Nicotine product

Abstract

The present invention relates to an oral nicotine composition with improved performance and a bag comprising the oral nicotine composition, wherein the oral nicotine composition comprises nicotine and oat fiber and / or oat flour.

Description

TECHNICAL FIELD

[0001] The present invention relates to an oral nicotine composition with improved properties and a pouch comprising the same, wherein the oral nicotine composition comprises nicotine and filler, the filler being based on oats. BACKGROUND

[0002] Intake of nicotine through smoking has many well-known disadvantages, especially health-related problems, including cancer.

[0003] Tobacco substitutes also have drawbacks, such as not providing smokers with sufficient relief from the craving for cigarettes, and some health-related problems.

[0004] EP3970513 discloses a nicotine composition not containing tobacco, wherein the pouch does not contain a specific amount of filler and natural fibers, which is an important feature to achieve the invented pouch and solve the problems of the existing pouches.

[0005] US2021307375 discloses many nicotine pouch compositions, wherein the pouch does not contain a specific amount of filler and natural fibers as disclosed herein. A healthier product is provided herein, which brings relief to the consumer from nicotine release while still maintaining the product moisture, bringing a good experience.

[0006] It is an object of the present invention to provide an oral nicotine composition in a pouch as a nicotine substitute, which is able to eliminate or reduce the problems and undesirable properties of the above-mentioned products. SUMMARY

[0007] It is an object of the present invention to mitigate, alleviate, or eliminate one or more of the above-identified deficiencies in the art and disadvantages singly or in any combination, and to address at least the problems specified.

[0008] In a first aspect, the present invention relates to an oral nicotine composition comprising 0.5 to 10 mg of nicotine and 30% to 75% by weight fraction of filler, and substantially no tobacco, wherein the filler is oat fiber, or oat flour, or a mixture thereof. The oral nicotine composition preferably does not contain a pH adjuster.

[0009] Many problems are solved by the oral nicotine composition, and a product is provided to provide an improved sensory experience for the consumer of the product. The oral nicotine composition provides a balanced / controlled release of nicotine and a sustained relief from the craving for cigarettes.

[0010] The product provides a smooth and pleasant feeling when placed under the lips, which is obtained from the unique combination of the ingredients claimed below. This also makes the product suitable for molding and adding to separate spaces (such as bags). Furthermore, the oral nicotine composition is improved over other similar oral nicotine compositions on the market in that it is less harmful to the oral mucosa and teeth in the mouth and provides a fresh feeling, i.e. does not contain irritating and / or corrosive adjuvants such as pH regulators, ammonium chloride, and preservatives.

[0011] Further, another advantage is that the product has a long-lasting taste and improves the storage capacity by keeping the humidity at an acceptable level during storage, which eliminates the problem of filler drying, which in turn inhibits the feeling of a dry, sticky product. The feeling of the product is very important for the consumer to accept the product. Further, by providing the presence of nicotine and excellent humidity, the growth of microorganisms is inhibited, which is advantageous for long-term storage.

[0012] In addition, all the ingredients of the oral nicotine composition are selected to provide a composition that uses less or no plastic and has a smaller footprint on the environment, i.e. is environmentally friendly.

[0013] In another aspect, the present invention relates to a container, such as a bag, comprising the oral nicotine composition described. The oral nicotine composition is for use in the oral cavity, comprising 0.5 mg to 12 mg of nicotine and 30% to 75% by weight of filler, and substantially no tobacco, wherein the filler is oat fiber, or oat flour, or a mixture thereof.

[0014] A method is provided by providing an oral nicotine container, such as a bag, which regulates the release of water-soluble ingredients from a composition located in the cavity of the container, such as a water-permeable bag. The release can be regulated, for example, by changing the packing density / molding of the composition and / or by changing the shape or material of the outer water-permeable bag. DETAILED DESCRIPTION

[0015] DEFINITIONS As used herein, "weight percent", "weight percent on a dry basis", and the like are defined to mean the weight percent of the ingredient based on the total weight of the dry ingredients, i.e. all the ingredients of the formulation, composition, or product as claimed, excluding the moisture content. Thus, "weight percent on a total weight basis" as used herein is the same as "weight percent on a wet weight basis".

