Dry product and buccal product

Abstract

The embodiment of the invention provides a dry product and a buccal product, the dry product provided by the embodiment of the invention comprises a drying agent, the drying agent comprises the following components in parts by mass: 60-85 parts of a moisture absorbent, 15-25 parts of a stabilizer, 5-8 parts of a forming agent and 1-2 parts of an antioxidant, and the dry product can be used for realizing high-temperature and low-temperature circulation, long-term high-temperature and high-humidity extreme environments and the like. The desiccant only absorbs free moisture in a package, does not take away moisture of the buccal product, and does not have the condition of moisture absorption failure or reaction with the buccal product, so that the form and the components of the buccal product are still kept stable in a severe storage / transportation environment, and the problem that the existing desiccant is difficult to absorb in a long-term or extreme environment is solved. And effective moisture prevention and self chemical stability maintenance cannot be carried out on the unsealed buccal product.

Description

dried products and oral products Technical Field

[0001] This application belongs to the field of oral product technology, specifically relating to a dried product and a sublingual product. Background Technology

[0002] Oral lozenges allow smokers to absorb active ingredients directly through the oral mucosa, helping them alleviate cravings. Compared to regular tobacco products, they reduce the intake of harmful substances such as tar and carbon monoxide, making them a healthier option for smokers trying to quit.

[0003] However, oral products are hygroscopic and cannot effectively maintain a low humidity environment inside the packaging after opening. This makes oral tobacco products susceptible to moisture during storage after opening, leading to problems such as softening, sticking, and prolonged disintegration time, which affects product quality.

[0004] However, commonly used desiccants (such as calcium chloride) are not well-suited to the product. They are prone to deliquescence and clumping after absorbing moisture, and may even react with trace components in the environment or oral tobacco products, posing a potential risk of producing harmful substances and odors. Summary of the Invention The technical problem to be solved by this application is to provide a dried product and a mouth-held product to improve the problem that existing desiccants cannot effectively prevent moisture from the opened mouth-held product and maintain their own chemical stability under long-term or extreme environments.

[0005] To improve the above problems, this application is achieved through the following technical solution: This application proposes a dried product, which includes a desiccant, wherein the desiccant comprises, by weight, 60-85 parts of hygroscopic agent, 15-25 parts of stabilizer, 5-8 parts of molding agent, and 1-2 parts of antioxidant.

[0006] Furthermore, in the dried product, the desiccant includes a primary desiccant and an auxiliary desiccant, wherein the desiccant also satisfies at least one of conditions (I) to (III): (I) by mass, it includes 40-55 parts of primary desiccant and 20-30 parts of auxiliary desiccant; (II) the primary desiccant includes at least one of sodium-modified montmorillonite, silica gel, modified attapulgite, and 3A molecular sieve; (III) the auxiliary desiccant includes at least one of anhydrous sodium sulfate, anhydrous calcium chloride, and anhydrous magnesium sulfate.

[0007] Furthermore, in the dried product, the stabilizer includes at least one of silicon dioxide and microcrystalline cellulose; and / or, the molding agent includes polyvinyl alcohol; and / or, the antioxidant includes at least one of trisodium citrate, sodium ascorbate, vitamin E, and tea polyphenols.

[0008] Furthermore, in the dried product, the silica is nano-sized silica; and / or, the degree of polymerization of the polyvinyl alcohol is less than or equal to 88.

[0009] Furthermore, the dried product also includes a breathable bag, and the desiccant is filled inside the breathable bag.

[0010] Furthermore, in the dried product, the pore size of the breathable bag is 0.1μm~0.2μm.

[0011] Furthermore, in the dried product, the breathable bag is a non-woven bag.

[0012] Furthermore, in the dried product, the particle size of the desiccant is 1mm to 2mm.

