Dual-purpose nicotine delivery membrane as well as preparation method and application thereof

Abstract

The invention discloses a dual-purpose nicotine delivery film and a preparation method and application thereof, and the dual-purpose nicotine delivery film comprises the following components in parts by weight: 10-25 parts of a film forming substrate, 3-8 parts of an adhesive, 3-8 parts of nicotine, 25-60 parts of a smoke agent or a humectant, 0.5-4 parts of a flavoring agent, 5-30 parts of a humidity regulator and 0.5-3 parts of an acid-base regulator. According to the dual-purpose nicotine delivery film, the effective components such as the tobacco extract, the nicotine salt, the polyhydric alcohol, the natural or synthetic flavor substance, the water and the weakly alkaline food additive are uniformly dispersed in the adhesion layer, so that the dual-purpose nicotine delivery film which not only can be used for heating non-combustible tobacco products but also can be used for oral transdermal delivery of nicotine products is obtained; the use ways of the obtained film are enriched, and the utilization rate of nicotine products is increased.

Description

TECHNICAL FIELD

[0001] The present application relates to the technical field of tobacco products, in particular to a dual-purpose nicotine delivery film and a preparation method and application thereof. BACKGROUND

[0002] In recent years, new tobacco products have become the realistic choice for tobacco companies in various countries to face the restrictions on traditional tobacco products due to their convenience and rich taste advantages, and have caused a worldwide consumer craze in a short period of time. Among them, the market share of heat-not-burn cigarettes is the highest, and the market size of oral tobacco products is the most significant in growth. Heat-not-burn cigarettes are generally composed of a cigarette (cartridge) and an external heat source (smoking set), and the smoking segment in the cigarette releases smoke aerosol containing nicotine, tobacco flavor substances and other components by means of external heat source heating, thereby achieving nicotine delivery. Nicotine film is a main way for nicotine to be absorbed through the oral mucosa, and the highest concentration of nicotine in the plasma after eating is close to that after smoking a cigarette. However, since the non-smoke tobacco stays in the oral cavity for a long time, the total amount of nicotine absorbed each time is about twice that of a cigarette, which greatly meets the needs of consumers.

[0003] Many prior art documents disclose various forms of smoking segment materials in heat-not-burn cigarettes, such as reconstituted tobacco base sheet; smoking rods prepared by casting, rolling, calendering or extrusion process (international patent, WO2011 / 101164A1); heat-reversible gels that can generate nicotine-containing aerosols (international patent, WO2018019543A1). In addition, researchers have also optimized the product form in terms of the smoking experience of oral tobacco, such as micro-pellet type oral tobacco with comfortable taste and good aroma uniformity (Chinese patent, CN119138640A); nicotine lozenges containing traditional Chinese medicine mixed extract, trace elements, vitamins and other ingredients, which have the function of preventing and treating oral ulcers (Chinese patent, CN115969898A). However, the above-mentioned materials can only provide one of the functions of generating aerosols by heating to deliver nicotine or transdermal delivery of nicotine, and the use is single and the function is limited.

[0004] It is particularly important to further optimize the components and formulations of nicotine delivery media, provide dual-purpose nicotine delivery films, optimize production processes, reduce production costs, and at the same time, adjust the use of products, improve the use efficiency of materials, specifically meet market demand, and obtain nicotine products with higher application value. However, the prior art lacks a preparation method for multi-purpose nicotine release material. SUMMARY

[0005] The technical problem to be solved by the present invention is to provide a dual-purpose nicotine delivery membrane, its preparation method and application. The effective components such as tobacco extract, nicotine salt, polyol, natural or synthetic flavoring substances, water, and weakly alkaline food additives are uniformly dispersed in an adhesive layer to obtain a dual-purpose nicotine delivery membrane that can be used in both heated non-combustible tobacco products and oral transdermal nicotine delivery products. This enriches the application of the obtained film and improves the utilization rate of nicotine products.

[0006] The technical problem to be solved by the present invention is achieved through the following technical solution: A dual-purpose nicotine delivery membrane comprises the following components in parts by weight: 10-25 parts film-forming substrate, 3-8 parts adhesive, 3-8 parts nicotine, 25-60 parts smoke generator or humectant, 0.5-4 parts flavoring agent, 5-30 parts humidity regulator, and 0.5-3 parts pH regulator.

[0007] Preferably, the above technical solution includes the following components by weight: 18 parts film-forming substrate, 5 parts adhesive, 5 parts nicotine, 42 parts smoke generator or humectant, 2 parts flavoring agent, 18 parts humidity regulator, and 2 parts acid-base regulator.