[0016] As used herein, the term "oral nicotine composition" refers to a composition suitable for use in an oral nicotine pouch, i.e., an oral pouch comprising nicotine. The oral nicotine composition can also be placed in other types of containers that can be placed in the mouth and sucked on to release the nicotine within the container, as long as the container is non-toxic, water soluble, and biodegradable.

[0017] As used herein, the term "pouch" is intended to refer to a container formed from a web of fibrous material that encloses a cavity. The pouch is designed for administration of an active ingredient in the mouth, and is therefore suitable for oral use, non-toxic, and biodegradable. For example, the fibrous material can form a woven or nonwoven web or fabric. For example, corresponding two pieces of web or fabric can be adhered to one another along their edges to form a cavity of nicotine and water-soluble composition, thereby sealing the pouch. To release the nicotine, the pouch is water permeable, allowing saliva in the mouth to pass through the pouch into the mouth, where the saliva contacts the nicotine, and the nicotine is released from the oral pouch.

[0018] As used herein, the term "pH adjusting agent" is intended to refer to one or more substances added to adjust and control the pH of an aqueous liquid, such as saliva, when the product containing the pH adjusting agent is dissolved or dispersed in the aqueous liquid.

[0019] As used herein, the term "nicotine" refers to nicotine in any form, including freebase nicotine extracted from tobacco and freebase nicotine manufactured synthetically, and freebase nicotine is not provided in the form of tobacco or tobacco powder. Nicotine can also be chemically bound to a resin, such as nicotine polacrilex. Nicotine can also be a mixture of different forms of nicotine.

[0020] As used herein, the term "freebase nicotine" refers to the non- protonated form of nicotine, and therefore does not include nicotine salts and nicotine complexes between nicotine and ion exchange resins. While freebase nicotine includes both freebase nicotine extracted from tobacco and freebase nicotine manufactured synthetically, freebase nicotine is not provided in the form of tobacco or tobacco powder. Typically, freebase nicotine is provided in the form of a liquid.

[0021] As used herein, the term "filler" is intended to refer to a material that increases the volume of fibers and / or powders. In one embodiment, the filler is present to increase the volume of the container, such as a pouch used under the lips.

[0022] As used herein, the term "substantially free of tobacco fibers" is intended to refer to less than 95% by weight of tobacco fibers, or even less than (e.g., 96%, 97%, 98%, 99% by weight) of tobacco fibers, or even free of tobacco fibers.

[0023] The present invention The present invention relates to an oral nicotine composition that is substantially free of tobacco fibers and includes nicotine, such as free base nicotine, nicotine salts, and nicotine bound to resin (such as polacrilex). The amount of nicotine is 0.5 mg to 12 mg (such as 1.0 mg to 10 mg, 1.0 mg to 5.0 mg, 1.0 mg to 4.0 mg, 1.0 mg to 3.0 mg, or 1.0 mg to 2.0 mg), such as 1.0 mg, 1.5 mg, 2.0 mg, 2.5 mg, 3.0 mg, 3.5 mg, 4.0 mg, 4.5 mg, or 5.0 mg. The amount of nicotine depends on the craving to be alleviated and other ingredients present in the composition.

[0024] The oral nicotine composition includes oat fiber, or oat flour, or mixtures thereof, in an amount of at least 30% by weight (such as at least 40%, 45%, 50%, 55%, 60%, 65%, 70%, 75%, or 40% to 80% by weight), such as 40% to 55% by weight, 30% to 75% by weight, 35% to 65% by weight, 30% to 55% by weight, or 45% to 55% by weight. The oat component increases the volume of the composition and affects the release of nicotine from the composition. For example, if there is not enough oat, all of the nicotine will be released immediately rather than over a period of time, resulting in an unbalanced product. Additionally, the oat swells upon absorption of saliva to form a pleasant, texturally suitable mass that the consumer can mold into a pillow-like structure to fit the cavity under the individual's lower lip. This is because the oat has a higher swelling capacity than other natural fibers.

