Nicotine composition and preparation method therefor, and nicotine pouch

Abstract

A nicotine composition and a preparation method therefor, and a nicotine pouch. The nicotine composition comprises the following components: a nicotine salt, a pH regulator, a binder, and a disintegrant.

Description

Nicotine composition and preparation method thereof, nicotine pouch

[0001] The present application claims priority to the Chinese patent application No. 202411062146.9 filed on August 02, 2024 with the China Patent Office, the content of which is incorporated herein by reference in its entirety. TECHNICAL FIELD

[0002] The present application relates to the technical field of nicotine pouch, in particular to a nicotine composition and preparation method thereof, nicotine pouch. BACKGROUND

[0003] The nicotine pouch is a smokeless tobacco product composed of cellulose, nicotine, flavoring agents and other additives, which allows nicotine to be absorbed through the oral mucosa by being placed between the gums and the lips. SUMMARY

[0004] However, the nicotine pouch in the related art has poor flowability of raw materials, and the nicotine effect is not fast enough and the heady feeling is not strong enough.

[0005] The present application provides a nicotine composition, which comprises the following components: nicotine salt, pH adjuster, binder and disintegrant.

[0006] The present application also provides a preparation method of the nicotine composition, which comprises: providing nicotine salt, pH adjuster, binder, disintegrant and solvent, mixing, granulating, drying to obtain the nicotine composition.

[0007] The present application also provides a nicotine pouch, which comprises the above nicotine composition. ADVANTAGEOUS EFFECTS

[0008] In the nicotine composition provided by the present application, the nicotine salt and the pH adjuster will undergo a neutralization reaction in a humid environment, releasing free nicotine which is then absorbed by the oral mucosa; the components in the nicotine composition can be bonded together by the binder, thereby reducing contact with water and avoiding the reaction between the nicotine salt and the pH adjuster during storage, thereby reducing the heady feeling; the bonded nicotine composition can rapidly disintegrate when it comes into contact with saliva, thereby accelerating the release of free nicotine. BRIEF DESCRIPTION OF DRAWINGS

[0009] Fig. 1 is a flowchart of the preparation method of the nicotine composition provided by the present application.

[0010] Fig. 2 is a finished product diagram of the nicotine composition provided by the present application.

[0011] Fig. 3 is a finished product diagram of the nicotine pouch provided by the present application. Embodiments of the present application

[0012] In the description of the present application, unless otherwise explicitly specified and limited, the terms "connected", "connected", "fixed" should be understood broadly, for example, it can be fixedly connected, or it can be detachably connected, or it can be integrated; it can be mechanically connected, or it can be electrically connected; it can be directly connected, or it can be indirectly connected through an intermediate medium; it can be the internal communication of two elements or the interaction relationship between two elements. For those skilled in the art, the specific meaning of the above terms in the present application can be understood according to the specific circumstances.

[0013] In the present application, unless otherwise explicitly specified and limited, the first feature "on" or "under" the second feature can include that the first and second features are in direct contact, or that the first and second features are not in direct contact but are in contact through another feature between them. Moreover, the first feature "on", "above" and "above" the second feature includes that the first feature is directly above and obliquely above the second feature, and the horizontal height of the first feature is higher than that of the second feature. The first feature "below", "below" and "below" the second feature includes that the first feature is directly below and obliquely below the second feature, and the horizontal height of the first feature is less than that of the second feature.

[0014] In the description of the present embodiment, the terms "up", "down", "left", "right", "front", "back" and other orientation or position relationships are based on the orientation or position relationship shown in the drawings, which is for the convenience of description and simplification of operation, and does not indicate or imply that the device or element referred to must have a particular orientation, be constructed and operated in a particular orientation, and therefore cannot be understood as a limitation on the present application. In addition, the terms "first" and "second" are used to distinguish the description and have no special meaning.

