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

Abstract

The present disclosure relates to the field of oral pouched non-tobacco products for delivering active substances to a user. More specifically, the present disclosure relates to a saliva-permeable pouch comprising a moist non-tobacco composition for oral use, said composition comprising i) a carrier material comprising a plant-based fiber, such as microcrystalline cellulose (MCC); ii) a pH regulator, such as sodium carbonate, and iii) arecoline, wherein said composition comprises from about 0.05 wt% to about 30 wt%, such as from about 3 wt% to about 15 wt%, of arecoline based on the total weight of said composition. The present disclosure relates to use of such as product as an alternative to a tobacco- and / or nicotine-based product.

Description

[0001] SALIVA PERMEABLE POUCH COMPRISING A MOIST NON-TOBACCO COMPOSITION

[0002] AND AN ACTIVE SUBSTANCE

[0003] TECHNICAL FIELD

[0004] The present disclosure relates to the field of oral pouched tobacco-free products for delivering active substances to a subject that will provide a pleasant, relaxing experience. It relates to oral products that, similar to snuff products, are provided in small pouches for easy adaption under the lip of and / or for chewing by a user. The products are tobacco-free and contain arecoline as an active substance.

[0005] BACKGROUND

[0006] Smokeless tobacco products for oral use, such as snuff, are very common in some countries, particularly Sweden. These products are available in loose form or as portion-packed in a soft material formed from a small pouch. The pouch is typically used by the user by placing the pouch containing the snuff product in the mouth, such as between the upper or lower gum and the lip, or in the cheek and then maintaining it there for a while until the contents of the product has been released into the mouth. Accordingly, the pouch material is permeable and releases parts of the snuff products continuously when placed in the mouth of the user. The pouch material holds the snuff product in place and should be formed from a material convenient and / or comfortable for the user to have positioned against the sensitive mucous membrane in the mouth.

[0007] Smokeless tobacco products are associated with a general odour that is not pleasant for the user or for the surroundings of the user. More importantly, snuff products also result in damage to the gum of the long-term user. Therefore, there has been a need for, and an increase of, smokeless oral products based on other materials than tobacco.

[0008] There are many tobacco-free products on the market today containing nicotine as an active substance. The effects of nicotine are well-known, and nicotine is often used in these products to provide an alternative nicotine source to smokeless tobacco products, such as snuff, and to tobacco products in a general sense. There are today no close alternatives to nicotine, i.e. , alternatives that that would provide a similar effect to nicotine, in oral smokeless tobacco-free products.

[0009] Arecoline is a nicotinic acid-based mild parasympathomimetic stimulant alkaloid that is found in the areca nut, the fruit of the areca palm (Areca catechu). It has been provided in the form of an odourless oily liquid and it is known to bring alertness, energy and sensations of relaxation to the user. Effects of arecoline have been described in relation to the nervous, cardiovascular, endocrine and digestive system of humans. Arecoline has also been suggested in the context of treating Alzheimer’s disease in view of its previously shown effects in learning abilities in healthy subjects. In some Asian cultures, the areca nut is chewed to obtain a stimulating effect, usually together with a betel leaf.

[0010] There is always a need in the art 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 for new products within this area that will provide similar effects to existing products comprising nicotine.

[0011] SUMMARY OF THE DISCLOSURE

[0012] The above need or problems have now been addressed and are at least mitigated by the provision herein of a saliva-permeable pouch comprising a moist non-tobacco composition comprising arecoline.

[0013] More specifically it is provided a. saliva-permeable pouch comprising a moist non-tobacco composition for oral use, said composition comprising: i) a carrier material comprising a plant-based fiber, such as microcrystalline cellulose (MCC); ii) a pH regulator, such as sodium carbonate, and iii) arecoline, wherein said composition comprises from about 0.05 wt% to about 30 wt%, such as from about 3 wt% to about 15 wt%, of arecoline, based on the total weight of said composition.

[0014] There is also provided herein the use of a saliva-permeable pouch comprising a moist non- tobacco composition comprising arecoline as described herein, as an alternative to a tobacco- and / or nicotine-based product. There is also provided herein the use of arecoline in an oral moist non-tobacco composition.

[0015] Particularly, the moist non-tobacco composition is nicotine-free. Hence, preferably, a saliva- permeable pouch comprising a moist non-tobacco composition of the present disclosure is nicotine-free.

