Saliva-permeable pouch comprising a moist tobacco-free composition and an active

Abstract

This disclosure relates to the field of orally packaged tobacco-free products for delivering active substances to users. More specifically, this disclosure relates to a saliva-permeable pouch for orally use comprising a moist tobacco-free composition, said composition comprising i) a carrier material, including plant-based fibers such as microcrystalline cellulose (MCC); ii) a pH adjuster such as sodium carbonate; and iii) arecoline, wherein said composition comprises arecoline in an amount of about 0.05% to about 30% by weight, for example, about 3% to about 15% by weight, based on the total weight of said composition. This disclosure relates to the use of such products as alternatives to tobacco-based and / or nicotine-based products.

Description

Technical Field

[0001] This disclosure relates to the field of orally administered, pouch-packaged, tobacco-free products for delivering an active substance to a subject, said active substance providing a pleasurable, relaxing experience. This disclosure relates to orally administered products, similar to snuff products, provided in small pouches for easy placement under the lips and / or chewing by the user. The products are tobacco-free and contain arecoline as the active substance. Background Technology

[0002] Smokeless tobacco products for oral use, such as snuff, are very common in some countries, particularly Sweden. These products are supplied in bulk or as individual packets of soft material formed into pouches. Users typically use the pouch by placing it in their mouth, for example, between the upper or lower gums and the lips, or inside the cheek, and holding it there for a period of time until the product contents are released into the mouth. Therefore, the pouch material is permeable and continuously releases a portion of the snuff product when placed in the user's mouth. The pouch material holds the snuff product in place and should be formed of a material that allows the user to easily and / or comfortably place it against the sensitive mucous membranes of the mouth.

[0003] Smokeless tobacco products often have an unpleasant odor that is unpleasant to users or those around them. More importantly, snuff products can damage the gums of long-term users. Therefore, there is a growing demand for smokeless oral products based on materials other than tobacco.

[0004] Many tobacco-free products on the market today contain nicotine as an active ingredient. The effects of nicotine are well-known, and it is commonly used in these products to provide an alternative source of nicotine to smokeless tobacco products (such as snuff) and tobacco products in general. Currently, there are no close nicotine substitutes in orally administered smokeless tobacco products—that is, substitutes that can provide similar effects to nicotine.

[0005] Arecoline is a mild parasympathomimetic alkaloid based on nicotinic acid, found in areca nut (areca palm) (areca fruit). Areca catechu Arecoline is found in the fruit of the areca nut. It is provided as a tasteless, oily liquid and is known to bring users a sense of alertness, energy, and relaxation. The effects of arecoline have been described in relation to the human nervous, cardiovascular, endocrine, and digestive systems. Given its previously shown effects on learning abilities in healthy subjects, arecoline has also been suggested for the treatment of Alzheimer's disease. In some Asian cultures, the areca nut is often chewed with betel leaves for its stimulating effect.

[0006] There is a persistent need in the field to identify products for delivering active substances and / or for providing alternatives to smokeless, tobacco-free products while still providing a stimulating effect to the user. There is also a general need in the field for new products that can provide effects similar to existing nicotine-containing products. Summary of the Invention

[0007] The aforementioned needs or problems have now been addressed and alleviated, at least by the saliva-permeable pouches containing a wet, tobacco-free composition with arecoline provided herein.

[0008] More specifically, a saliva-permeable pouch comprising a moist, tobacco-free composition for oral use is provided, said composition comprising:

[0009] i) Carrier materials, including plant-based fibers, such as microcrystalline cellulose (MCC); ii) pH adjusters, such as sodium carbonate, and iii) Arecoline, The composition contains arecoline at about 0.05% to about 30% by weight, for example about 3% to about 15% by weight, based on the total weight of the composition.

[0010] This document also provides the use of saliva-permeable pouches containing arecoline-containing wet tobacco-free compositions as alternatives to tobacco-based and / or nicotine-based products. The document also provides the use of arecoline in orally administered wet tobacco-free compositions.

[0011] In particular, the wet tobacco-free composition is nicotine-free. Therefore, preferably, the saliva-permeable pouch containing the wet tobacco-free composition disclosed herein is nicotine-free.

[0012] definition All words and terms used herein should be considered to have the same meaning as commonly given to them by those skilled in the art, unless otherwise apparent from the context.

[0013] The singular form “a / an” should be interpreted to also include the plural form.