[0015] The nicotine bag raw material in the related art has poor flowability, is easy to be oxidized and yellow, has not enough strong head feeling, has not enough fast nicotine action speed, and has short duration. Moreover, the nicotine bag raw material mainly uses a powder with a small size, has a humidity greater than 15%, and the nicotine salt directly contacts the pH adjuster.

[0016] The technical solution of the present application is as follows:

[0017] In a first aspect, as shown in FIG. 2, the present application provides a nicotine composition, which comprises the following components: nicotine salt, pH adjuster, binder and disintegrant.

[0018] In the present application, the nicotine salt and the pH adjuster will undergo a neutralization reaction in a humid environment to release free nicotine, which is then absorbed by the oral mucosa; the adhesive can bind the components in the nicotine composition together, thereby reducing contact with water, preventing the nicotine salt and the pH adjuster from reacting during storage, thereby increasing the storage time; the addition of disintegrants can cause the bound nicotine composition to disintegrate rapidly when it comes into contact with saliva, thereby accelerating the release of free nicotine. By adding both an adhesive and a disintegrant, the nicotine composition can be more easily stored, more easily maintained, and its release speed can be improved.

[0019] In some embodiments, the mass ratio of nicotine salt, pH adjuster, disintegrant, and adhesive is (0.6-4):(0.5-3):(3-6):(1-5). Within this mass ratio range, the nicotine composition can be more easily stored, more easily maintained, and its release speed can be improved.

[0020] In some embodiments, the nicotine salt includes one or more of nicotine tartrate, nicotine benzoate, nicotine lactate, and nicotine gluconate.

[0021] In some embodiments, the pH adjuster includes one or more of sodium carbonate and sodium bicarbonate.

[0022] In some embodiments, the pH adjuster is encapsulated in resin.

[0023] In the present application, the method of encapsulating the pH adjuster in resin can use embedding technology, which is a process of wrapping the pH adjuster with resin to provide performance support or chemical protection.

[0024] In some embodiments, the encapsulation method of the pH adjuster includes:

[0025] (1) providing resin and ethanol, configuring an ethanol solution of resin with a mass concentration of 20%-23%, adding the pH adjuster to the ethanol solution of resin, stirring at 40-45°C for 2-3h, and filtering;

[0026] (2) freezing the filtrate obtained by filtering at -20 to -25°C for 24-30h, and freeze-drying for 24-30h to obtain the pH adjuster encapsulated in resin.

[0027] In some embodiments, the pH adjuster is resin-encapsulated sodium carbonate.

[0028] In some embodiments, the disintegrant includes one or more of croscarmellose sodium, cross-linked polyvinylpyrrolidone, and sodium carboxymethyl starch.

[0029] In some embodiments, the disintegrant is sodium carboxymethyl starch.

[0030] In some embodiments, the binder comprises one or more of povidone K25 and povidone K30.

[0031] In the present application, the povidone K25 and povidone K30 can be medical grade, safe and non-toxic.

[0032] In some embodiments, the binder is povidone K30.

[0033] In some embodiments, the nicotine composition further comprises an additive, the additive comprising one or more of a sweetener, a flavoring agent, a filler, and a preservative.

[0034] In the present application, the flavoring agent and the sweetener can adjust the taste of the nicotine composition as needed.

[0035] In some embodiments, the mass ratio of the nicotine salt, the pH regulator, the disintegrant, the binder, the sweetener, the flavoring agent, the filler, and the preservative is (0.6-4):(0.5-3):(3-6):(1-5):(2.05-20.15):(0-5):(10-20):(0.01-0.05).

[0036] In some embodiments, the flavoring agent comprises, but is not limited to, one or more of peppermint essence, cinnamon essence, watermelon essence, lemon essence, sweet orange essence, pineapple essence, and blueberry essence.

[0037] In some embodiments, the filler comprises cellulose.

[0038] In some embodiments, the filler comprises at least one of microcrystalline cellulose, natural fiber, and cellulose derivative.

[0039] In some embodiments, the filler is microcrystalline cellulose.

