Active particles, methods of making the same, and oral products

Abstract

This application discloses an active particle, its preparation method, and an oral product, relating to the field of oral products. The active particle includes an excipient, an active ingredient, a water-soluble wall material, and a water-insoluble wall material; wherein the excipient is water-soluble, the water-soluble wall material comprises at least one of povidone, hydroxypropyl cellulose, and hydroxypropyl methylcellulose, and the water-insoluble wall material comprises ethyl cellulose. The water-soluble and water-insoluble wall materials in the active particle of this application work together to enable the active particle to simultaneously provide rapid initial stimulation and stable sustained release in the later stages, making the release rate of the active ingredient controllable throughout the process. This improves upon the problems of uncontrollable active ingredient release curves and the tendency of high-content active ingredients to cause mucosal irritation and damage in oral products of related technologies.

Description

Technical Field

[0001] This application relates to the field of oral products technology, and more particularly to an active particle, a method for preparing the same, and an oral product. Background Technology

[0002] In the field of oral products, especially oral sachets, achieving a balance between stable release of active ingredients and user experience has always been a core issue. Existing oral sachet manufacturing processes often involve mixing active ingredients such as nicotine / nicotine salts with a filling matrix using dry or wet methods, followed by packaging. The active ingredients are released through matrix adsorption and saliva penetration. However, this method suffers from difficulty in controlling the release rate. Because the active ingredient molecules are directly exposed to the filling matrix, they dissolve rapidly upon saliva entry, leading to a rapid increase in active ingredient concentration and a strong irritation sensation. After this rapid release, the active ingredient content drops quickly, becoming tasteless and unpleasant, typically lasting only 10-15 minutes. To prolong the irritation and meet the needs of individuals with high irritation thresholds, the active ingredient content in the oral sachet is often increased to satisfy different user experiences. However, simply increasing the amount of active ingredient in the product leads to rapid release, causing a large amount to enter the oral mucosa and bloodstream in a short time. This not only causes irritation and damage to the oral mucosa but also results in acute discomfort symptoms such as nausea and dizziness.

[0003] Therefore, the market urgently needs a new technology for preparing sustained-release oral products that can release quickly, maintain stimulating intensity for a longer period of time, and provide a good user experience at a low concentration of active ingredients. Summary of the Invention

[0004] The purpose of this application is to provide an active particle, a method for preparing the same, and an oral preparation thereof to solve the above-mentioned problems.

[0005] To achieve the above objectives, this application adopts the following technical solution: An active particle includes an excipient, an active ingredient, a water-soluble wall material, and a water-insoluble wall material; The excipient is water-soluble, the water-soluble wall material includes at least one of povidone, hydroxypropyl cellulose, and hydroxypropyl methylcellulose, and the water-insoluble wall material includes ethyl cellulose.

[0006] In some embodiments, the weight-average molecular weight of the ethyl cellulose is 14,000 to 65,000; And / or, the mass ratio of the active ingredient to the water-insoluble wall material is 2:1 to 4:1; And / or, the mass ratio of the water-insoluble wall material to the water-soluble wall material is 1:0.5 to 1:2; And / or, the mass ratio of the active ingredient to the excipient is 1:10 to 1:20.

[0007] In some embodiments, the active particles further comprise a surfactant, wherein the surfactant satisfies at least one of the following conditions: (I) The surfactant comprises at least one of Tween, Span, and poloxamer; (II) The mass ratio of the active ingredient to the surfactant is 10:0.5 to 10:2.

[0008] In some embodiments, the excipient comprises lactose; And / or, the active ingredient includes at least one of nicotine and nicotine derivatives; And / or, the particle size of the active particles is less than or equal to 200 μm.

[0009] This application also provides a method for preparing active particles, used to prepare the active particles as described above, wherein the preparation method includes: Obtain a first dispersion comprising a water-insoluble wall material, wherein the water-insoluble wall material comprises ethyl cellulose; The active ingredient, water-soluble wall material, and the first dispersion are mixed to obtain a second dispersion, wherein the water-soluble wall material comprises at least one of povidone, hydroxypropyl cellulose, and hydroxypropyl methylcellulose. The second dispersion is mixed with an excipient and then crushed to obtain the active particles, wherein the excipient has water-soluble properties.