[0016] DEFINITIONS

[0017] All words and terms used herein shall be considered to have the same meaning usually given to them by the person skilled in the art unless another meaning is apparent from the context.

[0018] The singular “a” and “an” shall be construed as including also the plural. Compositions “comprising” one or more recited elements may also include other elements not specifically recited. The term "comprising” also encompasses the term consisting of.

[0019] A “moist non-tobacco composition” may also be referred to herein, in short, as “a composition”, “a non-tobacco-composition” or the like.

[0020] By “water content” is in the context of the present disclosure intended water added during the production of a composition of the present disclosure and water provided by water-containing ingredients added to the composition of the present disclosure, such as aromas. The water content is given herein as percent by weight (wt%) of the total weight of the composition referred to. Further moisture may be provided to the composition by for example moisturizers such as propylene glycol.

[0021] A “pouch” according to the present disclosure is a form of a small, soft, sealed but permeable bag for keeping a moist non-tobacco composition of the present disclosure. The pouch is saliva-permeable. The permeability allows saliva to enter the moist non-tobacco composition and substances from the moist non-tobacco composition to travel through the material for release into the oral cavity of the user. The pouch is made from a material that is comfortable for the user to position under the lip. At the same time, or alternatively, the pouch may be made from a material that makes it suitable for chewing. Typically, the pouch is made from or comprises a cellulosic material. The pouch may also be freely positioned elsewhere in the mouth, i.e., other than under the lip of a user.

[0022] A “cellulose pouch” as referred to herein means that the material for the pouch includes cellulose, but it may also include other constituents suitable for the purpose of the pouch. Suitable sizes for the pouch are further described herein.

[0023] An “active substance” according to the present disclosure is a substance that exert an effect on the body when taken up by the body. The effect may for example be an invigorating and / or a stimulating effect. An active substance herein is arecoline.

[0024] A “carrier material” according to the present disclosure, is a material that carries the active substances and / or ingredients and allows or facilitates release thereof when positioned in the mouth of a user. Examples of carrier materials suitable for the purpose of the present disclosure are provided elsewhere herein.

[0025] “Saliva-permeable”, in the context of a pouch as described herein, relates to that said pouch is permeable in the sense that once the pouch is positioned in the mouth of a user, saliva is allowed to travel through the pouch material into the composition of the present disclosure positioned inside the pouch so as to provide further moisture to the composition but also to ensure that substances present in the composition can travel through the pouch material and into the mouth of the user. This is particularly important so that the active substance can reach the oral cavity of the user and provide the effect.

[0026] Herein “wt%”, “weight %” or “% by weight” refers to weight percent of an ingredient based on the total weight of the composition disclosed herein.

[0027] DETAILED DESCRIPTION OF THE DISCLOSURE

[0028] The present disclosure provides oral moist non-tobacco products which may be used to experience stimulating effects on the body and that also have an appealable taste and mouth feel. The oral moist non-tobacco products of the present disclosure are smokeless.

[0029] The present disclosure presents an alternative to nicotine-based products using arecoline as an active substance in oral smokeless products. It was surprisingly shown herein that such a substance was particularly suitable as an alternative to nicotine in oral pouched tobacco-free products. Therein, it could provide stimulating effects similar to nicotine when presented in such a context to the user. This substance may provide stimulating effects without compromising on potential toxicity and therefore serves a useful alternative to nicotine, which was not expected in view of effects known in the art. It is also a healthier alternative to the usage of areca nut. In this regard, it is an advantage to not provide arecoline in the form of areca (betel) nut in a moist non-tobacco composition of the present disclosure.

[0030] Arecoline (also known as arecaline, arecholine, arecolin, arecoline base, arekolin) is mainly known to in the Asian culture to be consumed in the form of chewing of the areca nut (betel nut), the fruit of the areca palm (Areca catechu). Arecoline is found in the seeds of the nut and the nuts are usually chewed together with betel leaves.

[0031] Arecoline (formula C8H13NO2)

[0032] The present inventor, when searching for alternatives to nicotine as an active substance for oral smokeless non-tobacco products identified this substance and found that it constituted a suitable stimulator providing effects similar to nicotine, and that in addition thereto worked well with the other ingredients in the product. Hence, based on these findings it was prepared a novel product with arecoline as a base active substance instead of nicotine that was combined with other ingredients together presenting an oral pouched product that may either be positioned under the lip or that may be chewed. The latter would particularly benefit users of the areca nut and provide a healthier alternative as the same invigorating effect would be provided by consuming one or more servings of the pouch product instead of consuming large amounts of nuts while also avoiding other ingredients of the areca nut.