[0040] In some embodiments, the sweetener comprises one or more of acesulfame potassium, chloro sucrose, maltitol, and mannitol.

[0041] In some embodiments, the sweetener comprises the following components by weight: 0.05-0.15 parts by weight of acesulfame potassium, 1-10 parts by weight of maltitol, and 1-10 parts by weight of mannitol.

[0042] In some embodiments, the preservative comprises one or more of potassium sorbate, sodium benzoate, and parahydroxybenzoate.

[0043] In some embodiments, the preservative is potassium sorbate.

[0044] In some embodiments, the particle size of the nicotine composition is 30-80 mesh. The particle size of the nicotine composition is the average particle size. In this particle size range, the nicotine release speed is faster, while the nicotine composition can be firmly bonded and not produce excessive dust.

[0045] In a second aspect, as shown in FIG. 1, the present application provides a preparation method of a nicotine composition, comprising the following steps:

[0046] S1, providing nicotine salt, pH adjuster, binder, disintegrant and solvent, mixing, granulating, drying to obtain nicotine composition.

[0047] In some embodiments, the solvent is anhydrous ethanol.

[0048] In the present application, the binder is soluble in ethanol and forms a bonding slurry with ethanol, so that the components can be bonded, and the nicotine composition is formed after drying. The nicotine salt can react with the pH adjuster under the condition of moisture to release free nicotine. By using anhydrous ethanol as the solvent, the problem of insufficient stability caused by using water as the solvent can be avoided. Moreover, ethanol has the characteristics of easy evaporation and easy drying. Ethanol will evaporate during the drying process to form the nicotine composition, which can improve the production efficiency of the nicotine composition. At the same time, even if a small amount of ethanol remains in the nicotine composition, it is also relatively safe to the human body. The anhydrous ethanol is food-grade anhydrous ethanol.

[0049] In some embodiments, the mass ratio of nicotine salt, pH adjuster, disintegrant, binder and anhydrous ethanol is (0.6-4):(0.5-3):(3-6):(1-5):(3-10). In this mass ratio range, the anhydrous ethanol can fully dissolve the binder, so that the nicotine composition can be better bonded together, and at the same time, the ethanol can be fully evaporated.

[0050] In some embodiments, the mass ratio of nicotine salt, pH adjuster, disintegrant, binder and anhydrous ethanol is (0.6-4):(0.5-3):(3-6):(1-5):(4-6).

[0051] In step S1,

[0052] In some embodiments, the nicotine salt, pH adjuster, binder, disintegrant and solvent are provided and mixed, including:

[0053] S11, providing solvent, flavoring agent and binder, dissolving the flavoring agent and binder in the solvent to obtain a granulation solution;

[0054] S12, providing nicotine salt, pH adjuster and disintegrant, mixing and then adding the granulation solution to obtain a wet powder.

[0055] In the present application, by dissolving the flavoring agent in the solvent, the flavoring agent can be fully mixed with other powders, so that the aroma of the flavoring agent is uniformly dispersed, thereby improving the user experience.

[0056] In some embodiments, the nicotine salt, the pH adjusting agent, the binder, the disintegrant, and the solvent are provided, mixed, including:

[0057] S11, providing a solvent and a binder, dissolving the binder in the solvent to obtain a granulation solution;

[0058] S12, providing a nicotine salt, a pH adjusting agent, a disintegrant, and an additive, mixing and then adding the granulation solution to obtain a wet powder, the additive including one or more of a sweetener, a filler, and a preservative.

[0059] In step S11,

[0060] In some embodiments, the mixing is by stirring, the stirring speed is 150 r / min-450 r / min, and the stirring time is 40 min-60 min.

[0061] In some embodiments, the wet powder is granulated, dried, and sieved to obtain a nicotine composition, including:

[0062] The wet powder is granulated, dried, and sieved to obtain a nicotine composition.

[0063] In some embodiments, the granulation includes: extruding through a 30-80 mesh screen. This granulation method is simple and easy to operate.