[0010] This application also provides a mouth-held product comprising the active particles described above.

[0011] In some embodiments, the oral product further includes at least one of a filler, a flavoring agent, and a pH adjuster.

[0012] In some embodiments, the filler includes at least one of microcrystalline cellulose and plant cellulose fibers; And / or, the flavoring agent includes at least one of sweeteners, cooling agents, flavorings, salting agents, and acidifiers; And / or, the pH adjuster includes at least one of sodium bicarbonate, sodium carbonate, potassium bicarbonate, potassium carbonate, calcium carbonate, and magnesium carbonate.

[0013] In some embodiments, the active particles account for 20% to 40% of the mass of the oral product.

[0014] In some embodiments, the oral article further includes a permeation bag in which the active particles are encapsulated.

[0015] Compared with the prior art, the beneficial effects of this application include: The water-soluble and water-insoluble wall materials in the active particles of this application work together to provide both rapid initial stimulation and stable, sustained release in the later stages. This ensures that the release rate of the active ingredient is controllable throughout the process, improving upon the problems of uncontrollable release curves and mucosal irritation and damage caused by high concentrations of active ingredients in oral products of related technologies. Specifically, in the initial stage of use, the water-soluble wall material imparts excellent wetting properties to the active particles, allowing saliva to quickly penetrate their interior. The water-soluble wall material dissolves rapidly upon contact with water, forming micropores on its surface, enabling the rapid release of some active ingredients and meeting the user's initial stimulation needs. In the later stage of use, the water-insoluble wall material forms a rigid framework structure with a hydrophobic barrier, spatially hindering the rapid diffusion of the active ingredient into the oral environment, slowing the release rate, and preventing a large amount of active ingredient from seeping out in a short period, thus achieving a stable, sustained release. The oral product of this application simultaneously possesses the advantages of rapid initial stimulation and stable, sustained release in the later stages, with the release rate of the active ingredient being controllable throughout the process. Attached Figure Description

[0016] To more clearly illustrate the technical solutions of the embodiments of this application, the accompanying drawings used in the embodiments will be briefly described below. It should be understood that the following drawings only show some embodiments of this application and should not be regarded as a limitation on the scope of this application.

[0017] Figure 1 The graph shows the change in nicotine release rate over time in the oral products of Examples 1-3. Figure 2 The graph shows the change in nicotine release rate over time in the oral products of Example 1 and Comparative Examples 1-2. Detailed Implementation

[0018] As used in this article: "Prepared from" is synonymous with "comprising". The terms "comprising", "including", "having", "containing", or any other variations thereof as used herein are intended to cover non-exclusive inclusion. For example, a composition, step, method, article, or apparatus that includes the listed elements is not necessarily limited to those elements, but may include other elements not expressly listed or elements inherent to such composition, step, method, article, or apparatus.

[0019] The conjunction "composed of..." excludes any unspecified elements, steps, or components. If used in a claim, this phrase makes the claim closed, excluding materials other than those described, except for associated conventional impurities. When the phrase "composed of..." appears in a clause of the body of a claim rather than immediately following it, it limits only the elements described in that clause; other elements are not excluded from the claim as a whole.

[0020] When a quantity, concentration, or other value or parameter is expressed as a range, a preferred range, or a range defined by a series of upper and lower preferred values, this should be understood as specifically disclosing all ranges formed by any pair of any upper or preferred value with any lower or preferred value, regardless of whether the range is disclosed individually. For example, when the range “1–5” is disclosed, the described range should be interpreted as including ranges “1–4”, “1–3”, “1–2”, “1–2 and 4–5”, “1–3 and 5”, etc. When numerical ranges are described herein, unless otherwise stated, the range is intended to include its endpoints and all integers and fractions within that range.

[0021] In these embodiments, unless otherwise specified, the portions and percentages are all by weight.

[0022] "Parts by mass" refers to the basic unit of measurement that expresses the mass ratio of multiple components. One part can represent any unit mass, such as 1g or 2.689g. If we say that component A has "a" parts by mass and component B has "b" parts by mass, it means the ratio of the mass of component A to the mass of component B is a:b. Alternatively, it can mean that the mass of component A is aK and the mass of component B is bK (where K is any number representing a multiplier). It is important to understand that, unlike parts by mass, the sum of the mass parts of all components is not limited to 100 parts.

