Oral product and preparation method therefor

Abstract

The present application belongs to the technical field of smokeless tobacco products. Disclosed are an oral product and a preparation method therefor. The oral product comprises an oral content, and the oral content comprises a substrate, an active agent and a binder, wherein the substrate is a water-soluble porous substrate; the active agent is attached to the pores and / or the surface of the substrate; and the binder coats the active agent and the substrate. The substrate, the active agent and the binder are, in parts by mass, 40-90 parts, 0.5-10 parts and 3-7 parts, respectively.

Description

Oral products and their preparation methods [Technical Field]

[0001] This application relates to the field of smokeless tobacco products technology, and in particular to a mouth-held product and its preparation method. [Background Technology]

[0002] Leaking products are smokeless products containing nicotine. They typically do not require combustion; instead, the nicotine is absorbed through the oral mucosa, providing a sense of nicotine satisfaction. However, existing nicotine-containing products dissolve at varying rates in the mouth, resulting in inconsistent nicotine release and impacting the user experience. [Summary of the Invention]

[0003] This application provides a mouth-held product and its preparation method, which can solve the technical problem of unstable nicotine release rate in mouth-held products.

[0004] To solve the above-mentioned technical problems, this application provides a mouthpiece, which includes mouth contents, a substrate, an active agent, and an adhesive. The substrate is a water-soluble porous substrate, the active agent is attached to the pores of the substrate and / or the surface of the substrate, and the adhesive coats the active agent and the substrate. By weight, the substrate, the active agent, and the adhesive are 40-90 parts, 0.5-10 parts, and 3-7 parts, respectively.

[0005] In one embodiment, the particle size of the oral contents is 120 μm-320 μm.

[0006] In one embodiment, the substrate includes at least one of porous gum arabic, porous maltodextrin, porous starch, and porous carboxymethyl cellulose.

[0007] In one embodiment, the pore size of the substrate is 5μm-30μm.

[0008] In one embodiment, the particle size of the substrate is 100μm-300μm.

[0009] In one embodiment, the active agent includes at least one of synthetic nicotine, natural nicotine, and nicotine derivatives; and / or, the binder includes at least one of sodium carboxymethyl cellulose, hydroxypropyl methylcellulose, microcrystalline cellulose, and low-substituted hydroxypropyl cellulose; and / or, the oral product further includes at least one of 1-3 parts by weight of a sweetener, 0.5-2 parts by weight of an edible flavoring, 0.1-0.5 parts by weight of a preservative, and 0.3-1 parts by weight of a pH adjuster.

[0010] In one embodiment, the time when 80% of the active ingredient in the oral product is released is defined as the peak time, and the peak time of the oral product is 4 min to 32 min.

[0011] This application also provides a method for preparing a mouthpiece, comprising: mixing raw materials to obtain a mixture, wherein, by mass parts, the raw materials include the following components: 40-90 parts of a substrate and 0.5-10 parts of an activator, the substrate being a water-soluble porous substrate; dissolving an adhesive in a solvent to obtain a coating solution, wherein, by mass parts, the adhesive is 3-7 parts and the solvent is 1-40 parts; coating the mixture with the coating solution to obtain coated particles; processing the coated particles to obtain mouth contents; and using the mouth contents to prepare a mouthpiece.

[0012] In one embodiment, the particle size of the oral contents is 120 μm-320 μm.

[0013] In one embodiment, the substrate includes at least one of porous gum arabic, porous maltodextrin, porous starch, and porous carboxymethyl cellulose.

[0014] In one embodiment, the pore size of the substrate is 5μm-30μm.

[0015] In one embodiment, the particle size of the substrate is 100μm-300μm.

[0016] In one embodiment, the raw materials also include at least one of the following in parts by weight: 1-3 parts sweetener, 0.5-2 parts flavoring, 0.1-0.5 parts preservative, and 0.3-1 parts pH adjuster.

[0017] In one embodiment, in the step of mixing the raw materials to obtain a mixture, the mixing speed is 300 rpm-400 rpm and the mixing time is 15 min-20 min; and / or, in the step of dissolving the adhesive in a solvent to obtain a coating solution, the dissolution temperature is 20℃-30℃, the stirring speed is 450 rpm-550 rpm, and the dissolution time is 1.0 h-2.0 h; and / or, in the step of coating the mixture with the coating solution to obtain coated granules, the coating treatment temperature is 40℃-50℃, the spray rate is 1.0 mL / min-2.0 mL / min, and the coating treatment time is 15 min-25 min; and / or, in the step of processing the coated granules to obtain oral contents, the coated granules are dried using a microwave dryer with a microwave power of 3-6 kW per kg of raw material and a drying time of 10 min-20 min.