[0025] A non-limiting example of a useful water-insoluble fiber is Vitacel® fiber. This fiber is primarily insoluble fiber, extracted and isolated from the skeletal material of renewable raw materials in a complex, defined process. The product has excellent properties, making it suitable for use in combination with nicotine. The fiber is available from J. RETTERMAIER & SÖHNE, among others, in Germany.

[0026] Oat fiber is tasteless, has a bulk density of about 200 to 300 g / l, and a fiber size of less than 100 pm, making the fiber easy to compress into a compact and suitable texture. Both oat fiber and oat flour have a high water binding activity (more than 450%) and a high oil absorption capacity (more than 300%), which is beneficial to achieve a product with moisture, such that the oral nicotine composition can maintain moisture during product storage and maintain its freshness and appeal over a long period of time. In addition, this makes oat fiber and oat flour suitable for use with water and humectants as a carrier / filling ingredient for nicotine to achieve an excellent oral nicotine composition and the oral nicotine composition can release nicotine with desirable release properties when used by a consumer. When the oral nicotine composition is preferably placed in a pouch and in contact with saliva, the oat fiber starts to absorb the saliva, nicotine is released into the oral cavity and absorbed into the blood, thereby causing a craving relief. Oat fiber and oat flour can be used alone or in combination, depending on the release properties to be achieved. In addition, oat leads to a texture that is homogenous and stable, preserves the shape of the product, brings a good sensory feeling, and can be molded into a suitable personal shape.

[0027] The oral nicotine composition does not substantially include any tobacco fiber, thus removing harmful ingredients present in tobacco fiber, such as carcinogens and heavy metals derived from tobacco plant cultivation and accumulated during growth. In addition, the composition does not substantially include any pH adjuster.

[0028] The composition can also include one or more humectants in an amount of 2% to 25% by weight fraction (such as 5% to 25% by weight fraction, 10% to 20% by weight fraction, 7% to 15% by weight fraction), such as 5%, 6%, 7%, 8%, 9%, 10%, 11%, 12%, 13%, 14%, or 15% by weight fraction. Examples of humectants are glycerin, alginate, triacetin modified starch, hydroxypropyl cellulose, pectin, xanthan gum, and mixtures thereof.

[0029] In one embodiment, the humectant is glycerin in an amount of 10% to 15% by weight fraction.

[0030] The humectant can be present in the oral nicotine composition along with water, where the amount of water is 5% to 50% by weight fraction (e.g., 10% to 40% by weight fraction, 10% to 30% by weight fraction, 10% to 20% by weight fraction, 7% to 15% by weight fraction), such as 5%, 6%, 7%, 8%, 9%, 10%, 11%, 12%, 13%, 14%, 15%, 16%, 17%, 18%, 19%, 20% by weight fraction. The humectant and water make the composition moist, thereby making the composition moldable into a composition having a relatively high density that can be added to a container, such as a pouch, during the product manufacturing process and further added to a package. Additionally, these ingredients improve the mouthfeel and eliminate dryness of the product.

[0031] In one embodiment, the amount of water is 5% to 25% by weight fraction, the amount of glycerol is 10% to 15% by weight fraction, and the amount of glycerol and water can be the same.

[0032] In addition to the humectant, a vegetable oil can also be included to increase the humectant activity and improve the oral nicotine composition, thereby highly improving the appearance of the oral nicotine composition. In one example, glycerol and vegetable oil are mixed and used as a suitable humectant. The amount of vegetable oil can be 0.1% to 3.0% by weight fraction.

[0033] The combination of nicotine, humectant, and water increases the preservation activity, thereby inhibiting the growth of microorganisms in a natural manner without the use of preservatives.

[0034] The oral nicotine composition can also include one or more sweeteners, thickening agents, and flavorings.

[0035] Examples of sweeteners include monosaccharides, disaccharides, trisaccharides, and polysaccharides; polyols, such as mannitol, erythritol, maltitol, and xylitol; natural and synthetic sweeteners, such as sucrose, chloro sucrose, mogroside, stevia, glucose, dextrose, maltose, fructose, saccharin, aspartame, acesulfame, neotame, chloro sucrose, saccharin, cyclamate, and mixtures thereof. The amount of polyol is 5% to 15% by weight fraction, such as 6%, 7%, 8%, 9%, 10%, 11%, 12%, 13%, 14% by weight fraction, and can be present individually or in a mixture of polyols. In one embodiment, the sweetener is mannitol, erythritol, or xylitol. The amount of other sweeteners, such as chloro sucrose, can be 0.1% to 1.0% by weight fraction.