[0023] "And / or" is used to indicate that one or both of the described situations may occur, for example, A and / or B includes (A and B) and (A or B).

[0024] An active particle includes an excipient, an active ingredient, a water-soluble wall material, and a water-insoluble wall material; wherein the excipient has water-soluble properties, the water-soluble wall material includes at least one of povidone, hydroxypropyl cellulose, and hydroxypropyl methylcellulose, and the water-insoluble wall material includes ethyl cellulose.

[0025] The term "water solubility" refers to the ability of an excipient to dissolve, disperse, or disintegrate upon contact with water, thereby causing the overall structure of the active particles to break down.

[0026] In the initial stages of use of active granules, the water-soluble wall material imparts excellent wetting properties, allowing saliva to penetrate rapidly. The water-soluble wall material dissolves quickly in water, forming micropores that enable the rapid release of some active ingredients, satisfying the user's initial stimulation needs. In the later stages of use, the water-insoluble wall material provides a rigid, hydrophobic barrier structure, hindering the rapid diffusion of active ingredients into the oral environment. This spatially slows the release rate, preventing a large amount of active ingredients from seeping out in a short time, thus achieving a slow release of active ingredients. This improves upon the shortcomings of other oral products in related technologies, such as uncontrollable release curves and the tendency of high-content active ingredients to cause mucosal irritation and damage.

[0027] In some embodiments, the weight-average molecular weight of ethyl cellulose is 14,000 to 65,000. If the weight-average molecular weight of ethyl cellulose is too low, the sustained-release effect is not obvious, and it is difficult to effectively control the release rate of the active ingredient. If the weight-average molecular weight of ethyl cellulose is too high, the active ingredient will be difficult to dissolve.

[0028] For example, the weight-average molecular weight of ethyl cellulose is 14,000, 20,000, 25,000, 30,000, 35,000, 40,000, 45,000, 50,000, 55,000, 60,000, 65,000, or any value between 14,000 and 65,000.

[0029] In some embodiments, the mass ratio of the active ingredient to the water-insoluble wall material is 2:1 to 4:1. If the proportion of the active ingredient is too low, the release of the active ingredient will be slow or incomplete; if the proportion of the active ingredient is too high, the content of the water-insoluble wall material will be relatively low, and a continuous hydrophobic barrier cannot be constructed, which will weaken the sustained-release effect.

[0030] For example, the mass ratio of the active ingredient to the water-insoluble wall material is 2:1, 3:1, 4:1, or any value between 2:1 and 4:1.

[0031] In some embodiments, the mass ratio of water-insoluble wall material to water-soluble wall material is 1:0.5 to 1:2. The water-insoluble wall material can form a continuous hydrophobic barrier framework, while the water-soluble wall material can form micropores after dissolving. When the mass ratio of water-insoluble wall material to water-soluble wall material is within the above range, the continuous and controllable release of active ingredients can be guaranteed.

[0032] For example, the mass ratio of water-insoluble wall material to water-soluble wall material is 1:0.5, 1:1, 1:1.5, 1:2, or any value between 1:0.5 and 1:2.

[0033] In some embodiments, the mass ratio of active ingredient to excipient is 1:10 to 1:20. If the proportion of excipient is too small, the components are prone to stratification during drying, resulting in uneven distribution; if the proportion of excipient is too large, it is difficult to achieve uniform mixing between the excipient and the dispersion.

[0034] This application allows for the adjustment of the composition of active particles, thereby regulating the release rate of active ingredients in the particles during the initial and later stages of use, achieving flexible control of the release effect and providing users with a personalized experience.

[0035] In some embodiments, the active particles further comprise a surfactant, which comprises at least one of Tween, Span, and poloxamer. The hydrophobic end of the surfactant can bind to the oily active ingredient, and the hydrophilic end of the surfactant can interact with polar groups in water-soluble wall materials (such as the hydroxyl groups of hydroxypropyl methylcellulose) and polar groups in water-insoluble wall materials (such as the ether bonds of ethyl cellulose), thereby breaking up the oily agglomeration of the active ingredient and enabling the active ingredient to be uniformly dispersed in the active particles.

