Nicotine products

Abstract

The present invention relates to an oral nicotine composition having improved properties, and a pouch containing the oral nicotine composition, wherein the oral nicotine composition comprises nicotine and oat fiber and / or oat powder.

Description

Technical Field

[0001] The present invention relates to an oral nicotine composition having improved properties, comprising nicotine and an oat-based filler, and a pouch containing the oral nicotine composition.

Background Art

[0002] The delivery of nicotine by smoking has many well-known drawbacks, particularly health-related problems including cancer.

[0003] Nicotine substitutes also have drawbacks such as insufficient relief of craving for smokers in recovery and some health-related problems.

[0004] European Patent Application Publication No. 3970513 discloses a nicotine composition without tobacco, but its pouch does not contain a specific amount of filler and natural fibers, which are important features for achieving the pouch of the present invention and removing the problems associated with known pouches.

[0005] U.S. Patent Application Publication No. 2021 / 307375 discloses many nicotine pouch compositions, but its pouch does not contain a specific amount of filler and natural fibers as disclosed herein, which results in a healthier product that provides a release of nicotine that is soothing to the consumer and maintains the humidity for a comfortable experience.

[0006] The object of the present invention is to provide a nicotine substitute in the form of an oral nicotine composition present in a pouch that can eliminate or reduce the problems and unpleasant characteristics associated with the products mentioned above.

Summary of the Invention

[0007] The object of the present invention is to alleviate, reduce, or eliminate one or more identified defects and disadvantages in the art, alone or in any combination, and at least solve the above-mentioned problems.

[0008] In a first embodiment, the present invention relates to an oral nicotine composition comprising 0.5 to 10 mg of nicotine and 30 to 75% by weight of a filler, which is oat fiber or oat powder or a mixture thereof, and is substantially free of tobacco. The oral nicotine composition preferably does not contain a pH adjuster.

[0009] Such oral nicotine compositions solve many problems and provide consumers with products that offer an improved sensory experience. Oral nicotine compositions provide balanced / controlled nicotine release and sustained craving relief.

[0010] The product provides a smooth and soft feel when placed under the lips, obtained by the unique combination of ingredients described in the attached claims. This also makes the product suitable for molding and adding to compartments such as pouches. In addition, the oral nicotine composition is an improvement over other comparable oral nicotine compositions on the market, the improvement being that the oral nicotine composition is less harmful to the oral mucosa and teeth and provides freshness, i.e., it does not contain irritating and / or corrosive excipients such as pH adjusters, ammonium chloride, and preservatives.

[0011] Furthermore, another advantage is that the product has a lasting flavor and improved shelf life by maintaining humidity during storage at an acceptable level, eliminating problems associated with filler drying and thus preventing the product from becoming dry and sticky. The feel of the product is crucial for consumer acceptance. In addition, providing perfect humidity and the presence of nicotine inhibits microbial growth, which enhances its long-term shelf life.

[0012] In addition, all components of the oral nicotine composition are selected to provide an environmentally friendly composition that uses less or no plastic, thus reducing its environmental footprint.

[0013] In another aspect, the present invention relates to an oral nicotine composition suitable for a container such as a pouch for delivery to the oral cavity, wherein the oral nicotine composition comprises 0.5 mg to 12 mg of nicotine and 30 to 75% by weight of a filler which is oat fiber or oat powder or a mixture thereof, and is substantially tobacco-free.

[0014] By providing oral nicotine containers such as pouches, a method is provided for regulating the release of water-soluble components from a composition placed in a container such as a water-permeable pouch. Such release can be regulated, for example, by modifying the packing density / molding of the composition and / or by modifying the shape or material of the outer water-permeable pouch. [Modes for carrying out the invention]

[0015] As used herein, definitions such as “weight percent” and “weight % based on dry weight” are intended to refer to the weight percentage of the component referred to, based on the total weight of the dry component, i.e., the total weight of all components of the preparation, composition, or product referred to, excluding moisture content. Thus, as used herein, “weight % based on total weight” is the same as “weight % based on wet weight.”

[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 containing nicotine. Oral nicotine compositions may also be placed in other types of inhalable containers that can be placed in the mouth to release the nicotine present in the container, provided that the container is non-toxic, water-soluble, and biodegradable.

[0017] As used herein, the term “pouch” is intended to mean a container typically formed by a woven fabric of a fibrous material enclosing a cavity. Pouches are designed for the oral administration of active ingredients and are therefore adapted for oral use, non-toxic, and may be biodegradable. The fibrous material may form, for example, a woven or non-woven fabric or cloth. A pouch may be sealed, for example, by joining two corresponding pieces of the fabric or cloth together along their edges to form a cavity for nicotine and a water-soluble composition. To release nicotine, the pouch is water-permeable, allowing saliva from the oral cavity to permeate the pouch and enter the cavity, at which point the saliva comes into contact with the nicotine, thereby releasing the nicotine from the oral pouch.

