Nicotine buccal release product and preparation method thereof

Abstract

The invention provides a nicotine buccal release product and a preparation method thereof, and relates to the technical field of nicotine buccal release products. The nicotine buccal release product comprises an active agent and a porous carrier, wherein the mass ratio of the porous carrier in the nicotine buccal release product is not less than 30%; wherein the porous carrier comprises at least one of silica gel powder and microporous ceramic. The advantages of high porosity, chemical stability and thermal stability of the porous carrier are utilized, and through the optimized formula and the precisely controlled production process, the release rate of nicotine can be effectively controlled, and the long-term stability of the product and the satisfaction degree of a user can be ensured.

Description

Technical Field

[0001] The present invention relates to the field of nicotine oral release products, and in particular to a nicotine oral release product and a preparation method thereof. Background Art

[0002] In modern life, as people's health awareness increases, the demand for nicotine substitutes is gradually increasing. Such products are designed to provide a safer and more controllable way to meet the needs of nicotine users while reducing the health risks of traditional use. The design of nicotine oral release products needs to ensure effective nicotine release while taking into account product stability and user acceptance, which is an important issue in the technical field.

[0003] Existing nicotine oral delivery products mostly use organic polymers or natural fibers as carrier materials. These materials have certain advantages in the adsorption and release of nicotine, but they also have some obvious shortcomings. For example, the performance of these materials in terms of chemical stability and thermal stability is usually unsatisfactory, which not only limits the storage conditions of the product, but also affects the use effect of the product in different environments.

[0004] Specifically, the carrier materials in the prior art are prone to degradation during storage, which not only reduces the product's service life, but may also lead to premature release of nicotine, affecting the user experience. At the same time, the pore structure of these materials is not easy to accurately control, which directly affects the sustained release performance of nicotine. The uneven or difficult to control nicotine release rate is a common problem in the prior art, which may cause users to experience inconsistent effects during use, thereby reducing product reliability and user satisfaction.

[0005] In summary, existing nicotine oral release products have defects in material selection, chemical and thermal stability, pore structure regulation, and nicotine release control. These defects not only affect the performance and user experience of the product, but also limit the application of the product in a wider range of environments. Therefore, developing new carrier materials to improve the uniformity and controllability of nicotine release is an urgent problem to be solved in this technical field. Summary of the invention

[0006] The first object of the present invention is to provide a nicotine oral release product and a preparation method thereof, wherein the nicotine oral release product can not only effectively control the release rate of nicotine, but also ensure the long-term stability of the product and the satisfaction of users.

[0007] In order to achieve the above-mentioned purpose of the present invention, the following technical solutions are particularly adopted:

[0008] The present invention provides a nicotine oral release product, comprising: an active agent and a porous carrier, wherein the mass proportion of the porous carrier in the nicotine oral release product is not less than 30%; wherein the porous carrier comprises at least one of silica gel powder and microporous ceramics. In one embodiment, the active agent comprises at least one of nicotine and a nicotine derivative.

[0009] In one embodiment, the pore size of the porous carrier is 1 μm-5 μm, and the particle size is 2 μm-10 μm; or, the pore size of the porous carrier is 5 μm-40 μm, and the particle size is 10 μm-50 μm.

[0010] In one embodiment, the composition further comprises at least one of a sweetener, a preservative, a pH adjuster, an edible flavor, a binder, and a release functional auxiliary material.

[0011] In one embodiment, the nicotine oral delivery product comprises, by weight:

[0012] 40 to 50 parts of porous carrier;

[0013] Release functional excipients 10 to 20 parts;

[0014] 1 to 10 parts of active agent;

[0015] 2 to 5 parts of adhesive;

[0016] 1 to 3 parts of edible flavor;

[0017] 10 to 20 parts of sweetener;

[0018] 0.1 to 0.5 parts of preservatives;

[0019] 0.5 to 1 part of pH adjuster

[0020] In one embodiment, the release functional excipient includes at least one of microcrystalline cellulose and polyglycolic acid; and / or, the sweetener includes at least one of xylitol, sorbitol, mannitol, igletol, lactitol, maltitol, isomalt, hydrogenated starch hydrolysate, erythritol, maltotriitol, aspartame, acesulfame potassium, saccharin sodium, sucralose, neotame, cyclamate, alitame, steviol glycosides, arabitol and monk fruit sweet; and / or, the pH adjuster includes at least one of citric acid, sodium citrate, sodium bicarbonate and sodium carbonate.

