

[0134] It was manufactured in the same manner as Manufacturing Example 1, except that the content of microcrystalline cellulose was 40 wt%.

[0135]

[0136] Comparative Example 3

[0137] It was manufactured in the same manner as Manufacturing Example 1, except that the content of microcrystalline cellulose was 55 wt%.

[0138]

[0139] The nicotine release rates of Manufacturing Example 1 and Comparative Examples 1 to 3 were analyzed. The nicotine release rates were evaluated by measuring the content of released nicotine after leaving the Manufacturing Example and Comparative Example in 1 liter of phosphate buffer maintained at 37°C and pH 7.4 for 1 minute using a USP paddle apparatus. The results are shown in Fig. 2 and Table 1.

[0140]

[0141] Classification Manufacturing Example 1 Comparative Example 1 Comparative Example 2 Comparative Example 3 MCC content (weight%) 20254055 Initial dissolution rate after 4 minutes (%) 17.5 16.11 1.76.12 Dissolution rate after 0 minutes (%) 70.159.96 1.75 1.2

[0142]

[0143] Manufacturing Example 1 showed the highest dissolution rate of 17.5% after the initial 4 minutes. However, as the content of microcrystalline cellulose increased, the dissolution rate tended to decrease after the initial 4 minutes due to the water-insoluble nature of microcrystalline cellulose (Comparative Examples 1 to 3).

[0144]

[0145] 2. Example 2: Nicotine release rate according to sugar alcohol addition

[0146] Manufacturing Example 2

[0147] A nicotine pouch containing a nicotine pouch filler was manufactured. The nicotine pouch filler contained nicotine, microcrystalline cellulose, and maltitol, wherein the content of maltitol was 70 wt% based on the total weight of solids, and the content of microcrystalline cellulose was 5 wt% based on the total weight of solids.

[0148]

[0149] Manufacturing Example 3

[0150] It was manufactured in the same manner as Manufacturing Example 2, except that the content of maltitol was 55 wt% based on the total weight of solids, and accordingly, the content of microcrystalline cellulose was 20 wt% based on the total weight of solids.

[0151]

[0152] The nicotine release rates of Manufacturing Examples 2 and 3 were analyzed. The nicotine release rates were evaluated using the same method as in Example 1 described above. The results are shown in Fig. 3.

[0153] As a result, Manufacturing Example 2 showed a nicotine release rate of 20% after the initial 4 minutes and 80% after 20 minutes, and Manufacturing Example 3 showed a nicotine release rate of 14% after the initial 4 minutes and 51.6% after 20 minutes. It is believed that the reason Manufacturing Example 2 showed a higher release rate than Manufacturing Example 3 is due to the higher sugar alcohol content.

[0154]

[0155] 3. Example 3: Particle size distribution and nicotine release rate according to the type of binder

[0156] Manufacturing Example 4

[0157] A nicotine pouch containing a nicotine pouch filler was manufactured. The nicotine pouch filler contained nicotine, microcrystalline cellulose, maltitol, a binder, a pH regulator, and a flavoring agent, wherein the binder was hydroxypropyl cellulose, and the content of the binder was 8 wt% based on the total weight of the solids.

[0158] The nicotine pouch filler was manufactured using a dry binder addition method. That is, nicotine, microcrystalline cellulose, maltitol, binder, pH adjuster, and flavoring were first mixed, and then the solvent (water alone, water + ethanol, or ethanol alone) was sprayed, followed by a granulation step.

[0159]

[0160] Manufacturing Example 5

[0161] It was manufactured in the same manner as Manufacturing Example 4, except that povidone K-25 was used as a binder and alcohol was applied as a solvent.

[0162]

[0163] Manufacturing Example 6

[0164] It was manufactured in the same manner as Manufacturing Example 4, except that low-substituted hydroxypropyl cellulose was used as a binder.

[0165]

[0166] The nicotine release rates of the above-mentioned manufacturing examples 2, 4 to 6 were analyzed. The nicotine release rates were evaluated using the same method as in Example 1 described above, and the results are shown in Table 2.

[0167] Distinction Manufacturing Example 2 Manufacturing Example 4 Manufacturing Example 5 Manufacturing Example 6 Initial 4 minutes after dissolution rate (%) 2017.5 15.3 13.8 20 minutes after dissolution rate (%) 80 70.16 1.95 5.3 Particle size distribution (%) Size 200㎛ or more 70 66.75 0.56 1.8 Size 50㎛ or less None None 2.2 1.6

[0168]

[0169] In Manufacturing Examples 2 and 4, nicotine pouch filler particles having a size of 200 μm or more were distributed at a rate of 66.7% or more, and nicotine pouch filler particles having a size of 50 μm or less were not present. Manufacturing Examples 2 and 4 showed a higher nicotine release rate not only initially but also after 20 minutes compared to Manufacturing Examples 5 and 6.

[0170]

[0171] 4. Example 4: Free-base nicotine production rate according to pH range and pH regulator ratio

[0172] Manufacturing Example 7

[0173] A nicotine pouch containing a nicotine pouch filler was manufactured. The nicotine pouch filler contained a pH adjuster, and the pH adjuster used was sodium bicarbonate and sodium carbonate in a ratio of 6:4.

