EP4193849A1 - 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
EP4193849A1
EP4193849A1 EP21212931.6A EP21212931A EP4193849A1 EP 4193849 A1 EP4193849 A1 EP 4193849A1 EP 21212931 A EP21212931 A EP 21212931A EP 4193849 A1 EP4193849 A1 EP 4193849A1
Authority
EP
European Patent Office
Prior art keywords
oral smokeless
carrier
oral
nonwoven
smokeless product
Prior art date
Legal status (The legal status 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 status listed.)
Pending
Application number
EP21212931.6A
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German (de)
English (en)
Inventor
Linnea SEILER
Elfstrand Andreas
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Swedish Match North Europe AB
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 EP21212931.6A priority Critical patent/EP4193849A1/fr
Priority to PCT/EP2022/084548 priority patent/WO2023104774A1/fr
Publication of EP4193849A1 publication Critical patent/EP4193849A1/fr
Pending legal-status Critical Current

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    • AHUMAN NECESSITIES
    • A24TOBACCO; CIGARS; CIGARETTES; SIMULATED SMOKING DEVICES; SMOKERS' REQUISITES
    • A24BMANUFACTURE OR PREPARATION OF TOBACCO FOR SMOKING OR CHEWING; TOBACCO; SNUFF
    • A24B13/00Tobacco for pipes, for cigars, e.g. cigar inserts, or for cigarettes; Chewing tobacco; Snuff
    • AHUMAN NECESSITIES
    • A24TOBACCO; CIGARS; CIGARETTES; SIMULATED SMOKING DEVICES; SMOKERS' REQUISITES
    • A24BMANUFACTURE OR PREPARATION OF TOBACCO FOR SMOKING OR CHEWING; TOBACCO; SNUFF
    • A24B15/00Chemical features or treatment of tobacco; Tobacco substitutes, e.g. in liquid form
    • A24B15/10Chemical features of tobacco products or tobacco substitutes
    • A24B15/16Chemical features of tobacco products or tobacco substitutes of tobacco substitutes
    • AHUMAN NECESSITIES
    • A24TOBACCO; CIGARS; CIGARETTES; SIMULATED SMOKING DEVICES; SMOKERS' REQUISITES
    • A24BMANUFACTURE OR PREPARATION OF TOBACCO FOR SMOKING OR CHEWING; TOBACCO; SNUFF
    • A24B15/00Chemical features or treatment of tobacco; Tobacco substitutes, e.g. in liquid form
    • A24B15/18Treatment of tobacco products or tobacco substitutes
    • A24B15/28Treatment of tobacco products or tobacco substitutes by chemical substances
    • A24B15/30Treatment of tobacco products or tobacco substitutes by chemical substances by organic substances
    • A24B15/302Treatment of tobacco products or tobacco substitutes by chemical substances by organic substances by natural substances obtained from animals or plants
    • A24B15/303Plant extracts other than tobacco