[0021] In addition, the present application also provides a method for preparing a nicotine oral release product as described in any of the aforementioned embodiments, comprising: mixing a nicotine oral release product raw material including an active agent and a porous carrier to obtain a mixture; wherein the porous carrier includes at least one of silica gel powder and microporous ceramics; adding a mixed solvent to the mixture to obtain a wetted material; granulating the wetted material to obtain material particles; and drying and sieving the material particles to obtain the nicotine oral release product.

[0022] In one embodiment, the mixing process has a mixing speed of 60 rpm to 100 rpm and a mixing time of 15 minutes to 30 minutes.

[0023] In one embodiment, the mixed solvent includes at least one of water and ethanol; and / or the amount of the mixed solvent contained in the wetting material is 20% to 30%.

[0024] In one embodiment, the drying temperature of the drying and screening treatment is 40°C to 60°C; and / or the drying time of the drying and screening treatment is 30 minutes to 60 minutes; and / or the mesh size of the drying and screening treatment includes at least one of 30 mesh and 60 mesh.

[0025] The present invention provides a nicotine oral release product and a preparation method thereof. The nicotine oral release product comprises: an active agent and a porous carrier, wherein the mass proportion of the porous carrier in the nicotine oral release product is not less than 30%; wherein the porous carrier comprises at least one of silica gel powder and microporous ceramics. The present invention adopts silica gel powder and / or microporous ceramics with a mass proportion of not less than 30% as a carrier, and utilizes the advantages of high porosity, chemical stability and thermal stability. Through these optimized formulas and precisely controlled production processes, it can not only effectively control the release rate of nicotine, but also ensure the long-term stability of the product and user satisfaction. BRIEF DESCRIPTION OF THE DRAWINGS

[0026] In order to more clearly illustrate the specific implementation methods of the present invention or the technical solutions in the prior art, the drawings required for use in the specific implementation methods or the description of the prior art will be briefly introduced below. Obviously, the drawings described below are some implementation methods of the present invention. For ordinary technicians in this field, other drawings can be obtained based on these drawings without paying creative work.

[0027] Figure 1 Schematic diagram of the process for preparing the nicotine oral delivery product in the embodiments of the present application;

[0028] Figure 2Schematic diagram of the dissolution curves of samples A and B in the examples of this application;

[0029] Figure 3 Schematic diagram of the peak time for samples A and B in the embodiments of the present application. DETAILED DESCRIPTION

[0030] The embodiments of the present invention will be described in detail below in conjunction with the examples, but it will be appreciated by those skilled in the art that the following examples are only used to illustrate the present invention and should not be considered as limiting the scope of the present invention. If no specific conditions are specified in the examples, the conditions are carried out according to normal conditions or the conditions recommended by the manufacturer. If the manufacturer of the reagents or instruments used is not specified, they are all conventional products that can be obtained commercially.

[0031] In an embodiment of the present application, a nicotine oral release product is provided, comprising: an active agent and a porous carrier, wherein the mass proportion of the porous carrier in the nicotine oral release product is not less than 30%; wherein the porous carrier comprises at least one of silica gel powder and microporous ceramics.

[0032] As mentioned above, silica gel powder is used as a porous carrier for nicotine oral delivery products. Silica gel powder has high porosity, good chemical stability and thermal stability, which enables it to effectively adsorb nicotine and control the release rate of nicotine during the use of oral cigarettes.

[0033] Silica gel powder is a powdery substance made of silicate material, usually obtained from sodium silicate or potassium silicate after a certain chemical reaction and drying treatment.

[0034] Silica gel powder has a large number of microporous structures, which can increase its surface area and thus improve its adsorption capacity. Silica gel powder does not react easily with other chemicals, which makes it stable in a variety of environments and not easy to decompose. Silica gel powder can withstand higher temperatures without decomposition, which makes it suitable for applications that require high temperature processing.