[0174]

[0175] Manufacturing Example 8

[0176] It was manufactured in the same manner as Manufacturing Example 7, except that sodium bicarbonate and sodium carbonate were used in a 7:3 ratio as pH adjusters.

[0177]

[0178] Comparative Example 4

[0179] It was manufactured in the same manner as Manufacturing Example 7, except that sodium bicarbonate and sodium carbonate were used in a ratio of 8:2 as pH adjusters.

[0180]

[0181] The pH and free-base nicotine production ratio of the nicotine pouch fillers of Manufacturing Examples 7 and 8 and Comparative Example 4 were investigated, and the results are shown in Table 3.

[0182] pH Free-base nicotine production rate (%) Manufacturing example 78.885 to 90% Manufacturing example 88.476% Comparative example 47.624%

[0183]

[0184] Unlike Comparative Example 4, Manufacturing Examples 7 and 8 showed results in which the pH of the saliva was 8.8 and 8.4, respectively, and the free-base nicotine production ratio was 76% or higher. This confirms that when saliva with a pH of 6.5 to 7.7 is introduced, the pH becomes 8.02 or higher, and thus more free-base nicotine is produced.

[0185]

[0186] From the above experimental examples, it is predicted that the use of the nicotine pouch filler described in the claims will facilitate the extraction of nicotine and promote the absorption of the extracted nicotine.

[0187]

[0188] Although the embodiments described above have been described with limited drawings, those skilled in the art will appreciate that various technical modifications and variations can be applied based on the above. For example, appropriate results can still be achieved even if the described techniques are performed in a different order than described, and / or components of the described systems, structures, devices, circuits, etc. are combined or combined in a different manner than described, or are replaced or substituted with other components or equivalents.

[0189]

[0190] Therefore, other implementations, other embodiments, and equivalents to the claims also fall within the scope of the claims described below.

Claims

1. Nicotine; A controlled-release excipient comprising at least one selected from the group consisting of cellulose and sugar alcohols; binder; pH adjuster; and containing fragrances; The content of the above nicotine is 2.5 to 10 wt% based on the weight of the total solid contents of the nicotine pouch filler, A nicotine pouch filler, wherein the content of the above-mentioned release controlling excipient is 5.5 to 36 times the content of the above-mentioned nicotine.

2. In paragraph 1, The above nicotine comprises a nicotine salt, A nicotine pouch filler, 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. In paragraph 1, The above release-controlling excipient comprises cellulose, A nicotine pouch filler wherein the nicotine is supported on the cellulose.

4. In paragraph 1, A nicotine pouch filler wherein the cellulose is at least one of microcrystalline cellulose and methyl cellulose.

5. In paragraph 1, A nicotine pouch filler, wherein the content of the cellulose is 5 to 20 wt% based on the weight of the total solid contents of the nicotine pouch filler.

6. In paragraph 1, 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.

7. In paragraph 1, A nicotine pouch filler, wherein the content of the sugar alcohol is 50 to 70 wt% based on the weight of the total solid contents of the nicotine pouch filler.

8. In paragraph 1, The binder comprises at least one selected from the group consisting of povidone K-25, hydroxypropyl cellulose, low-substituted hydroxypropyl cellulose, hydroxypropylmethyl cellulose (HPMC), and carboxymethylcellulose (CMC). A nicotine pouch filler, wherein the content of the binder is 8 to 10 wt% based on the weight of the total solid contents of the nicotine pouch filler.

9. In paragraph 1, A nicotine pouch filler, wherein the pH adjusting agent is at least one of sodium bicarbonate and sodium carbonate.

10. In paragraph 9, The above pH regulator includes sodium bicarbonate and sodium carbonate, A nicotine pouch filler wherein the weight ratio of sodium bicarbonate and sodium carbonate is 7:3 to 6:

4.

11. In paragraph 1, A nicotine pouch filler having a pH of 8.3 to 8.

5.

12. In paragraph 1, A nicotine pouch filler having a nicotine release performance of 15% to 25% within 4 minutes and a nicotine release performance of 70 to 80% within 20 minutes.

13. Nicotine pouch filler; and packaging materials; including; The above nicotine pouch filler is, nicotine; A controlled-release excipient comprising at least one selected from the group consisting of cellulose and sugar alcohols; binder; pH adjuster; and containing fragrances; The content of the above nicotine is 2.5 to 10 wt% based on the weight of the total solid contents of the nicotine pouch filler, A nicotine pouch wherein the content of the above-mentioned release controlling excipient is 5.5 to 36 times the content of the above-mentioned nicotine.

14. A step (S1) of mixing at least one selected from the group consisting of nicotine, a release-controlling excipient, a binder, a pH regulator, and a flavoring agent; Step of spraying the solvent (S2); and comprising a granulating step (S3); In the above step S1, the release-controlling excipient comprises at least one selected from the group consisting of cellulose and sugar alcohol, A method for producing a nicotine pouch filler, wherein in the above 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 wt% of the content of the cellulose, and the L / S ratio is 8 to 15%.

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