[0036] The active ingredients in this application are uniformly dispersed in the active particles, which avoids the problem of excessively high concentration of active ingredients in some areas of the active particles, improves the uniformity of the active ingredient content in the product, and thus improves the product uniformity, thereby improving the problem of poor product uniformity in sustained-release oral products in related technologies.

[0037] In some embodiments, Tween includes Tween 80.

[0038] In some embodiments, the mass ratio of active ingredient to surfactant is 10:0.5 to 10:2. If the surfactant content is too small, the interaction between the active ingredient and the water-insoluble wall material is weak, resulting in uneven dispersion in the water-insoluble wall material; if the surfactant content is too large, it will cause material waste and also affect the sustained-release effect.

[0039] For example, the mass ratio of active ingredient to surfactant is 10:0.5, 10:1, 10:1.5, 10:2, or any value between 10:0.5 and 10:2.

[0040] In some embodiments, the excipient comprises lactose.

[0041] In some embodiments, the active ingredient includes at least one of nicotine and nicotine derivatives. Nicotine includes at least one of natural nicotine and synthetic nicotine. Nicotine derivatives include one or more of nicotine salts, nicotine in a matrix such as a glycobase or an organometallic complex, nicotine-resin complexes, nicotine inclusion complexes, and non-covalently bound nicotine. Non-covalently bound nicotine includes at least one of nicotine lactate, nicotine malate, nicotine salicylate, nicotine cyclodextrin-encapsulated complexes, nicotine hydrochloride, nicotine dihydrochloride, nicotine tartrate, nicotine tartrate dihydrate, nicotine sulfate, zinc nicotine chloride, and nicotine benzoate. Nicotine derivatives also include nicotine containing substituents, such as at least one of 6-methylnicotine, 6-methylnicotine lactate, 6-methylnicotine malate, 6-methylnicotine salicylate, 6-methylnicotine cyclodextrin encapsulated complex, 6-methylnicotine hydrochloride, 6-methylnicotine dihydrochloride, 6-methylnicotine tartrate, 6-methylnicotine tartrate dihydrate, 6-methylnicotine sulfate, 6-methylnicotine zinc chloride, and 6-methylnicotine benzoate.

[0042] In some embodiments, the active ingredient may include substances with medical properties or other specific active properties, such as at least one of caffeine, tea polyphenols, theophylline, capsaicin, and vitamins.

[0043] In some embodiments, the particle size of the active particles is less than or equal to 200 μm. If the particle size of the active particles is too large, it will affect the uniformity of mixing between the active particles and the filler, and there will be a grainy feeling during use, causing an uncomfortable experience.

[0044] By adjusting the particle size of the active particles, the release rate of nicotine can be controlled. This allows for the adjustment of different levels of stimulation without increasing the amount of nicotine used, satisfying the taste preferences of different consumer groups and improving the user experience. The size of the active particles affects their specific surface area, which in turn affects the dissolution and diffusion of the active ingredients within the particles.

[0045] This application also provides a method for preparing active particles, for preparing active particles as described above, wherein the preparation method includes: obtaining a first dispersion comprising a water-insoluble wall material, wherein the water-insoluble wall material comprises ethyl cellulose; mixing the active ingredient, the water-soluble wall material and the first dispersion to obtain a second dispersion, wherein the water-soluble wall material comprises at least one of povidone, hydroxypropyl cellulose, and hydroxypropyl methylcellulose; mixing the second dispersion with an excipient and breaking it up to obtain active particles, wherein the excipient has water-dissolving properties.

[0046] In some embodiments, the first dispersion further includes an alcohol solvent, including ethanol. Preparing the first dispersion includes mixing a water-insoluble wall material and an alcohol solvent to obtain the first dispersion. In some embodiments, the preparation of the second dispersion includes: mixing the active ingredient, the water-soluble wall material, the surfactant, and the first dispersion to obtain the second dispersion; In some embodiments, after obtaining the second dispersion, the method further includes: adding an excipient to the second dispersion, kneading and dispersing it to obtain a wet material; drying the wet material to remove alcohol solvents; and pulverizing the dried material to obtain active particles.

