Smokeless oral products containing active agents and / or flavors

Abstract

The present disclosure relates to an oral smokeless product in the form of an oral patch comprising a thickener, a carrier, and an active agent and / or flavor, the carrier being a fibrous carrier made of a water-insoluble nonwoven material. The present disclosure also relates to a method for producing the oral smokeless product, comprising the steps of: providing a nonwoven material; providing a liquid flavor solution comprising a flavor, glycerol, alginate or gum acacia, water, and optionally an edible color; applying the liquid flavor solution to the nonwoven material; and optionally stamping individual oral smokeless products from the nonwoven sheet material.

Description

[Technical field]

[0001] The present disclosure relates to an oral smokeless product in the form of an oral patch comprising a carrier and an active agent and / or flavor. Additionally, the present disclosure relates to a method for producing the oral smokeless product. [Background technology]

[0002] Smokeless products for oral use are known in the art and include tobacco products and non-tobacco products.

[0003] Tobacco products for oral use can be provided in loose form or packaged in a saliva-permeable porous wrapping material that forms a pouch enclosing a tobacco-based filler material. Non-tobacco pouch products are generally provided in the form of a filler material that includes particulate material and / or fibers, which may be vegetable or man-made fibers of origin other than tobacco. Pouch products for oral use are generally used by the consumer placing the pouch between the upper or lower gums and lips and holding it there for a period of time. The pouch material holds the tobacco or non-tobacco filler material in place while allowing saliva to pass through the filler material and diffusion of flavors and actives, such as nicotine, from the tobacco material into the consumer's mouth.

[0004] The pouch material used in pouch products for oral use, also referred to as packaging material, can be a dry-bonded nonwoven comprising viscose rayon fibers, i.e., regenerated cellulose, and a polymer that acts as a binder in the nonwoven material and contributes to the sealing of the pouch during its manufacture, although other types of nonwoven materials can also be utilized.

[0005] Pouch products for oral use can form an unattractive bulge when placed under the lips and are therefore perceived by some users as being more noticeable than desired. A further concern is that bulky pouch products can cause discomfort, such as chafing or pressure, when placed under the user's lips.

[0006] Release rates of ingredients from oral pouch products have been reported to vary. Nicotine is known to be absorbed fairly slowly from pouch smokeless tobacco products.

[0007] US20170157106 discloses a composition that is useful for the delivery of various substances, such as nicotine. The composition includes a suspension in which an internal phase is surrounded by an external phase. The suspension can be combined with a carrier and various systems, and a product can be formed using the suspension. Products can also be formed using the suspension and optional carrier, such as oral strips, spray delivery systems, smokeless tobacco products, aerosol delivery devices, cigarettes, and packages.

[0008] AU2012207021 discloses a smokeless tobacco product comprising a tobacco composition in an insoluble matrix. Tobacco or an extract from tobacco, such as nicotine, can be distributed in the composition that is applied to the tobacco product, such as a film, tab, molded part, gel, consumable unit, insoluble matrix, and hollow shape. The active ingredient can be applied, for example, in a soluble gel film that can be applied in the mouth. The active ingredient can be disposed, for example, between two or more film layers. The product can be one that is applied to the oral cavity as a soluble film. Furthermore, the tobacco can be disposed in a carrier that is disposed in a pouch, or in a pouch material. The tobacco can be applied to a porous matrix or disposed in a stick or other handle. The matrix can also be chewed, for example, when the tobacco slurry is disposed in a waxy structure.

[0009] US9402414 discloses a smokeless tobacco article comprising a mixture of thermoplastic polymer particles and tobacco particles, which can be formed into a matrix that can be used as an oral product.

[0010] Satisfaction and perception of oral smokeless products are influenced by which ingredients are released and the rate at which the active ingredients are released. There is also a desire for oral articles to fit well in the mouth, be comfortable, and be discreet to use.

[0011] Thus, there is a need for an oral smokeless product that is comfortable to use and discreet, while still providing sufficient release of the product's ingredients.

[0012] The products disclosed herein are pouch-less products for oral use, also referred to herein as "oral patches", and may be nicotine-containing pouch-less products for oral use, wherein the nicotine is present in the form of nicotine base and / or a nicotine salt. [Prior art documents] [Patent documents]

[0013] [Patent Document 1] US20170157106 [Patent Document 2] AU2012207021 [Patent Document 3] US9402414 [Non-patent literature]

[0014] [Non-Patent Document 1] "Handbook of Nonwovens" by S.Russel, published by Woodhead Publ. Ltd., 2007 [Non-Patent Document 2] NF T51-800 Plastics - Specifications for plastics suitable for home composting (2015) [Non-Patent Document 3] OK compost HOME certification scheme of TUV AUSTRIA Belgium [Non-Patent Document 4] AS 5810 Biodegradable plastics - Biodegradable plastics suitable for home composting Summary of the Invention [Problem to be solved by the invention]

[0015] It is an object of the present disclosure to at least alleviate the above-mentioned problems and provide advantages and aspects not offered by the heretofore known art.

[0016] Furthermore, it is an object of the present disclosure to provide oral smokeless products that provide the consumer with a pleasant oral comfort, mouthfeel, and / or organoleptic experience during use.

[0017] It is an objective of the present disclosure to provide a fast and immediate release of active agents and / or flavors to provide instant gratification.

[0018] Another object of the present disclosure is to provide oral smokeless products that have a satisfactory release rate of active agents and / or flavors in the oral cavity under normal conditions.

[0019] These and other objects may be provided by a pouch-free oral smokeless product according to claim 1 and a method according to claim 26. Variations of the present disclosure are set out in the dependent claims and the following description. [Means for solving the problem]

[0020] The present disclosure provides an oral smokeless product in the form of an oral patch comprising a carrier and an active agent and / or flavor, the carrier being a fibrous carrier made of a water-insoluble nonwoven material, and the oral patch further comprising a thickening agent.

[0021] A nonwoven fabric is a fabric that is not produced by traditional textile forming processes such as weaving or knitting. Many different methods are known in the art for producing nonwoven materials. Further information on nonwoven fabrics can be found in "Handbook of Nonwovens" by S. Russell, published by Woodhead Publ. Ltd., 2007.

[0022] In terms of the web manufacturing method used, nonwovens can be either wet-laid or dry-formed.

[0023] Dry formed webs can be produced by processes such as carding, air laying, spunbonding, meltblowing, etc. In the case of carding, the production process can result in the fibers being substantially oriented in the carding direction, i.e., the machine direction. Dry formed nonwovens can include parallel laminated webs, cross laminated webs, or random laminated webs. Parallel laminated webs and cross laminated webs can include two or more superimposed web layers, which may be carded, while random laminated webs typically include a single web layer and may be air laid.

[0024] Several methods can be used to bond the fibers in the web together, also called web consolidation. Different types of bonding methods can be classified as mechanical bonding, such as needle punching, stitch bonding, hydroentanglement, chemical bonding, such as saturation bonding, spraying, foaming, powder bonding, print bonding, and thermal bonding, such as thermal calendaring, hot air bonding, ultrasonic bonding, radiant heat bonding. More than one bonding method can be used to consolidate nonwoven fabrics.

[0025] The thickening agent may include alginate, gum acacia, or a combination thereof, with alginate being the preferred thickening agent. Alginate may comprise 0.5% to 5%, preferably 0.7 to 2.0%, of the dry weight of the oral patch.

[0026] The thickening agent may comprise or consist of glycerol. Glycerol may constitute 15% to 35%, preferably 20% to 30%, of the dry mass of the oral patch. Glycerol may increase the softness and flexibility of the product.

