WO2023104774A1 - Produit oral sans fumée comprenant un agent actif et/ou un arôme - Google Patents

Produit oral sans fumée comprenant un agent actif et/ou un arôme Download PDF

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Publication number
WO2023104774A1
WO2023104774A1 PCT/EP2022/084548 EP2022084548W WO2023104774A1 WO 2023104774 A1 WO2023104774 A1 WO 2023104774A1 EP 2022084548 W EP2022084548 W EP 2022084548W WO 2023104774 A1 WO2023104774 A1 WO 2023104774A1
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WO
WIPO (PCT)
Prior art keywords
oral
oral smokeless
carrier
product according
smokeless product
Prior art date
Application number
PCT/EP2022/084548
Other languages
English (en)
Inventor
Linnea SEILER
Andreas ELFSTRAND
Original Assignee
Swedish Match North Europe Ab
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Swedish Match North Europe Ab filed Critical Swedish Match North Europe Ab
Priority to CN202280081041.0A priority Critical patent/CN118647285A/zh
Priority to EP22830259.2A priority patent/EP4444113A1/fr
Priority to CA3239405A priority patent/CA3239405A1/fr
Priority to KR1020247019997A priority patent/KR20240118783A/ko
Publication of WO2023104774A1 publication Critical patent/WO2023104774A1/fr
Priority to CONC2024/0007632A priority patent/CO2024007632A2/es

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Classifications

    • A—HUMAN NECESSITIES
    • A24—TOBACCO; CIGARS; CIGARETTES; SIMULATED SMOKING DEVICES; SMOKERS' REQUISITES
    • A24B—MANUFACTURE OR PREPARATION OF TOBACCO FOR SMOKING OR CHEWING; TOBACCO; SNUFF
    • A24B13/00—Tobacco for pipes, for cigars, e.g. cigar inserts, or for cigarettes; Chewing tobacco; Snuff
    • A—HUMAN NECESSITIES
    • A24—TOBACCO; CIGARS; CIGARETTES; SIMULATED SMOKING DEVICES; SMOKERS' REQUISITES
    • A24B—MANUFACTURE OR PREPARATION OF TOBACCO FOR SMOKING OR CHEWING; TOBACCO; SNUFF
    • A24B15/00—Chemical features or treatment of tobacco; Tobacco substitutes, e.g. in liquid form
    • A24B15/10—Chemical features of tobacco products or tobacco substitutes
    • A24B15/16—Chemical features of tobacco products or tobacco substitutes of tobacco substitutes
    • A—HUMAN NECESSITIES
    • A24—TOBACCO; CIGARS; CIGARETTES; SIMULATED SMOKING DEVICES; SMOKERS' REQUISITES
    • A24B—MANUFACTURE OR PREPARATION OF TOBACCO FOR SMOKING OR CHEWING; TOBACCO; SNUFF
    • A24B15/00—Chemical features or treatment of tobacco; Tobacco substitutes, e.g. in liquid form
    • A24B15/18—Treatment of tobacco products or tobacco substitutes
    • A24B15/24—Treatment of tobacco products or tobacco substitutes by extraction; Tobacco extracts
    • A24B15/241—Extraction of specific substances
    • A24B15/243—Nicotine
    • A—HUMAN NECESSITIES
    • A24—TOBACCO; CIGARS; CIGARETTES; SIMULATED SMOKING DEVICES; SMOKERS' REQUISITES
    • A24B—MANUFACTURE OR PREPARATION OF TOBACCO FOR SMOKING OR CHEWING; TOBACCO; SNUFF
    • A24B15/00—Chemical features or treatment of tobacco; Tobacco substitutes, e.g. in liquid form
    • A24B15/18—Treatment of tobacco products or tobacco substitutes
    • A24B15/28—Treatment of tobacco products or tobacco substitutes by chemical substances
    • A24B15/30—Treatment of tobacco products or tobacco substitutes by chemical substances by organic substances
    • A—HUMAN NECESSITIES
    • A24—TOBACCO; CIGARS; CIGARETTES; SIMULATED SMOKING DEVICES; SMOKERS' REQUISITES
    • A24B—MANUFACTURE OR PREPARATION OF TOBACCO FOR SMOKING OR CHEWING; TOBACCO; SNUFF
    • A24B15/00—Chemical features or treatment of tobacco; Tobacco substitutes, e.g. in liquid form
    • A24B15/18—Treatment of tobacco products or tobacco substitutes
    • A24B15/28—Treatment of tobacco products or tobacco substitutes by chemical substances
    • A24B15/30—Treatment of tobacco products or tobacco substitutes by chemical substances by organic substances
    • A24B15/302—Treatment of tobacco products or tobacco substitutes by chemical substances by organic substances by natural substances obtained from animals or plants
    • A24B15/303—Plant extracts other than tobacco
    • A—HUMAN NECESSITIES
    • A24—TOBACCO; CIGARS; CIGARETTES; SIMULATED SMOKING DEVICES; SMOKERS' REQUISITES
    • A24B—MANUFACTURE OR PREPARATION OF TOBACCO FOR SMOKING OR CHEWING; TOBACCO; SNUFF
    • A24B15/00—Chemical features or treatment of tobacco; Tobacco substitutes, e.g. in liquid form
    • A24B15/18—Treatment of tobacco products or tobacco substitutes
    • A24B15/28—Treatment of tobacco products or tobacco substitutes by chemical substances
    • A24B15/30—Treatment of tobacco products or tobacco substitutes by chemical substances by organic substances
    • A24B15/34—Treatment of tobacco products or tobacco substitutes by chemical substances by organic substances containing a carbocyclic ring other than a six-membered aromatic ring

Definitions

  • 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 a flavour. Further, the present disclosure relates to a method for manufacturing the oral smokeless product.
  • Smokeless products for oral use are well known in the art and include tobacco products as well as non-tobacco products.
  • Tobacco products for oral use may be offered in loose form or as portion-packed in a saliva-permeable, porous wrapper material forming a pouch enclosing a tobacco-based filling material.
  • Non-tobacco pouched products are commonly provided in the form of a filling material comprising a particulate material and/or fibers which may be plant fibers of other origin than tobacco or man-made fibers.
  • Pouched products for oral use are typically used by a consumer by placing the pouch between the upper or lower gum and the lip and retaining it there for a limited period of time. The pouch material holds the tobacco or non-tobacco filling material in place while allowing saliva to pass into the filling material and allowing flavours and active agents, e.g., nicotine to diffuse from the tobacco material into the consumer’s mouth.
  • the pouch material used in pouched products for oral use also called the packaging material, can be a dry-laid bonded nonwoven comprising viscose rayon fibres, i.e. , regenerated cellulose, and a polymer that acts as binder in the nonwoven material and contributes to sealing of the pouches during manufacturing thereof, although other types of nonwoven material may be utilized as well.
  • a dry-laid bonded nonwoven comprising viscose rayon fibres, i.e. , regenerated cellulose, and a polymer that acts as binder in the nonwoven material and contributes to sealing of the pouches during manufacturing thereof, although other types of nonwoven material may be utilized as well.
  • the pouched products for oral use are perceived by some users as being less discrete than desired as they may form an unappealing bulge when placed under the lip.