[0014] A composition that “comprising” one or more of the described elements may also include other elements not specifically described. The term “comprising” also includes the term “composed of”.

[0015] The term “wet tobacco-free composition” may also be referred to herein as “composition”, “tobacco-free composition” or similar terms.

[0016] In the context of this disclosure, "water content" means water added during the production of the compositions disclosed herein, as well as water provided by aqueous components (e.g., fragrances) added to the compositions disclosed herein. Water content as used herein is given as a percentage (wt%) of the total weight of the mentioned compositions. Additional moisture may be provided to the compositions, for example, by a humectant (such as propylene glycol).

[0017] According to this disclosure, a "bag" is a small, soft, sealed, but permeable pouch for containing the wet tobacco-free composition of this disclosure. The bag is saliva-permeable. This permeability allows saliva to enter the wet tobacco-free composition and allows substances from the wet tobacco-free composition to be released through the material into the user's mouth. The bag is made of a material that allows the user to comfortably place it under the lips. Alternatively, the bag may be made of a material that makes it suitable for chewing. Typically, the bag is made of or contains cellulose material. The bag can also be freely placed in other locations in the mouth, i.e., not limited to under the user's lips.

[0018] The term "cellulose bag" as used in this article refers to a bag made of cellulose, but it may also contain other components suitable for the bag's purpose. Suitable bag sizes are further described in this article.

[0019] According to this disclosure, an "active substance" is a substance that produces an effect on the body when ingested. Such effects may, for example, be an energizing and / or stimulating effect. The active substance in this document is arecoline.

[0020] According to this disclosure, a "carrier material" is a material that carries an active substance and / or ingredient and allows or facilitates its release when placed in a user's mouth. Examples of carrier materials suitable for the purposes of this disclosure are provided elsewhere herein.

[0021] In the context of this document, "saliva-permeable" means that the bag is permeable, implying that once the bag is placed in a user's mouth, saliva is allowed to pass through the bag material into the composition of this disclosure located inside the bag, thereby providing additional moisture to the composition and also ensuring that substances present in the composition can pass through the bag material into the user's mouth. This is particularly important for the active ingredients to reach the user's oral cavity and produce an effect.

[0022] In this document, “wt%”, “weight%” or “% (weight)” refers to the weight percentage of the components based on the total weight of the compositions disclosed herein. Detailed Implementation

[0023] This disclosure provides a wet, non-smoking product for oral use, which can be used to experience a stimulating effect on the body and also has an appealing taste and mouthfeel. The wet, non-smoking product for oral use disclosed herein is smokeless.

[0024] This disclosure proposes a nicotine-based product alternative, using arecoline as the active ingredient in orally administered smokeless products. Unexpectedly, this substance proves particularly suitable as a nicotine substitute in orally administered bagged tobacco-free products. When provided to the user in this context, it is able to provide a stimulating effect similar to nicotine. This substance can provide a stimulating effect without increasing potential toxicity, and therefore serves as a useful alternative to nicotine, which is not anticipated given the effects known in the art. This is also a healthier alternative to the use of areca nut. In this regard, it is advantageous not to provide arecoline in the form of areca nut in the wet tobacco-free compositions of this disclosure.

[0025] Arecoline (also known as arecaline, arecholine, arecolin, arecoline base, arekolin) is primarily known in Asian cultures for its use in chewing areca nuts (betel nuts) (areca tree) (areca nut). Areca catechu The fruit is consumed in its own form. Arecoline is found in the seeds of the fruit, and the fruit is usually chewed along with the leaves.

[0026]

[0027] Arecoline (molecular formula C8H) 13 NO2) While searching for a nicotine substitute as an active ingredient in orally administered smokeless and tobacco-free products, the inventors identified this substance and found that it constitutes a suitable stimulant, providing an effect similar to nicotine, and also works well with other ingredients in the product. Therefore, based on these findings, a new product using arecoline as the base active ingredient to replace nicotine was developed. This product, in combination with other ingredients, presents an orally administered pouch product that can be placed under the lips or chewed. The latter will be particularly beneficial to areca nut users, providing a healthier alternative because the same energizing effect can be achieved by consuming one or more pouches of the product instead of consuming large quantities of the fruit, while also avoiding other components of the areca nut.