[0027] The oral patches disclosed herein may comprise 0.5% to 5% of the dry weight of alginate, preferably 0.7 to 2.0% of the dry weight of alginate combined with 15% to 35% of the dry weight of glycerol, preferably 20% to 30% of the dry weight of glycerol.

[0028] The oral patch may include a sugar alcohol such as maltitol, mannitol, or isomalt, or a combination of two or more different sugar alcohols.

[0029] The sugar alcohol may constitute 20% to 45% of the dry weight of the oral patch. In addition to the sugar alcohol, the oral patch preferably comprises 15% to 35% of the dry weight of glycerol, preferably 20% to 30% of the dry weight of glycerol. The oral patch also preferably comprises 0.5% to 5% of the dry weight of alginate, preferably 0.7 to 2.0% of the dry weight of alginate.

[0030] The active agents and / or flavors may be uniformly distributed throughout the nonwoven carrier or may be selectively deposited in one or more portions of the nonwoven carrier.

[0031] The present disclosure also provides a method for producing the pouch-free oral smokeless products disclosed herein, the method comprising: - providing a nonwoven carrier material; - providing a liquid solution comprising flavours and / or activators, glycerol, alginate or gum acacia and water; and - applying a liquid solution to a nonwoven material Includes.

[0032] The method comprises: - punching out individual oral smokeless products from the nonwoven carrier material either before or after applying the liquid solution to the nonwoven carrier material. It may further include.

[0033] The carrier material may provide a plurality of openings and / or cavities to facilitate impregnation of the carrier with a liquid solution, the openings and / or cavities forming passageways into the fibrous structure of the carrier. The openings and / or cavities may further facilitate the flow of saliva into and through the oral smokeless product during use in the oral cavity of a user, thereby aiding in the release of flavors and / or actives into the oral cavity of a user.

[0034] The invention will now be further described, by way of non-limiting examples, with reference to the accompanying drawings, in which: [Brief description of the drawings]

[0035] [Figure 1] 1 shows a top view of an oral smokeless product disclosed herein. [Diagram 2] 2 shows a side view of the oral smokeless product of FIG. 1. [Diagram 3] FIG. 3 shows a perspective view of the oral smokeless device of FIG. 1 and FIG. 2. [Figure 4a] 1A-1D show plan views of examples of various shapes of oral smokeless products disclosed herein. [Figure 4b] 1A-1D show plan views of examples of various shapes of oral smokeless products disclosed herein. [Figure 4c] 1A-1D show plan views of examples of various shapes of oral smokeless products disclosed herein. [Figure 4d] 1A-1D show plan views of examples of various shapes of oral smokeless products disclosed herein. [Figure 4e]1A-1D show plan views of examples of various shapes of oral smokeless products disclosed herein. [Figure 4f] 1A-1D show plan views of examples of various shapes of oral smokeless products disclosed herein. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0036] As used herein, a "carrier material" is a nonwoven material that constitutes the only structure-providing element in the oral pouch-free products disclosed herein. The carrier material carries one or more active agents and / or one or more flavors that are substances intended to be transferred to the oral cavity of a user of the oral pouch-free products disclosed herein. The carrier material further comprises a thickening agent, such as alginate, gum acacia, glycerol, or combinations thereof.

[0037] "Pouchless product" or "oral patch" are terms used interchangeably for the oral smokeless products disclosed herein. A pouchless product or oral patch is a generally flat product that does not have an outer covering surrounding an inner filled cavity.

[0038] The term "tobacco material" is used herein to refer to a fibrous material of tobacco leaves or leaf parts such as flakes, stems, etc. The leaves and leaf parts can be finely divided (disintegrated), such as by grinding, cutting, shredding, or threshing, and the leaf parts can be incorporated into the tobacco material in a defined proportion.

[0039] As used herein, "tobacco" means any part of any member of the genus Nicotiana, such as leaves, stems, and petioles. Tobacco may be whole, shredded, threshed, cut, ground, cured, aged, fermented, or otherwise processed, such as granulated or encapsulated.

[0040] The pouchless oral smokeless products disclosed herein can contain tobacco that is added to the nonwoven carrier web in the form of a tobacco extract, which can be obtained by steeping tobacco material in water or alcohol.

[0041] Alternatively, or in addition, tobacco may be included in the oral smokeless products disclosed herein by incorporating tobacco fibers into a nonwoven carrier web.

[0042] Although tobacco-containing smokeless oral products are contemplated herein, the pouchless oral smokeless products disclosed herein are preferably tobacco-free pouchless oral smokeless products, such as tobacco-free nicotine-containing pouchless oral smokeless products.

[0043] The nicotine compound in the nicotine-containing tobacco-free or low-tobacco-containing product may be nicotine base or a nicotine salt, such as nicotine hydrochloride, nicotine dihydrochloride, nicotine monotartrate, nicotine bitartrate, nicotine bitartrate dihydrate, nicotine sulfate, nicotine zinc chloride monohydrate, nicotine salicylate, nicotine benzoate or nicotine polacrilex. The nicotine may be derived from tobacco raw materials or may be synthetically produced nicotine.

[0044] "Oral" and "oral use" are used herein in all contexts as descriptions for use within the oral cavity, such as by placement in the mouth. The oral patches disclosed herein are intended to be placed in the oral cavity, such as between the gums and the upper or lower lip, such that the entire oral patch is within the oral cavity. Thus, the pouchless products for oral use disclosed herein are intended to be contained entirely within the oral cavity during use and are not intended to be swallowed.

[0045] As used herein, "w / w%" or "wt%" or "% by weight" or "% by weight" refers to the percent by weight of the referenced component relative to the total weight of the referenced preparation, composition or product.

[0046] Referring to the drawings, the present disclosure provides an oral smokeless product 100 in the form of an oral patch comprising a carrier 101 and an active agent and / or flavor, the carrier being a fibrous carrier 101 made of a water-insoluble nonwoven material.

[0047] The fibrous carrier can be impregnated with an active agent and / or flavor. It is also contemplated that the fibrous carrier is applied with the active agent and / or flavor as a coating on one or both surfaces. A combination of impregnation and coating is also contemplated for the oral smokeless product disclosed herein. As an example, the oral smokeless product disclosed herein may be impregnated with a first flavor and then coated with a second flavor, so that the initial flavor sensation may be different from the long-term flavor sensation.

[0048] An example of an oral smokeless product or oral patch 100 is shown in Figures 1-3. The oral patch 100 shown in Figures 1-3 has a length l in a length direction L, a width w in a width direction W perpendicular to the length direction L, and a thickness t in a thickness direction T perpendicular to a plane determined by the length direction L and the width direction W. The patch in Figures 1-3 has a modified rectangular shape with rounded corners. However, the shape of the patch is not limited to the oral smokeless products disclosed herein, and the patch can have any useful shape, including the shapes shown in Figures 4a-4f.

[0049] The oral smokeless product of the present disclosure is a thin and flexible product. This thin product fits well in the consumer's mouth and conforms to the shape of the consumer's gums, making it very comfortable and unobtrusive to use. Furthermore, rapid delivery of flavors and / or actives is achieved. Rapid delivery is facilitated by the product having a large exposed surface relative to its volume. Furthermore, the slimness of the pouchless oral smokeless product and the absence of loose fill material eliminates the dripping associated with pouch smokeless tobacco products and the roughness that can be experienced with pouch non-tobacco products that have fill materials that include particles such as microcrystalline cellulose particles. These effects are appreciated by many consumers because they impart a pleasant mouthfeel to the oral smokeless product. Furthermore, the oral patch disclosed herein is resource-friendly due to its small mass and few ingredients.

[0050] As described herein, the nonwoven material may include biodegradable materials, such as biodegradable fibers and / or biodegradable binders. It may be preferred that the nonwoven carrier material is a biodegradable nonwoven carrier material.