[0035] In nicotine oral release products, silica gel powder is used as a carrier material to adsorb active agents and control the release rate of active agents through its pore structure. By adjusting the pore size and particle size of silica gel powder, formulas with different active agent release rates can be created to meet the usage needs of different consumers.

[0036] Microporous ceramics are ceramic materials with a large number of micropores, which are usually on the micrometer or even nanometer scale. Microporous ceramics have a wide range of applications in many fields due to their unique pore structure and properties.

[0037] Microporous ceramics have a high porosity, usually between 30% and 90%, which makes them have a low density and good air permeability. The size of the micropores is usually in the micron to nanometer level, which gives the material special filtering and adsorption properties. Microporous ceramics usually have good acid and alkali resistance and oxidation resistance, and can be used in harsh chemical environments. Microporous ceramics can withstand high temperatures and are not easily deformed or decomposed at high temperatures, making them suitable for high temperature environments. Despite their high porosity, microporous ceramics usually still have high mechanical strength and can withstand certain mechanical loads.

[0038] Furthermore, the active agent includes at least one of nicotine and nicotine derivatives.

[0039] The above-mentioned nicotine derivatives may refer to a series of compounds obtained by chemical synthesis or biological transformation from the molecular structure of nicotine. These derivatives may have similar or different biological activities as nicotine. Nicotine derivatives include but are not limited to nicotine salts, nicotine containing substituents, and nicotine salts containing substituents. For example, the following nicotine derivatives may be included but are not limited to: nicotine tartrate, hexamethyl nicotine, hexamethyl nicotine tartrate, nicotine benzoate, nicotine-alginate, nicotine-malate, nicotine-citrate, nicotine-lactate, nicotine-propionate and nicotine-succinate, etc.

[0040] Furthermore, the pore size of the porous carrier is 1 μm-5 μm, and the particle size is 2 μm-10 μm; or, the pore size of the porous carrier is 5 μm-40 μm, and the particle size is 10 μm-50 μm.

[0041] It should be noted that, in the embodiments of the present application, silica gel powder and / or microporous ceramics are used as carriers, and their high porosity is used to increase the contact area with the active agent, thereby optimizing the absorption and release efficiency of the active agent. The chemical stability and thermal stability of silica gel and ceramics also provide excellent quality assurance for the product. Among the main components of the product, silica gel powder and / or microporous ceramics, as porous carriers, can be adjusted according to their pore size and particle size, respectively, to construct a rapid release system and a slow release system, respectively, to meet the needs of different consumers.

[0042] In one embodiment, the nicotine oral release product has a faster release system: the pore size of the porous carrier is 1 μm-5 μm, and the particle size is 2 μm-10 μm; wherein the pore size can be 1 μm, 2 μm, 3 μm, 4 μm, 5 μm, etc.; the particle size can be 2 μm, 4 μm, 6 μm, 8 μm, 10 μm, etc.

[0043] In one embodiment, the nicotine oral release product has a relatively slow release system: the pore size of the porous carrier is 5μm-40μm, and the particle size is 10μm-50μm. The pore size can be 5μm, 10μm, 15μm, 20μm, 30μm, 40μm, 50μm, etc.; the particle size can be 10μm, 20μm, 30μm, 40μm, 50μm, etc.

[0044] By limiting the pore size and particle size of the porous carrier, the release kinetics of nicotine oral release products can be significantly optimized to meet the usage needs of different consumers. Specifically, the faster release system uses silica gel powder or microporous ceramics with smaller pore size (1μm-5μm) and particle size (2μm-10μm) as a carrier. Such a structure is conducive to the rapid absorption and rapid release of the active agent, providing rapid effects for users who need immediate refreshment or satisfy their smoking addiction. In contrast, the slower release system uses a carrier with a larger pore size (5μm-40μm) and particle size (10μm-50μm). This design helps to prolong the release time of the active agent and provide a stable and continuous supply of active agents for users seeking a more lasting effect. The advantage of this method is that it can provide customized active agent release solutions to suit the preferences and needs of different users, while ensuring the chemical and thermal stability of the product, improving the overall user experience and product safety.

[0045] In addition, due to the irregularity of particles, it is impossible to maintain completely consistent specifications for all particles during the actual production process. Therefore, the average pore size, average particle size, particle D50, etc. are generally used as standards, as long as the specifications of the particles used are within the corresponding range.