[0047] In some embodiments, the drying temperature is 40°C to 60°C, and the drying time is 4h to 8h. For example, the drying temperature is 40°C, 50°C, 60°C, or any value between 40°C and 60°C, and the drying time is 4h, 5h, 6h, 7h, 8h, or any value between 4h and 8h.

[0048] This application also provides a mouth-held product comprising the aforementioned active particles.

[0049] The oral products of this application include, but are not limited to, oral pouches, and may also be other oral dosage forms covered by this application. Oral pouches include, but are not limited to, nicotine pouches.

[0050] In some embodiments, the oral product further includes at least one of a filler, a flavoring agent, and a pH adjuster.

[0051] In some embodiments, the oral article also includes excipients. These excipients include, but are not limited to, at least one of antioxidants and lubricants. Those skilled in the art can select suitable types and amounts based on the needs of the oral article; the addition of these excipients does not affect the effectiveness of this application.

[0052] In some embodiments, the filler includes at least one of microcrystalline cellulose and plant cellulose fibers.

[0053] In some embodiments, plant cellulose fibers include at least one of wood pulp fiber and cotton cellulose.

[0054] In some embodiments, the flavoring agent includes at least one of sweeteners, cooling agents, flavorings, salting agents, and acidifiers.

[0055] In some embodiments, the flavoring includes lemon flavoring.

[0056] In some embodiments, the pH adjuster includes at least one of sodium bicarbonate, sodium carbonate, potassium bicarbonate, potassium carbonate, calcium carbonate, and magnesium carbonate.

[0057] In some embodiments, the active particles constitute 20% to 40% of the oral product by mass. If the proportion of active particles in the oral product is too small, the active particles and fillers will not mix evenly, and the low proportion of active particles will result in a lower release of the active ingredient and a poor user experience. If the proportion of active particles in the oral product is too large, it may lead to an excessive dose of the active ingredient, causing acute poisoning.

[0058] For example, the active particles in the oral product may be any value between 20%, 22%, 25%, 27%, 30%, 32%, 35%, 37%, 40%, or 20% to 40% by mass. In some embodiments, the oral article further includes a permeation bag in which the active particles are encapsulated.

[0059] A permeable bag is a bag that can be permeated with saliva, such as a non-woven bag.

[0060] The implementation schemes of this application will be described in detail below with reference to specific embodiments. However, those skilled in the art will understand that the following embodiments are only for illustrating this application and should not be regarded as limiting the scope of this application. Unless otherwise specified in the embodiments, conventional conditions or conditions recommended by the manufacturer shall apply. Reagents or instruments used without specified manufacturers are all conventional products that can be purchased commercially.

[0061] The raw material information used in the examples and comparative examples is as follows: The degree of methoxy substitution in hydroxypropyl methylcellulose is 28%–30%, and the degree of hydroxypropoxy substitution is 7%–12%. The weight-average molecular weight of ethyl cellulose is 20,000 to 40,000.

[0062] Example 1 The types and contents of raw materials used in Example 1 are shown in Table 1 below.

[0063] Table 1. Raw material types and content for Example 1

[0064] Example 1 provides a mouth-held product, the preparation method of which includes: (1) Preparation of active particles: Ethyl cellulose was added to anhydrous ethanol and stirred until completely dissolved to form a transparent solution; Add nicotine, Tween 80, and hydroxypropyl methylcellulose, and stir to mix and disperse evenly; Add lactose and mix and knead until the mixture is evenly combined. The obtained material was dried at a temperature of 50°C for 5 hours to remove ethanol. The dried material was pulverized using a pulverizer at a blade speed of 3000 rpm and passed through a 0.2 mm sieve to obtain active particles. The particle size distribution of the active particles was as follows: particles <75 μm accounted for approximately 50%, particles between 75 μm and 150 μm accounted for 30%, and particles between 150 μm and 200 μm accounted for 20%.

[0065] (2) Preparation of oral products: According to the addition amounts in Table 1, the active particles were mixed with microcrystalline cellulose, lemon flavoring and sodium bicarbonate to obtain a mixture. The mixture is packaged into breathable fiber bags to obtain the oral product (nicotine bag).