[0013] This application also proposes a method for preparing the dried product as described above. The method includes: mixing a hygroscopic agent and a stabilizer according to a mass ratio, then adding a molding agent solution and an antioxidant to obtain a paste solution; extruding and granulating the paste solution, and then drying it at 80~90℃ for 2~3 hours to form a desiccant, thereby obtaining the dried product.

[0014] This application also proposes a mouth-holding product, including a receiving element, a mouth-holding article located within the receiving element, and a dried article as described above.

[0015] Furthermore, in the oral product, the oral product includes at least one of oral dissolving film, oral tablet, chewing gum, oral pouch, and composite sheet of functional layer and support layer; and / or, the receiving element is a receiving box or receiving bag.

[0016] Furthermore, in the oral product, the moisture content of the oral product does not exceed 10%; and / or, in the oral product, the relative humidity inside the accommodating element does not exceed 40%.

[0017] Compared with the prior art, the embodiments of this application have the following advantages: In the embodiments of this application, the provided desiccant includes 60-85 parts of desiccant, 15-25 parts of stabilizer, 5-8 parts of molding agent, and 1-2 parts of antioxidant by weight. It can achieve that under extreme environments such as high and low temperature cycles and long-term high temperature and high humidity, the desiccant only absorbs free moisture in the packaging, without taking away the moisture of the oral product itself, and does not fail to absorb moisture or react with the oral product. This makes the form and composition of the oral product remain stable in harsh storage / transportation environments, improving the problem that existing desiccants cannot effectively prevent moisture from the opened oral product and maintain its own chemical stability under long-term or extreme environments.

[0018] It should be understood that the above general description and the following detailed description are exemplary and explanatory only, and do not limit this application. Attached Figure Description

[0019] Figure 1 is a flowchart of the preparation method of the dried product provided in the embodiment of this application. Detailed Implementation

[0020] To make the above-mentioned objectives, features and advantages of this application more apparent and understandable, the application will be further described in detail below with reference to the accompanying drawings and specific embodiments.

[0021] The terms "first" and "second" in the specification and claims of this application may explicitly or implicitly include one or more of the features. In the description of this application, unless otherwise stated, "multiple" means two or more. Furthermore, "and / or" in the specification and claims indicates at least one of the connected objects, and the character " / " generally indicates that the preceding and following objects are in an "or" relationship.

[0022] The inventors discovered that traditional oral tobacco products typically possess hygroscopic properties. Once opened, they cannot effectively maintain a low-humidity environment within the packaging, leading to softening, sticking, and prolonged disintegration during storage, thus affecting product quality. Existing desiccants (such as traditional calcium chloride) are prone to deliquescence and clumping after absorbing moisture, and may even react with the air inside the packaging or trace components of the oral product, posing a potential risk of generating harmful substances. Furthermore, existing desiccants lack compatibility with oral products, failing to meet the dual requirements of "stable moisture absorption" and "non-reactive properties" under long-term storage or extreme temperature and humidity conditions, thus failing to provide a continuous and safe storage environment for oral products.

[0023] To address the aforementioned issues, this application provides a dried product comprising a desiccant, wherein the desiccant comprises, by weight, 60-85 parts of a hygroscopic agent, 15-25 parts of a stabilizer, 5-8 parts of a molding agent, and 1-2 parts of an antioxidant.

[0024] Among them, the desiccant is used to absorb free moisture, the stabilizer can prevent the desiccant from clumping and inhibit the reaction, the forming agent can maintain the particle shape of the desiccant, and the antioxidant can effectively prevent the oxidation reaction of the components.

[0025] In this embodiment, the desiccant comprises, by weight, 60-85 parts of desiccant, 15-25 parts of stabilizer, 5-8 parts of molding agent, and 1-2 parts of antioxidant. It enables the desiccant to absorb only free moisture within the packaging under extreme environments such as high-low temperature cycling and long-term high-temperature and high-humidity conditions, without removing moisture from the oral product itself. It avoids moisture absorption failure or reaction with the oral product, ensuring that the oral product's form and composition remain stable even in harsh storage / transportation environments. This improves upon the problem that existing desiccants cannot effectively prevent moisture absorption and maintain chemical stability of opened oral products under long-term or extreme conditions.