[0046] Furthermore, it also includes at least one of a sweetener, a preservative, a pH adjuster, an edible flavor, a binder, and a release functional auxiliary material.

[0047] In addition to the active agent and the porous carrier, nicotine oral delivery products may also contain the following components, each with its own specific function:

[0048] The above sweeteners are used to provide sweetness, improve the taste of the product, and make it easier for consumers to accept. Common sweeteners include sucrose, fructose, xylitol, sorbitol, aspartame, saccharin sodium, etc.

[0049] The above preservatives are used to extend the shelf life of the product and prevent microbial growth and product spoilage. Commonly used preservatives include benzalkonium chloride, sodium benzoate, potassium sorbate, parabens, etc.

[0050] The pH adjuster is used to adjust the pH of the product to ensure that the product maintains stability and biological activity within an appropriate pH range. Common pH adjusters include citric acid, sodium bicarbonate, sodium carbonate, phosphates, etc.

[0051] The above-mentioned edible flavor is used to provide a taste, increase the aroma of the product, and provide a pleasant sensory experience. For example, it can be a natural or synthetic flavor, such as mint, fruit, herb, etc.

[0052] The above-mentioned binders are used to bind different ingredients together to form a stable product structure. Common binders include povidone, hypromellose, carboxymethyl cellulose, gelatin, etc.

[0053] The above-mentioned release functional excipients are used to control the release rate and mode of the active ingredient (such as nicotine), and may include various types of polymers and porous materials, such as polylactic acid-co-glycolic acid (PLGA), polyvinyl alcohol (PVA), and the like.

[0054] These components work together to not only ensure the safety and stability of nicotine oral delivery products, but also improve the product's sensory quality and consumer satisfaction.

[0055] Further, the nicotine oral release product comprises, by weight:

[0056] The porous carrier is 40 to 50 parts; for example, it can be 40 parts, 45 parts, 50 parts, etc.

[0057] The release functional auxiliary material is 10 to 20 parts; for example, it can be 10 parts, 15 parts, 20 parts, etc.

[0058] The active agent is 1 to 10 parts; for example, it can be 1 part, 2 parts, 4 parts, 6 parts, 8 parts, 10 parts, etc.

[0059] 2 to 5 parts of adhesive; for example, it can be 2 parts, 3 parts, 4 parts, 5 parts, etc.

[0060] 1 to 3 parts of edible flavor; for example, it can be 1 part, 2 parts, 3 parts, etc.

[0061] 10 to 20 parts of sweetener; for example, 10 parts, 15 parts, 20 parts, etc.

[0062] The preservative is 0.1 to 0.5 parts; for example, it can be 0.1, 0.3, 0.4, 0.5, etc.

[0063] The pH adjuster is 0.5 to 1 part, for example, 0.5, 0.7, 0.9, 1, etc.

[0064] Further, the release functional excipient includes at least one of microcrystalline cellulose and polyglycolic acid; and / or, the sweetener includes at least one of xylitol, sorbitol, mannitol, igletol, lactitol, maltitol, isomalt, hydrogenated starch hydrolysate, erythritol, maltotriitol, aspartame, acesulfame potassium, saccharin sodium, sucralose, neotame, cyclamate, alitame, steviol glycosides, arabitol and monk fruit sweet; and / or, the pH adjuster includes at least one of citric acid, sodium citrate, sodium bicarbonate and sodium carbonate.

[0065] In addition, reference Figure 1 In the present application, there is also provided a method for preparing the nicotine oral delivery product as described in the above embodiment, comprising:

[0066] S1, mixing raw materials of nicotine oral release product including active agent and porous carrier to obtain a mixture; wherein the porous carrier includes at least one of silica gel powder and microporous ceramic;

[0067] S2, adding a mixed solvent to the mixed material to obtain a wetted material;

[0068] S3, granulating the wetted material to obtain material particles;

[0069] S4, drying and sieving the material particles to obtain the nicotine oral release product.

[0070] As mentioned above, in step S1, this step involves mixing the active agent with raw materials such as a porous carrier. The active agent may include nicotine or its derivatives, and the porous carrier may be silica gel powder or microporous ceramic, so as to obtain a uniformly mixed raw material, which lays the foundation for subsequent granulation and molding. During the operation, it is necessary to ensure that all ingredients are evenly distributed to improve the consistency and quality of the final product.