  • a further concern is that the bulky pouched products may cause discomfort, such as chafing and pressure when placed under a lip of a user.
  • compositions that are useful for delivery of various materials, such as nicotine.
  • the compositions comprise a suspension wherein an internal phase is surrounded by an external phase.
  • the suspension can be combined with a carrier and various systems and the products can be formed with the suspension.
  • Products can also be formed with the suspension and an optional carrier, such as oral strips, spray delivery systems, smokeless tobacco products, aerosol delivery devices, cigarettes, and packaging.
  • AU2012207021 discloses a smokeless tobacco product comprising a tobacco composition in an insoluble matrix.
  • Tobacco or extract from tobacco such as nicotine
  • the active ingredient may for example be applied in a dissolvable gel film which may be applied in the mouth.
  • the active ingredient may, for example, be arranged between two or several film layers.
  • the product may be a product to be applied orally as a dissolvable film.
  • tobacco may be arranged in a carrier which is arranged in a pouch, or tobacco may be arranged in the pouch material.
  • Tobacco may be applied in a porous matrix or it may be disposed on a stick or other handle.
  • the matrix may also be chewable if, for example, a tobacco slurry is disposed within a waxy structure.
  • US9402414 discloses a smokeless tobacco article including a mixture of thermoplastic polymer particles and tobacco particles. The mixture may be formed into a matrix which may be used as an oral product.
  • the satisfaction and perception of oral smokeless products will be influenced by which component(s) is/are released as well as the release rate of the active component. There is also a desire that the oral article fits well in the mouth, is comfortable and can be used discretely.
  • the products as disclosed herein are pouchless products for oral use, also referred to herein as “oral patches” and may be nicotine-containing pouchless products for oral use, the nicotine being present in the form of nicotine base and/or a nicotine salt.
  • an object of the present disclosure to provide an oral smokeless product which provides a pleasant mouth comfort, mouthfeel and/or organoleptic experience of a consumer during use.
  • Another object of the present disclosure is to provide an oral smokeless product having a satisfactory release rate of an active agent and/or flavour in the oral cavity under normal conditions.
  • the present disclosure provides an oral smokeless product in the form of an oral patch comprising a carrier and an active agent and/or a flavour, wherein the carrier is a fibrous carrier consisting of a water insoluble nonwoven material and the oral patch further comprises a thickening agent.
  • Nonwovens are fabrics that are not produced by conventional textile forming processes such as weaving or knitting. Many different methods for the manufacturing of nonwoven materials are known in the art. Further information on nonwovens may be found in “Handbook of Nonwovens” by S. Russel, published by Woodhead Publ. Ltd., 2007.
  • nonwovens may be wet-laid or may be dry- formed.
  • Dry-formed webs may be produced by methods such as carding, air-laying, spunbonding, melt-blowing, etc. If carded, the manufacturing process may result in fibres being substantially oriented in the carding direction i.e. , in the machine direction. Dry-formed nonwoven may comprise parallel laid webs, cross laid webs or randomly laid webs. Parallel laid webs and cross laid webs may include two or more superimposed web layers, which may be carded, while randomly laid webs normally include a single web layer, which may be airlaid. Several methods may be used to bond together the fibres in the web, also called web consolidation.
  • the different types of bonding methods may be classified as mechanical bonding, e.g., needle punching, stitch bonding, hydroentanglement, as chemical bonding, e.g. saturation bonding, spray bonding, foam bonding, powder bonding, print bonding and as thermal bonding, e.g., hot calendering, through-air thermal bonding, ultrasonic bonding, radiant-heat bonding. More than one bonding method may be used to consolidate the nonwoven.
  • the thickening agent may comprise alginate, gum acacia, or combinations thereof, with alginate being a preferred thickening agent.
  • Alginate may constitute from 0.5 % to 5 % by dry weight of the oral patch, preferably from 0.7 to 2.0 %.
  • the thickening agent may comprise or consist of glycerol.
  • the glycerol may constitute from 15 % to 35 % by dry weight of the oral patch, preferably from 20 % to 30 %. Glycerol may increase the softness and flexibility of the product.
  • the oral patch as disclosed herein may comprise from 0.5 % to 5 % by dry weight of alginate, preferably from 0.7 to 2.0 % by dry weight of alginate in combination with from 15 % to 35 % by dry weight of glycerol, preferably in combination with from 20 % to 30 % by dry weight of glycerol.
  • the oral patch may comprise a sugar alcohol, such as maltitol, mannitol or isomalt, or combinations of two or more different sugar alcohols.
  • a sugar alcohol such as maltitol, mannitol or isomalt, or combinations of two or more different sugar alcohols.
  • the sugar alcohol may constitute from 20 % to 45 % by dry weight of the oral patch.
  • the oral patch preferably comprises from 15 % to 35 % by dry weight of glycerol, preferably from 20 % to 30 % by dry weight of glycerol, in addition to the sugar alcohol.
  • the oral patch preferably also comprises from 0.5 % to 5 % by dry weight of alginate, preferably from 0.7 to 2.0 % by dry weight of alginate.
  • the active agent and/or the flavour may be uniformly distributed within the nonwoven carrier or may be selectively deposited in one or more parts of the nonwoven carrier.
  • the present disclosure also provides a method for manufacturing a pouchless oral smokeless product as disclosed herein, the method comprising: providing a nonwoven carrier material; providing a liquid solution comprising flavour and/or an active agent, glycerol, alginate or gum acacia and water; and applying the liquid solution to the nonwoven material.
  • the method may further include: punching out individual oral smokeless products from the nonwoven carrier material before or after application of the liquid solution to the nonwoven carrier material.
  • the carrier material may be provided with a plurality of apertures and/or cavities to facilitate impregnation of the carrier with the liquid solution, the apertures and/or cavities forming passageways into the fibrous structure of the carrier.
  • the apertures and/or cavities may further promote saliva flow into and through the oral smokeless product during use in the oral cavity of a user, which may aid in releasing flavour and/or active agent into the oral cavity of the user.
  • Fig. 1 shows a planar view of an oral smokeless product as disclosed herein;
  • Fig. 2 shows a side view of the oral smokeless product in Fig. 1 ;
  • Fig. 3 shows a perspective view of the oral smokeless in Figs. 1 and 2;
  • Fig. 4a-4f show planar views of examples of differently shaped oral smokeless products as disclosed herein.
  • a “carrier material” as used herein is a nonwoven material constituting the sole structureproviding element in the oral pouchless products as disclosed herein.
  • the carrier material is loaded with one or more active agents and/or one or more flavourings which are substances intended for transferral to the oral cavity of a user of the oral pouchless products as disclosed herein.
  • the carrier material further contains a thickening agent, such as alginate, gum acacia, glycerol, or combinations thereof.
  • a “pouchles product” or an “oral patch” are terms which are used interchangeably for the oral smokeless products disclosed herein.
  • a pouchless product or oral patch is a generally flat product which does not have an outer cover enclosing an inner filled cavity.
  • tobacco material is used herein for fibrous material of tobacco leaves or parts of leaves, such as lamina and stem.
  • the leaves and parts of leaves may be finely divided (disintegrated), such as ground, cut, shredded or threshed, and the parts of leaves may be blended in defined proportions in the tobacco material.