[0028] Furthermore, to the inventors' knowledge, this is the first time a substance such as arecoline has been proposed as a substitute for nicotine. Nor was it anticipated that arecoline would function in the same manner or be adapted with other components of the composition to provide a suitable product for the purposes described herein.

[0029] According to this disclosure, the active substance, hereof arecoline, is applied to the oral mucosa in the form of a saliva-permeable pouch comprising a moist, tobacco-free composition, said pouch being placed in the oral cavity, preferably under the lips or elsewhere in the mouth, optionally wherein said pouch is adapted for chewing. By placing it in the mouth in this manner, the active substance comes into contact with and enters the oral mucosa. This results in rapid uptake of the active substance, thus producing a more rapid positive stimulating effect.

[0030] Therefore, users of the disclosed product experience the positive effects of the active substance more quickly than when the active substance is delivered, for example, by eating or drinking products containing the active substance (which need to be absorbed in the gastrointestinal tract).

[0031] Therefore, this document provides a saliva-permeable pouch containing a moist, tobacco-free composition for oral use. As described herein, the composition contains arecoline. Therefore, this document provides a moist, tobacco-free composition containing arecoline. Specifically, the moist, tobacco-free composition is nicotine-free. Therefore, specifically, the saliva-permeable pouch containing the moist, tobacco-free composition is nicotine-free.

[0032] More specifically, this document provides a saliva-permeable pouch for oral use comprising a wet, tobacco-free composition, said composition comprising: i) a carrier material, including plant-based fibers, such as microcrystalline cellulose (MCC); ii) a pH adjuster, such as sodium carbonate; and iii) arecoline, in amounts from about 0.05% to about 30% by weight, for example, from about 3% to about 15% by weight, based on the total weight of said composition.

[0033] The wet tobacco-free composition may be nicotine-free. Alternatively, it may contain nicotine in addition to arecoline. Preferably, the composition is nicotine-free. Therefore, preferably, the saliva-permeable pouch containing the wet tobacco-free composition of this disclosure is nicotine-free.

[0034] Therefore, the composition contains arecoline as an active substance to provide a stimulating effect. More specifically, based on the total weight of the wet tobacco-free composition, the composition may contain about 3% to about 30% or 3% to about 25% arecoline. Based on the total weight of the composition, the composition may contain about 3% to about 20% arecoline, for example about 3% to about 15% arecoline, for example about 3% to about 10% arecoline, for example about 3% to about 7% arecoline, for example about 4%, 5%, 6%, 7%, 8%, 9%, 10%, 11%, 12%, 13%, 14%, 15%, 16%, 17%, 18%, 19%, 20%, 21%, 22%, 23%, or 24% arecoline.

[0035] Arecoline can also be modified in various forms, such as variants or derivatives of arecoline, such as arecoline hydrobromide or other derivatives of arecoline. These modified forms or versions will be apparent to those skilled in the art. Modified forms of arecoline are included within the scope of this disclosure. Modified forms of arecoline will provide substantially the same function as the original substance. Therefore, modifications to arecoline are made for other purposes, such as improving the stability of the substance during storage.

[0036] Arecoline is typically supplied in powder form. When referred to herein as "arecoline" as an ingredient in the compositions disclosed herein, the amount mentioned refers to the amount of such powder. This powder contains at least 90%, such as at least 91%, 92%, 93%, 94%, 95%, 96%, 97%, 98%, 99%, or close to 100% arecoline, such as about 99.9% or about 99.99% arecoline. Specifically, the powder is about 99% arecoline.

[0037] According to this disclosure, arecoline is preferably provided in a substantially pure form. In the context of this disclosure, "substantially pure form" means that arecoline is provided in a form containing at least about 95% arecoline, such as at least about 96%, at least about 97%, at least about 98%, or at least about 99% arecoline, such as about 99.9% or 99.99% arecoline. Therefore, arecoline can be provided as an arecoline composition containing at least about 95% arecoline, such as at least about 96%, at least about 97%, at least about 98%, or at least about 99% arecoline, such as about 99.9% or 99.99% arecoline. In particular, according to this disclosure, arecoline can be provided as a powder containing at least about 95% arecoline, such as at least about 96%, at least about 97%, at least about 98%, or at least about 99% arecoline, such as about 99.9% or about 99.99% arecoline.