[0064] In some embodiments, the sieving includes: sieving through a 30-80 mesh screen.

[0065] In the present application, the drying process can cause the nicotine composition to form lumps, and sieving can make the nicotine composition form a uniform size.

[0066] In some embodiments, the drying temperature is 40-60°C, and the drying time is 15-25 min.

[0067] The types of binder, nicotine salt, pH adjusting agent, disintegrant, sweetener, filler, and preservative used in the preparation method of the nicotine composition provided in the present application are as described above.

[0068] In a third aspect, the embodiments of the present application provide a nicotine bag, including the above nicotine composition.

[0069] In some embodiments, as shown in FIG. 3, the nicotine bag includes a bag and the above nicotine composition, and the nicotine composition is arranged in the bag. The bag is used to contain the nicotine composition and can be made of non-woven fabric.

[0070] Example 1

[0071] A method for preparing a nicotine bag, comprising the following steps:

[0072] (1) 3 parts of povidone K30 and 2 parts of watermelon flavor were added to 6 parts of anhydrous ethanol, and stirred uniformly at room temperature with a magnetic stirrer at a speed of 350 r / min for 50 minutes to obtain a granulation solution;

[0073] (2) 20 parts of microcrystalline cellulose, 5 parts of carboxymethyl starch sodium, 1 part of nicotine bitartrate salt (formed by one nicotine cation and two tartrate anions), 2.5 parts of resin-sodium carbonate (resin-encapsulated sodium carbonate), 0.08 parts of acesulfame potassium, 8 parts of maltitol, 8 parts of mannitol and 0.05 parts of potassium sorbate were stirred uniformly, and then the granulation solution was added and stirred uniformly to obtain a wet powder;

[0074] (3) The wet powder was extruded through a 50-mesh screen to form granules, which were then dried in a 60℃ air-drying oven for 20 min to obtain coarse granules, which were then sieved through a 50-mesh screen to obtain a nicotine composition;

[0075] (4) The nicotine composition was loaded into a non-woven fabric bag to obtain a nicotine bag.

[0076] The preparation method of the resin-sodium carbonate comprises:

[0077] (1) Eudragit L100 acrylic resin was taken and configured into an ethanol solution with a mass concentration of 20%, and sodium carbonate was added to the aqueous solution to obtain a mixture solution;

[0078] (2) The mixture solution was stirred in a constant-temperature magnetic stirrer at a temperature of 40℃ for 2h, and then filtered;

[0079] (3) The filtrate obtained after filtration was placed in a refrigerator at -20℃ for 24h, and then placed in a freeze dryer for 24h to obtain resin-sodium carbonate.

[0080] Example 2

[0081] This example is basically the same as Example 1, except that the nicotine bitartrate salt in this example is replaced by nicotine gluconate salt.

[0082] Example 3

[0083] This example is basically the same as Example 1, except that the nicotine bitartrate salt in this example is replaced by nicotine benzoate salt.

[0084] Example 4

[0085] This example is basically the same as Example 1, except that the nicotine tartrate salt in this example is replaced with nicotine lactate salt.

[0086] Example 5

[0087] This example is basically the same as Example 1, except that the microcrystalline cellulose in this example is replaced with natural cellulose.

[0088] Example 6

[0089] This example is basically the same as Example 1, except that the povidone K30 in this example is replaced with povidone K25.

[0090] Example 7

[0091] This example is basically the same as Example 1, except that the sodium carboxymethyl starch in this example is replaced with cross-linked sodium carboxymethyl cellulose.

[0092] Example 8

[0093] This example is basically the same as Example 1, except that the sodium carboxymethyl starch in this example is replaced with cross-linked polyvinylpyrrolidone.

[0094] Example 9

[0095] This example is basically the same as Example 1, except that the watermelon flavor in this example is replaced with cinnamon flavor.

[0096] Example 10

[0097] This example is basically the same as Example 1, except that the sodium carboxymethyl starch in this example is used in an amount of 3 parts.