  • tobacco as used herein is meant any part, e.g., leaves, stems, and stalks, of any member of the genus Nicotiana.
  • the tobacco may be whole, shredded, threshed, cut, ground, cured, aged, fermented, or treated otherwise, e.g., granulated or encapsulated.
  • the pouchless oral smokeless products as disclosed herein may contain tobacco which has been added to the nonwoven carrier web in the form of a tobacco extract.
  • the tobacco extract may be obtained by soaking tobacco material in water or alcohol.
  • tobacco may be comprised in the oral smokeless products as disclosed herein by incorporating tobacco fibres in the nonwoven carrier web.
  • the pouchless oral smokeless products as disclosed herein are preferably tobacco free pouchless oral smokeless products, such as tobacco free nicotine containing pouchless oral smokeless products.
  • the nicotine compound in a nicotine containing tobacco free or low tobacco content product may be nicotine base or a nicotine salt such as nicotine hydrochloride, nicotine dihydrochloride, nicotine monotartrate, nicotine bitartrate, nicotine bitartrate dihydrate, nicotine sulphate, nicotine zinc chloride monohydrate, nicotine salicylate, nicotine benzoate or nicotine polacrilex.
  • the nicotine may be derived from tobacco material or may be synthetically produced nicotine.
  • oral and oral use is in all contexts used herein as a description for use in the oral cavity, such as by buccal placement.
  • the oral patches as disclosed herein are intended for placement within the oral cavity, such as between the gum and the upper or lower lip, such that the entire oral patch is contained in the oral cavity.
  • the pouchless products for oral use as disclosed herein are intended to be fully accommodated in the oral cavity during use and are not intended for swallowing.
  • % w/w or “wt%” or “weight %” or “% by weight” refers to the weight percent of the ingredient referred to of the total weight of the preparation, composition or product referred to.
  • an oral smokeless product 100 in the form of an oral patch comprising a carrier 101 and an active agent and/or a flavour, wherein the carrier is a fibrous carrier 101 consisting of a water insoluble nonwoven material.
  • the fibrous carrier may be impregnated with active agent and/or flavour. It is also contemplated to apply active agent and/or flavour as a coating on one or both surfaces of the fibrous carrier. Combinations of impregnation and coating are also contemplated for the oral smokeless products as disclosed herein.
  • an oral smokeless product as disclosed herein may be impregnated with a first flavour followed by coating with a second flavour, such that an initial flavour sensation may be different from a longtime flavour sensation.
  • FIG. 1 An example of an oral smokeless product or oral patch 100 is shown in Figures 1- 3.
  • the oral patch 100 which is shown in Figs. 1-3 has length I 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 the plane defined by the length direction L and the width direction W.
  • the patch in Figs. 1-3 has a modified rectangular shape with rounded corners.
  • the shape of the patch is not limiting to the oral smokeless products as disclosed herein and the patch may have any useful shape, including the shapes shown in Figs. 4a-4f.
  • the oral smokeless product of the disclosure is a thin, flexible product.
  • the thin product fits well into the consumer's mouth, and conforms to the shape of the consumer’s gums, making it highly comfortable and discrete to use.
  • a fast delivery of flavours and/or active agents will be achieved.
  • Fast delivery is promoted by the product having a large, exposed surface in relation to its volume.
  • the slimness of the pouchless oral smokeless product and the absence of a loose filling material eliminates the runniness associated with pouched smokeless tobacco products or the grittiness which may be experienced with pouched non-tobacco products having a filling material comprising particles such as microcrystalline cellulose particles.
  • the nonwoven material may comprise a biodegradable material, such as biodegradable fibres and/or a biodegradable binder. It may be preferred that the nonwoven carrier material is a biodegradable nonwoven carrier material.
  • the product may preferably be sufficiently biodegradable to meet home composting standards which may be different in different countries, e.g., 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.
  • home composting standards require the product to be broken down in a compost during the test time specified in the particular home composting standard.
  • Biodegradable products which are thrown on the ground, may disintegrate over time and eventually be integrated with the soil.
  • An advantage is that there will be less load on the environment.
  • the nonwoven material may comprise cellulosic fibres, including natural cellulosic fibres such as cotton, wood pulp, flax, hemp, etc., as well as manmade cellulosic fibres such as viscose, lyocell, and other regenerated cellulose fibres.
  • natural cellulosic fibres such as cotton, wood pulp, flax, hemp, etc.
  • manmade cellulosic fibres such as viscose, lyocell, and other regenerated cellulose fibres.
  • Cellulosic fibres have small capillaries in the fibres and the cellulosic fibres have good absorption and liquid distribution capacity. This may be an advantage when components such as a flavour and/or an active agent or active agents are applied to the nonwoven material e.g., by spraying or impregnating. Cellulosic fibres are also generally considered to be biodegradable.
  • the fibrous carrier preferably consists of a wet-laid nonwoven material, such as a wet-laid cellulosic nonwoven material.
  • a wet-laid nonwoven material has been found to have properties which are particularly suitable for use in an oral patch as disclosed herein.
  • the wet-laying process may be used to produce a fibrous web having a randomized fibre orientation, resulting in a nonwoven material with a higher surface friction than a comparative bonded carded nonwoven web which is commonly used as a pouch material in oral pouched products.
  • a high surface friction may be beneficial in that it increases the ability of an oral patch to stay in place after positioning in the oral cavity.
  • the wet method may further be advantageous due to its high production speed and low cost.
  • Wet-laid nonwoven materials are generally made from short fibres, with a fibre length in the order of from 3 mm to 25 mm, typically in the order of from 6 mm to 20 mm and with an aspect ratio (length/width) of from 300:1 to >700:1.
  • wet-laid webs are generally denser, stiffer and with lower tensile strength than webs made by dry-forming processes using longer and often curled staple-length fibres.
  • the wet-forming process may involve depositing multiple fibre layers onto each other.
  • the web may be reinforced by longer fibres or even by continuous filaments or combinations thereof.
  • the fibers in the web are preferably randomly arranged.
  • the basis weight of the wet-laid nonwoven webs may be varied within broad ranges.
  • wet-laid materials with a random fibre orientation are relatively uniform materials with low directionality, implying that the tensile strength of the material in the machine direction is in the same order as the tensile strength of the material in the cross machine direction.
  • a uniform material will also have a uniform porosity, thickness and density and will distribute water and soluble components uniformly in all directions which is an advantage both when producing the pouchless oral smokeless products as disclosed herein and during use of the oral smokeless product.
  • the fibres of the nonwoven material may comprise or consist of cellulosic fibres and the fibrous carrier may consist of wet-laid nonwoven material.
  • nonwoven materials used as pouch material for oral pouched products are commonly dry-formed, bonded carded webs with a majority of the fibres in the material arranged in the machine direction. Bonded carded webs have considerably lower tensile strength in the cross-machine direction than in the machine direction. In addition, fluid distribution in such materials will predominantly take place in the machine direction, parallel to the fibres in the material.