[0008] Preferably, in the above technical solution, the film-forming substrate is cellulose or its derivative; the adhesive is a polysaccharide or its derivative; the nicotine is derived from tobacco extract or nicotine salt; the smoke-generating agent or humectant is a polyol; the flavoring agent is a natural or synthetic flavoring substance; the humidity regulator is water; and the pH regulator is a weakly alkaline food additive.

[0009] Preferably, in the above technical solution, the film-forming substrate is selected from at least one of bacterial cellulose, nanocellulose, methylcellulose, hydroxypropyl methylcellulose, carboxymethylcellulose, ethylcellulose, and hydroxyethylcellulose; the adhesive is selected from at least one of guar gum, locust bean gum, agar, carrageenan, sodium alginate, xanthan gum, gellan gum, pectin, and sodium carboxymethylcellulose; and the smoking agent or humectant is selected from at least one of glycerol, 1,2-propanediol, and 1,3-propanediol.

[0010] Preferably, in the above technical solution, the tobacco extract is selected from at least one of the aqueous extract or ethanol extract of tobacco raw materials; the nicotine salt is an organic acid nicotine salt, selected from at least one of tartrate nicotine salt, malic acid nicotine salt, citrate nicotine salt, benzoic acid nicotine salt and salicylic acid nicotine salt.

[0011] Preferably, in the above technical solution, the flavoring agent is selected from at least one of citrus extract, berry extract, mango extract, apple extract, peach extract, ethyl maltol, sucralose, aspartame, menthol, caramelized malt extract, and cocoa extract; the pH adjuster is selected from at least one of sodium carbonate, sodium bicarbonate, and ammonium carbonate.

[0012] A method for preparing a dual-purpose nicotine delivery membrane includes the following steps: S1. Prepare an aqueous mixture containing a film-forming substrate and an adhesive, and then subject it to ultrasonic treatment for 0.5-2 h and heating and stirring at 50-80℃ for 2-8 h to obtain a uniform dispersion A; S2. Add nicotine, smoke generator or humectant, flavoring agent, and pH adjuster to uniform dispersion A, and then sonicate for 0.5-2 h and heat and stir at 30-50℃ for 2-8 h to obtain uniform dispersion B. S3. After defoaming the uniformly dispersed liquid B, it is coated, cast, extruded or hot-pressed to obtain a dual-purpose nicotine delivery membrane precursor with a thickness of 1~5 mm. After drying at 50~110℃, a dual-purpose nicotine delivery membrane is obtained.

[0013] Preferably, in the above technical solution, the nicotine in step S2 is derived from tobacco extract and prepared by the following method: (1) Prepare a mixture of tobacco leaves, tobacco powder and water or ethanol; (2) Pour the mixture into a round-bottom flask and stir and reflux at 70-90℃ for 3-8 h to obtain the extraction dispersion; (3) The above-mentioned extract dispersion was allowed to stand, filtered and concentrated to obtain tobacco extract.

[0014] Preferably, in the above technical solution, the concentration of the mixed liquid in step (1) is 5~10 g of tobacco leaves or tobacco powder per 100 mL of mixed liquid; and the nicotine content in the extract obtained in step (3) is 0.5~2 mg / mL.

[0015] Application of a dual-purpose nicotine delivery membrane in the preparation of heated non-combustible cigarettes, oral dissolving nicotine patches, and oral cigarettes.

[0016] The above-described technical solution of the present invention has the following beneficial effects: This invention provides a dual-purpose nicotine delivery membrane by optimizing the composition and formulation of the nicotine delivery medium. While optimizing the production process and reducing production costs, it also allows for flexible adjustment of product applications, improves material utilization efficiency, specifically meets market demands, and yields nicotine products with higher application value.

[0017] This invention provides a dual-purpose nicotine delivery membrane, comprising a cellulose-based film-forming substrate with certain strength and toughness, and effective components dispersed therein. This invention utilizes the hydrogen bonding interactions or molecular chain entanglement between cellulose and its derivatives and the adhesive to provide suitable mechanical strength for the dual-purpose nicotine delivery membrane, and controls the nicotine release rate and release time by adjusting the thickness, thereby solving the problem of balancing the strength of the delivery membrane material with the nicotine release effect.

[0018] This invention ensures the speed of smoke generation during heating without combustion and the speed of nicotine release through transdermal delivery by controlling the amount and type of nicotine added, as well as the amount of smoke-generating (humidifying) agent added, thereby enabling the dual-pathway use of the delivery membrane material. Attached Figure Description

[0019] Figure 1 The images show the appearance of the dual-purpose nicotine delivery membranes of Examples 1-3. Detailed Implementation

[0020] Various exemplary embodiments of the present invention will now be described in detail. It should be noted that, unless otherwise specifically stated, the relative arrangement, numerical expressions, and values ​​of the components and steps set forth in these embodiments do not limit the scope of the invention.

