Oral products and their preparation methods

Abstract

This application discloses a mouthwash and its preparation method, belonging to the field of mouthwash. The mouthwash includes a composition comprising a main filler and an active substance; the main filler includes tagatose; by mass parts, the main filler is 40-90 parts and the active substance is 0.1-10 parts. In this application, by setting the main filler to 40-90 parts, and by including tagatose, the mouthwash contains a relatively high amount of tagatose, ensuring that the mouthwash is less susceptible to moisture absorption during storage, thereby improving the mouthwash's taste.

Description

Technical Field

[0001] This application belongs to the field of oral products, specifically relating to an oral product and its preparation method. Background Technology

[0002] With the development of technology and people's increasing health awareness, their tolerance for secondhand smoke from regular cigarettes is decreasing, leading to a growing demand for non-combustible tobacco products. Among these, oral lozenges, as an alternative to traditional cigarettes, allow users to release nicotine simply by holding them in their mouths, without producing secondhand smoke. However, currently, oral lozenges tend to absorb moisture when stored, meaning they are susceptible to dampness, which affects the user's taste. Summary of the Invention

[0003] The purpose of this application is to provide a mouthwash product and its preparation method, at least to solve the problem that mouthwash products are easily affected by moisture, which affects the user's taste.

[0004] In a first aspect, embodiments of this application provide a mouth-held product comprising a composition, the composition comprising: a main filler and an active substance; the main filler comprising tagatose;

[0005] The main filler is 40-90 parts by mass, and the active substance is 0.1%-10%.

[0006] Optionally, the main filler may further include sugar alcohols, wherein the sugar alcohols are low hygroscopic sugar alcohols.

[0007] Optionally, the low-hygroscopic sugar alcohol includes at least one of mannitol, lactitol, isomaltitol, sorbitol, erythritol, maltitol, and arabinitol.

[0008] Optionally, in the main filler, the ratio of the content of tagatose to the content of sugar alcohol is 1:1 to 3:2.

[0009] Optionally, the composition further includes a pH adjuster, said pH adjuster comprising at least one of sodium bicarbonate, calcium carbonate, tartaric acid, benzoic acid, and calcium lactate; and / or,

[0010] The composition further includes a binder comprising at least one of sodium alginate, pregelatinized starch, gelatin, gum arabic, sodium carboxymethyl cellulose, polyethylene glycol, hydroxypropyl methylcellulose, and sodium hyaluronate; and / or,

[0011] The oral product further includes auxiliary fillers, which include at least one of microcrystalline cellulose, starch, and glyceryl behenate; and / or,

[0012] The oral product further includes a lubricant, said lubricant comprising at least one of magnesium stearate and silicon dioxide; and / or,

[0013] The composition further includes a sweetener comprising at least one of aspartame, sucralose, neotame, acesulfame potassium, neohesperidin dihydrochalcone, sodium saccharin, mogrosides, and steviol glycosides; and / or,

[0014] The composition further includes a flavoring agent, which includes a flavoring agent or a cooling agent; and / or,

[0015] The oral product further includes preservatives, which include at least one of potassium sorbate, polylysine hydrochloride, ascorbic acid, sodium ascorbate, methylparaben, ethylparaben, and nisin.

[0016] Optionally, the composition further includes, by parts by weight, a binder, said binder being 1-10 parts; and / or,

[0017] The oral product further includes a lubricant, said lubricant being 0.1-0.5 parts; and / or,

[0018] The oral product further includes an auxiliary filler, wherein the auxiliary filler is 1-20 parts; and / or,

[0019] The composition further includes a pH adjuster, wherein the pH range when the composition is dissolved is 6-10; and / or,

[0020] The composition further includes a sweetener, said sweetener being 0.01-1 part; and / or,

[0021] The composition further includes a flavoring agent, said flavoring agent being 0.1-12 parts; and / or,

[0022] The composition further includes a preservative, which is 0.01-1 part.

[0023] Optionally, the active substance is a nicotine agent, which includes at least one of natural nicotine, nicotine salts, synthetic nicotine, hexamethylnicotine, and nicotine salt complexes.

[0024] Optionally, the oral article may further include a saliva-permeable wrapper;

[0025] The composition is in the form of granules, and the particle size of the granular composition is between 75 μm and 750 μm;

[0026] The composition is filled into the package.

[0027] In a second aspect, embodiments of this application provide a preparation method for preparing the oral article described in any one of the first aspects above, the preparation method comprising:

[0028] The selected composition raw materials include first batch raw materials, which include a main filler and an active substance, wherein the main filler includes tagatose.

[0029] The solid raw materials in the first batch of raw materials are crushed and sieved to form initial raw material particles;

[0030] The liquid raw material in the first batch of raw materials is dissolved in ethanol to form an initial solution;

[0031] The initial raw material particles are mixed in a pellet mill;

[0032] The initial raw material particles, after being mixed, are then mixed with the initial solution to form wet particles;

[0033] The moistened particles are sieved and dried to obtain dry particles.

[0034] Optionally, after obtaining the dried particles, the preparation method further includes: sieving the dried particles and mixing the sieved dried particles with a second batch of raw materials in the composition, the second batch of raw materials including a lubricant.