[0066] Example 2 The difference between Example 2 and Example 1 is that in step (1), the dried material is pulverized using a pulverizer at a speed of 5000 rpm and passed through a sieve with a aperture of 0.2 mm to obtain active particles. In the active particles of step (1), particles <75 μm account for 70%, particles between 75 μm and 150 μm account for 20%, and particles between 150 μm and 200 μm account for 10%. Everything else is the same as in Example 1.

[0067] Example 3 The difference between Example 3 and Example 1 is as follows: The dried material is pulverized twice using a pulverizer. In the first pulverization, the pulverizer blade rotates at 2000 rpm. The pulverized particles are then sieved through a 150 μm sieve, and the undersize is collected. The oversize is then pulverized in a second pulverization at 3000 rpm. The undersize from the first pulverization and the particles from the second pulverization are combined and passed through a 0.2 mm sieve to obtain active particles. In the active particles of step (1), particles <75 μm account for 35%, particles between 75 μm and 150 μm account for 50%, and particles between 150 μm and 200 μm account for 15%. Everything else is the same as in Example 1.

[0068] Comparative Example 1 The difference between Comparative Example 1 and Example 1 is that hydroxypropyl methylcellulose (a water-soluble wall material) was not added in step (1). Everything else was the same as in Example 1.

[0069] Comparative Example 2 The difference between Comparative Example 2 and Example 1 is that step (1) is omitted, no active particles are added to Comparative Example 2, and 10 parts of nicotine are added to Comparative Example 2 to replace the active particles in Example 1. Everything else is the same as Example 1.

[0070] Comparative Example 3 The difference between Comparative Example 3 and Example 1 is that Tween 80 (surfactant) was not added. Everything else was the same as Example 1.

[0071] Release effect test: The oral products prepared in Examples 2 and 3 were subjected to nicotine release performance testing (i.e., nicotine release rate measurement), and the release results were compared with the test results of the oral product in Example 1. The test results are as follows: Figure 1 As shown.

[0072] Release tests showed that the oral product of Example 2 released approximately 60% of its nicotine amount after 5 minutes, indicating a faster release rate compared to the oral product of Example 1. The oral product of Example 3, however, had a slower release rate compared to the oral product of Example 1. This demonstrates that, without increasing the initial nicotine dosage, the release rate of nicotine can be adjusted by modifying the grinding process to obtain active particles with different particle size distributions, thereby achieving varying intensities of stimulation and catering to different user preferences.

[0073] The oral products prepared in Example 1, Comparative Example 1, and Comparative Example 2 were subjected to release performance testing. The testing procedure was as follows: the oral products were placed in artificial saliva, and samples were taken every 5 minutes to determine the nicotine release rate within 40 minutes. The test results are as follows. Figure 2 As shown.

[0074] Release tests showed that the oral product of Example 1 rapidly released approximately 40% of the nicotine within 5 minutes, followed by a slow release. The release amount was approximately 95% at 35 minutes and nearly 100% at 40 minutes. Compared to the oral product of Example 1, the nicotine release rate in the oral product of Comparative Example 1 was significantly slower, with a release rate of approximately 60% at 40 minutes, indicating incomplete release. The oral product of Comparative Example 2 released 60%–70% within 5 minutes and was nearly completely released within 10–15 minutes. The results indicate that the oral product (Comparative Example 2) prepared by directly mixing nicotine with the filling matrix and then dispensing it had an excessively fast release rate, while the oral product (Comparative Example 1) prepared using only ethyl cellulose as the wall material had a slow initial release and incomplete release. Adding the water-soluble wall material hydroxypropyl methylcellulose during the preparation of the active particles allows for the rapid release of some nicotine in the oral product within a short time. Combined with the water-insoluble wall material ethyl cellulose, a continuous release for 40 minutes can be achieved.

[0075] Content uniformity test: Ten bags of the oral products prepared in Example 1 and Comparative Example 3 were taken from each sample, and the relative content of nicotine in each bag was determined (with the labeled amount as 100%). The mean and relative standard deviation (RSD) of the relative content of the 10 bags were calculated. The test results are shown in Table 2 below.