[0021] Unless otherwise specified, the experimental methods used in the following examples are conventional methods, and the materials and reagents used are commercially available. Unless otherwise specified, the equipment used in the experiments is well known to those skilled in the art.

[0022] Example 1

[0023] (1) Formula: Hydroxyethyl cellulose, 10 parts by weight; sodium carboxymethyl cellulose, 3 parts by weight; nicotine citrate, 3 parts by weight; 1,2-propanediol, 60 parts by weight; menthol, 0.5 parts by weight; deionized water, 30 parts by weight; sodium bicarbonate, 0.5 parts by weight.

[0024] (2) Preparation method: Step S1: Disperse hydroxyethyl cellulose and sodium carboxymethyl cellulose in deionized water and heat and stir at 50°C for 2 hours to obtain a uniform dispersion A.

[0025] Step S2: Add nicotine citrate, 1,2-propanediol, menthol and sodium bicarbonate to dispersion A, and heat and stir at 30°C for 8 hours to obtain uniform dispersion B.

[0026] Step S3: After the dispersion B is allowed to stand to defoam, a wet film of about 5 mm thickness is formed by scraping and drying in an oven at 50°C to finally obtain a dual-purpose nicotine delivery membrane with a thickness of about 1 mm.

[0027] Example 2

[0028] (1) Formula: Hydroxypropyl methylcellulose, 18 parts by weight; sodium alginate, 5 parts by weight; tobacco ethanol extract (nicotine content 1 mg / mL), 5 parts by weight; glycerol, 42 parts by weight; ethyl maltol, 2 parts by weight; deionized water, 18 parts by weight; sodium carbonate, 2 parts by weight.

[0029] (2) Preparation of tobacco extract: Place 8g of tobacco powder in a round-bottom flask, add 100mL of ethanol, and stir under reflux at 80℃ for 5 hours. After cooling, filter and concentrate the filtrate to a nicotine content of 1mg / mL for later use.

[0030] (3) Delivery membrane preparation method: Step S1: Disperse hydroxypropyl methylcellulose and sodium alginate in an appropriate amount of deionized water, sonicate for 1 hour, and then heat and stir at 65°C for 5 hours to obtain a uniform dispersion A.

[0031] Step S2: Add the calculated amounts of tobacco ethanol extract, glycerol, ethyl maltol and sodium carbonate to dispersion A. After sonication for 1 hour, heat and stir at 40°C for 5 hours to obtain uniform dispersion B.

[0032] Step S3: After vacuum defoaming of dispersion B, a wet film of about 3 mm thickness is formed by casting. The film is then dried in an oven at 80°C to obtain a dual-purpose nicotine delivery film with a thickness of about 2 mm.

[0033] Example 3

[0034] (1) Formula: Methylcellulose, 25 parts by weight; guar gum, 8 parts by weight; nicotine tartrate salt, 8 parts by weight; a mixture of glycerol and 1,3-propanediol (1:1 by weight), 25 parts by weight; citrus extract, 4 parts by weight; deionized water, 5 parts by weight; ammonium carbonate, 3 parts by weight.

[0035] (2) Preparation method: Step S1: Disperse methylcellulose and guar gum in 5 parts by weight of deionized water, sonicate for 2 hours, and then heat and stir at 80°C for 8 hours to obtain a viscous uniform dispersion A.

[0036] Step S2: Add nicotine tartrate salt, a mixture of glycerol and 1,3-propanediol (mass ratio 1:1), citrus extract and ammonium carbonate to dispersion A. After sonication for 2 hours, heat and stir at 50°C for 2 hours to obtain uniform dispersion B.

[0037] Step S3: After defoaming dispersion B, a wet film of about 1 mm thickness is formed by hot pressing and then rapidly dried at 110°C to obtain a dual-purpose nicotine delivery film with a thickness of about 3 mm.

[0038] The above embodiments demonstrate that by adjusting the types and proportions of each component within the formulation range defined in the claims of this invention, the dual-purpose nicotine delivery membrane (such as...) can be successfully prepared. Figure 1 As shown, ac corresponds to Examples 1-3 above. This fully verifies the feasibility, versatility, and adjustability of the formulation of the present invention, and can stably achieve the dual functions of heating without burning and oral dissolution through the skin.