[0035] The main filler consists of 40-90 parts, including tagatose, and the active ingredient consists of 0.1-10 parts. Tatagatose has low hygroscopicity, thus providing a moisture-proof effect and preventing the oral product from easily absorbing moisture during storage. In other words, by setting the main filler to 40-90 parts, and including tagatose, the oral product effectively contains a relatively high amount of tagatose. Utilizing tagatose's low hygroscopicity, the oral product is less prone to moisture absorption during storage, thereby improving its taste. Attached Figure Description

[0036] Figure 1 This is a flowchart illustrating a preparation method provided in an embodiment of this application. Detailed Implementation

[0037] The terms "first" and "second" in the specification and claims of this application may explicitly or implicitly include one or more of the features. In the description of this application, unless otherwise stated, "multiple" means two or more. Furthermore, "and / or" in the specification and claims indicates at least one of the connected objects, and the character " / " generally indicates that the preceding and following objects are in an "or" relationship.

[0038] In the description of this application, it should be understood that the terms "center", "longitudinal", "lateral", "length", "width", "thickness", "upper", "lower", "front", "rear", "left", "right", "vertical", "horizontal", "top", "bottom", "inner", "outer", "clockwise", "counterclockwise", "axial", "radial", "circumferential", etc., indicating the orientation or positional relationship based on the orientation or positional relationship shown in the accompanying drawings, are only for the convenience of describing this application and simplifying the description, and do not indicate or imply that the device or element referred to must have a specific orientation, or be constructed and operated in a specific orientation, and therefore should not be construed as a limitation of this application.

[0039] In the description of this application, it should be noted that, unless otherwise expressly specified and limited, the terms "installation," "connection," and "linking" should be interpreted broadly. For example, they can refer to a fixed connection, a detachable connection, or an integral connection; they can refer to a mechanical connection or an electrical connection; they can refer to a direct connection or an indirect connection through an intermediate medium; and they can refer to the internal connection between two components. Those skilled in the art can understand the specific meaning of the above terms in this application based on the specific circumstances.

[0040] This application provides a mouth-held product comprising a composition including a main filler and an active substance; the main filler includes tagatose; by mass parts, the main filler is 40-90 parts and the active substance is 0.1-10 parts.

[0041] The main filler comprises 40-90 parts, including tagatose, and the active ingredient comprises 0.1-10 parts. Tatagatose has low hygroscopicity, thus providing a moisture-proof effect and preventing the oral product from easily absorbing moisture during storage. In other words, by setting the main filler to 40-90 parts, and including tagatose, the oral product effectively contains a significant amount of tagatose. Utilizing tagatose's low hygroscopicity, the oral product is prevented from becoming damp during storage, thereby improving its taste.

[0042] It should be noted that the mass fraction of the main filler can be any value between 40 and 90 parts. For example, the mass fraction of the main filler is 40 parts, 60 parts, 80 parts, or 90 parts. This application does not limit this specific amount. When the main filler includes tagatose, the mass fraction of the tagatose can be any value between 40 and 90 parts. For example, the mass fraction of the tagatose is 40 parts, 60 parts, 80 parts, or 90 parts.

[0043] In one embodiment, the main filler may further include a sugar alcohol, specifically a sugar alcohol with low hygroscopicity. Low hygroscopicity means that, under conditions of 50%-70% humidity, 23-25°C, and after being stored for 7 days, the percentage increase in weight after absorbing water is less than 2%, or the percentage change in moisture content is less than 2%. By incorporating a sugar alcohol with low hygroscopicity, the overall low hygroscopicity of the oral product is ensured while simultaneously improving its texture, thus further enhancing its flavor. In other words, by using a low-hygroscopic sugar alcohol other than tagatum, both the texture of the oral product and its resistance to moisture absorption can be ensured.

[0044] It should be noted that tagatose has lower hygroscopicity than sugar alcohols, so oral products contain more tagatose to ensure lower hygroscopicity. Secondly, adding sugar alcohols other than tagatose can improve the taste of oral products.

[0045] In one embodiment, the low hygroscopic sugar alcohol includes at least one of mannitol, lactitol, isomaltitol, sorbitol, erythritol, maltitol, and arabinitol.

[0046] In one embodiment, the low-hygroscopic sugar alcohol may include only one of mannitol, lactitol, isomaltitol, sorbitol, erythritol, maltitol, and arabinitol. For example, the low-hygroscopic sugar alcohol may include only mannitol, lactitol, isomaltitol, sorbitol, erythritol, maltitol, and arabinitol.

[0047] In one embodiment, the low-hygroscopic sugar alcohol may further include any two of mannitol, lactitol, isomaltitol, sorbitol, erythritol, maltitol, and arabinitol. For example, the low-hygroscopic sugar alcohol may include lactitol and lactitol, or, for another example, lactitol and isomaltitol, or, for yet another example, erythritol and maltitol, or, for yet another example, maltitol and arabinitol.

[0048] In one embodiment, the low-hygroscopic sugar alcohol may further include any three of mannitol, lactitol, isomaltitol, sorbitol, erythritol, maltitol, and arabinitol. For example, the low-hygroscopic sugar alcohol may include lactitol, lactitol, and isomaltitol; for another example, the low-hygroscopic sugar alcohol may include isomaltitol, sorbitol, and erythritol; for yet another example, the low-hygroscopic sugar alcohol may include erythritol, maltitol, and arabinitol.