[0076] Table 2 Comparison of oral products from Example 1 and Comparative Example 3

[0077] The results showed that the RSD value of the oral product of Comparative Example 3 (Example 4) was greater than that of Example 1, indicating that the content uniformity of the oral product of Comparative Example 3 was poor. This suggests that adding surfactants to the active particles can significantly improve the uniformity of nicotine content in oral products, thereby improving the homogeneity of the oral product.

[0078] Finally, it should be noted that the above embodiments are only used to illustrate the technical solutions of this application, and are not intended to limit them. Although this application has been described in detail with reference to the foregoing embodiments, those skilled in the art should understand that modifications can still be made to the technical solutions described in the foregoing embodiments, or equivalent substitutions can be made to some or all of the technical features therein. Such modifications or substitutions do not cause the essence of the corresponding technical solutions to deviate from the scope of the technical solutions of the embodiments of this application.

[0079] Furthermore, those skilled in the art will understand that although some embodiments herein include certain features included in other embodiments but not others, combinations of features from different embodiments are intended to be within the scope of this application and form different embodiments. For example, in the foregoing claims, any of the claimed embodiments can be used in any combination. The information disclosed in this background section is intended only to enhance the understanding of the general background of this application and should not be construed as an admission or in any way implying that such information constitutes prior art known to those skilled in the art.

Claims

1. An active particle, characterized in that, This includes excipients, active ingredients, water-soluble wall materials, and water-insoluble wall materials; The excipient is water-soluble, the water-soluble wall material includes at least one of povidone, hydroxypropyl cellulose, and hydroxypropyl methylcellulose, and the water-insoluble wall material includes ethyl cellulose.

2. The active particles according to claim 1, characterized in that, The weight-average molecular weight of the ethyl cellulose is 14,000 to 65,000. And / or, the mass ratio of the active ingredient to the water-insoluble wall material is 2:1 to 4:1; And / or, the mass ratio of the water-insoluble wall material to the water-soluble wall material is 1:0.5 to 1:2; And / or, the mass ratio of the active ingredient to the excipient is 1:10 to 1:

20.

3. The active particles according to claim 1, characterized in that, The active particles further comprise a surfactant, wherein the surfactant satisfies at least one of the following conditions: (I) The surfactant comprises at least one of Tween, Span, and poloxamer; (II) The mass ratio of the active ingredient to the surfactant is 10:0.5 to 10:

2.

4. The active particles according to any one of claims 1 to 3, characterized in that, The excipient contains lactose; And / or, the active ingredient includes at least one of nicotine and nicotine derivatives; And / or, the particle size of the active particles is less than or equal to 200 μm.

5. A method for preparing active particles, characterized in that, For preparing the active particles as described in any one of claims 1 to 4, wherein the preparation method comprises: Obtain a first dispersion comprising a water-insoluble wall material, wherein the water-insoluble wall material comprises ethyl cellulose; The active ingredient, water-soluble wall material, and the first dispersion are mixed to obtain a second dispersion, wherein the water-soluble wall material comprises at least one of povidone, hydroxypropyl cellulose, and hydroxypropyl methylcellulose. The second dispersion is mixed with an excipient and then crushed to obtain the active particles, wherein the excipient has water-soluble properties.

6. A mouth-held product, characterized in that, Includes the active particles as described in any one of claims 1 to 4.

7. The oral article according to claim 6, characterized in that, The oral product also includes at least one of fillers, flavoring agents, and pH adjusters.

8. The oral article according to claim 7, characterized in that, The filler includes at least one of microcrystalline cellulose and plant cellulose fiber; And / or, the flavoring agent includes at least one of sweeteners, cooling agents, flavorings, salting agents, and acidifiers; And / or, the pH adjuster includes at least one of sodium bicarbonate, sodium carbonate, potassium bicarbonate, potassium carbonate, calcium carbonate, and magnesium carbonate.

9. The oral article according to claim 6, characterized in that, The active particles constitute 20% to 40% of the mass of the oral product.

10. The oral article according to any one of claims 6 to 9, characterized in that, The oral product also includes a permeation bag, in which the active particles are encapsulated.

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