[0039] Although the present invention has been disclosed above with reference to embodiments, it is not intended to limit the present invention. Any person skilled in the art can make various different choices and modifications without departing from the spirit and scope of the present invention. Therefore, the scope of protection of the present invention is defined by the claims and their equivalents.

Claims

1. A dual use nicotine delivery film, characterized in that, The film-forming base material, the adhesive, the nicotine, the smoke agent or humectant, the flavoring agent, the humidity regulator, and the acid-base regulator are respectively 10-25 parts, 3-8 parts, 3-8 parts, 25-60 parts, 0.5-4 parts, 5-30 parts, and 0.5-3 parts by weight.

2. The dual-use nicotine delivery film of claim 1, wherein, The film-forming base material, the adhesive, the nicotine, the smoke agent or humectant, the flavoring agent, the humidity regulator, and the acid-base regulator are respectively 18 parts, 5 parts, 5 parts, 42 parts, 2 parts, 18 parts, and 2 parts by weight.

3. The dual-use nicotine delivery film of claim 1 or 2, wherein, The film-forming base material is cellulose or a derivative thereof; the adhesive is a polysaccharide or a derivative thereof; the nicotine is derived from a tobacco extract or a nicotine salt; the smoke agent or humectant is a polyhydric alcohol; the flavoring agent is a natural or synthetic flavoring substance; the humidity regulator is water; and the acid-base regulator is a weak alkaline food additive.

4. The dual-use nicotine delivery film of claim 3, wherein, The film-forming base material is selected from at least one of bacterial cellulose, nanocellulose, methyl cellulose, hydroxypropyl methyl cellulose, carboxymethyl cellulose, ethyl cellulose, and hydroxyethyl cellulose; the adhesive is selected from at least one of guar gum, locust bean gum, agar, carrageenan, sodium alginate, xanthan gum, gellan gum, pectin, and sodium carboxymethyl cellulose; the smoke agent or humectant is selected from at least one of glycerol, 1,2-propanediol, and 1,3-propanediol.

5. The dual-use nicotine delivery film of claim 3, wherein, The tobacco extract is selected from at least one of a water extract or an ethanol extract of tobacco raw material; and the nicotine salt is an organic acid nicotine salt selected from at least one of a tartaric acid nicotine salt, a malic acid nicotine salt, a citric acid nicotine salt, a benzoic acid nicotine salt, and a salicylic acid nicotine salt.

6. The dual-use nicotine delivery film of claim 3, wherein, The flavoring agent is selected from at least one of a citrus extract, a berry extract, a mango extract, an apple extract, a peach extract, ethyl maltol, sucralose, aspartame, menthol, caramelized malt extract, and a cocoa extract; and the acid-base regulator is selected from at least one of sodium carbonate, sodium bicarbonate, and ammonium carbonate.

7. The method of making a dual-use nicotine delivery film according to any one of claims 1-6, wherein, The method comprises the following steps: S1, preparing a water mixture containing a film-forming base material and an adhesive, and performing ultrasonic treatment for 0.5-2 h and heating and stirring at 50-80℃ for 2-8 h to obtain a uniform dispersion A; S2, adding nicotine, a smoke agent or humectant, a flavoring agent, and an acid-base regulator to the uniform dispersion A, and performing ultrasonic treatment for 0.5-2 h and heating and stirring at 30-50℃ for 2-8 h to obtain a uniform dispersion B; S3, defoaming the uniform dispersion B, and performing one of blade coating, flow casting, extrusion molding, and hot pressing to obtain a dual-purpose nicotine delivery film precursor with a thickness of 1-5 mm, and drying the dual-purpose nicotine delivery film precursor at 50-110℃ to obtain a dual-purpose nicotine delivery film.

8. The method of claim 7, wherein, The nicotine in step S2 is derived from a tobacco extract, which is prepared by the following method: (1) preparing a mixture of tobacco leaves, tobacco powder, and water or ethanol; (2) pouring the mixture into a round-bottom flask, and stirring and refluxing at 70-90℃ for 3-8 h to obtain an extraction dispersion; (3) standing the extraction dispersion, and filtering and concentrating to obtain a tobacco extract.

9. The method of claim 8, wherein, The concentration of the mixed solution in step (1) is 5-10 g of tobacco leaves or tobacco powder per 100 mL of the mixed solution; and the nicotine content in the obtained extraction solution in step (3) is 0.5-2 mg / mL.

10. Use of the dual-purpose nicotine delivery film according to any one of claims 1-6 in the preparation of a heat-not-burn cigarette, a buccal dissolving nicotine patch and a snus.

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