  • the primary functions of pouch materials are to contain a filling material in the pouch and prevent particulate material from escaping out of the pouch and into a user’s oral cavity while allowing generally unhindered passage of saliva and saliva soluble filling components through the pouch material. Therefore, the nonwoven pouch materials are thin, highly fluid permeable webs with a basis weight in the order of 15 g/m 2 to 40 g/m 2 .
  • the nonwoven material which is used as a substrate for the oral patches as disclosed herein may comprise or consist of biodegradable fibres.
  • Materials which are generally considered to be biodegradable and which are useful for the nonwoven materials as disclosed herein are natural cellulosic fibres such as cotton, flax, hemp, wood pulp; regenerated cellulose fibres such as viscose fibres and Lyocell fibres; poly hydroxy alkanoate fibres (PHA) such as poly hydroxy butyrate fibres (PHB); polybutylene succinate (PBS) fibres and polylactic acid (PLA) fibres.
  • PHA poly hydroxy alkanoate fibres
  • PBS polybutylene succinate
  • PSA polylactic acid
  • PHA fibers include PHBV (Poly(3-hydroxybutyrate-co-3-hydroxyvalerate), PHBH (Poly(3- hydroxybutyrate-co-3-hydroxyhexanoate), PH BO (poly(3-hydroxybutyrate-co-3- hydroxyoctanoate), PHBD (poly(3-hydroxybutyrate-co-3-hydroxydecanoate), P3HB (poly- 3-hydroxybutyrate) or P4HB (poly-4-hydroxybutyrate).
  • PHBV Poly(3-hydroxybutyrate-co-3-hydroxyvalerate
  • PHBH Poly(3- hydroxybutyrate-co-3-hydroxyhexanoate
  • PH BO poly(3-hydroxybutyrate-co-3- hydroxyoctanoate
  • PHBD poly(3-hydroxybutyrate-co-3-hydroxydecanoate
  • P3HB poly- 3-hydroxybutyrate
  • P4HB poly-4-hydroxybutyrate
  • the nonwoven material may comprise or consist of polymeric fibres from the group consisting of polyolefine fibres such as polypropylene (PP) fibres and polyethylene (PE) fibres; polyester fibres such as (polyethylene terephthalate (PET) fibres.
  • polyolefine fibres such as polypropylene (PP) fibres and polyethylene (PE) fibres
  • PET polyethylene terephthalate
  • Polymeric fibres as disclosed herein may be mono component fibres or multi component fibres, such as bicomponent fibers.
  • Bicomponent fibres of any of the polymers disclosed herein and/or any combination of the fibres are also contemplated for the nonwoven webs as disclosed herein.
  • nonwoven materials containing only biodegradable fibres may generally be preferred for use in the nonwoven carrier as disclosed herein.
  • the fibres may have a circular cross section or may be multi-lobal fibres, such as bi-lobal fibres, tri-lobal-fibres, etc. Multi-lobal fibres may be useful in the oral pouchless products as disclosed herein, as they may provide the oral pouchless product with a high load capacity for flavour and/or active agent.
  • the fibrous carrier may consist of a wet-laid, spun laced, spunbound, hydroentangled, bonded carded or air-laid nonwoven material. However, a wet-laid nonwoven material is generally preferred, as set out herein.
  • the fibrous carrier may comprise a binder material which may be in the form of binder fibres, such as thermoplastic binder fibres and/or which may be in the form of a resin binder. It may be preferred that the binder material is a biodegradeable material. As set out herein it may also be preferred that the fibres in the fibrous carrier are biodegradeable, such that the combination of fibres and binder material is biodegradeable.
  • the fibres of the fibrous carrier as disclosed herein may be made from a renewable raw material, such as natural cellulose fibres or regenerated cellulose fibers.
  • the present disclosure provides an oral smokeless pouchless product wherein the active agent may comprise or consist of nicotine, cannabinoid, caffeine, ginseng, taurine and/or BCAA (branched amino acids).
  • the active agent may comprise or consist of nicotine, cannabinoid, caffeine, ginseng, taurine and/or BCAA (branched amino acids).
  • Nicotine is a well-known stimulant and may be used for example as an anti-smoke agent for people trying to quit smoking.
  • the nicotine may have both sedative and stimulant effects on the body. Nicotine may give “kicks” which may be caused by nicotine stimulating the adrenal glands which results in release of adrenaline.
  • nicotine compound which is used will depend on the circumstances such as intended storage conditions for the product and/or the desired release rate.
  • nicotine present in the product in the form of nicotine base may provide a substantially immediate release and good absorption across mucosal membranes when a consumer places the product in the mouth but may be associated with poor storage stability due to oxidation and volatility. Therefore, the 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 bitartrate, nicotine bitartrate dihydrate, nicotine sulphate, nicotine zinc chloride monohydrate, nicotine salicylate, nicotine citrate, nicotine polacrilex, and any combination(s) thereof.
  • a pH adjuster may be included in the nicotine preparation so that the nicotine may be released as nicotine base in sufficient amount to allow for satisfactory absorption across the mucosal membranes when the product is placed in the oral cavity of a consumer.
  • the oral smokeless product may comprise a pH adjuster.
  • a pH adjuster as used herein is one or more substances added with the purpose to adjust and control the pH of an aqueous liquid, such as saliva when the pH adjuster is dissolved or dispersed in the aqueous liquid.
  • suitable pH adjusters to be used in the pouchless oral smokeless products disclosed herein are sodium carbonate, sodium hydroxide, potassium hydroxide, potassium carbonate, sodium carbonate, sodium bicarbonate, magnesium carbonate and any combinations thereof.
  • the amount of pH adjuster may be selected such that the product described herein, when immersed in purified water provides a pH above about 6.0 such as above about 7.0, such as pH within the range of from about 7.0 to about 10.0 or pH within the range of from about 8.0 to about 9.0, such as pH within the range of from about 8.3 to about 8.7.
  • the pH is determined by placing a sample having a weight of 5g ⁇ 0.1g in a 150 ml glass beaker to which 100 ml deionized water is added. The immersed sample is stirred for 5 to 10 minutes, taking care to adjust the stirring speed to avoid the formation of a vortex. The pH is then measured by submerging a pH meter electrode into the solution.
  • cannabidiol is a well-known stimulant the use of a cannabinoid such as cannabidiol as an active agent in oral smokeless products is more recent.
  • the cannabinoids are chemical compounds found in the cannabis plant.
  • the most well-known cannabinoid is tetrahydrocannabinol (THC), which has a psychotropic effect capable of affecting the mind, behaviour and/or emotions of an individual taking it.
  • THC tetrahydrocannabinol
  • CBD cannabidiol
  • Cannabidiol constitutes up to 40% of the cannabis plant.
  • Cannabidiol C21H30O2 may be extracted from the Cannabis plant or may be prepared synthetically.
  • Cannabidiol has shown to have e.g., anti-depressive effect, calming effect, anti-anxiety effect, sleep promoting effect, anti-inflammatory effect and antipsychotic effect. Further, cannabidiol has been shown to be effective in reduction of tobacco and/or nicotine addiction. Cannabidiol has been used in pharmaceutical compositions for antiepileptic effect and is also believed to be useful for treating diseases such as Parkinson disease and Crohn disease.
  • the cannabinoids contemplated for the oral smokeless products as disclosed herein may be one of 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), cannabielsoin (CBE) and cannabicitran (CBT).