[0049] In one embodiment, the low-hygroscopic sugar alcohol may further include any four of mannitol, lactitol, isomaltitol, sorbitol, erythritol, maltitol, and arabinitol. For example, the low-hygroscopic sugar alcohol may include mannitol, lactitol, isomaltitol, and sorbitol. Another example is that the low-hygroscopic sugar alcohol may include isomaltitol, sorbitol, erythritol, and maltitol. Yet another example is that the low-hygroscopic sugar alcohol may include sorbitol, erythritol, maltitol, and arabinitol.

[0050] In one embodiment, the low-hygroscopic sugar alcohol may further include any five of the following: mannitol, lactitol, isomaltitol, sorbitol, erythritol, maltitol, and arabinitol. For example, the low-hygroscopic sugar alcohol may include mannitol, lactitol, isomaltitol, sorbitol, and erythritol. Another example is that the low-hygroscopic sugar alcohol may include isomaltitol, sorbitol, erythritol, maltitol, and arabinitol. The low-hygroscopic sugar alcohol may also include any six of the following: mannitol, lactitol, isomaltitol, sorbitol, erythritol, maltitol, and arabinitol. Alternatively, the low-hygroscopic sugar alcohol may also include all of the following: mannitol, lactitol, isomaltitol, sorbitol, erythritol, maltitol, and arabinitol.

[0051] It should be noted that when the main filler also includes sugar alcohols other than tagatose, it is equivalent to the main filler including tagatose and sugar alcohols. The mass fraction of the main filler is 40-90 parts, which means that the mass fraction of tagatose and sugar alcohols as a whole is 40-90 parts.

[0052] In another embodiment, the content of tagatose in the main filler is greater than or equal to the content of sugar alcohols. This arrangement effectively results in a higher content of tagatose in the main filler, and tagatose has low hygroscopicity, thus reducing the overall hygroscopicity of the main filler and ensuring that the oral product is less susceptible to moisture absorption during placement.

[0053] In one embodiment, the ratio of tagatose to sugar alcohol in the main filler is 1:1 to 3:2. This configuration effectively uses tagatose as the primary filler in the oral product. The low hygroscopicity of tagatose prevents the product from becoming damp, while the low hygroscopicity of sugar alcohol ensures overall low hygroscopicity. Furthermore, the sugar alcohol improves the overall taste of the oral product. The 1:1 to 3:2 ratio also prevents insufficient sugar alcohol from negatively impacting the taste and avoids excessive sugar alcohol from affecting its hygroscopicity.

[0054] In one embodiment, the ratio of tagatose content to sugar alcohol content can be 1:1. In another embodiment, the ratio of tagatose content to sugar alcohol content can be 5:4. In yet another embodiment, the ratio of tagatose content to sugar alcohol content can be 3:2.

[0055] In another embodiment, by setting the main filler to include tagatose and a sugar alcohol with low hygroscopicity, the main filler has low hygroscopicity and is easy to dissolve. Therefore, after using these substances as the main filler, the oral product can be easily dissolved during the user's use of the oral product, and the oral product is not easy to absorb water and become damp during storage.

[0056] Additionally, in some embodiments, the composition may further include a pH adjuster, including at least one of sodium bicarbonate, calcium carbonate, tartaric acid, benzoic acid, modified carbonate, and calcium lactate; and / or, the composition may further include a binder, including at least one of sodium alginate, pregelatinized starch, gelatin, gum arabic, sodium carboxymethyl cellulose, polyethylene glycol, hydroxypropyl methylcellulose, and sodium hyaluronate; and / or, the oral article may further include an auxiliary filler, including at least one of microcrystalline cellulose, starch, and glyceryl behenate; and / or, the oral article may further include... The composition may include a lubricant, which may include at least one of magnesium stearate and silicon dioxide; and / or, the composition may further include a sweetener, which may include at least one of aspartame, sucralose, neotame, acesulfame potassium, neohesperidin dihydrochalcone, sodium saccharin, mogroside, and steviol glycoside; and / or, the composition may further include a flavoring agent, which may include flavoring or cooling agent; and / or, the oral product may further include a preservative, which may include at least one of potassium sorbate, polylysine hydrochloride, ascorbic acid, sodium ascorbate, methylparaben, ethylparaben, and nisin.

[0057] In some embodiments, the composition may further include, by weight parts, a binder of 1-10 parts; and / or, the oral article may further include a lubricant of 0.1-0.5 parts; and / or, the oral article may further include an auxiliary filler of 1-20 parts; and / or, the composition may further include a pH adjuster, wherein the pH range when the composition is dissolved is 7-10; and / or, the composition may further include a sweetener of 0.01-1 parts; and / or, the composition may further include a flavoring agent of 0.1-12 parts; and / or, the composition may further include a preservative of 0.01-1 parts.

[0058] When the composition includes a pH adjuster, the oral article may also include a pH adjuster, wherein the pH adjuster is 1-20 parts and the pH range of the composition is 7-10.

[0059] By incorporating pH adjusters, the pH of the oral product can be adjusted, resulting in different pH values ​​and thus affecting the rate at which nicotine is released. Specifically, the higher the pH of the environment in which the nicotine is produced, the faster the nicotine is released. Therefore, by adjusting the amount of pH adjuster, the pH of the oral product can be adjusted, thereby affecting the rate of nicotine release and creating different tastes, which in turn helps to improve the marketability of the oral product.

[0060] It should be noted that the mass fraction of the pH adjuster can be any value from 1 to 20 parts. For example, the mass fraction of the pH adjuster is 1 part, 5 parts, 7 parts, 10 parts, 15 parts, or 20 parts. This application does not limit the specific embodiment in this regard.