[0033] Also, this is to the best knowledge of the inventors the first time that a substance such as arecoline is presented as an alternative to nicotine. It was also not expected that arecoline would function in the same manner or align with the other ingredients of the composition to provide a suitable product for the purpose as described herein.

[0034] According to the present disclosure, the active substance, herein arecoline, is administered to the oral mucus membrane in the form of saliva-permeable pouch comprising a moist nontobacco composition that is placed in the oral cavity, preferably under the lip or in other parts of the mouth, optionally wherein said pouches are adapted for chewing. By being positioned in the mouth in this manner, the active substance come into contact with and enter the oral mucous membrane. This results in a rapid uptake of the active substances and therefore in a more rapid on-set of the positive stimulating effects of the active substances.

[0035] The user of a product of the present disclosure therefore experiences the positive effects of the active substances quicker than if the active substances, e.g., would be delivered by eating or drinking a product containing them whereby the active substances would have to be absorbed in the gastrointestinal tract.

[0036] Hence there is provided herein a saliva-permeable pouch comprising a moist non-tobacco composition for oral use. As mentioned herein, said composition comprises arecoline.

[0037] Accordingly, there is provided herein a moist non-tobacco composition comprising arecoline. Particularly, said moist non-tobacco composition is nicotine-free. Hence, particularly said saliva-permeable pouch comprising a moist non-tobacco composition is nicotine-free.

[0038] More specifically, there is provided herein a saliva-permeable pouch comprising a moist non- tobacco composition for oral use, said composition comprising: i) a carrier material comprising a plant-based fiber, such as microcrystalline cellulose (MCC); ii) a pH regulator, such as sodium carbonate, and iii) arecoline, about 0.05 wt% to about 30 wt%, such as from about 3 wt% to about 15 wt%, of arecoline, based on the total weight of said composition.

[0039] Said moist non-tobacco composition may be nicotine-free. Alternatively, it may contain nicotine in addition to arecoline. Preferably, the composition is nicotine-free. Hence, preferably, a saliva-permeable pouch comprising a moist non-tobacco composition of the present disclosure is nicotine-free.

[0040] Accordingly, the composition comprises arecoline as an active substance for providing the stimulating effect. More specifically, the composition may comprise from about 3 wt% to about 30 wt% or 3 wt% to about 25 wt% of arecoline, based on the total weight of the moist non-tobacco composition. Said composition may comprise from about 3 wt% to about 20 wt%, such as from about 3 wt% to about 15 wt%, such as from about 3 wt% to about 10 wt%, such as from about 3 wt% to about 7 wt%, such as about 4 wt%, 5 wt%, 6 wt%, 7 wt%, 8 wt%, 9 wt%, 10 wt%, 11 wt%, 12 wt%, 13 wt%, 14 wt%, 15 wt%, 16 wt%, 17 wt%, 18 wt%, 19 wt%, 20 wt%, 21 wt%, 22 wt%, 23 wt%, or 24 wt%, of arecoline based on the total weight of said composition.

[0041] Arecoline may also be provided in modified form, such as a variant or derivative of the substance arecoline, such as arecoline hydrobromide or other derivates of the substance arecoline. Such modified forms or versions will be evident for the skilled person within this field. Modified forms of arecoline are encompassed by the present disclosure. A modified form of arecoline will provide in essence the same functionality as the original substance. Hence the modifications to arecoline are made for other purposes, such as stability of the substance during storage.

[0042] Arecoline is typically provided as a powder. When it is referred to “arecoline” herein as an ingredient of a composition of the present disclosure, the amount referred to is the amount of such a powder. Such a powder comprises 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%. Particularly, said powder is about 99% of arecoline.

[0043] According to the present disclosure, arecoline is preferably provided in a substantially pure form. By a substantially pure form is in the context of the present disclosure intended that the arecoline is provided in form that 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% of arecoline, such as about 99.9% or 99.99% arecoline. Arecoline may therefore be provided as an arecoline composition comprising at least about 95% arecoline, such as at least about 96%, at least about 97%, at least about 98% or at least about 99% of arecoline, such as about 99.9% or 99.99% arecoline. In particular, in accordance with the present disclosure, the arecoline may be provided as a powder comprising at least about 95% arecoline, such as at least about 96%, at least about 97%, at least about 98% or at least about 99% of arecoline, such as about 99.9% or about 99.99% arecoline.