[0038] As is well known to those skilled in the art, arecoline can be obtained, for example, by chemical synthesis, or may have been isolated, extracted, or purified from its natural sources. The arecoline provided herein in wet, tobacco-free compositions is substantially or completely free of other parts of the areca nut (betel nut). Arecoline is classified herein as a dry ingredient (see Table 1). However, arecoline can be provided in any other form, such as an oily liquid, which is also included within the scope of this disclosure. As described elsewhere herein, arecoline variants or derivatives providing substantially the same activity and function are also contemplated in this context.

[0039] The bag can be made of a material suitable for both placement under the lips and chewing. Alternatively, it can be made of a material primarily suitable for placement under the lips. Alternatively, it can also be made of a material primarily suitable for chewing.

[0040] Suitable carrier materials for wet tobacco-free compositions comprise plant-based fibers. An example of a plant-based fiber is a cellulose fiber material or a derivative thereof. Cellulose fibers are fibers made from ethers or esters of cellulose. These can be obtained, for example, from the bark, wood, or leaves of plants or other plant-based materials. Cellulose fiber materials may also contain hemicellulose and lignin, the different percentages of which alter the mechanical properties of the fiber. Other examples of fibers suitable for use as carrier materials in this disclosure are oat fibers.

[0041] Examples of suitable cellulose materials or their derivatives are carboxymethyl cellulose (CMC) and microcrystalline cellulose (MCC), but are not limited thereto. Functionally, the carrier material is adapted to carry the active substance and also facilitates its passage through the pouch material into the mouth and through the user's mucous membranes, where it can exert its beneficial stimulating effect. The carrier materials disclosed herein are not limited thereto.

[0042] As described herein, the wet tobacco-free compositions of this disclosure contain a pH adjuster, such as sodium carbonate or calcium carbonate. This pH adjuster ensures that the pH of the disclosed compositions is maintained at an appropriate level to provide a sufficiently high-quality oral pouch product (i.e., a saliva-permeable pouch containing the wet tobacco-free composition), including maintaining the texture and flavor of the product and ensuring that the active ingredients function properly in the presence of the product. It is also important to ensure that no undesirable microbial growth occurs during product storage; therefore, a pH adjuster is present in the composition to ensure that such growth does not occur, or at least not to the extent that it impairs product quality.

[0043] Therefore, the pH adjuster in this composition ensures that the pH of the wet tobacco-free composition disclosed herein is between about 6.5 and 10. More specifically, the pH is generally between 6.5 and 8, for example, between about 7 and about 8. Examples of pH adjusters used in the compositions disclosed herein are sodium carbonate, but are not limited thereto.

[0044] As described elsewhere herein, the composition comprises a carrier material. Hereinafter, the composition may comprise about 40% to about 70% by weight of the carrier material based on the total weight of the wet tobacco-free composition, for example, about 40% to about 60% by weight, about 50% to about 60% by weight, or about 45%, 46%, 47%, 48%, 49%, 50%, 51%, 52%, 53%, 54%, 55%, 56%, 57%, 58%, or 59% by weight of the carrier material.

[0045] Specifically, a composition is provided comprising arecoline of about 3% to about 15% by weight, for example, about 3% to about 10% by weight, for example, about 4% or about 5% by weight, based on the total weight of the wet tobacco-free composition, and carrier material of about 50% to about 60% by weight, for example, about 54% or 55% by weight, based on the total weight of the wet tobacco-free composition.

[0046] In this document, the wet tobacco-free composition may also contain additional ingredients, such as one or more sweeteners, flavorings / fragrances, and / or salts. Exemplary sweeteners, flavorings / fragrances, and salts are provided elsewhere herein and may be used in any combination.

[0047] Therefore, this document also provides a wet tobacco-free composition, wherein the composition further comprises one or more of the following components in any combination: iv) one or more salts, such as sodium chloride and / or ammonium chloride; v) one or more humectants, such as propylene glycol; vi) one or more flavoring agents; and vii) one or more sweeteners. The composition may also contain water.

[0048] In this article, aromatics may also be referred to as flavoring agents or seasonings.

[0049] In this document, the composition may more specifically comprise one or more of the following components in any combination: iv) a salt, such as sodium chloride and / or ammonium chloride, comprising about 2% to about 5% by weight, for example about 2% to about 4% by weight, for example about 3%, 3.5% or 3.7% by weight, based on the total weight of the composition. v) A moisturizer, such as propylene glycol, comprising about 1.5% to about 4% by weight, for example about 2% to 3% by weight, based on the total weight of the composition. vi) about 3% to about 8% by weight, for example about 4% to about 6% by weight, for example about 5% or 5.1% by weight of the fragrance based on the total weight of the composition, and vii) A sweetener comprising about 0.1% to about 0.5% by weight, for example about 0.2% to about 0.4% by weight, for example about 0.3% by weight, based on the total weight of the composition.