[0018] The oral article provided in this application, based on the selection of raw material components and the control of the proportional relationship between the raw material components, has a water-soluble porous substrate as the base material, an active agent attached to the substrate, and an adhesive coating the active agent and the substrate. First, the adhesive forms a coating film on the outside of the substrate, allowing the adhesive to control the contact rate between the substrate and water, thereby controlling the release rate of the active ingredient in the active agent attached to the substrate. Second, the water-soluble porous substrate can dissolve in water, allowing the substrate to further control the release of the active ingredient in the active agent attached to the substrate, thereby stably controlling the release rate of the active ingredient. [Attached Image Description]

[0019] To more clearly illustrate the technical solutions in the embodiments of this application, the accompanying drawings used in the description of the embodiments will be briefly introduced below. Obviously, the accompanying drawings described below are only some embodiments of this application. For those skilled in the art, other drawings can be obtained based on these drawings without creative effort.

[0020] Figure 1 is a schematic flowchart of an embodiment of the preparation method provided in this application;

[0021] Figure 2 is a schematic flowchart of another embodiment of the preparation method provided in this application;

[0022] Figure 3 is a comparison of the dissolution test results between Example A and Comparative Example a;

[0023] Figure 4 is a comparison of the dissolution test results between Example A and Comparative Example b;

[0024] Figure 5 is a comparison of the dissolution test results between Example A and Comparative Example C;

[0025] Figure 6 is a comparison of the dissolution test results between Example A and Comparative Example d;

[0026] Figure 7 is a comparison of the dissolution test results between Example A and Comparative Example e;

[0027] Figure 8 is a comparison chart of the AD dissolution test results of the examples.

Detailed Implementation Methods

[0028] The present application will now be described in further detail with reference to the accompanying drawings and embodiments. It should be particularly noted that the following embodiments are for illustrative purposes only and do not limit the scope of the application. Similarly, the following embodiments are only some, not all, embodiments of the present application, and all other embodiments obtained by those skilled in the art without inventive effort are within the scope of protection of the present application.

[0029] In the description of this application, "multiple" means at least two, such as two, three, etc., unless otherwise explicitly specified. The terms "first," "second," and "third" in the embodiments of this application are for descriptive purposes only and should not be construed as indicating or implying relative importance or implicitly specifying the number of indicated technical features. Therefore, a feature defined as "first," "second," or "third" may explicitly or implicitly include at least one of that feature. All directional indications (such as up, down, left, right, front, back, etc.) in the embodiments of this application are only used to explain the relative positional relationships and movements between components in a specific orientation (as shown in the figures). If the specific orientation changes, the directional indication will also change accordingly. The terms "comprising" and "having," and any variations thereof, in the embodiments of this application are intended to cover non-exclusive inclusion. For example, a process, method, system, product, or device that includes a series of steps or units is not limited to the listed steps or units, but may optionally include steps or units not listed, or may optionally include other steps or components inherent to these processes, methods, products, or devices.

[0030] In this document, the term "embodiment" means that a particular feature, structure, or characteristic described in connection with an embodiment may be included in at least one embodiment of this application. The appearance of this phrase in various places throughout the specification does not necessarily refer to the same embodiment, nor is it a separate or alternative embodiment mutually exclusive with other embodiments. It will be explicitly and implicitly understood by those skilled in the art that the embodiments described herein can be combined with other embodiments.

[0031] This application provides a method for preparing an oral article. Referring to Figure 1, the preparation method may include steps S10-S40:

[0032] S10, the raw materials are mixed to obtain a mixture. Thorough mixing of the raw materials ensures a more uniform distribution of components in the prepared oral product, thereby improving the taste. The raw materials consist of a substrate and an active agent. The substrate serves as a carrier for the active agent. The active agent, as the main active ingredient, can release the active ingredient. The substrate is a water-soluble porous substrate that can adsorb the active agent. During the mixing of the raw materials, the active agent adheres to the pores and / or surface of the substrate. The water-soluble porous substrate is soluble in water. When the oral product is placed in the mouth, saliva, which is predominantly water, can dissolve the substrate, allowing the substrate to control the release of the active ingredient from the active agent attached to it.

[0033] The composition, by weight, is: 40-90 parts substrate and 0.5-10 parts activator. The selection of raw material components and the control of their proportional relationship allow the activator to adhere to the substrate, and in subsequent coating processes, the adhesive can coat both the activator and the substrate.