[0026] In one embodiment, the aforementioned desiccant includes a primary desiccant and a secondary desiccant, wherein, by weight, it comprises 40-55 parts of the primary desiccant and 20-30 parts of the secondary desiccant. Using the primary and secondary desiccant in a weight ratio of 40-55:20-30 as the desiccant in the desiccant effectively absorbs moisture while avoiding the absorption of moisture from the lozenges and preventing the particles from becoming fragile, thus achieving effective moisture control and stable shape.

[0027] In one specific embodiment, the primary hygroscopic agent includes at least one selected from sodium-modified montmorillonite, silica gel, modified attapulgite, and 3A molecular sieve. The aforementioned hygroscopic agents are safe and moisture-wicking, and do not react with the components of the oral product.

[0028] In one specific embodiment, the auxiliary hygroscopic agent includes at least one selected from anhydrous sodium sulfate, anhydrous calcium chloride, and anhydrous magnesium sulfate. The auxiliary hygroscopic agent can effectively assist in moisture absorption, effectively balancing the auxiliary effect with product stability while ensuring product safety.

[0029] In this embodiment, the mass fraction of the stabilizer is limited to 15-25 parts, which can achieve the effect of preventing agglomeration and avoid the problem of easy cracking of desiccant particles.

[0030] In one embodiment, the stabilizer includes at least one of silica and microcrystalline cellulose; wherein the silica can be nano-sized silica, which makes the stabilizer easy to disperse, achieves better inhibition of reaction, and avoids desiccant clumping.

[0031] In one embodiment, the molding agent includes polyvinyl alcohol, specifically low-polymerization-degree polyvinyl alcohol, which can effectively maintain the desiccant particle morphology without affecting the moisture absorption effect.

[0032] In some embodiments, the degree of polymerization of the polyvinyl alcohol is less than or equal to 88, for example, it can be a range of one or any two of 30, 40, 50, 60, 70, 80, 88.

[0033] In this embodiment of the application, the antioxidant is limited to 1 to 2 parts by mass, which can effectively achieve the antioxidant effect, prevent the ingredients from oxidizing and deteriorating, and does not affect the taste (such as astringent taste) or stability of the oral product. That is, it can balance the antioxidant efficiency with the safety and palatability of use.

[0034] In one embodiment, the antioxidants include at least one of trisodium citrate, sodium ascorbate, vitamin E, and tea polyphenols, all of which can safely inhibit the oxidation of components.

[0035] In one embodiment, the above-mentioned drying product further includes a breathable bag, in which a desiccant is filled.

[0036] In this embodiment, using a breathable bag to fill the desiccant can effectively prevent dust leakage without affecting the desiccant's ability to absorb moisture and dry the lozenges, and also avoid direct contact between the desiccant and the lozenges.

[0037] In this embodiment, the material of the breathable bag meets food contact safety standards (no migration of harmful substances), can block external moisture and impurities, has sufficient mechanical strength to prevent breakage and powder leakage, is resistant to high and low temperatures and does not release harmful substances, does not react with desiccants or oral tablet ingredients, and is suitable for batch packaging and processing with controllable costs.

[0038] In some embodiments, the pore size of the breathable bag is 0.1μm to 0.2μm, which effectively balances moisture absorption and drying performance with dust leakage prevention. In some embodiments, the pore size of the breathable bag can be one or any combination of 0.1μm, 0.15μm, and 0.2μm.

[0039] In some embodiments, the breathable bag is a non-woven bag, which enables the bag itself to have filtering properties, preventing large particles inside the bag from leaching out of the bag.

