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 at least one 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, as well as some health-related issues.

[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 would result in a more healthy product that provides a nicotine release that is soothing to the consumer and maintains the humidity for a comfortable experience.

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

Summary of the Invention

[0007] An object of the present invention is to alleviate, mitigate, or eliminate one or more specified defects and disadvantages in the art, either 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 12 mg of nicotine, 30 to 75% by weight of a filler selected from the group consisting of microcrystalline cellulose, cellulose and cellulose derivatives, and mixtures thereof, and 5 to 15% by weight of natural fibers, and substantially free of tobacco. The oral nicotine composition preferably does not contain pH adjusters.

[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] This product provides a smooth and soft feel when placed under the lips, achieved through a unique combination of ingredients present in the composition. 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, specifically in that it is less harmful to the oral mucosa and teeth, provides freshness, and is free from 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 embodiment, the present invention relates to a container such as a pouch containing an oral nicotine composition for delivery to the oral cavity, wherein the oral nicotine composition comprises 0.5 mg to 12 mg of nicotine, 30 to 75% by weight of a filler selected from the group consisting of microcrystalline cellulose, cellulose and cellulose derivatives, and mixtures thereof, and 5 to 15% by weight of natural fibers, and is substantially tobacco-free.

[0014] By providing oral nicotine containers such as pouches, products are provided that regulate the release of water-soluble components from a composition located within the cavity of a container such as a water-permeable pouch. Such release can be regulated, for example, by modifying the filling 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 a composition. In one embodiment, the filler is present to increase the volume of a container, such as a pouch used under the lips.

[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, and / or nicotine bound to a resin such as Polarcrilex. The amount of nicotine depends on the craving to be relieved, as well as other components present in the composition.

[0024] An oral nicotine composition contains one or more fillers, where the fillers are present in an amount of at least 30% by weight, for example, at least 40, 45, 50, 55, 60, 65, 70, 75% by weight, or 30% to 80% by weight, for example, 30% to 80%, 30% to 75%, 35% to 65%, 40% to 55%, 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 the nicotine will be released immediately and will not continue over a 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 30-75% by weight, for example, 35-65% by weight or 40-50% by weight of microcrystalline cellulose and 5-15% by weight of natural fibers, for example, 40, 45, or 50% by weight of microcrystalline cellulose and 5, 10, or 15% by weight of natural fibers.

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

[0027] In another embodiment, the fiber is at least oat fiber and / or oat powder, which is used alone or in combination with another filler. In one example, the oat fiber and / or oat powder is mixed with cellulose such as microcrystalline cellulose (MCC), where the filler is a mixture of microcrystalline cellulose in an amount of 30 - 75% by weight, such as 35 - 65% by weight or 40 - 50% by weight, and the oat fiber is in an amount of 5 - 15% by weight, such as 40, 45, 50% by weight of microcrystalline cellulose and 5, 10, 15% by weight of oat fiber. When using oats, the result is a homogeneous and stable composition that retains the shape of the product. When an oral nicotine composition containing oats is placed in the mouth, saliva moistens the oats, and the oats expand the pouch into a pillow-like structure, giving the oral nicotine composition a good sensory feel. In addition, it is possible for an individual user to mold the pouch into a suitable personal shape.

[0028] Non-limiting examples of water-insoluble fibers that can be used are Vitacel® fibers. They are mainly insoluble fibers extracted and isolated from the skeletal material of renewable raw materials in a complexly defined process. Their products have excellent properties suitable for use in combination with nicotine. These fibers are available from companies such as J. RETTENMAIER & SOEHNE in Germany.

[0029] When the above oral nicotine composition substantially does not contain tobacco fiber, carcinogenic substances and some heavy metals that naturally exist in the tobacco plant or are derived from the cultivation of the tobacco plant and accumulated during growth, i.e., harmful components present in the tobacco fiber, are removed.

[0030] The above composition may further contain one or more humectants in an amount of 2% to 25% by weight, for example, 5% to 25% by weight, 10% to 15% by weight, 7% to 15% by weight, for example, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15% by weight, or 20% by weight. Examples of humectants are glycerol, alginate, triacetin-modified starch, hydroxypropyl cellulose, pectin, and xanthan gum, or mixtures thereof.

[0031] In one embodiment, the humectant is glycerol in an amount of 5% to 25% by weight, for example, 20% by weight.