[0034] In one embodiment, the mass fraction of the substrate can be 40 parts, 45 parts, 50 parts, 55 parts, 60 parts, 65 parts, 70 parts, 75 parts, 80 parts, 85 parts, 90 parts, etc., or a range of any two of the above values, such as 40-55 parts, 60-85 parts, 50-70 parts, 75-90 parts, etc.

[0035] In one embodiment, the mass fraction of the active agent can be 0.5 parts, 1 part, 2 parts, 3 parts, 4 parts, 5 parts, 6 parts, 7 parts, 8 parts, 9 parts, 10 parts, etc., or a range of any two of the above values, such as 0.5 parts-5 parts, 6 parts-9 parts, 3 parts-6 parts, 7 parts-10 parts, etc.

[0036] S20, the adhesive is dissolved in a solvent to obtain a coating solution. The adhesive stabilizes the structure of the oral product, thereby allowing control over the release rate of the active ingredient. Dissolving the adhesive in a solvent ensures its complete dissolution, facilitating uniform coating of the adhesive onto the active agent and substrate during subsequent coating processes, thus enhancing the structural stability of the oral product.

[0037] Of these, the adhesive comprises 3-7 parts by weight, and the solvent comprises 1-40 parts by weight.

[0038] In one embodiment, the mass fraction of the adhesive can be 3 parts, 4 parts, 5 parts, 6 parts, 7 parts, or any range of any two of the above values, such as 3-5 parts, 6-7 parts, 4-6 parts, 5-7 parts, etc.

[0039] In one embodiment, the mass fraction of the solvent can be 1 part, 5 parts, 10 parts, 15 parts, 20 parts, 25 parts, 30 parts, 35 parts, 40 parts, etc., or a range of any two of the above values, such as 1 part to 20 parts, 25 parts to 40 parts, 5 parts to 15 parts, 10 parts to 30 parts, etc.

[0040] S30, the mixture is coated with a coating solution to obtain coated granules.

[0041] Through coating treatment, the adhesive coats the surfactant and the substrate, forming a coating film on the outside of the substrate. This allows the adhesive to control the contact rate between the substrate and water, thereby controlling the release rate of the active ingredients in the surfactant attached to the substrate.

[0042] S40, process the coated particles to obtain oral contents, and use the oral contents to prepare oral products.

[0043] Oral articles may also include a liquid-permeable bag, in which the oral contents are encapsulated. The liquid-permeable bag allows saliva to permeate, which can dissolve the substrate and thereby release the active ingredients in the surfactants attached to the substrate.

[0044] The preparation method provided in this application is based on the selection of raw material components and the control of the ratio between the raw material components. The substrate is a water-soluble porous substrate, the surfactant is attached to the substrate, and the adhesive coats the surfactant and the substrate. First, the adhesive forms a coating film on the outside of the substrate, so that the adhesive can control the contact rate between the substrate and water, thereby controlling the release rate of the active ingredient in the surfactant attached to the substrate. Second, the water-soluble porous substrate can dissolve in water, so that the substrate can further control the release of the active ingredient in the surfactant attached to the substrate, thereby stably controlling the release rate of the active ingredient.

[0045] In one embodiment, the substrate includes at least one of porous gum arabic, porous maltodextrin, porous starch, and porous carboxymethyl cellulose. Experiments show that porous gum arabic, porous maltodextrin, porous starch, and porous carboxymethyl cellulose dissolve at different rates in water. Therefore, the above-mentioned substrates can be selected to prepare products with different active ingredient release rates to meet the personalized needs of users.

[0046] As the adhesive dissolves in the oral cavity, the active ingredients in the surfactant attached to the substrate are continuously released. The peak time can be defined as the time when 80% of the active ingredients in the oral product are released. In one embodiment, the peak time of the oral product is 4 min-32 min. Specifically, when the substrate is porous gum arabic, the peak time of the oral product is 4 min-6 min, such as 4 min, 5 min, 6 min, or any range of two of the above values, such as 4 min-5 min, 5 min-6 min, etc. The release rate of the active ingredient is fast, and a fast-release product can be prepared. When the substrate is porous maltodextrin, the peak time of the oral product is 8 min-12 min, such as 8 min, 10 min, 12 min, etc., or any range of two of the above values, such as 8 min-10 min, 10 min-12 min, etc. The release rate of the active ingredient is relatively fast, and a faster-release product can be prepared. When the substrate is When using porous starch as the substrate, the peak time of the oral product is 18-22 minutes, such as 18, 20, or 22 minutes, or any combination of two of the above values, such as 18-20 minutes or 20-22 minutes. The release rate of the active ingredient is relatively slow, allowing for the preparation of slow-release products. When the substrate is porous carboxymethyl cellulose, the peak time of the oral product is 28-32 minutes, such as 28, 30, or 32 minutes, or any combination of two of the above values, such as 28-30 minutes or 30-32 minutes. The release rate of the active ingredient is also slow, allowing for the preparation of slow-release products. Therefore, the different peak times of products prepared using the above substrates can meet the personalized needs of users.