[0050] When references are made herein in the singular or plural form for salts, fragrances, and / or humectants, it means that the compositions of this disclosure may contain one type of salt, fragrance, and / or humectant, or alternatively, a mixture of different types of salts, fragrances, and / or humectants. The content of salts, fragrances, or humectants (e.g., % by weight or mg / g) refers to the total amount of salts, fragrances, or humectants in the compositions of this disclosure, regardless of type.

[0051] The water added during the preparation of the composition is itself the primary source of water content and moisture in the compositions of this disclosure. Water is typically added in an amount from about 20% to about 40% by weight, for example from about 26% to about 33% by weight, for example from about 27% to about 30% by weight, based on the total weight of the composition. This is illustrated, for example, in Table 1 of Example 1.

[0052] Water added during composition preparation via components other than water itself (e.g., aqueous components such as fragrances) typically contributes only a small amount to the overall water content and moisture content of the composition.

[0053] Therefore, the water content of the compositions disclosed herein includes the added water itself and the water provided by the aqueous components. The water content of the compositions disclosed herein is typically from about 20% by weight to about 45% by weight, for example from about 25% by weight to about 45% by weight, for example from 28% by weight to 35% by weight.

[0054] As described elsewhere in this article, other ingredients, such as humectants like propylene glycol, can contribute to the moisture content of the composition.

[0055] The compositions presented herein may also contain additional ingredients, such as other stabilizers, preservatives, etc.

[0056] Naturally, the total content of the ingredients adds up to 100% of the composition by weight.

[0057] In preparing the composition, water may optionally be added in the form of a water spray to adjust the consistency and texture of the final composition. During composition preparation, water / moisture is absorbed by the composition, primarily by the carrier material, to obtain a wet, tobacco-free composition.

[0058] As shown in Table 1 of Example 1, the "dry" (or non-aqueous) components provided in the compositions of this disclosure include, but are not limited to, plant-based fibers such as MCC, salt, arecoline (powder), and sweeteners. Based on the total weight of the compositions, the dry components constitute from about 50% to about 80% by weight, for example from about 60% to about 70% by weight, for example from about 61%, 62%, 63%, 64%, 65%, 66%, 67%, 68%, or 69% by weight.

[0059] The components provided as "fluids" include water, a humectant (propylene glycol), and a fragrance. All fluids contribute to the moisture content of the composition. Based on the total weight of the composition, the "fluid" components constitute from about 20% to about 50% by weight, for example, from about 30% to about 40% by weight.

[0060] In this document, the sweetener of component vii) of the composition disclosed herein may include one or more sweeteners such as acesulfame K, erythritol, sucralose and steviol glycosides, but is not limited thereto.

[0061] The components of the compositions mentioned herein and their amounts (defined in weight % or mg / g of the composition, or as otherwise defined) may be provided in any combination in the wet tobacco-free compositions of this disclosure.

[0062] In this document, one example of a bag disclosed herein is a bag containing about 600 mg of a wet, tobacco-free composition, said composition containing about 27 mg of arecoline.

[0063] This document also provides a pouch comprising a wet, non-tobacco composition, wherein the pouch is suitable for chewing and / or placement under the lips. When the pouch is suitable for chewing, the material of the pouch is preferably more abrasion-resistant. This is because the pouch should not easily tear and cause leakage of the composition when the user chews the pouch. Those skilled in the art can choose materials suitable for this purpose. Even if the pouch is made of such a material, it can alternatively be placed under the lips. Alternatively, the pouch can be made of a material that makes it suitable for placement under the lips but less suitable for chewing. Those skilled in the art will understand the differences between these products.

[0064] The use of saliva-permeable pouches containing a wet, tobacco-free composition as disclosed herein as alternatives to tobacco-based and / or nicotine-based products is also provided.