[0051] When biodegradable materials are used in the nonwoven material, several additional advantages may be obtained. For example, it may be preferable that the product may be sufficiently biodegradable to meet home composting standards, which may vary from country to country, such as NF T51-800 Plastics - Specifications for plastics suitable for home composting (2015), OK compost HOME certification scheme of TUV AUSTRIA Belgium, and AS 5810 Biodegradable plastics - Biodegradable plastics suitable for home composting. These home composting standards require that the product decomposes in compost during the test time specified in the particular home composting standard.

[0052] Biodegradable products that are thrown on the ground can break down over time and eventually become integrated into the soil, which has the advantage of putting less strain on the environment.

[0053] Nonwoven materials can include cellulosic fibers, including natural cellulosic fibers such as cotton, wood pulp, flax, hemp, and man-made cellulosic fibers such as viscose, lyocell, and other regenerated cellulosic fibers.

[0054] Cellulosic fibers have small capillaries in the fiber, and cellulosic fibers have good absorption and liquid distribution capabilities, which can be advantageous when ingredients such as flavors and / or actives are applied to the nonwoven material, for example by spraying or impregnation. Cellulosic fibers are also generally considered to be biodegradable.

[0055] The fibrous carrier preferably consists of a wetlaid nonwoven material, for example a wetlaid cellulosic nonwoven material.

[0056] Wet-laid nonwoven materials have been found to have particularly suitable properties for use in the oral patch disclosed herein.Wet-laid methods can be used to produce fibrous webs with randomized fiber orientation, resulting in nonwoven materials with higher surface friction than comparable bonded carded nonwoven webs, which are commonly used as pouch materials in oral pouch products.High surface friction can be beneficial in that it enhances the ability of oral patch to stay in place after being positioned in the oral cavity.

[0057] Compared to nonwoven materials made by dry web forming processes such as carding or air-laid and spun web processes, wet processes can be more advantageous due to higher production rates and lower costs.

[0058] Wet-laid nonwoven materials are generally made from short fibers, with fiber lengths of about 3 mm to 25 mm, typically about 6 mm to 20 mm, and aspect ratios (length / width) of 300:1 to >700:1. Because the fibers are relatively short, wet-laid webs are generally denser, stiffer, and have lower tensile strength than webs made by dry-forming methods that use fibers with longer, often curved, fiber lengths. To improve the strength of wet-laid webs, wet-forming methods can include a step of depositing multiple fiber layers on top of each other. Furthermore, the web can be reinforced by longer fibers or even by continuous filaments or a combination thereof. As described herein, the fibers in the web are preferably randomly arranged. The basis weight of wet-laid nonwoven webs can vary within a wide range.

[0059] A wet-laid material with random fiber orientation is a relatively uniform material with low directionality, meaning that the tensile strength of the material in the machine direction is similar to that of the material in the cross-machine direction. A uniform material also has uniform porosity, thickness and density, and distributes water and soluble components uniformly in all directions, which is an advantage both when manufacturing the pouchless oral smokeless products disclosed herein and during use of the oral smokeless products. In the oral smokeless products disclosed herein, the fibers of the nonwoven material can include or consist of cellulosic fibers, and the fibrous carrier can consist of a wet-laid nonwoven material.

[0060] This is in contrast to nonwoven materials used as pouch materials in oral pouch products. Such nonwoven materials are typically dry-formed, bonded carded webs with the majority of the fibers in the material oriented in the machine direction. Bonded carded webs have significantly lower tensile strength in the cross machine direction than in the machine direction. In addition, fluid distribution in such materials occurs primarily in the machine direction, parallel to the fibers in the material. The primary function of the pouch material is to contain the fill material in the pouch and prevent particulate materials from leaking out of the pouch into the user's mouth, while allowing saliva and saliva-soluble fill ingredients to pass through the pouch material largely unimpeded. Thus, nonwoven pouch materials are generally woven to a thickness of 15 g / m 2 ~40g / m 2 It is a thin, highly fluid permeable web having a basis weight of about 1000 g.

[0061] As disclosed herein, the nonwoven material used as the substrate of the oral patch disclosed herein can comprise or consist of biodegradable fibers. Materials generally considered to be biodegradable and useful for the nonwoven material disclosed herein include natural cellulosic fibers such as cotton, flax, hemp, wood pulp, etc.; regenerated cellulosic fibers such as viscose fibers and lyocell fibers; polyhydroxyalkanoate fibers (PHAs) such as polyhydroxybutyrate fibers (PHB); polybutylene succinate (PBS) fibers and polylactic acid (PLA) fibers.

[0062] PHA fibers include PHBV (poly(3-hydroxybutyrate-co-3-hydroxyvalerate)), PHBH (poly(3-hydroxybutyrate-co-3-hydroxyhexanoate)), PHBO (poly(3-hydroxybutyrate-co-3-hydroxyoctanoate)), PHBD (poly(3-hydroxybutyrate-co-3-hydroxydecanoate)), P3HB (poly-3-hydroxybutyrate) or P4HB (poly-4-hydroxybutyrate).

[0063] Combinations of the above fibers, as well as any bicomponent fibers of the above polymers, are also contemplated in the nonwoven materials disclosed herein.

[0064] Although generally less preferred, the nonwoven material may comprise or consist of polymeric fibers from the group consisting of polyolefin fibers, such as polypropylene (PP) fibers and polyethylene (PE) fibers; polyester fibers, such as polyethylene terephthalate (PET) fibers.

[0065] The polymeric fibers disclosed herein may be monocomponent fibers or multicomponent fibers, such as bicomponent fibers.

[0066] Any bicomponent fiber of the polymers disclosed herein and / or any combination of said fibers are also contemplated for the nonwoven webs disclosed herein, however, nonwoven materials containing only biodegradable fibers may generally be preferred for use with the nonwoven carriers disclosed herein.

[0067] The fibres may have a circular cross-section or may be multi-lobal fibres such as bi-lobal fibre, tri-lobal fibre etc. Multi-lobal fibres may be useful in the non-pouch oral products disclosed herein as they may impart a high loading capacity for flavours and / or actives to the non-pouch oral products.

[0068] The fibrous carrier can be made of wet-laid, spunlaced, spunbonded, hydroentangled, bonded-carded or airlaid nonwoven materials. However, wet-laid nonwoven materials, as described herein, are generally preferred. The fibrous carrier can include a binder material, which may be in the form of binder fibers, such as thermoplastic binder fibers, and / or in the form of a resin binder. It may be preferred that the binder material is a biodegradable material. It may also be preferred that the fibers in the fibrous carrier are biodegradable, such that the combination of the fibers and the binder material is biodegradable, as described herein.

[0069] The fibers of the fibrous carriers disclosed herein can be made from renewable sources, such as natural cellulose fibers or regenerated cellulose fibers.

[0070] The present disclosure provides oral smokeless pouchless products in which the active agents may include or consist of nicotine, cannabinoids, caffeine, ginseng, taurine and / or BCAAs (branched amino acids).

[0071] Nicotine is a well-known stimulant and may be used, for example, as a smoking cessation drug for those attempting to quit smoking. Nicotine may have both a sedative and a stimulant effect on the body. Nicotine may provide a "kick" that may be caused by stimulating the adrenal glands, resulting in the release of adrenaline.