[0047] In one embodiment, the active agent includes at least one of synthetic nicotine, natural nicotine, and nicotine derivatives. Nicotine derivatives include nicotine salts, nicotine substitutes, or salts of nicotine substitutes. Nicotine substitutes include 6-methylnicotine, and salts of nicotine substitutes include 6-methylnicotine salts, such as 6-methylnicotine tartrate or 6-methylnicotine benzoate. The active ingredient released by the aforementioned active agent includes nicotine, thereby providing consumers with a certain degree of nicotine satisfaction.

[0048] In one embodiment, the active agent includes at least one of caffeine and capsaicin. When the active agent includes capsaicin, the active ingredient released by the active agent includes capsaicin; when the active agent includes caffeine, the active ingredient released by the active agent includes caffeine, which can meet various user needs.

[0049] In one embodiment, the adhesive includes a substance or component with adhesive properties, and the adhesive itself can adhere to the surface of the substrate to form a coating film outside the substrate.

[0050] In one embodiment, the adhesive does not have adhesive ability in its undissolved state. After the adhesive is dissolved in a solvent, it forms a coating solution with adhesive ability. The coating solution is used to coat the mixture, and the adhesive coats the substrate, thereby forming a coating film on the outside of the substrate.

[0051] In one embodiment, the adhesive includes at least one of sodium carboxymethyl cellulose, hydroxypropyl methyl cellulose, microcrystalline cellulose, and low-substituted hydroxypropyl cellulose.

[0052] Solvents may include ethanol. In one embodiment, the solvent includes water. Compared to ethanol, oral products prepared using water as a solvent have a milder taste and can reduce oral irritation.

[0053] In one embodiment, the raw materials further include at least one of the following by weight: 1-3 parts sweetener, 0.5-2 parts flavoring, 0.1-0.5 parts preservative, and 0.3-1 part pH adjuster. The sweetener can increase the variety of flavors in the oral product. The flavoring is used to adjust the taste. The preservative makes the oral product less prone to spoilage, thereby ensuring its long-term safety. The pH adjuster is used to adjust the pH of the oral product to optimize the stability and release efficiency of the active ingredient.

[0054] In one embodiment, the mass fraction of the sweetener can be 1 part, 1.5 parts, 2 parts, 2.5 parts, 3 parts, etc., or a range of any two of the above values, such as 1 part-2 parts, 2 parts-3 parts, 1 part-2.5 parts, 1.5 parts-3 parts, etc.

[0055] In one embodiment, the sweetener includes at least one of xylitol, sorbitol, mannitol, iodine, lactitol, maltitol, isomaltitol, hydrogenated starch hydrolysate, erythritol, maltotriol, aspartame, acesulfame potassium, sodium saccharin, sucralose, neotame, cyclamate, alitane, steviol glycosides, arabinitol, and monk fruit sweetener.

[0056] In one embodiment, the mass fraction of the edible flavoring can be 0.5 parts, 0.8 parts, 1 part, 1.2 parts, 1.5 parts, 1.8 parts, 2 parts, etc., or a range of any two of the above values, such as 0.5 parts-1 part, 1.2 parts-2 parts, 0.8 parts-1.5 parts, 1 part-1.5 parts, etc.

[0057] In one embodiment, the edible flavoring includes at least one of peppermint flavoring, watermelon flavoring, apple flavoring, lemon flavoring, vanilla flavoring, and citrus flavoring.

[0058] In one embodiment, the mass fraction of the preservative may be 0.1 parts, 0.2 parts, 0.3 parts, 0.4 parts, 0.5 parts, etc., or a range of any two of the above values, such as 0.1 parts-0.3 parts, 0.4 parts-0.5 parts, 0.2 parts-0.4 parts, 0.3 parts-0.5 parts, etc.