[0044] As is well-known to the skilled person, arecoline may e.g., be chemically synthesized or it may have been isolated, extracted or purified from its natural source. Arecoline as provided herein in a moist non-tobacco composition is substantially or totally free from other parts of the areca (betel) nut. Herein arecoline is categorized as a dry ingredient (see Table 1). However, the arecoline may be provided in any other form, such as an oily liquid, which is also encompassed by the present disclosure. As explained elsewhere herein, variants or derivatives of arecoline that provide in essence the same activity and function, are also envisaged in the present context.

[0045] The pouch may be made from a material that makes it suitable both for positioning under the lip and for chewing. It may alternatively be made from a material that mainly makes it suitable for positioning under the lip. It may also alternatively be made from a material that mainly makes it suitable for chewing.

[0046] A suitable carrier material for use in a moist non-tobacco composition comprises a plantbased fiber. One example of a plant-based fiber is a cellulosic fiber material, or a derivative thereof. Cellulose fibers are fibers made with ethers or esters of cellulose. These can e.g., be obtained from the bark, wood or leaves of plants, or from other plant-based material. The cellulosic fiber material may also contain hemicellulose and lignin, with different percentages of these components altering the mechanical properties of the fibers. Other examples of fibers for use as a suitable carrier material of the present disclosure are oat fibers.

[0047] Examples of suitable cellulosic materials, or derivatives thereof, are carboxymethyl cellulose (CMC) and microcrystalline cellulose (MCC), but these are not limited thereto. Functionally the carrier material aligns with the active substance to carry the active substance also facilitating its travel through the pouch material into the mouth and through the mucous membrane of the user where it may exert its beneficial stimulating effect. A carrier material of the present disclosure is not limited thereto.

[0048] As mentioned herein, a moist non-tobacco composition of the present disclosure comprises a pH regulator, such as sodium carbonate or calcium carbonate. Such a pH regulator ensures that the pH of a composition of the present disclosure is maintained at a suitable level to provide an oral pouched product (i.e. the saliva-permeable pouch comprising the moist non- tobacco composition) with a sufficient quality including that the texture and the flavor of the product is maintained, and that the active substance can exert its function when present in the product. It is also important to ensure that there is no unwanted growth of microorganisms in the product when it is stored, thereby the presence of a pH regulator in the composition to ensure that such growth does not occur, or at least do not occur to an extent as to compromise on the quality of the product.

[0049] Hence, the pH regulator of the present composition ensures that the pH of the moist non- tobacco composition of the present disclosure is between about 6.5 and 10. More specifically, the pH is typically between 6.5 and 8, such as from about 7 to about 8. An example of a pH regulator for use in a composition disclosed herein is sodium carbonate, but is not limited thereto. As mentioned elsewhere herein, said composition comprises a carrier material. Herein, said composition may comprise from about 40 wt% to about 70 wt% of carrier material based on the total weight of said moist non-tobacco composition, such as from about 40 wt% to about 60 wt%, such as from about 50 wt% to about 60 wt%, such as about 45 wt%, 46 wt%, 47 wt%, 48 wt%, 49 wt%, 50 wt%, 51 wt%, 52 wt%, 53 wt%, 54 wt%, 55 wt%, 56 wt%, 57 wt%, 58 wt% or 59 wt% of carrier material, based on the total weight of the composition.

[0050] Specifically, there is provided a composition comprising from about 3 wt% to about 15 wt%, such as from about 3 wt% to about 10 wt%, such as about 4 wt% or about 5 wt% of arecoline, based on the total weight of the moist non-tobacco composition and from about 50 wt% to about 60 wt%, such as about 54 wt% or 55 wt% of a carrier material based on the total weight of the moist non-tobacco composition.

[0051] Herein, said moist non-tobacco composition may also comprise additional ingredients such as one or more sweeteners, flavors / aromas and / or salts. Exemplary such sweeteners, flavors / aromas and salts are provided elsewhere herein and may be used in any combination.

[0052] Hence, there is also provided herein a moist non-tobacco composition wherein said composition further comprises one or more of the following ingredients, in any combination: 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 aroma(s), and vii) one or more sweetener(s). Said composition may also include water.

[0053] Aromas may also be referred to herein as flavours or flavourings.