[0072] The choice of the nicotine compound used depends on circumstances such as the intended storage conditions of the product and / or the desired release rate. For example, nicotine present in the product in the form of nicotine base may be released substantially immediately when the consumer places the product in their mouth and may be well absorbed across mucous membranes, but may be associated with poor storage stability due to oxidation and volatility. Thus, nicotine may be provided in the product in a form other than nicotine base, such as in the form of a nicotine salt. Useful nicotine salts include nicotine hydrochloride, nicotine dihydrochloride, nicotine monotartrate, nicotine ditartrate, nicotine ditartrate dihydrate, nicotine sulfate, nicotine zinc chloride monohydrate, nicotine salicylate, nicotine citrate, nicotine polacrilex, and any combination thereof. A pH adjuster may be included in the nicotine formulation so that a sufficient amount of nicotine can be released as nicotine base when the product is placed in the consumer's mouth to allow sufficient absorption across mucous membranes.

[0073] As described herein, the smokeless oral product may include a pH adjusting agent. As used herein, a pH adjusting agent is one or more substances that are added to adjust and control the pH of an aqueous liquid, such as saliva, when the pH adjusting agent is dissolved or dispersed in the aqueous liquid. Examples of suitable pH adjusting agents for use in the pouchless oral smokeless products disclosed herein include sodium carbonate, sodium hydroxide, potassium hydroxide, potassium carbonate, sodium carbonate, sodium bicarbonate, magnesium carbonate, and any combination thereof.

[0074] The amount of pH adjuster can be selected to provide a pH greater than about 6.0, such as a pH greater than about 7.0, such as a pH in the range of about 7.0 to about 10.0, or a pH in the range of about 8.0 to about 9.0, such as a pH in the range of about 8.3 to about 8.7, when the product described herein is immersed in purified water.

[0075] The pH is determined by placing a sample with a mass of 5 g ± 0.1 g in a 150 ml glass beaker and adding 100 ml of deionized water to the beaker. The immersed sample is stirred for 5-10 minutes, carefully adjusting the stirring speed so that a vortex does not form. The pH is then measured by immersing a pH meter electrode in the solution.

[0076] While nicotine is a well-known stimulant, the use of cannabinoids such as cannabidiol as active agents in oral smokeless products is more recent. Cannabinoids are compounds found in the cannabis plant. The best-known cannabinoid is tetrahydrocannabinol (THC), which has psychoactive effects that can affect the mind, behavior, and / or emotions of individuals who take it. However, not all cannabinoids exhibit psychoactive effects. For example, the cannabinoid cannabidiol (CBD) is not associated with psychoactive effects. Cannabidiol constitutes up to 40% of the cannabis plant. Cannabidiol (CBD) is a cannabinoid that is found in the cannabis plant. 21 H 30 Cannabidiol (O2) can be extracted from the cannabis plant or prepared synthetically. Cannabidiol has been shown to have antidepressant, sedative, anxiolytic, sleep-promoting, anti-inflammatory and antipsychotic effects. In addition, cannabidiol has been shown to be effective in reducing tobacco and / or nicotine addiction. Cannabidiol has been used in pharmaceutical compositions for its anti-epileptic effects and is also believed to be useful in treating diseases such as Parkinson's disease and Crohn's disease.

[0077] Cannabinoids contemplated in the oral smokeless products disclosed herein may be one or more of the following: tetrahydrocannabinol (THC), tetrahydrocannabinolic acid (THCA), cannabidiol (CBD), cannabidiolic acid (CBDA), cannabinol (CBN), cannabigerol (CBG), cannabichromene (CBC), cannabicyclol (CBL), cannabivarin (CBV), tetrahydrocannabivarin (THCV), cannabidivarin (CBDV), cannabichromevarin (CBCV), cannabigerovarin (CBGV), cannabigerol monomethyl ether (CBGM), cannabiersoin (CBE), and cannabicitran (CBT).

[0078] The cannabinoids described herein may be non-psychotropic cannabinoids, i.e., cannabinoids that do not have psychotropic effects. Examples of non-psychotropic cannabinoids include cannabidiol (CBD) and cannabigerol (CBG). For example, the non-psychotropic cannabinoid may be cannabidiol (CBD), such as the (-)-enantiomer, (+)-enantiomer, or racemic mixture of cannabidiol (CBD). Furthermore, the non-psychotropic cannabinoid may be in the form of industrial hemp that does not contain tetrahydrocannabinol (THC) or contains a low concentration of THC, such as 0.5 wt% or less, based on the total mass of the industrial hemp.

[0079] It will be understood that the present disclosure also encompasses derivatives of the cannabinoids described herein. For example, one or more hydroxy groups present in the compounds may be alkylated or acylated.

[0080] Caffeine is also a well-known stimulant that may be used as an active agent in the oral smokeless products disclosed herein.

[0081] Further active agents that may be used in the oral smokeless products disclosed herein are ginseng, taurine and branched chain amino acids (BCAAs).

[0082] The oral smokeless products may include combinations of any of the disclosed active agents. Some of the active agents may be useful together.

[0083] Oral smokeless products may contain nicotine in an amount of from 1 mg to 25 mg, preferably from 1 mg to 10 mg or more preferably from 2 mg to 8 mg.

[0084] As disclosed herein, the active agent can include or consist of nicotine in the form of nicotine base or a nicotine salt. The nicotine salt can be selected from the group consisting of nicotine polacrilex, nicotine hydrochloride, nicotine dihydrochloride, nicotine monotartrate, nicotine bitartrate, nicotine bitartrate dihydrate, nicotine sulfate, nicotine zinc chloride monohydrate, nicotine salicylate, nicotine citrate, and any combination thereof.

[0085] The present disclosure can provide an oral smokeless product containing a flavoring agent. Any flavoring agent known in the art can be used, including fruit flavors such as lemon, apple, mango, banana, pear, orange, strawberry, hazelnut, etc., as well as menthol flavor, coffee flavor, tobacco flavor, licorice flavor, wintergreen flavor, etc.

[0086] The present disclosure may provide the rapid and improved release of flavor achieved in the thin oral smokeless products disclosed herein.

[0087] The present disclosure may provide an oral smokeless product, wherein the oral smokeless product does not contain tobacco.

[0088] The oral smokeless product may include a fibrous carrier that is a single layer nonwoven material. The single layer nonwoven material disclosed herein is a coherent, integrated fibrous nonwoven web. The single layer nonwoven web may be homogeneous through its thickness, or may include layers of different composition and / or different density.

[0089] A single layer material produces a cohesive oral smokeless product without the risk of delamination. A generally homogeneous porous nonwoven material constitutes a carrier that can efficiently carry actives and / or flavors and provides good fluid distribution in all directions of the carrier material. Furthermore, a single layer material is preferred over a laminate of multiple layers, as it provides an oral patch with better flexibility and conformability than a laminate material.

[0090] The smokeless oral product may have a thickness of 0.2 mm to 5 mm, such as 0.5 mm to 4 mm, such as 0.8 mm to 3 mm, such as 1.0 mm to 2.0 mm, such as 1.0 mm to 1.5 mm, such as 1.0 mm to 1.4 mm. It may be particularly preferred that the thickness of the smokeless oral product is 0.7 mm to 1.5 mm. The thickness of the smokeless oral product disclosed herein is measured using the EDANA WSP120.6(5) method with a 57 mm diameter probe at an applied pressure of 0.5 kPa.

[0091] The nonwoven material of the carrier of the smokeless oral product disclosed herein is 70 g / m 2 ~300g / m 2 , e.g. 70g / m 2 ~200g / m 2 , 70g / m 2 ~200g / m 2 or 70 g / m 2 ~150g / m 2 The mass of the carrier is the dry mass of the carrier. Preferably, the nonwoven material of the carrier of the oral smokeless product disclosed herein has a basis weight of 100 g / m 2 ~200g / m 2 For the pouchless oral smokeless products disclosed herein that are configured to be folded into smaller formats, the nonwoven carrier material preferably has a basis weight in the range of 50 g / m 2 ~100g / m 2 The nonwoven carrier material has an unfolded basis weight in the range of 100 g / m2 after double folding. 2 ~200g / m 2 The range is as follows.