[0071] In the above, in step S2, an appropriate amount of water or ethanol or other solvent is added to the mixture to make the mixture reach an appropriate humidity for subsequent granulation. The formation of a wet material is a necessary preparation before granulation. Appropriate humidity helps the formation and uniformity of particles during granulation. Specifically, the solvent can be added to the mixture by spraying or dripping, and the amount of the mixed solvent in the wet material is controlled to be 20% to 30% of the total weight.

[0072] In step S3, granulation is performed, and the wetted mixture can be processed into granules by extrusion or roller granulation technology. Preliminary granules are obtained, and the diameter of the granules can be 0.5-2 mm. Granulation helps to control the shape and size of the final product, which is convenient for subsequent drying and packaging. For example, an extruder or a roller granulator can be used for granulation, and the size and shape of the granules can be controlled by adjusting the pressure (e.g., 100-150 bar).

[0073] The above step S4 is a drying and sieving process, where the wet granules are dried in a dryer to remove excess water, and the granules that meet the specifications are screened using a screen, thereby obtaining dry and uniform granules that are suitable for packaging and use. Drying ensures the stability of the granules and extends the shelf life, and sieving ensures product quality and consistency.

[0074] The drying can be carried out in a fluidized bed dryer, with the temperature controlled at 40° C. to 60° C. for 30 to 60 minutes. Screens of different mesh sizes, such as 30 mesh or 60 mesh, can be used for sieving to remove oversized or undersized particles.

[0075] In addition, a packaging step can be set to automatically or semi-automatically weigh and package the qualified particles to ensure the sealing of the packaging.

[0076] Furthermore, the mixing speed of the mixing process is 60 rpm to 100 rpm; for example, it can be 60 rpm, 70 rpm, 80 rpm, 90 rpm, 100 rpm, etc.

[0077] The mixing time is 15 minutes to 30 minutes, for example, 15 minutes, 17 minutes, 18 minutes, 19 minutes, 20 minutes, 25 minutes, 30 minutes, etc.

[0078] Furthermore, the mixed solvent includes at least one of water and ethanol; and / or the amount of the mixed solvent contained in the wetting material is 20% to 30%, for example, 20%, 25%, 30%, etc.

[0079] Furthermore, the drying temperature of the drying and sieving treatment is 40°C to 60°C;

[0080] And / or, the drying time of the drying and sieving process is 30 minutes to 60 minutes;

[0081] And / or, the mesh size of the middle sieve in the drying and sieving process includes at least one of 30 mesh and 60 mesh.

[0082] As mentioned above, the mesh number of the sieve can be selected according to the different release systems to be prepared. Different mesh numbers can be selected for sieving. For the rapid release system, the corresponding mesh number can be 60 mesh, and the corresponding particle size can be 2 to 10 microns. A finer mesh can obtain finer particles, which is conducive to rapid dissolution. The mesh number corresponding to the slow release system can be 30 mesh, and the corresponding particle size can be 10 to 50 microns. A coarser mesh can prolong the nicotine release.

[0083] The present invention is further described below by means of specific examples, but it should be understood that these examples are only used for more detailed description and should not be construed as limiting the present invention in any form.

[0084] Example 1

[0085] In this embodiment, the following method is used to prepare a nicotine oral release product with a rapid release system. The various main ingredients and their amounts are shown in Table 1.

[0086] Table 1. Main ingredients and dosage of nicotine oral release product in Example 1

[0087] Element use Weight Silica gel powder (fine pores) Carrier, rapid release of nicotine 45 nicotine Main active ingredients 5 Microcrystalline Cellulose Enhanced structure 15 Sweetener - Sucralose Provides sweetness 5 Sweetener - Aspartame Provides sweetness 5 Sweetener-Neotame Provides sweetness 5 Mint flavor Provide taste 1 Povidone Adhesives 3 Benzalkonium chloride preservative 0.5 Sodium Citrate pH Adjusters 0.5 water Assist dissolution and molding 10

[0088] The average pore size of the silica gel powder is 3 μm, and the average particle size is 5 μmm.