  • THC tetrahydrocannabinol
  • THCA tetrahydrocannabinolic acid
  • CBD canna
  • the cannabinoid described herein may be a non-psychotropic cannabinoid, i.e. , a cannabinoid that is free from psychotropic effects.
  • non-psychotropic cannabinoids include cannabidiol (CBD) and cannabigerol (CBG).
  • CBD cannabidiol
  • the nonpsychotropic cannabinoid may be cannabidiol (CBD) such as a (-)-enantiomer, a (+)- enantiomer or a racemic mixture of cannabidiol (CBD).
  • non-psychotropic cannabinoid may be in the form of industrial hemp comprising no tetrahydrocannabinol (THC) or a low concentration of THC such as 0.5 wt% or lower based on the total weight of the industrial hemp.
  • THC tetrahydrocannabinol
  • the present disclosure also encompasses derivatives of a cannabinoid as described herein.
  • one or more hydroxyl groups present in the compound may be alkylated or acylated.
  • Caffeine is also a well-known stimulant which may be used as an active agent in the oral smokeless product as disclosed herein.
  • active agents which may be used in an oral smokeless product as disclosed herein are ginseng, taurine and branched-chain amino acids (BCAA).
  • the oral smokeless product may comprise a combination of any of the active agents as disclosed. Some of the active agents may be useful together.
  • the oral smokeless product may comprise nicotine in amount of 1 mg to 25 mg, preferably 1 mg to 10 mg or more preferably 2mg to 8 mg.
  • the active agent may comprise or consist of nicotine in the form of nicotine base or nicotine salt.
  • the nicotine salt may be selected from the group consisting of nicotine polacrilex, nicotine hydrochloride, nicotine dihydrochloride, nicotine monotartrate, nicotine bitartrate, nicotine bitartrate dihydrate, nicotine sulphate, nicotine zinc chloride monohydrate, nicotine salicylate, nicotine citrate, and any combination(s) thereof.
  • the present disclosure may provide an oral smokeless product comprising a flavourant.
  • a flavourant as known in the art may be used, including fruit flavours such as lemon, apple, mango, banana, pear, orange, strawberry, hazelnut, etc. as well as, menthol flavour, coffee flavour, tobacco flavour, liquorice flavour, Wintergreen flavour, etc.
  • the present disclosure may provide a fast and improved release of a flavour which is achieved with the thin oral smokeless product as disclosed herein.
  • the present disclosure may provide an oral smokeless product wherein the oral smokeless product is free from tobacco.
  • the oral smokeless product may comprise a fibrous carrier which is a single-layer nonwoven material.
  • a single-layer nonwoven material as disclosed herein is a coherent consolidated fibrous nonwoven web.
  • the single-layer nonwoven web may be homogeneous in the thickness direction or may contain strata of different composition and/or of different density.
  • a single layer material produces a coherent oral smokeless product with no risk of delamination.
  • a generally homogeneous porous nonwoven material constitutes a carrier which can be efficiently loaded with active agent and/or flavour and which provides good fluid distribution in all directions of the carrier material.
  • a single-layer material is preferred over laminates of multiple layers as it provides an oral patch having better flexibility and conformability than laminated materials.
  • the oral smokeless product may have a thickness of from 0.2 to 5 mm, such as from 0.5 to 4 mm, such as from 0.8 to 3 mm, such as from 1.0 mm to 2.0 mm, such as from 1.0 mm to 1.5 mm, such as from 1.0 mm to 1.4 mm. It may be particularly preferred that the thickness of the oral smokeless product is from 0.7 mm to 1.5 mm.
  • the thickness of an oral smokeless product as disclosed herein is measured using the EDANA WSP120.6(5) method at an applied pressure of 0.5 kPa and with a diameter of the probe of 57 mm.
  • the nonwoven material of the carrier of the oral smokeless product as disclosed herein may have a basis weight of from 70 g/m 2 to 300 g/m 2 , such as from 70 g/m 2 to 200 g/m 2 , from 70 g/m 2 to 200 g/m 2 or from 70 g/m 2 to 150 g/m 2 .
  • the weight of the carrier is the dry weight of the carrier.
  • the nonwoven material of the carrier of the oral smokeless product as disclosed herein has a basis weight in the range of from 100 g/m 2 to 200 g/m 2 .
  • the nonwoven carrier material preferably has a non-folded basis weight in the range of from 50 g/m 2 to 100 g/m 2 . After double folding of the nonwoven carrier material the folded basis weight will be in the range of from 100 g/m 2 to 200 g/m 2 .
  • the dry weight of the carrier may be from 0.02 g to 0.5 g, such as from 0.05 g to 0.3 g, preferably from 0.05 g to 0.2 g, and more preferred from 0.04 g to 0.1 g.
  • the oral pouchless product may have a dry weight of from 0.1 g to 1.0 g, preferably from 0.1 g to 0.5 g.
  • the product comprises the nonwoven web constituting the carrier, the applied thickening agent, active agent(s) and/or flavour(s), and any further additive as disclosed herein.
  • the weight of the product may be up to about 7 times the weight of the carrier..
  • the fibres of the fibrous carrier may have a linear density of 0.5 dtex-5.0 dtex, such as from 1.0 dtex to 3.0 dtex.
  • the oral smokeless pouchless product may have an area in the X-Y-plane of 1.0 cm 2 to 8 cm 2 , preferably from 1.0 cm 2 to 5 cm 2 and more preferred from 1.5 cm 2 to 4 cm 2 .
  • An oral pouchless product which is configured for folding into a smaller format may have an area which is e.g., twice the area of a corresponding pouchless product which is configured for being used in a non-folded state.
  • the present disclosure may provide an oral smokeless product, wherein the oral smokeless product has an oblong shape with the length as measured in the length direction being greater than the width, as measured in the width direction, wherein the oral smokeless product has a maximum width of 5 mm to 40 mm, such as 7 mm to 30 mm or 8 mm to 20 mm in the width direction, and a maximum length of 10 mm to 70 mm, such as 15 mm to 50 mm or 20 mm to 35 mm in the length direction.
  • the smaller widths apply to the oral smokeless products having the smaller lengths and the greater widths apply to the oral smokeless products having the greater lengths to obtain the oblong shape.
  • the oral smokeless product has an oblong shape with a maximum width within the range of from 8 to 20 mm and a maximum length within the range of from 20 mm to 35 mm.
  • the thickness of these products is preferably within the range of from 0.7 mm to 1.5 mm.
  • Such preferred dimensions also apply to oral smokeless pouchless products which are intended for folding into a use configuration, the dimensions then being applicable to the folded configuration of the oral smokeless pouchless product.
  • the oral patch 100 as disclosed herein may have a shape that indicates the flavour, such as a lemon shape for a lemon flavour, a banana shape for banana flavour, a coffee bean shape for coffee flavour, etc.
  • a lemon shaped oral patch 100a is shown in Fig. 4a
  • a coffee-bean shaped oral patch 10Of is shown in Fig. 4f.
  • any suitable shape such as any geometric shape including triangular, circular, rectangular, oval, dog-bone shape, etc., as well as decorative shapes such as a heart-shape, a leaf shape, a flower shape, a flash shape, a boomerang shape, or a drop-shape.