[0040] In one embodiment, the particle size of the desiccant is 1mm to 2mm. In this embodiment, particle porosity is controlled during the desiccant preparation process to slow down the moisture absorption rate and prevent excessive moisture absorption by the desiccant from affecting the moisture balance of the lozenges. This ensures that the lozenges can be stored stably after opening without becoming damp or hard, and the moisture absorption effect is consistent for each batch of products, making the process stable and controllable.

[0041] This application embodiment also provides a method for preparing the dried product as described above, as shown in Figure 1, including steps 101 to 102: Step 101, after mixing the hygroscopic agent and the stabilizer according to the mass ratio, add the molding agent solution and the antioxidant to obtain a paste fluid; Step 102, after extruding and granulating the paste fluid, dry it at 80℃~90℃ for 2~3 hours to form a desiccant to obtain the dried product.

[0042] In this embodiment, after the desiccant, stabilizer, molding agent and antioxidant are mixed into a paste-like fluid according to the mass ratio, the paste is formed by extrusion and the pore size is reduced and the particle density is increased to reduce large pores during granulation. Then, the small and medium pore structure is fixed by drying / activation at 80°C~90°C. This can slow down the moisture absorption rate of the desiccant, prevent the desiccant from absorbing too much moisture and affecting the moisture balance of the lozenges, and ensure that the lozenges can still be stored stably after opening without the problems of being damp and soft or dry and hard.

[0043] This application also provides a mouth-holding product, including a receiving member, a mouth-holding article located within the receiving member, and a dried article as described above.

[0044] Among them, the container is an object that can hold oral products and dried products, and can be a container box or a container bag.

[0045] Because the properties of the desiccant in the above-mentioned dried products match the formulation of the lozenges, the desiccant only absorbs free moisture in the packaging, does not remove the moisture from the lozenges themselves, and does not react with the ingredients of the lozenges. This can effectively improve the problem that existing lozenges do not have suitable desiccants and are prone to moisture after opening.

[0046] In one embodiment, the relative humidity inside the container does not exceed 40%, that is, due to the presence of the desiccant, the humidity inside the container can be quickly reduced to below 40% or even not exceeding 30%, effectively preventing the oral product from becoming damp and softening.

[0047] In one embodiment, the moisture content of the oral product is no more than 10%, which can effectively prevent it from penetrating to the surface of the product; alternatively, the moisture content of the oral product is not less than 6%, so as to ensure elasticity and avoid it being too hard and affecting the taste.

[0048] In one embodiment, the oral product includes an active substance, which includes at least one of nicotine preparations, tobacco extracts, ginseng extracts, green tea extracts, and vitamin preparations. The active substance can impart specific physiological effects (such as the satisfaction of nicotine) or sensory experiences (flavor) or other specific functions to the oral product. It can also dissolve rapidly in the oral cavity to release the active substance, help smokers alleviate withdrawal symptoms, and is not easily reacted with the desiccant, and can be stored for a long time after opening.

[0049] In some embodiments, the aforementioned nicotine agent includes at least one of nicotine and nicotine derivatives; the nicotine includes natural nicotine and / or synthetic nicotine, and the nicotine derivatives include one or more of nicotine salts, nicotine in a matrix such as a glycobase or an organometallic complex, nicotine-resin combinations, nicotine inclusion complexes, and non-covalently bound nicotine. Among these, nicotine inclusion complexes include nicotine poloxetine, etc., and non-covalently bound nicotine includes nicotine lactate, nicotine malate, nicotine salicylate, nicotine cyclodextrin encapsulated complexes, nicotine hydrochloride, nicotine dihydrochloride, nicotine tartrate, nicotine tartrate dihydrate, nicotine sulfate, nicotine zinc chloride, nicotine benzoate, etc. Nicotine derivatives also include nicotine containing substituents, such as one or more mixtures 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.

[0050] In some embodiments, the active substance may include substances with specific active properties, such as caffeine, theophylline, capsaicin, etc.