[0054] Herein, said composition may more specifically comprise one or more of the following ingredients, in any combination: iv) from about 2 wt% to about 5 wt%, such as from about 2 wt% to about 4 wt%, such as about 3 wt%, 3.5 wt% or 3.7 wt%, of salt, such as sodium chloride and / or ammonium chloride, based on the total weight of said composition, v) from about 1.5 wt% to about 4 wt%, such as about 2 wt% to 3 wt%, such as about 2.5 wt%, of moisturizer, such as propylene glycol, based on the total weight of said composition, vi) from about 3 wt% to about 8 wt%, such as about 4 wt% to about 6 wt%, such as about 5 wt% or 5.1 wt%, of aroma, based on the total weight of said composition, and vii) from about 0.1 wt% to about 0.5 wt%, such as about 0.2 wt% to about 0.4 wt%, such as about 0.3 wt%, of sweetener, based on the total weight of said composition.

[0055] When referring to salt, aroma and / or moisturizer in the singular or plural herein this means that a composition of the present disclosure can contain one type of salt, aroma and / or moisturizer or alternatively a mixture of different salts, aromas and / or moisturizers. The content (e.g., wt% or mg / g) of a salt, aroma or moisturizer refers to the total content of salt, aroma, or moisturizer, independently of type, in a composition of the present disclosure.

[0056] Water added perse to the composition when it is prepared is the main source of water content and moisture in a composition of the present disclosure. Water perse is typically added in an amount of from about 20 wt% to about 40 wt%, such as about 26 wt% to about 33 wt%, such as from about 27 wt% to about 30 wt%, based on the total weight of said composition. This is illustrated e.g., in Table 1 of example 1.

[0057] Water added through ingredients other than water perse, such as water-containing ingredients, such as aromas, when preparing the composition, usually only makes a minor contribution to the water content and moisture of the composition as a whole.

[0058] The water content of a composition of the present disclosure thus includes water added per se and water provided via water-containing ingredients. The water content of a composition as disclosed herein is typically from about 20 wt% to about 45 wt%, such as from about 25 wt% to about 45 wt%, such as 28 wt% to 35 wt%.

[0059] As mentioned elsewhere herein other ingredients, such as moisturizers, such as propylene glycol, may contribute to the moisture of the composition.

[0060] The composition presented herein may also comprise additional ingredients, such as other stabilizers, preservatives and the like.

[0061] Naturally, the total content of ingredients adds up to 100 wt% of the composition.

[0062] When preparing the composition, water may be added optionally as a water spray to adjust the consistency and texture of the final composition. When preparing the composition, the water / moisture is absorbed by the composition, mainly by the carrier material, to obtain a moist non-tobacco composition.

[0063] As illustrated in Table 1 of example 1, as “dry” (or non-water based) ingredients are provided in a composition of the present disclosure a plant-based fiber, such as MCC, a salt, arecoline (a powder) and sweeteners, but these are not limited thereto. The dry ingredients comprise from about 50 wt% to about 80 wt%, such as about 60 wt% to about 70 wt%, such as about 61 wt%, 62 wt%, 63 wt%, 64 wt%, 65 wt%, 66 wt%, 67 wt%, 68 wt%, or 69 wt% based on the total weight of said composition.

[0064] As “fluids” are provided the ingredients water, moisturizer (propylene glycol) and aromas. All fluids contribute to the moisture of said composition. The “fluid” ingredients comprise from about 20 wt% to about 50 wt%, such as from about 30 wt% to about 40 wt%, based on the total weight of the composition.

[0065] Herein, a sweetener of ingredient vii) of said composition of the present disclosure may comprise one or more of the sweeteners acesulfame K, erythritol, sucralose and stevia, but they are not limited thereto.

[0066] The herein mentioned ingredients of a composition of the present disclosure and their contents (as defined by wt% or mg / g of the composition, or as otherwise defined) may be provided in any combination in a moist non-tobacco composition of the present disclosure.

[0067] Herein, one example of a pouch of the present disclosure is a pouch comprising about 600 mg of a moist non-tobacco composition comprising about 27 mg of arecoline.

[0068] There is also provided herein a pouch comprising a moist non-tobacco composition, wherein such a pouch is is adapted for chewing and / or for positioning under the lip. When the pouch is adapted for chewing, the material of the pouch is preferably more resistant to wear. This is since the pouch should not easily break to cause leakage of the composition when the user chews the pouch. The skilled person can pick a suitable material for this purpose. Even if the pouch is made from such a material, it may alternatively also be positioned under the lip. Alternatively, the pouch may be made from a material which makes it suitable for positioning under the lip, but not so suitable for chewing. The skilled person will know the difference between such products.