[0061] In addition, the pH adjuster may include at least one of sodium bicarbonate, calcium carbonate, tartaric acid, benzoic acid, and calcium lactate. Specifically, the pH adjuster may include one of sodium bicarbonate, calcium carbonate, tartaric acid, benzoic acid, and calcium lactate; the pH adjuster may include any two of sodium bicarbonate, calcium carbonate, tartaric acid, benzoic acid, and calcium lactate; the pH adjuster may include any three of sodium bicarbonate, calcium carbonate, tartaric acid, benzoic acid, and calcium lactate; the pH adjuster may include any four of sodium bicarbonate, calcium carbonate, tartaric acid, benzoic acid, and calcium lactate; the pH adjuster may include any five of sodium bicarbonate, calcium carbonate, tartaric acid, benzoic acid, and calcium lactate; or the pH adjuster may include all of the substances in the list of sodium bicarbonate, calcium carbonate, tartaric acid, benzoic acid, and calcium lactate.

[0062] Additionally, when the composition includes a binder, the binder is present in 1-10 parts. By providing a binder, during the processing of the oral article, the binder can bind the particles of other materials forming the oral article together, thereby improving the cohesiveness between particles, avoiding the problem of easy separation between particles, and allowing smaller particles of other materials forming the oral article to agglomerate into larger particle groups, facilitating subsequent formation of the oral article.

[0063] It should be noted that the mass fraction of the adhesive can be any value from 1 to 10 parts. For example, the mass fraction of the adhesive is 1 part, 3 parts, 5 parts, 8 parts, or 10 parts. This application does not limit the specific amount of adhesive used in this embodiment.

[0064] In another embodiment, the binder may include at least one of sodium alginate, pregelatinized starch, gelatin, gum arabic, sodium carboxymethyl cellulose, polyethylene glycol, hydroxypropyl methylcellulose, and sodium hyaluronate. This arrangement makes the binder readily available, thereby reducing the cost of oral products.

[0065] The binder may include any one of sodium alginate, pregelatinized starch, gelatin, gum arabic, sodium carboxymethyl cellulose, polyethylene glycol, hydroxypropyl methylcellulose, and sodium hyaluronate; any two of sodium alginate, pregelatinized starch, gelatin, gum arabic, sodium carboxymethyl cellulose, polyethylene glycol, hydroxypropyl methylcellulose, and sodium hyaluronate; any three of sodium alginate, pregelatinized starch, gelatin, gum arabic, sodium carboxymethyl cellulose, polyethylene glycol, hydroxypropyl methylcellulose, and sodium hyaluronate; or any four of sodium alginate, pregelatinized starch, gelatin, gum arabic, sodium carboxymethyl cellulose, polyethylene glycol, hydroxypropyl methylcellulose, and sodium hyaluronate. The binder may include any five of the following: sodium alginate, pregelatinized starch, gelatin, gum arabic, sodium carboxymethyl cellulose, polyethylene glycol, hydroxypropyl methylcellulose, and sodium hyaluronate; the binder may include any six of the following: sodium alginate, pregelatinized starch, gelatin, gum arabic, sodium carboxymethyl cellulose, polyethylene glycol, hydroxypropyl methylcellulose, and sodium hyaluronate; the binder may include any seven of the following: sodium alginate, pregelatinized starch, gelatin, gum arabic, sodium carboxymethyl cellulose, polyethylene glycol, hydroxypropyl methylcellulose, and sodium hyaluronate; or the binder may include all of the following: sodium alginate, pregelatinized starch, gelatin, gum arabic, sodium carboxymethyl cellulose, polyethylene glycol, hydroxypropyl methylcellulose, and sodium hyaluronate.

[0066] Furthermore, when oral products include auxiliary fillers, these fillers can further fill the oral products, ensuring overall fullness and improving their aesthetics. The auxiliary fillers can include any one of microcrystalline cellulose, starch, and glyceryl behenate; any two of these substances; or all of these substances.

[0067] Furthermore, the mass fraction of the auxiliary filler can be any value from 1 to 20 parts. For example, the mass fraction of the auxiliary filler is 1 part, 5 parts, 7 parts, 10 parts, 15 parts, or 20 parts. This application does not limit the specific details of the embodiments described herein.

[0068] Additionally, when the oral product includes a lubricant, the lubricant is 0.1-0.5 parts. By incorporating a lubricant, during the processing of the oral product, if particles of other materials form large particle clusters, the lubricant can prevent these particle clusters from sticking together, thus avoiding the problem of large particles in the oral product that affect the user's taste.

[0069] In another embodiment, the lubricant may include at least one of magnesium stearate and silica. This arrangement makes the lubricant readily available, thereby reducing the cost of the oral product. In one embodiment, the lubricant may consist only of magnesium stearate, or it may consist only of silica, or it may include both magnesium stearate and silica.

[0070] In addition, the mass fraction of the lubricant can be any value between 0.1 and 0.5 parts. For example, the mass fraction of the lubricant can be 0.1 parts, 0.2 parts, 0.3 parts, 0.4 parts, or 0.5 parts.