[0051] In some implementations, the tobacco extract can be tailored to the flavor of the oral product and can be a flue-cured tobacco extract, a cigar tobacco extract, a burley tobacco extract, a sun-cured tobacco extract, a Zimbabwean extract, etc., to provide physiological satisfaction.

[0052] In some embodiments, the oral product further includes at least one of flavoring, sweetener, cooling agent, plasticizer, pH adjuster, antioxidant, colorant, filler, binder, lubricant and sustained-release agent.

[0053] Flavorings can improve taste and flavor, mask the odor of chemicals such as tobacco or nicotine, and enhance the user experience. Meanwhile, flavorings such as mint and spicy spices can stimulate the oral mucosa, promote saliva secretion, and help nicotine be released more quickly and absorbed through the mouth, enhancing its effect. Furthermore, the diverse flavor profiles of flavorings (such as coffee, chocolate, and cinnamon) can satisfy different consumer preferences and increase product appeal. In some embodiments, the aforementioned flavorings can be mint flavorings, menthol, fruit flavorings, etc.

[0054] The aforementioned sweeteners can mask the bitter or pungent taste of nicotine, tobacco, or plant fibers, enhancing the palatability of the product. Simultaneously, sweeteners can also increase pleasurable sensations and reduce user aversion. Furthermore, sweeteners work synergistically with flavorings to enhance the expression of fruity, minty, and other flavor profiles. In some embodiments, the sweetener includes at least one of sucralose, acesulfame potassium, steviol glycosides, aspartame, and neotame.

[0055] Cooling agents can enhance the user experience by simulating a cooling sensation, effectively neutralizing or masking the odor of active ingredients, reducing direct irritation of the active ingredients to the oral mucosa, and minimizing burning or numbness after use. In some embodiments, cooling agents may include at least one of menthol, N-ethyl-2-isopropyl-5-methylcyclohexaneformamide, menthyl lactate, menthyl acetate, and menthone glycerol ketal.

[0056] The aforementioned plasticizers can increase the softness and elasticity of oral products, preventing them from drying and cracking. They can also adjust the dissolution rate of nicotine and flavorings by regulating the porosity of the material. In some embodiments, the plasticizer includes at least one of propylene glycol, polyethylene glycol with a molecular weight of less than 1000 Daltons, and glycerin. This not only increases the softness and elasticity of oral products such as cigarette smokers but also locks in moisture, prevents the product from hardening, and extends its shelf life.

[0057] The pH adjuster not only neutralizes the irritation of acidic components and reduces the burning sensation in the mouth, maintaining a slightly alkaline environment, but also ensures that nicotine, in an alkaline environment (pH 8-9), exists in a non-ionic state, making it less prone to degradation and more easily absorbed through the oral mucosa, thus enhancing bioavailability and extending shelf life. In some embodiments, the pH adjuster may include at least one of sodium bicarbonate, sodium carbonate, and calcium carbonate.

[0058] Antioxidants can improve the chemical stability of a product during storage and prevent the degradation of active ingredients. In some embodiments, antioxidants include at least one of vitamin E, butylated hydroxyanisole, and ascorbic acid.

[0059] Colorants are used to give products a specific appearance color. In some embodiments, colorants include food colorings.

[0060] Fillers are used to adjust the density of the product to improve its texture. In some embodiments, fillers include mannitol.

[0061] In this context, the sustained-release agent is used to slow down the release of a specific flavor or to mask unpleasant tastes. In some embodiments, the sustained-release agent includes at least one of cyclodextrin and its derivatives.

[0062] The adhesive is used to maintain the shape of the lozenge. In some embodiments, the adhesive includes at least one of hydroxypropyl methylcellulose, starch, gelatin, hydroxypropyl methylcellulose, and hydroxypropyl cellulose.

[0063] The lubricant is used to prevent sticking. In some embodiments, the lubricant includes at least one of magnesium stearate, silica, micronized silica, and polyethylene glycol.