[0069] There is also provided the use of a saliva-permeable pouch comprising a moist non-tobacco composition as disclosed herein, as an alternative to a tobacco- and / or nicotine-based product.

[0070] There is also provided herein the use of arecoline in an oral moist non-tobacco composition, optionally wherein said composition is nicotine-free. Particularly, said oral moist non-tobacco composition is nicotine-free. There is also provided herein the use of arecoline in an oral moist non-tobacco composition, wherein said composition further comprises nicotine. There is also provided a use, wherein arecoline is provided in said composition in a substantially pure form, particularly wherein said 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% of arecoline, such as about 99.9% or about 99.99% arecoline, particularly wherein arecoline is provided as a powder. There is also provided herein such a use, wherein said composition is comprised in a saliva-permeable soft pouch for positioning under the lip and / or wherein said composition is comprised in a saliva-permeable soft pouch for chewing by a user. There is also provided a moist non-tobacco composition comprising a substantially pure form of arecoline, or a derivative or a variant thereof, wherein said substantially pure form provides 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% of arecoline, such as about 99.9% or about 99.99% arecoline, particularly wherein arecoline is provided as a powder, as described elsewhere herein. Preferably, said moist non-tobacco composition is nicotine-free.

[0071] There is also provided a saliva-permeable pouch comprising a moist non-tobacco composition comprising a substantially pure form of arecoline, or a derivative or variant thereof, as described elsewhere herein, particularly wherein arecoline is provided as a powder. Preferably, said moist non-tobacco composition is nicotine-free. Hence, preferably, a saliva-permeable pouch comprising a moist non-tobacco composition of the present disclosure is nicotine-free.

[0072] The moist non-tobacco composition as described herein is enclosed by a saliva-permeable pouch, wherein said saliva-permeable pouch is soft and suitable for positioning under the lip and / or for chewing. Such pouches are known in the art and one example is a cellulosic pouch, i.e., wherein the material is prepared from cellulose. Typically, the width of the pouch is from about 5 to about 20 mm, such as from about 10 to about 18 mm, such as from about 12 to about 15 mm, such as about 14 mm. Typically the length of the pouch is from about 20 mm to about 40 mm, such as from about 25 to about 35 mm, such as about 30 mm.

[0073] However, other dimensions or shapes of the pouch may also be used.

[0074] The texture of the moist non-tobacco composition and the softness of the material of the pouch, such as a cellulosic material presents the user with an appealing combination for comfortable positioning in the mouth, such as under the lip.

[0075] The pouches comprising a moist non-tobacco composition of the present disclosure may be placed in a container or a soft small bag. The container or bag provides for keeping of the pouches for the user. The container or bag may be made from a soft or a hard plastic material. The container may have a round or square shape and be in the form of a hard plastic material. The container may be a small rectangular shaped soft plastic bag. The bag may be of a transparent material or not, or a combination thereof.

[0076] The moist non-tobacco composition of the present disclosure will now be described with regards to the ingredients with reference to mg / g (mg per g) of the moist non-tobacco composition. Herein, a carrier material comprising a plant-based fiber, such as microcrystalline cellulose (MCC) may be present in an amount from about 400 mg / g to about 700 mg / g, such as from about 500 mg / g to 600 mg / g, such about 500 mg / g or 545 mg / g of the composition.

[0077] A salt, such as sodium chloride and / or ammonium chloride, may be present in an amount of from about 27 mg / g to about 47 mg / g, such as 34 mg / g to about 40 mg / g, such as about 37 mg / g or 40 mg / g of the composition.

[0078] A pH regulator, such as sodium carbonate, may be present in an amount of from about 1 mg / g to 5 mg / g, such as from 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.

[0079] Arecoline may be present in an amount from about such as from about 30 mg / g to about 60 mg / g, such as from about 40 mg / g to about 50 mg / g, such as about 45 mg / g of the composition.

[0080] Sometimes arecoline is present in larger amounts in said composition, even up to 180 mg / g, such as from about 100 mg / g to about 180 mg / g, such as from about 50 mg / g to about 100 mg / g, such as about from about 50 mg / g to about 75 mg / g of the composition. This means that the content of the other ingredients, such as the carrier material, is reduced to align with the larger amounts of arecoline in such a composition.

[0081] A sweetener may be present in an amount of from about 1 mg / g to about 5 mg / g, such as about 2 mg / g to about 3 mg / g, such as 3 mg / g of said composition.