[0071] Furthermore, when the composition includes a flavoring agent and a sweetener, the sweetener is 0.01-1 part and the flavoring agent is 0.1-12 parts. By incorporating both flavoring agents and sweeteners, the flavoring agent can adjust the taste and aroma of the oral product, while the sweetener can mask the mouthfeel, allowing the oral product to not only have the taste of nicotine but also other mouthfeelings, thus further enhancing the overall taste. Moreover, with only 0.01-1 parts of sweetener and 0.1-12 parts of flavoring agent, the mass fractions of both are relatively small, reducing the cost of the oral product.

[0072] It should be noted that the mass fraction of the sweetener can be any value between 0.01 and 1 part. For example, the mass fraction of the sweetener is 0.01 parts, 0.05 parts, 0.1 parts, 0.5 parts, or 1 part. This application does not limit the specific amount of sweetener used in this embodiment.

[0073] In addition, the mass fraction of the flavoring agent can be any value between 0.1 and 12 parts. For example, the mass fraction of the flavoring agent is 0.1 parts, 0.8 parts, 3 parts, 5 parts, 7 parts, or 12 parts.

[0074] In another embodiment, the sweetener may include at least one of aspartame, sucralose, neotame, acesulfame potassium, neohesperidin dihydrochalcone, sodium saccharin, mogrosides, and steviol glycosides, and the flavoring agent may include flavoring or cooling agents. This arrangement makes the sweetener and flavoring agent readily available, thereby reducing the cost of the oral product.

[0075] In another embodiment, the sweetener may include any one of aspartame, sucralose, neotame, acesulfame potassium, neohesperidin dihydrochalcone, sodium saccharin, mogroside, and steviol glycoside; the sweetener may include any two of aspartame, sucralose, neotame, acesulfame potassium, neohesperidin dihydrochalcone, sodium saccharin, mogroside, and steviol glycoside; the sweetener may include any three of aspartame, sucralose, neotame, acesulfame potassium, neohesperidin dihydrochalcone, sodium saccharin, mogroside, and steviol glycoside; the sweetener may include any one of aspartame, sucralose, neotame, acesulfame potassium, neohesperidin dihydrochalcone, sodium saccharin, mogroside, and steviol glycoside. Sweeteners may include any four of the following: Aspartame, sucralose, neotame, acesulfame potassium, neohesperidin dihydrochalcone, sodium saccharin, mogroside, and steviol glycosides; sweeteners may include any five of the following: aspartame, sucralose, neotame, acesulfame potassium, neohesperidin dihydrochalcone, sodium saccharin, mogroside, and steviol glycosides; sweeteners may include any six of the following: aspartame, sucralose, neotame, acesulfame potassium, neohesperidin dihydrochalcone, sodium saccharin, mogroside, and steviol glycosides; sweeteners may include any seven of the following: aspartame, sucralose, neotame, acesulfame potassium, neohesperidin dihydrochalcone, sodium saccharin, mogroside, and steviol glycosides. Flavoring agents may include only flavorings, or only cooling agents; of course, flavoring agents may also include both flavorings and cooling agents.

[0076] In one embodiment, the oral product may contain a preservative, with the preservative content being 0.01-1 part. By including a preservative, the oral product can be preserved for a long time, avoiding the problem of easy corrosion. Furthermore, the preservative content is 0.01-1 part, which is relatively low, avoiding the problem of potential harm to the human body from excessive preservatives.

[0077] It should be noted that, in one embodiment, the preservative may include any one of potassium sorbate, polylysine hydrochloride, ascorbic acid, sodium ascorbate, methylparaben, ethylparaben, and nisin, and the preservative may include multiple of potassium sorbate, polylysine hydrochloride, ascorbic acid, sodium ascorbate, methylparaben, ethylparaben, and nisin.

[0078] In another embodiment, the content of the preservative can be any value between 0.01 and 1 part. For example, the content of the preservative is 0.01 part, 0.1 part, 0.5 part, 0.7 part, 0.9 part, or 1 part. This application does not limit the specific amount of preservative used in this embodiment.

[0079] In some embodiments, the active substance is a nicotine agent, which may include at least one of natural nicotine, nicotine salts, synthetic nicotine, hexamethylnicotine, and nicotine salt complexes. Since the active substance is a nicotine agent, it can have a nicotine-releasing effect, allowing the user to feel the presence of nicotine when using the oral product provided in this application embodiment.

[0080] Furthermore, the mass fraction of the nicotine agent can be any value between 0.1 and 10 parts. For example, the mass fraction of the nicotine agent is 0.1 parts, 1 part, 5 parts, 7 parts, or 10 parts. This application does not limit the specific amount of nicotine agent used in this embodiment.

[0081] In another embodiment, the nicotine agent may include any one of natural nicotine, nicotine salts, synthetic nicotine, hexamethylnicotine, or nicotine salt complexes; the nicotine agent may include any two of natural nicotine, nicotine salts, synthetic nicotine, hexamethylnicotine, or nicotine salt complexes; the nicotine agent may include any three of natural nicotine, nicotine salts, synthetic nicotine, hexamethylnicotine, or nicotine salt complexes; the nicotine agent may include any four of natural nicotine, nicotine salts, synthetic nicotine, hexamethylnicotine, or nicotine salt complexes; and the nicotine agent may include all of the substances in the categories of natural nicotine, nicotine salts, synthetic nicotine, hexamethylnicotine, or nicotine salt complexes.

[0082] In addition, nicotine salts can include lactic acid, benzoic acid, tartaric acid, malic acid, etc.

[0083] In addition, nicotine salt complexes may include nicotine salts containing tartrate dihydrate.

