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 at least one filler. 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 comprising tobacco, wherein the pouch does not comprise 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 comprise a specific amount of filler and natural fibers as disclosed herein. A healthier product is provided herein, which provides consumers with relief from nicotine release while still maintaining the product moisture, resulting in 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 capable of eliminating or reducing 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 12 mg of nicotine, 30% to 75% by weight fraction of a filler, and 5% to 15% by weight fraction of a natural fiber and substantially no tobacco, wherein the filler is selected from at least one of microcrystalline cellulose, cellulose and cellulose derivatives, and mixtures thereof. The oral nicotine composition preferably does not comprise a pH adjuster.

[0009] Many problems are solved by the oral nicotine composition, and a product is provided to provide improved sensory perception for the consumer of the product. The oral nicotine composition provides a balanced / controlled release of nicotine and a lasting 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 ingredients in the composition. This also makes the product suitable for molding and adding to a separate space (such as a bag). 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] Furthermore, 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 dry, sticky feeling of the 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] Furthermore, 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. The oral nicotine composition delivers to the oral cavity 0.5 mg to 12 mg of nicotine, 30% to 75% by weight of filler, and 5% to 15% by weight of natural fibers and substantially no tobacco, wherein the filler is selected from at least one of microcrystalline cellulose, cellulose and cellulose derivatives, and mixtures thereof.

[0014] By providing an oral nicotine container, such as a bag, a product is provided that 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 weight basis", and the like are defined to mean the weight percent of an ingredient based on the total weight of dry ingredients, i.e. all ingredients of the formulation, composition, or product as indicated, 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 the 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, the 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 a composition. 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 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 / or nicotine bound to a 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 the other ingredients present in the composition.

[0024] The oral nicotine composition includes one or more fillers, where the amount of filler is at least 30% by weight, such as at least 40%, 45%, 50%, 55%, 60%, 65%, 70%, 75%, or 30% to 80% by weight, such as 30% to 80% by weight, 30% to 75% by weight, 35% to 65% by weight, 40% to 55% by weight, or 45% to 55% by weight. The fillers increase the volume of the composition and affect the release of nicotine from the composition. For example, if there is not enough filler, all of the nicotine would be released immediately rather than over an extended period of time, resulting in an unbalanced product. Examples of fillers include microcrystalline cellulose, cellulose and cellulose derivatives, and mixtures thereof.

[0025] In one embodiment, the filler is a mixture of microcrystalline cellulose (in an amount of 30% to 75% by weight, such as 35% to 65% by weight or 40% to 50% by weight) and natural fibers (in an amount of 5% to 15% by weight). For example, the amount of microcrystalline cellulose is 40%, 45%, 50% by weight and the amount of natural fibers is 5%, 10%, 15% by weight.

[0026] Examples of natural fibers include: wheat fibers, pea fibers, rice fibers, corn fibers, oat fibers, oat flour fibers, tomato fibers, barley fibers, rye fibers, sugar beet fibers, buckwheat fibers, potato fibers, cellulose fibers, apple fibers, cocoa fibers, bran fibers, bamboo fibers, and mixtures thereof.

[0027] In another embodiment, the fiber is at least oat fiber and / or oat flour used alone or in combination with another filler. In one example, the oat fiber and / or oat flour is mixed with cellulose, such as microcrystalline cellulose (MCC), wherein the filler is a mixture of microcrystalline cellulose (in an amount of 30% to 75% by weight fraction, such as 35% to 65% by weight fraction or 40% to 50% by weight fraction) and oat fiber (in an amount of 5% to 15% by weight fraction). For example, the microcrystalline cellulose is in an amount of 40%, 45%, 50% by weight fraction and the oat fiber is in an amount of 5%, 10%, 15% by weight fraction. In the case of using oat, the texture is homogenously stable, preserving the shape of the product. When the oral nicotine composition containing oat is put into the mouth, saliva wets the oat, the oat inflates the pouch into a pillow structure, and the oral nicotine composition brings a good sensory feeling. In addition, the individual user can mold the pouch into a suitable personal shape.

[0028] 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, suitable for use in combination with nicotine. The fiber is available from J. RETTERMAIER & SÖHNE, among others, in Germany.

[0029] The oral nicotine composition does not substantially contain any tobacco fiber, thus removing harmful ingredients present in tobacco fibers, such as carcinogens, heavy metals naturally occurring in the tobacco plant or derived from the cultivation of the tobacco plant and accumulated during the growth process.

[0030] 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 15% by weight fraction, 7% to 15% by weight fraction), such as 5%, 6%, 7%, 8%, 9%, 10%, 11%, 12%, 13%, 14%, 15%, or 20% by weight fraction. Examples of humectants are glycerin, alginate, triacetin modified starch, hydroxypropyl cellulose, pectin, xanthan gum, and mixtures thereof.

[0031] In one embodiment, the humectant is glycerin in an amount of 5% to 25% by weight fraction, such as 20% by weight fraction.

[0032] The humectant can be present in the oral nicotine composition along with water, wherein the amount of water is 5% to 30% by weight fraction (such as 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, which can be added to a container, such as a pouch, during the product manufacturing process and further added to a package. Further, the presence of these ingredients improves the mouth feel and eliminates dryness of the product.