[0065] This document also provides the use of arecoline in oral wet tobacco-free compositions, optionally wherein the compositions are nicotine-free. In particular, the oral wet tobacco-free compositions are nicotine-free. This document also provides the use of arecoline in oral wet tobacco-free compositions, wherein the compositions further contain nicotine. A use is also provided in which arecoline is provided in a substantially pure form in the composition, particularly wherein the substantially pure form comprises at least about 95% arecoline, such as at least about 96%, at least about 97%, at least about 98%, or at least about 99% arecoline, such as about 99.9% or about 99.99% arecoline, particularly wherein arecoline is provided in powder form. This document also provides a use in which the composition is contained in a saliva-permeable soft pouch for placement under the lips and / or in a saliva-permeable soft pouch for chewing by a user.

[0066] A wet tobacco-free composition comprising arecoline or its derivatives or variants in a substantially pure form is also provided, wherein the substantially pure form comprises at least about 95% arecoline, such as at least about 96%, at least about 97%, at least about 98%, or at least about 99% arecoline, such as about 99.9% or about 99.99% arecoline, particularly wherein arecoline is provided in powder form, as described elsewhere herein. Preferably, the wet tobacco-free composition is nicotine-free.

[0067] Also provided is a saliva-permeable pouch comprising a wet, tobacco-free composition containing arecoline or its derivatives or variants in a substantially pure form as described elsewhere herein, particularly wherein arecoline is provided in powder form. Preferably, the wet, tobacco-free composition is nicotine-free. Therefore, preferably, the saliva-permeable pouch comprising the wet, tobacco-free composition of this disclosure is nicotine-free.

[0068] The wet tobacco-free composition described herein is encapsulated in a saliva-permeable pouch, wherein the saliva-permeable pouch is soft and suitable for placement under the lips and / or for chewing. Such pouches are known in the art; one example is a cellulose pouch, wherein the material is prepared from cellulose. Typically, the width of the pouch is from about 5 to about 20 mm, for example from about 10 to about 18 mm, for example from about 12 to about 15 mm, for example from about 14 mm. Typically, the length of the pouch is from about 20 mm to about 40 mm, for example from about 25 to about 35 mm, for example from about 30 mm. However, pouches of other sizes or shapes may also be used.

[0069] The texture of the wet tobacco-free composition and the softness of the pouch material (e.g., cellulose material) provide the user with an attractive combination for comfortable placement in the mouth, such as under the lips.

[0070] A pouch containing the wet, tobacco-free composition of this disclosure can be placed in a container or a soft pouch. The container or pouch is used to store the pouch for the user. The container or pouch can be made of soft or rigid plastic material. The container can be round or square in shape and is made of rigid plastic material. The container can be a small rectangular soft plastic pouch. The pouch can be made of transparent or opaque material, or a combination thereof.

[0071] The composition of the wet tobacco-free composition of this disclosure will now be described with reference to mg / g (milligrams per gram of wet tobacco-free composition).

[0072] In this document, the carrier material, including plant-based fibers such as microcrystalline cellulose (MCC), may be present in amounts of about 400 mg / g to about 700 mg / g, for example, about 500 mg / g to 600 mg / g, for example, about 500 mg / g or 545 mg / g of the composition.

[0073] Salts, such as sodium chloride and / or ammonium chloride, may be present in amounts from about 27 mg / g to about 47 mg / g, for example, from 34 mg / g to about 40 mg / g, for example, about 37 mg / g or 40 mg / g of the composition.

[0074] pH adjusters, such as sodium carbonate, may be present in amounts from about 1 mg / g to 5 mg / g, such as about 2 mg / g to about 4 mg / g, such as about 3 mg / g or 3.5 mg / g, such as 3.3 mg / g of the composition.

[0075] Arecoline may be present in amounts of about 30 mg / g to about 60 mg / g, for example about 40 mg / g to about 50 mg / g, for example about 45 mg / g of the composition.

[0076] Sometimes arecoline is present in the composition in a larger amount, even up to 180 mg / g, for example, about 100 mg / g to about 180 mg / g, for example, about 50 mg / g to about 100 mg / g, for example, about 50 mg / g to about 75 mg / g of the composition. This means that the content of other components (such as carrier materials) is reduced to accommodate the larger amount of arecoline in such a composition.

[0077] The sweetener may be present in an amount from about 1 mg / g to about 5 mg / g, for example from about 2 mg / g to about 3 mg / g, for example 3 mg / g of the composition.