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 products are commonly provided in the form of a filling material comprising a particulate material and/or fibres which may be plant fibres of other origin than tobacco or man-made fibres.
  • 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.
  • 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.
  • 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 products as disclosed herein may be nicotine-containing products for oral use, the nicotine being present in the form of nicotine base and/or a nicotine salt.
  • WO 2012/134380 discloses an oral pouched nicotine product in which the low nicotine absorption rate through the mucosal membranes is improved by incorporation of a pH adjusting agent which converts nicotine salt into nicotine base in situ.
  • 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.
  • 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.
  • the active agent and/or the flavour may be uniformly distributed within the carrier or may be selectively deposited in one or more parts of the carrier.
  • the present disclosure also provides a method for manufacturing an oral smokeless product as disclosed herein, the method comprising:
  • the method may further include:
  • the carrier material may be provided with a plurality of apertures and/or cavities to facilitate impregnation of the carrier with the flavour 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.
  • 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 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 oral smokeless products as disclosed herein are preferably tobacco free oral smokeless products, such as tobacco free nicotine containing oral smokeless products.
  • the nicotine compound in a nicotine containing tobacco free or low tobacco content composition 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 implying a use of the products disclosed herein in the oral cavity, such as by buccal placement.
  • the products are, thus, intended for placement within the oral cavity, such as between the gum and the upper or lower lip, such that the entire product is contained in the oral cavity.
  • the 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 concerned.
  • 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 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 long-time 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 oral smokeless product and the absence of a filler composition eliminates the runniness associated with conventional 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.
  • the product may preferably be sufficiently biodegradeable 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.
  • 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, etc.
  • 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 may consist of a wet-laid nonwoven material.
  • a wet-laid nonwoven material has been found to have properties which are particularly suitable for oral use.
  • the pouch material used in oral pouched products is commonly a bonded carded nonwoven web, made from staple length fibres, e.g., viscose fibres.
  • the wet method may 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 6 mm to 40 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 fibres.
  • multiple fibre layers may be deposited onto each other, the web may be reinforced by longer fibres or even by continuous filaments or combinations thereof.
  • the fibres in the web may be randomly arranged or may be longitudinally arranged in a machine direction of the material which is the direction corresponding to the running direction of the machine in which the web is produced.
  • 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 oral smokeless products as disclosed herein and during use of the oral smokeless product.
  • the fibres of the nonwoven material may comprises cellulosic fibres and the fibrous carrier may consist of wet-laid nonwoven material.
  • the nonwoven material 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 fibres 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).
  • 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
  • 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 fibres.
  • 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 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 may be 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 fibres.
  • 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 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 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 C 21 H 30 O 2
  • Cannabidiol 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 antipsycotic 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 non-psychotropic 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.
  • ginseng ginseng, taurine and branched-chain amino acids (BCAA).
  • BCAA branched-chain amino acids
  • 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.
  • the oral smokeless product may comprise a fibrous carrier which is a multi-layer nonwoven material.
  • a multi-layer nonwoven material is implied a material which is a laminate formed from separately produced layers of nonwoven material which have been superposed and subsequently subjected to a bonding operation to bind the layers together.
  • the oral smokeless product may have a thickness of 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 a pressure of 0.5 kPa and with a diameter of the probe of 57mm.
  • the nonwoven material of the carrier of the oral smokeless product as disclosed herein may have a basis weight of 70 g/m 2 to 300 g/m 2 , such as 70 g/m 2 to 200 g/m 2 , 70 g/m 2 to 200 g/m 2 or 70 g/m 2 to 150 g/m 2 .
  • the weight of the carrier is the dry weight of the carrier.
  • the dry weight of the carrier may be 0.02 g to 0.5 g, such as 0.05 g to 0.3 g or preferably 0.05 g to 0.2 g.
  • the product may have a dry weight of 0.1 g to 1.0 g.
  • the product comprises the nonwoven web constituting the carrier and active agents and/or flavours.
  • the weight of the product may be up to about 7 times the weight of the carrier.
  • a major part of the weight of the product may be the weight of the active agent and/or the flavour.
  • 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 product may have a surface area of 1.0 cm 2 to 8 cm 2 , preferably from 1.0 cm 2 to 5 cm 2 .
  • 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 products which are intended for folding into a use configuration, the dimensions then being applicable to the folded configuration of the oral smokeless 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 100f 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 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.
  • 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 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. If torn along all three perforation lines 104, four oral patches 100e′, 100e ⁇ , 100e′′′, 100e ⁇ of equal size will be created from the elongated strip 100e. If torn along the centrally extending perforation line 104, two oral patches of equal size will be created, etc.
  • the 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 time and capacity (WATC) are measured according to SS-EN ISO 12625-8:2006, with the modification that after submerging the sample in water, the sample is subjected to a mechanical pressure until wet-through is achieved, which is easily confirmed by visual inspection. 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 active agent and/or flavour.
  • an oral smokeless product wherein the carrier has a dynamic coefficient of friction measured in accordance with ASTM D1894 of 0.6-1.2 on one side and of 0.05-0.3 on the other side.
  • the carrier nonwoven webs as disclosed herein may have a bending length of 10 to 30 cm and a bending stiffness of 200 mNcm to 350 mNcm, as measured according to WSP090.5.R4(12)A , ISO9073-7.
  • a carrier nonwoven web having a bending length and a bending stiffness within the ranges above may be preferred as it aids in accurate punching of the web. Furthermore, a relatively stiff oral patch is easier to handle by a consumer and to apply correctly in the oral cavity.
  • the present disclosure further provides a method for manufacturing an oral smokeless product as disclosed herein, the method comprising:
  • the method may further include:
  • the method may further comprise
  • the liquid flavour solution may be advantageous to apply in a separate step from the step of applying the aqueous solution comprising an active agent to the nonwoven carrier web.
  • the active agent separate from adding flavouring, sweeteners, pH regulators, etc., it has been found to be easier to control the amount of active agent which is applied to the nonwoven carrier web.
  • 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 the flavour solution.
  • Application of the flavour solution may e.g., be made by soaking the nonwoven carrier web in the flavour solution 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 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
  • 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. Alternatively, 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 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
  • the punching or cutting is advantageously performed before application of the active agent, e.g., nicotine.
  • the active agent e.g., nicotine.
  • the active agent e.g., nicotine
  • 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 punching or cutting step may be carried out before application of the liquid flavour solution. Punched-out individual nonwoven products may be impregnated in an impregnation step, for example in an impregnation bath, wherein pressure is applied mechanically by for example a calender roll, followed by a drying step.
  • the impregnation step may be carried out in an ultrasonic cleaner filled with the liquid flavour solution in which the nonwoven is submerged.
  • the ultrasonic vibrations assist in removing trapped air bubbles in the submerged material and facilitates impregnation of the nonwoven.
  • the drying step may be carried out by air-drying on a non-stick surface and the final step may be deposition of an active agent by a multi syringe dispenser or an automated liquid handler dispenser for microfluids, or the like.
  • 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 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 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 smokeless 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 thrown on the ground will degrade and disintegrate over time.
  • the 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 considerable difference in friction with regards to the respective sides may indicate a stay in place property.
  • Extraction tests for nicotine extraction were made on nonwoven patches according to the invention impregnated with nicotine in the amount of 3 mg/patch (NIL 3 mg).
  • the carrier nonwoven material was a wet-laid nonwoven web having a basis weight of 100 g/m 2 and being made of 1.7 dtex viscose fibres bonded with a chemical binder.
  • the patches were leaf-shaped with an average dry weight of 0.17 g per product.
  • the reference products were conventional pouched non-tobacco products: Zyn dry (3 mg nicotine) and Zyn slim (9 mg nicotine) from Swedish Match.
  • 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 5, 15 and 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.
  • NIL 3 mg 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.