[0064] In some embodiments, the oral article comprises, by weight, 60-75 parts of filler, 2-3.5 parts of binder, 0.5-1 part of lubricant, 0.1-0.3 parts of sweetener, and 1-2 parts of active substance.

[0065] In some embodiments, the oral article may further include 60-70 parts by weight of solvent. The solvent may be water, etc.

[0066] In some embodiments, the oral article further includes a water-permeable membrane, a base membrane, and a functional layer disposed between the water-permeable membrane and the base membrane, the functional layer including an active substance.

[0067] The base membrane is used to support the functional layer through coating and other methods; the functional layer includes active substances that can be released upon contact with saliva, thereby providing a stimulating sensation; the water-permeable membrane has water-permeable and water-locking functions, is covered on the surface of the functional layer, provides conditions for slow-release, and can also lock in some saliva, reducing the burning sensation in the throat and stomach.

[0068] In some embodiments, the above-mentioned oral article, by weight, comprises 60-75 parts of filler, 2-3.5 parts of adhesive, 0.5-1 part of lubricant, 0.1-0.3 parts of sweetener, and 1-2 parts of active substance; the base film comprises 8-15 parts of carrier fabric; and the water-permeable membrane comprises 7-14 parts of nonwoven fabric.

[0069] In some embodiments, the oral product is at least one of a lozenge, a dissolving film, a lozenge pouch, chewing gum, or a composite sheet with a functional layer and a support layer. The support layer provides structural support to the functional layer, giving the oral product both softness and rigidity; specifically, the support layer is the aforementioned base film or water-permeable film.

[0070] In some embodiments, the oral product provided in this application is a mouth bag, including a bag body, the ingredients of the oral product are filled in the bag body, and the bag body is permeable to saliva.

[0071] In some embodiments, the oral product is a product in which an oral dissolving film is encapsulated in a nonwoven bag permeable to saliva, i.e., a composite product of an oral bag and an oral dissolving film.

[0072] In some embodiments, the oral article is a product in which chewing gum composition particles are packaged in a saliva-permeable nonwoven bag, i.e., a composite product of oral bag and chewing gum.

[0073] In some embodiments, the oral product is a product in which a lozenge is packaged in a non-woven bag permeable to saliva, i.e., a composite product of a lozenge bag and a lozenge.

[0074] The bag can be a fiber bag, and it is treated with pure water, sodium alginate solution, sodium hyaluronate solution, hydroxypropyl methylcellulose solution, etc. to maintain the humidity of the oral product.

[0075] In some embodiments, the shape of the oral product can be irregular, such as cylindrical, granular, strip-shaped, sheet-like, filament-like, or spherical, and can be adjusted according to different design requirements.

[0076] The oral product provided in this application embodiment matches the desiccant provided in this application embodiment. It can achieve the following in extreme environments such as high and low temperature cycles and long-term high temperature and high humidity: the desiccant only absorbs free moisture in the packaging and does not remove moisture from the oral product itself. It does not fail to absorb moisture or react with the oral product. Therefore, in harsh storage / transportation environments, the oral product will not stick together due to moisture or become brittle due to dehydration. The shape and composition of the oral product will remain stable, which can effectively ensure safe use.

[0077] To make the inventive objectives, technical solutions, and beneficial effects of this application clearer, the application is further described below with reference to embodiments. It should be understood that these embodiments are for illustrative purposes only and are not intended to limit the scope of this application.

[0078] The present application will be described in detail below through embodiments.

[0079] Test method (1) Short-term 7-day high and low temperature cycle test: The high and low temperature cycle parameters of -10℃ (8 hours) → 25℃ (4 hours) → 40℃ (8 hours) → 25℃ (4 hours) are executed sequentially as 1 cycle, and the cycle is carried out continuously for 7 days (a total of 7 cycles). After that, the humidity inside the packaging, the appearance of the lozenge, the peeling force of the lozenge and the disintegration time of the lozenge are measured.