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

[0019] As used herein, the term "nicotine" refers to any form of nicotine, including both free-base nicotine extracted from tobacco and synthetically produced free-base nicotine, which is not available in the form of tobacco or tobacco powder. Nicotine can also be chemically bound to resins such as nicotine polarilex. Nicotine can also be a mixture of different nicotine forms.

[0020] As used herein, the term "freebase nicotine" refers to the unprotonated form of nicotine and therefore does not include nicotine salts or nicotine offered as a complex between nicotine and an ion-exchange resin. Freebase nicotine includes both freebase nicotine extracted from tobacco and freebase nicotine produced synthetically, while freebase nicotine is not offered in the form of tobacco or powdered tobacco. Typically, freebase nicotine is offered as a liquid.

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

[0022] As used herein, the term “substantially free of tobacco fiber” is intended to mean that the tobacco fiber content is less than 95% by weight, or even less, such as 96%, 97%, 98%, or 99% by weight, or even free of tobacco fiber.

[0023] invention The present invention relates to an oral nicotine composition that is substantially free of tobacco fiber, the composition containing nicotine in amounts of 0.5 mg to 12 mg, for example 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, for example 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, or 5.0 mg, such as free base nicotine, nicotine salts of nicotine bound to resins such as Polarcrilex. The amount of nicotine depends on the craving to be relieved and other components present in the composition.

[0024] Oral nicotine compositions contain oat fiber or oat powder or mixtures thereof, present in amounts of at least 30% by weight, for example, at least 40, 45, 50, 55, 60, 65, 70, 75% by weight, or 40% to 80% by weight, for example, 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 are not enough oats, all the nicotine will be released immediately and will not last for a period of time, resulting in an unbalanced product. In addition, oats swell into a smooth and sensory-pleasant composition when they absorb saliva, allowing consumers to mold the composition into a pillow-like structure that fits into the individual cavities under the lips. This is due to oats having higher swelling properties compared to other natural fibers.

[0025] A non-limiting example of usable water-insoluble fibers is Vitacel® fibers. These are primarily insoluble fibers extracted and isolated from the skeletal material of renewable raw materials through a complex, defined process. Their products possess exceptional properties that make them suitable for use in combination with nicotine. These fibers are available, for example, from J. RETTENMAIER & SOEHNE GmbH in Germany.

[0026] Oat fiber has no taste, has a high bulk density of about 200-300 g / l, and a fiber size of less than 100 μm that makes it easy to compress the fiber into a compact and suitable composition, and is particularly suitable. Both oat fiber and oat powder have high water-binding activity (over 450%) and high oil absorption capacity (over 300%), which is excellent for achieving a product with humidity related to an oral nicotine composition that can be maintained during storage of the product and kept fresh and attractive for a long time. In addition, this makes oat fiber and powder suitable for use as carrier / filler components for nicotine together with water and a humectant to achieve an excellent oral nicotine composition with an attractive release profile of nicotine from the oral nicotine composition upon use by consumers. The oral nicotine composition is preferably placed in a pouch, and when it comes into contact with saliva, the oat fiber begins to absorb the saliva, and nicotine is released into the oral cavity and absorbed into the bloodstream, causing relief of craving. Oat fiber and oat powder can be used alone or as a mixture thereof depending on the release profile to be achieved. In addition, oats not only maintain the shape of the product, but also give a good sensory feel and result in a homogeneous and stable composition that can be molded into a suitable personal shape upon use.

[0027] When the above oral nicotine composition substantially does not contain tobacco fiber, thereby removing harmful components present in tobacco fiber, such as carcinogenic substances and some heavy metals derived from the cultivation of tobacco plants and accumulated during growth. In addition, the above composition substantially does not contain any pH adjuster.

[0028] [[ID=⑧]]The above composition may further contain one or more humectants in an amount of 2% to 25% by weight, such as 5% to 25% by weight, 10% to 20% by weight, 7% to 15% by weight, such as 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, or 15% by weight. Examples of humectants are glycerol, alginate, triacetin-modified starch, hydroxypropyl cellulose, pectin, and xanthan gum, or mixtures thereof.

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

[0030] The humectant can be present in the oral nicotine composition together with water, where the water is present in an amount of 5% to 50% by weight, for example, 10% to 40% by weight, 10% to 30% by weight, 10% to 20% by weight, 7% to 15% by weight, for example 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20% by weight. The humectant and water humidify the composition, and thus enable the composition to be added into a container such as a pouch during the manufacture of the product, and furthermore, to be formed into a relatively high-density composition that can be added into the package. In addition, the above components improve the mouthfeel and eliminate drying of the product.