[0092] The dry mass of the support may be 0.02 g to 0.5 g, for example, 0.05 g to 0.3 g, preferably 0.05 g to 0.2 g, and more preferably 0.04 g to 0.1 g.

[0093] The non-buccal pouch product can have a dry mass of 0.1 g to 1.0 g, preferably 0.1 g to 0.5 g. The product includes the nonwoven web that constitutes the carrier, the applied thickener, active agent and / or flavor, and any further additives disclosed herein. The mass of the product may be up to about 7 times the mass of the carrier.

[0094] The fibers of the fibrous carrier can have a linear density of 0.5 dtex to 5.0 dtex, for example 1.0 dtex to 3.0 dtex.

[0095] The product without the oral smokeless pouch is 1.0 cm in the XY plane. 2 ~8cm 2 , preferably 1.0 cm 2 ~5cm 2 , more preferably 1.5 cm 2 ~4cm 2 An oral pouch-less product configured to be folded into a smaller format may, for example, have twice the area of ​​a corresponding pouch-less product configured for use in an unfolded state.

[0096] The present disclosure may provide an oral smokeless product, the oral smokeless product having a rectangular shape with a length measured in the length direction greater than the width measured in the width direction, the oral smokeless product having a maximum width in the width direction of 5 mm to 40 mm, for example 7 mm to 30 mm or 8 mm to 20 mm, and a maximum length in the length direction of 10 mm to 70 mm, for example 15 mm to 50 mm or 20 mm to 35 mm. To obtain a rectangular shape, the smaller width is applied to the oral smokeless product having a smaller length, and the larger width is applied to the oral smokeless product having a larger length. It may be preferable that the oral smokeless product has a rectangular shape with a maximum width in the range of 8 mm to 20 mm and a maximum length in the range of 20 mm to 35 mm. The thickness of these products is preferably in the range of 0.7 mm to 1.5 mm. Such preferred dimensions also apply to oral smokeless pouch-free products intended to be folded into a use form, and the dimensions are then applicable to the folded form of the oral smokeless pouch-free product.

[0097] The oral patch 100 disclosed herein can have a shape that indicates the flavor, such as a lemon shape for a lemon flavor, a banana shape for a banana flavor, a coffee bean shape for a coffee flavor, etc. As an example, a lemon shaped oral patch 100a is shown in FIG 4a, and a coffee bean shaped oral patch 100f is shown in FIG 4f.

[0098] It should be understood that any suitable shape may be used, including any geometric shape, including triangles, circles, rectangles, ovals, dog-bone shapes, etc., and decorative shapes, such as hearts, leaves, flowers, glitter, boomerangs, or drops, etc. Logo shapes may be used to indicate the commercial origin of the product.

[0099] A leaf-shaped oral patch as illustrated in Fig. 4b may enhance the eco-friendly aspect of the product. A kidney-shaped oral patch 100c as shown in Fig. 4c may be beneficial as all edges are smoothly curved and the kidney shape fits neatly between the gums and upper or lower lip of the user.

[0100] The nonwoven carrier material of the oral patches disclosed herein may be physically modified by providing perforations, cavities or embossments made in the nonwoven carrier material. The perforations, cavities or embossments may be purely decorative or may have a functional purpose in addition to altering the visual impression of the oral patch.

[0101] The perforations or cavities in the nonwoven carrier material can serve to enhance the impregnation of the carrier material by forming passages for the impregnating liquid to penetrate the fibrous structure. The perforations can also promote the flow of saliva through the oral patch during use, aiding in the rapid release of the active agent and / or flavor from the patch into the saliva. Such fluid flow promoting perforations can be distributed on the surface of the carrier material and can be arranged in a pattern.

[0102] As an example, leaf nerves 102 are shown in the leaf-shaped oral patch 100b shown in Fig. 4b. The leaf nerves 102 may be embossed lines or cuts applied completely or partially through the nonwoven carrier material. The embossed lines can act as folding instructions and increase the flexibility of the oral patch along the embossed lines. The embossed lines can also promote fluid transport along the embossed lines where the fibrous structure of the nonwoven carrier material is compressed, thus creating thin capillaries between the fibers in the embossed lines.

[0103] Compressed fibrous structures, such as compressed structures formed by embossing, have finer capillaries than the surrounding non-compressed fibrous structures. The portion of the oral patch having a compressed fibrous structure with fine capillaries will expel liquid from the portion of the non-compressed fibrous nonwoven carrier material. In addition, the compressed portion of the oral patch will release liquid and active agents in the liquid at a lower rate than the non-compressed portion of the oral patch. This effect of embossing can be used to control the release rate of active agents in the oral patch and extend the period during which active agents are released when the oral patch is placed in the mouth of a user.

[0104] Partial or complete cuts through the nonwoven carrier material can serve to increase flexibility and thereby improve conformability of the oral patch. Cuts and embossing can be used in combination to control the liquid distribution and flexibility of the oral patch.

[0105] The oral patches disclosed herein can include printed decoration, text, etc. Printing can be used alone or in combination with mechanical modifications of the nonwoven carrier material in the oral patch, such as embossing, perforations, or cavities formed in the surface of the nonwoven carrier material.

[0106] The heart-shaped oral patch 100d shown in Figure 4d has an embossed line 103 running down the center of the oral patch 100d in the longitudinal direction L. The embossed line 103 is a folding instruction along which a user can fold the oral patch 100d to create a smaller but thicker patch having two overlapping layers of nonwoven carrier material.

[0107] FIG. 4e shows a longitudinal strip 100e of nonwoven carrier material including three perforation lines 104 dividing the longitudinal strip 100e into four portions 100e', 100e'', 100e''', 100e''''. The longitudinal strip 100e can be torn along one or more of the perforation lines 104 to create oral patches having a smaller size than the longitudinal strip 100e. Tearing along all three perforation lines 104 creates four equally sized oral patches 100e', 100e'', 100e''', 100e'''' from the longitudinal strip 100e. Tearing along the centrally extending perforation line 104 creates two equally sized oral patches, etc. The perforation lines 104 can alternatively be used as fold instructions along which the longitudinal strip can be folded into a thicker multi-layer structure. A further option may be to sever the strip, for example along the central perforation line 104. The two portions of the strip may then be double folded along the remaining intact perforation line in each of the two portions.

[0108] It should be understood that the multi-patch product can take other forms than the elongated strip shown in FIG. 4e, such as a sheet of nonwoven carrier material that can be divided into a plurality of individual oral patches, or as a roll of nonwoven carrier material from which the individual oral patches can be torn or cut.

[0109] The fibrous carrier of the oral smokeless products disclosed herein may comprise a chemical binder, which is preferably a biodegradable and / or bio-based binder according to standard ISO / AWI 20200 Plastics, which relates to the determination of the degree of decomposition of plastic materials under simulated composting conditions in laboratory tests.

[0110] Of course, when the fibrous carrier comprises biodegradable fibers, it is particularly advantageous to use a biodegradable and / or bio-based binder.

[0111] It is possible to use other binders such as polyester, but as described herein, it is environmentally advantageous to use environmentally friendly binders, such as biodegradable and / or bio-based binders.

[0112] 70g / m 2 ~150g / m 2 The carrier with a mass of about 500 l / m 2 / sec~2000l / m 2 It can have a breathability of 1 / second.