  • a logo shape may be used to indicate commercial origin of the product.
  • a leaf shaped oral patch may enhance the environment friendly aspects 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 a user’s gum and upper or lower lip.
  • the nonwoven carrier material of the oral patch as disclosed herein may have been physically modified by having been provided with perforations, cavities or embossings made in the nonwoven carrier material.
  • the perforations, cavities or embossings may be purely decorative, or may have a functional purpose in addition to altering the visual impression of the oral patch.
  • Perforations or cavities in the nonwoven carrier material may serve to increase impregnability of the carrier material by forming passageways for impregnating liquid to penetrate into the fibrous structure.
  • the perforations may also promote saliva flow through the oral patch during use and aid in rapid release into the saliva of an active agent and/or flavour from the patch.
  • Such fluid flow enhancing perforations may be distributed over the surface of the carrier material and may be arranged in a pattern.
  • leaf nerves 102 are indicated in the leaf-shaped oral patch 100b which is shown in Fig. 4b.
  • the leaf nerves 102 may be embossed lines or cuts made completely or partly through the nonwoven carrier material.
  • the embossed lines may serve as bend indications, increasing the flexibility of the oral patch along the embossed lines.
  • Embossed lines may also promote fluid transport along the embossed lines where the fibrous structure of the nonwoven carrier material has been compacted, thus creating thinner capillaries between the fibres in the embosses lines.
  • a compacted fibrous structure such as a compacted structure formed by embossing has, finer capillaries than the surrounding non-compacted fibrous structure.
  • a part of the oral patch having a compacted fibrous structure with fine capillaries will drain liquid from parts of the fibrous nonwoven carrier material which has not been compacted.
  • a compacted part of the oral patch will release liquid and active agent in the liquid at a lower rate than less compact parts of the oral patch.
  • This effect of embossings may be used to control the release rate of an active agent in the oral patch and prolong the time period during which active agent is released when the oral patch is placed in a user’s mouth.
  • Partial or complete cuts through the nonwoven carrier material may serve to increase flexibility and thereby the conformability of the oral patch. Cuts and embossings may be used in combination to control liquid distribution and flexibility of the oral patch.
  • the oral patch as disclosed herein may be provided with printed decorations, text, etc.
  • Print may be used alone or in combination with mechanical modifications of the nonwoven carrier material in the oral patch, such as embossings, perforations or cavities formed in the surface of the nonwoven carrier material.
  • the heart-shaped oral patch 100d which is shown in Fig. 4d, has an embossed line 103 extending centrally in the longitudinal direction L of the oral patch 100d.
  • the embossed line 103 is a bend indication along which the oral patch 100d can be folded by a user to create a smaller but thicker patch having two superposed layers of the nonwoven carrier material.
  • Fig. 4e shows an elongated strip 100e of nonwoven carrier material comprising three perforation lines 104 dividing the elongated strip 100e into four portions 100e’, 100e”, 100e”’, 100e””.
  • the elongated strip 100e can be torn along one or more of the perforation lines 104 to create oral patches having a smaller size than the elongated strip 100e.
  • perforation lines 104 may alternatively be used as fold indications, along which the elongated strip may be folded into a thicker, multi-layered structure.
  • a further option may be to sever the strip along e.g., the central perforation line 104. The two parts of the strips may then be double folded along the intact perforation line remaining in each of the two parts.
  • a multi-patch product may take other forms than the elongated strip shown in Fig. 4e, such as a sheet of nonwoven carrier material which can be divided into multiple individual oral patches, or as a roll of nonwoven carrier material from which individual oral patches may be torn or cut.
  • the fibrous carrier of the oral smokeless product as disclosed herein may comprise a chemical binder, wherein the chemical binder preferably is a biodegradable and/or biobased binder according to the standard ISO/AWI 20200 Plastics.
  • ISO/AWI 20200 Plastics relates to determination of the degree of disintegration of plastic materials under simulated composting conditions in a laboratory test.
  • biodegradable and/or biobased binder when the fibrous carrier comprises biodegradable fibres.
  • binders are possible to use, such as polyester.
  • an environment friendly binder such as a biodegradable and/or biobased binder.
  • a carrier having a basis weight in the order of 70 g/m 2 to 150 g/m 2 may have an air permeability of 500 l/m 2 /sec to 2000 l/m 2 /sec.
  • the absorption capacity of the carrier may be from 500% to 800% of the dry weight of the carrier web.
  • Water absorption capacity is measured according to a method based on SS-EN ISO 12625-8:2006, with the modification that after submerging the sample in water, the sample is subjected to a negative pressure of 80kPa for 10 minutes, to ascertain that the carrier web is completely wet through. When the submerged material has been fully saturated with water, the sample is removed from the water and is allowed to drain for 2 minutes, followed by weighing.
  • a high absorption capacity may be desired as is allows the carrier to absorb a large quantity of a liquid containing thickening agent, active agent and/or flavour.
  • Impregnation of the carrier nonwoven may be facilitated by the addition of a surfactant in the nonwoven manufacturing process or when producing the fibres for the nonwoven web.
  • a way of increasing load capacity of the nonwoven web may be by using multilobal fibres which may contain active agent and/or flavour in the capillaries formed between the lobes on the surface.
  • the multilobal fibres may be regenerated cellulose fibres such as viscose or lyocell fibres.
  • the carrier nonwoven webs as disclosed herein may have a bending stiffness of from 2 N to 35 N as measured according to the Circular Bend Procedure in ASTM D4032 - 08 (Reapproved 2016) with the modification that the tests were performed on single-ply samples.
  • the oral pouchless products as disclosed herein are preferably relatively stiff in a dry condition, making the un-used product easy to handle and to place in the oral cavity. Upon wetting with saliva in the oral cavity, the product softens and becomes limp and conforms to the user’s gums.
  • the present disclosure further provides a method for manufacturing an oral smokeless product as disclosed herein, the method comprising: providing a nonwoven carrier material; providing a liquid solution comprising flavour and/or an active agent, glycerol, thickening agent such as alginate or gum acacia, water and optionally food colour; applying the liquid solution to the nonwoven carrier material.
  • the method may further include: punching out individual oral smokeless patches from the nonwoven carrier material.
  • the individual oral smokeless patches may be punched out before or after application of the liquid solution to the nonwoven carrier material.
  • the method may further comprise providing an aqueous solution comprising an active agent and water, and applying the aqueous solution to the nonwoven carrier material or to punched-out individual oral smokeless patches.
  • a liquid flavour solution in a separate step from a step of applying an aqueous solution comprising an active agent to the nonwoven carrier web.
  • an active agent separate from adding flavouring, sweeteners, pH regulators, etc.
  • the active agent is often a highly potent substance, such as nicotine, and needs to be handled with particular care in a production process.
  • the method of application of the active agent may be different from the method of application of a flavour solution.
  • Application of the flavour solution may e.g., be made by soaking the nonwoven carrier web in the flavour solution, by pressing or drawing the flavour solution into the nonwoven carrier web or by spraying the flavour solution onto the carrier web.