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

[0032] In addition to the humectant, vegetable oil can be included to enhance the moisturizing activity and improve the oral nicotine composition to such a highly improved appearance of the oral nicotine composition. In one example, glycerol and vegetable oil are mixed and used as a suitable humectant. The vegetable oil can be present in an amount of 0.1 to 3.0% by weight.

[0033] The combination of nicotine, humectant, and water enhances the preservation activity, and thus suppresses the growth of microorganisms in a natural way without using preservatives.

[0034] The oral nicotine composition can similarly contain one or more sweeteners, thickeners, and flavors.

[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, sucralose, monk fruit, stevia, glucose, dextrose, maltose, fructose, saccharin, aspartame, acesulfame, neotame, sucralose, saccharin and cyclamate, and mixtures thereof. Polyols may be present alone or as mixtures of polyols in amounts of 5% to 15% by weight, for example, 6, 7, 8, 9, 10, 11, 12, 13, 14% by weight. In one embodiment, the sweetener is a sugar alcohol, such as mannitol, erythritol or xylitol. Other sweeteners, such as sucralose, may be present in amounts of 0.1 to 1.0% by weight.

[0036] Examples of thickeners include alginates, sodium alginate, pectin, or synthetic versions thereof. Thickeners may be present in amounts up to 5% by weight.

[0037] Oral nicotine compositions further include at least one flavoring, whether natural or synthetic. Numerous synthetic and non-synthetic flavorings are available on the market and can be obtained from any suitable one that provides the desired flavor for the product.

[0038] The flavorings according to the present invention may include bergamot, eucalyptus, menthol, cinnamon, mint, peppermint, spearmint, apple, cherry, melon, mango, peach, passion fruit, orange, blood orange, grapefruit, mandarin, tangerine, licorice, ginger, vanilla, wintergreen, lemon, lime, strawberry, raspberry, salmonberry, lingonberry, cranberry, blueberry, muscadin berry, sea buckthorn, chocolate, green tea, violet, matcha, cola, lavender, acai, coffee, mocha, or mixtures thereof. Nicotine profile from the matrix.

[0039] In one embodiment, the oral nicotine composition contains silicon dioxide in an amount of 0.5% to 3% by weight.

[0040] In another embodiment, the present invention relates to an oral nicotine pouch containing an oral nicotine composition as defined above, and a method for preparing such a product. Such a method is described in the following steps, namely a) A step of providing a nicotine source, at least one filler, b) A step of mixing the nicotine source and filler provided in step a), c) Optionally, the powder mixture from step b) is sieved to form a composition, and d) Optionally, the step of filling a pouch with the powder composition. Includes. [Examples]

[0041] The oral nicotine composition is mixed according to general knowledge and filled into pouches.

[0042] [Table 1]

Claims

1. a. 0.5 to 12 mg of nicotine, b. A filler comprising a filler which is 30% to 75% by weight of natural oat fiber, or oat flour, or a mixture thereof, A substantially tobacco-free oral nicotine composition.

2. The oral nicotine composition according to claim 1, wherein the oral nicotine composition further comprises one or more humectants in an amount of 2% to 25% by weight.

3. The oral nicotine composition according to claim 1, wherein the oral nicotine composition further comprises one or more humectants in an amount of 10% to 15% by weight.

4. The oral nicotine composition according to any one of claims 1 to 3, wherein the oral nicotine composition further comprises 5% to 30% by weight of water.

5. The oral nicotine composition according to claim 3 or 4, wherein the humectant is selected from the group consisting of glycerol, alginate, triacetin-modified starch, hydroxypropyl cellulose, pectin, and xanthan gum, or mixtures thereof.

6. The oral nicotine composition according to claim 5, wherein the humectant is glycerol.

7. The oral nicotine composition according to any one of claims 1 to 6, further comprising one or more sugar alcohols selected from the group consisting of mannitol, sucralose, erythritol, and xylitol, or mixtures thereof.

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

9. An oral nicotine composition according to any one of claims 1 to 8, comprising silicon dioxide.

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

11. The oral nicotine composition according to any one of claims 1 to 10, wherein the nicotine is selected from the group consisting of free base nicotine, nicotine salt, nicotine bound to an ion exchange resin, or a mixture thereof.

12. The oral nicotine composition according to claim 11, wherein the nicotine is a nicotine salt.

13. An oral nicotine composition according to any one of claims 1 to 12, comprising one or more thickeners, sweeteners, flavorings, or pH adjusters.

14. An oral nicotine container comprising the oral nicotine composition according to any one of claims 1 to 13.

15. The oral nicotine container according to claim 14, which is an oral nicotine pouch.

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