[0113] Furthermore, the absorbency of the carrier may be 500%-800% of the dry mass of the carrier web. Water absorption is measured according to a method based on SS-EN ISO 12625-8:2006, with the modification that after immersion of the sample in water, the sample is exposed to a negative pressure of 80 kPa for 10 minutes to ensure that the carrier web is completely wetted. When the immersed material is completely saturated with water, the sample is removed from the water and allowed to drain for 2 minutes before being weighed.

[0114] A high absorptive capacity may be desired so that the carrier can absorb large amounts of liquid containing thickeners, actives and / or flavors.

[0115] Impregnation of the carrier nonwoven can be facilitated by adding a surfactant during the nonwoven manufacturing process or during the preparation of the fibers for the nonwoven web.

[0116] A method for improving the carrying capacity of nonwoven webs includes the use of multilobal fibers that can contain active agents and / or flavors in the capillaries formed between the lobes on the surface. The multilobal fibers may be regenerated cellulose fibers such as viscose or lyocell fibers.

[0117] The carrier nonwoven webs disclosed herein may have a bending stiffness of 2N to 35N measured according to the Circular Bend Procedure of ASTM D4032 - 08 (reapproved 2016), with the modification that testing is performed on single layer samples.

[0118] The non-buccal pouch products disclosed herein are preferably relatively rigid in a dry state, making the unused product easy to handle and place in the mouth, and when wetted with saliva in the mouth, the product softens and becomes pliable to conform to the user's gums.

[0119] The present disclosure further provides a method for producing the oral smokeless products disclosed herein, the method comprising: - providing a nonwoven carrier material; - providing a liquid solution comprising flavours and / or active agents, glycerol, a thickening agent such as alginate or gum acacia, water and, optionally, food colours; - applying the liquid solution to a nonwoven carrier material Includes.

[0120] The method may further include: - punching individual oral smokeless patches from the nonwoven carrier material. The individual oral smokeless patches can be punched before or after application of the liquid solution to the nonwoven carrier material.

[0121] An example of a liquid solution that is a liquid flavor solution is disclosed below. Ingredient amount (wt%) Glycerol 14 Alginate 0.75 water 40.1 KOH 0.01 Maltitol 40.1 Flavor 5.00 Total 100

[0122] When the liquid solution is a liquid flavor solution, the method comprises: - providing an aqueous solution comprising an activator and water; and - applying the aqueous solution to a nonwoven carrier material or to individual die-cut oral smokeless patches. It may further include.

[0123] It may be advantageous to apply the liquid flavor solution in a separate step from the step of applying the aqueous solution containing the active agent to the nonwoven carrier web. It has been found that adding the active agent separately from the addition of flavorants, sweeteners, pH adjusters, etc., allows for easier control of the amount of active agent applied to the nonwoven carrier web. Furthermore, active agents are often very potent substances, such as nicotine, which must be handled with special care during the manufacturing process.

[0124] Furthermore, the method of application of the active agent may be different from the method of application of the flavor solution. The flavor solution may be applied, for example, by immersing the nonwoven carrier web in the flavor solution, by applying pressure or suction to the nonwoven carrier web, or by spraying the flavor solution onto the carrier web. The active agent may, for example, be applied as drops onto the nonwoven carrier web, sprayed onto the nonwoven carrier web, or injected into the nonwoven carrier web.

[0125] In manufacturing methods in which the liquid solution contains both flavor and active agent, the liquid solution can be applied to the nonwoven carrier by immersing the nonwoven carrier web in the liquid solution, by applying pressure or drawing the liquid solution onto the nonwoven carrier web, or by spraying the liquid solution onto the carrier web. Because the liquid solution contains a thickening agent such as alginate, gum acacia, glycerol, or combinations thereof, it may be necessary to apply pressure, pour or draw the liquid solution onto the nonwoven carrier web to impregnate the nonwoven carrier web with the liquid solution.

[0126] An example of an aqueous solution containing nicotine as the active agent and water is disclosed below. Ingredient amount (wt%) Premix 40.0 KOH 5.3 Water 54.7 Total 100

[0127] The premix in this case contained 20.0% nicotine, 60.0% glycerol, 10% water and 10% tartaric acid.

[0128] The amount of nicotine or other active agent present in the oral smokeless product disclosed herein can be changed by changing the amount of premix in the aqueous solution. Thus, the amount of premix in the aqueous solution can be 20wt% to 100wt%, depending on the desired content of active agent in the oral smokeless product. When using 100% premix, the solution may need to be pH stabilized with a high concentration of pH adjuster, such as KOH or any other suitable pH adjuster disclosed herein.

[0129] In the methods for producing oral smokeless products disclosed herein, the active agent may comprise or consist of nicotine, cannabinoids, caffeine, ginseng, taurine and / or branched amino acids (BCAAs).

[0130] The different agent examples disclosed above may also be used in the process for producing an oral smokeless product.

[0131] In this method, the active agent may comprise or consist of nicotine, and the aqueous solution comprising nicotine may further comprise a pH adjuster, such as KOH.

[0132] The methods disclosed herein may include the following steps. - impregnating the carrier nonwoven material with the liquid flavor solution by immersing the carrier nonwoven material in a bath of the liquid flavor solution; - applying mechanical pressure to the carrier nonwoven material; and - drying the carrier nonwoven material. The method may further comprise the steps of: - applying an aqueous solution of an active agent to the carrier nonwoven material after drying the carrier nonwoven material.

[0133] The carrier nonwoven material can be impregnated with the liquid flavor solution while in the form of a coherent nonwoven carrier web. An aqueous solution of the active agent can then be applied to the dried, coherent nonwoven carrier web. Alternatively, but less preferably, the carrier nonwoven material can be impregnated with the liquid flavor solution while in the form of individual punched or cut patches of nonwoven material, and an aqueous solution of the active agent can then be applied to the dried patches of nonwoven material.

[0134] As a further option, the carrier nonwoven material, while in the form of a coherent nonwoven carrier web, is impregnated with a liquid flavor solution and then cut or punched to form individual nonwoven material patches. The drying step after application of the liquid flavor solution can be carried out before or after cutting or punching the continuous web to form the individual nonwoven material patches.

[0135] The dried individual nonwoven material patches can then be subjected to application of an aqueous solution containing an active agent.

[0136] It may be preferred that the cutting step is the final step performed after all additives have been applied to the nonwoven carrier web. The cutting step can be performed before or after drying of the impregnated nonwoven carrier web.

[0137] The method includes applying a liquid flavor solution to a coherent web of nonwoven carrier material followed by - passing the coherent web of impregnated nonwoven carrier material between rotating opposed rollers and / or scraping off excess liquid; - drying the coherent web of impregnated nonwoven carrier material, such as by air drying. The method may include draining excess liquid by

[0138] By adding an active agent such as nicotine in a manufacturing step separate from the step in which the nonwoven carrier web is impregnated with the flavor and thickener containing solution, the active agent can be applied locally only in the area where the individual patches are cut from the impregnated nonwoven web. Thus, when the individual patches are die cut or cut from the coherent nonwoven web, the portion of the coherent nonwoven web that is cut and discarded is free of nicotine or other active agent. Handling such waste material containing potentially harmful active agents must be done with care to avoid exposing machine operators to the active agent. Environmental considerations must also be considered when disposing of materials containing potentially harmful chemicals.

[0139] The smokeless oral products disclosed herein can be delivered to the consumer in other forms than as punched or cut patches. For example, the smokeless oral products can be delivered to the consumer in the form of bands, strips, or sheets from which the individual smokeless oral products can be separated by the consumer, such as by tearing or cutting. To facilitate the separation of the individual smokeless oral products from such a multi-product band, strip, or sheet without the use of tools, the band, strip, or sheet may be provided with a separation means, such as a perforation, tear, partial cut, etc.