[0033] In one embodiment, the amount of water is 5% to 25% by weight fraction, the amount of glycerol is 5% to 25% by weight fraction, and the amount of glycerol and water can be the same.

[0034] 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.

[0035] The combination of nicotine, humectant, water, and sodium chloride increases the preservation activity, thereby inhibiting the growth of microorganisms in a natural way without using a preservative.

[0036] The oral nicotine composition can also include one or more sweeteners, thickening agents, and flavorants. Preferably, the oral nicotine composition does not substantially include any pH adjuster.

[0037] Examples of sweeteners include monosaccharides, disaccharides, trisaccharides, and polysaccharides; polyols (sugar alcohols) such as mannitol, sucralose, erythritol, maltitol, and xylitol; natural and synthetic sweeteners such as sucrose, glucose, dextrose, maltose, fructose, saccharin, aspartame, acesulfame, neotame, sucralose, mogroside, stevia, saccharin, cyclamate, and mixtures thereof. The amount of sugar alcohol is 2% to 15% by weight fraction (such as 5% to 10% 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 sugar alcohols, wherein the sugar alcohol is mannitol, erythritol, or xylitol, or a mixture thereof. The amount of other sweeteners (such as sucralose) can be 0.1% to 1.0% by weight fraction.

[0038] 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.

[0039] The oral nicotine composition also includes at least one natural or synthetic flavorant. There are a large number of synthetic and non-synthetic flavorants on the market that can be obtained from any suitable source to provide the desired product flavor.

[0040] The flavorant according to the present application can include bergamot, eucalyptus, menthol, cinnamon, mint, peppermint, spearmint, apple, cherry, melon, mango, matcha, mocha, marmalade, honeydew, lime, tropical, peach, passion fruit, orange, blood orange, grapefruit, mandarin, licorice, ginger, vanilla, wintergreen, lemon, lime, strawberry, blueberry, raspberry, salmonberry, huckleberry, cranberry, blueberry, vitis rotundifolia, sea buckthorn, chocolate, green tea, lavender, violet, cola, acai, coffee, mocha, or mixtures thereof.

[0041] In one embodiment, the nicotine oral composition includes silicon dioxide in an amount of 0.5% to 3% by weight fraction.

[0042] In another embodiment, the present application relates to an oral nicotine pouch comprising the oral nicotine composition as described above, and also to a method of making such a product.

[0043] The method comprises the following steps: a) providing a nicotine source and at least one filler; b) mixing the nicotine source and the 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 pouch.

[0044] Examples The oral nicotine composition is mixed and packed into a pouch according to common knowledge.

[0045]

Claims

1. An oral nicotine composition, characterized in that, comprising: a. nicotine in an amount of 0.5 mg to 12 mg; b. a filler in an amount of 30% to 75% by weight selected from at least one of microcrystalline cellulose, cellulose and cellulose derivatives, and mixtures thereof; and c. a natural fiber in an amount of 5% to 15% by weight; and substantially free of tobacco.

2. The oral nicotine composition of claim 1, wherein, The filler is in an amount of 35% to 65% by weight.

3. The oral nicotine composition of claims 1 and 2, wherein, The filler is microcrystalline cellulose.

4. The oral nicotine composition of claims 1-3, wherein, The natural fiber is oat fiber.

5. The oral nicotine composition of any preceding claim, wherein, The oral nicotine composition further comprises one or more humectants in an amount of 2% to 25% by weight.

6. The oral nicotine composition of any preceding claim, wherein, The oral nicotine composition further comprises one or more humectants in an amount of 10% to 15% by weight.

7. The oral nicotine composition of any preceding claim, wherein, The oral nicotine composition further comprises water in an amount of 5% to 30% by weight.

8. The oral nicotine composition of claims 5-7, wherein, The humectant is selected from at least one of glycerin, alginate, triacetin modified starch, hydroxypropyl cellulose, pectin, xanthan gum, and mixtures thereof.

9. The oral nicotine composition of claim 8, wherein, The humectant is glycerin.

10. The oral nicotine composition of any preceding claim, wherein, Further comprising one or more sugar alcohols selected from at least one of mannitol, sucralose, erythritol, xylitol, and mixtures thereof.

11. The oral nicotine composition of claim 10, wherein, The sugar alcohol is in an amount of 2% to 10% by weight.

12. The oral nicotine composition of any preceding claim, wherein, Further comprising silicon dioxide.

13. The oral nicotine composition of claim 12, wherein, The silicon dioxide is in an amount of 0.5% to 3% by weight.

14. The oral nicotine composition of any preceding claim, wherein, The nicotine is selected from at least one of freebase nicotine, nicotine salt, nicotine bound to ion exchange resin, and mixtures thereof.

15. The oral nicotine composition of claim 14, wherein, The nicotine is nicotine salt.

16. The oral nicotine composition of any preceding claim, wherein, Further comprising one or more thickening agents, sweeteners, or flavorants.

17. An oral nicotine container, characterized in that, An oral nicotine composition according to any preceding claim.

18. The oral nicotine container of claim 17, wherein, The oral nicotine container is an oral nicotine pouch.

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