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EP21212931.6A 2021-12-07 2021-12-07 Produit oral sans fumée comprenant un agent actif et/ou un arôme Pending EP4193849A1 (fr)

Priority Applications (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
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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Citations (11)

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Publication number Priority date Publication date Assignee Title
AU2012207021A1 (en) 2003-11-07 2012-08-16 U.S. Smokeless Tobacco Company Llc Tobacco compositions
WO2012134380A1 (fr) 2011-03-29 2012-10-04 Chill Of Sweden Ab Sachet contenant de la nicotine sous forme de sel libre
US20160073689A1 (en) * 2014-09-12 2016-03-17 R.J. Reynolds Tobacco Company Nonwoven pouch comprising heat sealable binder fiber
WO2016083463A1 (fr) * 2014-11-25 2016-06-02 Swedish Match North Europe Ab Produit en sachet destiné à être administré par voie orale
US9402414B2 (en) 2013-03-14 2016-08-02 Altria Client Services Llc Smokeless tobacco article
US20170157106A1 (en) 2015-12-03 2017-06-08 Niconovum Usa, Inc. Multi-phase delivery compositions and products incorporating such compositions
WO2017093488A1 (fr) * 2015-12-02 2017-06-08 Swedish Match North Europe Ab Produit à priser oral en sachet
WO2018197454A1 (fr) * 2017-04-24 2018-11-01 Swedish Match North Europe Ab Produit humide et aromatisé à base de nicotine sous forme de sachet pour administration orale comprenant un triglycéride
WO2021099571A1 (fr) * 2019-11-20 2021-05-27 Swedish Match North Europe Ab Produit à base de nicotine en sachet pour administration orale contenant un matériau de remplissage comprenant des particules de nicotine
WO2021116884A1 (fr) * 2019-12-09 2021-06-17 Nicoventures Trading Limited Nappe en couches pour produit en sachet
WO2021219490A1 (fr) * 2020-04-27 2021-11-04 Nonwovenn Ltd Tissu non tissé pour produit en sachet destiné à être administré par voie orale, et procédés de fabrication d'un tissu non tissé

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AU2012207021A1 (en) 2003-11-07 2012-08-16 U.S. Smokeless Tobacco Company Llc Tobacco compositions
WO2012134380A1 (fr) 2011-03-29 2012-10-04 Chill Of Sweden Ab Sachet contenant de la nicotine sous forme de sel libre
US9402414B2 (en) 2013-03-14 2016-08-02 Altria Client Services Llc Smokeless tobacco article
US20160073689A1 (en) * 2014-09-12 2016-03-17 R.J. Reynolds Tobacco Company Nonwoven pouch comprising heat sealable binder fiber
WO2016083463A1 (fr) * 2014-11-25 2016-06-02 Swedish Match North Europe Ab Produit en sachet destiné à être administré par voie orale
WO2017093488A1 (fr) * 2015-12-02 2017-06-08 Swedish Match North Europe Ab Produit à priser oral en sachet
US20170157106A1 (en) 2015-12-03 2017-06-08 Niconovum Usa, Inc. Multi-phase delivery compositions and products incorporating such compositions
WO2018197454A1 (fr) * 2017-04-24 2018-11-01 Swedish Match North Europe Ab Produit humide et aromatisé à base de nicotine sous forme de sachet pour administration orale comprenant un triglycéride
WO2021099571A1 (fr) * 2019-11-20 2021-05-27 Swedish Match North Europe Ab Produit à base de nicotine en sachet pour administration orale contenant un matériau de remplissage comprenant des particules de nicotine
WO2021116884A1 (fr) * 2019-12-09 2021-06-17 Nicoventures Trading Limited Nappe en couches pour produit en sachet
WO2021219490A1 (fr) * 2020-04-27 2021-11-04 Nonwovenn Ltd Tissu non tissé pour produit en sachet destiné à être administré par voie orale, et procédés de fabrication d'un tissu non tissé

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