[0140] Conventional pouch oral smokeless smoke products may be unsatisfactory or unattractive to some users, or may be unsatisfactory in any situation where it is desired to be able to use the product discreetly. Conventional pouch products can be bulky and difficult to use unobtrusively under the lips.

[0141] In pouch products, a non-tobacco composition containing an active agent such as a nicotine or tobacco composition is typically filled into a non-woven pouch that is sealed at a longitudinal body seam and two end seams to form a pillow-like product having a thickness of about 5 mm. The seams are usually formed by adhesive, heat welding or ultrasonic welding and contain consolidated hardened material that can cause discomfort and can feel rough against the gum line and inside of the lips.

[0142] In the smokeless oral products disclosed herein, the nonwoven material constitutes the sole carrier for the thickener, actives and / or flavors, and determines the thickness and volume of the smokeless oral product. Because the smokeless oral products disclosed herein are in the form of a patch, the products do not include any seams.

[0143] The ability to create a satisfactory smokeless oral product without a seal is an important discovery because it eliminates the problem of seal failure that occurs with pouch products. Furthermore, the pouchless smokeless oral products disclosed herein are not only very discreet and unobtrusive, but also more comfortable to use in the mouth because they can almost perfectly conform to the contours of the user's gums.

[0144] The oral smokeless products disclosed herein do not suffer from the dripping that occurs with typical snus / nicotine pouch products due to the "snus-juice" that forms when the product comes into contact with saliva in the user's mouth. The thinness of the product and the large exposed surface area relative to the volume of the product also improves flavor and active agent delivery. The thin oral pouchless product releases nicotine quickly, mimicking the nicotine delivery experienced when smoking a cigarette. This will be particularly appreciated by those using the product as an aid to quitting smoking.

[0145] Biodegradable products are advantageous for many reasons. It is beneficial for the environment that the product is biodegradable and therefore can be recycled as compost, preferably in a home composting environment. The post-consumer product is in the form of a sheet or patch of soft, thin, non-woven material, which is spat out and disposed of after use. The biodegradability of the product can reduce the negative effects of littering in that the product, whether unintentionally or intentionally dropped on the ground, will decompose and break down over time.

[0146] The pouchless products disclosed herein are preferably also made of biodegradable materials, preferably bio-based materials.As described herein, it may be particularly preferred that the products are decomposable under home composting conditions.However, it may be sufficient for the products to meet industrial composting standards, since the discarded products after use can then be separated together with other industrial compostable materials.

[0147] Since the oral smokeless products disclosed in this specification do not require weldability, the nonwoven material that can be used as the carrier material can be freely selected based on criteria such as biodegradability, softness, hydrophilicity, and absorbency.

[0148] Due to their small volume, the products disclosed herein are resource and cost efficient as they do not require fillers such as snus, microcrystalline cellulose (MCC), vegetable fibers and similar ingredients. Additionally, shipping boxes and user packages can be made smaller.

[0149] The oral smokeless product disclosed herein may have a rectangular shape with a length in the longitudinal direction and a width in the transverse direction. The oral smokeless product may have a shape and size that fits the gums under the upper lip of the user and the available surface in the mouth. Since the shape and size of the gums vary from user to user, the oral smokeless product may be provided in different sizes and / or shapes to meet the needs of different users. The oral smokeless product may have rounded edges and no sharp corners. EXAMPLES

[0150] Friction measurement The static and kinetic coefficients of friction were measured according to ASTM D1894.

[0151] Example 1 The static and kinetic coefficients of friction (CoF) in Newtons (N) were determined for two comparable viscose nonwoven materials, the first of which was 30 g / m 2 The wet nonwoven fabric is: Static CoF: 0.7, dynamic CoF: 0.17.

[0152] The second material is 30g / m 2 Dry nonwoven fabric: Static CoF: 0.15, dynamic CoF: 0.06.

[0153] The higher value for the wet nonwoven indicates better stay-in-place properties for the patch made from the wet material.

[0154] Nicotine Extraction Example 2 Extraction tests for nicotine extraction were performed on nonwoven patches according to the invention, impregnated with nicotine in amounts of 2.5 mg / patch, 2.7 mg / patch and 3 mg / patch. The carrier nonwoven material was a wet-laid nonwoven web. Four different basis weights were tested: 70 g / m 2 , 100g / m 2 , 150g / m 2 , 200g / m 2 The carrier nonwoven material was made of 1.7 dtex viscose fibers bonded with a chemical binder. The patches labeled NIL 1 were leaf-shaped with an average dry weight of 0.17 g per product. The patches labeled NIL 2, 3, 4 and 5 were crescent-shaped with an average dry weight as listed in Table 1.

[0155] The reference products were conventional pouch non-tobacco products: Zyn dry® (3 mg nicotine) and Zyn slim® (9 mg nicotine) from Swedish Match. The reference product, designated "P", was a buccal pouch non-tobacco product with a filling comprising a matrix of particles of microcrystalline cellulose having an average particle size of 700 μm.

[0156] Test procedure Participants in the in vivo extraction study were treated to three replicate samples selected to hold the same weight of nonwoven fabric patches stored in individual vials. Participants were instructed to use a set of products limited to one use per day for a set period of time (5, 10, 15 or 30 minutes), making sure not to eat or drink during use, and then remove the product from under their lips and place it directly into a new vial with tweezers, which was then placed in the freezer. The used products were analyzed for nicotine content per unit, from which the nicotine extraction was calculated.

[0157] sample:

[0158] [Table 1]

[0159] The test samples were impregnated with a solution containing glycerol, sodium alginate, 42% water and maltitol, followed by dispensing of the nicotine premix solution to obtain the final nicotine dose / unit.NIL 2-5 samples had a glycerol content of approximately 23% of dry weight, an alginate content of approximately 1% of dry weight, and a maltitol content of approximately 30-35%.

[0160] The results are shown in Table 2 below. Values ​​were calculated as the average of all subjects. The number of subjects was 11 for NIL 1, 12 for NIL 2-5, and 9 for the reference product.

[0161] [Table 2]

[0162] As can be seen from Table 2, the nicotine extraction of the nicotine patch NIL 1 according to the invention was both faster and more complete than the conventional pouch non-tobacco products Zyn dry 3 mg and Zyn slim 9 mg after a test period of 30 minutes.

[0163] Comparing patches with different basis weights, 70 g / m 2 NIL 2 has a basis weight of 150 g / m 2 and 200 g / m 2 It was found that the nicotine in the patch was released almost three times more after 10 minutes of use compared to the NIL 3 and NIL 5 patches with a basis weight of 150 g / m2. 2 The amount of nicotine extracted from patch NIL 4 after 10 minutes was found to be somewhat higher than that from the corresponding non-perforated patch NIL 3, indicating that perforations in the carrier nonwoven fabric can enhance the release of nicotine from the buccal patch.

[0164] Absorption measurements Wet-laid viscose nonwoven webs corresponding to the webs used to prepare the NIL 1, 3 and 5 samples, and 250 g / m 2 The water absorption capacity of a wet-laid viscose nonwoven web having a basis weight of 100 g / m² was measured according to SS-EN ISO 12625-8:2006 with the modification that the carrier material / substrate was exposed to a negative pressure of 80 kPa for 10 minutes while immersed in water.

[0165] Sample preparation: Five pieces with a total mass of 5 grams were cut from each test nonwoven web. The five pieces of material were loosely rolled together and placed in a test basket as specified in SS-EN ISO 12625-8:2006. The test basket was placed in a container of water, with the entire basket and the sample submerged under the water.

[0166] The test basket and the container containing the sample were placed in a vacuum chamber and subjected to a pressure of -80 kPa for 10 minutes, after which the test basket was removed from the water and allowed to drop for 2 minutes.