[0098] Example 11

[0099] This example is basically the same as Example 1, except that the sodium carboxymethyl starch in this example is used in an amount of 6 parts.

[0100] Example 12

[0101] This example is basically the same as Example 1, except that the nicotine tartrate salt in this example is used in an amount of 4 parts.

[0102] Example 13

[0103] This example is basically the same as Example 1, except that the nicotine tartrate salt in this example is used in an amount of 0.6 parts.

[0104] Example 14

[0105] This example is basically the same as Example 1, except that the amount of povidone K30 in this example is 1 part.

[0106] Example 15

[0107] This example is basically the same as Example 1, except that the amount of acesulfame potassium in this example is 0.05 parts, the amount of maltitol is 5 parts, and the amount of mannitol is 5 parts.

[0108] Example 16

[0109] This example is basically the same as Example 1, except that the amount of acesulfame potassium in this example is 0.1 parts, the amount of maltitol is 5 parts, and the amount of mannitol is 10 parts.

[0110] Comparative Example 1

[0111] This example is basically the same as Example 1, except that the resin-sodium carbonate in this example is replaced by sodium carbonate.

[0112] Comparative Example 2

[0113] This example is basically the same as Example 1, except that sodium carboxymethyl starch is not used in this example.

[0114] Comparative Example 3

[0115] This example is basically the same as Example 1, except that the amount of povidone K30 in this example is 10 parts.

[0116] The nicotine bags in the examples and comparative examples (stored at a temperature of 22-28°C and a humidity of 40-70%) were subjected to sensory quality evaluation: 10 people were selected for each example and comparative example, and the nicotine bags were subjected to sensory evaluation. The sensory evaluation indicators are shown in Table 1, and the evaluation results are shown in Table 2.

[0117] Evaluation method: 10 sensory evaluators performed the evaluation, and the scoring method of blind evaluation was used. Each person scored after experiencing the above products, and the average value was obtained by removing one highest score and one lowest score.

[0118] Irritation refers to the uncomfortable feeling of the nicotine bag on the oral cavity, throat, etc.

[0119] Pungent feeling refers to the painful feeling of the nicotine bag on the oral cavity, throat, etc.

[0120] Head feeling refers to the feeling of the nicotine bag released in the oral cavity acting on the brain through blood circulation.

[0121] Satisfaction refers to the comprehensive feeling of the strength, concentration, and fragrance of the nicotine bag on the inside of the oral cavity.

[0122] Flavor refers to the overall performance of the taste, mouthfeel and aroma of the nicotine pouch that distinguishes it from other similar nicotine pouches.

[0123] Table 1 Sensory evaluation index

[0124]

[0125] Table 2 Sensory evaluation results of nicotine pouches

[0126] Experimental results Irritation pungent sensation headiness satisfaction flavor total score Example 1 14 15 20 8 19 95 Example 2 13 14 19 27 18 91 Example 3 14 14 20 8 17 93 Example 4 13 15 18 26 18 90 Example 5 14 15 20 8 19 95 Example 6 13 15 19 28 18 93 Example 7 14 14 17 27 17 90 Example 8 15 15 19 28 18 94 Example 9 14 15 20 8 19 96 Example 10 13 14 17 26 18 88 Example 11 14 15 19 27 19 94 Example 12 15 15 20 28 19 97 Example 13 13 14 18 26 17 88 Example 14 12 13 20 28 18 91 Example 15 13 15 20 29 16 93 Example 16 15 14 20 28 14 91 Comparative Example 1 29 20 23 16 80 Comparative Example 2 12 14 16 24 17 83 Comparative Example 3 8 14 15 24 17 75

[0127] From Table 2, it can be seen that:

[0128] The nicotine pouches prepared in Examples 1-16 have good performance in terms of irritation, pungent sensation, headiness, satisfaction and flavor. Compared with the comparative examples, Examples 1-16 have better sensory requirements in terms of satisfaction and irritation by adding resin-sodium carbonate and disintegrating agent. In Comparative Example 1, the pH regulator is not encapsulated, and after the product is prepared, it is easy to undergo neutralization reaction with nicotine salt, release free nicotine, and the aroma dissipates quickly, the nicotine breath is heavy, thus resulting in poor overall experience. In Comparative Example 2, no disintegrating agent is added, the release speed of free nicotine is slow, the headiness is slow, and the satisfaction is reduced. In Comparative Example 3, the amount of adhesive added is excessive, the release speed of free nicotine is slow, the headiness is slow, and the satisfaction is reduced.