[0082] Water perse may be added in an amount from about 200 mg to about 380 mg / g of said composition, such as from about 250 mg / g to about 310 mg / g, such as from about 240 mg to 300 mg, such as from about 250 mg to 290 mg / g of said composition.

[0083] A moisturizer, such as propylene glycol may be present in an amount of 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.

[0084] Aromas may be present in an amount of from about 40 mg / g to 60 mg / g, such as from about 45 mg / g to about 55 mg / g, such as about 50 mg / g or 51 mg / g of the composition.

[0085] More specifically, there is also provided herein a moist non-tobacco composition comprising: About 548 mg / g of a plant-based fiber, such as MCC,

[0086] About 3 mg / g or 4 mg / g of pH regulator, such as sodium carbonate,

[0087] About 37 mg / g of salt, such as sodium chloride,

[0088] About 45 mg / g of arecoline,

[0089] About 3 mg / g of sweetener, About 288 mg / g of water,

[0090] About 25 mg / g of moisturizer, such as propylene glycol, and

[0091] About 51 mg / g of aroma, based on the total weight of the composition.

[0092] More specifically, there is also provided a moist non-tobacco composition comprising:

[0093] About 55 wt% of a plant-based fiber, such as MCC,

[0094] About 0.3 wt% of pH regulator, such as sodium carbonate,

[0095] About 3.7 wt% of salt, such as sodium chloride,

[0096] About 4.5 wt% of arecoline,

[0097] About 0.3 wt% of sweetener,

[0098] About 28 wt% or 29 wt% of water,

[0099] About 2.5 wt% of moisturizer, such as propylene glycol, and

[0100] About 5 wt% of aroma, based on the total weight of the composition.

[0101] The total weight of said moist non-tobacco composition in a pouch of the present disclosure may be from about 0.3 g to about 1.5 g, such as from about 0.5 g to about 1 g, from about 0.5 g to about 0.8 g or about 0.6 g (600 mg).

[0102] A saliva-permeable pouch comprising a moist non-tobacco composition of the present disclosure may be prepared in the following exemplary manner. The ingredients of the composition are mixed to a homogenous blend followed by addition of liquid (such as water). By infusing the carrier material with all the ingredients in a specialized blender, all components of the composition are merged into one aggregate moist non-tobacco composition.

[0103] The specialized blender is a blender normally used for blending snuff products.

[0104] Preferably, the thereafter obtained non-tobacco composition is left to rest for about 12 to 24 h before packaging into saliva-permeable pouches.

[0105] The non-tobacco composition is thereafter run in a machine that portions it out into small soft saliva-permeable pouches made from a saliva-permeable material, such as a cellulose paper. The saliva-permeable pouches are pouches commonly used for packaging snuff products.

[0106] When adding the moist non-tobacco composition (blend) to the portioning machine, the composition (blend) is evenly distributed in the pipe of the machine. The evenly distributed composition (blend) is thereafter covered by the pouch material, weighted up into portions and subsequently laminated in both ends before cutting the pouches according to the preinstalled size selected for the particular pouch product.

[0107] The saliva-permeable pouches may come in different sizes and thereby contain varying amounts of the non-tobacco composition, as disclosed elsewhere herein.

[0108] After storing the saliva-permeable pouches for some time, the products may be checked for any presence of bacterial growth.

[0109] The present disclosure will now be illustrated by the following experimental section without intending to be limited thereto as it merely illustrates different ways of performing the disclosure.

[0110] EXPERIMENTAL SECTION

[0111] Example 1

[0112] Materials and methods

[0113] The ingredients of the non-tobacco composition of Table 1 can easily be obtained from suitable manufacturers. Propylene glycol is added as a moisturizer.

[0114] The dry ingredients of the compositions are mixed to a homogenous blend followed by addition of liquid (water). By infusing the carrier material with all the ingredients in a specialized blender, all components of the moist non-tobacco composition are merged into one aggregate moist non-tobacco composition. Arecoline is provided as a powder as described elsewhere herein.

[0115] The specialized blender is a blender normally used for blending snuff products.

[0116] Preferably, the thereafter obtained non-tobacco composition is left to rest for about 12 to 24 h before packaging into pouches.

[0117] The non-tobacco composition is thereafter run in a machine that portions it out into small soft pouches made from a saliva-permeable material, such as a cellulose paper. The pouches are pouches commonly used for packaging snuff products. The pouches may be made of different sizes of which one example is 14x30 mm.