[0059] In one embodiment, the preservative includes at least one of benzalkonium chloride, sodium chloride, sorbic acid, benzoic acid and its sodium salt, p-hydroxybenzoate and its sodium salt, disodium ethylenediaminetetraacetate, and sodium acetate.

[0060] In one embodiment, the mass fraction of the acid-base regulator can be 0.3 parts, 0.5 parts, 0.7 parts, 0.9 parts, 1 part, etc., or a range of any two of the above values, such as 0.3 parts-0.7 parts, 0.7 parts-1 part, 0.5 parts-0.7 parts, 0.5 parts-0.9 parts, etc.

[0061] In one embodiment, the acid-base regulator includes at least one of sodium carbonate, sodium bicarbonate, potassium carbonate, potassium bicarbonate, phosphate, hydroxide, and tris(hydroxymethyl)aminomethane.

[0062] Please refer to Figure 2. In one embodiment, step S05 is included before step S10:

[0063] S05. The substrate is sieved to control the particle size between 100μm and 300μm. A raw material screening machine can be used for substrate sieving. By sieving the substrate, the consistency of the particle size can be ensured, thereby making the dissolution rate of the substrate relatively stable and the peak time of the product meeting expectations.

[0064] Specifically, when the substrate is porous gum arabic or porous maltodextrin, the particle size of the substrate is controlled between 100μm and 300μm, such as 100μm, 150μm, 200μm, 250μm, 300μm, etc., or a range consisting of any two of the above values, such as 100μm-200μm, 200μm-300μm, 150μm-200μm, 250μm-300μm, etc.; when the substrate is porous starch, the particle size is controlled between 100μm and 300μm, such as 100μm-200μm, 200μm-300μm, 150μm-200μm, 250μm-300μm, etc. The particle size of the substrate is controlled between 150μm and 250μm; when the substrate is porous carboxymethyl cellulose, the particle size of the substrate is controlled between 200μm and 300μm, such as 200μm, 220μm, 250μm, 280μm, 300μm, etc., or any range of two of the above values, such as 200μm-250μm, 250μm-300μm, 220μm-250μm, 250μm-280μm, etc.

[0065] In one embodiment, the pore size of the substrate is 5μm-30μm. By controlling the pore size of the substrate, the consistency of the pore size can be ensured, thereby making the dissolution rate of the substrate relatively stable and the peak time of the product meets expectations.

[0066] Specifically, when the substrate is porous gum arabic, the pore size of the substrate is controlled between 5μm and 15μm, such as 5μm, 8μm, 10μm, 12μm, 15μm, etc., or any range of two of the above values, such as 5μm-10μm, 10μm-15μm, 8μm-12μm, 10μm-12μm, etc.; when the substrate is porous maltodextrin, the pore size of the substrate is controlled between 5μm and 10μm, such as 5μm, 8μm, 10μm, etc., or any range of two of the above values, such as 5μm-8μm, 8μm-10μm, etc.; when the substrate... When the substrate is porous starch, the pore size is controlled between 10μm and 15μm, such as 10μm, 12μm, 15μm, or any combination of two of the above values, such as 10μm-12μm, 12μm-15μm, etc. When the substrate is porous carboxymethyl cellulose, the pore size is controlled between 20μm and 30μm, such as 20μm, 22μm, 25μm, 28μm, 30μm, or any combination of two of the above values, such as 20μm-25μm, 25μm-30μm, 22μm-25μm, 25μm-28μm, etc.

[0067] In one embodiment, a high-speed mixer is used to mix the raw materials. In the step of mixing the raw materials to obtain a mixture, the mixing speed is 300 rpm-400 rpm, and the mixing time is 15 min-20 min. Exemplarily, the mixing speed can be 300 rpm, 320 rpm, 350 rpm, 380 rpm, 400 rpm, etc., or any range of two of the above values, such as 300 rpm-350 rpm, 350 rpm-400 rpm, 320 rpm-350 rpm, 380 rpm-400 rpm, etc.; the mixing time can be 15 min, 18 min, 20 min, etc., or any range of two of the above values, such as 15 min-18 min, 18 min-20 min, etc. By controlling the mixing speed and mixing time, the raw materials can be thoroughly mixed, resulting in a more uniform distribution of components in the prepared oral product, thereby improving the taste of the oral product.