[0080] (2) Long-term high temperature and high humidity storage test for 3 months: The desiccant and the air inside the packaging of the lozenges were continuously stored for 3 months at a temperature of 40℃±2℃ and a relative humidity of 75%±5%. Then, the new impurity peaks of nitrite, aldehydes, esters, etc. in the desiccant and the air inside the packaging were detected by high performance liquid chromatography (HPLC) and gas chromatography-mass spectrometry (GC-MS). The nicotine content, excipient purity, lozenge peeling force and lozenge disintegration time were also tested.

[0081] Example 1 (1) By weight, 45 parts of modified montmorillonite, 25 parts of anhydrous sodium sulfate, and 20 parts of silica were mixed, 6 parts of polyvinyl alcohol solution and 1.5 parts of trisodium citrate were added, and the mixture was stirred until it became a uniform paste. The mixture was granulated by extrusion with a particle size of 1.5 mm, dried at 80~90℃ for 2~3 hours, cooled and packaged in a breathable non-woven bag to obtain the dried product.

[0082] (2) Weigh 1.5 parts nicotine, 70 parts mannitol, 3 parts hydroxypropyl methylcellulose, 0.8 parts magnesium stearate, and 0.2 parts acesulfame potassium by weight, and add purified water at 200% of the solid ratio. Stir until completely dissolved to form a uniform and clear mixed solution. Coat the mixed solution evenly on the surface of the carrier cloth, dry it in a 60°C drying device until the moisture content is about 20%, cover the coated surface with a layer of nonwoven fabric, and then put it in a 60°C drying device to dry for 1 hour, so that the solution forms a film and is tightly bonded to the nonwoven fabric and the carrier cloth to obtain a composite film. Cut the composite film into corresponding sizes to obtain a lozenge with a nonwoven fabric layer.

[0083] (3) Pack 20 lozenges and 1 bag of desiccant into a round box to obtain the lozenge product.

[0084] The difference between Comparative Example 1 and Example 1 is that in step (3), 20 lozenges are directly packaged in a round box to obtain the lozenge product.

[0085] The oral products in Example 1 and Comparative Example 1 were subjected to a short-term 7-day high and low temperature cycling test, and the results are shown in Table 1.

[0086] Table 1

[0087] As shown in Table 1, the desiccant in Example 1 of this application can stably control the humidity inside the round box to below RH30% under short-term extreme temperature and humidity cycles, effectively preventing the lozenges from softening and sticking together, and without affecting their hardness and disintegration time; while in Comparative Example 1 without desiccant, the lozenges were severely damp and their performance was greatly reduced.

[0088] The oral products in Example 1 and Comparative Example 1 were subjected to long-term high-temperature and high-humidity storage tests for 3 months. The results showed that after 3 months of storage, no new impurity peaks such as nitrite, aldehydes, and esters appeared in the desiccant and the air inside the oral tablets in the packaging, which was consistent with the initial detection spectrum. The initial average nicotine content was 1.50%, which decreased to 1.49% after 1 month, 1.48% after 2 months, and 1.47% after 3 months, with a change rate of ≤±3%, which met the requirements for drug stability. Mannitol, hydroxypropyl methylcellulose and other excipients were detected by HPLC and no degradation product peaks were found, with a change rate of <1% compared with the initial content. The peel force of the oral tablets decreased from 3.5N in the initial state to 3.3N, and the adhesion strength remained stable. The disintegration time increased from 125.0s to 126.5s.

[0089] In Comparative Example 1, the peel force of the lozenge in the oral product decreased from 3.4N in the initial state to 0.9N, and the bonding force dropped sharply. Insufficient peel force can easily cause the non-woven fabric to delaminate and fall off, posing a risk of swallowing discomfort. The disintegration time of the lozenge in the oral product in Comparative Example 1 decreased from 124.8s to 81s.