[0084] In some embodiments, the oral article may also include a saliva-permeable encapsulation; the composition is in granular form, the particle size of the granular composition being between 75 μm and 750 μm; the composition is filled within the encapsulation.

[0085] With this design, when a user uses the oral product provided in this application embodiment, the package can ensure that the user's saliva penetrates into the package, thereby dissolving the composition inside the package. Furthermore, the presence of the package prevents the particulate composition from scattering in the user's mouth, thus avoiding the problem of reduced oral absorption of the oral product.

[0086] It should be noted that the composition can be in granular form or in block form. The specific shape of the composition is not limited in the embodiments of this application.

[0087] In another embodiment, the particle size of the particulate composition can be any value between 75 μm and 750 μm. For example, the particle size of the composition can be 75 μm, or 100 μm, 200 μm, 300 μm, 400 μm, 500 μm, 600 μm, or 750 μm.

[0088] In another embodiment, the oral article may simultaneously include sugar alcohol, nicotine agent, auxiliary filler, flavoring agent, sweetener, pH adjuster, preservative, binder, and lubricant, wherein the sugar alcohol is 40-90 parts, the nicotine agent is 0.1-10 parts, the auxiliary filler is 1-20 parts, the sweetener is 0.01-1 part, the flavoring agent is 0.1-12 parts, the pH adjuster is 1-20 parts, the preservative is 0.01-1 part, the binder is 1-10 parts, and the lubricant is 0.1-0.5 parts.

[0089] This application provides a preparation method for preparing oral products from any of the above embodiments, such as... Figure 1 As shown, the preparation method includes:

[0090] Step 101: Select the raw materials for the composition. The raw materials for the composition include the first batch of raw materials, which include the main filler and active substances. The main filler includes tagatose.

[0091] The first batch of raw materials can be divided according to mass parts. The mass parts of the main filler in the first batch of raw materials can be 40-90 parts, and the mass parts of the active substance can be 0.1-10 parts. When the main filler includes tagatose, the mass parts of tagatose can be 40-90 parts.

[0092] In addition, the main filler may also include sugar alcohols other than tagatose, which are low hygroscopic sugar alcohols, including at least one of mannitol, lactitol, isomaltitol, sorbitol, erythritol, maltitol, and arabinitol.

[0093] When the main filler includes tagatose and sugar alcohol, the total mass fraction of tagatose and sugar alcohol is 40-90 parts.

[0094] In addition, the active substance can be nicotine, and the mass fraction of nicotine can be 0.1 to 10 parts.

[0095] In addition, the first batch of raw materials may also include auxiliary fillers, the mass fraction of which may be 1 to 20 parts, and the auxiliary fillers include at least one of microcrystalline cellulose, starch, and behenicol glycerides.

[0096] In addition, the first batch of raw materials may also include pH adjusters, sweeteners, flavoring agents, and preservatives. The mass fraction of pH adjusters may be 1 to 20 parts, the mass fraction of sweeteners may be 0.01 to 1 part, the mass fraction of preservatives may be 0.01 to 1 part, and the mass fraction of flavoring agents may be 0.1 to 12 parts.

[0097] Step 102: Crush and sieve the solid raw materials in the first batch to form initial raw material particles.

[0098] When oral products include sugar alcohols, nicotine agents, auxiliary fillers, flavoring agents, sweeteners, pH adjusters, preservatives, binders, and lubricants, the solid raw materials of sugar alcohols, nicotine agents, auxiliary fillers, flavoring agents, sweeteners, pH adjusters, preservatives, and lubricants can be simultaneously pulverized and mixed. The mixed raw materials are then passed through a 20-mesh sieve to remove larger particles, forming initial raw material particles.

[0099] Step 103: Dissolve the liquid raw material in the first batch of raw materials in ethanol to form an initial solution.

[0100] In this process, the binder and flavoring agent are liquid raw materials, so that after the binder and flavoring agent are added to ethanol, the binder and flavoring agent dissolve in ethanol to form an initial solution.

[0101] Step 104: Mix the initial raw material particles in a pellet mill.

[0102] The granules that have passed through a 20-mesh sieve can be added to the granulator, which is the initial raw material granules. The granulator can run at a speed of 100-300 rpm, so that the granules are mixed evenly.

[0103] Step 105: Mix the initial raw material particles with the initial solution to form wet particles.

[0104] After the granulator has finished mixing the granules, the initial solution is slowly added to the granulator and continuously stirred at a speed of 100-300 rpm. The shearing paddle is then turned on and sheared at 800-1500 rpm to ensure that the initial solution and the granules in the granulator are completely mixed, thus forming wet granules.

[0105] Step 106: Sieve and dry the wet particles to obtain dry particles.

[0106] The process involves passing wet granules through a sieve with a mesh size of 20-40 mesh to ensure uniform particle size. The granules are then fed into a fluidized bed for drying, with the temperature and drying time carefully controlled to guarantee uniform drying. The fluidized bed temperature can be 40℃-60℃, and the drying time can be 0.5h-4h. This process yields dried granules.

[0107] In addition, in some embodiments, after obtaining the dried particles, the preparation method further includes: sieving the dried particles and mixing the sieved dried particles with a second batch of raw materials in the composition, the second batch of raw materials including a lubricant.