[0068] In one embodiment, a twin-shaft mixer is used to prepare the coating solution. In the step of dissolving the adhesive in the solvent to obtain the coating solution, the dissolution temperature is 20℃-30℃, the stirring speed is 450rpm-550rpm, and the dissolution time is 1.0h-2.0h. For example, the dissolution temperature can be 20℃, 22℃, 25℃, 28℃, 30℃, etc., or a range of any two of the above values, such as 20℃-25℃, 25℃-30℃, 22℃-25℃, 28℃-30℃, etc.; the stirring speed can be 450rpm, 480rpm, 500rpm, 520rpm, 550rpm, etc., or a range of any two of the above values, such as 450rpm-500rpm, 500rpm-550rpm, 480rpm-520rpm, 500rpm-520rpm, etc.; the dissolution time can be 1.0h, 1.2h, 1.5h, 1.8h, 2.0h, etc., or a range of any two of the above values, such as 1.0h-1.5h, 1.5h-2.0h, 1.2h-1.8h, 1.5h-1.8h, etc. By controlling the dissolution temperature, stirring speed, and dissolution time of the coating solution, the adhesive can be fully dissolved, which facilitates better coating of the active agent and substrate, thereby enhancing the structural stability of oral products.

[0069] In one embodiment, a fluidized bed coating machine is used to prepare coated particles. In the step of coating the mixture with a coating solution to obtain coated particles, the coating temperature is 40℃-50℃, the spray rate is 1.0mL / min-2.0mL / min, and the coating time is 15min-25min. Exemplarily, the coating temperature can be 40℃, 42℃, 45℃, 48℃, 50℃, etc., or any range of any two of the above values, such as 40℃-45℃, 45℃-50℃, 42℃-48℃, 45℃-48℃, etc.; the spray rate can be 1.0mL / min, 1.2mL / min, 1.5mL / min, 1.8mL / min, 2.0mL / min, etc., or any range of any two of the above values, such as 1.0mL / min- Spray rates can be 1.5 mL / min, 1.5 mL / min-2.0 mL / min, 1.2 mL / min-1.8 mL / min, 1.5 mL / min-1.8 mL / min, etc.; coating times can be 15 min, 18 min, 20 min, 22 min, 25 min, etc., or any range of two of the above values, such as 15 min-20 min, 20 min-25 min, 18 min-22 min, 20 min-22 min, etc. By controlling the treatment temperature, spray rate, and treatment time in the coating process, the adhesive can coat the active agent and the substrate, thereby effectively regulating and stably controlling the release rate of the active ingredient.

[0070] In one embodiment, in the step of processing the coated particles to obtain oral contents, a microwave dryer is used to dry the coated particles. The microwave power is 3-6 kW per kg of raw material, and the drying time is 10-20 minutes. For example, the microwave power per kg of raw material can be 3 kW, 4 kW, 5 kW, 6 kW, or any range of two of the above values, such as 3 kW-4 kW, 5 kW-6 kW, 3 kW-5 kW, 4 kW-6 kW, etc.; the drying time can be 10 minutes, 12 minutes, 15 minutes, 18 minutes, 20 minutes, or any range of two of the above values, such as 10 minutes-15 minutes, 15 minutes-20 minutes, 12 minutes-18 minutes, 15 minutes-18 minutes, etc. The microwave dryer ensures precise moisture control during the production process, thereby extending the product's shelf life.

[0071] In one embodiment, in the step of processing the coated particles to obtain oral contents, the dried coated particles are sieved to control the particle size of the oral contents between 120 μm and 320 μm. By sieving the coated particles, unqualified particles are removed, ensuring the consistency of the oral product and thus ensuring that the peak time of the product meets expectations.

[0072] Specifically, when the substrate is porous gum arabic or porous maltodextrin, the sieve mesh size is 70-100 mesh. Using a finer sieve, the particle size of the contents is controlled between 100μm and 300μm, such as 100μm, 150μm, 200μm, 250μm, 300μm, or any range of two of these values, such as 100μm-200μm, 200μm-300μm. Micrometers such as 150μm-250μm and 200μm-250μm allow for relatively small particle sizes of the oral contents, enabling the preparation of fast- or relatively fast-release products. When the substrate is porous starch, a medium-sized sieve (60-80 mesh) controls the particle size of the oral contents to be between 150μm and 250μm, for example, 150μm, 180μm, 200μm, 220μm, and 250μm. Alternatively, the particle size can be any range of two of the above values, such as 150μm-200μm, 200μm-250μm, 180μm-220μm, 200μm-220μm, etc., to ensure that the particle size of the oral contents is moderate, and the prepared product can balance the release rate and duration. When the substrate is porous carboxymethyl cellulose, the sieve mesh is 50-70 mesh, using a coarser sieve, and the particle size of the oral contents is controlled between 200μm-300μm, such as 200μm, 220μm, 250μm, 280μm, 300μm, etc., or any range of two of the above values, such as 200μm-250μm, 250μm-300μm, 220μm-250μm, 250μm-280μm, etc., to ensure that the particle size of the oral contents is larger, and a product with a longer release time can be prepared.