[0078] Water itself may be added in an amount of about 200 mg to about 380 mg / g of the composition, for example about 250 mg / g to about 310 mg / g, for example about 240 mg to 300 mg, for example about 250 mg to 290 mg / g of the composition.

[0079] Moisturizers, such as propylene glycol, may be present in amounts from about 15 mg / g to about 35 mg / g, such as about 20 mg / g to about 30 mg / g, such as about 25 mg / g of the composition.

[0080] The fragrance may be present in an amount of about 40 mg / g to 60 mg / g, for example about 45 mg / g to about 55 mg / g, for example about 50 mg / g or 51 mg / g of the composition.

[0081] More specifically, this document also provides a wet tobacco-free composition comprising, based on the total weight of the composition: Approximately 548 mg / g of plant-based fiber, such as MCC, pH adjusters of approximately 3 mg / g or 4 mg / g, such as sodium carbonate, Approximately 37 mg / g of salt, such as sodium chloride, Arecoline at approximately 45 mg / g Approximately 3 mg / g of sweetener, Approximately 288 mg / g of water, Approximately 25 mg / g of moisturizers, such as propylene glycol, and The fragrance is approximately 51 mg / g.

[0082] More specifically, a wet tobacco-free composition is also provided, comprising, based on the total weight of the composition: Approximately 55% by weight of plant-based fibers, such as MCC, Approximately 0.3% by weight of a pH adjuster, such as sodium carbonate, Approximately 3.7% by weight of salt, such as sodium chloride, Approximately 4.5% by weight of arecoline, Approximately 0.3% by weight of sweetener, Approximately 28% or 29% by weight of water, Approximately 2.5% by weight of a moisturizer, such as propylene glycol, and Approximately 5% by weight of fragrance.

[0083] The total weight of the wet tobacco-free composition described in this disclosure bag may be from about 0.3g to about 1.5g, for example from about 0.5g to about 1g, from about 0.5g to about 0.8g or about 0.6g (600mg).

[0084] The saliva-permeable pouch comprising the wet tobacco-free composition disclosed herein can be prepared by the following exemplary method: The components of the composition are mixed into a homogeneous mixture, and then a liquid (e.g., water) is added. By impregnating a carrier material with all the components in a dedicated mixer, all components of the composition are combined into an aggregated wet tobacco-free composition.

[0085] A specialized mixer is a mixer typically used for mixing snuff products.

[0086] Preferably, the tobacco-free composition obtained thereafter is left to stand for about 12 to 24 hours before being packaged into a saliva-permeable bag.

[0087] The tobacco-free composition is then processed in a machine that dispenses it into small, soft, saliva-permeable pouches made of a saliva-permeable material, such as cellulose paper. Saliva-permeable pouches are commonly used to package snuff products.

[0088] When the wet tobacco-free composition (mixture) is added to the filling machine, the composition (mixture) is evenly distributed in the machine's pipes. The evenly distributed composition (mixture) is then covered with bag material, the ingredients are weighed, and then laminated at both ends before the bag is cut to the preset size selected for that particular bag product.

[0089] Saliva-permeable pouches can come in different sizes and therefore contain varying amounts of tobacco-free composition, as described elsewhere in this article.

[0090] After storing the saliva-permeable bag for a period of time, you can check for any bacterial growth in the product.

[0091] This disclosure will now be illustrated by the following experimental section, but is not intended to be limited thereto, as it merely illustrates different ways of implementing this disclosure.

[0092] Experimental Section Example 1 Materials and methods The ingredients of the tobacco-free compositions in Table 1 are readily available from suitable manufacturers. Propylene glycol is added as a humectant.

[0093] The dry components of the composition are mixed into a homogeneous mixture, and then a liquid (water) is added. All components of the wet tobacco-free composition are combined into a single aggregated wet tobacco-free composition by impregnating a carrier material with all components in a dedicated mixer. Arecoline is provided in powder form as described elsewhere herein.

[0094] A specialized mixer is a mixer typically used for mixing snuff products.

[0095] Preferably, the tobacco-free composition obtained thereafter is left to stand for about 12 to 24 hours before being packaged into bags.

[0096] The tobacco-free composition is then processed in a machine that dispenses it into small, soft pouches made of a saliva-permeable material, such as cellulose paper. These pouches are commonly used to package snuff products. The pouches can be made in various sizes, one example being 14x30mm.