  • the active agent may e.g., be applied as drops on the nonwoven carrier web, may be sprayed onto the nonwoven carrier web, or may be injected into the nonwoven carrier web.
  • the liquid solution may be applied to the nonwoven carrier by soaking the nonwoven carrier web in the liquid solution, by pressing or drawing the liquid solution into the nonwoven carrier web or by spraying the liquid solution onto the carrier web.
  • the liquid solution comprises a thickening agent, such as alginate, gum acacia, glycerol or combinations thereof
  • impregnation of the nonwoven carrier web with the liquid solution may require that the liquid solution is pressed, injected or drawn by suction into the nonwoven carrier web.
  • An example of an aqueous solution comprising nicotine as an active agent and water is disclosed below.
  • the premix in this case comprises 20.0 % nicotine, 60.0 % glycerol, 10% water and 10% tartaric acid.
  • the amount of nicotine or other active agent present in the oral smokeless product as disclosed herein may be varied by varying the amount of premix in the aqueous solution.
  • the amount of premix in the aqueous solution may be from 20 wt% to 100 wt% depending on the desired content of active agent in the oral smokeless product. If 100 % premix is used, the solution may need to be pH stabilized with a higher concentration of pH regulator, such as KOH or any other suitable pH regulator as disclosed herein.
  • the active agent may comprise or consist of nicotine, cannabinoid, caffeine, ginseng, taurine and/or branched amino acids (BCAA).
  • the active agent may comprise or consist of nicotine and the aqueous solution comprising the nicotine may further comprise a pH regulator such as KOH.
  • the method disclosed herein may comprise the steps of impregnating the carrier nonwoven material with the liquid flavour solution by immersing the carrier nonwoven material in a bath of the liquid flavour solution, applying a mechanical pressure on the carrier nonwoven material; and drying the carrier nonwoven material.
  • the method may further comprise a step of: applying the aqueous solution of the active agent to the carrier nonwoven material after the step of drying the carrier nonwoven material.
  • the carrier nonwoven material may be impregnated with the liquid flavour solution while in the form of a coherent nonwoven carrier web. Subsequently, the aqueous solution of the active agent may be applied to the dried coherent nonwoven carrier web.
  • the carrier nonwoven material may be impregnated with the liquid flavour solution while in the form of punched-out or cut-out individual nonwoven material patches and the aqueous solution of the active agent may subsequently be applied to the dried nonwoven material patches.
  • a further alternative is that the carrier nonwoven material is impregnated with the liquid flavour solution while in the form of a coherent nonwoven carrier web and subsequently subjected to cutting or punching to form individual nonwoven material patches.
  • the drying step after application of the liquid flavour solution may be carried out before or after cutting or punching the continuous web to form the individual nonwoven material patches.
  • the dry individual nonwoven material patches may then be subjected to application of the aqueous solution containing the active agent.
  • the cutting step is a final step which is performed after application of all additives to the nonwoven carrier web.
  • the cutting step may be performed before or after drying of the impregnated nonwoven carrier web.
  • the method may comprise a step of expelling excess liquid after application of the liquid flavour solution to a coherent web of nonwoven carrier material by passing the coherent web of impregnated nonwoven carrier material between rotating opposing rollers and/or by scraping off excess liquid; drying the coherent web of impregnated nonwoven carrier material, such as by air drying.
  • the active agent By adding an active agent such as nicotine in a production step separate from impregnating the nonwoven carrier web with a solution containing flavour and a thickening agent, the active agent can be locally applied only within the areas where the individual patches are cut out from the impregnated nonwoven web. Thereby, there will be no nicotine or other active agents in portions of the coherent nonwoven web which are cut-away and discarded when individual patches are punched-out or cut-out from the coherent nonwoven web. Handling of such waste material containing a potentially harmful active agent must be made with care, avoiding exposure of machine operating personnel to the active agent. There is also an environmental aspect which must be considered when disposing of materials containing potentially harmful chemicals.
  • the oral smokeless product as disclosed herein may be delivered to a consumer in other forms than as a punched-out or cut-out patch.
  • the oral smokeless product may be delivered to a consumer in the form of a band, strip, or sheet from which individual oral smokeless products may be separated by the consumer, e.g., by tearing or cutting.
  • the band, strip or sheet may be provided with separation means such as perforations, tear notches, partial cuts, etc.
  • Conventional pouched oral smokeless products may be unsatisfactory or unappealing to some users or may be unsatisfactory in some situations where it would be desirable to be able to use the product discreetly.
  • the conventional pouched products are bulky and may be difficult to use inconspicuously under the lip.
  • a non-tobacco composition containing an active agent such as nicotine or a tobacco composition is filled in a nonwoven pouch which is commonly sealed in a lengthwise extending body seam and two end seams, forming a pillow-like product having a thickness in the order of 5 mm.
  • the seams are usually formed by adhesive, thermo-welding or ultrasonic welding and contain consolidated, stiffened material which may cause discomfort and may feel abrasive against the mucous membrane of the gums and the inside of the lip.
  • the nonwoven material constitutes the sole carrier of the thickening agent and the active agent and/or flavours and defines the thickness and the volume of the oral smokeless product.
  • the oral smokeless product as disclosed herein is in the form of a patch, the product is free from any seams.
  • the pouchless oral smokeless product as disclosed herein is highly discrete and inconspicuous, as well as being more comfortable to use in the mouth as it may conform almost perfectly to the shape of the user’s gums
  • the oral smokeless product as disclosed herein does not suffer from the runniness caused by the “snus-juice” that ordinary snus/nicotine pouch products produce when contacted by saliva in a user’s mouth.
  • the delivery of flavour and active agent will also be enhanced due to the thinness of the product and the large, exposed surface in relation to the volume of the product.
  • the thin oral pouchless product provides a fast release of nicotine, simulating the nicotine delivery experienced when smoking a cigarette. This may be particularly appreciated by people using the product as an aid in quitting smoking.
  • a biodegradable product is advantageous for many reasons. It is advantageous for the environment that the product is biodegradable so it can be recycled as compost, preferably in a home-composting environment.
  • the used product is in the form of a soft, thin sheet or patch of a nonwoven material which will be spitted out and discarded after use. Biodegradability of the products may mitigate the negative effects of littering in that products which are unintentionally or intentionally dropped on the ground will degrade and disintegrate over time.
  • the pouchless product as disclosed herein is preferably made from biodegradable and preferably also biobased materials. As set out herein, it may be particularly preferred that the product is degradable under home composting conditions. However, it may be sufficient that the product meets industry compost standards, as a used, discarded product may then be sorted together with other industry compostable materials.
  • the nonwoven materials available as the carrier material can be freely chosen based on criteria such as biodegradability, softness, hydrophilicity, absorption capacity, etc.
  • the product disclosed herein is resource and cost effective as no filler such as snus, microcrystalline cellulose (MCC), botanical fibres and similar components are needed. Further, transport boxes and user packages can be made smaller.
  • the oral smokeless product as disclosed herein may have an oblong form with a length in a length direction and a width in a width direction.
  • the oral smokeless product may have a shape and size which is adapted to the available surface of a user’s gum under the upper lip and in the mouth. As the shape and size of the gums differ between users, the oral smokeless product may be provided in different sizes and/or in different shapes to meet different user needs.