[0073] This application provides a mouth-holding article comprising mouth-holding contents, which include a substrate, an active agent, and an adhesive. The substrate is a water-soluble porous substrate. The active agent is attached to the pores and / or surface of the substrate. The adhesive coats the active agent and the substrate. By weight, the substrate, active agent, and adhesive are 40-90 parts, 0.5-10 parts, and 3-7 parts, respectively. The mouth-holding article can be prepared using the method described above. The mouth-holding article provided by this application, based on the selection of raw material components and the control of the proportional relationship between the raw material components, allows the active agent to be attached to the substrate, and the adhesive to coat the active agent and the substrate. First, the adhesive forms a coating film outside the substrate, enabling the adhesive to control the contact rate between the substrate and water, thereby controlling the release rate of the active ingredient in the active agent attached to the substrate. Second, the water-soluble porous substrate can dissolve in water, allowing the substrate to further control the release of the active ingredient in the active agent attached to the substrate, thus stably controlling the release rate of the active ingredient.

[0074] The present application will be described below through specific embodiments, in which oral articles are prepared according to the above preparation method. The following embodiments are only some examples of the present application and are not intended to limit the scope of the application.

[0075] Example A, the formulation is shown in Table 1.

[0076] Table 1 Formulation Table for Example A

[0077] Example B, the formulation is shown in Table 2.

[0078] Table 2 Formulation Table for Example B

[0079] Example C, the formulation is shown in Table 3.

[0080] Table 3 Formulation Table for Example C

[0081] Example D, the formulation is shown in Table 4.

[0082] Table 4 Formulation Table for Example D

[0083] A comparative example was set up according to Example A, and the formulation of the comparative example is shown in Table 5.

[0084] Table 5. Differences between the comparative example and Example A

[0085] Dissolution tests were conducted on the oral products prepared in the examples and comparative examples.

[0086] Equipment: Dissolution apparatus - paddle method;

[0087] Samples: 1g each of the different formulation powders from Examples A, B, C, D and Comparative Examples a, b, c, d, e;

[0088] Dissolution medium: artificial saliva - pH 6.8;

[0089] Sampling points: 0.5min, 1min, 2min, 5min, 10min, 15min, 20min, 30min, 40min, 60min;

[0090] Test conditions: heating temperature 37℃, rotation speed 100r / min;

[0091] Analytical method: Nicotine content was determined using high performance liquid chromatography.

[0092] The test results are shown in Tables 6 and 7 and Figures 3-8.

[0093] Table 6 Test Results of Examples

[0094] Table 7 Comparative Test Results

[0095] As shown in Figures 3-8, in Comparative Example a, the mismatch in the proportions of the raw material components makes it difficult for the surfactant to adhere to the substrate, or the adhesive fails to coat the surfactant and substrate, resulting in a kinked dissolution curve and unstable release rate of the active ingredient (nicotine). In Comparative Example e, the lack of a coating process makes it difficult for the adhesive to coat the surfactant and substrate, resulting in a kinked dissolution curve and unstable nicotine release rate. Compared to Comparative Example ae, the dissolution curve of Example AD is relatively smooth, indicating a more stable nicotine release rate in Example AD. The test results show that the preparation method provided in this application, based on the selection of raw material components and the control of the proportions between them, uses a water-soluble porous substrate, with the surfactant adhering to the substrate and the adhesive coating the surfactant and substrate, and can stably control the release rate of the active ingredient.

[0096] Furthermore, as can be seen from Figure 8, in Example AD, the substrates are porous gum arabic, porous maltodextrin, porous starch and porous carboxymethyl cellulose, respectively. The time when 80% of the active ingredient (nicotine) of the active agent in the oral product is released is taken as the peak time, and the peak time of the oral product is 4 min-32 min. Specifically, when the substrate is porous gum arabic, the peak time of the oral product is 4-6 minutes, indicating a rapid release of nicotine; porous gum arabic substrate can be used for fast-release products. When the substrate is porous maltodextrin, the peak time of the oral product is 8-12 minutes, indicating a relatively rapid release of nicotine; porous maltodextrin substrate can be used for fast-release products. When the substrate is porous starch, the peak time of the oral product is 18-22 minutes, indicating a relatively slow release of nicotine; porous starch substrate can be used for slower-release products. When the substrate is porous carboxymethyl cellulose, the peak time of the oral product is 28-32 minutes, indicating a slow release of nicotine; porous carboxymethyl cellulose substrate can be used for slow-release products. The different peak times of the products prepared using the above substrates can meet the personalized needs of users.