[0097] When the tobacco-free mixture is added to the machine, it is evenly distributed within the machine's tubing. The evenly distributed mixture is then covered with bag material, the ingredients are weighed, and then laminated at both ends before the bag is cut to the preset size selected for that particular saliva-permeable bag product.

[0098] The bags may come in different sizes and therefore contain different amounts of the tobacco-free composition. One example of a bag containing the tobacco-free composition is about 600 mg (0.6 g) in total weight.

[0099] After storing the bag for a period of time, check the product for any bacterial growth.

[0100] Table 1:

[0101] Table 1: Components of exemplary wet tobacco-free compositions of this disclosure.

Claims

1. A saliva-permeable pouch comprising a moist, tobacco-free composition for oral use, said composition comprising: i) Carrier materials, including plant-based fibers, such as microcrystalline cellulose (MCC); ii) pH adjusters, such as sodium carbonate; and iii) Arecoline, The composition contains arecoline at about 0.05% to about 30% by weight, for example about 3% to about 15% by weight, based on the total weight of the composition.

2. The saliva-permeable bag according to claim 1, wherein the composition comprises arecoline at about 3% to about 15% by weight, for example about 3% to about 10% by weight, for example about 3% to about 7% by weight, for example about 4%, 5%, 6%, 7%, 8%, or 9% by weight based on the total weight of the composition.

3. The saliva-permeable pouch according to any one of claims 1 to 2, wherein the arecoline in the wet tobacco-free composition is provided in a substantially pure form, particularly wherein the substantially pure form comprises at least about 95% arecoline, such as at least about 96%, at least about 97%, at least about 98%, or at least about 99% arecoline, such as about 99.9% or about 99.99% arecoline, particularly wherein the arecoline is provided in powder form.

4. The saliva-permeable pouch according to any one of the preceding claims, wherein the wet tobacco-free composition is nicotine-free.

5. The saliva-permeable bag according to any one of the preceding claims, wherein the composition comprises about 40% to about 70% by weight, for example about 50% to 60% by weight, of carrier material based on the total weight of the composition.

6. The saliva-permeable bag according to any one of the preceding claims, wherein the composition further comprises one or more of the following components: iv) One or more salts, such as sodium chloride and / or ammonium chloride; v) One or more moisturizers, such as propylene glycol; vi) one or more fragrances; and vii) One or more sweeteners.

7. The saliva-permeable bag of claim 6, wherein the composition comprises: iv) about 2% to about 5% by weight, for example about 3% or 3.7% by weight of salt, based on the total weight of the composition; v) A moisturizer, such as propylene glycol, comprising about 1.5% to about 4% by weight, for example about 2% to 3% by weight, for example about 2.5% by weight, based on the total weight of the composition; vi) Fragrances comprising about 3% to about 8% by weight, for example about 4% to about 6% by weight, for example about 5% or 5.1% by weight, based on the total weight of the composition; vii) A sweetener comprising about 0.1% to about 0.5% by weight, for example about 0.2% to about 0.4% by weight, for example about 0.3% by weight, based on the total weight of the composition.

8. The saliva-permeable bag according to any one of claims 6 or 7, wherein the sweetener of component vii) comprises one or more of acesulfame K, erythritol, sucralose, and steviol glycosides.

9. The saliva-permeable bag according to any one of the preceding claims, wherein the total content of the composition in each bag is about 600 mg, and wherein the content of arecoline is about 27 mg.

10. The saliva-permeable bag according to any one of the preceding claims, wherein the bag is adapted for chewing and / or placement under the lips.

11. Use of the saliva-permeable pouch according to any one of the preceding claims as a substitute for tobacco-based products.

12. Use of the saliva-permeable bag according to any one of the preceding claims as a substitute for nicotine products.

13. Use of arecoline in oral wet tobacco-free compositions, optionally wherein the compositions are free of nicotine.

14. The use according to any one of claims 11 to 13, wherein the wet tobacco-free composition is free of nicotine.

15. The use according to any one of claims 11 to 14, wherein the arecoline in the composition is provided in a substantially pure form, particularly wherein the substantially pure form comprises at least about 95% arecoline, such as at least about 96%, at least about 97%, at least about 98%, or at least about 99% arecoline, such as about 99.9% or about 99.99% arecoline, particularly wherein the arecoline is provided in powder form.

16. The use according to any one of claims 11 to 15, wherein the composition is contained in a saliva-permeable soft pouch for use by a user to place under the lips and / or chew.

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