  • the smokeless oral product may have rounded edges and may be free from sharp corners.
  • the second material was a dry laid nonwoven of 30 g/m 2 : Static CoF: 0,15, Dynamic CoF: 0,06.
  • the higher values for the wet-laid nonwoven indicate a better stay-in-place property for a patch made from a wet-laid material.
  • Extraction tests for nicotine extraction were made on nonwoven patches according to the invention and 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 , 100 g/m 2 , 150 g/m 2 and 200 g/m 2 .
  • the carrier nonwoven material was made of 1.7 dtex viscose fibres bonded with a chemical binder.
  • the patches labelled NIL 1 were leaf-shaped with an average dry weight of 0.17 g per product.
  • the patches labelled NIL 2, 3, 4 and and 5 were crescent-shaped with an average dry weight as set out in Table 1.
  • the reference products were conventional pouched non-tobacco products: Zyn dry ® (3 mg nicotine) and Zyn slim ® (9 mg nicotine) from Swedish Match.
  • the reference product labelled “P” was an oral pouched non-tobacco product, having a filling comprising a substrate material of particles of microcrystalline cellulose having an average particle size of 700 pm.
  • the participants in the in vivo extraction study were handled 3 replicates, selected to hold same weight, of nonwoven patches which were stored in individual vials.
  • the participants were instructed to use the set of products, restricted to one per day usage, for the stipulated time period (5, 10, 15 or 30 min), ensuring not to eat or drink during the usage, whereafter the products were removed from under the lip and directly put in new vials with a pair of tweezers and thereafter put in the freezer.
  • the used products were analyzed for nicotine content per unit from which a calculation of the nicotine extraction was performed.
  • the tested samples were impregnated in a solution containing glycerol, sodium alginate, 42% water and maltitol followed by dispensing a nicotine premix solution to obtain the final nicotine amount/unit.
  • the NIL 2-5 samples had an approximate glycerol content of 23 % by dry weight, an approximate alginate content of 1 % by dry weight, and a maltitol content of approximately 30-35 %.
  • the nicotine extraction for the nicotine patch NIL 1 according to the invention was both faster and more complete after a 30-minute test period, than for the traditional pouched non-tobacco products Zyn dry 3 mg and Zyn slim 9 mg.
  • NIL 2 having a basis weight of 70 g/m 2 was found to have released almost three times as much of the nicotine in the patch after having been used for 10 minutes, as compared to the NIL 3 and NIL 5 patches having a basis weight of 150 g/m 2 and 200 g/m 2 , respectively.
  • the amount of nicotine which had been extracted after 10 minutes from the perforated, 150 g/m 2 patch NIL 4 was found to be somewhat higher than for the corresponding non-perforated patch NIL 3, indicating that perforation of the carrier nonwoven may improve nicotine release from the oral patch.
  • the water absorption capacity of wet-laid viscose nonwoven webs corresponding to the webs used to prepare the NIL 1 , 3 and 5 samples, as well as a wet-laid viscose nonwoven web having a basis weight of 250 g/m 2 was measured according to SS-EN ISO 12625- 8:2006, with the modification that the carrier material/substrate was subjected to a negative pressure of 80 kPa for ten minutes whilst being submerged in water.
  • Sample preparation 5 pieces having a total weight of 5 grams were cut from each tested nonwoven web. The 5 pieces of material were loosely rolled together and placed in a test basket as specified in SS-EN ISO 12625-8:2006. The test basked was placed in a container with water with the whole basket and the sample beneath the water surface.
  • the container with the test basket and the sample was placed in a vacuum chamber and a pressure of -80 kPa was applied for 10 minutes.
  • the test basket was then lifted out of the water and allowed to drip off for 2 minutes.
  • the absorption capacity for a sample was determined as the weight of the wet sample in percent of the dry weight of the sample and was found to be similar for all tested materials:
  • the absorption capacity of the carrier nonwoven material used as a substrate in the oral patches as disclosed herein is preferably in the range from 500% to 800% of the dry weight of the carrier web.
  • the tested webs were:
  • the oral patches as disclosed herein are relatively stiff in an un-used condition, having an average stiffness higher than the stiffness of the dry nonwoven carrier web, such that the oral patches are easy to take out of a container and to place in the oral cavity.
  • the stiffness of an oral patch as disclosed herein is increased by the presence in the carrier web of thickening agents such as alginate and gum acacia as well as sugar alcohols such as mannitol, maltitol, isomalt, etc. While contributing to the stiffness of the product in the pre-use stage, alginates and gum acacia soften and become gelatinous when wet and the sugar alcohols dissolve in saliva, resulting in a product with increased flexibility and conformability.
  • a carrier nonwoven material comprising cellulosic fibers, such as a nonwoven web of viscose fibers will become limp upon wetting, thus further contributing to increasing flexibility and conformability of the oral patch during use. It was reported by the test persons in Example 1 , that the NIL 2 products made from the 70 g/m 2 were less preferred in that they became very flimsy and difficult to remove after use.

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Abstract

La présente invention concerne un produit oral sans fumée sous la forme d'un timbre oral comprenant un agent épaississant, un excipient, et un agent actif et/ou un support, le support étant un support fibreux constitué d'un matériau non tissé insoluble dans l'eau. La présente invention concerne également un procédé de fabrication du produit oral sans fumée, le procédé comprenant : - la fourniture d'un matériau non tissé ; - la fourniture d'une solution d'arôme liquide comprenant un arôme, du glycérol, de l'alginate ou de la gomme d'acacia, de l'eau et éventuellement un colorant alimentaire ; - l'application de la solution d'arôme liquide sur le matériau non-tissé ; et éventuellement - la découpe à la matrice de produits oraux sans fumée individuels dans le matériau en feuille non-tissé.
PCT/EP2022/084548 2021-12-07 2022-12-06 Produit oral sans fumée comprenant un agent actif et/ou un arôme WO2023104774A1 (fr)

Priority Applications (5)

Application Number Priority Date Filing Date Title
CN202280081041.0A CN118647285A (zh) 2021-12-07 2022-12-06 包含活性剂和/或香料的口含型无烟产品
EP22830259.2A EP4444113A1 (fr) 2021-12-07 2022-12-06 Produit oral sans fumée comprenant un agent actif et/ou un arôme
CA3239405A CA3239405A1 (fr) 2021-12-07 2022-12-06 Produit oral sans fumee comprenant un agent actif et/ou un arome
KR1020247019997A KR20240118783A (ko) 2021-12-07 2022-12-06 활성제 및/또는 향미제를 포함하는 구강 무연 제품
CONC2024/0007632A CO2024007632A2 (es) 2021-12-07 2024-06-18 Un producto oral sin humo que comprende un agente activo y/o un saborizante

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
EP21212931.6A EP4193849A1 (fr) 2021-12-07 2021-12-07 Produit oral sans fumée comprenant un agent actif et/ou un arôme
EP21212931.6 2021-12-07

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WO2023104774A1 true WO2023104774A1 (fr) 2023-06-15

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PCT/EP2022/084548 WO2023104774A1 (fr) 2021-12-07 2022-12-06 Produit oral sans fumée comprenant un agent actif et/ou un arôme

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