[0097] The above description is only a part of the embodiments of this application and does not limit the scope of protection of this application. Any equivalent device or equivalent process transformation made based on the content of this application specification and drawings, or direct or indirect application in other related technical fields, are similarly included in the patent protection scope of this application.

Claims

1. A mouth-held product, characterized in that, The invention includes an oral contents comprising a substrate, an active agent, and an adhesive, wherein the substrate is a water-soluble porous substrate, the active agent is attached to the pores of the substrate and / or the surface of the substrate, and the adhesive coats the active agent and the substrate, wherein the substrate, the active agent, and the adhesive are in parts by weight of 40-90 parts, 0.5-10 parts, and 3-7 parts, respectively.

2. The oral article according to claim 1, characterized in that, The particle size of the oral contents is 120μm-320μm.

3. The oral article according to claim 1, characterized in that, The substrate includes at least one of porous gum arabic, porous maltodextrin, porous starch, and porous carboxymethyl cellulose.

4. The oral article according to claim 1, characterized in that, The substrate has a pore size of 5μm-30μm.

5. The oral article according to claim 1, characterized in that, The particle size of the substrate is 100μm-300μm.

6. The oral article according to claim 1, characterized in that, The active agent includes at least one of synthetic nicotine, natural nicotine, and nicotine derivatives; and / or, The adhesive comprises at least one of sodium carboxymethyl cellulose, hydroxypropyl methyl cellulose, microcrystalline cellulose, and low-substituted hydroxypropyl cellulose; and / or, The oral product further includes at least one of the following by weight: 1-3 parts sweetener, 0.5-2 parts flavoring, 0.1-0.5 parts preservative, and 0.3-1 parts pH adjuster.

7. The oral article according to any one of claims 1-6, characterized in that, The time when 80% of the active ingredient of the active agent in the oral product is released is taken as the peak time, and the peak time of the oral product is 4 min-32 min.

8. A method for preparing a mouth-held product, characterized in that, include: The raw materials are mixed to obtain a mixture, wherein, by mass parts, the raw materials include the following components: 40-90 parts of substrate and 0.5-10 parts of activator, wherein the substrate is a water-soluble porous substrate; The adhesive is dissolved in a solvent to obtain a coating solution, wherein, by mass parts, the adhesive is 3-7 parts and the solvent is 1-40 parts; The mixture is coated with the coating solution to obtain coated granules. The coated particles are processed to obtain oral contents, and the oral contents are used to prepare the oral product.

9. The method for preparing the oral product according to claim 8, characterized in that, The particle size of the oral contents is 120μm-320μm.

10. The method for preparing the oral product according to claim 8, characterized in that, The substrate includes at least one of porous gum arabic, porous maltodextrin, porous starch, and porous carboxymethyl cellulose.

11. The method for preparing the oral product according to claim 8, characterized in that, The substrate has a pore size of 5μm-30μm.

12. The method for preparing an oral product according to claim 8, characterized in that, The particle size of the substrate is 100μm-300μm.

13. The method for preparing the oral product according to claim 8, characterized in that, The raw materials also include at least one of the following by weight: 1-3 parts sweetener, 0.5-2 parts flavoring, 0.1-0.5 parts preservative, and 0.3-1 parts pH adjuster.

14. The method for preparing an oral article according to any one of claims 8-13, characterized in that, In the step of mixing the raw materials to obtain a mixture, the mixing speed is 300 rpm-400 rpm, and the mixing time is 15 min-20 min; and / or, In the step of dissolving the adhesive in a solvent to obtain a coating solution, the dissolution temperature is 20℃-30℃, the stirring speed is 450rpm-550rpm, and the dissolution time is 1.0h-2.0h; and / or, In the step of coating the mixture with the coating solution to obtain coated granules, the coating temperature is 40℃-50℃, the spray rate is 1.0mL / min-2.0mL / min, and the coating time is 15min-25min; and / or, In the step of processing the coated particles to obtain oral contents, the coated particles are dried using a microwave dryer with a microwave power of 3-6 kW per kg of raw material and a drying time of 10-20 min.

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