[0089] Preparation method:

[0090] S1, mixing the raw materials of the nicotine oral release product including the active agent and the porous carrier to obtain a mixture; the mixing speed of the mixing process is 80 rpm and the mixing time is 20 minutes.

[0091] S2, adding a mixed solvent into the mixed material to obtain a wetting material; the mixed solvent is water; the amount of the mixed solvent contained in the wetting material is 25%.

[0092] S3, granulating the wetted material to obtain material particles; a drum granulator is used with a pressure of 120 bar and a target particle diameter of 0.6±0.1 mm.

[0093] S4, drying and sieving the material particles using a fluidized bed desiccant to obtain the nicotine oral release product. The drying temperature of the drying and sieving process is 50° C.; the drying time of the drying and sieving process is 45 minutes; and the mesh size of the sieve during the drying and sieving process is 60 meshes.

[0094] S5. Automatically or semi-automatically weigh and package the qualified particles to ensure the sealing of the packaging. During the process, the packaging needs to be kept dust-free and sealed.

[0095] Example 2

[0096] In this embodiment, the following method is used to prepare a nicotine oral release product with a rapid release system. The various main ingredients and their amounts are shown in Table 2.

[0097] Table 2. Main ingredients and dosage of nicotine oral release product in Example 2

[0098] Element use Weight Silica gel powder (coarse pores) Carrier, slow release of nicotine 45 nicotine Main active ingredients 5 Polyglycolic acid (PEG) Slow down the release rate 15 Sweetener - Sucralose Provides sweetness 7.5 Sweetener-Neotame Provides sweetness 7.5 Mint flavor Provide taste 1 Hydroxypropyl methylcellulose Adhesives 5 Benzalkonium chloride preservative 0.5 Sodium Citrate pH Adjusters 0.5 water Assist dissolution and molding 5

[0099] The average pore size of the silica gel powder is 30 μm, and the average particle size is 40 μm.

[0100] Preparation method: basically the same as Example 1, except that:

[0101] (1) Mixing speed 60 rpm; mixing time 30 minutes;

[0102] (2) The amount of the mixed solvent contained in the wetting material is 20%.

[0103] (3) Pressure 130 bar, target particle diameter 0.6 ± 0.1 mm.

[0104] (4) The drying temperature of the drying and sieving process is 50° C.; the drying time of the drying and sieving process is 60 minutes; and the mesh size of the sieve in the drying and sieving process is 30 meshes.

[0105] Test experiment:

[0106] Dissolution curve experiment:

[0107] Experimental methods:

[0108] Equipment: Dissolution apparatus - paddle method.

[0109] Sample: 1g of each of two powders with different formulas A and B.

[0110] Dissolution medium: artificial saliva - pH 6.8

[0111] Sampling points: 0.5min, 1min, 2min, 5min, 10min, 15min, 20min, 30min, 40min, 60min

[0112] Test conditions: heating temperature 37°C, speed 100r / min;

[0113] Analysis method: High performance liquid chromatography was used to detect nicotine content.

[0114] Experimental results:

[0115] Table 3. Dissolution curve test results

[0116] Sampling point (min) A(mg) B(mg) 0.5 4.61 3.74 1 8.92 7.15 2 16.44 13.45 5 25.65 17.44 10 29.4 22.53 15 29.68 26.54 20 29.92 27.73 30 28.61 29.14 40 29.15 29.37 60 29.25 29.79

[0117] Fitting release dynamic function: y = 100a(1-e -bt ).

[0118] The time when nicotine is released by 80% is taken as the peak time:

[0119] 1. Nicotine dissolution curve:

[0120] The release curve is Figure 2 shown. Figure 2 The nicotine release of two samples (A and B) over time is shown. Figure 2 As can be seen, the curve of sample A (blue) shows a faster nicotine release, reaching a plateau phase almost within 20 minutes, indicating that nicotine is released quickly and reaches a stable state quickly. The fitting parameters a=0.29 and b=0.39 indicate a higher initial release rate and a faster saturation point.

[0121] Although the overall trend of the curve of sample B (orange) is similar to that of sample A, the release rate is slightly slower and the time to reach saturation is slightly longer, which is reflected in the slightly lower decay constant b = 0.31.