[0036] Examples of thickening agents include alginate, sodium alginate, pectin, or synthetic forms thereof. The amount of thickening agent is up to 5% by weight fraction.

[0037] Oral nicotine compositions also include at least one natural or synthetic flavoring agent. A wide variety of synthetic and non-synthetic flavoring agents are available on the market and can be obtained from any suitable source to provide the desired product aroma.

[0038] The spices according to the present invention may include bergamot, eucalyptus, menthol, cinnamon, mint, peppermint, spearmint, apple, cherry, melon, mango, peach, passion fruit, orange, blood orange, grape, citrus, mandarin orange, licorice, ginger, vanilla, wintergreen, lemon, lime, strawberry, raspberry, salmonberry, blueberry, cranberry, blueberry, round-leaf grape, sea buckthorn, chocolate, green tea, violet, matcha, cola, lavender, acai berry, coffee, mocha, or mixtures thereof.

[0039] The release curve of nicotine in the controlled matrix.

[0040] In one embodiment, the oral nicotine composition comprises silica in an amount of 0.5% to 3% by weight.

[0041] In another embodiment, the present invention relates to an oral nicotine bag comprising the oral nicotine composition as described above, and also to a method for preparing such a product. The method comprises the steps of: a) providing a nicotine source and at least one filler; b) mixing the nicotine source and filler provided in step a); c) optionally sieving the powder mixture of step b) into a composition; and d) optionally filling the powder composition into a bag.

[0042] Example According to common knowledge, oral nicotine compositions are mixed and packaged into bags.

[0043]

Claims

1. An oral nicotine composition, characterized in that, include: a. Nicotine in doses ranging from 0.5 mg to 12 mg; as well as b. Filler in an amount of 30% to 75% by weight, which is natural oat fiber, or oat flour, or a mixture thereof; And it contains virtually no tobacco.

2. The oral nicotine composition according to claim 1, characterized in that, The oral nicotine composition further includes one or more humectants, said humectants being present in an amount of 2% to 25% by weight.

3. The oral nicotine composition according to claim 1, characterized in that, The oral nicotine composition further includes one or more humectants, said humectants being present in an amount of 10% to 15% by weight.

4. The oral nicotine composition according to any of the preceding claims, characterized in that, The oral nicotine composition further includes water, wherein the amount of water is 5% to 30% by weight.

5. The oral nicotine composition according to claims 3 and 4, characterized in that, The humectant is selected from at least one of glycerin, alginate, triacetin-modified starch, hydroxypropyl cellulose, pectin, xanthan gum, and mixtures thereof.

6. The oral nicotine composition according to claim 5, characterized in that, The moisturizer is glycerin.

7. The oral nicotine composition according to any of the preceding claims, characterized in that, It also includes one or more sugar alcohols selected from at least one of mannitol, sucralose, erythritol, xylitol, and mixtures thereof.

8. The oral nicotine composition according to claim 7, characterized in that, The amount of sugar alcohol is 2% to 10% by weight.

9. The oral nicotine composition according to any of the preceding claims, characterized in that, It also includes silicon dioxide.

10. The oral nicotine composition according to claim 9, characterized in that, The amount of silicon dioxide is 0.5% to 3% by weight.

11. The oral nicotine composition according to any of the preceding claims, characterized in that, The nicotine is selected from at least one of free nicotine, nicotine salts, nicotine bound to an ion exchange resin, and mixtures thereof.

12. The oral nicotine composition according to claim 11, characterized in that, The nicotine mentioned is nicotine salt.

13. The oral nicotine composition according to any of the preceding claims, characterized in that, It also includes one or more thickeners, sweeteners, flavorings, or pH adjusters.

14. An oral nicotine container, characterized in that, Including the oral nicotine composition according to any of the preceding claims.

15. The oral nicotine container according to claim 14, characterized in that, The oral nicotine container is an oral nicotine pouch.

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