[0118] When adding the non-tobacco blend to the machine, the blend is evenly distributed in the pipe of the machine. The evenly distributed blend is thereafter covered by the pouch material, weighted up into portions and subsequently laminated in both ends before cutting the pouches according to the pre-installed size selected for the particular saliva-permeable pouch product. The pouches may come in different sizes and thereby contain varying amounts of the nontobacco composition. One example of a total weight of a pouch comprising a non-tobacco composition is about 600 mg (0.6 g).

[0119] After storing the pouches for some time, the products are checked for any presence of bacterial growth.

[0120] Table 1 :

[0121] Table 1 : Ingredients of an exemplary moist non-tobacco composition of the present disclosure.

Claims

CLAIMS1. A saliva-permeable pouch comprising a moist non-tobacco composition for oral use, said composition comprising: i) a carrier material comprising a plant-based fiber, such as microcrystalline cellulose (MCC); ii) a pH regulator, such as sodium carbonate, and iii) arecoline, wherein said composition comprises from about 0.05 wt% to about 30 wt%, such as from about 3 wt% to about 15 wt%, of arecoline based on the total weight of said composition.

2. The saliva-permeable pouch of claim 1, wherein said composition comprises from about 3 wt% to about 15 wt%, such as about 3 wt% to about 10 wt%, such as about 3 wt% to about 7 wt%, such as about 4 wt%, 5 wt%, 6 wt%, 7 wt%, 8 wt%, 9 wt% of arecoline based on the total weight of said composition.

3. The saliva-permeable pouch of any one of claims 1 to 2, wherein arecoline is provided in said moist non-tobacco composition in a substantially pure form, particularly wherein said 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% of arecoline, such as about 99.9% or about 99.99% arecoline, particularly wherein arecoline is provided as a powder.

4. The saliva-permeable pouch of any one of the preceding claims, wherein said moist non-tobacco composition is nicotine-free.

5. The saliva-permeable pouch of any one of the preceding claims, wherein said composition comprises from about 40 wt% to about 70 wt% of carrier material based on the total weight of said composition, such as about 50 wt% to 60 wt%.

6. The saliva-permeable pouch of any one of the preceding claims, wherein said composition further comprises one or more of the following ingredients: 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 aromas, and vii) one or more sweeteners.

7. The saliva-permeable pouch of claim 6, wherein said composition comprises: iv) from about 2 wt% to about 5 wt%, such as about 3 wt% or 3.7 wt%, of salt, based on the total weight of said composition,v) from about 1.5 wt% to about 4 wt%, such as about 2wt% to 3 wt%, such as about 2.5 wt%, of moisturizer, such as propylene glycol, based on the total weight of said composition, vi) from about 3 wt% to about 8 wt%, such as about 4 wt% to about 6 wt%, such as about 5 wt% or 5.1 wt%, of aroma, based on the total weight of said composition, vii) from about 0.1 wt% to about 0.5 wt%, such as about 0.2 wt% to about 0.4 wt%, such as about 0.3 wt%, of sweetener, based on the total weight of said composition,8. The saliva-permeable pouch of any one of claims 6 or 7, wherein said sweetener of ingredient vii) comprise one or more of acesulfame K, erythritol, sucralose and Stevia.

9. The saliva-permeable pouch of any one of the preceding claims, wherein the total content of said composition per pouch is about 600 mg and wherein the content of arecoline is about 27 mg.

10. The saliva-permeable pouch of any one of the preceding claims, wherein said pouch is adapted for chewing and / or positioning under the lip.

11. Use of a saliva-permeable pouch of any one of the preceding claims, as an alternative to a tobacco-based product.

12. Use of a saliva-permeable pouch of any one of the preceding claims, as an alternative to a nicotine-based product.

13. Use of arecoline in an oral moist non-tobacco composition, optionally wherein said composition is nicotine-free.

14. The use of any one of claims 11 to 13, wherein said moist non-tobacco composition is nicotine-free.

15. The use of any one of claims 11 to 14, wherein arecoline is provided in said composition in a substantially pure form, particularly wherein said 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% of arecoline, such as about 99.9% or about 99.99% arecoline, particularly wherein arecoline is provided as a powder.

16. The use of any one of claims 11 to 15, wherein said composition is comprised in a saliva-permeable soft pouch for positioning under the lip and / or for chewing by a user.

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