Claims

1. A nicotine composition, comprising the following components: a nicotine salt, a pH regulator, a binder, and a disintegrant.

2. The nicotine composition of claim 1, wherein, The nicotine composition is in a granular form, and the particle size of the nicotine composition is 30-80 mesh; and / or The mass ratio of the nicotine salt, the pH regulator, the disintegrant, and the binder is (0.6-4):(0.5-3):(3-6):(1-5).

3. The nicotine composition of claim 1, wherein, The nicotine salt comprises one or more of nicotine tartrate, nicotine benzoate, nicotine lactate, and nicotine gluconate; and / or The pH regulator comprises one or more of sodium carbonate and sodium bicarbonate; and / or The pH regulator is encapsulated in a resin; and / or The disintegrant comprises one or more of crosscarmellose sodium, crosslinked polyvinylpyrrolidone, and sodium carboxymethyl starch; and / or The binder comprises one or more of povidone K25 and povidone K30. 4.The nicotine composition of claim 1, further comprising an additive, the additive comprising one or more of a sweetener, a flavoring agent, a filler, and a preservative.

5. The nicotine composition of claim 4, wherein, The mass ratio of the nicotine salt, the pH regulator, the disintegrant, the binder, the sweetener, the flavoring agent, the filler, and the preservative is (0.6-4):(0.5-3):(3-6):(1-5):(2.05-20.15):(0-5):(10-20):(0.01-0.05); and / or The flavoring agent comprises one or more of peppermint essence, cinnamon essence, watermelon essence, lemon essence, sweet orange essence, pineapple essence, and blueberry essence; and / or The filler comprises cellulose; and / or The sweetener comprises one or more of acesulfame potassium, sucralose, maltitol, and mannitol; and / or The preservative comprises one or more of potassium sorbate, sodium benzoate, and parahydroxybenzoate. 6.A method for preparing a nicotine composition, comprising the following steps: providing a nicotine salt, a pH regulator, a binder, a disintegrant, and a solvent, mixing, granulating, and drying to obtain a nicotine composition. 7.The method for preparing a nicotine composition of claim 6, wherein The granulating comprises: extruding and granulating through a 30-80 mesh screen; and / or The drying is performed at a temperature of 40-60℃ for 15-25 minutes; and / or The solvent is anhydrous ethanol, and the mass ratio of the nicotine salt, the pH regulator, the disintegrant, the binder, and the anhydrous ethanol is (0.6-4):(0.5-3):(3-6):(1-5):(3-10).

8. The method of preparing a nicotine composition according to claim 6, wherein, The providing a nicotine salt, a pH regulator, a binder, a disintegrant, and a solvent, mixing, granulating, and drying comprises: providing a solvent and a binder, dissolving the binder in the solvent to obtain a granulating solution; providing a nicotine salt, a pH regulator, and a disintegrant, mixing, and then adding the granulating solution to obtain a wet powder; granulating, drying, and sieving the wet powder to obtain a nicotine composition.

9. The method of preparing a nicotine composition according to claim 8, wherein, a flavouring agent is also added to the solvent in preparing the granulation solution; and / or a sweetening agent, a bulking agent and a preservative are also added to the granulation solution in preparing the wet powder.

10. A nicotine pouch comprising the nicotine composition according to any one of claims 1 to 5, or prepared by the method of preparing a nicotine composition according to any one of claims 6 to 9.

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