[0032] A humectant may be present in the oral nicotine composition together with water, in which case the water may be present in an amount of 5% to 30% by weight, for example, 10% to 30% by weight, 10% to 20% by weight, or 7% to 15% by weight, for example, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, or 20% by weight. The humectant and water humidify the composition, and therefore make it possible to mold the composition into a relatively dense composition that can be added to containers such as pouches during the manufacture of the product, and furthermore, can be added to packaging. In addition, the presence of these components improves the mouthfeel and prevents the product from drying out.

[0033] In one embodiment, water is present in an amount of 5% to 25% by weight, and glycerol is present in an amount of 5% to 25% by weight, and the amounts of glycerol and water may be the same.

[0034] In addition to humectants, vegetable oils may be included to enhance moisturizing activity and improve the appearance of the oral nicotine composition. In one example, glycerol and vegetable oil are mixed and used as a suitable humectant. The vegetable oil may be present in an amount of 0.1 to 3.0% by weight.

[0035] The combination of nicotine, a humectant, water, and sodium chloride enhances preservative activity, thus naturally inhibiting microbial growth without the use of preservatives.

[0036] Oral nicotine compositions may similarly contain one or more sweeteners, thickeners, and flavorings. Preferably, oral nicotine compositions are substantially free of any pH adjusters.

[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, monk fruit, stevia, saccharin and cyclamate, and mixtures thereof. Sugar alcohols may be present alone or as mixtures of sugar alcohols in amounts of 2% to 15% by weight, for example, 5% to 10% by weight, 6, 7, 8, 9, 10, 11, 12, 13, 14% by weight, where the sugar alcohol is mannitol, erythritol or xylitol, or a mixture thereof. Other sweeteners such as sucralose may be present in amounts of 0.1 to 1.0% by weight.

[0038] Examples of thickeners include alginates, sodium alginate, pectin, or synthetic versions thereof. Thickeners may be present in amounts up to 5% by weight.

[0039] 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.

[0040] The fragrances according to the present invention may include bergamot, eucalyptus, menthol, cinnamon, mint, peppermint, spearmint, apple, cherry, melon, mango, matcha, mocha, ginger peach, honey melon, lime, tropical, peach, passion fruit, orange, blood orange, grapefruit, mandarin, tangerine, licorice, ginger, vanilla, wintergreen, lemon, lime, strawberry, blueberry, raspberry, salmonberry, lingonberry, cranberry, blueberry, muscadin berry, sea buckthorn, chocolate, green tea, lavender, violet, cola, acai, coffee, mocha, or mixtures thereof.

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

[0042] 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.

[0043] Such a method involves 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]

[0044] The oral nicotine composition is mixed according to general knowledge and filled into pouches.

[0045] [Table 1]

Claims

1. a. 0.5 to 12 mg of nicotine, b. A filler selected from the group consisting of microcrystalline cellulose, cellulose and cellulose derivatives, and mixtures thereof, in an amount of 30 to 75% by weight, c. Contains 5-15% by weight of natural fibers, A substantially tobacco-free oral nicotine composition.

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

3. The oral nicotine composition according to claim 1 or 2, wherein the filler is microcrystalline cellulose.

4. The oral nicotine composition according to any one of claims 1 to 3, wherein the natural fiber is oat fiber.

5. The oral nicotine composition according to any one of claims 1 to 4, 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 according to any one of claims 1 to 5, 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 according to any one of claims 1 to 6, wherein the oral nicotine composition further comprises 5% to 30% by weight of water.

8. The oral nicotine composition according to claims 5 to 7, wherein the humectant is selected from the group consisting of glycerol, alginate, triacetin-modified starch, hydroxypropyl cellulose, pectin, and xanthan gum, or mixtures thereof.

9. The oral nicotine composition according to claim 8, wherein the humectant is glycerol.

10. The oral nicotine composition according to any one of claims 1 to 9, further comprising one or more sugar alcohols selected from the group consisting of mannitol, sucralose, erythritol, and xylitol, or mixtures thereof.

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

12. An oral nicotine composition according to any one of claims 1 to 11, comprising silicon dioxide.

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

14. The oral nicotine composition according to any one of claims 1 to 13, 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.

15. The oral nicotine composition according to claim 14, wherein the nicotine is a nicotine salt.

16. An oral nicotine composition according to any one of claims 1 to 15, comprising one or more thickeners, sweeteners, or flavorings.

17. An oral nicotine container comprising the oral nicotine composition according to any one of claims 1 to 16.

18. The oral nicotine container according to claim 17, which is an oral nicotine pouch.

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