[0108] The process involves passing the dried granules through a 20-40 mesh sieve to remove oversized particles, and then passing them through an 80-150 mesh sieve to remove undersized particles, thus obtaining dried granules of suitable size. These appropriately sized dried granules are then briefly and uniformly mixed with a lubricant to increase their flowability, resulting in the oral product.

[0109] The following describes the preparation of oral products using the above-described preparation method, and, based on existing oral product materials, the preparation of comparative oral products as follows: (Specific examples and comparative examples are provided below.)

[0110] Example 1

[0111] raw material use content Tagar filler 39.36％ Mannitol filler 17.00％ lactitol filler 10.30％ Isomaltitol filler 4.60％ microcrystalline cellulose auxiliary filler 5.00％ essence Flavoring agent 2.30％ Sodium alginate adhesive 4.60％ Pregelatinized starch adhesive 2.60％ gelatin adhesive 2.30％ Acesulfame K sweeteners 0.34％ Nicotine dihydrate containing tartaric acid salt Nicotine 8.90％ Sorbic acid preservative 0.12％ Sodium bicarbonate pH adjuster 2.00％ magnesium stearate lubricant 0.58％

[0112] Example 2

[0113]

[0114]

[0115] Example 3

[0116] raw material use content Tagar filler 34.50％ Mannitol filler 9.36％ lactitol filler 12.60％ Isomaltitol filler 2.30％ microcrystalline cellulose auxiliary filler 15.00％ essence Flavoring agent 8.30％ Sodium alginate adhesive 2.20％ Pregelatinized starch adhesive 4.20％ gelatin adhesive 2.20％ Acesulfame K sweeteners 0.34％ Nicotine dihydrate containing tartaric acid salt Nicotine 3.30％ Sorbic acid preservative 0.12％ Sodium bicarbonate pH adjuster 5.00％ magnesium stearate lubricant 0.58％

[0117] Example 4

[0118] raw material use content Tagar filler 27.80％ Mannitol filler 23.30％ lactitol filler 18.30％ Isomaltitol filler 2.20％ microcrystalline cellulose auxiliary filler 9.26％ essence Flavoring agent 5.00％ Sodium alginate adhesive 3.60％ Pregelatinized starch adhesive / gelatin adhesive 1.50％ Acesulfame K sweeteners 0.34％ Nicotine dihydrate containing tartaric acid salt Nicotine 3.00％ Sorbic acid preservative 0.12％ Sodium bicarbonate pH adjuster 5.00％ magnesium stearate lubricant 0.58％

[0119] Example 5

[0120]

[0121]

[0122] Example 6

[0123] raw material use content Tagar filler 80.00％ Mannitol filler / lactitol filler 2.40％ Isomaltitol filler / microcrystalline cellulose auxiliary filler 4.72％ essence Flavoring agent 3.50％ Sodium alginate adhesive / Pregelatinized starch adhesive 5.30％ gelatin adhesive 2.10％ Acesulfame K sweeteners 0.40％ Nicotine dihydrate containing tartaric acid salt Nicotine 0.30％ Sorbic acid preservative 0.12％ Sodium bicarbonate pH adjuster 0.58％ magnesium stearate lubricant 0.58％

[0124] Comparative Example 1

[0125]

[0126]

[0127] The samples prepared according to Examples 1 to 6 and the sample prepared according to Comparative Example 1 were placed in an environment with an ambient temperature of 25 degrees Celsius and an ambient humidity of 70% for comparison. The comparison results are as follows:

[0128] Comparison results

[0129] Sample Name Average unit weight 24-hour rate of change 48H rate of change 72H rate of change Comparative Example 1 0.4681 6.60％ 7.56％ 12.63％ Example 1 0.4314 1.65％ 2.53％ 3.15％ Example 2 0.4414 2.02％ 2.97％ 4.10％ Example 3 0.4125 2.30％ 2.81％ 5.24％ Example 4 0.4150 4.61％ 5.98％ 7.77％ Example 5 0.4588 2.48％ 3.15％ 4.94％ Example 6 0.4521 1.30％ 2.64％ 5.15％

[0130] In Examples 1 to 6, oral products were prepared using the sugar alcohols provided in this application. Comparative Example 1 used materials from existing oral products. The differences between Examples 1 to 6 include variations in the content of sugar alcohols, binders, auxiliary fillers, sweeteners, nicotine, preservatives, pH adjusters, and lubricants. Furthermore, the type of sugar alcohol in Comparative Example 1 differs from that in Examples 1 to 6. In the comparison results table, the 24H, 48H, and 72H change rates refer to the rate of change in the mass of the oral product. Of course, the percentage change in moisture content of the oral products prepared in Examples 1 to 6 and the oral products prepared in Comparative Example 1 can also be measured. Specifically, the moisture content of the oral products prepared in Examples 1 to 6 and the oral products prepared in Comparative Example 1 can be measured using a Karl Fischer moisture analyzer to determine the moisture changes of the oral products prepared in Examples 1 to 6 and the oral products prepared in Comparative Example 1 after being stored for different periods of time.