[0122] 2. Peak time diagram:

[0123] Peak time Figure 3 shown. Figure 3 The time point at which nicotine release reaches the maximum rate for the two samples, i.e. the peak time, is shown:

[0124] Sample A reached the peak release rate at 4.6 minutes.

[0125] Sample B reached the peak release rate at 7.4 minutes.

[0126] The information from these two charts indicates that Formulation A releases nicotine more quickly, while Formulation B releases it a little slower but more sustained. Formulation A may be more suitable for applications that require a quick release of nicotine, while Formulation B may be more suitable for those that require a more gradual and sustained release.

[0127] The above experimental data show that the formula has a good release effect and meets the requirements of different gradient designs.

[0128] Finally, it should be noted that the above embodiments are only used to illustrate the technical solutions of the present invention, rather than to limit it. Although the present invention has been described in detail with reference to the aforementioned embodiments, those skilled in the art should understand that they can still modify the technical solutions described in the aforementioned embodiments, or replace some or all of the technical features therein by equivalents. However, these modifications or replacements do not make the essence of the corresponding technical solutions deviate from the scope of the technical solutions of the embodiments of the present invention.

Claims

1. A nicotine oral release product, characterized in that: include: An active agent and a porous carrier, wherein the porous carrier accounts for no less than 30% by mass in the nicotine oral delivery product; Wherein, the porous carrier includes at least one of silica gel powder and microporous ceramics.

2. The nicotine oral delivery product according to claim 1, characterized in that The active agent includes at least one of nicotine and nicotine derivatives.

3. The nicotine oral delivery product according to claim 1, characterized in that The porous carrier has a pore size of 1 μm-5 μm and a particle size of 2 μm-10 μm; or The pore size of the porous carrier is 5 μm-40 μm, and the particle size is 10 μm-50 μm.

4. The nicotine oral delivery product according to claim 1, wherein: It also includes at least one of a sweetener, a preservative, a pH adjuster, an edible flavor, a binder, and a release functional auxiliary material.

5. The nicotine oral delivery product according to claim 4, characterized in that The nicotine oral release product comprises, by weight: 40 to 50 parts of porous carrier; Release functional excipients 10 to 20 parts; 1 to 10 parts of active agent; 2 to 5 parts of adhesive; 1 to 3 parts of edible flavor; 10 to 20 parts of sweetener; 0.1 to 0.5 parts of preservatives; 0.5 to 1 part of pH adjuster 6. The nicotine oral delivery product according to claim 4, characterized in that The release functional excipient comprises at least one of microcrystalline cellulose and polyglycolic acid; and / or, The sweetener comprises at least one of xylitol, sorbitol, mannitol, igletol, lactitol, maltitol, isomalt, hydrogenated starch hydrolysate, erythritol, maltotriitol, aspartame, acesulfame potassium, saccharin sodium, sucralose, neotame, sodium cyclamate, alitame, steviol glycosides, arabitol and monk fruit sweetener; and / or, The pH adjuster includes at least one of citric acid, sodium citrate, sodium bicarbonate and sodium carbonate.

7. A method for preparing a nicotine oral delivery product according to any one of claims 1 to 6, characterized in that: include: Mixing raw materials of nicotine oral release products including an active agent and a porous carrier to obtain a mixture; wherein the porous carrier includes at least one of silica gel powder and microporous ceramics; adding a mixed solvent to the mixed material to obtain a wetted material; Granulating the wetted material to obtain material particles; The material particles are dried and sieved to obtain the nicotine oral release product.

8. The method for preparing a nicotine oral delivery product according to claim 7, wherein: The mixing speed of the mixing process is 60 rpm to 100 rpm, and the mixing time is 15 minutes to 30 minutes.

9. The method for preparing a nicotine oral delivery product according to claim 7, wherein: The mixed solvent comprises at least one of water and ethanol; and / or, The amount of the mixed solvent contained in the wetting material is 20% to 30%.

10. The method for preparing a nicotine oral delivery product according to claim 7, wherein: The drying temperature of the drying and sieving treatment is 40°C to 60°C; and / or, The drying time in the drying and sieving process is 30 minutes to 60 minutes; and / or, The mesh size of the sieve in the drying and sieving process includes at least one of 30 mesh and 60 mesh.

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