[0167] The absorbency of the samples was determined as a percentage of the wet sample mass to the dry sample mass and was found to be comparable for all test materials: Sample 1 (100 g / m 2 ) - 675% Sample 2 (150 g / m 2 ) - 664% Sample 3 (200 g / m 2 ) - 667% Sample 4 (250 g / m 2 ) - 678%

[0168] The absorbent capacity of the carrier nonwoven material used as the substrate of the oral patch disclosed herein is preferably in the range of 500% to 800% of the dry weight of the carrier web.

[0169] Hardness Measurement The stiffness of the dry nonwoven carrier webs of Samples 1-5 above was tested according to ASTM D4032-08 (Reapproved 2016) Standard test Method for Stiffness of Fabric by the Circular Bend Procedure, with the modification that the testing was done on single layer samples.

[0170] The webs tested were: 70g / m with biodegradable binder 2 Viscose base - average hardness 2N 150g / m with biodegradable binder 2 Viscose base - average hardness 15N 200g / m with biodegradable binder 2 Viscose base - average hardness 18N 250g / m with biodegradable binder 2 Viscose base - average hardness 30N

[0171] It has been found that the oral patch disclosed herein is advantageously relatively stiff in its unused state, with an average stiffness higher than that of the dry nonwoven carrier web, so that the oral patch is easy to remove from the container and place in the oral cavity. The stiffness of the oral patch disclosed herein is increased by the presence of thickeners such as alginate and acacia gum, and sugar alcohols such as mannitol, maltitol, isomalt, in the carrier web. While contributing to the stiffness of the product before use, the alginate and acacia gum soften and gel when wet, and the sugar alcohol dissolves in saliva, resulting in a product with improved flexibility and conformability. The carrier nonwoven material containing cellulosic fibers, such as a nonwoven web of viscose fibers, becomes soft when wet, thus further contributing to the flexibility and conformability of the oral patch during use.

[0172] 70g / m 2 The NIL 2 product made from was reported by subjects in Example 1 to be less preferred in that it became very thin after use and was difficult to remove. [Explanation of symbols]

[0173] 100 Oral Smokeless Products 100 oral patches 100a Lemon Shaped Oral Patch 100b Leaf-shaped oral patch 100c kidney-shaped oral patch 100d Heart Shaped Mouth Patch 100e Vertical Strip 100f Coffee bean shaped oral patch 101 Carrier 102 Leaf veins 103 Embossed Line 104 Perforation

Claims

1. Carrier (101), Activators and / or flavors A pouch-less oral smokeless product in the form of an oral patch (100) containing, The carrier (101) is made of a water-insoluble fibrous nonwoven fabric material. An oral smokeless product characterized in that the oral patch further contains a thickening agent.

2. The oral smokeless product according to claim 1, wherein the thickening agent comprises alginate, acacia gum, or a combination thereof.

3. The oral smokeless product according to claim 1, wherein the thickening agent contains or consists of an alginate, and the alginate constitutes 0.5% to 5% of the dry mass of the oral patch (100).

4. The oral smoke-free product according to claim 1, wherein the oral patch (100) contains glycerol.

5. The oral smokeless product according to claim 4, wherein the glycerol constitutes 15% to 35% of the dry mass of the oral patch (100).

6. The oral smokeless product according to claim 1, wherein the oral patch (100) contains a sugar alcohol, such as maltitol, mannitol, or isomalt, or a combination of two or more different sugar alcohols.

7. The oral smokeless product according to claim 6, wherein the sugar alcohol constitutes 20% to 45% of the dry mass of the oral patch (100).

8. The oral smokeless product according to claim 1, wherein the carrier (101) contains or consists of a biodegradable material.

9. The oral smoke-free product according to claim 1, wherein the fibers of the fibrous nonwoven fabric material include or consist of cellulose fibers.

10. The oral smoke-free product according to claim 1, wherein the carrier (101) is made of a wet nonwoven fabric material.

11. The oral smoke-free product according to claim 10, wherein the wet nonwoven fabric material has a random fiber orientation.

12. The oral smoke-free product according to claim 1, wherein the activator is selected from the group consisting of nicotine, cannabinoids, caffeine, ginseng, taurine and / or branched amino acids (BCAAs), or any combination thereof.

13. The oral smokeless product according to claim 1, wherein the oral smokeless product contains 1 mg to 25 mg of nicotine, preferably 1 mg to 10 mg of nicotine, or more preferably 2 mg to 8 mg of nicotine.

14. The oral smokeless product according to claim 1, wherein the activator contains or consists of nicotine in the form of a nicotine base or a nicotine salt.

15. The oral smokeless product according to claim 1, wherein the oral smokeless product is a non-tobacco product.

16. The oral smokeless product according to claim 1, wherein the oral smokeless product comprises a pH adjuster.

17. The oral smoke-free product according to claim 1, wherein the carrier (101) is composed of a single layer of nonwoven fabric material.

18. The oral smokeless product according to claim 1, wherein the oral smokeless product has a thickness (t) of 0.2 mm to 5 mm.

19. The aforementioned carrier is 70 g / m 2 ~300g / m 2 The oral smokeless product according to claim 1, having a basis mass.

20. The oral smokeless product according to claim 1, wherein the carrier (101) has a dry mass of 0.02 g to 0.2 g, for example, a dry mass of 0.05 g to 0.2 g.

21. The oral smokeless product according to claim 1, wherein the fibers of the fibrous carrier (101) have a linear density of 0.5 dtex to 5 dtex.

22. The aforementioned oral smoke-free product is 1.0 cm 2 ~8cm 2 The oral smokeless product according to claim 1, having a surface area.

23. The oral smokeless product according to claim 1, wherein the oral smokeless product has a rectangular shape with a length (l) in the longitudinal direction (L) and a width (w) in the width direction (W), and the oral smokeless product has a maximum width (w) of 5 mm to 20 mm in the width direction (W) and a maximum length (l) of 10 mm to 35 mm in the longitudinal direction (L).

24. The oral smokeless product according to claim 1, wherein the carrier (101) comprises a chemical binder.

25. The oral smokeless product according to claim 1, wherein the water absorption capacity of the carrier is 500% to 800% of the dry mass of the carrier web.

26. A method for manufacturing a pouch-less oral smokeless product according to claim 1, - A step of preparing a single-layer nonwoven fabric carrier material in the form of an aggregated nonwoven web or as individual patches of the nonwoven fabric carrier material; - A step of preparing a liquid solution containing flavors and / or activators, thickeners, such as glycerol, alginate, or acacia gum, and water; - Step of applying the liquid solution to the nonwoven fabric material. Methods that include...

27. A method for producing a pouch-free oral smokeless product according to claim 26, wherein the liquid solution is a liquid flavor solution containing the flavor and the thickener.

28. A method for manufacturing a pouch-less oral smokeless product according to claim 27, - A step of preparing an aqueous solution containing an activator and water; and - The step of applying the aqueous solution to the aggregated nonwoven web or to the individual oral smokeless products. Methods that further include the above.

29. The aforementioned nonwoven fabric carrier material is in the form of an aggregated nonwoven fabric web. - A process of separating individual oral smokeless products from the aggregated nonwoven fabric web by cutting or punching, etc. The method according to claim 26, further comprising:

30. A method for producing a pouch-less oral smoke-free product according to claim 26, wherein the oral smoke-free product contains nicotine, cannabinoids, caffeine, ginseng, taurine and / or branched amino acids (BCAAs), or contains an activator comprising these.

31. The method according to claim 30, wherein the activator contains or comprises nicotine, and the solution containing the activator further contains a pH adjuster such as potassium hydroxide (KOH).

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