[0131] Furthermore, as can be seen from the comparison results table above, the oral product in Comparative Example 1 showed a greater change in mass after being left for a period of time, indicating that the oral product in Comparative Example 1 absorbed more moisture and was prone to becoming damp. The oral products in Examples 1 to 6, after being left for the same period, showed significantly less change in mass than the oral product in Comparative Example 1, thus demonstrating that the oral products in Examples 1 to 6 were less susceptible to moisture. Specifically, the oral product obtained in Comparative Example 1 increased in mass by 6.6% after 24 hours, while the oral products obtained in Examples 1 to 6 increased in mass by a maximum of 4.61% after 24 hours. Clearly, the oral products obtained in Examples 1 to 6 have better moisture-proof effects. Similarly, the oral product obtained in Comparative Example 1 increased in mass by 7.56% after 48 hours, while the oral products obtained in Examples 1 to 6 increased in mass by a maximum of 5.98% after 48 hours. Clearly, the oral products obtained in Examples 1 to 6 have better moisture-proof effects. Likewise, the oral product obtained in Comparative Example 1 increased in mass by 12.63% after 72 hours, while the oral products obtained in Examples 1 to 6 increased in mass by a maximum of 7.77% after 24 hours. Clearly, the oral products obtained in Examples 1 to 6 have better moisture-proof effects.

[0132] In the description of this specification, the references to terms such as "one embodiment," "some embodiments," "illustrative embodiment," "example," "specific example," or "some examples," etc., indicate that a specific feature, structure, material, or characteristic described in connection with that embodiment or example is included in at least one embodiment or example of this application. In this specification, the illustrative expressions of the above terms do not necessarily refer to the same embodiment or example. Furthermore, the specific features, structures, materials, or characteristics described may be combined in any suitable manner in one or more embodiments or examples.

[0133] Although embodiments of this application have been shown and described, those skilled in the art will understand that various changes, modifications, substitutions and alterations can be made to these embodiments without departing from the principles and spirit of this application, the scope of which is defined by the claims and their equivalents.

Claims

1. A mouth-held product, characterized in that, The composition includes: a main filler and an active substance; the main filler includes tagatose; The main filler is 40-90 parts by mass, and the active substance is 0.1-10 parts.

2. The oral article according to claim 1, characterized in that, The main filler also includes sugar alcohols, which are low-hygroscopic sugar alcohols.

3. The oral article according to claim 2, characterized in that, The low hygroscopic sugar alcohols include at least one of mannitol, lactitol, isomaltitol, sorbitol, erythritol, maltitol, and arabinitol.

4. The oral article according to claim 2, characterized in that, In the main filler, the ratio of the content of tagatose to the content of sugar alcohol is 1:1-3:

2.

5. The oral article according to claim 1, characterized in that, The composition further includes a pH adjuster, said pH adjuster comprising at least one of sodium bicarbonate, calcium carbonate, tartaric acid, benzoic acid, and calcium lactate; and / or, The composition further includes a binder comprising at least one of sodium alginate, pregelatinized starch, gelatin, gum arabic, sodium carboxymethyl cellulose, polyethylene glycol, hydroxypropyl methylcellulose, and sodium hyaluronate; and / or, The oral product further includes auxiliary fillers, which include at least one of microcrystalline cellulose, starch, and glyceryl behenate; and / or, The oral product further includes a lubricant, said lubricant comprising at least one of magnesium stearate and silicon dioxide; and / or, The composition further includes a sweetener comprising at least one of aspartame, sucralose, neotame, acesulfame potassium, neohesperidin dihydrochalcone, sodium saccharin, mogrosides, and steviol glycosides; and / or, The composition further includes a flavoring agent, which includes a flavoring agent or a cooling agent; and / or, The oral product further includes preservatives, which include at least one of potassium sorbate, polylysine hydrochloride, ascorbic acid, sodium ascorbate, methylparaben, ethylparaben, and nisin.

6. The oral article according to claim 1, characterized in that, Measured by mass parts The composition further includes an adhesive, said adhesive being 1-10 parts; and / or, The oral product further includes a lubricant, said lubricant being 0.1-0.5 parts; and / or, The oral product further includes an auxiliary filler, wherein the auxiliary filler is 1-20 parts; and / or, The composition further includes a pH adjuster, wherein the pH range when the composition is dissolved is 7-10; and / or, The composition further includes a sweetener, said sweetener being 0.01-1 part; and / or, The composition further includes a flavoring agent, said flavoring agent being 0.1-12 parts; and / or, The composition further includes a preservative, which is 0.01-1 part.

7. The oral article according to claim 1, characterized in that, The active substance is a nicotine agent, which includes at least one of natural nicotine, nicotine salts, synthetic nicotine, hexamethylnicotine, and nicotine salt complexes.

8. The oral article according to claims 1-7, characterized in that, The oral product also includes a saliva-permeable wrapper; The composition is in the form of granules, and the particle size of the granular composition is between 75 μm and 750 μm; The composition is filled into the package.

9. A method for preparing a mouth-held product, characterized in that, The method for preparing the oral article according to any one of claims 1-8 comprises: The selected composition raw materials include first batch raw materials, which include a main filler and an active substance, wherein the main filler includes tagatose. The solid raw materials in the first batch of raw materials are crushed and sieved to form initial raw material particles; The liquid raw material in the first batch of raw materials is dissolved in ethanol to form an initial solution; The initial raw material particles are mixed in a pellet mill; The initial raw material particles, after being mixed, are then mixed with the initial solution to form wet particles; The moistened particles are sieved and dried to obtain dry particles.

10. The method for preparing the oral product according to claim 9, characterized in that, After obtaining the dried granules, the preparation method further includes: sieving the dried granules and mixing the sieved dried granules with a second batch of raw materials in the composition, the second batch of raw materials including a lubricant.

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