[0090] After three months of long-term high temperature and high humidity storage, no harmful substances were produced by the desiccant, and the nicotine content, excipient purity, and physical properties of the oral tablets remained stable. This verified the core effect of the desiccant: "it does not react and absorbs moisture stably for a long time." It also solved the three major pain points of existing technologies: "insufficient / excessive moisture absorption, easy reaction, and long-term failure."

[0091] In summary, the desiccant provided in this application includes a desiccant, which comprises 60-85 parts by weight of hygroscopic agent, 15-25 parts of stabilizer, 5-8 parts of molding agent, and 1-2 parts of antioxidant. This desiccant can absorb only free moisture within the packaging under extreme environments such as high and low temperature cycles and long-term high temperature and humidity, without removing moisture from the oral product itself. It does not fail to absorb moisture or react with the oral product, ensuring that the oral product's form and composition remain stable even in harsh storage / transportation environments. This improves upon the problem that existing desiccants cannot effectively prevent moisture from entering opened oral products and maintain their chemical stability under long-term or extreme environments.

[0092] Although preferred embodiments of the present application have been described, those skilled in the art, upon learning the basic inventive concept, can make other changes and modifications to these embodiments. Therefore, the claims are intended to be interpreted as including the preferred embodiments as well as all changes and modifications falling within the scope of the embodiments of the present application.

[0093] The above provides a detailed description of a dried product, its preparation method, and an oral product provided by this application. Specific examples have been used to illustrate the principles and implementation methods of this application. The descriptions of the above embodiments are only for the purpose of helping to understand the method and core ideas of this application. At the same time, for those skilled in the art, there will be changes in the specific implementation methods and application scope based on the ideas of this application. Therefore, the content of this specification should not be construed as a limitation of this application.

Claims

1. A dried product, characterized in that, It includes a desiccant, which, by weight, comprises: 60-85 parts of hygroscopic agent, 15-25 parts of stabilizer, 5-8 parts of molding agent, and 1-2 parts of antioxidant.

2. The dried product according to claim 1, characterized in that, The hygroscopic agent includes a primary hygroscopic agent and a secondary hygroscopic agent, wherein the hygroscopic agent also satisfies at least one of conditions (I) to (III): (I) by mass, it includes 40 to 55 parts of primary hygroscopic agent and 20 to 30 parts of secondary hygroscopic agent; (II) the primary hygroscopic agent includes at least one of sodium-modified montmorillonite, silica gel, modified attapulgite, and 3A molecular sieve; (III) the secondary hygroscopic agent includes at least one of anhydrous sodium sulfate, anhydrous calcium chloride, and anhydrous magnesium sulfate.

3. The dried product according to claim 1, characterized in that, The stabilizer includes at least one of silicon dioxide and microcrystalline cellulose; and / or the molding agent includes polyvinyl alcohol; and / or the antioxidant includes at least one of trisodium citrate, sodium ascorbate, vitamin E, and tea polyphenols.

4. The dried product according to claim 3, characterized in that, The silica is nanoscale silica; and / or the degree of polymerization of the polyvinyl alcohol is less than or equal to 88.

5. The dried product according to claim 1, characterized in that, The dried product also includes a breathable bag, and the desiccant is filled inside the breathable bag.

6. The dried product according to claim 5, characterized in that, The pore size of the breathable bag is 0.1μm~0.2μm.

7. The dried product according to any one of claims 1 to 6, characterized in that, The particle size of the desiccant is 1mm to 2mm.

8. A mouth-holding product comprising a receiving element, a mouth-holding article located within the receiving element, and a dried article as claimed in any one of claims 1 to 7.

9. The oral product according to claim 8, characterized in that, The oral product includes at least one of oral dissolving film, oral tablet, chewing gum, oral pouch, and composite sheet of functional layer and support layer; and / or, the receiving element is a receiving box or receiving bag.

10. The oral product according to claim 8 or 9, characterized in that, The moisture content of the oral product does not exceed 10%; and / or, the relative humidity within the container of the oral product does not exceed 40%.

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